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full study rank 61796 study protocol section identification module n c t id NCT04831814 org study id info org study id 61355143 organization org full name Prince of Songkla University org class OTHER brief title Narrow Band Imaging in Diagnosis of Colorectal Polyps official title Near-focus Versus Normal-focus Narrow Band Imaging Colonoscopy in Diagnosis of Colorectal Polyps Based on Combined NICE and WASP Classification: a Randomized Controlled Trial status module status verified date March 2021 overall status Completed expanded access info has expanded access No start date struct start date April 4, 2019 start date type Actual primary completion date struct primary completion date July 2, 2020 primary completion date type Actual completion date struct completion date January 14, 2021 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 11, 2021 last update post date struct last update post date May 12, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Nisa Netinatsunton responsible party investigator title Principal Investigation responsible party investigator affiliation Prince of Songkla University lead sponsor lead sponsor name Prince of Songkla University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary polypectomies and to save costs of tissue pathology. NICE (NBI International Colorectal Endoscopic) and WASP (Workgroup on Serrated Polyps and Polyposis) classification were developed for diagnosis of adenomatous and sessile serrated polyps, respectively. detailed description Near-focus (NF) narrow-band imaging (NBI) is an image-magnifying technology which enables optical magnification of up to 65x in near focus (NF) compared with 52x in normal standard focus (SF) with the simple push of a button of the endoscope to be interchangeable between NF and SF. There were few studies comparing diagnostic accuracy between NF and SF in the diagnosis of colorectal polyps. So, our aim of the current study is to compare accuracy of NF NBI compared with SF NBI in the optical diagnosis of neoplastic and non-neoplastic polyp and the accuracy of NF NBI versus SF NBI in distinguishing serrated adenoma from hyperplastic polyp in sessile lesions using histologic evaluation as the gold standard. conditions module condition list condition Colorectal Polyp Colorectal Neoplasms design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 118 enrollment type Actual arms interventions module arm group list arm group arm group label Near Focus NBI arm group type Experimental arm group description Use of the Near Focus NBI to make optical diagnosis arm group intervention list arm group intervention name Diagnostic Test: Near Focus NBI arm group label Standard Focus NBI arm group type Active Comparator arm group description Use of the Standard Focus NBI to make optical diagnosis arm group intervention list arm group intervention name Diagnostic Test: Standard Focus NBI intervention list intervention intervention type Diagnostic Test intervention name Near Focus NBI intervention description Colonoscopy with near focus narrowing band imaging technology . Optical specifications include a 2 mm near field focal depth. Optical diagnosis of polyps were according to NICE and WASP, respectively. intervention arm group label list intervention arm group label Near Focus NBI intervention type Diagnostic Test intervention name Standard Focus NBI intervention description Colonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively. intervention arm group label list intervention arm group label Standard Focus NBI outcomes module primary outcome list primary outcome primary outcome measure Rate of accurate polyp histology predictions by the Endoscopists in the two groups. primary outcome description Measure of the percentage of accurate predictions by the endoscopists in the differentiation of neoplastic from non neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without near focus features primary outcome time frame At the time of procedure primary outcome measure Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups. primary outcome description Measure of the percentage od accurate predictions by the endoscopists in the differentiation of sessile serrated polyps/adenoma from hyperplastic polyps, using the high definition NBI colonoscopy with and without near focus features. primary outcome time frame At the time of procedure secondary outcome list secondary outcome secondary outcome measure The polyp detection rate secondary outcome description The prevalence of patients with at least one polyp was detected secondary outcome time frame At the time of procedure secondary outcome measure The adenoma detection rate secondary outcome description The prevalence of patients with at least one adenoma was detected secondary outcome time frame At the time of procedure secondary outcome measure Diagnostic Characteristics secondary outcome description Compare the diagnostic characteristic (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without near focus features. secondary outcome time frame At the time of procedure eligibility module eligibility criteria Inclusion Criteria: Patients who were scheduled for colonoscopy at NKC institute Exclusion Criteria: Inflammatory bowel disease Polyposis syndrome Colorectal cancer Active gastrointestinal bleeding Pregnant woman Inadequate bowel preparation Contraindication for polyps removal healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name NISA NETINATSUNTON, MD. overall official affiliation NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University overall official role Principal Investigator location list location location facility Prince Songkla University location city Hat Yai location state Songkhla location zip 90110 location country Thailand derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015179 condition mesh term Colorectal Neoplasms condition mesh id D000011127 condition mesh term Polyps condition ancestor list condition ancestor condition ancestor id D000020763 condition ancestor term Pathological Conditions, Anatomical condition ancestor id D000007414 condition ancestor term Intestinal Neoplasms condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000003108 condition ancestor term Colonic Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000012002 condition ancestor term Rectal Diseases condition browse leaf list condition browse leaf condition browse leaf id M17042 condition browse leaf name Colorectal Neoplasms condition browse leaf as found Colorectal Neoplasms condition browse leaf relevance high condition browse leaf id M13163 condition browse leaf name Polyps condition browse leaf as found Polyps condition browse leaf relevance high condition browse leaf id M21672 condition browse leaf name Pathological Conditions, Anatomical condition browse leaf relevance low condition browse leaf id M9600 condition browse leaf name Intestinal Neoplasms condition browse leaf relevance low condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M5488 condition browse leaf name Colonic Diseases condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M13996 condition browse leaf name Rectal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04831814
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full study rank 61660 study protocol section identification module n c t id NCT04833582 org study id info org study id ZN-c3-003 organization org full name K-Group Beta org class INDUSTRY brief title A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma official title A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 1, 2021 start date type Actual primary completion date struct primary completion date August 30, 2023 primary completion date type Anticipated completion date struct completion date December 30, 2023 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date August 9, 2022 last update post date struct last update post date August 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name K-Group Beta lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary This is a phase 1/2 study of ZN-c3 in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma. detailed description This is a phase 1/2 dose escalation and dose expansion study, evaluating the clinical activity and safety, pharmacodynamics, and pharmacokinetics of ZN-c3 in combination with gemcitabine in relapsed or refractory osteosarcoma. conditions module condition list condition Osteosarcoma design module study type Interventional phase list phase Phase 1 Phase 2 design info design allocation N/A design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 84 enrollment type Anticipated arms interventions module arm group list arm group arm group label Combination ZN-c3 with Gemcitabine arm group type Experimental arm group intervention list arm group intervention name Drug: ZN-c3 Drug: Gemcitabine intervention list intervention intervention type Drug intervention name ZN-c3 intervention description ZN-c3 is an investigational drug. intervention arm group label list intervention arm group label Combination ZN-c3 with Gemcitabine intervention type Drug intervention name Gemcitabine intervention description Gemcitabine is an approved drug intervention arm group label list intervention arm group label Combination ZN-c3 with Gemcitabine intervention other name list intervention other name Gemzar outcomes module primary outcome list primary outcome primary outcome measure Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events. primary outcome time frame Through Cycle 1 (21 days) Phase 1 primary outcome measure Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1. primary outcome description EFS at 18 weeks is defined as time from study enrollment until date of disease progression, or detection of disease at a previously uninvolved site, or date of death of the subjects at 18 weeks. primary outcome time frame During phase 2, at 18 weeks secondary outcome list secondary outcome secondary outcome measure Event-free survival (EFS) per RECIST Guideline version 1.1. secondary outcome description EFS is defined as time from study enrollment until date of last contact, date of disease progression, or detection of disease at a previously uninvolved site, or date of death. secondary outcome time frame At 12 months secondary outcome measure Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1. secondary outcome description OS is defined as the time from date of first dosing until the date of death. secondary outcome time frame At 12 months secondary outcome measure The frequency and severity of adverse events (AEs) and laboratory abnormalities per the National Cancer Institute Common Terminology (NCI CTCAE) version 5.0.lities. secondary outcome time frame Through completion, approximately 42 months secondary outcome measure Plasma pharmacokinetics (PK) maximum concentration (Cmax). secondary outcome time frame Through completion, approximately 42 months secondary outcome measure Plasma PK time to maximum concentration (Tmax). secondary outcome time frame Through completion, approximately 42 months secondary outcome measure Area under the plasma concentration versus timepoint curve (AUC last). secondary outcome time frame Through completion, approximately 42 months secondary outcome measure Terminal half-life of the plasma PK concentration. secondary outcome time frame Through completion, approximately 42 months eligibility module eligibility criteria Inclusion Criteria: Age ≥ 12 years at the time of informed consent Bodyweight ≥ 40 kg Histologically documented relapsed or metastatic osteosarcoma. Must have measurable disease according to RECIST Guideline version 1.1 criteria. Adequate hematologic and organ function. Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: Unresolved toxicity of Grade >1 attributed to prior therapies (excluding: Grade ≤2 neuropathy, alopecia, or skin pigmentation) Prior therapy with a WEE1 inhibitor A serious illness or medical condition(s). Pregnant or lactating females. Females of childbearing potential with a positive serum pregnancy test <14 days to Day 1. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid. History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP). Taking medications with a known risk of TdP. Administration of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors. healthy volunteers No gender All minimum age 12 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Project Director central contact role Contact central contact phone (858) 263-4333 central contact e mail [email protected] location list location location facility Site 0106 location status Recruiting location city Los Angeles location state California location zip 90095 location country United States location facility Site 0124 location status Not yet recruiting location city Oakland location state California location zip 94609 location country United States location facility Site 0195 location status Recruiting location city Santa Monica location state California location zip 90403 location country United States location facility Site 0105 location status Recruiting location city New York location state New York location zip 10065 location country United States location facility Site 0107 location status Recruiting location city Cincinnati location state Ohio location zip 45229 location country United States location facility Site 0123 location status Not yet recruiting location city Portland location state Oregon location zip 97239 location country United States location facility Site 0193 location status Not yet recruiting location city Memphis location state Tennessee location zip 38105 location country United States location facility Site 0197 location status Not yet recruiting location city Nashville location state Tennessee location zip 37332 location country United States location facility Site 0103 location status Recruiting location city Houston location state Texas location zip 77030 location country United States location facility Site 0188 location status Recruiting location city Richmond location state Virginia location zip 23298 location country United States location facility Site 0122 location status Recruiting location city Seattle location state Washington location zip 98195 location country United States location facility Site 3604 location status Recruiting location city Bordeaux location zip 33000 location country France location facility Site 3601 location status Not yet recruiting location city Lyon location zip 69008 location country France location facility Site 3602 location status Not yet recruiting location city Marseille location zip 13385 location country France location facility Site 3606 location status Not yet recruiting location city Paris location zip 75248 location country France location facility Site 3605 location status Recruiting location city Toulouse location zip 31100 location country France derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012516 condition mesh term Osteosarcoma condition ancestor list condition ancestor condition ancestor id D000018213 condition ancestor term Neoplasms, Bone Tissue condition ancestor id D000009372 condition ancestor term Neoplasms, Connective Tissue condition ancestor id D000018204 condition ancestor term Neoplasms, Connective and Soft Tissue condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000012509 condition ancestor term Sarcoma condition browse leaf list condition browse leaf condition browse leaf id M14486 condition browse leaf name Osteosarcoma condition browse leaf as found Osteosarcoma condition browse leaf relevance high condition browse leaf id M19511 condition browse leaf name Neoplasms, Bone Tissue condition browse leaf relevance low condition browse leaf id M11469 condition browse leaf name Neoplasms, Connective Tissue condition browse leaf relevance low condition browse leaf id M19502 condition browse leaf name Neoplasms, Connective and Soft Tissue condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M14479 condition browse leaf name Sarcoma condition browse leaf relevance low condition browse leaf id T4340 condition browse leaf name Osteosarcoma condition browse leaf as found Osteosarcoma condition browse leaf relevance high condition browse leaf id T5284 condition browse leaf name Soft Tissue Sarcoma condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id C000056507 intervention mesh term Gemcitabine intervention ancestor list intervention ancestor intervention ancestor id D000000964 intervention ancestor term Antimetabolites, Antineoplastic intervention ancestor id D000000963 intervention ancestor term Antimetabolites intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000000998 intervention ancestor term Antiviral Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M113169 intervention browse leaf name Gemcitabine intervention browse leaf as found Open- intervention browse leaf relevance high intervention browse leaf id M3433 intervention browse leaf name Antimetabolites intervention browse leaf relevance low intervention browse leaf id M3466 intervention browse leaf name Antiviral Agents intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents intervention browse leaf relevance low intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04833582
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full study rank 61910 study protocol section identification module n c t id NCT04830319 org study id info org study id HTLVIDA organization org full name Pedreira, Érika, M.D. org class INDIV brief title Pilates Method in People With HAM/TSP official title Therapeutic Effect of the Pilates Method in People With HAM/TSP: a Randomized Crossover Study status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date February 20, 2018 start date type Actual primary completion date struct primary completion date August 20, 2018 primary completion date type Actual completion date struct completion date March 15, 2020 completion date type Actual study first submit date May 23, 2018 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 1, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Pedreira, Érika, M.D. lead sponsor class INDIV oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Individuals with HTLV-1 secondary myelopathy (HAM/TSP) may have motor and sensory alterations, which may result in reduced functional performance and consequent risk of falls. The aim of the study is to verify the therapeutic effect of a Pilates exercise program on functional performance and risk of falls, when compared to task-oriented training, of people with HAM / TSP. This is a randomized, crossover clinical trial performed with individuals with HAM / TSP who are attended at a referral center who is able to perform gait whether or not to use a walking aid. Amputees, with psychiatric disorders, rheumatic or orthopedic diseases and other associated neurological disorders, which could influence the balance and functional mobility, as well as pregnant women, were excluded. Participants will be submitted to the initial evaluation of functional mobility, balance, gait balance, fatigue, gait endurance, sphincter changes and questioned about the occurrence of falls in the last three months and will answer a semi-structured questionnaire about their conjugality. They will be allocated randomly to two groups. One will perform the Pilates Method protocol and the other task-oriented training. The first group, called test-control group (GTC), will initiate the protocol with exercises of the Pilates method; the control-test group (GCT) will initiate the task-oriented training protocol. A p <0.05 will be considered a statistically significant difference. conditions module condition list condition HAM/TSP HTLV-1 Secondary Myelopathy Balance Gait Balance Functional Mobility design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Investigator enrollment info enrollment count 22 enrollment type Actual arms interventions module arm group list arm group arm group label Test-control group (TCG) arm group type Experimental arm group description The test-control group (TCG) will initiate the protocol with exercises of the Pilates method, which includes exercises in soil, that associate the correct respiratory movement with muscular strengthening and control, stretching from the eccentric movement, selective upper and lower trunk movements. There will be used accessories described by the method for their realization. Participants will perform the first week of awareness and body alignment exercises for 10 minutes, 10 minute breath perception, 10 minute proximal muscle accuracy and control, and 10 minute stretches; from the second week will be included selective trunk movements, with muscle strengthening of lower limbs. Rest intervals will be performed between exercises.After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. The TCG group will then conduct 20 task-oriented training sessions arm group intervention list arm group intervention name Other: Pilates Method Other: task-oriented training protocol arm group label Control-test group (CTG) arm group type Active Comparator arm group description The control-test group (CTG) will initiate the task-oriented training protocol. The task-oriented training protocol will include functional exercise drills, such as sit-up and workout, obstacle course workout, speed-and-direction workout, balance workout, work-up and downhill workout, each tasks performed for eight minutes, with two minutes of rest between them. The difficulty in carrying out the tasks will be progressively adjusted. At all times, individuals will be instructed to contract the pelvic floor musculature. After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. Next, the CTG group will perform 20 sessions of Pilates exercises. arm group intervention list arm group intervention name Other: Pilates Method Other: task-oriented training protocol intervention list intervention intervention type Other intervention name Pilates Method intervention description includes exercises in soil, that associate the correct respiratory movement with muscular strengthening and control, stretching from the eccentric movement, selective upper and lower trunk movements. There will be used accessories described by the method for their realization. Participants will perform the first week of awareness and body alignment exercises for 10 minutes, 10 minute breath perception, 10 minute proximal muscle accuracy and control, and 10 minute stretches; from the second week will be included selective trunk movements, with muscle strengthening of lower limbs. Rest intervals will be performed between exercises. intervention arm group label list intervention arm group label Control-test group (CTG) Test-control group (TCG) intervention type Other intervention name task-oriented training protocol intervention description The control-test group (CTG) will initiate the task-oriented training protocol. The task-oriented training protocol will include functional exercise drills, such as sit-up and workout, obstacle course workout, speed-and-direction workout, balance workout, work-up and downhill workout, each tasks performed for eight minutes, with two minutes of rest between them. The difficulty in carrying out the tasks will be progressively adjusted. At all times, individuals will be instructed to contract the pelvic floor musculature. After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. Next, the CTG group will perform 20 sessions of Pilates exercises. intervention arm group label list intervention arm group label Control-test group (CTG) Test-control group (TCG) outcomes module primary outcome list primary outcome primary outcome measure Balance primary outcome description Berg's Balance Scale (BBS) primary outcome time frame 15 minutes primary outcome measure Functional Mobility primary outcome description Timed up and Go (TUG) primary outcome time frame 3 minutes primary outcome measure Gait Balance primary outcome description Dynamic Gait Index (DGI) primary outcome time frame 10 minutes primary outcome measure Balance primary outcome description Balance Evaluation Systems Test of dynamic balance (mini-BESTest) primary outcome time frame 20 minutes eligibility module eligibility criteria Inclusion Criteria: individuals with probable and/or defined diagnosis of HAM / TSP, according to WHO criteria, of both sexes, aged 18 to 64 years. Exclusion Criteria: individuals with lower limb amputation, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other associated neurological disorders, and those who have difficulty understanding the assessment instruments. healthy volunteers No gender All minimum age 18 Years maximum age 64 Years std age list std age Adult contacts locations module location list location location facility Universidade Católica do Salvador location city Salvador location state Bahia location zip 40000-00 location country Brazil i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013118 condition mesh term Spinal Cord Diseases condition ancestor list condition ancestor condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11459 condition browse leaf name Neoplasm Metastasis condition browse leaf relevance low condition browse leaf id M4286 condition browse leaf name Bone Marrow Diseases condition browse leaf relevance low condition browse leaf id M15067 condition browse leaf name Spinal Cord Diseases condition browse leaf as found Myelopathy condition browse leaf relevance high condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id T2845 condition browse leaf name Human T-cell Leukemia Virus Type 1 condition browse leaf relevance low condition browse leaf id T2840 condition browse leaf name HTLV-1 Associated Myelopathy/tropical Spastic Paraparesis condition browse leaf as found HAM/TSP condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04830319
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full study rank 61476 study protocol section identification module n c t id NCT04835974 org study id info org study id No-reflow phenomenon organization org full name Assiut University org class OTHER brief title the No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI) official title Metabolic Profile as a Predictor of No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI) status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 1, 2021 start date type Anticipated primary completion date struct primary completion date May 1, 2022 primary completion date type Anticipated completion date struct completion date May 2022 completion date type Anticipated study first submit date March 23, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 13, 2021 last update post date struct last update post date April 14, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name El Zahraa Gamal responsible party investigator title Metabolic profile as a predictor of no reflow in diabetic patients treated with primary Percutaneous Coronary Intervention (PCI) . responsible party investigator affiliation Assiut University lead sponsor lead sponsor name Assiut University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary 1- to find metabolic factors that correlate with the development of no reflow phenomenon that may help prevent its occurrence . detailed description Acute myocardial infarction (AMI) with its accompanying adverse sequelae is one of the most common causes of morbidity and mortality in the world . Although reperfusion techniques for ST- elevation myocardial infarction (STEMI ) are constantly improving, no-reflow can still lead to poor prognosis . At present, the exact mechanism of no-reflow remains unclear, but clinical and laboratory findings suggest that it is related to the embolism of the capillary bed, ischemic injury, vascular endothelial dysfunction, production of oxygen free radical , and other factors . The no-reflow phenomenon is one of complications of poor functional and clinical outcomes for patients with (AMI) . The no-reflow phenomenon is present in 25% to 30% of patients with (AMI) underwent successful coronary recanalization, as shown by angiography . The myocardial no-reflow phenomenon is associated with a reducution of antegrade myocardial blood flow inspite of an open infarct-related artery in patients with (STEMI ) undergoing (PCI). Importantly, no-reflow is known to be related to unfavorable clinical outcome and prognosis . The cause of this complex phenomenon is the variable combination of four pathogenetic components: distal atherothrombotic embolization, ischemic injury, reperfusion injury and susceptibility of coronary microcirculation to injury . As a consequence, appropriate strategies are expected to prevent or treat these components are expected to avoid the no-reflow. Coronary reperfusion therapy is widely performed in patients with (AMI) . However, in spite of patency of the infarct-related artery , there is no guarantee of salvage of myocardium at risk of ischemia .The no-reflow phenomenon is found in >30% of patients after thrombolysis or catheter-based (PCI) for (AMI) . It is important, therefore, to be able to predict which lesions are high risk for no reflow before beginning PCI . There are numerous recognized risk factors for the development of coronary artery disease (CAD), one of the best known is the association between blood lipids and CAD . Several prospective studies have established that the risk of cardiac morbidity and mortality is directly related to the concentration of plasma cholesterol. ' The most prevalent view is that the increased risk of myocardial infarction associated with elevated plasma cholesterol levels can be adequately explained on the basis of the increase in number and severity of coronary atherosclerotic vascular lesions . . conditions module condition list condition No-Reflow Phenomenon design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 120 enrollment type Anticipated arms interventions module arm group list arm group arm group label diabetic patients with reflow phenomenon arm group type Experimental arm group description All Assiut University heart Hospital patients ,and who meet the listed inclusion and exclusion criteria will be eligible for the study. Patients' charts will be retrieved based on their intervention procedures. The charts will be reviewed and eligible patients will be filtered. The needed variables will be entered into our data base for later data analysis. arm group intervention list arm group intervention name Diagnostic Test: 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S intervention list intervention intervention type Diagnostic Test intervention name 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S intervention description Blood samples were obtained before PCI, and the following parameters will be measured: LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. Glycemia will be assessed : RBS ( random blood sugar ) . Serum Uric acid : S .UA intervention arm group label list intervention arm group label diabetic patients with reflow phenomenon outcomes module primary outcome list primary outcome primary outcome measure measure serum random blood sugar primary outcome description to detect the correlation between the diabetus mellitus (serum random blood sugar) and no-reflow phenomenon and analysis of this metabolic factors in patient withSTEMI who will undergo primaru PCI and show its effects on no-reflow phenomenon that may help prevent its occurrence . primary outcome time frame baseline secondary outcome list secondary outcome secondary outcome measure measure the serum uric acid secondary outcome description to detect the correlation between the serum uric acid , lipid profile and no-reflow phenomenon and show other metabolic factors effects on no-reflow to avoid its occurance secondary outcome time frame baseline secondary outcome measure measure the lipid profile secondary outcome description to detect the correlation between lipid profile and no-reflow phenomenon secondary outcome time frame baseline eligibility module eligibility criteria Inclusion Criteria: diabetic patients with STEMI treated with primary PCI Exclusion Criteria: non diabetic . with selected PCI (1) a history of an unprotected left main artery with severe liver and kidney diseases or coronary artery bypass grafting . (2) patients who had valvular disease or cardiomyopathy . (3) severe dissection, thromboembolism in other parts, or vasospasm; and known malignancy . (4) patients with contraindications for anticoagulant therapy, such as active visceral hemorrhage, hemorrhagic stroke, or ischemic stroke within half a year (including transient ischemic attack), or aortic dissection, or patients with hematological diseases complicated with coagulation disorders . healthy volunteers Accepts Healthy Volunteers gender All std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name alzahraa gamal, master central contact role Contact central contact phone 01026181748 central contact e mail [email protected] central contact name hatem abdel elrahman central contact role Contact central contact phone 01005212162 central contact e mail [email protected] references module reference list reference reference p m i d 6683937 reference type background reference citation Bernstein JM, Lee J, Conboy K, Ellis E, Li P. The role of IgE mediated hypersensitivity in recurrent otitis media with effusion. Am J Otol. 1983 Jul;5(1):66-9. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000054318 condition mesh term No-Reflow Phenomenon condition ancestor list condition ancestor condition ancestor id D000007511 condition ancestor term Ischemia condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M26773 condition browse leaf name No-Reflow Phenomenon condition browse leaf as found No-Reflow Phenomenon condition browse leaf relevance high condition browse leaf id M9695 condition browse leaf name Ischemia condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16429 intervention browse leaf name Uric Acid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04835974
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full study rank 61749 study protocol section identification module n c t id NCT04832425 org study id info org study id PRAX-114-213 organization org full name Praxis Precision Medicines org class INDUSTRY brief title A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder official title A Phase 2/3 Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of PRAX-114 in Participants With Major Depressive Disorder status module status verified date July 2022 overall status Completed expanded access info has expanded access No start date struct start date March 30, 2021 start date type Actual primary completion date struct primary completion date May 5, 2022 primary completion date type Actual completion date struct completion date May 5, 2022 completion date type Actual study first submit date March 19, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 20, 2022 last update post date struct last update post date July 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Praxis Precision Medicines lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary This is a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of PRAX-114 in participants with moderate to severe major depressive disorder (MDD). Participants will be randomized to receive 28 days of either 40 mg PRAX-114 or placebo in a 1:1 ratio. conditions module condition list condition Major Depressive Disorder keyword list keyword Mood Disorders Depressive Disorder Depression Depressive Disorder, Unipolar Depressive Symptoms Agents, GABA Receptors, GABA-A Allosteric Regulation design module study type Interventional phase list phase Phase 2 Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 216 enrollment type Actual arms interventions module arm group list arm group arm group label PRAX-114 arm group type Experimental arm group description 40 mg PRAX-114 once daily arm group intervention list arm group intervention name Drug: PRAX-114 arm group label Placebo arm group type Placebo Comparator arm group description Placebo once daily arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name PRAX-114 intervention description 40 mg once daily intervention arm group label list intervention arm group label PRAX-114 intervention type Drug intervention name Placebo intervention description Placebo once daily intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Change from baseline in 17-Item Hamilton Depression Rating Scale (HAM-D17) total score at Day 15 primary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. primary outcome time frame 15 days secondary outcome list secondary outcome secondary outcome measure Change from baseline in HAM-D17 total score at Day 29 secondary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. secondary outcome time frame 29 days secondary outcome measure Change from baseline in HAM-D17 total score at all other time points secondary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. secondary outcome time frame 8 days, 22 days, 36 days, and 43 days secondary outcome measure Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 15 and all other time points secondary outcome description The CGI-S assesses the clinician's impression of the participant's current depression symptoms. The clinician should use his/her total clinical experience with this patient population and rate the current severity of the participant's mental illness on a 7-point scale from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Clinical Global Impression-Improvement (CGI-I) score at Day 15 and all other time points secondary outcome description The CGI-I assesses the participant's improvement (or worsening). The clinician is required to assess the participant's condition relative to Baseline (Day 1) on a 7-point scale from 1 (Very much improved) to 7 (Very much worse). secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure HAM-D17 response (reduction from baseline score of ≥50%) at Day 15, Day 29, and all other time points secondary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure HAM-D17 remission (total score of ≤7) at Day 15, Day 29, and all other time points secondary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Change from baseline in the Symptoms of Depression Questionnaire (SDQ) total and sub-scale scores at Day 15 and all other time points secondary outcome description The SDQ is a 44-item, self-report scale assessing the severity of symptoms across several subtypes of depression. Items are scored on a 7-point scale (ranging from 1 to 6). The SDQ total score is the sum of all 44 item scores and ranges from 44 to 264 with higher scores indicating worse symptoms. secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Patient Global Impression-Improvement (PGI-I) score at Day 15 and all other time points secondary outcome description The PGI-I scale is a global self-assessment used to rate the response of a participant's condition to therapy or intervention. It consists of 1 question that asks the participant to rate their current condition compared to how it was prior to beginning treatment on a scale of 1 (very much better) to 7 (very much worse). secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Change from baseline in the Work and Social Adjustment Scale (WSAS) at Day 15 and all other time points secondary outcome description The WSAS assesses the degree to which mental health problems interfere with day-to-day functioning in 5 domains: work, social leisure activities, private leisure activities, home- management, and personal relationships. The WSAS total score is the sum of the 5 item scores and ranges from 0 to 40, with higher scores indicating poorer adjustment. secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Change from baseline in the 12-Item Short Form Survey (SF-12) at Day 15 and all other time points secondary outcome description The SF-12 is composed of 12 questions covering 8 dimensions of health: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Total scores range from 0 (worse health) to 100 (better health). secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Incidence and severity of Adverse Events (AE) secondary outcome description An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study drug, whether or not considered related to the study drug. secondary outcome time frame 43 days secondary outcome measure Incidence of AEs by preferred term secondary outcome description The incidence of AEs will be reported by preferred term, including any terms related to clinically significant changes in body temperature, pulse rate, respiratory rate, blood pressure (systolic and diastolic), clinical laboratory measures (chemistry, hematology, urinalysis, and coagulation), and electrocardiogram parameters (heart rate, PR, QRS, QT, and corrected QT intervals). secondary outcome time frame Up to 43 days secondary outcome measure Incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicidal ideation or behavior secondary outcome description The C-SSRS is composed of 5 yes/no questions addressing suicidal behavior and 5 yes/no questions addressing suicidal ideation, with sub-questions assessing the severity. Incidence is measured as the number of "yes" answers indicating the presence of suicidal ideation or behavior. secondary outcome time frame Up to 43 days eligibility module eligibility criteria Inclusion Criteria: Recurrent MDD diagnosis with a current episode duration of at least 8 weeks and no more than 24 months. HAM-D17 total score of ≥23 at Screening and Baseline. Body mass index (BMI) between 18 and 38 kg/m2 (inclusive). Exclusion Criteria: Lifetime history of seizures, including febrile seizures. Neurodegenerative disorder (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, or Huntington's disease). Lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive compulsive disorder or a history of a psychotic mood episode in last 2 years. Any current psychiatric disorder (other than MDD). Lifetime history of treatment resistant depression. Received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) within the last year or transcranial magnetic stimulation (TMS) within the last 6 months prior to Screening. Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name VP, Clinical Development overall official affiliation Praxis Precision Medicines overall official role Study Director location list location location facility Praxis Research Site location city Phoenix location state Arizona location zip 85012 location country United States location facility Praxis Research Site location city Garden Grove location state California location zip 92845 location country United States location facility Praxis Research Site location city Lafayette location state California location zip 94549 location country United States location facility Praxis Research Site location city Lemon Grove location state California location zip 91945 location country United States location facility Praxis Research Site location city Oceanside location state California location zip 92056 location country United States location facility Praxis Research Site location city Pico Rivera location state California location zip 90660 location country United States location facility Praxis Research Site location city Redlands location state California location zip 92374 location country United States location facility Praxis Research Site location city Jacksonville location state Florida location zip 32256 location country United States location facility Praxis Research Site location city Orange City location state Florida location zip 32763 location country United States location facility Praxis Research Site location city Orlando location state Florida location zip 32801 location country United States location facility Praxis Research Site location city Atlanta location state Georgia location zip 30331 location country United States location facility Praxis Research Site location city Decatur location state Georgia location zip 30030 location country United States location facility Praxis Research Site location city Chicago location state Illinois location zip 60076 location country United States location facility Praxis Research Site location city Gaithersburg location state Maryland location zip 20877 location country United States location facility Praxis Research Site location city Worcester location state Massachusetts location zip 01655 location country United States location facility Praxis Research Site location city O'Fallon location state Missouri location zip 63368 location country United States location facility Praxis Research Site location city Las Vegas location state Nevada location zip 89102 location country United States location facility Praxis Research Site location city Berlin location state New Jersey location zip 08009 location country United States location facility Praxis Research Site location city Marlton location state New Jersey location zip 08053 location country United States location facility Praxis Research Site location city Cedarhurst location state New York location zip 11516 location country United States location facility Praxis Research Site location city Rochester location state New York location zip 14618 location country United States location facility Praxis Research Site location city Staten Island location state New York location zip 10312 location country United States location facility Praxis Research Site location city Dayton location state Ohio location zip 45417 location country United States location facility Praxis Research Site location city Allentown location state Pennsylvania location zip 18104 location country United States location facility Praxis Research Site location city Media location state Pennsylvania location zip 19063 location country United States location facility Praxis Research Site location city Memphis location state Tennessee location zip 38119 location country United States location facility Praxis Research Site location city Austin location state Texas location zip 78737 location country United States location facility Praxis Research Site location city San Antonio location state Texas location zip 78229 location country United States location facility Praxis Research Site location city Charlottesville location state Virginia location zip 22903 location country United States location facility Praxis Research Site location city Everett location state Washington location zip 98201 location country United States location facility Praxis Research Site location city Noble Park location state Victoria location zip 3174 location country Australia i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004194 condition mesh term Disease condition mesh id D000003866 condition mesh term Depressive Disorder condition mesh id D000003863 condition mesh term Depression condition mesh id D000003865 condition mesh term Depressive Disorder, Major condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000019964 condition ancestor term Mood Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depressive Disorder condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf as found Depressive Disorder condition browse leaf relevance high condition browse leaf id M6212 condition browse leaf name Depressive Disorder, Major condition browse leaf as found Major Depressive Disorder condition browse leaf relevance high condition browse leaf id M20988 condition browse leaf name Mood Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M225603 intervention browse leaf name Pramoxine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04832425
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full study rank 61330 study protocol section identification module n c t id NCT04837872 org study id info org study id 17-0241 organization org full name University of Colorado, Denver org class OTHER brief title Static Progressive Splinting in the Management of Knee Stiffness Following Total Knee Arthroplasty official title Static Progressive Splinting in the Management of Knee Stiffness Following Total Knee Arthroplasty status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date May 25, 2017 start date type Actual primary completion date struct primary completion date February 27, 2018 primary completion date type Actual completion date struct completion date February 12, 2019 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 13, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Colorado, Denver lead sponsor class OTHER collaborator list collaborator collaborator name Panorama Orthopedics & Spine Center collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to determine the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following total knee arthroplasty (TKA). Data from this trial will be utilized in a NIH grant application for a larger randomized controlled trial directly comparing static progressive splinting to manipulation under anesthesia (MUA) which is the current standard of care for knee stiffness after TKA. detailed description Total knee arthroplasty (TKA) is the standard of care to manage the pain and disability associated with end-stage knee osteoarthritis, with more than 700,000 TKA surgeries performed annually in the United States. Knee stiffness, commonly caused by arthrofibrosis, is an infrequent, but debilitating complication of TKA, with an incidence upwards of 5% postoperatively. As a predominant failure mechanism, knee stiffness accounts for 28% of hospital readmissions due to surgical complications within 90 days of discharge, and 10% of all revisions within 5 years of initial surgery within the United States. With the incidence of TKA projected to reach 3.5 million by 2030, the growing cohort of TKA patients with postoperative knee stiffness provides an important target for research. Several treatments for knee stiffness have been described including static progressive splinting and manipulation under anesthesia (MUA). To date, no studies have compared the use of static progressive splinting in the early management of individuals presenting with knee stiffness after TKA to more commonly utilized surgical procedures such as MUA. Witvrouw and colleagues compared a computer-controlled passive motion device to MUA for individuals with knee stiffness after TKA and found that stretching device had similar outcomes to MUA in terms of range of motion (ROM) and self-reported pain, stiffness and function. A key limitation of this study is that the computer-controlled motion device is not commercially available and therefore translation of this technology into practice is unlikely. However, this study does demonstrate that conservative stretching techniques may be as efficacious as costlier surgical techniques as well as may cause fewer adverse events such as quadriceps tendon rupture and fractures. Only one study to date has examined the utilization of static progressive splinting after TKA. In this study, they enrolled patients who had already failed MUA and conservative physical therapy management strategies. They found that the average ROM increase for patients was 25° as well as 92% of patients were satisfied with the results and no complications occurred with use of the device. Key limitations to this study are the lack of a comparison group as well as static progressive splinting was utilized after MUA had already failed. It is unknown how individuals would respond to this treatment compared to MUA. Therefore, the purpose of our study is to determine the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following TKA within the current surgical practice of Dr. Jared Foran at Panorama Orthopedics & Spine Center. Data from this trial will be utilized in a NIH grant application for a larger randomized controlled trial directly comparing static progressive splinting to MUA which is the current standard of care for knee stiffness after TKA. conditions module condition list condition Arthroplasty, Replacement, Knee keyword list keyword static progressive splinting manual therapy physical therapy rehabilitation arthrofibrosis design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 10 enrollment type Actual arms interventions module arm group list arm group arm group label Multimodal Physical Therapy (MPT) arm group type Experimental arm group description The multimodal physical therapy (MPT) program consisted of manual therapy, therapeutic exercise, and utilization of a static progressive splint (Joint Active Systems SPS Knee, Effingham, IL). Although the primary focus of this study was on improving knee flexion ROM, two protocols were developed: one to improve flexion deficits and one to improve extension deficits. Participants in the MPT group received physical therapy 2x per week for 4 weeks. They were instructed to use the static progressive splint(s) 3x per day for 30 minute sessions (90 minutes total per day) for each splint (e.g., 90 minutes for flexion splint, 90 minutes for extension splint). arm group intervention list arm group intervention name Other: Multimodal Physical Therapy (MPT) intervention list intervention intervention type Other intervention name Multimodal Physical Therapy (MPT) intervention description Individualized physical therapy and static progressive splint (flexion with or without extension splint). intervention arm group label list intervention arm group label Multimodal Physical Therapy (MPT) outcomes module primary outcome list primary outcome primary outcome measure Range of Motion primary outcome description Passive knee flexion and extension measured with goniometry primary outcome time frame 4 weeks secondary outcome list secondary outcome secondary outcome measure Adherence to Splint Use secondary outcome description Adherence to splint use was tracked with a log completed by participants; they were instructed to place a checkmark for each day they used the JAS splint per protocol (30-minute sessions, 3 times daily). Adherence was calculated as days of splint use completed divided by days of splint use prescribed; a priori adherence levels were considered acceptable if the mean was ≥ 80 percent. secondary outcome time frame 4 weeks secondary outcome measure Satisfaction with Splint secondary outcome description Satisfaction was assessed with a 7-point Likert scale ranging from 1 "extremely dissatisfied" to 7 "extremely satisfied". Participants responded based on the following instruction: please rate your satisfaction with your knee splint on the scale. A priori satisfaction was considered acceptable if the median score was ≥ 4 ("somewhat satisfied" or higher). secondary outcome time frame 4 weeks secondary outcome measure Safety of splint use: adverse events secondary outcome description Count and description of adverse events related to splint use secondary outcome time frame 4 weeks eligibility module eligibility criteria Inclusion Criteria: Undergone a unilateral primary Total Knee Arthroplasty (TKA) for end-stage osteoarthritis Knee stiffness in the first 6 weeks post-operative defined as knee flexion < 100 degrees Exclusion Criteria: Preoperative knee range of motion less than 15-110 degrees Intraoperative (closed) range of motion < 0-120 degrees Radiographic signs of heterotopic ossification Misaligned components or component-related failures of knee prosthesis that could be responsible for difficulties with motion Signs and symptoms consistent with joint infection Signs and symptoms consistent with complex regional pain syndrome healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Panorama Orthopedics & Spine Center location city Golden location state Colorado location zip 80401 location country United States references module reference list reference reference p m i d 16490357 reference type background reference citation Yercan HS, Sugun TS, Bussiere C, Ait Si Selmi T, Davies A, Neyret P. Stiffness after total knee arthroplasty: prevalence, management and outcomes. Knee. 2006 Mar;13(2):111-7. Epub 2006 Feb 20. reference p m i d 23954423 reference type background reference citation Schroer WC, Berend KR, Lombardi AV, Barnes CL, Bolognesi MP, Berend ME, Ritter MA, Nunley RM. Why are total knees failing today? Etiology of total knee revision in 2010 and 2011. J Arthroplasty. 2013 Sep;28(8 Suppl):116-9. doi: 10.1016/j.arth.2013.04.056. Epub 2013 Aug 15. reference p m i d 23645339 reference type background reference citation Schairer WW, Vail TP, Bozic KJ. What are the rates and causes of hospital readmission after total knee arthroplasty? Clin Orthop Relat Res. 2014 Jan;472(1):181-7. doi: 10.1007/s11999-013-3030-7. reference p m i d 17403800 reference type background reference citation Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. reference p m i d 19826784 reference type background reference citation Bonutti PM, Marulanda GA, McGrath MS, Mont MA, Zywiel MG. Static progressive stretch improves range of motion in arthrofibrosis following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2010 Feb;18(2):194-9. doi: 10.1007/s00167-009-0947-1. Epub 2009 Oct 14. reference p m i d 25513992 reference type background reference citation Manrique J, Gomez MM, Parvizi J. Stiffness after total knee arthroplasty. J Knee Surg. 2015 Apr;28(2):119-26. doi: 10.1055/s-0034-1396079. Epub 2014 Dec 16. reference p m i d 22864680 reference type background reference citation Witvrouw E, Bellemans J, Victor J. Manipulation under anaesthesia versus low stretch device in poor range of motion after TKA. Knee Surg Sports Traumatol Arthrosc. 2013 Dec;21(12):2751-8. doi: 10.1007/s00167-012-2152-x. Epub 2012 Aug 3. reference p m i d 35337388 reference type derived reference citation Rauzi MR, Foran JRH, Bade MJ. Multimodal conservative management of arthrofibrosis after total knee arthroplasty compared to manipulation under anesthesia: a feasibility study with retrospective cohort comparison. Pilot Feasibility Stud. 2022 Mar 25;8(1):71. doi: 10.1186/s40814-022-01026-y. see also link list see also link see also link label Most Frequent Operating Room Procedures Performed in U.S. Hospitals, 2003-2012 see also link u r l http://www.hcup-us.ahrq.gov/reports/statbriefs/sb186-Operating-Room-Procedures-United-States-2012.jsp i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022
NCT04837872
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full study rank 61292 study protocol section identification module n c t id NCT04838366 org study id info org study id Carbohydrateloading organization org full name Armed Police Force Hospital, Nepal org class OTHER_GOV brief title Effect of Preoperative Carbohydrate Loading in Femur Fracture official title The Effect of Pre-operative Carbohydrate Loading in Femur Fracture: A Randomized Controlled Trial status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date June 1, 2021 start date type Actual primary completion date struct primary completion date July 30, 2021 primary completion date type Actual completion date struct completion date August 1, 2021 completion date type Actual study first submit date April 3, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date May 16, 2022 last update post date struct last update post date May 20, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Dev Ram Sunuwar responsible party investigator title Dietitian/Researcher responsible party investigator affiliation Armed Police Force Hospital, Nepal lead sponsor lead sponsor name Armed Police Force Hospital, Nepal lead sponsor class OTHER_GOV oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Femur fracture is very common in older people. It makes the people bedridden for long time at hospital. The fracture of femur is generally managed by the surgical procedure. Prolonged fasting for surgery makes the patients harassed physically as well as mentally. The long fasting state emphasizes the body more in catabolic state which increases the insulin resistivity. Pre-operative carbohydrate loading before two hours the surgery has been launched in practice to overcome these problems in the world context, however it is not in existence in Nepal. The aim of the study is to evaluate the effect of pre-operative carbohydrate loading in the case of femur fracture surgery. This study utilize a hospital based randomized control trial study design to assess the effect of carbohydrate loading before two hours the surgery over the completely fasting state. A representative sample size of 66 patients (control group =33 and study group =33) aged 50 years and above having femur fracture planned for surgery will be selected for research. The pre-operative nutritional status will be identified and the post-operative outcomes will be measured by Visual Analogue Score (VAS) and Cumulative Ambulatory Score (CAS). Statistical analysis will be performed using chi square test, independent sample t-test or Mann-Whitney U test to compare between the outcome of study groups and control groups. The outcome of the study may provide a platform to the anaesthesiologists and surgeons towards the emerging concept of pre-operative carbohydrate loading practice in Orthopedics surgery in Nepal. detailed description Femur fracture is one of the most common cause for hospital stay in the case of elder people. Besides these, the patients have the stress of surgery. According to existing practice, the patients are kept in fasting state from the midnight that makes the patients physically as well as mentally discomfort. The patients go in the catabolic state. In addition to these, the prevalence of malnutrition in older people having hip fracture ranges from 2% to 63%. Now the new concept has been launched that the patients should be fed 50 gram carbohydrate two hours prior to the surgery, called carbohydrate loading. The study reveals that preoperative carbohydrate loading decreases the insulin resistance and improves metabolic functions. It presents the patients in anabolic state rather than catabolic state, resulting in the less post-operative protein and nitrogen loss, which facilitates the wound healing. It improves the recovery rate, and hence decreases the length of post-operative stay at hospital, that brings the smile in the face of patients and reduces the treatment cost too. Similarly, it is also associated with significantly better well-being. In Nepal, there is the practice of giving anesthesia to the patient in complete fasting state. The prolonged fasting state adds the harassment in the patients. Now, the practice of preoperative carbohydrate loading before two hours of surgery is preferred in the world context to minimize the problem of patients discomfort and to maximize better outcome. However, this type of trend is not practiced in Nepal. Furthermore, the issue of nutrition is not prioritized in orthopedics in Nepal. So, this study will also evaluate the nutritional status of the patients under study to relate with the outcomes. The sample size will be calculated based on the previous similar study with a Mean + SE of Cumulative Ambulatory score (Study groups Vs Control groups: 12.76 + 0.33 Vs 12.02 + 0.32). Considering this data with taking α level of significance at 5% and power of 80%, the sample size will be calculated using test comparing independent two means in Stata/MP version 14.1 (StataCorp LP, College Station, Texas). The calculated sample size is 60. To take into account with 10% loss through follow-up and drop out, the total sample size will be 66 (33 participants in each group.) conditions module condition list condition Femur Fracture keyword list keyword Femur fracture Carbohydrate loading Visual Analogue Score (VAS) Cumulative Ambulatory Score (CAS) design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Participants will be randomized in a 1:1 ratio, and assigned into study group and control group randomly through computer generated block randomization. design primary purpose Supportive Care design masking info design masking None (Open Label) enrollment info enrollment count 66 enrollment type Actual arms interventions module arm group list arm group arm group label Intervention arm group type Experimental arm group description The study group will be intervened with carbohydrate loading as the protocol made by ERAS(Li et al., 2021). We will provide glucose-D. arm group intervention list arm group intervention name Dietary Supplement: Carbohydrate loading arm group label Usual care arm group type No Intervention arm group description The control group will be kept in fasting condition from midnight as a traditional practice in existence. intervention list intervention intervention type Dietary Supplement intervention name Carbohydrate loading intervention description study group will be intervened with carbohydrate loading as the protocol made by ERAS(Li et al., 2021). Surgical patients will be asked to drink a beverage containing 100 grams carbohydrate the night before surgery. On the day of surgery, patients will drink a beverage containing 50 grams carbohydrate 2 hours before surgery under the supervision of research team member. We will provide glucose-D (Dabur Nepal Private Limited, Bara, Nepal, (Regd No.: 3506/045/046, DFTQC No.: 01-33-55-03-218). intervention arm group label list intervention arm group label Intervention outcomes module primary outcome list primary outcome primary outcome measure wellbeing of the patients primary outcome description The visual analog scale (VAS) will be used to evaluate the well-being of the patients (pain, thirst, and hungry) after surgery. The VAS scores will be recorded on the morning of the first and second postoperative day (24, and 48 hours post-operative, respectively) for groups. primary outcome time frame One week primary outcome measure Functional mobility of the patients primary outcome description The Cumulative Ambulatory Score (CAS) will be applied to find out the mobility function after surgery. The CAS scores will be recorded on the morning of the first, second, and third postoperative day (24, 48, and 72 hours post-operative, respectively) for both groups. primary outcome time frame One week secondary outcome list secondary outcome secondary outcome measure Change serum albumin level secondary outcome description Serum albumin level will be assessed after surgery for both groups secondary outcome time frame One week eligibility module eligibility criteria Inclusion Criteria: • Patients of age 50 years and above with femur fracture scheduled for surgery under spinal anesthesia Exclusion Criteria: Pre-existing diabetes (Type I or II) Previous intolerance to carbohydrate drinks Pathological fracture or any suspected pathology Failure case of surgery or non-union case healthy volunteers Accepts Healthy Volunteers gender All minimum age 50 Years std age list std age Adult Older Adult contacts locations module location list location location facility Dev Ram Sunuwar location city Kathmandu location state Bagmati location zip +977 location country Nepal references module reference list reference reference p m i d 24417824 reference type result reference citation Bilku DK, Dennison AR, Hall TC, Metcalfe MS, Garcea G. Role of preoperative carbohydrate loading: a systematic review. Ann R Coll Surg Engl. 2014 Jan;96(1):15-22. doi: 10.1308/003588414X13824511650614. Review. reference p m i d 22035956 reference type result reference citation Breedveld-Peters JJ, Reijven PL, Wyers CE, van Helden S, Arts JJ, Meesters B, Prins MH, van der Weijden T, Dagnelie PC. Integrated nutritional intervention in the elderly after hip fracture. A process evaluation. Clin Nutr. 2012 Apr;31(2):199-205. doi: 10.1016/j.clnu.2011.10.004. Epub 2011 Oct 28. reference p m i d 33731057 reference type result reference citation Li ZE, Lu SB, Kong C, Sun WZ, Wang P, Zhang ST. Comparative short-term outcomes of enhanced recovery after surgery (ERAS) program and non-ERAS traditional care in elderly patients undergoing lumbar arthrodesis: a retrospective study. BMC Musculoskelet Disord. 2021 Mar 17;22(1):283. doi: 10.1186/s12891-021-04166-z. reference p m i d 29786478 reference type result reference citation From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO), Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rüfenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. reference p m i d 36042436 reference type derived reference citation Chaudhary NK, Sunuwar DR, Sharma R, Karki M, Timilsena MN, Gurung A, Badgami S, Singh DR, Karki P, Bhandari KK, Pradhan PMS. The effect of pre-operative carbohydrate loading in femur fracture: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Aug 30;23(1):819. doi: 10.1186/s12891-022-05766-z. see also link list see also link see also link label Chada, R. R., Maryada, V. R., Mulpur, P., Reddy, A., & Maska, A. (2019). Does Preoperative Carbohydrate Loading Help Outcomes in Total Knee Replacement Surgery? J Nutri Med Diet Care, 5(1), 36. see also link u r l https://clinmedjournals.org/articles/jnmdc/journal-of-nutritional-medicine-and-diet-care-jnmdc-5-036.pdf i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000050723 condition mesh term Fractures, Bone condition mesh id D000005264 condition mesh term Femoral Fractures condition ancestor list condition ancestor condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition ancestor id D000007869 condition ancestor term Leg Injuries condition browse leaf list condition browse leaf condition browse leaf id M25523 condition browse leaf name Fractures, Bone condition browse leaf as found Fracture condition browse leaf relevance high condition browse leaf id M7554 condition browse leaf name Femoral Fractures condition browse leaf as found Femur Fracture condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M10033 condition browse leaf name Leg Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions
NCT04838366
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full study rank 61645 study protocol section identification module n c t id NCT04833777 org study id info org study id Bio2640 organization org full name University of Saskatchewan org class OTHER brief title Does a Different Local Anesthetic Improve Pain After Carpal Tunnel Release? official title Does Addition of Longer-acting Local Anesthetic Improve the Post-operative Pain After Carpal Tunnel Release? A Randomized Controlled Study status module status verified date July 2021 overall status Recruiting expanded access info has expanded access No start date struct start date July 1, 2021 start date type Actual primary completion date struct primary completion date April 1, 2023 primary completion date type Anticipated completion date struct completion date April 1, 2023 completion date type Anticipated study first submit date March 26, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date July 10, 2021 last update post date struct last update post date July 16, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name David Sauder responsible party investigator title Principal Investigator, orthopedic surgeon responsible party investigator affiliation University of Saskatchewan lead sponsor lead sponsor name University of Saskatchewan lead sponsor class OTHER collaborator list collaborator collaborator name Saskatoon City Hospital collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study is being conducted to determine whether addition of a longer-acting local anesthetic to our current anesthetic protocol improves the post-operative pain after carpal tunnel release. Participants undergoing carpal tunnel release (CTR) will be randomly assigned to one of two groups: the standard anesthetic or the longer-acting anesthetic. Participants will not be aware of their assignment. Carpal tunnel release will be performed in the standard fashion at our hospital. Participants will record their post-operative pain on a visual scale at 2, 4, 6, 8, and 10 hours after surgery. They will also record the location of their post-operative numbness at the same time intervals. The day after surgery, a research nurse will call each participant to inquire about their post-operative pain scores and numbness. Participants will also be asked about their consumption of oral painkillers (e.g. Tylenol, ibuprofen) during the first 24 hours. Participants will be re-assessed 3 months after surgery to evaluate improvement in carpal tunnel symptoms. Participants who wish to have carpal tunnel release on both wrists will be randomized to receive one type of anesthetic for the first side and will receive the other anesthetic for the second side. They will not be made aware of which medication is used for each side. This will allow us to directly compare the difference in pain experience between the two anesthetics. We hypothesize that use of a longer-acting local anesthetic will lead to decreased post-operative pain, especially in the first 4-8 hours after surgery. detailed description A research nurse will meet with each patient presenting for outpatient CTR surgery at the Saskatoon City Hospital procedure room. He or she will obtain informed consent for interested participants. The patient will be assigned a subject number and be randomized to standard vs. bupivacaine treatment based on a computer algorithm. Participants will complete the Boston Carpal Tunnel Questionnaire as a baseline for comparison as well as a brief questionnaire on demographics. For those patients that are having both sides released during the study period, the first side will be randomized based on the study protocol and the second side will be anesthetized with the other treatment. They will be blinded to both procedures such that we can directly compare their operative experience. The surgeon will draw up and mix the pre-determined local anesthetic (LA) for each patient based on the randomization protocol. The research nurse (who will be performing all assessments) and the patient will remain blinded to the type of anesthetic. The two types of anesthetic will be: 10 mL 1% lidocaine with 1:100,000 epinephrine and 1 mL 8.4% sodium bicarbonate (standard treatment) 5 mL 1% lidocaine with 1:100,000 epinephrine + 5 mL 0.5% bupivacaine with 1:100,000 epinephrine and 1 mL 8.4% sodium bicarbonate (bupivacaine treatment) The participants will be anesthetized in the standard fashion, with all 11 mL of LA infiltrated subcutaneously into the area of the incision. After a delay of 20-40 minutes, the CTR will be carried out using the standard mini-open approach. Patients will be provided with the standard post-operative instructions regarding activity and wound care. After the procedure, participants will complete a short questionnaire (VAS) about any pain experienced during the administration of the local anesthetic and during the procedure. Patients will be sent home with instructions to complete a pain and numbness assessment at 2, 4, 6, 8, and 10 hours after surgery. They will be provided with a form containing the VAS and the times at which they are to self-administer this pain scoring system. Additionally, they will be provided with 20 Tylenol tablets (325mg each) and 20 ibuprofen tablets (200mg each), with instructions to take 1-2 tablets of one or both analgesics every 6 hours as needed during the first 24 hours. They will be asked to document the times at which they took the medications, as well as the dosages taken. They will be asked to refrain from using other types of pain medications, if possible. They will also be asked to document use of any other analgesics including Cannabis. Any questions will be answered by the research nurse before leaving clinic. The day after surgery, at the 24 hour mark, the research nurse will call each patient and inquire about their pain scores and numbness at 2, 4, 6, 8, and 10 hours, as well as the present time (24 hours). He or she will also ask about the number of Tylenol and/or ibuprofen pills taken during the first 24 hours, as well as the timing of consumption. This information recorded on a password-protected datasheet which contains only the subject number (no identifiers). The patient will return for their standard follow-ups. At 3 months, the research nurse will repeat the Boston Carpal Tunnel Questionnaire to assess outcome. At this time, if the patient wishes, they may be unblinded. For patients wishing for bilateral CTR, the first will be performed according to the randomization protocol as described above. The contralateral CTR will be performed 2-8 weeks later (as standard in our practice), with the alternate anesthetic (e.g. first CTR with standard treatment, second CTR with bupivacaine treatment). The same post-operative assessment will be performed for the second CTR. Patients will remain blinded to their type of anesthetic in each wrist until 3 months after the second surgery is performed. At that time, they will be asked by the research nurse whether the first or second surgery provided a better pain experience. Only after this will they be unblinded, if desired. conditions module condition list condition Carpal Tunnel Syndrome keyword list keyword lidocaine bupivacaine carpal tunnel release design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Single Group Assignment design intervention model description The study model for the primary outcome will be single group (patients randomized to one of two anesthetic types). However, select patients who wish to have bilateral carpal tunnel release will be entered into a crossover model, such that they will be randomized for their first surgery and receive the other type of anesthetic for their second surgery. design primary purpose Treatment design masking info design masking Double design masking description The surgeon administering the local anesthetic will not be blinded, however the participant and the research nurse (measuring outcomes) will be. design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 140 enrollment type Anticipated arms interventions module arm group list arm group arm group label Lidocaine arm group type Active Comparator arm group description Administration of subcutaneous lidocaine as local anesthetic prior to carpal tunnel release (lidocaine intervention) arm group intervention list arm group intervention name Drug: Local Anesthetics Lidocaine arm group label Bupivacaine arm group type Experimental arm group description Administration of subcutaneous bupivacaine + lidocaine as local anesthetic prior to carpal tunnel release (bupivacaine intervention) arm group intervention list arm group intervention name Drug: Local Anesthetics Bupivacaine intervention list intervention intervention type Drug intervention name Local Anesthetics Lidocaine intervention description 10 mL 1% lidocaine with 1:100,000 epinephrine and 1 mL 8.4% sodium bicarbonate intervention arm group label list intervention arm group label Lidocaine intervention type Drug intervention name Local Anesthetics Bupivacaine intervention description 5 mL 1% lidocaine with 1:100,000 epinephrine + 5 mL 0.5% bupivacaine with 1:100,000 epinephrine and 1 mL 8.4% sodium bicarbonate intervention arm group label list intervention arm group label Bupivacaine outcomes module primary outcome list primary outcome primary outcome measure Post-operative pain primary outcome description Severity of pain as measured by the Visual Analogue Scale primary outcome time frame 2 hours post-op primary outcome measure Post-operative pain primary outcome description Severity of pain as measured by the Visual Analogue Scale primary outcome time frame 4 hours post-op primary outcome measure Post-operative pain primary outcome description Severity of pain as measured by the Visual Analogue Scale primary outcome time frame 6 hours post-op primary outcome measure Post-operative pain primary outcome description Severity of pain as measured by the Visual Analogue Scale primary outcome time frame 8 hours post-op primary outcome measure Post-operative pain primary outcome description Severity of pain as measured by the Visual Analogue Scale primary outcome time frame 10 hours post-op primary outcome measure Post-operative pain primary outcome description Severity of pain as measured by the Visual Analogue Scale primary outcome time frame 24 hours post-op primary outcome measure Post-operative analgesia primary outcome description Number of Tylenol and Ibuprofen tablets taken post-operatively primary outcome time frame 24 hours secondary outcome list secondary outcome secondary outcome measure Post-operative numbness secondary outcome description Location of total and partial post-operative numbness in hand (thumb, index, middle, ring, little finger) secondary outcome time frame 2 hours post-op secondary outcome measure Post-operative numbness secondary outcome description Location of total and partial post-operative numbness in hand (thumb, index, middle, ring, little finger) secondary outcome time frame 4 hours post-op secondary outcome measure Post-operative numbness secondary outcome description Location of total and partial post-operative numbness in hand (thumb, index, middle, ring, little finger) secondary outcome time frame 6 hours post-op secondary outcome measure Post-operative numbness secondary outcome description Location of total and partial post-operative numbness in hand (thumb, index, middle, ring, little finger) secondary outcome time frame 8 hours post-op secondary outcome measure Post-operative numbness secondary outcome description Location of total and partial post-operative numbness in hand (thumb, index, middle, ring, little finger) secondary outcome time frame 10 hours post-op secondary outcome measure Post-operative numbness secondary outcome description Location of total and partial post-operative numbness in hand (thumb, index, middle, ring, little finger) secondary outcome time frame 24 hours post-op secondary outcome measure Symptom change at 3 months secondary outcome description Carpal tunnel symptoms at 3 months post-op, measured by the Boston Carpal Tunnel Questionnaire secondary outcome time frame pre-operative (immediately before surgery), 3 months after surgery secondary outcome measure Preference of anesthetic type secondary outcome description For patients with bilateral surgery only (they will have received a different anesthetic for each surgery). Patients will indicate their preference of lidocaine vs bupivacaine on a simple questionnaire asking which anesthetic provided a preferable post-operative pain experience. secondary outcome time frame 3 months after second surgery eligibility module eligibility criteria Inclusion Criteria: Patients aged >18 years undergoing carpal tunnel release Exclusion Criteria: Patients aged <18 years Patients undergoing repeat carpal tunnel release Patients undergoing simultaneous procedures for other hand/wrist pathology at the time of carpal tunnel release (i.e. trigger finger release, Dupuytren's, etc.) Patients with a history of Rheumatoid Arthritis or a history or previous trauma or surgery to the local area (i.e. distal radius fracture) Patients who lack the capacity to provide informed consent or understand the nature of the project healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name David Sauder, MD central contact role Contact central contact phone 306-955-9800 central contact e mail [email protected] overall official list overall official overall official name David Sauder, MD overall official affiliation University of Saskatchewan overall official role Principal Investigator location list location location facility Saskatoon City Hospital location status Recruiting location city Saskatoon location state Saskatchewan location zip S7K 0M7 location country Canada location contact list location contact location contact name David Sauder, MD location contact role Contact location contact phone 306-955-9800 location contact e mail [email protected] i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002349 condition mesh term Carpal Tunnel Syndrome condition ancestor list condition 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intervention browse leaf relevance low intervention browse leaf id M22330 intervention browse leaf name Sodium Channel Blockers intervention browse leaf relevance low intervention browse leaf id M29178 intervention browse leaf name Diuretics, Potassium Sparing intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev AnArAg intervention browse branch name Anti-Arrhythmia Agents intervention browse branch abbrev ChanBlk intervention browse branch name Channel Blockers intervention browse branch abbrev VaCoAg intervention browse branch name Vasoconstrictor Agents intervention browse branch abbrev Resp intervention browse branch name Respiratory System Agents
NCT04833777
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full study rank 61807 study protocol section identification module n c t id NCT04831671 org study id info org study id A095899 organization org full name Cambridge University Hospitals NHS Foundation Trust org class OTHER brief title MRI Assessment of Cartilage Damage in Tibial Nailing official title A Pilot Randomised Prospective Comparison of Two Approaches for Tibial Nailing Using Clinical and Novel Imaging Outcome Measures status module status verified date May 2022 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date April 1, 2022 start date type Actual primary completion date struct primary completion date October 2023 primary completion date type Anticipated completion date struct completion date October 2023 completion date type Anticipated study first submit date March 26, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 11, 2022 last update post date struct last update post date May 12, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mr Andrew Carrothers responsible party investigator title Consultant Trauma and Orthopaedic Surgeon responsible party investigator affiliation Cambridge University Hospitals NHS Foundation Trust lead sponsor lead sponsor name Cambridge University Hospitals NHS Foundation Trust lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Fractures of the tibia (shin bone) are frequently treated with a metal nail that is passed down the inside of the bone (an intra-medullary nail). This nail is inserted through the top of the tibia at the level of the knee joint. There are two ways for the nail to be inserted - either through an incision below the patella (kneecap) or above the patella. The benefit of the incision above the patella is that it can make it technically easier to insert the nail into the correct position. However, the perceived risk of damage to the knee cartilage has prevented this technique from being widely adopted. The investigators will use MRI scanning to assess the cartilage for damage using both techniques. The results will enable the investigators to determine if the theoretical risk of cartilage damage is found in real-world scenarios and to generate data for further, larger studies. detailed description Intra-medullary nailing is a common form of treatment for a variety of tibial shaft fractures. Traditionally this has been done via an infra-patella approach. More recently the use of a supra-patella approach has become more popular. However, there are concerns that the supra-patella approach may cause unacceptable damage to the cartilage of the patello-femoral joint (PFJ). This study will use a novel MRI technique developed at the University of Cambridge to compare the amount of damage caused to the knee joint by both infra- and supra-patella nailing techniques. Specific cartilage assessment sequences will enable a fuller assessment of cartilage damage than can be achieved with normal structural sequences. Participants will also be asked to complete Patient Reported Outcome Measures (PROMs) regarding their injury to assess their clinical outcome. Infra-patella and supra-patella nailing techniques are now both routine methods of carrying out intra-medullary nailing of the tibia. Further evidence is required, however, in order to fully assess whether one method is superior to the other. conditions module condition list condition Tibial Fractures keyword list keyword MRI Cartilage Damage Surgical Techniques design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) design masking description It is not possible to mask participants or investigators as the surgical interventions in each arm will have different scars, making blinding impossible. enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label Infra-patella nailing arm group type Active Comparator arm group description Participants will have their closed tibial shaft fracture treated with an intra-medullary nail inserted through an infra-patella approach. arm group intervention list arm group intervention name Other: Surgical Approach - Infra-patella nailing arm group label Supra-patella nailing arm group type Experimental arm group description Participants will have their closed tibial shaft fracture treated with an intra-medullary nail inserted through an supra-patella approach. arm group intervention list arm group intervention name Other: Surgical Approach - Supra-patella nailing intervention list intervention intervention type Other intervention name Surgical Approach - Infra-patella nailing intervention description The intra-medullary nail will be introduced via an infra-patella incision. intervention arm group label list intervention arm group label Infra-patella nailing intervention type Other intervention name Surgical Approach - Supra-patella nailing intervention description The intra-medullary nail will be introduced via a supra-patella incision. intervention arm group label list intervention arm group label Supra-patella nailing outcomes module primary outcome list primary outcome primary outcome measure Change in cartilage appearance by MRI Assessment primary outcome description Change in cartilage appearance of the ipsilateral knee using MRI scanning primary outcome time frame Pre-intervention, Day 1 post operatively, 6 months secondary outcome list secondary outcome secondary outcome measure Change in Lysholm Knee Score secondary outcome description Change in Lysholm Knee Score (Scored 0-100, higher scores are better) secondary outcome time frame Pre-intervention, 6 weeks, 12 weeks, 6 months secondary outcome measure Change in Tegner Activity Scale secondary outcome description Change in Tegner Activity Scale (Scored 0-10, higher scores are move active) secondary outcome time frame Pre-intervention, 6 weeks, 12 weeks, 6 months secondary outcome measure Change in EQ-5D-5L secondary outcome description Change in EQ-5D-5L (EuroQol 5 Dimension 5 Level) (Each domain scored 1-5, lower scores are better) secondary outcome time frame Pre-interventional , 6 weeks, 12 weeks, 6 months other outcome list other outcome other outcome measure Bony Union of Fracture other outcome description Bony union will be assessed by plain radiograph other outcome time frame 6 weeks other outcome measure Bony Union of Fracture other outcome description Bony union will be assessed by plain radiograph other outcome time frame 12 weeks other outcome measure Bony Union of Fracture other outcome description Bony union will be assessed by plain radiograph other outcome time frame 6 months other outcome measure Post-operative Complications other outcome description Post operative complications will be recorded other outcome time frame up to 6 months other outcome measure Return to work/employment status other outcome description Patient return to normal activity will be recorded other outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria: Closed tibial shaft fracture suitable for intramedullary nailing Able to consent Able to undergo MRI scanning Able to attend follow up for 6 months post operatively Suitable for surgery Exclusion Criteria: Polytrauma Ipsilateral acute ligamentous knee injury A contra-indication to MRI scanning healthy volunteers No gender All minimum age 18 Years maximum age 50 Years std age list std age Adult contacts locations module overall official list overall official overall official name Andrew Carrothers, FRCS (Tr & Orth) overall official affiliation Cambridge University Hospitals NHS Foundation Trust overall official role Principal Investigator location list location location facility Addenbrooke's Hospital location city Cambridge location state Cambridgeshire location zip CB2 0QQ location country United Kingdom i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013978 condition mesh term Tibial Fractures condition ancestor list condition ancestor condition ancestor id D000050723 condition ancestor term Fractures, Bone condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition ancestor id D000007869 condition ancestor term Leg Injuries condition browse leaf list condition browse leaf condition browse leaf id M25523 condition browse leaf name Fractures, Bone condition browse leaf relevance low condition browse leaf id M15889 condition browse leaf name Tibial Fractures condition browse leaf as found Tibial Fractures condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M10033 condition browse leaf name Leg Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions
NCT04831671
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full study rank 61728 study protocol section identification module n c t id NCT04832698 org study id info org study id 2020-0071 secondary id info list secondary id info secondary id NCI-2020-06610 secondary id type Registry Identifier secondary id domain CTRP (Clinical Trial Reporting Program) secondary id 2020-0071 secondary id type Other Identifier secondary id domain M D Anderson Cancer Center organization org full name M.D. Anderson Cancer Center org class OTHER brief title Survey of Current Interventional and Diagnostic Imaging Residents After Participation in Endovascular Simulator Training official title Survey of Current Interventional and Diagnostic Imaging Residents After Participation in Endovascular Simulator Training Regimen status module status verified date September 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 8, 2020 start date type Actual primary completion date struct primary completion date January 1, 2023 primary completion date type Anticipated completion date struct completion date January 1, 2023 completion date type Anticipated study first submit date September 15, 2020 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date September 22, 2022 last update post date struct last update post date September 26, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name M.D. Anderson Cancer Center lead sponsor class OTHER collaborator list collaborator collaborator name National Cancer Institute (NCI) collaborator class NIH oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study looks at the comfort of interventional and diagnostic imaging residents in performing simulated endovascular procedures after completing training on the Mentice endovascular simulator device. Implementation of a training curriculum with radiology residents interested in interventional radiology will help facilitate hands-on training in a low-risk environment and allow for safer future patient encounters. detailed description PRIMARY OBJECTIVE: I. To measure trainee comfort performing simulated endovascular procedures after completing training on the Mentice endovascular simulator device. OUTLINE: Participants complete a survey over 10 minutes before and after completing training and using the Mentice endovascular simulator device. conditions module condition list condition Malignant Vascular Neoplasm design module study type Observational design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 9 enrollment type Anticipated arms interventions module arm group list arm group arm group label Observational (survey administration) arm group description Participants complete a survey over 10 minutes before and after completing training and using the Mentice endovascular simulator device. arm group intervention list arm group intervention name Other: Survey Administration intervention list intervention intervention type Other intervention name Survey Administration intervention description Complete survey intervention arm group label list intervention arm group label Observational (survey administration) outcomes module primary outcome list primary outcome primary outcome measure Trainees' feelings about using simulation to help with procedural training primary outcome description Will measure how trainees feel about using simulation to help with procedural training, and how comfortable trainees feel performing various endovascular procedures after undergoing training on the Mentice simulator machine. primary outcome time frame through study completion, an average of 1 year eligibility module eligibility criteria Inclusion Criteria: Current interventional and diagnostic radiology residents participating in the training curriculum on the Mentice Endovascular Simulator will be eligible to participate in the survey healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Current interventional and diagnostic radiology residents participating in the training curriculum on the Mentice Endovascular Simulator at MD Anderson Cancer Center. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Joshua D Kuban central contact role Contact central contact phone 713-792-1846 central contact e mail [email protected] overall official list overall official overall official name Joshua D Kuban overall official affiliation M.D. Anderson Cancer Center overall official role Principal Investigator location list location location facility M D Anderson Cancer Center location status Recruiting location city Houston location state Texas location zip 77030 location country United States location contact list location contact location contact name Joshua D. Kuban location contact role Contact location contact phone 713-792-1846 location contact e mail [email protected] location contact name Joshua D. Kuban location contact role Principal Investigator references module see also link list see also link see also link label MD Anderson Cancer Center Website see also link u r l http://www.mdanderson.org derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000019043 condition mesh term Vascular Neoplasms condition mesh id D000009383 condition mesh term Neoplasms, Vascular Tissue condition ancestor list condition ancestor condition ancestor id D000012983 condition ancestor term Soft Tissue Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition browse leaf list condition browse leaf condition browse leaf id M11480 condition browse leaf name Neoplasms, Vascular Tissue condition browse leaf as found Vascular Neoplasm condition browse leaf relevance high condition browse leaf id M20221 condition browse leaf name Vascular Neoplasms condition browse leaf as found Vascular Neoplasm condition browse leaf relevance high condition browse leaf id M14937 condition browse leaf name Soft Tissue Neoplasms condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases
NCT04832698
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full study rank 61861 study protocol section identification module n c t id NCT04830969 org study id info org study id STUDY00000962 organization org full name State University of New York at Buffalo org class OTHER brief title Impact of Periodontal Therapy on Patients With Diabetes official title Impact of Periodontal Therapy on Patients With Diabetes: A Pilot Study acronym DMRCT status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date November 8, 2016 start date type Actual primary completion date struct primary completion date January 28, 2021 primary completion date type Actual completion date struct completion date January 28, 2021 completion date type Actual study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 14, 2021 last update post date struct last update post date April 19, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Robert Schifferle, DDS, PhD responsible party investigator title Principal Investigator responsible party investigator affiliation State University of New York at Buffalo lead sponsor lead sponsor name State University of New York at Buffalo lead sponsor class OTHER collaborator list collaborator collaborator name Sunstar, Inc. collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export No description module brief summary With poorly controlled diabetes, periodontal status often worsens, and with severe periodontal conditions there is often poorer glycemic control. There are few published reports investigating the efficacy of periodontal therapy in diabetics and fewer that include evaluation of the oral microbial profiles (the microbiome). The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial of participants with and without diabetes and with periodontal disease. Two different treatments will be used: Scaling and root planning (SRP) alone, or SRP and supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks) The main goal of this clinical trial is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status in participants. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of new therapies for periodontal disease and diabetes. detailed description With poorly controlled diabetes, periodontal disease worsens, and with severe periodontal conditions, there is often poorer glycemic control. Published papers conclude that periodontal treatment leads to a reduction in hemoglobin A1c; however, other studies show limited or no improvement. Some patients do not respond well to professional periodontal therapy, even without diabetes, which could be related to poor oral hygiene and/or host factors including microbial profiles. There are few published papers investigating the efficacy of periodontal therapy in diabetics and fewer that include assessment of the oral microbiome. The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial. It has been shown that chlorhexidine gluconate rinse leads to significant clinical improvement over standard periodontal therapy alone, and interdental tooth cleaners remove more dental plaque (leading to reduced gingival inflammation) effectively than brushing alone. Therefore, in this study, standard periodontal therapy, scaling and root planning (SRP) will be provided alone, or SRP plus supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks), to diabetics and non-diabetics with periodontal disease to determine the differences in response between the groups. The main aim of this study is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status of subjects with and without type 2 diabetes and with periodontal disease. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of novel new targeted therapies of both periodontal disease and diabetes. conditions module condition list condition Diabetes Mellitus, Type II Periodontitis design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Care Provider Investigator Outcomes Assessor enrollment info enrollment count 104 enrollment type Actual arms interventions module arm group list arm group arm group label A: Diabetic + SRP + SPT arm group type Experimental arm group description The first group, A, includes diabetics with periodontal disease; they will receive standard therapy, scaling & root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. arm group intervention list arm group intervention name Drug: Chlorhexidine gluconate oral rinse Procedure: Scaling & Root Planing Device: Soft Picks arm group label B: Non-Diabetic + SRP + SPT arm group type Experimental arm group description The second group, B, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling & root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. arm group intervention list arm group intervention name Drug: Chlorhexidine gluconate oral rinse Procedure: Scaling & Root Planing Device: Soft Picks arm group label C: Diabetic + SRP arm group type Active Comparator arm group description The third group, C, includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). arm group intervention list arm group intervention name Procedure: Scaling & Root Planing arm group label D: Non-Diabetic + SRP arm group type Active Comparator arm group description The second group, D, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). arm group intervention list arm group intervention name Procedure: Scaling & Root Planing intervention list intervention intervention type Drug intervention name Chlorhexidine gluconate oral rinse intervention description Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops. intervention arm group label list intervention arm group label A: Diabetic + SRP + SPT B: Non-Diabetic + SRP + SPT intervention other name list intervention other name Paroex intervention type Procedure intervention name Scaling & Root Planing intervention description SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. intervention arm group label list intervention arm group label A: Diabetic + SRP + SPT B: Non-Diabetic + SRP + SPT C: Diabetic + SRP D: Non-Diabetic + SRP intervention other name list intervention other name SRP intervention type Device intervention name Soft Picks intervention description Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores. intervention arm group label list intervention arm group label A: Diabetic + SRP + SPT B: Non-Diabetic + SRP + SPT outcomes module primary outcome list primary outcome primary outcome measure Change in Probing pocket depth at the 6-month post-SRP completed at Baseline primary outcome description Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured primary outcome time frame Baseline to 6 months secondary outcome list secondary outcome secondary outcome measure Changes in Bleeding on Probing at 3, 6, 9,12 months after treatment at Baseline secondary outcome description 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. secondary outcome time frame Baseline to 3 months; Baseline to 6 months; Baseline to 9 months; Baseline to 12 months secondary outcome measure Changes in Clinical attachment level at 3, 6, 9,12 months after treatment at Baseline secondary outcome description The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive. secondary outcome time frame Baseline to 3 months; Baseline to 6 months; Baseline to 9 months; Baseline to 12 months secondary outcome measure Changes in Gingival Index at 3, 6, 9,12 months after treatment at Baseline secondary outcome description Gingival index is determined on 6 sites of all teeth present, except for the third molars. 0 is the absence of inflammation, 1 is the presence of inflammation (redness). secondary outcome time frame Baseline to 3 months; Baseline to 6 months; Baseline to 9 months; Baseline to 12 months secondary outcome measure Change in Plaque Index at 3, 6, 9,12 months after treatment at Baseline secondary outcome description Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. secondary outcome time frame Baseline to 3 months; Baseline to 6 months; Baseline to 9 months; Baseline to 12 months secondary outcome measure Change in Probing Pocket Depth at 3, 6, 9, and 12 months after treatment secondary outcome description Probing depth (PD) or probing pocket depth (PPD), measured on six surfaces/tooth, is the distance in millimeters (mm) from the gingival margin to the base of the gingival pocket secondary outcome time frame Baseline to 3 months; Baseline to 6 months; Baseline to 9 months; Baseline to 12 months secondary outcome measure Changes in Hemoglobin A1c at 3, 6, and 12 months after treatment secondary outcome description Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes. secondary outcome time frame Baseline to 3 months; Baseline to 6 months; Baseline to 12 months secondary outcome measure Changes in Fasting blood glucose at 3, 6, and 12 months after treatment secondary outcome description Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes. secondary outcome time frame Baseline to 3 months; Baseline to 6 months; Baseline to 12 months secondary outcome measure Change in insulin at 3, 6, and 12 months after treatment secondary outcome description Insulin is measured in a fasting state from a blood draw and indicates the body's baseline resistance or sensitivity to insulin. It is used to monitor the amount of insulin produced and identify insulin resistance. If the level is low (less than 2 mcUnit/mL) it means not enough insulin is being produced; if the level is high (more than 20 mcUnit/mL) it indicates diabetes and insulin resistance (or another metabolic disorder). secondary outcome time frame Baseline to 3 months; Baseline to 6 months; Baseline to 12 months secondary outcome measure Change in high sensitivity C-reactive protein at 3, 6, and 12 months after treatment secondary outcome description The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause secondary outcome time frame Baseline to 3 months; Baseline to 6 months; Baseline to 12 months secondary outcome measure Change in the subgingival plaque microbiome after periodontal treatment in group with SRP alone versus SRP + SPT. secondary outcome description Recent data indicate that the oral microbiome has essential functions in maintaining oral and systemic health. However, there is not much information available, and there are not many published reports investigating the benefits of periodontal therapy on the microbiome in diabetics. We think the microbiome influences clinical response to periodontal therapy and systemic changes showing improvement in diabetes status. We will examine the subgingival plaque microbiome in the four groups of participants. We will compare the different kinds and numbers of bacteria before and after the two treatments (SRP alone versus SRP+SPT (use of a mouthrinse and Soft Picks)) of periodontitis in diabetics and non-diabetics. secondary outcome time frame Baseline to 3 months; Baseline to 6 months; Baseline to 12 months secondary outcome measure Change in the salivary microbiome after periodontal treatment in group with SRP alone versus SRP + SPT secondary outcome description Recent data indicate that the oral microbiome has essential functions in maintaining oral and systemic health. However, there is not much information available, and there are not many published reports investigating the benefits of periodontal therapy on the microbiome in diabetics. We think the microbiome influences clinical response to periodontal therapy and systemic changes showing improvement in diabetes status. We will examine the salivary microbiome in the four groups of participants. We will compare the different kinds and numbers of bacteria before and after the two treatments (SRP alone versus SRP+SPT (use of a mouthrinse and Soft Picks)) of periodontitis in diabetics and non-diabetics. secondary outcome time frame Baseline to 3 months; Baseline to 6 months; Baseline to 12 months secondary outcome measure Change in the gut microbiome after periodontal treatment in group with SRP alone versus SRP + SPT secondary outcome description Recent data indicate that the oral microbiome has essential functions in maintaining oral and systemic health. In addition, there is not much information about how the gut (intestinal) microbiome influences general and oral health especially in periodontitis and diabetics. We think the gut microbiome may change after periodontal therapy is provided and after systemic changes showing improvement in diabetes status occur. We will examine the gut microbiome in the four groups of participants. We will compare the different kinds and numbers of bacteria before and after the two treatments of periodontitis (SRP alone versus SRP+SPT (use of a mouthrinse and Soft Picks)) in diabetics and non-diabetics. secondary outcome time frame Baseline to 3 months; Baseline to 6 months; Baseline to 12 months eligibility module eligibility criteria Inclusion Criteria: Be able to understand the informed consent form and be willing and able to read and sign it. At least 25 years of age. Be able to understand and follow directions for study procedures. At least 14 natural teeth, not counting third molars ("wisdom teeth"). At least 2 interproximal sites with CAL >= 4 mm or at least 2 interproximal sites with PD >= 5 mm. Exclusion Criteria: Presence of orthodontic appliances ("braces"). An abnormal condition of lips, lining of the mouth, tongue, or gums (except for periodontal disease). If subject has a cold sore, canker sore, or injury in their mouth, they may return after the sore or injury heals. Abscess of the gingiva caused by periodontal disease, or visible gross tooth decay A broken tooth root or an abscessed tooth. Subject may be allowed to participate in the study after the condition is successfully treated. Periodontal treatment or antibiotic therapy in the past 6 months. Have used cigarettes or other tobacco products in the past year. Body mass index (BMI) is > 40. Have regularly used non-steroidal anti-inflammatory drugs (such as >= 325 mg aspirin or ibuprofen) over the past 3 weeks. Regularly using drugs that weaken the immune system (such as corticosteroids taken by mouth or injection, and cyclosporine). Have participated in another clinical research study in the past 30 days. Pregnant or breastfeeding. Have a condition that we feel will make study participation unsafe or difficult for the patient. Require premedication for dental exams. healthy volunteers No gender All minimum age 25 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Robert E Schifferle, DDS, PhD overall official affiliation University at Buffalo, State University of New York overall official role Principal Investigator location list location location facility University at Buffalo location city Buffalo location state New York location zip 14214 location country United States references module reference list reference reference p m i d 2209317 reference type background reference citation Nelson RG, Shlossman M, Budding LM, Pettitt DJ, Saad MF, Genco RJ, Knowler WC. Periodontal disease and NIDDM in Pima Indians. Diabetes Care. 1990 Aug;13(8):836-40. doi: 10.2337/diacare.13.8.836. reference p m i d 9527565 reference type background reference citation Taylor GW, Burt BA, Becker MP, Genco RJ, Shlossman M, Knowler WC, Pettitt DJ. Non-insulin dependent diabetes mellitus and alveolar bone loss progression over 2 years. J Periodontol. 1998 Jan;69(1):76-83. doi: 10.1902/jop.1998.69.1.76. reference p m i d 24708451 reference type background reference citation Arora N, Papapanou PN, Rosenbaum M, Jacobs DR Jr, Desvarieux M, Demmer RT. Periodontal infection, impaired fasting glucose and impaired glucose tolerance: results from the Continuous National Health and Nutrition Examination Survey 2009-2010. J Clin Periodontol. 2014 Jul;41(7):643-52. doi: 10.1111/jcpe.12258. Epub 2014 May 25. reference p m i d 23631575 reference type background reference citation Engebretson S, Kocher T. Evidence that periodontal treatment improves diabetes outcomes: a systematic review and meta-analysis. J Periodontol. 2013 Apr;84(4 Suppl):S153-69. doi: 10.1902/jop.2013.1340017. reference p m i d 23106512 reference type background reference citation Sgolastra F, Severino M, Pietropaoli D, Gatto R, Monaco A. Effectiveness of periodontal treatment to improve metabolic control in patients with chronic periodontitis and type 2 diabetes: a meta-analysis of randomized clinical trials. J Periodontol. 2013 Jul;84(7):958-73. doi: 10.1902/jop.2012.120377. Epub 2012 Oct 29. reference p m i d 24346989 reference type background reference citation Engebretson SP, Hyman LG, Michalowicz BS, Schoenfeld ER, Gelato MC, Hou W, Seaquist ER, Reddy MS, Lewis CE, Oates TW, Tripathy D, Katancik JA, Orlander PR, Paquette DW, Hanson NQ, Tsai MY. The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial. JAMA. 2013 Dec 18;310(23):2523-32. doi: 10.1001/jama.2013.282431. reference p m i d 25234213 reference type background reference citation Borgnakke WS, Chapple IL, Genco RJ, Armitage G, Bartold PM, D'Aiuto F, Eke PI, Giannobile WV, Kocher T, Kornman KS, Lang NP, Madianos PN, Murakami S, Nishimura F, Offenbacher S, Preshaw PM, Rahman AU, Sanz M, Slots J, Tonetti MS, Van Dyke TE. The multi-center randomized controlled trial (RCT) published by the journal of the American Medical Association (JAMA) on the effect of periodontal therapy on glycated hemoglobin (HbA1c) has fundamental problems. J Evid Based Dent Pract. 2014 Sep;14(3):127-32. doi: 10.1016/j.jebdp.2014.04.017. Epub 2014 May 21. reference p m i d 19722792 reference type background reference citation Colombo AP, Boches SK, Cotton SL, Goodson JM, Kent R, Haffajee AD, Socransky SS, Hasturk H, Van Dyke TE, Dewhirst F, Paster BJ. Comparisons of subgingival microbial profiles of refractory periodontitis, severe periodontitis, and periodontal health using the human oral microbe identification microarray. J Periodontol. 2009 Sep;80(9):1421-32. doi: 10.1902/jop.2009.090185. reference p m i d 22324467 reference type background reference citation Colombo AP, Bennet S, Cotton SL, Goodson JM, Kent R, Haffajee AD, Socransky SS, Hasturk H, Van Dyke TE, Dewhirst FE, Paster BJ. Impact of periodontal therapy on the subgingival microbiota of severe periodontitis: comparison between good responders and individuals with refractory periodontitis using the human oral microbe identification microarray. J Periodontol. 2012 Oct;83(10):1279-87. doi: 10.1902/jop.2012.110566. Epub 2012 Feb 10. reference p m i d 25398868 reference type background reference citation Kirst ME, Li EC, Alfant B, Chi YY, Walker C, Magnusson I, Wang GP. Dysbiosis and alterations in predicted functions of the subgingival microbiome in chronic periodontitis. Appl Environ Microbiol. 2015 Jan;81(2):783-93. doi: 10.1128/AEM.02712-14. Epub 2014 Nov 14. reference p m i d 23673380 reference type background reference citation Wang J, Qi J, Zhao H, He S, Zhang Y, Wei S, Zhao F. Metagenomic sequencing reveals microbiota and its functional potential associated with periodontal disease. Sci Rep. 2013;3:1843. doi: 10.1038/srep01843. reference p m i d 25074492 reference type background reference citation Perez-Chaparro PJ, Goncalves C, Figueiredo LC, Faveri M, Lobao E, Tamashiro N, Duarte P, Feres M. Newly identified pathogens associated with periodontitis: a systematic review. J Dent Res. 2014 Sep;93(9):846-58. doi: 10.1177/0022034514542468. Epub 2014 Jul 29. reference p m i d 1524682 reference type background reference citation Beiswanger BB, Mallat ME, Jackson RD, Mau MS, Farah CF, Bosma ML, Bollmer BW, Hancock EB. Clinical effects of a 0.12% chlorhexidine rinse as an adjunct to scaling and root planing. J Clin Dent. 1992;3(2):33-8. reference p m i d 16965522 reference type background reference citation Faveri M, Gursky LC, Feres M, Shibli JA, Salvador SL, de Figueiredo LC. Scaling and root planing and chlorhexidine mouthrinses in the treatment of chronic periodontitis: a randomized, placebo-controlled clinical trial. J Clin Periodontol. 2006 Nov;33(11):819-28. Epub 2006 Sep 11. reference p m i d 24407549 reference type background reference citation Abouassi T, Woelber JP, Holst K, Stampf S, Doerfer CE, Hellwig E, Ratka-Kruger P. Clinical efficacy and patients' acceptance of a rubber interdental bristle. A randomized controlled trial. Clin Oral Investig. 2014 Sep;18(7):1873-80. doi: 10.1007/s00784-013-1164-3. Epub 2014 Jan 10. reference p m i d 23305133 reference type background reference citation Santos VR, Lima JA, Miranda TS, Goncalves TE, Figueiredo LC, Faveri M, Duarte PM. Full-mouth disinfection as a therapeutic protocol for type-2 diabetic subjects with chronic periodontitis: twelve-month clinical outcomes: a randomized controlled clinical trial. J Clin Periodontol. 2013 Feb;40(2):155-62. doi: 10.1111/jcpe.12040. i p d sharing statement module i p d sharing No annotation section annotation module unposted annotation unposted responsible party Robert Schifferle, DDS, PhD, Principal Investigator, State University of New York at Buffalo unposted event list unposted event unposted event type Release unposted event date July 12, 2022 unposted event type Reset unposted event date August 11, 2022 unposted event type Release unposted event date October 20, 2022 unposted event type Reset unposted event date November 15, 2022 derived section misc info module version holder December 02, 2022 submission tracking submission info list submission info submission release date July 12, 2022 submission reset date August 11, 2022 submission release date October 20, 2022 submission reset date November 15, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010518 condition mesh term Periodontitis condition mesh id D000003920 condition mesh term Diabetes Mellitus condition mesh id D000003924 condition mesh term Diabetes Mellitus, Type 2 condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000010510 condition ancestor term Periodontal Diseases condition ancestor id D000009059 condition ancestor term Mouth Diseases condition ancestor id D000009057 condition ancestor term Stomatognathic Diseases condition browse leaf list condition browse leaf condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes condition browse leaf relevance high condition browse leaf id M12579 condition browse leaf name Periodontitis condition browse leaf as found Periodontitis condition browse leaf relevance high 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Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC07 condition browse branch name Mouth and Tooth Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000002710 intervention mesh term Chlorhexidine intervention mesh id C000010882 intervention mesh term Chlorhexidine gluconate intervention ancestor list intervention ancestor intervention ancestor id D000000891 intervention ancestor term Anti-Infective Agents, Local intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention ancestor id D000004202 intervention ancestor term Disinfectants intervention ancestor id D000003879 intervention ancestor term Dermatologic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M5105 intervention browse leaf name Chlorhexidine intervention browse leaf as found Of 2 intervention browse leaf relevance high intervention browse leaf id M344698 intervention browse leaf name Chlorhexidine gluconate intervention browse leaf as found Prolonged intervention browse leaf relevance high intervention browse leaf id M3367 intervention browse leaf name Anti-Infective Agents, Local intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents intervention browse leaf relevance low intervention browse leaf id M6535 intervention browse leaf name Disinfectants intervention browse leaf relevance low intervention browse leaf id M6226 intervention browse leaf name Dermatologic Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Derm intervention browse branch name Dermatologic Agents
NCT04830969
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full study rank 61412 study protocol section identification module n c t id NCT04836806 org study id info org study id STUDY00001722 organization org full name Emory University org class OTHER brief title Cetirizine and Famotidine for COVID-19 official title Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Cetirizine and Famotidine in Reducing the Duration of Symptoms in Patients With COVID-19: A Pilot Study status module status verified date August 2021 overall status Withdrawn why stopped Study stopped due to issues with enrollment and lack of funding. expanded access info has expanded access No start date struct start date August 2021 start date type Anticipated primary completion date struct primary completion date July 2022 primary completion date type Anticipated completion date struct completion date July 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 16, 2021 last update post date struct last update post date August 20, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Humphrey Lam responsible party investigator title Assistant Professor responsible party investigator affiliation Emory University lead sponsor lead sponsor name Emory University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary This study is a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of cetirizine and famotidine in reducing the duration of symptoms in patients with COVID-19. Secondary aims are to determine if cetirizine and famotidine decrease severity and duration of symptoms, incidence of hospitalizations, ICU admissions, and death. detailed description COVID-19 is a disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Patients with COVID-19 may present with a myriad of symptoms ranging from fever and cough to more severe symptoms such as shortness of breath. Cetirizine and famotidine are commonly administered medications that can be found over-the-counter. They are well tolerated and have low potential for drug-drug interaction. With it's anti-inflammatory properties via modulation of proinflammatory cytokines, cetirizine may be an effective symptomatic therapeutic for COVID-19. With possible antiviral properties, famotidine may have a role in therapy as well. After a positive COVID test has been confirmed, participants with be randomized to take cetirizine and famotidine or a placebo for 10 days and the study medication will be shipped to them. Participants will record their symptoms for 30 days and any serious adverse events will be followed for up to 60 days. conditions module condition list condition Covid19 design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label cetirizine and famotidine arm group type Experimental arm group description Participants testing positive for COVID-19 who are randomized to take cetirizine and famotidine for 10 days. arm group intervention list arm group intervention name Drug: Cetirizine and Famotidine arm group label Placebo arm group type Placebo Comparator arm group description Participants testing positive for COVID-19 who are randomized to take a placebo to match cetirizine and famotidine for 10 days. arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name Cetirizine and Famotidine intervention description Participants will take 10 milligrams (mg) of cetirizine once a day and 20 mg of famotidine twice a day for 10 days (two pills in the morning and one in the evening). intervention arm group label list intervention arm group label cetirizine and famotidine intervention other name list intervention other name Zyrtec Pepcid intervention type Drug intervention name Placebo intervention description Participants will take placebos to match 10 mg of cetirizine once a day and 20 mg of famotidine twice a day for 10 days (two pills in the morning and one in the evening). intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Time to resolution of symptoms primary outcome description Participants will record their oral temperature and the presence of COVID-19 symptoms of cough, shortness of breath/difficulty breathing, fatigue, myalgias, headache, loss of taste, loss of smell, sore throat, rhinorrhea, congestion, nausea/vomiting, diarrhea, and feverishness/chills, twice daily for up to 14 days. The number of days until resolution of overall symptoms of COVID-19 will be compared between study arms. primary outcome time frame Day 30 secondary outcome list secondary outcome secondary outcome measure Severity of Symptoms secondary outcome description Participants will record their severity of COVID-19 symptoms of cough, shortness of breath/difficulty breathing, fatigue, myalgias, headache, loss of taste, loss of smell, sore throat, rhinorrhea, congestion, nausea/vomiting, diarrhea, and feverishness/chills on a four-point scale (where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe) twice daily for up to 14 days. secondary outcome time frame Day 30 secondary outcome measure Time to Resolution of Individual Symptoms secondary outcome description Participants will record their oral temperature and the presence of COVID-19 symptoms of cough, shortness of breath/difficulty breathing, fatigue, myalgias, headache, loss of taste, loss of smell, sore throat, rhinorrhea, congestion, nausea/vomiting, diarrhea, and feverishness/chills, twice daily for up to 14 days. The number of days until resolution of individual symptoms of COVID-19 will be compared between study arms. secondary outcome time frame Day 30 secondary outcome measure Incidence of Hospitalization secondary outcome description Hospitalizations will be compared between study arms. secondary outcome time frame Day 30 secondary outcome measure Incidence of Intensive Care Unit (ICU) Admission secondary outcome description Admissions to the ICU will be compared between study arms. secondary outcome time frame Day 60 secondary outcome measure Incidence of Death secondary outcome description The number of deaths will be compared between study arms. secondary outcome time frame Day 60 eligibility module eligibility criteria Inclusion Criteria: 18 years old and above positive COVID-19 test (antigen or PCR) symptomatic from COVID-19 symptoms less than or equal to 7 days Exclusion Criteria: already enrolled in another COVID-19 drug study chronically taking a H1-receptor antagonist or H2-receptor antagonist have taken H1-receptor antagonist or H2-receptor antagonist less than 72 hours from expressed interest in the study. history of an adverse reaction to H1 or H2-receptor antagonists severe liver disease severe renal disease taking steroids taking hydroxychloroquine and/or azithromycin already participating in a COVID-19 vaccine trial already received a COVID-19 vaccine symptoms greater than 7 days have had COVID-19 more than once healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Humphrey Lam, MD overall official affiliation Emory University overall official role Principal Investigator location list location location facility Emory University Hospital at Wesley Woods COVID-19 Testing Facility location city Atlanta location state Georgia location zip 30329 location country United States location facility Emory Healthcare Network Peachtree Immediate Care COVID-19 Testing Centers location city Atlanta location state Georgia location zip 30339 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id D000017332 intervention mesh term Cetirizine intervention mesh id D000015738 intervention mesh term Famotidine intervention ancestor list intervention ancestor intervention ancestor id D000000897 intervention ancestor term Anti-Ulcer Agents intervention ancestor id D000005765 intervention ancestor term Gastrointestinal Agents intervention ancestor id D000006635 intervention ancestor term Histamine H2 Antagonists intervention ancestor id D000006633 intervention ancestor term Histamine Antagonists intervention ancestor id D000018494 intervention ancestor term Histamine Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018926 intervention ancestor term Anti-Allergic Agents intervention ancestor id D000039563 intervention ancestor term Histamine H1 Antagonists, Non-Sedating intervention ancestor id D000006634 intervention ancestor term Histamine H1 Antagonists intervention browse leaf list intervention browse leaf intervention browse leaf id M17455 intervention browse leaf name Famotidine intervention browse leaf as found Indirect intervention browse leaf relevance high intervention browse leaf id M18772 intervention browse leaf name Cetirizine intervention browse leaf as found VO2 intervention browse leaf relevance high intervention browse leaf id M3340 intervention browse leaf name Antacids intervention browse leaf relevance low intervention browse leaf id M3371 intervention browse leaf name Anti-Ulcer Agents intervention browse leaf relevance low intervention browse leaf id M8033 intervention browse leaf name Gastrointestinal Agents intervention browse leaf relevance low intervention browse leaf id M8863 intervention browse leaf name Histamine H2 Antagonists intervention browse leaf relevance low intervention browse leaf id M8860 intervention browse leaf name Histamine intervention browse leaf relevance low intervention browse leaf id M212140 intervention browse leaf name Histamine phosphate intervention browse leaf relevance low intervention browse leaf id M8861 intervention browse leaf name Histamine Antagonists intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse leaf id M20115 intervention browse leaf name Anti-Allergic Agents intervention browse leaf relevance low intervention browse leaf id M8862 intervention browse leaf name Histamine H1 Antagonists intervention browse leaf relevance low intervention browse leaf id M23979 intervention browse leaf name Histamine H1 Antagonists, Non-Sedating intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev AAll intervention browse branch name Anti-Allergic Agents
NCT04836806
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full study rank 61221 study protocol section identification module n c t id NCT04839289 org study id info org study id SRF-311 organization org full name Sonova AG org class INDUSTRY brief title Hearing Aid Signal Processing Comparative Study official title A Study to Compare Patient Perceptions of Two Different Hearing Aid Signal Processing Philosophies status module status verified date July 2021 overall status Completed expanded access info has expanded access No start date struct start date July 1, 2021 start date type Actual primary completion date struct primary completion date August 31, 2021 primary completion date type Actual completion date struct completion date August 31, 2021 completion date type Actual study first submit date February 25, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date November 25, 2021 last update post date struct last update post date December 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Sonova AG lead sponsor class INDUSTRY oversight module is f d a regulated drug No is f d a regulated device Yes description module brief summary Participants will be fit with each of two hearing instruments in an ABA cross-over design. The study will consist of a total of three approximately 10-day home trials with the devices. Participants will be asked to provide qualitative feedback to investigators regarding the performance of and their preference for each hearing instrument. conditions module condition list condition Hearing Loss, Sensorineural design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Treatment design masking info design masking Single design masking description Identifying information will be removed from the hearing instruments before fitting the participants. However, participants may be able to research hearing instruments and identify devices based on physical appearance. design who masked list design who masked Participant enrollment info enrollment count 17 enrollment type Actual arms interventions module arm group list arm group arm group label A-B-A arm group type Experimental arm group description Participants will be fit with hearing instruments A and B in the following order: Hearing instrument A Hearing instrument B Hearing instrument A arm group intervention list arm group intervention name Device: Receiver-in-canal hearing instrument; Manufacturer A Device: Receiver-in-canal hearing instrument; Manufacturer B arm group label B-A-B arm group type Experimental arm group description Participants will be fit with hearing instruments A and B in the following order: Hearing instrument B Hearing instrument A Hearing instrument B arm group intervention list arm group intervention name Device: Receiver-in-canal hearing instrument; Manufacturer A Device: Receiver-in-canal hearing instrument; Manufacturer B intervention list intervention intervention type Device intervention name Receiver-in-canal hearing instrument; Manufacturer A intervention description Commercially available receiver-in-canal hearing instrument from manufacturer A intervention arm group label list intervention arm group label A-B-A B-A-B intervention type Device intervention name Receiver-in-canal hearing instrument; Manufacturer B intervention description Commercially available receiver-in-canal hearing instrument from manufacturer B intervention arm group label list intervention arm group label A-B-A B-A-B outcomes module primary outcome list primary outcome primary outcome measure Custom designed questionnaire primary outcome description Qualitative feedback questionnaire authored by the investigators to gather feedback on particular areas of focus. Subjects will rate hearing performance and satisfaction on a Likert scale with lowest number equivalent to worst performance or least satisfied (1) and higher number equivalent to best performance or most satisfied (10). primary outcome time frame End of home trial 1 (10 days after study start) primary outcome measure Custom designed questionnaire primary outcome description Qualitative feedback questionnaire authored by the investigators to gather feedback on particular areas of focus. Subjects will rate hearing performance and satisfaction on a Likert scale with lowest number equivalent to worst performance or least satisfied (1) and higher number equivalent to best performance or most satisfied (10). primary outcome time frame End of home trial 2 (20 days after study start) primary outcome measure Custom designed questionnaire primary outcome description Qualitative feedback questionnaire authored by the investigators to gather feedback on particular areas of focus. Subjects will rate hearing performance and satisfaction on a Likert scale with lowest number equivalent to worst performance or least satisfied (1) and higher number equivalent to best performance or most satisfied (10). primary outcome time frame End of home trial 3 (30 days after study start) eligibility module eligibility criteria Inclusion Criteria: Moderate to severe sensorineural hearing loss Current hearing aid user Exclusion Criteria: Lack of willingness to wear study devices for approximately one month Inability to travel to study appointments or to complete questionnaires. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult contacts locations module location list location location facility Phonak Audiology Research Center location city Aurora location state Illinois location zip 60504 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000034381 condition mesh term Hearing Loss condition mesh id D000006319 condition mesh term Hearing Loss, Sensorineural condition ancestor list condition ancestor condition ancestor id D000006311 condition ancestor term Hearing Disorders condition ancestor id D000004427 condition ancestor term Ear Diseases condition ancestor id D000010038 condition ancestor term Otorhinolaryngologic Diseases condition ancestor id D000012678 condition ancestor term Sensation Disorders condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M23573 condition browse leaf name Hearing Loss condition browse leaf as found Hearing Loss condition browse leaf relevance high condition browse leaf id M8559 condition browse leaf name Hearing Loss, Sensorineural condition browse leaf as found Hearing Loss, Sensorineural condition browse leaf relevance high condition browse leaf id M5992 condition browse leaf name Deafness condition browse leaf relevance low condition browse leaf id M8552 condition browse leaf name Hearing Disorders condition browse leaf relevance low condition browse leaf id M6753 condition browse leaf name Ear Diseases condition browse leaf relevance low condition browse leaf id M12113 condition browse leaf name Otorhinolaryngologic Diseases condition browse leaf relevance low condition browse leaf id M14642 condition browse leaf name Sensation Disorders condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC09 condition browse branch name Ear, Nose, and Throat Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04839289
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full study rank 61924 study protocol section identification module n c t id NCT04830137 org study id info org study id NX-2127-001 organization org full name Nurix Therapeutics, Inc. org class INDUSTRY brief title A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies official title A Phase 1, Dose Escalation, Safety and Tolerability Study of NX-2127, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed/Refractory B-cell Malignancies status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 5, 2021 start date type Actual primary completion date struct primary completion date October 2023 primary completion date type Anticipated completion date struct completion date November 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 2, 2021 study first post date type Actual last update submit date November 15, 2022 last update post date struct last update post date November 16, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Nurix Therapeutics, Inc. lead sponsor class INDUSTRY oversight module is f d a regulated drug Yes is f d a regulated device No description module brief summary This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-2127 in patients with advanced B-cell malignancies. detailed description Phase 1a is a dose escalation to evaluate the safety and tolerability of NX-2127 in adult patients with relapsed/refractory (R/R) B-cell malignancies, who have required and received at least 2 prior systemic therapies (or 1 prior therapy for patients with WM) and for whom no other therapies are known to provide clinical benefit. Phase 1b will investigate the efficacy of NX-2127 at the dose selected in Phase 1a in up to 5 cohorts of patients with R/R B-cell malignancy indications who have received at least 2 prior systemic therapies (or 1 prior therapy for patients with WM): Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with no BTK C481 mutation BTK C481 mutation-positive CLL/SLL Mantle Cell Lymphoma (MCL) Follicular lymphoma (FL) or Marginal Zone Lymphoma (MZL) Diffuse Large B-cell Lymphoma (DLBCL) or Waldenstrom Macroglobulinemia (WM) conditions module condition list condition Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL) Waldenstrom Macroglobulinemia (WM) Mantle Cell Lymphoma (MCL) Marginal Zone Lymphoma (MZL) Follicular Lymphoma (FL) Diffuse Large B-cell Lymphoma (DLBCL) keyword list keyword BTK Degrader BTK Inhibitor B-cell Malignancy Lymphoma C481 C481S IMiD Lenalidomide Pomalidomide Bruton's Tyrosine Kinase NX-2127 Targeted Protein Degradation Chimeric Targeting Molecule (CTM) design module study type Interventional phase list phase Phase 1 design info design allocation Non-Randomized design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 130 enrollment type Anticipated arms interventions module arm group list arm group arm group label Phase 1a Dose Escalation arm group type Experimental arm group description Multiple dose levels of NX-2127 to be evaluated; determination of MTD/Phase 1b recommended dose arm group intervention list arm group intervention name Drug: NX-2127 arm group label Phase 1b Dose Expansion in CLL or SLL with no BTK C481 mutation arm group type Experimental arm group description CLL/SLL patients with no BTK C481 mutation whose disease has failed treatment with a BTK inhibitor arm group intervention list arm group intervention name Drug: NX-2127 arm group label Phase 1b Dose Expansion in BTK C481 mutation-positive CLL/SLL arm group type Experimental arm group description BTK C481 mutation-positive CLL/SLL patients whose disease has failed treatment with a BTK inhibitor arm group intervention list arm group intervention name Drug: NX-2127 arm group label Phase 1b Dose Expansion in MCL arm group type Experimental arm group description MCL patients whose disease has failed treatment with a BTK inhibitor and an anti-CD20 monoclonal antibody (mAb) based regimen arm group intervention list arm group intervention name Drug: NX-2127 arm group label Phase 1b Dose Expansion in FL or MZL arm group type Experimental arm group description FL or MZL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen arm group intervention list arm group intervention name Drug: NX-2127 arm group label Phase 1b Dose Expansion in DLBCL or WM arm group type Experimental arm group description DLBCL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen and an anthracycline or WM patients whose disease has failed treatment with a BTK inhibitor arm group intervention list arm group intervention name Drug: NX-2127 intervention list intervention intervention type Drug intervention name NX-2127 intervention description Oral NX-2127 intervention arm group label list intervention arm group label Phase 1a Dose Escalation Phase 1b Dose Expansion in BTK C481 mutation-positive CLL/SLL Phase 1b Dose Expansion in CLL or SLL with no BTK C481 mutation Phase 1b Dose Expansion in DLBCL or WM Phase 1b Dose Expansion in FL or MZL Phase 1b Dose Expansion in MCL outcomes module primary outcome list primary outcome primary outcome measure Number of Participants with Protocol Specified Dose-Limiting Toxicities primary outcome description Phase 1a primary outcome time frame 10 months primary outcome measure To establish the MTD and/or recommended Phase 1b dose of NX-2127 primary outcome description Phase 1a primary outcome time frame 10 months primary outcome measure To evaluate the clinical activity of NX-2127 at the recommended Phase 1b dose based on overall response rate (ORR) as assessed by the Investigator primary outcome description Phase 1b primary outcome time frame Up to 24 months primary outcome measure Number of Participants with Adverse Events and Clinical Laboratory Abnormalities primary outcome description Phase 1a/1b primary outcome time frame Up to 3 years secondary outcome list secondary outcome secondary outcome measure Pharmacokinetic (PK) Profile of NX-2127: Maximum Serum Concentration secondary outcome description Phase 1a/1b - Sampling following the first dose, pre and post-dose at selected cycles, and at the end of treatment secondary outcome time frame Up to 3 years secondary outcome measure Duration of response (DOR) as assessed by the Investigator secondary outcome description Phase 1a/1b secondary outcome time frame Up to 3 Years secondary outcome measure Progression-free survival (PFS) as assessed by the Investigator secondary outcome description Phase 1a/1b secondary outcome time frame Up to 3 Years secondary outcome measure Overall survival (OS) as assessed by the Investigator secondary outcome description Phase 1b secondary outcome time frame Up to 24 months secondary outcome measure To further evaluate the safety and tolerability of NX-2127 by collecting adverse events, treatment emergent adverse events, and incidence of all deaths secondary outcome description Phase 1b secondary outcome time frame Up to 24 months secondary outcome measure Complete response (CR) rate / CR with incomplete marrow recovery as assessed by the Investigator secondary outcome description Phase 1a/1b secondary outcome time frame Up to 3 years eligibility module eligibility criteria Inclusion Criteria: Patients must be ≥ 18 years of age Patients must have measurable disease per disease-specific response criteria Patients with indolent forms of NHL must meet the criteria requiring systemic treatment (i.e., iwCLL, IWG, or Lugano Classification of Lymphoma response criteria) Patients with transformed lymphoma are eligible for the study with the exception of those who have prolymphocytic leukemia, MCL with blastoid histology, MCL with pleomorphic morphology, or MCL with known TP53 mutation Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ and bone marrow function, in the absence of growth factors Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol Inclusion Criteria for Patients in Phase 1a: Have histologically confirmed R/R CLL, SLL, WM, MCL, and MZL, FL(grade 1 - 3b), or DLBCL Received at least 2 prior systemic therapies (or 1 prior therapy for patients with WM) and have no other therapies known to provide clinical benefit Must require systemic therapy Inclusion Criteria for Patients in Phase 1b: Must have one of the following histologically documented R/R B-cell malignancies: CLL/SLL with no BTK C481 mutation whose disease has failed treatment with a BTKi; BTK C481 mutation-positive CLL/SLL whose disease has failed treatment with a BTKi; MCL whose disease has failed treatment with BTKi and an anti-CD20 mAb-based regimen FL (grade 1 - 3b) or MZL whose disease has failed treatment with anti-CD20 mAb-based regimen; DLBCL whose disease has failed treatment with an anti-CD20 mAb-based regimen and an anthracycline (either progressed post stem cell transplant or transplant-ineligible) or WM whose disease has failed treatment with BTKi Exclusion Criteria: History of CNS lymphoma/leukemia in remission for less than 2 years Active, uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia History of known/suspected other autoimmune disease (exception(s): patients with alopecia, vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed.) Unable to swallow capsules or have a condition that may interfere in the delivery, absorption, or metabolism of the study drug Bleeding diathesis, or other known risk for acute blood loss Patients requiring ongoing treatment with chronic, therapeutic anticoagulation with warfarin or patients treated with dual anti-platelet therapy and vitamin K antagonists Prior radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation) Toxicities from previous anticancer therapies must have resolved to baseline levels or to Grade 1 (except for alopecia, hypothyroidism with adequate replacement therapy, hypopituitarism with adequate replacement therapy, peripheral neuropathy or hematologic parameters meeting inclusion criteria). Active known second malignancy Patient has had major surgery (e.g. requiring general anesthesia) within 4 weeks before the planned first dose of study drug Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: patients with well-controlled HIV (e.g., CD4 > 350/mm3 and undetectable viral load) are eligible. Current active liver disease from any cause Active viral reactivation (e.g., CMV or EBV) Use of systemic corticosteroids (> 20 mg/day prednisone or equivalent) within 15 days, or other immunosuppressive drugs within 30 days, prior to start of the study Clinically significant, uncontrolled cardiac, cardiovascular disease, or history of myocardial infarction within 6 months of planned start of study drug Patient is taking strong or moderate cytochrome P450 3A (CYP3A) inducers or inhibitors or inhibitors of P-glycoprotein healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Patient Outreach central contact role Contact central contact phone (415)-230-7806 central contact phone ext 7806 central contact e mail [email protected] overall official list overall official overall official name Paula O'Connor, MD overall official affiliation Nurix Therapeutics, Inc. overall official role Study Director location list location location facility City of Hope location status Recruiting location city Duarte location state California location zip 91010 location country United States location facility University of California Irvine location status Recruiting location city Orange location state California location zip 92868 location country United States location facility University of California San Francisco Medical Center location status Recruiting location city San Francisco location state California location zip 94143 location country United States location facility Sarah Cannon Research Institute at Colorado Blood Cancer Institute location status Recruiting location city Denver location state Colorado location zip 80218 location country United States location facility Sarah Cannon Research Institute at Florida Cancer Specialists location status Recruiting location city Sarasota location state Florida location zip 34203 location country United States location facility National Institutes of Health Clinical Center location status Recruiting location city Bethesda location state Maryland location zip 20814 location country United States location facility Memorial Sloan Kettering Cancer Center location status Recruiting location city New York location state New York location zip 10065 location country United States location facility University of Cincinnati Medical Center location status Recruiting location city Cincinnati location state Ohio location zip 45267 location country United States location facility OSU Wexner Medical Center location status Recruiting location city Columbus location state Ohio location zip 43210 location country United States location facility Sarah Cannon Research Institute at Tennessee Oncology location status Recruiting location city Nashville location state Tennessee location zip 37203 location country United States location facility MD Anderson Cancer Center location status Recruiting location city Houston location state Texas location zip 77030 location country United States location facility Swedish Cancer Institute location status Recruiting location city Seattle location state Washington location zip 98104 location country United States references module reference list reference reference p m i d 36375120 reference type derived reference citation Zhang D, Harris HM, Chen J, Judy JT, James G, Kelly A, McIntosh J, Tenn-McClellan A, Ambing ER, Tan YS, Lu H, Gajewski S, Clifton MC, Yung S, Robbins DW, Piroozia M, Skånland SS, Gaglione EM, Mhibik M, Underbayev C, Ahn I, Sun C, Herman SEM, Noviski MA, Wiestner A. -----NRX-0492 Degrades Wildtype and C481 Mutant BTK and Demonstrates in vivo Activity in CLL Patient Derived Xenografts. Blood. 2022 Nov 14. pii: blood.2022016934. doi: 10.1182/blood.2022016934. 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browse leaf id M233278 intervention browse leaf name Pomalidomide intervention browse leaf relevance low intervention browse leaf id T22 intervention browse leaf name Tyrosine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev AA intervention browse branch name Amino Acids
NCT04830137
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full study rank 61762 study protocol section identification module n c t id NCT04832256 org study id info org study id 2015-67-07/07 organization org full name Zonguldak Bulent Ecevit University org class OTHER brief title Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels official title Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels: Noninvasive Carbon Monoxide Monitoring status module status verified date May 2022 overall status Completed expanded access info has expanded access No start date struct start date January 1, 2016 start date type Actual primary completion date struct primary completion date December 31, 2018 primary completion date type Actual completion date struct completion date June 1, 2019 completion date type Actual study first submit date March 30, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 1, 2022 last update post date struct last update post date May 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Bengü Gülhan Aydin responsible party investigator title Associate Professor Doctor responsible party investigator affiliation Zonguldak Bulent Ecevit University lead sponsor lead sponsor name Zonguldak Bulent Ecevit University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary To observe the effect of different fresh flows (1 L / min and 4 L / min) on the carboxyhemoglobin level non-invasively and continuous measurement and to determine the contribution of smoking to the intraoperative carbon monoxide accumulation. conditions module condition list condition Fresh Flow Carboxyhemoglobinemia keyword list keyword Low flow anesthesia Non-invasive carboxyhemoglobinemia monitoring Smoking design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 64 enrollment type Actual arms interventions module arm group list arm group arm group label High Flow anesthesia arm group description administered 4 L/min fresh gas flow during general anesthesia arm group intervention list arm group intervention name Device: Radical-7 Pulse CO-Oximeter arm group label Low Flow Anesthesia arm group description administered 1 L/min fresh gas flow during general anesthesia arm group intervention list arm group intervention name Device: Radical-7 Pulse CO-Oximeter intervention list intervention intervention type Device intervention name Radical-7 Pulse CO-Oximeter intervention description COHb measurement monitoring from finger pulp with a non-invasive measurement device called Masimo Radical-7 Pulse co-oximeter (Masimo Corporation, Irvine, USA) intervention arm group label list intervention arm group label High Flow anesthesia Low Flow Anesthesia outcomes module primary outcome list primary outcome primary outcome measure effects of different fresh gas flows on carboxyhemoglobin levels primary outcome description To observe the effect of different fresh flows (1 L / min and 4 L / min) on the carboxyhemoglobin level by non-invasive and continuous measurement. primary outcome time frame during surgery secondary outcome list secondary outcome secondary outcome measure effects of smoking on carbon monoxide accumulation. secondary outcome description to determine the contribution of smoking to intraoperative carbon monoxide accumulation. secondary outcome time frame during surgery eligibility module eligibility criteria Inclusion Criteria: ASA I-II Undergo 2-4 hours of elective surgery Exclusion Criteria: Cardiovascular disease diabetes mellitus kidney, liver failure chronic obstructive pulmonary disease patients with opioid sensitivity morbidly obese personal or family history of malignant hyperthermia history of prolonged recovery from anesthesia alcohol addicted pregnant and breastfeeding women patients allergic to study drugs healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult study population A total of 64 patients in ASA I-II risk group, aged 18-65, undergoing 2-4 hours of elective surgery sampling method Probability Sample contacts locations module location list location location facility Zonguldak Bülent Ecevit University Medicine Faculty location city Zonguldak location state Kozlu location zip 67600 location country Turkey references module reference list reference reference p m i d 35964947 reference type derived reference citation Koksal BG, Kucukosman G, Ozcan P, Baytar C, Bollucuoglu K, Okyay RD, Ayoglu H. Effects of different fresh gas flows on carboxyhemoglobin levels: non-invasive carbon monoxide monitoring: A randomized clinical trial. Saudi Med J. 2022 Aug;43(8):891-898. doi: 10.15537/smj.2022.43.8.20220424. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002249 condition mesh term Carbon Monoxide Poisoning condition ancestor list condition ancestor condition ancestor id D000005739 condition ancestor term Gas Poisoning condition ancestor id D000011041 condition ancestor term Poisoning condition ancestor id D000064419 condition ancestor term Chemically-Induced Disorders condition browse leaf list condition browse leaf condition browse leaf id M13083 condition browse leaf name Poisoning condition browse leaf relevance low condition browse leaf id M4659 condition browse leaf name Carbon Monoxide Poisoning condition browse leaf as found Carboxyhemoglobinemia condition browse leaf relevance high condition browse leaf id M29455 condition browse leaf name Chemically-Induced Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC25 condition browse branch name Substance Related Disorders condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M4658 intervention browse leaf name Carbon Monoxide intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04832256
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full study rank 61317 study protocol section identification module n c t id NCT04838041 org study id info org study id PRO00040685 organization org full name Medical College of Wisconsin org class OTHER brief title Protocol Number: HJKC3-0003. Treatment Free Remission After Combination Therapy With Asciminib (ABL001) Plus Imatinib in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation official title Protocol Number: HJKC3-0003. Treatment Free Remission After Combination Therapy With Asciminib (ABL001) Plus Imatinib in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date November 11, 2021 start date type Actual primary completion date struct primary completion date June 2028 primary completion date type Anticipated completion date struct completion date July 2029 completion date type Anticipated study first submit date March 26, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date May 3, 2022 last update post date struct last update post date May 5, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ehab L Atallah responsible party investigator title Professor responsible party investigator affiliation Medical College of Wisconsin lead sponsor lead sponsor name Medical College of Wisconsin lead sponsor class OTHER collaborator list collaborator collaborator name H. Jean Khoury Cure CML Consortium collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary This is a single-arm phase II study that will enroll a minimum of 41 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue imatinib. All patients must be restarted on imatinib at the time of relapse in order to be eligible for this trial. detailed description This trial will use a combination of asciminib 40 mg by mouth (PO) twice daily (BID) plus imatinib (maximum dose of 400 mg PO once daily) in the combination treatment phase. The BCR-ABL tyrosine kinase inhibitor (TKI) that will be used for this trial is imatinib. All eligible patients will begin asciminib in combination with imatinib on cycle 1 day 1 of the combination phase. They will continue combination therapy for a total of 12 cycles (minimum of 12 months). Each cycle will be ~28 days. At the end of 12 cycles asciminib will be discontinued and any patient who has met the criteria for the treatment-free remission (TFR) screening phase will enter into the TFR phase. Once in the TFR phase, patients will discontinue their imatinib and be monitored off treatment. The primary endpoint of this study is the 12-month "second" TFR rate after completion of 12 cycles of combination therapy. Patients will remain in the TFR phase of the study for up to three years and will have central polymerase chain reaction (PCR) testing during the first two years. Therefore, the total duration of the subject participation trial will be approximately five years (one year on combination treatment phase plus three years in the TFR phase plus one year of long-term follow-up post TFR or early discontinuation. conditions module condition list condition Chronic Phase Chronic Myelogenous Leukemia keyword list keyword chronic myelogenous leukemia treatment-free remission tyrosine kinase inhibitors H. Jean Khoury Cure CML Consortium design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 51 enrollment type Anticipated arms interventions module arm group list arm group arm group label Combination Therapy and Remission Phase arm group type Experimental arm group description All eligible patients will begin a combination of asciminib plus imatinib cycle 1 day 1 in the combination treatment phase. They will continue combination therapy for a total of 12 cycles (minimum of 12 months). At the end of 12 cycles asciminib will be discontinued and any patient who has met the criteria for the treatment free remission (TFR) screening phase will enter into the TFR phase. Once in the TFR phase, patients will discontinue their imatinib and be monitored off treatment. arm group intervention list arm group intervention name Drug: Asciminib Drug: Imatinib intervention list intervention intervention type Drug intervention name Asciminib intervention description 40 mg by mouth (PO) twice a day (BID). intervention arm group label list intervention arm group label Combination Therapy and Remission Phase intervention other name list intervention other name ABL001 intervention type Drug intervention name Imatinib intervention description 400 mg by mouth (PO) once daily intervention arm group label list intervention arm group label Combination Therapy and Remission Phase intervention other name list intervention other name Gleevec Glivec outcomes module primary outcome list primary outcome primary outcome measure One-year "second" treatment-free remission. primary outcome description This will be measured by the number of subjects who achieve one-year treatment-free remission after 12 months of combination therapy with imatinib plus asciminib. These subjects have previously failed a first treatment free remission attempt. primary outcome time frame 1 years eligibility module eligibility criteria Inclusion Criteria: Age ≥18 years old. Willing and able to give informed consent. Diagnosed with CML in chronic phase and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR-ABL protein. Subtype classification whether b3a2 (e14a2) or b2a2 (e13a2) is not required for study eligibility. Must have a documented history of attempting only one prior imatinib discontinuation under the guidance of a treating physician. Must have met all the following criteria prior to first attempt to discontinue their imatinib: Stable molecular response (MR4; < 0.01% IS) for > 2 years, as documented on at least four tests, performed at least three months apart (e.g. If a patient has had >4 PCR tests performed during the two years leading up to their initial TKI discontinuation, any value between 0.01 and 0.05% IS is considered a stable result, however, at least four tests must be < 0.01% IS). Treatment with imatinib for a minimum of three years prior to discontinuing imatinib. Must have relapsed (defined as loss of major molecular response (MMR), real-time quantitative polymerase chain reaction (RQ-PCR) for BCR-ABL >0.1% IS after first attempted imatinib discontinuation. After first failed TFR attempt, must have a minimum duration of one year of retreatment with imatinib (up to 400mg PO QD), and must plan to remain on imatinib for a minimum of 12 months during the combination treatment phase. Eastern Cooperative Oncology Group (ECOG) performance status 0-3. Must have a RQ-PCR for BCR-ABL < 0.0032% IS (MR4.5) reported by the trial designated central lab at the time of study enrollment. Female patients must meet one of the following: Postmenopausal for at least one year before the screening visit, Surgically sterile, If they are of childbearing potential, agree to practice two effective methods of contraception from the time of signing of the informed consent form through 90 days after the last dose of study drug, Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable contraception methods.) Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following: Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Exclusion Criteria: A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study. History of accelerated or blast phase CML. A second malignancy requiring active treatment. History of recent (within 12 months) acute pancreatitis or chronic pancreatitis Subjects who have previously received treatment with asciminib. Subjects with platelet (PLT) count < 100 × 109/L or an absolute neutrophil count (ANC) of < 1 × 109/L or hemoglobin < 8 g/dL. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≥3 times the institutional upper limit of normal. Creatinine ≥ 2 times the institutional upper limit of normal. Total bilirubin ≥ 1.5 times the institutional upper limit of normal (unless direct bilirubin is within normal limits). Lipase > institutional upper limit of normal. Pregnant or lactating. Unable to comply with lab appointment schedule and patient-reported outcome (PRO) assessments. Another investigational drug within four weeks of enrollment. Any serious medical or psychiatric illness that could, in the investigator's opinion, interfere with the completion of treatment according to this protocol. Patient has undergone a prior allogeneic stem cell transplant. Screening 12-lead ECG showing a baseline corrected QT interval >480msec (patients with a pacemaker will still be eligible with QTc>500msec). Eligibility for the TFR Phase: Stable molecular response (MR4.5; < 0.0032% IS) documented on at least three tests (may include TFR phase screening PCR) by the trial designated lab, performed approximately three months apart while on combination phase TFR phase screening PCR RQ-PCR for BCR-ABL < 0.0032% IS (MR4.5) by the trial designated lab ECOG 0-3 Completion of 12 cycles on the combination therapy phase healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Medical College of Wisconsin Cancer Center Clinical Trials Office central contact role Contact central contact phone 414-805-8900 central contact e mail [email protected] central contact name Ehab Atallah, MD central contact role Contact central contact phone 414-805-4600 central contact e mail [email protected] overall official list overall official overall official name Ehab Atallah, MD overall official affiliation Medical College of Wisconsin overall official role Principal Investigator overall official name Michael J. Mauro, MD overall official affiliation Memorial Sloan Kettering Cancer Center overall official role Study Chair location list location location facility The Barbara Ann Karmanos Cancer Institute location status Recruiting location city Detroit location state Michigan location zip 48201 location country United States location contact list location contact location contact name Sharon Prokop location contact role Contact location contact phone 313-576-9363 location contact e mail [email protected] location contact name Jay Yang, MD location contact role Principal Investigator location facility Froedtert Hospital & the Medical College of Wisconsin location status Recruiting location city Milwaukee location state Wisconsin location zip 53226 location country United States location contact list location contact location contact name Ehab Atallah, MD location contact role Contact location contact phone 414-805-4600 location contact e mail [email protected] location contact name Ehab Atallah, MD location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007938 condition mesh term Leukemia condition mesh id D000007951 condition mesh term Leukemia, Myeloid condition mesh id D000015464 condition mesh term Leukemia, Myelogenous, Chronic, BCR-ABL Positive condition mesh id D000015466 condition mesh term Leukemia, Myeloid, Chronic-Phase condition ancestor list condition ancestor condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000009196 condition ancestor term Myeloproliferative Disorders condition ancestor id D000001855 condition ancestor term Bone Marrow Diseases condition ancestor id D000006402 condition ancestor term Hematologic Diseases condition browse leaf list condition browse leaf condition browse leaf id M10097 condition browse leaf name Leukemia condition browse leaf as found Leukemia condition browse leaf relevance high condition browse leaf id M10107 condition browse leaf name Leukemia, Myeloid condition browse leaf as found Myelogenous Leukemia condition browse leaf relevance high condition browse leaf id M17275 condition browse leaf name Leukemia, Myelogenous, Chronic, BCR-ABL Positive condition browse leaf as found Chronic myelogenous leukemia condition browse leaf relevance high condition browse leaf id M17277 condition browse leaf name Leukemia, Myeloid, Chronic-Phase condition browse leaf as found Chronic phase chronic myelogenous leukemia condition browse leaf relevance high condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M11301 condition browse leaf name Myeloproliferative Disorders condition browse leaf relevance low condition browse leaf id M4286 condition browse leaf name Bone Marrow Diseases condition browse leaf relevance low condition browse leaf id M8642 condition browse leaf name Hematologic Diseases condition browse leaf relevance low condition browse leaf id T3995 condition browse leaf name Myeloid Leukemia condition browse leaf as found Myeloid Leukemia condition browse leaf relevance high condition browse leaf id T1309 condition browse leaf name Chronic Myeloid Leukemia condition browse leaf as found Chronic Myeloid Leukemia condition browse leaf relevance high condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse leaf id T1311 condition browse leaf name Chronic Myeloproliferative Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000068877 intervention mesh term Imatinib Mesylate intervention ancestor list intervention ancestor intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000047428 intervention ancestor term Protein Kinase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention browse leaf list intervention browse leaf intervention browse leaf id M324 intervention browse leaf name Imatinib Mesylate intervention browse leaf as found Arthritis intervention browse leaf relevance high intervention browse leaf id M24973 intervention browse leaf name Protein Kinase Inhibitors intervention browse leaf relevance low intervention browse leaf id T22 intervention browse leaf name Tyrosine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev AA intervention browse branch name Amino Acids
NCT04838041
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full study rank 61888 study protocol section identification module n c t id NCT04830605 org study id info org study id 1-10-72-296-20 organization org full name Aarhus University Hospital org class OTHER brief title Feasibility Test of the Treatment Program iACT-by Proxy - a Single Case Experimental Design official title Feasibility Test of the Treatment Program iACT-by Proxy - a Single Case Experimental Design status module status verified date November 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date June 2022 start date type Anticipated primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date November 2023 completion date type Anticipated study first submit date March 26, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date November 26, 2021 last update post date struct last update post date November 29, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Katrine Ingeman Beck responsible party investigator title Psychologist responsible party investigator affiliation Aarhus University Hospital lead sponsor lead sponsor name Aarhus University Hospital lead sponsor class OTHER collaborator list collaborator collaborator name University of Aarhus collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Health anxiety by proxy is defined as parents' obsessive worries about their child's health. It is a newly described phenomenon, where the parent has persistent and distressing fears that his or her child may suffer from a serious disease that is being overlooked. These intrusive thoughts may lead to excessive attention directed towards their child's body and a tendency to interpret natural bodily sensations as unnatural and abnormal. As a consequence, parents with health anxiety by proxy may repetitively perform bodily inspections of their child. Besides the stress related to worrying about your child's health, the condition can also cause frequent and unnecessary medical examinations of the child. As a possible consequence of this parental behavior, the child may be at risk of developing similar maladaptive illness behaviors, illness perceptions and illness worries. Currently, the phenomenon is widely overlooked and no treatment for health anxiety by proxy exists. The aim of the study is to test the feasibility and possible effect of an internet-based treatment program for health anxiety by proxy (iACT-by-proxy) using a single-case experimental design. Design The iACT-by-proxy is being tested in a single-case experimental design with multiple baselines. In a multiple baseline design the participants have different baseline lengths but the same intervention and follow-up period. The rationale behind the different baseline lengths is that it will be evident if target outcome measures change at intervention entry, but not during baseline. Thus the participants' baseline-period functions as their own control. Hypotheses Patients will report a significant decrease in selected self-report measures of health anxiety by proxy answered every other day when comparing the baseline period to the interven-tion period. Patient self-report measures of health anxiety by proxy, emotional distress, and illness perception and catastrophizing when the child has symptoms will have decreased after intervention. Participants Parents assessed with health anxiety by proxy with children under 18years. Recruitment Participants are assessed with health anxiety by proxy using the Health Anxiety by Proxy Scale (HAPYS).Participants self-refer to the project through the webpage www.helbredsangst.dk. After diagnostic video-interview they are included in the project. detailed description Background Health anxiety by proxy is a newly described phenomenon, where the parent has persistent and distressing fears that his or her child may suffer from a serious disease that is being overlooked. These intrusive thoughts may lead to excessive attention directed towards their child's body and a tendency to interpret natural bodily sensations as abnormal. As a consequence, parents with health anxiety by proxy may repetitively perform bodily inspections of their child or have medicial examinations conducted (1, 2). As a possible consequence of this parental behavior, the child may be at risk of developing similar maladaptive illness behaviors, illness perceptions and illness worries(3). Research on parents suffering from health anxiety has found evidence of health anxiety symptoms being transmitted from parent to child (4, 5) indicating that the parent's response to the child's health complaints (6) and how the parent copes with own symptoms may influence the health attitudes and behaviors of the child(7-10). This risk may be especially high if the parent suffers from health anxiety by proxy because the child is exposed to a particular preoccupation with and fear of illness and symptoms. For these reasons health anxiety by proxy is an important but neglected clinical phenomenon. Therefore, it is important to develop and test treatment targeting health anxiety by proxy. Internet-based treatment is a relatively new approach that compares favourably with face-to-face treatment (15, 16). The Research Clinic for Functional Disorders and Psychosomatics (Research Clinic), Aarhus University Hospital (AUH) has recently developed an internet-based treatment program (iACT) for health anxiety based on principles from Acceptance and Commitment Therapy (ACT)(17). This treatment has shown promising results (14, 18) and is used as a template for the development of specialised treatment for parents with health anxiety by proxy. The treatment is called iACT-by proxy and is targeting parents' maladaptive anxiety-driven behaviour towards their child with focus on exposure therapy in the context of ACT principles. The aim of the study is to test the feasibility and possible effect of the iACT- by proxy treatment program for health anxiety by proxy using a single-case experimental design. Hypotheses Patients will report a significant decrease in selected self-report measures of health anxiety by proxy answered every other day when comparing the baseline period to the interven-tion period. Patient self-report measures of health anxiety by proxy, emotional distress, and illness perception and catastrophizing when the child has symptoms will have decreased after intervention. Criteria for success of feasibility The treatment modules will be well received by the patients regarding format, length, content and contact to the therapist as measured by patient self-report on selected questions and with semi-structured interviews. Patients will log in to the modules on a weekly basis and will complete at least 6 out of 8 modules in the treatment. A module is complete when all text has been read in the module and corresponding exercises have been performed. Self-reported negative effects of participating are low. Method Participants and recruitment The patients apply for participation in the project through the webpage www.helbredsangst.dk using NemID. On the webpage the patient will find information about health anxiety by proxy and the research project. When logging in the participant is met with written information about participation and a following statement of consent giving permission to the health professionals in the project to directly collect health information from the patient record and use questionnaire data for research purposes in anonymised form. NemID is accepted as a digital signature by the Data Protection Agency. After the statement of consent, the participant is redirected to a questionnaire about physical and psychological symptoms, and personal background information. If the questionnaire is complete and the consent is signed the participant is self-referred. The participant will be invited to a video-assessment through e-boks. Assessment All participants are assessed using a shorter standardised diagnostic interview based on SCAN (Schedules for Clinical Assessment in Neuropsychiatry (21)) and supplemented with assessment of health anxiety by proxy using the HAPYS. The passed information from the patient record concerning the patients' somatic and psychiatric health information is necessary supplementary information for conducting a thorough assessment. The interview is conducted using an encrypted link for a video-service hosted by the Central Denmark Region (rooms.rm.dk) which comply with the General Data Protection Regulation (GDPR). At the beginning of the interview, the health-professional ensures that the interview will be uninterrupted. The participant can have lay representative present during the interview if preferred. Informed consent All participants receive written and verbal information about the project. The participants receive the written information at self-referral. Verbal information is given by the health-professional performing the diagnostic assessment at the Research Clinic, AUH. They sign two consents; one when they complete the self-referral before the diagnostic interview, which gives the responsible investigators direct access to collect information from the electronic patient record for the purpose of using the participant's health information; and one consent when entering the research project after the diagnostic assessment. Signing the final consent the participants enters the project, gives permission to publish the research data, and gives permission to being contacted during the study period. In order to uphold the treatment responsibility, the participant provides a phone number of a relative in case of suicide suspicion. The system allows the participant to log out and log in again at a later time providing the participant with the opportunity to reflect before signing the consent. If the consent is not signed within two weeks after the interview the participant will be excluded from the study. Design The single-case experimental study will be designed with multiple baselines comparing the individuals' baseline level of health anxiety by proxy with the level of health anxiety by proxy during and following participation in the treatment (19, 22). In a multiple baseline design, the participants have different baseline lengths but the same intervention and follow-up period. The baseline and intervention period serves as two study conditions, a control (baseline) and a treatment condition (intervention) with N equally spaced measurement occasions(19). The base-line length is randomly assigned to the participants and serves as each participants' own control-condition. This makes it possible to have a small number of participants. If the intervention shows effect a change in the anxiety level will be detected during the intervention period. Measurements All measures are self-report measures obtained through the secure web-based software platform for data collection REDCap (Research Electronic Data Capture)(23, 24) hosted at Aarhus University. Assessment Short version of Schedules for Clinical Assessment in Neuropsychiatry (20, 21) The Health Anxiety by Proxy Scale (HAPYS) (Ingeman et al., submitted) Primary outcome The target measures of health anxiety by proxy are answered though a link in a SMS to the participants every other day from start of baseline to end of follow-up. The order of the items will be random each day. The target measures contain items of core characteristics of health anxiety by proxy which have been selected from the HAPYS based on the following: Secondary outcome Standardised self-report questionnaires will be answered four times during the study period (before baseline, right before treatment entry (end of baseline), end of treatment, and at 4-weeks follow-up. Feasibility outcome Participants are asked to provide feedback on format, length and content of the treatment program as well as on the contact to the therapist after each treatment-module and in a semi-structured phone-interview with the Ph.D.-student after treatment end. Intervention The treatment is an eight-week therapist-supported internet-based program based on written psychoeducation, audio-files, behavioural exposure exercises, homework and videos distributed in eight short modules. Data analysis Analysis will be divided into primary outcome and secondary outcome. The primary outcome will be analysed using visual analysis of plotting data and observing if the measures decreases at time of intervention entry (19). Further, using a Bayesian analysis of clinically significant change will quantify the evidence for the size and presence of an intervention effect (35, 36). The secondary outcome is analysed by determining Jacobsen's Reliable Change Index and from this determine that the change seen is not at result of measurement error and whether it is clinically significant(19, 37). The online free-text-answers and the interview on formalities and contact to therapist will be explored using thematic analysis focusing on all participant-experiences. Funding The Ph.D.-student and the Department of Child and Adolescent Psychiatry has initiated the research project in collaboration with the Research Clinic, AUH and received funding from numerous funds. Ethics The project is conducted in accordance to the rules in the Helsinki-Declaration. The project is registered under the Central Denmark Region's records of research projects (Den interne fortegnelse over forskningsprojekter ved Region Midt; 1-16-02-921-17). There is no previous research data suggesting that internet-based treatment for health anxiety, anxiety or depression are associated with any form of risk (12, 14-16, 18). Data protection All information concerning the participants is protected by the data protection act and the data protection regulation. All personal data including name, telephone number and social security number is encrypted. The questionnaires are not personally identifiable, but have a random ID-number. The participants provide written informed consent to publish data in a single-case format where each participant's data is reported separately, but anonymized. The platform hosting the treatment program was developed and programmed at the Research Clinic for Functional Disorders and Psychosomatics. All access to the server goes through an encrypted SSL-connection, and data pooling is being logged with IP and user-ID. NemID is used to log in to the platform. Access to the questionnaire data is only granted to researchers in the project and the data will be kept anonymously after project-end. Project group The project is conducted at the Research Clinic in collaboration with the Department of Child and Adolescent Psychiatry, AUH. The project group consist of Katrine Ingeman Beck, psychologist (PhD student)1,2, Charlotte Ulrikka Rask, MD, professor, PhD1,2 (Main supervisor); Lisbeth Frostholm, head psychologist, associate professor, PhD3,2 (Co-supervisor); Kristi Wright, psychologist, associate professor, PhD4 (Co-supervisor); Ditte Hoffmann Jensen, psychologist, PhD3 (Co-supervisor). Department of Child and Adolescent Psychiatry, AUH, Psychiatry, Aarhus, Denmark. Department of Clinical Medicine, Aarhus University, Denmark The Research Clinic, AUH, Aarhus, Denmark. Department of Psychology, Faculty of Arts, University of Regina, Canada. conditions module condition list condition Anxiety State Anxiety Disorders keyword list keyword Internet-based treatment Single-case experimental design design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design intervention model description The study is a single-case experimental design with multiple baselines. This means the participants have different baseline lengths but the same intervention and follow-up period and that they all receive the same intervention. The baseline and intervention period serves as two study conditions, a control (baseline) and a treatment condition (intervention) with N equally spaced measurement occasions. The baseline length is randomly assigned to the participants and serves as each participants' own control-condition. This makes it possible to have a small number of participants. If the intervention shows effect a change in the anxiety level will be detected during the intervention period regardless of when the intervention-period was initiated. design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 5 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intervention arm group type Experimental arm group description Internet-delivered treatment for parents with health anxiety on behalf of their child. Eight weeks with therapist support. arm group intervention list arm group intervention name Behavioral: Internet-based treatment intervention list intervention intervention type Behavioral intervention name Internet-based treatment intervention description The intervention is an internet-based psychotherapy treatment with eight modules based on acceptance and commitment therapy and with written therapist contact through eight weeks. intervention arm group label list intervention arm group label Intervention outcomes module primary outcome list primary outcome primary outcome measure SMS-data primary outcome description Four questions assessing patients anxiety level is sent to the patient every day by sms. primary outcome time frame Up to 15 weeks secondary outcome list secondary outcome secondary outcome measure The health anxiety by proxy scale secondary outcome description Self-report questionnaire assessing parent's worries about their child's health secondary outcome time frame Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks secondary outcome measure The Adult Response to Children's Symptoms (ARCS) - parent form (revised) secondary outcome description Self-report questionnaire assessing parent's reactions when their child has symptoms secondary outcome time frame Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks secondary outcome measure Pain Catastrophizing Scale - parent version secondary outcome description Self-report measure assessing parental catastrophic thinking when their child is in pain. secondary outcome time frame Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks secondary outcome measure The Whiteley-6 Index secondary outcome description Self-report measure assessing health related worries secondary outcome time frame Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks secondary outcome measure SCL-8 (emotional distress) secondary outcome description Self-report measure assessing emotional distress secondary outcome time frame Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks secondary outcome measure WHO-5 Well-Being Index secondary outcome description Self-report measure assessing general well-being secondary outcome time frame Baseline, 1-3 weeks, 9-11 weeks, 13-15 weeks secondary outcome measure Experience of Service Questionnaire secondary outcome description Self-report measure assessing the experience of the treatment received secondary outcome time frame 13-15 weeks secondary outcome measure The Negative Effects Questionnaire secondary outcome description Self-report measure assessing negative effects of psychotherapy secondary outcome time frame 13-15 weeks secondary outcome measure Internet Evaluation and Utility Questionnaire secondary outcome description Self-report measure assessing the dilivery of internet-based treatment. secondary outcome time frame 13-15 weeks eligibility module eligibility criteria Inclusion Criteria: Parents of age Assessed with severe health anxiety by proxy At least one child under 18 years Healthy children without severe hospital-treatment-requiring diagnoses or disabilities Read, write and speak Danish Exclusion Criteria: Comorbid diagnoses of substance abuse, bipolar disorder, psychotic disorders (ICD-10: F20-29) or autism spectrum disorder. Recently starting up psychotropic drug (with-in the last two months) Suicidal risk healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Katrine Ingeman Beck, PhD-student central contact role Contact central contact phone 004530687532 central contact e mail [email protected] central contact name Charlotte Ulrikka Rask, Med.Dr central contact role Contact central contact e mail [email protected] overall official list overall official overall official name Charlotte Ulrikka Rask, Med.Dr overall official affiliation Aarhus University Hospital overall official role Study Chair references module reference list reference reference p m i d 27222022 reference type background reference citation Lockhart E. Health anxiety in children and parents. BMJ. 2016 May 24;353:i2891. doi: 10.1136/bmj.i2891. reference p m i d 28950218 reference type background reference citation Thorgaard MV, Frostholm L, Walker L, Jensen JS, Morina B, Lindegaard H, Salomonsen L, Rask CU. Health anxiety by proxy in women with severe health anxiety: A case control study. J Anxiety Disord. 2017 Dec;52:8-14. doi: 10.1016/j.janxdis.2017.09.001. Epub 2017 Sep 11. reference type background reference citation Thorgaard MV, Frostholm L, Rask CU. Childhood and family factors in the development of health anxiety: A systematic review. Children's Health Care. 2017:1-41 reference p m i d 27909834 reference type background reference citation Thorgaard MV, Frostholm L, Walker LS, Stengaard-Pedersen K, Karlsson MM, Jensen JS, Fink P, Rask CU. Effects of maternal health anxiety on children's health complaints, emotional symptoms, and quality of life. Eur Child Adolesc Psychiatry. 2017 May;26(5):591-601. doi: 10.1007/s00787-016-0927-1. 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Epub 2019 May 9. reference p m i d 18929686 reference type background reference citation Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. reference p m i d 26520223 reference type background reference citation de Vries RM, Hartogs BM, Morey RD. A Tutorial on Computing Bayes Factors for Single-Subject Designs. Behav Ther. 2015 Nov;46(6):809-23. doi: 10.1016/j.beth.2014.09.013. Epub 2014 Oct 7. Review. reference p m i d 26449152 reference type background reference citation de Vries RM, Meijer RR, van Bruggen V, Morey RD. Improving the analysis of routine outcome measurement data: what a Bayesian approach can do for you. Int J Methods Psychiatr Res. 2016 Sep;25(3):155-67. doi: 10.1002/mpr.1496. Epub 2015 Oct 8. Review. reference p m i d 2002127 reference type background reference citation Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12. i p d sharing statement module i p d sharing Yes i p d sharing description Individual participant data that underlie the results reported in this article will be available after deidentification (text, tables, figures, and appendices). i p d sharing info type list i p d sharing info type Study Protocol i p d sharing time frame Beginning 6 months and ending 36 months following article publication. i p d sharing access criteria Data will be shared with researchers who provide a methodologically sound proposal. The type of analyses are defined by the aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. Proposals should be directed to [email protected]. To gain access, data requestors will need to sign a data access agreement. After 36 months the data will be available in a data warehouse but without investigator support. document section large document module large doc list large doc large doc type abbrev Prot large doc has protocol Yes large doc has s a p No large doc has i c f No large doc label Study Protocol large doc date March 22, 2021 large doc upload date 03/26/2021 09:20 large doc filename Prot_000.pdf derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001008 condition mesh term Anxiety Disorders condition ancestor list condition ancestor condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M3476 condition browse leaf name Anxiety Disorders condition browse leaf as found Anxiety condition browse leaf relevance high condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions
NCT04830605
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full study rank 61899 study protocol section identification module n c t id NCT04830462 org study id info org study id H-20028894 or 126496 organization org full name Herlev and Gentofte Hospital org class OTHER brief title Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation official title Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 15, 2021 start date type Actual primary completion date struct primary completion date April 15, 2023 primary completion date type Anticipated completion date struct completion date May 15, 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date August 3, 2022 last update post date struct last update post date August 4, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Niklas Lorentsson responsible party investigator title MD responsible party investigator affiliation Herlev and Gentofte Hospital lead sponsor lead sponsor name Herlev and Gentofte Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study will be investigating the effect of latent tuberculosis infection (LTBI) treatment on glucose tolerance and low-grade inflammation. Almost a century ago, researchers proposed that diabetes (DM) was associated with increased risk of Tuberculosis infection (TB). A more recent systematic review concluded that DM increases the relative risk for TB 3.1 times. Reversely, TB may affect the glycaemic control; TB is in many cases a chronic infection characterised by long term low-grade inflammation and weight loss, and persons with TB are known to be at risk of hyperglycaemia and DM at time of diagnosis. A latent infection with the m.tuberculosis bacteria is "silent" without symptoms. 1,7 billion have LTBI on a global scale. Event though the infected person does not experience symptoms, increased background inflammation has been shown in LTBI patients in previous studies. We also know that an increase in inflammatory markers precedes clinical development of DM, and that subclinical inflammation contributes to insulin resistance. We hypothesise that LTBI contributes to dysregulated glucose metabolism due to increased low-grade inflammation, and that treatment will reduce low-grade inflammation and improve glucose tolerance. conditions module condition list condition Latent Tuberculosis Diabetes Mellitus, Type 2 keyword list keyword low-grade inflammation glucose metabolism body composition cytokines adipokines biomarkers design module study type Interventional phase list phase Phase 4 design info design allocation Non-Randomized design intervention model Parallel Assignment design intervention model description The study consists of two arms with different patient populations. Both arms will receive identical treatment. Arm A will have type 2 diabetes and latent tuberculosis infection (LTBI). Group B will not have any form of diabetes, but LTBI. design primary purpose Basic Science design masking info design masking None (Open Label) enrollment info enrollment count 190 enrollment type Anticipated arms interventions module arm group list arm group arm group label LTBI and DM arm group type Other arm group description Participants with LTBI and DM will be treated with Rifampicin or Isoniazid at the treating physicians discretion arm group intervention list arm group intervention name Drug: Rifampicin 300 Mg Oral Capsule Drug: Isoniazid 300 Mg ORAL TABLET arm group label LTBI without DM arm group type Other arm group description Participants with LTBI without DM will be treated with Rifampicin or Isoniazid at the treating physicians discretion arm group intervention list arm group intervention name Drug: Rifampicin 300 Mg Oral Capsule Drug: Isoniazid 300 Mg ORAL TABLET intervention list intervention intervention type Drug intervention name Rifampicin 300 Mg Oral Capsule intervention description Rifampicin 600 mg orally once daily for 4 months intervention arm group label list intervention arm group label LTBI and DM LTBI without DM intervention type Drug intervention name Isoniazid 300 Mg ORAL TABLET intervention description Isoniazid 300 mg daily for 6 months intervention arm group label list intervention arm group label LTBI and DM LTBI without DM outcomes module primary outcome list primary outcome primary outcome measure OGTT (oral glucose tolerance test) primary outcome description Reduction in plasma glucose area under the curve during OGTT primary outcome time frame Time Frame: 4-6 months (depending on treatment) secondary outcome list secondary outcome secondary outcome measure Changes in insulin production secondary outcome description Insulin/c-peptid, HOMA-B pre and post treatment secondary outcome time frame Time Frame: 4-6 months (depending on treatment) secondary outcome measure Changes in insulin resistance secondary outcome description HOMA-IR pre and post treatment secondary outcome time frame Time Frame: 4-6 months (depending on treatment) secondary outcome measure Changes in low-grade inflammatory markers and in adipokines secondary outcome description A panel of cytokines and adipokines secondary outcome time frame Time Frame: 4-6 months (depending on treatment) secondary outcome measure INF-gamma change secondary outcome description Changes in IFN-γ levels after incubation with saline solution, TB antigen or phytohemagglutinin A Pre, during and post treatment secondary outcome time frame Time Frame: 4-6 months (depending on treatment) secondary outcome measure Changes in body composition secondary outcome description Body composition pre and post treatment measured with DEXA-scanning and/or bioimpedance secondary outcome time frame Time Frame: 4-6 months (depending on treatment) eligibility module eligibility criteria Inclusion Criteria: Inclusion criteria for the LTBIDM arm: 18+ years Known DM type 2 Inclusion criteria for LTBI arm 18+ years LTBI positive No diagnosis with or known DM (1 and 2) Exclusion Criteria (both arms) : Previous treatment for TB or LTBI Pregnancy Type 1 DM Known immunosuppression such as: HIV, steroid treatment within 14 days before inclusion, daily NSAID treatment, ongoing chemotherapy, ongoing immunomodulating treatment or splenectomy Known contraindication to both study drugs Known active liver disease Known severe inflammatory or rheumatological diseases with immune activation and need for prolonged systemic treatment such as IBD, RA, Psoriasis and Wegners granulomatosis Recent antibiotic treatment (>2 days) or severe infection within 14 days before enrollment Known active cancer healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Niklas Lorentsson, MD central contact role Contact central contact phone 31617979 central contact e mail [email protected] central contact name Pernille Ravn, ass.Prof central contact role Contact central contact e mail [email protected] location list location location facility Herlev-Gentofte Hospital location status Recruiting location city Copenhagen location country Denmark location contact list location contact location contact name Niklas Lorentsson, MD location contact role Contact location contact phone 31617979 location contact e mail [email protected] location contact name Pernille Ravn, ass.Prof location contact role Contact location contact e mail [email protected] derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000014376 condition mesh term Tuberculosis condition mesh id D000055985 condition mesh term Latent Tuberculosis condition mesh id D000003924 condition mesh term Diabetes Mellitus, Type 2 condition mesh id D000007249 condition mesh term Inflammation condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000009164 condition ancestor term Mycobacterium Infections condition ancestor id D000000193 condition ancestor term Actinomycetales Infections condition ancestor id D000016908 condition ancestor term Gram-Positive Bacterial Infections condition ancestor id D000001424 condition ancestor term Bacterial Infections condition ancestor id D000001423 condition ancestor term Bacterial Infections and Mycoses condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000003920 condition ancestor term Diabetes Mellitus condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000085343 condition ancestor term Latent Infection condition browse leaf list condition browse leaf condition browse leaf id M6271 condition browse leaf name Diabetes Mellitus, Type 2 condition browse leaf as found Diabetes Mellitus, Type 2 condition browse leaf relevance high condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M16279 condition browse leaf name Tuberculosis condition browse leaf as found Tuberculosis condition browse leaf relevance high condition browse leaf id M9445 condition browse leaf name Inflammation condition browse leaf as found Inflammation condition browse leaf relevance high condition browse leaf id M27563 condition browse leaf name Latent Tuberculosis condition browse leaf as found Latent Tuberculosis condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M11271 condition browse leaf name Mycobacterium Infections condition browse leaf relevance low condition browse leaf id M3874 condition browse leaf name Bacterial Infections condition browse leaf relevance low condition browse leaf id M18404 condition browse leaf name Gram-Positive Bacterial Infections condition browse leaf relevance low condition browse leaf id M11288 condition browse leaf name Mycoses condition browse leaf relevance low condition browse leaf id M3873 condition browse leaf name Bacterial Infections and Mycoses condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000012293 intervention mesh term Rifampin intervention mesh id D000007538 intervention mesh term Isoniazid intervention ancestor list intervention ancestor intervention ancestor id D000000904 intervention ancestor term Antibiotics, Antitubercular intervention ancestor id D000000995 intervention ancestor term Antitubercular Agents intervention ancestor id D000000900 intervention ancestor term Anti-Bacterial Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention ancestor id D000007917 intervention ancestor term Leprostatic Agents intervention ancestor id D000019384 intervention ancestor term Nucleic Acid Synthesis Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000065695 intervention ancestor term Cytochrome P-450 CYP2B6 Inducers intervention ancestor id D000065693 intervention ancestor term Cytochrome P-450 Enzyme Inducers intervention ancestor id D000065696 intervention ancestor term Cytochrome P-450 CYP2C8 Inducers intervention ancestor id D000065697 intervention ancestor term Cytochrome P-450 CYP2C19 Inducers intervention ancestor id D000065698 intervention ancestor term Cytochrome P-450 CYP2C9 Inducers intervention ancestor id D000065701 intervention ancestor term Cytochrome P-450 CYP3A Inducers intervention ancestor id D000054872 intervention ancestor term Fatty Acid Synthesis Inhibitors intervention ancestor id D000000960 intervention ancestor term Hypolipidemic Agents intervention ancestor id D000000963 intervention ancestor term Antimetabolites intervention ancestor id D000057847 intervention ancestor term Lipid Regulating Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M14270 intervention browse leaf name Rifampin intervention browse leaf as found Gender intervention browse leaf relevance high intervention browse leaf id M9722 intervention browse leaf name Isoniazid intervention browse leaf as found S-1 intervention browse leaf relevance high intervention browse leaf id M3374 intervention browse leaf name 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All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Lipd intervention browse branch name Lipid Regulating Agents
NCT04830462
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full study rank 61275 study protocol section identification module n c t id NCT04838587 org study id info org study id 1091-2020 organization org full name Centre for Infectious Disease Research in Zambia org class OTHER brief title An Epidemiological Surveillance Study to Determine the Incidence of ETEC in Children and Infants in Lusaka official title An Epidemiological Surveillance Study to Determine the Incidence of ETEC in Children and Infants in Lusaka. acronym ETEC-Surv status module status verified date July 2022 overall status Completed expanded access info has expanded access No start date struct start date October 15, 2020 start date type Actual primary completion date struct primary completion date October 15, 2021 primary completion date type Actual completion date struct completion date October 15, 2021 completion date type Actual study first submit date February 5, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 19, 2022 last update post date struct last update post date July 20, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Centre for Infectious Disease Research in Zambia lead sponsor class OTHER collaborator list collaborator collaborator name European and Developing Countries Clinical Trials Partnership (EDCTP) collaborator class OTHER_GOV collaborator name Scandinavian Biopharma AB collaborator class INDUSTRY collaborator name Göteborg University collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Diarrhoea is the one of the top five leading causes of death among children below the age of five years, globally. It is estimated that one in ten deaths in children under five is attributed to diarrhoea. Enterotoxigenic E.coli (ETEC) is one of the major causative agents of moderate-to-severe (MSD) diarrhoea among children both globally and in Zambia. The overall aim of this study is to document the burden of ETEC associated diarrhoea in Zambian children under 3 years of age. detailed description This study seeks to determine diarrhoea aetiology, calculate the incidence of moderate-to-severe ETEC-associated diarrhea, and describe the frequency of ETEC colonization factors and enterotoxin types in children under 3 years old in Zambia. These data are required for the design of an anticipated phase 3 trial of the leading ETEC vaccine (ETVAX®) that will be evaluated in Zambia from 2021 onwards. The following are the research questions that this study seeks to answer: What is the incidence of MSD with confirmed ETEC aetiology in children under three years old in Zambia? What are the prevalent colonization toxins and factors (CFs) in diarrhoeagenic isolates of ETEC infections in children in Zambia? What are the other common pathogens causing diarrhoea in Zambian children? This prospective, observational, longitudinal study is proposed at five health facilities in Lusaka. The proposed study sites are Chawama, George, Kanyama, Chainda, and Matero Health Facilities. These facilities are located within typical peri-urban settlements of Lusaka and serves communities with a cumulative total population of over 1 million people. The study will be done in two stages beginning with a household census in the study catchment area of the participating health facilities and then followed by the passive diarrhoea surveillance stage. A surveillance system for passive case detection of diarrhoea will be set up at each facility for the 12-months of the project to detect any seasonal variations of disease burden. Prior to commencement, several community sensitization activities will be conducted within the catchment areas of the health facility. A stool sample will be collected from each participant who presents to the health facility and is eligible for enrollment. All research samples will be collected at the study site and laboratory assays will be performed as per written SOPs and will be a part of the study documentation. All the samples will be processed in Zambia using the Novodiag® platform. The Novodiag® (Mobidiag Ltd, Finland) is a novel multiplex molecular platform that is based on real-time PCR and microarray technology and can identify various gastroenteritis causing bacteria, parasites and viruses as well as carry out antimicrobial resistance gene testing of organisms. conditions module condition list condition Diarrhea Toddlers Escherichia Coli Diarrhea keyword list keyword Incidence Epidemiology design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective bio spec bio spec retention Samples With DNA bio spec description faecal specimen enrollment info enrollment count 6828 enrollment type Actual arms interventions module arm group list arm group arm group label 6750 Children <3 years ( 5 sites) arm group description A total of 6750 children from the will be identified from the respective health facility catchment area during the Census stage of the study. Each of the 5 health facilities will identify 1350 children under 3 years of age in their respective catchment area. During the Surveillance stage, the participants will be enrolled into the study if and when they present with diarrhoea at the Health facility. arm group intervention list arm group intervention name Other: No intervention will be done intervention list intervention intervention type Other intervention name No intervention will be done intervention description No intervention,Only passive surveillance of Diarrhoea cases will be done intervention arm group label list intervention arm group label 6750 Children <3 years ( 5 sites) outcomes module primary outcome list primary outcome primary outcome measure Incidence of MSD ETEC diarrhoea in Zambia. primary outcome description Number of cases of moderate to severe diarrhoea (MSD) with confirmed ETEC aetiology in children under 3 years old in Zambia and the risk factors for ETEC diarrhoea primary outcome time frame 12 months secondary outcome list secondary outcome secondary outcome measure Virulence factors of ETEC isolates secondary outcome description The prevalent ETEC virulence factors (LT, STh and STp ) and colonisation factors (CFA/I, CS1, CS2, CS3, CS4, CS5, CS6, CS7, CS8, CS12, CS14, CS17) in diarrhoeagenic isolates of ETEC. secondary outcome time frame 12 months secondary outcome measure The common pathogens causing MSD in children less than 3 years secondary outcome description Number of diarrhoea cases due to Shigella, campylobacter coli/jejuni, Clostridium difficile, EAEC, EHEC, EPEC, Salmonella, Vibrio cholerae, Vibrio parahaemolyticus and Yersinia enterocolitica. secondary outcome time frame 12 months secondary outcome measure Seasonality of ETEC diarrhoea secondary outcome description The incidence of ETEC positive diarrhoea cases per month for 1 year. secondary outcome time frame 12 months secondary outcome measure Antimicrobial resistance pattern of ETEC secondary outcome description AMR pattern for ETEC will be determined by presence or absence of 9 major carbapenemases genes (KPC, NDM, VIM, IMP, OXA-23, OXA-24, OXA-48/181, OXA-51, OXA-58) secondary outcome time frame 12 months eligibility module eligibility criteria Inclusion Criteria: A child < 36 months old at the time of enrolment. A child presenting with diarrhoea (i.e. > 3 episodes of looser than normal stools in 24 hours) at a health facility within the study catchment area and in possession of a study ID number. Parents of eligible children, able to understand the study information and give informed consent by signature or thumbprint. (NB. illiterate participants will be able to give consent in the presence of an impartial witness) Children living within the study catchment area served by each participating health facility and in possession of a study ID number The parent/s who is willing to comply with all stipulated study procedures. Parents who are willing to allow their child to submit a stool sample for testing. Exclusion Criteria: Children presenting to the health facility without a study ID number Any child born after the Census has taken place Any child currently participating in the OEV124 study healthy volunteers Accepts Healthy Volunteers gender All maximum age 36 Months std age list std age Child study population This study is a multi-site longitudinal observation study, to be conducted at Matero First Level Hospital, Chawama First Level Hospital, George Clinic, Kanyama First Level Hospital and Chainda clinic in Lusaka. The facilities are situated in a typical peri-urban settlement area of Lusaka and serves a community with a combined population of about 1 million. We assume that all sites have similar incidence of ETEC diarrhoea, therefore, each of the 5 sites will enroll 1350 children bringing our total sample size for the study to 6,750 participants. sampling method Probability Sample contacts locations module overall official list overall official overall official name Roma Chilengi, MBChB overall official affiliation Centre for Infectious Disease Research in Zambia overall official role Principal Investigator overall official name Monde Muyoyeta, MBChB overall official affiliation Centre for Infectious Disease Research in Zambia overall official role Principal Investigator location list location location facility Chawama First level hospital location city Lusaka location zip 10101 location country Zambia location facility George Clinic location city Lusaka location zip 10101 location country Zambia location facility Kanyama First Level Hospital location city Lusaka location zip 10101 location country Zambia location facility Matero Clinical Research Site, Chainda South CRS location city Lusaka location zip 10101 location country Zambia i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004927 condition mesh term Escherichia coli Infections condition mesh id D000003967 condition mesh term Diarrhea condition ancestor list condition ancestor condition ancestor id D000012817 condition ancestor term Signs and Symptoms, Digestive condition ancestor id D000004756 condition ancestor term Enterobacteriaceae Infections condition ancestor id D000016905 condition ancestor term Gram-Negative Bacterial Infections condition ancestor id D000001424 condition ancestor term Bacterial Infections condition ancestor id D000001423 condition ancestor term Bacterial Infections and Mycoses condition ancestor id D000007239 condition ancestor term Infections condition browse leaf list condition browse leaf condition browse leaf id M6311 condition browse leaf name Diarrhea condition browse leaf as found Diarrhea condition browse leaf relevance high condition browse leaf id M7229 condition browse leaf name Escherichia coli Infections condition browse leaf as found Escherichia Coli condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14774 condition browse leaf name Signs and Symptoms, Digestive condition browse leaf relevance low condition browse leaf id M7070 condition browse leaf name Enterobacteriaceae Infections condition browse leaf relevance low condition browse leaf id M3874 condition browse leaf name Bacterial Infections condition browse leaf relevance low condition browse leaf id M18401 condition browse leaf name Gram-Negative Bacterial Infections condition browse leaf relevance low condition browse leaf id M11288 condition browse leaf name Mycoses condition browse leaf relevance low condition browse leaf id M3873 condition browse leaf name Bacterial Infections and Mycoses condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC01 condition browse branch name Infections
NCT04838587
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full study rank 61771 study protocol section identification module n c t id NCT04832139 org study id info org study id B7841009 secondary id info list secondary id info secondary id 2020-004369-38 secondary id type EudraCT Number organization org full name Pfizer org class INDUSTRY brief title A Study of Marstacimab to Compare Prefilled Pen (PFP) Device to Prefilled Syringe (PFS) Device official title A PHASE 1, OPEN-LABEL, RANDOMIZED, 4-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF MARSTACIMAB (PF-06741086) PREFILLED SYRINGE DEVICE AND PREFILLED PEN DEVICE FOLLOWING SUBCUTANEOUS ADMINISTRATION IN HEALTHY ADULT MALE PARTICIPANTS status module status verified date July 2022 overall status Terminated why stopped The study was terminated due to a change in the benefit/risk assessment for the further administration of marstacimab in a healthy volunteer population. expanded access info has expanded access No start date struct start date March 30, 2021 start date type Actual primary completion date struct primary completion date November 22, 2021 primary completion date type Actual completion date struct completion date November 22, 2021 completion date type Actual study first submit date March 26, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 7, 2022 last update post date struct last update post date July 11, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Pfizer lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary The goal in this study is to show that there are not significant differences in biologic activity of the study drug when administered using either the prefilled pen and prefilled syringe. conditions module condition list condition Healthy Volunteers keyword list keyword Bioequivalence Phase 1 Prefilled Pen Prefilled syringe pharmacokinetic subcutaneous hemophilia design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Basic Science design masking info design masking None (Open Label) enrollment info enrollment count 22 enrollment type Actual arms interventions module arm group list arm group arm group label Marstacimab Prefilled Pen (PFP), then marstacimab Preflled Syringe (PFS) arm group type Experimental arm group description Participants will first receive single dose PFP, then PFS, then repeating single dose PFP, then single dose PFS with a minimum of 21 days between single doses. arm group intervention list arm group intervention name Drug: Marstacimab PFP Drug: Marstacimab PFS arm group label Marstacimab PFS, then marstacimab PFP arm group type Experimental arm group description Participants will first receive single dose PFS, then PFP, then repeating single dose PFS, then single dose PFP with a minimum of 21 days between single doses. arm group intervention list arm group intervention name Drug: Marstacimab PFP Drug: Marstacimab PFS intervention list intervention intervention type Drug intervention name Marstacimab PFP intervention description 300 milligrams (mg) subcutaneous injection marstacimab PFP intervention arm group label list intervention arm group label Marstacimab PFS, then marstacimab PFP Marstacimab Prefilled Pen (PFP), then marstacimab Preflled Syringe (PFS) intervention other name list intervention other name PF-06741086 intervention type Drug intervention name Marstacimab PFS intervention description 300 mg subcutaneous injection of marstacimab PFS intervention arm group label list intervention arm group label Marstacimab PFS, then marstacimab PFP Marstacimab Prefilled Pen (PFP), then marstacimab Preflled Syringe (PFS) intervention other name list intervention other name PF-06741086 outcomes module primary outcome list primary outcome primary outcome measure Area Under the plasma concentraiton time Curve from time zero extrapolated to infinite time (AUCinf) primary outcome time frame Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose primary outcome measure Maximum observed plasma concentration (Cmax) primary outcome time frame Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose secondary outcome list secondary outcome secondary outcome measure Area under the concentration time curve from time 0 to time of last quatifiable concenteration secondary outcome time frame Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose secondary outcome measure Time for Cmax secondary outcome time frame Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose secondary outcome measure Apparent clearance after subcutaneous dose secondary outcome time frame Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose secondary outcome measure Apparent volume of distribution after subcutaneous dose secondary outcome time frame Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose secondary outcome measure Terminal half-life after subcutaneous dose secondary outcome time frame Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose secondary outcome measure Incidence of clinically significant laboratory value abnormalities secondary outcome time frame Baseline through the end of study, approximately 161 days secondary outcome measure Incidence of anti-drug antibody against marstacimab secondary outcome time frame From Day 1, Period 1 through Day 21, Period 4 over a total of 84 days secondary outcome measure Incidence of Adverse Events secondary outcome time frame Baseline through the end of study, approximately 161 days secondary outcome measure Incidence of neutralizing antibody against marstacimab secondary outcome time frame From Day 1, Period 1 through Day 21, Period 4 over a total of 84 days secondary outcome measure Incidence of Serious Adverse Events secondary outcome time frame Baseline through the end of study, approximately 161 days eligibility module eligibility criteria Inclusion Criteria: Male participants who are overtly healthy as determined by medical evaluation Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. BMI of 17.5 to 30.5 kg/m2; and a total body weight ≥ 50 kg (110 lb). Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease Any condition possibly affecting drug absorption (eg, conditions affecting SC administration) Previous or current treatment for and/or history of coronary artery diseases, venous or arterial thrombosis, or ischemic disease. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb or HCVAb Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality or COVID-19 related condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). A positive urine drug test at screening and/or admission Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results Participants with ANY of the following abnormalities in clinical laboratory tests at screening: AST or ALT level ≥1.5 × ULN; Total bilirubin level ≥1.5 × ULN. An estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 based on the CKD-EPI equation. Resistance to activated protein C (or Factor V Leiden mutation), prothrombin 20210 mutation, antithrombin III deficiency, protein C deficiency, or protein S deficiency. Presence of Lupus anticoagulant anti-cardiolipin antibodies (IgG, IgM or IgA) High sensitivity C-reactive protein (hsCRP) above the upper limits of normal Abnormal hematology values as defined by the following laboratory tests at Screening and/or admission: Platelet count <100,000/uL Hemoglobin level <10 g/dL A positive COVID-19 test. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of the protocol Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members healthy volunteers Accepts Healthy Volunteers gender Male gender based Yes minimum age 18 Years maximum age 55 Years std age list std age Adult contacts locations module overall official list overall official overall official name Pfizer CT.gov Call Center overall official affiliation Pfizer overall official role Study Director location list location location facility Brussels Clinical Research Unit location city Brussels location state Bruxelles-capitale, Région DE location zip B-1070 location country Belgium references module see also link list see also link see also link label To obtain contact information for a study center near you, click here. see also link u r l https://pmiform.com/clinical-trial-info-request?StudyID=B7841009 i p d sharing statement module i p d sharing No i p d sharing description Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id T2710 condition browse leaf name Hemophilia condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev Rare condition browse branch name Rare Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04832139
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full study rank 61214 study protocol section identification module n c t id NCT04839380 org study id info org study id INCB 18424-901 organization org full name Incyte Corporation org class INDUSTRY brief title The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis official title An Open-Label, Single-Arm Study to Evaluate the Effect of Ruxolitinib 1.5% Cream on Itch in Adult Participants With Atopic Dermatitis acronym SCRATCH-AD status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date October 11, 2021 start date type Actual primary completion date struct primary completion date November 6, 2022 primary completion date type Anticipated completion date struct completion date November 21, 2022 completion date type Anticipated study first submit date April 8, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 12, 2022 last update post date struct last update post date July 13, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Incyte Corporation lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in participants with Atopic Dermatitis. conditions module condition list condition Atopic Dermatitis keyword list keyword ruxolitinib Itch Chronic Pruritus design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) design masking description Open Label enrollment info enrollment count 48 enrollment type Anticipated arms interventions module arm group list arm group arm group label Treatment Group : Ruxolitinib arm group type Experimental arm group description ruxolitinib cream 1.5% will be applied twice daily as a thin film. arm group intervention list arm group intervention name Drug: ruxolitinib cream intervention list intervention intervention type Drug intervention name ruxolitinib cream intervention description ruxolitinib cream 1.5% will be applied twice daily as a thin film intervention arm group label list intervention arm group label Treatment Group : Ruxolitinib intervention other name list intervention other name INCB018424 outcomes module primary outcome list primary outcome primary outcome measure Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline primary outcome description PP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable". Participants will be evaluated by asking to assign a numerical score representing their itch at the worst moment during the previous 24 hours. primary outcome time frame 2 Days secondary outcome list secondary outcome secondary outcome measure modified Peak Pruritus Numerical Rating Scale (mPP-NRS) secondary outcome description mPP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable". Participants will be asked to evaluate the current intensity of their itch at the time of assessment. secondary outcome time frame 1 Day secondary outcome measure Change in Peak Pruritus Numerical Rating Scale (PPR-NRS) from baseline secondary outcome description PP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable". Participants will be evaluated by asking to assign a numerical score representing their itch at the worst moment during the previous 24 hours. secondary outcome time frame Day 3 through Day 29 secondary outcome measure 1-grade decrease in mPP-NRS secondary outcome description Define as proportion of participants achieving at least a 1-grade decrease from baseline in mPP-NRS. secondary outcome time frame 1 Day secondary outcome measure 1-grade decrease in PP-NRS secondary outcome description Define as proportion of participants achieving at least a 1-grade decrease from baseline in PP-NRS. secondary outcome time frame Day 2 through Day 29 secondary outcome measure 2-grade decrease in mPP-NRS secondary outcome description Define as proportion of participants achieving at least a 2-grade decrease from baseline in mPP-NRS. secondary outcome time frame 1 Day secondary outcome measure 2-grade decrease in PP-NRS secondary outcome description Define as proportion of participants achieving at least a 2-grade decrease from baseline in PP-NRS. secondary outcome time frame Day 2 through Day 29 secondary outcome measure Time to achieve Minimal Clinically Important Difference (MCID) secondary outcome description Defined as ≥ 2-grade reduction in PP-NRS and mPP-NRS from baseline. secondary outcome time frame 29 Days secondary outcome measure Change in Investigator Global Assessment (IGA) from baseline secondary outcome description The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. secondary outcome time frame Days 8,15, and 29 secondary outcome measure Proportion of participants achieving the Investigator Global Assessment-Treatment Success (IGA-TS) secondary outcome description Defined as IGA score of 0 or 1 in IGA with at least a 2-grade reduction from baseline. secondary outcome time frame Days 8, 15, and 29 secondary outcome measure Incidence and severity of local and systemic Adverse Events (AEs) secondary outcome description Local and systemic Adverse Events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. secondary outcome time frame Up to 85 Days eligibility module eligibility criteria Inclusion Criteria: Participant has clinically confirmed diagnosis of active AD for at least a 6-months. Participant has chronic pruritus related to AD for at least 3 months . Participant has an overall BSA (excluding palms, soles, scalp, genitals, and folds) affected by AD of 1%-20% on Day 1. Participant has an IGA score of at least 2 on Day 1. Participant has a single PP-NRS score ≥ 4 in the 24-hour period prior to the screening visit. Willingness to avoid pregnancy or fathering children. Participant must be willing to comply with all study procedures and restrictions including discontinuation of all current therapies for AD and pruritus (unless otherwise specified), and must be available for the duration of the study. Exclusion Criteria: Female participnat who is breastfeeding, pregnant, or planning to become pregnant during the study. Participant had significant flares or unstable course in AD. Participant has clinically infected AD or has used antibiotics (systemic or topical) for their infected AD within 2 weeks prior to the run-in period. Participant has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments. Participant has any clinically significant medical condition or physical/laboratory/vital sign abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results. Participant has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the run-in period. Participant is unlikely, in the opinion of the investigator, to be compliant with study procedures and requirements. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Incyte Corporation Call Center (US) central contact role Contact central contact phone 1.855.463.3463 central contact e mail [email protected] central contact name Incyte Corporation Call Center (ex-US) central contact role Contact central contact phone +800 00027423 central contact e mail [email protected] location list location location facility Innovoderm Research location status Recruiting location city Montreal location state Quebec location zip H2K 4LS location country Canada i p d sharing statement module i p d sharing Yes i p d sharing description Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) i p d sharing time frame Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications. i p d sharing access criteria Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement. i p d sharing u r l https://www.incyte.com/our-company/compliance-and-transparency derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003876 condition mesh term Dermatitis, Atopic condition mesh id D000003872 condition mesh term Dermatitis condition mesh id D000004485 condition mesh term Eczema condition ancestor list condition ancestor condition ancestor id D000012871 condition ancestor term Skin Diseases condition ancestor id D000012873 condition ancestor term Skin Diseases, Genetic condition ancestor id D000030342 condition ancestor term Genetic Diseases, Inborn condition ancestor id D000017443 condition ancestor term Skin Diseases, Eczematous condition ancestor id D000006969 condition ancestor term Hypersensitivity, Immediate condition ancestor id D000006967 condition ancestor term Hypersensitivity condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M6219 condition browse leaf name Dermatitis condition browse leaf as found Dermatitis condition browse leaf relevance high condition browse leaf id M13548 condition browse leaf name Pruritus condition browse leaf relevance low condition browse leaf id M6223 condition browse leaf name Dermatitis, Atopic condition browse leaf as found Atopic Dermatitis condition browse leaf relevance high condition browse leaf id M6807 condition browse leaf name Eczema condition browse leaf as found Atopic Dermatitis condition browse leaf relevance high condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse leaf id M14828 condition browse leaf name Skin Diseases, Genetic condition browse leaf relevance low condition browse leaf id M22839 condition browse leaf name Genetic Diseases, Inborn condition browse leaf relevance low condition browse leaf id M18864 condition browse leaf name Skin Diseases, Eczematous condition browse leaf relevance low condition browse leaf id M9170 condition browse leaf name Hypersensitivity condition browse leaf relevance low condition browse leaf id M9172 condition browse leaf name Hypersensitivity, Immediate condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04839380
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full study rank 61569 study protocol section identification module n c t id NCT04834765 org study id info org study id TVanLith organization org full name Florida State University org class OTHER brief title Mindfulness-Based Art Therapy and Generation Z official title Using the Arts as a Proactive Mental Health Strategy for Generation Z status module status verified date April 2022 overall status Completed expanded access info has expanded access No start date struct start date April 5, 2020 start date type Actual primary completion date struct primary completion date February 22, 2022 primary completion date type Actual completion date struct completion date April 5, 2022 completion date type Actual study first submit date March 17, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 4, 2022 last update post date struct last update post date April 5, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Theresa Van Lith responsible party investigator title Associate Professor & Clinical Coordinator of Art Therapy responsible party investigator affiliation Florida State University lead sponsor lead sponsor name Florida State University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary A randomized controlled trial will be conducted to determine the unique role of the arts as a proactive mental health strategy for college students in Generation Z. Arts-only, mindfulness-only, and arts-based mindfulness interventions as they compare to a non-intervention control group. These interventions will be delivered using a minimal contact, web-based approach. Psychological and physiological outcomes will be measured to determine if arts-related interventions activate unique and distinguishable mechanisms of change compared to the mindfulness only intervention and non-intervention control groups. In addition, protective effects will be assessed based on student participants' response to an acute academic stress simulation. Qualitative data in the form of transcribed exit interviews will be analyzed to characterize the unique needs of Generation Z students, along with level of engagement, intervention acceptance and satisfaction. detailed description To reach the general population of college students, a technology-assisted approach is paramount. This multidisciplinary project will tease apart the mechanisms of change and implications of employing art therapy approaches for anxiety and stress reduction in college students at much more nuanced level than previously tested using the MBAT approach designed and comparing it to its main components as isolated interventions. Based on the previous two studies and the accumulated research explored, the following study aims and hypotheses will guide the proposed study. These are: Aim 1. To examine the psychological and physiological differences between an Mindfulness-based Art Therapy (MBAT) intervention, its components as isolated Art-Only (AO) and Mindfulness-Only (MO) interventions, and a non-intervention control (C) using a minimal contact, web-based approach with students in Generation Z. Hypothesis 1: MBAT, AO, and MO will produce distinguishable differences in participant outcomes related to anxiety and stress symptomology, protective factors against chronic stress, and the biological stress response compared to a non-intervention control. Aim 2. To evaluate how these interventions affect participants' responses to an acute academic stress simulation using the TSST paradigm. Hypothesis 2: Results of self-report assessments and saliva samples collected during the acute academic stress simulation will produce distinguishable differences between group conditions, suggesting that the art-based interventions engage unique mechanisms of change compared to the Mindfulness-Only intervention. Aim 3. To determine which intervention produces the greatest participant satisfaction and acceptance. Hypothesis 3: Participants of the MBAT and AO interventions will report higher levels of study engagement, overall study satisfaction, and intervention acceptance compared to participants of the MO intervention and non-intervention control group conditions. B. Research Design The study will investigate the fundamental science underlying MBAT, a specific evidence-based form of therapy that includes mindfulness practices like meditation and yoga, and art therapy. The application of MBAT as a proactive mental health strategy in a pragmatic real-world setting is urgently needed, particularly given the stigma that surrounds mental health. The multidisciplinary team includes detailed expertise in art therapy, clinical psychology, mindfulness, and biological mechanisms. The study will involving using simple but validated psychological and biological measures to evaluate relatively brief, technology-assisted art-based mindfulness. The study will involve conducting a randomized control research design to meet the specific aims proposed. College students will be randomized into one of four group conditions: 1) MBAT; 2) AO; 3) MO; or 4) C. Interventions will be administered using Canvas, the pre-existing learning management system of Florida State University. Students will be able to join the study on Canvas, complete the self-report measures, and receive nearly all of the intervention material virtually, eliminating several of the issues with current mental health programs. There are no studies that specifically examine the effects of mindfulness based art therapy on inflammation or stress mediators besides our preliminary findings (Beerse et al., 2019). Biological research in art therapy to date has been limited to cortisol analysis alone, with a focus on the impact of different art materials on physiological stress. The proposed study will identify several interrelated biological systems influenced by the intervention and position us to isolate key mechanistic processes. Importantly, the study will involve using non-invasive biological sampling of saliva and will use the TSST to mimic acute academic stress; neither approach has been applied to MBAT. Additionally, minimal research has been conducted on the application of MBAT with young adults except studies related to serious health diagnoses such as cancer, palliative care, or heart disease. Therefore, this project addresses this gap in research using a research strategy that studies a general population, ensures easy reproducibility, and promotes the advancement of related innovative practices in arts research. The proposed approach thus has the potential to innovate the delivery of a cost-effective and efficacious alternative therapy that could reduce the societal burden of mental health symptoms and build resiliency among young adults. conditions module condition list condition Anxiety Depression keyword list keyword Stress design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Factorial Assignment design intervention model description 3 intervention groups- Mindfulness only, Art Therapy only and combined Mindfulness based Art Therapy. 1 control group. design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 86 enrollment type Actual arms interventions module arm group list arm group arm group label Mindfulness arm group type Active Comparator arm group description Participants will be engaging in a mindfulness tasks twice per week for 5 weeks in which they will learn techniques through the use of yoga, meditation and breathwork. arm group intervention list arm group intervention name Other: Mindfulness-only arm group label Art Therapy arm group type Active Comparator arm group description Participants will engage in art therapy with the use of clay twice per week through prompts. arm group intervention list arm group intervention name Other: Art-only arm group label Mindfulness based Art Therapy arm group type Active Comparator arm group description Participants will engage in both mindfulness activities and art therapy twice per week and will learn techniques through the use of yoga, mediation, breathwork and art. arm group intervention list arm group intervention name Other: Mindfulness-based art therapy arm group label Control Group arm group type No Intervention arm group description Participants will go about daily life as usual. intervention list intervention intervention type Other intervention name Mindfulness-based art therapy intervention description The researchers developed a novel MBAT intervention consisting of 10 easily reproducible, clay-based MBAT directives, administered through an online platform delivery strategy. By developing an MBAT intervention that uses an online delivery strategy, the researchers realized it may have the potential of decreasing demands placed on counseling centers. intervention arm group label list intervention arm group label Mindfulness based Art Therapy intervention type Other intervention name Art-only intervention description The AO modules consist of an open-ended art-making exercise, with minimal direction. The AO intervention is designed as an 'art for art's sake' intervention with the focus on the art-making and less on outcome or product. Participants are asked to pull their ball of clay out and spend ten minutes creating a form from the clay to visually express their experience in the present moment. intervention arm group label list intervention arm group label Art Therapy intervention type Other intervention name Mindfulness-only intervention description The MO modules consist of only the mindfulness practices from the ABM intervention. The participants to follow along with a five-minute light yoga sequence, where asanas (yoga postures) are cued with breath. Yoga, for the purposes of the study, is explicitly defined to participants as the unity of breath with body movement. Poses were chosen based on their accessibility to a variety of body types and abilities, and chosen because they are documented to aid in grounding, increased haptic awareness, lowered levels of stress and anxiety, and restoration. intervention arm group label list intervention arm group label Mindfulness outcomes module primary outcome list primary outcome primary outcome measure IL-6 Saliva Elisa primary outcome description Tests for levels human Interleukin-6 primary outcome time frame Change from Week 1 to twice during Week 5 conducted before and after TSST primary outcome measure Salimetrics Cortisol EIA Test primary outcome description Tests for salivary cortisol levels primary outcome time frame Change from Week 1 to twice during Week 5 conducted before and after TSST secondary outcome list secondary outcome secondary outcome measure Generalized Anxiety Disorder 7 (GAD-7)- Spitzer et al. 2006 secondary outcome description Assesses anxiety symptoms. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity. Scores above 10 are considered to be in the clinical range. secondary outcome time frame Within first four weeks before study commences, then change from Week 1, to during Week 5, and then to 6 week follow-up secondary outcome measure Somatic Symptom Scale 8 (SSS-8)- Gierk et al. 2014 (A brief version of the popular Patient Health Questionnaire - 15) secondary outcome description Assesses presence and severity of common somatic symptoms. A score of 0 to 3 points were classified as "no to minimal" severity, a score of 4 to 7 points as "low," a score of 8 to 11 points as "medium," a score of 12 to 15 points as "high," and a score of 16 points or higher as "very high." secondary outcome time frame Change from Week 1, to during Week 5, and then to 6 week follow-up secondary outcome measure Pittsburgh Sleep Quality Index (PSQI)- Buysse 1989 secondary outcome description Assesses sleep quality. The PSQI includes a scoring key for calculating a patient's seven sub scores, each of which can range from 0 to 3. The sub scores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. secondary outcome time frame Change from Week 1, to during Week 5, and then to 6 week follow-up secondary outcome measure 5 Facet Mindfulness Questionnaire Short Form (FFMQ)- Bohlmeijer et al. 2011 secondary outcome description Assesses 5 facets of mindfulness- observation, description, awareness of actions, non-judgement and non-reaction. Items scored on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true). Facet scores were computed by summing the scores on the individual items. Facet scores range from 8 to 40 (except for the nonreactivity facet, which ranges from 7 to 35), with higher scores indicating more mindfulness. secondary outcome time frame Change from Week 1, to during Week 5, and then to 6 week follow-up secondary outcome measure Perceived Stress Scale 10 (PSS-10)- Cohen, Kamarck and Mermelstein 2016 secondary outcome description Assesses perceptions of stress. PSS-10 scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. secondary outcome time frame Change from Week 1, to during Week 5, and then to 6 week follow-up secondary outcome measure Patient Health Questionnaire 9 (PHQ-9)- Kroenke et al. 1999 secondary outcome description Measures depression severity. This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 0- not at all, 1- several days, 2- more than half the days, 3- nearly every day, respectively. PHQ-9 total score for the nine items ranges from 0 to 27. 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression. secondary outcome time frame Change from Week 1, to during Week 5, and then to 6 week follow-up secondary outcome measure Oldenburg Burnout Inventory (OBI)- Demerouti & Bakker 2007 secondary outcome description Assesses burnout via disengagement and exhaustion. The subject is presented with a series of 16 statements, which they may agree or disagree with and is asked to indicate the degree of agreement or disagreement. The 16 items are divided between two subscales, the items are also summed to form two sub-totals. Disengagement items: 1, 3, 6, 7, 9, 11, 13 and 15; Exhaustion items: 2, 4, 5, 8, 10, 12, 14 and 16. For items 2, 3, 4, 6, 8, 9, 11 and 12, the scale is reversed, with Strongly Agree answers scoring 4 and Strongly Disagree answers scoring 1. A total OLBI score can be reached by summing the two sub-totals. The higher the score, the greater the level of burnout. Some therapists may categorize the OLBI scores under low, medium or high but no widespread consensus exists. secondary outcome time frame Change from Week 1, to during Week 5, and then to 6 week follow-up secondary outcome measure The DSM-5 Level 1 Cross-Cutting Symptom Measure (DSM5_Level 1) secondary outcome description Consists of 23 questions that assess 13 psychiatric domains, including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. Nineteen of the 25 items on the measure are each rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). The higher the score the more severity of the symptoms. The suicidal ideation, suicide attempt, and substance abuse items are each rated on a "Yes, No, or Don't Know" scale. secondary outcome time frame Within first four weeks before study commences eligibility module eligibility criteria Inclusion Criteria: Enrolled full time in an academic program at Florida State University and fit within age category of Generation Z Exclusion Criteria: Regular tobacco smoking and over the age of 25 healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 25 Years std age list std age Adult contacts locations module overall official list overall official overall official name Theresa Van Lith, PhD overall official affiliation Florida State University overall official role Principal Investigator location list location location facility Florida State University location city Tallahassee location state Florida location zip 32308 location country United States references module reference list reference reference p m i d 34479649 reference type derived reference citation Van Lith T, Cheshure A, Pickett SM, Stanwood GD, Beerse M. Mindfulness based art therapy study protocol to determine efficacy in reducing college stress and anxiety. BMC Psychol. 2021 Sep 3;9(1):134. doi: 10.1186/s40359-021-00634-2. document section large document module large doc list large doc large doc type abbrev ICF large doc has protocol No large doc has s a p No large doc has i c f Yes large doc label Informed Consent Form large doc date August 31, 2020 large doc upload date 03/31/2021 01:31 large doc filename ICF_000.pdf derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003863 condition mesh term Depression condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf relevance low condition browse leaf id M3476 condition browse leaf name Anxiety Disorders condition browse leaf relevance low condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions
NCT04834765
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full study rank 61180 study protocol section identification module n c t id NCT04839822 org study id info org study id 2471/2020 organization org full name Medical University of Vienna org class OTHER brief title Efficacy of Edupression.Com® in Depressive Patients official title Efficacy of the Digital Self-help Programme Edupression.Com® Evaluated Within a Randomized Controlled Trial in Mild to Moderate Unipolar Depressive Patients acronym eFICASY status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 28, 2021 start date type Actual primary completion date struct primary completion date April 14, 2023 primary completion date type Anticipated completion date struct completion date April 14, 2023 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 21, 2022 last update post date struct last update post date July 26, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Lukas Pezawas responsible party investigator title Assoc.Prof. Priv.Doz. Dr. responsible party investigator affiliation Medical University of Vienna lead sponsor lead sponsor name Medical University of Vienna lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The aim of the study is to investigate the efficacy and adherence of the digital self-help programme edupression.com®. detailed description The edupression.com® self-help app is an evidence-based low-level psychosocial intervention, which a can be used as as monotherapy as first-line treatment in mild to moderate depressive patients or as complimentary treatment independent of previous therapy response or depression severity. The two foundations of edupression.com® are evidence-based psychoeducation with CBT elements, as well as self-monitoring in the mood chart. Evidence for the efficacy of this approach stems from a large body of literature regarding eHealth (healthcare services provided electronically via the internet) applications in depression. This study's aim is to investigate edupression.com®'s capability to improve the illness course directly by reducing depressive symptoms (primary objective) and indirectly by fostering positive health care effects (secondary objective). The reduction of relapse risk and other preventive effects expected from other studies are beyond the time frame of this study. Beyond the evaluation of edupression.com®, this study could elucidate the general role of psychoeducation and mood tracking in online mental health to improve depression symptoms and adherence. Objectives: The primary objective is to test the clinical efficacy (at least 50% symptom reduction over a 3-month period) of edupression.com® in mild to moderate unipolar depressed patients. The secondary objective is to demonstrate positive health care effects within this 3-month trial period such as psychoeducation, quality of life, patient empowerment and other factors. Study Design: The study design of this clinical trial is consistent with a monocentric, prospective, longitudinal, randomized controlled clinical trial. Patients, currently diagnosed with a mild to moderate major depressive episode (MDE) will be invited to use the digital self-help programme. Following the inclusion procedure, patients will be randomly assigned in a 1:1 ratio to two different treatment arms (A vs. B). Participants of the intervention arm will get full access to the edupression.com® website, while participants of the control arm will get access to a control version of edupression.com® limited to medically useful tips, that have not been shown to be effective in improving depressive symptoms in randomized controlled trials (RCTs). conditions module condition list condition Depressive; Episode, Major Recurrent Depressive Disorder, Current Episode Moderate Recurrent Depressive Disorder, Current Episode Mild keyword list keyword Depression Internet-Based Intervention Mobile Applications design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design masking description Participants are blinded with respect to the study arm and will unlikely determine if they are part of the intervention or active control. design who masked list design who masked Participant enrollment info enrollment count 154 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intervention Arm: Psychoeducation with elements of CBT & mood chart. arm group type Experimental arm group description Patients will receive full access to edupression.com® immediately after inclusion. This intervention includes all medical mechanisms of action of edupression.com®: Psychoeducation with elements of CBT (learning content and exercises) and a mood chart (depression symptom monitoring). arm group intervention list arm group intervention name Other: edupression.com® arm group label Active control arm: (occupational) interventions and progress monitoring. arm group type Active Comparator arm group description These patients will also receive an edupression.com® account with different content. This content will be limited to medically useful tips, that have have not been shown to be effective in improving depressive symptoms in RCTs. Patients of both arms will be instructed to use chat functions to contact study personnel and to fill out questionnaires and tests to collect outcome and additional measures. arm group intervention list arm group intervention name Other: Health tips Diagnostic Test: Surveys Other: Popular psychological interventions intervention list intervention intervention type Other intervention name edupression.com® intervention description Edupression.com® is an evidence-based self-help program that was developed for the treatment of mild to moderate unipolar depression. It is based on two core foundations, psychoeducation with elements of cognitive behavior therapy (CBT) and a mood chart. Both foundations are registered as a medical product. As such, detailed risk management documentation includes probability and severity of adverse events. Moreover, detailed strategies such as warnings were implemented in the software and documented accordingly. It can be used on a PC as well as on mobile devices (browser, App) at any time. intervention arm group label list intervention arm group label Intervention Arm: Psychoeducation with elements of CBT & mood chart. intervention type Other intervention name Health tips intervention description Interventions that do not directly target depression: general health tips (diet, lifestyle, smoking, etc.), occupational health interventions (back pain prevention, breaks,...), etc. intervention arm group label list intervention arm group label Active control arm: (occupational) interventions and progress monitoring. intervention type Diagnostic Test intervention name Surveys intervention description Quizzes and surveys for course monitoring (including suicidality), but without extensive reports. intervention arm group label list intervention arm group label Active control arm: (occupational) interventions and progress monitoring. intervention type Other intervention name Popular psychological interventions intervention description Popular psychological interventions, which have not been shown to be effective in studies: Affirmation phrases, motivational sayings and quotes (known also from calendars), tests (e.g., Rorschach interpretation), exercises (emotion recognition of faces), multimedia content (pleasant music, landscape images, interviews of famous people with depression), etc. intervention arm group label list intervention arm group label Active control arm: (occupational) interventions and progress monitoring. outcomes module primary outcome list primary outcome primary outcome measure Therapy response primary outcome description Depression severity change from baseline to end of study (EOS) [Time Frame: 3 months], compared between treatment vs. control arm measured with the Patient Health Questionnaire. Patient Health Questionnaire scores range from 0 to 27, with a higher score being associated with a higher level of depression. primary outcome time frame 3 months secondary outcome list secondary outcome secondary outcome measure Change of Depression Literacy secondary outcome description Depression Literacy change from baseline to end of study (EOS) [Time Frame: 3 months], compared between treatment vs. control arm measured with the Depression Literacy scale (D-Lit). secondary outcome time frame 3 months secondary outcome measure Change of Quality of Life secondary outcome description Change of quality of life in four domains from baseline to End of Study (EOS) [Time Frame: 3 months] measured with the World Health Organization quality of life scale (WHOQOL-BREF). secondary outcome time frame 3 months secondary outcome measure Change of Satisfaction with Life secondary outcome description Change of satisfaction with life from baseline to End of Study (EOS) [Time Frame: 3 months] measured with the Satisfaction with Life scale (SWLS). secondary outcome time frame 3 months secondary outcome measure Change of Disease Model secondary outcome description Change of disease model from baseline to End of Study (EOS) [Time Frame: 3 months] measured with the brief version of the illness perception questionnaire (B-IPQ). secondary outcome time frame 3 months secondary outcome measure Change of Attitudes towards Internet Interventions secondary outcome description Change of attitudes towards internet interventions in four domains from baseline to End of Study (EOS) [Time Frame: 3 months] measured with the Attitudes towards Psychological Online Interventions Questionnaire (APOI). secondary outcome time frame 3 months eligibility module eligibility criteria Inclusion Criteria: Male/female Age 18-65 years ICD-10 diagnosis F32.0 & F32.1, depressive episode mild & moderate & F33.0 & F33.1, Recurrent depressive disorder mild & moderate (M.I.N.I.) PHQ-9 (Patient Health Questionnaire-9) score ≥5 ability to be managed as outpatients adherence to the study protocol incl. willingness and minimal experience to understand instructions for edupression.com® Exclusion Criteria: previous or concurrent major medical or neurological illness any history of non-response to either psychotherapy/eHealth interventions (min. 3 month) or medication (min. 6 weeks, adequate antidepressive drug dosing) or any kind of therapy resistance participants in the active phase of other interventional studies ICD-10 diagnosis of substance dependence within the past year, except for caffeine or nicotine or current substance abuse ICD-10 diagnosis of schizophrenia, schizoaffective disorder, bipolar affective disorder, persistent mood disorders, or an anxiety disorder being acutely suicidal either indicated by a score ≥3 on item 9 (suicidal thoughts) on the PHQ-9 or according to the investigator´s opinion failures to comply with the study protocol or to follow the instructions of the investigating team healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Lukas M Pezawas, MD, Prof. central contact role Contact central contact phone 004314040035470 central contact e mail [email protected] central contact name Gabriele Fischer, MD, Prof. central contact role Contact central contact phone 004314040035470 central contact e mail [email protected] overall official list overall official overall official name Markus Dold, MD, Priv.Doz. overall official affiliation Medical University of Vienna overall official role Study Chair overall official name Lukas M Pezawas, MD, Prof. overall official affiliation Medical University of Vienna overall official role Principal Investigator overall official name Gabriele Fischer, MD, Prof. overall official affiliation Medical University of Vienna overall official role Study Chair overall official name Lucie Bartova, MD overall official affiliation Medical University of Vienna overall official role Study Chair location list location location facility Medical University of Vienna location status Recruiting location city Vienna location zip 1090 location country Austria location contact list location contact location contact name Lukas Pezawas, MD location contact role Contact location contact e mail [email protected] references module reference list reference reference p m i d 32553848 reference type background reference citation Huckvale K, Nicholas J, Torous J, Larsen ME. Smartphone apps for the treatment of mental health conditions: status and considerations. Curr Opin Psychol. 2020 Dec;36:65-70. doi: 10.1016/j.copsyc.2020.04.008. Epub 2020 May 4. Review. reference p m i d 31675391 reference type background reference citation Park C, Zhu J, Ho Chun Man R, Rosenblat JD, Iacobucci M, Gill H, Mansur RB, McIntyre RS. Smartphone applications for the treatment of depressive symptoms: A meta-analysis and qualitative review. Ann Clin Psychiatry. 2020 Feb;32(1):48-68. Review. reference p m i d 29422409 reference type background reference citation Andrews G, Basu A, Cuijpers P, Craske MG, McEvoy P, English CL, Newby JM. Computer therapy for the anxiety and depression disorders is effective, acceptable and practical health care: An updated meta-analysis. J Anxiety Disord. 2018 Apr;55:70-78. doi: 10.1016/j.janxdis.2018.01.001. Epub 2018 Feb 1. reference p m i d 21712998 reference type background reference citation Cuijpers P, Donker T, Johansson R, Mohr DC, van Straten A, Andersson G. Self-guided psychological treatment for depressive symptoms: a meta-analysis. PLoS One. 2011;6(6):e21274. doi: 10.1371/journal.pone.0021274. Epub 2011 Jun 21. reference p m i d 11556941 reference type background reference citation Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. reference p m i d 25547711 reference type background reference citation Etkin A, Patenaude B, Song YJ, Usherwood T, Rekshan W, Schatzberg AF, Rush AJ, Williams LM. A cognitive-emotional biomarker for predicting remission with antidepressant medications: a report from the iSPOT-D trial. Neuropsychopharmacology. 2015 May;40(6):1332-42. doi: 10.1038/npp.2014.333. Epub 2014 Dec 30. reference p m i d 27405091 reference type background reference citation Ben-Haim MS, Williams P, Howard Z, Mama Y, Eidels A, Algom D. The Emotional Stroop Task: Assessing Cognitive Performance under Exposure to Emotional Content. J Vis Exp. 2016 Jun 29;(112). doi: 10.3791/53720. reference p m i d 26331687 reference type background reference citation Schröder J, Sautier L, Kriston L, Berger T, Meyer B, Späth C, Köther U, Nestoriuc Y, Klein JP, Moritz S. Development of a questionnaire measuring Attitudes towards Psychological Online Interventions-the APOI. J Affect Disord. 2015 Nov 15;187:136-41. doi: 10.1016/j.jad.2015.08.044. Epub 2015 Aug 28. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004194 condition mesh term Disease condition mesh id D000012008 condition mesh term Recurrence condition mesh id D000003866 condition mesh term Depressive Disorder condition mesh id D000003863 condition mesh term Depression condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000020969 condition ancestor term Disease Attributes condition ancestor id D000019964 condition ancestor term Mood Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition browse leaf list condition browse leaf condition browse leaf id M14002 condition browse leaf name Recurrence condition browse leaf as found Recurrent condition browse leaf relevance high condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depressive Disorder condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf as found Depressive Disorder condition browse leaf relevance high condition browse leaf id M21853 condition browse leaf name Disease Attributes condition browse leaf relevance low condition browse leaf id M20988 condition browse leaf name Mood Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders
NCT04839822
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full study rank 61423 study protocol section identification module n c t id NCT04836663 org study id info org study id TQ-B3525-II-03 organization org full name Chia Tai Tianqing Pharmaceutical Group Co., Ltd. org class INDUSTRY brief title A Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors official title A Open-label, Multicenter Phase II Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 23, 2021 start date type Actual primary completion date struct primary completion date September 30, 2022 primary completion date type Anticipated completion date struct completion date December 30, 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date May 27, 2021 last update post date struct last update post date June 1, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Chia Tai Tianqing Pharmaceutical Group Co., Ltd. lead sponsor class INDUSTRY oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with recurrent / metastatic advanced endometrial cancer, cervical cancer and ovarian cancer with PIK3CA and / or PIK3R1 / 2 gene-altered (mutation or amplification). Endometrial cancer, cervical cancer and ovarian cancer are divided into three cohorts, each cohort administrated TQ-B3525 tablet orally once a day. conditions module condition list condition Advanced Endometrial Cancer, Cervical Cancer and Ovarian Cancer design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 90 enrollment type Anticipated arms interventions module arm group list arm group arm group label TQ-B3525 tablet arm group type Experimental arm group intervention list arm group intervention name Drug: TQ-B3525 tablet intervention list intervention intervention type Drug intervention name TQ-B3525 tablet intervention description TQ-B3525 tablet administered orally once a day. Each cycle is 28 days. intervention arm group label list intervention arm group label TQ-B3525 tablet outcomes module primary outcome list primary outcome primary outcome measure Overall response rate (ORR) assessed by Independent Review Committee primary outcome description Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC. primary outcome time frame up to 48 weeks secondary outcome list secondary outcome secondary outcome measure Overall response rate (ORR) assessed by Investigator secondary outcome description Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator. secondary outcome time frame up to 48 weeks secondary outcome measure Disease control rate（DCR） secondary outcome description Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD). secondary outcome time frame up to 48 weeks secondary outcome measure Duration of disease remission (DOR) secondary outcome description The time from the first evaluation of the subject as CR or PR to the first evaluation of the subject as PD or death (whichever occurs first). secondary outcome time frame up to 48 weeks secondary outcome measure Progression-free survival (PFS) secondary outcome description PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause. secondary outcome time frame up to 48 weeks secondary outcome measure Overall survival (OS) secondary outcome description OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. secondary outcome time frame up to 72 weeks secondary outcome measure DOR rate (≥ 6 months) (percentage of subjects with disease remission duration ≥ 6 months) secondary outcome description The percentage of subjects achieving CR or PR was recorded for the first time to 6 months after the first time of objective tumor progression or death due to any cause (whichever occurred first) was recorded. secondary outcome time frame up to 48 weeks eligibility module eligibility criteria Inclusion Criteria: 1. Pathologically confirmed malignant gynecological neoplasm. 2. Has PIK3CA and/or PIK3R1/2 Gene-altered. 3.Unresectable, locally advanced recurrent and/or metastatic tumors, has at least 1 measurable lesion. 4.Failed with standard treatment or has no effective treatment. 5. 18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 1, Life expectancy ≥ 3 months. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration. 7.Understood and signed an informed consent form. Exclusion Criteria: 1.Has untreated or active central nervous system metastases. 2.Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration. 3. Insufficient hematopoietic function of bone marrow. 4. Dysfunction of liver and kidney. 5. Bleeding risk. 6. Dysfunction of gastrointestinal tract. 7.Dysfunction of heart and cerebral vessels. 8.Has received PI3K, AKT, mTOR inhibitor. 9.Has participated in other clinical trails within 30 days. 10. Has received surgery, or unhealed wounds within 4 weeks before the first administration. 11. Has received organ grafting, or hematopoietic stem cell transplantation within 60 days before the first administration, or host versus graft reaction. 12. The patients required immunosuppressor, or the whole-body, or absorbable local hormone therapy for immunosuppression purposes and continued to use within 7 days before the initial administration (daily dose of glucocorticoid <10 mg, except metacortandracin or other therapeutic hormones and so on). 13. Has active infections. 14. Has human immunodeficiency virus (HIV). 15. Pregnant or lactating women. 16. Has psychotropic substances abuse or a mental disorder. 17. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion. 18. Patient's compliance is inadequate. healthy volunteers No gender Female minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility The First People's Hospital of Changzhou location status Not yet recruiting location city Changzhou location state Jiangsu location zip 213003 location country China location contact list location contact location contact name Weiqing Zhao, Doctor location contact role Contact location contact e mail [email protected] location contact name Weiqing Zhao, Doctor location contact role Principal Investigator location facility Nanjing Drum Tower Hospital location status Not yet recruiting location city Nanjing location state Jiangsu location country China location contact list location contact location contact name Huaijun Zhou, Doctor location contact role Contact location contact e mail [email protected] location contact name Huaijun Zhou, Doctor location contact role Principal Investigator location facility Fudan University Shanghai Cancer Center location status Recruiting location city Shanghai location state Shanghai location zip 200032 location country China location contact list location contact location contact name Xiaohua Wu, Doctor location contact role Contact location contact e mail [email protected] location contact name Xiaohua Wu, Doctor location contact role Principal Investigator location facility Gynecology Hospital of Fudan University location status Not yet recruiting location city Shanghai location state Shanghai location zip 200090 location country China location contact list location contact location contact name Xiaojun Chen, Doctor location contact role Contact location contact e mail [email protected] location contact name Xiaojun Chen, Doctor location contact role Principal Investigator location facility Sir Run Run Shaw Hospital Medical School Zhejiang University location status Not yet recruiting location city Hangzhou location state Zhejiang location zip 310016 location country China location contact list location contact location contact name Xian Wang, Doctor location contact role Contact location contact e mail [email protected] location contact name Xian Wang, Doctor location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000016889 condition mesh term Endometrial Neoplasms condition mesh id D000005833 condition mesh term Genital Neoplasms, Female condition ancestor list condition ancestor condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000014594 condition ancestor term Uterine Neoplasms condition ancestor id D000014591 condition ancestor term Uterine Diseases condition browse leaf list condition browse leaf condition browse leaf id M14002 condition browse leaf name Recurrence condition browse leaf relevance low condition browse leaf id M4982 condition browse leaf name Uterine Cervical Neoplasms condition browse leaf relevance low condition browse leaf id M12126 condition browse leaf name Ovarian Neoplasms condition browse leaf relevance low condition browse leaf id M1704 condition browse leaf name Carcinoma, Ovarian Epithelial condition browse leaf relevance low condition browse leaf id M8097 condition browse leaf name Genital Neoplasms, Female condition browse leaf as found Gynecologic Tumors condition browse leaf relevance high condition browse leaf id M18387 condition browse leaf name Endometrial Neoplasms condition browse leaf as found Endometrial Cancer condition browse leaf relevance high condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M16494 condition browse leaf name Uterine Neoplasms condition browse leaf relevance low condition browse leaf id M16491 condition browse leaf name Uterine Diseases condition browse leaf relevance low condition browse leaf id T4352 condition browse leaf name Ovarian Cancer condition browse leaf as found Ovarian Cancer condition browse leaf relevance high condition browse leaf id T4354 condition browse leaf name Ovarian Epithelial Cancer condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04836663
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full study rank 61407 study protocol section identification module n c t id NCT04836871 org study id info org study id DFPPv1.0 organization org full name Zhongnan Hospital org class OTHER brief title Double Filtration Plasmapheresis Combined With Chemotherapy official title Clinical Research of Double Filtration Plasmapheresis Combined With Chemotherapy to Remove M Protein in Multiple Myeloma status module status verified date July 2021 overall status Recruiting expanded access info has expanded access No start date struct start date May 15, 2021 start date type Actual primary completion date struct primary completion date April 30, 2024 primary completion date type Anticipated completion date struct completion date October 31, 2024 completion date type Anticipated study first submit date March 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 10, 2021 last update post date struct last update post date July 16, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Fuling Zhou responsible party investigator title Head, Division of Hematology; Professor of Hematology; Doctoral advisor responsible party investigator affiliation Zhongnan Hospital lead sponsor lead sponsor name Fuling Zhou lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Evaluation of double filtration plasmapheresis combined with chemotherapy for the treatment of abnormalities of M protein or renal function due to the multiple myeloma. conditions module condition list condition Multiple Myeloma design module study type Interventional phase list phase Phase 1 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label Double filtration plasmapheresis (DFPP) combined with chemotherapy arm group type Experimental arm group intervention list arm group intervention name Combination Product: DFPP combined with chemotherapy intervention list intervention intervention type Combination Product intervention name DFPP combined with chemotherapy intervention description Double filtration plasmapheresis combined with chemotherapy intervention arm group label list intervention arm group label Double filtration plasmapheresis (DFPP) combined with chemotherapy outcomes module primary outcome list primary outcome primary outcome measure M protein clearance rate primary outcome description before each treatment of Double filtration plasmapheresis (DFPP) primary outcome time frame 1hour primary outcome measure M protein clearance rate primary outcome description after each treatment of DFPP primary outcome time frame 1hour primary outcome measure creatinine clearance rate primary outcome description before each treatment of DFPP primary outcome time frame 1hour primary outcome measure creatinine clearance rate primary outcome description after each treatment of DFPP primary outcome time frame 1hour primary outcome measure albumin concentration primary outcome description before each treatment of DFPP primary outcome time frame 1hour primary outcome measure albumin concentration primary outcome description after each treatment of DFPP primary outcome time frame 1hour primary outcome measure serum-free light chain levels primary outcome description before each treatment of DFPP primary outcome time frame 1hour primary outcome measure serum-free light chain levels primary outcome description after each treatment of DFPP primary outcome time frame 1hour primary outcome measure blood urea nitrogen primary outcome description before each treatment of DFPP primary outcome time frame 1hour primary outcome measure blood urea nitrogen primary outcome description after each treatment of DFPP primary outcome time frame 1hour primary outcome measure Platelet concentrations primary outcome description before each treatment of DFPP primary outcome time frame 1hour primary outcome measure Platelet concentrations primary outcome description after each treatment of DFPP primary outcome time frame 1hour eligibility module eligibility criteria Inclusion Criteria: Multiple myeloma patients who are diagnosed by bone marrow morphology and immunology Patients with stable condition after conventional treatment Patients with renal insufficiency or abnormal M protein Patients over 18 years of age Liver function: blood bilirubin ≤ 35μmol/L, enzymes aspartate transaminase (AST)/aka alanine aminotransferase (ALT) is less than 2 times the upper limit of normal Normal heart function Physical condition score 0-2 level (ECOG score) Obtain an informed consent form signed by the patient or family member Exclusion Criteria: Allergies or obvious contraindications to any of the drugs involved in the plan Severe heart disease, including myocardial infarction and cardiac insufficiency. Suffering from other organ malignancies Active tuberculosis patients and HIV-positive patients At the same time suffering from other blood system diseases Pregnant or lactating women Able to understand or follow the research plan Past history of intolerance or allergy to similar drugs Patients under 18 years of age Participating in other clinical researchers at the same time There are any other circumstances that hinder the progress of the research healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Zhongnan Hospital of Wuhan University location status Recruiting location city Wuhan location state Hubei location zip 430071 location country China location contact list location contact location contact name Fuling Zhou, director location contact role Contact location contact phone +86-02767813137 location contact e mail [email protected] i p d sharing statement module i p d sharing Yes derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009101 condition mesh term Multiple Myeloma condition mesh id D000054219 condition mesh term Neoplasms, Plasma Cell condition ancestor list condition ancestor condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000020141 condition ancestor term Hemostatic Disorders condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000010265 condition ancestor term Paraproteinemias condition ancestor id D000001796 condition ancestor term Blood Protein Disorders condition ancestor id D000006402 condition ancestor term Hematologic Diseases condition ancestor id D000006474 condition ancestor term Hemorrhagic Disorders condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11210 condition browse leaf name Multiple Myeloma condition browse leaf as found Multiple Myeloma condition browse leaf relevance high condition browse leaf id M26741 condition browse leaf name Neoplasms, Plasma Cell condition browse leaf as found Multiple Myeloma condition browse leaf relevance high condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M21130 condition browse leaf name Hemostatic Disorders condition browse leaf relevance low condition browse leaf id M4211 condition browse leaf name Blood Coagulation Disorders condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M12330 condition browse leaf name Paraproteinemias condition browse leaf relevance low condition browse leaf id M4229 condition browse leaf name Blood Protein Disorders condition browse leaf relevance low condition browse leaf id M8642 condition browse leaf name Hematologic Diseases condition browse leaf relevance low condition browse leaf id M8712 condition browse leaf name Hemorrhagic Disorders condition browse leaf relevance low condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T3947 condition browse leaf name Multiple Myeloma condition browse leaf as found Multiple Myeloma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M11299 intervention browse leaf name Myeloma Proteins intervention browse leaf relevance low intervention browse leaf id M12331 intervention browse leaf name Paraproteins intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04836871
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full study rank 61672 study protocol section identification module n c t id NCT04833426 org study id info org study id NL7436209120 secondary id info list secondary id info secondary id 2020-003012-27 secondary id type EudraCT Number secondary id 2020-6874 secondary id type Other Identifier secondary id domain CMO Arnhem-Nijmegen organization org full name Canisius-Wilhelmina Hospital org class OTHER brief title Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy official title Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy acronym ENFORCE status module status verified date July 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date October 1, 2022 start date type Anticipated primary completion date struct primary completion date April 2024 primary completion date type Anticipated completion date struct completion date April 2027 completion date type Anticipated study first submit date February 5, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date July 26, 2022 last update post date struct last update post date July 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Canisius-Wilhelmina Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Besins Healthcare collaborator class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Sexual dysfunction is a common side effect of radical prostatectomy (RP) and has a significant negative impact on quality of life. With age the testosterone level in men declines; around 30% of men over 70 years of age meet the criteria of testosterone deficiency (TD). The negative impact of both TD and RP on sexual performance are likely to add up. The aim of this study is to assess the efficacy and safety of testosterone replacement therapy (TRT) on functional and oncological outcomes in testosterone deficient men following RP for prostate cancer (PCa). detailed description Rationale: Radical prostatectomy (RP) is currently the most common treatment for non-metastatic prostate cancer (PCa). Two frequent side effects of this procedure are urinary incontinence and erectile dysfunction, both having a significant negative impact on quality of life. Additionally, it is known that with age the testosterone level in men declines. This does not lead to symptoms in all men (asymptomatic testosterone deficiency). Both testosterone deficiency (TD) and radical prostatectomy are well-established to have a significant negative impact on sexual performance and are likely to add up in patients with a low testosterone following RP. Objective: The aim of this study is to assess the effect of testosterone replacement therapy (TRT) on functional and oncological outcomes in testosterone deficient men following RP for PCa. Study design: This study is a phase 3 prospective, randomized, placebo-controlled, single-blind clinical trial. Study population: All men over 18 years old diagnosed with non-metastatic prostate cancer who are scheduled for RP within three months as primary treatment, can be prescreened for inclusion. Prior to the RP, serum testosterone will be determined. Subsequently, within six weeks after the RP, serum testosterone will be determined again and patients will be screened for inclusion. If necessary, a third measurement of testosterone will be done. Eligible patients meet the criteria for TD and other inclusion criteria. Intervention: Patients will be randomized for testosterone replacement therapy (TRT) or placebo as a daily administered topical gel starting within 8 weeks after RP. Patients will receive TRT or placebo for one year following RP and will be monitored for another year for functional outcomes and for four more years to establish 5-year biochemical recurrence (BCR) free survival. Main study parameters/endpoints: The primary study endpoint is a clinically relevant (12 points or more) difference in the EPIC-26 domain for sexual functioning 12 months after RP in favor of testosterone deficient men receiving TRT compared with testosterone deficient men receiving placebo. Secondary endpoints include: urinary incontinence score, hormonal functioning score and BCR-free survival. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The number of visits and blood drawings are equal to standard of care follow-up after RP, with the exception of two or three extra blood samples at the first prescreening visit and within six weeks following RP. We ask patients to remain with their hospital for 24 months after RP for follow-up and to complete online questionnaires for the given visits. The five-year biochemical recurrence (BCR) free survival will be obtained through patient's medical records and if insufficient, through the Dutch Cancer Registry (NKR). Patients who receive TRT or placebo can experience local side-effects such as itching, rash and/or irritation at the site of application. In addition, patients who receive TRT can experience systemic sideeffects are gain of weight, hot flashes, acne and an increase in red blood count level. Furthermore, TRT might improve sexual functioning, urinary continence, hormonal functioning and BCR-free survival, but this is not certain and is subject of research in this study. conditions module condition list condition Prostatic Neoplasms Hypogonadism Testosterone Deficiency keyword list keyword Prostate cancer Prostatectomy Hypogonadism Testosterone deficiency design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 140 enrollment type Anticipated arms interventions module arm group list arm group arm group label Testosterone therapy arm group type Active Comparator arm group description Daily application of two pump auctions of 16.2mg/ml testosterone gel. Dosage may be altered depending on clinical response arm group intervention list arm group intervention name Drug: Testosterone gel arm group label Placebo therapy arm group type Placebo Comparator arm group description Daily application of two pump auctions of placebo gel. arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name Testosterone gel intervention description Topical gel containing testosterone intervention arm group label list intervention arm group label Testosterone therapy intervention type Drug intervention name Placebo intervention description Topical gel without active substance intervention arm group label list intervention arm group label Placebo therapy intervention other name list intervention other name Placebo gel outcomes module primary outcome list primary outcome primary outcome measure Clinically relevant (≥12 points) difference in the EPIC-26 sexual functioning domain score, 12 months after radical prostatectomy between groups. primary outcome description Functional recovery after radical prostatectomy will be assessed by EPIC-26 questionnaire, a Patient Reported Outcome Measure (PROM). Patients will be asked to complete this questionnaire online. primary outcome time frame 12 months secondary outcome list secondary outcome secondary outcome measure Clinically relevant (≥12 points) difference in the EPIC-26 sexual functioning domain score 3 months after radical prostatectomy between groups. secondary outcome description Clinical relevance (>12 points) for sexual function domain score as measured by EPIC-26. secondary outcome time frame 3 months secondary outcome measure Clinically relevant (≥12 points) difference in the EPIC-26 sexual functioning domain score 24 months after radical prostatectomy between groups. secondary outcome description Clinical relevance (>12 points) for sexual function domain score as measured by EPIC-26. secondary outcome time frame 24 months secondary outcome measure Clinically relevant (≥9 points) difference in the EPIC-26 urinary incontinence domain score, 12 months after radical prostatectomy between groups. secondary outcome description Clinical relevance (>9 points) for Urinary incontinence domain score as measured by EPIC-26. secondary outcome time frame 12 months secondary outcome measure Clinically relevant (≥9 points) difference in the EPIC-26 urinary incontinence domain score, 24 months after radical prostatectomy between groups. secondary outcome description Clinical relevance (>9 points) for Urinary incontinence domain score as measured by EPIC-26. secondary outcome time frame 24 months secondary outcome measure Clinically relevant (≥6 points) difference in the EPIC-26 for hormonal functioning domain score, 12 months after radical prostatectomy between groups. secondary outcome description Clinical relevance (>6 points) for hormonal functioning domain score as measured by EPIC-26. secondary outcome time frame 12 months secondary outcome measure Clinically relevant (≥6 points) difference in the EPIC-26 for hormonal functioning domain score, 24 months after radical prostatectomy between groups. secondary outcome description Clinical relevance (>6 points) for hormonal functioning domain score as measured by EPIC-26. secondary outcome time frame 24 months secondary outcome measure Difference in biochemical recurrence rate between groups. secondary outcome description Biochemical recurrence (BCR) is defined as the occurrence of measurable (>0.1 ng/ml) prostate specific antigen (PSA), during routinely follow-up up to five years after surgery, determined at two different occasions with at least one week between them.The BCR-rate between the placebo and control group will be compared to determine the influence of testosterone therapy on BCR. secondary outcome time frame 5 years eligibility module eligibility criteria Inclusion Criteria: Unmeasurable PSA after RP pT2-pT3a after RP ISUP 1-3 regardless of surgical margins ISUP 4-5 with negative surgical margins At least one-sided nerve-sparing procedure Baseline score sexual functioning domain of ≥ 40 points (EPIC-26) Exclusion Criteria: Metastatic disease (cN1/M1) pT3b or pT4 after RP Prior treatment for PCa Prior TRT Medical history of male breast- or liver carcinoma Uncontrolled hypertension General contra-indication for TRT Allergy for components in TRT Use of vitamin K-antagonists BMI > 30 healthy volunteers No gender Male minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Diederik Baas, MSc central contact role Contact central contact phone +31243658190 central contact e mail [email protected] overall official list overall official overall official name Diederik Somford, MD, PhD overall official affiliation Canisius-Wilhelmina Hospital overall official role Principal Investigator location list location location facility Jeroen Bosch Hospital location city 's-Hertogenbosch location country Netherlands location contact list location contact location contact name Rob Wijn, MD location contact role Contact location facility Netherlands Cancer Institute location city Amsterdam location country Netherlands location contact list location contact location contact name Pim van Leeuwen, MD, PhD location contact role Contact location facility Catharina Hospital location city Eindhoven location country Netherlands location contact list location contact location contact name Eric Vrijhof, MD, PhD location contact role Contact location facility Zuyderland location city Heerlen location country Netherlands location contact list location contact location contact name Max Bruins, MD, PhD location contact role Contact location facility St. Antonius Hospital location city Nieuwegein location country Netherlands location contact list location contact location contact name Harm van Melick, MD, PhD location contact role Contact location facility Radboud university medical center location city Nijmegen location country Netherlands location contact list location contact location contact name Michiel Sedelaar, MD, PhD location contact role Contact i p d sharing statement module i p d sharing Undecided document section large document module large doc list large doc large doc type abbrev Prot_SAP large doc has protocol Yes large doc has s a p Yes large doc has i c f No large doc label Study Protocol and Statistical Analysis Plan large doc date December 8, 2020 large doc upload date 02/05/2021 05:52 large doc filename Prot_SAP_000.pdf derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011471 condition mesh term Prostatic Neoplasms condition mesh id D000007006 condition mesh term Hypogonadism condition ancestor list condition ancestor condition ancestor id D000006058 condition ancestor term Gonadal Disorders condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000005834 condition ancestor term Genital Neoplasms, Male condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000011469 condition ancestor term Prostatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M9208 condition browse leaf name Hypogonadism condition browse leaf as found Hypogonadism condition browse leaf relevance high condition browse leaf id M13487 condition browse leaf name Prostatic Neoplasms condition browse leaf as found Prostatic Neoplasms condition browse leaf relevance high condition browse leaf id M8315 condition browse leaf name Gonadal Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M8098 condition browse leaf name Genital Neoplasms, Male condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M13485 condition browse leaf name Prostatic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000013739 intervention mesh term Testosterone intervention ancestor list intervention ancestor intervention ancestor id D000000728 intervention ancestor term Androgens intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M15661 intervention browse leaf name Testosterone intervention browse leaf as found Less intervention browse leaf relevance high intervention browse leaf id M3211 intervention browse leaf name Androgens intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04833426
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full study rank 61618 study protocol section identification module n c t id NCT04834128 org study id info org study id TCB008-002 organization org full name TC Biopharm org class INDUSTRY brief title A Phase II Safety and Tolerability Study of TCB008 in Patients With COVID-19 official title A Phase II Safety and Tolerability, Inter-patient Pre-defined Dose Study of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (TCB008) in Patients Diagnosed With COVID-19 status module status verified date March 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date December 13, 2021 start date type Actual primary completion date struct primary completion date November 1, 2022 primary completion date type Anticipated completion date struct completion date November 1, 2022 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date March 8, 2022 last update post date struct last update post date March 24, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name TC Biopharm lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary A Phase II safety and tolerability study of expanded gamma delta T cell lymphocytes (TCB008) in patients diagnosed with COVID-19. detailed description The aim of this Phase II study is to evaluate the safety and tolerability of ex-vivo expanded gamma delta T-cells (TCB008) manufactured from a single allogeneic unmatched or partially, randomly matched, unrelated donor, in patients with COVID-19. The trial is designed to identify an optimal, safe dose of allogeneic γδ T cells in a population of patients with COVID-19. There will be 4 patient Cohorts. Cohorts 1 - 3 will receive a pre-defined dosing schedule, with Cohort 4 being treated with a dose selected upon completion of the first 3 Cohorts. In order to investigate immunogenicity assessment/sensitisation effects, patients in the expansion cohort who do not experience adverse reactions meeting dose limiting toxicity (DLT) criteria after the first administration will receive re-infusion with the same dose on Day 10 after the first infusion. conditions module condition list condition COVID - 19 keyword list keyword ATMP design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design intervention model description open-label, safety and tolerability, escalating dose, single arm study design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 12 enrollment type Anticipated arms interventions module arm group list arm group arm group label γδ T cells (IMP, TCB008) arm group type Experimental arm group description Patients will receive an infusion of γδ T cells (IMP, TCB008) following informed consent after admission to hospital for SARS-CoV-2 infection (COVID-19). arm group intervention list arm group intervention name Drug: TCB008 intervention list intervention intervention type Drug intervention name TCB008 intervention description administration of gamma delta T cells by IV bolus injection intervention arm group label list intervention arm group label γδ T cells (IMP, TCB008) outcomes module primary outcome list primary outcome primary outcome measure Assessment of treatment emergent adverse events (AEs) - Safety primary outcome description Safety of IMP assessed by incidence of treatment-emergent adverse events (AEs) per patient, graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0 primary outcome time frame 30 and 90 days after IMP administration primary outcome measure Incidence of dose-limiting toxicities (DLTs) - Tolerability primary outcome description Tolerability of IMP assessed by incidence of dose-limiting toxicities (DLT's) graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0 primary outcome time frame 30 and 90 days after IMP administration primary outcome measure Establish Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) - Tolerability primary outcome description Tolerability of IMP assessed by incidence of dose-limiting toxicities (DLT's) graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0 primary outcome time frame Approx 1 year other outcome list other outcome other outcome measure Persistence of gamma delta T cells other outcome description Assessment of the persistence of gamma delta T cells in the peripheral blood os dosed patients using flow cytometry other outcome time frame Approx 1 year other outcome measure Phenotype of gamma delta T cells other outcome description Assessment of the phenotype of gamma delta T cells in the peripheral blood of dosed patients using flow cytometry other outcome time frame Approx 1 year eligibility module eligibility criteria Inclusion Criteria: Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); - willingness and capability to complete all the study procedures Age 18-65 years (inclusive) at the time of signing ICF Any gender Patients with a positive diagnosis of COVID-19 either identified in the community as at risk of progression of disease or already hospitalized with new changes on CXR or CT scan compatible with COVID19, or patients requiring supplemental oxygen, but for whom dexamethasone is not yet indicated according to current standard of care recommendations. The product would be indicated for patients categorized as per the WHO ordinal scale 2,3 or 4: i.e., ambulatory (or community identified) patients with limitations of activity, judged as at risk for progression of disease, as well as hospitalized patients not yet requiring oxygen therapy or receiving non-invasive low flow oxygen therapy, which does not yet indicate the need to commence dexamethasone therapy. Exclusion Criteria Patients requiring high-flow oxygen therapy and/or dexamethasone according to the current standard of care. Patients suffering from severe cognitive impairment or mental illness Pregnant and/or lactating women Patients participating in other CTIMP clinical studies at the same time Active autoimmune disease or Graft versus Host Disease (GVHD) Patients with any major comorbidity (e.g., diabetes, cardiovascular and pulmonary diseases, malignancies on active treatment) unless their pre-morbid Karnofsky performance status was ≥ 80% Patients with documented history of immunological disorders Immunocompromised patients defined as those with human immunodeficiency virus infection with a CD4 cell count of less than 200 per microliter or uncontrolled viremia, prolonged use of glucocorticoids or other immunomodulating medications, a history of bone marrow or organ transplantation ALT / AST> 5 times the upper limit of the normal Neutrophils <500 / mm3 Platelets <50.000 / mm3 Patients known or suspected to have sensitivity against mouse immunoglobulins or iron-dextran. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module location list location location facility Royal Victoria Infirmary location city Newcastle location country United Kingdom derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04834128
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full study rank 61266 study protocol section identification module n c t id NCT04838704 org study id info org study id RCMvsCM organization org full name Zhejiang University org class OTHER brief title Ruxolitinib With Calcineurin and Methotrexate vs. Calcineurin Plus Methotrexate and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis for HLA-haploidentical Hematopoietic Stem Cell Transplantation official title Ruxolitinib With Calcineurin and Methotrexate vs. Calcineurin Plus Methotrexate and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis for HLA-haploidentical Hematopoietic Stem Cell Transplantation status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 8, 2021 start date type Actual primary completion date struct primary completion date January 31, 2023 primary completion date type Anticipated completion date struct completion date January 31, 2025 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name He Huang responsible party investigator title Professor responsible party investigator affiliation Zhejiang University lead sponsor lead sponsor name Zhejiang University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Low Dose Ruxolitinib with Calcineurin and Methotrexate vs. Calcineurin plus Methotrexate and Mycophenolate mofetil as Graft Versus Host Disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system. detailed description The is a prospective, randomized two-arm, and multicenter study. To compare the efficacy and safety of low-dose ruxolitinib combined with calcineurin and methotrexate vs. calcineurin plus methotrexate and mycophenolate mofetil as graft versus host disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system. conditions module condition list condition Graft Versus Host Disease keyword list keyword Graft Versus Host Disease ruxolitinib HLA-haploidentical hematopoietic stem cell transplantation design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 206 enrollment type Anticipated arms interventions module arm group list arm group arm group label RUX group arm group type Experimental arm group intervention list arm group intervention name Drug: Ruxolitinib+Calcineurin +Methotrexate arm group label Control group arm group type Active Comparator arm group intervention list arm group intervention name Drug: Calcineurin +Methotrexate+Mycophenolate mofetil intervention list intervention intervention type Drug intervention name Ruxolitinib+Calcineurin +Methotrexate intervention description low-dose ruxolitinib combine with calcineurin and short course of methotrexate. intervention arm group label list intervention arm group label RUX group intervention type Drug intervention name Calcineurin +Methotrexate+Mycophenolate mofetil intervention description calcineurin and short course of methotrexate and mycophenolate mofetil intervention arm group label list intervention arm group label Control group outcomes module primary outcome list primary outcome primary outcome measure 100-day cumulative II-IV aGVHD incidence after HSCT primary outcome description 100-day cumulative II-IV aGVHD incidence after HSCT primary outcome time frame 100-day after HSCT through study completion, an average of 1 year secondary outcome list secondary outcome secondary outcome measure cumulative cGVHD incidence secondary outcome description cGVHD incidence after HSCT secondary outcome time frame Time after HSCT through study completion, an average of 1 year secondary outcome measure overall survival secondary outcome description overall survival after HSCT secondary outcome time frame Time after HSCT through study completion, an average of 1 year secondary outcome measure adverse effects secondary outcome description drug related adverse effects secondary outcome time frame Time after intervention through study completion, an average of 1 year secondary outcome measure cumulative incidence of relapse after HSCT secondary outcome description cumulative incidence of relapse after HSCT secondary outcome time frame Time after HSCT through study completion, an average of 1 year eligibility module eligibility criteria Inclusion Criteria: Patients must be diagnosed with malignant hematological disease. aged 12-70 years. Received HLA-haploidentical hematopoietic stem cell transplantation. received myeloablative conditioning Karnofsky score ≥70. creatinine clearance ≥60 mL/min (according to the Cockcroft-Gault formula). (7) liver and kidney function: aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of the normal range (ULN), total bilirubin ≤ 2 × ULN; serum creatinine ≤ 1.5 × ULN. 8) left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography (ECHO). 9) life expectancy >12 weeks. 10) Voluntarily signed the consent form and could understand and comply with the requirements of the study. Exclusion Criteria: Active autoimmune disease, such as SLE, rheumatoid arthritis, etc. Current clinically significant active cardiovascular disease such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by New York Heart Association (NYHA) functional class, or a history of myocardial infarction within 6 months prior to enrollment. Other serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes). human immunodeficiency virus (HIV) infection. cirrhosis of the liver, active hepatitis. Pregnant or lactating women. Patients who are concurrently enrolled in any clinical trials of similar drugs. healthy volunteers No gender All minimum age 12 Years maximum age 70 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Yanmin Zhao, PhD central contact role Contact central contact phone +8615858199217 central contact e mail [email protected] location list location location facility The First Hospital of Zhejiang Medical Colleage Zhejiang University location status Recruiting location city Hangzhou location state Zhejiang location zip 310006 location country China location contact list location contact location contact name Yanmin Zhao, PhD location contact role Contact location contact phone +8615858199217 location contact e mail [email protected] i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006086 condition mesh term Graft vs Host Disease condition ancestor list condition ancestor condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M8341 condition browse leaf name Graft vs Host Disease condition browse leaf as found Graft Versus Host Disease condition browse leaf relevance high condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T2832 condition browse leaf name Homologous Wasting Disease condition browse leaf as found Graft Versus Host Disease condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000009173 intervention mesh term Mycophenolic Acid intervention mesh id D000008727 intervention mesh term Methotrexate intervention ancestor list intervention ancestor intervention ancestor id D000000020 intervention ancestor term Abortifacient Agents, Nonsteroidal intervention ancestor id D000000019 intervention ancestor term Abortifacient Agents intervention ancestor id D000012102 intervention ancestor term Reproductive Control Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000000964 intervention ancestor term Antimetabolites, Antineoplastic intervention ancestor id D000000963 intervention ancestor term Antimetabolites intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000003879 intervention ancestor term Dermatologic Agents intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000005493 intervention ancestor term Folic Acid Antagonists intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000018501 intervention ancestor term Antirheumatic Agents intervention ancestor id D000019384 intervention ancestor term Nucleic Acid Synthesis Inhibitors intervention ancestor id D000000903 intervention ancestor term Antibiotics, Antineoplastic intervention ancestor id D000000904 intervention ancestor term Antibiotics, Antitubercular intervention ancestor id D000000995 intervention ancestor term Antitubercular Agents intervention ancestor id D000000900 intervention ancestor term Anti-Bacterial Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M11280 intervention browse leaf name Mycophenolic Acid intervention browse leaf as found Vitamin D intervention browse leaf relevance high intervention browse leaf id M10855 intervention browse leaf name Methotrexate intervention browse leaf as found Block intervention browse leaf relevance high intervention browse leaf id M3433 intervention browse leaf name Antimetabolites intervention browse leaf relevance low intervention browse leaf id M6226 intervention browse leaf name Dermatologic Agents intervention browse leaf relevance low intervention browse leaf id M7770 intervention browse leaf name Folic Acid intervention browse leaf relevance low intervention browse leaf id M16698 intervention browse leaf name Vitamin B Complex intervention browse leaf relevance low intervention browse leaf id M7771 intervention browse leaf name Folic Acid Antagonists intervention browse leaf relevance low intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse leaf id M19757 intervention browse leaf name Antirheumatic Agents intervention browse leaf relevance low intervention browse leaf id M3374 intervention browse leaf name Anti-Bacterial Agents intervention browse leaf relevance low intervention browse leaf id M3376 intervention browse leaf name Antibiotics, Antitubercular intervention browse leaf relevance low intervention browse leaf id M3463 intervention browse leaf name Antitubercular Agents intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents intervention browse leaf relevance low intervention browse leaf id T447 intervention browse leaf name Folinic Acid intervention browse leaf relevance low intervention browse leaf id T446 intervention browse leaf name Folic Acid intervention browse leaf relevance low intervention browse leaf id T448 intervention browse leaf name Folate intervention browse leaf relevance low intervention browse leaf id T475 intervention browse leaf name Vitamin B9 intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents intervention browse branch abbrev Derm intervention browse branch name Dermatologic Agents intervention browse branch abbrev Repr intervention browse branch name Reproductive Control Agents intervention browse branch abbrev Micro intervention browse branch name Micronutrients intervention browse branch abbrev Hemat intervention browse branch name Hematinics intervention browse branch abbrev Vi intervention browse branch name Vitamins
NCT04838704
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full study rank 61355 study protocol section identification module n c t id NCT04837547 org study id info org study id BCC017 organization org full name Wake Forest University Health Sciences org class OTHER brief title PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy official title PEACH TRIAL- Precision mEdicine and Adoptive Cellular tHerapy for the Treatment of Recurrent Neuroblastoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) acronym PEACH status module status verified date March 2022 overall status Recruiting expanded access info has expanded access No start date struct start date September 20, 2021 start date type Actual primary completion date struct primary completion date September 2025 primary completion date type Anticipated completion date struct completion date September 2030 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 20, 2022 last update post date struct last update post date April 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Wake Forest University Health Sciences lead sponsor class OTHER collaborator list collaborator collaborator name University of Florida collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary A Phase I open-label, multicenter study, to evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed DIPG or recurrent neuroblastoma with molecular targeted therapy in combination with adoptive cell therapy (Total tumor mRNA-pulsed autologous Dendritic Cells (DCs) (TTRNA-DCs), Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) and Autologous G-CSF mobilized Hematopoietic Stem Cells (HSCs)). conditions module condition list condition Neuroblastoma Diffuse Intrinsic Pontine Glioma design module study type Interventional phase list phase Phase 1 design info design allocation Non-Randomized design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 24 enrollment type Anticipated arms interventions module arm group list arm group arm group label Arm 1: Subjects with Diffuse Intrinsic Pontine Glioma (DIPG). arm group type Experimental arm group description This Phase I study is will utilize a standard 3+3 dose escalation design to establish the MTD and will evaluate the following three pre-specified dose levels of xALT: Dose Level 1: 3 x10^7 cells/kg Dose Level +1: 3 x10^8 cells/kg Dose Level -1: 3 x10^6 cells/kg The dose escalation scheme will be evaluated for Arm 1 and Arm 2 separately. For each Study Arm, a minimum of 4 DLT evaluable subjects and a maximum of 12 DLT evaluable subjects will be enrolled (a total of 8 to 24 DLT evaluable subjects). arm group intervention list arm group intervention name Biological: Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) arm group label Arm 2: Relapsed/Refractory Neuroblastoma (NB) arm group type Experimental arm group description This Phase I study is will utilize a standard 3+3 dose escalation design to establish the MTD and will evaluate the following three pre-specified dose levels of xALT: Dose Level 1: 3 x10^7 cells/kg Dose Level +1: 3 x10^8 cells/kg Dose Level -1: 3 x10^6 cells/kg The dose escalation scheme will be evaluated for Arm 1 and Arm 2 separately. For each Study Arm, a minimum of 4 DLT evaluable subjects and a maximum of 12 DLT evaluable subjects will be enrolled (a total of 8 to 24 DLT evaluable subjects). arm group intervention list arm group intervention name Biological: Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) intervention list intervention intervention type Biological intervention name Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) intervention description There will be two immunotherapy products manufactured and administered to subjects enrolled on this trial. The first product will be autologous dendritic cells (DCs) loaded with total tumor messenger ribonucleic acid (mRNA) (TTRNA) derived from malignant tumors. The second product will be autologous T lymphocytes stimulated ex vivo against TTRNA antigens for autologous transfer (TTRNA-xALT). DCs are professional antigen-presenting cells critical for the initiation of B and T-cell responses in vivo. intervention arm group label list intervention arm group label Arm 1: Subjects with Diffuse Intrinsic Pontine Glioma (DIPG). Arm 2: Relapsed/Refractory Neuroblastoma (NB) intervention other name list intervention other name xALT outcomes module primary outcome list primary outcome primary outcome measure Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability primary outcome description To evaluate the dose-limiting toxicities (DLTs) and to establish the maximum tolerated dose (MTD) of treating children with molecular targeted therapy in combination with adoptive cellular therapy primary outcome time frame 2 years secondary outcome list secondary outcome secondary outcome measure Number of Participants with Adverse Events as a Measure of Safety and Tolerability secondary outcome description To evaluate the overall safety profile of study treatment secondary outcome time frame 2 years plus 30 days secondary outcome measure Number of Participants that are able to have vaccine produced and delivered secondary outcome description To evaluable the feasibility of producing and administering the protocol directed therapy secondary outcome time frame 2 years secondary outcome measure Number of participants with progression free survival (PFS) during study secondary outcome description To determine the activity of treatments chosen based on Progression free survival (PFS) secondary outcome time frame 7 years secondary outcome measure Number of participants with overall survival (OS) during study secondary outcome description To determine the activity of treatments chosen based on Overall Survival (OS) secondary outcome time frame 7 years secondary outcome measure Determine the Overall Response Rate (ORR) of Participants using INSS Response Evaluation Criteria for NB and RANO criteria for DIPG secondary outcome description To determine the activity of treatments chosen based on Overall Response Rate (ORR) secondary outcome time frame 2 years eligibility module eligibility criteria Inclusion Criteria: Subjects must have proven pediatric cancer with confirmation at diagnosis or at the time of recurrence/progression and clinical determination of disease for which there is no known effective curative therapy or disease that is refractory to established proven therapies fitting into one of the following categories: Disease Status: High Risk Neuroblastoma- Patients that have relapsed following standard of care therapy or having progressed during standard of care therapy and non-responsive/progressive to accepted curative chemotherapy. Neuroblastoma must be age >12 months at enrollment Diffuse Intrinsic Pontine (or other brain stem) Glioma Newly-diagnosed patients willing to undergo biopsy Must be within 2 months of diagnosis and prior to starting radiation DIPG must be ≥ 3 years of age at enrollment All subjects must be age ≤ 30 years at enrollment Patient and/or parents/guardian willing to consent to biopsy for obtaining tumor material for confirmatory diagnosis and/or tumor RNA extraction and amplification. Subjects must have measurable disease as defined Per section 8 at the time of biopsy and tumor must be accessible for biopsy. Tumor samples submitted for analysis must contain >30% viable tumor tissue to qualify. In addition, subjects with NB disease confined to the bone marrow are eligible to enroll if the degree of marrow involvement is expected to be >30%. Current disease state must be one for which there is currently no known effective therapy Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing. Lansky or Karnofsky Score must be ≥ 60 Bone Marrow: ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported) Platelets ≥ 100,000/µl (can be transfused) Hemoglobin > 8 g/dL (can be transfused) Renal: Serum creatinine ≤ upper limit of institutional normal. Adequate liver function must be demonstrated, defined as: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND ALT (SGPT) ≤ 3 times upper limit of normal (ULN) for age AST (SGOT) ≤ 3 times upper limit of normal (ULN) for age. Subjects with CNS disease currently taking steroids must have been on a stable dose of steroids for at least one week prior to their biopsy and must not have progressive hydrocephalus at enrollment. A negative serum pregnancy test is required for female participants of childbearing potential (≥13 years of age or after onset of menses) Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrel implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended. Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines Post-Biopsy: Patients with post-biopsy neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration. Exclusion Criteria: Absence of tumor on biopsy specimen or a diagnosis other than NBL or glioma on biopsy Known autoimmune or immunosuppressive disease or human immunodeficiency virus infection. Subjects with significant renal, cardiac, pulmonary, hepatic or other organ dysfunction. Prior allergic reaction to GM-CSF or Td. Subjects who have received any cytotoxic chemotherapy within the last 7 days prior to biopsy or focal radiotherapy in the case of patients with diffuse intrinsic pontine (or other brain stem) gliomas Subjects with NBL who have received any radiotherapy to the primary sample site within the last 14 days (radiation may be included in treatment decision after biopsy). Subjects receiving any investigational drug concurrently. Subjects with uncontrolled serious infections or a life-threatening illness (unrelated to tumor) Subjects with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study healthy volunteers No gender All minimum age 1 Year maximum age 30 Years std age list std age Child Adult contacts locations module central contact list central contact central contact name G Bergendahl, MSN central contact role Contact central contact phone (704) 355-1220 central contact e mail [email protected] overall official list overall official overall official name Giselle Sholler, MD overall official affiliation Beat Childhood Cancer at Atrium Health overall official role Study Chair overall official name Duane Mitchell, M.D., Ph.D. overall official affiliation University of Florida overall official role Study Chair location list location location facility University of Florida location status Recruiting location city Gainesville location state Florida location zip 32611 location country United States location contact list location contact location contact name Marcia Hodik, RN location contact role Contact location contact phone 352-273-9050 location contact e mail [email protected] location contact name Elias Sayour, MD location contact role Principal Investigator location facility Levine Children's Hospital location status Recruiting location city Charlotte location state North Carolina location zip 28204 location country United States location contact list location contact location contact name Abigail Moore location contact role Contact location contact phone 980-442-2356 location contact e mail [email protected] location contact name Lauren Smith location contact role Contact location contact e mail [email protected] location contact name Chad Jacobsen, MD location contact role Principal Investigator references module see also link list see also link see also link label Beat Childhood Cancer Consortium website see also link u r l http://www.beatcc.org i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000005910 condition mesh term Glioma condition mesh id D000009447 condition mesh term Neuroblastoma condition mesh id D000080443 condition mesh term Diffuse Intrinsic Pontine Glioma condition ancestor list condition ancestor condition ancestor id D000018302 condition ancestor term Neoplasms, Neuroepithelial condition ancestor id D000017599 condition ancestor term Neuroectodermal Tumors condition ancestor id D000009373 condition ancestor term Neoplasms, Germ Cell and Embryonal condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009380 condition ancestor term Neoplasms, Nerve Tissue condition ancestor id D000018241 condition ancestor term Neuroectodermal Tumors, Primitive, Peripheral condition ancestor id D000018242 condition ancestor term Neuroectodermal Tumors, Primitive condition ancestor id D000020295 condition ancestor term Brain Stem Neoplasms condition ancestor id D000015192 condition ancestor term Infratentorial Neoplasms condition ancestor id D000001932 condition ancestor term Brain Neoplasms condition ancestor id D000016543 condition ancestor term Central Nervous System Neoplasms condition ancestor id D000009423 condition ancestor term Nervous System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M14002 condition browse leaf name Recurrence condition browse leaf relevance low condition browse leaf id M8172 condition browse leaf name Glioma condition browse leaf as found Glioma condition browse leaf relevance high condition browse leaf id M11543 condition browse leaf name Neuroblastoma condition browse leaf as found Neuroblastoma condition browse leaf relevance high condition browse leaf id M2159 condition browse leaf name Diffuse Intrinsic Pontine Glioma condition browse leaf as found Diffuse Intrinsic Pontine Glioma condition browse leaf relevance high condition browse leaf id M19599 condition browse leaf name Neoplasms, Neuroepithelial condition browse leaf relevance low condition browse leaf id M18997 condition browse leaf name Neuroectodermal Tumors condition browse leaf relevance low condition browse leaf id M19540 condition browse leaf name Neuroectodermal Tumors, Primitive condition browse leaf relevance low condition browse leaf id M11470 condition browse leaf name Neoplasms, Germ Cell and Embryonal condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11477 condition browse leaf name Neoplasms, Nerve Tissue condition browse leaf relevance low condition browse leaf id M19539 condition browse leaf name Neuroectodermal Tumors, Primitive, Peripheral condition browse leaf relevance low condition browse leaf id M21261 condition browse leaf name Brain Stem Neoplasms condition browse leaf relevance low condition browse leaf id M17050 condition browse leaf name Infratentorial Neoplasms condition browse leaf relevance low condition browse leaf id M4361 condition browse leaf name Brain Neoplasms condition browse leaf relevance low condition browse leaf id M11519 condition browse leaf name Nervous System Neoplasms condition browse leaf relevance low condition browse leaf id M18089 condition browse leaf name Central Nervous System Neoplasms condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id T2519 condition browse leaf name Glioma condition browse leaf as found Glioma condition browse leaf relevance high condition browse leaf id T4085 condition browse leaf name Neuroblastoma condition browse leaf as found Neuroblastoma condition browse leaf relevance high condition browse leaf id T1865 condition browse leaf name Diffuse Intrinsic Pontine Glioma condition browse leaf as found Diffuse Intrinsic Pontine Glioma condition browse leaf relevance high condition browse leaf id T4092 condition browse leaf name Neuroepithelioma condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04837547
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full study rank 61737 study protocol section identification module n c t id NCT04832581 org study id info org study id ECaliskan organization org full name Istanbul University-Cerrahpasa org class OTHER brief title Developing Self-care Behaviors for Urinary Tract Infections official title Effectiveness Of The Self-Care Behavior Development Program For Urinary Tract Infections in Pregnant, Women status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date January 20, 2020 start date type Actual primary completion date struct primary completion date June 3, 2020 primary completion date type Actual completion date struct completion date July 8, 2020 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 1, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Esra Çalışkan responsible party investigator title Principal Investigator responsible party investigator affiliation Istanbul University-Cerrahpasa lead sponsor lead sponsor name Istanbul University-Cerrahpasa lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The research was designed in a randomized controlled quasi-experimental type in order to reveal the effect of "Self-Care Behaviors Development Program for Urinary Tract Infections" prepared according to Orem's Self Care Model on the behavioral change in pregnant women. detailed description Study Population and Sample The universe of the study consists of all women who have been diagnosed with pregnancy who admitted to the pregnant outpatient clinics of hospitals and who meet the inclusion and exclusion criteria. Pregnant women were selected by simple random sampling method and included in the study. n=(Nt^2 pq)/(d^2 (N-1)+t^2 pq) According to his formula, n = 29.828625 was found at the significance level of α = 0.05 at 0.05 margin of error. n = Number of women to be included in the sampling N = the number of participants that make up the universe of the research (3000) p = Frequency of occurrence (0.02) q = frequency of occurrence of the event (1-p) t = t table value at the error level detected at a certain degree of freedom (1.96) d = the desired deviation value (0.05) according to the frequency of occurrence of the event When the urinary system infection is seen as 2% in pregnant women (Ayhan et al.2008) and the number of live births of the hospital in one year is taken as 3000 reference (Hospital archive) α = 0.05 at the significance level of 0.05 The number of pregnant women to be sampled in the margin of error is 30 people. It is planned to work with a total of 60 participants, 30 for the experimental group and 30 for the control group. Randomization was applied to determine the experimental and control groups. Data Collection Tools Before determining the data collection tools, the literature about the research subject was searched. Tools were determined in accordance with the information obtained from the literature. At the same time, a Self-Care Behaviors Development Program was created, and it was decided to implement the program with the pregnant women in the experimental group by face-to-face meeting and then by phone call. Two forms and an inventory were used to collect data in the study. Data collection tools used in research; Pregnant Information Form Pregnant Evaluation Form Genital Hygiene Behaviors Inventory Pregnancy Education Brochure Data Collection The pregnant women who accepted to participate in the study were informed about the purpose and importance of the research, data collection tools and methods, and the flow of the study. While a brochure was given to the pregnant women in the control group (after the end of the study) in the randomization table, the pregnant women in the experimental group were informed that they were included in a training and counseling program and that they would be interviewed again by phone. Each pregnant participating in the study was also informed that she could quit the study at any time. The data collection of the research took place in 4 stages. Preparation phase Before starting the study, the written permissions of the study (the permission of the ethics committee, the permission of the institution where the study will be conducted and the use of the Genital Hygiene Behavior Inventory used in the study were obtained. First stage Determination of groups and randomization: It was planned to have an experimental and a control group according to the type of study. Determination of the patients included in the experimental and control groups was made using the randomization program. Obtaining Informed Volunteer Consent: After obtaining the necessary permissions for the study, the researcher gave written and verbal expressions about the study in a language they understand to the pregnant women who met the inclusion criteria of the study. After the written consent form was signed by the pregnant women who accepted to participate in the study, the study was carried out by the researcher using a face-to-face interview technique. Second stage After all the necessary permissions and preparations for the study were made, the data collection tools of the study (Pregnant Information Form, Genital Hygiene Behavior Inventory) were filled in in accordance with the information obtained from the patients. After the information obtained, the "Self-Care Behaviors Development Program for Urinary Tract Infections" prepared for the pregnant women in the experimental group was applied. Pregnancy Follow-up Form and Genital Hygiene Behavior Inventory were applied to the pregnant women in the experimental group 2 weeks after the end of the program, in order to evaluate the effectiveness of the training by the researcher using the telephone interview technique. Third stage All information obtained by the researcher and from the patient records were recorded in the Pregnant Information Form, Pregnancy Evaluation Form and Genital Hygiene Behavior Inventory. The recorded data were transferred to the computer environment by the researcher, and the data were evaluated and statistically analyzed. Data Evaluation The evaluation and statistical analysis of the data were performed in computer environment using the Statistical Pocket Program Statistical Package for the Social Sciences (statistics program for social sciences = SPSS 22.0). In the first stage, percentages and averages were calculated in the calculation of the distribution of the data of the study. In the second stage, when the numerical data met the normal distribution criteria, statistical analysis was performed using an independent sample t test, considering the distribution of normality. Numerical data that did not show normal distribution were evaluated using the Mann Whitney U test. Variables specified in frequency will be analyzed by Chi-square test. P <0.05 was considered statistically significant. conditions module condition list condition Urinary Tract Infection During Pregnancy keyword list keyword Nursing Care During Pregnancy Orem Self Care Model Urinary Tract Infection design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description There are two groups in the study, namely the experiment (33) and the control (34) group. The experimental group was included in the program based on the Orem Self Care Model. The program includes anatomical, physiological and hormonal changes during pregnancy, urinary system infections and preventive measures. In the experimental and control groups, the data were collected byface-to-face interview technique and telephone interviews. Pregnant Information Form, Pregnant Evaluation Form, Genital Hygiene Behavior Inventory (GHBI) and routine laboratory testsof pregnant women were used to collect data. design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 67 enrollment type Actual arms interventions module arm group list arm group arm group label Experimental Group arm group type Experimental arm group description The experimental group was informed that they participated in a study. After the data collection forms were introduced, written and verbal consents were obtained. Information has been received. The experimental group was included in the program based on the Orem Self Care Model. The program includes anatomical, physiological and hormonal changes during pregnancy, urinary system infections and preventive measures. A phone call was scheduled 2 weeks later. Second evaluation forms were applied. Both groups were informed that the study was concluded. arm group intervention list arm group intervention name Behavioral: The Self-Care Behavior Development Program arm group label Control Group arm group type No Intervention arm group description The control group was informed that they participated in a study. After the data collection forms were introduced, written and verbal consents were obtained. Information has been received. A phone call was scheduled 2 weeks later. Second evaluation forms were applied. After the research was completed, information was given in order to avoid bias and the brochure was delivered. Both groups were informed that the study was concluded. intervention list intervention intervention type Behavioral intervention name The Self-Care Behavior Development Program intervention description This program, which is based on the Orem Self Care Model, includes anatomical, physiological and hormonal changes, urinary system infections and preventive measures during pregnancy. The program is different from other researches in that it is based on a methodological theory and is created with up-to-date information. intervention arm group label list intervention arm group label Experimental Group outcomes module primary outcome list primary outcome primary outcome measure Genital Hygiene Behavior Inventory (GHBI) primary outcome description Likert type inventory consisting of 27 questions evaluating genital hygiene behaviors.Inventory was applied to all pregnant women participating in the study at the beginning and at the end of the study. primary outcome time frame 2 weeks primary outcome measure Pregnant Information Form primary outcome description The form consists of 8 sections including sociodemographic information, information about pregnancy, urinary characteristics, hygiene habits, information about sexuality and pain status, examinations of the pregnant (such as full urinalysis) and the observation form. The form was created by researchers in line with the literature. It was used to take the first anamnesis of the pregnant woman. primary outcome time frame 2 weeks primary outcome measure Pregnancy Evaluation Form primary outcome description The form consists of six sections including anthropometric information, information about pregnancy, urinary characteristics, hygiene habits, information about sexuality and pain status. The form was created by researchers in line with the literature. It was used for the post-training evaluation of the pregnant woman. primary outcome time frame 2 weeks eligibility module eligibility criteria Inclusion Criteria: Agreeing to participate in the study, To speak and understand Turkish, Access to patient records, Pregnancy diagnosis by ultrasound Exclusion Criteria: The pregnant woman does not want to participate in the Self-Care Behaviors Development Program for Urinary Tract Infections prepared according to Orem's Self-Care Model, Pregnant's use of corticosteroids healthy volunteers Accepts Healthy Volunteers gender Female gender based Yes gender description The research is planned to be conducted with pregnant women. minimum age 22 Years maximum age 49 Years std age list std age Adult contacts locations module location list location location facility Esra Çalışkan location city İstanbul location country Turkey location facility Nevin Hotun Şahin location city İstanbul location country Turkey references module reference list reference reference p m i d 31146773 reference type background reference citation Azami M, Jaafari Z, Masoumi M, Shohani M, Badfar G, Mahmudi L, Abbasalizadeh S. The etiology and prevalence of urinary tract infection and asymptomatic bacteriuria in pregnant women in Iran: a systematic review and Meta-analysis. BMC Urol. 2019 May 30;19(1):43. doi: 10.1186/s12894-019-0454-8. reference p m i d 26450405 reference type background reference citation Easter SR, Cantonwine DE, Zera CA, Lim KH, Parry SI, McElrath TF. Urinary tract infection during pregnancy, angiogenic factor profiles, and risk of preeclampsia. Am J Obstet Gynecol. 2016 Mar;214(3):387.e1-7. doi: 10.1016/j.ajog.2015.09.101. Epub 2015 Oct 9. reference p m i d 19469432 reference type result reference citation Amiri FN, Rooshan MH, Ahmady MH, Soliamani MJ. Hygiene practices and sexual activity associated with urinary tract infection in pregnant women. East Mediterr Health J. 2009 Jan-Feb;15(1):104-10. reference p m i d 23885968 reference type result reference citation Emiru T, Beyene G, Tsegaye W, Melaku S. Associated risk factors of urinary tract infection among pregnant women at Felege Hiwot Referral Hospital, Bahir Dar, North West Ethiopia. BMC Res Notes. 2013 Jul 25;6:292. doi: 10.1186/1756-0500-6-292. reference p m i d 29653573 reference type result reference citation Ghouri F, Hollywood A, Ryan K. A systematic review of non-antibiotic measures for the prevention of urinary tract infections in pregnancy. BMC Pregnancy Childbirth. 2018 Apr 13;18(1):99. doi: 10.1186/s12884-018-1732-2. reference p m i d 20225781 reference type result reference citation Haider G, Zehra N, Munir AA, Haider A. Risk factors of urinary tract infection in pregnancy. J Pak Med Assoc. 2010 Mar;60(3):213-6. reference p m i d 9378932 reference type result reference citation Stapleton A, Stamm WE. Prevention of urinary tract infection. Infect Dis Clin North Am. 1997 Sep;11(3):719-33. Review. see also link list see also link see also link label Related Info see also link u r l http://dergipark.org.tr/tr/pub/vansaglik/issue/54113/615967 see also link label Related Info see also link u r l http://dergipark.org.tr/tr/download/article-file/29284 see also link label Related Info see also link u r l http://dergipark.org.tr/tr/download/article-file/29709 see also link label Related Info see also link u r l http://dergipark.org.tr/tr/download/article-file/835961 see also link label Related Info see also link u r l http://dergipark.org.tr/tr/download/article-file/1104822 see also link label Related Info see also link u r l http://dergipark.org.tr/tr/download/article-file/1039581 i p d sharing statement module i p d sharing No i p d sharing description Research results will be shared. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007239 condition mesh term Infections condition mesh id D000003141 condition mesh term Communicable Diseases condition mesh id D000014552 condition mesh term Urinary Tract Infections condition ancestor list condition ancestor condition ancestor id D000020969 condition ancestor term Disease Attributes condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000014570 condition ancestor term Urologic Diseases condition browse leaf list condition browse leaf condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf as found Infection condition browse leaf relevance high condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf as found Infection condition browse leaf relevance high condition browse leaf id M16454 condition browse leaf name Urinary Tract Infections condition browse leaf as found Urinary Tract Infections condition browse leaf relevance high condition browse leaf id M21853 condition browse leaf name Disease Attributes condition browse leaf relevance low condition browse leaf id M16471 condition browse leaf name Urologic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions
NCT04832581
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full study rank 61517 study protocol section identification module n c t id NCT04835441 org study id info org study id AIS-A03 organization org full name Alpine Immune Sciences, Inc. org class INDUSTRY brief title ALPN-101 in Systemic Lupus Erythematosus official title A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus acronym Synergy status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 22, 2021 start date type Actual primary completion date struct primary completion date November 2023 primary completion date type Anticipated completion date struct completion date January 2024 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 14, 2022 last update post date struct last update post date October 17, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Alpine Immune Sciences, Inc. lead sponsor class INDUSTRY oversight module is f d a regulated drug Yes is f d a regulated device No description module brief summary This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 in adults with moderate to severe active systemic lupus erythematosus (SLE) conditions module condition list condition Systemic Lupus Erythematosus keyword list keyword CD28 ICOS Autoimmune disease Immune system disease Immunosuppressive agent design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 130 enrollment type Anticipated arms interventions module arm group list arm group arm group label ALPN-101 arm group type Experimental arm group intervention list arm group intervention name Drug: ALPN-101 arm group label Placebo arm group type Placebo Comparator arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name ALPN-101 intervention description Blinded ALPN-101 will be administered intervention arm group label list intervention arm group label ALPN-101 intervention type Drug intervention name Placebo intervention description Blinded placebo matching ALPN-101 will be administered. intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Adverse Events primary outcome description Type, incidence, and severity of adverse events as assessed by CTCAE primary outcome time frame From study Day 1 until End of Study (28 weeks) eligibility module eligibility criteria Inclusion Criteria: Written informed consent Age 18 to 65 Diagnosis of lupus for ≥ 6 months prior to Screening Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test at Screening Active lupus at Screening and Baseline, as defined per-protocol and confirmed by the study's medical monitor, including a SLEDAI score at Screening of ≥ 6 and a clinical score at Baseline of ≥ 4 Standard lupus medications must be stable prior to Screening Women must have a PAP smear and known HPV status within 12 months of Day 1 All participants must use highly effective birth control if they/their partner are capable of becoming pregnant Exclusion Criteria: Life-threatening or organ system-threatening lupus activity that is anticipated to require increased treatment during the study Proteinuria consistent with nephrotic syndrome Active lupus-related neuropsychiatric disease Drug-induced lupus Any serious health condition that would place the subject at undue risk from the study or would confound interpretation of safety or efficacy outcomes Recent or serious ongoing infection; risk or history of serious infection Receipt of live vaccination within 8 weeks of Day 1, or expected to require live vaccination during the study Unacceptable Screening laboratory results History of new, ongoing, or recurrent malignancy ≤ 5 years prior to Day 1, with some exceptions per-protocol Pregnant or breastfeeding at the time of screening, or plans to become pregnant ≤ 3 months following the last dose of study drug Prior diagnosis of, or fulfills diagnostic criteria for, another rheumatic disease that overlaps with lupus or another autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study Diagnosis of, or fulfills diagnostic criteria for, fibromyalgia Functional class IV lupus Does not meet protocol washout periods for concomitant medications Serious lupus disease activity, which warrants immediate immunosuppressive therapy not appropriate for the study or which makes the possibility of receiving placebo or investigational agent an inappropriate risk Ongoing participation in another therapeutic clinical trial Known hypersensitivity to ALPN-101, components thereof, or excipients contained in the drug formulation healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Marcus Martin central contact role Contact central contact phone 1 404 309 8902 central contact e mail [email protected] overall official list overall official overall official name Rachel Peterson, MD overall official affiliation Alpine Immune Sciences, Inc. overall official role Study Director location list location location facility Investigational Site (107) location status Recruiting location city Anniston location state Alabama location zip 36207 location country United States location facility Investigational Site (158) location status Recruiting location city Tucson location state Arizona location zip 85704 location country United States location facility Investigational Site (174) location status Recruiting location city La Jolla location state California location zip 92037 location country United States location facility Investigational Site (155) location status Recruiting location city Los Angeles location state California location zip 90022 location country United States location facility Investigational Site (109) location status Recruiting location city San Diego location state California location zip 92020 location country United States location facility Investigational Site (169) location status Recruiting location city Santa Barbara location state California location zip 93108 location country United States location facility Investigational Site (106) location status Recruiting location city DeBary location state Florida location zip 32713 location country United States location facility Investigational Site (170) location status Recruiting location city Fort Lauderdale location state Florida location zip 33309 location country United States location facility Investigational Site (120) location status Recruiting location city Hialeah location state Florida location zip 33016 location country United States location facility Investigational Sites (134, 153) location status Recruiting location city Miami location state Florida location zip 33165 location country United States location facility Investigational Site (152) location status Recruiting location city Ormond Beach location state Florida location zip 32174 location country United States location facility Investigational Site (151) location status Recruiting location city Palm Harbor location state Florida location zip 34684 location country United States location facility Investigational Site (133) location status Recruiting location city Plantation location state Florida location zip 33324 location country United States location facility Investigational Site (131) location status Recruiting location city Port Orange location state Florida location zip 32127 location country United States location facility Investigational Site (163) location status Recruiting location city Tampa location state Florida location zip 33606 location country United States location facility Investigational Site (114) location status Recruiting location city Atlanta location state Georgia location zip 30342 location country United States location facility Investigational Site (173) location status Recruiting location city Idaho Falls location state Idaho location zip 83404 location country United States location facility Investigational Site (156) location status Recruiting location city Skokie location state Illinois location zip 60076 location country United States location facility Investigational Site (154) location status Recruiting location city Bowling Green location state Kentucky location zip 42101 location country United States location facility Investigational Site (138) location status Recruiting location city Grand Blanc location state Michigan location zip 48439 location country United States location facility Investigational Site (164) location status Recruiting location city Las Vegas location state Nevada location zip 89128 location country United States location facility Investigational Site (175) location status Recruiting location city Brooklyn location state New York location zip 11220 location country United States location facility Investigational Site (115) location status Recruiting location city Manhasset location state New York location zip 11030 location country United States location facility Investigational Site (179) location status Recruiting location city Charlotte location state North Carolina location zip 28277 location country United States location facility Investigational Site (167) location status Withdrawn location city Oklahoma City location state Oklahoma location zip 73102 location country United States location facility Investigational Site (112) location status Recruiting location city Crossville location state Tennessee location zip 38555 location country United States location facility Investigational Site (145) location status Recruiting location city Jackson location state Tennessee location zip 38305 location country United States location facility Investigational Site (186) location status Recruiting location city Memphis location state Tennessee location zip 38119 location country United States location facility Investigational Site (171) location status Recruiting location city Baytown location state Texas location zip 77521 location country United States location facility Investigational Site (143) location status Recruiting location city Bellaire location state Texas location zip 77401 location country United States location facility Investigational Site (118) location status Recruiting location city Colleyville location state Texas location zip 76034 location country United States location facility Investigational Site (166) location status Recruiting location city Fort Worth location state Texas location zip 76107 location country United States location facility Investigational Site (121) location status Recruiting location city Houston location state Texas location zip 77089 location country United States location facility Investigational Site (172) location status Recruiting location city Houston location state Texas location zip 77095 location country United States location facility Investigational Site (104) location status Recruiting location city Mesquite location state Texas location zip 75150 location country United States location facility Investigational Site (162) location status Recruiting location city San Antonio location state Texas location zip 78215 location country United States location facility Investigational Site (127) location status Recruiting location city San Antonio location state Texas location zip 78229 location country United States location facility Investigational Site (178) location status Recruiting location city Roanoke location state Virginia location zip 24016 location country United States location facility Investigational Site (124) location status Recruiting location city Dijon location state Bourgogne location zip 21000 location country France location facility Investigational Site (149) location status Recruiting location city Marseille location zip 13285 location country France location facility Investigational Site (123) location status Recruiting location city Nice location country France location facility Investigational Site (128) location status Recruiting location city Paris location country France location facility Investigational Site (161) location status Recruiting location city Paris location country France location facility Investigational Site (180) location status Recruiting location city Budapest location country Hungary location facility Investigational Site (181) location status Recruiting location city Budapest location country Hungary location facility Investigational Site (183) location status Recruiting location city Székesfehérvár location country Hungary location facility Investigational Site (122) location status Recruiting location city Junggu location state Daegu location zip 41944 location country Korea, Republic of location facility Investigational Site (117) location status Recruiting location city Donggu location state Gwangu location zip 61469 location country Korea, Republic of location facility Investigational Site (125) location status Recruiting location city Seoul location zip 3080 location country Korea, Republic of location facility Investigational Site (116) location status Recruiting location city Suwon location zip 16499 location country Korea, Republic of location facility Investigational Site (160) location status Recruiting location city Elbląg location country Poland location facility Investigational Site (110) location status Recruiting location city Kraków location zip 30-363 location country Poland location facility Investigational Site (108) location status Recruiting location city Poznań location zip 60-848 location country Poland location facility Investigational Site (119) location status Recruiting location city Poznań location zip 61-397 location country Poland location facility Investigational Site (165) location status Recruiting location city Wrocław location zip 50-244 location country Poland location facility Investigational Site (113) location status Recruiting location city Wrocław location zip 51-124 location country Poland location facility Investigational Site (137) location status Recruiting location city Coruna location zip 15006 location country Spain location facility Investigational Site (126) location status Recruiting location city Madrid location zip 28905 location country Spain location facility Investigational Site (139) location status Recruiting location city Sevilla location zip 41010 location country Spain location facility Investigational Site (142) location status Recruiting location city Seville location country Spain i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008180 condition mesh term Lupus Erythematosus, Systemic condition ancestor list condition ancestor condition ancestor id D000003240 condition ancestor term Connective Tissue Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M10329 condition browse leaf name Lupus Erythematosus, Systemic condition browse leaf as found Systemic Lupus Erythematosus condition browse leaf relevance high condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M5616 condition browse leaf name Connective Tissue Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04835441
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full study rank 61675 study protocol section identification module n c t id NCT04833387 org study id info org study id B2019-092 organization org full name Sun Yat-sen University org class OTHER brief title PD-1 Antibody Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer official title PD-1 Antibody as a Sequential Therapy Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer: an Open, Multi-center, Phase II Clinical Trial status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date January 1, 2021 start date type Actual primary completion date struct primary completion date December 31, 2024 primary completion date type Anticipated completion date struct completion date December 31, 2026 completion date type Anticipated study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 10, 2021 last update post date struct last update post date April 14, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Pei-Rong Ding responsible party investigator title Professor responsible party investigator affiliation Sun Yat-sen University lead sponsor lead sponsor name Sun Yat-sen University lead sponsor class OTHER collaborator list collaborator collaborator name Liaoning Tumor Hospital & Institute collaborator class OTHER collaborator name Fudan University collaborator class OTHER oversight module is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 antibody following preoperative Chemoradiotherapy with capecitabine for pMMR/MSS rectal cancer staged as locally advanced (cT3-T4N+/-M0 for rectal cancer). This treatment will be given during the window period until surgical resection of the tumor. conditions module condition list condition Lynch Syndrome design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design intervention model description PD-1 design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label PD-1 antibody + capecitabine + radiation arm group type Experimental arm group intervention list arm group intervention name Drug: PD-1 antibody intervention list intervention intervention type Drug intervention name PD-1 antibody intervention description Capecitabine:Dose of 1650mg/m2,14days; Radiation:50Gy/25 fractions;IBI308: 200mg on day1 of each cycle, 3 cycles; Surgical therapy:The resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR) intervention arm group label list intervention arm group label PD-1 antibody + capecitabine + radiation outcomes module primary outcome list primary outcome primary outcome measure Pathological complete response primary outcome description Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging primary outcome time frame 1 year secondary outcome list secondary outcome secondary outcome measure Relapse-free survival (RFS) secondary outcome time frame 3 years secondary outcome measure Overall survival (OS) secondary outcome time frame 3 years secondary outcome measure Clinical complete response (CCR) secondary outcome time frame 1 year eligibility module eligibility criteria Inclusion Criteria: Patients who personally provided written consent for participation in the study Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor was at a distance of 12 cm or less from the AV before CRT Primary rectal cancer histopathologically confirmed to be adenocarcinoma Clinical stage of T3,and T4 ,N any,M0,before CRT Macroscopic radical resection could be feasible, based on diagnostic imaging before CRT Patients with the ECOG performance status of 0 or 1 at the time of enrollment Patients without distant metastasis on the imaging test before CRT Preoperative biopsy of tumor immunohistochemistry TPS>1% or CPS>1 Life expectancy of greater than 2 years No signs of intestinal obstruction; or the obstruction has been relieved after the proximal colostomy operation Hematology: WBC>4000/mm3; PLT>100000/mm3; Hb>10g/dL Liver function: SGOT and SGPT are less than 1.5 times the normal value; bilirubin is less than 1.5mg/dL Renal function: creatinine <1.8mg/dL Others: non-pregnant or breast-feeding women; no other malignant diseases (except for non-melanoma or cervical carcinoma in situ) within 5 years or during the same period; no mental illness that causes the inability to obtain informed consent; no other serious diseases that can shorten the survival time disease. Have not received rectal surgery in the past; Have not received chemotherapy or radiotherapy in the past; Have not received biological treatment in the past; Past endocrine therapy: unlimited. Exclusion Criteria: Rectal cancer with unstable microsatellite (MSI or dMMR); Preoperative biopsy of tumor immunohistochemistry TPS≤1% or CPS≤1 Known history of human immunodeficiency virus (HIV) or chronic hepatitis B or C (high copy viral DNA); Autoimmune diseases; Other active clinical serious infections (>NCI-CTC version 3.0); Patients in clinical phase I; There is evidence that there is distant metastasis before surgery; Cachexia, decompensation of organ function; Have a history of pelvic or abdominal radiotherapy; Multiple primary cancers; Patients who need treatment for seizures (such as steroids or anti-epileptic treatment); Have a known additional malignant tumors within 5 years. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer; Chronic inflammatory bowel disease, intestinal obstruction; Drug abuse and medical, psychological or social conditions may interfere with patients' participation in research or have an impact on the evaluation of research results; Known or suspected to be allergic to the study drug or to any drug given in connection with this test; Any unstable conditions or situations that may endanger patient safety and compliance healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Peirong Ding, Doctor central contact role Contact central contact phone 13543478645 Ext. +86 central contact e mail [email protected] location list location location facility 651 Dongfeng Road East location status Recruiting location city Guangzhou location state Guangdong location zip 510060 location country China location contact list location contact location contact name Peirong Ding, Doctor location contact role Contact location contact phone 13543478645 location contact phone ext +86 location contact e mail [email protected] location contact name Wu Jiang, Doctor location contact role Contact location contact phone 15989120166 location contact phone ext +86 location contact e mail [email protected] i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003123 condition mesh term Colorectal Neoplasms, Hereditary Nonpolyposis condition ancestor list condition ancestor condition ancestor id D000015179 condition ancestor term Colorectal Neoplasms condition ancestor id D000007414 condition ancestor term Intestinal Neoplasms condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000009386 condition ancestor term Neoplastic Syndromes, Hereditary condition ancestor id D000003108 condition ancestor term Colonic Diseases condition ancestor id D000030342 condition ancestor term Genetic Diseases, Inborn condition ancestor id D000049914 condition ancestor term DNA Repair-Deficiency Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M17042 condition browse leaf name Colorectal Neoplasms condition browse leaf relevance low condition browse leaf id M5503 condition browse leaf name Colorectal Neoplasms, Hereditary Nonpolyposis condition browse leaf as found Lynch Syndrome condition browse leaf relevance high condition browse leaf id M9600 condition browse leaf name Intestinal Neoplasms condition browse leaf relevance low condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M11483 condition browse leaf name Neoplastic Syndromes, Hereditary condition browse leaf relevance low condition browse leaf id M5488 condition browse leaf name Colonic Diseases condition browse leaf relevance low condition browse leaf id M22839 condition browse leaf name Genetic Diseases, Inborn condition browse leaf relevance low condition browse leaf id M25284 condition browse leaf name DNA Repair-Deficiency Disorders condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000000906 intervention mesh term Antibodies intervention ancestor list intervention ancestor intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf as found Period intervention browse leaf relevance high intervention browse leaf id M377 intervention browse leaf name Capecitabine intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents
NCT04833387
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full study rank 61837 study protocol section identification module n c t id NCT04831281 org study id info org study id ATH-1017-PD-0201 organization org full name Athira Pharma org class INDUSTRY brief title ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial) official title A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date January 20, 2022 start date type Actual primary completion date struct primary completion date October 2023 primary completion date type Anticipated completion date struct completion date November 2023 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 17, 2022 last update post date struct last update post date May 19, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Athira Pharma lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary This study is designed to evaluate the safety and treatment effects of fosgonimeton (ATH-1017) in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized treatment duration of 26 weeks. detailed description The study is designed to evaluate the safety and treatment effects of ATH-1017 in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized, double-blind, placebo-controlled, parallel-arm treatment duration of 26 weeks. conditions module condition list condition Parkinson Disease Dementia Dementia With Lewy Bodies keyword list keyword Parkinson's Disease Dementia Dementia with Lewy Bodies Dementia HGF/MET Hepatocyte Growth Factor Neurotrophic ATH-1017 Event-Related Potential ERP P300 design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 75 enrollment type Anticipated arms interventions module arm group list arm group arm group label 40mg Dose arm group type Experimental arm group description Daily subcutaneous injection of 40mg ATH-1017 arm group intervention list arm group intervention name Drug: ATH-1017 arm group label 70mg Dose arm group type Experimental arm group description Daily subcutaneous injection of 70mg ATH-1017 arm group intervention list arm group intervention name Drug: ATH-1017 arm group label Placebo arm group type Placebo Comparator arm group description Daily subcutaneous injection of Placebo arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name ATH-1017 intervention description Daily subcutaneous injection of ATH-1017 in a pre-filled syringe intervention arm group label list intervention arm group label 40mg Dose 70mg Dose intervention type Drug intervention name Placebo intervention description Daily subcutaneous injection of Placebo in a pre-filled syringe intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Overall treatment effect of ATH-1017 as reflected by the Global Statistical Test primary outcome description As reflected by the composite Global Statistical Test (GST) primary outcome time frame Week 26 secondary outcome list secondary outcome secondary outcome measure Event-Related Potential secondary outcome description Event-related potential (ERP) P300 latency change from baseline secondary outcome time frame Week 2, 12, 26 secondary outcome measure Cognition secondary outcome description Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog13] change from baseline (Range of 0 to 85, where 0 is least impairment and 85 is most severe impairment) secondary outcome time frame Week 2, 12, 20, and 26 secondary outcome measure Clinical Global Impression of Change secondary outcome description Clinical Global Impression of Change (CGI-C) change from baseline (Range of 1 to 7, where 1 is marked improvement and 7 is marked worsening) secondary outcome time frame Week 12 and 26 secondary outcome measure Activities of Daily Living secondary outcome description Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-item version [ADCS-ADL23] change from baseline (Range of 0 to 78, where a higher score indicates greater function) secondary outcome time frame Week 12 and 26 other outcome list other outcome other outcome measure Motor Function other outcome description Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score other outcome time frame Week 12, 26 eligibility module eligibility criteria Inclusion Criteria: Subjects with confirmed diagnosis of Parkinson's disease or Dementia with Lewy Bodies MoCA score 11 to 23, inclusive, at screening Probable Parkinson's Disease Dementia or Lewy Body Dementia BMI between ≥ 16and ≤ 35 kg/m2 for females and between≥ 18 and ≤ 35 kg/m2 for males at Screening Reliable and capable support person/caregiver, who is willing to accept responsibility for supervising the treatment or, if required, administering study drug, and assessing the condition of the subject throughout the study in accordance with all protocol requirements Exclusion Criteria: Hoehn-Yahr stage 5 History of significant neurological disease other than PDD or DLB that may affect cognition at onset of dementia Subjects on deep brain stimulation History of brain MRI scan indicative of any other significant abnormality History of unexplained loss of consciousness, and epileptic fits Hearing test result considered unacceptable for auditory ERP P300 assessment Diagnosis of severe major depressive disorder even without psychotic features (GDS score [15-item scale] >7 at Screening) Significant suicide risk based on C-SSRS Significant psychosis (according to Diagnostic and Statistical Manual of Mental Disorders) Moderate or severe substance abuse disorder (according to DSM-5) Myocardial infarction or unstable angina within the last 6 months Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable) Clinically significant ECG abnormality at Screening Chronic kidney disease (eGFR < 45 mL/min using Cockcroft-Gault formula) Hepatic impairment with alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of normal, or Child-Pugh class B and C Malignant tumor within 3 years before Screening Memantine at any dose or combination Donepezil at 23 mg healthy volunteers No gender All minimum age 40 Years maximum age 85 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Hans Moebius, MD, PhD central contact role Contact central contact phone (425) 620-8501 central contact e mail [email protected] location list location location facility Parkinson's Disease and Movement Disorders Center of Boca Raton location status Recruiting location city Boca Raton location state Florida location zip 33486 location country United States location contact list location contact location contact name Mariana Carvalho location contact role Contact location contact phone 561-392-1818 location contact phone ext 2 location contact e mail [email protected] location contact name Stuart Isaacson, MD location contact role Principal Investigator location facility Premiere Research Institute location status Recruiting location city West Palm Beach location state Florida location zip 33407 location country United States location contact list location contact location contact name Colleen Reiser location contact role Contact location contact phone 561-296-3853 location contact e mail [email protected] location contact name Paul Winner, MD location contact role Principal Investigator location facility iResearch Atlanta, LLC location status Recruiting location city Decatur location state Georgia location zip 30030 location country United States location contact list location contact location contact name Katie Prowse location contact role Contact location contact phone 404-537-1281 location contact e mail [email protected] location contact name Kimball Johnson, MD location contact role Principal Investigator location facility QUEST Research Institute location status Recruiting location city Farmington Hills location state Michigan location zip 48334 location country United States location contact list location contact location contact name Denise location contact role Contact location contact phone 248-957-8940 location contact e mail [email protected] location contact name Aaron Ellenbogen, DO, MPH location contact role Principal Investigator location facility Summit Research Network location status Recruiting location city Portland location state Oregon location zip 97210 location country United States location contact list location contact location contact name Recruitment Team location contact role Contact location contact phone 503-228-2273 location contact e mail [email protected] location contact name Scott Losk, PhD location contact role Principal Investigator location facility Center for Cognitive Health location status Recruiting location city Portland location state Oregon location zip 97225 location country United States location contact list location contact location contact name Andrew Van Dinter location contact role Contact location contact phone 503-207-2066 location contact e mail [email protected] location contact name Michael Mega, MD, PhD location contact role Principal Investigator location facility Keystone Clinical Studies LLC location status Recruiting location city Plymouth Meeting location state Pennsylvania location zip 19462 location country United States location contact list location contact location contact name Rachel Glick location contact role Contact location contact phone 610-277-8073 location contact e mail [email protected] location contact name Cherian Verghese, MD location contact role Principal Investigator location facility Northwest Clinical Research Center location status Recruiting location city Bellevue location state Washington location zip 98007 location country United States location contact list location contact location contact name Kimberly Wheeler location contact role Contact location contact phone 425-453-0404 location contact e mail [email protected] location contact name Arif Khan, MD location contact role Principal Investigator location facility Evergreen Health Research location status Recruiting location city Kirkland location state Washington location zip 98034 location country United States location contact list location contact location contact name Sameera Hasan location contact role Contact location contact phone 425-899-5385 location contact e mail [email protected] location contact name Daniel Burdick, MD location contact role Principal Investigator location facility Inland Northwest Research LLC location status Recruiting location city Spokane location state Washington location zip 99202 location country United States location contact list location contact location contact name Melissa Bixby location contact role Contact location contact phone 509-960-2818 location contact e mail [email protected] location contact name Jason Aldred, MD location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010300 condition mesh term Parkinson Disease condition mesh id D000003704 condition mesh term Dementia condition mesh id D000000544 condition mesh term Alzheimer Disease condition mesh id D000020961 condition mesh term Lewy Body Disease condition ancestor list condition ancestor condition ancestor id D000020734 condition ancestor term Parkinsonian Disorders condition ancestor id D000001480 condition ancestor term Basal Ganglia Diseases condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000009069 condition ancestor term Movement Disorders condition ancestor id D000080874 condition ancestor term Synucleinopathies condition ancestor id D000019636 condition ancestor term Neurodegenerative Diseases condition ancestor id D000019965 condition ancestor term Neurocognitive Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition ancestor id D000024801 condition ancestor term Tauopathies condition browse leaf list condition browse leaf condition browse leaf id M12365 condition browse leaf name Parkinson Disease condition browse leaf as found Parkinson's Disease condition browse leaf relevance high condition browse leaf id M6056 condition browse leaf name Dementia condition browse leaf as found Dementia condition browse leaf relevance high condition browse leaf id M21846 condition browse leaf name Lewy Body Disease condition browse leaf as found Dementia With Lewy Bodies condition browse leaf relevance high condition browse leaf id M3037 condition browse leaf name Alzheimer Disease condition browse leaf as found Dementia condition browse leaf relevance high condition browse leaf id M21647 condition browse leaf name Parkinsonian Disorders condition browse leaf relevance low condition browse leaf id M24756 condition browse leaf name Ganglion Cysts condition browse leaf relevance low condition browse leaf id M15510 condition browse leaf name Synovial Cyst condition browse leaf relevance low condition browse leaf id M3926 condition browse leaf name Basal Ganglia Diseases condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M11181 condition browse leaf name Movement Disorders condition browse leaf relevance low condition browse leaf id M2217 condition browse leaf name Synucleinopathies condition browse leaf relevance low condition browse leaf id M20711 condition browse leaf name Neurodegenerative Diseases condition browse leaf relevance low condition browse leaf id M20989 condition browse leaf name Neurocognitive Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id M22155 condition browse leaf name Tauopathies condition browse leaf relevance low condition browse leaf id T2192 condition browse leaf name Familial Alzheimer Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M11052 intervention browse leaf name Mitogens intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04831281
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full study rank 61573 study protocol section identification module n c t id NCT04834713 org study id info org study id XJTU1AF-CRF-2020-013 organization org full name First Affiliated Hospital Xi'an Jiaotong University org class OTHER brief title Study on the Relationship Between Neutrophil-mediated Thrombocytopenia and the Condition and the Course of Disease in Patients With HFRS official title Study on the Relationship Between Neutrophil-mediated Thrombocytopenia and the Condition and the Course of Disease in Patients With HFRS status module status verified date September 2021 overall status Recruiting expanded access info has expanded access No start date struct start date October 9, 2020 start date type Actual primary completion date struct primary completion date February 28, 2024 primary completion date type Anticipated completion date struct completion date February 28, 2024 completion date type Anticipated study first submit date December 24, 2020 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 1, 2021 last update post date struct last update post date September 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name First Affiliated Hospital Xi'an Jiaotong University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Thrombocytopenia is an important pathological feature of HFRS（Hemorrhagic Fever With Renal Syndrome, HFRS）. However, the cause of thrombocytopenia in HFRS is not yet fully understood. Neutrophils, as the largest number of white blood cells in the human body, can widely participate in the immune process of viral infections. Previous studies have found that the neutrophils of patients with acute myocardial infarction can interact with activated platelets and further mediate platelet phagocytosis.Therefore, this study aims to systematically elucidate the immunological process of neutrophil mediated thrombocytopenia in patients with HFRS by exploring the correlation between platelet activation, neutrophil activation and neutrophil proportion of adherent / phagocytic platelets peripheral blood of HFRS patients, and to analyze its relationship with the course of HFRS disease, which lays a theoretical foundation for further understanding the pathogenesis of HFRS and provides a basis for clinical use. conditions module condition list condition Hemorrhagic Fever With Renal Syndrome design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Cross-Sectional enrollment info enrollment count 28 enrollment type Anticipated arms interventions module arm group list arm group arm group label Mild patients arm group description defined as patients who had kidney injury without oliguria and hypotension arm group intervention list arm group intervention name Other: clinical classification of HFRS arm group label moderate patients arm group description defined as patients who had uremia, effusion (bulbar conjunctiva), hypotension, hemorrhage (skin and mucous membranes), and AKI with typical oliguria arm group intervention list arm group intervention name Other: clinical classification of HFRS arm group label severe patients arm group description defined as patients who had severe uremia, effusion (bulbar conjunctiva and either peritoneum or pleura), hemorrhage (skin and mucous membranes), hypotension and AKI with oliguria (urine output of 50-500 mL/day) for ≤ 5 days or anuria (urine output of < 100 mL/day) for ≤ 2 days arm group intervention list arm group intervention name Other: clinical classification of HFRS arm group label critical patients arm group description defined as patients who usually had one or more of the following complications compared with the severe patients: refractory shock (≥ 2 days), visceral hemorrhage, heart failure, pulmonary edema, brain edema, severe secondary infection, and severe AKI with oliguria (urine output of 50-500 mL/day) for > 5 days or anuria (urine output of < 100 mL/day) for > 2 days arm group intervention list arm group intervention name Other: clinical classification of HFRS arm group label healthy control arm group description defined as people without HFRS intervention list intervention intervention type Other intervention name clinical classification of HFRS intervention description Based upon clinical classification of HFRS , the patients were classified into four types intervention arm group label list intervention arm group label Mild patients critical patients moderate patients severe patients outcomes module primary outcome list primary outcome primary outcome measure Changes in the platelet activation ratio, % primary outcome description flow cytometry primary outcome time frame through study completion, an average of 2 year primary outcome measure Changes in neutrophils MPO content, MFI primary outcome description enzyme-linked immunosorbent assay primary outcome time frame through study completion, an average of 2 year primary outcome measure Changes in the neutrophils with adherent platelets, % primary outcome description flow cytometry primary outcome time frame through study completion, an average of 2 year primary outcome measure Changes in the neutrophils with internalized platelets, % primary outcome description flow cytometry primary outcome time frame through study completion, an average of 2 year secondary outcome list secondary outcome secondary outcome measure Changes in Neutrophils Mac-1 expression, MFI secondary outcome description flow cytometry secondary outcome time frame through study completion, an average of 2 year secondary outcome measure Changes in the platelets with phosphatidylserine exposure,% secondary outcome description flow cytometry secondary outcome time frame through study completion, an average of 2 year eligibility module eligibility criteria Inclusion Criteria: Age ≥18 years; Clinical diagnosis meets the diagnostic criteria of the national HFRS prevention and treatment plan (Hantavirus-specific IgM antibody is positive). The classification and staging standards of HFRS patients are based on the "Expert Consensus of Shaanxi Province on Diagnosis and Treatment of Hemorrhagic Fever with Renal Syndrome". Exclusion Criteria: Age <18 years; Have a history of kidney disease; Have a history of liver disease; Have a history of malignant tumor; Receive dialysis treatment before admission; Combined with hypertension, coronary heart disease and diabetes history; Combined with HIV infection and patients with autoimmune diseases and pregnancy. gender All minimum age 18 Years std age list std age Adult Older Adult study population This project intends to collect about 160 inpatients (the First Affiliated Hospital of Xi'an Jiaotong University) who were diagnosed with HFRS between 2021.01-2023.06 for follow-up research, including about 40 cases of light, medium, severe, and critical. 40 healthy people served as normal controls. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name xiaojiao Li central contact role Contact central contact phone 0086-17521011271 central contact e mail [email protected] central contact name lin Su central contact role Contact central contact phone 0086-18280308359 central contact e mail [email protected] overall official list overall official overall official name xiaojiao Li overall official affiliation First Affiliated Hospital of Xian Jiaotong University overall official role Study Director location list location location facility First Affiliated Hospital of Xian Jiaotong university location status Recruiting location city Xi'an location state Shaanxi location zip 710061 location country China location contact list location contact location contact name Xiaojiao Li location contact role Contact location contact phone 0086-17521011271 location contact e mail [email protected] derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006482 condition mesh term Hemorrhagic Fevers, Viral condition mesh id D000006480 condition mesh term Hemorrhagic Fever with Renal Syndrome condition mesh id D000013921 condition mesh term Thrombocytopenia condition ancestor list condition ancestor condition ancestor id D000001791 condition ancestor term Blood Platelet Disorders condition ancestor id D000006402 condition ancestor term Hematologic Diseases condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000018778 condition ancestor term Hantavirus Infections condition ancestor id D000002044 condition ancestor term Bunyaviridae Infections condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M15832 condition browse leaf name Thrombocytopenia condition browse leaf as found Thrombocytopenia condition browse leaf relevance high condition browse leaf id M2455 condition browse leaf name Hyperthermia condition browse leaf relevance low condition browse leaf id M7616 condition browse leaf name Fever condition browse leaf relevance low condition browse leaf id M8718 condition browse leaf name Hemorrhagic Fever with Renal Syndrome condition browse leaf as found Hemorrhagic Fever With Renal Syndrome condition browse leaf relevance high condition browse leaf id M8720 condition browse leaf name Hemorrhagic Fevers, Viral condition browse leaf as found Hemorrhagic Fever condition browse leaf relevance high condition browse leaf id M4224 condition browse leaf name Blood Platelet Disorders condition browse leaf relevance low condition browse leaf id M8642 condition browse leaf name Hematologic Diseases condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M20016 condition browse leaf name Hantavirus Pulmonary Syndrome condition browse leaf relevance low condition browse leaf id M19993 condition browse leaf name Hantavirus Infections condition browse leaf relevance low condition browse leaf id T5864 condition browse leaf name Viral Hemorrhagic Fever condition browse leaf as found Hemorrhagic Fever condition browse leaf relevance high condition browse leaf id T2665 condition browse leaf name Hantavirus Pulmonary Syndrome condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04834713
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full study rank 61376 study protocol section identification module n c t id NCT04837274 org study id info org study id IRB2008-0164F organization org full name Texas A&M University org class OTHER brief title Anderson Study 1 - Tart Cherry Study official title Effects Of Tary Cherry Ingestion On Food-Induced Serum Uric Acid Elevation acronym AS1 status module status verified date October 2022 overall status Completed expanded access info has expanded access No start date struct start date April 10, 2020 start date type Actual primary completion date struct primary completion date June 1, 2021 primary completion date type Actual completion date struct completion date June 1, 2021 completion date type Actual study first submit date March 31, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 18, 2022 last update post date struct last update post date October 19, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Richard B. Kreider responsible party investigator title Executive Director, Human Clinical Research Facility responsible party investigator affiliation Texas A&M University lead sponsor lead sponsor name Texas A&M University lead sponsor class OTHER collaborator list collaborator collaborator name Anderson Global Group, LLC collaborator class UNKNOWN oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to examine if tart cherry reduces food-induced elevations in serum uric acid. detailed description Gout is a painful form of arthritis that is caused by hyperuricemia (high uric acid levels) that form crystals in the joints. Ingestion of food and/or beverages containing high purine levels (e.g., beef, game meats, liver, shellfish, herring, mackerel, anchovies, sardines, mushrooms, dried beans and peas, sweetbreads, excessive alcohol, etc.) increase uric acid levels and thereby can complicate the management of uric acid levels in individuals with hyeruricemia and/or gout. Prior research has shown that ingestion of a chrysanthemum flower oil containing a high level of polyphenols significantly reduced the uricemic response to ingesting a meal high in purines. Additionally, black cherry and grape juice extracts are purported to have uric acid lowering properties. We have previoulsy reported that tart cherry powder, another naturally occuriring source of phlyphenols, lessens exercise-induced inflammation. This study will examine if tart cherry can also reduce the uricemic response to ingesting a high purine containing meal. If so, this may provide another dietary approach to help individuals manage their uric acid levels. conditions module condition list condition Health Services Research design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Treatment design masking info design masking Double design masking description Double (Participant, Investigator) design who masked list design who masked Participant Investigator enrollment info enrollment count 24 enrollment type Actual arms interventions module arm group list arm group arm group label Placebo arm group type Placebo Comparator arm group description Dextrose (480 mg) arm group intervention list arm group intervention name Dietary Supplement: Placebo arm group label Active arm group type Experimental arm group description Tart Cherry (480 mg) arm group intervention list arm group intervention name Dietary Supplement: Active intervention list intervention intervention type Dietary Supplement intervention name Placebo intervention description Dextrose (480 mg) intervention arm group label list intervention arm group label Placebo intervention type Dietary Supplement intervention name Active intervention description Tary Cherry (480 mg) intervention arm group label list intervention arm group label Active outcomes module primary outcome list primary outcome primary outcome measure Uric Acid Changes primary outcome description Serum Uric Acid changes to ingesting a high purine containing meal, primary outcome time frame Measured at baseline (prior to supplementation (Pre)), and after 60, 120, 180 and 240 minutes secondary outcome list secondary outcome secondary outcome measure Side Effects Assessment secondary outcome description Abdominal Side Effects Assessment on a 5 point likert scale secondary outcome time frame Measured at baseline prior to supplementation (Pre) secondary outcome measure Side Effects Assessment secondary outcome description Abdominal Side Effects Assessment on a 5 point likert scale secondary outcome time frame Measured after 240 minutes (Post) eligibility module eligibility criteria Inclusion Criteria: They are healthy males or females ages 30 to 60 years with fasting serum uric acid (UA) levels between 5.5 and 8.0 mg/dl obtained during the familiarization/screening visit; They have a willingness to provide voluntary, written, informed consent to participate in the study; Exclusion Criteria: They take prescription (Rx) medications (i.e., Uloric, Krystexxa, etc.) or dietary supplements known to have UA-reducing activity (i.e., black cherry, devil's claw, grape seed extracts, etc.); They have regular diseases requiring regular prescription (Rx) medications (birth control is allowed); They have abnormal/out of range values in laboratory tests determined at the familiarization/screening visit; They have an allergy to tart cherry or immunoglobulin E; They are pregnant, trying to become pregnant or breastfeeding; healthy volunteers Accepts Healthy Volunteers gender All minimum age 30 Years maximum age 60 Years std age list std age Adult contacts locations module overall official list overall official overall official name Richard B Kreider, PhD overall official affiliation Texas A&M University overall official role Principal Investigator location list location location facility Exercise & Sport Nutrition Lab - Human Clinical Research Facility location city College Station location state Texas location zip 77845 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16429 intervention browse leaf name Uric Acid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04837274
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full study rank 61533 study protocol section identification module n c t id NCT04835233 org study id info org study id 19479 organization org full name Federal University of Paraíba org class OTHER brief title Effectiveness of the Use of Methyldopa in Comparison to Captopril in Hypertension Post Partum official title Effectiveness of the Use of Methyldopa in Comparison to Captopril in the Control of Blood Pressure in the Puerperium: Randomized Clinical Trial status module status verified date March 2021 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date March 1, 2021 start date type Actual primary completion date struct primary completion date August 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Rossana Mariana Carvalho de Paiva Marques responsible party investigator title MD responsible party investigator affiliation Federal University of Paraíba lead sponsor lead sponsor name Federal University of Paraíba lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary In hypertensive mothers, it is common in clinical practice to substitute methyldopa for another medication, such as captopril, immediately after delivery, which may, as a consequence, cause a rebound effect or an initial lack of blood pressure control until the new medication had a more complete action. Thus, the treatment of hypertension in the puerperium is generally guided by expert opinion and recommendations for guidelines, based on non-robust evidence. OBJECTIVE: To evaluate the control of blood pressure in postpartum women with hypertensive syndromes during pregnancy with the maintenance of the continued use of previously used methyldopa compared to switching from antihypertensive regimen to the use of captopril. METHOD: Randomized, double-blind, drug controlled clinical trial. EXPECTED RESULT: better pressure control with the continued use of methyldopa. conditions module condition list condition Postpartum Hypertension design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 180 enrollment type Anticipated arms interventions module arm group list arm group arm group label methyldopa arm group type Experimental arm group description maintaining postpartum the use of methyldopa 250 mg 01 tablet every 8 hours, being able to double the dose depending on pressure levels, up to 15 days postpartum arm group intervention list arm group intervention name Drug: Methyldopa 250 MG arm group label captopril arm group type Active Comparator arm group description postpartum exchange methyldopa for captopril 25 mg 01 tablet every 8 hours, doubling the dose depending on pressure levels, up to 15 days postpartum arm group intervention list arm group intervention name Drug: Methyldopa 250 MG intervention list intervention intervention type Drug intervention name Methyldopa 250 MG intervention description maintaining postpartum the use of methyldopa 250 mg 01 tablet every 8 hours, being able to double the dose depending on pressure levels, up to 15 days postpartum intervention arm group label list intervention arm group label captopril methyldopa outcomes module primary outcome list primary outcome primary outcome measure Values of blood pressure (systolic blood pressure) primary outcome description systolic blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication primary outcome time frame every 4 hours immediately after the use of medication until hospital discharge primary outcome measure Values of blood pressure (dyastolic blood pressure) primary outcome description diastolic blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication primary outcome time frame every 24 hours immediately after the use of medication until hospital discharge primary outcome measure Values of blood pressure ( mean arterial pressure) primary outcome description mean blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication primary outcome time frame every 4 hours immediately after the use of medication until hospital discharge primary outcome measure Values of heart rate primary outcome description values of heart rate bpm (beat per minute) after starting postpartum medication primary outcome time frame every 4 hours immediately after the use of medication until hospital discharge primary outcome measure Frequency of hypertensive peaks primary outcome description numbers of hypertensive peaks (Systolic Blood Pressure ≥160 mmHg and / or Diastolic Blood Pressure ≥ 110 mmHg) after starting postpartum medication primary outcome time frame every 4 hours immediately after the use of medication until hospital discharge secondary outcome list secondary outcome secondary outcome measure Profile of the following laboratory tests ( protein urinary) on admission and their evolution during the puerperium secondary outcome description Profile of the following laboratory tests on admission and their evolution during the days of puerperium: urinary protein / creatinine (P / C) ratio (measured in mg / dL). Values greater than 300mg/dL of protein in 24h are indicative of pre-eclampsia. secondary outcome time frame the first before delivery and the next every 24 hours after delivery until the normalization of the values secondary outcome measure Profile of the following laboratory tests ( urea) on admission and their evolution during the puerperium secondary outcome description Profile of the following laboratory tests on admission and their evolution during the puerperium: urea ( blood dosage) measure of value ( mg/dL) secondary outcome time frame the first before delivery and the next every 24 hours after delivery until the normalization of the values secondary outcome measure Profile of the following laboratory tests (creatinine) on admission and their evolution during the puerperium secondary outcome description Profile of the following laboratory tests on admission and their evolution during the puerperium: creatinine ( blood dosage) measure of value ( mg/dL) secondary outcome time frame the first before delivery and the next every 24 hours after delivery until the normalization of the values secondary outcome measure Profile of the following laboratory tests (DHL) on admission and their evolution during the puerperium secondary outcome description Profile of the following laboratory tests on admission and their evolution during the puerperium: lactic dehydrogenase -DHL ( blood dosage) measure of value ( UI/L) secondary outcome time frame the first before delivery and the next every 24 hours after delivery until the normalization of the values secondary outcome measure Profile of the following laboratory tests (uric acid) on admission and their evolution during the puerperium secondary outcome description Profile of the following laboratory tests on admission and their evolution during the puerperium: uric acid (blood dosage) measure of value mg/dL secondary outcome time frame the first before delivery and the next every 24 hours after delivery until the normalization of the values secondary outcome measure Profile of the following laboratory tests aspartate transferase (AST)) on admission and their evolution during the puerperium secondary outcome description Profile of the following laboratory tests on admission and their evolution during the puerperium: aspartate transferase (blood dosage) measure of value U/L secondary outcome time frame the first before delivery and the next every 24 hours after delivery until the normalization of the values secondary outcome measure Profile of the following laboratory tests alanine transferase (ALT) on admission and their evolution during the puerperium secondary outcome description Profile of the following laboratory tests on admission and their evolution during the puerperium: alanine transferase (ALT) (blood dosage) measure of value U/L secondary outcome time frame the first before delivery and the next every 24 hours after delivery until the normalization of the values secondary outcome measure Profile of the following laboratory tests (total bilirubins, direct and indirect ) on admission and their evolution during the puerperium secondary outcome description Profile of the following laboratory tests on admission and their evolution during the puerperium: total bilirubins, direct and indirect (blood dosage)- measure of value U/L secondary outcome time frame the first before delivery and the next every 24 hours after delivery until the normalization of the values secondary outcome measure Profile of the following laboratory tests (platelets) on admission and their evolution during the puerperium secondary outcome description Profile of the following laboratory tests on admission and their evolution during the puerperium: platelets/ µL (blood dosage) secondary outcome time frame the first before delivery and the next every 24 hours after delivery until the normalization of the values secondary outcome measure Profile of the following laboratory tests (glomerular filtration rate) on admission and their evolution during the puerperium secondary outcome description Profile of the following laboratory tests on admission and their evolution during the puerperium: calculated by formula Modification of Diet Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration ( CKD-EPI), obtained by the site: http://mdrd.com/ secondary outcome time frame the first before delivery and the next every 24 hours after delivery until the normalization of the values secondary outcome measure Profile of the following laboratory tests (sodium, potassium and chlorine) on admission and their evolution during the puerperium secondary outcome description Profile of the following laboratory tests on admission and their evolution during the puerperium: sodium, potassium and chlorine - measure of value (mEq/L) secondary outcome time frame the first before delivery and the next every 24 hours after delivery until the normalization of the values secondary outcome measure Days of hospital stay after delivery until blood pressure control secondary outcome description Days of hospital stay after delivery until blood pressure control (more than 50% of blood pressure measurements less than or equal to 140 x 90 mmHg) secondary outcome time frame number of days (24 hours) from postpartum hospitalization until normalization of blood pressure secondary outcome measure Need for drug use for hypertensive peak ( yes or no) secondary outcome description Clonidine was the drug of choice in the study. The hypertensive peak was considered to be greater than or equal to systolic pressure 160 mmHg and / or diastolic pressure greater than or equal to 110 mmHg. secondary outcome time frame every 4 hours immediately after the use of medication until hospital discharge secondary outcome measure Need to associate another hypotensive drug to control blood pressure ( yes or no) secondary outcome description Need to associate another hypotensive drug to control blood pressure until blood pressure control (more than 50% of blood pressure measurements less than or equal to 140 x 90 mmHg) secondary outcome time frame immediately after the use of medication until hospital discharge secondary outcome measure use of analgesic and anti-inflammatory ( yes or no) secondary outcome description need for analgesic and anti-inflammatory use and the amount used (number of doses) secondary outcome time frame number of doses in 24 hours for postpartum analgesia secondary outcome measure Use of antihypertensive drugs at the time of hospital discharge ( yes or no) secondary outcome description patient was discharged using antihypertensive medication secondary outcome time frame immediately after discharge from the hospital up to 15 days after delivery secondary outcome measure Frequency of adverse effects most often described with medications ( yes or no) secondary outcome description numbers of adverse effects most often described with medications: drowsiness, headache, dizziness, orthostatic hypotension, nausea, vomiting, diarrhea, dry mouth, dry cough, skin rashes, itching, arthralgia, skin lesions, dysgeusia, angioedema secondary outcome time frame immediately after the use of medication until hospital discharge secondary outcome measure maternal complicatios ( yes or no) secondary outcome description maternal complications (eclampsia, HELLP syndrome, impending eclampsia, oliguria, puerperal complications and maternal death) and complications related to hypertensive peaks (stroke, acute myocardial infarction and acute lung edema) secondary outcome time frame immediately after the use of medication until hospital discharge secondary outcome measure satisfactory breastfeeding secondary outcome description satisfactory, unsatisfactory and with difficulty reported by the mother secondary outcome time frame immediately after the use of medication until hospital discharge secondary outcome measure degree of maternal satisfaction with medication secondary outcome description I hated it, I didn't like it, indifferent, I liked it, I loved it (scale of faces) secondary outcome time frame immediately after the use of medication until hospital discharge secondary outcome measure Postpartum depression secondary outcome description Edinburgh Postpartum Depression Scale (EPDS) secondary outcome time frame immediately after the use of medication until return for evaluation of the patient 15 days after delivery secondary outcome measure Neonatal outcomes ( bradycardia) -yes or no secondary outcome description bradycardia( below 100 beats per minute of the newborn) secondary outcome time frame immediately after the use of medication until hospital discharge secondary outcome measure Neonatal outcomes ( hypoglycemia) -yes or no secondary outcome description blood glucose below < 45 mg/dL secondary outcome time frame immediately after the use of medication until hospital discharge secondary outcome measure Neonatal outcomes (Hypothermia) -yes or no secondary outcome description Hypothermia below 36,5 degree celsius secondary outcome time frame immediately after the use of medication until hospital discharge secondary outcome measure Neonatal outcomes (comorbidity) -yes or no secondary outcome description Some unfavorable clinical condition of the newborn (comorbidity) secondary outcome time frame immediately after the use of medication until hospital discharge secondary outcome measure Neonatal outcomes (hypotension) -yes or no secondary outcome description mean arterial pressure (mmHg) below gestational age (weeks) secondary outcome time frame immediately after the use of medication until hospital discharge eligibility module eligibility criteria Inclusion Criteria: puerpera; hypertensive; use of methyldopa during pregnancy at a minimum dose of 750 mg / day, for at least 07 days before delivery Exclusion Criteria: Use of other antihypertensive medications or illicit drugs that may interfere with maternal hemodynamics, and / or Contraindications to the use of captopril or methyldopa healthy volunteers No gender Female minimum age 18 Years maximum age 50 Years std age list std age Adult contacts locations module overall official list overall official overall official name Andre Telis Araujo, PhD overall official affiliation Federal University of Paraíba overall official role Principal Investigator overall official name Luiz Aparecido Bortolotto, PhD overall official affiliation FMUSP overall official role Principal Investigator location list location location facility UFPB Paraíba Federal University location city João Pessoa location state Paraíba location zip 58050-585 location country Brazil i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006973 condition mesh term Hypertension condition ancestor list condition ancestor condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M9176 condition browse leaf name Hypertension condition browse leaf as found Hypertension condition browse leaf relevance high condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000008750 intervention mesh term Methyldopa intervention ancestor list intervention ancestor intervention ancestor id D000000959 intervention ancestor term Antihypertensive Agents intervention ancestor id D000013565 intervention ancestor term Sympatholytics intervention ancestor id D000001337 intervention ancestor term Autonomic Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000058647 intervention ancestor term Adrenergic alpha-2 Receptor Agonists intervention ancestor id D000000316 intervention ancestor term Adrenergic alpha-Agonists intervention ancestor id D000000322 intervention ancestor term Adrenergic Agonists intervention ancestor id D000018663 intervention ancestor term Adrenergic Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention browse leaf list intervention browse leaf intervention browse leaf id M4628 intervention browse leaf name Captopril intervention browse leaf relevance low intervention browse leaf id M10877 intervention browse leaf name Methyldopa intervention browse leaf as found Oatmeal intervention browse leaf relevance high intervention browse leaf id M3429 intervention browse leaf name Antihypertensive Agents intervention browse leaf relevance low intervention browse leaf id M15496 intervention browse leaf name Sympatholytics intervention browse leaf relevance low intervention browse leaf id M19899 intervention browse leaf name Adrenergic Agents intervention browse leaf relevance low intervention browse leaf id M2820 intervention browse leaf name Adrenergic alpha-Agonists intervention browse leaf relevance low intervention browse leaf id M2825 intervention browse leaf name Adrenergic Agonists intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev AnAg intervention browse branch name Antihypertensive Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04835233
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full study rank 61416 study protocol section identification module n c t id NCT04836754 org study id info org study id Covid-19 organization org full name Halic University org class OTHER brief title The Effect of Covid-19 on Breast Milk Microbiome and Its Bioactive Components official title The Effect of Covid-19 on Breast Milk Microbiome and Its Bioactive Components status module status verified date December 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 1, 2022 start date type Anticipated primary completion date struct primary completion date July 1, 2022 primary completion date type Anticipated completion date struct completion date September 1, 2022 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date December 2, 2021 last update post date struct last update post date December 16, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Aysu Yıldız Karaahmet responsible party investigator title PhD responsible party investigator affiliation Halic University lead sponsor lead sponsor name Aysu Yıldız Karaahmet lead sponsor class OTHER collaborator list collaborator collaborator name Hacettepe University collaborator class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Coronavirus disease (Covid-19) is a new public health crisis threatening humanity caused by SARS-CoV-2. Although it originated in China's Hubei province in late 2019, it has spread to many countries around the world. Although Covid-19 first caused infection by affecting the lung, current data showed that the gastrointestinal tract was also affected by detecting viral RNA in Covid-19-infected human intestinal epithelial cells and feces. The association has been confirmed by showing that patients hospitalized with COVID-19 have significant changes in intestinal bacterioma. These changes have been characterized by a significant reduction in gut microbiome (BM) diversity associated with gastrointestinal complaints of the acute phase of infection (e.g. abdominal pain, nausea, vomiting, diarrhea), depletion of beneficial bacterial symbionts, and enrichment of opportunistic pathogens (e.g. Streptococcus, Rothia, Actinomyces). In particular, recent studies have evidence that patients with Covid-19 are more prone to a dysbiosis profile of the gut microbiota, infected individuals present irregular gut microbiota, and even dysbiosis (disruption of microbiota balance) in the gut microbiota. The first case reports reported in China suggested that there was no virus found in amniotic fluid, umbilical cord blood, throat swabs of the newborn, placenta, vaginal fluid, and breast milk samples infected with Covid-19. The latest data indicate that there is no vertical transmission to the fetus, and so far, no viruses have been found in the cord blood of newborns born from Covid-19 positive pregnant women, nasal sampling and amniotic fluid and placentas of pregnant women. However, the effect of intestinal microbial structure affected by Covid-19 on breast milk microbiota and the effect of a dysbiosis to occur on infant health or the effect of the healing properties of breast milk on Covid-19 are still not clearly known. This views are that intestinal microbial colonization originating from the gastrointestinal system affected by Covid-19 will affect breast milk microbial colonization. However, there is no study on this subject. For this purpose, aim in this study was to determine the breast milk microbiome and biologically active proteins (secretory immunoglobulin A (sIgA), lysozyme, lactoferrin, osteoprotegerin (OPG), leptin, adiponectin and β-endorphin (b-) levels of mothers who had Covid-19 with healthy mothers. will be compared. detailed description Coronavirus disease (Covid-19) is a new public health crisis threatening humanity caused by SARS-CoV-2. Although it originated in China's Hubei province in late 2019, it has spread to many countries around the world (Wang et al., 2020). In patients with Covid-19, severe cases of respiratory, hepatic, gastrointestinal and neurological complications and a complex clinical picture that eventually turns into death are observed (Guo et al., 2020; Li et al., 2020). The underlying pathophysiological mechanisms are complex and multifactorial, and have been summarized as a hyper-response of the immune system that causes an inflammatory / cytokine storm (Li et al., 2020). Although Covid-19 caused infection by first affecting the lung, current data showed that the gastrointestinal system was also affected by detecting viral RNA in human intestinal epithelial cells and feces infected with Covid-19 (Cheng et al., 2002; Wu et al., 2020). This is thought to be caused by the relationship between the gut microbiota and the lung axis. Studies have demonstrated that Bacteroidetes and Firmicutes bacteria, which are dominant in intestinal colonization, are also dominant in the lung (Bacteroidetes, Firmicutes and Proteobacteria) (Zhang et al., 2020). In short, while intestinal microbiota causes lung diseases, respiratory tract virus infections also cause confusion in the intestinal microbiota. In fact, many studies have shown that respiratory infections are associated with a change in the composition of the gut microbiota (Groves et al., 2020). The high-throughput 16S rRNA amplicon sequence and shotgun metagenomic sequence analyzes demonstrated that hospitalized COVID-19 patients had significant changes in the intestinal bacterioma, and the relationship was confirmed. These changes have been characterized by a significant reduction in gut microbiome (BM) diversity associated with gastrointestinal complaints of the acute phase of infection (e.g. abdominal pain, nausea, vomiting, diarrhea), depletion of beneficial bacterial symbionts, and enrichment of opportunistic pathogens (e.g. Streptococcus, Rothia, Actinomyces) (Gu et al., 2020; Zuo et al., 2020). In particular, recent studies have evidence that patients with Covid-19 are more prone to dysbiosis profile of the gut microbiota, infected individuals present irregular gut microbiota and even dysbiosis (disruption of microbiota balance) in the gut microbiota (Gu et al., 2020; Zuo et al., 2020 ). The intestinal flora plays a protective role in many metabolic and immune functions of the host, i.e. against pathogenic colonization of the virus, including training and strengthening the immune system to fight infections (Fernandes et al., 2019). Looking at the composition of the gut flora, it is highly dynamic from birth and is shaped by different environmental factors (e.g. diet, breast milk pre- / probiotics, drugs) resulting in various microbial-host functions (Koppel, Maini Rekdal, Balskus, 2017; Weiss, Hennet, 2017) . Human gastrointestinal tract (GIS), 2000 'classified into 12 different phyla, the most common (> 90%) Proteobacteria (Gram-negative), Firmicutes (Gram-positive), Actinobacteria (Gram-positive) and Bacteroidetes (Gram-negative) phyla. It is believed that human intestinal viroma, consisting of both prokaryotic and eukaryotic viruses, shares important information with all microbial components and can affect overall human health by shaping the structure and function of the intestinal community (Cani , 2018; Garmaeva et al., 2019). Breast milk is the bioactive component that most affects the formation of neonatal microbial colonization in the postnatal period and provides us with information about human future health. Breast milk is not only the best nutritional source for babies, but it is also known to contain immune components such as secretory antibodies, immune cells, antimicrobial proteins (such as lactoferrin and lysozyme), cytokines, and human milk oligosaccharide. Before the 2000s, breast milk was thought to be sterile, and the presence of bacteria indicated contamination or infection. However, several researchers have shown that breast milk has been colonized with bacteria since pregnancy and contains commensal bacteria in particular. In a study, it was found that Proteobacteria (Gram-negative), Firmicutes (Gram-positive), Actinobacteria (Gram-positive) and Bacteroidetes (Gram-negative) phyla, which are dominant in maternal intestinal colonization, are among the breast milk microbes Firmicutes, Proteobacteria Bacteroidetes and Actinobacteria. It has been proved that breast milk originates from the mother's gastrointestinal system in this case (Ojo et al., 2018). In addition, the same study showed that there were bacteria sharing the same strains in the mother's intestine, the baby's intestine and breast milk, and the mother's commensal bacteria had vertical transmission to the infant's intestine through breast milk. Human coronaviruses were defined as enveloped, positive-sensitive, single-stranded RNA viruses, first described in 1965 (Tyrrell and Bynoe, 1965). There are seven identified strains known to infect humans. Four of the strains (alphacoronaviruses 229E, NL63, OC43, and betacoronavirus HKU1) are ubiquitous in humans and cause the common cold. There are questions about the effect of human coronaviruses on pregnant, maternal and infant health and the transmission status is not clear. Pregnancy alters a woman's immune system and makes them more susceptible to infections. However, there is currently no evidence that pregnant women are more likely to be affected by COVID 19 or serious illness as a result, compared to the general population. Although the mechanism is unclear, there is limited evidence that one of the four strains (229E) mentioned above can be transmitted vertically from mothers to infants (Gagneur et al., 2008). The presence of this virus (229E) in neonatal gastric samples suggests that a possible mechanism for infection is through breast milk, but this study did not specifically evaluate breast milk (Gagneur et al., 2008). The first case reports reported in China suggested that there was no virus in amniotic fluid, umbilical cord blood, throat swabs of the newborn, placenta, vaginal fluid, and breast milk samples infected with Covid-19 (Johns et al, 2013). The latest data indicate that there is no vertical transmission to the fetus, and so far, no viruses have been found in the cord blood of newborns born from Covid-19 positive pregnant women, nasal sampling and amniotic fluid and placentas of pregnant women. However, the effect of intestinal microbial structure affected by Covid-19 on breast milk microbiota and the effect of a dysbiosis to occur on infant health or the effect of the healing properties of breast milk on Covid-19 are still not clearly known. This study views are that intestinal microbial colonization originating from the gastrointestinal system affected by Covid-19 will affect breast milk microbial colonization. However, there is no study on this subject. Breast milk is a golden nutrient that provides critical nutrients and bioactive compounds that support growth and immune development during infancy. Variation in milk components and bioactive compounds as a result of demographic and genetic factors, the mother's lifestyle and exposure has both positive and negative effects on infant health (Abrahamsson et al., 2009; de Andres et al., 2018; Johns et al. , 2013). It has been reported that babies who are breastfed have a dynamic gut microbiome and the incidence of some diseases has decreased (Abrahamsson et al., 2009; de Andres et al., 2018). In addition to macro and micronutrients and bioactive compounds, breast milk contains many types of bacteria. Lactoferrin is one of the important bioactive components in breast milk. The lactoferrin in breast milk can support a local intestinal environment, such as microbiota that strengthens the innate defenses of newborns. Lactoferrin promotes the growth of favorable gut microbiota and the proliferation of enterocytes through direct anti-inflammatory and immunomodulatory effects. The action of lactoferrin on cell receptors prevents viral damage, surface accumulation and cell entry. In this way, it protects and strengthens mucosal immunity and intestinal epithelial barrier. It is believed that breast milk, particularly lactoferrin, exhibits potential antiviral effects. The challenge is how effective they are in preventing viral infections such as coronaviruses (de Andres et al., 2018). We believe early breastfeeding provides vital prevention during viral outbreaks due to the high value of colostrum and breast milk and the specific role of lactoferrin, but more clinical evidence is needed. These effects and mechanisms have not been tested on Covid-19, but we can consider this approach as they affect other coronaviruses. In addition, breast milk components containing approximately 109 bacteria are known to affect the baby's own microbiome and immune system (Ruiz et al., 2019). However, contrary to what is known, breast milk microbiota and its influencing factors are only recently being discovered and understood (McGuire & McGuire, 2017; Moossavi et al., 2019; Williams et al., 2017). In addition, while exploring the effects of certain components in breast milk on the nursing baby, we tend to ignore the dynamic state and effect of other components that could greatly affect the results. While it was known that the microbiome, which we cannot see with the naked eye, could affect individuals, it was not thought that our world would change that much with a single virus, Covid-19. While the microbiome we often ignore because it is invisible to us reminds us of a world that has profound effects on our health and well-being, how does Covid-19 affect this world and breast milk? For this purpose, aim in this study was to determine the breast milk microbiome and biologically active proteins (secretory immunoglobulin A (sIgA), lysozyme, lactoferrin, osteoprotegerin (OPG), leptin, adiponectin and β-endorphin (b-) levels of mothers who had Covid-19 with healthy mothers. will be compared. A total of 20 mothers (10 mothers) and healthy (10 mothers) who had Covid-19 in the last month of pregnancy between April 2021 and June 2021 will be included in the study and the mothers will be given an appointment on the 15th day and will start with taking breast milk samples and 16sRNA microbiota. Analyzing the microbiota content of breast milk and the levels of biologically active proteins (secretory immunoglobulin A (sIgA), lysozyme, lactoferrin, osteoprotegerin (OPG), leptin, adiponectin and β-endorphin (b)) in breast milk content will be evaluated. Hypothesis in this study is that breast milk microbiota will differ in variety and composition in mothers who have had Covid-19. In this direction, as a result of the research; Conducting microbial analysis to evaluate the content of microbiota and bioactive components by taking the milk of mothers who have had Covid-19 during pregnancy, - In line with the results obtained, it is planned to give correct advice and guidance in accordance with an urgent problem. conditions module condition list condition Covid19 Human Milk keyword list keyword covid-19 human milk microbiota microbiome bioactive ingredient design module study type Observational patient registry Yes target duration 1 Day design info design observational model list design observational model Case-Control design time perspective list design time perspective Cross-Sectional enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label Case group arm group description Pregnant women with Covid-19 arm group label Control groups arm group description Pregnant women who do not have Covid-19 outcomes module primary outcome list primary outcome primary outcome measure data analysis:maternal and infant health primary outcome description Data Collection Form, Quality of Life Scale primary outcome time frame postpartum 15th day primary outcome measure Microbiological Analysis:human milk primary outcome description 16sRNA analysis primary outcome time frame postpartum 15th day eligibility module eligibility criteria Inclusion Criteria: The cognitive level of the mother is sufficient to understand and answer the questions, Having a single pregnancy, Mother's ability to read, write and understand Turkish The time of delivery is in the range of 37 <GH <42 weeks Not having a chronic disease of the mother (Diabetes, hypertension, hypothyroidism etc.) Vaginal delivery The mother's not using antibiotic derivative drugs during pregnancy Getting 10 points below the Beck Depression Scale Absence of prematurity, Introuterine Growth Retardation (IUGR) or genetic disease in the newborn Birth weight in the range of 2500-4000 gr Absence of a gastrointestinal disease in the newborn Feeding more than 50% of the baby with breast milk Absence of Premature Membrane Rupture (PROM) for more than 24 hours at birth Exclusion Criteria: Expressing breast milk or having problems with the breast, The mother's use of probiotics before randomization and during pregnancy, The inclusion of sampled mothers in other clinical studies at the same time. healthy volunteers Accepts Healthy Volunteers gender Female gender based Yes gender description mothers on the first day after birth minimum age 18 Years maximum age 35 Years std age list std age Adult study population The sample of the study: The population of the study will be 20 mothers who are hospitalized in the obstetrics clinic of the SBU Istanbul Sultangazi Haseki Training and Research Hospital for emergency delivery, who had Covid-19 during pregnancy (10 mothers) and healthy (10 mothers). Power analysis to determine the size, G-Power 3.1.9.2. program (Zuo et al., 2020). According to this calculation, a total of 20 mothers, a minimum of 10 mothers in each group, will be included in the sample, with a 95% confidence interval, alpha 0.05 and 80% power, with a 20% improvement difference between the two groups. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Aysu Y Yıldız Karaahmet, PhD Student central contact role Contact central contact phone 05414679620 central contact e mail [email protected] central contact name Gülümser Dolgun, Professor central contact role Contact central contact phone 05414679620 central contact e mail [email protected] overall official list overall official overall official name Aysu Yıldız Karaahmet, Phd.Student overall official affiliation Halic University overall official role Principal Investigator overall official name Gülümser Dolgun, Profesor overall official affiliation Istanbul University-Cerrahpasa overall official role Study Director overall official name Ceren Ozkul Kocak, Asist prof overall official affiliation Hacettepe University overall official role Study Director location list location location facility Haseki Training and Research Hospital location city Sultangazi location state Istanbul location country Turkey location contact list location contact location contact name Aysu Yıldız Karaahmet, phd student location contact role Principal Investigator location contact name Gülümser Dolgun, prof location contact role Sub-Investigator location contact name Ceren Ozkul koçak, Asist prof location contact role Sub-Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04836754
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full study rank 61433 study protocol section identification module n c t id NCT04836533 org study id info org study id MH126187 secondary id info list secondary id info secondary id R33MH126187 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/R33MH126187 organization org full name Queens College, The City University of New York org class OTHER brief title Enhancing Processing Speed and Executive Functioning in Depressed Older Adults With Computerized Cognitive Training official title Optimizing Placebo Effects in Depressed Older Adults: Enhancing Processing Speed and Executive Functioning With Computerized Cognitive Training status module status verified date March 2021 overall status Withdrawn why stopped Conflicts at the study site prevented the study from being carried out expanded access info has expanded access No start date struct start date April 1, 2022 start date type Actual primary completion date struct primary completion date October 24, 2022 primary completion date type Actual completion date struct completion date October 24, 2022 completion date type Actual study first submit date March 29, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 24, 2022 last update post date struct last update post date October 26, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Queens College, The City University of New York lead sponsor class OTHER collaborator list collaborator collaborator name National Institute of Mental Health (NIMH) collaborator class NIH collaborator name New York State Psychiatric Institute collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary The purpose of this research study is to determine how treatment response may change depending on how studies are designed, and if mobile cognitive training can be used to improve treatment response in depressed older adults. detailed description Major Depressive Disorder (MDD) is a leading cause of disability, morbidity, and mortality across the lifespan and poses a particularly severe public health problem in late life. Late-life depression (LLD) is highly recurrent, can become chronic, and is often difficult to treat. Antidepressant treatment is often ineffective in this population because of the presence of neurocognitive factors including slow processing speed (PS), executive dysfunction (ED), and cerebrovascular disease (CVD) that interfere with treatment. It is crucial, therefore, that we develop interventions that address antidepressant non-response and dramatically improve the quality of life of millions of vulnerable older adults. We recently determined that an important cause of non-response in this population is impaired expectancy effects, which in turn are compromised by slow speed of processing. We propose, therefore, that antidepressant non-response in older adults with PS deficits is caused by expectancy failure and that targeting PS deficits prior to antidepressant treatment will restore the capacity to form expectations thereby improving antidepressant treatment response. An excellent candidate for improving PS is computerized cognitive training (CCT), i.e., exercises that target, train, and strengthen specific cognitive processes with the use of structured drills and repeated practice. To test our expectancy-processing speed model, 100 depressed adults age 60 and over with PS deficits will be recruited. Participants will be randomized to either CCT or control (Solitaire) for 4 weeks. Both conditions will train 25 minutes per day, 7 days per week. At the conclusion of this four-week period, patients will be randomly assigned to high versus low expectancy treatment conditions. Patients assigned to the low expectancy condition will be told they will receive either placebo or escitalopram when in fact they will receive escitalopram for eight weeks. Patients assigned to the high expectancy condition will be told they will receive escitalopram for eight weeks. Neuropsychological assessment will occur at baseline and weeks 4 and 12 whereas MRI scans will be conducted at baseline and week 4. Clinical assessments will be conducted biweekly throughout the study. The goals of this study are to 1) To determine whether PS mediates the relationship between CCT and expectancy, and 2) To compare endpoint depression scores as a function of CCT and expectancy conditions. At the screening evaluation, informed consent for the screening evaluation is obtained. Participants subsequently undergo a psychiatric clinical interview using the Structured Clinical Interview Diagnostic for DSM-V (SCID-V), 24- item Hamilton Rating Scale for Depression (HRSD), Clinical Global Impressions Scale - Severity (CGI-Severity), Cumulative Illness Rating Scale for Geriatrics (CIRS-G) and Antidepressant Treatment History Form (ATHF) to document depression diagnosis, severity, and medical comorbidity. WAIS-IV Digit Symbol Coding will be completed to determine whether the patient meets inclusion criteria for PS (>1 SD on age adjusted norms). If the patient is eligible for study entry, participation in the research protocol will be discussed and informed consent will be obtained. After consent is obtained, patients will receive a comprehensive baseline neuropsychological assessment and MRI (structural, resting state, and DTI). Neuropsychological assessments include MMSE, WAIS-IV Coding, NIH Toolbox Cognition Battery, NIH Supplement Auditory Verbal Learning Test (Rey), Trail Making Test (Part A and B), Stroop Color-Word Test, and The Letter and Animal Naming Test. These measures will capture global cognitive functioning, processing speed, attention, and response inhibition, and verbal fluency. After testing, patients will be randomized to either CCT or active control for 4 weeks (25'/day, 7 days/week). Patients randomized to CCT will complete seven 25-minute sessions per week for 4 weeks using BrainHQ's Double Decision in the experimental condition (a processing speed exercise) and BrainHQ solitaire in the control condition. At the conclusion of this four-week period, patients will complete a second neuropsychological assessment and a second fMRI (to determine change in resting-state BOLD signal in the CCN). Patients will then be randomly assigned to high versus low expectancy treatment conditions. Patients assigned to the low expectancy condition will be told they will receive either placebo escitalopram when in fact they will receive escitalopram for eight weeks. Patient assigned to the high expectancy condition will be told and they will receive escitalopram for eight weeks. Expectancy is measured at baseline and after informing patients of their randomization status. The difference between their pre and post randomization expectancy regarding treatment improvement is the expectancy effect. At the conclusion of the eight-week clinical trial, the difference in antidepressant response observed between the open and placebo-controlled medication treatments is a measure of the expectancy contribution to outcome. Neuropsychological assessment will occur again at the conclusion of the escitalopram trial (week 12). Clinical assessments will be conducted biweekly throughout the study. The novel experimental therapeutics approach taken in this proposal cuts across several research themes (prevention and translation) and addresses many of the challenges (digital technology and neural circuits) elaborated in NIMH's Strategic Plan for mental health research in the 21st century. Consistent with NIMH goals, it also develops strategies for tailoring existing interventions to optimize outcomes and elucidates the mechanism by which antidepressant treatment in LLD can be restored. conditions module condition list condition Depression in Old Age Depression design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Factorial Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label Computerized Cognitive Training arm group type Experimental arm group description Those assigned to the computerized cognitive training arm prior to antidepressant trial enrollment will receive computerized cognitive training that includes games that scale in difficulty. arm group intervention list arm group intervention name Other: Experimental: Computerized Cognitive Training arm group label Solitaire Training arm group type Active Comparator arm group description Those assigned to the solitaire training arm prior to antidepressant trial enrollment will receive computerized solitaire games. arm group intervention list arm group intervention name Other: Active Comparator: Solitaire Training arm group label Open-label antidepressant treatment arm group type Experimental arm group description Those assigned to receive open-label antidepressant treatment will begin with 10 mg of escitalopram. If the participant cannot tolerate or has an adverse reaction to escitalopram, duloxetine will be offered instead. arm group intervention list arm group intervention name Drug: Experimental: Open-label antidepressant treatment arm group label Placebo-controlled antidepressant treatment arm group type Placebo Comparator arm group description Those assigned to the placebo-controlled group will be told that they have a 50/50 chance of receiving either escitalopram or placebo. arm group intervention list arm group intervention name Other: Placebo Comparator: Placebo-controlled antidepressant treatment intervention list intervention intervention type Other intervention name Experimental: Computerized Cognitive Training intervention description Participants will complete 4 weeks of executive functioning / processing speed training through the BrainHQ platform on their personal computers. intervention arm group label list intervention arm group label Computerized Cognitive Training intervention type Drug intervention name Experimental: Open-label antidepressant treatment intervention description Participants will be assigned to open-label or placebo-controlled antidepressant treatment for 8 weeks. intervention arm group label list intervention arm group label Open-label antidepressant treatment intervention type Other intervention name Active Comparator: Solitaire Training intervention description Participants will complete 4 weeks of Solitaire training through the BrainHQ platform on their personal computers. intervention arm group label list intervention arm group label Solitaire Training intervention type Other intervention name Placebo Comparator: Placebo-controlled antidepressant treatment intervention description Participants will be told they have a 50/50 chance of receiving a placebo or antidepressant. intervention arm group label list intervention arm group label Placebo-controlled antidepressant treatment outcomes module primary outcome list primary outcome primary outcome measure Hamilton Rating Scale for Depression (HRSD) Change primary outcome description Clinician-rated measure of depressive severity composed of 24 questions used to measure changes in depressive symptoms and monitor safety during the study. primary outcome time frame Screen, Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12 primary outcome measure Treatment Credibility Expectancy Scale (CES) - item 4 Change primary outcome description Self-report scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. Item 4 measures how much improvement in depression symptoms is expected. primary outcome time frame Baseline, Week 0 primary outcome measure Processing Speed Change - WAIS-IV Coding primary outcome description Processing speed will be assessed using Coding from the Wechsler Adult Intelligence Scale-IV (WAIS-IV), the NIH Toolbox Pattern Comparison Processing Speed Test, and Trail Making Test A. From these 3 tests, a composite score (primary outcome) is derived by extracting a latent factor and factor loadings, creating a purer measure of processing speed than raw scores from an individual test or a sum total score. primary outcome time frame Baseline, Weeks 4, 12 primary outcome measure Processing Speed Change - NIHH Toolbox Pattern Comparison Processing Speed Test primary outcome description Processing speed will be assessed using Coding from the Wechsler Adult Intelligence Scale-IV (WAIS-IV), the NIH Toolbox Pattern Comparison Processing Speed Test, and Trail Making Test A. From these 3 tests, a composite score (primary outcome) is derived by extracting a latent factor and factor loadings, creating a purer measure of processing speed than raw scores from an individual test or a sum total score. primary outcome time frame Baseline, Weeks 4, 12 primary outcome measure Processing Speed Change - Trail Making Test A primary outcome description Processing speed will be assessed using Coding from the Wechsler Adult Intelligence Scale-IV (WAIS-IV), the NIH Toolbox Pattern Comparison Processing Speed Test, and Trail Making Test A. From these 3 tests, a composite score (primary outcome) is derived by extracting a latent factor and factor loadings, creating a purer measure of processing speed than raw scores from an individual test or a sum total score. primary outcome time frame Baseline, Weeks 4, 12 primary outcome measure Resting State Functional Connectivity Index Change primary outcome description Measure of resting state fMRI. primary outcome time frame Baseline, Week 4 secondary outcome list secondary outcome secondary outcome measure Secondary Clinical Global Impressions (CGI) Severity and Improvement secondary outcome description Scales measuring the clinician's view of subjects' global functioning that will provide a clinical assessment of subjects at each visit and help maintain safety by identifying clinical worsening. secondary outcome time frame Screen, Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12 secondary outcome measure Inventory for Depressive Symptomatology Self-Report (IDS-SR) secondary outcome description The IDS-SR is a standard self-report measure of depression severity that will be used to measure changes in depressive symptoms and monitor safety during the study. secondary outcome time frame Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12 secondary outcome measure Cumulative Illness Rating Scale for Geriatrics (CIRS-G) secondary outcome description Provides quantitative ratings of chronic illness burden. Presence of illness is rated from 0 to 4 in 14 different medical domains. Scores range from 0-56. secondary outcome time frame Screen secondary outcome measure NIH Toolbox Auditory Verbal Learning Test - Rey (RAVLT) secondary outcome description Measures immediate recall. Unrelated words presented via audio recording and participant recalls as many as possible secondary outcome time frame Baseline, Weeks 4, 12 secondary outcome measure Stroop Color-Word Test (Stroop) secondary outcome description Baseline, Weeks 4, 12 secondary outcome time frame Measure of response inhibition sensitive to frontal lobe dysfunction. This test is divided into three conditions: color naming, word reading, and colorword inhibition. secondary outcome measure Letter and Animal Naming Test secondary outcome description Test measuring the verbal fluency component of executive functioning. Requires subjects to generate words that begin with a particular letter or belong to a particular semantic category as quickly as possible secondary outcome time frame Baseline, Weeks 4, 12 secondary outcome measure World Health Organization Disability Assessment Schedule 2.0 (WHODAS2.0) secondary outcome description This 36-item self-report provides a global measure of disability and 7 domain-specific scores based on the conceptual framework of the International Classification of Functioning, Disability, and Health (ICF). secondary outcome time frame Screen, Weeks 4, 6, 8, 10, 12 secondary outcome measure Trail Making Test A and B secondary outcome description Paper and pencil test that assesses (A) speeded attention and (B) the switching component of executive function. This test has two conditions: (A) number sequencing and (B) number-letter sequencing. secondary outcome time frame Baseline, Weeks 4, 12 secondary outcome measure NIH Toolbox Flanker Inhibitory Control and Attention Test secondary outcome description Measures attention and executive functioning. The allocation of one's limited capacities to deal with an abundance of environmental stimulation secondary outcome time frame Baseline, Weeks 4, 12 secondary outcome measure NIH Toolbox Picture Sequence Memory Test secondary outcome description Measures episodic memory. Cognitive processes involved in the acquisition, storage, and retrieval of new information. secondary outcome time frame Baseline, Weeks 4, 12 secondary outcome measure NIH Toolbox List Sorting Working Memory Test secondary outcome description Measures working memory. The ability to store information until the amount of information to be stored exceeds one's capacity to hold that information. secondary outcome time frame Baseline, Weeks 4, 12 secondary outcome measure NIH Toolbox Picture Vocabulary Test secondary outcome description Measures receptive vocabulary administered in a computer-adaptive test (CAT) format. Respondents select the picture that most closely matches the meaning of the word. secondary outcome time frame Baseline, Weeks 4, 12 secondary outcome measure NIH Toolbox Oral Reading Recognition Test secondary outcome description Measures reading and decoding skill and crystallized abilities. Participant is asked to read and pronounce letters and words as accurately as possible. secondary outcome time frame Baseline, Weeks 4, 12 secondary outcome measure NIH Toolbox Dimensional Card Change Sort Test secondary outcome description Measures executive function. The capacity to plan, organize and monitor the executive of behaviors that are strategically directed in a goal-oriented manner. secondary outcome time frame Baseline, Weeks 4, 12 secondary outcome measure NIH Toolbox Pattern Comparison Processing Speed Test secondary outcome description Assesses the amount of information that can be processed within a certain unit of time. Items are simple so as to purely measure processing speed. secondary outcome time frame Baseline, Weeks 4, 12 secondary outcome measure Diffusion Tensor Imaging (fractional anisotropy and mean diffusivity) secondary outcome description Measures of brain white matter integrity. secondary outcome time frame Baseline, Week 4 other outcome list other outcome other outcome measure Structured Clinical Interview Diagnostic for DSM-V (SCIDV) other outcome description Structured clinical interview to assess current and past psychiatric diagnoses. other outcome time frame Screen other outcome measure Mini-Mental Status Exam (MMSE) other outcome description A brief, structured 30-item mental status examination that measures concentration or working memory, language and praxis, orientation, memory, and attention span other outcome time frame Screen other outcome measure Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Symbol Coding other outcome description Participants are required to copy symbols paired with numbers in a 120 second time limit. The score is the number correct in the allotted time. other outcome time frame Screen, Weeks 4, 12 eligibility module eligibility criteria Inclusion Criteria: Age greater than or equal to 60 years DSM5 Diagnosis of Major Depressive Disorder (MDD), Persistent Depressive Disorder, or Depression Not Otherwise Specified (NOS) Hamilton Rating Scale for Depression (HRSD) score ≥ 20 Decreased processing speed (1 SD below age-adjusted norms on the WAIS-IV Digit Symbol Coding Test) Access to a computer with daily internet access Willing to and capable of providing informed consent and complying with all study procedures. At the end of the CCT phase (week 4), depression severity will be reassessed. To be eligible for Phase 2 (SSRI trial), participants will be required to have an HRSD score ≥ 14. Exclusion Criteria: Diagnosis of substance abuse or dependence (excluding Tobacco Use Disorder) within the past 12 months History of psychosis, psychotic disorder, mania, or bipolar disorder Primary neurological disorder, including dementia, stroke, Parkinson's disease, epilepsy, etc. Mini Mental Status Examination (MMSE) score less than 24 HRSD suicide item greater than 2 or Clinical Global Impressions (CGI)-Severity score of 7 at baseline History of allergic or adverse reaction to escitalopram, or non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20 mg) during the current episode Current or recent (within the past 2 weeks) treatment with psychotherapy, antidepressants, antipsychotics, mood stabilizers Contraindication to MRI scanning (such as metal in body) or inability to tolerate the scanning procedures History of significant radioactivity exposure (nuclear medicine studies or occupational exposure). healthy volunteers No gender All minimum age 50 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Joel R Sneed, PhD overall official affiliation Queens College and NYSPI overall official role Principal Investigator location list location location facility New York State Psychiatric Institute location city New York location state New York location zip 10032 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003863 condition mesh term Depression condition mesh id D000003866 condition mesh term Depressive Disorder condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition ancestor id D000019964 condition ancestor term Mood Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse leaf id M20988 condition browse leaf name Mood Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000000928 intervention mesh term Antidepressive Agents intervention ancestor list intervention ancestor intervention ancestor id D000011619 intervention ancestor term Psychotropic Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M3399 intervention browse leaf name Antidepressive Agents intervention browse leaf as found Enhancement intervention browse leaf relevance high intervention browse leaf id M17135 intervention browse leaf name Citalopram intervention browse leaf relevance low intervention browse leaf id M299 intervention browse leaf name Duloxetine Hydrochloride intervention browse leaf relevance low intervention browse leaf id M6256 intervention browse leaf name Dexetimide intervention browse leaf relevance low intervention browse leaf id M13626 intervention browse leaf name Psychotropic Drugs intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev PsychDr intervention browse branch name Psychotropic Drugs intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev AnDyAg intervention browse branch name Anti-Dyskinesia Agents
NCT04836533
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full study rank 61761 study protocol section identification module n c t id NCT04832269 org study id info org study id ZKSJ0130 organization org full name Jena University Hospital org class OTHER brief title Effects of a Multiple Sclerosis Relapse Therapy on Offspring Neurocognitive Development and Behaviour official title Effects of a Multiple Sclerosis Relapse Therapy With Methylprednisolone (MP) During Pregnancy on Offspring Cognitive Function, Stress Sensitivity, Behaviour and Functional and Structural Brain Development acronym MS-Children status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date October 19, 2020 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date February 18, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date August 8, 2022 last update post date struct last update post date August 9, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Florian Rakers responsible party investigator title Principal Investigator responsible party investigator affiliation Jena University Hospital lead sponsor lead sponsor name Jena University Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Ruhr University of Bochum collaborator class OTHER collaborator name Interdisciplinary Center of Clinical Research of the Medical Faculty Jena collaborator class UNKNOWN collaborator name Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Introduction: Fetal exposure to glucocorticoids (GCs) used to induce fetal lung maturation in women threatened by premature labour is known to induce aberrations in brain development and stress sensitivity, cognitive dysfunction and neuro-psychiatric disorders in later life which all predict early brain ageing. Another common source of fetal GC exposure is the treatment of relapses in multiple sclerosis (MS), the most common neurological disease in young women. Despite the lack of studies, the 300-fold higher dosage of GCs for MS relapse treatment compared to obstetric indications is considered harmless for the fetus . Objectives: To examine the effects of GCs for MS relapse treatment during pregnancy on offspring structural and functional brain development, stress sensitivity, and cognitive and behavioural performance. Methods: Epidemiological multi-centre cohort study in 80 children and adolescents aged 8 to 18 years whose mothers received GCs to treat a MS relapse during pregnancy compared to unexposed participants. Expected Impact: Creating a guideline-changing evidence-based risk-benefit assessment regarding benefits of the MS relapse therapy for the mother and potential harm to the child. detailed description Introduction: Multiple Sclerosis (MS) affects 1 in 1,000 people in industrialised countries, mainly women of childbearing age. To prevent MS relapses, most patients receive disease-modifying therapies (DMTs). However, most DMTs - with the exception of interferons and glatiramer acetate - are not approved during pregnancy. Consequently, DMTs are regularly discontinued during pregnancy with a subsequently increased risk of relapses. Thus, relapses during pregnancy are a common phenomenon. The average relapse rate per year in pregnant MS patients not taking DMTs during the 1st and 2nd trimester is nearly identical to the pre-partum period after which it significantly declines during the 3rd Trimester. The German Neurologic Society estimates that approximately 25% of all pregnant women with MS will suffer a relapse during their pregnancy period(s). It is generally recommended by European and US guidelines to treat MS relapses during pregnancy with the synthetic glucocorticoid (GC) methylprednisolone (MP), which is thought to be harmless for the unborn. However, regardless of the undoubtedly positive effects of GCs for MS relapse treatment, there is considerable doubt as to whether synthetic GCs are as low in side effects for the child as MS guidelines assume. The fetus develops in the presence of very low GC levels because it is unable to produce cortisol until the end of pregnancy and about 90% of maternal cortisol is being inactivated by the placental enzyme 11ß-HSD2. In contrast to maternal cortisol, synthetic GCs are no substrate for the placental enzyme 11ß-HSD2 and, thus, pass the placenta without being inactivated. Once within the fetal circulation, GCs interfere with the development of the fetal central nervous system (CNS). The effects of synthetic GCs on fetal development and health and disease in later life as well as the mechanisms mediating these effects are best characterised for betamethasone exposure to induce fetal lung maturation in babies threatening premature labour as this treatment is used in nearly 10% of all pregnancies. In various studies excess exposure to synthetic GCs is associated with reduced birth weight, altered fetal brain development e.g., by direct effect on neuro- and gliogenesis via anti-proliferative effects on neural stem/progenitor cells, and persisting functional changes of the stress axis with its two arms, the hypothalamus-pituitary-adrenal axis (HPAA) and the autonomic nervous system (ANS). Supraphysiological GC concentrations are also thought to reset the set point of the negative feedback regulation of the fetal HPAA which results in an increase of HPAA activity in later life. Increased HPAA activity has been associated with increased stress sensitivity and a number of behavioural changes and neuropsychiatric disorders including anxiety, depressive-like disorders, and attention deficit hyperactivity disorder (ADHD). The relationship between adverse environmental influences during critical periods of fetal life, such as exposure to excess GC, and offspring health in later life is the basis of the 'Fetal Programming' hypothesis. A predecessor study of the investigators' work group tested the hypothesis that fetal betamethasone treatment impairs structural and functional brain development as well as stress sensitivity leading to disturbances in overall neurocognitive performance and behaviour in later life. It is noteworthy, that the dosage of betamethasone (2 x 12mg, 24h apart) was approximately 300-fold lower than the dosage used to treat MS relapses (1000mg over 3-5 days). As a major study outcome, the investigators noticed detrimental effects of prenatal betamethasone exposure on general cognitive ability at the age of 8 - 9 years. Intelligence quotient (IQ)-scores in children who were prenatally exposed to betamethasone were on average 10.5 points lower than in controls, with a large effect size of d = 0.68. Even though IQ-scores of betamethasone-exposed children were still within the expected population range, the investigators assume that this difference is clinically relevant and impedes future life success of the participants. In addition, children exposed to betamethasone showed a significant increase in ADHD related symptoms on the International Classification of Diseases (ICD)-10-based rating scale, the Diagnostik-System für psychische Störungen nach ICD-10 und DSM-5 für Kinder und Jugendliche-III, with a medium effect size of d = 0.51. Electroencephalographic (EEG) analysis showed that BM-exposed children had a higher spectral edge frequency at rest and during stress suggesting a reduced overall neuroelectric relaxation capacity. Heart Rate Variability (HRV) analysis revealed a resetting of the ANS in betamethasone-exposed children. Objectives: The primary goal of this study is to examine the general cognitive ability as a marker of brain development of children of MS patients who received MP to treat an MS relapse during pregnancy. The secondary goals are to determine the effects of MP administered during pregnancy on offspring structural and functional brain development and neuropsychiatric and behavioural performance. Stress sensitivity and epigenetic changes of GC receptor function will be measured to determine underlying mechanisms. The study is based on the following hypotheses: Fetal exposure to MP during relapse treatment in pregnant MS patients leads to disturbances in structural and functional brain development due to the maturational potential of MP which induces asymmetries in the complex sequence of the maturation of cerebral functional systems with lifelong changes in brain function, permanent alterations in HPAA sensitivity and autonomic function which are associated with neuropsychiatric and behavioural disturbances in later life, and alterations in GC receptor function and methylation of the GC receptor gene (NR3C1) and the H19/IGF2 locus as the underlying mechanisms linking MP exposition during pregnancy and offspring cognitive and behavioural functioning in later life. Methods: The investigators will carry out a multicentre, observational, cross-sectional study in children and adolescents aged 8 to 18 years. The study design is retrospective due to ethical considerations of withholding the standard relapse treatment and the long study duration of at least 10 years. Following recruitment, all participants will undergo the same examination procedures in one study visit consisting of two days. By extending the study visit to two days, the investigators ensure stress-free examinations. In general, day 1 and day 2 of the study visits take place in direct succession. However, in case of scheduling issues or if the children and their parents live close by and do not want to stay overnight, there may be a few days in between. The sequence of examinations was chosen in such a way that blood sampling and neuropsychological examinations induce as little stress as possible for the participants. Functional brain development: The investigators will apply state-of-the-art neurocognitive, behavioural and mental health measures to determine the stage of functional brain development: General cognitive ability (primary endpoint) is determined using German age-appropriate versions of the Reynolds Intellectual Assessment Scales and Screening (RIAS) intelligence test. Behaviour is measured using three external assessment questionnaires which are routinely used in clinics and the scientific community. The German rating scale Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-/Hyperaktivitätsstörungen (FBB-ADHS) is based on the ICD-10 criteria for ADHD and assesses inattentiveness, hyperactivity, and impulsivity. The child behaviour checklist (CBCL), an established diagnostic screening procedure, measures psychopathological abnormalities in children and adolescents. The strengths and difficulties questionnaire (SDQ) assesses children's strengths and weaknesses. The Continuous Performance Test (CPT) is a clinically and scientifically established instrument to detect selective attention, vigilance, and impulsive behaviour with sufficient reliability and validity. Motor development is assessed using the Movement Assessment Battery for Children - Second Edition (M-ABC 2), which allows a reliable and time-efficient assessment of motor-coordinative deficits. Structural brain development: The stage of structural brain development will be quantified based on a volumetric T1-MRI standard sequence using markers such as gyrification and cortical thickness as well as the BrainAge Score, which was development by the investigators' research group. The investigators expect that prenatal MP has a significant effect on brain age since GCs accelerate tissue differentiation and maturation at the expense of tissue growth. Stress sensitivity and autonomic function: The individual stress sensitivity including the function of the HPAA and the autonomic nervous system is examined using the Trier Social Stress Test (TSST). This is an established and commonly used tool for children to generate a reproducible psychophysiological stress response using a simulated examination situation. It comprises a 10 minute rest period and a task period consisting of five-minute story-telling and mental arithmetic periods, which is completed in front of an "examination committee". Saliva samples for measurement of cortisol levels and alpha-amylase are taken before and during the stress test to determine HPAA and sympathetic activity at rest and during activation. In addition, continuous electrocardiography (ECG) and EEG leads are performed. The autonomic activity is also determined using HRV analysis from the derived ECG based on established HRV standards as well as on innovative nonlinear information based approaches developed at the department. Autonomic activity reflected in HRV is a sensitive marker of disturbances in the neurodevelopmental trajectory. Neurophysiological activation is measured using power spectral and nonlinear EEG analysis techniques. Mechanism: The investigators will determine GC receptor sensitivity and epigenetic changes of the NR3C1 promoter and the H19/IGF2 locus. Expected Impact: The results of this study will improve the ability of clinicians to make an evidence-based benefit-risk assessment regarding the continuation of a DMT during pregnancy under consideration of its safety under 'real world' conditions in relation to the potential long-term risks of an acute relapse therapy with MP for the health of the unborn child in later life. The investigators expect that the results will provide an additional argument (1) to continue immunomodulatory relapse prophylaxis, e.g. with interferons during pregnancy, especially in light of their recently recognized relative safety for the child, or (2) to choose a long-acting DMT such as cladribine that provides lasting protection from relapses during pregnancy. conditions module condition list condition Multiple Sclerosis keyword list keyword fetal programming pregnancy relapse therapy design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Retrospective bio spec bio spec retention Samples With DNA bio spec description GC receptor sensitivity, methylation of the GR-receptor gene enrollment info enrollment count 80 enrollment type Anticipated arms interventions module arm group list arm group arm group label MP exposed group arm group description children and adolescents (aged 8 to 18 years) of mothers with prenatal exposition to MP in the context of an MS relapse therapy arm group intervention list arm group intervention name Other: Exposure to methylprednisolone during pregnancy arm group label MP non-exposed group/control group arm group description children and adolescents of mothers suffering from MS aged 8 to 18 years intervention list intervention intervention type Other intervention name Exposure to methylprednisolone during pregnancy intervention description Exposure to methylprednisolone during pregnancy in the context of an MS relapse therapy intervention arm group label list intervention arm group label MP exposed group outcomes module primary outcome list primary outcome primary outcome measure General cognitive ability - Reynolds Intellectual Assessment Scales and Screening (RIAS) primary outcome description Intelligence quotient as measured by RIAS, higher scores denote better outcome. primary outcome time frame approx. 30 - 40 min. secondary outcome list secondary outcome secondary outcome measure Structural brain development - BrainAge score secondary outcome description Volumetric cranial MRI change in standard T1 sequences (Developmental biomarker) secondary outcome time frame approx. 20 min. secondary outcome measure Salivary cortisol decay curve secondary outcome description Salivary cortisol concentration (nmol/l) before, during, and after Trier Social Stress Test secondary outcome time frame approx. 5 min. per swab secondary outcome measure Salivary alpha-amylase secondary outcome description Salivary alpha-amylase concentration (U/ml) before, during, and after Trier Social Stress Test secondary outcome time frame approx. 5 min. per swab secondary outcome measure Heart rate variability secondary outcome description Heart rate variability (band power low frequency, high frequency, and ratio; msec^2/Hz) before, during, and after the Trier Social Stress Test secondary outcome time frame approx. 75 min. secondary outcome measure Spectral edge frequency in the EEG secondary outcome description Fast Fourier transformation to measure cerebral activity before, during, and after the Trier Social Stress Test secondary outcome time frame approx. 75 min. secondary outcome measure External assessment sheet for attention deficit / hyperactivity disorder (FBB-ADHS, German Version) secondary outcome description Questionnaire for parents assessing attention deficit hyperactivity disorder associated behaviour. Items based on symptoms of hyperkinetic disorder (International Classification of Diseases-10) and attention deficit hyperactivity disorder (Diagnostic and Statistical Manual of Mental Disorders-5). Higher scores denote worse outcome. secondary outcome time frame approx. 15 - 20 min. secondary outcome measure Child Behavior Checklist (CBCL/6-18R) secondary outcome description Questionnaire for parents assessing the child's behavioural symptoms on eight scales - (1) anxious/depressed, (2) withdrawn/depressed, (3) somatic complaints, (4) social problems, (5) thought, sleep, and repetitive behaviour problems, (6) attention problems, (7) rule-breaking behaviour, and (8) aggressive behaviour. Higher scores denote worse outcome. secondary outcome time frame approx. 15 - 20 min. secondary outcome measure Strengths and Difficulties Questionnaire (SDQ-Deu-S) secondary outcome description Brief screening questionnaire for parents assessing emotional and behavioural problems, hyperactivity and inattention, peer relationship problems, and prosocial behaviour. Higher score denote worse outcome. secondary outcome time frame approx. 15 - 20 min. secondary outcome measure Continuous Performance Test (CPT) secondary outcome description Computer-based test of selective attention, vigilance, and impulsivity, measured as reaction time, performance variability, and commission and omission errors. Higher scores denote poorer performance. secondary outcome time frame approx. 15 min. secondary outcome measure Emotional excitability scale from Personality questionnaire for children between 9 and 14 years (PFK 9-14, German Version) secondary outcome description Computer-based personality assessment reported by the child; for ages 9 - 14 secondary outcome time frame approx. 15 min. secondary outcome measure Movement Assessment Battery for Children - Second Edition (M-ABC-2) secondary outcome description Motor impairment assessment for ages 3 - 16 secondary outcome time frame approx. 20 - 30 min. secondary outcome measure Child anxiety test III (KAT-III, German version) secondary outcome description State and trait anxiety in children aged 6 - 18 years; before and after the Trier Social Stress Test; higher scores denotes higher subjective anxiety secondary outcome time frame approx. 5 min. each other outcome list other outcome other outcome measure Methylation of GR-receptor gene other outcome description DNA methylation at GC receptor gene NR3C1 and at the H19 locus other outcome time frame approx. 10 min. eligibility module eligibility criteria Inclusion Criteria: MS diagnosis was made based on the McDonald criteria valid at the time of diagnosis Written consent by the legal guardians of the participating child following a detailed oral and written education Exposed group (n=40): Children and adolescents (aged 8 to 18 years) of mothers with prenatal exposition to MP in the context of a MS relapse therapy Non-exposed group (n=40): Children and adolescents of mothers suffering from MS without MP therapy during pregnancy (aged 8 to 18 years) matched for age, gender and social background Exclusion Criteria: Perinatal complications such as cerebral bleeding, neonatal intensive care with ventilation, prenatal therapy with glucocorticoids except for an MS relapse Maternal abuse of noxious agents during pregnancy Long-term glucocorticoid medication (e.g. asthma) Preterm births (before 36 weeks of pregnancy) Severe disease making an examination impossible (e.g. mental retardation) disease-modifying therapy during pregnancy healthy volunteers No gender All minimum age 8 Years maximum age 18 Years std age list std age Child Adult study population The study population is composed of children aged 8 to 18 from mothers with multiple sclerosis who received methylprednisolone in pregnancy and children aged 8 to 18 from mothers with multiple sclerosis without methylprednisolone therapy during pregnancy sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Michelle Dreiling, Dr. central contact role Contact central contact phone +493641 9 32 35 93 central contact e mail [email protected] central contact name Florian Rakers, PD Dr. central contact role Contact central contact phone +493641 9 32 34 67 central contact e mail [email protected] overall official list overall official overall official name Florian Rakers overall official affiliation University Hospital Jena overall official role Principal Investigator overall official name Matthias Schwab, Prof. Dr. overall official affiliation University Hospital Jena overall official role Study Director location list location location facility Ruhr University of Bochum location status Recruiting location city Bochum location zip 44791 location country Germany location contact list location contact location contact name Michelle Dreiling location contact role Contact location contact phone +4936419323593 location contact e mail [email protected] location facility University Hospital Jena location status Recruiting location city Jena location zip 07747 location country Germany location contact list location contact location contact name Michelle Dreiling location contact role Contact location contact phone +4936419323593 location contact e mail [email protected] location contact name Florian Rakers location contact role Contact location contact phone +4936419323467 location contact e mail [email protected] references module reference list reference reference p m i d 24863382 reference type background reference citation Moisiadis VG, Matthews SG. 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Guidline for the treatment of Multiple Sklerosis. https://www.dgn.org/images/red_leitlinien/LL_2012/pdf/030-050l_S2e_Multiple_Sklerose_Diagnostik_Therapie_Archiv-min.pdf. Published 2012 reference p m i d 30612100 reference type background reference citation Dobson R, Dassan P, Roberts M, Giovannoni G, Nelson-Piercy C, Brex PA. UK consensus on pregnancy in multiple sclerosis: 'Association of British Neurologists' guidelines. Pract Neurol. 2019 Apr;19(2):106-114. doi: 10.1136/practneurol-2018-002060. Epub 2019 Jan 5. reference type background reference citation Hagmann-von Arx P, Grob A. RIAS-Reynolds intellectual assessment scales and screening: deutschspra-chige Adaptation der Reynolds Intellectual Assessment Scales (RIAS) & des Reynolds Intellectual Screening Test (RIST) von Cecil R. Reynolds und Randy W. Kamphaus: Manual. Hans Huber; 2014 reference type background reference citation Malik M. Heart rate variability: Standards of measurement, physiological interpretation, and clinical use: Task force of the European Society of Cardiology and the North American Society for Pacing and Electrophysi-ology. Annals of Noninvasive Electrocardiology. 1996;1(2):151-181 reference p m i d 35557615 reference type derived reference citation Kozik V, Schwab M, Thiel S, Hellwig K, Rakers F, Dreiling M. Protocol for a Cross-Sectional Study: Effects of a Multiple Sclerosis Relapse Therapy With Methylprednisolone on Offspring Neurocognitive Development and Behavior (MS-Children). Front Neurol. 2022 Apr 26;13:830057. doi: 10.3389/fneur.2022.830057. eCollection 2022. see also link list see also link see also link label Official web page providing study information see also link u r l http://www.ms-kinder.de i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009103 condition mesh term Multiple Sclerosis condition mesh id D000012598 condition mesh term Sclerosis condition mesh id D000012008 condition mesh term Recurrence condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000020278 condition ancestor term Demyelinating Autoimmune Diseases, CNS condition ancestor id D000020274 condition ancestor term Autoimmune Diseases of the Nervous System condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition 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full study rank 61191 study protocol section identification module n c t id NCT04839679 org study id info org study id 20-005385 organization org full name Mayo Clinic org class OTHER brief title A Study to Evaluate Visually Inspired Patient Education Material on Willingness to Pursue Radiation Therapy official title A Randomized Clinical Trial to Study the Utility of Visually Inspired Patient Education Material on Willingness to Pursue Radiation Therapy in American Indian and Alaska Native Individuals (VIEW Study) status module status verified date July 2022 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date March 30, 2021 start date type Actual primary completion date struct primary completion date April 1, 2023 primary completion date type Anticipated completion date struct completion date April 1, 2023 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 18, 2022 last update post date struct last update post date July 19, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Samir Patel responsible party investigator title Principal Investigator responsible party investigator affiliation Mayo Clinic lead sponsor lead sponsor name Mayo Clinic lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This research study is being done in order to better understand and identify American Indian/Alaskan Native (AI/AN) cancer patients' attitudes and beliefs towards radiation therapy treatment plans and their willingness to pursue them. conditions module condition list condition Patient Education in Radiation Oncology keyword list keyword Radiation therapy Patient education Radiation oncology Native Americans design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Health Services Research design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Standard of Care Mayo Clinic booklet arm group type Active Comparator arm group description Subjects will receive the standard Mayo Clinic educational booklet in preparation for clinically indicated radiation therapy treatment arm group intervention list arm group intervention name Behavioral: Mayo Clinic Educational Booklet arm group label Culturally Oriented Education arm group type Experimental arm group description Subjects will receive a culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner in addition to the standard Mayo Clinic booklet arm group intervention list arm group intervention name Behavioral: Culturally Oriented Educational Brochure Behavioral: Mayo Clinic Educational Booklet intervention list intervention intervention type Behavioral intervention name Culturally Oriented Educational Brochure intervention description Culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner intervention arm group label list intervention arm group label Culturally Oriented Education intervention type Behavioral intervention name Mayo Clinic Educational Booklet intervention description "An Introduction to Radiation Simulation and Treatment"- Barbara Woodward Lips, Patient Education Center intervention arm group label list intervention arm group label Culturally Oriented Education Standard of Care Mayo Clinic booklet outcomes module primary outcome list primary outcome primary outcome measure Change in patient anxiety primary outcome description Measured using self-reported Hospital Anxiety and Depression Scale (HADS) Survey to ascertain any anxiety and/or depression that they may be experiencing with respect to their diagnosis and treatment. Questionnaire total score reported on a scale of 0-7 = normal, 8-10 borderline abnormal (borderline case), 11-21 abnormal (case) primary outcome time frame Baseline, day 14 primary outcome measure Radiotherapy completion rates in the AI/AN community primary outcome description Number of participates to complete radiation therapy as prescribed primary outcome time frame 90 days primary outcome measure Change in patient perception of information received primary outcome description Measured by the EORTC QLQ - INFO25 survey, which is a validated instrument that will gauge their satisfaction with the information they received regarding their diagnosis and treatment plan. Questionnaire of 24 questions regarding information received during treatment using a scale of 1 (not at all) to 4 (very much). primary outcome time frame Baseline, day 14 eligibility module eligibility criteria Inclusion Criteria: Patient at least 18 years of age with cancer diagnosis. Radiation therapy is recommended for their cancer treatment as a next step in their cancer care. Cognitive capacity to complete a paper-and-pencil survey. Ability to communicate and understand English with proficiency to provide informed consent and complete a paper-and-pencil survey. Exclusion Criteria: Patient < 18 years of age. Patient does not have a cancer diagnosis. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Samir H Patel, MD overall official affiliation Mayo Clinic overall official role Principal Investigator location list location location facility Mayo Clinic in Arizona location city Phoenix location state Arizona location zip 85054 location country United States references module see also link list see also link see also link label Mayo Clinic Clinical Trials see also link u r l https://www.mayo.edu/research/clinical-trials derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009369 condition mesh term Neoplasms condition browse leaf list condition browse leaf condition browse leaf id M26290 condition browse leaf name Respiratory Aspiration condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04839679
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full study rank 61257 study protocol section identification module n c t id NCT04838821 org study id info org study id R020-SABI-00268 organization org full name Caja Costarricense de Seguro Social org class OTHER_GOV brief title Efficacy and Safety of Three Different Doses of an Anti SARS-CoV-2 Hyperimmune Equine Serum in COVID-19 Patients official title Randomized, Placebo-controlled, Double-blind, Multicenter Clinical Study to Compare the Efficacy and Safety of the Administration of Three Different Doses of an Anti-SARS-CoV-2 Hyperimmune Equine Serum Formulation in Hospitalized COVID-19 Patients (SECR-02) acronym SECR-02 status module status verified date May 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 29, 2021 start date type Actual primary completion date struct primary completion date July 29, 2021 primary completion date type Anticipated completion date struct completion date September 29, 2021 completion date type Anticipated study first submit date March 23, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date May 20, 2021 last update post date struct last update post date May 21, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Caja Costarricense de Seguro Social lead sponsor class OTHER_GOV collaborator list collaborator collaborator name Universidad de Costa Rica collaborator class OTHER collaborator name Ministry of Health Costa Rica collaborator class UNKNOWN oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Passive immunotherapy is a therapeutic alternative used in a variety of infectious diseases including COVID-19. Equine polyclonal hyperimmune sera is a source of neutralizing antibodies against SARS-CoV-2 and a therapeutic alternative under investigation in COVID-19 patients. In the previous study NCT04610502 no significant variations were observed regarding efficacy and safety between two different pharmaceutical preparations of equine hyperimmune sera and adequate tolerability was reported with both investigational products. Formulations were produced through repeated immunization with viral recombinant proteins and contain either antibodies against SARS-CoV-2 S1 protein (S type) or a combination of viral proteins that included S1, N (nuclear), E (envelop) and M (membrane) (M type). Another investigation (NCT04494984) found that the administration of a pharmaceutical preparation similar to the S type produced clinical improvement in hospitalized patients with SARS-CoV-2 pneumonia, particularly those with severe disease. Aim: Evaluate the efficacy and safety of three different doses of an anti-SARS-CoV-2 hyperimmune equine serum formulation (S-type) as an addition to the standard therapeutic approach in adult hospitalized patients with a diagnosis of moderate or severe COVID-19, radiological findings consistent with pneumonia and a symptom onset period not exceeding 10 days. A total of 156 patients will be included and randomly divided into four groups, each group will receive a different dose of the investigational drug. On day 1, all participants will receive a single intravenous infusion containing the specified dose according to their assigned group. Clinical assessments, laboratory determinations that include: viral load, antibodies quantification, inflammatory and coagulation markers, cytokines levels as well as standard evaluations will be performed for each patient. Data will be collected for all groups on Days 0 to 7, 14 and 28 or at discharge after completion of treatment. The study will end for each participant on the day of discharge from the hospital. conditions module condition list condition Covid19 keyword list keyword Covid19 Anti-SARS-CoV-2 hyperimmune equine serum Neutralizing antibodies Passive Immunotherapy design module study type Interventional phase list phase Phase 2 Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description 156 participants will be allocated randomly to either one of three treatment groups or to placebo through an internet based randomizer (Studyrandomizer.com). Participants can withdraw from the study at any time. design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 156 enrollment type Anticipated arms interventions module arm group list arm group arm group label Anti SARS-CoV-2 equine hyperimmune serum arm group type Experimental arm group description All participants in the treatment groups will receive a single intravenous infusion on day 1 containing the specified dose according to their assigned group 12mg/kg, 30 mg/kg or 56mg/kg. Total volume of the infusion is 180ml, to be administered during a time period of at least 1 hour. Study participants will be followed during their hospitalization until they are discharged and on Study Day 28. arm group intervention list arm group intervention name Biological: Anti SARS-CoV-2 equine hyperimmune serum arm group label Placebo arm group type Experimental arm group description All participants in the placebo group will receive a single intravenous infusion on day 1 containing a specified volume of a saline IV solution preparation. Total volume of the infusion is 180ml, to be administered during a time period of at least 1 hour. Study participants will be followed during their hospitalization until they are discharged and on Study Day 28. arm group intervention list arm group intervention name Biological: placebo intervention list intervention intervention type Biological intervention name Anti SARS-CoV-2 equine hyperimmune serum intervention description All participants in the treatment groups will receive a single intravenous infusion on day 1 containing the specified dose according to their assigned group 12mg/kg, 30 mg/kg or 56mg/kg. Total volume of the infusion is 180ml, to be administered during a time period of at least 1 hour. Study participants will be followed during their hospitalization until they are discharged and on Study Day 28. intervention arm group label list intervention arm group label Anti SARS-CoV-2 equine hyperimmune serum intervention type Biological intervention name placebo intervention description All participants in the placebo group will receive a single intravenous infusion on day 1 containing a specified volume of a saline IV solution preparation. Total volume of the infusion is 180ml, to be administered during a time period of at least 1 hour. Study participants will be followed during their hospitalization until they are discharged and on Study Day 28. intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Crude Mortality in COVID-19 patients primary outcome description The primary endpoint will be the difference in the proportion of deaths from all causes at 7 and 28 days after the administration of the investigational product between the study groups. primary outcome time frame day 7 and 28 secondary outcome list secondary outcome secondary outcome measure Mechanical ventilation assistance (MVA) secondary outcome description Change in MVA requirement days between study groups at day 28. secondary outcome time frame day 28 secondary outcome measure Hospital stay secondary outcome description Change in the overall in-hospital at day 28 stay between study groups. secondary outcome time frame day 28 secondary outcome measure Inflammatory markers IL6 secondary outcome description Changes in IL-6 levels to be evaluated at days 0, 1, 2, 3, 5, 7, 14 or at time of discharge between study groups. secondary outcome time frame Days 0, 1, 2, 3, 5, 7, and 14 or discharge secondary outcome measure Inflammatory markers CRP secondary outcome description Change in CRP levels to be evaluated at days 0, 1, 2, 3, 5, 7, 14 or at time of discharge between study groups. secondary outcome time frame Days 0, 1, 2, 3, 5, 7, and 14 or discharge secondary outcome measure Inflammatory markers Procalcitonin secondary outcome description Change in procalcitonin levels to be evaluated at days 0, 1, 2, 3, 5, 7, 14 or at time of discharge between study groups. secondary outcome time frame Days 0, 1, 2, 3, 5, 7, and 14 or discharge secondary outcome measure Inflammatory markers Ferritin secondary outcome description Change in ferritin levels to be evaluated at days 0, 1, 2, 3, 5, 7, 14 or at time of discharge between study groups. secondary outcome time frame Days 0, 1, 2, 3, 5, 7, and 14 or discharge secondary outcome measure Thrombotic markers PTT secondary outcome description Changes in PTT levels to evaluated at days 0, 1, 2, 3, 5, 7, 14 or at time of discharge between study groups. secondary outcome time frame Days 0, 1, 2, 3, 5, 7, and 14 or discharge secondary outcome measure Thrombotic markers PT secondary outcome description Changes in PT levels to evaluated at days 0, 1, 2, 3, 5, 7, 14 or at time of discharge between study groups. secondary outcome time frame Days 0, 1, 2, 3, 5, 7, and 14 or discharge secondary outcome measure Thrombotic markers D Dimer secondary outcome description Changes in D Dimer levels to evaluated at days 0, 1, 2, 3, 5, 7, 14 or at time of discharge between study groups. secondary outcome time frame Days 0, 1, 2, 3, 5, 7, and 14 or discharge secondary outcome measure Thrombotic markers Fibrinogen secondary outcome description Changes in Fibrinogen levels to evaluated at days 0, 1, 2, 3, 5, 7, 14 or at time of discharge between study groups. secondary outcome time frame Days 0, 1, 2, 3, 5, 7, and 14 or discharge secondary outcome measure SpO2/FIO2 ratio secondary outcome description Change in the SpO2/FIO2 ratio to evaluated at days 0, 1, 2, 3, 4, 5, 6, 7 and 14 or at time of discharge between study groups secondary outcome time frame Days 0, 1, 2, 3, 4, 5, 6, 7 and 14 or discharge secondary outcome measure Changes in viral load secondary outcome description Change in viral load from baseline to 3 and 7 days after the start of the treatment between study groups secondary outcome time frame Days 0, 3, 7 secondary outcome measure Modified Sequential Organ Failure Assessment (mSOFA) secondary outcome description Change in the mSOFA score to evaluated at days 0, 1, 2, 3, 5, 7 and 14 or at time of discharge between study groups. secondary outcome time frame Time Frame: Days 0, 1, 2, 3, 5, 7 and 14 or discharge secondary outcome measure WHO 8 point ordinal scale secondary outcome description Change in the WHO 8 point ordinal scale of clinical status to evaluated at days 0, 1, 2, 3, 4, 5, 6, 7, 14 and 28 or at time of discharge between study groups. secondary outcome time frame Days 0, 1, 2, 3, 4, 5, 6, 7, 14 and 28 or discharge secondary outcome measure Anti SARS-CoV-2 antibodies secondary outcome description Change in the anti SARS-CoV-2 antibodies titer levels to evaluated at days 0, 1, 2, 3, 5, 7 and 14 or at time of discharge between study groups. secondary outcome time frame Days 0, 1, 2, 3, 5, 7 and 14 or discharge secondary outcome measure Adverse events secondary outcome description Incidence of adverse events as measured by CTCAE v. 5.0 at day 28 between study groups. secondary outcome time frame day 28 eligibility module eligibility criteria Inclusion Criteria: Subjects male or female, aged 18 and over. Acceptance to participate in the study by the signature of the informed consent by the subject or relative (if applicable). SARS-CoV-2 infection confirmed by reverse transcriptase -polymerase chain reaction (RT-PCR). SARS-CoV-2 pneumonia confirmed by chest X-ray. Patients with moderate or severe disease clinical presentation of the disease that require hospitalization. Being within 10 days of the initial COVID-19 related symptoms onset. Admission in the participating center within a 24hour period. Female patients of child-bearing age with a negative pregnancy test. Exclusion Criteria: COVID-19 patients that do not require hospitalization (outpatient setting). Patients who are participating in other therapeutic clinical trials. COVID-19 patients who have received convalescent plasma treatment. Critical disease COVID- 19 patients (respiratory failure, septic shock, and/or multiple organ dysfunction, admission PaO2/FIO2 ratio < 100). Previously snake bitten individuals that received any type of equine hyperimmune serum treatment. History of an allergic reaction due to contact or exposure to horses. Pregnant or breastfeeding women. Patients who, at the investigator´s discretion, are not likely to comply with study indications and procedures. Patients currently undergoing hemodialysis in a renal support program. Individuals who were previously classified by their treating physicians (prior to the COVID-19 diagnosis), of having an unfavorable prognosis with a short lifespan due to a concomitant disease other than the study disease. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Centro Especializado de Atención COVID19 (CEACO) location status Recruiting location city San José location country Costa Rica location contact list location contact location contact name Rodrigo Aguilar, MD location contact role Contact location contact phone 22328233 location contact e mail [email protected] location contact name José Acuña, MD location contact role Sub-Investigator location facility Hospital Dr. Rafael Ángel Calderón Guardia location status Recruiting location city San José location country Costa Rica location contact list location contact location contact name Taciano Lemos, MD location contact role Contact location contact phone 21014837 location contact e mail [email protected] location contact name Jose Pablo Madrigal, MD location contact role Sub-Investigator location facility Hospital México location status Recruiting location city San José location country Costa Rica location contact list location contact location contact name Douglas Montero, MD location contact role Contact location contact phone 21047555 location contact e mail [email protected] location contact name Henry Chan, MD location contact role Sub-Investigator location facility Hospital San Juan de Dios location status Recruiting location city San José location country Costa Rica location contact list location contact location contact name Ileana Balmaceda, MD location contact role Contact location contact phone 25478000 location contact e mail [email protected] location contact name Mario Sibaja, MD location contact role Contact location contact name Juan Ignacio Silesky, MSc location contact role Sub-Investigator location contact name Ann Echeverri, MD location contact role Sub-Investigator location contact name Mario Sibaja, MD location contact role Sub-Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf relevance low intervention browse leaf id M20287 intervention browse leaf name Antibodies, Blocking intervention browse leaf relevance low intervention browse leaf id M21013 intervention browse leaf name Pharmaceutical Solutions intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions
NCT04838821
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full study rank 61658 study protocol section identification module n c t id NCT04833608 org study id info org study id 2018P002864 organization org full name Massachusetts General Hospital org class OTHER brief title Managing Pain in Patients With MTP Arthritis official title Using Flexible Carbon Fiber Insoles for 1st Metatarsophalangeal Arthritis Lead to Pain Reduction and High Compliance Rate: A Randomized Controlled Trial status module status verified date March 2021 overall status Completed expanded access info has expanded access No start date struct start date April 30, 2019 start date type Actual primary completion date struct primary completion date February 27, 2020 primary completion date type Actual completion date struct completion date May 31, 2020 completion date type Actual study first submit date March 31, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Gregory Waryasz, M.D. responsible party investigator title Orthopaedic Surgeon responsible party investigator affiliation Massachusetts General Hospital lead sponsor lead sponsor name Massachusetts General Hospital lead sponsor class OTHER collaborator list collaborator collaborator name VKTRY Gear collaborator class UNKNOWN oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Hallux rigidus is a degenerative disease of the first metatarsophalangeal (MTP) joint which affect 2.5% of people over the age of 50. As the arthritis progresses, patients pain levels increase and range of motion decreases. Non-operative management includes the use of NSAIDS, intra-articular injections, shoe modification, activity modifications, and physical therapy. Oral NSAID have been used extensively to reduce swelling and pain but have been found unsatisfactory in providing pain relief. Injections have been shown relieve pain in patients with grade 1 MTP arthritis. Shoe modifications and orthotics can modify the biomechanics of the MTP joint and thereby alleviate pain. Based on expert opinions, it seems the Morton extensions may alleviate pain but are also poorly tolerated by patients due to it's uncomfortable shape, coincidently leading to a low patient compliance rate. VKTRY insoles were initially designed to increase ground force leading to a harder push off for faster running or higher jumping. To enable energy return the insole needed to be extremely rigid and therefore consists out of a full-length Carbon-Fiber base. Unexpectedly the Carbon fiber base makes this a highly rigid construct which will likely benefit those patients with MTP arthritis as it will take away much movement of the MTP joint, without having an uncomfortable shape, i.e. patients can use this insole in their own shoes, possibly leading to a higher patient compliance and, simultaneously, to better outcome. Even though this insole is being widely used by athletes, no one has explored its role for treating patients with MTP joint arthritis. Therefore, the aim of this study is to compare the VKTRY insole to the current Morton extension insoles in a blinded randomized controlled trial detailed description Subject Enrollment: Patients were introduced to the study by Foot and Ankle orthopaedic surgeons if they were identified as having hallux rigidis. If the patient agreed, an authorized member of the study staff went through the study in detail and addressed any questions the patients had. If the patient was willing to participate, informed consent was obtained. We emphasized that not participating in the study will not affect their care now or in the future. Once informed consent was obtained, the patient was randomized into one of two groups. Morton Extensions along with current pain management protocol VKTRY insoles along with the current pain management protocol Explanatory variables gathered: Basic patient characteristics Range of motion at 1st MTP joint Hallux Rigidus severity grading Patients were evaluated at the initial appointment, 2 weeks, 6 weeks, and 12 weeks following their initial appointment. The surveys were given to the patients during each evaluation time point. Sample Size Calculation: Based on power analysis to detect a minimal clinically important difference of 10.6 (+/- 4.6 SD) points in the PROMIS pain intensity score between patients using the Vktory carbon fiber insole and patients using Morton's extension insole with an overall two-tailed Type-1 rate of 5%, 80% statistical power and accounting for a 30% lost to follow up, we needed 14 patients in total. conditions module condition list condition Hallux Rigidus keyword list keyword 1st metatarsophalangeal joint arthritis 1st MTP arthritis Hallux Rigidus foot Insole carbon fiber insole Morton extension insole design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 14 enrollment type Actual arms interventions module arm group list arm group arm group label Vktory Carbon fiber insoles arm group type Active Comparator arm group description VKTRY insoles were initially designed to increase ground force leading to a harder push off for faster running or higher jumping. To enable energy return the insole needed to be extremely rigid and therefore consists out of a full length Carbon-Fiber base. Unexpectedly the Carbon fiber base makes this a highly rigid construct which will likely benefit those patients with MTP arthritis as it will take away much movement of the MTP joint, without having an uncomfortable shape, i.e. patients can use this insole in their own shoes, possibly leading to a higher patient compliance and, simultaneously, to better outcome arm group intervention list arm group intervention name Device: Vktory insoles arm group label Morton's extension insoles arm group type Active Comparator arm group description Based on expert opinions, it seems the Morton extensions may alleviate pain but are also poorly tolerated by patients due to its uncomfortable shape, coincidently leading to a low patient compliance rate. arm group intervention list arm group intervention name Device: Morton's extension insoles intervention list intervention intervention type Device intervention name Vktory insoles intervention description Patients were randomized into either the Carbon fiber insole group or Morton's extension group. intervention arm group label list intervention arm group label Vktory Carbon fiber insoles intervention other name list intervention other name Carbon fiber insoles intervention type Device intervention name Morton's extension insoles intervention description Patients were randomized into either the Vktory carbon fiber insole group or Morton's extension insole group. intervention arm group label list intervention arm group label Morton's extension insoles outcomes module primary outcome list primary outcome primary outcome measure Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) pain score at 2 weeks, 6 weeks, and 12 weeks primary outcome description PROMIS Bank v1.1 pain interference and PROMIS Scale v1.0 pain intensity were completed. Pain Interference instrument measures the self-reported impact of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The Pain Intensity instrument is universal rather than disease-specific. The initial items in the Pain Intensity item bank assess pain intensity utilizing a 7-day recall period (items include the phrase "the past 7 days") while the latter item asks patients to rate their pain intensity at the moment. primary outcome time frame At initial visit, 2 weeks, 6 weeks and 12 weeks primary outcome measure Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) Physical Function at 2 weeks, 6 weeks, and 12 weeks primary outcome description PROMIS Bank v2.0 Physical Function was completed. Items included in this reflect mobility, upper limb function (eg, carrying a bag of groceries), and full-body activities (eg, run errands and shop). For the PROMIS measure, the mean T-score in the United States general population is 50 with a SD of 10. Higher scores reflect better physical function. primary outcome time frame At initial visit, 2 weeks, 6 weeks and 12 weeks primary outcome measure Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) Global Health at 2 weeks, 6 weeks, and 12 weeks primary outcome description PROMIS SF v1.1 Global Health was completed. The PROMIS Global health was assessed to understand how patient's symptoms affected physical function, pain, fatigue, emotional distress, social health. The PROMIS global health consists of 10 items with 9 items using five-category response scales, and one item (rating of pain on average) using a response scale of 0-10 that is recoded to five categories. primary outcome time frame At initial visit, 2 weeks, 6 weeks and 12 weeks primary outcome measure Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) Depression at 2 weeks, 6 weeks, and 12 weeks primary outcome description PROMIS Bank v1.0 Depression was completed. The items in the questionnaire focus on the negative moods, emotions, self-image, social cognition and cognitive deficits. A 5-point verbal scale was used to measure patients experience related to their symptoms. primary outcome time frame At initial visit, 2 weeks, 6 weeks and 12 weeks primary outcome measure Change from Baseline Compliance and activity Questionnaire at 2 weeks, 6 weeks, and 12 weeks primary outcome description Patient compliance was assessed by asking whether the patient used the orthosis - or not. This parameter had two choices that the patient would respond "Yes" or "No" which referred to whether they used the orthosis on the day they completed the questionnaire. Lastly, the comfort rate was measured with a 0-100 Likert scale, where a score of 0 indicated "least comfort" and a score of 100 reflected "best comfort". primary outcome time frame At initial visit, 2 weeks, 6 weeks and 12 weeks eligibility module eligibility criteria Inclusion Criteria: Adult patients (over 18 years old) with MTP joint arthritis Adults who were competent and able to consent on their behalf Patients who were seen at Massachusetts General Hospital and Newton Wellesley Hospital Exclusion Criteria: Patients who had history of 1st MTP joint injection Patients that have already used similar orthotics or had prior surgery to the foot Patients who will be treated surgically healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Gregory Waryasz, MD overall official affiliation Massachusetts General Hospital overall official role Principal Investigator location list location location facility Massachusetts General Hospital location city Boston location state Massachusetts location zip 02120 location country United States location facility Newton Wellesley Hospital location city Newton location state Massachusetts location zip 02462 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001168 condition mesh term Arthritis condition mesh id D000020859 condition mesh term Hallux Rigidus condition mesh id D000020857 condition mesh term Hallux Limitus condition ancestor list condition ancestor condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000005531 condition ancestor term Foot Deformities, Acquired condition ancestor id D000005530 condition ancestor term Foot Deformities condition ancestor id D000018409 condition ancestor term Foot Injuries condition ancestor id D000007869 condition ancestor term Leg Injuries condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition browse leaf list condition browse leaf condition browse leaf id M3628 condition browse leaf name Arthritis condition browse leaf as found Arthritis condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M21759 condition browse leaf name Hallux Rigidus condition browse leaf as found Hallux Rigidus condition browse leaf relevance high condition browse leaf id M21757 condition browse leaf name Hallux Limitus condition browse leaf as found Hallux Rigidus condition browse leaf relevance high condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M12 condition browse leaf name Congenital Abnormalities condition browse leaf relevance low condition browse leaf id M7806 condition browse leaf name Foot Deformities condition browse leaf relevance low condition browse leaf id M7808 condition browse leaf name Foot Deformities, Congenital condition browse leaf relevance low condition browse leaf id M7807 condition browse leaf name Foot Deformities, Acquired condition browse leaf relevance low condition browse leaf id M19681 condition browse leaf name Foot Injuries condition browse leaf relevance low condition browse leaf id M10033 condition browse leaf name Leg Injuries condition browse leaf relevance low condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth intervention browse module intervention mesh list intervention mesh intervention mesh id D000077482 intervention mesh term Carbon Fiber intervention ancestor list intervention ancestor intervention ancestor id D000000891 intervention ancestor term Anti-Infective Agents, Local intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M1808 intervention browse leaf name Carbon Fiber intervention browse leaf as found Benzocaine intervention browse leaf relevance high intervention browse leaf id M3367 intervention 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NCT04833608
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full study rank 61862 study protocol section identification module n c t id NCT04830956 org study id info org study id DEJ475-E004 organization org full name Alcon Research org class INDUSTRY brief title Evaluation of Comfort in Subjects With Moderate Dry Eye Disease official title Evaluation of Comfort in Subjects With Moderate Dry Eye Disease status module status verified date November 2021 overall status Completed expanded access info has expanded access No start date struct start date June 30, 2021 start date type Actual primary completion date struct primary completion date November 10, 2021 primary completion date type Actual completion date struct completion date November 10, 2021 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date November 15, 2021 last update post date struct last update post date November 16, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Alcon Research lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export Yes description module brief summary The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia. conditions module condition list condition Dry Eye keyword list keyword Dry eye design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 40 enrollment type Actual arms interventions module arm group list arm group arm group label Sequence 1 arm group type Experimental arm group description FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. arm group intervention list arm group intervention name Other: FID123238 Other: Systane Hydration arm group label Sequence 2 arm group type Experimental arm group description FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. arm group intervention list arm group intervention name Other: FID123238 Other: Systane Hydration arm group label Sequence 3 arm group type Experimental arm group description FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. arm group intervention list arm group intervention name Other: FID123238 Other: Systane Hydration arm group label Sequence 4 arm group type Experimental arm group description FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. arm group intervention list arm group intervention name Other: FID123238 Other: Systane Hydration arm group label Sequence 5 arm group type Experimental arm group description FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. arm group intervention list arm group intervention name Other: FID123238 Other: Systane Hydration intervention list intervention intervention type Other intervention name FID123238 intervention description Lubricant applied to the ocular surface intervention arm group label list intervention arm group label Sequence 1 Sequence 2 Sequence 3 Sequence 4 Sequence 5 intervention type Other intervention name Systane Hydration intervention description Drops applied to the ocular surface intervention arm group label list intervention arm group label Sequence 1 Sequence 2 Sequence 3 Sequence 4 Sequence 5 outcomes module primary outcome list primary outcome primary outcome measure Change from baseline in comfort rating primary outcome description A visual analogue scale will be used primary outcome time frame Baseline, up to 12 Hours (Day 1, each product) eligibility module eligibility criteria Key Inclusion Criteria: Able to understand and sign an information consent letter Willing and able to follow instructions and maintain the appointment schedule Has dry eye symptoms Key Exclusion Criteria: Has suffered any ocular injury to either eye in the past 12 weeks Is pregnant or lactating at the time of enrollment Other protocol-specified inclusion/exclusion criteria may apply. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Clinical Trial Lead, Dry Eye overall official affiliation Alcon Research, LLC overall official role Study Director location list location location facility Alcon Investigator 8169 location city Carlton location state Victoria location zip 3053 location country Australia derived section misc info module version holder December 02, 2022 removed country list removed country United States condition browse module condition mesh list condition mesh condition mesh id D000015352 condition mesh term Dry Eye Syndromes condition mesh id D000007638 condition mesh term Keratoconjunctivitis Sicca condition mesh id D000005128 condition mesh term Eye Diseases condition ancestor list condition ancestor condition ancestor id D000007766 condition ancestor term Lacrimal Apparatus Diseases condition ancestor id D000007637 condition ancestor term Keratoconjunctivitis condition ancestor id D000003231 condition ancestor term Conjunctivitis condition ancestor id D000003229 condition ancestor term Conjunctival Diseases condition ancestor id D000007634 condition ancestor term Keratitis condition ancestor id D000003316 condition ancestor term Corneal Diseases condition browse leaf list condition browse leaf condition browse leaf id M17192 condition browse leaf name Dry Eye Syndromes condition browse leaf as found Dry Eye condition browse leaf relevance high condition browse leaf id M9816 condition browse leaf name Keratoconjunctivitis Sicca condition browse leaf as found Dry Eye condition browse leaf relevance high condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf as found Eye Disease condition browse leaf relevance high condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M9815 condition browse leaf name Keratoconjunctivitis condition browse leaf relevance low condition browse leaf id M9938 condition browse leaf name Lacrimal Apparatus Diseases condition browse leaf relevance low condition browse leaf id M5607 condition browse leaf name Conjunctivitis condition browse leaf relevance low condition browse leaf id M5605 condition browse leaf name Conjunctival Diseases condition browse leaf relevance low condition browse leaf id M9812 condition browse leaf name Keratitis condition browse leaf relevance low condition browse leaf id M5691 condition browse leaf name Corneal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04830956
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full study rank 61492 study protocol section identification module n c t id NCT04835766 org study id info org study id Uro-PAS organization org full name Tanta University org class OTHER brief title Urodynamic Changes Following Bladder Injury official title Urodynamic Changes Following Bladder Injury During Surgical Management of Placenta Accreta Spectrum: A Multicenter Study acronym Uro-PAS status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 1, 2021 start date type Actual primary completion date struct primary completion date July 31, 2023 primary completion date type Anticipated completion date struct completion date July 31, 2023 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 18, 2022 last update post date struct last update post date October 20, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ayman S Dawood, MD responsible party investigator title Assistant professor responsible party investigator affiliation Tanta University lead sponsor lead sponsor name Tanta University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study is a unique one as it si done for first time to all patients following bladder injury in PAS surgery. Bladder function will be assessed by urodynamic study. detailed description Patients will be initially assessed by overactive bladder (OAB) and incontinence questionnaire. Examination was done to determine any neurological, or congenital abnormalities. Urodynamic study (UDS) will done for all patients. The patients will be asked to drink fluids to obtain a comfortably full bladder. Initially, a pelvic-abdominal ultrasound was done followed by the UDS. Urodynamic study consisted of uroflowmetry (volume: ≥150 ml and Qmax: 20-30 ml/s); filling cystometry in physiological or medium filling rate of 40 ml/min (using normal saline at room temperature through a double lumen urethral catheter); stress leak test; and pressure flow study. No sedation will be administered during the study as the patient should be aware. The patients were placed in a semi-seated lithotomy position. After a detailed explanation to the patient, the examination will begin by passing a catheter into the bladder (5 Fr) to measure the postvoiding residual urine followed by filling the bladder and measuring the intravesical pressure through the catheter. A rectal catheter was placed for measuring the abdominal pressure. The systems will be always zeroed at the atmospheric pressure. The patients will be periodically asked to cough to check the operation of the equipment and instructed to report her sensations. The volume of the first sensation of filling, first desire (1 s) and second desire (2 s) were recorded. When the bladder was filled up to 150 ml, patients were asked to cough (Valsalva) to predict the stress leakage. If not occur at 150 ml, the bladder was refilled, and the stress test was repeated until the leakage occurred or the bladder capacity was reached. Additionally, any unidentified involuntary detrusor contractions will be noted. When the patient had the urge to void, the permission for voiding will be given. Then voiding cystometrogram (pressure-flow) was performed and the urodynamic parameters, such as maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax) will be observed. conditions module condition list condition Urologic Injuries Urodynamic Changes Bladder Dysfunction design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 120 enrollment type Anticipated arms interventions module arm group list arm group arm group label Symptomatic group arm group description These patients had bladder injury during PAS surgery and had Lower urinary tract symptoms arm group intervention list arm group intervention name Diagnostic Test: Urodynamic study arm group label Asymptomatic group arm group description These patients had bladder injury during PAS surgery and had no Lower urinary tract symptoms arm group intervention list arm group intervention name Diagnostic Test: Urodynamic study intervention list intervention intervention type Diagnostic Test intervention name Urodynamic study intervention description Uroflowmetry, voiding cystometrogram, maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax). intervention arm group label list intervention arm group label Asymptomatic group Symptomatic group outcomes module primary outcome list primary outcome primary outcome measure Bladder dysfunction primary outcome description Uroflowmerty measuring the flow of urine in ml per minute primary outcome time frame 6 months primary outcome measure Residual urine volume primary outcome description Assessed by ultrasound to measure volume of residual urine primary outcome time frame 6 months primary outcome measure maximum flow rate primary outcome description Urodynamic study primary outcome time frame 6 months primary outcome measure Detrusor pressure at maximum flow primary outcome description Urodynamic study primary outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria: Age 20-40 years Placenta accreta managed either by cesarean hysterectomy or by uterine sparing conservative treatment Bladder injury was diagnosed and repaired during surgery 6 months ago. Exclusion Criteria: Patients with neurological problems Presence of congenital urinary system anomalies Urinary tract infections (UTIs) Previous urologic surgeries Patients with stone bladder or tumour Diabetic patients gender Female minimum age 20 Years maximum age 40 Years std age list std age Adult study population This study is multi-center descriptive cohort study. This study will be conducted at Urology departments. Cases were recruited from both Obstetrics and gynecology and Urology departments of Al-Azhar University and Tanta University. All cases had past history of bladder injury during PAS surgery either by hysterectomy or uterine sparing techniques. sampling method Probability Sample contacts locations module central contact list central contact central contact name Ayman Dawoog, MD central contact role Contact central contact phone +202020972067 central contact e mail [email protected] central contact name Ayman Dawood, MD central contact role Contact central contact phone +201020972067 central contact e mail [email protected] location list location location facility Ayman Shehata Dawood location status Recruiting location city Tanta location state Algharbia location zip 31111 location country Egypt location contact list location contact location contact name Salah Zeidan, MD location contact role Contact location contact phone +201020972067 location contact e mail [email protected] location contact name Ayman Dawood, MD location contact role Contact location contact phone +201020972067 location contact e mail [email protected] i p d sharing statement module i p d sharing Yes i p d sharing description On request i p d sharing info type list i p d sharing info type Study Protocol i p d sharing time frame 3 months derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000014947 condition mesh term Wounds and Injuries condition browse leaf list condition browse leaf condition browse leaf id M12963 condition browse leaf name Placenta Accreta condition browse leaf relevance low condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf as found Injury condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries
NCT04835766
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full study rank 61240 study protocol section identification module n c t id NCT04839042 org study id info org study id SC-Ad6-1-002 organization org full name Tetherex Pharmaceuticals Corporation org class INDUSTRY brief title A Phase 1, First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers official title A Phase 1, First-In-Human, Open-label, Single Ascending Dose and Multidose Study to Assess the Safety, Reactogenicity, and Immunogenicity of the Adenovirus Vector SARS-CoV-2 Investigational Product SC-Ad6-1 Given Via Intramuscular or Intranasal Administration in Healthy Volunteers status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 28, 2021 start date type Actual primary completion date struct primary completion date June 30, 2023 primary completion date type Anticipated completion date struct completion date June 30, 2023 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date October 18, 2022 last update post date struct last update post date October 19, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Tetherex Pharmaceuticals Corporation lead sponsor class INDUSTRY oversight module is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary This is a single-centre, open-label, first-in-human, single ascending dose and multiple dose study to assess the safety, reactogenicity, and immunogenicity of the SC-Ad6-1 investigational product when administered via the intramuscular (IM) or intranasal (IN) route in healthy volunteers. conditions module condition list condition Covid19 design module study type Interventional phase list phase Phase 1 design info design allocation Non-Randomized design intervention model Sequential Assignment design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 130 enrollment type Anticipated arms interventions module arm group list arm group arm group label SC-Ad6-1 Low Dose Intramuscular arm group type Experimental arm group description Low Dose SC-Ad6-1, I.M., single-dose (Day 1) arm group intervention list arm group intervention name Biological: SC-Ad6-1 arm group label SC-Ad6-1 Medium Dose Intramuscular arm group type Experimental arm group description Medium Dose SC-Ad6-1, I.M., single-dose (Day 1) arm group intervention list arm group intervention name Biological: SC-Ad6-1 arm group label SC-Ad6-1 High Dose #1 Intramuscular arm group type Experimental arm group description High Dose #1 SC-Ad6-1, I.M., single-dose (Day 1) arm group intervention list arm group intervention name Biological: SC-Ad6-1 arm group label SC-Ad6-1 High Dose #2 Intramuscular arm group type Experimental arm group description High Dose #2 SC-Ad6-1, I.M., single-dose (Day 1) arm group intervention list arm group intervention name Biological: SC-Ad6-1 arm group label SC-Ad6-1 Multiple Dose Intramuscular arm group type Experimental arm group description Multiple Dose SC-Ad6-1, I.M., multiple-dose (Day 1 and Day 22) arm group intervention list arm group intervention name Biological: SC-Ad6-1 arm group label SC-Ad6-1 High Dose #3 Intramuscular Booster arm group type Experimental arm group description High Dose #3 SC-Ad6-1, I.M., single-dose booster (Day 1) arm group intervention list arm group intervention name Biological: SC-Ad6-1 arm group label SC-Ad6-1 Low Dose Intranasal arm group type Experimental arm group description Low Dose SC-Ad6-1, I.N., single-dose (Day 1) arm group intervention list arm group intervention name Biological: SC-Ad6-1 arm group label SC-Ad6-1 Medium Dose Intranasal arm group type Experimental arm group description Medium Dose SC-Ad6-1, I.N., single-dose (Day 1) arm group intervention list arm group intervention name Biological: SC-Ad6-1 arm group label SC-Ad6-1 High Dose #1 Intranasal arm group type Experimental arm group description High Dose #1 SC-Ad6-1, I.N., single-dose (Day 1) arm group intervention list arm group intervention name Biological: SC-Ad6-1 arm group label SC-Ad6-1 High Dose #2 Intranasal arm group type Experimental arm group description High Dose #2 SC-Ad6-1, I.N., single-dose (Day 1) arm group intervention list arm group intervention name Biological: SC-Ad6-1 arm group label SC-Ad6-1 Multiple Dose Intranasal arm group type Experimental arm group description Multiple Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 22) arm group intervention list arm group intervention name Biological: SC-Ad6-1 arm group label SC-Ad6-1 High Dose #3 Intranasal Booster arm group type Experimental arm group description High Dose #3 SC-Ad6-1, I.N., single-dose booster (Day 1) arm group intervention list arm group intervention name Biological: SC-Ad6-1 arm group label SC-Ad6-1 High Dose #4 Intranasal Booster arm group type Experimental arm group description High Dose #4 SC-Ad6-1, I.N., single-dose booster (Day 1) arm group intervention list arm group intervention name Biological: SC-Ad6-1 intervention list intervention intervention type Biological intervention name SC-Ad6-1 intervention description SC-Ad6-1, I.M., single or multiple-dose intervention arm group label list intervention arm group label SC-Ad6-1 High Dose #1 Intramuscular SC-Ad6-1 High Dose #2 Intramuscular SC-Ad6-1 High Dose #3 Intramuscular Booster SC-Ad6-1 Low Dose Intramuscular SC-Ad6-1 Medium Dose Intramuscular SC-Ad6-1 Multiple Dose Intramuscular intervention type Biological intervention name SC-Ad6-1 intervention description SC-Ad6-1, I.N., single or multiple-dose intervention arm group label list intervention arm group label SC-Ad6-1 High Dose #1 Intranasal SC-Ad6-1 High Dose #2 Intranasal SC-Ad6-1 High Dose #3 Intranasal Booster SC-Ad6-1 High Dose #4 Intranasal Booster SC-Ad6-1 Low Dose Intranasal SC-Ad6-1 Medium Dose Intranasal SC-Ad6-1 Multiple Dose Intranasal outcomes module primary outcome list primary outcome primary outcome measure Number of participants with solicited local and systemic adverse events for 7 days Following Each Dose primary outcome description Solicited local adverse events are defined as pain, redness and swelling at the site of dose administration for the intramuscular arms and are defined as stuffy nose, runny nose, nasal discomfort, loss of smell, sore or scratchy throat for the intranasal arms. Solicited systemic adverse events for both routes of administration are defined as fever, headache, muscle pain, joint pain, fatigue, nausea or vomiting, and chills. primary outcome time frame 7 days following each dose primary outcome measure Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons primary outcome time frame Up to 106 days following first dose primary outcome measure Humoral response to SARS-CoV-2 as measured by neutralizing antibodies using wild-type virus assay primary outcome time frame Up to 106 days following first dose secondary outcome list secondary outcome secondary outcome measure Humoral response to SARS-CoV-2 as measured by serum IgG and IgA antibodies to the SARS-CoV-2 spike protein (ELISA) secondary outcome time frame Up to 106 days following first dose secondary outcome measure Humoral response to SARS-CoV-2 as measured by mucosal IgA antibodies to the SARS-CoV-2 spike protein (ELISA) and total mucosal IgA secondary outcome time frame Up to 106 days following first dose secondary outcome measure Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot) secondary outcome time frame Up to 106 days following first dose secondary outcome measure Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA)) secondary outcome time frame Up to 106 days following first dose eligibility module eligibility criteria Key Inclusion Criteria: Adult males and females, 18 to 60 years of age (inclusive) Body mass index ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight ≥ 50 kg at screening Must have been fully vaccinated against COVID-19 and received last dose not less than 3 months prior to Day 1 (High Dose #3 I.M. and I.N. booster arms only) and not less than 5 months prior to Day 1 (High Dose #4 I.N. booster arm only) Key Exclusion Criteria: History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease History of chronic respiratory disorders including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent (≤14 days prior to Screening) or ongoing respiratory tract infection History of thrombosis (e.g., deep vein thrombosis, pulmonary embolism, etc.), any coagulation dysregulation disorder, or a history of thrombosis noted in immediate family members History of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood Known previous infection with SARS-CoV-2 or presence of antibodies against SARS-CoV-2 or a positive SARS-CoV-2 PCR test (non-booster arms only) Any history of malignant disease ≤5 years prior to registration History of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 60 Years std age list std age Adult contacts locations module central contact list central contact central contact name Russell Rother, Ph.D. central contact role Contact central contact phone 855-222-0722 central contact e mail [email protected] overall official list overall official overall official name Russell Rother, Ph.D. overall official affiliation Tetherex Pharmaceuticals Corporation overall official role Study Director location list location location facility Tetherex Study Site location status Recruiting location city Brisbane location state Queensland location country Australia derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M2762 condition browse leaf name Adenoviridae Infections condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id C000025945 intervention mesh term Cloricromen intervention ancestor list intervention ancestor intervention ancestor id D000010975 intervention ancestor term Platelet Aggregation Inhibitors intervention browse leaf list intervention browse leaf intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse leaf id M229456 intervention browse leaf name Cloricromen intervention browse leaf as found ng/dL intervention browse leaf relevance high intervention browse leaf id M13017 intervention browse leaf name Platelet Aggregation Inhibitors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev PlAggInh intervention browse branch name Platelet Aggregation Inhibitors
NCT04839042
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full study rank 61226 study protocol section identification module n c t id NCT04839224 org study id info org study id 4-2020-1491 organization org full name Yonsei University org class OTHER brief title Comparing Between CO2 and Phenylephrine Treatment in Patients With Progressive Lacunar Infarction (CARBOGEN Study) official title Comparing Between CO2 and Phenylephrine Treatment in Patients With Progressive Lacunar Infarction (CARBOGEN Study) status module status verified date May 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 5, 2021 start date type Actual primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date March 2023 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date May 17, 2021 last update post date struct last update post date May 20, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Yonsei University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Lacunar infarction is an ischemic stroke occurred by small perforating artery occlusion . Twenty percent of ischemic stroke is lacunar infarction. However, outcome of lacunar infarction is excellent, about 20-40% patients are suffered neurological worsening. Progressive lacunar infarction is associated poor functional outcome and neurological deficit. Currently, no treatment for progressive lacunar infarction is recommended on the guideline. Several small study reported that phenylephrine and magnesium may be helpful for progressive lacunar infarction. Carbogen is a mixture of 5% CO2 with 95% O2. Carbogen is safe and it is used for the treatment of sudden sensory neural hearing loss or ocular ischemia. CO2 dilate cerebral arteriole and concentration of CO2 is correlated with cerebral blood flow. Lacunar infarction is small and perfused with marginal flow by neighboring perforating arteriole. Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressive lacunar infarction. Induced hypertension is alternative treatment of progressive lacunar infarction. Increasing blood pressure also induce cerebral blood flow. Phenylephrine is an α1 agonist, phenylephrine act on peripheral artery and little effect on cerebral artery or heart. Several studies reported that the effectiveness of phenylephrine on progressing stroke. Therefore, this study will compare the effectiveness of carbogen versus phenylephrine in lacunar infarction patients who suffered neurological worsening. conditions module condition list condition Acute Ischemic Stroke keyword list keyword CO2 carbogen phenylephrine lacunar infarction progressive stroke design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description The study is a single center, prospective, randomized, open-label trial with blinded end-point assessment (PROBE) design study. For the patients with neurological worsening after lacunar infarction, the carbogen group and the phenylephrine group will be randomized by 1: 1. Patients will be enrolled from April 2021 to December 2022 (based on the date of stroke). We will collect medical history, laboratory findings, neurological scores, and functional recovery. Functional recovery scores are performed by independent researchers in the blind state. All data is collected using e-CRF, and the image study will be anonymized and sent to the central adjudication. Central adjudication will review the image study. design primary purpose Treatment design masking info design masking Single design masking description Three months after discharge, the independence assessment will be performed by the researcher who don't know the patients group. design who masked list design who masked Outcomes Assessor enrollment info enrollment count 40 enrollment type Anticipated arms interventions module arm group list arm group arm group label Carbogen group arm group type Experimental arm group intervention list arm group intervention name Drug: carbogen arm group label Phenylephrine group arm group type Active Comparator arm group intervention list arm group intervention name Drug: phenylephrine intervention list intervention intervention type Drug intervention name carbogen intervention description Patients will inhale carbogen gas for 10 minutes and rest for 50 minutes. intervention arm group label list intervention arm group label Carbogen group intervention type Drug intervention name phenylephrine intervention description Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg. intervention arm group label list intervention arm group label Phenylephrine group outcomes module primary outcome list primary outcome primary outcome measure percent improvement of NIHSS score in each group primary outcome description (baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100 primary outcome time frame 48 hours primary outcome measure difference of NIHSS score in each group primary outcome description baseline NIHSS score-post-treatment NIHSS score primary outcome time frame 48 hours primary outcome measure percent improvement of MRC score in each group primary outcome description (baseline MRC score-post-treatment MRC score)/baseline MRC score×100 primary outcome time frame within 48 hours primary outcome measure difference of MRC score in each group primary outcome description baseline MRC score-post-treatment MRC score primary outcome time frame within 48 hours primary outcome measure Safety outcome: Side effect primary outcome description Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc) primary outcome time frame within 7 days primary outcome measure Safety outcome: discontinuing patients primary outcome description Number of discontinuing patients due to side effects primary outcome time frame within 7 days secondary outcome list secondary outcome secondary outcome measure Comparison between groups by percent improvement of NIHSS score secondary outcome description (baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100 secondary outcome time frame 48 hours secondary outcome measure Comparison between groups by difference of NIHSS score secondary outcome description baseline NIHSS score-post-treatment NIHSS score secondary outcome time frame 48 hours secondary outcome measure Comparison between groups by percent improvement in MRC score secondary outcome description (baseline MRC score-post-treatment MRC score)/baseline MRC score×100 secondary outcome time frame within 48 hours secondary outcome measure Comparison between groups by difference of MRC score secondary outcome description baseline MRC score-post-treatment MRC score secondary outcome time frame within 48 hours secondary outcome measure Functional independence secondary outcome description modified Rankin score 0 to 2 secondary outcome time frame upon discharge, 3 months after onset eligibility module eligibility criteria Inclusion Criteria: Age ≥20 years Anterior circulation progressive lacunar infarction. Neurological worsening either 1 point in NIHSS score or MRC grade Exclusion Criteria: Age <20 Cortical infarction Posterior circulation lacunar infarction Relevant artery stenosis more than 50% or occlusion Moyamoya disease Difficulty in inhalation of Carbogen (panic, severe anxiety disorder) Drug allergy for phenylephrine Persistent bradycardia (pulse rate < 50 /min) History of hemorrhagic stroke Pre-stroke mRS ≥2 healthy volunteers No gender All minimum age 20 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Hyo Suk Nam, MD, PhD central contact role Contact central contact phone 82-2-2228-1617 central contact e mail [email protected] overall official list overall official overall official name Hyo Suk Nam, MD, PhD overall official affiliation Department of Neurology, Yonsei University College of Medicine overall official role Principal Investigator location list location location facility Yonsei University Health System, Severance Hospital location status Recruiting location city Seoul location country Korea, Republic of location contact list location contact location contact name Hyo Suk Nam, MD, PhD location contact role Contact location contact phone 82-2-2228-1617 location contact e mail [email protected] i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000083242 condition mesh term Ischemic Stroke condition mesh id D000059409 condition mesh term Stroke, Lacunar condition mesh id D000007238 condition mesh term Infarction condition ancestor list condition ancestor condition ancestor id D000020521 condition ancestor term Stroke condition ancestor id D000002561 condition ancestor term Cerebrovascular Disorders condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000007511 condition ancestor term Ischemia condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000009336 condition ancestor term Necrosis condition ancestor id D000059345 condition ancestor term Cerebral Small Vessel Diseases condition ancestor id D000083244 condition ancestor term Thrombotic Stroke condition ancestor id D000020520 condition ancestor term Brain Infarction condition browse leaf list condition browse leaf condition browse leaf id M9695 condition browse leaf name Ischemia condition browse leaf relevance low condition browse leaf id M21459 condition browse leaf name Stroke condition browse leaf relevance low condition browse leaf id M2401 condition browse leaf name Ischemic Stroke condition browse leaf as found Acute Ischemic Stroke condition browse leaf relevance high condition browse leaf id M9434 condition browse leaf name Infarction condition browse leaf as found Infarction condition browse leaf relevance high condition browse leaf id M28616 condition browse leaf name Stroke, Lacunar condition browse leaf as found Lacunar Infarction condition browse leaf relevance high condition browse leaf id M4962 condition browse leaf name Cerebrovascular Disorders condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M11436 condition browse leaf name Necrosis condition browse leaf relevance low condition browse leaf id M28590 condition browse leaf name Cerebral Small Vessel Diseases condition browse leaf relevance low condition browse leaf id M2402 condition browse leaf name Thrombotic Stroke condition browse leaf relevance low condition browse leaf id M21458 condition browse leaf name Brain Infarction condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000010656 intervention mesh term Phenylephrine intervention mesh id D000010109 intervention mesh term Oxymetazoline intervention ancestor list intervention ancestor intervention ancestor id D000002316 intervention ancestor term Cardiotonic Agents intervention ancestor id D000009184 intervention ancestor term Mydriatics intervention ancestor id D000001337 intervention ancestor term Autonomic Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000013566 intervention ancestor term Sympathomimetics intervention ancestor id D000014662 intervention ancestor term Vasoconstrictor Agents intervention ancestor id D000014663 intervention ancestor term Nasal Decongestants intervention ancestor id D000019141 intervention ancestor term Respiratory System Agents intervention ancestor id D000058646 intervention ancestor term Adrenergic alpha-1 Receptor Agonists intervention ancestor id D000000316 intervention ancestor term Adrenergic alpha-Agonists intervention ancestor id D000000322 intervention ancestor term Adrenergic Agonists intervention ancestor id D000018663 intervention ancestor term Adrenergic Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000020011 intervention ancestor term Protective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M12183 intervention browse leaf name Oxymetazoline intervention browse leaf as found Migraine intervention browse leaf relevance high intervention browse leaf id M12713 intervention browse leaf name Phenylephrine intervention browse leaf as found Migraine intervention browse leaf relevance high intervention browse leaf id M4724 intervention browse leaf name Cardiotonic Agents intervention browse leaf relevance low intervention browse leaf id M11291 intervention browse leaf name Mydriatics intervention browse leaf relevance low intervention browse leaf id M15497 intervention browse leaf name Sympathomimetics intervention browse leaf relevance low intervention browse leaf id M16561 intervention browse leaf name Vasoconstrictor Agents intervention browse leaf relevance low intervention browse leaf id M7118 intervention browse leaf name Ephedrine intervention browse leaf relevance low intervention browse leaf id M26739 intervention browse leaf name Pseudoephedrine intervention browse leaf relevance low intervention browse leaf id M16562 intervention browse leaf name Nasal Decongestants intervention browse leaf relevance low intervention browse leaf id M20290 intervention browse leaf name Respiratory System Agents intervention browse leaf relevance low intervention browse leaf id M19899 intervention browse leaf name Adrenergic Agents intervention browse leaf relevance low intervention browse leaf id M2820 intervention browse leaf name Adrenergic alpha-Agonists intervention browse leaf relevance low intervention browse leaf id M2825 intervention browse leaf name Adrenergic Agonists intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse leaf id M21022 intervention browse leaf name Protective Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev VaCoAg intervention browse branch name Vasoconstrictor Agents intervention browse branch abbrev Resp intervention browse branch name Respiratory System Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev CaAg intervention browse branch name Cardiotonic Agents intervention browse branch abbrev CNSSti intervention browse branch name Central Nervous System Stimulants
NCT04839224
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full study rank 61359 study protocol section identification module n c t id NCT04837495 org study id info org study id IRB3200 organization org full name Assiut University org class OTHER brief title Stellate Ganglion Block in Control of Arrhythmia in Laparoscopic Cholecystectomy official title Stellate Ganglion Block Efficacy in Control of Arrhythmia and Cardiovascular Changes in Addition to, Postoperative Analgesia in Laparoscopic Cholecystectomy status module status verified date October 2022 overall status Completed expanded access info has expanded access No start date struct start date April 30, 2021 start date type Actual primary completion date struct primary completion date July 25, 2022 primary completion date type Actual completion date struct completion date July 31, 2022 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 5, 2022 last update post date struct last update post date October 6, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Emad Zarief , MD responsible party investigator title professor responsible party investigator affiliation Assiut University lead sponsor lead sponsor name Assiut University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary During Laparoscopic cholecystectomy, carbon dioxide (CO2) pneumoperitoneal laparoscopic surgery, CO2-pneumoperitoneum activates the sympathoadrenomedullary system to increase the release of catecholamines such as epinephrine (E) norepinephrine (NE) and dopamine (DA). During stress, E and NE are secreted by the adrenal medulla into blood circulation to promote glycogenolysis to increase blood glucose, speed up lipolysis and accelerate heartbeats. Stellate g anglion block (SGB) reters to the blockade of sympathetic nerves including the large area covered by middle cervical, vertebral arterial. stellate ganglions and ther pre- and post- ganglions. SGB affects both peripheral and central nervous systems. In the peripheral system. the sympathetic pre- and post-ganglionic fibers in the innervated areas of stellate ganglion are affected. Therefore, the control of vascular dilatation and constriction, muscular movement, bronchial smooth muscle relaxation and contraction, and pain conduction, by sympathetic nerves is inhibited. In the central nervous system, the hypothalamus is mainly involved in the regulation of systemic autonomic nervous, immune and endocrine systems, and to maintain homeostasis. CO2-pneumoperitoneum causes severe stress-related homeostatic disorders including arrhythmia and blood pressure changes. This study will examine the effects of stellate ganglion block (SGB) on hemodynamics and stress response in patients undergoing CO-pneumoperitoneal surgery. detailed description Laparoscopic surgery is being increasingly recognized for its advantages of minimal invasiveness. mild postoperative pain, short length of hospitalization and rapid recovery and is widely used in general surgery, obstetrics. gynecology and urology. Laparoscopic cholecystectomy (LC) has become the gold standard for surgically treating benign diseases of the gallbladder. During carbon dioxide (CO2) pneumoperitoneal laparoscopic surgery, CO2-pneumoperitoneum activates the sympathoadrenomedullary system to increase the release of catecholamines such as epinephrine (E) norepinephrine (NE) and dopamine (DA). During stress, E and NE are secreted by the adrenal medulla into blood circulation to promote glycogenolysis to increase blood glucose, speed up lipolysis and accelerate heartbeats. Stellate g anglion block (SGB) reters to the blockade of sympathetic nerves including the large area covered by middle cervical, vertebral arterial. stellate ganglions and ther pre- and post- ganglions. SGB affects both peripheral and central nervous systems. In the peripheral system. the sympathetic pre- and post-ganglionic fibers in the innervated areas of stellate ganglion are affected. Therefore, the control of vascular dilatation and constriction, muscular movement, bronchial smooth muscle relaxation and contraction, and pain conduction, by sympathetic nerves is inhibited. In the central nervous system, the hypothalamus is mainly involved in the regulation of systemic autonomic nervous, immune and endocrine systems, and to maintain homeostasis. CO2-pneumoperitoneum causes severe stress-related homeostatic disorders including arrhythmia and blood pressure changes. This study will examine the effects of stellate ganglion block (SGB) on hemodynamics and stress response in patients undergoing CO-pneumoperitoneal surgery. conditions module condition list condition Arrythmia Pain, Acute keyword list keyword Arrythmia Acute pain design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 40 enrollment type Actual arms interventions module arm group list arm group arm group label Stellate Ganglion block group arm group type Active Comparator arm group description will include 20 patients: each one will receive 10 ml lidocaine 2% right stellate ganglion block (RSGB) under sonar guidance arm group intervention list arm group intervention name Procedure: right stellate ganglion block arm group label Control group arm group type No Intervention arm group description will include 20 patients: a control group intervention list intervention intervention type Procedure intervention name right stellate ganglion block intervention description The skin should be anaesthetised with lidocaine 2%. Using a lateral approach and in-plane imaging, a blunt regional anaesthesia needle should be advanced deep to the carotid sheath towards the longus colli muscle. Following careful aspiration, inject 10 ml lidocaine 2% that will result in expansion of the fascia of the longus colli. Confirmation of the SGB success can be detected by warming of left upper limb and left Horner's syndrome. intervention arm group label list intervention arm group label Stellate Ganglion block group outcomes module primary outcome list primary outcome primary outcome measure Arrhythmia primary outcome description the incidnese of Arrhythmia primary outcome time frame introperative period secondary outcome list secondary outcome secondary outcome measure Postoperative pain secondary outcome description Numeric Rating Scale and Visual Analog Scale will be used to evaluate post operative analgesia secondary outcome time frame 24 hours postoperatively eligibility module eligibility criteria Inclusion Criteria: Aged 18 -60 years american society of anesthesiologists status I-II Scheduled for elective laparoscopic cholecystectomy Exclusion Criteria: Patients with chronic renal dysfunction. Patients with hypo/hyper-thyroidism. Patients with diseases of the autonomic and central nervous systems. Patients with cardiopulmonary dysfunction. Patients with history of treatment with long-term oral tranquilizers. healthy volunteers No gender All minimum age 20 Years maximum age 60 Years std age list std age Adult contacts locations module location list location location facility Emad Zarief Kamel Said location city Assiut location zip 71111 location country Egypt i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001145 condition mesh term Arrhythmias, Cardiac condition mesh id D000059787 condition mesh term Acute Pain condition ancestor list condition ancestor condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M3605 condition browse leaf name Arrhythmias, Cardiac condition browse leaf as found Arrhythmia condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M28678 condition browse leaf name Acute Pain condition browse leaf as found Pain, Acute condition browse leaf relevance high condition browse leaf id M24756 condition browse leaf name Ganglion Cysts condition browse leaf relevance low condition browse leaf id M15510 condition browse leaf name Synovial Cyst condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M10166 intervention browse leaf name Lidocaine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev AnArAg intervention browse branch name Anti-Arrhythmia Agents intervention browse branch abbrev ChanBlk intervention browse branch name Channel Blockers
NCT04837495
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full study rank 61754 study protocol section identification module n c t id NCT04832360 org study id info org study id RCA241570A organization org full name University of Georgia org class OTHER brief title Testing Financial Incentive Interventions in Dyadic-Smoker Couples official title Testing Financial Incentive Interventions in Dyadic-Smoker Couples status module status verified date October 2022 overall status Completed expanded access info has expanded access No start date struct start date January 15, 2021 start date type Actual primary completion date struct primary completion date August 1, 2022 primary completion date type Actual completion date struct completion date August 1, 2022 completion date type Actual study first submit date January 8, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 31, 2022 last update post date struct last update post date November 2, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Michelle R Vandellen responsible party investigator title Associate Professor, Principal Investigator responsible party investigator affiliation University of Georgia lead sponsor lead sponsor name University of Georgia lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The proposed study investigates the feasibility and efficacy of FITs in dual-smoker couples [DSCs]. The core design is a three-group mixed repeated measures design, in which participants are randomized into one of three conditions (control [CTL], dyadic target [DT] FIT or single target [ST] FIT) and tracked across 3 months. The FIT involves monetary incentives for online psychoeducation completion and smoking abstinence at follow-up. detailed description The proposed study investigates the feasibility and efficacy of FITs in dual-smoker couples [DSCs]. The core design is a three-group mixed repeated measures design, in which participants are randomized into one of three conditions (control [CTL], dyadic target [DT] FIT or single target [ST] FIT) and tracked across 3 months. During this time, participants will complete a baseline session and a follow-up. Between these visits, all participants will have access to a voluntary brief cessation program (i.e., online psychoeducation created for this study using Beat the Pack materials and resources from NCI, NIH + Nicotine Replacement Therapy [NRT]). The FIT involves monetary incentives for online psychoeducation completion and smoking abstinence at follow-up. In the ST condition, one member of each couple (i.e., the target) will receive monetary incentives; in the DT condition, both members of the couple will receive monetary incentives. This design allows for preliminary consideration of FITs in DSCs and tests whether FITs for both members of the dyad synergistically enhances outcomes. conditions module condition list condition Nicotine Dependence design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Other design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 190 enrollment type Actual arms interventions module arm group list arm group arm group label Control (CTL) arm group type Experimental arm group description Participants do not receive financial incentive intervention arm group intervention list arm group intervention name Behavioral: Financial Incentives arm group label Single Target (ST) arm group type Experimental arm group description One member of each dyadic-smoking couple will receive financial incentive intervention arm group intervention list arm group intervention name Behavioral: Financial Incentives arm group label Dyadic Target (DT) arm group type Experimental arm group description Both members of each dyadic-smoking couple will receive financial incentive intervention arm group intervention list arm group intervention name Behavioral: Financial Incentives intervention list intervention intervention type Behavioral intervention name Financial Incentives intervention description Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking) intervention arm group label list intervention arm group label Control (CTL) Dyadic Target (DT) Single Target (ST) outcomes module primary outcome list primary outcome primary outcome measure Smoking Abstinence primary outcome description Percentage of participants who have quit smoking by the follow-up study cessation verified biochemically primary outcome time frame Follow-up study session 3 months post-baseline session primary outcome measure Feasibility of Financial Incentives Treatment in Dyadic-smoker couples as assessed by number of dyads retained in study primary outcome description Number of people who contact the study team; number of complete dyads prescreened; percentage of eligible dyads enrolled; percentage of enrolled dyads retained through follow-up; percentage enrolled participants who drop out due to study procedures/burden; subjective ratings of benefits and costs of participating in study primary outcome time frame Through study recruitment and study completion, an average of five months eligibility module eligibility criteria Inclusion Criteria: both members: age of 18+ smoke 5+ combustible cigarettes/day may not have participated in pilot study Exclusion Criteria: < 8th grade capacity to read/write in English hospitalization in recent 6 months current drug or alcohol use disorder psychotic symptoms medical exclusion for use of NRT healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Michelle R vanDellen, PhD overall official affiliation University of Georgia overall official role Principal Investigator location list location location facility University of Georgia location city Athens location state Georgia location zip 30602 location country United States i p d sharing statement module i p d sharing Yes i p d sharing description Data will be shared with other researchers who request it. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code i p d sharing time frame Undecided i p d sharing access criteria Researchers must make request for data and materials to the PI document section large document module large doc list large doc large doc type abbrev ICF large doc has protocol No large doc has s a p No large doc has i c f Yes large doc label Informed Consent Form large doc date November 11, 2020 large doc upload date 06/17/2022 12:21 large doc filename ICF_000.pdf derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000014029 condition mesh term Tobacco Use Disorder condition ancestor list condition ancestor condition ancestor id D000019966 condition ancestor term Substance-Related Disorders condition ancestor id D000064419 condition ancestor term Chemically-Induced Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M15937 condition browse leaf name Tobacco Use Disorder condition browse leaf as found Nicotine Dependence condition browse leaf relevance high condition browse leaf id M20990 condition browse leaf name Substance-Related Disorders condition browse leaf relevance low condition browse leaf id M29455 condition browse leaf name Chemically-Induced Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC25 condition browse branch name Substance Related Disorders condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions
NCT04832360
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full study rank 61914 study protocol section identification module n c t id NCT04830267 org study id info org study id Camresbrt organization org full name Chongqing University Cancer Hospital org class OTHER brief title The Efficacy of Camrelizumab Plus Stereotactic Body Radiotherapy in R/M HNSCC official title A Phase II Randomized Trial of Camrelizumab With Stereotactic Body Radiotherapy Versus Camrelizumab Alone in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma status module status verified date March 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 1, 2021 start date type Actual primary completion date struct primary completion date August 1, 2024 primary completion date type Anticipated completion date struct completion date August 1, 2026 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date March 31, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ying Wang responsible party investigator title Associate Director of Chongqing University Cancer Hospital responsible party investigator affiliation Chongqing University Cancer Hospital lead sponsor lead sponsor name Chongqing University Cancer Hospital lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Camrelizumab is an antibody targeting programmed death receptor 1 (PD-1) and its ligand programmed death-ligand 1 (PD- L1) that is designed to boost the immune system. It does this by allowing immune cells to fight the cancer. Camrelizumab has been approved by China's National Medical Products Administration (NMPA) for the treatment of esophageal cancer, liver cancer and lung cancer. It is currently under study for the treatment of head and neck squamous cell cancer. detailed description All eligible patients will be equally randomized between the 2 following treatment groups: Standard treatment group: Camrelizumab 200mg IV every 2 weeks. Experimental group: Stereotactic body radiotherapy 27Gy/3F and Camrelizumab 200mg IV every 2 weeks. conditions module condition list condition Head and Neck Squamous Cell Carcinoma keyword list keyword Camrelizumab Stereotactic body radiotherapy R/M head and neck squamous cell carcinoma Best overall response design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 70 enrollment type Anticipated arms interventions module arm group list arm group arm group label Camrelizumab alone arm group type Active Comparator arm group description Camrelizumab 200mg IV every 2 weeks arm group intervention list arm group intervention name Drug: Camrelizumab arm group label Stereotactic body radiotherapy plus Camrelizumab arm group type Experimental arm group description Stereotactic body radiotherapy 27Gy/3F and Camrelizumab 200mg IV every 2 weeks arm group intervention list arm group intervention name Drug: Camrelizumab Radiation: Stereotactic body radiotherapy intervention list intervention intervention type Drug intervention name Camrelizumab intervention description Camrelizumab 200mg IV starting day 1 and then every 2 weeks thereafter. Treatment with Camrelizumab will continue until progression or unacceptable toxicity. intervention arm group label list intervention arm group label Camrelizumab alone Stereotactic body radiotherapy plus Camrelizumab intervention other name list intervention other name Anti-PD-1 antibody intervention type Radiation intervention name Stereotactic body radiotherapy intervention description Image guided, stereotactic body radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Camrelizumab). intervention arm group label list intervention arm group label Stereotactic body radiotherapy plus Camrelizumab intervention other name list intervention other name SBRT outcomes module primary outcome list primary outcome primary outcome measure Best overall response (BOR) primary outcome description As determined by the investigator using RECIST 1.1 criteria between patients receiving Camrelizumab and stereotactic body radiotherapy and those receiving Camrelizumab alone. BOR rate is defined as the number of patients randomized to a given arm with a best overall response of complete response (CR) or partial response (PR) of non-irradiated lesions divided by the total number of patients randomized to the given arm. In order to ascertain this endpoint, efforts will be made so that patients will be followed for 96 weeks or until progression of disease (and treatment cessation), whichever comes first. At each time-point, subjects should have CT/MR of neck, chest, abdomen, and pelvis with contrast. primary outcome time frame Time Frame: 96 weeks eligibility module eligibility criteria Inclusion Criteria: Signed Written Informed Consent Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations. Target Population: Males and females ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Histologically confirmed metastatic or recurrent HNSCC, including nasopharynx WHO Type I-III histologies. Subjects must have at least two lesions: At least one lesion must be safely amenable to irradiation. This can be a lesion that was previously irradiated as long as prior radiation was at least 6 months prior to projected first fraction of SBRT and as long as reirradiation dose constraints are being met. A separate, not-to-be-irradiated lesion measurable by CT or MRI per RECIST 1.1 criteria. A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 5 unstained slides of tumor sample obtained via excisional, incisional, or core needle biopsy from a metastatic or loco-regionally recurrent lesion. If 3 unstained are unavailable from a metastatic or loco-regionally recurrent lesion, with permission of the PI, FFPE tumor tissue from the primary disease site at the time of original diagnosis is acceptable. For oropharynx or nasopharynx primary lesions, documentation of viral status is required (e.g. high risk HPV sub-type PCR, p16 IHC, HPV ISH, EBER, etc). Tests done on primary tumor specimens from date of initial diagnosis at outside institutions are sufficient to meet this criterion Prior palliative or curative radiotherapy must be completed at least 14 days prior to randomization. Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses >10mg/day prednisone or equivalent) must be discontinued at least 14 days prior to Camrelizumab administration. Screening laboratory values must meet the following criteria (using CTCAE v4.0) and should be obtained within 28 days prior to randomization: WBC ≥ 2 K/microliter Neutrophils ≥ 1.5 K/microliter Platelets ≥ 100 K/microliter Hemoglobin ≥ 9.0 g/deciliter Serum Creatinine ≤ 1.5 x ULN or creatinine clearance > 40ml/min using the Cockcroft-Gault formula. Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL AST/ALT ≤ 3 x ULN Total bilirubin <1.5 x ULN (except subjects with Gilbert Syndrome who can have total bilirubin <3.0 mg/deciliter). Subjects must have a resting baseline O2 saturation by pulse oximetry of >=92% at rest. Reproductive Status: Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 28 days prior to randomization. Women must not be breastfeeding Women of childbearing potential must agree to follow instructions for method(s) of contraception from time of enrollment for the duration of treatment with Camrelizumab plus 5 half- lives plus 30 days for a total of 23 weeks post treatment completion. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving Camrelizumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception. Azoospermic males and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements. However, they still must have a pregnancy test. Exclusion Criteria: Target Disease Exceptions: Active brain metastases (untreated brain metastases or growth on imaging as defined below) or leptomeningeal disease are not allowed. Subjects with brain metastases are eligible if these have been treated and there is no MRI (or CT if MRI contraindicated) evidence of progression for at least 8 weeks after treatment for these metastases is complete and within 28 days prior to first study treatment. Histologically confirmed non-squamous histologies are not allowed; an exception is made for WHO Type I-III nasopharynx histologies. Medical History and Concurrent Diseases: Any medical disorder that, in the opinion of the investigator, might increase the risk associated with study participation or interferes with the interpretation of study results. Prior active malignancy within the previous 3 years except for locally curable cancers such as basal or squamous skin cancer, superficial bladder, low risk prostate cancer, breast, or cervix cancer. If other prior malignancy was active within prior 3 years, enrollment requires approval of a principal investigator. Patients should be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration should be excluded. Inhaled or topical steroids and adrenal replacement doses >10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Physical and Laboratory Test Findings: Positive test for hepatitis B virus surface antigen or hepatitis C virus ribonucleic acid indicating acute or chronic infection. Known history of testing positive for HIV or known AIDS. Any grade 4 laboratory abnormalities. Allergies and Adverse Drug Reaction History of allergy to Camrelizumab components History of severe hypersensitivity reaction to any monoclonal antibody. Prohibited or Restricted Treatments: The following medications are prohibited during the study: Immunosuppressive agents (except to treat a drug-related adverse event). Systemic corticosteroids > 10 mg daily prednisone equivalent save for exclusion outlined in the below paragraphs. Any concurrent chemotherapy, hormonal therapy, immunotherapy, or investigational agents for treatment of cancer. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jiangdong Sui, Ph.D, M.D. central contact role Contact central contact phone 13594190011 central contact e mail [email protected] central contact name Ying Wang, Ph.D, M.D. central contact role Contact central contact phone 13996412826 central contact e mail [email protected] overall official list overall official overall official name Ying Wang, Ph.D, M.D. overall official affiliation Chongqing University Cancer Hospital overall official role Principal Investigator location list location location facility Chongqing University Cancer Hospital location status Recruiting location city Chongqing location state Chongqing location zip 400030 location country China location contact list location contact location contact name Jiangdong Sui, Ph.D, M. D. location contact role Contact location contact phone 13594910011 location contact e mail [email protected] location contact name Ying Wang, Ph.D, M. D. location contact role Contact location contact phone 13996412826 location contact e mail [email protected] location contact name Ying Wang, Ph.D, M. D. location contact role Principal Investigator location contact name Jiangdong Sui, Ph.D, M. D. location contact role Sub-Investigator references module reference list reference reference p m i d 30191365 reference type background reference citation McDermott DF, Shah R, Gupte-Singh K, Sabater J, Luo L, Botteman M, Rao S, Regan MM, Atkins M. Quality-adjusted survival of nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma: a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis. Qual Life Res. 2019 Jan;28(1):109-119. doi: 10.1007/s11136-018-1984-3. Epub 2018 Sep 6. reference p m i d 30110194 reference type background reference citation Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, Ott PA, Peltola K, Jaeger D, Evans J, de Braud F, Chau I, Harbison CT, Dorange C, Tschaika M, Le DT. CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer. J Clin Oncol. 2018 Oct 1;36(28):2836-2844. doi: 10.1200/JCO.2017.76.6212. Epub 2018 Aug 15. Erratum In: J Clin Oncol. 2019 Feb 10;37(5):443. reference p m i d 30213452 reference type background reference citation Fang W, Yang Y, Ma Y, Hong S, Lin L, He X, Xiong J, Li P, Zhao H, Huang Y, Zhang Y, Chen L, Zhou N, Zhao Y, Hou X, Yang Q, Zhang L. Camrelizumab (SHR-1210) alone or in combination with gemcitabine plus cisplatin for nasopharyngeal carcinoma: results from two single-arm, phase 1 trials. Lancet Oncol. 2018 Oct;19(10):1338-1350. doi: 10.1016/S1470-2045(18)30495-9. Epub 2018 Sep 10. reference p m i d 21300764 reference type background reference citation Burnette BC, Liang H, Lee Y, Chlewicki L, Khodarev NN, Weichselbaum RR, Fu YX, Auh SL. The efficacy of radiotherapy relies upon induction of type i interferon-dependent innate and adaptive immunity. Cancer Res. 2011 Apr 1;71(7):2488-96. doi: 10.1158/0008-5472.CAN-10-2820. Epub 2011 Feb 7. reference p m i d 23861514 reference type background reference citation Sharma A, Bode B, Studer G, Moch H, Okoniewski M, Knuth A, von Boehmer L, van den Broek M. Radiotherapy of human sarcoma promotes an intratumoral immune effector signature. Clin Cancer Res. 2013 Sep 1;19(17):4843-53. doi: 10.1158/1078-0432.CCR-13-0352. Epub 2013 Jul 16. reference p m i d 24382348 reference type background reference citation Deng L, Liang H, Burnette B, Beckett M, Darga T, Weichselbaum RR, Fu YX. Irradiation and anti-PD-L1 treatment synergistically promote antitumor immunity in mice. J Clin Invest. 2014 Feb;124(2):687-95. doi: 10.1172/JCI67313. Epub 2014 Jan 2. reference p m i d 22397654 reference type background reference citation Postow MA, Callahan MK, Barker CA, Yamada Y, Yuan J, Kitano S, Mu Z, Rasalan T, Adamow M, Ritter E, Sedrak C, Jungbluth AA, Chua R, Yang AS, Roman RA, Rosner S, Benson B, Allison JP, Lesokhin AM, Gnjatic S, Wolchok JD. Immunologic correlates of the abscopal effect in a patient with melanoma. N Engl J Med. 2012 Mar 8;366(10):925-31. doi: 10.1056/NEJMoa1112824. reference p m i d 24563870 reference type background reference citation Golden EB, Demaria S, Schiff PB, Chachoua A, Formenti SC. An abscopal response to radiation and ipilimumab in a patient with metastatic non-small cell lung cancer. Cancer Immunol Res. 2013 Dec;1(6):365-72. doi: 10.1158/2326-6066.CIR-13-0115. reference p m i d 24819861 reference type background reference citation Zandberg DP, Strome SE. The role of the PD-L1:PD-1 pathway in squamous cell carcinoma of the head and neck. Oral Oncol. 2014 Jul;50(7):627-32. doi: 10.1016/j.oraloncology.2014.04.003. Epub 2014 May 10. Review. reference p m i d 32822275 reference type background reference citation McBride S, Sherman E, Tsai CJ, Baxi S, Aghalar J, Eng J, Zhi WI, McFarland D, Michel LS, Young R, Lefkowitz R, Spielsinger D, Zhang Z, Flynn J, Dunn L, Ho A, Riaz N, Pfister D, Lee N. Randomized Phase II Trial of Nivolumab With Stereotactic Body Radiotherapy Versus Nivolumab Alone in Metastatic Head and Neck Squamous Cell Carcinoma. J Clin Oncol. 2021 Jan 1;39(1):30-37. doi: 10.1200/JCO.20.00290. Epub 2020 Aug 21. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000002294 condition mesh term Carcinoma, Squamous Cell condition mesh id D000077195 condition mesh term Squamous Cell Carcinoma of Head and Neck condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000018307 condition ancestor term Neoplasms, Squamous Cell condition ancestor id D000006258 condition ancestor term Head and Neck Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition browse leaf list condition browse leaf condition browse leaf id M14002 condition browse leaf name Recurrence condition browse leaf relevance low condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf as found Carcinoma condition browse leaf relevance high condition browse leaf id M4702 condition browse leaf name Carcinoma, Squamous Cell condition browse leaf as found Squamous Cell Carcinoma condition browse leaf relevance high condition browse leaf id M1689 condition browse leaf name Squamous Cell Carcinoma of Head and Neck condition browse leaf as found Head and Neck Squamous Cell Carcinoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M19604 condition browse leaf name Neoplasms, Squamous Cell condition browse leaf relevance low condition browse leaf id M8500 condition browse leaf name Head and Neck Neoplasms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04830267
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full study rank 61338 study protocol section identification module n c t id NCT04837768 org study id info org study id Progesterone in HRT FET cycles organization org full name Cairo University org class OTHER brief title Effect of Intramuscular Progesterone Supplementation on Clinical and Ongoing Pregnancy Rates in Patients With Low Serum Progesterone Levels on the Day of Embryo Transfer in Artificial Frozen Cycles official title Effect of Intramuscular Progesterone Supplementation on Clinical and Ongoing Pregnancy Rates in Patients With Low Serum Progesterone Levels on the Day of Embryo Transfer in Artificial Frozen Cycles status module status verified date March 2022 overall status Completed expanded access info has expanded access No start date struct start date July 27, 2021 start date type Actual primary completion date struct primary completion date March 1, 2022 primary completion date type Actual completion date struct completion date March 15, 2022 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date March 15, 2022 last update post date struct last update post date March 17, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Abdelfatah Mohamed Kamel Eldesouky responsible party investigator title Assistant Lecturer in the Department of Obstetrics and Gynecology responsible party investigator affiliation Cairo University lead sponsor lead sponsor name Cairo University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to investigate whether intramuscular progesterone supplementation will improve clinical pregnancy rates and ongoing pregnancy rates in patients with decreased serum progesterone levels on the day of embryo transfer in artificial frozen cycles. detailed description Cryopreservation of frozen-thawed embryos has become a cardinal procedure in assisted reproductive therapies. This can be attributed to the development of the vitrification process and the improvement of embryo survival rates after thawing, leading to the progressive increase in the use of frozen embryo transfer (FET). The need for FET has also increased greatly due to the implementation of a single embryo transfer policy in many areas of the world to reduce multiple pregnancies. This has led to an increase in surplus embryos derived from ovarian stimulation cycles. Moreover, although the 'freeze all' technique or elective embryo cryopreservation was mainly developed for patients with an increased risk of developing ovarian hyperstimulation syndrome, its use has now been extended to cover other indications, such as cycles involving pre-implantation genetic diagnosis, late-follicular progesterone elevation and embryo-endometrial asynchrony. Despite this increased need for FET, there still exists debate over the best method to implement the practice. The two most common used treatment regimens to prepare the endometrium for embryo transfer are the so-called natural cycle (NC) and the hormone replacement therapy (HRT) cycle. In a NC FET, there is no medical intervention apart from ultrasound monitoring during the proliferative phase, to schedule the transfer when the endometrium is synchronized to the developmental stage of the embryo. Although the advantage is the absence of estrogen supplementation, this protocol entails more frequent visits to the clinic and less cycle control. Despite this, there is still an ongoing debate whether frozen embryos transferred in a 'more physiologic' non-stimulated endometrium, may not only result in higher pregnancy rates, but also potentially decrease maternal and neonatal morbidity. On the other hand, in the HRT cycle, also referred to as an artificial cycle, exogenous administration of estrogens and progesterone is used to mimic a natural cycle and therefore endometrial development. Although originally developed to allow embryo transfers in recipients of donated oocytes, the HRT protocol has proven to be successful in the general population as well. The advantage of this protocol is the easy scheduling and minimal cycle monitoring. There are however, potential disadvantages associated with its widespread usage, including the increased expense and risks of estrogen supplementation such as thromboembolic events. Generally speaking, in HRT cycles, progesterone supplementation begins once the proliferation of the endometrium with the administration of estrogens is considered sufficient. Progesterone is initiated to promote the final phase of endometrial preparation prior to embryo transfer, however, there is little agreement on the ideal route or dose of progesterone supplementation itself. As regards the route of administration, when compared to intramuscular (IM) injections, patients seem to prefer the vaginal route owing to its quick, easy and painless administration. Despite this, there is limited data comparing IM versus vaginal progesterone administration, with some being in favour of the IM route and others showing no significant differences in terms of outcome. However, the more recent focus on intramuscular rather than the traditional transvaginal progesterone supplementation, stems from newer mounting evidence that transvaginal supplementation not only increases vaginal discharge, but also has a limited effect in increasing serum progesterone levels. Boynukalin et al., 2019 explored the idea of intramuscular progesterone supplementation in HRT FET cycles further, by substituting the traditional vaginal progesterone with 100mg of daily IM progesterone during endometrial preparation and thereafter till the 10th week of pregnancy. They found that the mean progesterone level on the day of ET was significantly higher in patients who later had an ongoing pregnancy (28 ng/ml) than those who did not have an ongoing pregnancy (16.4 ng/ml) with a p-value of 0.039. They did however conclude, that further investigation is needed for the individualization of intramuscular progesterone doses to reach optimal pregnancy rates. Thus, more attention has been given recently to measuring serum progesterone during HRT FET cycles. Kofinas et al., 2015 suggested that progesterone levels >20 ng/ml (possibly due to an escape ovulation and subsequent embryo-endometrial asynchrony) on the day of transfer have been associated with decreased ongoing pregnancy and live birth rates. On the other hand, Yovich, et al., 2015 proposed an optimal mid-luteal progesterone range between 22 and 31 ng/ml. Most recently, Labarta et al., 2017 investigated the relationship between serum progesterone levels on the day of embryo transfer (ET) and ongoing pregnancy rate (OPR). Their study recommended a minimum serum progesterone threshold (9.2 ng/ml) to optimize OPR in artificial cycles using transvaginal progesterone and this value could theoretically be used to decide if ET should be postponed or not. Extrapolating from this data, we intend to investigate whether intramuscular progesterone supplementation can help improve OPR rates in the aforementioned patients with decreased serum progesterone on the day of ET. In other words, we intend to investigate further the concept of individualizing luteal phase support in HRT FET cycles. conditions module condition list condition Serum Progesterone Levels Progesterone Supplementation Frozen Embryo Transfer Clinical Pregnancy Rates Ongoing Pregnancy Rates design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design intervention model description Patients undergoing frozen cycles following ICSI will receive artificial endometrial preparation from day 2/3 of their cycle in the form of 2mg Estradiol Valerate pills thrice daily for 7-10 days. After confirming endometrial thickness > 7mm via TVS, progesterone supplementation will start via Prontogest® 400mg vaginal pessaries twice daily for 5 days, ending with the day of embryo transfer (ET). On the morning of ET, serum progesterone will be measured and if the value is over 9.2ng/ml, only the traditional twice daily vaginal progesterone will be resumed until 12 weeks gestation. If the value is under 9.2 ng/ml, intramuscular progesterone supplementation with Prontogest® 100mg will be added in twice-weekly doses (every 3 days) to the vaginal supplementation. Quantitative β-hcg 2 weeks after ET to detect chemical pregnancies. Ultrasound 4 weeks after ET to detect clinical pregnancies. Ultrasound repeated at 12 weeks to confirm ongoing pregnancy rates. design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 354 enrollment type Actual arms interventions module arm group list arm group arm group label Serum Progesterone Levels >9.2 ng/ml arm group type Active Comparator arm group description These patients will receive only twice-daily vaginal progesterone supplementation following embryo transfer arm group intervention list arm group intervention name Drug: Twice-daily transvaginal progesterone supplementation arm group label Serum Progesterone Levels <9.2 ng/ml arm group type Active Comparator arm group description These patients will receive twice-weekly intramuscular progesterone supplementation in addition to the twice-daily vaginal supplementation following embryo transfer arm group intervention list arm group intervention name Drug: Twice-weekly intramuscular + Twice-daily transvaginal progesterone supplementation intervention list intervention intervention type Drug intervention name Twice-daily transvaginal progesterone supplementation intervention description Patients with serum progesterone levels >9.2 ng/ml on the day of embryo transfer in artificial frozen cycles will receive the traditional twice-daily vaginal progesterone supplementation till 12 weeks gestation. intervention arm group label list intervention arm group label Serum Progesterone Levels >9.2 ng/ml intervention type Drug intervention name Twice-weekly intramuscular + Twice-daily transvaginal progesterone supplementation intervention description Patients with serum progesterone levels <9.2 ng/ml on the day of embryo transfer in artificial frozen cycles will receive the twice-daily vaginal progesterone in addition to twice-weekly intramuscular progesterone supplementation till 12 weeks gestation. intervention arm group label list intervention arm group label Serum Progesterone Levels <9.2 ng/ml outcomes module primary outcome list primary outcome primary outcome measure Clinical pregnancy rates primary outcome description Detected via ultrasound primary outcome time frame 4 weeks after the day of embryo transfer secondary outcome list secondary outcome secondary outcome measure Ongoing pregnancy rates secondary outcome description Detected via ultrasound secondary outcome time frame 12 weeks after the day of embryo transfer eligibility module eligibility criteria Inclusion Criteria: Age range 20-40 years BMI < 40 kg/m2 Endometrial thickness >7mm Double embryo transfer (Day 5), Grade 1 or 2. Exclusion Criteria: Autoimmune diseases Uncontrolled medical conditions Recurrent implantation failure Anatomical uterine abnormalities as polyps, fibroids or Müllerian anomalies. healthy volunteers No gender Female minimum age 20 Years maximum age 40 Years std age list std age Adult contacts locations module location list location location facility Cairo University, Faculty of Medicine, Department of Obstetrics and Gynecology location city Cairo location zip 11956 location country Egypt location facility AlBoshra IVF & Infertility Treatment Centre location city Cairo location zip 12611 location country Egypt references module reference list reference reference p m i d 29040638 reference type background reference citation Labarta E, Mariani G, Holtmann N, Celada P, Remohi J, Bosch E. Low serum progesterone on the day of embryo transfer is associated with a diminished ongoing pregnancy rate in oocyte donation cycles after artificial endometrial preparation: a prospective study. Hum Reprod. 2017 Dec 1;32(12):2437-2442. doi: 10.1093/humrep/dex316. Erratum In: Hum Reprod. 2018 Jan 1;33(1):178. reference p m i d 31783865 reference type background reference citation Boynukalin FK, Gultomruk M, Turgut E, Demir B, Findikli N, Serdarogullari M, Coban O, Yarkiner Z, Bahceci M. Measuring the serum progesterone level on the day of transfer can be an additional tool to maximize ongoing pregnancies in single euploid frozen blastocyst transfers. Reprod Biol Endocrinol. 2019 Nov 29;17(1):102. doi: 10.1186/s12958-019-0549-9. reference p m i d 26238390 reference type background reference citation Kofinas JD, Blakemore J, McCulloh DH, Grifo J. Serum progesterone levels greater than 20 ng/dl on day of embryo transfer are associated with lower live birth and higher pregnancy loss rates. J Assist Reprod Genet. 2015 Sep;32(9):1395-9. doi: 10.1007/s10815-015-0546-7. Epub 2015 Aug 4. Erratum in: J Assist Reprod Genet. 2016 Mar;33(3):431. reference p m i d 26099447 reference type background reference citation Yovich JL, Conceicao JL, Stanger JD, Hinchliffe PM, Keane KN. Mid-luteal serum progesterone concentrations govern implantation rates for cryopreserved embryo transfers conducted under hormone replacement. Reprod Biomed Online. 2015 Aug;31(2):180-91. doi: 10.1016/j.rbmo.2015.05.005. Epub 2015 May 18. reference p m i d 29025055 reference type background reference citation Mackens S, Santos-Ribeiro S, van de Vijver A, Racca A, Van Landuyt L, Tournaye H, Blockeel C. Frozen embryo transfer: a review on the optimal endometrial preparation and timing. Hum Reprod. 2017 Nov 1;32(11):2234-2242. doi: 10.1093/humrep/dex285. reference p m i d 24847018 reference type background reference citation Shapiro DB, Pappadakis JA, Ellsworth NM, Hait HI, Nagy ZP. Progesterone replacement with vaginal gel versus i.m. injection: cycle and pregnancy outcomes in IVF patients receiving vitrified blastocysts. Hum Reprod. 2014 Aug;29(8):1706-11. doi: 10.1093/humrep/deu121. Epub 2014 May 20. reference p m i d 24606090 reference type background reference citation Paulson RJ, Collins MG, Yankov VI. Progesterone pharmacokinetics and pharmacodynamics with 3 dosages and 2 regimens of an effervescent micronized progesterone vaginal insert. J Clin Endocrinol Metab. 2014 Nov;99(11):4241-9. doi: 10.1210/jc.2013-3937. Epub 2014 Feb 25. derived section misc info module version holder December 02, 2022 intervention browse module intervention mesh list intervention mesh intervention mesh id D000011374 intervention mesh term Progesterone intervention ancestor list intervention ancestor intervention ancestor id D000011372 intervention ancestor term Progestins intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M13397 intervention browse leaf name Progesterone intervention browse leaf as found Selected intervention browse leaf relevance high intervention browse leaf id M13396 intervention browse leaf name Progestins intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04837768
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full study rank 61708 study protocol section identification module n c t id NCT04832958 org study id info org study id PSMA RGS organization org full name IRCCS San Raffaele org class OTHER brief title Imaging Guided Surgery to Improve the Detection of Lymph Node Metastases in Prostate Cancer Patients official title The Role of Imaging Guided Surgery to Improve the Detection of Lymph Node Metastases in Prostate Cancer Patients Treated With Radical Prostatectomy and Extended Pelvic Lymph Node Dissection status module status verified date August 2021 overall status Recruiting expanded access info has expanded access No start date struct start date May 15, 2021 start date type Actual primary completion date struct primary completion date November 15, 2023 primary completion date type Anticipated completion date struct completion date November 15, 2024 completion date type Anticipated study first submit date April 3, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date August 24, 2021 last update post date struct last update post date August 25, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Giorgio Gandaglia responsible party investigator title MD responsible party investigator affiliation IRCCS San Raffaele lead sponsor lead sponsor name IRCCS San Raffaele lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The project aims at assessing the role of radio-guided surgery in the detection of lymph node invasion (LNI) in prostate cancer (PCa) patients undergoing radical prostatectomy (RP) by using an intraoperative gamma probe and a radioactive labelled PSMA ligand (99mTc-PSMA-I&S). We hypothesize that 99mTc-PSMA-I&S radio-guided surgery (99mTc-PSMA-RGS) might assist physicians in the identification of patients with LNI candidate for an extended pelvic lymph node dissection (ePLND). Overall, 100 men with a LNI risk >5% according to the Briganti nomogram will be submitted to 68Ga-PSMA PET/MRI followed by 99mTc-PSMA-RGS and ePLND. The aims are 1) to assess the safety and tolerability of 99mTc-PSMA-I&S; 2) to assess the accuracy of 99mTc-PSMA-RGS in the identification of LNI compared to available clinical tools and to molecular imaging (i.e., 68Ga-PSMA PET/MRI); 3) to assess whether 99mTc-PSMA-RGS would allow for the identification of positive nodes outside the standard ePLND template. detailed description Potential participants will be identified, screened and recruited by the Urologists working at the Department of Urology, IRCCS San Raffaele, Milan, Italy. A total of 100 patients affected by PCa with a risk of LNI >5% according to the Briganti nomogram and planned to receive RARP with an ePLND according to the European Association of Urology (EAU) guidelines will be identified and enrolled in the study. The patient must personally sign and date the latest approved version of the Informed Consent Form (ICF) before any trial specific procedures are performed. Written and verbal versions of the Patient Information and Informed Consent will be presented to the participants detailing no less than: The exact nature of the trial The surgical procedures The implications and constraints of the protocol The known side effects and any risks involved in taking part The clear statement that the participant is free to withdraw from the trial at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal. The participant will be allowed as much time as wished to consider the information and the opportunity to question the Investigator, their GP or other independent parties to decide whether they will participate in the trial. Written Informed Consent will then be obtained by means of participant dated signature and dated signature of the person who presented and obtained the Informed Consent. The person who obtained the consent must be suitably qualified and experienced, and have been authorized to do so by the Principal Investigator. A copy of the signed Informed Consent will be given to the participant. The original signed form will be retained at the trial Centre. A Patient ID number will be assigned to each patient after the ICF signature: this number corresponds to the Progressive Number assigned in chronological order beginning from 001 (i.e. 001, 002, etc.). For instance, the first patient enrolled will receive the following ID Number: 001. During Visit 1, the following data will be collected: Demographics Compliance with inclusion/exclusion criteria Informed consent Previous & concomitant pathologies/previous significant surgeries (including the Charlson Comorbidity Index) Previous & concomitant medications Prostate cancer characteristics including PSA values, biopsy grade group, clinical stage and the risk of LNI calculated according to the Briganti nomogram [12] Vital signs Laboratory testing (absolute neutrophil count; platelets; haemoglobin; serum creatinine) The week before surgery patients will undergo a 68Ga-PSMA PET/MRI or PET/CT scan for preoperative staging. Simultaneous PET/MRI will start 60 minutes after the administration of approximately 160MBq of PSMA with the following protocol: localizer MRI scans to define the number of table positions (PET-FOV) to acquire (4-min/table position); specific attenuation correction and anatomical localization MR sequences at each PET-FOV; pelvic mpMRI protocol according to European Society of Urogenital Radiology guidelines. A positive 68Ga-PSMA PET/MRI will be defined as the presence of any uptake at the level of the pelvic and/or retroperitoneal nodes. The results of this procedure will not change the initially planned treatment. 99mTc-PSMA-I&S will be intravenously injected the day before surgery (day -1). 99mTc-PSMA-I&S will be prepared using a synthesis kit previously described [25]. SPECT/CT imaging will be performed the same day of treatment administration (day -1) to document positive tracer uptake and will serve as quality control for tracer injection and distribution. All procedures will be performed through a trans-peritoneal approach using the Da Vinci Xi (Intuitive Surgical, Sunnyvale, CA, USA) robotic Surgical System. The patient will be placed in a Trendelenburg position. After incision of the peritoneum, release of the bladder laterally to the endopelvic fascia, the ureter will be localized. A drop-in gamma probe will be used for in vivo intraoperative measurements to identify metastatic lesions at the level of the internal iliac, external iliac, obturatory and common iliac stations. A positive finding at PSMA-RGS will be defined as the presence of a count rate of at least twice as compared to the background reference (namely, fatty tissue of each patient). All positive lesions (a count rate of at least twice as compared to the background reference) will be excised. Ex vivo gamma measurements will be performed to immediately to confirm the removal of the radioactive lesion or to prompt further search in case of a missing signal. All the removed tissue will be collected separately according to the site of resection. conditions module condition list condition Prostate Cancer keyword list keyword radical prostatectomy lymph node dissection lymph node invasion design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Radioguided surgery arm group type Experimental arm group description 68Ga-PSMA PET/MRI acquisition 99mTc-PSMA-I&S intravenous injection the day before surgery 99mTc-PSMA-I&S SPECT/CT imaging 99mTc-PSMA-RGS to detect an increased count rate at the level of the nodal stations Robot-assisted ePLND followed by RP 99mTc-PSMA-RGS to detect an increased count rate in the prostatic fossa after removal of the primary tumor Histopathological examination Monitoring of adverse events and perioperative outcomes after surgery arm group intervention list arm group intervention name Drug: 99m-TC-PSMA-I&S intervention list intervention intervention type Drug intervention name 99m-TC-PSMA-I&S intervention description 99mTc-PSMA-I&S intravenous injection the day before surgery 99mTc-PSMA-I&S SPECT/CT imaging 99mTc-PSMA-RGS to detect an increased count rate at the level of the nodal stations intervention arm group label list intervention arm group label Radioguided surgery outcomes module primary outcome list primary outcome primary outcome measure Rate of lymph node invasion primary outcome description Rate of LNI observed at final pathology after 99mTc-PSMA-RGS (histopathological evaluation of the lymph nodes) primary outcome time frame 12 weeks secondary outcome list secondary outcome secondary outcome measure Side effects secondary outcome description Side effects associated with the administration of 99mTC-PSMA-I&S (day 0) secondary outcome time frame day 0 secondary outcome measure Postoperative complications secondary outcome description Rate of intraoperative complications associated with 99mTc-PSMA-RGS assessed at visit 2 secondary outcome time frame day 28 and day 84 secondary outcome measure Nodal invasion outside the template secondary outcome description Rate of LNI observed at final pathology in nodes outside the extended nodal dissection template detected only by 99mTc-PSMA-RGS secondary outcome time frame 12 weeks eligibility module eligibility criteria Inclusion Criteria: Male patients Age between 18 and 80 years Biopsy proven PCa with a LNI risk >5% according to the Briganti nomogram Planned to receive a RARP with an ePLND Able to understand and willing to sign a written informed consent document Exclusion Criteria: Receipt of neoadjuvant therapies Inability to complete the imaging examinations according to the prospective protocol Evidence of metastatic disease at conventional imaging before surgery Evidence of clinical lymphadenopathies at conventional imaging before surgery Life expectancy of less than 12 months Previous chemotherapy Previous brachytherapy or external beam radiotherapy Unstable cardiovascular disease Congestive Heart Failure (CHF) Clinically significant hepatobiliary or renal disease History of significant CNS injuries within 6 months Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial Medical history of allergic disease or reactions likely to be exacerbated by the IMPs used in this study or by any of the components of the radiotracers (99mTc-PSMA-I&S and 68Ga-PSMA) Patients who received an experimental drug in the context of clinical trials within 30 days from the administration of the radiotracers in the current investigation or within 5 half-lives of the experimental drug itself healthy volunteers No gender Male minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module location list location location facility Ospedale San Raffaele location status Recruiting location city Milan location state MI location zip 20132 location country Italy location contact list location contact location contact name Giorgio Gandaglia, MD location contact role Contact location contact phone 00390226434066 location contact e mail [email protected] location contact name Elio Mazzone location contact role Contact location contact e mail [email protected] location contact name Francesco Montorsi, Prof location contact role Sub-Investigator location contact name Alberto Briganti, Prof location contact role Sub-Investigator location contact name Nicola Fossati, MD location contact role Principal Investigator location contact name Elio Mazzone, MD location contact role Sub-Investigator location contact name Vito Cucchiara, MD location contact role Sub-Investigator references module reference list reference reference p m i d 35879127 reference type derived reference citation Gandaglia G, Mazzone E, Stabile A, Pellegrino A, Cucchiara V, Barletta F, Scuderi S, Robesti D, Leni R, Samanes Gajate AM, Picchio M, Gianolli L, Brembilla G, De Cobelli F, van Oosterom MN, van Leeuwen FWB, Montorsi F, Briganti A. Prostate-specific membrane antigen Radioguided Surgery to Detect Nodal Metastases in Primary Prostate Cancer Patients Undergoing Robot-assisted Radical Prostatectomy and Extended Pelvic Lymph Node Dissection: Results of a Planned Interim Analysis of a Prospective Phase 2 Study. Eur Urol. 2022 Oct;82(4):411-418. doi: 10.1016/j.eururo.2022.06.002. Epub 2022 Jul 22. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011471 condition mesh term Prostatic Neoplasms condition mesh id D000008207 condition mesh term Lymphatic Metastasis condition ancestor list condition ancestor condition ancestor id D000005834 condition ancestor term Genital Neoplasms, Male condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000011469 condition ancestor term Prostatic Diseases condition ancestor id D000009362 condition ancestor term Neoplasm Metastasis condition ancestor id D000009385 condition ancestor term Neoplastic Processes condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M13487 condition browse leaf name Prostatic Neoplasms condition browse leaf as found Prostate Cancer condition browse leaf relevance high condition browse leaf id M11459 condition browse leaf name Neoplasm Metastasis condition browse leaf relevance low condition browse leaf id M10356 condition browse leaf name Lymphatic Metastasis condition browse leaf as found Lymph Node Metastases condition browse leaf relevance high condition browse leaf id M8098 condition browse leaf name Genital Neoplasms, Male condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M13485 condition browse leaf name Prostatic Diseases condition browse leaf relevance low condition browse leaf id M11482 condition browse leaf name Neoplastic Processes condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M346678 intervention browse leaf name Gallium 68 PSMA-11 intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04832958
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full study rank 61184 study protocol section identification module n c t id NCT04839770 org study id info org study id MIECH-2020-01 organization org full name Clearmind Biomedical Inc. org class INDUSTRY brief title MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage official title The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage (MIECH): An Open-label, Non-randomized, Single-arm Pilot Study status module status verified date February 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 7, 2020 start date type Actual primary completion date struct primary completion date September 2022 primary completion date type Anticipated completion date struct completion date December 2022 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date February 23, 2022 last update post date struct last update post date March 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Clearmind Biomedical Inc. lead sponsor class INDUSTRY collaborator list collaborator collaborator name Chang Gung Memorial Hospital collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary The primary objective of this trial is to provide preliminary safety data of minimally invasive endoscopic surgery using the Axonpen™ system for spontaneous intracerebral hemorrhage (ICH). The effectiveness of the Axonpen™ system in early hematoma removal and the surgical impact on subject's functional recovery will also be evaluated. The Axonpen™ system, consisting of a neuroendoscope (Axonpen) and a monitor (Axonmonitor), is cleared by FDA and indicated for the illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the ventricular system or cerebrum. detailed description In the present trial, the FDA-cleared Axonpen™ system was applied on the ICH surgery. The Axonpen™ System is a neuroendoscope combined with the functions of hematoma aspiration and irrigation, aiming to minimize surgical brain injury, optimize surgical procedure, and be available for early hematoma evacuation. The technique of minimally invasive endoscopic neurosurgery for ICH is still considered in development; however, a retrospective study [Kuo et al.] has shown that early and complete evacuation of ICH may lead to improved outcomes in selected patients, where the neurosurgeons utilized combination of the existing instruments, such as a rod-lens endoscope with irrigation system and a suction coagulator, to enable visualization, aspiration, and irrigation of the hematoma to be worked simultaneously. The technology employed and the results revealed in the previous study provide a proof of concept for the Axonpen™ system, and also imply that the current device could be safe and effective in the management of ICH. conditions module condition list condition Intracerebral Hemorrhage Cerebral Hemorrhage Intracranial Hemorrhage Basal Ganglia Hemorrhage keyword list keyword Intracerebral Hemorrhage Cerebral Hemorrhage Intracranial Hemorrhage ICH Stroke Endoscopic Hematoma Evacuation Minimally Invasive Surgery Endoscopic Neurosurgery design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 15 enrollment type Anticipated arms interventions module arm group list arm group arm group label Axonpen arm group type Experimental arm group description Subjects will receive minimally invasive endoscopic surgery using the Axonpen™ system for early hematoma evacuation (within 48 hours post-ictus). arm group intervention list arm group intervention name Device: Axonpen system intervention list intervention intervention type Device intervention name Axonpen system intervention description The Axonpen™ system, containing the Axonpen and the Axonmonitor, has been cleared for the illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the ventricular system or cerebrum. The Axonpen is a neuroendoscope integrated with suction (sourced from hospital vacuum) and irrigation (sourced from third-party saline infusion bag) functions. The Axonmonitor is used for view and storage of the endoscopic image. The Axonpen™ system is intended to optimize the procedure of minimally invasive neurosurgery for early ICH evacuation. intervention arm group label list intervention arm group label Axonpen outcomes module primary outcome list primary outcome primary outcome measure Rate of Mortality primary outcome description Safety will be assessed by determining mortality within 30 days post-operation for all subjects primary outcome time frame 30 days primary outcome measure Number of Adverse events (AEs), Serious Adverse Events (SAEs), and Unanticipated Device Effects (UDEs) primary outcome description AEs, SAEs, and UDEs will be observed from the beginning of the surgery until the last follow-up visit (Day 180) for safety monitoring, and their relation to the study device will be analyzed primary outcome time frame 180 days secondary outcome list secondary outcome secondary outcome measure Hemorrhage volume secondary outcome description Residual hematoma will be measured via 6 & 72 hours post-operation CT. Reduction (%) of hemorrhage volume will be assessed by comparing with pre-operation CT secondary outcome time frame 6 and 72 hours secondary outcome measure Glasgow Coma Scale (GCS) secondary outcome description Clinical assessment for level of consciousness and responsiveness before and after surgery (Assessed by the sum of E/V/M scores. E: Eye opening, 1 = None - 4 = Spontaneous. V: Verbal response, 1 = None - 5 = Normal conversation. M: Motor response, 1 = None - 6 = Normal) secondary outcome time frame 180 days secondary outcome measure modified Rankin Scale (mRS) secondary outcome description Functional outcomes will be measured via mRS at 72 hours and 7 days post-operation, hospital discharge, and 40, 90, 180 days follow-up visits (Scale ranges from 1 to 7, 1 = No symptoms - 7 = Dead) secondary outcome time frame 180 days secondary outcome measure Glasgow Outcome Scale Extended (GOSE) secondary outcome description Functional outcomes will be measured via GOSE at 72 hours and 7 days post-operation, hospital discharge, and 40, 90, 180 days follow-up visits (Scale ranges from 1 to 8, 1 = Death - 8 = Upper good recovery) secondary outcome time frame 180 days secondary outcome measure Length of ICU secondary outcome description Duration of stay in the ICU secondary outcome time frame Number of days from admission, up to 180 days secondary outcome measure Length of hospitalization secondary outcome description Duration of stay in the hospital secondary outcome time frame Number of days from admission to discharge, up to 180 days eligibility module eligibility criteria Inclusion Criteria: Patients who fulfill ALL the inclusion criteria will be enrolled: Age 20-80 years, all genders/sexes are inclusive; Evidence of a spontaneous basal ganglia ICH on CT scan; Patient, or a family member with legally authorized responsibility, has given informed consent; GCS of 6-14; Volume of hematoma in range of 30-80 ml as measured by the ABC/2 method; Can receive surgical treatment within 48 hours after ictus. Exclusion Criteria: Patients who fulfill ANY ONE of the exclusion criteria should not be enrolled: Previous symptomatic stroke with neurological sequelae (per history or as seen on initial CT scan); ICH known or suspected by study investigator to be secondary to aneurysm, vascular malformation, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, thrombolytic therapy, tumor, or infection; Acute or active infection signs requiring treatment at the time of admission; Significant ventricular extension of the hemorrhage; more than 30 mL of intraventricular hemorrhage; Refractory elevated ICP after placement of an EVD (external ventricular drain); Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome; Minimally invasive neurosurgery could not be commenced within 48 hours of onset. The case shall be excluded when the time of onset cannot be estimated and is judged with controversy by the investigator; The hematological effects of any previous anticoagulants are not completely reversed (platelet count < 100 × 10^3/μL; international normalized ratio (INR) > 1.4); Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency; Any condition that could impose hazards to the patient with the MIN or affect the participation of the patient in the study. The judgment is left to the discretion of the investigator; Major surgery within the preceding 14 days which poses risk in the opinion of the investigator; Any history or current evidence suggestive of venous or arterial thrombotic events within the previous 12 months, including clinical, ECG, laboratory, or imaging findings; Use of heparin, low-molecular weight heparin, GPIIb/IIIa antagonist, antiplatelet agents, or oral anticoagulation (e.g., warfarin, factor Xa inhibitor, thrombin inhibitor) within the previous 14 days, irrespective of laboratory values; Pregnancy, breast-feeding, or positive pregnancy test (either serum or urine) (Woman of child-bearing potential must have a negative pregnancy test prior to the study procedure.); Participation in any investigational study in the last 30 days; Known terminal illness or planned withdrawal of care or comfort care measures. healthy volunteers No gender All minimum age 20 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Hsiu-Jen Lin, PhD central contact role Contact central contact phone +886-2-22697417 central contact phone ext 108 central contact e mail [email protected] central contact name Chun-Wei Yang central contact role Contact central contact phone +886-2-22697417 central contact phone ext 107 central contact e mail [email protected] location list location location facility Chang Gung Memorial Hospital (Linkou Branch) location status Recruiting location city Taoyuan location zip 333423 location country Taiwan location contact list location contact location contact role Contact location contact phone +886-3-3281200 location contact phone ext 2412 location contact name Chi-Cheng Chuang, MD location contact role Principal Investigator references module reference list reference reference p m i d 21456936 reference type background reference citation Kuo LT, Chen CM, Li CH, Tsai JC, Chiu HC, Liu LC, Tu YK, Huang AP. Early endoscope-assisted hematoma evacuation in patients with supratentorial intracerebral hemorrhage: case selection, surgical technique, and long-term results. Neurosurg Focus. 2011 Apr;30(4):E9. doi: 10.3171/2011.2.FOCUS10313. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002543 condition mesh term Cerebral Hemorrhage condition mesh id D000020300 condition mesh term Intracranial Hemorrhages condition mesh id D000020145 condition mesh term Basal Ganglia Hemorrhage condition mesh id D000006470 condition mesh term Hemorrhage condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000002561 condition ancestor term Cerebrovascular Disorders condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000020144 condition ancestor term Basal Ganglia Cerebrovascular Disease condition ancestor id D000001480 condition ancestor term Basal Ganglia Diseases condition browse leaf list condition browse leaf condition browse leaf id M21459 condition browse leaf name Stroke condition browse leaf relevance low condition browse leaf id M8708 condition browse leaf name Hemorrhage condition browse leaf as found Hemorrhage condition browse leaf relevance high condition browse leaf id M4944 condition browse leaf name Cerebral Hemorrhage condition browse leaf as found Intracerebral Hemorrhage condition browse leaf relevance high condition browse leaf id M24756 condition browse leaf name Ganglion Cysts condition browse leaf relevance low condition browse leaf id M21266 condition browse leaf name Intracranial Hemorrhages condition browse leaf as found Intracranial Hemorrhage condition browse leaf relevance high condition browse leaf id M8645 condition browse leaf name Hematoma condition browse leaf relevance low condition browse leaf id M15510 condition browse leaf name Synovial Cyst condition browse leaf relevance low condition browse leaf id M21133 condition browse leaf name Basal Ganglia Hemorrhage condition browse leaf as found Basal Ganglia Hemorrhage condition browse leaf relevance high condition browse leaf id M4962 condition browse leaf name Cerebrovascular Disorders condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M3926 condition browse leaf name Basal Ganglia Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases
NCT04839770
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full study rank 61812 study protocol section identification module n c t id NCT04831606 org study id info org study id EmoLED_DF_001 organization org full name Emoled org class INDUSTRY brief title Blue Light Photobiomodulation Therapy on Neuroischemic Patients official title A Single-center Prospective Randomized Controlled Study on the Efficacy of Blue Light in the Therapy of Neuro-ischemic Foot Lesions in Patients With Type I or II Diabetes in a Combined Hospital /Territory Treatment Regimen. acronym HERMES status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 31, 2021 start date type Actual primary completion date struct primary completion date May 2022 primary completion date type Anticipated completion date struct completion date August 2022 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 20, 2022 last update post date struct last update post date May 26, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Emoled lead sponsor class INDUSTRY collaborator list collaborator collaborator name Ospedale San Donato collaborator class OTHER collaborator name University of Pisa collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a pilot case/control clinical study on a group of outpatients with diabetic foot lesions aiming to verify the efficacy and safety of the Blue light photobiomodulation therapy with EmoLED medical device, in addition to standard therapy compared to the standard therapy alone, evaluating the percentage of healed lesions (which have reached complete and lasting re-epithelialization), the evaluation of the healing time and reduction of the ulcerated area during the time of observation, the perception of pain and the quality of life of the enrolled patients. The aim of this study is therefore to determine any differences in outcome between the two groups considered and, in particular, if the therapy of the group being treated is more effective than the standard therapy in terms of percentage of healed lesions, healing time, and reduction of the ulcerated area, pain perception, and quality of life, and is at least as safe in terms of occurrence of adverse events. detailed description This study will be conducted according to the standards of Good Clinical Practice and in compliance with the principles set out in the Declaration of Helsinki, with the UNI_ISO_14155_2011 standard, and with all relevant local laws and regulations applicable to clinical trials that use patients as the research object. This clinical investigation in the various centers involved cannot begin before having received the favorable written approval of the Ethics Committee of the coordinating center and the respective Ethics Committees. The medical assistance provided to the subject is the responsibility of adequately qualified doctors, as all the centers involved in this study are centers specialized in the treatment of the pathology object of the clinical trial (Diabetology units or Diabetic Foot clinics). During this trial, the patients' right to physical and mental integrity, the right to privacy, and the protection of data concerning them will be respected following Directive 95/46/EC. This clinical investigation has been designed in such a way as to cause as little pain, discomfort, fear, and other foreseeable risks for the subject as possible and the degree of discomfort related to the trial itself or the treatment with the medical device in question is almost nil, considered the clinical evaluation report of the device and the safety data obtained from post-marketing surveillance. The degree of discomfort/pain of the enrolled patients is however subject to continuous verification during the clinical trial, through a special questionnaire on the detection of discomfort connected to participation in the study in question. The risk/benefit ratio will be constantly checked throughout the trial, taking into account any adverse events / device-related accidents or non-serious side effects reported by the main investigators, and the preliminary assessment of the benefits found on patients who have completed the study process. The principal investigator of each center is responsible for adequate conduct of the study of his own center and the coordination of the personnel involved. Must be responsible for all medical decisions relating to the study and ensure that adequate medical assistance is provided to the subject in case of adverse events. The investigator should conduct the study following the protocol agreed with the sponsor and the authorities. To verify that the rights, safety, and well-being of enrolled patients are protected, that the data communicated are reliable and solid, and that the clinical investigation is conducted in compliance with the prescriptions of current legislation, the sponsor guarantees adequate monitoring of the conduct of this clinical investigation. The monitoring of the clinical investigation is entrusted to the sponsor's staff adequately trained. To ensure compliance with ICH/GCP guidelines and current legislation, such personnel will be responsible for ensuring that the Study is conducted in full compliance with the Standard Operating Procedures, the Protocol, and other written instructions. The main responsibilities of the personnel carrying out the monitoring are to ensure adherence to the Protocol, to ensure that data is recorded and reported accurately and completely, and to verify that informed consent has been obtained and recorded for all subjects before they participate in the study. Researchers will be contacted at regular intervals throughout the study period. To check and verify the various documents (Data Collection Cards or CRFs and other relevant documents containing the original data) relating to the Study to verify compliance with the Protocol and to ensure the completeness, consistency, and accuracy of the recorded data. Monitoring staff will conduct a center opening visit (SIV), a minimum of three visits during the study (MOV) to be scheduled approximately one after 1 or 2 months after SIV based on the number of patients enrolled, one at two-thirds of the enrollment and another after the observations on the last patient. Finally, once all the open issues have been resolved (open queries, clarifications, etc.), we will proceed with the center closing visit (COV). Should additional monitoring visits be necessary, the staff will schedule them with the principal investigator. conditions module condition list condition Diabetic Foot Ulcer design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description A double-blind pilot trial on outpatients affected by diabetic foot ulcers, followed in an integrated way by both a specialized center and the home nursing network, for a period of 24 weeks. The specialist center will characterize the patient, set the therapy, and evaluate them monthly, the nursing service will treat them at home biweekly. The physician in charge of the monthly evaluation is unaware of the patient's arm. During therapy, the patient will wear blinding glasses, the control arm will simulate the use of the device switching it on without aiming it at the wound. After a two-week pre-enrollment period to evaluate the wound progression applying only the standard care (if the wound reduces 50% or more, the patient will be excluded), the patient will be randomized into one of the study arms: the control arm will continue with the standard treatment, while the EmoLED Arm will receive EmoLED's therapy in addition to the standard treatment. design primary purpose Treatment design masking info design masking Triple design masking description Patients will be randomized into the two arms of the study according to a list of random numbers generated by special IT tools and communicated by the scientific supervisor to the Care Provider via e-mail . It is a 1: 1, single-block randomization of 40 patients distributed in the two groups (treated and control). After the two-week enrollment observation period, the Investigator at the outpatient center will ascertains the conditions for the study prosecution and will notify the Head of the Care Providers to take charge of the patient included in the study and to proceed with the assignment to one of the groups. In this way, the Investigator at the outpatient center will be blinded to the treatment performed at home by the patient. All patients will receive a pair of blinding glasses at the enrollment and will be required to wear them during therapy. design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 40 enrollment type Anticipated arms interventions module arm group list arm group arm group label Control Arm arm group type Active Comparator arm group description Patients will receive a biweekly standard treatment at home according to the International Working Group on Diabetic Foot consisting of: Debridement of the lesion, unloading with a brace up to the calf, non-removable (except for contraindications), dressing of the wound with advanced dressings in use at the specialized center and in the home care network. arm group intervention list arm group intervention name Procedure: debridement Device: Offloading Device: Advanced dressing arm group label EmoLED Arm arm group type Experimental arm group description Patients on top of the standard treatment of the control arm will receive EmoLED blue light irradiation for two minutes at each biweekly medication. arm group intervention list arm group intervention name Procedure: debridement Device: Offloading Device: Advanced dressing Device: Blue Light Photobiomodulation intervention list intervention intervention type Procedure intervention name debridement intervention description Cleaning of the wound area intervention arm group label list intervention arm group label Control Arm EmoLED Arm intervention type Device intervention name Offloading intervention description Offloading performed with a standard brace to the calf (Optima Diab, from Molliter). intervention arm group label list intervention arm group label Control Arm EmoLED Arm intervention type Device intervention name Advanced dressing intervention description Protect the wound with Advanced dressing intervention arm group label list intervention arm group label Control Arm EmoLED Arm intervention type Device intervention name Blue Light Photobiomodulation intervention description 2 minutes irradiation of blue light performed with EmoLED device intervention arm group label list intervention arm group label EmoLED Arm outcomes module primary outcome list primary outcome primary outcome measure Percentage of healed lesions on the total lesions treated for each arm primary outcome description Percentage of lesions showing a lasting and complete re-epithelialization in each group after twenty-four weeks. Healing must be confirmed by the Principal Investigator or his staff during an outpatient visit at the reference center participating in the study primary outcome time frame 24 weeks (20 weeks treatment plus 4 weeks post treatment observation) secondary outcome list secondary outcome secondary outcome measure Healing time secondary outcome description Number of days needed to reach a lasting and complete re-epithelialization within the observation period secondary outcome time frame 24 weeks other outcome list other outcome other outcome measure Reduction of the lesion surface in both arms, measured in absolute terms (square centimeters) and as % of the initial size. other outcome description At each outpatient control visit, a photograph image will be acquired with the device in the use of the structure (WoundViewer from Omnidermal Biomedics Srl). The device takes pictures and calculates automatically the area of the wounds through a validated algorithm. other outcome time frame once every 4 weeks for 20 weeks plus the last control visit at 24 weeks if needed other outcome measure Quality of life level (QoL), measured with specific questionnaires (EuroQoL-5D) other outcome description At the first and last visit in the outpatient center information on the patient's quality of life will be collected using standard models such as the EQ-5D and the Wound-QoL both available and validate in the Italian language. other outcome time frame 16 weeks (last outpatient visit) other outcome measure Pain perception measured according to the VAS scale other outcome description At each visit the patient pain perception will be measured using the standard VAS scale method other outcome time frame 20 weeks other outcome measure Comparative Evaluation of costs associated with the therapy. other outcome description Both sanitary costs and patients' costs (including caregiver if present) in connection with the therapy will be recorded. Through a questionnaire to be filled at the last visit by the patient, the caregiver, the home nurse, and the outpatient center all direct, indirect, medical personnel, and societal costs will be recorded. the home nurses and outpatient center will fill a questionnaire regarding direct and indirect costs connected with the therapy for both arms. other outcome time frame 16 weeks other outcome measure Patient's therapy acceptance other outcome description at the control visit a questionnaire to evaluate the therapy's acceptance will be given to patients of both arms. other outcome time frame 24 weeks other outcome measure Appreciation, complexity and usefulness of the EmoLED therapy by the operator other outcome description a specific questionnaire will be administered to the personnel to evaluate appreciation, complexity and usefulness of the EmoLED therapy. other outcome time frame 24 weeks other outcome measure Number of Treatment-Emergent Adverse Events other outcome description All incidents according to the definition of the EU regulation 2017/745 on Medical Devices will be properly reported their gravity and relation with the therapy evaluated. It will be counted the number and gravity of occurred adverse events on both arms other outcome time frame 24 weeks other outcome measure Evaluation of cost-effectiveness of using EmoLED for the treatment of ulcers other outcome description Evaluation of cost-effectiveness using EmoLED in the treatment of ulcers through economic-organizational impact survey. other outcome time frame 24 weeks eligibility module eligibility criteria Inclusion Criteria: Patients suffering from neuro-ischemic diabetic foot ulcer grade IC or IIC according to the University of Texas Wound Classification; If the patient has two or more lesions, which may fall within the inclusion criteria, the most serious lesion (index lesion) will be selected and followed for the entire duration of the study. Patients who, following hospital discharge or after the first outpatient assessments, are followed by Home Care and are always monitored at the same referral center; Patients with type I or II diabetes, with blood glucose ≤ 10%; Patients willing to constantly wear the offload braces prescribed by the reference center; Patients with ulcer localized on the finger, lateral, plantar, or dorsal part of the foot with an extension greater than 1 sqcm; Patients with confirmed neuropathy with Monofilament (Semmes-Weinstein 5.07 / 10g); Patients with ABPI between 0.7 - 0.9, ankle PA> 70mmHg, TcPO2 between 36 - 50 mmHg; Patients with lesions lasting between 1 and 24 months; Patients who understand the purpose of the Clinical Study and provide their informed consent in writing. Exclusion Criteria: Patients who have participated in a clinical study with a drug or medical device for less than a month; Patients who are unable to understand the aims and objectives of the study; Patients who are bedridden or unable to walk or Patients with neoplasms; Patients with pressure ulcers; Patients who have infectious signs according to IDSA criteria; Patients who underwent revascularization in the previous two months; Patients who have presented an acute ischemic event within the previous 3 months; Patients with heel injuries; Patients with nephropathy undergoing dialysis; Patients with osteomyelitis; Patients with Charcot's neuro-arthropathy: Patient on high dose corticosteroid therapy (≥ 40 mg/day); Patients with a history of self-harm who can voluntarily alter the course of healing; Patients with psychiatric disorders; Women who are pregnant or breastfeeding; Patients with pathologies or under treatment with drugs that induce photosensitization of the skin; Patients with a life expectancy of less than one year. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Duccio Rossi, Biologist central contact role Contact central contact phone +390550751960 central contact e mail [email protected] central contact name Magali Maffucci, Biologist central contact role Contact central contact phone +390550751960 central contact e mail [email protected] overall official list overall official overall official name Alberto Piaggesi, Doctor overall official affiliation Pisa University Hospital overall official role Study Chair overall official name Alessia Scatena, Doctor overall official affiliation San Donato Hospital overall official role Principal Investigator location list location location facility San Donato Hospital location status Recruiting location city Arezzo location zip 52100 location country Italy location contact list location contact location contact name Alessia Scatena, Doctor location contact role Contact location contact phone +393283281501 location contact e mail [email protected] location contact name Sara Sandroni, Doctor location contact role Sub-Investigator references module reference list reference reference p m i d 31189038 reference type background reference citation Greenhalgh DG. Management of Burns. N Engl J Med. 2019 Jun 13;380(24):2349-2359. doi: 10.1056/NEJMra1807442. No abstract available. reference p m i d 17309691 reference type background reference citation Mast BA, Schultz GS. Interactions of cytokines, growth factors, and proteases in acute and chronic wounds. Wound Repair Regen. 1996 Oct;4(4):411-20. doi: 10.1046/j.1524-475X.1996.40404.x. i p d sharing statement module i p d sharing No document section large document module large doc list large doc large doc type abbrev Prot large doc has protocol Yes large doc has s a p No large doc has i c f No large doc label Study Protocol large doc date February 24, 2021 large doc upload date 05/20/2022 05:25 large doc filename Prot_001.pdf derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000017719 condition mesh term Diabetic Foot condition mesh id D000016523 condition mesh term Foot Ulcer condition ancestor list condition ancestor condition ancestor id D000003925 condition ancestor term Diabetic Angiopathies condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000007871 condition ancestor term Leg Ulcer condition ancestor id D000012883 condition ancestor term Skin Ulcer condition ancestor id D000012871 condition ancestor term Skin Diseases condition ancestor id D000048909 condition ancestor term Diabetes Complications condition ancestor id D000003920 condition ancestor term Diabetes Mellitus condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000003929 condition ancestor term Diabetic Neuropathies condition ancestor id D000005534 condition ancestor term Foot Diseases condition browse leaf list condition browse leaf condition browse leaf id M9695 condition browse leaf name Ischemia condition browse leaf relevance low condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M16358 condition browse leaf name Ulcer condition browse leaf relevance low condition browse leaf id M19085 condition browse leaf name Diabetic Foot condition browse leaf as found Diabetic Foot condition browse leaf relevance high condition browse leaf id M18071 condition browse leaf name Foot Ulcer condition browse leaf as found Foot Ulcers condition browse leaf relevance high condition browse leaf id M6272 condition browse leaf name Diabetic Angiopathies condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M10035 condition browse leaf name Leg Ulcer condition browse leaf relevance low condition browse leaf id M14838 condition browse leaf name Skin Ulcer condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse leaf id M25157 condition browse leaf name Diabetes Complications condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M6276 condition browse leaf name Diabetic Neuropathies condition browse leaf relevance low condition browse leaf id M7810 condition browse leaf name Foot Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases
NCT04831606
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full study rank 61551 study protocol section identification module n c t id NCT04834999 org study id info org study id AUUR2020DKRW_4 organization org full name University of Aarhus org class OTHER brief title Validation of Instruments for Clinical Trial on Patients With Bipolar Disorder in Rwanda official title Validation and Transcultural Adaptation of Instruments Used in a Clinical Trial on Patients With Bipolar Disorder in Rwanda status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 15, 2021 start date type Anticipated primary completion date struct primary completion date February 15, 2022 primary completion date type Anticipated completion date struct completion date February 15, 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Aarhus lead sponsor class OTHER collaborator list collaborator collaborator name University of Rwanda collaborator class OTHER collaborator name Mental Health Centre Copenhagen collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study evaluates the cultural and linguistic sensitivity and psychometric properties of a set of four adapted measurement instruments essential to determining the efficacy of group-psychoeducation for patients with bipolar disorder in Rwanda, and one screening tool for bipolar disorder. The four well-known instruments are; The Young Mania Rating Scale (YMRS), The Medical Adherence Scale (MARS), The Internalized Stigma of Mental Illness Scale-9 (ISMI-9), and the Mood disorder Questionnaire (MDQ). Each instrument will be culturally adapted and validated using a forward-backward translation, consensus conference, and cognitive interviews. detailed description In the present study, our aim is to translate, culturally adapt and validate four used scales for use in patients with bipolar disorder. The four scales are: The Medical Adherence Scale (MARS), used to assess beliefs and barriers to medication adherence. The scale has 10-items, a total scores on the MARS may range between 0 and 10, with a higher score indicating better medication adherence. Internalized Stigma of Mental Illness Inventory - 9-item Version (ISMI-9) used to assess self-stigma. The scale consists of nine questions evaluated on a four-point Likert scale from 1 (strongly agree) to 4 (strongly disagree). The resulting score should range from 1 to 4. A score ranging between 1.00-2.50: does not report high internalized stigma vs. a score ranging between 2.51-4.00: indicating high internalized stigma The Young Mania Rating Scale (YMRS) is a clinical interview scale to assess the severity of manic states and has 11-items. The Mood Disorder Questionnaire, is a self-reported screening instrument used for identifying persons likely to have bipolar disorder. The instrument comprising a list of 13 hypomanic symptoms. The translation and adaptation process: One a nonprofessional translator, bilingual and knowledgeable about mental health care. The second is a translator with no particular knowledge about mental health healthcare. Following the forward translations, a meeting will be held to generate an agreed version. Next, two professional, bilingual, native English speakers back-translated the synthesized version to English. After that, an expert meeting will be held with all translators and five clinicians. Item by item, all versions, and back translations will be discussed to agree on an optimal pre-version for semantic and conceptual equivalence between the original English and the Kinyarwanda version. After that, the tools will be validated among 500 participants. conditions module condition list condition Mental Disorder design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 500 enrollment type Anticipated arms interventions module intervention list intervention intervention type Other intervention name Validation of questionnaires in Kinyarwanda intervention description Four questionnaires, three self-report instruments (Medication Adherence Rating Scale, Internalized Stigma of Mental Illness Inventory - 9-item Version and the Mood Disorder Questionnaire) and one clinical interview (the Young Mania Rating Scale) outcomes module primary outcome list primary outcome primary outcome measure Adaption and validation of the Rwandese version of the Mood Disorder Questionnaire for screening for Bipolar Disorder primary outcome description The study aims to adapt and validate the Mood Disorder Questionnaire to improve the detection of bipolar disorder in Rwanda primary outcome time frame Ten months primary outcome measure Adaption and validation of the Rwandese version of the Medication Adherence Rating Scale (MARS). primary outcome description The study aims to adapt and validate the Medication Adherence Rating Scale (MARS) and to access the medical adherence primary outcome time frame Ten months primary outcome measure Adaption and validation of the Rwandese version of The Internalized Stigma of Mental Illness Scale-9 (ISMI-9) primary outcome description The study aims to adapt and validate The Internalized Stigma of Mental Illness Scale-9 (ISMI-9) to measure the overall self-stigma of mental illness among persons with psychiatric disorders in Rwanda. primary outcome time frame Ten months primary outcome measure Adaption and validation of the Rwandese version of the Young Mania Rating Scale primary outcome description The study aims to adapt and validate the Young Mania Rating Scale primary outcome time frame Ten months eligibility module eligibility criteria Participants for validation of the YMRS and the MARS: Inclusion Criteria: Patients with a diagnosis of BD type I or II, that meets DSM-IV diagnostic criteria given by a trained psychiatrist Participants for validation of the ISMI-9: Inclusion Criteria: A diagnosis of mental disorder that meets DSM-IV diagnostic criteria given by a trained psychiatrist Participants for validation of the MDQ: Inclusion Criteria: Patient with a diagnosis of BD type I or II, or major depression that meets DSM-IV diagnostic criteria given by a trained psychiatrist Volunteers with no history or family history of the psychiatric disorder will be recruited as controls. Exclusion Criteria for all participants: Insufficient understanding of Kinyarwanda Clinical evidence of substantial cognitive impairments. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Participants with a mental illness will be recruited at their scheduled outpatient clinic visit, during which they complete the Kinyarwanda version of the instruments. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Caroline J Arnbjerg, Msc central contact role Contact central contact phone +250786917224 central contact e mail [email protected] central contact name Emmanuel Musoni Rwililiza, Msc central contact role Contact central contact phone +250788568244 central contact e mail [email protected] overall official list overall official overall official name Per Kallestrup, Prof. overall official affiliation University of Aarhus overall official role Study Chair location list location location facility The University Teaching Hospital of Kigali (CHUK) and Ndera Hospital location city Kigali location country Rwanda location contact list location contact location contact name Emmanuel Musoni Rwililiza, Msc location contact role Contact location contact phone +250788568244 location contact e mail [email protected] i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001714 condition mesh term Bipolar Disorder condition mesh id D000001523 condition mesh term Mental Disorders condition ancestor list condition ancestor condition ancestor id D000068105 condition ancestor term Bipolar and Related Disorders condition browse leaf list condition browse leaf condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf as found Mental Disorders condition browse leaf relevance high condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id M4148 condition browse leaf name Bipolar Disorder condition browse leaf as found Bipolar Disorder condition browse leaf relevance high condition browse leaf id M226 condition browse leaf name Bipolar and Related Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions
NCT04834999
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full study rank 61252 study protocol section identification module n c t id NCT04838886 org study id info org study id Gazi 2 organization org full name Gazi University org class OTHER brief title The Effect of Telerehabilitation Based Pilates Training in Multiple Sclerosis Patients official title The Effect of Telerehabilitation Based Pilates Training on Physical Performance and Quality of Life in Multiple Sclerosis Patients status module status verified date May 2022 overall status Completed expanded access info has expanded access No start date struct start date April 15, 2021 start date type Actual primary completion date struct primary completion date May 15, 2022 primary completion date type Actual completion date struct completion date May 25, 2022 completion date type Actual study first submit date March 30, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date May 25, 2022 last update post date struct last update post date May 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Kader Eldemir responsible party investigator title Research Assistant responsible party investigator affiliation Gazi University lead sponsor lead sponsor name Gazi University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin, oligodendrocyte, and axon damage. MS usually begins with attacks due to demyelination of axons in the brain, optic nerve, and spinal cord; over time it develops into a neurodegenerative disease associated with neurotrophic support deficiency and neuronal loss. In MS, various loss of strength, balance, fatigue, cognitive and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders affect the quality of life by limiting the individual's activities and participation in their daily lives. Therefore, it is important to treat these disorders in the treatment of MS. There are various pharmacological treatments and invasive procedures for the management of MS symptoms and one of the most commonly used treatment options is rehabilitation. Clinically-based exercise and rehabilitation are some of the most beneficial rehabilitation strategies in people with MS (PwMS). Clinically-based exercise and rehabilitation have been shown to stabilize or improve many physical symptoms of MS including loss of strength, balance dysfunction, impaired mobility, and fatigue. These benefits have led many practitioners to consider physical exercise as a nonpharmaceutical disease-modifying treatment. However, due to various factors such as mobility disorders, fatigue, and related problems, geographic location, time constraints, transportation difficulties, health insurance coverage, and financial burden, clinical-based exercise may be problematic in some pwMS. To overcome these challenges, approaches to rehabilitation have been developed such as telerehabilitation. The telerehabilitation system provides benefits such as continuity in patient education and rehabilitation, showing progress in rehabilitation, making changes in the treatment program, and saving individuals time and financial expenses. It is also an innovative and potential alternative to face-to-face interventions for treating disease-related disorders in pwMS. In literature, there are many studies examining the effectiveness of telerehabilitation in pwMS. According to these studies, ıt has been shown that telerehabilitation, with its technical facilities, had the potential to make clinical interventions widely accessible and effective for MS, however, telerehabilitation-based interventions could not replace traditional interventions but could perfectly complement. It has been found that telerehabilitation improved balance and postural control in MS patients and had no side effects. However, it was emphasized that the evidence levels of the studies were insufficient for methodological reasons. It has been determined additional studies are needed to investigate examining the effect on walking. Another clinical-based exercise method is Pilates. Pilates is a "core" stability-based exercise method that includes endurance, flexibility, movement, posture, and respiratory control. Studies have shown that Pilates training can improve balance, mobility, and muscle strength, fatigue in pwMS due to its structure consisting of balance and strengthening exercises. When the literature is reviewed in terms of Telerehabilitation based on Pilates in pwMS, it is seen that there are only two studies. In both studies, pwMS were given 20 minutes of yoga, 20 minutes of Pilates, and 20 minutes of dual-task exercise. However, these studies were in the project phase and the results are still not reported. On the other hand, in both studies, Pilates is given as combined training. As a result, telerehabilitation is an alternative method to MS treatment. In addition, while there are many clinical-based Pilates studies in the literature, telerehabilitation-based Pilates studies are insufficient. Telerehabilitation-based Pilates training studies are needed. Therefore, the investigators planned this study to investigate the effect of telerehabilitation-based pilates training on physical performance and quality of life in pwMS. detailed description This study is planned as a randomized control trial. Patients will be randomly divided into two groups as intervention and control. The intervention group will be received telerehabilitation-based pilates training three times a week for six weeks. Telerehabilitation-based pilates will be provided via videoconferencing. The first session will be the introduction session, patients will be informed about basic principles of Pilates and it will be included teaching inward movement of the lower abdominal wall and supine exercises of segmental movements involving trunk muscle recruitment to maintain a neutral posture. Afterward the session, a typical session will be included supine, side-lying, quadruped exercise, sitting on the exercise ball, and standing exercises. Exercises will be included thoracic extension, general abdominal strengthening, core stabilization exercises for the deep abdominal muscles. The difficulty of these exercises will be gradually increased and focused on keeping neutral positions of the spine in different gravity orientations. The control group will be a wait-list group without any additional specific treatment. All assessments will be done before and after the 6-week intervention program or waiting period. The demographic characteristics of the participants initially will be taken and the Expanded Disability Status Scale score of those of MS will be recorded. Primary outcomes are balance, gait, core endurance and power, and muscle strength; secondary outcomes are physical activity, fatigue, and quality of life conditions module condition list condition Multiple Sclerosis keyword list keyword Multiple Sclerosis Pilates Exercise Telerehabilitation Physical performance Balance Gait Fatigue design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Intervention and control groups design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 30 enrollment type Actual arms interventions module arm group list arm group arm group label Exercise group arm group type Experimental arm group description The intervention group will be received telerehabilitation-based pilates training three times a week for 6 weeks. arm group intervention list arm group intervention name Other: Telerehabilitation-based Pilates Exercise arm group label Waitlist arm group type No Intervention arm group description The control group will be a wait-list group without any additional specific treatment. intervention list intervention intervention type Other intervention name Telerehabilitation-based Pilates Exercise intervention description The group that will receive telerehabilitation-based pilates training via telerehabilitation intervention arm group label list intervention arm group label Exercise group outcomes module primary outcome list primary outcome primary outcome measure Dynamic Balance- Baseline primary outcome description Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. (0 = worst,56 = best) primary outcome time frame Assessment will be conducted before the intervention primary outcome measure Dynamic Balance-Post intervention primary outcome description Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. (0 = worst,56 = best) primary outcome time frame Assessment will be conducted immediately after the intervention. primary outcome measure Static Balance- Baseline primary outcome description Biodex Balance System primary outcome time frame Assessment will be conducted before the intervention. primary outcome measure Static Balance- Post intervention primary outcome description Biodex Balance System primary outcome time frame Assessment will be conducted immediately after the intervention. primary outcome measure An individual's confidence in performing activities- Baseline primary outcome description Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best) primary outcome time frame Assessment will be conducted before the intervention. primary outcome measure An individual's confidence in performing activities- Post intervention primary outcome description Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best) primary outcome time frame Assessment will be conducted immediately after the intervention. primary outcome measure Exercise capacity- Baseline primary outcome description Six minute walk test primary outcome time frame Assessment will be conducted before the intervention. primary outcome measure Exercise capacity- Post intervention primary outcome description Six minute walk test primary outcome time frame Assessment will be conducted immediately after the intervention. primary outcome measure Gait parameters- Baseline primary outcome description Wearable system (G-Walk) primary outcome time frame Assessment will be conducted before the intervention. primary outcome measure Gait parameters- Post intervention primary outcome description Wearable system (G-Walk) primary outcome time frame Assessment will be conducted immediately after the intervention. primary outcome measure Functional mobility- Baseline primary outcome description Timed up go test primary outcome time frame Assessment will be conducted before the intervention. primary outcome measure Functional mobility- Post intervention primary outcome description Timed up go test primary outcome time frame Assessment will be conducted immediately after the intervention. primary outcome measure Core endurance- Baseline primary outcome description Mcgill core endurance tests primary outcome time frame Assessment will be conducted before the intervention. primary outcome measure Core endurance- Post intervention primary outcome description Mcgill core endurance tests primary outcome time frame Assessment will be conducted immediately after the intervention. primary outcome measure Core strength- Baseline primary outcome description Mcgill core strength tests primary outcome time frame Assessment will be conducted before the intervention. primary outcome measure Core strength-Post intervention primary outcome description Mcgill core strength tests primary outcome time frame Assessment will be conducted immediately after the intervention. primary outcome measure Muscle Strength outcomes- Baseline primary outcome description Hand dynamometer (Baseline®, White Plains, New York, US) primary outcome time frame Assessment will be conducted before the intervention. primary outcome measure Muscle Strength outcomes- Post intervention primary outcome description Hand dynamometer (Baseline®, White Plains, New York, US) primary outcome time frame Assessment will be conducted immediately after the intervention. secondary outcome list secondary outcome secondary outcome measure Physical activity level- Baseline secondary outcome description international physical activity questionnaire (IPAQ). IPAQ assesses physical activity undertaken across a comprehensive set of domains including leisure time, domestic and gardening (yard) activities, work-related and transport-related activity. The items were structured to provide separate scores on walking; moderate-intensity; and vigorous-intensity activity as well as a combined total score to describe overall level of activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activity. (0 Metabolic equivalents (MET) minutes/week= worst, >3000 MET minutes/week= best) secondary outcome time frame Assessment will be conducted before the intervention. secondary outcome measure Physical activity level- Post intervention secondary outcome description international physical activity questionnaire (IPAQ). IPAQ assesses physical activity undertaken across a comprehensive set of domains including leisure time, domestic and gardening (yard) activities, work-related and transport-related activity. The items were structured to provide separate scores on walking; moderate-intensity; and vigorous-intensity activity as well as a combined total score to describe overall level of activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activity. (0 Metabolic equivalents (MET) minutes/week= worst, >3000 MET minutes/week= best) secondary outcome time frame Assessment will be conducted immediately after the intervention. secondary outcome measure Fatigue severity- Baseline secondary outcome description Fatigue severity scale, A self-report scale is a 9-item scale which measures the severity of fatigue. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63 (9 = best, 63 = worst) secondary outcome time frame Assessment will be conducted before the intervention. secondary outcome measure Fatigue severity- Post intervention secondary outcome description Fatigue severity scale, A self-report scale is a 9-item scale which measures the severity of fatigue. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63 (9 = best, 63 = worst) secondary outcome time frame Assessment will be conducted immediately after the intervention. secondary outcome measure Impact of fatigue on activities- Baseline secondary outcome description Fatigue impact scale. The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Answers are scored on a four point scale where 0 = no problem and 4 = extreme problem. (0 = best, 160 = worst) secondary outcome time frame Assessment will be conducted before the intervention. secondary outcome measure Impact of fatigue on activities- Post intervention secondary outcome description Fatigue impact scale. The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Answers are scored on a four point scale where 0 = no problem and 4 = extreme problem. (0 = best, 160 = worst) secondary outcome time frame Assessment will be conducted immediately after the intervention. secondary outcome measure Health related quality of life- Baseline secondary outcome description Multiple Sclerosis Quality of Life (MSQOL)-54 scale.. There is no single overall score for the MSQOL-54. Two summary scores -physical health and mental health- can be derived from a weighted combination of scale scores. (0=worst, 100=best) secondary outcome time frame Assessment will be conducted before the intervention. secondary outcome measure Health related quality of life- Post intervention- Post intervention secondary outcome description Multiple Sclerosis Quality of Life (MSQOL)-54 scale.. There is no single overall score for the MSQOL-54. Two summary scores -physical health and mental health- can be derived from a weighted combination of scale scores. (0=worst, 100=best) secondary outcome time frame Assessment will be conducted immediately after the intervention. eligibility module eligibility criteria Inclusion Criteria: 18-65 years of age Voluntarily participate in research to accept Having a diagnosis of "Multiple Sclerosis" by a specialist physician Relapse free in the last 3 mounts An Expanded Disability Status Scale (EDSS) score less than or equal to 4 Exclusion Criteria: Any cardiovascular, orthopedic, visual, hearing, and perception problems that may affect the results of the research. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Kader Eldemir, PT, MSc. overall official affiliation Research Assistant overall official role Study Chair overall official name Arzu Güçlü-Gündüz, PT, PhD overall official affiliation Professor overall official role Study Director location list location location facility Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation location city Ankara location country Turkey references module see also link list see also link see also link label related info see also link u r l https://pubmed.ncbi.nlm.nih.gov/?term=Web-based+interventions+in+multiple+sclerosis%3A+the+potential+of+tele-rehabilitation see also link label related info see also link u r l https://pubmed.ncbi.nlm.nih.gov/29859267/ see also link label related info see also link u r l https://pubmed.ncbi.nlm.nih.gov/30744491/ i p d sharing statement module i p d sharing No i p d sharing description There is not a plan to make individual participant data but when the statistical analysis of all data are made, all results will be shared derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009103 condition mesh term Multiple Sclerosis condition mesh id D000012598 condition mesh term Sclerosis condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000020278 condition ancestor term Demyelinating Autoimmune Diseases, CNS condition ancestor id D000020274 condition ancestor term Autoimmune Diseases of the Nervous System condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000003711 condition ancestor term Demyelinating Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11212 condition browse leaf name Multiple Sclerosis condition browse leaf as found Multiple Sclerosis condition browse leaf relevance high condition browse leaf id M14567 condition browse leaf name Sclerosis condition browse leaf as found Sclerosis condition browse leaf relevance high condition browse leaf id M7516 condition browse leaf name Fatigue condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M21251 condition browse leaf name Demyelinating Autoimmune Diseases, CNS condition browse leaf relevance low condition browse leaf id M21247 condition browse leaf name Autoimmune Diseases of the Nervous System condition browse leaf relevance low condition browse leaf id M6061 condition browse leaf name Demyelinating Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders
NCT04838886
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full study rank 61227 study protocol section identification module n c t id NCT04839211 org study id info org study id 3763-GOA organization org full name Dokuz Eylul University org class OTHER brief title Inspiratory Muscle Training in Heart Failure official title Effects of High Intensity Interval-Based Inspiratory Muscle Training in Patients With Heart Failure status module status verified date November 2022 overall status Completed expanded access info has expanded access No start date struct start date June 3, 2021 start date type Actual primary completion date struct primary completion date November 21, 2022 primary completion date type Actual completion date struct completion date November 21, 2022 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date November 21, 2022 last update post date struct last update post date November 23, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Aylin Tanriverdi responsible party investigator title Research assistant responsible party investigator affiliation Dokuz Eylul University lead sponsor lead sponsor name Dokuz Eylul University lead sponsor class OTHER collaborator list collaborator collaborator name Dokuz Eylül University, Scientific Research Projects Coordination Unit collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to investigate the potential effects of inspiratory muscle training on cardiovascular, respiratory, physical, and psychosocial functions in patients with heart failure. detailed description Heart failure is a syndrome that leads to decreased cardiac output, inflammation, increased catabolism, and prolonged immobilization, causing inspiratory muscle weakness. Cardiac rehabilitation is a well-known treatment approach in heart failure however, the participation rate in cardiac rehabilitation is low. Therefore, inspiratory muscle training may serve as an alternative approach in patients with heart failure. Patients will be randomly allocated into the inspiratory muscle training group and control group. The inspiratory muscle training (IMT) group will carry out IMT sessions three days per week for 8 weeks by using an inspiratory threshold loading device. Each session will consist of seven cycles including 2 min of breathing on an inspiratory loading device followed by 1 min of rest and will last 21 min. IMT will be performed at the tolerable maximum load for each 2-min work interval and will be progressively increased over the 8 weeks. The control group will perform unloaded IMT by using an inspiratory threshold loading device during all training sessions. Data will be collected before and after the treatment by a masked outcome assessor. conditions module condition list condition Chronic Heart Failure design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 34 enrollment type Actual arms interventions module arm group list arm group arm group label Inspiratory muscle training arm group type Experimental arm group description High-intensity interval-based inspiratory muscle training arm group intervention list arm group intervention name Device: Inspiratory muscle training arm group label Sham inspiratory muscle training arm group type Sham Comparator arm group description Unloaded inspiratory muscle training arm group intervention list arm group intervention name Device: Sham inspiratory muscle training intervention list intervention intervention type Device intervention name Inspiratory muscle training intervention description Inspiratory muscle training will be performed three sessions per week as one supervised and two unsupervised for 8 weeks using an inspiratory muscle training device (PowerBreath). The inspiratory muscle training session will consist of 7 cycles including a 2:1 ratio of work and rest interval. Resistance will be adjusted to the highest tolerable load and will be gradually increased. intervention arm group label list intervention arm group label Inspiratory muscle training intervention type Device intervention name Sham inspiratory muscle training intervention description Sham inspiratory muscle training will be performed three sessions per week as one supervised and two unsupervised for 8 weeks using an inspiratory muscle training device (PowerBreath). The inspiratory muscle training session will consist of 7 cycles including a 2:1 ratio of work and rest interval. Resistance will be adjusted to the unloaded. intervention arm group label list intervention arm group label Sham inspiratory muscle training outcomes module primary outcome list primary outcome primary outcome measure Heart rate variability primary outcome description Heart rate variability analysis, which gives information about the cardiac autonomic function, will be obtained from a short-term 5-min ECG recording using a SphygmoCor device. primary outcome time frame change from baseline to 8 weeks primary outcome measure Arterial stiffness primary outcome description Arterial stiffness will be measured using a SphygmoCor device. primary outcome time frame change from baseline to 8 weeks secondary outcome list secondary outcome secondary outcome measure Maximal inspiratory pressure secondary outcome description Maximal inspiratory pressure (MIP) will be measured using an electronic mouth pressure device. A higher inspiratory pressure indicates better inspiratory muscle strength. secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Maximal expiratory pressure secondary outcome description Maximal expiratory pressure (MEP) will be measured using an electronic mouth pressure device. A higher expiratory pressure indicates better expiratory muscle strength. secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Respiratory muscle endurance secondary outcome description Respiratory muscle endurance will be measured using an inspiratory muscle training device (PowerBreath). Higher values indicate better respiratory muscle endurance. secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Forced vital capacity (FVC) secondary outcome description Forced vital capacity will be measured using a spirometer secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Forced expiratory volume in 1 second (FEV1) secondary outcome description The pulmonary function will be measured using a spirometer secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Forced expiratory flow at 25-75% of the vital capacity (FEF 25-75%) secondary outcome description Forced expiratory flow at 25-75% of the vital capacity will be measured using a spirometer secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Dyspnea secondary outcome description Dyspnea will be assessed with the modified Medical Research Council (mMRC) scale. mMRC is a scale of 5 items (0-4). Higher scores indicate higher dyspnea perception. secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Diaphragm thickness secondary outcome description Diaphragm thickness will be measured using a two-dimensional ultrasound machine. secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Quadriceps muscle strength secondary outcome description Quadriceps muscle strength will be measured using a dynamometer. Higher values indicate better quadriceps muscle strength. secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Balance secondary outcome description Balance performance will be assessed with a Balance Master System. secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Functional capacity secondary outcome description Functional capacity will be assessed with 6 minute walk test. secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Physical activity secondary outcome description Physical activity will be assessed with an activity monitor (SenseWear Armband) for consecutive 7 days. secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Frailty secondary outcome description Physical frailty will be assessed with Field Frailty Phenotype. Field Frailty Phenotype consists of 5 criteria and scores 0 to 5. A score of 3-5 indicates frailty. secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Fatigue secondary outcome description Fatigue will be assessed with Fatigue Impact Scale. Fatigue Impact Scale is a 40-item questionnaire. Each item is scored from 0-4 (a 4-point severity scale). The highest score is 160. secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Disease-specific quality of life secondary outcome description Disease-specific quality of life will be assessed with Minnesota Living with Heart Failure Questionnaire. It is a 21-item questionnaire. Each item is scored from 0-5 (a 5-point severity scale). The highest score is 105. secondary outcome time frame change from baseline to 8 weeks secondary outcome measure Health-related quality of life secondary outcome description Health-related quality of life will be assessed with Short-Form 36 Health Survey Questionnaire (SF-36). SF-36 consists of 8 domains. Higher scores indicate a better health-related quality of life. secondary outcome time frame change from baseline to 8 weeks eligibility module eligibility criteria Inclusion Criteria: Diagnosis of heart failure with reduced ejection fraction Clinically stable Functional class II-III according to the New York Heart Association functional classification Having inspiratory muscle weakness (MIP<70%) Volunteer to participation Exclusion Criteria: Congenital heart disease Severe valvular heart disease Cardiac device such as implantable cardioverter defibrillator or cardiac resynchronization therapy Neurological disease Conditions that may limit the physical mobility healthy volunteers No gender All minimum age 45 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Sema Savci overall official affiliation Dokuz Eylul University overall official role Study Director location list location location facility Dokuz Eylul University, School of Physical Therapy and Rehabilitation location city Izmir location zip 35340 location country Turkey i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006333 condition mesh term Heart Failure condition ancestor list condition ancestor condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M8573 condition browse leaf name Heart Failure condition browse leaf as found Heart Failure condition browse leaf relevance high condition browse leaf id M26290 condition browse leaf name Respiratory Aspiration condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04839211
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full study rank 61538 study protocol section identification module n c t id NCT04835168 org study id info org study id BT-11-EoE organization org full name Landos Biopharma Inc. org class INDUSTRY brief title Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis official title A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis status module status verified date March 2022 overall status Withdrawn why stopped The closure of the study is driven by the decision to redesign the study protocol for future studies. expanded access info has expanded access No start date struct start date January 30, 2022 start date type Anticipated primary completion date struct primary completion date April 30, 2022 primary completion date type Anticipated completion date struct completion date June 30, 2022 completion date type Anticipated study first submit date March 10, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date March 10, 2022 last update post date struct last update post date March 25, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Landos Biopharma Inc. lead sponsor class INDUSTRY oversight module is f d a regulated drug Yes is f d a regulated device No description module brief summary The proposed Phase 1b study design is a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis. The primary and secondary objectives of this study is to establish safety and pharmacokinetics of orodispersible BT-11 in active eosinophilic esophagitis (EoE). The exploratory objectives of this study will include effects on disease activity measured by symptoms, endoscopy, histology and biomarkers, health-related quality of life, pharmacokinetics, and safety. detailed description A total of 36 subjects with active eosinophilic esophagitis (≥ 15 eosinophils/HPF; SDI PRO ≥ 5) will be randomized in a 1:1:1 ratio to receive BT-11 500 mg twice daily, BT-11 1000 mg once daily, or placebo. Each of the treatment arms will comprise 12 subjects. The randomization will be stratified by ongoing PPI use at baseline (yes/no) and prior corticosteroid use (yes/no). The study will consist of a 28-day screening period, a 12-week induction phase, and a 2-week post-treatment safety follow-up period. A final analysis will be conducted after all subjects have reached Week 12. conditions module condition list condition Eosinophilic Esophagitis design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label BT-11 500mg arm group type Experimental arm group description Oral arm group intervention list arm group intervention name Drug: BT-11 500mg arm group label BT-11 1000mg arm group type Experimental arm group description Oral arm group intervention list arm group intervention name Drug: BT-11 1000mg arm group label BT-11 Placebo arm group type Placebo Comparator arm group description Oral arm group intervention list arm group intervention name Drug: BT-11 Placebo intervention list intervention intervention type Drug intervention name BT-11 500mg intervention description Subjects will be randomized (1:1:1) to receive BT-11 1000 mg once daily, BT-11 500 mg twice daily, or placebo twice daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive tubes containing the study drug (BT-11 1000 mg, BT-11 500 mg, or placebo). intervention arm group label list intervention arm group label BT-11 500mg intervention type Drug intervention name BT-11 1000mg intervention description Subjects will be randomized (1:1:1) to receive BT-11 1000 mg once daily, BT-11 500 mg twice daily, or placebo twice daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive tubes containing the study drug (BT-11 1000 mg, BT-11 500 mg, or placebo). intervention arm group label list intervention arm group label BT-11 1000mg intervention type Drug intervention name BT-11 Placebo intervention description Subjects will be randomized (1:1:1) to receive BT-11 1000 mg once daily, BT-11 500 mg twice daily, or placebo twice daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive tubes containing the study drug (BT-11 1000 mg, BT-11 500 mg, or placebo). intervention arm group label list intervention arm group label BT-11 Placebo outcomes module primary outcome list primary outcome primary outcome measure Incidence and severity of AEs primary outcome time frame 12 Weeks eligibility module eligibility criteria Inclusion Criteria: male and female subjects aged 18 to 65 years with a diagnosis of eosinophilic esophagitis for at least 3 months; active eosinophilic esophagitis with ≥ 15 eosinophils/HPF in at least 2 of 3 biopsied levels of the esophagus (distal, mid, or proximal), SDI PRO ≥ 5 and 2 or more episodes of dysphagia per week on average; willing to adhere to a stable diet throughout the study. Exclusion Criteria: any active or history of gastrointestinal conditions aside from eosinophilic esophagitis including Crohn's disease, ulcerative colitis, celiac disease or achalasia; gross endoscopic abnormalities in the stomach or duodenum at baseline or found on biopsy specimens; impending or history of need for esophageal surgery; esophageal strictures incapable of being passed by endoscope without dilation; use of biologics, corticosteroids, or immunosuppressants within 4 weeks or 5 half-lives prior to baseline, whichever is longer; recent bacterial, fungal or viral infection prior to screening or baseline; presence or history of any medical condition, including cancer, that may influence the results of the study healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Simon Lichtiger, MD overall official affiliation Landos Biopharma Inc. overall official role Study Director i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004941 condition mesh term Esophagitis condition mesh id D000057765 condition mesh term Eosinophilic Esophagitis condition ancestor list condition ancestor condition ancestor id D000004935 condition ancestor term Esophageal Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005759 condition ancestor term Gastroenteritis condition ancestor id D000004802 condition ancestor term Eosinophilia condition ancestor id D000007960 condition ancestor term Leukocyte Disorders condition ancestor id D000006402 condition ancestor term Hematologic Diseases condition ancestor id D000006969 condition ancestor term Hypersensitivity, Immediate condition ancestor id D000006967 condition ancestor term Hypersensitivity condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M7243 condition browse leaf name Esophagitis condition browse leaf as found Esophagitis condition browse leaf relevance high condition browse leaf id M28004 condition browse leaf name Eosinophilic Esophagitis condition browse leaf as found Eosinophilic Esophagitis condition browse leaf relevance high condition browse leaf id M7237 condition browse leaf name Esophageal Diseases condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M8027 condition browse leaf name Gastroenteritis condition browse leaf relevance low condition browse leaf id M7113 condition browse leaf name Eosinophilia condition browse leaf relevance low condition browse leaf id M10115 condition browse leaf name Leukocyte Disorders condition browse leaf relevance low condition browse leaf id M8642 condition browse leaf name Hematologic Diseases condition browse leaf relevance low condition browse leaf id M9170 condition browse leaf name Hypersensitivity condition browse leaf relevance low condition browse leaf id M9172 condition browse leaf name Hypersensitivity, Immediate condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T2089 condition browse leaf name Eosinophilic Gastroenteritis condition browse leaf as found Eosinophilic Esophagitis condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04835168
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full study rank 61381 study protocol section identification module n c t id NCT04837209 org study id info org study id 20-649 organization org full name Massachusetts General Hospital org class OTHER brief title Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer official title A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR) acronym NADiR status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 21, 2021 start date type Actual primary completion date struct primary completion date April 1, 2023 primary completion date type Anticipated completion date struct completion date December 1, 2029 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 13, 2022 last update post date struct last update post date April 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Alice Ho responsible party investigator title Principal Investigator responsible party investigator affiliation Massachusetts General Hospital lead sponsor lead sponsor name Massachusetts General Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Johns Hopkins University collaborator class OTHER collaborator name University of North Carolina collaborator class OTHER collaborator name University of Pennsylvania collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No is u s export No description module brief summary This research study is looking to see whether the combination of Dostarlimab and Niraparib plus Radiation Therapy (RT) is safe and effective in participants with metastatic triple negative breast cancer. The names of the study treatment involved in this study are: Dostarlimab Niraparib Radiation Therapy (RT), which is given per standard of care. detailed description This is an open-label, phase II study that will evaluate how safe and well the combination of niraparib, dostarlimab, and Radiation Therapy (RT) works in metastatic triple negative breast cancer. Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage associated with metastatic triple negative breast cancer from occurring. Dostarlimab is a type of immunotherapy. It is believed to work by inhibiting (stopping) a protein called PD-1 from working. The PD-1 protein controls parts of the immune system (the system in a person's body that fights against diseases) by shutting down certain immune responses that are responsible for recognizing and destroying cancer cells. The investigators believe that dostarlimab may inhibit the PD-1 protein on triple negative breast cancer cells, thus allowing the immune cells to recognize and destroy cancer cells.Radiation therapy is a standard-of-care treatment that is given to stop the growth of tumors. Radiation therapy can also stimulate the immune system, which leads to the destruction of tumor cells in the treated areas. Combining radiation therapy with anti-cancer drugs like dostarlimab and niraparib may increase the ability of the immune system to control or destroy cancer cells throughout the body. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive the study drugs for up to 2 years or until their triple negative breast cancer worsens Participants will then be followed for up to 5 years. It is expected that about 32 people will take part in this research study. The FDA has not approved niraparib for metastatic triple negative breast cancer, but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has not approved dostarlimab as treatment for any disease. conditions module condition list condition Breast Cancer Triple Negative Breast Cancer keyword list keyword Breast Cancer Triple Negative Breast Cancer design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 32 enrollment type Anticipated arms interventions module arm group list arm group arm group label Niraparib + Dostarlimab + Radiation therapy arm group type Experimental arm group description Study cycle length is 3 weeks. Participants will receive: Niraparib 1x daily during each study cycle Dostarlimab 1x every 3 weeks for 4 study cycles, then 1x every 6 weeks beginning on Cycle 5 Radiation therapy will be given on Days 1, 2, and 3 of Cycle 1. arm group intervention list arm group intervention name Drug: Niraparib Drug: Dostarlimab Radiation: Radiation therapy intervention list intervention intervention type Drug intervention name Niraparib intervention description Capsule, taken by mouth intervention arm group label list intervention arm group label Niraparib + Dostarlimab + Radiation therapy intervention other name list intervention other name Zejula intervention type Drug intervention name Dostarlimab intervention description Intravenous infusion intervention arm group label list intervention arm group label Niraparib + Dostarlimab + Radiation therapy intervention other name list intervention other name TSR-042 WBP-285 intervention type Radiation intervention name Radiation therapy intervention description Radio Therapy intervention arm group label list intervention arm group label Niraparib + Dostarlimab + Radiation therapy outcomes module primary outcome list primary outcome primary outcome measure Overall response rate (ORR)-RECIST primary outcome description Primary endpoint of the study is ORR as measured by RECIST v1.1. ORR will be estimated with the 95% confidence interval, based on the exact binomial distribution primary outcome time frame Enrollment to end of treatment up to 5 years secondary outcome list secondary outcome secondary outcome measure Overall response rate (ORR) by irRECIST criteria secondary outcome description Assessed by irRECIST (Immune-related Response Evaluation Criteria in Solid Tumors) secondary outcome time frame Enrollment to end of treatment up to 5 years secondary outcome measure Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 secondary outcome description NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting secondary outcome time frame Enrollment to end of treatment up to 5 years secondary outcome measure Overall survival (OS) secondary outcome description The OS rate will be estimated by the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation secondary outcome time frame First day of study treatment to the date of death due to any cause, assessed up to 5 years secondary outcome measure Progression-free survival (PFS) secondary outcome description The PFS rate will be estimated by the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation secondary outcome time frame First day of study treatment to the date of disease progression or death due to any cause, whichever came first, assessed up to 5 years secondary outcome measure Change in Quality of Life secondary outcome description To evaluate the change from baseline to 10-weeks in quality of life as assessed by the PROMIS Global Health measure. Survey item responses are based on a 5-point Likert Scale ranging from 1 to 5, with 5 being the best outcome. secondary outcome time frame First day of study treatment to 10 weeks secondary outcome measure Change in PRO-CTCAE secondary outcome description To assess the change from baseline to 10 weeks in patient reported symptoms, as assessed by PRO-CTCAE measure secondary outcome time frame First day of study treatment to 10 weeks secondary outcome measure Change in Social Activity Level secondary outcome description To assess the change from baseline to 10 weeks in social activity level, as assessed by PROMIS Ability to Participate in Social Roles and Activities measure secondary outcome time frame First day of study treatment to 10 weeks secondary outcome measure Trial Satisfaction secondary outcome description To assess trial satisfaction at the end of study treatment, as assessed by Was It Worth It (WIWI) measure. secondary outcome time frame First day of study treatment to end of treatment, assessed up to 2 years other outcome list other outcome other outcome measure Changes in TILs other outcome description Evaluate CD8+/CD3+ T cell infiltration pre-treatment will be compared to CD8+/CD3+ T cell infiltration during treatment (week 7), and correlation with objective response other outcome time frame Enrollment to end of treatment up to 5 years other outcome measure ctDNA other outcome description To evaluate changes in ctDNA using a patient-specific NGS ctDNA assay other outcome time frame Enrollment to end of treatment up to 2 years other outcome measure Quality of Life as assessed by the PROMIS Global Health Measure other outcome description To evaluate differences in quality of life for patients who respond vs. do not respond to treatment as well as for patients with an initial appearance of progression followed by a response (pseudo-progression) other outcome time frame Enrollment to end of treatment up to 5 years other outcome measure PRO-CTCAE other outcome description To evaluate differences in toxicities for patients who respond vs. do not respond to treatment as well as for patients with an initial appearance of progression followed by a response (pseudo-progression). other outcome time frame Enrollment to end of treatment up to 5 years other outcome measure Trial Satisfaction other outcome description To evaluate differences in trial satisfaction for patients who respond vs. do not respond to treatment as well as for patients with an initial appearance of progression followed by a response (pseudo-progression) other outcome time frame Enrollment to end of treatment up to 5 years other outcome measure Social Activity Level other outcome description To evaluate differences in social activity level for patients who respond vs. do not respond to treatment as well as for patients with an initial appearance of progression followed by a response (pseudo-progression) other outcome time frame Enrollment to end of treatment up to 5 years eligibility module eligibility criteria Inclusion Criteria: Age ≥ 18 years. ECOG performance status ≤ 1 Histologically or cytologically-confirmed TNBC (ER <1%, PR <1%, HER-2-neu 0-1+ by IHC or non-FISH-amplified63. ER-low, PR-low (defined as ER and/or PR 1-10%) and HER2-negative patients may also be eligible, as per treating MD discretion). Metastatic or recurrent TNBC. Prior progression on immune-checkpoint inhibitor and/or PDL1-negative. Note: PDL1-status may be determined on tissues from either primary or mTNBC. PD-L1 status must be determined by an FDA-approved assay approved for breast cancer, such as PharmDx IHC (22C3) for pembrolizumab, Ventana (SP142) for atezolizumab No more than 2 prior lines of systemic therapy for inoperable/recurrent or metastatic disease. Note: Prior line of systemic therapy includes targeted or biologic agents in combination or the absence of chemotherapy Radiation is clinically indicated for local control or palliation. At least one tumor for which RT is considered clinically appropriate. At least one radiographically-confirmed metastases index lesion that will not undergo RT and is measurable based on RECIST v1.1. Prior therapy with targeted agents or other forms of immunotherapy is allowed Prior RT is permitted, provided the treating radiation oncologist deems that study RT treatment planning guidelines can be achieved. Available archived tumor tissue of a metastatic tumor collected up to 28 days prior to registration. If archival tissue is unavailable, participant willingness to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 28 days prior to study registration. Adequate organ function (assessed within 8 days prior to initiation of protocol treatment, unless otherwise indicated) as follows: Hematology Absolute Neutrophil Count (ANC) ≥1500/mm3 Platelet Count ≥100,000/mm3 Hemoglobin ≥9.0 g/dL Renal Function Serum Creatinine ≤ 1.5 x upper limit of normal (ULN) or Measured or calculated a creatinine clearance ≥ 60 mL/min for participant with (GFR can also be used in place of creatinine creatinine levels > 1.5 X ULN or CrCl Hepatic Function Total Bilirubin ≤ 1.5 mg/dL (Direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 ULN) INR, PT, aPTT ≤ 1.5 x ULN (participants receiving anticoagulant therapy must have PT or PTT within therapeutic range) Albumin ≥ 2.5 mg/dL Aspartate Aminotransferase (AST) ≤ 2.5 x ULNb Alanine Aminotransferase (ALT) ≤ 2.5 x ULNb ULN = upper normal limit of institution's normal range Creatinine clearance should be calculated per institutional standard. Participants with liver metastases may have AST and/or ALT ≤ 5 x ULN Female participant has a negative urine or serum pregnancy test within 7 days prior to study treatment if a woman has child-bearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons): ≥45 years of age and has not had menses for >1 year Patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure. Women of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 180 days after the last dose of study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient. Male participant agrees to use an adequate method of contraception starting with the first dose of study treatment through 90 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient. Male subjects must not donate sperm starting with the first dose of study drug through 90 days after the last dose of study drug. Participant must agree not to breastfeed during the study or for 30 days after the last dose of study treatment. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment. Ability to swallow (whole) and retain oral medications. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Participants who meet any of the following criteria will be excluded: Known germline or somatic BRCA mutation-positive status Known active brain metastases or LMD (leptomeningeal disease). Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [using the identical imaging modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not been using steroids for at least 7 days prior to study treatment. Known additional malignancy that progressed or required treatment in the last 2 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Prior treatment with either a PARP inhibitor or ICI is permitted, however, prior receipt of both therapies is excluded Receipt of >2 lines of chemo in the metastatic setting (including targeted or biologic agents in combination or the absence of chemotherapy) Hypersensitivity to niraparib or dostarlimab components or its excipients. Participation in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks (or at least 5 half-lives from previous therapy) of the first dose of study treatment. Receipt of prior cytotoxic therapy or targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., > Grade 1 or at baseline) from adverse events due to a previously administered agent, including grade 2 alopecia. Note: Participants with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Patients who have undergone any major surgery within 3 weeks prior to study entry: patients must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Use of local corticosteroid injections (e.g. intra-articular injections), inhaled, intranasal, ophthalmic, and topical corticosteroids, and subjects requiring corticosteroid pre-medication for hypersensitivity reactions (e.g. CT scan pre-medication) are allowed. Known history of/active, non-infectious pneumonitis requiring treatment with steroids or has history of/active interstitial lung disease. Active infection requiring systemic therapy. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. Participant has a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression. Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 180 days after the last dose of trial treatment. Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). Known active Hepatitis B (e.g., HbsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). Known history of active TB (Bacillus Tuberculosis) Receipt of a live vaccine within 14 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy. Participant must not have received colony stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy. Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment. Patient experienced ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Alice Ho, MD, MBA central contact role Contact central contact phone (617) 724-1160 central contact e mail [email protected] overall official list overall official overall official name Alice Ho, MD, MBA overall official affiliation Massachusetts General Hospital overall official role Principal Investigator location list location location facility Sibley Memorial Hospital location status Recruiting location city Washington location state District of Columbia location zip 20016 location country United States location contact list location contact location contact name Jean Wright, MD location contact role Contact location contact phone 202-537-4787 location contact name Jean Wright, MD location contact role Principal Investigator location facility Massachusetts General Hospital Cancer Center location status Recruiting location city Boston location state Massachusetts location zip 02114 location country United States location contact list location contact location contact name Alice Ho, MD, MBA location contact role Contact location contact phone 617-724-1160 location contact e mail [email protected] location contact name Alice Ho, MD, MBA location contact role Principal Investigator location facility University of North Carolina Medical Center location status Not yet recruiting location city Chapel Hill location state North Carolina location zip 27514 location country United States location contact list location contact location contact name Gaorav Gupta, MD, PhD location contact role Contact i p d sharing statement module i p d sharing Yes i p d sharing description The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) i p d sharing time frame Data can be shared no earlier than 1 year following the date of publication i p d sharing access criteria Contact the Partners Innovations team at http://www.partners.org/innovation derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001943 condition mesh term Breast Neoplasms condition mesh id D000064726 condition mesh term Triple Negative Breast Neoplasms condition ancestor list condition ancestor condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000001941 condition ancestor term Breast Diseases condition ancestor id D000012871 condition ancestor term Skin Diseases condition browse leaf list condition browse leaf condition browse leaf id M4372 condition browse leaf name Breast Neoplasms condition browse leaf as found Breast Cancer condition browse leaf relevance high condition browse leaf id M29526 condition browse leaf name Triple Negative Breast Neoplasms condition browse leaf as found Triple Negative Breast Cancer condition browse leaf relevance high condition browse leaf id M4370 condition browse leaf name Breast Diseases condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id C000545685 intervention mesh term Niraparib intervention ancestor list intervention ancestor intervention ancestor id D000067856 intervention ancestor term Poly(ADP-ribose) Polymerase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M289473 intervention browse leaf name Niraparib intervention browse leaf as found Table intervention browse leaf relevance high intervention browse leaf id M205 intervention browse leaf name Poly(ADP-ribose) Polymerase Inhibitors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04837209
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full study rank 61203 study protocol section identification module n c t id NCT04839523 org study id info org study id PTB01 organization org full name Molnlycke Health Care AB org class INDUSTRY brief title Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns official title An Open, Non-comparative, Multi-center Investigation to Evaluate Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 10, 2021 start date type Actual primary completion date struct primary completion date December 31, 2023 primary completion date type Anticipated completion date struct completion date December 31, 2023 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 6, 2022 last update post date struct last update post date April 8, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Molnlycke Health Care AB lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is u s export No description module brief summary This a multi-center, open label, non-comparative, study that will evaluate the clinical safety and performance of Exufiber Ag+ and Exufiber dressings, separately, when used as intended in moderate to high exuding partial thickness burns (PTBs) through assessment of wound progression from baseline to the Subject's last clinical follow-up visit. Sixty-eight (68) eligible subjects, with moderate to high exuding partial-thickness burns, will be selected for treatment with either Exufiber Ag+ silver-coated gelling dressing, or Exufiber gelling dressing. The study will last 5 weeks, with a requirement of 5 study visits in total, including dressing changes at each study visit. detailed description This is a multi-center study taking place in the United States, and conducted at 3-4 sites/locations. It is designed as an open, non-comparative study to test the safety and performance of Exufiber Ag+ and Exufiber in managing burn healing. The primary objective of this study is to evaluate the clinical safety and performance of all study dressings, separately, when used as intended in moderate to high exuding partial thickness burns (PTBs) through assessment of wound progression from baseline to the Subject's last clinical follow-up visit. The dressings are intended to promote healing through the management of the wound environment. Sixty-eight (68) subjects with partial thickness burns will be treated with either Exufiber Ag+ (34 subjects) or Exufiber (34 subjects) primary dressings, at the discretion of the Investigator. Secondary dressings should be non-adherent, non-antimicrobial dressings (local treatment praxis). Each Subject will be evaluated at five (5) planned study visits for a maximum total treatment period of up to 21 days, unless the burn heals. Visit 1 is a baseline visit to enroll Subjects and determine burn extent. Each Subject will be assigned to either Exufiber Ag+ or Exufiber primary dressings and treated according to the Instructions for Use (IFU) and the local clinical routine. Visit 2 is a Confirmation Visit at up to 3 days, where the Investigator will confirm the burn meets study eligibility, and has not progressed to a full-thickness burn. Visits 3, 4, and 5 are follow-up visits at days 7, 14, and 21, respectively, from the date of the primary dressing application. At each follow-up visit the Subject will return to the clinic for evaluation and primary dressing change. Wound progression will be determined by the Investigator at each study visit and measured by three outcome variables (Deteriorated, No Change, Improved). Images of the wound at each follow up visit will be analyzed to determine changes in wound size. Secondary endpoints will be collected identically at each visit at each clinical site to assess safety and performance of the dressings. The secondary objectives are: To evaluate time to discontinuation of study dressings from baseline to the last clinical follow-up visit, up to 21 days. To evaluate clinical outcomes of the study wound from baseline to the last clinical visit up to 21 days. To evaluate epithelization from baseline to the last clinical follow-up visit up to 21 days based on digital photo imaging software measurements. To evaluate a change in wound size from baseline to the last clinical follow-up visit up to 21 days based on digital photo and imaging software measurements. To evaluate healing status, including exudate levels, infection status, and proportion of burn healed, by clinician's visual judgement, at Confirmation Visit (up to 72 hours) and at each clinic follow-up visit, up to 21 days. To evaluate Subject-reported pain at application, during wear, and at dressing changes through questionnaires at each clinic follow-up visit up to 21 days. To evaluate treatment and dressing selections, including type and quantity, at application and at each clinic follow-up visit up to 21 days. To evaluate clinician handling of the dressing at application and at every dressing change performed at the clinic, from baseline and at each follow-up visit up to 21 days. To evaluate clinician assessment of the dressing at application and at every dressing change performed at the clinic, from baseline and at each follow-up visit up to 21 days. conditions module condition list condition Partial-thickness Burn design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design masking description Wound size and tissue type will be assessed by a single, blinded, third-party clinician. The clinician will use imaging software to measure the size of the wound and identify tissue types, from baseline to last clinical follow-up. design who masked list design who masked Outcomes Assessor enrollment info enrollment count 68 enrollment type Anticipated arms interventions module arm group list arm group arm group label Exufiber arm group type Experimental arm group description Treatment with Exufiber gelling fiber dressing arm group intervention list arm group intervention name Device: Exufiber arm group label Exufiber Ag+ arm group type Experimental arm group description Treatment with Exufiber Ag+ silver-coated, gelling fiber dressing arm group intervention list arm group intervention name Device: Exufiber Ag+ intervention list intervention intervention type Device intervention name Exufiber intervention description A sterile nonwoven wound dressing made from highly absorbent PVA fibers. intervention arm group label list intervention arm group label Exufiber intervention type Device intervention name Exufiber Ag+ intervention description A sterile nonwoven wound dressing made from highly absorbent PVA fibers, and coated with silver sulphate. intervention arm group label list intervention arm group label Exufiber Ag+ outcomes module primary outcome list primary outcome primary outcome measure Wound progression primary outcome description A subjective measurement to determine wound progression since the last visit, determined by three outcome variables: Deteriorated No Change Improved primary outcome time frame 5 weeks secondary outcome list secondary outcome secondary outcome measure Time to discontinuation of study dressings secondary outcome description Measured by time (in days) from baseline to last clinical follow-up secondary outcome time frame 5 weeks secondary outcome measure Wound Size secondary outcome description Wound size (measured in inches or centimeters), at each study visit, from baseline to last clinical follow-up, using planimetry software to obtain measurements from digital photographs. Measurements to include length, width, and depth. secondary outcome time frame 5 weeks secondary outcome measure Re-epithelialization of wound secondary outcome description A measure of re-epithelization tissue, as a percentage of wound, from baseline to last clinical follow-up, using planimetry software to obtain measurements from digital photographs. secondary outcome time frame 5 weeks secondary outcome measure Wound Exudate secondary outcome description Evaluate the level of wound exudate, using the variables listed below: Dry Moist Wet Saturated Leaking secondary outcome time frame 5 weeks secondary outcome measure Wound Maceration secondary outcome description Determine the presence of wound maceration, using the variables listed below: Yes No secondary outcome time frame 5 weeks secondary outcome measure Proportion of Burn Healed secondary outcome description Evaluate the proportion of the burn that is healed, by clinician judgement, using the variables listed below: No healing 0-30% healed 31-70% healed 71-99% healed 100% healed secondary outcome time frame 5 weeks secondary outcome measure Blistering secondary outcome description Determine the presence of wound blistering, using the variables listed below: Yes No secondary outcome time frame 5 weeks secondary outcome measure Wound Redness/Irritation peri-wound skin secondary outcome description Determine the presence of redness and irritation on the peri-wound skin, using the variables listed below: Yes No secondary outcome time frame 5 weeks secondary outcome measure Exudate Nature secondary outcome description Determine the nature of wound exudate, using the variables listed below: Serous Serosanguinous Sanguineous Purulent secondary outcome time frame 5 weeks secondary outcome measure Malodor secondary outcome description Determine the presence of wound malodor, using the variables listed below: None Slight Moderate Strong secondary outcome time frame 5 weeks secondary outcome measure Burn odor secondary outcome description Determine the presence of burn odor, using the variables listed below: Yes No secondary outcome time frame 5 weeks secondary outcome measure Local infection secondary outcome description Determine the presence of signs of local wound infection, using the variables listed below: New / Increasing Pain Delayed / Stalled Healing Purulent discharge Erythema Local Warmth Exudation Odor Pyrexia Induration Leukocytosis Edema / Swelling Eschar secondary outcome time frame 5 weeks secondary outcome measure Subject pain secondary outcome description Measured at dressing application, change, and removal, using a patient reported outcome questionnaire that is used to evaluate pain intensity on a validated scale from 0-10. A higher score correlates with greater experienced pain. secondary outcome time frame 5 weeks secondary outcome measure Dressing Adherence secondary outcome description Subjective measurement to asses performance of the primary dressing and its adherence to the wound bed, using the variables listed below: Yes No secondary outcome time frame 5 weeks secondary outcome measure Rewetting secondary outcome description Subjective measurement to asses performance of the primary dressing and the need for re-wetting prior to removal, using the variables listed below: Yes No secondary outcome time frame 5 weeks secondary outcome measure Dressing ability to rehydrate secondary outcome description Subjective measurement to asses performance of the primary dressing and its ability to rehydrate the wound, using the variables listed below: Very poor Poor Good Very good N/A secondary outcome time frame 5 weeks secondary outcome measure Dressing ability to retain exudate secondary outcome description Subjective measurement to asses performance of the primary dressing and its ability to retain wound exudate, using the variables listed below: Very poor Poor Good Very good N/A secondary outcome time frame 5 weeks secondary outcome measure Dressing ability to absorb blood secondary outcome description Subjective measurement to asses performance of the primary dressing and its ability to absorb blood, using the variables listed below: Very poor Poor Good Very good N/A secondary outcome time frame 5 weeks secondary outcome measure Dressing ability to retain slough secondary outcome description Subjective measurement to asses performance of the primary dressing and its ability to retain slough, using the variables listed below: Very poor Poor Good Very good N/A secondary outcome time frame 5 weeks secondary outcome measure Dressing ability to clean wound bed secondary outcome description Subjective measurement to asses performance of the primary dressing and its ability to clean the wound bed, using the variables listed below: Very poor Poor Good Very good N/A secondary outcome time frame 5 weeks secondary outcome measure Dressing ability to retain gelling properties secondary outcome description Subjective measurement to asses performance of the primary dressing and its ability to retain its gelling properties, using the variables listed below: Very poor Poor Good Very good N/A secondary outcome time frame 5 weeks secondary outcome measure Dressing ability to retain balanced moist environment secondary outcome description Subjective measurement to asses performance of the primary dressing and its ability to retain a balanced moist environment, using the variables listed below: Very poor Poor Good Very good N/A secondary outcome time frame 5 weeks secondary outcome measure Dressing conformability secondary outcome description Subjective measurement to assess performance of the primary dressing and its ability to conform, using the variables listed below: Very poor Poor Good Very good N/A secondary outcome time frame 5 weeks secondary outcome measure Dressing flexibility secondary outcome description Subjective measurements to assess performance of the primary dressing and its flexibility, using the variables listed below: Very poor Poor Good Very good N/A secondary outcome time frame 5 weeks secondary outcome measure Ease of dressing application secondary outcome description Subjective measurement to assess the handling of the primary dressing and ease of dressing application, using the variables listed below: Very poor Poor Good Very good N/A secondary outcome time frame 5 weeks secondary outcome measure Ease of dressing removal with and without moistening secondary outcome description Subjective measurement to assess the handling of the primary dressing and ease of removal with and without moistening, using the variables listed below: Very poor Poor Good Very good N/A secondary outcome time frame 5 weeks secondary outcome measure Dressing removal in one piece secondary outcome description Subjective measurement to assess the handling of primary dressing and its ability to be removed in one piece, using the variables listed below: Yes No secondary outcome time frame 5 weeks secondary outcome measure Residuals of dressing material in the wound or surrounding skin secondary outcome description Subjective measurement to assess presence of primary dressing residuals in the wound or surrounding skin at the time of removal, using the variables listed below: Yes No secondary outcome time frame 5 weeks secondary outcome measure Bleeding at removal secondary outcome description Subjective measurement to assess presence of bleeding at the time of primary dressing removal, using the variables listed below: Yes No secondary outcome time frame 5 weeks eligibility module eligibility criteria Inclusion Criteria: Signed informed consent Burn of thermal origin Patients presenting with partial thickness burns covering < 5% TBSA for study treatment TBSA covered with any burn type is ≤15%, with a maximum of 10% being full thickness burns Clean wounds with ≤10% necrotic tissue Patients presenting with moderate to high exuding wounds Serous or Serosanguinous exudate Patient is not contraindicated for the dressing to which he/she is assigned Exclusion Criteria: Electrical Burns Chemical Burns including acidic or basic sources Ionizing radiation injuries Dry wounds Neonates Patients with delayed presentation for burn care (>72 hours from time of injury) Before entry into the study, treatment to the study wound included an active agent that would confound study results, as determined by the Investigator Burns under study treatment transitioning to full thickness, or deep partial thickness burns requiring surgical treatment Clinically infected burn Patients with insulin dependent diabetes mellitus Patients treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone per day or equivalent Patients who have used immunosuppressive agents, radiation or chemotherapy within past 30 days Known allergy/hypersensitivity to any of the components of the investigation products History of comorbid conditions or diagnoses associated with higher risk of infection as determined by the Investigator Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer, severe anemia) Patients that are not expected to comply with the investigation due to physical and/or mental conditions Pregnancy Participation in other clinical investigation(s) within 1 month prior to start of the investigation Previously enrolled in this investigation healthy volunteers No gender All minimum age 4 Weeks std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Jennifer O'Connell central contact role Contact central contact phone +1 470 694-0750 central contact e mail [email protected] location list location location facility Drexel Univerisity location status Recruiting location city Philadelphia location state Pennsylvania location zip 19102 location country United States location contact list location contact location contact name Paul Glat, MD location contact role Contact location contact name Paul Glat, MD location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002056 condition mesh term Burns condition ancestor list condition ancestor condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition browse leaf list condition browse leaf condition browse leaf id M4478 condition browse leaf name Burns condition browse leaf as found Burn condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions
NCT04839523
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full study rank 61186 study protocol section identification module n c t id NCT04839744 org study id info org study id SYSA1803-CSP-005 organization org full name CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. org class INDUSTRY brief title A Comparative Study of TG103 Produced by Two Manufacturing Processes in Chinese Healthy Male Subjects official title A Randomized, Open-label, Parallel-Group, Comparative Study in Chinese Healthy Male Subjects to Evaluate the Safety and Pharmacokinetic Profile of TG103 Injection Produced by Two Different Manufacturing Processes status module status verified date December 2021 overall status Completed expanded access info has expanded access No start date struct start date May 18, 2021 start date type Actual primary completion date struct primary completion date June 15, 2021 primary completion date type Actual completion date struct completion date July 2, 2021 completion date type Actual study first submit date March 25, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date December 7, 2021 last update post date struct last update post date December 22, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study is designed to evaluate the comparability of TG103 injection subject to changes in the manufacturing process in Chinese healthy male subjects. detailed description This is a randomized, open-label, parallel-group, comparative study to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles, safety, and immunogenicity of TG103 injection produced by two different manufacturing processes in Chinese healthy male subjects. Approximately 24 eligible subjects will be randomized in a 1:1 ratio to receive a single dose of TG103 produced by the modified manufacturing process or TG103 produced by the original manufacturing process via subcutaneous (SC) injection. conditions module condition list condition Healthy Male Subjects design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 24 enrollment type Actual arms interventions module arm group list arm group arm group label TG103 produced by the modified manufacturing process arm group type Experimental arm group description A single dose of TG103 (15mg) produced by the modified manufacturing process will be administered subcutaneously (SC) in healthy male subjects. arm group intervention list arm group intervention name Drug: TG103 produced by the modified manufacturing process arm group label TG103 produced by the original manufacturing process original manufacturing process arm group type Active Comparator arm group description A single dose of TG103 (15mg) produced by the original manufacturing process will be administered subcutaneously (SC) in healthy male subjects. arm group intervention list arm group intervention name Drug: TG103 produced by the original manufacturing process intervention list intervention intervention type Drug intervention name TG103 produced by the modified manufacturing process intervention description Drug: TG103 (a modified manufacturing process), 15mg, SC intervention arm group label list intervention arm group label TG103 produced by the modified manufacturing process intervention type Drug intervention name TG103 produced by the original manufacturing process intervention description Drug: TG103 (the original manufacturing process), 15mg, SC intervention arm group label list intervention arm group label TG103 produced by the original manufacturing process original manufacturing process outcomes module primary outcome list primary outcome primary outcome measure Peak Plasma Concentration (Cmax) primary outcome time frame Day1-5, 7,9,10, 15, and 28 primary outcome measure Area under the plasma concentration versus time curve (AUC) primary outcome time frame Day1-5, 7,9,10, 15, and 28 secondary outcome list secondary outcome secondary outcome measure Change from baseline in Fasting blood glucose(FPG) secondary outcome description Pharmacodynamic (PD) parameters after administration of of TG103 secondary outcome time frame Day1-5, and 7 secondary outcome measure Change from baseline in 2-hour postprandial blood glucose(2hPG) secondary outcome description Pharmacodynamic (PD) parameters after administration of of TG103 secondary outcome time frame Day1-5, and 7 secondary outcome measure Number of participants with treatment-emergent adverse events secondary outcome description Pharmacodynamic (PD) parameters after administration of of TG103 secondary outcome time frame Up to 28 days secondary outcome measure Concentration of Antidrug antibodies(ADA) secondary outcome description ADA after administration of of TG103 secondary outcome time frame Day1, 15, and 28 eligibility module eligibility criteria Inclusion Criteria: 1. Male subjects between 18 and 45 years of age, inclusive; 2. The subject is in good health as determined by medical history, physical examination and clinical laboratory parameters, such as vital signs, 12-lead ECG, imaging examinations (such as thyroid color Doppler ultrasound, abdominal color Doppler ultrasound, chest X-ray); 3. Weight ≥ 50kg, body mass index (BMI) between 19-26 kg / m2 (inclusive) [BMI = weight (kg) / height 2 (m2)]; 4. The subject has a blood glucose between 3.9-6.1 mmol / L (exclusive) and the HbA1c < 6.5%; 5. From the date of signing an informed consent to at least 3 months after the administration, the subject must use reliable contraceptive methods to prevent pregnancy; 6. The subjects fully understand the content of the trial and the possible adverse reactions, have the ability to communicate with the researchers normally, willing and able to comply with all requirements defined in the protocol; 7. Voluntarily to participate in the study and sign the informed consent form. Exclusion Criteria: 1. Subjects who have a history of certain allergic conditions (such as asthma, urticaria), or have a history of allergy to two or more drugs or food, or may be allergic to the test drug and the related compounds; 2. Have a history of serious diseases, such as neurological, hepatic, renal, cardiovascular, haematological, pulmonary diseases, or other significant diseases capable of significantly altering the absorption, metabolism, or elimination of the study drug, of constituting a risk when taking the study drug; or of interfering with the interpretation of data; 3. Have undergone major surgery within 3 months before screening or have severe infection within 4 weeks before screening; 4. With thyroid dysfunction requiring drug treatment, or not reaching clinical stability after treatment, or with other endocrine diseases that may affect blood glucose metabolism; 5. Have a history of or current pancreatitis (history of chronic or acute pancreatitis); 6. Have a history of or current cholecystitis; 7. With clinically significant abnormal gastric emptying (such as gastric outlet obstruction) and severe chronic gastrointestinal diseases (such as active ulcer within 6 months); 8. Have a history (or family history) of medullary thyroid cancer (MTC), type 2 multiple endocrine neoplasia syndrome or other hereditary diseases that are thought to induce MTC; 9. Have a history of malignant tumour, mental illness, depression, anxiety and epilepsy; 10. Have a history of drug dependence in the past one year or have a positive urine drug screen before administration; 11. Vaccinated within 28 days before screening or planned to be vaccinated within 1 week after receiving the study drug; 12. Have a positive test result of hepatitis B surface antigen, hepatitis C antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody; 13. Blood loss greater than 400 ml due to blood donation or other reasons within 3 months before screening; 14. Have used Glucagon-like peptide-1 (GLP-1) analogues, GLP-1 receptor agonists or any other incretin analogues three months before the planned study drug , or other drugs that are thought to affect the trial in the opinion of the researchers; 15. Within 3 months before administration, subjects used drugs that may cause changes in blood glucose level; 16. Have used any prescription drug, Chinese herbal medicine or over-the-counter drug within 15 days before screening that are capable of affecting the PK, PD and safety outcomes; 17. Average alcohol intake is more than 21 units of alcohol (male) per week (1 unit ≈ 360mL beer, or 45mL spirits with 40% alcohol content, or 150mL wine) within the 3 months prior to screening, or a positive ethanol breath test at screening; 18. Regularly consumption of caffeine is more than 600 mg per day within the 3 months prior to screening (one cup of coffee contains about 100 mg of caffeine, one cup of tea contains about 30 mg of caffeine, and one can of coke contains about 20 mg of caffeine), or those who used caffeinated products within 48 hours before administration; 19. Smoking more than 5 cigarettes per day within 3 months prior to screening; 20. According to the judgment of the researcher, the subjects have special dietary requirements; 21. With dermatitis or abnormal skin conditions at or around the site of administration; 22. Have participated in another clinical trial involving an investigational product within 3 months prior to the planned administration of the study drug; or the last dose of the previous investigational product has been given in less than 3 months before the screening; or those who would try to participate in other clinical trials during the study period; 23. Not suitable for this study in the researcher's opinion, such as subjects with poor compliance (long-term business trip, planned relocation, etc.). healthy volunteers Accepts Healthy Volunteers gender Male minimum age 18 Years maximum age 45 Years std age list std age Adult contacts locations module overall official list overall official overall official name Juan Li overall official affiliation The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School overall official role Principal Investigator location list location location facility The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School location city Nanjing location state Jiangsu location zip 210008 location country China i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022
NCT04839744
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full study rank 61810 study protocol section identification module n c t id NCT04831632 org study id info org study id 091/2020 organization org full name Hospital El Cruce org class OTHER brief title Diagnostic Performance Assessment of Qualitative Ifobt and Quantitative Ifobt for Advanced Neoplastic official title Diagnostic Performance Assessment of Qualitative Ifobt and Various Quantitative Ifobt Cut-off Points for Advanced Neoplastic Wound Screening in an Argentine Patient Cohort status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 1, 2021 start date type Anticipated primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name CECILIA CURVALE responsible party investigator title Clinical Investigator responsible party investigator affiliation Hospital El Cruce lead sponsor lead sponsor name CECILIA CURVALE lead sponsor class OTHER collaborator list collaborator collaborator name Ministry of Public Health, Argentina collaborator class OTHER_GOV oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary In Argentina, there is vast experience in qualitative iFOBT population screening that is part of the CRC Prevention and Early Detection National Program. The screening's cut-off point is at 50 ng/mL buffer. Its positivity rate for 2019 has been an average of 26.15%, over the double of the one reported in the international literature (7.5-11%) for this cut-off point (1). There are no studies that assess such technology and suggest an appropriate cut-off point for this population. The goal of this study is to assess the diagnostic performance of the qualitative iFOBT used in the present and the quantitative iFOBT with various cut-off points for advanced neoplastic wound screening (colorectal cancer and advanced adenoma) in an Argentine patient cohort. conditions module condition list condition Colorectal Neoplasms keyword list keyword screening colorectal cancer fecal immunochemical test FIT accuracy design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Cross-Sectional enrollment info enrollment count 630 enrollment type Anticipated arms interventions module arm group list arm group arm group label people aged 50-75 arm group description men and women aged 50-75 who belong to Hospital El Cruce's coverage area and do not have personal history of colorectal cancer or inflammatory bowel disease, personal or family history of syndromes of predisposition to known cancers, or family history of colorectal cancer in a first-degree relative aged less than 60 arm group intervention list arm group intervention name Diagnostic Test: quantitative and qualitative iFOBTs intervention list intervention intervention type Diagnostic Test intervention name quantitative and qualitative iFOBTs intervention description They will have their qualitative and quantitative iFOBTs done within the week prior to the VCC study completion. The reading of both of them will be done in Hospital El Cruce's laboratory. The result of the qualitative iFOBT will have two valid expressions: positive or negative.The result of the quantitative iFOBT will be expressed as µg from hemoglobin per gram of fecal matter through the use of automatized equipment for laboratory analysis. intervention arm group label list intervention arm group label people aged 50-75 outcomes module primary outcome list primary outcome primary outcome measure diagnostic performance primary outcome description To determine the diagnostic performance of the quantitative iFOBT with various cut-off points and the qualitative iFOBT, compared to the VCC, when detecting advanced colon neoplasms. primary outcome time frame 2 years secondary outcome list secondary outcome secondary outcome measure qualitative iFOBT positivity rate secondary outcome description To set the qualitative iFOBT positivity rate at 50 ng/mL in a controlled Argentine cohort. secondary outcome time frame 2 years eligibility module eligibility criteria Inclusion Criteria: men and women aged 50-75 Hospital El Cruce's coverage area and Exclusion Criteria: those that have taken part in a previous VCC screening in the 5 past years or in a CRC screening program the year before the recruitment personal history of colorectal cancer or inflammatory bowel disease, personal or family history of syndromes of predisposition to known cancers, or family history of colorectal cancer in a first-degree relative aged less than 60 those refuse to sign the consent form to take part in this study healthy volunteers Accepts Healthy Volunteers gender All minimum age 50 Years maximum age 75 Years std age list std age Adult Older Adult study population people who belong to Hospital El Cruce's coverage area sampling method Probability Sample contacts locations module central contact list central contact central contact name Raúl Matanó, Doctor central contact role Contact central contact phone 5492214203306 central contact e mail [email protected] central contact name Cecilia Curvale, Doctor central contact role Contact central contact phone 5491140878193 central contact e mail [email protected] location list location location facility Hospital El Cruce location city Florencio Varela location state Buenos Aires location zip 1888 location country Argentina i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015179 condition mesh term Colorectal Neoplasms condition ancestor list condition ancestor condition ancestor id D000007414 condition ancestor term Intestinal Neoplasms condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000003108 condition ancestor term Colonic Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000012002 condition ancestor term Rectal Diseases condition browse leaf list condition browse leaf condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M17042 condition browse leaf name Colorectal Neoplasms condition browse leaf as found Colorectal Neoplasms condition browse leaf relevance high condition browse leaf id M9600 condition browse leaf name Intestinal Neoplasms condition browse leaf relevance low condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M5488 condition browse leaf name Colonic Diseases condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M13996 condition browse leaf name Rectal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M207490 intervention browse leaf name Chrysarobin intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04831632
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full study rank 61590 study protocol section identification module n c t id NCT04834492 org study id info org study id Crowe type 4 organization org full name Private Ortopedia Hospital, Seyhan Adana org class OTHER brief title The Results of Total Hip Arthroplasty in Crowe Type 4 Hips. official title At Least 10-Year Results of Cementless Ceramic-On-Ceramic Total Hip Arthroplasty Performed With Transverse Subtrochanteric Osteotomy in Crowe Type 4 Hips. status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date July 15, 2020 start date type Actual primary completion date struct primary completion date February 10, 2021 primary completion date type Actual completion date struct completion date March 30, 2021 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Cagri Ors responsible party investigator title Medical Doctor responsible party investigator affiliation Private Ortopedia Hospital, Seyhan Adana lead sponsor lead sponsor name Private Ortopedia Hospital, Seyhan Adana lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Total hip arthroplasty (THA) performed for developmental dysplasia of the hip (DDH) is a technically difficult procedure with a high complication rate, especially in the presence of completely dislocated hips. This study aimed to evaluate the results of at least 10 years of follow-up results of cementless, ceramic-on-ceramic (CoC) total hip arthroplasty performed with transverse subtrochanteric osteotomy in Crowe type 4 hips. detailed description We reviewed retrospectively 67 hips of 50 patients which underwent CoC, cementless THA with transverse subtrochanteric osteotomy between 2008 and 2011. Clinical and radiological data of the hips were examined. Clinical results were evaluated using the Harris Hip Score (HHS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). conditions module condition list condition The Results of Total Hip Arthroplasty in Crowe Type 4 Dysplastic Hips keyword list keyword Developmental dysplasia of the hip, total hip arthroplasty, transverse subtrochanteric shortening osteotomy, ceramic on ceramic, cementless. design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Retrospective enrollment info enrollment count 67 enrollment type Actual arms interventions module intervention list intervention intervention type Procedure intervention name Total hip arthroplasty intervention description Total hip arthroplasty in Crowe type 4 developmental dysplasia of the hip. outcomes module primary outcome list primary outcome primary outcome measure Clinical results primary outcome description Haris Hip Score primary outcome time frame minimum 10 year follow-up eligibility module eligibility criteria Inclusion Criteria: Crowe type 4 developmental dysplasia of the hip Exclusion Criteria: Primary Coxarthrosis gender All std age list std age Child Adult Older Adult study population Crowe type 4 developmental dysplasia of the hip patient sampling method Probability Sample contacts locations module location list location location facility Private Ortopedia Hospital location city Adana location state Seyhan location zip 01130 location country Turkey i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M2364 condition browse leaf name Developmental Dysplasia of the Hip condition browse leaf relevance low condition browse leaf id M8846 condition browse leaf name Hip Dislocation, Congenital condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev All condition browse branch name All Conditions
NCT04834492
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full study rank 61597 study protocol section identification module n c t id NCT04834401 org study id info org study id US-TYS-11909 organization org full name St. Barnabas Medical Center org class OTHER brief title Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in Multiple Sclerosis official title Evaluating the Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in People With Multiple Sclerosis status module status verified date August 2022 overall status Completed expanded access info has expanded access No start date struct start date March 22, 2021 start date type Actual primary completion date struct primary completion date May 17, 2022 primary completion date type Actual completion date struct completion date May 17, 2022 completion date type Actual study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 16, 2022 last update post date struct last update post date August 18, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Matthew A. Tremblay responsible party investigator title Director of Multiple Sclerosis Research responsible party investigator affiliation St. Barnabas Medical Center lead sponsor lead sponsor name St. Barnabas Medical Center lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This observational study is intended to evaluate the effect of disease modifying therapies on antibody responses to the mRNA-1273 vaccine (Moderna) for COVID-19. We hypothesize that the use of certain disease modifying therapies, particularly ocrelizumab, will mute and/or shorten the duration of humoral response to mRNA vaccines. detailed description COVID-19 is a potentially fatal respiratory illness, caused by the novel coronavirus, SARS-CoV-2, which developed into a pandemic claiming the lives of over 500,000 people in the United States and over 2.5 million worldwide. Antibodies against the spike glycoprotein are believed to confer immunity to SARS-CoV-2. Multiple sclerosis (MS) is an autoimmune disease of the central nervous system, which is typically treated with immunomodulating medications, referred to as disease modifying therapies (DMTs). Some DMTs resulted in a diminished capacity to develop antibodies against natural infection with SARS-CoV-2. This study is designed to evaluate and compare the effect of DMTs on antibody response to mRNA vaccines for COVID-19. Serum samples will be collected from 30 participants per treatment arm at 8 weeks, 24 weeks, 36 weeks, and 48 weeks, following vaccination with mRNA-1273. Geometric mean titers of anti-SARS-CoV-2 spike IgG will be measured to evaluate and compare peak antibody titers, as well as the duration of antibody response. The results will likely impact clinical decision-making, and guide treatment strategies for safely managing MS during the ongoing pandemic. conditions module condition list condition Multiple Sclerosis Covid19 keyword list keyword mRNA vaccine Ocrelizumab Natalizumab Dimethyl Fumarate Diroximel Fumarate Interferon Beta SARS-CoV-2 design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective bio spec bio spec retention Samples With DNA bio spec description Serum will be stored for up to 2 years from enrollment enrollment info enrollment count 45 enrollment type Actual arms interventions module arm group list arm group arm group label Natalizumab arm group description Natalizumab (minimum of 6 doses at standard interval) arm group label Fumarates arm group description Fumarates (dimethyl fumarate or diroximel fumarate) arm group label Interferon Beta 1a arm group description Interferon Beta 1a (or pegylated Interferon Beta-1a) arm group label Ocrelizumab arm group description Ocrelizumab (minimum of 2 full cycles of 600mg) outcomes module primary outcome list primary outcome primary outcome measure Geometric mean titers (GMT) of anti-SARS-CoV-2 spike IgG for each treatment at 8 weeks from initial vaccination dose primary outcome description Serum Sample primary outcome time frame 8 weeks secondary outcome list secondary outcome secondary outcome measure Proportion of participants with >4 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks secondary outcome description Serum sample secondary outcome time frame 8 weeks secondary outcome measure Proportion of participants with >2 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks secondary outcome description Serum Sample secondary outcome time frame 8 weeks secondary outcome measure Median time from peak to complete absence of anti-SARS-CoV-2 IgG for each treatment arm secondary outcome description Serum Sample secondary outcome time frame 18 months secondary outcome measure Proportion of spike-specific T-cells/Total T cells secondary outcome description Whole Blood Sample secondary outcome time frame 36 Weeks other outcome list other outcome other outcome measure Proportion of participants with known vaccine-related side effects other outcome description Questionnaire other outcome time frame 8 weeks other outcome measure COVID-19 Infections other outcome description Number of participants with PCR-confirmed COVID-19 infection following vaccination other outcome time frame 18 months other outcome measure Effect of Duration of DMT use on Humoral Response to mRNA-1273 other outcome description Correlation between duration of DMT and GMT values for SARS-CoV-2 IgG within each treatment arm other outcome time frame 8 week eligibility module eligibility criteria Inclusion Criteria: Men and women aged 18 to 65 years inclusive Patients who have signed written informed consent. Patients stable on current MS DMT for >6 months including: Natalizumab (received a minimum of 6 doses per USPI) Fumarates (dimethyl fumarate or diroximel fumarate) Interferon Beta 1a (or pegylated Interferon Beta-1a) Ocrelizumab (received a minimum of 2 full cycles per USPI) Exclusion Criteria: Known history of SARS-CoV-2 infection Is pregnant or breastfeeding ≤6 months on current therapy (MS Participants) Participation in another investigational study Recent immunization with a non-COVID vaccine (within 4 weeks) Known or suspected allergy or history of anaphylaxis or other significant adverse reaction to the COVID-19 vaccine or its excipients Absolute lymphocyte count <0.5 x 10^9/L Concurrent Intravenous or Subcutaneous Immunoglobulin treatment (IVIG/SCIG) Received systemic corticosteroids < 30 days prior to Vaccine Dose 1 Visit and Assessment Schedule: Participants will agree to five visits during the study and serum will be collected at the following time points: Baseline/Screening visit 8 weeks after 1st dose/4 weeks after 2nd dose (+/- 1 week) 24 weeks (+/- 2 weeks) 36 weeks (+/- 4 weeks) 48 weeks (+/- 4 weeks) Approximately 20ml of blood will be collected per patient per each visit. Data Collection Plan and Patient Privacy Protection Prior to any testing under this protocol, including screening tests and assessments, candidates must also provide all authorizations required by local law (e.g., PHI authorization in North America). The subject will not be identified by name in the CRF or in any study reports, and these reports will be used for research purposes only. Ethics committees and various government health agencies may inspect the records of this study. Every effort will be made to keep the subject's personal medical data confidential. gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult study population Participants will be identified from the MS Center utilizing the electronic medical record, clinic visits or telephone encounters related to COVID-19 vaccination and recruited consecutively. Patients who appear to meet eligibility criteria will be contacted by research staff and offered informed consent using the Multiple Sclerosis Comprehensive Care Center standard protocol. If possible the baseline serum sample will be collected at the initial research visit, following the informed consent process. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Matthew A Tremblay, MD, PhD overall official affiliation RWJBarnabas Health overall official role Principal Investigator location list location location facility Saint Barnabas Medical Center location city Livingston location state New Jersey location zip 07039 location country United States i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000009103 condition mesh term Multiple Sclerosis condition mesh id D000012598 condition mesh term Sclerosis condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000020278 condition ancestor term Demyelinating Autoimmune Diseases, CNS condition ancestor id D000020274 condition ancestor term Autoimmune Diseases of the Nervous System condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000003711 condition ancestor term Demyelinating Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11212 condition browse leaf name Multiple Sclerosis condition browse leaf as found Multiple Sclerosis condition browse leaf relevance high condition browse leaf id M14567 condition browse leaf name Sclerosis condition browse leaf as found Sclerosis condition browse leaf relevance high condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M21251 condition browse leaf name Demyelinating Autoimmune Diseases, CNS condition browse leaf relevance low condition browse leaf id M21247 condition browse leaf name Autoimmune Diseases of the Nervous System condition browse leaf relevance low condition browse leaf id M6061 condition browse leaf name Demyelinating Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf relevance low intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse leaf id M288912 intervention browse leaf name Ocrelizumab intervention browse leaf relevance low intervention browse leaf id M411 intervention browse leaf name Natalizumab intervention browse leaf relevance low intervention browse leaf id M9559 intervention browse leaf name Interferons intervention browse leaf relevance low intervention browse leaf id M431 intervention browse leaf name Dimethyl Fumarate intervention browse leaf relevance low intervention browse leaf id M18396 intervention browse leaf name Interferon-beta intervention browse leaf relevance low intervention browse leaf id M272 intervention browse leaf name Interferon beta-1a intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev Derm intervention browse branch name Dermatologic Agents
NCT04834401
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full study rank 61435 study protocol section identification module n c t id NCT04836507 org study id info org study id CRC01-01 organization org full name Curocell Inc. org class INDUSTRY brief title Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma Patients official title An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 2, 2021 start date type Actual primary completion date struct primary completion date May 2023 primary completion date type Anticipated completion date struct completion date February 2028 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 29, 2021 last update post date struct last update post date May 3, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Curocell Inc. lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This is a multi-center, phase I/II study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma. conditions module condition list condition Relapsed Large B-cell Lymphoma Refractory Large B-cell Lymphoma Diffuse Large B-cell Lymphoma (DLBCL) Primary Mediastinal Large B-Cell Lymphoma (PMBCL) High-grade B-cell Lymphoma Transformed Follicular Lymphoma (TFL) keyword list keyword CRC01 anti-CD19 CAR-T CAR-T CAR T cells Chimeric antigen receptor PD-1 knock down TIGIT knock down design module study type Interventional phase list phase Phase 1 Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 91 enrollment type Anticipated arms interventions module arm group list arm group arm group label CRC01 arm group type Experimental arm group description A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CRC01. arm group intervention list arm group intervention name Biological: CRC01 Drug: Fludarabine Drug: Cyclophosphamide intervention list intervention intervention type Biological intervention name CRC01 intervention description A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg. intervention arm group label list intervention arm group label CRC01 intervention type Drug intervention name Fludarabine intervention description Administered according to package insert intervention arm group label list intervention arm group label CRC01 intervention type Drug intervention name Cyclophosphamide intervention description Administered according to package insert intervention arm group label list intervention arm group label CRC01 outcomes module primary outcome list primary outcome primary outcome measure Phase 1 Study: Maximum Tolerated Dose (MTD) which will be the Recommended Phase 2 Dose (RP2D) primary outcome time frame 28 days primary outcome measure Phase 2 Pivotal Study: Overall Response Rate (ORR) primary outcome description ORR is defined as the incidence of either a complete response (CR) or a partial response (PR) per the Lugano Criteria for Response Assessment (2014). primary outcome time frame 5 years secondary outcome list secondary outcome secondary outcome measure Time to response (TTR) secondary outcome time frame 5 years secondary outcome measure Duration of overall response (DOR) secondary outcome time frame 5 years secondary outcome measure Event free survival (EFS) secondary outcome time frame 5 years secondary outcome measure Progression free survival (PFS) secondary outcome time frame 5 years secondary outcome measure Overall survival (OS) secondary outcome time frame 5 years secondary outcome measure Incidence and severity of adverse events (AEs) secondary outcome time frame 5 years secondary outcome measure Incidence of immunogenicity to CRC01 secondary outcome time frame 5 years secondary outcome measure Number of participants with presence of exposure to replication-competent lentivirus (RCL) as Assessed by quantitative polymerase chain reaction (qPCR) secondary outcome time frame 5 years secondary outcome measure Incidence of secondary malignancy secondary outcome time frame 5 years secondary outcome measure Peak concentration (Cmax) of CRC01 transduced cells into target tissues secondary outcome time frame 5 years secondary outcome measure Area under the concentration versus time curve (AUC) of CRC01 transduced cells into target tissues secondary outcome time frame 5 years secondary outcome measure Time to maximum observed concentration (Tmax) of CRC01 transduced cells into target tissues secondary outcome time frame 5 years eligibility module eligibility criteria Inclusion Criteria: ≥ 19 years of age and provided written informed consent Histologically confirmed following large B-cell lymphomas according to the World Health Organization classification 2017 Diffuse large B-cell lymphoma, not otherwise specified Including Large cell transformation from follicular lymphoma (Transformed follicular lymphoma) High-grade B-cell lymphoma, not otherwise specified High-grade B-cell lymphoma with double-hit/triple-hit Primary mediastinal large B cell lymphoma Relapsed or refractory disease after ≥ two lines of chemotherapy including rituximab, anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT) or being ineligible for or not consenting to ASCT. At least one measurable lesion (Long diameter ≥ 1.5cm) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Adequate renal and hepatic functions based on the laboratory test results Total Bilirubin ≤ 2.0mg/dL with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ≤ 3 X ULN and direct bilirubin ≤ 1.5 X ULN. Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 3 X Upper Limit of Normal (ULN) for age with exception of liver metastasis; patients with liver metastasis may be included if their AST and ALT are ≤ 5 X ULN. Serum creatinine ≤ 1.5 X ULN Estimated Glomerular Filtration Rate (eGFR) ≥ 60mL/min/1.73m2 Adequate hematologic function without transfusions within 2 weeks prior to screening for the study defined as followings: Hemoglobin > 8.0g/㎗ Absolute Neutrophil Count (ANC) > 1,000/㎕ Absolute Lymphocyte Count (ALC) ≥ 300/㎕ Platelets ≥ 50,000/㎕ Must have a minimum level of pulmonary reserve defined as; ≤ Grade 1 dyspnea per Common terminology criteria for adverse events (CTCAE) v5.0 pulse oxygenation > 91% on room air Hemodynamically stable, without pericardial effusion and Left Ventricle Ejection Fraction (LVEF) ≥ 50% confirmed by Echocardiogram (ECG) or Multigated Radionuclide Angiography (MUGA) Must have an apheresis product of non-mobilized cells accepted for manufacturing Life expectancy ≥ 12 weeks Women of child-bearing potential and all male participants must agree to use highly effective methods of contraception for at least 12 months following CRC01 infusion and until CRC01 are no longer present by PCR on two consecutive tests Exclusion Criteria: Patients with the following medical history Previous or concurrent malignancy with the following exceptions: Adequately treated basal cell or squamous cell carcinoma without evidence of recurrence for at least 3 years prior to the study In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study A primary malignancy which has been completely resected and in complete remission for ≥ 5 years Unstable angina and/or myocardial infarction within 12 months prior to screening Thromboembolic events, pulmonary embolism or bleeding diatheses within 6 months prior to screening Hypoxemia, significant pleural effusion or significant EKG findings within 6 months prior to the screening Patients with the following concurrent disease at screening: Central Nervous System (CNS) involvement by malignancy by MRI at screening Active infection with hepatitis B (HBsAg positive. But, in case of HBcAb IgG positive, the patient can be enrolled in this study if he/she takes prophylactic anti-viral agent.) Active infection with hepatitis C (HCV RNA positive) Human immunodeficiency virus (HIV) positive Active neurological auto-immune or inflammatory disorder (e.g. Guillain Barre Syndrome, Amyotrophic Lateral Sclerosis) Ventricular tachycardia and atrial fibrillation with rapid ventricular response not controlled with medical treatment within 3 months prior to screening Rapidly progressing the disease as per investigator's discretion Had major surgery requiring general anesthesia or mechanical ventilation within 4 weeks prior to screening (For video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery can be applied with within 2 weeks prior to screening.) Severe infection requiring anti-bacterial, anti-fungal or anti-viral medication or uncontrolled active infection The following treatment history is excluded: Prior treatment with any prior anti-CD19/anti-CD3 therapy or any other anti-CD19 therapy Prior treatment with any adoptive T cell therapy Treatment with any prior gene therapy product Prior allogeneic HSCT Patients on oral anticoagulation therapy Eligible for and consenting to ASCT Use of investigational medicinal product/device within 4 weeks prior to screening Pregnant or lactating women Hypersensitivity reaction to the excipients of CRC01 cell product The following treatments are excluded: Anti-neoplastic therapies including chemotherapy, biologic agents, retinoid therapy, radiotherapy, immune therapy, hormonal therapy, etc. other than lymphodepleting chemotherapy within 2 weeks of leukapheresis and within 2 weeks of CRC01 infusion Steroids: therapeutic doses of steroids must be stopped > 7 days prior to leukapheresis and > 5 days prior to CRC01 infusion. However, the following physiological replacement doses of steroids are allowed: < 6 mg/m2/day hydrocortisone or equivalent Immunosuppression: any immunosuppressive medication must be stopped > 4 weeks prior to leukapheresis and > 4 weeks prior to CRC01 infusion Antibody use including anti-CD20 therapy within 4 weeks prior to CRC01 infusion CNS disease prophylaxis must be stopped > 1 week prior to CRC01 infusion (e.g. intrathecal methotrexate) Other protocol-related inclusion/exclusion may apply. healthy volunteers No gender All minimum age 19 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Bom-I Kwon, BSc central contact role Contact central contact phone +82428633698 central contact e mail [email protected] central contact name Gunsoo Kim, MSc central contact role Contact central contact e mail [email protected] location list location location facility Samsung Medical Center location status Recruiting location city Seoul location zip 06351 location country Korea, Republic of location contact list location contact location contact name Wonseog Kim, MD, PhD location contact role Contact location contact phone +821099335823 location contact e mail [email protected] references module reference list reference reference p m i d 34628052 reference type derived reference citation Lee YH, Lee HJ, Kim HC, Lee Y, Nam SK, Hupperetz C, Ma JSY, Wang X, Singer O, Kim WS, Kim SJ, Koh Y, Jung I, Kim CH. PD-1 and TIGIT downregulation distinctly affect the effector and early memory phenotypes of CD19-targeting CAR T cells. Mol Ther. 2022 Feb 2;30(2):579-592. doi: 10.1016/j.ymthe.2021.10.004. Epub 2021 Oct 8. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008223 condition mesh term Lymphoma condition mesh id D000016393 condition mesh term Lymphoma, B-Cell condition mesh id D000016403 condition mesh term Lymphoma, Large B-Cell, Diffuse condition ancestor list condition ancestor condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000008206 condition ancestor term Lymphatic Diseases condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000008228 condition ancestor term Lymphoma, Non-Hodgkin condition browse leaf list condition browse leaf condition browse leaf id M10372 condition browse leaf name Lymphoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id M10373 condition browse leaf name Lymphoma, Follicular condition browse leaf relevance low condition browse leaf id M17980 condition browse leaf name Lymphoma, B-Cell condition browse leaf as found B-Cell Lymphoma condition browse leaf relevance high condition browse leaf id M17983 condition browse leaf name Lymphoma, Large B-Cell, Diffuse condition browse leaf as found Diffuse Large B-cell Lymphoma (DLBCL) condition browse leaf relevance high condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M10355 condition browse leaf name Lymphatic Diseases condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M10374 condition browse leaf name Lymphoma, Non-Hodgkin condition browse leaf relevance low condition browse leaf id T3543 condition browse leaf name Lymphosarcoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id T2361 condition browse leaf name Follicular Lymphoma condition browse leaf as found Follicular lymphoma condition browse leaf relevance high condition browse leaf id T640 condition browse leaf name B-cell Lymphoma condition browse leaf as found B-Cell Lymphoma condition browse leaf relevance high condition browse leaf id T1866 condition browse leaf name Diffuse Large B-Cell Lymphoma condition browse leaf as found Diffuse Large B-Cell Lymphoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000003520 intervention mesh term Cyclophosphamide intervention mesh id C000024352 intervention mesh term Fludarabine intervention ancestor list intervention ancestor intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018501 intervention ancestor term Antirheumatic Agents intervention ancestor id D000018906 intervention ancestor term Antineoplastic Agents, Alkylating intervention ancestor id D000000477 intervention ancestor term Alkylating Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000019653 intervention ancestor term Myeloablative Agonists intervention browse leaf list intervention browse leaf intervention browse leaf id M5879 intervention browse leaf name Cyclophosphamide intervention browse leaf as found Based intervention browse leaf relevance high intervention browse leaf id M283219 intervention browse leaf name Fludarabine intervention browse leaf as found Twice daily intervention browse leaf relevance high intervention browse leaf id M225481 intervention browse leaf name Fludarabine phosphate intervention browse leaf relevance low intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse leaf id M19757 intervention browse leaf name Antirheumatic Agents intervention browse leaf relevance low intervention browse leaf id M20095 intervention browse leaf name Antineoplastic Agents, Alkylating intervention browse leaf relevance low intervention browse leaf id M2972 intervention browse leaf name Alkylating Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04836507
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full study rank 61535 study protocol section identification module n c t id NCT04835207 org study id info org study id primary ( PCI ) organization org full name Assiut University org class OTHER brief title Metabolic Profile as a Predictor of No-reflow in Diabetic Patients official title Metabolic Profile as a Predictor of No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention ( PCI ) . status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 2021 start date type Anticipated primary completion date struct primary completion date April 2022 primary completion date type Anticipated completion date struct completion date April 2022 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name El Zahraa Gamal responsible party investigator title Metabolic profile as a predictor of no reflow in diabetic patients treated with primary Percutaneous Coronary Intervention (PCI) . responsible party investigator affiliation Assiut University lead sponsor lead sponsor name El Zahraa Gamal lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary to find metabolic factors that correlate with the development of no-reflow phenomenon that may help prevent its occurrence detailed description Acute myocardial infarction (AMI) with its accompanying adverse sequelae is one of the most common causes of morbidity and mortality in the world . Although reperfusion techniques for ST- elevation myocardial infarction (STEMI ) are constantly improving, no-reflow can still lead to poor prognosis . At present, the exact mechanism of no-reflow remains unclear, but clinical and laboratory findings suggest that it is related to the embolism of the capillary bed, ischemic injury, vascular endothelial dysfunction, production of oxygen free radical , and other factors . The no-reflow phenomenon is one of complications of poor functional and clinical outcomes for patients with (AMI) . The no-reflow phenomenon is present in 25% to 30% of patients with (AMI) underwent successful coronary recanalization, as shown by angiography . The myocardial no-reflow phenomenon is associated with a reducution of antegrade myocardial blood flow inspite of an open infarct-related artery in patients with (STEMI ) undergoing (PCI) . Importantly, no-reflow is known to be related to unfavorable clinical outcome and prognosis . The cause of this complex phenomenon is the variable combination of four pathogenetic components: distal atherothrombotic embolization, ischemic injury, reperfusion injury and susceptibility of coronary microcirculation to injury . As a consequence, appropriate strategies are expected to prevent or treat these components are expected to avoid the no-reflow. Coronary reperfusion therapy is widely performed in patients with (AMI) . However, in spite of patency of the infarct-related artery , there is no guarantee of salvage of myocardium at risk of ischemia .The no-reflow phenomenon is found in >30% of patients after thrombolysis or catheter-based (PCI) for (AMI) . It is important, therefore, to be able to predict which lesions are high risk for no reflow before beginning PCI . Many of the well-accepted risk factors for no-reflow are similar to other well-accepted cardiovascular risk factors, such as hypertension, smoking, dyslipidemia, diabetes, and other inflammatory processes. As such, there are some generally accepted measures associated with a lower incidence of no-reflow following PCI for STEMI. For example, in patients with diabetes, optimal blood sugar control before the procedure can reduce the occurrence of no-reflow . There are numerous recognized risk factors for the development of coronary artery disease (CAD), one of the best known is the association between blood lipids and CAD . Several prospective studies have established that the risk of cardiac morbidity and mortality is directly related to the concentration of plasma cholesterol. ' The most prevalent view is that the increased risk of myocardial infarction associated with elevated plasma cholesterol levels can be adequately explained on the basis of the increase in number and severity of coronary atherosclerotic vascular lesions . . Hyperglycemia is associated with The increased mortality in patients with acute myocardial infarction which caused by a larger infarct size, a high incidence of congestive heart failure, and cardiogenic shock, and death after AMI., . However, the underlying mechanisms of these deleterious effects of hyperglycemia are not well understood Uric acid (UA) is a byproduct the terminal steps of purine catabolism, . uric acid synthesis is increased under tissue ischemia. Therefore, elevated uric acid may affect prognosis of (AMI). A few studies have doucomented that UA is associated with therapeutic results in patients with AMI. UA level is appeared to be related to infarct size and hemodynamic derangement. Although prompt restoration of myocardial blood flow is very important for patients with AMI, high levels of UA are doucoumented to be significantly associated with the presence of slow coronary flow conditions module condition list condition Acute Myocardial Infarction (AMI) design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 120 enrollment type Anticipated arms interventions module intervention list intervention intervention type Other intervention name 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S intervention description Blood samples were obtained before PCI, and the following parameters will be measured: 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S outcomes module primary outcome list primary outcome primary outcome measure detection correlation between DM and no-reflow phenomenon primary outcome description measurment of random blood sugar in diabetic patients treated with primary Percutaneous Coronary Intervention ( PCI ) .and show its effects on reflow primary outcome time frame baseline secondary outcome list secondary outcome secondary outcome measure detection correlation between other metabolic factors as serum uric acid and no-reflow phenomenon secondary outcome description Blood samples were obtained before PCI, and the following parameters will be measured :Serum Uric acid : S .UA secondary outcome time frame baseline secondary outcome measure detection correlation between other metabolic factors as LDL\HDL and no-reflow phenomenon secondary outcome description Blood samples were obtained before PCI, and the following parameters will be measured :(LDL\HDL :(low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotei secondary outcome time frame baseline eligibility module eligibility criteria Inclusion Criteria: diabetic patients with ST- elevation myocardial infarction (STEMI ) treated with primary Percutaneous Coronary Intervention ( PCI ) . Exclusion Criteria: diabetic patients with ST- elevation myocardial infarction (STEMI ) treated with primary Percutaneous Coronary Intervention ( PCI ) : but have (1) a history of an unprotected left main artery with severe liver and kidney diseases or coronary artery bypass grafting . (2) patients who had valvular disease or cardiomyopathy . (3) severe dissection, thromboembolism in other parts, or vasospasm; and known malignancy . (4) patients with contraindications for anticoagulant therapy, such as active visceral hemorrhage, hemorrhagic stroke, or ischemic stroke within half a year (including transient ischemic attack), or aortic dissection, or patients with hematological diseases complicated with coagulation disorders . gender All std age list std age Child Adult Older Adult study population diabetic patients with STEMI treated with primary PCI sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name alzahraa gamal, master central contact role Contact central contact phone 01026181748 central contact e mail [email protected] central contact name hatem abdel elrahman central contact role Contact central contact phone 01005212162 central contact e mail [email protected] references module reference list reference reference p m i d 6683937 reference type background reference citation Bernstein JM, Lee J, Conboy K, Ellis E, Li P. The role of IgE mediated hypersensitivity in recurrent otitis media with effusion. Am J Otol. 1983 Jul;5(1):66-9. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009203 condition mesh term Myocardial Infarction condition mesh id D000007238 condition mesh term Infarction condition ancestor list condition ancestor condition ancestor id D000007511 condition ancestor term Ischemia condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000009336 condition ancestor term Necrosis condition ancestor id D000017202 condition ancestor term Myocardial Ischemia condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M11307 condition browse leaf name Myocardial Infarction condition browse leaf as found Myocardial Infarction condition browse leaf relevance high condition browse leaf id M9434 condition browse leaf name Infarction condition browse leaf as found Infarction condition browse leaf relevance high condition browse leaf id M9695 condition browse leaf name Ischemia condition browse leaf relevance low condition browse leaf id M11436 condition browse leaf name Necrosis condition browse leaf relevance low condition browse leaf id M5698 condition browse leaf name Coronary Artery Disease condition browse leaf relevance low condition browse leaf id M18658 condition browse leaf name Myocardial Ischemia condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04835207
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full study rank 61374 study protocol section identification module n c t id NCT04837300 org study id info org study id Majmaah University organization org full name Majmaah University org class OTHER brief title Resisted Sprint and Plyometric Training on Lower Limb Functional Performance in Young Adult Male Football Players. official title Effect of Resisted Sprint and Plyometric Training on Lower Limb Functional Performance in Young Adult Male Football Players. A Randomized Control Trial status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date December 16, 2020 start date type Actual primary completion date struct primary completion date February 10, 2021 primary completion date type Actual completion date struct completion date March 25, 2021 completion date type Actual study first submit date April 3, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Shahnaz Hasan, PhD responsible party investigator title Associate Professor responsible party investigator affiliation Majmaah University lead sponsor lead sponsor name Majmaah University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This study aims to evaluate the short-term effects of resisted sprint training on sprint performance together with lower limb physiological and functional performance in young professional football players. detailed description Ninety collegiate football players were recruited, with a mean age of 20.48 at the university campus. All of which were randomly divided into two experimental groups RST(n=30), PLT (n=30) participated in training for six weeks on alternate days (i.e., three sessions per week) and one control group (n=30) did not train. The control group was instructed to maintain regular activities and avoid any strenuous physical activity during the study. No significant between-group baseline or pre-to-post-training differences in anthropometrics were observed. Under the Declaration of Helsinki, participants were informed about the study's possible risks and benefits, and all participants have signed informed consent before participation in the study. Ethical sub-committee of College of applied medical science, Majmaah, Saudi Arabia approved this study (Ethics Number: MUREC-Dec.15/COM-2020 / 13-2). conditions module condition list condition Football Players keyword list keyword Strength Plyometric training Function performance Resisted sprint training design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized controlled trial design primary purpose Basic Science design masking info design masking Single design masking description Participants design who masked list design who masked Participant enrollment info enrollment count 90 enrollment type Actual arms interventions module arm group list arm group arm group label Experimental-1 arm group type Experimental arm group description Resisted Sprint Training arm group intervention list arm group intervention name Other: Resisted Sprint Traininig arm group label Experimental-2 arm group type Experimental arm group description Plyometric Training arm group intervention list arm group intervention name Other: Resisted Sprint Traininig arm group label Control arm group type No Intervention arm group description No Training intervention list intervention intervention type Other intervention name Resisted Sprint Traininig intervention description The Participants in this group had received plyometrics exercises; double leg jumping, drop jumping, hopping, bounding and hurdling. intervention arm group label list intervention arm group label Experimental-1 Experimental-2 intervention other name list intervention other name Plyometric Training outcomes module primary outcome list primary outcome primary outcome measure Knee Extensors Strength Test. primary outcome description Pretest and post intervention strength measure. primary outcome time frame After 6 weeks of intervention. primary outcome measure Sprint Test. primary outcome description Pretest and post intervention sprint measure. primary outcome time frame After 6 weeks of intervention. primary outcome measure Single-Leg Triple Hop Test. primary outcome description Pretest and post intervention single-leg triple hop measure. primary outcome time frame After 6 weeks of intervention. eligibility module eligibility criteria Inclusion Criteria: Young players aged between 18 and 25 years required frequent sprinting Exclusion Criteria: Current injury to lower limb. Surgery affecting lower limb function. Any cardio-respiratory diseases. Impairments of spine or lower extremities. healthy volunteers Accepts Healthy Volunteers gender Male gender based Yes gender description Male minimum age 18 Years maximum age 25 Years std age list std age Adult contacts locations module overall official list overall official overall official name Shahnaz Hasan, PhD overall official affiliation Majmaah University overall official role Principal Investigator location list location location facility Football Playground location city Riyadh location zip 110045 location country Saudi Arabia references module reference list reference reference p m i d 34206346 reference type derived reference citation Hasan S, Kandasamy G, Alyahya D, Alonazi A, Jamal A, Unnikrishnan R, Muthusamy H, Iqbal A. Effect of Resisted Sprint and Plyometric Training on Lower Limb Functional Performance in Collegiate Male Football Players: A Randomised Control Trial. Int J Environ Res Public Health. 2021 Jun 22;18(13). pii: 6702. doi: 10.3390/ijerph18136702. i p d sharing statement module i p d sharing No i p d sharing description Data has been kept secure with the principal investigator Dr. Shahnaz Hasan and the sub-investigator due to the confidentiality issues. derived section misc info module version holder December 02, 2022
NCT04837300
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full study rank 61858 study protocol section identification module n c t id NCT04831008 org study id info org study id 2020-149 organization org full name Delray Medical Center org class OTHER brief title Comparison of Figure-Of-Eight Suture Perclose ProGlide Suture-Mediated Closure official title Comparison of Figure-Of-Eight Suture and Perclose ProGlide Suture-Mediated Closure System in Achieving Hemostasis After a Large Bore Venous Access. status module status verified date August 2021 overall status Recruiting expanded access info has expanded access No start date struct start date August 6, 2020 start date type Actual primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date December 2022 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date August 17, 2021 last update post date struct last update post date August 19, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Houman Khalili MD responsible party investigator title Principal Investigator responsible party investigator affiliation Delray Medical Center lead sponsor lead sponsor name Delray Medical Center lead sponsor class OTHER collaborator list collaborator collaborator name Florida Atlantic University collaborator class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique. detailed description Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis. conditions module condition list condition Venous Puncture keyword list keyword Perclose Device Figure-of-eight suture design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Other design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 50 enrollment type Anticipated arms interventions module arm group list arm group arm group label Figure-of-eight arm group type Active Comparator arm group description Using the figure-of-eight closure technique when closing access for structural heart therapies. arm group intervention list arm group intervention name Other: Figure-of-eight suture arm group label Perclose Device arm group type Active Comparator arm group description Using the Perclose device when closing access for structural heart therapies. arm group intervention list arm group intervention name Other: Perclose Device intervention list intervention intervention type Other intervention name Figure-of-eight suture intervention description Using the figure-of-eight closure technique when closing access for structural heart therapies. intervention arm group label list intervention arm group label Figure-of-eight intervention type Other intervention name Perclose Device intervention description Using the Perclose device when closing access for structural heart therapies. intervention arm group label list intervention arm group label Perclose Device outcomes module primary outcome list primary outcome primary outcome measure Hemostasis Time primary outcome description To assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access primary outcome time frame Immediate primary outcome measure Procedure Time primary outcome time frame Immediate primary outcome measure Access Site Complication primary outcome time frame 1 month eligibility module eligibility criteria Inclusion Criteria: All patients who successfully undergo venous large bore access sheath placement for structural heart procedures. Exclusion Criteria: Patients who do not consent Minors or those unable to consent healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 90 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Donna Cabral central contact role Contact central contact phone 561.495.3238 central contact e mail [email protected] central contact name Hamza Lodhi, MD central contact role Contact central contact e mail [email protected] overall official list overall official overall official name Houman Khalili, MD overall official affiliation Delray Medical Center overall official role Principal Investigator overall official name Brijeshwar Maini overall official affiliation Delray Medical Center overall official role Principal Investigator location list location location facility Delray Medical Center location status Recruiting location city Delray Beach location state Florida location zip 33484 location country United States location contact list location contact location contact name Donna Cabral location contact role Contact location contact phone 561-495-3238 location contact e mail [email protected] derived section misc info module version holder December 02, 2022 intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M8728 intervention browse leaf name Hemostatics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Coag intervention browse branch name Coagulants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04831008
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full study rank 61493 study protocol section identification module n c t id NCT04835753 org study id info org study id taibah university organization org full name Taibah University org class OTHER brief title Shock Wave and Spastic Cerebral Palsy Equines Foot official title Effects Of Extracorporeal Shock Wave On Spastic Equines Foot In Children With Hemiplegic Cerebral Palsy acronym CP status module status verified date April 2021 overall status Active, not recruiting expanded access info has expanded access No start date struct start date January 1, 2021 start date type Actual primary completion date struct primary completion date March 30, 2021 primary completion date type Actual completion date struct completion date May 15, 2021 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Hatem Abd Elmohsen Abdel Hamid Emara responsible party investigator title DR responsible party investigator affiliation Taibah University lead sponsor lead sponsor name Taibah University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary A double-blind randomized controlled study was carried out on 34 children (19 boys and 15 girls) in the age ranged from 7 to 9 years old with spastic hemiplegia were randomly allocated to one of two groups: control or study group. The two groups received traditional therapeutic exercises for 12 weeks. Additionally, study group received rESW (one session/week) on gastrocnemius and soleus muscles (1500 shots/muscle, frequency of 4Hz, energy of 0.030 mJ/mm2). All children were evaluated at baseline, and after 12 weeks by Modified Ashworth Scale, Biodex system 4 isokinetic dynamometer, Gross Motor Function Measure (GMFM-88), dimensions "D" standing and "E" walking, Trost Selective Motor Control Test, and Single Leg Standing Test. detailed description Both groups underwent conventional physical therapy program which included muscle stretching, strengthening exercises, neurodevelopmental techniques, proprioceptive training, and balance and gait training for three months (3 days/week ,1 hour/day). Study group Subjects in this group received the traditional physical therapy treatment plus true radial ESWT.A rESW pneumatic device (SHOCK MED, Italy) was used to provide one session per week (for a total of 12-week) of shock wave intervention. The pressure pulses were focused on the muscle belly of the planter flexor hypertonic muscles. Standard ultrasonic gel was used as a contact medium. A total of 1500 shots with a pressure of 1.5 bar and an energy flux density (EFD) of 0.030 mJ/mm2 were applied with the repetition frequency of shock wave irradiation of 4 pulses per second (Hz). The rESW session lasted about 6 minutes and was painless; thus, local anesthesia was not required. conditions module condition list condition Cerebral Palsy keyword list keyword Cerebral Palsy Extracorporeal Shock Wave Therapy Hemiplegia selective motor control design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 34 enrollment type Actual arms interventions module arm group list arm group arm group label study group arm group type Experimental arm group description received the traditional physical therapy program as muscle stretching and strengthening and neurodevelopmental techniques, proprioceptive training, and balance and gait training plus shock wave on the muscle belly of the planter flexor hypertonic muscles. arm group intervention list arm group intervention name Device: shock wave Other: traditional physical therapy program arm group label control group arm group type Other arm group description received the traditional physical therapy program as muscle stretching and strengthening and neurodevelopmental techniques, proprioceptive training, and balance and gait training .these traditional therapy had been approved by previous studies its effectiveness in management cerebral palsy child arm group intervention list arm group intervention name Other: traditional physical therapy program intervention list intervention intervention type Device intervention name shock wave intervention description true radial ESWT.A rESW pneumatic device (SHOCK MED, Italy) was used to provide one session per week (for a total of 12-week) intervention arm group label list intervention arm group label study group intervention type Other intervention name traditional physical therapy program intervention description lower limbs muscles stretch and strength in addition to balance and gait training intervention arm group label list intervention arm group label control group study group outcomes module primary outcome list primary outcome primary outcome measure Biodex system primary outcome description The Biodex system 4 (Biodex Medical, Shirley, NY, USA) was used for the quantitative biomechanical assessment of the spasticity of the affected side ankle plantar flexor muscle primary outcome time frame 12 weeks primary outcome measure The modified Ashworth scale primary outcome description The modified Ashworth scale, which is a six-point ordinal scale for grading (0, 1, 1+, 2, 3, and 4) was applied for clinical assessment of spasticity of ankle plantar flexors. primary outcome time frame 12 weeks primary outcome measure Single Leg Standing Test (SLS) primary outcome description The SLS is a simple and effective test to assess static balance. It is conducted by measuring the time that a child can maintain balance by lifting the foot according to the signal "Start." The average of three measures was used. primary outcome time frame 12 weeks primary outcome measure The Trost Selective Motor Control test (TSMC) primary outcome description The TSMC test was used to assess ability of the child to perform isolated movement of the ankle. primary outcome time frame 12 weeks eligibility module eligibility criteria Inclusion Criteria: 1) children who could walk independently or with assistive devices ,2) children with motor dysfunction graded as a 1 or 2 on the Gross Motor Function Classification System (GMFCS), 3) children scoring 1or1+ on the Modified Ashworth Scale (MAS), 4) Dynamic ankle contracture which was confirmed if ankle equinus was observed during ambulation and passive dorsiflexion of the ankle could be accomplished beyond the neutral position with knee extended Exclusion Criteria: 1) children older than 9 years or younger than 7 years, 2) previous botulinum toxin type A injection in the gastrocnemius muscle or serial casting of the ankle within 6 months prior to enrollment, 3) fixed ankle contracture, and 4) surgery of the lower limbs in the past 12 months. healthy volunteers No gender All minimum age 7 Years maximum age 9 Years std age list std age Child contacts locations module overall official list overall official overall official name hatem emaraa, PHD overall official affiliation Taibah University,saudi arabia overall official role Principal Investigator location list location location facility Taibah University location city Al Madīnah location zip 42353 location country Saudi Arabia derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010243 condition mesh term Paralysis condition mesh id D000002547 condition mesh term Cerebral Palsy condition ancestor list condition ancestor condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000001925 condition ancestor term Brain Damage, Chronic condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M4948 condition browse leaf name Cerebral Palsy condition browse leaf as found Cerebral Palsy condition browse leaf relevance high condition browse leaf id M14729 condition browse leaf name Shock condition browse leaf relevance low condition browse leaf id M11237 condition browse leaf name Muscle Spasticity condition browse leaf relevance low condition browse leaf id M12309 condition browse leaf name Paralysis condition browse leaf as found Palsy condition browse leaf relevance high condition browse leaf id M8667 condition browse leaf name Hemiplegia condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M4359 condition browse leaf name Brain Injuries condition browse leaf relevance low condition browse leaf id M4354 condition browse leaf name Brain Damage, Chronic condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04835753
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full study rank 61470 study protocol section identification module n c t id NCT04836052 org study id info org study id MRC-04-20-1120 organization org full name Hamad Medical Corporation org class INDUSTRY brief title Omega-3 Oil Use in COVID-19 Patients in Qatar official title Omega-3 Oil Use in COVID-19 Patients in Qatar: a Randomized Controlled Trial acronym Omega3 status module status verified date March 2021 overall status Recruiting expanded access info has expanded access No start date struct start date December 24, 2020 start date type Actual primary completion date struct primary completion date August 24, 2021 primary completion date type Anticipated completion date struct completion date December 24, 2021 completion date type Anticipated study first submit date March 14, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Hamad Medical Corporation lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary COVID-19 infection has been widely spread since December 2019 and causing many comorbidities and fatalities. The most common clinical presentation of COVID-19 patients admitted to ICUs is respiratory failure , hypoxia and acute lung injury. While new therapies and vaccines are urgently being investigated, they may take an inordinate time to get to right people. Omega-3-oil has been shown to have less proinflammatory mediators that may have immunomodulating, anti-inflammatory and antiviral effect. Two main fatty acids in omega-3-oil including eicosapentaenoic acid and docosahexaenoic acid have shown benefit in patients with ARDS as well. So, the investigators proposed a randomized controlled study to evaluate the effectiveness of omega-3-oil supplementation 2 gm PO/NGT/OGT twice daily for 28 days or till discharge or till death in COVID-19 critically ill patients admitted to ICU who require oxygen support. detailed description The outbreak of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) due to a novel coronavirus (COVID-19) has emerged from Wuhan, China in late December 2019 and spread rapidly worldwide. Until July 16, 2020, there has been more than 13 million confirmed cases worldwide and ~580,000 deaths attributed to the disease. With the fast evolution of this worldwide public-health emergency, the general public has demanded the urgent investigation of potentially beneficial drugs that may improve the outcome of those affected by SARS-CoV-2 infection. While new therapies and vaccines are urgently being investigated, they may take an inordinate time, or never be identified. In the world today, there is only one drug approved by the FDA for COVID-19 (Remdesivir), while the investigation of several other re-purposed drugs is potentially suggested for SARS-CoV-2 treatment. Many trials are taking place around the world, including some utilizing potentially dangerous drugs with considerable side effects and enormous costs. However, the clinical effectiveness and safety of all pharmacologic therapies so far have not been fully proven. The preliminary findings about this disease indicates that patients with cardiovascular risk factors including diabetes, obesity and other pre-existing cardiovascular diseases have worse outcomes. Additionally, severe respiratory infection and hypoxia associate with severe COVID-19 might trigger many pathological pathways which leads to cardiovascular sequelae. In a cohort of 416 hospitalized patients with COVID-19, myocardial injury defined by an elevated high sensitivity troponin I level was associated with in-hospital mortality. Another study of 187 hospitalized patients with COVID-19 showed a similar association. Interestingly, the highest mortality rates were observed among patients with pre-existing cardiovascular disease. Importantly, none of the published experiences from anywhere in the world has explored omega-3 oil and its known protective cardiovascular benefits. Omega-3 fatty acids are found in food such as fish and flaxseed as well as in dietary supplements labeled omega-3-oil.The beneficiary role of Omega-3 polyunsaturated fatty acids (PUFA), namely eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from fish, other marine sources, and supplements, have been shown to be anti-inflammatory through several cellular mechanisms including their incorporation into cellular membranes and resulting altered synthesis of eicosanoids. There is the potential that arachidonic acid (AA,) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and other dietary unsaturated fatty acids can inactivate enveloped viruses. It is thought that these fatty acids and others cause leakages or lysis of the viral envelopes by disrupting the membrane integrity, amongst other potential mechanisms. Indeed, the supplementation of EPA and DHA raises the level of these fatty acids in the phospholipids of cells involved in inflammation in a time and dose-dependent fashion at the expense of AA4. Li and colleagues reviewed 89 systematic reviews and meta-analyses investigating fish intake and all-cause mortality, concluding that fish intake at 2-4 servings per week is associated with the largest risk reduction. In animal models despite these potential positive effects, there is conflicting evidence in relation to fish or fish oil consumption for some viral infections. In influenza models, fish oil-fed mice demonstrated impaired resistance to influenza infection due to their immunomodulatory and anti-inflammatory properties, which negatively dampened the immune response of the mice against the infection. In another mouse model, fish oil intake delayed influenza virus clearance and impaired the immune response in the lungs of mice by disrupting interferon-γ and immunoglobulin A. A further study indicated that it may be due to the impairment of virus-specific T lymphocyte cytotoxicity. Despite the potential benefit, there are few human studies with omega 3 and immune and inflammatory response. The recent proposed benefit for omeg-3-oil is unique, EPA and DHA which are main fatty acids in omega-3-oils may act as substrates for the synthesis of specialized pro-resolving lipid mediators such as maresins, resolvins, and protectins, of which protectins may reduce the replication of influenza and potentially affect the inflammatory manifestations of respiratory viral diseases. Notably, an in vitro model of human cells (Huh-7 and VeroE6) infected with a human coronavirus (HCoV-229E) demonstrated that several bioactive lipids downstream of phospholipase A2 (PLA2) activation were upregulated by the host cells. It is postulated that coronaviruses modulate the host lipid profile to optimize and maintain a specific homeostasis for viral replication. However, exogenous supplementation of AA and linoleic acid suppressed viral replication by interfering with the optimal host lipid conditions for viral replication. Notably, exogenous supplementation of AA and linoleic acid was also conserved when human cells were infected with MERS. However, exogenous supplementation of AA and linoleic acid suppressed viral replication by interfering with the optimal host lipid conditions for viral replication. Notably, exogenous supplementation of AA and linoleic acid was also conserved when human cells were infected with MERS. EPA, DHA, and AA also inhibited the replication of enterovirus A71 and coxsackievirus A16.While it is suggested that the oral or intravenous administration of various bioactive lipids could potentially reduce the severity and/or enhance the recovery of those infected with COVID-19, a dietary prophylactic approach or a dietary strategy for recovering patients is also worth considering. Further research is certainly required, as increasing AA via the diet might seem counterintuitive, as it is mainly proinflammatory. Other clinical research about several lung infections, found the administration of PUFA can improve the outcome of the patient in acute pneumonia. Recent study reported that the dietary supplementation of ω-3 PUFA can exert an overall beneficial effect against acute pneumonia through the upregulation of the host's specific and nonspecific immune defenses. Inflammation resolution is strongly dependent on lipid mediators, the specialized pro-resolution mediators (SPMs). As mentioned above, omega-3 polyunsaturated fatty acids (n-3 PUFAs) are precursors of very potent SPMs, including resolvins, protectins and maresins. In addition, they are associated with a less aggressive inflammatory initiation, after competing with omega-6 fatty acids for eicosanoid synthesis. Therefore, it makes sense to consider the use of n-3 PUFAs for clinical management of COVID-19 patients. Recent clinical studies In ARDS patients, the enteral use of n-3 PUFAs has been associated to oxygenation improvement, reduced duration of mechanic ventilation as well as shorter ICU length of stay. In another study, critically ill patients receiving parenteral nutrition therapy enriched with fish oil lipid emulsion (rich in n-3 PUFAs EPA and DHA) were reported to have decreased infection and sepsis risk (40% to 56%, respectively) and a reduction of length of hospital and ICU stay by about two day. As eluded previously, 2 cohort studies from China indicate that a significant proportion of hospitalized patients with COVID-19 developed some degree of myocardial injury. Coronary atherosclerotic plaques are more prone to rupture in response to an exacerbated inflammatory response during SARS-CoV-2. The use of n-3 FA (4-6 g/d) for improving atherosclerotic cardiovascular disease risk in patients with hypertriglyceridemia is supported by a 25% reduction in major adverse cardiovascular events in REDUCE-IT. Furthermore, several drugs will increase triglyceride concentrations in patients with underlying high triglycerides. The effects of n-3 FA on drug-induced HTG have received relatively little attention, but n-3 FAs have uniformly been reported to lower triglycerides when used with interferon-α, antipsychotics, l-asparaginase, oral estrogens, protease inhibitors, retinoic acid, and sirolimus. In contrast with COVID-19 there is scarce of information published till now about role of n-3 FAs. Collectively, these findings suggest that omega-3 fatty acids have properties that could improve oxygenation and outcome of COVID-19 patients. The utilization of omega-3-oil as safe, available and inexpensive therapy could be a promising therapeutic approach against SARS-CoV-2. Moreover, recent analysis of 8 studies showed that consumption of omega 3 oil up to 10 gm per day is safe in ICU. However, due to lack of sufficient clinical data supporting either the beneficial or harmful effects of omega-3 oil use in patients with COVID-19, the optimal strategy for the management of in COVID-19 is uncertain and remains to be elucidated - putting together all the known properties of omega 3 and what is known about the COVID-19, the investigators hypothesize that omega 3 could have a significant beneficial impact on the clinical outcome of infected patients. The aim of this study is to investigate in-hospital use of omega-3 oil and mechanical ventilator days, improvement in oxygenation, need for ventilator in non-ventilated patients, ICU- length of stay, hospital related length of stay, thrombosis, all-cause morbidity and mortality in COVID-19 patients in a in randomized prospective controlled trial. There is no study or evidence on Omega 3 and COVID-19 infection and respiratory failure. The investigators propose a randomized controlled study to minimize the risk of bias and confounding factors. conditions module condition list condition COVID-19 design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 372 enrollment type Anticipated arms interventions module arm group list arm group arm group label omega-3-oil arm arm group type Experimental arm group description patients admitted to ICU in HMC on any kind of oxygen support will get omega-3-oil 2 gm PO/NGT/OGT twice daily for 28 days or till ICU discharge or till death . arm group intervention list arm group intervention name Drug: Omega 3 fatty acid arm group label standard of care arm ( no omega -3-oil ) arm group type No Intervention arm group description patients admitted to ICU in HMC on any kind of oxygen support will get ( standard of care= No Omega-3-oil ) but their labs will be monitored intervention list intervention intervention type Drug intervention name Omega 3 fatty acid intervention description omega-3-oil 2 gm twice daily PO/NGT/OGT for 28 days or ICU discharge or death. intervention arm group label list intervention arm group label omega-3-oil arm outcomes module primary outcome list primary outcome primary outcome measure mechanical ventilator free days primary outcome description 28 minus (days patient spent on ventilator if successfully liberated from ventilator) primary outcome time frame 28 days secondary outcome list secondary outcome secondary outcome measure Change in oxygenation secondary outcome description PaO2/FiO2 secondary outcome time frame days 1, 3, 7 secondary outcome measure Hospital Mortality secondary outcome description death during 28 days secondary outcome time frame 28 days eligibility module eligibility criteria Inclusion Criteria: adult ICU patients ≥18 years confirmed COVID-19 infection on-Oxygen support (mechanical ventilation, face masks, nasal cannula, etc.) Previous history of omega-3-oil with discontinuation of at least 1 month prior to admission Exclusion Criteria: soya bean oil allergy fish allergy peanut allergy fish oil allergy pregnant women Continuous use of Omega-3-oil till admission healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Sandro Rizoli, PhD central contact role Contact central contact phone +97444396157 central contact e mail [email protected] central contact name AHMED ABDELBARI, Msc central contact role Contact central contact phone +974-55810575 central contact e mail [email protected] location list location location facility Hamad Medical Corporation location status Recruiting location city Doha location state DC location zip 3050 location country Qatar location contact list location contact location contact name Sandro Rizoli, phD location contact role Contact location contact phone +974-44396157 location contact e mail [email protected] location contact name AHMED ABDELBARI, Msc location contact role Contact location contact phone +974-55810575 location contact e mail [email protected] derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections 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NCT04836052
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full study rank 61456 study protocol section identification module n c t id NCT04836234 org study id info org study id DGD170001 organization org full name University of Malaya org class OTHER brief title Chewing Gum Effect in Reducing Orthodontic Pain After Separator and Initial Arch Wire Placement official title The Effect of the Chewing Gum in Alleviating Orthodontic Pain After Separator and Initial Arch Wire Placement: A Randomized Clinical Trial status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 6, 2019 start date type Actual primary completion date struct primary completion date August 2021 primary completion date type Anticipated completion date struct completion date August 2021 completion date type Anticipated study first submit date November 5, 2020 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Malaya lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Pain is the most claimed complaint from orthodontic treatment. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affects patients' compliance to treatment and even becomes the main reason for discontinuing orthodontic treatment. For years, orthodontic patients have reported using analgesics during orthodontic treatment to ease the pain. However, analgesics have many side effects such as allergic reactions, bleeding disorders, gastric ulcers, liver toxicity and their potential influence in slowing down tooth movement. This study aimed to investigate the effectiveness of chewing gums in pain reduction in Malaysian multi-ethnic orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in our future practice. detailed description Orthodontic treatment have been shown to cause varying degrees of discomforts and pain to the patients. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affect patients' compliance to the treatment and even become a main reason of discontinuing orthodontic treatment. Patients have reported using of analgesic particularly NSAIDS and Paracetamol during orthodontic treatment to ease the pain. However, NSAIDS have been associated with various side effects such as allergic reactions, bleeding disorders and gastric ulcers had raised the concern of orthodontists. Studies on animals have shown that NSAIDS slower the rate of tooth movement, hence affecting orthodontic treatment efficacy. Paracetamol have been reported to cause liver toxicity in the case of over dosage. The action of chewing the gum can produce forces to temporary displace the teeth sufficiently to allow blood flow through compressed area, preventing the build-up of metabolic products, thus reduce the pain severity. In addition, non-sugared chewing gum has anti-caries effect which is very important to prevent caries formation during orthodontic treatment. This study aimed to investigate the effectiveness of chewing gum in pain reduction in orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in future practice. conditions module condition list condition Orthodontic Pain keyword list keyword Chewing gum, Orthodontic pain design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Method of randomization using online randomization software. All 108 participants will be randomly allocated into 2 groups with a 1:1 allocation. Participants will be grouped into either group 1 (Intervention group, chewing gum) or group 2 (Control group, no chewing gum given) by using block randomization with block size of 4. Each group will have 54 participants. Concealment of the allocation sequence will be done by concealing the sequence in opaque envelopes. design primary purpose Treatment design masking info design masking Double design masking description Blinding of participants is not possible during allocation, treatment and data collection. However, blinding can be done during data processing, analysing and data collection for secondary outcome on appliances failure rate. design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 108 enrollment type Anticipated arms interventions module arm group list arm group arm group label intervention group arm group type Experimental arm group description Participants will receive Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum. They will be instructed to chew the gum for pain relief after the separator and initial arch wire placement if required. Chew the gums for 10-12 minutes and as much as they want whenever they feel discomfort or pain. They are free to take any medication when necessary and respond to the questionnaires on the amount of chewing gum and analgesics used. arm group intervention list arm group intervention name Other: Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum arm group label Control group arm group type No Intervention arm group description Participants will not receive any prescription after the separators and initial arch wires placement. They will be specifically asked not to chew chewing gum. As in the intervention group, they can take any medication when they feel necessary and respond to the questionnaires on the amount of analgesics used. intervention list intervention intervention type Other intervention name Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum intervention description Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum 65g 40 pieces intervention arm group label list intervention arm group label intervention group outcomes module primary outcome list primary outcome primary outcome measure Pain assessment after separators and initial arch wire placement. primary outcome description Level of pain on the Numerical pain rating scale (NRS) primary outcome time frame At 6 hours after separators and initial arch wire placement. primary outcome measure Pain assessment after separators and initial arch wire placement. primary outcome description Level of pain on the Numerical pain rating scale (NRS) primary outcome time frame At 24 hours after separators and initial arch wire placement. primary outcome measure Pain assessment after separators and initial arch wire placement. primary outcome description Level of pain on the Numerical pain rating scale (NRS) primary outcome time frame At 48 hours after separators and initial arch wire placement. secondary outcome list secondary outcome secondary outcome measure Reported use of chewing gum and analgesics. secondary outcome description Amount of chewing gums and medications consumed after the separator and initial arch wire placement secondary outcome time frame Immediately after the separator and archwire placements until up to 6 hours secondary outcome measure Reported use of chewing gum and analgesics. secondary outcome description Amount of chewing gums and medications consumed after the separator and initial arch wire placement secondary outcome time frame from 6 hours to 24 hours after the separator and archwire placements secondary outcome measure Reported use of chewing gum and analgesics. secondary outcome description Amount of chewing gums and medications consumed after the separator and initial arch wire placement secondary outcome time frame from 24 hours to 48 hours after the separator and archwire placements secondary outcome measure Recorded appliances breakages. secondary outcome description Frequency of appliances breakages secondary outcome time frame Immediately after the separator and archwire placements until 2 days after the separator and archwire placement eligibility module eligibility criteria Inclusion Criteria: Patients about to undergo orthodontic treatment with maxillary and mandibular fixed appliances Orthodontic treatment include the extraction of the permanent first or second premolars Age 16 years and above Exclusion Criteria: Significant medical problem or cleft lip and palate. Pregnant lady Occurrence of using analgesics or antibiotics History of asthma or unstable asthma the last year Oral surgery in the previous 4 weeks healthy volunteers Accepts Healthy Volunteers gender All minimum age 16 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Poon Pei San central contact role Contact central contact phone 0127691145 central contact e mail [email protected] central contact name Siti Adibah Othman, Prof central contact role Contact central contact phone 012-2635088 central contact e mail [email protected] overall official list overall official overall official name Siti Adibah Othman, Prof overall official affiliation Faculty of Dentistry, University of Malaya overall official role Study Director overall official name Zamros Yuzadi Mohd Yusof, Prof overall official affiliation Faculty Of Dentistry, University of Malaya overall official role Study Director overall official name Poon Pei San overall official affiliation Faculty of dentistry, University of Malaya overall official role Principal Investigator location list location location facility Postgraduate Orthodontic Clinic, Faculty of Dentistry, University Malaya location status Recruiting location city Kuala Lumpur location state Wilayah Persekutuan Kuala Lumpur location zip 50603 location country Malaysia location contact list location contact location contact name Pei San Poon location contact role Contact location contact phone 0127691145 location contact e mail [email protected] references module reference list reference reference p m i d 22812440 reference type background reference citation Benson PE, Razi RM, Al-Bloushi RJ. The effect of chewing gum on the impact, pain and breakages associated with fixed orthodontic appliances: a randomized clinical trial. Orthod Craniofac Res. 2012 Aug;15(3):178-87. doi: 10.1111/j.1601-6343.2012.01546.x. Epub 2012 Jun 22. reference p m i d 27476354 reference type background reference citation Ireland AJ, Ellis P, Jordan A, Bradley R, Ewings P, Atack NE, Griffiths H, House K, Moore M, Deacon S, Wenger N, Worth V, Scaysbrook E, Sandy JR. Comparative assessment of chewing gum and ibuprofen in the management of orthodontic pain with fixed appliances: A pragmatic multicenter randomized controlled trial. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):220-7. doi: 10.1016/j.ajodo.2016.02.018. reference p m i d 8893104 reference type background reference citation Kehoe MJ, Cohen SM, Zarrinnia K, Cowan A. The effect of acetaminophen, ibuprofen, and misoprostol on prostaglandin E2 synthesis and the degree and rate of orthodontic tooth movement. Angle Orthod. 1996;66(5):339-49. reference p m i d 20578865 reference type background reference citation Xiaoting L, Yin T, Yangxi C. Interventions for pain during fixed orthodontic appliance therapy. A systematic review. Angle Orthod. 2010 Sep;80(5):925-32. doi: 10.2319/010410-10.1. Review. reference p m i d 19361739 reference type background reference citation Salmassian R, Oesterle LJ, Shellhart WC, Newman SM. Comparison of the efficacy of ibuprofen and acetaminophen in controlling pain after orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):516-21. doi: 10.1016/j.ajodo.2007.05.020. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf relevance low intervention browse leaf id T303 intervention browse leaf name Strawberry intervention browse leaf as found Opiate intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev HB intervention browse branch name Herbal and Botanical
NCT04836234
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full study rank 61616 study protocol section identification module n c t id NCT04834154 org study id info org study id IRB-57111 secondary id info list secondary id info secondary id NCI-2021-06706 secondary id type Other Identifier secondary id domain Clinical Trials Reporting Program (CTRP) secondary id BRS0123 secondary id type Other Identifier secondary id domain Stanford OnCore Number organization org full name Stanford University org class OTHER brief title Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients official title Addressing Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients status module status verified date June 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date March 15, 2021 start date type Actual primary completion date struct primary completion date October 31, 2024 primary completion date type Anticipated completion date struct completion date October 31, 2026 completion date type Anticipated study first submit date March 22, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date June 21, 2022 last update post date struct last update post date June 23, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Stanford University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of the study is to:Translate a mindfulness program into Spanish for Latina patients with breast cancer.Train a community health worker to facilitate the mindfulness program. Determine if this program is culturally acceptable and feasible, and Obtain pilot data on the program's effectiveness in reducing anxiety and depression detailed description Primary aims of this study are to: 1) translate a behavioral health intervention into Spanish, 2) deliver it to a population of Spanish speaking Latina breast cancer patients, and 3) determine acceptability and feasibility. Secondary aims are to gather preliminary data on anxiety, depression and sleep quality pre and post intervention. conditions module condition list condition Breast Cancer Depression, Anxiety Mindfulness Sleep Disturbance keyword list keyword behavioral intervention Spanish speaking Latina Breast Cancer Mindfulness design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Supportive Care design masking info design masking None (Open Label) enrollment info enrollment count 31 enrollment type Actual arms interventions module arm group list arm group arm group label Mindfulness group visit arm group type Active Comparator arm group description Participants will attend 6 weekly educational and mindfulness sessions arm group intervention list arm group intervention name Behavioral: Mindfulness arm group label Wait list control arm group type Placebo Comparator arm group description Participants will be placed on a wait list arm group intervention list arm group intervention name Behavioral: Control group intervention list intervention intervention type Behavioral intervention name Mindfulness intervention description 6 weekly 2.0 hour video-conferenced group sessions with the following components: 1) short grounding meditation, 2) check in/review of prior weeks practice and symptoms, 3) educational topic, 3) main meditation, 4) reflection on meditation, and 5) action plan formation intervention arm group label list intervention arm group label Mindfulness group visit intervention other name list intervention other name Educational video intervention type Behavioral intervention name Control group intervention description Wait list control intervention arm group label list intervention arm group label Wait list control outcomes module primary outcome list primary outcome primary outcome measure Acceptability change across session primary outcome description The Acceptability scale was developed for this study and is a 5 point Likert scored scale that will be administered after end of each weeks for 6 weeks. There are two questions with scores ranging from "strongly disagree" (score 0), "disagree" (score 1), "neutral" (score 2), "agree" (score 3), and "strongly agree" (score 4). Scores range from 0 to 8 with the higher scores representing greater levels of acceptability. It has 2 additional open ended questions: "What changes did you make in your daily routine as a result of this intervention, if none, why" and "Were there any barriers to making changes you listed on your action plan, if so what were they? The scale takes approximately 5 minutes to complete. Acceptability change will be measured after each session (week 1-6). The mean score with standard deviation for each 6 sessions and acceptability will be reported. primary outcome time frame End of each week for 6 weeks primary outcome measure Difference in Feasibility primary outcome description The Feasibility and Satisfaction scale was developed for this study and is a 5 point Likert scored scale that will be administered at at time of completion of intervention or at time of withdraw (if participant withdraws prior to completion of intervention.) Five questions are scored from "strongly disagree" (score 0), "disagree" (score 1), "neutral" (score 2), "agree" (score 3), and "strongly agree" (score 4). Scores range from 0 to 20 with higher scores representing greater levels of feasibility. Differences in Feasibility will be evaluated and reported. There is also 1 open-ended question "What is the optimal number of visits" with continuous numeric score (participants able to write in number of preferred visits) with higher score representing desire for greater number of visits. The scale takes approximately 5-10 minutes to complete primary outcome time frame Through study completion, an average of 1 year secondary outcome list secondary outcome secondary outcome measure Differences in Generalized Anxiety Disorder-7 (GAD7) between time points. secondary outcome description The GAD7 is a well validated seven-item self-administered questionnaire used to measure anxiety. It has 7 questions with Likert scores ranging from "not at all" (score 0), "several days" (score 1), "more than half the days" (score 2), and "nearly every day (score 3).Scores range from 0 to 21 with higher scores indicating higher levels of anxiety, and a cutoff of or above 10 representing high likelihood of generalized anxiety disorder. Difference in GAD-7 measured at three time points (week 1 and 6 of the intervention and 3 months post intervention) will be compared and reported. The scale takes approximately 5-10 minutes to complete secondary outcome time frame Three time points (week 1 and 6 of intervention, and 3 months post intervention.) secondary outcome measure Differences in Center for Epidemiological Studies-Depression (CES-D) between time points. secondary outcome description The CES-D scale is a well validated self-administered questionnaire used to measure depression. The 20 item scale has Likert scores ranging from "rarely or none of the time" (score 0), "some or little of the time" (score 1), "moderate or much of the time" (score 2), and "most or almost all the time" (score 3).Scores range from 0 to 60 with higher scores indicated greater depressive symptoms. A cut off at or above 20 has sensitivity 79% and specificity of 80% for major depression. Difference in CES-D measured at three time points (week 1 and 6 of the intervention and 3 months post intervention) will be reported and compared. The scale takes approximately 5-10 minutes to complete. secondary outcome time frame Three time points (week 1 and 6 of intervention, and 3 months post intervention.) secondary outcome measure Differences in PROMIS-SD between time points secondary outcome description The Participant Reported Outcomes Measurement Information System (PROMIS) Adult Short Form: Sleep Disturbance (PROMIS-SD), is an 8 item scale measuring overall sleep quality, disturbances, and satisfaction over the past 7 days on 5 point Likert scale with scores ranging from 1 to 5. Raw scores are converted into t scores ranging from 28.9 to 76.5, with higher scores indicating greater sleep disturbance. Exploratory analysis will compare scores at three time points (week 1 and 6 of the intervention and 3 months post intervention). The scale takes approximately 2 minutes to complete 26 and is available in Spanish. secondary outcome time frame Three time points (week 1 and 6 of intervention, and 3 months post intervention.) eligibility module eligibility criteria Inclusion Criteria: Self reported diagnosis of invasive breast cancer who has currently or within last 12 months been in active treatment (surgery, chemotherapy, or radiation) or on endocrine therapy Self-identified anxiety (persistent worry or nervousness), depression (feeling sad, little interest or pleasure in doing things or hopeless), or sleep disturbance. Breast cancer related treatment (surgery, radiation, chemotherapy) or endocrine therapy within the last 12 months Self identifies as Spanish speaking Self identifies as Latinx / Latina / Latino Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Non-Spanish speaking other diagnosis besides invasive breast cancer (ie Ductal carcinoma in situ (DCIS), fibroadenoma, abnormal mammogram but not yet with final diagnosis, non-breast cancer patients) comorbid bipolar affective disorder or psychotic disorder (as self-identified by patient after asking "do you have any other psychiatric conditions") inability to physically or psychologically attend group sessions, and by discretion of the study coordinator. Patients currently participation in stress reduction or mindfulness groups/interventions will be excluded from participation Cancer "survivors" if not in active or endocrine treatment healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Maria G Juarez-Reyes, MD, PhD overall official affiliation Stanford University overall official role Study Director overall official name Lisa Golman-Rosas, PhD overall official affiliation Stanford University overall official role Principal Investigator location list location location facility Stanford University location city Palo Alto location state California location zip 94305 location country United States references module reference list reference reference p m i d 2265888 reference type background reference citation Zich JM, Attkisson CC, Greenfield TK. Screening for depression in primary care clinics: the CES-D and the BDI. Int J Psychiatry Med. 1990;20(3):259-77. reference p m i d 16717171 reference type background reference citation Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. reference p m i d 2748771 reference type background reference citation Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. reference p m i d 25727241 reference type background reference citation Akman T, Yavuzsen T, Sevgen Z, Ellidokuz H, Yilmaz AU. Evaluation of sleep disorders in cancer patients based on Pittsburgh Sleep Quality Index. Eur J Cancer Care (Engl). 2015 Jul;24(4):553-9. doi: 10.1111/ecc.12296. Epub 2015 Mar 1. reference p m i d 24831042 reference type background reference citation Wu HS, Harden JK. Symptom burden and quality of life in survivorship: a review of the literature. Cancer Nurs. 2015 Jan-Feb;38(1):E29-54. doi: 10.1097/NCC.0000000000000135. reference p m i d 29058128 reference type background reference citation Chen D, Yin Z, Fang B. Measurements and status of sleep quality in patients with cancers. Support Care Cancer. 2018 Feb;26(2):405-414. doi: 10.1007/s00520-017-3927-x. Epub 2017 Oct 23. Review. reference p m i d 26963792 reference type background reference citation Carlson LE. Mindfulness-based interventions for coping with cancer. Ann N Y Acad Sci. 2016 Jun;1373(1):5-12. doi: 10.1111/nyas.13029. Epub 2016 Mar 9. Review. reference p m i d 22803933 reference type background reference citation Vøllestad J, Nielsen MB, Nielsen GH. Mindfulness- and acceptance-based interventions for anxiety disorders: a systematic review and meta-analysis. Br J Clin Psychol. 2012 Sep;51(3):239-60. doi: 10.1111/j.2044-8260.2011.02024.x. Epub 2011 Sep 9. Review. reference p m i d 23541163 reference type background reference citation Hoge EA, Bui E, Marques L, Metcalf CA, Morris LK, Robinaugh DJ, Worthington JJ, Pollack MH, Simon NM. Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. J Clin Psychiatry. 2013 Aug;74(8):786-92. doi: 10.4088/JCP.12m08083. reference p m i d 30916356 reference type background reference citation Schell LK, Monsef I, Wöckel A, Skoetz N. Mindfulness-based stress reduction for women diagnosed with breast cancer. Cochrane Database Syst Rev. 2019 Mar 27;3:CD011518. doi: 10.1002/14651858.CD011518.pub2. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001943 condition mesh term Breast Neoplasms condition mesh id D000020920 condition mesh term Dyssomnias condition mesh id D000020447 condition mesh term Parasomnias condition ancestor list condition ancestor condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000001941 condition ancestor term Breast Diseases condition ancestor id D000012871 condition ancestor term Skin Diseases condition ancestor id D000012893 condition ancestor term Sleep Wake Disorders condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M4372 condition browse leaf name Breast Neoplasms condition browse leaf as found Breast Cancer condition browse leaf relevance high condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf relevance low condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf relevance low condition browse leaf id M21808 condition browse leaf name Dyssomnias condition browse leaf as found Sleep Disturbance condition browse leaf relevance high condition browse leaf id M21395 condition browse leaf name Parasomnias condition browse leaf as found Sleep Disturbance condition browse leaf relevance high condition browse leaf id M3476 condition browse leaf name Anxiety Disorders condition browse leaf relevance low condition browse leaf id M4370 condition browse leaf name Breast Diseases condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse leaf id M14848 condition browse leaf name Sleep Wake Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04834154
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full study rank 61353 study protocol section identification module n c t id NCT04837573 org study id info org study id 21-002949 organization org full name University of California, Los Angeles org class OTHER brief title Feasibility & Acceptability of a Virtual Sister Circle Intervention for Black Women With Depressive Symptoms official title Evaluating the Feasibility and Acceptability of a Therapeutically-Grounded Virtual Sister Circle Intervention for Black Women With Depressive Symptoms status module status verified date June 2022 overall status Recruiting expanded access info has expanded access No start date struct start date November 1, 2021 start date type Actual primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date March 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date June 3, 2022 last update post date struct last update post date June 8, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Kia Skrine Jeffers, PhD, RN, PHN responsible party investigator title Assistant Professor responsible party investigator affiliation University of California, Los Angeles lead sponsor lead sponsor name Kia Skrine Jeffers, PhD, RN, PHN lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to evaluate the feasibility and acceptability of a protocol for middle- and older-aged Black women with depressive symptoms. conditions module condition list condition Depressive Symptoms Depression keyword list keyword Sister Circle Black Women design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label Group 1 Intervention, Weeks 1-8 arm group type Experimental arm group description During Weeks 1-8, Group 1 receives the Intervention and Group 2 receives no treatment. arm group intervention list arm group intervention name Behavioral: Sister Circle protocol arm group label Group 2 Intervention, Weeks 9-16 arm group type Active Comparator arm group description During Weeks 9-16, Group 2 receives the Intervention and Group 1 receives no treatment. arm group intervention list arm group intervention name Behavioral: Sister Circle protocol intervention list intervention intervention type Behavioral intervention name Sister Circle protocol intervention description The intervention is an 8-week, therapeutically-informed protocol. intervention arm group label list intervention arm group label Group 1 Intervention, Weeks 1-8 Group 2 Intervention, Weeks 9-16 outcomes module primary outcome list primary outcome primary outcome measure Recruitment, completion, and retention rates of participants primary outcome description 80 percent recruitment, 80 percent completion, and 75 percent retention primary outcome time frame 16 weeks primary outcome measure Assess Acceptability according to the Theoretical Framework of Acceptability primary outcome description Qualitative assessment of Acceptability. The interview guide will be organized according to the constructs of the Theoretical Framework of Acceptability. Methodological conventions of qualitative description will be used to analyze the data. primary outcome time frame 16 weeks secondary outcome list secondary outcome secondary outcome measure Changes in Perceived Stress Scale (PSS) from baseline at 8 weeks and 16 weeks secondary outcome description Exploratory description of effect sizes secondary outcome time frame baseline, 8 weeks, 16 weeks secondary outcome measure Changes in Positive and Negative Affect Schedule (PANAS) Scale from baseline at 8 weeks and 16 weeks secondary outcome description Exploratory description of effect sizes secondary outcome time frame baseline, 8 weeks, 16 weeks secondary outcome measure Changes in Acceptance and Action Questionnaire II (AAQ-II) from baseline at 8 weeks and 16 weeks secondary outcome description Exploratory description of effect sizes secondary outcome time frame baseline, 8 weeks, 16 weeks eligibility module eligibility criteria Inclusion Criteria: Identify as Black or African American Identify as female Age 40 years and older Community-dwelling Self-report of experiencing depressive symptoms Ability to commit to the 8-week intervention Access to Zoom Speak and read English Exclusion Criteria: Have a diagnosis of bipolar, but is not taking medication for the condition Experiencing psychosis healthy volunteers No gender Female gender based Yes gender description Self-identified females minimum age 40 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Kia Skrine Jeffers, PhD, RN, PHN central contact role Contact central contact phone 310-267-0483 central contact e mail [email protected] overall official list overall official overall official name Kia Skrine Jeffers, PhD, RN, PHN overall official affiliation University of California, Los Angeles overall official role Principal Investigator location list location location facility University of California, Los Angeles location status Recruiting location city Los Angeles location state California location zip 90095 location country United States location contact list location contact location contact name Kia Skrine Jeffers, PhD location contact role Contact location contact phone 818-613-8952 location contact e mail [email protected] derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003863 condition mesh term Depression condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depressive Symptoms condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf relevance low condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions
NCT04837573
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full study rank 61395 study protocol section identification module n c t id NCT04837027 org study id info org study id AAAT1306 organization org full name Columbia University org class OTHER brief title Effect of Training on Brain Volume in Ataxia official title Balance Versus Aerobic Training in Degenerative Cerebellar Diseases status module status verified date October 2022 overall status Completed expanded access info has expanded access No start date struct start date September 1, 2021 start date type Actual primary completion date struct primary completion date March 16, 2022 primary completion date type Actual completion date struct completion date March 16, 2022 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 10, 2022 last update post date struct last update post date October 12, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Columbia University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The primary aim is to show balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression. The second aim is to demonstrate aerobic exercise improves balance and gait in DCD persons by affecting brain processes and slowing cerebellar atrophy. detailed description Individuals with degenerative cerebellar disease (DCD) exhibit gradual loss of coordination resulting in impaired balance, gait deviations, and severe, progressive disability. With no available disease-modifying medications, balance training is the primary treatment option to improve motor skills and functional performance. There is no evidence, however, that balance training impacts DCD at the tissue level. Aerobic training, on the other hand, may modify DCD progression as evident from animal data. Compared to sedentary controls, aerobically trained DCD rats have enhanced lifespan, motor function, and cerebellar Purkinje cell survival. Numerous animal studies also document that aerobic training has a direct, favorable effect on the brain that includes production of neurotrophic hormones, enhancement of neuroplasticity mechanisms, and protection from neurotoxins. The effects of aerobic training in humans with DCD are relatively unknown, despite these encouraging animal data. A single study to date has evaluated the benefits of aerobic exercise on DCD in humans, and this was a secondary outcome of the study. Although participants performed limited aerobic training during the study, modest functional benefits were still detected. The main objective of this project will be to compare the benefits of aerobic versus balance training in DCD. We hypothesize that both aerobic and balance training will improve function in DCD subjects, but that the mechanisms in which these improvements occur differ. 1) Balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression. 2) Aerobic exercise improves balance and gait in DCD persons by impacting the cerebellum conditions module condition list condition Spinocerebellar Ataxias keyword list keyword Ataxia Cerebellum Cerebellar degeneration design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Single blinded randomized controlled trial design primary purpose Treatment design masking info design masking Single design masking description The outcome assessor will know that the participant has received balance or aerobic training, but will not be aware of which group the participant belonged. design who masked list design who masked Outcomes Assessor enrollment info enrollment count 36 enrollment type Actual arms interventions module arm group list arm group arm group label Aerobic training arm group type Experimental arm group description Participants will be given a stationary exercise bike for home use. They will be instructed to use the exercise bike five times a week for thirty-minute sessions. The exercise intensity prescription will be based on the subject's VO2max determined on pre-test day. The exercise program will start at 60% of intensity per session, and then will be increased by steps of 5% intensity every 2 sessions until participants reach 30 minutes of training at 80% intensity. Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be instructed to log each training session. Subjects will record duration of exercise, perceived exertion, average heart rate, maximum heart rate, and distance. arm group intervention list arm group intervention name Behavioral: Aerobic training arm group label Balance training arm group type Active Comparator arm group description Balance Training A physical therapist will tailor a home balance training program for each participant based on pre- training capabilities. Subjects will be asked to perform exercises five times a week for thirty-minute sessions. Both dynamic and static exercises will be performed in sitting and standing positions. Exercises will start with stabilizing in a challenging static position and progress to dynamic arm and leg movements in the same or modified position. Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be required to log their exercise effort in terms of frequency and level of balance challenge. Individuals will be instructed to perform more difficult exercises if balance arm group intervention list arm group intervention name Behavioral: Balance training intervention list intervention intervention type Behavioral intervention name Aerobic training intervention description Aerobic training on stationary bike 5x a week for 30 minutes a day intervention arm group label list intervention arm group label Aerobic training intervention type Behavioral intervention name Balance training intervention description Training 5x a week for 30 minutes. Standard of care intervention arm group label list intervention arm group label Balance training outcomes module primary outcome list primary outcome primary outcome measure Cerebellar volume primary outcome description Cranial MRI will be performed in all participants using a 3-T scanner. Using each individual's T1-weighted image, structural imaging measures of cerebellar brain volume will be derived using the FreeSurfer software package (http:// surfer.nmr.mgh.harvard.edu/). FreeSurfer will automatically assign a neuroanatomic label to each voxel. From this labeling, a set of volumetric regions of interest is defined. The calculated volume within the cerebellar region is adjusted for variations in individual's intracranial brain volume (ICV) which is measured using BrainWash (an automatic - Page 3 of 5 [DRAFT] - multi-atlas skull-striping software package). We will process the longitudinal T1-weighted images primary outcome time frame 6 months secondary outcome list secondary outcome secondary outcome measure Cognition secondary outcome description The NIH toolbox will be used before and after training to determine impact of training on cognition secondary outcome time frame 6 months secondary outcome measure Ataxia severity secondary outcome description The Scale for the Assessment and Rating of Ataxia (SARA) will be done to before and after training. This scale ranges from 0 to 40 with higher scores indicating more ataxia secondary outcome time frame 6 months secondary outcome measure Gait speed secondary outcome description Participants will walk 8 meters as fast as possible secondary outcome time frame 6 months secondary outcome measure Balance secondary outcome description The dynamic gait index will be performed to test balance secondary outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria: Diagnosed with spinocerebellar ataxia Cerebellar atrophy on MRI Prevalence of ataxia on clinical exam Ability to safely ride a stationary exercise bike Exclusion Criteria: Other neurologic conditions • Heart disease Cognitive impairment Medical instability healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Scott Barbuto, MD PhD overall official affiliation Columbia University overall official role Principal Investigator location list location location facility Columbia University Irving Medical Center location city New York location state New York location zip 10032 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001259 condition mesh term Ataxia condition mesh id D000002524 condition mesh term Cerebellar Ataxia condition mesh id D000020754 condition mesh term Spinocerebellar Ataxias condition mesh id D000013132 condition mesh term Spinocerebellar Degenerations condition ancestor list condition ancestor condition ancestor id D000020820 condition ancestor term Dyskinesias condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000002526 condition ancestor term Cerebellar Diseases condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000013118 condition ancestor term Spinal Cord Diseases condition ancestor id D000020271 condition ancestor term Heredodegenerative Disorders, Nervous System condition ancestor id D000019636 condition ancestor term Neurodegenerative Diseases condition ancestor id D000030342 condition ancestor term Genetic Diseases, Inborn condition browse leaf list condition browse leaf condition browse leaf id M3717 condition browse leaf name Ataxia condition browse leaf as found Ataxia condition browse leaf relevance high condition browse leaf id M4925 condition browse leaf name Cerebellar Ataxia condition browse leaf as found Ataxia condition browse leaf relevance high condition browse leaf id M21663 condition browse leaf name Spinocerebellar Ataxias condition browse leaf as found Spinocerebellar Ataxia condition browse leaf relevance high condition browse leaf id M15081 condition browse leaf name Spinocerebellar Degenerations condition browse leaf as found Spinocerebellar Ataxia condition browse leaf relevance high condition browse leaf id M4927 condition browse leaf name Cerebellar Diseases condition browse leaf relevance low condition browse leaf id M21727 condition browse leaf name Dyskinesias condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M15067 condition browse leaf name Spinal Cord Diseases condition browse leaf relevance low condition browse leaf id M21245 condition browse leaf name Heredodegenerative Disorders, Nervous System condition browse leaf relevance low condition browse leaf id M20711 condition browse leaf name Neurodegenerative Diseases condition browse leaf relevance low condition browse leaf id M22839 condition browse leaf name Genetic Diseases, Inborn condition browse leaf relevance low condition browse leaf id T5352 condition browse leaf name Spinocerebellar Ataxia condition browse leaf as found Spinocerebellar Ataxia condition browse leaf relevance high condition browse leaf id T1041 condition browse leaf name Cerebellar Degeneration condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04837027
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19970, 3929, 19191, 1116, 1249, 8830, 21484, 10803, 23992, 10803, 5099, 3164, 10803, 2076, 2173, 4746, 1739, 22496, 13196, 1981, 1372, 2190, 1981, 1372, 1981, 1372, 3107, 23877, 15421, 2013, 1981, 1372, 2076, 17635, 1981, 1372, 6136, 4539, 27989, 21868, 1209, 1129, 1549, 170, 19255, 6730, 8295, 1111, 1313, 1329, 119, 1220, 1209, 1129, 10154, 1106, 1329, 1103, 6730, 8295, 1421, 1551, 170, 1989, 1111, 3961, 118, 2517, 6887, 119, 1109, 6730, 7657, 24259, 1209, 1129, 1359, 1113, 1103, 2548, 112, 188, 159, 2346, 1477, 22871, 3552, 1113, 3073, 118, 2774, 1285, 119, 1109, 6730, 1788, 1209, 1838, 1120, 2539, 110, 1104, 7657, 1679, 4912, 117, 1105, 1173, 1209, 1129, 2569, 1118, 3343, 1104, 126, 110, 7657, 1451, 123, 6887, 1235, 6635, 2519, 1476, 1904, 1104, 2013, 1120, 2908, 110, 7657, 119, 4539, 27989, 21868, 1209, 1129, 12017, 5392, 1118, 174, 118, 6346, 1137, 2179, 1106, 2590, 1251, 3243, 1164, 1103, 6730, 11309, 1105, 1209, 1129, 10154, 1106, 9366, 1296, 2013, 4912, 119, 12859, 26394, 1209, 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1106, 9366, 1147, 6730, 3098, 1107, 2538, 1104, 5625, 1105, 1634, 1104, 5233, 4506, 119, 26381, 1209, 1129, 10154, 1106, 3870, 1167, 2846, 11536, 1191, 5233, 1981, 1372, 9108, 2190, 1981, 1372, 9108, 1271, 4108, 2328, 17564, 1348, 131, 18757, 13831, 2013, 9108, 2190, 9108, 9108, 2076, 4108, 2328, 17564, 1348, 9108, 1271, 23877, 15421, 2013, 9108, 6136, 23877, 15421, 2013, 1113, 19255, 8295, 126, 1775, 170, 1989, 1111, 1476, 1904, 170, 1285, 9108, 1981, 1372, 3107, 2190, 9108, 1981, 1372, 3107, 23877, 15421, 2013, 9108, 2076, 4108, 2328, 17564, 1348, 9108, 1271, 18757, 13831, 2013, 9108, 6136, 5513, 126, 1775, 170, 1989, 1111, 1476, 1904, 119, 6433, 1104, 1920, 9108, 1981, 1372, 3107, 2190, 9108, 1981, 1372, 3107, 18757, 13831, 2013, 13950, 13196, 2425, 9386, 2190, 2425, 9386, 2425, 9386, 4929, 24664, 1874, 23033, 1197, 3884, 2425, 9386, 6136, 140, 23851, 1348, 25827, 2240, 1209, 1129, 1982, 1107, 1155, 6635, 1606, 170, 124, 118, 157, 14884, 2511, 119, 7993, 1296, 2510, 112, 188, 157, 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3718, 9386, 4929, 3291, 25763, 3718, 9386, 6136, 1109, 151, 2240, 3048, 6806, 8757, 1209, 1129, 1215, 1196, 1105, 1170, 2013, 1106, 4959, 3772, 1104, 2013, 1113, 1884, 25763, 3718, 9386, 1159, 4207, 127, 1808, 3718, 9386, 4929, 1335, 7897, 1465, 20997, 3718, 9386, 6136, 1109, 20334, 1111, 1103, 19721, 1105, 21632, 1158, 1104, 1335, 7897, 1465, 113, 13411, 9664, 114, 1209, 1129, 1694, 1106, 1196, 1105, 1170, 2013, 119, 1188, 3418, 9123, 1121, 121, 1106, 1969, 1114, 2299, 7432, 7713, 1167, 1120, 7897, 1465, 3718, 9386, 1159, 4207, 127, 1808, 3718, 9386, 4929, 144, 21263, 2420, 3718, 9386, 6136, 4539, 27989, 21868, 1209, 2647, 129, 4865, 1112, 2698, 1112, 1936, 3718, 9386, 1159, 4207, 127, 1808, 3718, 9386, 4929, 18757, 13831, 3718, 9386, 6136, 1109, 9652, 176, 21263, 7448, 1209, 1129, 1982, 1106, 2774, 5233, 3718, 9386, 1159, 4207, 127, 1808, 11768, 13196, 11768, 9173, 3561, 17855, 140, 10587, 3464, 131, 12120, 8517, 22583, 1181, 1114, 6898, 13335, 9014, 23033, 1197, 1120, 7897, 1465, 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full study rank 61572 study protocol section identification module n c t id NCT04834726 org study id info org study id 848696 organization org full name University of Pennsylvania org class OTHER brief title COVID-19 Vaccine Text Outreach official title Pragmatic Trial of COVID Vaccine Text Outreach Interventions status module status verified date August 2021 overall status Completed expanded access info has expanded access No start date struct start date April 29, 2021 start date type Actual primary completion date struct primary completion date June 4, 2021 primary completion date type Actual completion date struct completion date July 6, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 30, 2021 last update post date struct last update post date September 1, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Shivan J Mehta responsible party investigator title Principal Investigator responsible party investigator affiliation University of Pennsylvania lead sponsor lead sponsor name University of Pennsylvania lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This project aims to evaluate different approaches to increase COVID-19 vaccine uptake among at-risk patients at Penn Medicine in an equitable and systematic manner through a centralized outreach program. The investigators will evaluate different text-based scheduling and messaging approaches informed by behavioral science to increase uptake among eligible patients, including the use of clinician endorsement, opt-out framing, and scarcity. detailed description This project will evaluate a centralized approach to increasing COVID through direct outreach to eligible patients via text messaging. This pragmatic randomized controlled trial has the following aims: Aim 1: To conduct systematic large scale text message outreach for vaccine delivery among a defined group of Penn Medicine in a way that advances equity. Aim 2: To offer different scheduling workflows through text messaging that might increase uptake and reduce disparities. Aim 3: To compare the equity and efficiency of different messages informed by behavioral science, including PCP endorsement, opt-out framing, and scarcity. conditions module condition list condition Covid19 keyword list keyword Vaccination Uptake Text Messaging Outreach design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Factorial Assignment design primary purpose Health Services Research design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 19554 enrollment type Actual arms interventions module arm group list arm group arm group label 1: Usual Care arm group type Active Comparator arm group description Patients will receive a phone call to schedule their appointment from an Access Center representative. Access Center representatives will make up to 3 attempts to schedule an appointment with the patient. Patients randomized to this arm will not receive any text messaging. arm group intervention list arm group intervention name Behavioral: Phone Call arm group label 2A: Call Back + Standard Msg arm group type Experimental arm group description The message describes that the patient is eligible for the COVID vaccine. Will include a prompt to agree to scheduling. The access center will call these patients back to schedule, calling up to 3 times. arm group intervention list arm group intervention name Behavioral: Opt-In (Call-Back) Behavioral: Standard Message arm group label 2B: Call Back + Clinician Endorsement arm group type Experimental arm group description The message will describe an endorsement from the provider to get the vaccination. Will include a prompt to agree to scheduling. The access center will call these patients back to schedule, calling up to 3 times. arm group intervention list arm group intervention name Behavioral: Opt-In (Call-Back) Behavioral: Clinician Endorsement arm group label 2C: Call Back + Scarcity arm group type Experimental arm group description The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine. Will include a prompt to agree to scheduling. The access center will call these patients back to schedule, calling up to 3 times. arm group intervention list arm group intervention name Behavioral: Opt-In (Call-Back) Behavioral: Scarcity arm group label 2D: Call Back + Opt-Out Framing arm group type Experimental arm group description The message will highlight that a vaccine is reserved for the patient, implying that they need to opt-outWill include a prompt to agree to scheduling. The access center will call these patients back to schedule, calling up to 3 times. arm group intervention list arm group intervention name Behavioral: Opt-In (Call-Back) Behavioral: Opt-Out Framing arm group label 3A: In-Bound Call + Standard Msg arm group type Experimental arm group description The message describes that the patient is eligible for the COVID vaccine. Will include a prompt to agree to scheduling, which will be followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment. arm group intervention list arm group intervention name Behavioral: Opt-in (In-Bound) Behavioral: Standard Message arm group label 3B: In-Bound Call + Clinician Endorsement arm group type Experimental arm group description The message will describe an endorsement from the provider to get the vaccination. Will include a prompt to agree to scheduling, which will be followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment. arm group intervention list arm group intervention name Behavioral: Opt-in (In-Bound) Behavioral: Clinician Endorsement arm group label 3C: In-Bound Call + Scarcity arm group type Experimental arm group description The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine. Will include a prompt to agree to scheduling, which will be followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment. arm group intervention list arm group intervention name Behavioral: Opt-in (In-Bound) Behavioral: Scarcity arm group label 3D: In-Bound Call + Opt-Out Framing arm group type Experimental arm group description The message will highlight that a vaccine is reserved for the patient, implying that they need to opt-out. Will include a prompt to agree to scheduling, which will be followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment. arm group intervention list arm group intervention name Behavioral: Opt-in (In-Bound) Behavioral: Opt-Out Framing intervention list intervention intervention type Behavioral intervention name Opt-In (Call-Back) intervention description Messaging will include a prompt to agree to scheduling. If patient agrees, the access center will call these patients back to schedule, calling up to 3 times. intervention arm group label list intervention arm group label 2A: Call Back + Standard Msg 2B: Call Back + Clinician Endorsement 2C: Call Back + Scarcity 2D: Call Back + Opt-Out Framing intervention type Behavioral intervention name Opt-in (In-Bound) intervention description Messaging will include a prompt to agree to scheduling followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment. intervention arm group label list intervention arm group label 3A: In-Bound Call + Standard Msg 3B: In-Bound Call + Clinician Endorsement 3C: In-Bound Call + Scarcity 3D: In-Bound Call + Opt-Out Framing intervention type Behavioral intervention name Standard Message intervention description The message describes that the patient is eligible for the COVID vaccine. intervention arm group label list intervention arm group label 2A: Call Back + Standard Msg 3A: In-Bound Call + Standard Msg intervention type Behavioral intervention name Clinician Endorsement intervention description The message will describe an endorsement from the provider to get the vaccination. intervention arm group label list intervention arm group label 2B: Call Back + Clinician Endorsement 3B: In-Bound Call + Clinician Endorsement intervention type Behavioral intervention name Scarcity intervention description The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine. intervention arm group label list intervention arm group label 2C: Call Back + Scarcity 3C: In-Bound Call + Scarcity intervention type Behavioral intervention name Opt-Out Framing intervention description This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out. intervention arm group label list intervention arm group label 2D: Call Back + Opt-Out Framing 3D: In-Bound Call + Opt-Out Framing intervention type Behavioral intervention name Phone Call intervention description The access center will call these patients to schedule their vaccine appointment. These patients will not receive text messaging. intervention arm group label list intervention arm group label 1: Usual Care outcomes module primary outcome list primary outcome primary outcome measure Dose 1 Completion primary outcome description Percentage of patients who complete the first dose of the COVID vaccine within 1 month of initial outreach primary outcome time frame 1 month secondary outcome list secondary outcome secondary outcome measure Dose 1 Completion secondary outcome description Percentage of patients who complete the first dose of the COVID vaccine within 2 months of initial outreach secondary outcome time frame 2 months secondary outcome measure Vaccine Completion secondary outcome description Percentage of patients who complete the vaccination process within 2 months of initial outreach secondary outcome time frame 2 months eligibility module eligibility criteria Inclusion Criteria: patients of Penn Medicine aged 18+ who reside in Philadelphia and who have had at least 1 visit in the past 5 years with a Penn Medicine primary care provider (PCP) Exclusion Criteria: Patients who have completed any dose of the vaccine at Penn Medicine, are currently scheduled to receive the vaccine, have externally documented vaccination records, or have previously received text-message based vaccine outreach. healthy volunteers No gender All minimum age 16 Years std age list std age Child Adult Older Adult contacts locations module overall official list overall official overall official name Shivan Mehta, MD overall official affiliation University of Pennsylvania overall official role Principal Investigator location list location location facility Hospital of the University of Pennsylvania location city Philadelphia location state Pennsylvania location zip 19104 location country United States references module reference list reference reference p m i d 35696165 reference type derived reference citation Mehta SJ, Mallozzi C, Shaw PA, Reitz C, McDonald C, Vandertuyn M, Balachandran M, Kopinsky M, Sevinc C, Johnson A, Ward R, Park SH, Snider CK, Rosin R, Asch DA. Effect of Text Messaging and Behavioral Interventions on COVID-19 Vaccination Uptake: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2216649. doi: 10.1001/jamanetworkopen.2022.16649. i p d sharing statement module i p d sharing No annotation section annotation module unposted annotation unposted responsible party Shivan J Mehta, Principal Investigator, University of Pennsylvania unposted event list unposted event unposted event type Release unposted event date March 2, 2022 unposted event type Reset unposted event date March 16, 2022 derived section misc info module version holder December 02, 2022 submission tracking submission info list submission info submission release date March 2, 2022 submission reset date March 16, 2022 submission release date June 16, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04834726
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full study rank 61271 study protocol section identification module n c t id NCT04838639 org study id info org study id 360-101 organization org full name Otsuka Pharmaceutical Factory, Inc. org class INDUSTRY brief title Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects official title A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 When Administered Orally to Healthy and Obese Adult Subjects status module status verified date April 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date June 14, 2021 start date type Actual primary completion date struct primary completion date March 31, 2022 primary completion date type Actual completion date struct completion date September 2022 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 19, 2022 last update post date struct last update post date April 20, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Otsuka Pharmaceutical Factory, Inc. lead sponsor class INDUSTRY collaborator list collaborator collaborator name Celerion collaborator class INDUSTRY oversight module is f d a regulated drug Yes is f d a regulated device No description module brief summary This clinical trial is the first-in-human study of NO-13065. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses and food effect of NO-13065 in healthy and obese adult subjects. conditions module condition list condition Obesity design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 84 enrollment type Actual arms interventions module arm group list arm group arm group label NO-13065, oral tablet arm group type Experimental arm group intervention list arm group intervention name Drug: NO-13065 arm group label Placebo matched to NO-13065, oral tablet arm group type Placebo Comparator arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name NO-13065 intervention description Single ascending doses of NO-13065 in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065. Single ascending dose of NO-13065 with food effect arm. Multiple ascending doses of NO-13065 for 10 or up to 28 days in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065. intervention arm group label list intervention arm group label NO-13065, oral tablet intervention type Drug intervention name Placebo intervention description Two subjects per cohort will take a matched placebo. intervention arm group label list intervention arm group label Placebo matched to NO-13065, oral tablet outcomes module primary outcome list primary outcome primary outcome measure The number and severity of treatment emergent adverse events (TEAEs) primary outcome description To assess the safety and tolerability of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects. primary outcome time frame Up to 35 days secondary outcome list secondary outcome secondary outcome measure Maximum plasma concentration (Cmax) secondary outcome description To assess Cmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects. secondary outcome time frame Up to 35 days secondary outcome measure Area under the plasma concentration-time curve (AUC) secondary outcome description To assess AUC of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects. secondary outcome time frame Up to 35 days secondary outcome measure Time to reach Cmax (Tmax) secondary outcome description To assess Tmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects. secondary outcome time frame Up to 35 days secondary outcome measure Apparent first-order terminal elimination half-life (t ½) secondary outcome description To assess t ½ of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects. secondary outcome time frame Up to 35 days secondary outcome measure Correlation between QTc and NO-13065 plasma concentrations secondary outcome description To explore the correlation between changes in QTc interval (msec) and NO-13065 plasma concentrations, appropriate correction method for QTc interval calculation such as QTcF will used for analysis. secondary outcome time frame Up to 29 days eligibility module eligibility criteria Inclusion Criteria: Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age Continuous non-smoker Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or safety ECGs. Women of non-childbearing potential only Able to understand and sign a written informed consent form prior to initiation of study procedures. Exclusion Criteria: Subject is mentally or legally incapacitated or has significant emotional problems History or presence of clinically significant medical or psychiatric condition or disease History or presence : Familial hyperlipidemia, Diabetes, Bleeding disorder(s), including relevant familial history, Thromboembolic disease, Bleeding in the gastrointestinal tract or CNS, Hepatobillary disease, Gilbert's syndrome History or presence of alcohol or drug abuse. Has liver function test(s) including ALT, AST, GGT, and/or ALP or total bilirubin that are > ULN at screening or check-in. Positive urine drug or alcohol results. healthy volunteers Accepts Healthy Volunteers gender All minimum age 19 Years maximum age 55 Years std age list std age Adult contacts locations module overall official list overall official overall official name Koushi Iwata overall official affiliation Otsuka Pharmaceutical Factory, Inc. overall official role Study Chair location list location location facility Celerion location city Lincoln location state Nebraska location zip 68502 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04838639
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full study rank 61177 study protocol section identification module n c t id NCT04839861 org study id info org study id 874MIGH21 organization org full name Neuromotion Labs org class INDUSTRY brief title Examining the Impacts of Parent-Child Interactive Activities official title Examining the Impacts of Parent-Child Interactive Activities as an Adjunct to Mightier Play status module status verified date October 2021 overall status Completed expanded access info has expanded access No start date struct start date May 7, 2021 start date type Actual primary completion date struct primary completion date October 13, 2021 primary completion date type Actual completion date struct completion date October 13, 2021 completion date type Actual study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date October 19, 2021 last update post date struct last update post date October 20, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Neuromotion Labs lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to demonstrate the effects of online and offline play of games on the Mightier game platform, in comparison to the effects of Mightier online play alone. detailed description Mightier is a mobile app-based biofeedback video game platform that facilitates emotion regulation skill-building among children ages 6-14. The technology behind Mightier's mobile app has been validated in two independent sham-controlled randomized controlled trials, where the investigators have seen decreases in clinical symptoms of aggression and disruptive behaviors, as well as lowered family stress without adverse events. Mightier will soon introduce offline Mightier Family Games to its product line. Mightier Family Games will include offline, interactive components that have not previously been incorporated into Mightier play. Studies have shown that improvements in child behavior and child-parent relationships are among the many benefits of family play. For the proposed study, families with no prior Mightier exposure will engage in different types of Mightier play for six weeks, to demonstrate the effects of online and offline Mightier play in comparison to the effects of Mightier online play alone. Mightier will recruit families through social media, then Mightier will randomly assign participants to one of two groups: a Mightier online play only group, and a Mightier online and offline play group. The investigators will aim to enroll 20 participants in each group. conditions module condition list condition Emotional Regulation design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 42 enrollment type Actual arms interventions module arm group list arm group arm group label Mightier Online Games arm group type Active Comparator arm group description 6 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier online games at least 3 times a week for the 6 week duration. arm group intervention list arm group intervention name Behavioral: Mightier online gameplay arm group label Mightier Online Plus Offline Family Games arm group type Experimental arm group description 6 weeks of use ad-libitum. Parents will be encouraged to have their children play Mightier online games at least 3 times a week for the 6 week duration. Parents will be encouraged to play Mightier offline Family Games at least once a week for the 6 week duration. arm group intervention list arm group intervention name Behavioral: Mightier Family Games Behavioral: Mightier online gameplay intervention list intervention intervention type Behavioral intervention name Mightier Family Games intervention description Mightier Family Games includes five offline card games that can be played by two or more people. During card game play, one player wears the Mightier heart rate monitor, and can see a representation of their heart rate on a separate screen within the Mightier app. Each game includes elements that are tied to heart rate. intervention arm group label list intervention arm group label Mightier Online Plus Offline Family Games intervention type Behavioral intervention name Mightier online gameplay intervention description Mightier is a video-game-based biofeedback intervention that capitalizes on children's love of video games to increase emotional awareness and facilitate emotion regulation practice through heart rate (HR) control. Each family receives a Mightier Kit (Mighty Band heart rate monitor, dedicated Mightier tablet unless the family prefers to use their own device) and the Mightier App. Children wear a "Mighty Band" heart rate monitor on their arm while they play any one of 26+ games. As their heart rate rises the games become more difficult. For example, during a cooking game, smoke may appear on the screen and obscure the player's view. Children can either opt into an explicit cool down activity (deep breathing, progressive muscle relaxation, crossing the midline, or visualization) or cool down on their own. intervention arm group label list intervention arm group label Mightier Online Games Mightier Online Plus Offline Family Games intervention other name list intervention other name Mightier outcomes module primary outcome list primary outcome primary outcome measure Change in child irritability from baseline measured on ARI-P at Week 7 primary outcome description Affective Reactivity Index-Parent Report (ARI-P): The ARI is a 7-item scale that consists of 6 symptom items and 1 impairment item. The scale was designed to determine irritable mood rather than behavioral consequences such as hostility and acts of aggression (Stringaris et al., 2012). The individual items are scored 0,1, 2, and only the first six items are summed to form the total score, with a minimum score of 0 and a maximum score of 18, and higher scores indicating greater severity of irritability symptoms. The seventh item is an impairment item and it is analysed separately, with a minimum score of 0 and a maximum score of 3, and higher scores indicating greater irritability symptom severity. primary outcome time frame Baseline and Week 7 primary outcome measure Change in child-parent relationship from baseline measured on CPRS-SF at Week 7 primary outcome description Child-Parent Relationship Scale (CPRS-SF): The CPRS-SF is a 15- item The CPRS (Pianta, 1992) is a self-report instrument completed by parents that assesses their perceptions of their relationship with their child. The 15 items are rated on 5-point Likert scales. It is applicable to children ages 3-12. The CPRS-SF is scored in two subscales: an 8-item Conflict subscale (minimum score = 8, maximum score = 40, higher score indicates greater conflict), and a 7-item Closeness subscale (minimum score = 7, maximum score = 35, with greater score indicating greater closeness). primary outcome time frame Baseline and Week 7 primary outcome measure Parent perception of change in child emotion regulation from baseline measured on GIS at Week 7 primary outcome description Global Improvement Scale (GIS): The GIS is a parent self-report question that asks parents if they have noticed any overall improvements in their child's emotion regulation, with response options ranging from (1) very much improved to (7) very much worse. Minimum score = 1, Maximum score = 7, with higher numbers indicating less improvement, or worsening. The GIS has not been scientifically validated. primary outcome time frame Week 7 eligibility module eligibility criteria Inclusion Criteria: Age 6-12 at the time of screening Regular access to WiFi (for Mightier gameplay device connection) Exclusion Criteria: Prior Mightier use Diagnosed Intellectual Disability (by history) Planned medication changes during the 6-week study period healthy volunteers Accepts Healthy Volunteers gender All minimum age 6 Years maximum age 12 Years std age list std age Child contacts locations module overall official list overall official overall official name Jason Kahn, PhD overall official affiliation Neuromotion Labs Inc overall official role Principal Investigator location list location location facility Neuromotion Labs location city Boston location state Massachusetts location zip 02111 location country United States references module reference list reference reference p m i d 22574736 reference type background reference citation Stringaris A, Goodman R, Ferdinando S, Razdan V, Muhrer E, Leibenluft E, Brotman MA. The Affective Reactivity Index: a concise irritability scale for clinical and research settings. J Child Psychol Psychiatry. 2012 Nov;53(11):1109-17. doi: 10.1111/j.1469-7610.2012.02561.x. Epub 2012 May 10. reference type background reference citation RC Pianta - Unpublished measure, University of Virginia, 1992 i p d sharing statement module i p d sharing No i p d sharing description Only Mightier research staff will have access to individual participant data, including family demographics data and data from parent self-report measures. derived section misc info module version holder December 02, 2022
NCT04839861
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full study rank 61320 study protocol section identification module n c t id NCT04838002 org study id info org study id Yuzuncu Yil University Turkey organization org full name Yuzuncu Yıl University org class OTHER brief title The Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis official title Comparative Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis: A Randomised Sham-controlled Trial status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date August 7, 2019 start date type Actual primary completion date struct primary completion date April 10, 2020 primary completion date type Actual completion date struct completion date April 10, 2020 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Şeyhmus KAPLAN responsible party investigator title Principal Investigator responsible party investigator affiliation Yuzuncu Yıl University lead sponsor lead sponsor name Şeyhmus KAPLAN lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary To date, focused and radial types of extracorporeal shock wave therapy have been effectively used in lateral epicondylitis. However, studies directly addressing a comparison between radial and focused types of extracorporeal shock wave therapy in lateral epicondylitis have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused extracorporeal shock wave therapy options on lateral epicondylitis. conditions module condition list condition Lateral Epicondylitis Pain design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 87 enrollment type Actual arms interventions module arm group list arm group arm group label Focus ESWT arm group type Active Comparator arm group intervention list arm group intervention name Device: Extracorporeal shock wave arm group label Radial ESWT arm group type Active Comparator arm group intervention list arm group intervention name Device: Extracorporeal shock wave arm group label Sham ESWT arm group type Sham Comparator arm group intervention list arm group intervention name Device: Extracorporeal shock wave intervention list intervention intervention type Device intervention name Extracorporeal shock wave intervention description Focus and Radial types Extracorporeal shock wave therapy intervention arm group label list intervention arm group label Focus ESWT Radial ESWT Sham ESWT outcomes module primary outcome list primary outcome primary outcome measure Visual Analogue Scale primary outcome description pain evaluation, higher scores mean a worse outcome. primary outcome time frame 1 min. primary outcome measure Patient-Rated Tennis Elbow Evaluation primary outcome description Scale, Higher scores represent higher level of pain and disability. primary outcome time frame 5 min. eligibility module eligibility criteria Inclusion Criteria: Clinical diagnosis of lateral epicondylitis be aged ≥18 at the time of diagnosis be give informed consent Exclusion Criteria: be have not completed the assessment process. elbow deformity psychological illness healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Şeyhmus Kaplan overall official affiliation Yuzuncu Yıl University overall official role Principal Investigator location list location location facility Yuzuncu Yil University location city Van location country Turkey i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013716 condition mesh term Tennis Elbow condition ancestor list condition ancestor condition ancestor id D000070639 condition ancestor term Elbow Tendinopathy condition ancestor id D000052256 condition ancestor term Tendinopathy condition ancestor id D000009135 condition ancestor term Muscular Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000001134 condition ancestor term Arm Injuries condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition ancestor id D000013708 condition ancestor term Tendon Injuries condition browse leaf list condition browse leaf condition browse leaf id M14729 condition browse leaf name Shock condition browse leaf relevance low condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M15638 condition browse leaf name Tennis Elbow condition browse leaf as found Lateral Epicondylitis condition browse leaf relevance high condition browse leaf id M26166 condition browse leaf name Tendinopathy condition browse leaf relevance low condition browse leaf id M627 condition browse leaf name Elbow Tendinopathy condition browse leaf relevance low condition browse leaf id M11244 condition browse leaf name Muscular Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M3596 condition browse leaf name Arm Injuries condition browse leaf relevance low condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M15631 condition browse leaf name Tendon Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases
NCT04838002
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full study rank 61409 study protocol section identification module n c t id NCT04836845 org study id info org study id Yuzuncu Yil University Van organization org full name Yuzuncu Yıl University org class OTHER brief title Comparation of Radial and Focused Extracorporeal Shock Waves in Calcaneal Spur: A Randomised Sham-controlled Trial official title Comparative Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Calcaneal Spur: A Randomised Sham-controlled Trial status module status verified date January 2022 overall status Completed expanded access info has expanded access No start date struct start date August 7, 2019 start date type Actual primary completion date struct primary completion date April 10, 2020 primary completion date type Actual completion date struct completion date April 10, 2020 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date January 4, 2022 last update post date struct last update post date January 20, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Volkan Şah responsible party investigator title Principal Investigator responsible party investigator affiliation Yuzuncu Yıl University lead sponsor lead sponsor name Yuzuncu Yıl University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary To date, focused and radial types of ESWT have been effectively used in calcaneal spur. However, studies directly addressing a comparison between radial and focused types of ESWT in calcaneal spur have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused ESWT options on calcaneal spur. conditions module condition list condition Calcaneal Spur design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 92 enrollment type Actual arms interventions module arm group list arm group arm group label Focus extracorporeal shock wave therapy arm group type Active Comparator arm group intervention list arm group intervention name Device: Focus extracorporeal shock wave therapy arm group label Radial extracorporeal shock wave therapy arm group type Active Comparator arm group intervention list arm group intervention name Device: Radial extracorporeal shock wave therapy arm group label Sham extracorporeal shock wave therapy arm group type Sham Comparator arm group intervention list arm group intervention name Device: Sham extracorporeal shock wave therapy intervention list intervention intervention type Device intervention name Focus extracorporeal shock wave therapy intervention description Focus extracorporeal shock wave therapy, device: Electronica, Pagani, Italy intervention arm group label list intervention arm group label Focus extracorporeal shock wave therapy intervention type Device intervention name Radial extracorporeal shock wave therapy intervention description Radial extracorporeal shock wave therapy, device: Electronica, Pagani, Italy intervention arm group label list intervention arm group label Radial extracorporeal shock wave therapy intervention type Device intervention name Sham extracorporeal shock wave therapy intervention description Sham extracorporeal shock wave therapy, device: Electronica, Pagani, Italy intervention arm group label list intervention arm group label Sham extracorporeal shock wave therapy outcomes module primary outcome list primary outcome primary outcome measure Visual Analogue Scale primary outcome description pain evaluation, higher scores mean a worse outcome. primary outcome time frame 1 min. primary outcome measure American Orthopedic Foot and Ankle Score primary outcome description higher scores mean a better outcome. primary outcome time frame 5 min. primary outcome measure FOOT FUNCTION INDEX primary outcome description higher scores mean a worse outcome. primary outcome time frame 7 min. eligibility module eligibility criteria Inclusion Criteria: Clinical and radiological diagnosis of plantar calcaneal spur be aged ≥18 at the time of diagnosis be give informed consent Exclusion Criteria: have not completed the assessment process. foot deformity psychological disease healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Şeyhmus Kaplan overall official affiliation Yuzuncu Yıl University overall official role Study Director location list location location facility Yuzuncu Yil University location city Van location country Turkey i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000036982 condition mesh term Heel Spur condition ancestor list condition ancestor condition ancestor id D000005096 condition ancestor term Exostoses condition ancestor id D000015576 condition ancestor term Hyperostosis condition ancestor id D000001847 condition ancestor term Bone Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000005534 condition ancestor term Foot Diseases condition browse leaf list condition browse leaf condition browse leaf id M14729 condition browse leaf name Shock condition browse leaf relevance low condition browse leaf id M23810 condition browse leaf name Heel Spur condition browse leaf as found Calcaneal Spur condition browse leaf relevance high condition browse leaf id M7391 condition browse leaf name Exostoses condition browse leaf relevance low condition browse leaf id M17536 condition browse leaf name Osteochondroma condition browse leaf relevance low condition browse leaf id M27100 condition browse leaf name Osteophyte condition browse leaf relevance low condition browse leaf id M17344 condition browse leaf name Hyperostosis condition browse leaf relevance low condition browse leaf id M4278 condition browse leaf name Bone Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M7810 condition browse leaf name Foot Diseases condition browse leaf relevance low condition browse leaf id T4301 condition browse leaf name Osteochondroma condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04836845
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full study rank 61673 study protocol section identification module n c t id NCT04833413 org study id info org study id ZSE-202104 organization org full name Shanghai Zhongshan Hospital org class OTHER brief title Regimen Switch After Intensive Insulin Therapy official title Effectiveness of Regimen Switch After Intensive Insulin Therapy in Hospitalized Patients With Type 2 Diabetes status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 15, 2021 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date April 3, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date October 17, 2022 last update post date struct last update post date October 18, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Shanghai Zhongshan Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Insulin intensive therapy have traditionally been considered a sequential therapy in type 2 diabetes last choice, a number of guidelines and consensus recommendations insulin intensive therapy can be as obvious hyperglycemia in patients with newly diagnosed T2DM part of a line, a subset of patients after insulin intensive treatment target often need to change to other treatments, especially for senile diabetes patients, due to its self management ability, simplify the insulin solution is more urgent. Current clinical guidelines do not provide specific clinical guidance, such as the timing and method of switch after initial insulin intensive therapy. The purpose of this study was to explore the timing, suitable population and conversion methods of insulin regimens after treatment. detailed description Selecting initial insulin intensive therapy during the period of hospitalization in patients with type 2 diabetes, collect the basic information and biochemical information collection, including gender, age, duration of diabetes, intensive glucose-lowering treatment plan before treatment, diabetes complications, merger disease, smoking, drinking, height, weight, blood pressure, fasting glucose, glycosylated hemoglobin and glycosylated serum protein, insulin, c-peptide, liver and kidney function, blood lipid, blood routine, hypoglycemia is happening almost 1 month. Follow-up was conducted in January, March and June. Endocrinologists decide whether to continue the original hypoglycemic regimen or adjust it according to the glycemic control goals, islet β-cell function, diabetes complications, complications, hypoglycemia and other combination drugs, as well as patients' treatment willingness and compliance. To compare the timing of conversion of treatment regimens, the proportion of conversion to each regimen and the situation of reaching the standard, and to further analyze and compare the characteristics of people who switched to different regimens, in order to establish the basis for the selection of adjustment regimens after insulin treatment. conditions module condition list condition Insulin design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 1000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Continue intensive treatment group arm group description Patients with type 2 diabetes who continued intensive treatment within 6 months after hospital discharge arm group intervention list arm group intervention name Drug: Continuous intensive insulin therapy arm group label Premixed insulin treatment group arm group description Patients with type 2 diabetes who changed to premixed insulin within 6 months after hospital discharge arm group intervention list arm group intervention name Drug: Continuous intensive insulin therapy arm group label Basic insulin treatment group arm group description Patients with type 2 diabetes who changed to basic insulin treatment within 6 months after hospital discharge arm group intervention list arm group intervention name Drug: Continuous intensive insulin therapy arm group label Oral hypoglycemic drug treatment group arm group description Patients with type 2 diabetes who changed to oral hypoglycemic drug treatment within 6 months after hospital discharge intervention list intervention intervention type Drug intervention name Continuous intensive insulin therapy intervention description After initial intensive insulin therapy in hospital, patients were grouped according to different treatment regimens within 6 months of discharge intervention arm group label list intervention arm group label Basic insulin treatment group Continue intensive treatment group Premixed insulin treatment group intervention other name list intervention other name Premixed insulin therapy Basic insulin therapy Oral hypoglycemic drug therapy outcomes module primary outcome list primary outcome primary outcome measure Change in HbA1c primary outcome description HbA1c in different conversion regimens primary outcome time frame 1，3，6 months secondary outcome list secondary outcome secondary outcome measure The average blood glucose secondary outcome description The average blood glucose in different conversion regimens secondary outcome time frame 1，3，6 months secondary outcome measure Fasting blood glucose secondary outcome description Fasting blood glucose in different conversion regimens secondary outcome time frame 1，3，6 months secondary outcome measure Postprandial blood glucose secondary outcome description Postprandial blood glucose in different conversion regimens secondary outcome time frame 1，3，6 months secondary outcome measure Incidence of hypoglycemia secondary outcome description Incidence of hypoglycemia in different conversion regimens secondary outcome time frame 1，3，6 months secondary outcome measure Impact on body weight secondary outcome description Impact on body weight in different conversion regimens secondary outcome time frame 1，3，6 months eligibility module eligibility criteria Inclusion Criteria: Patients with type 2 diabetes; Patients who started intensive insulin therapy during hospitalization Age ≥18 years old Exclusion Criteria: Type 1 diabetes, special type diabetes Acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmolarity) Severe infection pregnancy or planned pregnancy Participating in other clinical studies or trials healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population 2021.4 -- 2022.6 Adult patients with type 2 diabetes admitted to the endocrinology department of a level-2 or higher hospital and initiated intensive insulin therapy during hospitalization sampling method Probability Sample contacts locations module central contact list central contact central contact name Xiao ying Li, MD central contact role Contact central contact phone 13651913857 central contact e mail [email protected] central contact name Ying Chen, MD central contact role Contact central contact phone 15351890068 central contact e mail [email protected] location list location location facility Zhongshan hospital location status Not yet recruiting location city Shanghai location state Shanghai location zip 200032 location country China location contact list location contact location contact name Xiao ying Li, MD location contact role Contact location contact phone 13651913857 location contact e mail [email protected] location contact name Juan yu Fan, MD location contact role Contact location contact phone 18101947845 location contact e mail [email protected] location facility Department of Endocrinoogy, Zhongshan Hospital Fudan University location status Recruiting location city Shanghai location country China location contact list location contact location contact name Yujuan Fan location contact role Contact location contact phone 18101947845 location contact e mail [email protected] references module reference list reference reference p m i d 25825361 reference type result reference citation Home PD, Dain MP, Freemantle N, Kawamori R, Pfohl M, Brette S, Pilorget V, Scherbaum WA, Vespasiani G, Vincent M, Balkau B. Four-year evolution of insulin regimens, glycaemic control, hypoglycaemia and body weight after starting insulin therapy in type 2 diabetes across three continents. Diabetes Res Clin Pract. 2015 May;108(2):350-9. doi: 10.1016/j.diabres.2015.01.030. Epub 2015 Jan 23. reference p m i d 25952532 reference type result reference citation Jin SM, Kim JH, Min KW, Lee JH, Ahn KJ, Park JH, Jang HC, Park SW, Lee KW, Won KC, Kim YI, Chung CH, Park TS, Lee JH, Lee MK. Basal-prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: A 24-week randomized non-inferiority trial. J Diabetes. 2016 May;8(3):405-13. doi: 10.1111/1753-0407.12312. Epub 2015 Jun 29. reference p m i d 28661564 reference type result reference citation Weng J. Short-term intensive insulin therapy could be the preferred option for new onset Type 2 diabetes mellitus patients with HbA1c > 9. J Diabetes. 2017 Oct;9(10):890-893. doi: 10.1111/1753-0407.12581. Epub 2017 Aug 22. reference p m i d 30291106 reference type result reference citation Davies MJ, D'Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018 Dec;41(12):2669-2701. doi: 10.2337/dci18-0033. Epub 2018 Oct 4. reference p m i d 26459273 reference type result reference citation Bellido V, Suarez L, Rodriguez MG, Sanchez C, Dieguez M, Riestra M, Casal F, Delgado E, Menendez E, Umpierrez GE. Comparison of Basal-Bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes. Diabetes Care. 2015 Dec;38(12):2211-6. doi: 10.2337/dc15-0160. Epub 2015 Oct 12. reference p m i d 28251792 reference type result reference citation Mauricio D, Meneghini L, Seufert J, Liao L, Wang H, Tong L, Cali A, Stella P, Carita P, Khunti K. Glycaemic control and hypoglycaemia burden in patients with type 2 diabetes initiating basal insulin in Europe and the USA. Diabetes Obes Metab. 2017 Aug;19(8):1155-1164. doi: 10.1111/dom.12927. Epub 2017 Apr 10. reference p m i d 29053215 reference type result reference citation Russell-Jones D, Pouwer F, Khunti K. Identification of barriers to insulin therapy and approaches to overcoming them. Diabetes Obes Metab. 2018 Mar;20(3):488-496. doi: 10.1111/dom.13132. Epub 2017 Nov 22. reference p m i d 28483786 reference type result reference citation Bowering K, Case C, Harvey J, Reeves M, Sampson M, Strzinek R, Bretler DM, Bang RB, Bode BW. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care. 2017 Jul;40(7):951-957. doi: 10.2337/dc16-1770. Epub 2017 May 8. reference p m i d 26512041 reference type result reference citation Lind M, Hirsch IB, Tuomilehto J, Dahlqvist S, Ahren B, Torffvit O, Attvall S, Ekelund M, Filipsson K, Tengmark BO, Sjoberg S, Pehrsson NG. Liraglutide in people treated for type 2 diabetes with multiple daily insulin injections: randomised clinical trial (MDI Liraglutide trial). BMJ. 2015 Oct 28;351:h5364. doi: 10.1136/bmj.h5364. reference p m i d 33298426 reference type result reference citation American Diabetes Association. 15. Diabetes Care in the Hospital: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S211-S220. doi: 10.2337/dc21-S015. i p d sharing statement module i p d sharing Undecided i p d sharing description Clinical study Report may be shared derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M6271 condition browse leaf name Diabetes Mellitus, Type 2 condition browse leaf relevance low condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000007328 intervention mesh term Insulin intervention mesh id C000557859 intervention mesh term Insulin, Globin Zinc intervention mesh id D000007004 intervention mesh term Hypoglycemic Agents intervention ancestor list intervention ancestor intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M9517 intervention browse leaf name Insulin intervention browse leaf as found Time intervention browse leaf relevance high intervention browse leaf id M172956 intervention browse leaf name Insulin, Globin Zinc intervention browse leaf as found Time intervention browse leaf relevance high intervention browse leaf id M9206 intervention browse leaf name Hypoglycemic Agents intervention browse leaf as found Congestive intervention browse leaf relevance high intervention browse leaf id M16920 intervention browse leaf name Zinc intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Hypo intervention browse branch name Hypoglycemic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Micro intervention browse branch name Micronutrients
NCT04833413
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full study rank 61819 study protocol section identification module n c t id NCT04831515 org study id info org study id EX-MKTG-122 organization org full name Coopervision, Inc. org class INDUSTRY brief title Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers official title Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers status module status verified date February 2022 overall status Completed expanded access info has expanded access No start date struct start date March 29, 2021 start date type Actual primary completion date struct primary completion date July 2, 2021 primary completion date type Actual completion date struct completion date July 2, 2021 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual results first submit date January 20, 2022 results first submit q c date January 20, 2022 results first post date struct results first post date February 11, 2022 results first post date type Actual last update submit date February 11, 2022 last update post date struct last update post date February 15, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Coopervision, Inc. lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device Yes is u s export Yes description module brief summary The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each. detailed description This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience. conditions module condition list condition Astigmatism design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 48 enrollment type Actual arms interventions module arm group list arm group arm group label Lens A arm group type Experimental arm group description daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. arm group intervention list arm group intervention name Device: Lens A Device: Lens B arm group label Lens B arm group type Active Comparator arm group description daily disposable soft contact lens - control lens Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. arm group intervention list arm group intervention name Device: Lens A Device: Lens B intervention list intervention intervention type Device intervention name Lens A intervention description daily disposable soft contact lens - test lens intervention arm group label list intervention arm group label Lens A Lens B intervention type Device intervention name Lens B intervention description daily disposable soft contact lens - control lens intervention arm group label list intervention arm group label Lens A Lens B outcomes module primary outcome list primary outcome primary outcome measure Overall Ease of Lens Handling primary outcome description Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy) primary outcome time frame 1 week secondary outcome list secondary outcome secondary outcome measure Visual Acuity secondary outcome description Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) secondary outcome time frame Baseline - after lenses have settled for 10 minutes secondary outcome measure Visual Acuity secondary outcome description Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) secondary outcome time frame 1 week eligibility module eligibility criteria Inclusion Criteria: Is at least 18 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Self reports having a full eye examination in the previous two years; Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum; Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC; Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees; Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively; Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters Exclusion Criteria: Is participating in any concurrent clinical or research study; Habitually wears one of the study contact lenses; Has any known active ocular disease and/or infection that contraindicates contact lens wear; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; Has known sensitivity to the diagnostic sodium fluorescein used in the study; Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; Has undergone refractive error surgery or intraocular surgery. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Lyndon Jones, PhD, FCOptom overall official affiliation Centre for Ocular Research and Education overall official role Study Director location list location location facility Golden Optometric Group location city Whittier location state California location zip 90606 location country United States location facility Golden Vision location city Sarasota location state Florida location zip 34237 location country United States location facility Sacco Eye Group location city Vestal location state New York location zip 13850 location country United States location facility Athens Eye Care location city Athens location state Ohio location zip 45701 location country United States results section participant flow module flow group list flow group flow group id FG000 flow group title Lens A, Then Lens B flow group description Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens flow group id FG001 flow group title Lens B, Then Lens A flow group description Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens flow period list flow period flow period title First Intervention flow milestone list flow milestone flow milestone type STARTED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 24 flow achievement group id FG001 flow achievement num subjects 24 flow milestone type COMPLETED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 24 flow achievement group id FG001 flow achievement num subjects 23 flow milestone type NOT COMPLETED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 0 flow achievement group id FG001 flow achievement num subjects 1 flow drop withdraw list flow drop withdraw flow drop withdraw type Adverse Event flow reason list flow reason flow reason group id FG000 flow reason num subjects 0 flow reason group id FG001 flow reason num subjects 1 flow period title Second Intervention flow milestone list flow milestone flow milestone type STARTED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 24 flow achievement group id FG001 flow achievement num subjects 23 flow milestone type COMPLETED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 24 flow achievement group id FG001 flow achievement num subjects 23 flow milestone type NOT COMPLETED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 0 flow achievement group id FG001 flow achievement num subjects 0 baseline characteristics module baseline group list baseline group baseline group id BG000 baseline group title Overall Study baseline group description daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens baseline denom list baseline denom baseline denom units Participants baseline denom count list baseline denom count baseline denom count group id BG000 baseline denom count value 48 baseline measure list baseline measure baseline measure title Age, Categorical baseline measure param type Count of Participants baseline measure unit of measure Participants baseline class list baseline class baseline class denom list baseline class denom baseline class denom units Participants baseline class denom count list baseline class denom count baseline class denom count group id BG000 baseline class denom count value 48 baseline category list baseline category baseline category title <=18 years baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 0 baseline category title Between 18 and 65 years baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 48 baseline category title >=65 years baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 0 baseline measure title Age, Continuous baseline measure param type Mean baseline measure dispersion type Standard Deviation baseline measure unit of measure years baseline class list baseline class baseline class denom list baseline class denom baseline class denom units Participants baseline class denom count list baseline class denom count baseline class denom count group id BG000 baseline class denom count value 48 baseline category list baseline category baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 32.5 baseline measurement spread 6.8 baseline measure title Sex: Female, Male baseline measure param type Count of Participants baseline measure unit of measure Participants baseline class list baseline class baseline class denom list baseline class denom baseline class denom units Participants baseline class denom count list baseline class denom count baseline class denom count group id BG000 baseline class denom count value 48 baseline category list baseline category baseline category title Female baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 34 baseline category title Male baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 14 baseline measure title Race and Ethnicity Not Collected baseline measure population description Race and Ethnicity were not collected from any participant. baseline measure param type Count of Participants baseline measure unit of measure Participants baseline class list baseline class baseline class denom list baseline class denom baseline class denom units Participants baseline class denom count list baseline class denom count baseline class denom count group id BG000 baseline class denom count value 0 baseline measure title Region of Enrollment baseline measure param type Number baseline measure unit of measure participants baseline class list baseline class baseline class title United States baseline class denom list baseline class denom baseline class denom units Participants baseline class denom count list baseline class denom count baseline class denom count group id BG000 baseline class denom count value 48 baseline category list baseline category baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 48 outcome measures module outcome measure list outcome measure outcome measure type Primary outcome measure title Overall Ease of Lens Handling outcome measure description Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy) outcome measure reporting status Posted outcome measure param type Mean outcome measure dispersion type Standard Deviation outcome measure unit of measure units on a scale outcome measure time frame 1 week outcome group list outcome group outcome group id OG000 outcome group title Lens A outcome group description Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens outcome group id OG001 outcome group title Lens B outcome group description Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens outcome denom list outcome denom outcome denom units Participants outcome denom count list outcome denom count outcome denom count group id OG000 outcome denom count value 47 outcome denom count group id OG001 outcome denom count value 47 outcome class list outcome class outcome category list outcome category outcome measurement list outcome measurement outcome measurement group id OG000 outcome measurement value 9.0 outcome measurement spread 1.1 outcome measurement group id OG001 outcome measurement value 8.8 outcome measurement spread 1.5 outcome measure type Secondary outcome measure title Visual Acuity outcome measure description Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) outcome measure reporting status Posted outcome measure param type Mean outcome measure dispersion type Standard Deviation outcome measure unit of measure logMAR outcome measure time frame Baseline - after lenses have settled for 10 minutes outcome group list outcome group outcome group id OG000 outcome group title Lens A outcome group description Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens outcome group id OG001 outcome group title Lens B outcome group description Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens outcome denom list outcome denom outcome denom units Participants outcome denom count list outcome denom count outcome denom count group id OG000 outcome denom count value 47 outcome denom count group id OG001 outcome denom count value 47 outcome class list outcome class outcome category list outcome category outcome measurement list outcome measurement outcome measurement group id OG000 outcome measurement value -0.06 outcome measurement spread 0.06 outcome measurement group id OG001 outcome measurement value -0.06 outcome measurement spread 0.06 outcome measure type Secondary outcome measure title Visual Acuity outcome measure description Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) outcome measure reporting status Posted outcome measure param type Mean outcome measure dispersion type Standard Deviation outcome measure unit of measure logMAR outcome measure time frame 1 week outcome group list outcome group outcome group id OG000 outcome group title Lens A outcome group description Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens outcome group id OG001 outcome group title Lens B outcome group description Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens outcome denom list outcome denom outcome denom units Participants outcome denom count list outcome denom count outcome denom count group id OG000 outcome denom count value 47 outcome denom count group id OG001 outcome denom count value 47 outcome class list outcome class outcome category list outcome category outcome measurement list outcome measurement outcome measurement group id OG000 outcome measurement value -0.06 outcome measurement spread 0.06 outcome measurement group id OG001 outcome measurement value -0.05 outcome measurement spread 0.06 adverse events module events frequency threshold 1 events time frame From dispense up to 1 week on each study lenses for a total of 2 weeks event group list event group event group id EG000 event group title Lens A event group description Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens event group deaths num affected 0 event group deaths num at risk 48 event group serious num affected 0 event group serious num at risk 48 event group other num affected 0 event group other num at risk 48 event group id EG001 event group title Lens B event group description Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens event group deaths num affected 0 event group deaths num at risk 48 event group serious num affected 0 event group serious num at risk 48 event group other num affected 1 event group other num at risk 48 other event list other event other event term inferior single corneal peripheral ulcer other event organ system Eye disorders other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 48 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 48 more info module certain agreement agreement p i sponsor employee No agreement restrictive agreement No point of contact point of contact title Jose A. Vega, O.D., MSc, FAAO point of contact organization Coopervision point of contact e mail [email protected] point of contact phone 9256213761 document section large document module large doc list large doc large doc type abbrev Prot_SAP large doc has protocol Yes large doc has s a p Yes large doc has i c f No large doc label Study Protocol and Statistical Analysis Plan large doc date February 10, 2021 large doc upload date 01/18/2022 17:21 large doc filename Prot_SAP_000.pdf derived section misc info module version holder December 02, 2022 removed country list removed country Canada condition browse module condition mesh list condition mesh condition mesh id D000001251 condition mesh term Astigmatism condition ancestor list condition ancestor condition ancestor id D000012030 condition ancestor term Refractive Errors condition ancestor id D000005128 condition ancestor term Eye Diseases condition browse leaf list condition browse leaf condition browse leaf id M3710 condition browse leaf name Astigmatism condition browse leaf as found Astigmatism condition browse leaf relevance high condition browse leaf id M14024 condition browse leaf name Refractive Errors condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04831515
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full study rank 61264 study protocol section identification module n c t id NCT04838730 org study id info org study id CR-0719 organization org full name Hanita Lenses org class INDUSTRY brief title Influence of Clearing Open-capsule Device on Refractive Predictability in Cataract Patients official title Influence of Clearing Open-capsule Device on Refractive Predictability in Cataract Patients status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date January 1, 2019 start date type Actual primary completion date struct primary completion date January 1, 2023 primary completion date type Anticipated completion date struct completion date January 1, 2023 completion date type Anticipated study first submit date March 10, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Hanita Lenses lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary CleaRing is intended to reduce posterior capsular opacification in cataract patients. The device is intended to be implanted together with standard posterior chamber IOL during cataract surgery. detailed description Study Design: This study is a prospective, single-group, single-center, open-label study. Each study subject will be implanted with a CleaRing device together with SeeLens AF IOL in a single eye. Study population: Men and women designated for cataract surgery that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the study. Enrollment: A total of 20 subjects will be enrolled. Investigational sites: Single-center study. Duration of Subject participation: The primary endpoint will be achieved when the study subject has completed a 1-month follow-up after the implantation of the CleaRing device. Study Group: Each subject will be implanted with a CleaRing device together with SeeLens AF IOL in a single eye. Visits & Procedures Pre-operative visit: 0-3 months prior to the implantation procedure. The visit will include the subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed. Complete anamnesis will be taken including the subject's medical complaints, medical history, medication use, and ophthalmic examinations. Surgical procedure: Standard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL. Follow-up: All subjects will have regular follow-up visits at the following post-operative periods: 1 day, 7 days, and 1 month. All postoperative visits will include a complete ophthalmic examination, a record of medications used, and documentation of adverse events. conditions module condition list condition Cataract design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label single-arm arm group type Experimental arm group description Hanita CleaRing device (CE approved; AMAR Certificate) arm group intervention list arm group intervention name Device: Surgical procedure intervention list intervention intervention type Device intervention name Surgical procedure intervention description Standard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL. intervention arm group label list intervention arm group label single-arm outcomes module primary outcome list primary outcome primary outcome measure VISUAL ACUITY primary outcome description Distance (far) manifest refraction and the testing distance used will be recorded on the case report forms. Manifest refraction will be determined using the maximum plus for best visual acuity method. The distance manifest refraction will be done with a distance adjusted chart but not less than 4 meters. The actual manifest refraction distance will be noted on the case report forms. Visual acuity will be measured with either Snellen or ETDRS format charts for distance. Results will be recorded in a LogMar scale. primary outcome time frame 1 month primary outcome measure SLIT LAMP EXAM primary outcome description The slit lamp exam will include the measurement of aqueous cell and flare, and the measurement of corneal edema by a standard grading system. It will also include an evaluation for the presence of pupillary irregularities, iris atrophy and pigment dispersion, degree of posterior capsular opacification and correct position of the IOL and the CleaRing device. For the evaluation of aqueous cells and flare, use a slit lamp beam 0.3 mm wide and 1 mm high, and use the following grading: Cells none (0) = no cells seen trace (+1) = 1-5 cells seen mild (+2) = 6-15 cells seen moderate (+3) = 16-30 cells seen severe (+4) = > 30 cells seen Flare none (0) = No Tyndall effect trace (+1) = Tyndall effect barely discernible mild (+2) = Tyndall beam in anterior chamber is mildly intense moderate (+3) = Tyndall beam in anterior chamber is moderately intense severe (+4) = Tyndall beam is severely intense. The aqueous has a white and milky appearance. primary outcome time frame 1 month primary outcome measure MEASUREMENT OF INTRAOCULAR PRESSURE primary outcome description Intraocular pressure will be measured using Goldmann applanation tonometry or other validated methods. primary outcome time frame 1 month eligibility module eligibility criteria Inclusion Criteria: The subject is between 50 and 80 years of age The subject is designated for cataract surgery Eye designated for the study fulfills the following criteria: Potentially able to achieve a good vision (by the opinion of the investigator) ACD is at least 2.5mm (from epithelium) Corneal astigmatism is at most 2.0 DPT Axial length is between 22.0 and 26.0 mm Able to obtain pupil dilation of at least 6.0 mm Average keratometry values between 42.0 and 46.0 D Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed Exclusion Criteria: Subject diagnosed with glaucoma of any type or having intraocular pressure above 24mmHg Subject who has undergone previous intraocular surgery in eye designated for the study Subject with a corneal abnormality that would prevent stable and reliable refraction Subject with weak or torn zonules Subject with Pseudoexfoliation syndrome (PEX) Subject with amblyopia Subject with a retinal disease that in the opinion of the principal investigator would prevent stable and reliable refraction or might be worsened due to implantation of the device Subject is diagnosed with active anterior segment intraocular inflammation Subject is obligated to previous participation in another study with any investigational drug or device within the past 30 days Subject is pregnant healthy volunteers No gender All minimum age 50 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Inbal Ratner central contact role Contact central contact phone 0526505531 central contact e mail [email protected] location list location location facility Wolfson location status Recruiting location city H̱olon location country Israel location contact list location contact location contact name Inbal Ratner location contact role Contact location contact e mail [email protected] annotation section annotation module unposted annotation unposted responsible party Hanita Lenses unposted event list unposted event unposted event type Release unposted event date August 25, 2022 unposted event type Unrelease unposted event date August 29, 2022 derived section misc info module version holder December 02, 2022 submission tracking submission info list submission info submission release date August 25, 2022 submission unrelease date August 29, 2022 submission release date August 29, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002386 condition mesh term Cataract condition ancestor list condition ancestor condition ancestor id D000007905 condition ancestor term Lens Diseases condition ancestor id D000005128 condition ancestor term Eye Diseases condition browse leaf list condition browse leaf condition browse leaf id M4790 condition browse leaf name Cataract condition browse leaf as found Cataract condition browse leaf relevance high condition browse leaf id M10069 condition browse leaf name Lens Diseases condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04838730
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full study rank 61418 study protocol section identification module n c t id NCT04836728 org study id info org study id E20210014 organization org full name Tianjin Medical University Cancer Institute and Hospital org class OTHER brief title Study of Chemotherapy and PD-1 Inhibitor Combination With Autologous CIK Cell Immunotherapy to Treat Lung Cancer official title A Randomized, Multicenter,Open-label Phase II Study is to Evaluate the Effects of Chemotherapy and Sintilimab or in Combination With Autologous Cytokine-induced Killer Cell Immunotherapy in Patients With Stage IV Non-small-cell Lung Cancer acronym CCICC-002b status module status verified date March 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Anticipated primary completion date struct primary completion date June 1, 2022 primary completion date type Anticipated completion date struct completion date December 1, 2023 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Tianjin Medical University Cancer Institute and Hospital lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This prospective,multicenter, open-labe phase II study is to evaluate the effects of autologous cytokine-induced killer cell immunotherapy combination with PD-1 inhibitor and chemotherapy in the first-line treatment of IV non-small cell lung cancer. conditions module condition list condition Non-small Cell Lung Cancer Metastatic First-line Treatment design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 156 enrollment type Anticipated arms interventions module arm group list arm group arm group label arm 1 arm group type Experimental arm group description IBI308 intravenous infusion 200mg d1; Pemetrexed intravenous infusion 500mg/m2 d2 or Albumin paclitaxel intravenous infusion 260mg/m2 d2; Carboplatin intravenous infusion AUC5 d2; CIK cells, 1x10^10 (10 billion ), intravenous infusion,d14; Q3W. arm group intervention list arm group intervention name Biological: CIK cell injection Drug: Sintilimab Injection Drug: Pemetrexed Drug: Albumin paclitaxel Drug: Carboplatin arm group label arm 2 arm group type Active Comparator arm group description IBI308 intravenous infusion 200mg d1; Pemetrexed intravenous infusion 500mg/m2 d2 or Albumin paclitaxel intravenous infusion 260mg/m2 d2; Carboplatin intravenous infusion AUC5 d2; arm group intervention list arm group intervention name Drug: Sintilimab Injection Drug: Pemetrexed Drug: Albumin paclitaxel Drug: Carboplatin intervention list intervention intervention type Biological intervention name CIK cell injection intervention description CIK cells, more than 1x10^10 (10 billion ), intravenous infusion,d14; Q3W. intervention arm group label list intervention arm group label arm 1 intervention other name list intervention other name Autologous cytokine-induced killer cells intervention type Drug intervention name Sintilimab Injection intervention description Sintilimab Injection intravenous infusion 200mg d1 intervention arm group label list intervention arm group label arm 1 arm 2 intervention other name list intervention other name PD-1 inhibitor intervention type Drug intervention name Pemetrexed intervention description Pemetrexed intravenous infusion 500mg/m2 d2 intervention arm group label list intervention arm group label arm 1 arm 2 intervention other name list intervention other name Pemetrexed injection intervention type Drug intervention name Albumin paclitaxel intervention description Albumin paclitaxel intravenous infusion 260mg/m2 d2 intervention arm group label list intervention arm group label arm 1 arm 2 intervention other name list intervention other name Albumin paclitaxel Injection intervention type Drug intervention name Carboplatin intervention description Carboplatin intravenous infusion AUC5 d2 intervention arm group label list intervention arm group label arm 1 arm 2 intervention other name list intervention other name Carboplatin injection outcomes module primary outcome list primary outcome primary outcome measure Overall response rate primary outcome description ORR was calculated by the percentage of patients with a confirmed complete (CR) or partial response (PR). primary outcome time frame Time Frame: 2 years secondary outcome list secondary outcome secondary outcome measure Overall survival secondary outcome description Time from the first use of the study drug to the death of the subject secondary outcome time frame up to 3 years secondary outcome measure Progression-free survival secondary outcome description Time from the first dose of study drug to the first disease progression (imaging) secondary outcome time frame up to 24 months eligibility module eligibility criteria Inclusion Criteria: Agreeing to participate in this study and signing a written informed consent. Male or female,from 18 to 75 years (including 18 and 75 years). The life expectancy will be longer than 3 months and can be followed up. Patients with stage IV NSCLC were confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion. Initial medical treattment.Patients with adenocarcinoma need wild type of EGFR gene and ALK fusion gene negative to be included in this study. ECOG score will be 0 or 1 within 7 days before randomization. Within 14 days before the start of treatment, the results of laboratory test of blood routine, liver, kidney function and hormone levels must be met the following criteria: White blood cells: more than 3.0 × 109/L; Platelets: more than 100 × 109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 80g/L; Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN); Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN; Serum bilirubin: less than 1.25 × ULN; Serum creatinine: less than 1.25 × ULN. Cortisol and thyroid function will be in the normal range. The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss). Female subjects must take effective contraceptive measures throughout the study period; serum or urine pregnancy test results must be negative during screening and the whole study period. Male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment. Exclusion Criteria: Subjects who meet any of the following criteria could not participate in this study: Adenocarcinoma subjects with EGFR sensitive mutation or ALK translocation; molecular detection of EGFR-sensitive mutations or ALK translocations is not required in squamous carcinoma patients. NSCLC that had received chemotherapy in the past. Other malignant tumors needed treatment within five years. Allogeneic tissue/organ transplantation. Participating in research drug therapy within 4 weeks before the first administration of the trial. Systemic glucocorticoid therapy or any other form of immunosuppressive therapy (except glucocorticoid preconditioned with docetaxel) is being administered within 3 days before the first administration of the experimental therapy. Received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy or major surgery within 4 weeks before the first use of the drug; received chest radiotherapy greater than 30 Gy within 6 months before the first use of the drug; and received chest radiotherapy with 30 Gy or less within 1 month before the first use of the drug. Previous treatment with PD-1/PD-L1 antibodies. Over the past two years, patients with active autoimmune diseases requiring systemic treatment, such as the use of corticosteroids, or immunosuppressants. Substitution therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not a systemic treatment. Patients with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA > 10^3 copies/ml) or hepatitis C (hepatitis C antibody positive), and HCV-RNA higher than the detection limit of the analytical method. Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis. Patients with active infections requiring systemic intravenous therapy. Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc. Subjects who are known to be allergic to any of the constituents of the drug being studied. Subjects with a recent history of drug abuse (including alcohol) within one year. Compliance is poor and can not cooperate with clinical research. Female subjects who are pregnant or breastfeeding, or who are expected to be pregnant during the trial. healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Xiubao Ren, MD. Ph.D central contact role Contact central contact phone 86-22-23340123 central contact phone ext 3173 central contact e mail [email protected] central contact name Liang Liu, MD. Ph.D central contact role Contact central contact phone 86-22-23340123 central contact phone ext 3172 central contact e mail [email protected] overall official list overall official overall official name Liang Liu, MD. Ph.D overall official affiliation Hospital overall official role Study Director location list location location facility Tianjin Medical University Cancer Institute and Hospital location city Tianjin location state Tianjin location zip 300060 location country China i p d sharing statement module i p d sharing Yes i p d sharing description This is a multicenter, prospective clinical trial. Eight centers provide data to each other. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code i p d sharing time frame 3 years i p d sharing access criteria All patients derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008175 condition mesh term Lung Neoplasms condition mesh id D000002289 condition mesh term Carcinoma, Non-Small-Cell Lung condition ancestor list condition ancestor condition ancestor id D000012142 condition ancestor term Respiratory Tract Neoplasms condition ancestor id D000013899 condition ancestor term Thoracic Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000002283 condition ancestor term Carcinoma, Bronchogenic condition ancestor id D000001984 condition ancestor term Bronchial Neoplasms condition browse leaf list condition browse leaf condition browse leaf id M10324 condition browse leaf name Lung Neoplasms condition browse leaf as found Lung Cancer condition browse leaf relevance high condition browse leaf id M4698 condition browse leaf name Carcinoma, Non-Small-Cell Lung condition browse leaf as found Non-Small Cell Lung Cancer condition browse leaf relevance high condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf relevance low condition browse leaf id M14131 condition browse leaf name Respiratory Tract Neoplasms condition browse leaf relevance low condition browse leaf id M15810 condition browse leaf name Thoracic Neoplasms condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M4692 condition browse leaf name Carcinoma, Bronchogenic condition browse leaf relevance low condition browse leaf id M4412 condition browse leaf name Bronchial Neoplasms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000017239 intervention mesh term Paclitaxel intervention mesh id D000068196 intervention mesh term Albumin-Bound Paclitaxel intervention mesh id D000016190 intervention mesh term Carboplatin intervention mesh id D000068437 intervention mesh term Pemetrexed intervention mesh id D000082082 intervention mesh term Immune Checkpoint Inhibitors intervention ancestor list intervention ancestor intervention ancestor id D000000972 intervention ancestor term Antineoplastic Agents, Phytogenic intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000050257 intervention ancestor term Tubulin Modulators intervention ancestor id D000050256 intervention ancestor term Antimitotic Agents intervention ancestor id D000050258 intervention ancestor term Mitosis Modulators intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000005493 intervention ancestor term Folic Acid Antagonists intervention ancestor id D000019384 intervention ancestor term Nucleic Acid Synthesis Inhibitors intervention browse leaf list intervention browse leaf intervention browse leaf id M18689 intervention browse leaf name Paclitaxel intervention browse leaf as found From intervention browse leaf relevance high intervention browse leaf id M231 intervention browse leaf name Albumin-Bound Paclitaxel intervention browse leaf as found From intervention browse leaf relevance high intervention browse leaf id M17802 intervention browse leaf name Carboplatin intervention browse leaf as found Program intervention browse leaf relevance high intervention browse leaf id M264 intervention browse leaf name Pemetrexed intervention browse leaf as found These intervention browse leaf relevance high intervention browse leaf id M2343 intervention browse leaf name Immune Checkpoint Inhibitors intervention browse leaf as found Ergometer intervention browse leaf relevance high intervention browse leaf id M25350 intervention browse leaf name Tubulin Modulators intervention browse leaf relevance low intervention browse leaf id M25349 intervention browse leaf name Antimitotic Agents intervention browse leaf relevance low intervention browse leaf id M7770 intervention browse leaf name Folic Acid intervention browse leaf relevance low intervention browse leaf id M16698 intervention browse leaf name Vitamin B Complex intervention browse leaf relevance low intervention browse leaf id M7771 intervention browse leaf name Folic Acid Antagonists intervention browse leaf relevance low intervention browse leaf id T447 intervention browse leaf name Folinic Acid intervention browse leaf relevance low intervention browse leaf id T446 intervention browse leaf name Folic Acid intervention browse leaf relevance low intervention browse leaf id T448 intervention browse leaf name Folate intervention browse leaf relevance low intervention browse leaf id T475 intervention browse leaf name Vitamin B9 intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Micro intervention browse branch name Micronutrients intervention browse branch abbrev Hemat intervention browse branch name Hematinics intervention browse branch abbrev Vi intervention browse branch name Vitamins
NCT04836728
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full study rank 61623 study protocol section identification module n c t id NCT04834063 org study id info org study id Soh-Med-21-03-12 organization org full name Sohag University org class OTHER brief title Serum Selenium and Zinc Levels in Non-alcoholic Fatty Liver Disease Patients official title Evaluation of Serum Selenium and Zinc Levels in Non-alcoholic Fatty Liver Disease Patients acronym NAFLD status module status verified date November 2021 overall status Completed expanded access info has expanded access No start date struct start date March 15, 2021 start date type Actual primary completion date struct primary completion date September 5, 2021 primary completion date type Actual completion date struct completion date September 25, 2021 completion date type Actual study first submit date March 30, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date November 1, 2021 last update post date struct last update post date November 2, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mona Mohammed Abdelrhman responsible party investigator title Principal investigator responsible party investigator affiliation Sohag University lead sponsor lead sponsor name Sohag University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Non-alcoholic fatty liver disease (NAFLD) includes a wide range of disorders that consist of simple fatty infiltration, steatohepatitis (NASH), and end-stage liver disease (cirrhosis). NAFLD is the most common cause of chronic liver disease worldwide and increases the risk of end-stage liver disease and hepatocellular carcinoma (HCC) . While risk factors such as obesity, diabetes, and a sedentary lifestyle may increase the risk of NAFLD, studies have shown that environmental exposures may further contribute to the pathogenesis of NAFLD. Although the pathogenic role of macronutrients is well established in both NAFLD and obesity, the contribution of micronutrients to NAFLD pathogenesis has garnered less attention than with obesity. Selenium is an essential element in many biological functions and is an important component of human nutrition. Exposure to selenium can be found in nature, such as rocks and sediment, air, soil, fuel oil, drinking water and nutritional supplementation. It is a major component of many enzymes such as glutathione peroxidase and plays an important role in anti-oxidation, DNA synthesis, reproduction, muscle function, and thyroid metabolism. Selenium concentrations have been studied in many diseases and organ systems including the liver. However, the exact relationship between selenium in patients with NAFLD is unclear. Selenium is an essential element in many biological functions and is an important component of human nutrition. It is a major component of many enzymes such as glutathione peroxidase and plays an important role in anti-oxidation, DNA synthesis, reproduction, muscle function, and thyroid metabolism. Selenium concentrations have been studied in many diseases and organ systems including the liver. However, the exact relationship between selenium in patients with NAFLD is unclear. Despite data suggesting mineral deficiencies in NAFLD patients, most data do not support insufficient mineral consumption as a possible mechanism for these deficiencies, except in the case of zinc deficiency. Zinc is the second most prevalent trace element in the body. It is integrally involved in the normal life cycle and has many important regulatory, catalytic, and defensive functions. Zinc deficiency occurs in many types of liver disease, especially more advanced/decompensated disease. detailed description We aim firstly to assess the serum selenium and zinc level in NAFLD patients, secondly to detect the association between hepatic fibrosis, steatosis, and serum selenium level in NAFLD patients, thirdly to detect if there is a synergistic effect of both molecules. Patients and methods Study design: Case-control study. Studied population & locality: This study will be conducted on two groups: Group (1): include 70 patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Tropical medicine and gastroenterology department, Sohag University Hospitals during the period from March 2021 to August 2021. Group (2): a control group of 30 healthy volunteers who looks normal on ultrasonographic examination. Exclusion criteria: Any patient with a chronic liver disease rather than NAFLD. Methods: All included patients will be subjected to: Detailed history, complete general and systemic examination. BMI will be calculated as follow Abdominal Ultrasonography. Laboratory investigations: Fasting blood sugar Serum lipogram. Liver function tests. CBC. Estimation of serum selenium and zinc level. Liver stiffness measurements to detect the degree of fibrosis and measurement of the degree of steatosis using (Fibroscan). Ethical considerations: The study will be approved by The Ethical committee of medical research, Sohag Faculty of Medicine, Sohag University. After an explanation about the nature of the procedures, possible complications, benefits, and steps of the study, all patients and controls will give written informed consent for participating in the study, performing the abdominal ultrasound, taking blood samples, performing fibroscan. Statistical analysis: Data will be analyzed using STATA version 12.1. Quantitative data were represented as mean, standard deviation, median, and range. Data will be analyzed using a student t-test to compare the means of the two groups. Qualitative data will be presented as numbers and percentages and will be compared using either the Chi-square test or Fisher exact test. P-value will be considered significant if it was less than 0.05. conditions module condition list condition NAFLD keyword list keyword NAFLD Fibrosis selenium zinc design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective enrollment info enrollment count 80 enrollment type Actual arms interventions module arm group list arm group arm group label NAFLD Cases arm group description Non- alcoholic fatty liver disease arm group intervention list arm group intervention name Diagnostic Test: Serum Zinc a level Diagnostic Test: serum selenium level Diagnostic Test: Fibroscan measurement arm group label control arm group description healthy individual with normal liver on abdominal ultrasound arm group intervention list arm group intervention name Diagnostic Test: Serum Zinc a level Diagnostic Test: serum selenium level Diagnostic Test: Fibroscan measurement intervention list intervention intervention type Diagnostic Test intervention name Serum Zinc a level intervention description Diagnostic test intervention arm group label list intervention arm group label NAFLD Cases control intervention type Diagnostic Test intervention name serum selenium level intervention description Diagnostic test intervention arm group label list intervention arm group label NAFLD Cases control intervention type Diagnostic Test intervention name Fibroscan measurement intervention description Diagnostic test intervention arm group label list intervention arm group label NAFLD Cases control outcomes module primary outcome list primary outcome primary outcome measure serum selenium level in NAFLD patients primary outcome time frame during the period from March 2021 to August 2021 primary outcome measure the association between hepatic fibrosis and serum selenium level in NAFLD patients primary outcome time frame during the period from March 2021 to August 2021 primary outcome measure serum zinc level in NAFLD patients primary outcome time frame during the period from March 2021 to August 2021 primary outcome measure the association between hepatic fibrosis and serum zinc level in NAFLD patients primary outcome time frame during the period from March 2021 to August 2021 eligibility module eligibility criteria Inclusion Criteria: patients diagnosed to have NAFLD by ultrasonography presented to the outpatient clinic of Tropical medicine and gastroenterology department, Sohag University Hospitals during the period from March 2021 to August 2021. Exclusion Criteria: Any patient with a chronic liver disease rather than NAFLD healthy volunteers Accepts Healthy Volunteers gender All minimum age 20 Years maximum age 80 Years std age list std age Adult Older Adult study population group (1): patients diagnosed to have NAFLD by ultrasonography presented to the outpatient clinic of Tropical medicine and gastroenterology department, Sohag University Hospitals during the period from March 2021 to August 2021. Group (2): a control group of 30 healthy volunteers who looks normal on ultrasonographic examination sampling method Probability Sample contacts locations module overall official list overall official overall official name Radwa Farag, MD overall official affiliation Sohag University overall official role Study Chair overall official name Yasser Amin, MD overall official affiliation Sohag University overall official role Study Chair overall official name Haitham Attia, MD overall official affiliation Sohag University overall official role Study Chair overall official name Ahmed Abdallah, MD overall official affiliation Sohag University overall official role Study Chair location list location location facility Mona Mohammed Abdelrahman location city Sohag location country Egypt references module reference list reference reference p m i d 31531097 reference type background reference citation Kosari F, Jamali R, Ramim T, Mosavi Jahan Abad E. The Correlation between Serum Zinc Level and Liver Histology in Non-Alcoholic Steatohepatitis. Iran J Pathol. 2019 Winter;14(1):17-25. doi: 10.30699/IJP.14.1.17. Epub 2018 Dec 27. reference p m i d 32745632 reference type background reference citation Reja M, Makar M, Visaria A, Marino D, Rustgi V. Increased serum selenium levels are associated with reduced risk of advanced liver fibrosis and all-cause mortality in NAFLD patients: National Health and Nutrition Examination Survey (NHANES) III. Ann Hepatol. 2020 Nov - Dec;19(6):635-640. doi: 10.1016/j.aohep.2020.07.006. Epub 2020 Jul 31. reference p m i d 20407430 reference type background reference citation Aigner E, Strasser M, Haufe H, Sonnweber T, Hohla F, Stadlmayr A, Solioz M, Tilg H, Patsch W, Weiss G, Stickel F, Datz C. A role for low hepatic copper concentrations in nonalcoholic Fatty liver disease. Am J Gastroenterol. 2010 Sep;105(9):1978-85. doi: 10.1038/ajg.2010.170. Epub 2010 Apr 20. reference p m i d 30294653 reference type background reference citation Pickett-Blakely O, Young K, Carr RM. Micronutrients in Nonalcoholic Fatty Liver Disease Pathogenesis. Cell Mol Gastroenterol Hepatol. 2018 Aug 23;6(4):451-462. doi: 10.1016/j.jcmgh.2018.07.004. eCollection 2018. Review. reference p m i d 22307488 reference type background reference citation Mohammad MK, Zhou Z, Cave M, Barve A, McClain CJ. Zinc and liver disease. Nutr Clin Pract. 2012 Feb;27(1):8-20. doi: 10.1177/0884533611433534. Review. Erratum in: Nutr Clin Pract. 2012 Apr;27(2):305. Mohommad, Mohammad K [corrected to Mohammad, Mohammad K]. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008107 condition mesh term Liver Diseases condition mesh id D000005234 condition mesh term Fatty Liver condition mesh id D000065626 condition mesh term Non-alcoholic Fatty Liver Disease condition ancestor list condition ancestor condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition browse leaf list condition browse leaf condition browse leaf id M10259 condition browse leaf name Liver Diseases condition browse leaf as found Liver Disease condition browse leaf relevance high condition browse leaf id M7527 condition browse leaf name Fatty Liver condition browse leaf as found Fatty Liver condition browse leaf relevance high condition browse leaf id M29693 condition browse leaf name Non-alcoholic Fatty Liver Disease condition browse leaf as found Non-alcoholic Fatty Liver Disease condition browse leaf relevance high condition browse leaf id M7637 condition browse leaf name Fibrosis condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id T5868 condition browse leaf name Visceral Steatosis condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000012643 intervention mesh term Selenium intervention ancestor list intervention ancestor intervention ancestor id D000000975 intervention ancestor term Antioxidants intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000020011 intervention ancestor term Protective Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000014131 intervention ancestor term Trace Elements intervention ancestor id D000018977 intervention ancestor term Micronutrients intervention browse leaf list intervention browse leaf intervention browse leaf id M10262 intervention browse leaf name Liver Extracts intervention browse leaf relevance low intervention browse leaf id M14607 intervention browse leaf name Selenium intervention browse leaf as found Prenatal intervention browse leaf relevance high intervention browse leaf id M16920 intervention browse leaf name Zinc intervention browse leaf relevance low intervention browse leaf id M3444 intervention browse leaf name Antioxidants intervention browse leaf relevance low intervention browse leaf id M21022 intervention browse leaf name Protective Agents intervention browse leaf relevance low intervention browse leaf id M20162 intervention browse leaf name Micronutrients intervention browse leaf relevance low intervention browse leaf id M16037 intervention browse leaf name Trace Elements intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Hemat intervention browse branch name Hematinics intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Micro intervention browse branch name Micronutrients
NCT04834063
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full study rank 61520 study protocol section identification module n c t id NCT04835402 org study id info org study id EPIC-1 secondary id info list secondary id info secondary id 2020-004536-22 secondary id type EudraCT Number secondary id N-20200085 secondary id type Other Identifier secondary id domain The North Denmark Region Committee on Health Research Ethics organization org full name Aalborg University Hospital org class OTHER brief title Electroporation Potentiated Immunotherapy in Cancer official title A Phase II Study of Electroporation Potentiated Immunotherapy in Liver Metastatic acronym EPIC-1 status module status verified date March 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date May 26, 2021 start date type Actual primary completion date struct primary completion date March 7, 2022 primary completion date type Actual completion date struct completion date December 2025 completion date type Anticipated study first submit date March 24, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date March 8, 2022 last update post date struct last update post date March 9, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery responsible party investigator title Professor of surgery, Consultant surgeon, DMSc responsible party investigator affiliation Aalborg University Hospital lead sponsor lead sponsor name Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery lead sponsor class OTHER collaborator list collaborator collaborator name Odense University Hospital collaborator class OTHER collaborator name Aalborg University collaborator class OTHER collaborator name Danish Cancer Society collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device Yes is u s export Yes description module brief summary The study is investigating the efficacy and safety of combined irreversible electroporation (IRE) and checkpoint inhibition in metastatic pancreatic cancer. detailed description The aim of the study is to investigate whether checkpoint inhibition in conjunction with IRE of a single liver metastasis can elicit a systemic anticancer immune response in patients with pancreatic cancer. Adult patients, in WHO performance status 0-1, with liver metastatic pancreatic cancer, intolerant to or progressing on first or further lines of chemotherapy can enter the trial. Pembrolizumab infusion is given every six weeks for up to six months. IRE of a single liver metastasis is performed between the first and second pembrolizumab infusion. Response to the therapy is examined by CT (RECIST) on non-IRE-ablated lesions every 2 months. Assessments of changes in peripheral blood immune cell composition, tumor gene expression and tumor infiltrating lymphocytes is performed on serial biopsies and blood samples. conditions module condition list condition Pancreas Cancer, Metastatic keyword list keyword Irreversible electroporation Pembrolizumab Immune checkpoint inhibitor design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 8 enrollment type Actual arms interventions module arm group list arm group arm group label Intervention arm group type Experimental arm group description Day 1: Pembrolizumab 400mg Day 10: Irreversible electroporation Day 42/84/126/168: Pembrolizumab 400mg arm group intervention list arm group intervention name Drug: Pembrolizumab Device: Irreversible electroporation intervention list intervention intervention type Drug intervention name Pembrolizumab intervention description 400mg every 6 weeks intervention arm group label list intervention arm group label Intervention intervention other name list intervention other name Irreversible electroporation (NanoKnife(tm), Angiodynamics) intervention type Device intervention name Irreversible electroporation intervention description Percutaneous ablation of one liver metastasis intervention arm group label list intervention arm group label Intervention intervention other name list intervention other name NanoKnife(tm) (Angiodynamics) outcomes module primary outcome list primary outcome primary outcome measure Objective response rate (ORR) according to RECIST 1.1 primary outcome description (in patients receiving at least one dose of pembrolizumab, IRE and an evaluable CT-scan) primary outcome time frame 6 months after treatment start primary outcome measure Serious adverse reaction (SAR) rate according to CTCAE v5 primary outcome description (in patients receiving at least one dose of pembrolizumab) primary outcome time frame cumulative after 12 months after treatment start secondary outcome list secondary outcome secondary outcome measure Median overall survival secondary outcome time frame Through study completion, an average of 1 year secondary outcome measure Median progression-free survival secondary outcome time frame Through study completion, an average of 1 year secondary outcome measure ORR secondary outcome description (in patients that have received at least one dose of pembrolizumab and an evaluable CT-scan) secondary outcome time frame 2 months, 4 months and 6 months after treatment start secondary outcome measure Clinical benefit ratio secondary outcome description (defined as objective response or stable disease for at least 8 weeks during treatment in patients receiving at least one dose of pembrolizumab, IRE and an evaluable CT-scan) secondary outcome time frame 8 weeks after treatment start secondary outcome measure Serum CA-19-9 response secondary outcome description (response defined as a decrease of at least 20 % observed during treatment in patients with elevated CA 19-9 at baseline) secondary outcome time frame 2 months, 4 months and 6 months after treatment start secondary outcome measure Survival rate secondary outcome time frame 6 months and 12 months after treatment start secondary outcome measure Progression-free survival rate secondary outcome time frame 6 months and 12 months after treatment start secondary outcome measure Mean difference in perceived quality of life measured by EORTC QLQ-C30 v3 secondary outcome description (for subscales: Global health status, Physical functioning, Fatigue, Nausea and vomiting, Pain, Appetite loss and Diarrhea) secondary outcome time frame 2 months, 4 months, 6 months, 8 months, 10 months and 12 months after treatment start secondary outcome measure Mean difference in nutrition status measured by PG-SGA-SF secondary outcome description (difference in total numerical score of the patient-generated subjective global assessment (short form) PG-SGA(c) SF (range 0-37, lower is better) secondary outcome time frame 2 months, 4 months, 6 months, 8 months, 10 months and 12 months after treatment start secondary outcome measure Difference in peripheral blood naïve T cell count prior to IRE-treatment, 1 day after IRE-treatment and 6 weeks after IRE-treatment compared to baseline secondary outcome description (based on flow cytometry measures of naïve, EM, CM, EFF, TE, EX T cells, Tregs, cDC1, cDC2, pDC and MDSC concentrations) secondary outcome time frame 8 days, 11 days, 52 days after treatment start secondary outcome measure Difference in peripheral blood effector memory T cell count prior to IRE-treatment, 1 day after IRE-treatment and 6 weeks after IRE-treatment compared to baseline secondary outcome description (based on flow cytometry measures of naïve, EM, CM, EFF, TE, EX T cells, Tregs, cDC1, cDC2, pDC and MDSC concentrations) secondary outcome time frame 8 days, 11 days, 52 days after treatment start secondary outcome measure Difference in peripheral blood central memory T cell count prior to IRE-treatment, 1 day after IRE-treatment and 6 weeks after IRE-treatment compared to baseline secondary outcome description (based on flow cytometry measures of naïve, EM, CM, EFF, TE, EX T cells, Tregs, cDC1, cDC2, pDC and MDSC concentrations) secondary outcome time frame 8 days, 11 days, 52 days after treatment start secondary outcome measure Difference in peripheral blood effector T cell count prior to IRE-treatment, 1 day after IRE-treatment and 6 weeks after IRE-treatment compared to baseline secondary outcome description (based on flow cytometry measures of naïve, EM, CM, EFF, TE, EX T cells, Tregs, cDC1, cDC2, pDC and MDSC concentrations) secondary outcome time frame 8 days, 11 days, 52 days after treatment start secondary outcome measure Difference in peripheral blood terminally differentiated effector T cell count prior to IRE-treatment, 1 day after IRE-treatment and 6 weeks after IRE-treatment compared to baseline secondary outcome description (based on flow cytometry measures of naïve, EM, CM, EFF, TE, EX T cells, Tregs, cDC1, cDC2, pDC and MDSC concentrations) secondary outcome time frame 8 days, 11 days, 52 days after treatment start secondary outcome measure Difference in peripheral blood exhausted T cell count prior to IRE-treatment, 1 day after IRE-treatment and 6 weeks after IRE-treatment compared to baseline secondary outcome description (based on flow cytometry measures of naïve, EM, CM, EFF, TE, EX T cells, Tregs, cDC1, cDC2, pDC and MDSC concentrations) secondary outcome time frame 8 days, 11 days, 52 days after treatment start secondary outcome measure Difference in peripheral blood regulatory T cell count prior to IRE-treatment, 1 day after IRE-treatment and 6 weeks after IRE-treatment compared to baseline secondary outcome description (based on flow cytometry measures of naïve, EM, CM, EFF, TE, EX T cells, Tregs, cDC1, cDC2, pDC and MDSC concentrations) secondary outcome time frame 8 days, 11 days, 52 days after treatment start secondary outcome measure Difference in peripheral blood conventional dendritic cell type 1 count prior to IRE-treatment, 1 day after IRE-treatment and 6 weeks after IRE-treatment compared to baseline secondary outcome description (based on flow cytometry measures of naïve, EM, CM, EFF, TE, EX T cells, Tregs, cDC1, cDC2, pDC and MDSC concentrations) secondary outcome time frame 8 days, 11 days, 52 days after treatment start secondary outcome measure Difference in peripheral blood conventional dendritic cell type 2 count prior to IRE-treatment, 1 day after IRE-treatment and 6 weeks after IRE-treatment compared to baseline secondary outcome description (based on flow cytometry measures of naïve, EM, CM, EFF, TE, EX T cells, Tregs, cDC1, cDC2, pDC and MDSC concentrations) secondary outcome time frame 8 days, 11 days, 52 days after treatment start secondary outcome measure Difference in peripheral blood plasmacytoid dendritic cell count prior to IRE-treatment, 1 day after IRE-treatment and 6 weeks after IRE-treatment compared to baseline secondary outcome description (based on flow cytometry measures of naïve, EM, CM, EFF, TE, EX T cells, Tregs, cDC1, cDC2, pDC and MDSC concentrations) secondary outcome time frame 8 days, 11 days, 52 days after treatment start secondary outcome measure Difference in peripheral blood myeloid-derived suppressor cell count prior to IRE-treatment, 1 day after IRE-treatment and 6 weeks after IRE-treatment compared to baseline secondary outcome description (based on flow cytometry measures of naïve, EM, CM, EFF, TE, EX T cells, Tregs, cDC1, cDC2, pDC and MDSC concentrations) secondary outcome time frame 8 days, 11 days, 52 days after treatment start secondary outcome measure Histological tumor regression grade in tumor biopsies after pembrolizumab and after pembrolizumab + IRE compared to baseline secondary outcome description (based on the CAP regression grading system) secondary outcome time frame 10 days and 52 days after treatment start secondary outcome measure Difference in tumor RNA expression after pembrolizumab and after pembrolizumab + IRE compared to baseline secondary outcome description (based on NanoString RNA panCancer IO 360 gene panel. Analysis will explore the cancer-immunological mechanisms of the therapy in order to guide future studies. No specific outcomes are predetermined) secondary outcome time frame 10 days and 52 days after treatment start secondary outcome measure Difference in (histological) tumor infiltrating leukocyte (TIL) pattern after pembrolizumab and after pembrolizumab + IRE compared to baseline secondary outcome description (Based on analysis by immunohistochemistry. The relative concentration of leukocytes will be estimated and compared. The exact subpopulations of leukocytes will be based on the findings in outcomes 12 and 14, to validate the results) secondary outcome time frame 10 days and 52 days after treatment start secondary outcome measure Adverse event rate (CTCAEv5, all grades) secondary outcome description (all events registered during active treatment and follow-up) secondary outcome time frame cumulative after 12 months after treatment start eligibility module eligibility criteria Inclusion Criteria: Histologically verified pancreatic adenocarcinoma, based on either a biopsy of the primary tumor or a metastasis One liver metastasis treatable by IRE (as determined by MDT at Aalborg University Hospital) One tumor lesion suited for repeated biopsy by transcutaneous core needle (preferably another lesion than that used for IRE) At least one measurable lesion (RECIST version 1.1) other than the liver metastasis to be treated by IRE At least one course of chemotherapy for metastatic or inoperable disease discontinued due to treatment failure or intolerance Performance status 0-1 ASA ≤ 3 ≥ 18 years of age Written and orally informed consent Sufficient available histological tumor material stored in biobank or obtainable by new biopsy Patient acceptance of collection of blood samples for translational research and two additional biopsies during treatment Adequate bone marrow function, liver function, and renal function (within 7 days prior to enrollment): Neutrophils (ANC) ≥ 1.5 x 109/l Platelet count ≥ 100 x 109/l Hemoglobin ≥ 6 mmol/l Plasma bilirubin ≤ 1.5 x ULN Plasma alanine transaminase (ALAT) < 5 x ULN Plasma creatinine ≤ 1.5 x ULN INR ≤ 1.5 Exclusion Criteria: Underlying medical disease not adequately treated (e.g. poorly regulated diabetes and symptomatic cardiac disease) Prior or current autoimmune disorder with risk of serious toxicity during treatment with checkpoint inhibitor Acute myocardial infarction, cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within 6 months from start of treatment Previous reception of allogeneic stem cells or solid organ donation Active infection requiring systemic therapy within 7 days prior to treatment initiation Positive HIV, HBV, and HCV test results (prior testing or new testing in patients at risk) Active psychiatric disease or history of drug or alcohol abuse affecting participation Allergy to active substance or any of the auxiliary agents, including known severe allergy to anesthetic agent, paralytic agent or any of the equipment used during treatment Expected need for systemic corticosteroid or other systemic immunosuppressive drug during the course of this clinical trial. A low dose of e.g. prednisone ≤ 10 mg/day is permitted for maximally 7 consecutive days Coexisting malignant disease, except non-melanoma skin cancer Symptomatic or untreated CNS metastases Liver cirrhosis Child Pugh >A Pregnant or breast-feeding patients. For women of childbearing potential, a negative pregnancy test (minimum sensitivity 25mIU(hCG)/ml) is mandatory prior to inclusion and every month during the trial Women of childbearing potential not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment. Male patients with a fertile partner are also required to secure effective methods of contraception (definition available in protocol) Previous immunotherapy Patients referred from a hospital outside of Denmark Major dilation of veins or bowel obstructing the needle path Persistent atrial fibrillation Metal objects (e.g. biliary SEMS) within 5 cm of ablation target Cardiac pacemaker or ICD, that cannot be safely disconnected during IRE treatment healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Morten Ladekarl, DMSc overall official affiliation Department of Oncology overall official role Principal Investigator location list location location facility Department of Oncology location city Aalborg location state North Denmark Region location zip DK-9000 location country Denmark i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010190 condition mesh term Pancreatic Neoplasms condition ancestor list condition ancestor condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004701 condition ancestor term Endocrine Gland Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000010182 condition ancestor term Pancreatic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M12262 condition browse leaf name Pancreatic Neoplasms condition browse leaf as found Pancreas Cancer condition browse leaf relevance high condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M7015 condition browse leaf name Endocrine Gland Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M12254 condition browse leaf name Pancreatic Diseases condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id T4387 condition browse leaf name Pancreatic Cancer condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id C000582435 intervention mesh term Pembrolizumab intervention ancestor list intervention ancestor intervention ancestor id D000074322 intervention ancestor term Antineoplastic Agents, Immunological intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M289070 intervention browse leaf name Pembrolizumab intervention browse leaf as found Cognitive intervention browse leaf relevance high intervention browse leaf id M2343 intervention browse leaf name Immune Checkpoint Inhibitors intervention browse leaf relevance low intervention browse leaf id M10262 intervention browse leaf name Liver Extracts intervention browse leaf relevance low intervention browse leaf id M1346 intervention browse leaf name Antineoplastic Agents, Immunological intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Hemat intervention browse branch name Hematinics
NCT04835402
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full study rank 61831 study protocol section identification module n c t id NCT04831359 org study id info org study id Tissue Doppler assesment organization org full name Assiut University org class OTHER brief title Tissue Doppler Assessment of Right Ventricle Function in Pediatrics Underwent Chemotherapy official title Tissue Doppler Assessment of Right Ventricular Function in Newly Diagnosed Pediatric Cancer Patients Underwent Chemotherapy in South Egypt Cancer Institute status module status verified date March 2021 overall status Recruiting expanded access info has expanded access No start date struct start date February 20, 2021 start date type Actual primary completion date struct primary completion date February 20, 2022 primary completion date type Anticipated completion date struct completion date April 20, 2022 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Reham M Farghally responsible party investigator title Resident responsible party investigator affiliation Assiut University lead sponsor lead sponsor name Assiut University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Tissue Doppler assessment of right ventricular function in newly diagnosed pediatric cancer patients underwent chemotherapy in South Egypt Cancer Institute. detailed description The incidence of cancer is always increasing and it is predicted that the incidence will increase to 45% by 2030(1). The introduction of new chemotherapeutic agents significantly improved survival, but also revealed large spectrum of cardiotoxicity manifestations (2). There are many factors that increase the risk of cardiotoxicity caused by different chemotherapeutic agents, such as type of chemotherapy, cumulative dose, concomitant or previous radiotherapy, and comorbidities (3). Chemotherapeutic regimens which contain anthracyclines, cyclophosphamide, fluorouracil, cisplatin, taxanes and trastuzumab cause early and late cardiotoxicity (4). The majority of published studies are focused on left ventricle dysfunction in patients receiving cardiotoxic chemotherapy. However, the right ventricle has been ignored for a long time and a little attention has been directed to show the effect of chemotherapy on right ventricle function. Right ventricle dysfunction is associated with increased morbidity and mortality in many cardiovascular diseases (5). The structure of cardiomyocytes and blood supply between the left and right ventricles are similar. Given the smaller mass and fewer myofibrils of right ventricle, chemotherapy may theoretically cause a more significant impact on it (6). The right ventricle has a complex geometric shape which includes smooth muscular inflow, outflow and a trabecular apical region so echocardiographic assessment of right ventricle is difficult (7). M-mode echocardiography, two-dimensional echocardiography, conventional Doppler echocardiography, and myocardial Doppler tissue imaging are all used to evaluate right ventricular function and provide accurate prognostic information especially when used in combination conditions module condition list condition Pediatric Cancer Patients design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 50 enrollment type Anticipated arms interventions module intervention list intervention intervention type Device intervention name Doppler ultrasound intervention description Tissue Doppler ultrasound on pediatric patients outcomes module primary outcome list primary outcome primary outcome measure Effect of chemotherapy on right ventricular function primary outcome description The correlation between echocardiographic parameters of the RV, measured with transthoracic echocardiography before and after chemotherapy primary outcome time frame Baseline to 45 days eligibility module eligibility criteria Inclusion Criteria: Patients of 1-18 years who are newly diagnosed to have cancer and will be referred to South Egypt cancer institute for receiving chemotherapy Exclusion Criteria: patients with left ventricular (EF) <50% before chemotherapy Previous heart disease Renal failure significant valvular disease gender All minimum age 1 Year maximum age 16 Years std age list std age Child study population - Patients of 1-18 years who are newly diagnosed to have cancer and will be referred to South Egypt cancer institute sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Reham M Farghally central contact role Contact central contact phone 01094099458 central contact e mail [email protected] central contact name Duaa M Raafat central contact role Contact central contact phone 01223112124 central contact e mail [email protected] location list location location facility Assiut university location status Recruiting location city Assiut location country Egypt location contact list location contact location contact name Reham Farghally location contact role Contact location contact phone 01094099458 location contact e mail [email protected] location contact name Duaa Raafat location contact role Contact location contact phone 01223112124 location contact e mail [email protected] references module reference list reference reference p m i d 19403886 reference type background reference citation Smith BD, Smith GL, Hurria A, Hortobagyi GN, Buchholz TA. Future of cancer incidence in the United States: burdens upon an aging, changing nation. J Clin Oncol. 2009 Jun 10;27(17):2758-65. doi: 10.1200/JCO.2008.20.8983. Epub 2009 Apr 29. reference p m i d 1748012 reference type background reference citation Dell'Italia LJ. The right ventricle: anatomy, physiology, and clinical importance. Curr Probl Cardiol. 1991 Oct;16(10):653-720. Review. reference p m i d 17577017 reference type background reference citation Carver JR, Shapiro CL, Ng A, Jacobs L, Schwartz C, Virgo KS, Hagerty KL, Somerfield MR, Vaughn DJ; ASCO Cancer Survivorship Expert Panel. American Society of Clinical Oncology clinical evidence review on the ongoing care of adult cancer survivors: cardiac and pulmonary late effects. J Clin Oncol. 2007 Sep 1;25(25):3991-4008. doi: 10.1200/JCO.2007.10.9777. Epub 2007 Jun 18. reference p m i d 27057977 reference type background reference citation Surkova E, Muraru D, Iliceto S, Badano LP. The use of multimodality cardiovascular imaging to assess right ventricular size and function. Int J Cardiol. 2016 Jul 1;214:54-69. doi: 10.1016/j.ijcard.2016.03.074. Epub 2016 Mar 25. Review. reference p m i d 12413440 reference type background reference citation Burgess MI, Bright-Thomas RJ, Ray SG. Echocardiographic evaluation of right ventricular function. Eur J Echocardiogr. 2002 Dec;3(4):252-62. Review. reference p m i d 25559473 reference type background reference citation Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003. reference p m i d 19423286 reference type background reference citation Koestenberger M, Ravekes W, Everett AD, Stueger HP, Heinzl B, Gamillscheg A, Cvirn G, Boysen A, Fandl A, Nagel B. Right ventricular function in infants, children and adolescents: reference values of the tricuspid annular plane systolic excursion (TAPSE) in 640 healthy patients and calculation of z score values. J Am Soc Echocardiogr. 2009 Jun;22(6):715-9. doi: 10.1016/j.echo.2009.03.026. Epub 2009 May 7. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022
NCT04831359
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full study rank 61451 study protocol section identification module n c t id NCT04836299 org study id info org study id RCT01 organization org full name Universidad Mayor de San Simón org class OTHER brief title Clinical Trial to "Study the Efficacy and Therapeutic Safety of Ivermectin: (SAINTBO) official title Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Therapeutic Safety of Ivermectin Versus Placebo Associated With Standard of Care Treatment in the Early Phase of Coronavirus Infection (COVID19). acronym SAINTBO status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 8, 2021 start date type Anticipated primary completion date struct primary completion date July 8, 2021 primary completion date type Anticipated completion date struct completion date December 5, 2021 completion date type Anticipated study first submit date March 2, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Jorge Luis Aviles responsible party investigator title MD. MPH. PhDc. responsible party investigator affiliation Universidad Mayor de San Simón lead sponsor lead sponsor name Universidad Mayor de San Simón lead sponsor class OTHER collaborator list collaborator collaborator name Barcelona Institute for Global Health collaborator class OTHER collaborator name Université Catholique de Louvain collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Coronavirus disease (COVID-19) is an infectious disease caused by a new virus. The disease causes a respiratory illness (such as the flu) with symptoms such as cough, fever, and, in more severe cases, respiratory distress, even developing Acute Respiratory Distress Syndrome, evolving in some cases with the death of the patient. Currently, there are no specific treatments for COVID-19. Currently, there are several ongoing clinical trials evaluating possible treatments. Recently, Leon Caly reports here that Ivermectin, an FDA-approved antiparasitic that was shown to have broad-spectrum antiviral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero cells. hours after infection with SARS-CoV-2 capable of a 5000-fold reduction in viral RNA at 48 h. (1) Ivermectin, therefore, warrants further investigation for possible benefits in humans. The reason for this study is to understand the effect of the drug in eradicating the virus. It is a randomized controlled trial to evaluate the efficacy of Ivermectin in COVID-19. The recruited patient will be assigned to two groups, (1) a group received ivermectin plus care treatment (2) the placebo group plus standard care treatment. The result will be recorded by documenting the RT-PCR reports confirmed at the time of recruitment and at 7 and 14 days within the framework of the study, then they will be adapted to the national care protocol, with 9 scheduled clinical and telemedicine interviews. It will be a randomized controlled trial to be run in RT-PCR confirmed COVID-19 patients who meet the inclusion criteria (asymptomatic/mild to moderate severity). They will be divided into groups after randomization. Group A will be administered one (1) a group received ivermectin plus standard of care treatment (2) the placebo group plus standard of care treatment, along with the existing inpatient and outpatient management clinical guidelines of the hospitals participating in the study, these being adapted to the National standard. The reverse transcriptase-polymerase chain reaction (RT-PCR) will be carried out on days 7 and 14 after the therapeutic intervention and the duration of time at which the RT-PCR becomes negative and/or clinical evolution of the patient will be compared in both study groups. The dose of the drug is not subject to change according to the patient's response or the possible side effect of being administered in a single dose. detailed description STUDY DESIGN It is a double-blind, randomized, placebo-controlled superiority trial with two parallel arms. Participants will be randomized to receive a single 600 µg / kg dose of ivermectin or placebo, and the number of patients in the treatment and placebo groups will be in a 2: 1 ratio for the intervention group. The trial statistician will generate the randomization code using blocks of four individuals to ensure the balance between groups. The assignment will be carried out by the main investigator using opaque envelopes, after obtaining informed consent and verification of compliance with all the inclusion and exclusion criteria. The investigational product will be administered by personnel who are not involved in patient care or monitoring of study participants. Participants will be followed up at their homes for a period of 28 days. A patient can discontinue her participation in the study at any time and for any reason. The principal investigator and the panel of experts that make up the safety and adverse effects committee may also withdraw a patient from the study if they believe it is in the best interest of the patient. Serious adverse events (SAEs) related to ivermectin will be followed until they resolve or up to 28 days after the participant's final visit, whichever occurs first. All other SAEs deemed unrelated to ivermectin will be followed up until the participant's final visit or for a specified period at the discretion of the principal investigator. The study will end when the final randomized patient has completed the study, all planned visits have been completed, and inconsistencies in the data have been resolved. OBJECTIVES Primary objective • To explore the efficacy and therapeutic safety of Ivermectin in patients with non-severe and low-risk COVID-19 in the first 72 hours after the onset of symptoms, through the negativization of the polymerase chain in real time. RT-PCR (nasopharyngeal swab) and clinical improvement on day 7 and 28 after treatment, to explore its possible use in the fight against the pandemic. Secondary objectives To evaluate the efficacy of ivermectin in reducing the SARS-CoV-2 viral load in the nasopharyngeal swab on day 7 after treatment. To evaluate the efficacy of ivermectin in improving the progression of symptoms in treated patients. Assess the proportion of seroconversions in patients treated on day 21. Evaluate the safety of ivermectin at the proposed dose. Determine the magnitude of the immune response against SARS-CoV-2 Evaluate the early kinetics of immunity against SARS-CoV-2 conditions module condition list condition Covid19 keyword list keyword Efficacy Safety Ivermectin design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized, double-blind, Placebo-controlled parallel clinical trial to "Study the efficacy and therapeutic safety of Ivermectin associated with standard of care treatment versus placebo with standard of care treatment in the early phase of coronavirus infection (COVID19). A PHASE II pilot study. design primary purpose Treatment design masking info design masking Double design masking description The participants, care providers and also investigator will be blinded for this study design. design who masked list design who masked Participant Care Provider enrollment info enrollment count 90 enrollment type Anticipated arms interventions module arm group list arm group arm group label Ivermectin arm group type Experimental arm group description Participants will receive a single 600 µg / kg dose of ivermectin. arm group intervention list arm group intervention name Drug: Ivermectin arm group label Placebo Comparator arm group type Placebo Comparator arm group description Participants will receive a single dose of placebo. arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name Ivermectin intervention description Participants will be randomly assigned to receive a single 600 µg / kg dose of ivermectin or placebo. intervention arm group label list intervention arm group label Ivermectin intervention other name list intervention other name A intervention type Drug intervention name Placebo intervention description Participants will be randomly assigned to receive a single of placebo. intervention arm group label list intervention arm group label Placebo Comparator intervention other name list intervention other name B outcomes module primary outcome list primary outcome primary outcome measure Evolution of viral load primary outcome description A comparison will be made between the initial viral load before the dose of ivermectin with respect to the viral load on the third day after the administration of the drug. The primary outcome of interest will be the correlation between the use of a treatment regimen containing Ivermectin plus the standard of care, with the endpoint of measurement relative to the difference in viral loads. primary outcome time frame 3 days primary outcome measure Clinical remission primary outcome description Clinical remission, defined as a remission of all the patient's symptoms based on the clinical management protocol. The primary outcome of interest will be the correlation between the use of a treatment regimen containing Ivermectin plus the standard of care, initiated early after the confirmed diagnosis of COVID-19 with the endpoint of measurement relative to the difference in clinical evolution. primary outcome time frame 28 days secondary outcome list secondary outcome secondary outcome measure Clinical signs of toxicity secondary outcome description The secondary outcome of interest will be the correlation between these treatment regimens and the appearance of clinical signs of toxicity or adverse effects (defined as the first clinical or laboratory finding of a neurological, hepatic, renal, hematological, or pancreatic alteration, or verification of alterations in pupillometry during the outpatient clinical course or hospitalization. secondary outcome time frame 28 days other outcome list other outcome other outcome measure Need for supplemental oxygen other outcome description The need for supplemental oxygen implementation will be evaluated other outcome time frame 28 days other outcome measure Hospital stay other outcome description The need for hospital care and the stay both in general wards and in intensive care (ICU) will be evaluated. other outcome time frame 3 months other outcome measure Need for mechanical ventilation other outcome description The need to implement the intervention through mechanical ventilation will be evaluated. other outcome time frame 21 days eligibility module eligibility criteria Inclusion Criteria: Confirmed case of COVID-19 in national reference hospitals - COVID sentinel hospitals. Male and female patients 18 to 75 years (inclusive) of age. Supply of signed and dated informed consent form Declared availability to comply with all study procedures and availability for the duration of the study. In good general health with mild or moderate symptoms during the first week of disease evolution (onset of symptoms maximum 7 days before recruitment). Ability to take oral medications and be willing to adhere to the medication consumption regimen prescribed in the study. The patient must, in the opinion of the principal investigator, be able to comply with all the requirements of the clinical trial (including home monitoring during isolation). The patient is able and willing to comply with the requirements of this test protocol. Voluntarily signed informed consent obtained prior to any proceeding related to the trial. Exclusion Criteria: Known history of ivermectin allergy Hypersensitivity to any component of ivermectin or the excipients of the brand to be used. COVID-19 pneumonia Diagnosed by the treating physician Identified on a chest x-ray Fever or cough present for more than 48 hours. immunoglobulin G (IgG) positive against SARS-CoV-2 by a rapid diagnostic test 8. Recent travel history to loa endemic countries (Angola, Cameroon, Central African Republic, Chad, the Democratic Republic of the Congo, Ethiopia, Equatorial Guinea, Gabon, Republic of the Congo, Nigeria, and Sudan) 9. Current use of quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir, or cobicistat. Use of critical drugs such as warfarin. healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jorge L Aviles, MPH central contact role Contact central contact phone +59170745106 central contact e mail [email protected] overall official list overall official overall official name Carlos L Erostegui, MPH overall official affiliation Universidad Mayor de San Simón overall official role Study Director location list location location facility Universidad Mayor de San Simón location city Cochabamba location country Bolivia references module reference list reference reference p m i d 32533071 reference type background reference citation Heidary F, Gharebaghi R. Ivermectin: a systematic review from antiviral effects to COVID-19 complementary regimen. J Antibiot (Tokyo). 2020 Sep;73(9):593-602. doi: 10.1038/s41429-020-0336-z. Epub 2020 Jun 12. reference p m i d 32322397 reference type background reference citation Choudhary R, Sharma AK. Potential use of hydroxychloroquine, ivermectin and azithromycin drugs in fighting COVID-19: trends, scope and relevance. New Microbes New Infect. 2020 Apr 22;35:100684. doi: 10.1016/j.nmni.2020.100684. eCollection 2020 May. reference p m i d 12362927 reference type background reference citation Guzzo CA, Furtek CI, Porras AG, Chen C, Tipping R, Clineschmidt CM, Sciberras DG, Hsieh JY, Lasseter KC. Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects. J Clin Pharmacol. 2002 Oct;42(10):1122-33. doi: 10.1177/009127002401382731. reference p m i d 32378737 reference type background reference citation Schmith VD, Zhou JJ, Lohmer LRL. The Approved Dose of Ivermectin Alone is not the Ideal Dose for the Treatment of COVID-19. Clin Pharmacol Ther. 2020 Oct;108(4):762-765. doi: 10.1002/cpt.1889. Epub 2020 Jun 7. reference p m i d 32462282 reference type background reference citation Rizzo E. Ivermectin, antiviral properties and COVID-19: a possible new mechanism of action. Naunyn Schmiedebergs Arch Pharmacol. 2020 Jul;393(7):1153-1156. doi: 10.1007/s00210-020-01902-5. Epub 2020 May 27. reference p m i d 32251768 reference type background reference citation Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3. reference p m i d 32473642 reference type background reference citation Sharun K, Dhama K, Patel SK, Pathak M, Tiwari R, Singh BR, Sah R, Bonilla-Aldana DK, Rodriguez-Morales AJ, Leblebicioglu H. Ivermectin, a new candidate therapeutic against SARS-CoV-2/COVID-19. Ann Clin Microbiol Antimicrob. 2020 May 30;19(1):23. doi: 10.1186/s12941-020-00368-w. reference p m i d 32293834 reference type background reference citation Simsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145. reference p m i d 32330482 reference type background reference citation Bray M, Rayner C, Noël F, Jans D, Wagstaff K. Ivermectin and COVID-19: A report in Antiviral Research, widespread interest, an FDA warning, two letters to the editor and the authors' responses. Antiviral Res. 2020 Jun;178:104805. doi: 10.1016/j.antiviral.2020.104805. Epub 2020 Apr 21. reference p m i d 32314704 reference type background reference citation Chaccour C, Hammann F, Ramón-García S, Rabinovich NR. Ivermectin and COVID-19: Keeping Rigor in Times of Urgency. Am J Trop Med Hyg. 2020 Jun;102(6):1156-1157. doi: 10.4269/ajtmh.20-0271. reference p m i d 32283237 reference type background reference citation Patri A, Fabbrocini G. Hydroxychloroquine and ivermectin: A synergistic combination for COVID-19 chemoprophylaxis and treatment? J Am Acad Dermatol. 2020 Jun;82(6):e221. doi: 10.1016/j.jaad.2020.04.017. Epub 2020 Apr 10. No abstract available. reference p m i d 29626533 reference type background reference citation Badhan R, Zakaria Z, Olafuyi O. The Repurposing of Ivermectin for Malaria: A Prospective Pharmacokinetics-Based Virtual Clinical Trials Assessment of Dosing Regimen Options. J Pharm Sci. 2018 Aug;107(8):2236-2250. doi: 10.1016/j.xphs.2018.03.026. Epub 2018 Apr 5. reference p m i d 28482929 reference type background reference citation Aroke D, Tchouakam DN, Awungia AT, Mapoh SY, Ngassa SN, Kadia BM. Ivermectin induced Steven-Johnsons syndrome: case report. BMC Res Notes. 2017 May 8;10(1):179. doi: 10.1186/s13104-017-2500-5. reference p m i d 27960597 reference type background reference citation Alout H, Foy BD. Ivermectin: a complimentary weapon against the spread of malaria? Expert Rev Anti Infect Ther. 2017 Mar;15(3):231-240. doi: 10.1080/14787210.2017.1271713. Epub 2016 Dec 29. Review. reference p m i d 26697814 reference type background reference citation Chosidow A, Gendrel D. [Safety of oral ivermectin in children]. Arch Pediatr. 2016 Feb;23(2):204-9. doi: 10.1016/j.arcped.2015.11.002. Epub 2015 Dec 14. Review. French. reference p m i d 25480657 reference type background reference citation Foletto VR, Vanz F, Gazarini L, Stern CA, Tonussi CR. Efficacy and security of ivermectin given orally to rats naturally infected with Syphacia spp., Giardia spp. and Hymenolepis nana. Lab Anim. 2015 Jul;49(3):196-200. doi: 10.1177/0023677214562850. Epub 2014 Dec 5. reference p m i d 31978945 reference type background reference citation Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. reference p m i d 32007143 reference type background reference citation Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30. reference p m i d 32031570 reference type background reference citation Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113. see also link list see also link see also link label SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) see also link u r l https://www.isglobal.org/healthisglobal/-/custom-blog-portlet/ivermectin-and-covid-19-how-a-flawed-database-shaped-the-covid-19-response-of-several-latin-american-countries/2877257/0 i p d sharing statement module i p d sharing Yes i p d sharing description It is planned to grant the respective information stored in a repository. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code i p d sharing time frame until August 2021 i p d sharing access criteria unrestricted access derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id D000007559 intervention mesh term Ivermectin intervention ancestor list intervention ancestor intervention ancestor id D000000977 intervention ancestor term Antiparasitic Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M9742 intervention browse leaf name Ivermectin intervention browse leaf as found Vincristine intervention browse leaf relevance high intervention browse leaf id M3446 intervention browse leaf name Antiparasitic Agents intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04836299
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full study rank 61481 study protocol section identification module n c t id NCT04835909 org study id info org study id NCT2021UTC organization org full name Brain In Game scientific-technical service org class OTHER brief title Board Games Among Mild Cognitive Impairment Patients Experience (GAME Project) official title Effectiveness on Cognition of a Cognitive Training Intervention Based on Modern Board and Card Games in Mild Cognitive Impairment Patients: a Randomized Controlled Trial acronym GAME-Project status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date February 16, 2021 start date type Actual primary completion date struct primary completion date March 2024 primary completion date type Anticipated completion date struct completion date March 2024 completion date type Anticipated study first submit date March 22, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name jaume march llanes responsible party investigator title Effectiveness on Cognition of a Cognitive Training Intervention Based on Modern Board and Card Games in Mild Cognitive Impairment Patients: a Randomized Controlled Trial responsible party investigator affiliation Brain In Game scientific-technical service lead sponsor lead sponsor name Brain In Game scientific-technical service lead sponsor class OTHER collaborator list collaborator collaborator name University Hospital of Santa Maria, Lleida collaborator class UNKNOWN oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Nowadays, on geriatric centres, cognitive decline used to be prevented by pen and paper exercises (Calero García & Navarro Gonzalez, 2006). However, as Lampit et al. (2014) suggest, studies based on the efficacy and effectiveness of new cognitive-based interventions in order to improve these cognitive processes are fundamental (Lampit et al., 2014). Cognitive-based interventions are interventions that directly or indirectly try to improve cognitive processes (Chiu et al., 2017). Between the different kinds of cognitive-based interventions, cognitive training permits stablish randomized controlled trials. Cognitive training consists of repeating during a concrete time a standardized set of tasks in order to maintain or improve one or some cognitive processes. Meta-analysis studies have shown that computerized cognitive training can improve in a moderate size some cognitive processes in elderly people with mild cognitive impairment or dementia (Hill et al., 2017) and without those diagnoses (Lampit, Hallock, & Valenzuela, 2014; Chiu et al., 2017). Although it seems that computerized training is effective, safe and secure, it is important to note the social component of the definition of health (OMS, 1948). Chang, Wray & Lin (2014) found that social relationships predict the use of leisure activities and this predict a better physical health and wellbeing psychological. In fact, a comparative study found that those elderly people that have played board games have a 15% lower risk of having dementia diagnose and problems related with memory (Dartigues et al., 2013). To sum up, the aim of this research project is to test the effectiveness of a cognitive training based on modern board and card games in elderly people with a diagnose of mild-cognitive impairment in comparison to do cognitive paper and pencil tasks or in a wait-list comparison group. conditions module condition list condition Cognitive Impairment, Mild keyword list keyword Memory Executive Functions Cognitive training Cognitive enrichment Modern board and card games design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 112 enrollment type Anticipated arms interventions module arm group list arm group arm group label Behavioral: modern board and card games arm group type Experimental arm group description Participants will play modern board and card games in groups at medical center 2 times per week for at least 1 hour over a period of 16 weeks. arm group intervention list arm group intervention name Behavioral: Modern board and card games group arm group label Behavioral: paper and pencil tasks arm group type Active Comparator arm group description Participants will do cognitive paper and pencil tasks in groups at medical center 2 times per week for at least 1 hour over a period of 16 weeks. arm group intervention list arm group intervention name Behavioral: Paper and pencil tasks group arm group label Wait-list arm group type No Intervention arm group description Participants will be in a wait-list over a period of 16 weeks. Then, they received the board and card games' or paper and pencil tasks' intervention. intervention list intervention intervention type Behavioral intervention name Modern board and card games group intervention description Modern board and card games group intervention arm group label list intervention arm group label Behavioral: modern board and card games intervention type Behavioral intervention name Paper and pencil tasks group intervention description Paper and pencil tasks group intervention arm group label list intervention arm group label Behavioral: paper and pencil tasks outcomes module primary outcome list primary outcome primary outcome measure Change in cognitive impairment from baseline to post intervention primary outcome description Addenbrooke's Cognitive Examination primary outcome time frame Baseline and post intervention (after 16 weeks) primary outcome measure Change in visuoconstruction, immediate memory and long-term memory from baseline to post intervention primary outcome description Copy, draw after 3 and after 25 minuts of Rey-Osterrieth Complex Figure Test primary outcome time frame Baseline and post intervention (after 16 weeks) primary outcome measure Change in verbal long-term memory from baseline to post intervention primary outcome description Rey Auditory Verbal Learning Test (RAVLT) primary outcome time frame Baseline and post intervention (after 16 weeks) primary outcome measure Change in verbal short-term memory from baseline to post intervention primary outcome description Digit Memory Test Forward primary outcome time frame Baseline and post intervention (after 16 weeks) primary outcome measure Change in verbal working memory from baseline to post intervention primary outcome description Digit Memory Test Backward primary outcome time frame Baseline and post intervention (after 16 weeks) primary outcome measure Change in visuospatial short-term memory from baseline to post intervention primary outcome description Visual Memory Test Forward primary outcome time frame Baseline and post intervention (after 16 weeks) primary outcome measure Change in visuospatial working memory from baseline to post intervention primary outcome description Visual Memory Test Backward primary outcome time frame Baseline and post intervention (after 16 weeks) primary outcome measure Change in visuospatial processing from baseline to post intervention primary outcome description Trail Making Test A and Symbol Digit Modalities Test (SDMT) primary outcome time frame Baseline and post intervention (after 16 weeks) primary outcome measure Change in flexibility from baseline to post intervention primary outcome description Trail Making Test B and 5 digits test primary outcome time frame Baseline and post intervention (after 16 weeks) primary outcome measure Change in inhibition from baseline to post intervention primary outcome description 5 digits test primary outcome time frame Baseline and post intervention (after 16 weeks) primary outcome measure Change in phonemic and semantic fluency from baseline to post intervention primary outcome description Animals category and P, M, R letters, Spanish version primary outcome time frame Baseline and post intervention (after 16 weeks) secondary outcome list secondary outcome secondary outcome measure Change in neuropsychiatric symptoms from baseline to post intervention secondary outcome description Neuropsychiatric Inventory (NPI), Self-reported and caregivers spanish versions. Higher scores mean higher neuropsychiatric symptomatology. secondary outcome time frame Baseline and post intervention (after 16 weeks) secondary outcome measure Change in psychological well-being from baseline to post intervention secondary outcome description Euro Quality of Life Scale (EQ-5D), Self-reported and caregivers spanish versions. Higher scores mean higher quality of life. Visual analogue scale: minimum value=0, maximum value=100. secondary outcome time frame Baseline and post intervention (after 16 weeks) secondary outcome measure Change in depressive symptoms from baseline to post intervention secondary outcome description Geriatric Depression Scale (GDS), Spanish version. Higher scores mean higher depressive symptomatology. Minimum value = 0, maximum value = 15. secondary outcome time frame Baseline and post intervention (after 16 weeks) other outcome list other outcome other outcome measure Social Status Index and sociodemographical information other outcome description Hollingshead Index, age, sex, birth location other outcome time frame Baseline other outcome measure Cognitive reserve questionnaire other outcome description Cognitive reserve questionnaire (CRC), spanish version other outcome time frame Baseline other outcome measure Premorbid cognitive function other outcome description The Word Accentuation Test (TAP), spanish version other outcome time frame Baseline eligibility module eligibility criteria Inclusion Criteria: Participation in cognitive disease center Amnestic MCI diagnoses (clinical diagnoses following the guidelines of Petersen et al. 2011) Global deterioration scale (GDS) 2-3 values Participation assessing outcomes of the caregivers in the study Exclusion Criteria: Participation in another cognitive training program Dementia, neurologic or other disease non-neurodegenerative, which could affect cognitive change over time (medical-reported) Severe visual impairment, language impairment or motoric impairment of the upper extremity which significantly affects ability to solve jigsaw puzzles (medical-reported) healthy volunteers No gender All minimum age 60 Years std age list std age Adult Older Adult contacts locations module location list location location facility Faculty of Education, Psychology and Social Work; University of Lleida location status Recruiting location city Lleida location zip 25001 location country Spain location contact list location contact location contact name Jorge Moya-Higueras, PhD location contact role Contact location contact phone 973706509 location contact phone ext 6509 location contact e mail [email protected] location contact name Jaume March-Llanes, PhD location contact role Principal Investigator location contact name Verónica Estrada-Plana, MsC location contact role Sub-Investigator location facility Cognitive disorders unity, Santa Maria's University Hospital, GSS location status Recruiting location city Lleida location zip 25198 location country Spain location contact list location contact location contact name Beatriu Lara Consuegra, MsC location contact role Contact location contact phone +34 972727222 location contact phone ext 1571 location contact e mail [email protected] references module reference list reference reference type background reference citation Calero García, M. D., & Navarro Gonzalez, E. (2006). Eficacia de un programa de entrenamiento en memoria en el mantenimiento de ancianos con y sin deterioro cognitivo. Clínica y Salud, 17(2), 187-202. reference p m i d 24884905 reference type background reference citation Chang PJ, Wray L, Lin Y. Social relationships, leisure activity, and health in older adults. Health Psychol. 2014 Jun;33(6):516-23. doi: 10.1037/hea0000051. reference p m i d 28459873 reference type background reference citation Chiu HL, Chu H, Tsai JC, Liu D, Chen YR, Yang HL, Chou KR. The effect of cognitive-based training for the healthy older people: A meta-analysis of randomized controlled trials. PLoS One. 2017 May 1;12(5):e0176742. doi: 10.1371/journal.pone.0176742. eCollection 2017. reference p m i d 23988362 reference type background reference citation Dartigues JF, Foubert-Samier A, Le Goff M, Viltard M, Amieva H, Orgogozo JM, Barberger-Gateau P, Helmer C. Playing board games, cognitive decline and dementia: a French population-based cohort study. BMJ Open. 2013 Aug 29;3(8):e002998. doi: 10.1136/bmjopen-2013-002998. reference p m i d 27838936 reference type background reference citation Hill NT, Mowszowski L, Naismith SL, Chadwick VL, Valenzuela M, Lampit A. Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. Am J Psychiatry. 2017 Apr 1;174(4):329-340. doi: 10.1176/appi.ajp.2016.16030360. Epub 2016 Nov 14. Review. reference p m i d 25405755 reference type background reference citation Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov. Review. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000060825 condition mesh term Cognitive Dysfunction condition ancestor list condition ancestor condition ancestor id D000003072 condition ancestor term Cognition Disorders condition ancestor id D000019965 condition ancestor term Neurocognitive Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M28858 condition browse leaf name Cognitive Dysfunction condition browse leaf as found Cognitive Impairment condition browse leaf relevance high condition browse leaf id M5453 condition browse leaf name Cognition Disorders condition browse leaf relevance low condition browse leaf id M20989 condition browse leaf name Neurocognitive Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions
NCT04835909
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full study rank 61410 study protocol section identification module n c t id NCT04836832 org study id info org study id OSU-20179 secondary id info list secondary id info secondary id NCI-2021-01355 secondary id type Registry Identifier secondary id domain CTRP (Clinical Trial Reporting Program) organization org full name Ohio State University Comprehensive Cancer Center org class OTHER brief title Acalabrutinib and Duvelisib for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin Lymphoma official title A Phase Ib/II Study of Duvelisib and Acalabrutinib in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (DUAL Trial) status module status verified date June 2022 overall status Withdrawn why stopped PI decision start date struct start date July 1, 2022 start date type Anticipated primary completion date struct primary completion date December 31, 2023 primary completion date type Anticipated completion date struct completion date December 31, 2024 completion date type Anticipated study first submit date March 9, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date June 2, 2022 last update post date struct last update post date June 7, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Narendranath Epperla responsible party investigator title Principal Investigator responsible party investigator affiliation Ohio State University Comprehensive Cancer Center lead sponsor lead sponsor name Narendranath Epperla lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary This phase Ib/II trial studies the side effects of acalabrutinib and duvelisib and how well they work in treating patients with indolent non-Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Acalabrutinib inhibits a signaling molecule called Bruton tyrosine kinase and blocks cancer cell proliferation, growth, and survival. Duvelisib is designed to block a protein called PI3 kinase in order to stop cancer growth and cause changes in the immune system that may allow the immune system to better act against cancer cells. Giving acalabrutinib and duvelisib together may work better to block cancer growth than therapy of either drug alone. detailed description PRIMARY OBJECTIVES: I. To assess the safety and tolerability of the combination of acalabrutinib and duvelisib in patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL). II. Determine maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). III. To estimate the overall response rate (ORR, Lugano 2014, computed tomography [CT] based) of acalabrutinib in combination with duvelisib at 6 months in follicular lymphoma (FL) and marginal zone lymphoma (MZL) cohorts. SECONDARY OBJECTIVES: I. To evaluate the activity of acalabrutinib and duvelisib as measured by ORR based on positron emission tomography (PET) scan at 6 months, duration of response (DOR) and 2-year progression-free survival (PFS). II. To capture patient-reported outcomes (PROs). EXPLORATORY OBJECTIVE: I. To determine the correlation of the clinical activity of acalabrutinib in combination with duvelisib with established biomarkers and identify putative novel markers. OUTLINE: This is a phase Ib, dose-escalation study of duvelisib, followed by a phase II study. Patients receive acalabrutinib orally (PO) twice daily (BID), and duvelisib PO BID on days 1-28. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 19, patients receive acalabrutinib PO BID for up to 60 months in absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, and then every 3 months thereafter. conditions module condition list condition Recurrent Follicular Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Nodal Marginal Zone Lymphoma Recurrent Splenic Marginal Zone Lymphoma Refractory Follicular Lymphoma Refractory Indolent Non-Hodgkin Lymphoma Refractory Marginal Zone Lymphoma Refractory Nodal Marginal Zone Lymphoma Refractory Splenic Marginal Zone Lymphoma design module study type Interventional phase list phase Phase 1 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label Treatment (acalabrutinib, duvelisib) arm group type Experimental arm group description Patients receive acalabrutinib PO BID, and duvelisib PO BID on days 1-28. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 19, patients receive acalabrutinib PO BID for up to 60 months in absence of disease progression or unacceptable toxicity. arm group intervention list arm group intervention name Drug: Acalabrutinib Drug: Duvelisib intervention list intervention intervention type Drug intervention name Acalabrutinib intervention description Given PO intervention arm group label list intervention arm group label Treatment (acalabrutinib, duvelisib) intervention other name list intervention other name ACP-196 Bruton Tyrosine Kinase Inhibitor ACP-196 Calquence intervention type Drug intervention name Duvelisib intervention description Given PO intervention arm group label list intervention arm group label Treatment (acalabrutinib, duvelisib) intervention other name list intervention other name 8-Chloro-2-phenyl-3-((1S)-1-(7H-purin-6-ylamino)ethyl)isoquinolin-1(2H)-one Copiktra INK-1197 IPI-145 outcomes module primary outcome list primary outcome primary outcome measure Incidence of adverse events primary outcome description Adverse events and toxicities of the combination regimen will be summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria; toxicities will be tabulated overall and also by dose level. primary outcome time frame Up to 30 days after completion of treatment primary outcome measure Overall response rate (ORR) (assessed by computed tomography) primary outcome description Will be defined as the proportion of patients achieving a complete or partial response according to the Lugano Lymphoma Response Criteria by 6 months; any eligible patient who begins treatment with the combination regimen will be included in the denominator when calculating the ORR. ORR will be reported with a 95% binomial exact confidence interval. primary outcome time frame At 6 months secondary outcome list secondary outcome secondary outcome measure Complete response (CR) (assessed by positron emission tomography) secondary outcome description Will be defined as the proportion of patients achieving a complete response according to the Lugano Lymphoma Response Criteria by 6 months; any eligible patient who begins treatment with the combination regimen will be included in the denominator when calculating the CR. CR will be reported with a 95% binomial exact confidence interval. secondary outcome time frame At 6 months secondary outcome measure Duration of response (DOR) secondary outcome description Will be estimated using Kaplan-Meier method. Approximate 95% confidence intervals (CIs) for median DOR will be computed using the formula proposed by Brookmeyer and Crowley. secondary outcome time frame Time from the first tumor assessment supports the response to the time of confirmed disease progression or death due to any cause, whichever occurs first, assessed up to 60 months secondary outcome measure Progression-free survival secondary outcome description PFS rates at 2-year and 95% CIs will be estimated using Kaplan-Meier methodology. Median PFS and its 95% CI will be calculated. secondary outcome time frame Time from first dose to documented disease progression, or death from any cause, whichever occurs first, assessed at 2 years secondary outcome measure Patient reported outcomes (PROs) secondary outcome description This will be a descriptive outcome that will be reported cumulatively rather than individual domains. Measures and assessment points are as follows: Sociodemographics (Screening only), PRO-CTCAE and Mood (POMS-s) C1 thru 12-months (10 data points), Stress (IES) and Quality of Life (SF-36), C1 thru 12-months (4 data points), and Life Events, Social Network Index (SNI), and Anxiety (GAD-7) and Depressive (PHQ-9) symptoms (Screening/C1 and 12 months). secondary outcome time frame Up to 12 months other outcome list other outcome other outcome measure Biomarker analyses other outcome description The effect of acalabrutinib and duvelisib will be analyzed on blood and tissue (lymph node or bone marrow, if involved) samples. Correlations between subject characteristics and outcome measures and correlations among outcomes measures will be explored using regression models or other appropriate techniques. other outcome time frame Up to 60 months other outcome measure Pharmacokinetics analyses other outcome description Blood samples will be collected at baseline, after the first dose, and at a steady state for all the patients at each dose level during the phase 1 portion of the study. This will enable us to understand the impact that each study drug may have on the other at these time points. other outcome time frame Up to 60 months eligibility module eligibility criteria Inclusion Criteria: >= 18 years of age Histologically confirmed iNHL of any of the following subtypes recognized by the World Health Organization (WHO) classification: follicular lymphoma and marginal zone lymphoma (splenic, nodal and extranodal) Patients must meet clinical criteria for requiring treatment At least two prior systemic therapies for FL (phase 2 portion) and one prior systemic therapy for MZL. Prior autologous stem cell transplant is permitted. Prior CAR-T cell therapy is permitted. For the phase 1 portion, patients receiving one prior systemic therapy are allowed. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Creatinine clearance >= 50 ml/min using a 24-hour creatinine clearance or estimated creatinine clearance using the Cockcroft-Gault equation Bilirubin < 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 1.5 x ULN Absolute neutrophil count (ANC) > 1000/mm^3 (without growth factor support) Platelet > 75,000/mm^3 (without transfusion support) Unless related to bone marrow involvement with the disease, in which case platelets must be > 50,000/mm^3 Hemoglobin >= 8 gm/dL Willing and able to participate in all required evaluations and procedures in this study protocol Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information Radiographically measurable disease by computed tomography (CT) scan, defined as at least one node > 1.5 cm in size or assessable disease Woman of childbearing potential (WOCBP) who are sexually active must agree to use highly effective methods of contraception during treatment and for 2 days after the last dose of acalabrutinib, and 30 days after the last dose of duvelisib. WOCBP should have negative pregnancy test at screening and follow up throughout the study. Male subjects must agree to use highly effective methods of contraception during the study and up to 1 month after last dose of duvelisib. Male fertility may be impaired based on animal data (per duvelisib label) Exclusion Criteria: Prior exposure to a BCR inhibitor (e.g., BTK inhibitors, phosphoinositide-3 kinase [PI3K], or Syk inhibitors) or BCL-2 inhibitor Patients with grade 3B FL or clinical evidence of transformation to aggressive lymphoma Central nervous system (CNS) involvement Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer which will not limit survival to < 1 year Clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Note: Subjects with controlled, asymptomatic atrial fibrillation can enroll in study Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease) Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura) Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists Prothrombin time (PT)/international normalized ratio (INR) or activated partial thromboplastin time (aPTT) (in the absence of lupus anticoagulant) > 2 x ULN Requires treatment with proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Note: Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug Major surgical procedure within 28 days of the first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug Pregnancy or lactation, or intending to become pregnant during the study Concurrent participation in another therapeutic clinical trial Known history of infection with human immunodeficiency virus (HIV) History of progressive multifocal leukoencephalopathy Grade >= 2 toxicity (other than alopecia) continuing from prior anticancer therapy Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function Prior history of drug-induced colitis or drug-induced pneumonitis History of chronic liver disease or veno-occlusive disease Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) once daily (QD) Uncontrolled viral, bacterial, fungal or parasitic infection that is untreated or unresponsive to antimicrobial therapy NOTE: Subjects on antimicrobial, antifungal, or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met Concurrent administration of medications or foods that are strong or moderate inhibitors or strong inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start of study intervention Patients with prior allogeneic transplantation Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening History of tuberculosis treatment within the 2 years prior to study entry Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy). Subjects with clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea, vomiting or any other condition that will interfere significantly with drug absorption Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection (i.e., subjects with detectable viral load) Administration of a live or live attenuated vaccine within 6 weeks of study entry Infection with hepatitis B, hepatitis C Subjects with a positive hepatitis B surface antigen (HBsAg) Subjects with a positive hepatitis B core antibody (HBcAb) must have negative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) to be eligible and must be periodically monitored for HBV reactivation by institutional guidelines Subject who are hepatitis C antibody (HepcAb) positive will need to have a negative polymerase chain reaction (PCR) and must be willing to undergo DNA PCR testing during the study to be eligible Investigators who strongly believe that a positive HBcAb is false (negative hepatitis C [hep C] PCR) due to passive immunization from previous immunoglobulin infusion therapy should consider the risk-benefit for the patient given the potential for reactivation healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Narendranath Epperla, MD overall official affiliation Ohio State University Comprehensive Cancer Center overall official role Principal Investigator references module see also link list see also link see also link label The Jamesline see also link u r l http://cancer.osu.edu i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 removed country list removed country United States condition browse module condition mesh list condition mesh condition mesh id D000008223 condition mesh term Lymphoma condition mesh id D000008224 condition mesh term Lymphoma, Follicular condition mesh id D000008228 condition mesh term Lymphoma, Non-Hodgkin condition mesh id D000018442 condition mesh term Lymphoma, B-Cell, Marginal Zone condition mesh id D000012008 condition mesh term Recurrence condition ancestor list condition ancestor condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000008206 condition ancestor term Lymphatic Diseases condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000020969 condition ancestor term Disease Attributes condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000016393 condition ancestor term Lymphoma, B-Cell condition browse leaf list condition browse leaf condition browse leaf id M14002 condition browse leaf name Recurrence condition browse leaf as found Recurrent condition browse leaf relevance high condition browse leaf id M10372 condition browse leaf name Lymphoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id M10373 condition browse leaf name Lymphoma, Follicular condition browse leaf as found Follicular lymphoma condition browse leaf relevance high condition browse leaf id M19707 condition browse leaf name Lymphoma, B-Cell, Marginal Zone condition browse leaf as found Nodal Marginal Zone Lymphoma condition browse leaf relevance high condition browse leaf id M10374 condition browse leaf name Lymphoma, Non-Hodgkin condition browse leaf as found Non-Hodgkin's Lymphoma condition browse leaf relevance high condition browse leaf id M17980 condition browse leaf name Lymphoma, B-Cell condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M10355 condition browse leaf name Lymphatic Diseases condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M21853 condition browse leaf name Disease Attributes condition browse leaf relevance low condition browse leaf id T3543 condition browse leaf name Lymphosarcoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id T2361 condition browse leaf name Follicular Lymphoma condition browse leaf as found Follicular lymphoma condition browse leaf relevance high condition browse leaf id T3612 condition browse leaf name Marginal Zone Lymphoma condition browse leaf as found Marginal zone lymphoma condition browse leaf relevance high condition browse leaf id T640 condition browse leaf name B-cell Lymphoma condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id C000604908 intervention mesh term Acalabrutinib intervention ancestor list intervention ancestor intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M272672 intervention browse leaf name Acalabrutinib intervention browse leaf as found Diphtheria intervention browse leaf relevance high intervention browse leaf id T22 intervention browse leaf name Tyrosine intervention browse leaf as found Fistula intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev AA intervention browse branch name Amino Acids
NCT04836832
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full study rank 61669 study protocol section identification module n c t id NCT04833465 org study id info org study id Pro00015629 organization org full name Children's National Research Institute org class OTHER brief title Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions official title Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions status module status verified date August 2021 overall status Recruiting expanded access info has expanded access No start date struct start date July 16, 2021 start date type Actual primary completion date struct primary completion date September 1, 2022 primary completion date type Anticipated completion date struct completion date April 1, 2023 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date August 2, 2021 last update post date struct last update post date August 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Julia Finkel responsible party investigator title Professor of Anesthesiology and Pediatrics responsible party investigator affiliation Children's National Research Institute lead sponsor lead sponsor name Children's National Research Institute lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations. This would enable objective assessment of pain and treatment in these populations and enable a much more precise approach to treatment. Such an endpoint stands to significantly improve outcomes in these patients by eliminating the need for a trial-and-error approach to treatment. This is a single site observational study that aims to collect initial pilot data in three distinct patient groups. As this is observational, there is no randomization or blinding in the study. Patients will be followed for a period of one year after enrollment. Baseline measurements will be taken at the time of enrollment, and at each subsequent standard of care clinic visit as feasible, for a period of one year. As this is an observational study, there will be no change to the treatment for any patient due to research activities. The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. The secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. This is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect. conditions module condition list condition Juvenile Idiopathic Arthritis Systemic Lupus Erythematosus Fibromyalgia design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 90 enrollment type Anticipated arms interventions module arm group list arm group arm group label JIA arm group description Patients ages 5-21 with a diagnosis of JIA. arm group intervention list arm group intervention name Other: No Intervention arm group label SLE arm group description Patients ages 5-21 with a diagnosis of SLE. arm group intervention list arm group intervention name Other: No Intervention arm group label FM arm group description Patients ages 5-21 with a diagnosis of FM. arm group intervention list arm group intervention name Other: No Intervention intervention list intervention intervention type Other intervention name No Intervention intervention description No Intervention intervention arm group label list intervention arm group label FM JIA SLE outcomes module primary outcome list primary outcome primary outcome measure Index Characterization primary outcome description The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. primary outcome time frame 1 Year secondary outcome list secondary outcome secondary outcome measure Treatment Effect secondary outcome description The secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. This is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect. secondary outcome time frame 1 Year eligibility module eligibility criteria Inclusion Criteria: In order to be eligible for inclusion in the study, an individual must meet all of the following criteria: Male or female ≥ 5 years of age at screening. Documentation of a JIA, SLE or FM diagnosis as evidenced by history Exclusion Criteria: Any individual who meets any of the following criteria will be excluded from participation in this study: • Documented history of eye disease precluding pupillometry healthy volunteers No gender All minimum age 5 Years maximum age 21 Years std age list std age Child Adult study population 30 subjects from each of the three populations of interest will be enrolled for this study. sampling method Probability Sample contacts locations module location list location location facility Children's National Health System location status Recruiting location city Washington location state District of Columbia location zip 20010 location country United States location contact list location contact location contact name Julia C Finkel, MD location contact role Contact location contact phone 202-476-4867 location contact e mail [email protected] location contact name Julia C Finkel, MD location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000005356 condition mesh term Fibromyalgia condition mesh id D000001171 condition mesh term Arthritis, Juvenile condition mesh id D000008180 condition mesh term Lupus Erythematosus, Systemic condition ancestor list condition ancestor condition ancestor id D000001168 condition ancestor term Arthritis condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000009135 condition ancestor term Muscular Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000003240 condition ancestor term Connective Tissue Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M7638 condition browse leaf name Fibromyalgia condition browse leaf as found Fibromyalgia condition browse leaf relevance high condition browse leaf id M3628 condition browse leaf name Arthritis condition browse leaf relevance low condition browse leaf id M10329 condition browse leaf name Lupus Erythematosus, Systemic condition browse leaf as found Systemic Lupus Erythematosus condition browse leaf relevance high condition browse leaf id M11313 condition browse leaf name Myofascial Pain Syndromes condition browse leaf relevance low condition browse leaf id M3631 condition browse leaf name Arthritis, Juvenile condition browse leaf as found Juvenile Idiopathic Arthritis condition browse leaf relevance high condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M11244 condition browse leaf name Muscular Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse leaf id M5616 condition browse leaf name Connective Tissue Diseases condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases
NCT04833465
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full study rank 61556 study protocol section identification module n c t id NCT04834934 org study id info org study id AI-SCoRE organization org full name IRCCS San Raffaele org class OTHER brief title Artificial Intelligence - SARS-CoV-2 Risk Evaluation official title Artificial Intelligence - SARS-CoV-2 Risk Evaluation acronym AI-SCoRE status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date February 16, 2020 start date type Actual primary completion date struct primary completion date September 30, 2020 primary completion date type Actual completion date struct completion date June 2021 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Antonio Esposito responsible party investigator title Associate Professor responsible party investigator affiliation IRCCS San Raffaele lead sponsor lead sponsor name IRCCS San Raffaele lead sponsor class OTHER collaborator list collaborator collaborator name Regione Lombardia collaborator class OTHER collaborator name Orobix Srl collaborator class UNKNOWN collaborator name Microsoft Corporation collaborator class INDUSTRY collaborator name ASST Bergamo Est collaborator class UNKNOWN collaborator name Centro Cardiologico Monzino collaborator class OTHER collaborator name NVIDIA Corporation collaborator class UNKNOWN collaborator name PORINI Srl collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The management of COVID-19 patients in overwhelmed hospital facing the pandemic is a clinical challenge. The improvement of decision making may allow a better allocation of available resources and a better treatment of patients at higher risk. Chest CT has been widely adopted for COVID-19 pneumonia diagnosis. Several experiences documented the capability of Artificial Intelligence to improve and fasten COVID-19 pneumonia detection, mainly using chest X-ray. Aim of the present study was to develop and validate an Artificial Intelligence approach integrating clinical and imaging data (automatically extracted through the adoption of dedicated neural networks) for the creation of a cloud platform capable of performing automatic patients risk stratification. Such an approach could be used for triage of COVID-19 patients in the emergency department, with the aim to improve healthcare personnel decision-making and allocation of resources during health emergencies. conditions module condition list condition Covid19 keyword list keyword Artificial Intelligence Covid19 Chest CT design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 2000 enrollment type Anticipated arms interventions module arm group list arm group arm group label COVID-19 first wave patients arm group description 1700 patients retrospectively enrolled in 15 Italian hospitals from 16/2/2020 to 29/4/2020. arm group label COVID-19 second wave patients arm group description 300 patients prospectively enrolled in IRCCS San Raffaele Hospital from 19/10/2020 to 31/12/2020. outcomes module primary outcome list primary outcome primary outcome measure Training, testing and validation of an AI platform for predicting Italian first wave Covid-19 patients prognosis. primary outcome time frame 9 months secondary outcome list secondary outcome secondary outcome measure Validation of the developed AI platform on italian second wave of Covid-19 patients secondary outcome time frame 3 months eligibility module eligibility criteria Inclusion Criteria: confirmed SARS-CoV-2 infection with RT-PCR non contrast chest CT scan performed within 72 hours after admission to the emergency department Exclusion Criteria: age < 18 ys healthy volunteers No gender All minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult study population Patients with confirmed SARS-CoV-2 infection with RT-PCR who performed non contrast chest CT scan within 72 hours after admission to the emergency department sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Antonio Esposito, MD central contact role Contact central contact phone +390226436102 central contact e mail [email protected] central contact name Carlo Tacchetti, MD central contact role Contact central contact e mail [email protected] overall official list overall official overall official name Antonio Esposito, MD overall official affiliation IRCCS San Raffaele overall official role Principal Investigator location list location location facility IRCCS San Raffaele location status Recruiting location city Milano location zip 20132 location country Italy location contact list location contact location contact name Antonio Esposito location contact role Contact location contact e mail [email protected] references module reference list reference reference p m i d 32202722 reference type background reference citation Emanuel EJ, Persad G, Upshur R, Thome B, Parker M, Glickman A, Zhang C, Boyle C, Smith M, Phillips JP. 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Epub 2020 Sep 9. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04834934
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full study rank 61605 study protocol section identification module n c t id NCT04834297 org study id info org study id STUDY00001552 organization org full name Tufts Medical Center org class OTHER brief title Use of SVS Device to Improve Outcomes for Neonatal Opioid Withdrawal Syndrome. official title Prapela™ SVS: A Cost-effective Stochastic Vibro-tactile Stimulation Device to Improve the Clinical Course of Infants With Neonatal Opioid Withdrawal Syndrome. status module status verified date November 2021 overall status Recruiting expanded access info has expanded access No start date struct start date November 21, 2021 start date type Actual primary completion date struct primary completion date December 30, 2022 primary completion date type Anticipated completion date struct completion date May 31, 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 24, 2021 last update post date struct last update post date December 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Tufts Medical Center lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Maternal use and addiction to opioids has resulted in an unprecedented rise in drug withdrawal complications in newborns known as neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome (NAS). Between 2004 and 2016, NOWS admissions increased more than fourfold with an average hospital stay nearly 3.2 times longer (15.9 hospital days compared with 4.98) than for a non-NOWS patient resulting in a surge in annual costs to almost $573 million with 83% attributed to state Medicaid programs. While there is no accepted standard for treating NAS, non-pharmacological bundles are recommended, as an initial course of treatment moving to pharmacological care when required. Unfortunately, non-pharmacological care (swaddling, rocking, frequent feedings, and skin contact) require significant use of human resources. To reduce the increasing burden on limited resources, the evidence emerges that hospitals are trying to adapt baby products for consumers that were neither intended nor tested for use in NAS infants as part of their non-pharmacological bundle. The objective of this application is to establish the safety, efficacy, and acceptability of our hospital bassinet pad with stochastic vibrotactile stimulation (SVS) technology as an adjunctive, non-pharmacological treatment to improve the care of infants with NOWS. To accomplish the objective, the investigators plan to execute the following specific aims; 1) determine the efficacy of the SVS hospital bassinet pad, 2) demonstrate the safety of the SVS hospital bassinet pad, and 3) assess acceptability of the device with clinical staff and parents caring for infants with NOWS. The successful completion of the project will provide data to support FDA clearance for commercialization of this low-cost, non-pharmacological device to improve the clinical course of newborns with NOWS. detailed description In preliminary work using a research grade device, the investigators tested stochastic vibrotactile stimulation (SVS) in infants with NOWS. Twenty six full term infants who were opioid exposed, as determined by meconium drug screening tests and/or maternal self-report, were studied. Infants were excluded if any of the following characteristics were present: congenital abnormality, anatomic brain abnormality, hydrocephalus, intraventricular hemorrhage > grade 2, seizure disorder not related to withdrawal, significant cardiac shunt, anemia and/or infection. Using a single session, within-subject design characteristics were compared during periods on and off SVS. Movement, heart rate, respiratory rate, temperature and oxygen saturation were quantified by continuous physiologic measurement. Infants were between 38.3 and 44.7 weeks at the time of study. This novel work demonstrated that SVS reduced prolonged movement activity and improved cardiorespiratory function in the opioid-exposed neonates with 35% reduction in movement and significant reductions in tachypnea and tachycardia. There were no noted adverse effects; specifically no alterations in temperature control or oxygen saturation. Parents and nurses reported that infants seemed less irritable, calmer, and slept better. Specific Aim #1: To determine the efficacy of the Prapela SVS device in preventing the need for pharmacologic treatment in term infants ≥37 weeks gestation with prenatal opioid exposure. Hypotheses: 1A. The use of the Prapela SVS device will reduce the need for pharmacologic treatment for NOWS by 22.5%. 1B. The Prapela SVS device will reduce periods of cries characterized as fussy and pain in the two study groups. 1.1 1A. Study Intervention and Timing: Parents of infants at risk for NOWS will be approached for consent within the first 24 hours after birth prior to manifestation of withdrawal symptoms. After informed written consent is obtained the study procedures will be initiated. SVS will be delivered with a specially-constructed mattress developed during Phase I of the SBIR that delivers gentle, random, low-level stimulation (30-60 Hz, 10-12 micrometers RMS) in continuously. SVS will be added to existing non-pharmacologic care within the first 24 hours of birth until day 5 or until pharmacologic treatment is initiated. The rationale for the selection of this experimental window are: 1. Majority of infants do not start manifesting signs of NOWS prior to 24hours of life. 2. Most infants who require treatment with opioids for severe withdrawal typically begin treatment on day 3 to 5 of life. 3. To test the efficacy of the SVS device, we seek to study the infant who has not yet manifested signs of NOWS and determine if it is safe and effective in preventing the need for pharmacotherapy. All infants enrolled will remain on the SVS mattress throughout the first 5 days of life or until pharmacologic treatment is started except for periods of care and feeding. The use of infant swings or other motion devices will be prohibited once enrolled in the study. Two thirds (80 infants) will be randomized to receive the SVS mattress and one-third (40 infants) will receive standard care only. 1. B Maternal and infant clinical characteristics: Clinical characteristics of the mother and infant will be abstracted from the medical record by a trained research coordinator using standardized definitions. Modified Finnegan scores or Eat, Sleep and Console (ESC) score will be abstracted from the medical record and summed over each 24 hour period. The nursing team providing clinical care to these infants are trained in using both the scoring tools. Caregiver's assessment of infant state will be recorded every 6 hours in a bedside diary. Missing data will be explicitly noted. 1C. Environmental and physiological measurements: Analyses of Cry Characteristics: To further characterize the ability of the SVS device to soothe infants with NOWS, we will utilize novel technology developed and patented by Dr. Ariana Anderson at UCLA called the ChatterBaby. Her work is based on the known association of abnormal cry with abnormal central nervous system development or disease. A more recent version of the ChatterBaby cry detection and cry translation algorithms will be used for this study. These algorithms are trained against hours of non-cry data, including NICU ambient sound, to robustly identify crying periods by automation. The cry during three primary states (fussy, hungry, pain) will be quantified and analyzed between the two groups. Specific Aim #2: Demonstrate the safety of the SVS hospital bassinet for infants with NOWS. 2. Hypothesis: The device will meet non-clinical safety standards required for FDA clearance. Additionally, non-clinical studies (including electrical, thermal safety, biocompatibility, and electromagnetic compatibility) will be completed to verify the device meets or exceeds safety requirements for FDA clearance. Sampling before and after clinical use, as well as durability testing will be performed to ensure that the devices deliver the specified vibration over time. Prapela has prepared a data development plan (DDP) that aligns with the proposed measures to mitigate the identified risks to health of the Prapela® SVS Hospital Bassinet Pad. Specific Aim #3: Assess the acceptability of the SVS mattress to infants' mothers and nurses. Hypothesis: The Prapela SVS device will be accepted and valued by both nursing caregivers and parents. A questionnaire will be administered at the end of the experimental period to both the nursing staff present on the final shift of the period and to the mother, or other care-giver if mother not able to be present. conditions module condition list condition Neonatal Opioid Withdrawal Syndrome design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 120 enrollment type Anticipated arms interventions module arm group list arm group arm group label SVS mattress arm group type Experimental arm group description Infants randomized to the experimental arm will have the SVS mattress placed in their crib within 24 hours of birth and will continue till discharge home after the completion of monitoring phase of NOWS or till determination is made to initiate pharmacotherapy for NOWS. arm group intervention list arm group intervention name Other: Prapela SVS mattress arm group label Standard mattress arm group type No Intervention arm group description Infants randomized to the no intervention arm will continue to be cared for using the standard hospital crib mattress throughout their birth hospitalization. intervention list intervention intervention type Other intervention name Prapela SVS mattress intervention description The intervention will be using the Prapela SVS crib mattress to complement non-pharmacological management of NOWS for the purposes of prevention of pharmacological treatment of NOWS intervention arm group label list intervention arm group label SVS mattress outcomes module primary outcome list primary outcome primary outcome measure Number of participants requiring pharmacologic treatment of NOWS primary outcome description All the infants enrolled in the study will be assessed for the need of pharmacological management of NOWS with initiation of morphine sulfate, based on either the modified Finnegan score or ESC tool. primary outcome time frame Baseline up to Day 5 of life secondary outcome list secondary outcome secondary outcome measure Mean daily percentage of time characterized as pain or fussy crying secondary outcome description This outcome is calculated as the total daily duration of crying categorized as pain or fussy by the ChatterBaby algorithm, divided by 24 hours. For each participant, we will consider the daily percentage of time characterized as pain or fussy crying, from randomization to Day 5 of life or initiation of pharmacologic treatment for NOWS (whichever occurs first). This will be analyzed using mixed effects linear regression models. secondary outcome time frame Baseline up to day 5 of life secondary outcome measure Mean modified Finnegan score secondary outcome description The modified Finnegan score is measured on a scale from 0 to 45. Larger scores indicate more severe symptoms of withdrawal. For participants assessed with the modified Finnegan score, we will consider the daily average score, from randomization to Day 5 of life or initiation of pharmacologic treatment for NOWS. We will analyze the repeated measures of the daily average modified Finnegan score by using mixed effects linear regression models. secondary outcome time frame Baseline up to day 5 of life secondary outcome measure Mean ESC score secondary outcome description An ESC score will be calculated based on the count of symptoms present on the assessment tool, ranging from 0 to 3. Larger scores indicate more severe symptoms of withdrawal. For participants assessed with the ESC tool, we will consider the daily average score, from randomization to Day 5 of life or initiation of pharmacologic treatment for NOWS. We will analyze the repeated measures of the daily average ESC score by using mixed effects linear regression models. secondary outcome time frame Baseline up to day 5 of life secondary outcome measure Mean number of days until readiness for hospital discharge secondary outcome description Measured as the number of days to readiness of discharge from hospital. We will compare the distributions of the number of days until readiness for discharge by using a negative binomial regression model. secondary outcome time frame Duration of hospital stay, an expected average of 11 days eligibility module eligibility criteria Inclusion Criteria: 1. Infants ≥ 37 weeks gestation with prenatal opioid exposure Exclusion Criteria: Infants < 37 weeks gestational age at birth Infants receiving opioids for non-NOWS indications Infants with congenital anomalies Infants with known central nervous system anomalies Infants with seizures unrelated to opioid withdrawal Infants with hydrocephalus Infants with intraventricular hemorrhage ≥ grade 2 (Papille Scale) Infants with severe anemia (hemoglobin < 8) Infants with suspected and/or confirmed infection Infants deemed to be clinically unstable by their medical provider Multiple births healthy volunteers No gender All minimum age 0 Days maximum age 1 Day std age list std age Child contacts locations module central contact list central contact central contact name Rachana Singh, MD, MS central contact role Contact central contact phone 617-636-5322 central contact e mail [email protected] central contact name John Konsin central contact role Contact central contact phone 833-772-7352 central contact e mail [email protected] overall official list overall official overall official name Rachana Singh, MD, MS overall official affiliation Tufts Medical Center overall official role Principal Investigator location list location location facility Tufts Medical Center location status Recruiting location city Boston location state Massachusetts location zip 02111 location country United States location contact list location contact location contact name Rachana Singh, MD, MS location contact role Contact location contact phone 617-636-5322 location contact e mail [email protected] location contact name Allison Nolan location contact role Contact location contact phone 617-636-5322 location contact e mail [email protected] derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013577 condition mesh term Syndrome condition mesh id D000013375 condition mesh term Substance Withdrawal Syndrome condition ancestor list condition ancestor condition ancestor id D000004194 condition ancestor term Disease condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000019966 condition ancestor term Substance-Related Disorders condition ancestor id D000064419 condition ancestor term Chemically-Induced Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf as found Syndrome condition browse leaf relevance high condition browse leaf id M15314 condition browse leaf name Substance Withdrawal Syndrome condition browse leaf as found Withdrawal Syndrome condition browse leaf relevance high condition browse leaf id M20990 condition browse leaf name Substance-Related Disorders condition browse leaf relevance low condition browse leaf id M29455 condition browse leaf name Chemically-Induced Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC25 condition browse branch name Substance Related Disorders condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3185 intervention browse leaf name Analgesics, Opioid intervention browse leaf relevance low intervention browse leaf id M5544 intervention browse leaf name Complement System Proteins intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04834297
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full study rank 61444 study protocol section identification module n c t id NCT04836390 org study id info org study id CHLA-20-00314 organization org full name Children's Hospital Los Angeles org class OTHER brief title Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults With High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant official title A Phase II Pilot Study of Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults With High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant: A Multicenter Pediatric Transplantation and Cellular Therapy Consortium (PTCTC) Study acronym EXCEL status module status verified date October 2021 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date August 24, 2021 start date type Actual primary completion date struct primary completion date May 2026 primary completion date type Anticipated completion date struct completion date May 2028 completion date type Anticipated study first submit date March 18, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 1, 2021 last update post date struct last update post date November 3, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Children's Hospital Los Angeles lead sponsor class OTHER collaborator list collaborator collaborator name Nationwide Children's Hospital collaborator class OTHER collaborator name Seattle Children's Hospital collaborator class OTHER oversight module is f d a regulated drug No is f d a regulated device Yes is unapproved device Yes description module brief summary This is a Phase II pilot study to determine the efficacy of three fixed dose (1 x 108/kg) infusions of ex-vivo expanded human leukocyte antigen (HLA)-haploidentical donor natural killer (NK) cells (haploNK) in children and young adults with high risk acute myeloid leukemia (AML) undergoing HLA-haploidentical hematopoietic cell transplant (haploHCT) with a busulfan and cyclophosphamide-based myeloablative conditioning regimen and post-transplant cyclophosphamide (PTCy) for graft versus host disease (GVHD) prophylaxis. The investigators will also demonstrate the feasibility of performing this trial in a multi-center study. The investigators hypothesize that the infusion of haploNK in this setting will facilitate immune reconstitution and decrease relapse rates and infectious complications without increasing GVHD, resulting in improved survival as compared to recent historical cohorts of haploHCT without NK cell infusion. conditions module condition list condition Acute Myeloid Leukemia design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label Treatment Arm arm group type Experimental arm group description All subjects will receive NK infusions. arm group intervention list arm group intervention name Device: Haploidentical IL-21-Expanded Natural Killer Cells intervention list intervention intervention type Device intervention name Haploidentical IL-21-Expanded Natural Killer Cells intervention description Peripheral blood (PB) ≤ 450 mL and based on donor weight (minimum 10 ml/kg) will be drawn from the HLA-haploidentical donor at least 16 days before the scheduled day of transplant (Day 0). HaploNK cells will be manufactured from the PB of the donor after co-culture with irradiated feeder cells (IFC) as described in Section 2.4. The recipients will receive three NK cell infusions on Day-1, Day+7 (± 1 day) and Day+42 (up to Day+90) from day of transplant (Day 0). intervention arm group label list intervention arm group label Treatment Arm outcomes module primary outcome list primary outcome primary outcome measure 1-year RFS primary outcome description The proportion and corresponding 95% exact binomial CI of patients who are relapse-free at 1-year from day of transplant (Day 0) primary outcome time frame 1 year secondary outcome list secondary outcome secondary outcome measure Number of functional donor-derived NK cells generated from the device secondary outcome description Product manufacturing failure is defined as inability to generate sufficient NK cell product due to failure to meet release criteria or insufficient cells for at least one full dose (≤10^8/NK cells/kg ABW). secondary outcome time frame 2 years secondary outcome measure GVHD incidence secondary outcome description The incidence of Grade II- IV aGVHD (Day +100) and cGVHD (Day+180, +1 year), opportunistic infections (+1 year), and OS (+1 year and +2 year). secondary outcome time frame 2 years secondary outcome measure KIR ligand-ligand mismatch secondary outcome description The presence of KIR ligand-ligand mismatch between HLA-haploidentical donor and host and the impact on relapse rate. secondary outcome time frame 2 years secondary outcome measure Incidence of mixed donor chimerism secondary outcome description Mixed donor chimerism is defined as >5%, but <95%, donor cells detected. Full donor chimerism is defined as >95% donor. secondary outcome time frame 2 years secondary outcome measure Cumulative incidence of neutrophil engraftment secondary outcome description The cumulative incidence of neutrophil engraftment from the time of transplant will be estimated using the cumulative incidence function with death and relapse prior to engraftment as the competing risk. The definition of neutrophil engraftment is a post-nadir ANC > 500/mm3 for three consecutive laboratory values obtained on different days. The first of the three days will be designated as the day of neutrophil recovery. secondary outcome time frame 2 years secondary outcome measure Cumulative incidence of platelet engraftment secondary outcome description The cumulative incidence of platelet engraftment from the time of transplant will be estimated using the cumulative incidence function with death and relapse prior to engraftment as the competing risk. The definition of platelet engraftment is sustained platelet count > 20,000/mm3 with no platelet transfusions in the preceding seven days. The first of three consecutive measurements on different days will be designated as the day of initial platelet recovery. secondary outcome time frame 2 years eligibility module eligibility criteria Inclusion Criteria: Age ≤ 25 years at time of enrollment High-risk AML, as defined by one of the following: a. AML in CR1 (defined as <5% blasts in BM by morphology and flow cytometry) having at least one of these high-risk features: i. Mutations associated with high risk disease (Appendix A). Other high-risk features not explicitly stated in Appendix A can be considered after discussion/approval with the protocol chair/team ii. MRD-positive at the end of Induction I chemotherapy (defined as flow cytometry ≥ 0.1% blasts) b. AML in ≥CR2 (defined by <5% blasts in BM by morphology and flow cytometry) Recovery from prior cycle of chemotherapy as defined by an absolute neutrophil count ≥ 500/mm3 AML secondary to select germline marrow failure disorders (with exception of Fanconi Anemia) may be eligible but require approval from Protocol Chairs prior to enrollment. Performance status ≥70% (Lansky for <16 years; Karnofsky for ≥16 years) Adequate major organ system function as demonstrated by: Renal: Creatinine clearance (CrCl) ≥60 mL/min/1.73m2 by Cockcroft-Gault formula, Schwartz formula, or nuclear GFR study (Table 3) Hepatic: Total bilirubin <2 mg/dL (unless due to Gilbert syndrome) and ALT and AST < 5x ULN Cardiac: LVEF at rest ≥50% or SF ≥27% (by MUGA or ECHO) Pulmonary: DLCO, FEV1, and FVC ≥ 50% of predicted corrected for hemoglobin. For patients <7 years of age or those unable to perform PFTs: O2 Sat >92% on room air by pulse oximetry and on no supplemental O2 at rest The patient, patient's parent, guardian, or legal representative can provide written informed consent Exclusion Criteria: Active extramedullary disease Unresolved/ongoing and serious viral, bacterial, or fungal infection despite appropriate treatment Positive pregnancy test in a female of child-bearing potential (FCBP) Inability to comply with medical therapy or follow-up Prior allogeneic transplant Patients with Fanconi Anemia and Down syndrome healthy volunteers No gender All minimum age 0 Years maximum age 25 Years std age list std age Child Adult contacts locations module overall official list overall official overall official name Michael L Pulsipher, MD overall official affiliation Children's Hospital Los Angeles overall official role Study Director location list location location facility Children's Hospital Los Angeles location city Los Angeles location state California location zip 90027 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007938 condition mesh term Leukemia condition mesh id D000007951 condition mesh term Leukemia, Myeloid condition mesh id D000015470 condition mesh term Leukemia, Myeloid, Acute condition ancestor list condition ancestor condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition browse leaf list condition browse leaf condition browse leaf id M10097 condition browse leaf name Leukemia condition browse leaf as found Leukemia condition browse leaf relevance high condition browse leaf id M10107 condition browse leaf name Leukemia, Myeloid condition browse leaf as found Myeloid Leukemia condition browse leaf relevance high condition browse leaf id M17279 condition browse leaf name Leukemia, Myeloid, Acute condition browse leaf as found Acute Myeloid Leukemia condition browse leaf relevance high condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id T3995 condition browse leaf name Myeloid Leukemia condition browse leaf as found Myeloid Leukemia condition browse leaf relevance high condition browse leaf id T182 condition browse leaf name Acute Myeloid Leukemia condition browse leaf as found Acute Myeloid Leukemia condition browse leaf relevance high condition browse leaf id T188 condition browse leaf name Acute Non Lymphoblastic Leukemia condition browse leaf as found Acute Myeloid Leukemia condition browse leaf relevance high condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04836390
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full study rank 61927 study protocol section identification module n c t id NCT04830098 org study id info org study id CHRİOEXERCİSE001 organization org full name Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey org class OTHER brief title Comparison of the Effectiveness of Spinal Stabilization Exercises and Chiropractic Spinal Manipulation official title Comparison of the Effectiveness of Spinal Stabilization Exercises and Chiropractic Spinal Manipulation in Healthy Individuals status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date March 5, 2021 start date type Actual primary completion date struct primary completion date April 16, 2021 primary completion date type Actual completion date struct completion date May 17, 2021 completion date type Actual study first submit date March 26, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 2, 2021 study first post date type Actual last update submit date June 6, 2021 last update post date struct last update post date June 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mesut Arslan responsible party investigator title Head of Therapy and Rehabilitation Department responsible party investigator affiliation Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey lead sponsor lead sponsor name Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary It is the study of the effectiveness of spinal stabilization exercises and chiropractic spinal manipulation in healthy individuals. In addition, it was planned to investigate the effects of spinal stabilization exercises and manipulation on muscle strength, muscular endurance, balance and proprioception, depression and quality of life. detailed description It is the study of the effectiveness of spinal stabilization exercises and chiropractic spinal manipulation in healthy individuals. In addition, it was planned to investigate the effects of spinal stabilization exercises and manipulation on muscle strength, muscular endurance, balance and proprioception, depression and quality of life. Eighty healthy individuals between the ages of 18-45 who voluntarily participated in the study from students or academic/administrative staff at Gümüşhane University were included in the study. The study program was explained to the participants in line with the Informed Consent Form. It was included in the study after the relevant form was signed by the participant. Healthy individuals to participate in the study will be randomly divided into 4 groups; randomization will be done by "Research Randomizer" computer program. Group 1 Stabilization group (n = 20), Group 2 Manipulation group (n = 20), Group 3 Stabilization and Manipulation group (n = 20), Group 4 Control group (n = 20). Group 1 will be given stabilization exercises for a total of 18 sessions, 3 times a week for 6 weeks, each session for 45 minutes. Group 2 will be applied high-speed low-amplitude (HVLA) chiropractic manipulation for a total of 6 sessions, once a week for 6 weeks. Group 3 will be given both stabilization exercises and manipulation exercises. The fourth group will be followed as a control group and no application will be made. Prone plunk, side plunk and sorenson tests for muscular endurance in the individuals participating in the study; Quadriceps muscle strength for muscle strength assessment; Joint position sense for propioception; Y balance test for balance; Short Form-36 (SF-36) for quality of life; Beck Depression Inventory was planned to be evaluated before, after and 1 months for psychosomatic evaluation. conditions module condition list condition Healthy Individuals keyword list keyword Spinal stabilization Exercise Manipulation Chiropractic design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Supportive Care design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 80 enrollment type Actual arms interventions module arm group list arm group arm group label Stabilization group arm group type Experimental arm group description Stabilization group will be given stabilization exercises for a total of 18 sessions, 3 times a week for 6 weeks, each session for 45 minutes. arm group intervention list arm group intervention name Other: Spinal stabilization exercises arm group label Manipulation group arm group type Experimental arm group description Manipulation group be applied high-speed low-amplitude (HVLA) chiropractic manipulation for a total of 6 sessions, once a week for 6 weeks. arm group intervention list arm group intervention name Other: Chiropractic manipulation arm group label Stabilization and Manipulation group arm group type Experimental arm group description Stabilization and Manipulation group will be given both stabilization exercises and manipulation exercises. arm group intervention list arm group intervention name Other: Spinal stabilization exercises Other: Chiropractic manipulation arm group label Control group arm group type No Intervention arm group description No application will be made in the control group. intervention list intervention intervention type Other intervention name Spinal stabilization exercises intervention description It will be given stabilization exercises for a total of 18 sessions, 3 times a week for 6 weeks, each session for 45 minutes. intervention arm group label list intervention arm group label Stabilization and Manipulation group Stabilization group intervention type Other intervention name Chiropractic manipulation intervention description It will be applied high-speed low-amplitude (HVLA) chiropractic manipulation for a total of 6 sessions, once a week for 6 weeks. intervention arm group label list intervention arm group label Manipulation group Stabilization and Manipulation group outcomes module primary outcome list primary outcome primary outcome measure Joint position sense change primary outcome description The knee to be evaluated in a closed and quiet environment was positioned at 60 degrees of flexion joint angle for five seconds, and the person was asked to perceive this angular position. Then, the knee was relaxed and the person was asked to return to the joint position he perceived and hold for five seconds at that point. The difference is considered as the error angle. The error angle was calculated by taking the average of 3 trials. Measurements were made with the participants' eyes closed primary outcome time frame Before starting study, after the study is finished, 1 month after the end of the study primary outcome measure Quadriceps muscle strength change primary outcome description During the test, after the participant completed the maximum knee extension, the evaluator stabilized the applied thigh with one hand and placed the dynamometer perpendicular to the leg 1-2 cm above the level of the malleoli with the other hand. A thin towel was placed between the dynamometer and the leg so that the dynamometer did not hurt the leg during the measurement. During the test, the "make test" technique, which requires isometric contraction, was applied. (Make test is the protocol of the person applying the maximum force against the device while the meter keeps the dynamometer constant). After the knee extension was completed, the participant was asked to maintain the maximum isometric contraction for 5 seconds. The average of 3 consecutive maximum contraction measurement values made at 30-second intervals was calculated primary outcome time frame Before starting study, after the study is finished, 1 month after the end of the study primary outcome measure Y balance test change primary outcome description It was used for dynamic balance of individuals. The validity reliability of the test was determined by Plisky et al. ICC range was 0.85-0.01 intrarater and 0.99-1.00 interrater [30]. The amount of lying on the dominant extremities of the individuals was measured. The subject was asked to stand on one foot at the midpoint of the test setup and touch with the tip of the toe while maintaining his balance with the other foot in the anterior, posteromedial and posterolateral directions. The test was repeated 3 times in all directions, averaged and recorded in cm. primary outcome time frame Before starting study, after the study is finished, 1 month after the end of the study primary outcome measure Prone Plank Test change primary outcome description It is a valid and reliable test used to measure the endurance of core region muscles [27]. The participant is asked to lie face down and rise on their elbows and toes while keeping the body in a straight line. The total time is recorded. The time is stopped if the participant lowers or lifts his body. primary outcome time frame Before starting study, after the study is finished, 1 month after the end of the study primary outcome measure Side Plank Test change primary outcome description It evaluates the endurance of the lateral trunk flexor muscles. The participant is asked to lie on his side on the elbow with the legs in full extension. Participant is asked to lift the lower limbs so that the hips and back are aligned and maintain this position. The total time is recorded. If the participant dropped his hip, the time was stopped. Measurements were repeated on both sides, right and left. primary outcome time frame Before starting study, after the study is finished, 1 month after the end of the study primary outcome measure Sorenson test change primary outcome description Participant lies face down with his torso hanging from the table above the Anterior Superior Iliac Spine (ASIS) level. Thighs and legs are stabilized using straps. Participant then places his hands diagonally on the shoulders and is asked to lift his body at the same level with the table. Participant is asked to hold this position as long as possible and the total time is recorded. primary outcome time frame Before starting study, after the study is finished, 1 month after the end of the study secondary outcome list secondary outcome secondary outcome measure Short Form-36 change secondary outcome description Developed to evaluate the quality of life, this scale was developed by Koçyiğit et al. Turkish validity and reliability study was conducted by [33]. SF-36 is a 36-item scale that includes physical and mental health inquiries. The high score obtained from the scale, which is evaluated between 0 and 100 points, indicates good health. secondary outcome time frame Before starting study, after the study is finished, 1 month after the end of the study secondary outcome measure Beck Depression Inventory change secondary outcome description Hisli et al. It is a scale consisting of 21 items, whose Turkish validity and reliability study was conducted by [35]. The high score obtained from the scale, which is between 0 and 63 points, indicates the presence of high depression. 0-9 points are defined as minimal depression, 10-16 points mild depression, 17-29 points moderate depression, and 30-63 points severe depression. secondary outcome time frame Before starting study, after the study is finished, 1 month after the end of the study eligibility module eligibility criteria Inclusion Criteria: Healthy volunteer individuals (Female and Male), Between the ages of 18-45, No pain, trauma or surgery history in the last 6 months, Without any chronic disease (Obesity, Diabetes, Hypertension, Osteoporosis), Individuals who had not received any treatment for spinal problems before were included in the study. Exclusion Criteria: Conditions where chiropractic spinal manipulation is contraindicated (Inflammation, infection, malignancy, blood coagulation disorder, etc.) Any injury during the working process, Individuals who did not attend the work program regularly were not included in the study. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 45 Years std age list std age Adult contacts locations module location list location location facility Gumushane University location city Gumushane location zip 29000 location country Turkey i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022
NCT04830098
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full study rank 61886 study protocol section identification module n c t id NCT04830631 org study id info org study id B-2004/608-004 organization org full name Seoul National University Hospital org class OTHER brief title tDCS Response Prediction Using EEG in Stroke official title Prediction of Transcranial Direct Current Stimulation (tDCS) Responses Using Electroencephalography (EEG )in Patients With Chronic Stroke status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 1, 2020 start date type Actual primary completion date struct primary completion date March 2024 primary completion date type Anticipated completion date struct completion date March 2024 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 15, 2022 last update post date struct last update post date May 17, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Won-Seok Kim responsible party investigator title Associate professor responsible party investigator affiliation Seoul National University Bundang Hospital lead sponsor lead sponsor name Seoul National University Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Rusk Rehabilitation Hospital collaborator class UNKNOWN oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Patients with chronic stroke (>6 months after stroke) having unilateral upper limb hemiparesis will be recruited. Patients will maintain their usual inpatient rehabilitation including occupational therapy. At baseline (T0) and after 2weeks of enrollment (T1), Fugl-Meyer assessment (FMA) will be assessed at each time. And patients with the changes of FMA between T0 and T1 less than 3 points will be finally recruited. The enrolled patients will receive additional 30-min cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex for 10 consecutive weekdays, with maintaining their usual conventional rehabilitation. At T1 and immediately after 10-seessions of tDCS (T2) and 1 month after completing 10-tDCS session (T3), FMA, Actional Research Arm Test (ARAT), Box and Block Test (BBT) and electroencephalography (EEG) were measured. conditions module condition list condition Stroke Rehabilitation Transcranial Direct Current Stimulation Motor Recovery design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 100 enrollment type Anticipated arms interventions module intervention list intervention intervention type Device intervention name Cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex intervention description Cathodal tDCS will be applied to the contralesional motor cortex with 2mA intesntisy for 30 mins/day. Total 10 sessions will be applied. outcomes module primary outcome list primary outcome primary outcome measure Changes in Fugl-Meyer Assesment Score 1 primary outcome time frame Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS) secondary outcome list secondary outcome secondary outcome measure Changes in Fugl-Meyer Assesment Score 2 secondary outcome time frame Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS) secondary outcome measure Changes in Action Research Arm Test Score 1 secondary outcome time frame Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS) secondary outcome measure Changes in Action Research Arm Test Score 2 secondary outcome time frame Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS) secondary outcome measure Changes in Box and Block Test Score 1 secondary outcome time frame Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS) secondary outcome measure Changes in Box and Block Test Score 2 secondary outcome time frame Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS) secondary outcome measure Changes in EEG index1 secondary outcome description Various kinds of EEG indexe.g., network indexes, event-related dysynchronization, mu suppression) will be surveyed. secondary outcome time frame Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS) secondary outcome measure Changes in EEG index 2 secondary outcome description Various kinds of EEG indexe.g., network indexes, event-related dysynchronization, mu suppression) will be surveyed. secondary outcome time frame Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS) eligibility module eligibility criteria Inclusion Criteria: age ranges from 19 to 85 yrs old stroke patients with unilateral hemiparesis 1st ever stroke chronic stroke (>6 months after stroke) Exclusion Criteria: recurrent stroke history of traumatic brain injury Minimental state examination score is 15 or less. Unstable medical conditions Severe delirium, disorders of consciousness pregnancy can not attach tDCS electrode on the scalp due to skin conditions can not maintain the sitting position intracranial metals healthy volunteers No gender All minimum age 19 Years maximum age 85 Years std age list std age Adult Older Adult study population Chronic stroke patients with unilateral hemiparesis sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Won-Seok Kim central contact role Contact central contact phone +82317877735 central contact e mail [email protected] location list location location facility Seoul National University Bundang Hospital location status Recruiting location city Seongnam-si location state Gyeonggi-do location zip 13620 location country Korea, Republic of location contact list location contact location contact name Won-Seok Kim location contact role Contact location contact phone 0317877735 location contact e mail [email protected] location contact name Won-Seok Kim, MD location contact role Principal Investigator location facility Rusk Rehabilitation Hospital location status Recruiting location city Seongnam-si location state Please Select location zip 13620 location country Korea, Republic of location contact list location contact location contact name Chaiyoung Lim, MD location contact role Contact location contact name Chaiyoung Lim, MD location contact role Principal Investigator i p d sharing statement module i p d sharing Undecided i p d sharing description After completing the study, EEG indexes and behavioral outcomes will be considered to be shared with researchers who have the clear and reasonable purpose to use our data. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000020521 condition mesh term Stroke condition ancestor list condition ancestor condition ancestor id D000002561 condition ancestor term Cerebrovascular Disorders condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M21459 condition browse leaf name Stroke condition browse leaf as found Stroke condition browse leaf relevance high condition browse leaf id M4962 condition browse leaf name Cerebrovascular Disorders condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04830631
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full study rank 61725 study protocol section identification module n c t id NCT04832737 org study id info org study id RC001 organization org full name University of Huddersfield org class OTHER brief title Strength-based Treatment Approach for Adults With ADHD official title Could a Strength- Based Treatment Improve Self-management in Adults With Attention Deficit Hyperactivity Disorder status module status verified date October 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date September 6, 2021 start date type Actual primary completion date struct primary completion date April 1, 2023 primary completion date type Anticipated completion date struct completion date April 23, 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date October 31, 2022 last update post date struct last update post date November 2, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Rebecca Champ responsible party investigator title Principal Investigator responsible party investigator affiliation University of Huddersfield lead sponsor lead sponsor name University of Huddersfield lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of the research is to develop a treatment program with positive self-awareness and self-determination outcomes for adults with Attention Deficit Hyperactivity Disorder (ADHD). Current treatments are based in a characterisation of ADHD oriented on deficits impairing everyday functioning, with primary goals of symptom control and reduction. However, treatment approaches are not standardised and only evidence short-term effectiveness. This project proposes an alternative approach to understanding ADHD behaviours, supported by Self Determination Theory (SDT). Research shows SDT based treatment approaches can support engagement of intrinsic motivation and longterm integration of behavioural change. ADHD research shows individuals are impaired in some contexts but not in others and can manage well, indicating potential for ADHD neurodiverse "strengths" which could be developed and supported. Recent psychology research recommends cultivating positive psychological factors and emotions to improve mental health and wellbeing. Adults aged 18+ with a confirmed ADHD diagnosis will be invited to participate in two projects: Intensive online interviews of 1 hour will be conducted to identify, explore, and construct a theory about the factors, or "natural strengths" in lived experience of ADHD that help individuals to overcome everyday impairments. These factors will be incorporated into a pilot feasibility study of an SDT based 12-week treatment programme focusing on understanding the lived experience of ADHD and building on these strengths. The treatment will be designed for individual participants and delivered online. This study will have two sets of participants: one group will go directly to treatment, the other will go on a 12-week waiting list to create a comparison group. The second group will then be offered the 12-week treatment. Measures of experience of the participants will be looking for the feasibility, acceptability and efficacy of this treatment, as well as indicators of symptom improvement, and changes in self-awareness and self-regulation skills. detailed description ADHD symptoms negatively affect daily functioning both at work and at home, and have long-term impact in academic, occupational, social and emotional areas of functioning. Effective, long-term treatment outcomes benefit both the individual with ADHD and society as undiagnosed and untreated adults with ADHD may become an economic burden due to increased health care costs and decreased productivity at work. Russell Barkley postulated the first unifying theory of ADHD which places a core deficit of behavioural inhibition at the source of ADHD behaviours. Barkley's model is built upon observation of perceived chronic difficulties in behaviour, measured as "excessive or inappropriate for their age or development level.". Since the publication of this model, several theoretical models were proposed which attribute alternative cognitive sources for the development of ADHD symptoms, but Barkley's model forms the foundation for primary treatment recommendations. A recent review of the theories of ADHD recommended that more testable hypotheses need to be produced. While a variety of different interventions are available and the benefit of other forms of support is acknowledged (e.g. psychotherapy or coaching), the National Institute for Health and Care Excellence (NICE) only recommends interventions that match a similar protocol to medications: Randomised Controlled Trials (RCTs), which are primarily based in Cognitive Behavioural Therapy (CBT). It is therefore hypothesised that much of current research for the characterisation of ADHD is based on a cognitive behavioural paradigm that is deficit-focused with primary treatment outcomes of symptom reduction and control of maladaptive behaviours. Research in psychology suggests that a deficit-focus may not be the best approach to improving mental health, and it may be necessary to develop positive psychological factors and emotions that cultivate health and wellbeing. In ADHD, research suggests that this includes cognitive dynamism, creativity, and resilience, among others. There is a paucity of research in this area. This project proposes an alternative approach to understanding and working with ADHD behaviours, supported by Self Determination Theory (SDT). SDT is an empirical, organismic dialectical approach to human motivation and personality, originating in Positive Psychology. SDT guided research focuses on conditions that enhance intrinsic motivation, self-regulation, and wellbeing. The positive approach to active energisation and intention of behaviour in SDT is closely aligned to evidence of positive engagement in ADHD (e.g. via interest), therefore viewing ADHD behaviours from an SDT perspective allows for a different understanding of the action and intention of behaviour. An SDT based approach combined with psychotherapeutic principles for integration of a positive concept of self provides tools which are potentially effective for long term treatment. One of the challenges to designing effective treatment is the variability of impairment experienced by individuals with ADHD. Impairments are viewed as "clusters" of chronic difficulty for everyone with an ADHD diagnosis, however individual profiles can differ significantly. This implies there are situations or contexts where individuals with ADHD can function successfully. Two phases of this project have been developed to support this hypothesis. The aim of Phase 2 is to generate a theory, grounded in data, that explains a) why and how individuals with ADHD experience variable impairment; b) the impact of variable impairment for those with ADHD; and c) processes and strategies used by those with ADHD to resolve their main concerns regarding the impact and consequences of the variable impairment of ADHD. The purpose is to identify universal selective strengths that support individuals with ADHD to manage the variability of their impairment. In support of these alternative theories and approaches, Phase 3 of this project aims to examine the participant acceptability, feasibility, and efficacy of a novel strength - based programme of therapeutic self-development, psychoeducation and skills training for adults with a diagnosis of ADHD. This programme will use a multi-modal psychotherapeutic approach and educational methodology to assist participants in understanding ADHD and develop self-management skills. While ADHD is primarily viewed as a neurobiological disorder with no cure, the possibility that ADHD may confer advantages to the individual is widely debated. Research on phenomena concerning the experience of ADHD has theoretical implications, and grounded theory is presented as a research methodology that is ideal for an area where not much research or theorising has been done before. There are currently several methodological approaches to grounded theory, and for this project it was deemed most appropriate to use a Constructivist approach. This approach introduces a pragmatic epistemological perspective on the researcher by recognising the subjectivity and researcher involvement in construction and interpretation of data in theory construction. This was thought to be an important element to monitor during the research process due to the researcher's own personal experience of ADHD. In keeping with the focus on selecting cases which may provide new insights for developing theory, this project will aim to approach three different groups for participation: NHS patients from the Adult ADHD Clinic at the Southwest Yorkshire Partnership NHS Foundation Trust; university students at the University of Huddersfield and the University of Cambridge; and ADHD Support Groups for adults with ADHD. Analysis of individual case studies was considered, however as current perspectives of positive psychological factors in ADHD are identified as "individual strengths", it was thought a case comparison on interviews might identify the phenomenon in a more universal way. The Phase 2 grounded theory research aims to reach saturation following analysis of 5-10 participant interviews. However, due to the nature of grounded theory, this can only be finalised as part of the process. It is possible more participants will Unlike other qualitative methods, grounded theory approaches recommend that the inquiry shapes the data collection. This process of finding and generating data that is "rich", or detailed, focused, and full, provides solid material for substantive analysis. Therefore, this project will identify some areas to begin initial data collection, while remaining open to emerging potential data examples. These areas are intensive interviews, videos, and memos or field notes by the researcher. Study Design - Pilot Study This is a wait list control study design with pre-, within, and post-treatment measures. A rolling entry of participants will be conducted, where once individuals have been screened their entry into the study will begin. A maximum of 30 adults aged 18+ with a confirmed diagnosis of ADHD will be allocated using block randomisation to the SDT theory-based model or wait list over a 12-week period. Following the 12-week wait, the wait list group will also be enrolled in the SDT theory-based model. This ensures all participants receive the opportunity to experience the treatment. Participants will be recruited from NHS patients at the Adult ADHD Clinic at the Southwest Yorkshire Partnership NHS Foundation Trust only.Phase 3 is a pilot feasibility study, and the aim is to recruit 15 participants per arm for the two arm pilot study. Acceptability, feasibility, and efficacy of the intervention will be measured by attendance and completion of evaluation forms at the end of each session. A follow up interview a week post-treatment will provide an opportunity for feedback and evaluation by post-treatment measures. Due to Covid-19 restrictions for research that requires in-person contact, consideration for the safety of participants and institution and NHS staff was incorporated into this study design. All interviews, screening, and treatment sessions will be conducted online, on an NHS approved video platform. To test for treatment effects within the two groups, the psychometric data before and after therapy will be analysed statistically using a paired samples t-test, or dependant t-test. To test for treatment effects within the two groups, the psychometric data before and after therapy will be analysed statistically using the non-parametric paired-Wilcoxon test. Cohen's D will be calculated as a measure of effect size. To reduce bias, an intention to treat analysis will be used but it is recognised that challenges may occur due to missing data; based on withdrawal, loss to follow up, or non-response of assessment questionnaires and the degree of this this will be considered at the time of analysis. Therefore, the study will be reviewed using the revised Cochrane risk-of-bias tool for randomised trials (RoB 2). All analysis will be conducted with SPSS version 26. The ethical process for this project is being reviewed by the University of Huddersfield School of Human and Health Sciences - School Research Ethics and Integrity Committee (SREIC) and will be reviewed by a relevant NHS ethics committee. Governance approvals will be obtained from university and NHS Trust sites. All sessions with Participants will be held in adherence with the Ethical Framework for Good Practice set by the UK Council for Psychotherapy (UKCP). A British Association for Counselling and Psychotherapy (BACP) accredited psychotherapy supervisor will be engaged for two hours per month or one hour for every six patient sessions for the duration of the project to measure progress and review case work with participants if needed. Participants will receive an invitation to an initial interview to discuss participation in the study. An information sheet detailing the purpose, activities, outcomes, and results of Phase 2 will be provided, including the researcher contact details (name, phone number, email address). Participants will be encouraged to read the information sheet again and ask questions on the assessment day prior to signing the consent form. The voluntary nature of participation and the ability to withdraw an individual's consent at any time will be emphasised during the study. For the Phase 2 intensive interviews, all participants will be entered into a draw for a £50 Amazon voucher. This was suggested by the lived experience group as contribution to research for ADHD was not considered enough of a benefit alone. For participants in the Phase 3 pilot study, they will receive 11 weekly sessions of individually focused therapeutic coaching support which is not currently accessible within the service. It is possible that a waitlist control design study might be an incentive for participants to join, as all participants in the study will eventually receive the intervention. However, we considered it unethical to offer a place in the study without the option to receive the intervention. Participants will be given a minimum of 24 hours and up to three days to consider participation in the study, and the researcher will be available to answer any questions they have. A critical element of this research project is the exploration and representation of the lived experience of adults with ADHD, and the applicability, efficacy, and accessibility of the results. Therefore, this project has involved a patient participation group in pre-study preparation before recruitment. A small group of 5-6 adults with ADHD who expressed strong interest in the research have reviewed and refined recruitment materials for Phase 2 and Phase 3, including the recruitment flyers, patient information sheets, consent forms and interview guide. conditions module condition list condition Attention Deficit Hyperactivity Disorder design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description This is a wait list control study design with pre-, within, and post-treatment measures. A rolling entry of participants will be conducted, where once individuals have been screened their entry into the study will begin. A maximum of 30 adults aged 18+ with a confirmed diagnosis of ADHD will be allocated using block randomisation to the SDT theory-based model or wait list over a 12-week period. Following the 12-week wait, the wait list group will also be enrolled in the SDT theory-based model. This ensures all participants receive the opportunity to experience the treatment. design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 23 enrollment type Actual arms interventions module arm group list arm group arm group label Intervention arm group type Experimental arm group description SDT theory-based psychotherapeutic treatment model arm group intervention list arm group intervention name Behavioral: ADDapt Ability Framework arm group label Control arm group type No Intervention arm group description Wait List intervention list intervention intervention type Behavioral intervention name ADDapt Ability Framework intervention description 12 week individual therapeutic coaching intervention intervention arm group label list intervention arm group label Intervention outcomes module primary outcome list primary outcome primary outcome measure Weiss Functional Impairment Rating Scale -WFIRS primary outcome description Measures change in severity of ADHD symptoms. Lilkert scale where the total score can be reviewed, or a mean score from each relevant domain. Higher scores mean worse outcome. primary outcome time frame Baseline and immediately after intervention primary outcome measure Patient Heath Questionniare (PHQ)- 9 primary outcome description Major Depressive Disorder section of larger PHQ measuring change in severity of Depression symptoms. Minimim score 0, maximum score 27, higher scores mean worse outcome. primary outcome time frame Baseline and immediately after intervention primary outcome measure General Anxiety Disorder (GAD) 7 primary outcome description Measures change in severity of Anxiety symptoms. Scale score ranges from 0 to 21 with cut points of 5, 10, and 15 that might be interpreted as representing mild, moderate, and severe levels of anxiety. Higher scores mean worse outcome. primary outcome time frame Baseline and immediately after intervention primary outcome measure Harter's Self Perception Profile primary outcome description Measures changes in self awareness. Each item has minimum score of 1, maximum score of 4. Mean scores are calculated for each of 12 sub-domains. Higher scores mean better outcome. primary outcome time frame Baseline and immediately after intervention primary outcome measure Index of Autonomous Functioning -IAF primary outcome description Measures changes in feeling self-determined. Each item scores minimum 1, maximum 5 and total is calculated by averaging scores from 15 items. Higher scores mean better outcome. primary outcome time frame Baseline and immediately after intervention primary outcome measure Perceived Choice and Awareness of Self Scale -PCASS primary outcome description Measures changes in feeling self-determined. Likert 10-item scale, with two 5-item subscales with minimum of 1 and maximum of 5 on each item. Total is calculated by averaging scores in each subscale, with higher scores meaning a better outcome. primary outcome time frame Baseline and immediately after intervention primary outcome measure Personal Questionnaire - PQ primary outcome description Measure change in participant selected specific psychological difficulties. 10 problems are measured weekly with score of minimum 1, maximum 7. Total is calculated by averaging scores in each subscale, with higher scores meaning a better outcome. primary outcome time frame During the intervention eligibility module eligibility criteria Inclusion Criteria: Confirmed diagnosis of ADHD Age 18 or older Access to computer or smartphone with an internet connection Exclusion Criteria: Co-morbid diagnosis (e.g. Autism, Bi-polar, Learning Disabilities, Traumatic Brain Injury, Psychosis or Tourette's) Substance abuse disorders Other mental health disorders (e.g. PTSD, Oppositional Defiant Disorder Personality Disorders healthy volunteers No gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Barry Tolchard overall official affiliation University of Huddersfield overall official role Study Chair location list location location facility University of Huddersfield location city Huddersfield location state West Yorkshire location zip HD1 3DH location country United Kingdom location facility Manygates Adult ADHD Clinic location city Wakefield location state West Yorkshire location zip WF1 5PN location country United Kingdom references module reference list reference reference type background reference citation Armstrong, T. 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All participant case records will be held in accordance with the Data Protection Act. Records will be kept both in electronic and hard copy form. The participants' home addresses and telephone numbers will be kept on a secure database and spreadsheet on NHS/University computers in compliance to the Data Protection Act. Data held in the NVivo database will be anonymised and only accessible by password protected researcher login. All manual records will be kept in a locked cabinet accessible by the researcher only. In accordance with the Data Protection Act personal data will not be retained for longer than is necessary. The University of Huddersfield recommends that data is stored for 10 years to aid transparency and integrity of research. Long term storage of data will be accessible by the researcher only. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006948 condition mesh term Hyperkinesis condition mesh id D000001289 condition mesh term Attention Deficit Disorder with Hyperactivity condition ancestor list condition ancestor condition ancestor id D000019958 condition ancestor term Attention Deficit and Disruptive Behavior Disorders condition ancestor id D000065886 condition ancestor term Neurodevelopmental Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition ancestor id D000020820 condition ancestor term Dyskinesias condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M3746 condition browse leaf name Attention Deficit Disorder with Hyperactivity condition browse leaf as found Attention Deficit Hyperactivity Disorder condition browse leaf relevance high condition browse leaf id M9151 condition browse leaf name Hyperkinesis condition browse leaf as found Hyperactivity condition browse leaf relevance high condition browse leaf id M20983 condition browse leaf name Attention Deficit and Disruptive Behavior Disorders condition browse leaf relevance low condition browse leaf id M29797 condition browse leaf name Neurodevelopmental Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id M21727 condition browse leaf name Dyskinesias condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M13626 intervention browse leaf name Psychotropic Drugs intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev PsychDr intervention browse branch name Psychotropic Drugs intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04832737
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full study rank 61714 study protocol section identification module n c t id NCT04832880 org study id info org study id The AMMURAVID trial secondary id info list secondary id info secondary id 2020-001854-23 secondary id type EudraCT Number organization org full name ASST Fatebenefratelli Sacco org class OTHER brief title Factorial Randomized Trial of Rendesivir and Baricitinib Plus Dexamethasone for COVID-19 (the AMMURAVID Trial) official title Factorial, Multicentric, Randomized Clinical Trial of Remdesivir and Immunotherapy in Combination With Dexamethasone for Moderate COVID-19 (the AMMURAVID Trial) acronym AMMURAVID status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 6, 2021 start date type Anticipated primary completion date struct primary completion date March 2022 primary completion date type Anticipated completion date struct completion date December 2022 completion date type Anticipated study first submit date October 12, 2020 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Enrico Tombetti responsible party investigator title Assistant Professor responsible party investigator affiliation ASST Fatebenefratelli Sacco lead sponsor lead sponsor name ASST Fatebenefratelli Sacco lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Background: In the current worldwide medical emergency, a rapid identification of effective therapeutic strategy is crucial. So far, therapy with dexamethasone, remdesivir and baricitinib have been associated with evidence of impact on the clinical impact on COVID-19, but the effect of baricitinib and remdesivir in combination with dexamethasone. The AAMMURAVID trial is endorced and supported by the Italian Regulatory agency (AIFA-Agenzia Italiana del Farmaco) conditions module condition list condition Covid19 keyword list keyword remdesivir baricitinib dexamethasone design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Factorial design with four-stages (K=4). Three interim analyses are pre-planned. At each stage, the use of remdesivir and/or baricitinib might be suspended due to futility or ef-ficacy. Overall, we will accept a two-sided alpha error of alpha=0.05 and a beta error of β=0.10. design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 4000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Control arm (dexamethasone arm) arm group type Experimental arm group description IV dexamethasone 6 mg for 10 days arm group intervention list arm group intervention name Drug: Dexamethasone arm group label Remdesivir arm arm group type Experimental arm group description IV dexamethasone 6 mg for 10 days + remdesivir IV 200 mg on day 1, followed by 100 mg die until day 10 arm group intervention list arm group intervention name Drug: Remdesivir Drug: Dexamethasone arm group label Baricitinib arm arm group type Experimental arm group description IV dexamethasone 6 mg for 10 days + baricitinib 4 mg die for 10 days. For patients aged > 75 years or estimated GFR < 60 ml/min*1.73m2, baricitinib dose is reduced to 2 mg for 10 days. arm group intervention list arm group intervention name Drug: Baricitinib Oral Tablet [Olumiant] Drug: Dexamethasone arm group label Remdesivir + baricitinib arm arm group type Experimental arm group description IV dexamethasone 6 mg for 10 days + remdesivir IV 200 mg on day 1, followed by 100 mg die until day 10 + baricitinib 4 mg die for 10 days. For patients aged > 75 years or estimated GFR < 60 ml/min*1.73m2, baricitinib dose is reduced to 2 mg for 10 days. arm group intervention list arm group intervention name Drug: Baricitinib Oral Tablet [Olumiant] Drug: Remdesivir Drug: Dexamethasone intervention list intervention intervention type Drug intervention name Baricitinib Oral Tablet [Olumiant] intervention description Baricitinib 4 mg die (2 mg for patients aged > 75 years) for 10 days. intervention arm group label list intervention arm group label Baricitinib arm Remdesivir + baricitinib arm intervention other name list intervention other name Olumiant intervention type Drug intervention name Remdesivir intervention description Intravenous remdesivir 200 mg on day 1, followed by remdesivir 100 mg die until day 10 intervention arm group label list intervention arm group label Remdesivir + baricitinib arm Remdesivir arm intervention other name list intervention other name Veklury intervention type Drug intervention name Dexamethasone intervention description Intravenous dexamethasone 6 mg for 10 days intervention arm group label list intervention arm group label Baricitinib arm Control arm (dexamethasone arm) Remdesivir + baricitinib arm Remdesivir arm outcomes module primary outcome list primary outcome primary outcome measure Prevention of very severe respiratory failure or mortality primary outcome description Composite outcome: Development of very severe respiratory failure (PaO2/FiO2 <150 mmHg) or mortality primary outcome time frame Day1-Day 28 secondary outcome list secondary outcome secondary outcome measure Prevention of mortality secondary outcome description Proportion of dead patients secondary outcome time frame Day 7 secondary outcome measure Prevention of mortality secondary outcome description Proportion of dead patients secondary outcome time frame Day 14 secondary outcome measure Prevention of mortality secondary outcome description Proportion of dead patients secondary outcome time frame Day 21 secondary outcome measure Prevention of mortality secondary outcome description Proportion of dead patients secondary outcome time frame Day 28 secondary outcome measure Prevention of mortality secondary outcome description Survival analysis secondary outcome time frame Day 1-28 secondary outcome measure Prevention of very severe respiratory failure secondary outcome description Proportion of patients with PaO2/FiO2 <150 mmHg secondary outcome time frame Day 7 secondary outcome measure Prevention of very severe respiratory failure secondary outcome description Proportion of patients with PaO2/FiO2 <150 mmHg secondary outcome time frame Day 14 secondary outcome measure Prevention of very severe respiratory failure secondary outcome description Proportion of patients with PaO2/FiO2 <150 mmHg secondary outcome time frame Day 21 secondary outcome measure Prevention of very severe respiratory failure secondary outcome description Proportion of patients with PaO2/FiO2 <150 mmHg secondary outcome time frame Day 28 secondary outcome measure Prevention of very severe respiratory failure secondary outcome description Time to development very severe respiratory failure (PaO2/FiO2 <150 mmHg) secondary outcome time frame Day 1-28 secondary outcome measure Prevention of very severe respiratory failure or mortality secondary outcome description Composite outcome: Development of very severe respiratory failure (PaO2/FiO2 <150 mmHg) or mortality secondary outcome time frame Day 7 secondary outcome measure Prevention of very severe respiratory failure or mortality secondary outcome description Composite outcome: Development of very severe respiratory failure (PaO2/FiO2 <150 mmHg) or mortality secondary outcome time frame Day 14 secondary outcome measure Prevention of very severe respiratory failure or mortality secondary outcome description Composite outcome: Development of very severe respiratory failure (PaO2/FiO2 <150 mmHg) or mortality secondary outcome time frame Day 21 secondary outcome measure Incidence of Adeverse Events secondary outcome description Proportion of number of AEs and SAEs (according to the Common Terminology Criteria for Adverse Events -CTCAE, Version 5.0) secondary outcome time frame Day 7 secondary outcome measure Incidence of Adeverse Events secondary outcome description Proportion of number of AEs and SAEs (according to the Common Terminology Criteria for Adverse Events -CTCAE, Version 5.0) secondary outcome time frame Day 14 secondary outcome measure Incidence of Adeverse Events secondary outcome description Proportion of number of AEs and SAEs (according to the Common Terminology Criteria for Adverse Events -CTCAE, Version 5.0) secondary outcome time frame Day 21 secondary outcome measure Incidence of Adeverse Events secondary outcome description Proportion of number of AEs and SAEs (according to the Common Terminology Criteria for Adverse Events -CTCAE, Version 5.0) secondary outcome time frame Day 28 secondary outcome measure Incidence of bacterial/fungal infections secondary outcome description Rate of bacterial/fungal infections secondary outcome time frame Day 7 secondary outcome measure Incidence of bacterial/fungal infections secondary outcome description Rate of bacterial/fungal infections secondary outcome time frame Day 14 secondary outcome measure Incidence of bacterial/fungal infections secondary outcome description Rate of bacterial/fungal infections secondary outcome time frame Day 21 secondary outcome measure Incidence of bacterial/fungal infections secondary outcome description Rate of bacterial/fungal infections secondary outcome time frame Day 28 secondary outcome measure Reduction of the requirements of orotracheal intubation/ECMO secondary outcome description Proportion of patients requiring orotracheal intubation/ECMO secondary outcome time frame Day 7 secondary outcome measure Reduction of the requirements of orotracheal intubation/ECMO secondary outcome description Proportion of patients requiring orotracheal intubation/ECMO secondary outcome time frame Day 14 secondary outcome measure Reduction of the requirements of orotracheal intubation/ECMO secondary outcome description Proportion of patients requiring orotracheal intubation/ECMO secondary outcome time frame Day 21 secondary outcome measure Reduction of the requirements of orotracheal intubation/ECMO secondary outcome description Proportion of patients requiring orotracheal intubation/ECMO secondary outcome time frame Day 28 secondary outcome measure Reduction of the requirements of orotracheal intubation/ECMO secondary outcome description Days with orotracheal intubation/ECMO secondary outcome time frame Day 1-28 secondary outcome measure Evolution of the NEWS-2 score secondary outcome description Course in the National Early Warning Score-2 score (0-20, with higher scores worse) secondary outcome time frame Day 1-28 secondary outcome measure Evolution of the MELD score secondary outcome description Course in the Model for End-Stage Liver Disease score (scores >=6, higher scores worse) secondary outcome time frame Day 1-28 secondary outcome measure Velocity in clinical improvement secondary outcome description Time to clinical improvement (defined as one of the following: a) discharge, b) absent ventilator support with NEWS-2 score ≤3 and MELD ≤13) secondary outcome time frame Day 1-28 secondary outcome measure Velocity in discharge secondary outcome description Time to discharge secondary outcome time frame Day 1-28 secondary outcome measure Velocity in discharge secondary outcome description Proportion of discherged patients secondary outcome time frame Day 7 secondary outcome measure Velocity in discharge secondary outcome description Proportion of discherged patients secondary outcome time frame Day 14 secondary outcome measure Velocity in discharge secondary outcome description Proportion of discherged patients secondary outcome time frame Day 21 secondary outcome measure Velocity in discharge secondary outcome description Proportion of discherged patients secondary outcome time frame Day 28 secondary outcome measure Fever disappearance secondary outcome description Proportion of patients on persistent defervescence (last day of T<37.0°C, without recurrent T>37.0° for at least 4 days) secondary outcome time frame Day 7 secondary outcome measure Fever disappearance secondary outcome description Proportion of patients on persistent defervescence (last day of T<37.0°C, without recurrent T>37.0° for at least 4 days) secondary outcome time frame Day 14 secondary outcome measure Fever disappearance secondary outcome description Proportion of patients on persistent defervescence (last day of T<37.0°C, without recurrent T>37.0° for at least 4 days) secondary outcome time frame Day 21 secondary outcome measure Fever disappearance secondary outcome description Proportion of patients on persistent defervescence (last day of T<37.0°C, without recurrent T>37.0° for at least 4 days) secondary outcome time frame Day 28 secondary outcome measure Fever disappearance secondary outcome description Time to persistent defervescence persistent defervescence (last day of T<37.0°C, without recurrent T>37.0° for at least 4 days) secondary outcome time frame Day 1-28 secondary outcome measure Changes in periperal blood leukocyte number secondary outcome description Course of periperal blood leukocyte number secondary outcome time frame Day 1-28 secondary outcome measure Changes in periperal blood neutrophils counts secondary outcome description Comparison of the course of neutrophils counts at full blood counts among the treatment arm, as assessed by repeated measures analysis. secondary outcome time frame Day 1-28 secondary outcome measure Changes in periperal blood lymphocytes secondary outcome description Comparison of the course of lymphocytes counts at full blood counts among the treatment arm, as assessed by repeated measures analysis. secondary outcome time frame Day 1-28 secondary outcome measure Changes in periperal blood platelets secondary outcome description Comparison of the course of plateletscounts at full blood counts among the treatment arm, as assessed by repeated measures analysis. secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood hemoglobin levels secondary outcome description Course of blood hemoglobin secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood creatinine levels secondary outcome description Course of blood creatine levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood albumin secondary outcome description Course of blood albumin levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood bilirubin secondary outcome description Course of blood bilirubin levles secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood LDH secondary outcome description Course of blood LDH levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood AST secondary outcome description Course of blood AST levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood ALT secondary outcome description Course of blood ALT levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood CK secondary outcome description Course of blood CK levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood C-reactive protein secondary outcome description Course of blood C-reactive protein levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood IL-6 secondary outcome description Course of blood IL-6 levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood protrombine time (INR) secondary outcome description Course of blood protrombine time (INR) secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood ferritin secondary outcome description Course of blood ferritin levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood troponin T secondary outcome description Course of blood troponin T levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood triglycerides secondary outcome description Course of blood triglycerides levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood HDL-colesterol secondary outcome description Course of blood HDL-colesterol levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood total colesterol secondary outcome description Course of blood total colesterol levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in blood D-Dimer secondary outcome description Course of blood D-Dimer levels secondary outcome time frame Day 1-28 secondary outcome measure Changes in PaO2 at arterial gas analysis secondary outcome description Course of PaO2 at arterial gas analysis and PaO2/FiO2 secondary outcome time frame Day 1-28 secondary outcome measure Changes in PaO2/FiO2 secondary outcome description Course of PaO2/FiO2 secondary outcome time frame Day 1-28 secondary outcome measure Development of late complications secondary outcome description Death secondary outcome time frame 6 months secondary outcome measure Development of late complications secondary outcome description New Hospital admissions secondary outcome time frame 6 months secondary outcome measure Development of late complications secondary outcome description Proportion of patients developing new medical conditions in each interventional arm as compared to the control arm. Specific focus to: new-onset interstitial lung disease new onset respiratory failure requiring O2 therapy or ventilation therapy at home thromboembolic event ischemic events (stroke, acute coronary syndromes, pe-ripheral ischemias) arterial hypertension secondary outcome time frame 6 months secondary outcome measure Development of late complications secondary outcome description Proportion of patients with FVC < 70% of predicted, FEV1 < 70% predicted and DLCO < 80% predicted secondary outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria: Adults aged > 18 years able to provide a valid informed consent to the study Documented COVID-19 by direct testing (positive PCR), with lung infiltrates at imaging (Chest-X ray or CT) and requirement of oxygen supplementation Less than 10 days form symptoms onset Cytokine storm, using the criteria developed at Temple University (all of the three below criteria): CRP > 46 mg/l Ferritin > 250 ng/ml One variable of each of the three clusters below Cluster 1 Albumin < 2.8 g/dl Lymphocytes <10.2 % of WBC Absolute neutrophil count > 11400/mm3 Cluster 2 ALT > 60 U/L AST > 87 U/L D-dimers > 4930 µg/l fibrinogen-equivalent-units (FEU). LDH >416 U/L High sensitivity troponin > 1.09 ng/ml Cluster 3 Anion Gap at arterial blood gas < 6.8 mM Chloride > 106 mM Potassium > 4.9 mM BUN:creatinine ratio > 29 PaO2/FiO2 200-400 mmHg, while in oxygen therapy or continuous positive airway pressure (C-PAP) For women of childbearing potential and men: agreement to use contraception in the case of heterosexual intercourses before day 28 with a failure rate < 1% per year (bilateral tubal ligation, male sterilisation, hormonal contraceptives inhibiting ovulation, hormone-release or copper intrauterine devices). For men enrolled in the study, condom use is allowed. Exclusion criteria: Orotracheal intubation or ECMO support Active solid / hematologic cancer (including invasive non-melanoma skin cancer) Hypersensitivity or contra-indications to one of the investigational agents (including history of deep vein thrombosis / pulmonary thromboembolism within 12 weeks prior to screening) Other active concurrent viral, fungal or bacterial infections (including active tuberculosis/latent TB treated for less than 4 weeks, HIV and HCV/HBV infections) Pregnancy/breastfeeding Incapability to provide a valid informed consent (including age < 18 years old) Heart failure with NYHA >= 2 or any acute cardiac or vascular event requiring therapy in the previous 12 months Chronic renal failure (baseline GFR < 45 ml/min*1.73m2) Liver cirrhosis moderate / severe (Child-Pugh B or C) Chronic respiratory failure requiring O2 therapy or ventilation therapy at home Blood neutrophils <1000/mcL, platelet <50000/mcL, Hb levels <80 g/l ALT/AST > 5 times UNL Use of any biologic agent or small molecule inhibitor and other investigational drugs in the previous 4 weeks or 5 half-lives (whichever is longer). Specific cut-offs for wash-out are required for the following therapies: B-cell targeted therapies: 24 weeks or 5 half-lives (whichever is longer) TNF-inhibitors: 2 weeks or 5 half-lives (whichever is longer) JAK-inhibitors: 1 week or 5 half-lives (whichever is longer) Use of other immunosuppressive agents in the last 3 months (chronic use of topical steroids and systemic steroids with a dose ≤5 mg of prednisone equivalents is allowed) Use of any other investigational therapy for COVID-19 (including IV immunoglobulins, convalescent COVID-19 plasma or monoclonal antibodies) Impossibility to discontinue Strong inhibitors of OAT3 (such as probenecid) at study entry Any other condition judged by the local investigator as a contra-indication to eligibility Subjects who have received live vaccines within 4 weeks before the study or are planned to receive live vaccine in the first months after study enrolment. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Enrico Tombetti, MD, PhD central contact role Contact central contact phone 3289098793 central contact phone ext +39 central contact e mail [email protected] central contact name Massimo Galli, Prof central contact role Contact central contact phone 3358058990 central contact phone ext +39 central contact e mail [email protected] overall official list overall official overall official name Massimo Galli, MD, PhD overall official affiliation ASST Fatebenefratelli Sacco and Milan University overall official role Principal Investigator location list location location facility Ospedali Riuniti delle Marche location city Ancona location country Italy location contact list location contact location contact name Marcello Tavio, Prof location contact role Contact location contact name [email protected] location contact role Contact location facility Ospedale Parini location city Aosta location country Italy location contact list location contact location contact name Magnani Silvia Carla Maria location contact role Contact location contact e mail [email protected] location facility Ospedale SS Annunziata -Chieti location city Chieti location country Italy location contact list location contact location contact name Jacopo Vecchiet, Prof location contact role Contact location contact e mail [email protected] location facility Ospedale S Anna location city Como location country Italy location contact list location contact location contact name Luigi Pusterla, MD location contact role Contact location contact e mail [email protected] location facility Ospedale di Ferrara location city Ferrara location country Italy location contact list location contact location contact name Carlo Contini, Prof location contact role Contact location contact e mail [email protected] location facility Ospedale di Firenze and Empoli location city Firenze location country Italy location contact list location contact location contact name Massimo Di Pietro, MD location contact role Contact location contact e mail [email protected] location facility Ospedali Galliera location city Genova location country Italy location contact list location contact location contact name Emanuele Pontali, MD location contact role Contact location contact e mail [email protected] location facility H Goretti location city Latina location country Italy location contact list location contact location contact name Miriam Lichtner, Prof location contact role Contact location contact e mail [email protected] location facility Ospedale Manzoni location city Lecco location country Italy location contact list location contact location contact name Stefania Piconi, MD location contact role Contact location contact e mail [email protected] location facility Ospedale di Legnago location city Legnago location country Italy location contact list location contact location contact name Pierangelo Rovere, MD location contact role Contact location contact e mail [email protected] location facility Ospedale di Legnano location city Legnano location country Italy location contact list location contact location contact name Stefano Rusconi, Prof location contact role Contact location contact e mail [email protected] location facility ASST Fatebenefratelli-Sacco location city Milan location country Italy location contact list location contact location contact name Massimo Galli, Prof location contact role Contact location contact e mail [email protected] location facility ASST Santi Paolo e Carlo location city Milan location country Italy location contact list location contact location contact name Antonella D'arminio monforte, Prof location contact role Contact location contact e mail [email protected] location facility IRCCS San Raffaele location city Milan location country Italy location contact list location contact location contact name Antonella Castagna, Prof location contact role Contact location contact e mail [email protected] location facility Ospedale di Perugia location city Perugia location country Italy location contact list location contact location contact name Andrea Tosti, MD location contact role Contact location contact e mail [email protected] location facility Ospedale San Salvatore location city Pesaro location country Italy location contact list location contact location contact name Francesco, MD location contact role Contact location contact e mail [email protected] location facility Ospedali di Prato e Pistoia location city Prato location country Italy location contact list location contact location contact name Pierluigi Blanc, MD location contact role Contact location contact e mail [email protected] location facility Policlinico Tor Vergata location city Roma location country Italy location contact list location contact location contact name Massimo Andreoni, Prof location contact role Contact location contact e mail [email protected] location facility Ospedale Cattinara e Maggiore location city Trieste location country Italy location contact list location contact location contact name Roberto Luzzati location contact role Contact location contact e mail [email protected] location facility Ospedale di Udine location city Udine location country Italy location contact list location contact location contact name Carlo Tascini, Prof location contact role Contact location contact e mail [email protected] location facility Azienda Ospedaliera Integrata -Verona location city Verona location country Italy location contact list location contact location contact name Evelina Tacconelli, Prof location contact role Contact location contact phone 3497790711 location contact phone ext +39 location contact e mail [email protected] i p d sharing statement module i p d sharing No i p d sharing description The e-CRF platform (Cloud-R) ensures data protection and satisties all quality requirements for data management and protection of patients confidentiality. Confidential data will be available only for physicians in charge of individual patients. Anonymized data will be made available to other research upon written request accompanied with a motivation and a scientific rationale derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id 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condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id C000606551 intervention mesh term Remdesivir intervention mesh id D000003907 intervention mesh term Dexamethasone intervention ancestor list intervention ancestor intervention ancestor id D000000893 intervention ancestor term Anti-Inflammatory Agents intervention ancestor id D000000932 intervention ancestor term Antiemetics intervention ancestor id D000001337 intervention ancestor term Autonomic Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000005765 intervention ancestor term Gastrointestinal Agents intervention ancestor id D000005938 intervention ancestor term Glucocorticoids intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000018931 intervention ancestor term Antineoplastic Agents, Hormonal intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000000963 intervention ancestor term Antimetabolites intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000998 intervention ancestor term Antiviral Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M6254 intervention browse leaf name Dexamethasone intervention browse leaf as found Blood intervention browse leaf relevance high intervention browse leaf id M235540 intervention browse leaf name Dexamethasone acetate intervention browse leaf relevance low intervention browse leaf id M341692 intervention browse leaf name Remdesivir intervention browse leaf as found Genital intervention browse leaf relevance high intervention browse leaf id M3369 intervention browse leaf name Anti-Inflammatory Agents intervention browse leaf relevance low intervention browse leaf id M3403 intervention browse leaf name Antiemetics intervention browse leaf relevance low intervention browse leaf id M8033 intervention browse leaf name Gastrointestinal Agents intervention browse leaf relevance low intervention browse leaf id M8199 intervention browse leaf name Glucocorticoids intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse leaf id M20119 intervention browse leaf name Antineoplastic Agents, Hormonal intervention browse leaf relevance low intervention browse leaf id M3433 intervention browse leaf name Antimetabolites intervention browse leaf relevance low intervention browse leaf id M3466 intervention browse leaf name Antiviral Agents intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev AnEm intervention browse branch name Antiemetics intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents
NCT04832880
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full study rank 61332 study protocol section identification module n c t id NCT04837846 org study id info org study id 00093255 organization org full name Medical University of South Carolina org class OTHER brief title Multicenter Study Into Individualized Scanning for Coronary Artery Disease official title Multicenter Study Into Individualized Scanning for Coronary Artery Disease acronym MINDS-CAD status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 29, 2021 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 22, 2022 last update post date struct last update post date April 25, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name U. Joseph Schoepf, MD responsible party investigator title Professor responsible party investigator affiliation Medical University of South Carolina lead sponsor lead sponsor name Medical University of South Carolina lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary To evaluate intravascular attenuation of the coronary arteries and image quality in an individualized scan and CM injection protocol whereas both scan and injection parameters are tailored to the individual patient in a North American, European and Asian patient population. To evaluate the radiation dose and contrast media dose of this individualized approach for CCTA in an American, European and Chinese patient population. To evaluate the injection parameters required for an average American, European and Chinese patient population. conditions module condition list condition Coronary Artery Disease design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective enrollment info enrollment count 300 enrollment type Anticipated arms interventions module arm group list arm group arm group label Prospective CCTA Arm arm group intervention list arm group intervention name Other: Differing Tube Voltage Administration intervention list intervention intervention type Other intervention name Differing Tube Voltage Administration intervention description Subjects will undergo CCTA utilizing a scan and contrast media injection protocol that will be tailored to individual body habitus. intervention arm group label list intervention arm group label Prospective CCTA Arm outcomes module primary outcome list primary outcome primary outcome measure Evaluation of Intravascular Attenuation primary outcome description To measure the amount of Hounsfield units in different anatomical structures produced by an amount of contrast media. Using Hounsfield units coupled with image quality to determine if a scan of diagnostic value has been attained. primary outcome time frame At time of CCTA scan eligibility module eligibility criteria Inclusion Criteria: To be eligible for the study: (All answers must be "YES" for subject to be eligible.) Referred for a clinically indicated CCTA scan. Patient aged older than 18. Subject must provide written informed consent prior to any study-related procedures being performed. Subject must be willing to comply with all clinical study procedures. Atypical or typical complaints of angina. No previous cardiovascular history. Possibility of 'flash' mode scan; patient heart rate below 70 beats per minute and regular rhythm. Exclusion Criteria: The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.) Contraindications for CT coronary angiography, including: Inability to perform a breath hold for at least the expected scan time Unstable angina Hemodynamic instability Known history of CAD Pregnancy Renal insufficiency (defined as Creatinine <1.5 mg/dL or GFR<30 mL/min) Iodine allergy Insufficient cannula venous access (preferred 18G, minimal 20G cannula) Subject has an acute psychiatric disorder. Subject is unwilling to comply with the requirements of the protocol. Subject has previously entered this study. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Adults with complaints of angina, referred for a clinically indicated CCTA scan sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Mark Ghent, BA central contact role Contact central contact phone 843-876-7148 central contact e mail [email protected] central contact name Vincent Giovagnoli, BS central contact role Contact central contact phone 843-876-4922 central contact e mail [email protected] location list location location facility Medical University of South Carolina location status Recruiting location city Charleston location state South Carolina location zip 29425 location country United States location contact list location contact location contact name Jordan Fash, MHA location contact role Contact location contact phone 843-876-7148 location contact e mail [email protected] location contact name Lauren Ellis location contact role Contact location contact e mail [email protected] location contact name Joseph Schoepf, MD location contact role Principal Investigator i p d sharing statement module i p d sharing Yes derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003324 condition mesh term Coronary Artery Disease condition mesh id D000017202 condition mesh term Myocardial Ischemia condition mesh id D000003327 condition mesh term Coronary Disease condition ancestor list condition ancestor condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000001161 condition ancestor term Arteriosclerosis condition ancestor id D000001157 condition ancestor term Arterial Occlusive Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M5698 condition browse leaf name Coronary Artery Disease condition browse leaf as found Coronary Artery Disease condition browse leaf relevance high condition browse leaf id M18658 condition browse leaf name Myocardial Ischemia condition browse leaf as found Coronary Artery Disease condition browse leaf relevance high condition browse leaf id M5701 condition browse leaf name Coronary Disease condition browse leaf as found Coronary Artery Disease condition browse leaf relevance high condition browse leaf id M9695 condition browse leaf name Ischemia condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id M3621 condition browse leaf name Arteriosclerosis condition browse leaf relevance low condition browse leaf id M3617 condition browse leaf name Arterial Occlusive Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04837846
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full study rank 61845 study protocol section identification module n c t id NCT04831177 org study id info org study id TFLADE organization org full name Assiut University org class OTHER brief title Thin-Flap Laser in Situ Keratomileusis Associated Dry Eye official title Thin-Flap Laser in Situ Keratomileusis Associated Dry Eye status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date June 1, 2019 start date type Actual primary completion date struct primary completion date September 1, 2020 primary completion date type Actual completion date struct completion date September 1, 2020 completion date type Actual study first submit date March 31, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mahmoud Abdel-Radi responsible party investigator title Principal Investigator responsible party investigator affiliation Assiut University lead sponsor lead sponsor name Assiut University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Laser in situ keratomileusis (LASIK) eye surgery continues to be the most common refractive procedure used to correct different forms of ametropia. Although the introduction of femtosecond technology has markedly reduced the incidence of intraoperative flap complications and allowed a better control on flap parameters, dry eye remains one of the most challenging postoperative complications. detailed description The pathophysiology of post LASIK dry eye is not clear; however, many mechanisms have been suggested including inflammation, loss of conjunctival goblet cells during suction, exacerbation of a preexisting dry eye, abnormal interaction between the lid margins and the ocular surface. Intact corneal sensation is crucial for proper tear production and distribution on the ocular surface as well as maintaining the normal dynamics of eyelid blinking. Disruption of corneal nerves in LASIK decreases the release of neurotrophic factors necessary for the normal function of the corneal epithelium as well as the integrity of the lacrimal functional unit, a condition referred to as LASIK induced neurotrophic epitheliopathy (LINE) that largely contributes to the development of post- LASIK dry eye . Many studies evaluated the incidence of post-refractive dry eye after LASIK compared to flapless laser vision correction (LVC) procedures such as PRK and small incision lenticule extraction (SMILE). The aim of this study is to assess and compare different dry eye parameters following LASIK with planned thin flaps created by femtosecond laser (FS) and mechanical microkeratome (MK). conditions module condition list condition Myopic LASIK Candidates With Spherical Equivalent up to - 10 Diopters keyword list keyword Dry eye Femtolaser Laser in situ keratomileusis design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 55 enrollment type Actual arms interventions module arm group list arm group arm group label Patients planned to undergo Femtosecond laser FS assisted LASIK arm group type Active Comparator arm group description In FS group, Allegretto WaveLight FS-200 femtosecond laser was used to create flaps with flap thickness planned to be 100 um. arm group intervention list arm group intervention name Procedure: Laser in situ keratomileusis arm group label Patients planned to undergo Microkeratome MK assisted LASIK arm group type Active Comparator arm group description In MK group, Moria 2 Microkeratome was used to create flaps with flap thickness planned to be 100 um. arm group intervention list arm group intervention name Procedure: Laser in situ keratomileusis intervention list intervention intervention type Procedure intervention name Laser in situ keratomileusis intervention description Laser in situ keratomileusis LASIK is a procedure used to correct different types of ametropia through a creation of corneal flap whether with femtosecond laser or mechanically with a microkeratome followed by application of excimer laser to correct different refractive errors including Myopia, Hyperopia and Astigmatism. intervention arm group label list intervention arm group label Patients planned to undergo Femtosecond laser FS assisted LASIK Patients planned to undergo Microkeratome MK assisted LASIK outcomes module primary outcome list primary outcome primary outcome measure Tear film break up time TBUT primary outcome description Fluorescein strip was inserted in the lower conjunctival fornix for few seconds then removed and the patient was asked to frequently blink, the stained tear film was observed with slit lamp (cobalt blue filter) till the appearance of the first black (dry) spot and the time interval in seconds was measured primary outcome time frame 6 months primary outcome measure Schirmer I test primary outcome description Whatman filter paper (35 mm long) was folded 5mm and inserted in the lower conjunctival fornix away from the cornea and the patient was asked to blink normally. After 5minutes the paper was removed, and the amount of wetting in millimeters was measured. primary outcome time frame 6 months primary outcome measure Ocular Surface Disease Index OSDI primary outcome description A questionnaire consisting of 12 questions. Each question with a score from 0 to 4, the OSDI score is calculated by multiplying the sum by 25 and dividing by the number of questions answered. This yields a score from 0 to 100. The results of OSDI score can be graded as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eye (33-100) primary outcome time frame 6 months primary outcome measure Lower Tear meniscus height (LTMH) primary outcome description Anterior segment Optical coherence tomography (AS-OCT) examination was scheduled in the afternoon. The lower TMH was evaluated with a vertical scan centered on the inferior cornea and the lower eyelid. The lower TMH was measured with a special caliper tool incorporated in the device in micrometers and the height of the tear meniscus is the distance between 2 points ,one where the meniscus intersects the inferior cornea superiorly and the other where the meniscus intersects the lower eyelid margin inferiorly. primary outcome time frame 6 months primary outcome measure Lower Tear meniscus area (LTMA) primary outcome description The lower TMA was evaluated using AS-OCT with a vertical scan centered on the inferior cornea and the lower eyelid then a built in software caliper tool was used to determine the borders of the tear meniscus and calculate the area (TMA) in millimeter square (mm2). primary outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria: Candidates for Laser Vision Correction (LVC). Eyes with spherical equivalent (SE) up to - 10 diopters (D), Corneal thickness at thinnest location of ≥ 500 um and estimated postoperative residual stromal bed of at least 300 um Exclusion Criteria: Patients with symptoms or signs of dry eye (TBUT <10 sec, Schirmer I test <10mm and Ocular Surface Disease Index OSDI score >13), Posterior blepharitis, contact lens wearers , Ocular surface disease , Systemic diseases contraindicating LASIK and previous ocular surgery. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility TIBA eye center location city Assiut location zip 71516 location country Egypt references module reference list reference reference p m i d 31712000 reference type background reference citation Sambhi RS, Sambhi GDS, Mather R, Malvankar-Mehta MS. Dry eye after refractive surgery: a meta-analysis. Can J Ophthalmol. 2020 Apr;55(2):99-106. doi: 10.1016/j.jcjo.2019.07.005. Epub 2019 Aug 20. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015352 condition mesh term Dry Eye Syndromes condition ancestor list condition ancestor condition ancestor id D000007766 condition ancestor term Lacrimal Apparatus Diseases condition ancestor id D000005128 condition ancestor term Eye Diseases condition browse leaf list condition browse leaf condition browse leaf id M11320 condition browse leaf name Myopia condition browse leaf relevance low condition browse leaf id M17192 condition browse leaf name Dry Eye Syndromes condition browse leaf as found Dry Eye condition browse leaf relevance high condition browse leaf id M9816 condition browse leaf name Keratoconjunctivitis Sicca condition browse leaf relevance low condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M9938 condition browse leaf name Lacrimal Apparatus Diseases condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04831177
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full study rank 61809 study protocol section identification module n c t id NCT04831645 org study id info org study id MedShape011221 organization org full name MedShape, Inc org class INDUSTRY brief title The Use of a Dynamic Sustained Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis official title The Use of a Dynamic Sustained Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date May 24, 2021 start date type Actual primary completion date struct primary completion date May 24, 2024 primary completion date type Anticipated completion date struct completion date May 24, 2024 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 24, 2021 last update post date struct last update post date May 25, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name MedShape, Inc lead sponsor class INDUSTRY collaborator list collaborator collaborator name CurveBeam LLC collaborator class UNKNOWN collaborator name Orthopedic Foot and Ankle Center, Ohio collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is u s export No description module brief summary The purpose of this study is to determine the clinical efficacy of a novel sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis utilizing longitudinal weight-bearing computed tomographic imaging. Of particular focus will be assessment of compressive element recovery and its relation to fusion development over time and weight-bearing status. Additionally, the study will incorporate longitudinal fusion assessment to evaluate differences between three-dimensional weight-bearing computed tomography (WBCT) scans and two-dimensional radiographs (X-rays) at multiple points of the fusion process. Finally, the study will evaluate the differences in WBCT-based fusion assessment between automated and manual methodologies for fusion area calculation. detailed description This study is a collaborative effort between the Orthopedic Foot and Ankle Center, MedShape, Inc, and CurveBeam. This is a prospective investigation to assess the clinical outcomes of patients with a tibiotalocalcaneal arthrodesis with the Sustained Dynamic Compression Intramedullary Nail (DynaNail), including longitudinal assessment with weight-bearing CT. The investigators plan to enroll 45 patients. No placebo control will be used, as there is no other IM nail available capable of providing sustained compression. Additionally, given that many patients receiving this treatment have had prior failed treatments and face poor alternatives such as amputation, using a prior-generation IM nail as a control treatment would be unethical. Design: This is a prospective, single-group study. Patients of the Orthopedic Foot and Ankle Center who are scheduled to undergo TTC arthrodesis will be screened for eligibility and informed consent will be obtained from those who meet the inclusion/exclusion criteria. Subjects will be assessed pre-operatively and then at five post-operative intervals: 1 week, 6 weeks, 3 months, 6 months, and 12 months. A WBCT scan will be obtained at each interval. Selection of Subjects: Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon or his/her physician assistant based on clinical exam and radiographic findings. Patients will be screened for eligibility by the research coordinator/ key personnel in close coordination with the surgeon and co-investigator. Pre-operative Questionnaire: After informed consent, the patients will be asked to complete patient reported outcomes questionnaires that are part of the SOS Registry associated with function and pain, including VAS, VR-12, FFI-R, FAAM, AOS, and AOFAS. The patients will also be asked to provide information related to prior medical history (including potential co-morbidities associated with non-union, i.e. tobacco usage, neuropathy, renal disease, obesity, etc.) and surgical history of the subject lower extremity. Surgery: The following surgical procedure is standard of care. The surgical procedure will involve both tibiotalar and talocalcaneal joint preparation through any approach (lateral, posterior, anterior with sinus tarsi). The use of supplemental bone graft is at the discretion of the treating surgeon but must be documented. The MedShape DynaNail will then be inserted according to the manufacturer's technique. The patient will be placed in a short leg splint and kept non-weight bearing initially. The patient will be discharged from the hospital when medically ready. Weight-bearing will start at seven weeks post-surgery. Follow-Up Visits and Questionnaires: The patient will return to clinic for visits at the following intervals after surgery: 1 week, 6 weeks, 3 months, 6 months, and 12 months. At each of these time points, a clinical exam will be conducted, and SOS patient questionnaires will be administered, as well as a radiographic and clinical follow-up form. Additionally, radiograph and weight-bearing CT imaging will be obtained of both the ankle and subtalar joints. At 3 months and 12 months post-op, all X-ray and CT images will be de-identified, burned to a DVD, and copies will be sent to both co-sponsors. conditions module condition list condition Ankle Arthritis Arthritis Foot keyword list keyword Subtalar Arthrodesis Intramedullary Nail Ankle Arthrodesis Internal Fixation Sustained Compression Longitudinal Computed Tomography Tibiotalar Arthrodesis Joint Fusion design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 45 enrollment type Anticipated arms interventions module intervention list intervention intervention type Device intervention name DynaNail intervention description Utilization of a novel dynamic compression pseudoelastic intramedullary nail intervention type Procedure intervention name Tibiotalocalcaneal Arthrodesis intervention description Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. intervention other name list intervention other name Subtalar Arthrodesis Tibiotalar Arthrodesis outcomes module primary outcome list primary outcome primary outcome measure Fusion primary outcome description Joint Fusion, as measured by radiographs and CT scans. Fusion rates will be assessed based on varying CT fusion areas. Fusion rates based on X-Ray vs CT assessment will also be compared. CT fusion rates based on varying fusion areas will be compared with PROM data to assess which fusion area actually corresponds to increased function and reduced pain. primary outcome time frame Pre-Operative to 1 year post-surgery secondary outcome list secondary outcome secondary outcome measure VAS secondary outcome description Visual Analog Scaled (VAS) - Rates the intensity of pain from 0 - 10 with 10 being the worst pain possible and 0 being no pain. secondary outcome time frame Pre-Operative up to one year post-surgery secondary outcome measure VR-12 secondary outcome description The Veterans RAND 12 Item Health Survey (VR-12, formerly called the Veterans SF-12) was developed from the Veterans RAND 36 (VR-36, formerly called the Veterans SF-36), which was modified from the original MOS SF-36. The VR-12 measures Physical functioning (PF), social functioning (SF), role limitation due to physical problems (RP), role limitation due to emotional problems (RE), mental health (MH), energy and vitality (VT), bodily pain (BP) and general perception of health (GH). Standard based scoring (sometimes called norm based scoring) is used to calculate the physical component summary (PCS) and mental component summary (MCS) for both measures. The PCS and MCS are standardized using a t-score transformation and normed to a US population at a score of 50 and a standard deviation of 10. Higher scores indicate better health. secondary outcome time frame Pre-Operative up to one year post-surgery secondary outcome measure FFI-R secondary outcome description Foot Function Index-Revised - Measures the impact of foot pathology on function in terms of pain, disability, and activity restriction. The score is a percentage. The higher the score, the greater the disability. secondary outcome time frame Pre-Operative up to one year post-surgery secondary outcome measure FAAM secondary outcome description Foot and Ankle Ability Measure - Measures patient capacity for sports and activities of daily living (ADL). The final score is a percentage. The higher final score represents a higher level of physical function. secondary outcome time frame Pre-Operative up to one year post-surgery secondary outcome measure AOS secondary outcome description Ankle Osteoarthritis Scale - Measures pain levels and difficulty performing various activities of daily living. A line-based scale with range from no pain to the worst pain imaginable. secondary outcome time frame Pre-Operative up to one year post-surgery secondary outcome measure AOFAS secondary outcome description American Orthopaedic Foot and Ankle Society Scale - Clinician-based outcome that measures foot/ankle pain, function, and alignment. The lower the score, the greater the disability. The maximum score is 100. secondary outcome time frame Pre-Operative up to one year post-surgery other outcome list other outcome other outcome measure Automated vs Manual Fusion Assessment other outcome description Fusion area calculation over time will be assessed not only by two clinically-trained reviewers, but also using CurveBeam's automated CubeVue assessment software. Averaged clinician results will be compared with CubeVue-calculated data. other outcome time frame Up to one year post-surgery eligibility module eligibility criteria Inclusion Criteria: Meets indications for TTC arthrodesis and receives the DynaNail implant Able to understand the requirements of the study Willing to comply with the study protocol Sign an Informed consent 18 years of age or older Exclusion Criteria: Investigator determines that the subject is unlikely to comply with the requirements of the study Non-English speaker Blind Illiterate Prisoner healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients of the Orthopedic Foot and Ankle Center with end-stage tibiotalar (ankle) and talocalcaneal (subtalar) joint arthritis from any etiology will be eligible to enroll in the study. In general, tibiotalar and subtalar arthritis is caused by trauma. Traumatic injuries have no predilection for race, religion, cultural background, etc. Therefore, all demographic groups will have access to this study and should be represented. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Kenneth M Dupont, Ph.D. central contact role Contact central contact phone 6782353336 central contact e mail [email protected] central contact name Antonio Malloy-McCoy, MPH central contact role Contact central contact phone 614-895-8747 central contact phone ext 187 central contact e mail [email protected] overall official list overall official overall official name Gregory C Berlet, MD overall official affiliation Orthopedic Foot and Ankle Center overall official role Principal Investigator location list location location facility Orthopedic Foot and Ankle Center location status Recruiting location city Worthington location state Ohio location zip 43085 location country United States location contact list location contact location contact name Antonio Malloy-McCoy, MPH location contact role Contact location contact phone 614-895-8747 location contact phone ext 187 location contact e mail [email protected] location contact name Gregory C Berlet, MD location contact role Contact location contact e mail [email protected] location contact name Gregory C Berlet, MD location contact role Principal Investigator location contact name Patrick Bull, DO location contact role Sub-Investigator location contact name Terrence M Philbin, DO location contact role Sub-Investigator location contact name Mark A Prissel, DPM location contact role Sub-Investigator location contact name Christopher F Hyer, DPM location contact role Sub-Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001168 condition mesh term Arthritis condition ancestor list condition ancestor condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition browse leaf list condition browse leaf condition browse leaf id M3628 condition browse leaf name Arthritis condition browse leaf as found Arthritis condition browse leaf relevance high condition browse leaf id M3322 condition browse leaf name Ankylosis condition browse leaf relevance low condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04831645
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full study rank 61383 study protocol section identification module n c t id NCT04837183 org study id info org study id 20-001448 organization org full name Mayo Clinic org class OTHER brief title Catheter Ablation of Ventricular Arrhythmia Reduces Skin Sympathetic Activity official title Catheter Ablation of Ventricular Arrhythmia Reduces Skin Sympathetic Activity status module status verified date December 2021 overall status Recruiting expanded access info has expanded access No start date struct start date November 15, 2021 start date type Actual primary completion date struct primary completion date March 4, 2023 primary completion date type Anticipated completion date struct completion date March 4, 2025 completion date type Anticipated study first submit date March 16, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date December 7, 2021 last update post date struct last update post date December 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Yong-Mei Cha responsible party investigator title Principal Investigator responsible party investigator affiliation Mayo Clinic lead sponsor lead sponsor name Mayo Clinic lead sponsor class OTHER collaborator list collaborator collaborator name Cedars-Sinai Medical Center collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study is being done to determine whether there is an increase in sympathetic nerve activity before the onset of ventricular arrhythmias or irregular heartbeat rhythm. In addition, this study is looking at the relationship between sympathetic nerve activity and how patients with ventricular arrhythmias respond to catheter ablation treatment. conditions module condition list condition Ventricular Tachycardia design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 40 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure Change in amplitude of skin sympathetic nerve activity primary outcome description measured in µV primary outcome time frame Baseline, 24 hours post catheter ablation and approximately 3-6 months post-operative primary outcome measure Change in LF/HF ratio primary outcome description low frequency (LF)/high frequency (HF) ratio of the skin sympathetic nerve activity primary outcome time frame Baseline, 24 hours post catheter ablation and approximately 3-6 months post-operative eligibility module eligibility criteria Inclusion Criteria: Patients who have sustained VA (VA ≥ 30s or receiving appropriate ICD therapies) are presented to the clinic or admitted to the hospital within 7 days of episodes. The causes of VA are associated with structural heart diseases including ischemic or nonischemic cardiomyopathy (idiopathic cardiomyopathy, hypertrophic cardiomyopathy, cardiac sarcoidosis or amyloidosis, and arrhythmogentic right ventricular dysplasia). Subjects are 18 years of age and older. Exclusion Criteria: Advanced comorbid conditions with life expectancy < 1 year. Unwilling or unable to return for required follow-up visits. Female patients who is pregnant or of childbearing potential and not on a reliable form of birth control. Pacing artifacts prevents Skin Sympathetic Nerve Activity (SKNA) analyses. Allergic to skin patch electrodes. Vulnerable populations (fetuses, neonates, pregnant women, prisoners, institutionalized individuals). healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population All patients will undergo catheter ablation to control VA recommended by current guideline. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Brian W Liddell, BS central contact role Contact central contact phone 507-255-8717 central contact e mail [email protected] overall official list overall official overall official name Yong-Mei Cha, MD overall official affiliation Mayo Clinic overall official role Principal Investigator location list location location facility Mayo Clinic in Rochester location status Recruiting location city Rochester location state Minnesota location zip 55905 location country United States location contact list location contact location contact name Brian W Liddell, BS location contact role Contact location contact phone 507-255-8717 location contact e mail [email protected] references module see also link list see also link see also link label Mayo Clinic Clinical Trials see also link u r l https://www.mayo.edu/research/clinical-trials derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013610 condition mesh term Tachycardia condition mesh id D000017180 condition mesh term Tachycardia, Ventricular condition ancestor list condition ancestor condition ancestor id D000001145 condition ancestor term Arrhythmias, Cardiac condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000075224 condition ancestor term Cardiac Conduction System Disease condition browse leaf list condition browse leaf condition browse leaf id M15536 condition browse leaf name Tachycardia condition browse leaf as found Tachycardia condition browse leaf relevance high condition browse leaf id M3605 condition browse leaf name Arrhythmias, Cardiac condition browse leaf relevance low condition browse leaf id M18640 condition browse leaf name Tachycardia, Ventricular condition browse leaf as found Ventricular Tachycardia condition browse leaf relevance high condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id M1472 condition browse leaf name Cardiac Conduction System Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04837183
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