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NCT00258596 | ALL | ADULT, OLDER_ADULT | Coronary Artery Disease|Coronary Disease|Coronary Stenosis | DEVICE: sirolimus-eluting stent | The binary restenosis rate (defined as restenosis >50% on follow-up angiography) at six-month angiography | Primary intracoronary stent placement after successfully crossing chronic total occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. Whether sirolimus-eluting stents are superior to bare metal stents in CTO is unknown. In this prospective randomized trial, bare metal stent implantation will be compared with sirolimus-eluting stent implantation for the treatment of chronic total coronary occlusions. A total of 200 patients will be followed up for 6, 12, and 24 months with angiographic follow-up at 6 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is the binary angiographic restenosis and reocclusion rate at 6 month follow-up. |
NCT02472223 | ALL | ADULT, OLDER_ADULT | Conjunctivitis|Adenoviral Conjunctivitis | DRUG: Betadine 5%|DRUG: Artificial Tears | Percent Change From Peak Viral Load, To compare efficacy of Betadine 5% to artificial tears to change from peak viral load in Adenoviral conjunctivitis, 21 days | The primary aim of this pilot study is to generate data needed to design a definitive trial to compare the safety and efficacy of standard care with artificial tears vs. Betadine 5% (5% povidone-iodine) for the treatment of pink eye due to adenovirus. There is currently no FDA approved treatment for pink eye, a common and highly contagious eye infection caused by adenovirus. Standard care as recommended by the American Academy of Ophthalmology and American Optometric Association is instillation of artificial tears to relieve symptoms and possibly reduce the virus population. Betadine 5% is a commercially available, broad-spectrum antiseptic ophthalmic solution used for over 50 years to prepare the patient's eye and surrounding area for eye surgery. Because Betadine 5% kills bacteria and viruses, it may be useful in treating adenoviral conjunctivitis. Betadine 5% is inexpensive, safe, widely available, and immune to the development of bacterial/viral resistance. Betadine 5% has the potential to significantly impact the clinical management of "pink eye" worldwide.
This pilot study has received funding from the National Eye Institute. Participants who meet eligibility criteria will be randomized using a masked randomization packet to receive one-time, in-office treatment with either artificial tears or Betadine 5%.
Patients who agree to study participation will answer questions about their pink eye symptoms, medical and ocular history, have an eye examination and be tested to confirm "pink eye" due to adenovirus using a FDA approved "point of care" immunoassay. Participants testing positive for adenovirus will have a tear sample taken to measure viral load by qPCR. Randomization and a one-time treatment with either (standard care) artificial tears or Betadine 5% will be done on the first visit. Follow-up visits are at 1,4,7,14 and 21 days. At each visit, symptoms of pink eye are asked, a standardized study eye examination is given by the masked clinician and a sample of tears is taken to assess viral load by qPCR. |
NCT01149369 | ALL | ADULT, OLDER_ADULT | Gastroparesis | DRUG: Aprepitant|DRUG: Placebo | Number of Participants With Improvement in Nausea, The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (VAS) scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of \< 25 mm., 4 weeks | The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin. |
NCT00808743 | ALL | ADULT, OLDER_ADULT | Familial Adenomatous Polyposis|Duodenal Neoplasms|Duodenal Polyps | DRUG: Celecoxib|DRUG: Ursodeoxycholic acid|DRUG: Placebo | Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures), Baseline, 6 months | Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP. |
NCT02301975 | ALL | CHILD, ADULT, OLDER_ADULT | Asthma | DRUG: Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler|DRUG: Placebo inhalation powders via ELLIPTA inhaler|DRUG: Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler|DRUG: Placebo inhalation powder via ACCUHALER/DISKUS inhaler|DRUG: Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler | Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population, FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the mixed model repeated measures (MMRM) model and least square mean and standard error were calculated. The analysis was performed on ITT Population which comprised of all participants randomized to treatment and who received at least one dose of study medication., Baseline and Week 24|Change From Baseline in PM FEV1 Using Per Protocol (PP) Population, FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the MMRM models and least square mean and standard error were calculated. The analysis was performed on PP Population which comprised of all participants in the ITT Population who did not had any full protocol deviations., Baseline and Week 24 | This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate \[FP\]/salmeterol 250/50 microgram \[mcg\]twice daily \[BD\]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA.
SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies. |
NCT02777151 | ALL | ADULT | Healthy Volunteers | DRUG: REGN3470-3471-3479|DRUG: Placebo | Incidence and severity of TEAEs through the end of the study visit in subjects treated with REGN3470-3471-3479 in a fixed dose combination, From baseline up to day 169 | This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and immunogenicity of REGN3470-3471-3479 in healthy adult volunteers. |
NCT00004732 | ALL | ADULT, OLDER_ADULT | Atherosclerosis|Stroke|Carotid Stenosis|Cerebral Infarction|Myocardial Infarction | PROCEDURE: Carotid Endarterectomy (CEA)|DEVICE: Carotid Artery Stenting (CAS) | Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years., The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (\>=50%) or asymptomatic (\>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years., 30 days and 4 years | The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of carotid endarterectomy (CEA) for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic). |
NCT00643019 | FEMALE | CHILD, ADULT | Sexually Transmitted Disease|Secondary Prevention|Behavioral Modification|Public Health | BEHAVIORAL: SAFE Behavioral Intervention|OTHER: Control | Re-infection with a non-viral sexually transmitted infection, 1 year | This trial randomizes young Mexican American and African American women with a sexually transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus control with the goal of preventing recurrent sexually transmitted infections. |
NCT01375777 | ALL | ADULT, OLDER_ADULT | Hyperlipidemia | BIOLOGICAL: Evolocumab|DRUG: Ezetimibe|OTHER: Placebo to Evolocumab | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12, LDL-C was measured using ultracentrifugation., Baseline and Week 12 | The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia. |
NCT00373009 | ALL | ADULT | Low Back Pain | BEHAVIORAL: Traditional Army training|BEHAVIORAL: Core stabilization exercise only|BEHAVIORAL: Psychosocial education class only|BEHAVIORAL: Core stabilization and psychosocial education | Episodes of low back pain, 2 years|Duration of low back pain, 2 years|Severity of low back pain, 2 years | We are studying whether specific back exercise and education programs effectively limit the development of chronic low back pain in Soldiers in the United States Army. These programs represent the current best evidence for prevention of low back pain from an exercise and education perspective. This innovative study will investigate whether a combination of evidence-based exercise and education programs effectively decreases the impact of chronic low back pain, when compared to individual evidence-based exercise and education programs, or a traditionally implemented exercise program. |
NCT02231606 | ALL | CHILD | Myopia | OTHER: Free Glasses|OTHER: Upgrade Glasses 1|OTHER: Upgrade Glasses 2 | Glasses purchase proportion, Proportion of children in each group requiring glasses whose families select to purchase them., 8 months after the start of the project. | The aim of the project is to create, study and advocate for a model that can be adopted by the Chinese government to provide spectacles for all children sustainable. |
NCT02517476 | ALL | CHILD, ADULT, OLDER_ADULT | Malnutrition | DIETARY_SUPPLEMENT: Nutritional therapy | primary composite endpoint, Number of participants with adverse events including
1. All-cause mortality
2. Admission to the intensive care unit
3. Unplanned hospital readmission after hospital discharge
4. Major complications including nosocomial infection or abscess requiring antibiotic treatment, respiratory failure with need for invasive or non-invasive ventilation, major cardiovascular event or pulmonary embolism, acute renal failure (defined by 2x increase of baseline creatinine or new requirement of dialysis), gastro-intestinal hemorrhage or intestinal perforation assessed by medical chart review and telephone interview
5. decline in functional status of 10% or more from admission to day 30 measured by the Barthel's index assessed by patient interview on admission and after 30 days, measured at day 30 by telephone interview | The aims of the randomized-controlled, multicenter EFFORT trial are to assess the effects of early nutritional therapy in regard to effectiveness, safety and costs when applied to the heterogenous, polymorbid medical inpatient population. EFFORT will not only answer the question about overall benefit or harm, but using a physio-pathological mechanistic approach, it also will explore and provide conclusive answers about whether, why, how, and in which patient populations nutritional therapy does and does not works. |
NCT00385957 | ALL | ADULT, OLDER_ADULT | HIV Infections | DRUG: AZT+3TC+IDV+RTV|DRUG: AZT+3TC+EFV | Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.|Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months. | The study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 \< 100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI). |
NCT03541382 | ALL | CHILD, ADULT, OLDER_ADULT | HIV/AIDS | DEVICE: OraQuick® HIV Self-Test | Percentage of self-reported lifetime testing in adolescents aged 15-19 years old, Measured 8-12 weeks post-intervention | The aim of this study is to determine the benefits, costs and safety of community-led delivery of HIV self-testing (HIVST) kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older. |
NCT00105612 | ALL | CHILD, ADULT, OLDER_ADULT | Alzheimer's Disease|Aging | DEVICE: Memory and Organizational Aid|BEHAVIORAL: Standard Informed Consent Process | MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities | The purpose of this trial is to test whether a memory and organizational aid in the form of a document that summarizes and simplifies a study's key points can improve the decision-making abilities and competency of mild to early moderate Alzheimer's disease (AD) patients. |
NCT01398579 | ALL | ADULT, OLDER_ADULT | Intestinal Metaplasia|Intestinal Dysplasia | PROCEDURE: Gastroscopy | Percentage of accurate endoscopic diagnosis made with pCLE compared with histopathology diagnosis, For each patient, the minimum sites of pCLE examination must consist of 2 sites at antrum, 1 site at the incisura, 2 sites at the corpus, and 1 site at the cardia. When suspicious lesions are present, more sites of pCLE examination will be allowed. Each site of pCLE examination will be biopsied and sent for histology.The pCLE examination will be video recorded and interpretation will be done independently on a separate day from the endoscopy day.The analysis will be by per biopsy site matched with corresponding video sequence, An average of 1 week for which histology report will be out for comparison | The investigators hypothesis that
1. clinical applicability and overall diagnostic sensitivity and specificity of pCLE for diagnosing gastric preneoplastic and neoplastic lesions is acceptable
2. pCLE, as compared to white-light endoscopy (WLE), AFI and magnifying NBI has higher sensitivity and specificity for the diagnosing gastric pre-neoplastic and neoplastic lesions |
NCT04057313 | ALL | ADULT, OLDER_ADULT | Hemodialysis Complication | DIETARY_SUPPLEMENT: Coffee | number of headache episodes, number of headache episodes during or immediately after dialysis over 12, 4 weeks | Coffee is the most consumed drink worldwide, sometimes needed to boost energy and other times to entertain social connectivity. Caffeine is mostly present unbound in the plasma, only 10 to 30% of caffeine binds to plasma proteins. It is distributed freely into the intracellular space, and it has a small distribution volume. Therefore, caffeine can pass through the dialysis membrane during a standard hemodialysis session. In hemodialysis patients, headache occurs in 40 to 75% of patients. Some authors have suggested that one of the reasons of headache during hemodialysis is caffeine withdrawal. This trial aims to find whether coffee intake during hemodialysis reduces the headache episodes. It is a randomized double blind multicenter trial where 160 patients will be randomized to 2 groups: group 1 of 80 patients will be given a cup of coffee each dialysis session for 4 weeks and group 2 will receive decaffeinated coffee each dialysis session for 4 weeks. |
NCT02816008 | ALL | ADULT, OLDER_ADULT | Cognition Disorders|Cognitive Deficits | BEHAVIORAL: Cognitive rehabilitation training with RGS in the clinic|BEHAVIORAL: Passive/conventional cognitive training at home. | Change in Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-up, Measurement of attention, Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)|Change in Corsi block tapping test from baseline to end of treatment and to follow-up, Measurement of attention, Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)|Change in Trail Making Test, Part A from baseline to end of treatment and to follow-up, Measurement of attention, Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)|Change in Rey Auditory Verbal Learning Test from baseline to end of treatment and to follow-up, Measurement of episodic memory, Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)|Change in Digit Span Backward WAIS-IV from baseline to end of treatment and to follow-up, Measurement of working memory, Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)|Change in Corsi block-tapping test reversed from baseline to end of treatment and to follow-up, Measurement of working memory, Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)|Change in Frontal Assessment Battery from baseline to end of treatment and to follow-up, Measurement of executive functioning, Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)|Change in Trail Making Test, Part B from baseline to end of treatment and to follow-up, Measurement of set-shifting, Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)|Change in Digit Symbol Coding in WAIS-IV from baseline to end of treatment and to follow-up, Measurement of processing speed, Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)|Change in Star Cancellation test from baseline to end of treatment and to follow-up, Measurement of spatial neglect, Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | Cognitive rehabilitation is defined as a systematic functionally oriented intervention of therapeutic cognitive activities based on the assessment and understanding of patient's brain behavior deficits. This project focuses on restoring cognitive functions in order to understand the underlying deficits in the patient's brain by developing integrated cognitive rehabilitation scenarios in virtual reality that combine memory, attention and problem solving training with context specific motor movements. |
NCT01144338 | ALL | ADULT, OLDER_ADULT | Type 2 Diabetes Mellitus | DRUG: Exenatide Once Weekly|DRUG: Placebo | Primary Efficacy Outcome MACE Events, The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.
The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo., Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|Primary Safety Outcome MACE Events, The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.
The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo., Time to first event. Information collected during study period (anticipated to be up to 7.5 years). | This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke. |
NCT01181323 | FEMALE | ADULT | Influenza | OTHER: Placebo|BIOLOGICAL: Cold-adapted live attenuated influenza virus vaccine, trivalent|OTHER: Placebo|BIOLOGICAL: Trivalent inactivated influenza vaccine | Number of Participants Reporting Serious Adverse Events (SAEs), Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes, regardless of relationship to study product or study participation., Day 0 to Day 180 post vaccination|Number of Participants Reporting New Onset Chronic Medical Conditions, New onset chronic medical condition was defined as any new ICD-10 diagnosis for a participant that was expected to continue for at least 6 months and require continued health care intervention. ICD-10 = International Statistical Classification of Diseases and Related Health Problems, 10th revision. Maternal participants were asked at each visit through 180 days after enrollment if they or their infants had any new diagnosis., Day 0 to Day 180 post vaccination|Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination, Maternal participants maintained a memory aid to record daily the occurrence in their infants of systemic adverse events of fever (defined as rectal temperature 37.8 degrees Celsius or greater), drowsiness, irritability/fussiness, loss of appetite, nasal congestion, difficulty breathing, runny nose, and cough for 11 days (Day 0-10) after maternal vaccination based on protocol-defined grading (none, mild, moderate or severe) for each symptom. Rectal temperature was measured once daily. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 11 days., Day 0 to Day 10 post vaccination|Number of Participating Reporting Non-serious Unsolicited Adverse Events Related to Vaccination Within 28 Days of Maternal Vaccination, Adverse events (AE) for this protocol used the International Conference on Harmonization (ICH) guideline E6 definition of AE, any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product regardless of its causal relationship to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product. Related was defined as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event. Non-serious AEs were those that did not meet the definition of serious (see Outcome Measure 1). Maternal participants were queried at each visit through 28 days after vaccination for the occurrence of any AE for her or the infant separately from the pre-defined solicited symptoms., Day 0 to Day 28 post vaccination|Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains, Breast milk was collected at Day 0 prior to vaccination and again at 28 days following vaccination for testing in IgA and IgG ELISA Assays. The ELISA assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons's vaccine, A/California/7/2009 (H1N1). The lower limit of detection is 5.82 units/mL for IgA and 2.56 units/mL for IgG. Titers below the limit of detection were reported as one-half the limit of detection., Day 0 and 28 post vaccination|Number of Infant Participants With Medically Attended Respiratory or Gastrointestinal AEs 28-42 Days After Maternal Vaccination, Maternal participants were contacted by telephone at Day 42 to report all medically attended respiratory or gastrointestinal adverse events occurring in the infant participants between 28 and 42 days after maternal vaccination., Within 28-42 days after maternal vaccination|Number of Maternal Participants Reporting Fever After Vaccination, Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days., Day 0-7 post vaccination|Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination, Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, weakness, and chills for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days., Day 0-7 post vaccination|Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination, Participants maintained a memory aid to record daily the occurrence of local symptoms of nasal congestion, runny nose, cough, sore throat, nasal bleeding, pain at injection site, tenderness at injection site, and swelling at injection site for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days., Day 0-7 post vaccination|Number of Maternal Participants Reporting Solicited Quantitative Local Symptoms After Vaccination, Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days., Day 0-7 post vaccination | The purpose of this research study is to learn more about the safety of 2 licensed flu vaccines, nasal spray and flu vaccine shot, in mothers and their infants, when given to women who are breastfeeding and to compare the immune response (body's defense against foreign substances) of breastfeeding mothers, who receive intranasal flu vaccine, with breastfeeding mothers receiving the flu vaccine shot. Healthy women (240 volunteers, 28-120 days post delivery) who plan to breastfeed through 28 days post vaccination and who have not received influenza vaccine for the influenza season for which they are being enrolled, will be assigned by chance to 1 of the 2 vaccines in the following manner: flu vaccine nasal spray and a placebo (inactive substance) shot or a flu vaccine shot and a placebo nasal spray. Study procedures include: nasal swabs, blood samples, and completion of memory aids. Participants will be involved in this United States based study for about 6 months. |
NCT01291355 | FEMALE | ADULT | Maternal Distress in Labor|Persistent Occipitoposterior or Occipitoanterior Position|Dystocia|Fetal Position and Presentation Abnormalities | OTHER: Specific maternal position during the labor | Fetal presentation after the intervention compare to control group, Diagnosis of the fetal presentation will be measured by an ultra-sound one hour after the randomization in both groups: intervention and control, One hour after the randomization for the study | The aim of the study is to evaluate the efficacy of a specific maternal position to correct fetal position in occipito-posterior during the labor.
The investigators hypothesize that the maternal position described by the Dr de Gasquet facilitate the rotation in occipito-anterior during the labor.
The calculated sample size is 438 participants (219 in each group) |
NCT03081143 | ALL | ADULT, OLDER_ADULT | Advanced Gastric or EGJ Cancer | DRUG: FOLFIRI|DRUG: Ramucirumab|DRUG: Paclitaxel | OS Rate at 6 months primary endpoint for phase II, OS Rate at 6 months is defined at the proportion of patients being known to be alive at 6 months after randomisation, 6 months after randomization|overall survival (OS) co-primary endpoint for phase III, duration from date of randomization to death, from date of randomization to 1 year after end of treatment|Objective Overall Response Rate (ORR) co-primary endpoint for phase III, proportion of patients with complete or partial response (CR + PR) according to RECIST 1.1, from randomization for the time of treatment with a maximum of 1 year | This clinical trial will evaluate whether it is beneficial in terms of prolongation of survival to combine FOLFIRI (standard treatment) with ramucirumab compared to the standard treatment of ramucirumab plus paclitaxel in patients with advanced gastric cancer after failure of one prior line of palliative chemotherapy. This trial aims to investigate the efficacy and safety of ramucirumab plus FOLFIRI (investigational arm A) compared to paclitaxel plus ramucirumab (control arm B). |
NCT02402855 | FEMALE | ADULT, OLDER_ADULT | Pregnancy | OTHER: Delivery of a prepaid payment card|OTHER: Interview with a sociologist|OTHER: No intervention | Occurence of complication(s) of pregnancy, wether maternal, fetal or neonatal, Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date. | This study aims to evaluate the impact of financial support on improving the management of prenatal care in pregnant women with low incomes. The judgment criterion is clinically pertinent: complications of pregnancy. This study also aims to evaluate attitudes to this approach through a qualitative survey.
It is planned to include 4000 women distributed into two arms of 2000 each. One group will receive financial support (prepaid payment card credited for each consultation attended according to the scheduled follow-up as recommended by the Haute Autorité de Santé); the other group will not. The management of the pregnancy for both groups will not be modified. |
NCT04157153 | ALL | ADULT, OLDER_ADULT | Coronary Artery Disease | DEVICE: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold | In scaffold late lumen loss, Independent Core Lab Assessment, At 6 months after index procedure | A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled. |
NCT01732822 | ALL | ADULT, OLDER_ADULT | Peripheral Artery Disease | DRUG: Ticagrelor|DRUG: Clopidogrel | Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke, Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date), From randomization to PACD, an average of 2.5 years | The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease. |
NCT00288613 | ALL | ADULT, OLDER_ADULT | Kidney Failure, Chronic|End Stage Renal Disease, Requiring Dialysis | null | Hospitalizations, To compare the all-cause hospitalizations reported in days per patient year on daily hemodialysis using NxStage System One hemodialysis device to thrice-weekly conventional in-center dialysis using a matched cohort from the US Renal Data System (USRDS) database, duration of study participation | Purpose The purpose of this study is to compare the economical impact and clinical parameters of short daily hemodialysis using the NxStage® System One hemodialysis device with thrice-weekly conventional in-center dialysis using a matched cohort from the US Renal Data System (USRDS) database. |
NCT01500733 | ALL | ADULT, OLDER_ADULT | Leukemia|Leukemia, Lymphocytyc|CLL (Chronic Lymphocytic Leukemia)|SLL (Small Lymphocytic Lymphoma) | DRUG: PCI 32765 | Overall Response Rate at 6 Months, The primary endpoint was response after 6 cycles of therapy. Overall response rate was calculated as complete response plus partial response, based on the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2008 criteria.as follows:
Complete response (CR): all group A and group B criteria are met
* Group A criteria: resolution of enlarged lymph nodes, normal size spleen and liver, absolute lymphocyte count \< 4,000/uL, normocellular bone marrow with \< 30% lymphocytes without nodules
* Group B criteria: improved blood count (platelet count \> 100,000/uL, hemoglobin \> 11.0 g/dL, neutrophils \> 1,500/uL)
Partial response (PR): at least 2 of the group A criteria plus one of the group B criteria are met
* Group A criteria: \>=50% decrease in target lymph nodes, \>=50% decrease in spleen size, \>=50% decrease in liver size, 50% reduction in marrow infiltrates
* Group B criteria: platelet count \> 100,000/uL, hemoglobin \> 11.0 g/dL, neutrophils \> 1,500/uL, 6 months | Background:
- Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) are types of blood or lymph node cancers that mostly affect the elderly. CLL/SLL both create abnormal white blood cells that hurt the immune system and make it more difficult to fight infections. These cancers are usually diagnosed after age 50; more than half of the people with CLL/SLL are over age 70. Elderly people often do not respond well to standard chemotherapy for CLL/SLL. They may have other health problems that make chemotherapy difficult. In addition, individuals who have a genetic abnormality called 17p deletion also do not respond well to standard treatments for CLL/SLL. Researchers want to test a new cancer treatment drug, PCI-32765, to see if it can treat CLL/SLL in these hard-to-treat groups.
Objectives:
- To see if PCI-32765 is a safe and effective treatment for CLL/SLL in older people and people with 17p deletion.
Eligibility:
* Individuals over 65 years of age who have CLL/SLL.
* Individuals at least 18 years of age who have CLL/SLL and 17p deletion.
Design:
* Participants will be screened with a medical history, physical exam, and imaging studies. Blood and urine samples will be taken. Optional bone marrow and lymph node biopsies may also be taken.
* Participants will take PCI-32765 capsules every day for 28 days (one cycle of treatment). Treatment will be monitored with frequent blood tests and clinic visits.
* PCI-32765 will be given for six cycles of treatment. Those who benefit from the drug will continue to take it as long as there are no side effects and the disease does not progress. Those who do not benefit will stop treatment and have regular followup exams. |
NCT00560053 | ALL | CHILD, ADULT, OLDER_ADULT | Multiple Myeloma | DRUG: Alternating chemotherapy|PROCEDURE: Autologous Transplantation|DRUG: Maintenance|PROCEDURE: Second transplantation|PROCEDURE: ALOGENIC MINI TRASPLANTATION | null | The study objectives are to investigate the toxicity and the BUMEL response rate; in patients who reach the CR after autotransplantation, investigate if negativization of IF, influences in disease evolution; in patients in PR after autotransplantation, analyze if the second intensive procedure is capable of increasing the response rate and increasing the survival so that patients who reached the CR with the first transplantation; Patients with MM primarily resistant to the chemotherapy, investigate the efficacy of a double transplantation; patients submitted to double transplantation, control the efficacy of the second transplantation in front of allogenic transplantation. |
NCT00526448 | ALL | ADULT, OLDER_ADULT | Chronic Hepatitis C | DRUG: ribavirin|DRUG: ribavirin|DRUG: Peginterferon alfa-2a|DRUG: epoetin beta | % patients with RNA-HCV < 50 UI/ml, 24 weeks after the end of treatment | To compare the sustained virological response (SVR = ribonucleic acid (RNA) - hepatitis C virus (HCV) undetectable at week 24 before end the treatment) in chronic hepatitis C patients genotype 1-4 co-infected with HIV-HCV, treated with Peginterferón alfa-2a (40 KD) 180 µg/week and Ribavirin (2000 mg/day during 4 weeks, follow of 1000-1200 mg/day, according to body weight); versus Peginterferón alfa-2a (40 KD) 180 μg/week and Ribavirin (1000-1200 mg/day, according to body weight).
To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to week 72, in SVR of these patients with genotypes 1-4 without rapid virological response (RVR = RNA - HCV undetectable at 4 week). |
NCT01881568 | ALL | ADULT, OLDER_ADULT | Blood Loss | DRUG: Tranexamic Acid|DRUG: Tranexamic Acid | Blood transfusion rate, Number of transfused patients in each arm/Total number of patients in each arm, participants will be followed for the duration of hospital stay, an expected average of 5 days | The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled, randomized, double blind clinical trial that compare efficacy and safety of topical TA versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79). |
NCT02447276 | ALL | ADULT, OLDER_ADULT | Osteoarthritis, Knee|Osteoarthritis, Hip | DRUG: REGN475|DRUG: Placebo | The primary endpoint in the study is the change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score., Baseline to week 16 | The primary objective of this study is to evaluate the effectiveness of REGN475 compared to placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a history of inadequate joint pain relief or intolerance to current analgesic therapy. |
NCT04444674 | ALL | ADULT, OLDER_ADULT | Coronavirus | BIOLOGICAL: ChAdOx1 nCoV-19|BIOLOGICAL: Normal saline 0.9% | Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-negative adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety), Number of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination, and unsolicited adverse events for 28 days following vaccination.
Assess occurrence of disease enhancement episodes and serious adverse events in year post vaccination, Up to 12 months post enrollment|Determine if there is a reduction of severe and non-severe COVID-19 disease in HIV-negative adults who receive candidate vaccine ChAdOx1 nCoV-19 compared to placebo recipients (efficacy), Virologically-confirmed COVID-19 clinical disease will be defined as an acute respiratory illness that is clinically consistent with COVID-19 disease, AND SARS-CoV-2 RT-PCR positivity., Up to 12 months post enrollment|Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-positive adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety), Number of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination, and unsolicited adverse events for 28 days following vaccination.
Assess occurrence of disease enhancement episodes and serious adverse events in year post vaccination, Up to 12 months post enrollment|Assess cellular Immunogenicity of ChAdOx1 nCoV-19 in people living with HIV (immunogenicity), Assessing the Interferon-gamma (IFN-γ) enzyme- linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein and Th1 and Th2 cytokine response profile at 3-4 days after vaccination, Up to 12 months post enrollment|Assess humoral immunogenicity of ChAdOx1 nCoV-19 in people living with HIV, Assessing Enzyme-linked immunosorbent assay (ELISA) or fluorescence based micro-bead immunosorbent assay on luminex platform to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) and Virus neutralising antibody (NAb) assays against live and/or pseudotyped SARS-CoV-2 virus, Up to 12 months post enrollment | A Phase I/II, double-blinded, placebo-controlled, individually randomized trial to assess safety, immunogenicity and efficacy of the candidate Coronavirus disease (COVID-19) vaccine ChAdOx1 nCoV-19 in adults aged 18-65 years living with and without HIV in South Africa. The vaccine or placebo will be administered via an intramuscular injection into the deltoid muscle of the non-dominant arm. |
NCT00096824 | ALL | ADULT, OLDER_ADULT | HIV Infections | BEHAVIORAL: Neurological assessment | null | The purpose of this study is to determine how often dementia and other neurological problems occur in people with HIV. Participants of ACTG A5175 will enroll in this study. |
NCT02029742 | ALL | CHILD, ADULT | Sickle Cell Disease | BEHAVIORAL: Community Health Worker (CHW)|BEHAVIORAL: Education | Effect size of the intervention on hydroxyurea (HU) adherence, In this feasibility study, feasibility will be assessed of our methods, the impact of the intervention on adherence to hydroxyurea, and the ability to retain subjects throughout the 6 month period. These data will be used to calculate the effect size of the intervention to estimate the sample needed for a larger trial., 6 months | The investigators propose that culturally aligned community-based interventions in our multi-ethnic sickle cell disease (SCD) population, augmented by task-focused communication technology, can improve self-managed adherence to hydroxyurea (HU) by decreasing barriers to use, supporting parent-youth partnerships for chronic disease self-management and reinforcing the behavior of daily medication use. Culturally aligned community health workers (CHW) are a well-established means to support chronic disease self-management by underserved families, in partnership with medical homes. CHWs can identify and address multiple barriers and reinforce developmentally appropriate self-management to help youth reach and maintain their best fetal hemoglobin (HbF) levels. However, this strategy alone may be insufficient to achieve daily HU adherence. The investigators therefore propose a feasibility trial to test the feasibility and acceptability of a structured intervention of CHW support to address existing barriers to improve HU use, augmented by daily cue-based parent and youth text message reminders, to efficiently extend CHW family support and reinforce family partnerships for self-management. |
NCT02697929 | ALL | ADULT, OLDER_ADULT | Postoperative Residual Curarization|Liver Transplantation | DRUG: sugammadex|DRUG: Neostigmine | Recovery time from moderate neuromuscular block to a TOF ratio more than 0.9 after administration of sugammadex or neostigmine using TOF-Watch SX., 30 minutes | Cirrhotic patients undergoing liver transplantation are at very high risk of post operative complication such as post-operative residual curarization.
Rocuronium is a neuromuscular blocking agent that nowadays can be safely and rapidly antagonized with sugammadex.
No one study compared sugammadex versus neostigmine after rocuronium infusion during liver transplantation. |
NCT03048422 | FEMALE | ADULT, OLDER_ADULT | HIV Infections | DRUG: Dolutegravir|DRUG: Emtricitabine/tenofovir alafenamide|DRUG: Emtricitabine/tenofovir disoproxil fumarate|DRUG: Efavirenz/emtricitabine/tenofovir disoproxil fumarate | Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery, Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories. This outcome was evaluated in the non-inferiority (primary outcome) and superiority (secondary outcome) analyses. The intention-to-treat analysis included all randomized women who had viral load data available. The per-protocol analysis excluded women who modified randomized treatment (stopped, paused, switched, added any treatment) before viral load evaluation at delivery, with the exception of women who modified randomized treatment for use of a concomitant medication., Delivery|Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome, Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (\<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (\<37 completed weeks), or small for gestational age (\<10th percentile by INTERGROWTH 21st Standards), Delivery|Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event, The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.
Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks., From randomization up to 74 weeks|Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event, The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause., From birth through Week 50 postpartum | The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil fumarate, and efavirenz/emtricitabine/tenofovir disoproxil fumarate in pregnant women living with HIV-1 and to compare the safety of these regimens for their infants. |
NCT01866930 | ALL | ADULT, OLDER_ADULT | Chronic Hepatitis C Infection | BIOLOGICAL: Pegylated Interferon Lambda-1a|DRUG: Daclatasvir (DCV)|DRUG: Ribasphere (RBV) | Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12), SVR12 was defined as HCV RNA less than lower limit of quantification (\< LLOQ) (25 IU/mL; target detected or not detected) at follow-up week 12., Follow-up week 12 | To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1 |
NCT02108210 | FEMALE | ADULT | Chronic Fatigue Syndrome | DRUG: Anakinra|DRUG: Placebo | CIS (checklist individual strength, compared to baseline), To investigate the role of the cytokine IL-1 in the pathogenesis of CFS and to find leads for future treatment of CFS, a disorder for which there is no proven effective drug treatment. The primary outcome measure will be fatigue severity at 4 weeks measured with the Checklist Individual Strength (CIS)., 4 weeks, measurement will be repeated up to 26 weeks | Rationale: Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine network has been suspected to play a role in the pathophysiology of CFS. Although derangements of the cytokine network in CFS are controversial, a major problem is that many studies did not use adequate controls. In addition, all studies have been performed on peripheral venous blood of the patients. As cytokines mainly act in the tissues, e.g., the brain, the information that can be derived from peripheral blood cells is limited. The only information regarding the possible role of cytokines in the pathophysiology of CFS could come from intervention studies in which pathogenetically important cytokines are inhibited. A potentially relevant cytokine which can be blocked in humans without severe side effects is IL-1. Although it is plausible that these cytokines play a role in CFS, there is limited evidence for this.
Objective: To investigate the effect on symptomatology of interference with IL-1 in CFS patients.
Study design: A randomized placebo controlled study will be performed to determine whether interference with IL-1 is able to reduce fatigue and disabilities in CFS patients.
Study population: Female CFS patients without psychiatric co-morbidity will be included in this study. Patients of the outpatient clinic of the Department of General internal medicine and the Expert Centre for Chronic Fatigue (ECCF) will be asked to participate in the study. Patients will be asked to bring a healthy neighbourhood control to their first study visit.
Intervention: After inclusion patients will be randomized to receive one of the following treatments:
* interleukin-1 inhibitor Anakinra (IL-1Ra) for 4 weeks (N=25);
* placebo for 4 weeks (N=25).
Main study parameters/endpoints: The primary outcome measure will be fatigue severity measured with the Checklist Individual Strength (CIS) at 4 weeks, measurement will be repeated up to 26 weeks.
Secondary outcome measures will be:
* level of functional impairment measured with the Sickness Impact Profile (SIP8) total score;
* physical and social functioning assessed with the subscale physical functioning and social functioning of the SF-36;
* level of psychological distress assessed with the total score on the Symptom Checklist-90 (SCL-90);
* pain severity assessed with a Visual Analog Scale (VAS);
* cytokine measurement in blood (plasma and blood in Pax-gene tubes) and saliva (at protein and mRNA level);
* cortisol measurement in saliva and hair;
* microbiome determination in faeces;
* body temperature and pulse rate. |
NCT03020719 | ALL | CHILD | Cystic Fibrosis | DRUG: Oral Glutathione|DRUG: Placebo | Change in Weight-for-age Z-score, Difference between the oral glutathione and placebo groups in the 24-week change from baseline in weight-for-age Z-score. Weight-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean., Baseline to 24 weeks | The purpose of this randomized, placebo-controlled (Phase II) study will be to further evaluate the effects of oral glutathione on growth in children with CF. |
NCT00873704 | ALL | ADULT, OLDER_ADULT | Surgical Wound Infection|Vascular Surgery | OTHER: supplemental postoperative oxygen | surgical wound infection, 30 days | The purpose of this study was to test the hypothesis that supplemental postoperative oxygen reduces the risk of surgical wound infection in patients following lower limb vascular surgery. |
NCT01842594 | ALL | ADULT, OLDER_ADULT | Sarcoma | DRUG: Sirolimus and hydroxychloroquine | The Maximum Standardized Uptake Values (SUVmax) Change on PET/CT Scan, A baseline whole-body \[18F\]-fluorodeoxyglucose(FDG) PET was performed before therapy initiation. Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks. A second \[18F\]-FDG PET was performed after treatment completion. SUVs were calculated for all lesions. Regions of interest (ROI) were contoured to represent tumors (\>2 cm) and organs (lungs, spleen, and liver) on all transaxial and coronal slices. ROIs were normalized for injection dose and body weight, and the maximum voxel value was recorded for each region or organ. The highest SUV measured with increased uptake was considered the SUVmax. Correlative diagnostic CT examinations were used for accurate localization of the lesions. The most intense uptake at baseline was identified as the index lesion and evaluated for treatment response., 2 Weeks | Determine the objective response rate in sarcoma patients treated with hydroxychloroquine and sirolimus. |
NCT00792051 | ALL | CHILD, ADULT, OLDER_ADULT | Influenza Virus Infection | BIOLOGICAL: Inactivated influenza vaccine|BIOLOGICAL: Saline | The proportions of subjects and household contacts with serology-confirmed influenza infection during follow-up among the 2 intervention arms., nine months | While immunisation of school-age children against influenza is not recommended in Hong Kong, past experience in Japan and elsewhere suggests that immunisation of children may protect the wider community through its indirect transmission-limiting impact as well as the direct immunologic protection afforded vaccinated children themselves. We aim to assess whether vaccinating children against influenza protects vaccinees as well as their household contacts from infection. |
NCT01206062 | ALL | ADULT, OLDER_ADULT | Hypertension | DRUG: Intensive control of SBP|DRUG: Standard control of SBP | Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death, 6 years | Elevated blood pressure (BP) is an important public health concern. It is highly prevalent, the prevalence may be increasing, and it is a risk factor for several adverse health outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline in cognitive function. The Systolic Blood Pressure Intervention Trial (SPRINT) is a 2-arm, multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended will reduce cardiovascular disease (CVD) risk. |
NCT04755530 | MALE | ADULT, OLDER_ADULT | Overweight or Obesity|Metabolic Syndrome | DIETARY_SUPPLEMENT: Regular whole milk|DIETARY_SUPPLEMENT: Yogurt with live bacteria|DIETARY_SUPPLEMENT: Yogurt with inactivated bacteria|DIETARY_SUPPLEMENT: Acidified whole milk | Liver fat, Measurements of liver fat by Magnetic Resonance Imaging, Change from Week 0 to week 16 | The study will be conducted as a randomized controlled trial with four parallel arms including four dairy products. We will investigate the health effects of including yogurt in the diet through a 16-weeks intervention period among 100 volunteering males with symptoms of the metabolic syndrome. The study has a total duration of 20 weeks as a wash out period of four weeks will be initiated prior to the intervention. |
NCT04261335 | ALL | CHILD | Hypoxia-Ischemia, Brain | BIOLOGICAL: CL2020 cells | Incidence of adverse events, Any adverse events are summarized., until 12 weeks after the administration | The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy. In addition, we will evaluate the efficacy of CL2020 cells for infant development. |
NCT02745392 | ALL | ADULT, OLDER_ADULT | Acute Migraine | DRUG: ZP-Zolmitriptan|DRUG: Placebo | Proportion of Subjects With Pain Freedom, Pain Freedom at 2 hours post study drug administration is one of the co-primary endpoints. Subjects were queried via their eDiary about their level of migraine pain (none, mild, moderate, or severe) at various intervals post-dose. Subjects who answered none at 2 hours post study drug were considered pain free at 2 hours., 2 hours|Proportion of Subjects With Freedom From Most Bothersome Pre-specified Other Symptom (Nausea, Photophobia, or Phonophobia Pre-specified by Subject), The proportion of subjects with freedom from the subject's pre-specified most bothersome symptom at 2 hours is one of two parts of the co-primary efficacy endpoint. This endpoint will be evaluated separately but both endpoints have to be met statistically for the study to be considered a success., 2 hours | This is a randomized, double-blind, multi-center, parallel-group study designed to compare the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle systems to placebo. |
NCT00969982 | FEMALE | CHILD, ADULT, OLDER_ADULT | Abortion, Induced | DRUG: mifepristone+misoprostol|DRUG: misoprostol+placebo | Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention., 48 hours|Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus., 48 hours | The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 120 women in each country comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion. |
NCT02247258 | ALL | CHILD, ADULT, OLDER_ADULT | Crohn Disease|Recurrence|Azathioprine|Prevention | DRUG: Azathioprine|DRUG: Azathioprine in case of endoscopic recurrence|PROCEDURE: Ileocolonoscopy|PROCEDURE: Small bowel follow trough | Endoscopic remission, The proportion of patients with endoscopic remission (Rutgeerts' postoperative endoscopic score i0 or i1) at 102 weeks, Week 102 | The objective of this study is to evaluate if in the prevention of postoperative recurrence of ileal Crohn's disease immediate initiation of azathioprine postoperatively is superior to delayed (6- 12 mths.) introduction of azathioprine upon disease recurrence assessed by endoscopic criteria. The primary endpoint, disease recurrence, encompasses symptomatic and surgical recurrence as well as severe endoscopic lesions at the final, 2 year, assessment. |
NCT04381936 | ALL | CHILD, ADULT, OLDER_ADULT | Severe Acute Respiratory Syndrome | DRUG: Lopinavir-Ritonavir|DRUG: Corticosteroid|DRUG: Hydroxychloroquine|DRUG: Azithromycin|BIOLOGICAL: Convalescent plasma|DRUG: Tocilizumab|BIOLOGICAL: Immunoglobulin|DRUG: Synthetic neutralising antibodies|DRUG: Aspirin|DRUG: Colchicine|DRUG: Baricitinib|DRUG: Anakinra|DRUG: Dimethyl fumarate|DRUG: High Dose Corticosteroid|DRUG: Empagliflozin|DRUG: Sotrovimab|DRUG: Molnupiravir|DRUG: Paxlovid|DRUG: Baloxavir Marboxil|DRUG: Oseltamivir|DRUG: Low-dose corticosteroids: Dexamethasone|DRUG: Low-dose corticosteroids: Dexamethasone | All-cause mortality, For each pairwise comparison with the 'no additional treatment' arm, the primary objective is to provide reliable estimates of the effect of study treatments on all-cause mortality., Within 28 days after randomisation|Influenza co-primary outcome: All-cause mortality (with subsidiary analysis of cause of death and death at various timepoints following discharge), Within 28 days after randomisation|Influenza co-primary outcome: Time to discharge alive from hospital, Within the first 28-days | RECOVERY is a randomised trial of treatments to prevent death in patients hospitalised with pneumonia.
The treatments being investigated are:
COVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Empagliflozin, Sotrovimab, Molnupiravir, Paxlovid or Anakinra (children only)
Influenza: Baloxavir marboxil, Oseltamivir, Low-dose corticosteroids - Dexamethasone
Community-acquired pneumonia: Low-dose corticosteroids - Dexamethasone |
NCT03024827 | ALL | CHILD | Epileptic Encephalopathy | DRUG: CanniMed® 1:20 | Heart Rate, Up to 6 months|Blood Pressure, Up to 6 months|Weight, Up to 6 months|Complete Blood Count (CBC) and Differential, Up to 6 months|Sodium, potassium, chloride, calcium, magnesium, phosphate and carbon dioxide (mmol/L), Up to 6 months|Blood Urea Nitrogen (mmol/L), Up to 6 months|Creatinine (umol/L), Up to 6 months|Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-glutamyl transferase (GGT) and Lipase (U/L), Up to 6 months|Total and Direct Bilirubin (umol/L), Up to 6 months|Albumin (g/L), Up to 6 months|Total Cholesterol and Triglyceride (mmol/L), Up to 6 months|Clobazam and Norclobazam Levels (umol/L), For participants taking clobazam who become excessively sedated, Up to 6 months|Clonazepam Level (umol/L), For participants taking clonazepam who become excessively sedated, Up to 6 months|Urine Ketones, For participants on the ketogenic diet, Up to 6 months|Trough Level of Concomitant Anti-Convulsants, Measure interactions with any anti-convulsants participants may be already on, Up to 7 months|Adverse Events, Side effect rating scale, includes items related to sleepiness/lethargy, irritability, nausea/vomiting and diarrhea, Through study completion, up to 7 months|2-hour Electroencephalogram (EEG) Recording, Up to 6 months | This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal Extract in a small group of children with refractory epileptic encephalopathy. The dosage of Cannabis Herbal Extract will be gradually increased over a four month time period. |
NCT02705560 | ALL | ADULT | Healthy | OTHER: Cow´s milk (3.9% fat, pasteurized)|OTHER: hard, yellow cheese|OTHER: Soy based drink | Identification of dietary biomarkers of cheese and milk intake, 24 hours | Dietary biomarkers are compounds in biofluids that directly reflect the intake of specific foods or food groups. Their exploration and use in the field of dietary assessments could provide an objective measure of actual intake complementing classical assessment methods (e.g. food frequency questionnaire, 24h recalls). To date, only a limited number of foods have been covered by validated biomarkers.
The study is part of the international project "The Food Biomarker Alliance (FOODBALL)". The study described here has been assigned to assess biomarkers of the intake of milk and cheese. Up to now, there is an evident lack of data on specific and validated biomarkers of milk and cheese (dairy products), which belong to the most relevant public health related foods in Europe. This study will further provide novel insights into the influence of fermentation of milk-based foods on metabolic effects and postprandial adaptations, which has not yet been studied in depth before using cheese as fermented product. Outcomes will support and expand earlier findings on correlation between the intake of fermented dairy products intake and human health. |
NCT01422551 | FEMALE | ADULT, OLDER_ADULT | Breast Cancer | BEHAVIORAL: Cognitive Behavioral Stress Management|BEHAVIORAL: a psycho-educational control | change from baseline to 12 month follow-up in psychosocial adaptation (less negative affect and social disruption; more benefit finding and positive affect), changes in a composite composed of negative affect measures plus a measure of social disruption plus a measure of benefit finding plus a measure of positive affect, baseline and 6 and 12 month follow-up | The purpose of this study is to test the effects of a 10-wk cognitive behavioral stress management (CBSM) intervention vs. a single-day psycho-educational seminar on psychosocial adaptation and physiological adaptation in women being treated for stage I-III breast cancer. |
NCT03009435 | FEMALE | ADULT, OLDER_ADULT | Fetal Manual Rotation | OTHER: prophylactic manual rotation | Percentage of spontaneous vaginal delivery, At the time of delivery | Introduction:
The frequency of fetuses in occiput posterior position during labor is approximately 20 %, in which 5% remain occiput posterior at the end of labor. Occiput posterior position is associated with higher risks of caesarean deliveries and operative vaginal deliveries. The manual rotation to promote rotation from a posterior to an anterior position has been proposed to reduce the extraction rate. There is no randomised trial comparing the effect of manual rotation and expectant management. We propose a protocol for a prospective, monocentric, randomised controlled clinical trial in order to show that the rate of spontaneous vaginal delivery is higher with manual rotation of occiput posterior position than with an expectative management.
Methods:
Every 37 weeks with a singleton pregnancy with a clinical occiput posterior position suspicion confirmed by a transabdominal ultrasound at full dilatation will be eligible. Participants will be randomised to either prophylactic manual rotation (experimental group) or expectative management (control group). Based on an alpha value of 0.05 and gaining 20% for spontaneous vaginal delivery, 238 participants will need to be enrolled.
The primary outcome will be spontaneous vaginal delivery. Secondary outcomes will be operative delivery rate (caesarean section , vacuum or forceps deliveries), significant maternal and perinatal mortality/morbidity.
Analysis will be by intention-to-treat averaging a 24-month period. |
NCT00855322 | ALL | ADULT, OLDER_ADULT | Arthritis, Rheumatoid | OTHER: Gym exercise group intervention|OTHER: Hydrotherapy group exercise intervention|OTHER: Control group | Stanford Health Assessment Questionnaire, Baseline, 8 weeks and 24 weeks | The purpose of this study is to determine whether exercise is beneficial for people with rheumatoid arthritis(RA) taking antiTNFalpha medication |
NCT04784780 | ALL | ADULT, OLDER_ADULT | Chronic Constipation | DRUG: Elobixibat 10mg|DRUG: Placebo | Change in the number of complete spontaneous bowel movements at week 12, Change in the number of complete spontaneous bowel movements at week 12 of the treatment period from week 2 of the observation period. \*Spontaneous defecation without residual sensation., Week 12 | In this double-blind comparative study, AJG533 (elobixibat) 10 mg or AJG533 placebo was orally administered once daily before meals for 12 weeks in patients with chronic constipation, and the primary endpoint was the change from Week 2 of the observation period in the number of complete spontaneous bowel movements (CSBM) at Week 12 of the treatment period. The primary endpoint was the change in the number of complete spontaneous bowel movements (CSBM) from Week 2 of the observation period. |
NCT00795912 | ALL | ADULT, OLDER_ADULT | Heart Failure | DRUG: Atorvastatin | hsCRP, TNF-alpha, IL-6, 6 months | Inflammation and fibrosis may be important contributors to worsening heart failure. As well as lowering cholesterol, statins are also known to reduce inflammatory markers such as C-reactive protein which are elevated in severe heart failure. Therefore, this project will evaluate the benefit, if any, of statins on markers of heart structure and function, on inflammatory markers and markers of fibrosis in patients with normal cholesterol. |
NCT02572115 | ALL | CHILD, ADULT, OLDER_ADULT | After-hours Care | BEHAVIORAL: Akutknappen - used|BEHAVIORAL: Akutknappen - not used | Patient satisfaction and feeling of safety with the intervention measured by questionnaire, Measured by questionnaire after contact with the OOH-PC sent out 2-4 days after contact|Frequencies of patients who jumped the line, Numbers and statistics from data provider, Up to 4 months | The purpose of this randomized controlled trial is to test the use of an emergency button that allows patients to jump the telephone waiting line at the out-of-hours primary care in two regions in Denmark if they perceive their illness as acute and severe. |
NCT00168558 | ALL | CHILD | Measles | BIOLOGICAL: Measles vaccine | Vaccine efficacy, Assessed by study completion|Measles specific mortality, Assessed by study completion|All cause sex-specific mortality until 3 years of age, Assessed by study completion | The specific aims are to examine in Guinea-Bissau:
* whether the standard titre Schwarz (SW) or standard-titre Edmonston-Zagreb (EZ) measles vaccine will be the best vaccine strain for use in a routine one-dose measles vaccination schedule and a two-dose measles vaccination schedule in terms of antibody response, protection against measles and child survival, and
* whether the standard-titre Edmonston-Zagreb (EZ) vaccine will be suitable for use in a very early two-dose schedule vaccinating at 4½ and 9 months of age |
NCT03885648 | FEMALE | ADULT, OLDER_ADULT | Breast Cancer | null | Metagenomic study of mammary microbiota, Composition of bacteria, archaea, fungi and viruses present in breast tissue of women with breast cancer compared with that of women without breast cancer., December 31, 2020|Metagenomic study of intestinal microbiota, Composition of bacteria, archaea, fungi and viruses present in stool samples of women with breast cancer compared with that of women without breast cancer., December 31, 2020 | Breast cancer ranks first in women, and is the second cause of death in this gender. In addition to genetics, the environment contributes to the development of the disease, although the factors involved are not well known. Among the latter is the influence of microorganisms and, therefore, attention is recently being paid to the mammary microbiota. The hypothesis of this study is that the risk of breast cancer could be associated with the composition and functionality of the mammary/gut microbiota, and that exposure to environmental contaminants (endocrine disruptors, EDCs) might contribute to alter the microbiota.
This is a case-control clinical study that will be performed in women between 25 and 70 years of age. Cases will be women diagnosed and surgically intervened of breast cancer (stages I and II). Women with antecedents of cancer or advanced tumor stage (metastasis), or who have received antibiotic treatment within 3 months prior to recruitment, or any neoadjuvant therapy, will be excluded. Controls will be women surgically intervened of breast augmentation or reduction. Women with oncological, gynecological or endocrine history, and those who have received antibiotic treatment within 3 months prior to recruitment will also be excluded. Blood, urine, breast tissue and stool samples will be collected. Data regarding anthropometric, sociodemographic, reproductive history, tumor features and dietary habits will be gathered.
Metabolomic studies will be carried out in stool and breast tissue samples. Metagenomic studies will also be performed in stool and breast tissue samples to ascertain the viral, fungal, bacterial and archaea populations of the microbiota. Quantitation of estrogens, estrogen metabolites and EDCs in samples of serum, urine and breast tissue will also be performed.
This is the first time that the contribution of bacteria, archaea, viruses and fungi together with their alteration by environmental contaminants to the risk of breast cancer will be evaluated in the same study. Results obtained could contribute to elucidate risk factors, improve the prognosis, as well as to propose novel intervention studies in this disease. |
NCT02691013 | ALL | ADULT, OLDER_ADULT | Delirium|Sleep Deprivation | DRUG: Ramelteon|DRUG: Placebo | Duration of Delirium, Measured twice daily during the ICU stay using the Confusions Assessment Method instrument., Twice daily for up to 10 days|Total Duration of Sleep, Participants wore an actigraphy device on their wrist for the duration of their ICU stay. This device continuously measures activity, and thus estimates sleep time., Daily for up to 10 days | Sleep deprivation is known to affect brain function but is often ignored in the sickest patients including those in the intensive care unit after major surgery. In these patients, the levels of melatonin can also be altered. Melatonin is a hormone secreted in the brain that maintains the body's sleep-wake, or circadian, cycle. The investigators want to test whether improving sleep quality affects the risk of developing confusion (delirium) in patients having clot removed from their lung (open heart surgery). In order to improve sleep quality, the investigators will conduct a study of Ramelteon, a medication that mimics the activity of melatonin and measure its effects on levels of melatonin and monitor sleep. |
NCT01033188 | ALL | ADULT | Knee Outcome, Subjective | PROCEDURE: Single bundle|PROCEDURE: Double bundle | KOOS score(QOL), 1-5 years | There has been an increased awareness towards ACL (anterior cruciate ligament) injuries for Norwegian teams, particularly in handball and soccer. The reported number of reconstructions in Norway ranges from 1500 to 2000 per year, and in the United States from 50,000 to 100,000 per year, making ACL reconstruction one of the most common orthopaedic procedures performed, especially among young, active and healthy individuals. However, reports state that there is a subset of patients (10-40%) who remain subjectively and objectively unstable and/or are unable to regain prior function. Additionally, it has been reported that degenerative joint disease is associated with traditional single-bundle ACL reconstructions in up to 50% of the patients in long term follow up studies.
It is well known that the ACL is composed of 2 functional bundles named after their tibial attachments, the anteromedial (AM) and posterolateral (PL) bundles.
It is believed that the current single-graft, single-bundle technique for reconstructing the anterior cruciate ligament does not anatomically reconstruct either one of these bundles.
In the last two years, the double bundle technique has been introduced and a few clinical studies are available, however only a few RCTs.
Further study is very important to determine if double-bundle ACL reconstructions should be performed, if single-bundle reconstructions can be adjusted to better adapt to their biomechanical insufficiency in restoring internal rotation torques and valgus moments, and also in trying to identify which patients might better benefit from single-bundle versus double-bundle ACL reconstructions. |
NCT01394458 | ALL | ADULT, OLDER_ADULT | Catheter Related Infection|Bacteremia | OTHER: 30 % ethanol / 4% sodium citrate catheter locking solution|DRUG: Heparin 1000 u / ml | Documentation of Serious Adverse Events (SAE) with the use of a 30% ethanol / 4% sodium citrate catheter locking solution., This outcome will monitor the safety of the ethanol/sodium citrate catheter locking solution., 6 months | Currently in Canada, either 4% sodium citrate or heparin 1,000-10,000 U/ml solutions are "locked" into hemodialysis catheters between dialysis sessions to prevent thrombosis. The use of an ethanol/sodium citrate locking solution may have advantages over either of these agents alone. The investigators hypothesize that the 30 % ethanol/4% sodium citrate catheter locking solution is safe and effective in the prevention of catheter-related infections and thrombosis. |
NCT04058483 | ALL | ADULT, OLDER_ADULT | Testing the Hypnotizability of Healthy Volunteers | OTHER: Hypnotizability testing | Reliability of HIP and rHIP test scores, Calculate the correlation between the HIP and rHIP, Through study completion, approximately 2 months. | The purpose of the study is to determine if hypnotizability can be reliably tested over the phone, without having to see or touch a patient. The scores from a new test for hypnotizability by phone will be compared to the scores from a standard in-person test, to make sure the results are similar. |
NCT03605173 | ALL | ADULT, OLDER_ADULT | Osteoporosis | DIAGNOSTIC_TEST: free vitamin d test|DIAGNOSTIC_TEST: total vitamin d | Free vitamin D, measured using free vitamin D Elisa kit, ! day|Total vitamin D, It is measured as a part of routine investigation at the time of admission, ! day | According to the free hormone hypothesis, the biological activity of a hormone is carried by the portion that is not bound to protein or its carrier in circulation. Based on this, we believe that the free vitamin d, which is the proportion of Vitamin D unbound to vitamin D binding protein and albumin, performs the calcium-regulating functions of the vitamin. Hence, our objective is to study whether free vitamin correlated better with BMD and fracture than the total vitamin D. |
NCT01218685 | ALL | CHILD, ADULT, OLDER_ADULT | Immunocompromised Patients|Safety of Pandemic Influenza A (H1N1)Vaccine|Immunogenicity of Pandemic Influenza A (H1N1)Vaccine | BIOLOGICAL: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS | Antibody titers of 1:40 or more for influenza A pandemic (H1N1), the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay, 21 days after vaccination | The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised disease, elderly and pregnants. The primary immunological endpoint is to analyze the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay 21 days after 1 dose of the vaccine. Volunteers will be monitored for safety during 21 days after vaccination. Volunteers will be recruited based on inclusion and exclusion criteria. Vaccine composition is: 15 micrograms of split inactivated virus (A/California/7/2009 (H1N1) (NYMC X179A). The hypothesis of the study is that the vaccine is safe and immunogenic in the volunteers recruited. |
NCT00139750 | ALL | ADULT, OLDER_ADULT | Smoking Cessation | DRUG: CP-526,555 (varenicline) | 4-week continuous quit rate (CQR) for Weeks 9-12 | The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit. |
NCT03336359 | ALL | ADULT, OLDER_ADULT | Colon Adenoma | DIAGNOSTIC_TEST: Tandem colonoscopy | Adenoma/polyp detection rate, Percentage of patients with adenoma/polyp detected, first-pass colonoscopy | This is a prospective randomized trial comparing the adenoma detection rate of LCI with NBI. Eligible patients are randomly allocated in a 1:1 ratio to undergo tandem colonoscopy with LCI (LCI group) or NBI (NBI group). Randomization will be carried out by computer generated random sequences and stratified according to endoscopist's experiences (experienced versus fellows) and indications of colonoscopy (symptomatic vs screening/surveillance).
The primary outcome of this study is to compare the adenoma or polyp detection rates by LCI and NBI during the first examination. Secondary outcomes included adenoma/polyp miss rate by LCI or NBI. Other outcomes include sessile serrated adenomas or polyps (SSA/P) detection rates and advanced adenoma detection rates. |
NCT00445601 | ALL | ADULT, OLDER_ADULT | Bladder Cancer | DRUG: gemcitabine hydrochloride|OTHER: placebo | Disease Recurrence Rate, Percentage of patients who experienced a recurrence of grade 1 or 2 superficial transitional cell cancer of the bladder between the date of registration and 24 months. Disease recurrence considered to occur at date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence were censored at the time of their last cystoscopy., Up to 2 Years | RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder after surgery may kill more tumor cells. It is not yet known whether giving gemcitabine directly into the bladder is more effective than a placebo in treating bladder cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine to see how well it works when given directly into the bladder compared with a placebo after surgery in treating patients with newly diagnosed or recurrent bladder cancer. |
NCT01363583 | ALL | CHILD, ADULT, OLDER_ADULT | Traumatic Brain Injury | DRUG: epoprostenol versus normal saline|DRUG: normal saline | Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo, 24 hours | This study is a prospective consecutive double-blinded randomized study on the effect of PGI2, prostacyclin (epoprostenol, Flolan®) versus placebo (saline)in patients with severe traumatic brain injury. All patients with severe traumatic brain injury were eligible for inclusion. Inclusion criteria: verified traumatic brain injury, Glasgow Coma Score (GCS) at intubation and sedation of ≤ 8, age 15-70 years, a first-recorded cerebral perfusion pressure (CPP) of \> 10 mm Hg, and arrival within 24 hours after trauma.
Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a lactate/pyruvate ratio,as measured by cerebral microdialysis after 24 hours of treatment.
A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers, measured by different cytokines. |
NCT02920268 | FEMALE | CHILD | Functional Abdominal Pain|IBS | OTHER: Dance and yoga intervention | Faces pain scale (FPS-R), Has the perceived abdominal pain decreased by a 8 months long intervention with regular dance and yoga for girls with recurrent abdominal pain, measured immediately after the intervention compared to the control group? The primary outcome is the proportion of girls in each group that have lowered their maximal abdominal pain measured by Faces Pain Scale (FPS-R)., 24 months | Recurrent abdominal pain affects up to 37% of school-age children, mostly girls. These problems results in decreased quality-of-life, absence from school, lower sleep quality and increased health-care consumption. Long-term effects are lasting pain-symptoms and increased risk for psychiatric illness.
The scientific evidence for interventions towards long-term pain in children is limited and pharmacological treatment is not effective. Cognitive behavioral therapy has shown some effect but is time- and resource consuming. Dance and yoga can enhance positive protective factors through better body awareness and increased self-regulation. Relaxation in yoga also has positive effect on abdominal pain.
The aim of this study is to evaluate the effects of an intervention with dance and yoga for girls, 9 to 13 years old, with recurrent abdominal pain. The participants will be identified through pediatric clinics in Örebro County, primary health care and school health care. They will be randomized to intervention with weekly dance- and yoga class for 8 months or control group with standard treatment. Primary outcome is the fraction of girls in each group who, direct after intervention, has decreased their maximum pain measured by Faces Pain Scale. Secondary outcomes are stress, psychical health, well-being, school and sleep functions, physical activity and health-economy. The study group will be followed up for two years.
Just-in-TIME is an interdisciplinary research group with expertise in interventions for psychosomatic problems in children and adolescents. TIME, which stands for Try, Identify, Move and Enjoy, also characterizes this project, aiming at decreasing recurrent abdominal pain through an intervention with dance and yoga for 9-13 year old girls. |
NCT03595176 | ALL | CHILD, ADULT, OLDER_ADULT | Coronary Artery Disease|Myocardial Infarction | DEVICE: Lithotripsy | Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure, The primary safety endpoint was freedom from MACE at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Pivotal Analysis Set., within 30 days of index procedure|Number of Participants With Procedural Success (Residual Stenosis <50%), The primary effectiveness endpoint was Procedural Success defined as stent delivery with a residual in-stent stenosis \<50% (core laboratory assessed) and without in-hospital MACE. The primary endpoints were analyzed using the Pivotal Analysis Set., 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure | The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study. |
NCT03500991 | ALL | CHILD, ADULT | Central Nervous System Tumor, Pediatric|Glioma|Ependymoma|Medulloblastoma|Germ Cell Tumor|Atypical Teratoid/Rhabdoid Tumor|Primitive Neuroectodermal Tumor|Choroid Plexus Carcinoma|Pineoblastoma | BIOLOGICAL: HER2-specific chimeric antigen receptor (CAR) T cell | Establish the safety, defined by the adverse events, of HER2-specific CAR T cell infusions delivered by a central nervous system (CNS) catheter into the tumor resection cavity or ventricular system, The type, frequency, severity, and duration of adverse events as a result of HER2-specific CAR T cell infusion will be summarized, up to 6 months|Establish the feasibility, defined by the ability to produce and administer CAR T cell product, of HER2-specific CAR T cell product infusions delivered by a central nervous system (CNS) catheter into the tumor resection cavity or ventricular system, The proportion of products successfully manufactured and infused will be measured, 28 days | This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with autologous CD4 and CD8 T cells lentivirally transduced to express a HER2-specific chimeric antigen receptor (CAR) and EGFRt, delivered by an indwelling catheter in the tumor resection cavity or ventricular system in children and young adults with recurrent or refractory HER2-positive CNS tumors. A child or young adult with a refractory or recurrent CNS tumor will have their tumor tested for HER2 expression by immunohistochemistry (IHC) at their home institution or at Seattle Children's Hospital. If the tumor is HER2 positive and the patient meets all other eligibility criteria, including having a CNS catheter placed into the tumor resection cavity or into their ventricular system, and meets none of the exclusion criteria, then they can be apheresed, meaning T cells will be collected. The T cells will then be bioengineered into a second-generation CAR T cell that targets HER2-expressing tumor cells. The patient's newly engineered T cells will then be administered via the indwelling CNS catheter for two courses. In the first course they will receive a weekly dose of CAR T cells for three weeks, followed by a week off, an examination period, and then another course of weekly doses for three weeks. Following the two courses, patient's will undergo a series of studies including MRI to evaluate the effect of the CAR T cells and may have the opportunity to continue receiving additional courses of CAR T cells if the patient has not had adverse effects and if more of their T cells are available.
The hypothesis is that an adequate amount of HER2-specific CAR T cells can be manufactured to complete two courses of treatment with three doses given on a weekly schedule followed by one week off in each course. The other hypothesis is that HER-specific CAR T cells safely can be administered through an indwelling CNS catheter to allow the T cells to directly interact with the tumor cells for each patient enrolled on the study safely can be delivered directly into the brain via indwelling catheter. Secondary aims of the study will include to evaluate CAR T cell distribution with the cerebrospinal fluid (CSF), the extent to which CAR T cells egress or traffic into the peripheral circulation or blood stream, and, if tissues samples from multiple time points are available, also evaluate the degree of HER2 expression at diagnosis versus at recurrence. |
NCT01038102 | ALL | ADULT, OLDER_ADULT | Obesity|Diabetes|Insulin Resistance|Fatty Liver | OTHER: PUFA Diet|OTHER: SFA diet | Hepatic steatosis by MRT, 10 weeks | The purpose of this study is to investigate whether substituting saturated fats with polyunsaturated fats reduces fatty liver and improves insulin action and other metabolic variables in abdominally obese subjects |
NCT01249625 | ALL | ADULT, OLDER_ADULT | Influenza|Respiratory Syncytial Viruses|Paramyxoviridae Infections|Coronavirus|Rhinovirus | DEVICE: N95 Respirator|DEVICE: Medical/surgical mask | Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events, Number of influenza A and B events in healthcare practitioners wearing N95 respirators compared to medical masks., 60 weeks | Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace, there is very little clinical evidence that respirators prevent healthcare personnel (HCP) from airborne infectious diseases. Scientific investigation of this issue has been quite complicated, primarily because the use of respirators has become "the standard of care" for protection against airborne diseases in some instances, even without sufficient evidence to support their use. The key question remains: How well do respirators prevent airborne infectious diseases? The answer to this important question has important medical, public health, political and economic implications. |
NCT00112723 | ALL | ADULT, OLDER_ADULT | Adult Lymphocyte Depletion Hodgkin Lymphoma|Adult Lymphocyte Predominant Hodgkin Lymphoma|Adult Mixed Cellularity Hodgkin Lymphoma|Adult Nodular Sclerosis Hodgkin Lymphoma|Anaplastic Large Cell Lymphoma|Angioimmunoblastic T-cell Lymphoma|Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue|Nodal Marginal Zone B-cell Lymphoma|Recurrent Adult Diffuse Large Cell Lymphoma|Recurrent Adult Diffuse Mixed Cell Lymphoma|Recurrent Adult Diffuse Small Cleaved Cell Lymphoma|Recurrent Adult Grade III Lymphomatoid Granulomatosis|Recurrent Adult Hodgkin Lymphoma|Recurrent Adult T-cell Leukemia/Lymphoma|Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma|Recurrent Grade 1 Follicular Lymphoma|Recurrent Grade 2 Follicular Lymphoma|Recurrent Grade 3 Follicular Lymphoma|Recurrent Mantle Cell Lymphoma|Recurrent Marginal Zone Lymphoma|Recurrent Mycosis Fungoides/Sezary Syndrome|Recurrent Small Lymphocytic Lymphoma|Refractory Multiple Myeloma|Splenic Marginal Zone Lymphoma|Stage I Multiple Myeloma|Stage II Multiple Myeloma|Stage III Multiple Myeloma|Waldenström Macroglobulinemia | DRUG: alvocidib | Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I), Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy., 28 days|Maximum Tolerated Dose (MTD), The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT., 28 days|Complete and Partial Response Rate (Phase II), Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria., Up to 2 years|Qualitative and Quantitative Toxicities in Regard to Organ Specificity, The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients., Up to 30 days after completion of study treatment|Lymphoid/Plasma Cell Malignancies, Identify subsets, based on levels of response (PR and SD), of lymphoid / plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of flavopiridol., Up to 2 years | This phase I/II trial is studying the side effects and best dose of flavopiridol and to see how well it works in treating patients with lymphoma or multiple myeloma. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. |
NCT02931838 | ALL | ADULT, OLDER_ADULT | Psoriasis | DRUG: BMS-986165|DRUG: Placebo for BMS-986165 | The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12), Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity., Day 1 to Day 85|Number of Participants With Adverse Events, The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation, Day 1 to day 115 | A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165 |
NCT03464110 | ALL | ADULT, OLDER_ADULT | Improved Communication Between Clinician and Patient | BEHAVIORAL: Communication Intervention | Change in quality of communication with black patients as measured by a summary of clinician-encounter counts derived from audio recordings, Determine the effect of a clinician communication coaching intervention versus control on racial disparities in objective measures of communication quality, Baseline, 7 months|Change in quality of communication with white patients by continuous measure using a linear mixed-effects model., Determine the effect of a clinician communication coaching intervention versus control on racial disparities in objective measures of communication quality, Baseline, 7 months | The purpose of this study is to determine the effect of a clinician communication coaching intervention versus control on an objective measure of the quality of communication (primary outcome) and patients' perceptions of the quality of patient-centered care (secondary outcome), both overall and within Black and White patients. |
NCT02897076 | FEMALE | ADULT | Neonatal Complications | DRUG: betamethasone 24 mg|DRUG: 12mg betamethasone +placebo | severe RDS defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life, The primary assessment criterion is severe respiratory distress syndrome(RDS) defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life. It is considered as a binary endpoint: failure if there is occurrence of RDS, or not failure., 48 hours of life | Extensive animal studies have indicated that antenatal betamethasone exposure results in altered developmental trajectories of several fetal systems. Follow up of a randomized controlled trial has shown that antenatal betamethasone exposure might result in insulin resistance 30 years later. Furthermore, animal studies and randomized trials in Humans have clearly demonstrated that betamethasone-induced growth alterations were dose-related.
In ewes, a 50% reduced dose regimen resulted in maximal improvement in preterm lamb lung function, similar to those obtained after a full dose.
Our hypothesis is that antenatal betamethasone after a 50% dose reduction, justified by the potential long term effects of this drug, is not inferior to a full dose to promote fetal lung maturation in Humans. |
NCT04065984 | ALL | ADULT, OLDER_ADULT | Rectal Cancer|Colorectal Cancer|Colon Cancer|Colo-rectal Cancer|Sarcopenia|Sarcopenic Obesity|Advanced Cancer|Recurrent Rectal Cancer | DEVICE: Microstim 2v2 Stimulator | Mean muscle attenuation pre and postoperatively, The difference in mean muscle attenuation (MA) measured in Hounsfield units between the pre- operative and 3 month post-operative CT scan in the NMES treatment group and the placebo NMES group., 2 years | Muscle is lost as part of the rectal cancer disease process. Surgery to treat rectal cancer and its subsequent immobility leads to increased muscle loss. Neuromuscular electrical stimulation (NMES) has been shown in previous studies in the critically ill to maintain muscle mass. The investigators aim to examine whether NMES use in the pre and postoperative setting preserves muscle mass, speeds up recovery and improves outcomes in advanced rectal cancer patients undergoing curative surgery. This is a phase II double blind randomised controlled clinical trial. |
NCT02032186 | FEMALE | ADULT | Magnesium Deficiency|Preterm Birth|Extreme Immaturity | DRUG: Magnesium citrate | Preterm birth, Delivery before 37 gestational week, Delivery | The investigators propose a preventive strategy that may reduce the risk of placental vascular disease and its negative consequences for both the fetus (e.g., poor fetal growth or stillbirth)and mother (e.g., the hypertensive disorders of pregnancy), and which, in turn, should reduce the need for indicated preterm delivery. This strategy is a multicenter, randomized double-blind, placebo-controlled clinical trial (RCT) comparing magnesium citrate supplementation with placebo, each starting at 12 to 20 weeks gestation and continued until delivery. Magnesium citrate is a safe and inexpensive compound that is easily absorbed by the intestinal tract. The results of this RCT may be especially relevant in low and middle income countries that have high rates of prematurity, and limited resources for acute newborn and maternal care. |
NCT02590965 | ALL | ADULT, OLDER_ADULT | Non-small Cell Lung Cancer | DRUG: Fruquintinib|DRUG: Placebo | Progressive free survival (PFS), To compare the Progressive Free Survival (PFS) of Fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients advanced non-squamous NSCLC patients who failed to standard second-line chemotherapy according to RECIST 1.1, measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year | This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial to evaluate the efficacy and safety of Fruquintinib plus best supportive care in patients with advanced non-squamous non-small cell lung cancer who failed to second-line standard chemotherapy. |
NCT00735397 | ALL | CHILD, ADULT, OLDER_ADULT | Epilepsy | DRUG: perampanel | Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs), An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed., From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years. | The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures. |
NCT02769676 | FEMALE | CHILD, ADULT | Contraception | OTHER: 3-week visit|OTHER: usual care | Initiation of LARC by time of standard postpartum visit, Initiation of LARC method, 4-8 weeks postpartum | The current postpartum care model of a single visit 4-6 weeks after delivery does not optimally address contraceptive needs. By this visit, many women have resumed sexual activity, potentially putting them at risk for unintended and rapid repeat pregnancy. In addition, many women with pregnancy-related Medicaid lose insurance coverage at this time, making it difficult to obtain long-acting reversible contraception (LARC) if desired. Therefore, an earlier postpartum visit may remove barriers to improve access to LARC thereby, reducing unintended and rapid repeat pregnancy. Our primary objective is to determine whether an additional 3-week postpartum visit, compared to usual postpartum care, will affect the initiation of LARC by 6 weeks postpartum. |
NCT02762240 | ALL | CHILD, ADULT, OLDER_ADULT | Quality Control | OTHER: DHQP 2016|OTHER: DHQP 2018 | Changes in number of prescribed drugs in patients above 65 years in the observation periods., Data regarding Prescription medication is retrieved from Nationwide Medication Database (MD), 6 months periods | Accreditation is used increasingly in health systems worldwide. However, there is a lack of evidence of the effectiveness of accreditation. The overall aim of this study is to evaluate the effectiveness of a mandatory accreditation in general practice. |
NCT01056640 | ALL | ADULT, OLDER_ADULT | Health Care Quality|Health Care Access | DEVICE: Intel Health Guide|OTHER: Usual Care | Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease., 12 months | Background: Older adults with multiple chronic illnesses are at risk for worsening functional and medical status with ensuing hospitalization. One goal of medical care is to prevent this decline. One method that may help slow this functional and medical decline is home telemonitoring.
Specific aim: To determine the effectiveness of home telemonitoring compared to usual care in reducing combined outcomes of hospitalization and emergency room visits in an at risk population over 60 years of age.
Materials and Methods: This will be a randomized trial of 200 patients into one of two interventions. Home telemonitoring involves the use of a computer device at home which records biometric and symptom data from patients. This information is monitored by mid level providers associated with the primary care medical practice. Usual care involves patients who make appointments with their providers as problems arise and utilize ongoing support like a 24 hours nurse line. The study participants are adults over 60 years of age within the highest 10% on elderly risk assessment (ERA) scores. Patients will have initial evaluations of gait, quality of life (SF12), Kokmen test of mental status, and PHQ 9. Patients will be followed for 1 year for primary outcomes of hospitalizations and emergency room visits. Secondary analysis will include quality of life, compliance with the device and attitudes about telemonitoring. Sample size is based upon an 80% power to detect a 36% difference between the groups. The primary analysis will involve Cox proportional time to event analysis comparing both interventions for telemonitoring or usual care. Secondary analysis will use T-test comparisons for continuous variables (quality of life, attitudes) and chi square for proportional analysis. |
NCT00164658 | ALL | ADULT, OLDER_ADULT | Coronary Heart Disease|Stroke|Diabetes|Breast Cancer|Ovarian Cancer|Colorectal Cancer | BEHAVIORAL: Familial risk assessment and personalized prevention messages | Change in stage of adoption of health behaviors and referral for additional screening and follow up for high risk participants at 6 month post evaluation | The study will evaluate the effect of familial risk assessment and prevention prompts tailored to familial risk on health behaviors and use of preventive services among adults who are members of primary care practices in the U.S. |
NCT01163149 | ALL | CHILD, ADULT, OLDER_ADULT | Hypophosphatasia | DRUG: asfotase alfa|DRUG: asfotase alfa | Change From Baseline to Week 24 for Plasma Pyridoxal-5' Phosphate (PLP), Blood samples were collected to evaluate the effect of asfotase alfa on reduction in plasma pyridoxal-5' phosphate (PLP), Baseline, Week 24|Change From Baseline to Week 24 for Plasma Inorganic Pyrophosphate (PPi), Blood samples were collected to evaluate the effect of asfotase alfa on reduction in plasma inorganic pyrophosphate (PPi), Baseline, Week 24|Safety and Tolerability of Asfotase Alfa, The safety and tolerability of daily subcutaneous (SC) injections of asfotase alfa was assessed by routine monitoring of patients for treatment-emergent adverse events (TEAEs) and injection-associated reactions (IARs)., Up to 288 weeks exposure to asfotase alfa | This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of two doses of the study drug called asfotase alfa as compared to a control group to see effects on adolescents and adults with HPP. |
NCT00069784 | ALL | ADULT, OLDER_ADULT | Diabetes Mellitus, Non-Insulin-Dependent | DRUG: insulin glargine (HOE901)|DRUG: omega-3 polyunsaturated fatty acids (PUFA)|DRUG: placebo|DEVICE: reusable pen device for insulin injection | Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke, Number of participants with a first occurrence of one of the above events.
The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.
Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of CV death, nonfatal MI or nonfatal stroke) is provided in the first row of the statistical table., from randomization until study cut-off date (median duration of follow-up: 6.2 years)|Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF), Number of participants with a first occurrence of one of the above events (revascularization procedures included coronary artery bypass graft, percutaneous transluminal coronary angioplasty (PTCA) i.e. balloon, PTCA with stent, other percutaneous intervention, carotid angioplasty with/without stent, carotid endarterectomy, peripheral angioplasty with or without stent, peripheral vascular surgery, and limb amputation due to vascular disease).
The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.
Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of the events) is provided in the first row of the statistical table., from randomization until study cut-off date (median duration of follow-up: 6.2 years) | The primary objectives of the ORIGIN study were:
* To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
* To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.
The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:
* total mortality (all causes);
* the risk of diabetic microvascular outcomes;
* the rate of progression of IGT or IFG to type 2 diabetes. |
NCT01440101 | ALL | ADULT, OLDER_ADULT | Multiple Sclerosis | DRUG: Natalizumab (BG00002)|DRUG: Placebo | Part A: Number of Participants With Adverse Events (AEs), AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. Serious AE (SAE)=any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, was a life threatening event; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; or any other medically important event that, in the opinion of the Investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as related or not related; severity was categorized as mild, moderate, or severe., Baseline (Week 0) to Week 24|Part B: Rate of Development of New Active Lesions Over 24 Weeks, New active lesions were the sum of the gadolinium-enhancing (Gd+) lesions and any new or newly enlarging T2 hyperintense lesions that did not enhance as seen on cranial magnetic resonance imaging (MRI) scans. The rate is calculated for each participant as the ordinary least squares slope of the cumulative new active lesions over time., Baseline (Week 0) to Week 24 | The primary objective of Part A is to determine the safety and tolerability of natalizumab administered over 24 weeks in Japanese participants with relapsing-remitting multiple sclerosis (MS). The endpoints for this will include assessment of adverse evetns (AEs), changes in laboratory evaluations, vital signs, Expanded Disability Status Scale (EDSS) scores, and changes in physical and neurological examination findings. The secondary objectives of Part A are to characterize the pharmacokinetics (PK) profile and pharmacodynamics (PD) of natalizumab.
The primary objective of Part B is to determine if natalizumab, when compared to placebo, is effective in treating Japanese participants with relapsing-remitting MS, as measured by new active lesions on cranial magnetic resonance imaging (MRI) scans over 24 weeks. New active lesions are the sum of the gadolinium-enhancing (Gd+) lesions and any new or newly-enlarging T2-hyperintense lesions that do not enhance. The primary endpoint is the rate of development of new active lesions over 24 weeks.
Secondary objectives of Part B are to determine over 24 weeks whether natalizumab, when compared to placebo, is effective in reducing the frequency of clinical exacerbations, reducing the number of Gd+ lesions, reducing the number of new or newly-enlarging T2-hyperintense lesions on brain MRI scans, increasing the proportion of relapse-free participants, and improving outcomes on visual analog scale (VAS) assessing the participant's global impression of his/her well-being. Additional objectives are to assess the safety and tolerability, the incidence of serum antibodies to natalizumab and the PK profile of natalizumab. |
NCT02378714 | ALL | ADULT, OLDER_ADULT | Nicotine Dependence|Major Depressive Disorder | DRUG: Varenicline|BEHAVIORAL: BASC|BEHAVIORAL: Standard treatment | Bioverified Point-prevalence Abstinence at 27 Weeks, Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for \>7 days prior to week 27 (24 weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 27., 27 weeks (24-weeks post-target quit date)|Adverse Event and Serious Adverse Event Rates, Adverse event and serious adverse event rates between varenicline and placebo arms. A previously developed algorithm was used to classify side effect reports as adverse events (AEs) or serious adverse events (SAEs) (Schnoll et al. 2019).
Reference: Schnoll, R., Leone, F., Weisbrot, J., Veluz-Wilkins, A., Miele, A., Hole, A., Jao, N.C., Wileyto, E.P., Carroll, A.J., Kalhan, R., Patel, J., Langer, C., \& Hitsman, B. (2019). A randomized controlled trial of 24-weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence. Psycho-Oncology, 28, 561-569., Weeks 1 (1-week before starting medication), 6, and 14 (end of medication) | Persons who struggle with depression smoke at high rates and experience low quit rates in treatment. The best way to improve cessation treatment for this underserved population remains unknown. The proposed trial tests whether the combination of varenicline and behavioral mood management treatment enhances long-term abstinence for depressed smokers and, if so, whether this treatment achieves its effects through addressing the unique psychological factors that appear to maintain tobacco dependence for these smokers. |
NCT00987961 | ALL | ADULT, OLDER_ADULT | Opiate Dependence | BEHAVIORAL: Linkage | opioid use, baseline, 1-month, 3-months, 6-months|HIV risk behavior, baseline, 1-month, 3-months, 6-months | This study tests whether starting Suboxone (buprenorphine) during a medical hospitalization, and then providing an appointment (a "link") for after discharge to maintenance buprenorphine in an outpatient setting will reduce HIV risk behavior in individuals who inject opioids. |
NCT01427192 | ALL | ADULT, OLDER_ADULT | Pulmonary Hypertension|Breathing-Related Sleep Disorder | DRUG: acetazolamide|OTHER: Supplemental oxygen|PROCEDURE: Non-invasive ventilation|OTHER: Room air|DRUG: Placebo tablet | exercise capacity, Assessment by the 6 minute walk distance, 1 week|Quality of Life, Assessment by the short form of the SF 36 questionnaire, 1 week | The purpose of this study is to study the differential short-term effect of nocturnal oxygen, acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms, exercise capacity and nocturnal breathing disturbances in subjects with pulmonary hypertension and sleep related breathing disorders
* Trial with medicinal product |
NCT01904994 | ALL | ADULT, OLDER_ADULT | HIV (Human Immunodeficiency Virus) | PROCEDURE: POC (point-of-care) CD4+ (cluster of differentiation 4) Count|PROCEDURE: Accelerated ART (antiretroviral therapy) Initiation|BEHAVIORAL: Basic Care and Prevention Package|BEHAVIORAL: Cellular Appointment Reminders and Follow-Up|OTHER: Financial Incentive | Change in proportion of participants who both link to care at assigned study unit within 1 month and are retained in care at the designated study unit 12 months after HIV (Human Immunodeficiency Virus) diagnosis, Combined outcome of linkage to HIV care within 1 month after testing HIV positive and retention in care 12 months after testing.
Participants are considered to achieve this outcome if they successfully link to the HIV clinic at their study unit (SU) within 1 month of testing HIV positive and are retained in care at the HIV clinic at their SU 12 months after testing HIV positive, as measured from medical records., one month after enrollment, 12 months after enrollment | Despite increased HIV (Human Immunodeficiency Virus) infection testing in Africa, many patients never enroll in subsequent HIV care after testing or remain in care after an initial enrollment. This study's aim is to improve linkage to HIV care and retention in HIV care through the use of feasible, evidence-based, and practical interventions. The study takes place in Swaziland, the country with the highest HIV prevalence (24%) in sub-Saharan Africa. The study will randomize groups of HIV testing sites and affiliated clinics to either standard of care or a combined intervention strategy (CIS) which consists of point-of care CD4 (cluster differentiation 4 (CD4)) testing at time of HIV testing, fast-track HIV medications for those who are eligible for treatment,mobile phone appointment reminders, care bags filled with health prevention materials, and financial incentives. The study outcomes are linkage to and retention in care as well as cost effectiveness, feasibility of interventions, and patient acceptability of interventions. |
NCT03796858 | ALL | ADULT, OLDER_ADULT | Arthritis, Psoriatic | DRUG: Guselkumab 100 mg|DRUG: Placebo | Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24, The ACR 20 Response is defined as greater than or equal to (\>=) 20 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter \[mm\], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, \[0 mm=no pain to 100 mm=worst possible pain\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP)., Week 24 | The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease. |
NCT00390754 | FEMALE | ADULT | Fertility | BEHAVIORAL: Education for pregnancy planning | Number of episodes of use of home pregnancy test kits, 6 month followup | The objective of this study is to determine whether women in a Medicaid population at risk for unintended pregnancy will keep a home pregnancy test on hand and (if necessary) use it appropriately. |
NCT00497055 | ALL | ADULT | Substance Abuse|HIV Infections | DRUG: Aripiprazole|DRUG: Placebo | To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals., To test the hypothesis that aripiprazole 20 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent individuals, as determined by the proportion of methamphetamine-positive urines in the aripiprazole versus placebo group., Final study visit at week 12|To Measure the Acceptability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, by Determining (Via Electronic Pill Caps [MEMS or Medication Event Monitoring System]) Medication Adherence to Aripiprazole and Placebo., To measure the acceptability of aripiprazole and placebo among methamphetamine-dependent individuals, by determining (via electronic pill caps \[MEMS or Medication Event Monitoring System\]) medication adherence to aripiprazole and placebo. (Percent adherence from MEMS is determined by 100\* the number of days where MEMS registered an opening out of the number of days a dose was prescribed for each arm.), Adherence as determined by MEMS (throughout study, up to 12 weeks)|To Measure the Safety and Tolerability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, as Determined by the Number of Adverse Clinical Events in the Aripiprazole and Placebo Arms., Total reported adverse events (throughout study, up to 12 weeks) | Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual behavior among men who have sex with men (MSM), putting meth-using MSM at extraordinarily high risk for transmitting or acquiring HIV. This study is a randomized, double-blind, placebo-controlled trial of the medication aripiprazole for methamphetamine-using individuals, including MSM, and will assess efficacy, acceptability, tolerability, safety, and adherence to study medication. |
NCT01880554 | ALL | ADULT, OLDER_ADULT | Liver Metastases From Colorectal Primary Cancer | DEVICE: Contrast-enhanced intraoperative ultrasound | Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases., The clinical utility will be evaluated in terms of justified modification of the surgical procedure following contrast-enhanced intra-operative ultrasound (CE-IOUS), compared to the surgical procedure following conventional intra-operative ultrasound. For each patient, we will consider CE-IOUS to be clinically useful:
* if the surgical procedure envisaged at the end of the CE-IOUS is different from the surgical procedure envisaged at the end of the conventional ultrasound
* and if the surgical procedure envisaged at the end of the CE-IOUS is justified We reported the percentage of patients for whom there was a modified and justified surgical gesture following CE-IOUS., At time of surgery | Hypothesis: Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.
This study is a two-stage phase II multicenter study (Simon's two-stage). |
NCT03023111 | ALL | ADULT, OLDER_ADULT | Cutaneous Leishmaniasis | DRUG: Sbv|DRUG: Miltefosine plus placebo|DRUG: Miltefosine plus GM-CSF | Final cure rate or complete cicatrization of the ulcer, All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients. Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements., 6 months after the end of treatment | Cutaneous leishmaniasis (CL) standard treatment is done with parenteral pentavalent antimony (Sbv) at the dose of 15-20mg / kg per day for 20 days. However, therapeutic failure has been described in up to 50% of patients, and the long period of 60 to 90 days required for healing of the ulcerated lesion indicate the need for alternative drugs. Currently the alternatives include other parenteral drugs such as pentamidine and amphotericin B, whose use is limited either by toxicity or because, as with Sbv, the parenteral route hinders adherence and regularity of treatment in the rural area. Recent studies by our group indicate that oral miltefosine is the most effective drug for the treatment of patients with CL caused by L. (V.) guyanensis and L. (V.) braziliensis in Brazil, with a cure rate of 71.4% and 75% respectively. CL pathogenesis is associated with intense inflammatory infiltrate and tissue damage. Previous trials associating GM-CSF to Sbv improved the cure rate of CL caused by L. (V.) braziliensis. The objective of this trial is to evaluate the therapeutic response to the use of miltefosine associated to GM-CSF in the treatment of CL caused by L. (V.) braziliensis in an endemic region in Bahia and Ceará, and by L. (V.) guyanensis in the Amazon region. |
NCT00963157 | ALL | ADULT, OLDER_ADULT | Influenza | DRUG: AS03|BIOLOGICAL: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A | Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine, Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more., Day 0 prior to vaccination and 8 days after the first H1N1 vaccination|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine, Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more., Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine, Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more., Day 0 prior to vaccination and 8 days after the first H1N1 vaccination|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine, Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more., Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs), Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses., Day 0 through Day 365 after the last vaccination|Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination, Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE \>12.6 seconds), partial thromboplastin time (\>40.7 seconds), platelets (\>=401,000 or \<=129,000 cells/square millimeter), white blood cells (\>10,800 or \<3800 cells/microliter), neutrophils (\>8000 or \<1800 cells/microliter), and lymphocytes(\>4100 or \<850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility., 8-10 days after first vaccination|Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination, Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE \>12.6 seconds), partial thromboplastin time (\>40.7 seconds), platelets (\>=401,000 or \<=129,000 cells/square millimeter), white blood cells (\>10,800 or \<3800 cells/microliter), neutrophils (\>8000 or \<1800 cells/microliter), and lymphocytes(\>4100 or \<850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility., 8-10 days after second vaccination|Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination, Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE \>146 or \<135 mEq/L), potassium (\>5.3 or \<3.5 mEq/L), creatinine (\>1.4 mg/dL), Alanine transaminase (\>52.7 U/L), Albumin (\<3.2 g/dL), and total protein (\<6.0 g/dL participants age 18-64 years, \<5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility., 8-10 days after first vaccination|Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination, Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE \>146 or \<135 mEq/L), potassium (\>5.3 or \<3.5 mEq/L), creatinine (\>1.4 mg/dL), Alanine transaminase (\>52.7 U/L), Albumin (\<3.2 g/dL), and total protein (\<6.0 g/dL participants age 18-64 years, \<5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility., 8-10 days after second vaccination|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination, Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days., Within 8 days (Day 0-7) post first vaccination|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination, Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days., Within 8 days (Day 0-7) post second vaccination|Number of Participants Reporting Fever After the First Vaccination, Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days., Within 8 days (Day 0-7) post first vaccination|Number of Participants Reporting Fever After the Second Vaccination, Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days., Within 8 days (Day 0-7) post second vaccination|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination, Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days., Within 8 days (Day 0-7) post first vaccination|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination, Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days., Within 8 days (Day 0-7) post second vaccination|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination, Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days., Within 8 days (Day 0-7) post first vaccination|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination, Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days., Within 8 days (Day 0-7) post second vaccination|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine, Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 8 after the first vaccination|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine, Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 21 after the first vaccination|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine, Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 8 after the first vaccination|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine, Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater., Day 21 after the first vaccination | The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot when it is given with or without an "adjuvant." An adjuvant is a substance that may cause the body to produce more antibodies when it is given with a vaccine. This study will also compare how age affects the body's response to the H1N1 flu shot. In this study, 3 strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2 strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250 individuals greater than or equal to age 65. Study procedures include: physical exam, blood samples, completing a memory aid to record vaccine side effects, medications and daily oral temperature. Participants will be involved in study related procedures for up to 13 months. |
NCT01640080 | ALL | ADULT | Major Depressive Disorder | DRUG: Esketamine|DRUG: Esketamine|DRUG: Placebo | Change from Day 1 (baseline) to Day 2 in the Montgomery Asberg Depression Rating Scale (MADRS) total score in the double-blind treatment phase, The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition., Day 1 (baseline), Day 2 | The purpose of this study is to assess the efficacy of esketamine compared with placebo in improving symptoms of depression in patients with treatment resistant depression. |