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NCT03524508 | ALL | ADULT, OLDER_ADULT | Metastatic Biliary Tract Cancer | DRUG: Onivyde|DRUG: 5-FU/LV | Progression Free Survival by independent central reviewer, Progression-free survival is the time from the date of enrollment to the earlier of the date of confirmed progression or death from any cause., from the date of enrollment to the earlier of the date of confirmed progression or death from any cause. (assessed up to 36 months) | The purpose of this study is to evaluate the efficacy and safety of combination of fluorouracil/folinic acid and liposomal irinotecan(Onivyde) compared with fluoruracil/folinic acid in patients with metastatic biliary tract cancer which progressed on 1st line gemcitabine/cisplatin. |
NCT00112086 | FEMALE | ADULT, OLDER_ADULT | Ovarian Neoplasms|Fallopian Tube Neoplasms|Peritoneal Neoplasms | DRUG: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) | proportion of clinical complete remission | A feasibility study of neoadjuvant chemotherapy (NAC) followed by interval cytoreductive surgery (ICS) and postoperative chemotherapy for stage III/IV mullerian carcinomas such as ovarian, tubal and peritoneal carcinomas. |
NCT01796613 | FEMALE | ADULT | Contraception | DEVICE: Vaginal Ring - intermittent regimen|DEVICE: Vaginal Ring - continuous regimen | vaginal bacterial counts, Changes from baseline (pre-ring use) in vaginal bacterial counts and in the absence/presence of bacterial vaginosis-related bacteria as measured with quantitative real time polymerase chain reaction (PCR)., 5 months | The study is a multidisciplinary research project and has two main aims:
1. To determine the safety of a contraceptive vaginal ring (CVR) in women, with an emphasis on its effect on the vaginal microenvironment after different durations of use: the vaginal microbiome, biofilm formation on epithelial cells and rings, inflammation and immune activation in the vagina
2. To investigate the feasibility, acceptability and adherence to vaginal ring use in Rwandan women, including attitudes towards a future multi-purpose vaginal ring for prevention of both pregnancy and sexually transmitted infections (STI). |
NCT00351390 | ALL | ADULT, OLDER_ADULT | Congestive Heart Failure | OTHER: Drug therapy for HF|OTHER: NT-proBNP guided HF therapy | Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events, One year | Levels of amino-terminal pro-brain natriuretic peptide (NT-proBNP) a hormone released from the heart in patients with heart failure (HF) are strongly prognostic of adverse events, such as hospitalization or death from HF. Therapies that are beneficial for HF (such as beta blockers or angiotensin converting enzyme inhibitors) tend to lower levels of NT-proBNP in parallel with improvements in outcomes of patients so treated. Importantly, Nt-proBNP levels may identify a patient at high risk for adverse outcome from their HF, even in periods of apparent stability.
It remains unclear, however, whether treating patients based on their NT-proBNP concentrations would be associated with better outcomes compared to standard HF therapy without measurement of NT-proBNP values.
The goal of the PROTECT study is to evaluate whether treatment of patients with advanced and recently destabilized HF would benefit from NT-proBNP guided HF treatment, compared to standard HF therapy without such 'hormone guided' treatment. |
NCT00631345 | ALL | ADULT, OLDER_ADULT | Prediabetes|Obesity | BEHAVIORAL: Group-Based Lifestyle Intervention (Phases 1 and 2)|OTHER: Individual Education Program (All Phases)|BEHAVIORAL: Self-Directed Maintenance (Phase 3)|BEHAVIORAL: Extended Group Maintenance (Phase 3) | Fasting Glucose, Change in fasting glucose will be analyzed independently at 12 months (incorporating baseline and 6 month data) and will be used to report the average effect of the intervention during the first year. The analysis at 24 months (incorporating data from baseline, 18 and 24 months) will evaluate the long-term effects of the intervention by examining the average intervention effect during the second year of the intervention period., Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization | The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized trial designed to test the effectiveness of a lay-health counselor led community-based diabetes prevention program in reducing blood glucose in people at risk for developing diabetes mellitus. |
NCT02339363 | ALL | CHILD | Anxiety|Psychological Stress | BEHAVIORAL: Sitting Meditation|BEHAVIORAL: Hatha yoga | Working Memory Capacity: Automated Operational Span Task (AOSPAN), Participants completed the AOSPAN prior to beginning their group condition (sitting meditation, Hatha yoga, or waitlist control) and again at the end of the 4-week intervention (waitlist) period., pre-intervention and post-intervention (waitlist), t the end of the 4-week intervention (waitlist) period | The present study was a randomized controlled trial that explored the feasibility, acceptability, and effectiveness of short-term mindfulness training among adolescents. The primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress Reduction components-sitting meditation and hatha yoga-on working memory, stress, anxiety and mindfulness. The influence of daily home practice compliance on intervention outcomes was also examined. |
NCT03167125 | ALL | ADULT, OLDER_ADULT | Colorectal Cancer | OTHER: Automated Prompts|OTHER: Automated Plus Live Prompts | Increased colorectal cancer screening rates, Fecal testing completion, Up to 4 years (study period) | The overall goal of this study is to test strategies to raise rates of colorectal cancer screening among the Latino population in a federally qualified health center that operates multiple clinics. This intervention study will test automated and live prompts to a direct-mail fecal testing program in two phases.
In Phase I (Years 01 - 02), the investigators will tailor and define intervention components using a community-based participatory research approach called boot camp translation (BCT). The ultimate design of the intervention will be defined by patient and provider feedback from BCT. The investigators will then conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts (i.e., automated phone calls, text messages) to alert and remind patients to complete screening, 2) live prompts (i.e., live phone calls), and 3) a combination approach of automated plus live prompts.
In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted intervention to additional clinics within the partnering health center using a two-arm main trial.
Both phases will be guided by an advisory group of clinicians, researchers, policy makers, and patients. |
NCT02812706 | ALL | ADULT, OLDER_ADULT | Multiple Myeloma | DRUG: Isatuximab SAR650984 | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs), DLTs: AEs occurring during 1st treatment cycle, assessed per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03. DLTs included: Hematologic DLTs: Grade(G) 4 neutropenia(N) lasting greater than or equal to (\>=) 5 days; G3 to G4 N with fever or microbiologically or radiographically documented infection; G4 thrombocytopenia lasting for \>=5 days; thrombocytopenia, treatment delay greater than (\>)14 days due to hematologic toxicity. Non-hematologic DLTs: G\>=3 non-hematological AE, excluding G3 fatigue, G 3 to 4 electrolyte abnormalities, G3 nausea/vomiting/diarrhea if responsive to optimal medical management within 48 hours or allergic reaction/ hypersensitivity attributed to isatuximab; AE that required treatment delay for \>14 days. Any other toxicity deemed by Investigator or sponsor to be dose-limiting, regardless of the grade, was also considered DLT., Cycle 1 (28 days)|Phase 2: Percentage of Participants With Overall Response (OR), Percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) assessed by International Myeloma Working Group (IMWG) uniform response criteria. sCR: CR as defined plus normal FLC ratio \& absence of clonal cells in bone marrow. CR: negative immunofixation on serum \& urine; disappearance of any soft tissue plasmacytomas; \<5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65. VGPR: serum \& urine M-protein detectable by immunofixation; \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 h; \>90% decrease in difference between involved \& uninvolved FLC levels required. PR: \>=50% reduction of serum M-protein \& reduction in 24h urinary M protein by \>=90%/\<200 mg/24 h; if serum \& urine M-protein unmeasurable:\>=50% decrease in difference between involved \& uninvolved FLC; if serum \& urine M-protein not measurable:\>=50% reduction in plasma cells required, in place of M-protein., From the date of the first response until the primary analysis data cut-off date of 31 July 2018 (median duration of follow-up was 24.14 weeks) | Primary Objectives:
* Phase I: To evaluate safety and tolerability of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.
* Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.
Secondary Objectives:
* To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events were assessed.
* To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule.
* To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria.
* To assess the relationship between Baseline cluster of differentiation 38 (CD38) receptor density on multiple myeloma cells and efficacy. |
NCT02861534 | ALL | ADULT, OLDER_ADULT | Heart Failure|Chronic Heart Failure With Reduced Ejection Fraction | DRUG: Vericiguat|DRUG: Placebo for vericiguat | Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization, Time to First Occurrence of Composite Endpoint of CV Death or HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any HF hospitalization or CV death event at the time of analysis were censored at their last available information, the date of their non-CV death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A clinical events committee (CEC) reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided., Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019) | This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure with reduced ejection fraction (HFrEF). The primary hypothesis is vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF. |
NCT01252875 | ALL | ADULT, OLDER_ADULT | Ischemic Stroke|Transient Ischemic Attack|Atherosclerotic Stenosis | PROCEDURE: Target : 100 mg/dL (+/-10 mg/dL)|PROCEDURE: 70 mg/dL | recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death., recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death., each 6 months | The aim of this study is the evaluation of two usual care strategies after stroke or TIA : achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will use the statin and titrate the dosage to achieve the target assigned by randomization in monotherapy or in combination with ezetimibe or other drugs.
The primary end-point is the occurrence of recurrent non fatal stroke, non fatal MI, and vascular death in each group.
3760 patients will be recruited and followed for eight and a half years maximum. |
NCT04790786 | ALL | CHILD, ADULT, OLDER_ADULT | Covid19 | BIOLOGICAL: Lilly Bamlanivimab|BIOLOGICAL: Regeneron Casirivimab + Imdevimab|BIOLOGICAL: Lilly Bamlanivimab + Etesevimab|BIOLOGICAL: Sotrovimab|BIOLOGICAL: Bebtelovimab | Hospital-free Days, Days alive and free from hospitalization. Patients that are both living and not in the hospital will meet criteria to be counted in this outcome. Deaths were rare and therefore the upper and lower end of the IQR are both 28, in addition to the median. This outcome measure does reflect median hospital free days and interquartile ranges for all groups., 28 days after initial participation | Multiple monoclonal antibodies (mABs) have been shown to reduce viral burden and improve clinical outcomes, have been granted FDA Emergency Use Authorization (EUA) for use in select populations, and are routinely used in the UPMC Health System, which has made expanded access a priority. However, the comparative effectiveness of these mABS is unknown. The National Academies of Sciences, Engineering, and Medicine has called for expanded access and clinical use of mABs, noting it is "critical to collect data and evaluate whether they are working as predicted". This pragmatic evaluation will determine the relative effects of the EUA-governed mABs versus each other. When U.S. government mAB policies change (e.g., FDA grants or revokes EUAs), UPMC Health System policies and the evaluated mABs will accordingly change. |
NCT00119418 | FEMALE | ADULT | Hot Flashes|Menopause | DRUG: TU 025 Keishi Bukuryo Gan | frequency and severity of hot flashes by Mayo Hot Flash Diary | This study tests to see if TU 025 Keishi Bukuryo Gan reduces the frequency and severity of hot flashes in post-menopausal American women. This study will also estimate the best dose amount and determine the common short-term side effects and risks. |
NCT02462668 | ALL | ADULT, OLDER_ADULT | Respiratory Failure | PROCEDURE: Bag-mask ventilation|PROCEDURE: Noninvasive positive pressure ventilation(NIPPV)|PROCEDURE: fibreoptic bronchoscopy assisted intubation | Change in pulse oxymetry(SpO2), From time of randomization until connect to ventilator 30min | This study is to investigate the efficiency and safety of fibreoptic bronchoscopy assisted intubation during noninvasive positive pressure ventilation in respiratory failure patients. Half of the participants will receive preoxygenation with noninvasive ventilator and fibreoptic bronchoscopy intubation during NIPPV. While the other half using usual preoxygenation(bag-mask ventilation ). |
NCT01366976 | ALL | ADULT, OLDER_ADULT | Cardiopulmonary Bypass Induced Lipid Peroxidation | DRUG: Acetaminophen | Plasma Isofuran Concentrations, Plasma isofuran concentrations as a measure of lipid peroxidation, 24 hours|Plasma F2-isoprostane Concentrations, Plasma F2-isoprostane concentrations as a measure of lipid peroxidation, 24 hours | Acute kidney injury is a major complication of cardiac surgery requiring cardiopulmonary bypass (CPB). Hemolysis and rhabdomyolysis frequently occur during CPB. Hemolysis leads to an increase in free hemoglobin, whereas rhabdomyolysis leads to an increase in myoglobin. Free plasma hemoglobin and myoglobin have been shown to be independent predictors of the acute kidney injury that results from CPB. When these hemeproteins are released into the plasma, they undergo redox cycling, generating radical species that initiate lipid peroxidation and a cascade of oxidative damage to cellular membranes, notably in the kidney. F2-isoprostanes and isofurans are sensitive and specific markers of oxidative stress in vivo, and are increased after CPB, particularly in those patients with acute kidney injury. Acetaminophen inhibits the lipid peroxidation catalyzed by myoglobin and hemoglobin. Moreover, in an animal model of rhabdomyolysis-induced kidney injury, acetaminophen significantly attenuated the decrease in creatinine clearance compared to control. The current proposal tests the central hypothesis that acetaminophen will attenuate the lipid peroxidation associated with the hemolysis and rhabdomyolysis that occur in patients undergoing CPB. Demonstration that acetaminophen inhibits the lipid peroxidation resulting from CPB would provide a rationale for a prospective randomized trial to test the hypothesis that acetaminophen will reduce the acute kidney injury that results from CPB. |
NCT02621112 | ALL | ADULT, OLDER_ADULT | Renal Failure | BIOLOGICAL: Intradermal HBVv with imiquimod|BIOLOGICAL: Intradermal HBVv with aqueous cream|BIOLOGICAL: Intramuscular HBVv with aqueous cream | Seroprotection rate to HBV, percentage of recruited subjects with anti-HBs \>10 mIU/mL, 12 months after first dose of hepatitis B vaccine | Hepatitis B virus infection remains an important clinical issue among patients on renal replacement therapy. Seroconversion rate as defined by an anti-HBs Ab titer \> 10 IU/L after intramuscular hepatitis B vaccination (HBVv) remains poor in this cohort. Factors associated with inadequate anti-HBs response include older age, diabetes mellitus, obesity and low hepatitis B vaccine dose. Various small-scale studies including multiple high dose intramuscular vaccination or multiple small dose intradermal vaccination were attempted with variable response. Recent study on dose sparing seasonal influenza vaccine delivered via a novel intradermal microneedle has demonstrated good immunogenic responses similar to full-dose intramuscular vaccination. Imiquimod, a synthetic TLR7 agonist useful for the treatment of DNA virus infection, has been shown to improve vaccine immunogenicity. The investigators therefore propose a prospective, randomized study to compare the safety and immunogenicity of intradermal hepatitis B vaccination with this novel device with intramuscular in patients on renal replacement therapy. |
NCT00386100 | ALL | ADULT, OLDER_ADULT | Diabetes Mellitus, Type 2 | DRUG: Avandamet 6 mg/1500 mg (ttd)|DRUG: Avandamet 4 mg/1000 mg (ttd)|DRUG: Avandamet 2 mg/500 mg (ttd)|DRUG: Avandamet 8 mg/ 2000 mg (ttd)|DRUG: Metformin 500 mg (ttd)|DRUG: Metformin 1000 mg (ttd)|DRUG: Metformin 1500 mg (ttd)|DRUG: Metformin 2000 mg (ttd) | Change From Baseline in HbA1c at Week 80, Blood was taken for serum HbA1c measurements. Change from baseline was calculated as the Week 80 value minus the baseline value. Last observation carried forward (LOCF) was not used for this analysis., Baseline and Week 80 | This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2 study visits), followed by an 80 week double-blind treatment period (11 study visits). Also, a sub-study was included to look at changes in bone mineral density (BMD) at the lumbar spine. |
NCT01899443 | ALL | ADULT, OLDER_ADULT | Osteoarthritis | OTHER: Observation | Percentage of participants experiencing the composite outcome up to 35 days post surgery., The proportion of patients in each group (compliant and non-compliant groups) that experience one or more of the following outcomes - death, readmission, reoperation or surgical complication - up to 35 days post-surgery. Analyses will adjust for patient and service provider confounders., 35 days post total hip or knee replacement surgery | Primary total knee or total hip replacement surgeries are costly high volume procedures \& outcomes may be affected by surgical \& care processes \& individual patient characteristics. The primary hypotheses is that non compliance with recommended practice impacts patient outcomes (e.g. the likelihood of complications following surgery). The primary aims of the study are to evaluate the links between processes \& outcomes \& if possible develop a model that will improve patient outcomes \& reduce unnecessary practice variation whilst considering costs. |
NCT00986791 | ALL | ADULT, OLDER_ADULT | Acute Fracture Surgery|Alcohol Cessation Intervention|Postoperative Complications|Infection|Ankle Injuries | OTHER: GSP-A | Postoperative Complications, A composite outcome including postoperative infections, second surgery, dislocated fracture, mal-union and other complications requiring treatment (neurological, pneumonia, thrombosis etc.), 6 weeks + 3,6,9 and 12 months | Hazardous alcohol intake is an independent risk factor for postoperative complications after major and minor operations, elective and emergency procedures for men and women.
The aim of this study is to evaluate the effect of a 6-week Gold Standard Programme for alcohol cessation intervention in the perioperative period compared to the daily routine guidelines for patients with hazardous alcohol intake undergoing ankle fracture surgery. |
NCT03736837 | ALL | ADULT, OLDER_ADULT | Non Small Cell Lung Cancer | DRUG: Anlotinib Plus Icotinib | PFS（Progress free survival）, The PFS time is defined as time from enrollment to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of : "death", "last tumor assessment", "last follow up date" or "last date in drug log", each 42 days up to PD or death (up to 24 months) | Evaluate the efficacy and safety of Anlotinib plus Icotinib as the first-line treatment in patients with sensitive EGFR mutations advanced non-small cell lung cancer. |
NCT00559416 | ALL | ADULT, OLDER_ADULT | HIV Infections | DRUG: Cell Transfer | Safety, survival of transferred cells. | Some HIV-infected individuals have a white blood cell marker known as HLA-B\*57 that appears to help control the progress of the disease; however, not all who have the HLA-B\*57 marker are able to control the infection. This study will examine the effects of giving white blood cells with HLA-B\*57 from an individual who controls HIV infection to an individual who cannot control HIV infection, as a form of HIV treatment. All candidates will be screened with a medical history, physical examination, and blood and urine tests.
Both donor and recipient volunteers must be HIV-positive individuals 18 years of age or older who have the HLA-B\*57 marker and are receiving care. Donor candidates must have positive HIV antibody tests for at least seven years with a recent CD4 cell count greater than 400 cells/mm?, HIV viral load less than 50 copies/mL, and no previous HIV viral load greater than 1,000 copies/mL. Recipient candidates must have positive HIV antibody tests with a recent CD4 cell count less than 400 cells/mm? and HIV viral load greater than 10,000 copies/mL, and must have failed at least two prior combination antiretroviral regimes and are willing to receive or resume combination antiretroviral therapy. Donor volunteers will be excluded if they have taken certain antiretrovirals drugs, have a medical history of cancer or of other blood-borne illnesses, or have other medical conditions that might interfere with the study. Recipient volunteers will be excluded if they have a medical history of malignant cancer or other medical conditions that might possibly interfere with the study.
Donors will undergo apheresis to separate white blood cells from circulating blood before the red blood cells and plasma are returned to the bloodstream. The procedure will take up to five hours, and donors will be required to return for additional tests. Donors may be asked to return for further white blood cell donations, a maximum of six procedures per year.
Recipients will undergo apheresis to obtain stem cells for possible use in the study, and will be admitted to an NIH Clinical Center inpatient unit to receive an infusion of white blood cells and undergo a series of blood tests both before and after the infusion. The infusion process will take two hours. After being discharged, recipients will be asked to return to the Clinical Center for monitoring and follow-up tests, and may receive further infusions. |
NCT02860013 | ALL | CHILD, ADULT, OLDER_ADULT | Heart Failure | DEVICE: Telemedicine | Mental health related quality of life (SF-36 questionnaire mental scores), Changes in mental health-related quality of life (SF-36 questionnaire mental score) at baseline to follow-up., 12 month follow-up|Incremental cost-effectiveness ratio (ICER), The main outcome for cost is incremental cost-effectiveness ratio (ICER). ICER is measured as the total cost per quality adjusted life years (QALY) increased from baseline to follow-up., 12 month follow-up | There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from Heart Failure that may benefit from telehealth compared with only standard treatment and care. The second objective is to examine the additional costs of the telehealth solution and assess whether this solution is a cost-effective way to care for patients with Heart Failure across patients and municipality districts.
It is hypothesized that telehealth care will increase patients quality adjusted life years compared to usual practice, since no difference in mortality and a higher health related quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in the number of admissions and readmissions to hospitals and a 30% reduction in the number of outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to whether these savings are offset by other costs such as more visits to general practitioners, community care or the implementation costs. |
NCT00127452 | ALL | ADULT, OLDER_ADULT | Cardiovascular Diseases | DIETARY_SUPPLEMENT: margarine spread | Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG), monitored during intervention | The Alpha Omega Trial is a randomized, placebo-controlled, double-blind dietary intervention study in 4837 postmyocardial infarction patients in the Netherlands to examine whether incidence of cardiovascular diseases during 40 months of follow-up can be prevented by low doses of omega-3 polyunsaturated fatty acids. The key objectives are:
* to examine the effect of low-dose supplementation (400 mg/day) of eicosapentaenoic acid and docosahexaenoic acid on incidence of cardiovascular diseases; and
* to examine the effect of low-dose supplementation (2 g/day) of alpha-linolenic acid on incidence of cardiovascular diseases. |
NCT02252172 | ALL | ADULT, OLDER_ADULT | Multiple Myeloma | DRUG: Daratumumab IV|DRUG: Lenalidomide|DRUG: Dexamethasone|DRUG: Daratumumab SC | Primary: Progression-free Survival (PFS), PFS is defined as time from date of randomization to either progressive disease (PD) or death, whichever occurs first based on computerized algorithm as per International Myeloma Working Group (IMWG) criteria. PD is defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to \[\>=\] 0.5 gram per deciliter \[g/dL\] and \>=200 milligram \[mg\]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than \[\>\]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to Plasma cell (PC) proliferative disorder., From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years) | The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT). |
NCT05181176 | ALL | CHILD | Body Weight | DIETARY_SUPPLEMENT: Coffee|DIETARY_SUPPLEMENT: Green tea|DIETARY_SUPPLEMENT: Herbal tea (placebo) | effect tea and coffee consumption on body weight, change in BMI Z score, 6 months | Introduction: The influence of tea or coffee supplementation on body weight in adolescents has never been tested. The aim of the present study was to investigate the effect of tea and coffee consumption on body weight and body fat in an obese adolescent population.
Methods: Randomized clinical trial, parallel group study comparing 3 weight loss interventions comprised of a similar dietary recommendation with either coffee (coffee group), tea (tea group) or placebo (herbal tea). Sociodemographic data and medical history details were retrieved from medical files. The body mass index Z (BMI Z) score and fat percentage as measured by bioelectrical impedance were compared between groups at 3 and 6 months. |
NCT00000400 | ALL | ADULT, OLDER_ADULT | Osteoporosis | DRUG: Human parathyroid hormone [hPTH-(1-34)]|DRUG: alendronate | change in spine bone mineral density, study months 30 (phase A), 42 (phase B), 54 (phase C) | This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies. |
NCT00907062 | ALL | CHILD, ADULT | Vitiligo Vulgaris | DIETARY_SUPPLEMENT: Ginkgo biloba | Vitiligo European Task Force assessment form, 12 weeks | Vitiligo is a common hypopigmentation disorder with significant psychological impact if occurring before adulthood. One study investigating the use of Ginkgo biloba for the treatment of vitiligo in adults reports effectiveness, but has significant flaws. We endeavor to conduct an open label pilot clinical trial replicating the previous trial on 12 adolescents 12 to 18 years old. The purpose of the pilot is to test the feasibility of recruitment and patient retention, variability of outcome measures, and identify major safety concerns. The pilot will use 60 mg of standardized G. biloba two times per day (BID) for 12 weeks. The primary outcome will be the validated Vitiligo European Task Force (VETF) evaluation form, secondary outcomes will include the Vitiligo Area Scoring Index (VASI), assess repigmentation via photographs, and will monitor and report adverse reactions. |
NCT00795613 | ALL | ADULT | HODGKIN LYMPHOMA | DRUG: ESCALATED BEACOPP|DRUG: CONVENTIONAL ABVD | progression-free survival (PFS), 3 year | The purpose of this multicenter clinical trial is to assess the clinical impact of dose intensification performed very early during treatment in a subset of poor prognosis, advanced-stage Hodgkin Lymphoma patients, defined as PET-positive after two courses of conventional adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD) chemotherapy. |
NCT00365391 | ALL | ADULT, OLDER_ADULT | Adult Primary Hepatocellular Carcinoma|Advanced Adult Primary Liver Cancer|Localized Unresectable Adult Primary Liver Cancer|Recurrent Adult Primary Liver Cancer | BIOLOGICAL: bevacizumab|DRUG: erlotinib hydrochloride | Number of Patients With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR)., Responses to erlotinib and bevacizumab treatment were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of the longest diameters., Patients were able to continue treatment indefinitely and were evaluated every cycle until discontinued treatment. | This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with advanced liver cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and erlotinib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with erlotinib may kill more tumor cells |
NCT02818140 | ALL | ADULT, OLDER_ADULT | Kidney Stone | PROCEDURE: Ropivacaine TQL block|PROCEDURE: Saline TQL block|DRUG: Ropivacaine|DRUG: Saline|DEVICE: Ultrasound | Total morphine consumption, Morphine consumption in the first 6 hours postoperatively - data from PCA pump and patient medical record, 6 hours postoperatively | Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime.
We hypothesize that active (ropivacaine) transmuscular quadratus lumborum (TQL) block will significantly reduce postoperative opioid consumption and pain following PNL operation compared with placebo (saline) TQL block.
The aim of this study is to investigate the effect of ultrasound-guided (USG) TQL block concurrent with a multimodal analgesic regime compared to the multimodal analgesic regime alone (and placebo TQL block) in a randomized and placebo controlled design. |
NCT00710398 | FEMALE | ADULT | Overweight|Obesity | BEHAVIORAL: Exercise - Aerobic and Resistance|BEHAVIORAL: Dietary - Caloric Restriction | Fat mass, lean mass, bone mass (BMD, BMC), total mass (measured via DXA scan), Measured at weeks 0, 8 and 16 | Diets all share the same principle: eat less energy than you need. This results in weight loss. However, the weight loss is usually a combination of a loss of body fat and muscle mass. Additionally, one's bones may begin to weaken, albeit very slowly, while on a diet, which could have serious long-term consequences. Thus, the investigators believe that the goal of any weight loss strategy should be to lose body fat and spare muscle. The investigators reasoning is two-fold. 1) Fat is not only stored under the skin, but also in and around the internal organs. When this occurs, the organ itself may not function properly. Losing fat mass is a very good thing from a health standpoint, since fat is not just a storage site for extra energy. Scientists have now shown that 'extra' body fat itself can actually secrete substances and when these substances get into your blood, they cause many problems and may even contribute to the development of diabetes. 2) Sparing muscle as an individual loses weight is very important. Muscle is a very 'metabolically active' tissue and is, by analogy, like the body's furnace. Muscle burns fuel from the food individuals eat and also from stored fuels, like fat. Hence, it's easy to see why you don't want to lose muscle because you'd be losing one of your body's best fat burners. More importantly, muscle is also a big storage site and furnace for blood sugar. In people with diabetes (elevated blood sugar), a big part of the problem is with their muscles - they simply do not take up and store or burn enough sugar. For these reasons, your goal should be to lose fat and preserve muscle while dieting.
There are many different diets to choose from (e.g. high protein, low carbohydrate, high fat, high fiber, etc.). A diet that has been shown to be quite successful, however, is one that is higher in protein (but not excessive). Thus, in this study, the investigators are proposing to test whether a higher protein (with dairy) and calcium diet promotes body fat loss and muscle mass retention. The investigators believe that a diet higher in protein (with an emphasis on dairy), but still within accepted healthy ranges, with higher dietary calcium may result in greater loss of body fat and retention of muscle than a diet with a conventional amount of protein and adequate calcium or a conventional amount of protein with little calcium (i.e. low dairy). Based on previous research, the investigators think that people with low calcium intakes to begin with would stand to benefit the most. There is also a good reason to think that the high protein/high calcium diet may result in greater reductions in blood cholesterol and blood sugar, both of which would reduce a person's risk for heart disease and diabetes.
The investigators will test this diet in premenopausal women who are overweight or obese. The investigators believe that this group is a good one to target for several reasons. First, women of this age who are overweight or obese are, if they continue to carry this excess weight, are at serious risk for developing chronic diseases such as heart disease, diabetes, and possibly cancer at an early age. Second, these women will often begin to gradually consume less dairy because many perceive dairy foods as fattening. Thus, if the investigators proposals are correct the investigators will hopefully be able to equip health professionals with a tried and tested, palatable, dietary strategy in a population segment who, because of their age, would benefit greatly were their disease risk to be reduced. |
NCT02129946 | ALL | ADULT, OLDER_ADULT | Type 2 Diabetes Mellitus | OTHER: Resistant Starch | Fasting and postprandial blood glucose, Blood glucose will be measured in the fasting state and postprandially (during a 3-hour oral glucose tolerance test) on the first and last study days of both treatment periods., up to day 57 of both treatment periods|Fasting and postprandial insulin, Circulating insulin will be measured in the fasting state and postprandially (during a 3-hour oral glucose tolerance test) on the first and last study days of both treatment periods., up to day 57 of both treatment periods | The purpose of this study is to determine if consumption of bagels made with resistant starch for 8 weeks can improve markers of type 2 diabetes, colon cancer and satiety in adults. |
NCT04829266 | FEMALE | ADULT, OLDER_ADULT | Anxiety|Cesarean Section | BEHAVIORAL: mental simulation | willingness to verticalize, Percentage of women who were willing to verticalize after listening to the recording. Assessed on a on a six-point scale., Immediately after a single mental simulation|verticalization, Percentage of the success of verticalization after listening to the recording., Immediately after a single mental simulation|duration of the first mobilization, Time form the start of the measurement was set at getting out of bed from a sitting position, and the end of the measurement was set at the patient's return to bed., Immediately after a single mental simulation | Mental simulations can motivate patients for their first verticalization after cesarean section, although perceived anxiety before verticalization may reduce a positive effect of mental simulations. |
NCT00042289 | ALL | CHILD, ADULT, OLDER_ADULT | HIV Infections | DRUG: atazanavir/cobicistat|DRUG: darunavir/ritonavir dosage #1|DRUG: darunavir/ritonavir dosage #2|DRUG: darunavir/ritonavir dosage #3|DRUG: elvitegravir/cobicistat|DRUG: dolutegravir|DRUG: tenofovir alafenamide fumarate (TAF)|DRUG: TAF w/cobicistat|DRUG: TAF w/cobicistat or ritonavir|DRUG: efavirenz|DRUG: darunavir/cobicistat|DRUG: lopinavir/ritonavir dosage #1|DRUG: atazanavir/ritonavir/tenofovir dosage #1|DRUG: rifampicin|DRUG: ethambutol|DRUG: isoniazid|DRUG: pyrazinamide|DRUG: kanamycin|DRUG: amikacin|DRUG: capreomycin|DRUG: moxifloxacin|DRUG: levoflaxacin|DRUG: ofloxacin|DRUG: ethionamide/prothionamide|DRUG: terizidone/cycloserine|DRUG: para-aminosalicylic acid (PAS)|DRUG: high dose INH|DRUG: bedaquiline|DRUG: clofazamine|DRUG: delamanid|DRUG: linezolid|DRUG: pretomanid|DRUG: ethinyl estradiol|DRUG: etonogestrel implant|DRUG: nevirapine|DRUG: amprenavir|DRUG: abacavir|DRUG: lopinavir/ritonavir dosage #2|DRUG: indinavir/ritonavir dosage #1|DRUG: fosamprenavir/ritonavir|DRUG: lopinavir/ritonavir dosage #3|DRUG: atazanavir/ritonavir dosage #1|DRUG: didanosine delayed release (Videx® EC)|DRUG: emtricitabine|DRUG: tenofovir|DRUG: nelfinavir dosage #1|DRUG: tipranavir/ritonavir|DRUG: lopinavir/ritonavir dosage #4|DRUG: raltegravir|DRUG: etravirine|DRUG: maraviroc|DRUG: atazanavir/ritonavir dosage #2|DRUG: tenofovir/atazanavir/ritonavir dosage #2|DRUG: nelfinavir dosage #2|DRUG: indinavir/ritonavir dosage #2|DRUG: rilpivirine|DRUG: darunavir/ritonavir dosage #4 | PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule., Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.|PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule., Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.|PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs, Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing., Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.|PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24 (area under the curve from 0 to 24 hours) were determined using the linear trapezoidal rule., Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.|PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule., Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.|PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose., Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.|PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose., Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.|PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose., Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.|PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose., Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.|PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose., Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.|PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose., Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.|PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose., Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 12 hrs after an observed dose.|PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose.
For the TAF 25 mg q.d., 10 mg q.d. w/COBI, and 25 mg q.d. w/COBI or RTV boosting arms, samples were all below the limit of quantification and statistical analyses were not conducted., Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.|PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose., Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.|Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V., Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.|Number of Women Who Met PK Target of Maximum Concentration (Cmax) for First Line TB Drugs, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. See PK target in Protocol Appendix V.
No results are available for this outcome measure at this time. The TB drugs are being assayed in batches (not real-time) after the study completion. Labs have been experiencing additional delays due to urgent COVID-19 pandemic related work., Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.|Plasma Concentration for Contraceptives, Serum concentrations of the contraceptives. Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs., Measured at 6-7 weeks after contraceptive initiation postpartum|Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear trapezoidal rule., Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing.|Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms, Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the linear trapezoidal rule., Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing. | IMPAACT P1026s is a Phase IV prospective clinical study to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study also evaluated the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs were evaluated by measuring the amount of medicine present in blood and/or vaginal secretions. |
NCT01707004 | ALL | ADULT, OLDER_ADULT | Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome|Adult Acute Myeloid Leukemia in Remission|Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities|Adult Acute Myeloid Leukemia With Del(5q)|Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)|Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)|Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)|Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)|de Novo Myelodysplastic Syndromes|Previously Treated Myelodysplastic Syndromes|Recurrent Adult Acute Myeloid Leukemia|Secondary Acute Myeloid Leukemia | DRUG: decitabine|DRUG: fludarabine phosphate|DRUG: busulfan|DRUG: cyclophosphamide|DRUG: tacrolimus|DRUG: mycophenolate mofetil|BIOLOGICAL: filgrastim|RADIATION: total-body irradiation|PROCEDURE: allogeneic bone marrow transplantation|OTHER: laboratory biomarker analysis | Overall Survival (OS), Will be analyzed using Kaplan-Meier (KM) method, and OS will be obtained from the KM estimates along with 95% confidence intervals., Day 100 | This phase II trial studies how well decitabine and total-body irradiation followed by donor bone marrow transplant and cyclophosphamide works in treating patients with relapsed or refractory acute myeloid leukemia. Giving decitabine and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving decitabine and total-body irradiation before the transplant together with high-dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening. |
NCT01981746 | MALE | ADULT | Muscle Strength|Healthy Volunteers | PROCEDURE: Adductor canal block with ropivacaine 0.1% | Number of subjects with reduced quadriceps strength, The difference between the two volumes in number of subjects experiencing a reduction in quadriceps muscle strength by more than 25% from baseline in two consecutive assessments., 0.5 to 6 hours post block | To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce the number of subjects with impaired muscle strength following adductor canal block. We hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps strength compared with an adductor canal block with 30 ml. |
NCT00234286 | ALL | CHILD, ADULT, OLDER_ADULT | Death|Pain|Dyspnea | BEHAVIORAL: Comfort care education intervention | Presence of Order for Opioid Pain Medication, Presence of order for opioid pain medication at time of death based on abstraction of electronic medical record, Pre and Post Intervention | The BEACON trial (Best Practices for End-of-Life Care for Our Nations' Veterans) was a six-site implementation study to evaluate a multi-component, education-based intervention to improve the quality of end-of-life care provided in VA Medical Centers. |
NCT03110653 | ALL | ADULT, OLDER_ADULT | Anesthesia|Pain | DRUG: Remifentanil|DRUG: NaCl 0.9% | First demand of postoperative analgesic, the first demand of post-operative analgesic will be compared in both groups., 24 hours postoperative | Modern anesthesia has made a lot of progress, however, postoperative pain remains one of the major problems associated with patient discomfort, prolonged hospital stay and increased health care costs.
Remifentanil is an ultra-short-acting phenylpiperidine opioid analgesic with high lipid solubility and a rapid onset of effect.
Recently, opioid use has also been associated with postoperative opioid-induced hyperalgesia or acute opioid tolerance. An immediate discontinuation of remifentanil has been associated to increased postoperative pain levels.
We would like to investigate whether a gradual post-operative withdrawal of remifentanil is indeed associated with less immediate pain compared to after an abrupt withdrawal in surgical patients undergoing minor surgery. |
NCT02360215 | ALL | ADULT, OLDER_ADULT | Cognitive Impairment|Metastatic Malignant Neoplasm in the Brain|Solid Neoplasm | RADIATION: Whole brain radiation therapy with hippocampal avoidance|DRUG: Memantine|RADIATION: Whole brain radiation therapy | Time to Neurocognitive Failure, Neurocognitive failure is defined as the first failure, defined as a neurocognitive decline using the reliable change index (RCI) on at least one of the following assessments or parts of : Hopkins Verbal Learning Test - Revised (HVLT-R), Trail Making Test (TMT), or Controlled Oral Word Association (COWA). The HVLT-R has 3 parts that were analyzed separately for decline: Total Recall, Delayed Recall, and Delayed Recognition. The TMT has 2 parts that were analyzed separately: Part A and Part B. Neurocognitive failure rate is estimated using the cumulative incidence method. Analysis was planned to occur after 233 events were reported. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Six-month rates are provided.Analysis was planned to occur after 233 events were reported., From randomization to last follow-up. Maximum follow-up was 15.6 months. | This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help limit the radiation-induced cognitive decline. It is not yet known whether giving memantine hydrochloride and WBRT with or without hippocampal avoidance works better in reducing neurocognitive decline in patients with brain metastases. |
NCT02929147 | ALL | ADULT, OLDER_ADULT | Supratentorial Neoplasms | DRUG: Morphine|DRUG: Dexketoprofen|DRUG: Placebo | Integrated Pulmonary Index (IPI), Change from Beseline IPI values in postoperative first 24 hours.(at 10th minute, 1, 2, 6, 12, and 24 hours post dose) | An optimal analgesic therapy is very important for postoperative recovery. In recent years, several studies showed that the prevalence of the moderate to severe pain after craniotomy ranged from 69 to 87% of patients. In a previous study, the investigators showed that the use of morphine based patient controlled analgesia prevented moderate to severe postoperative pain in patients undergoing supratentorial craniotomy. Morphine related side effects such as sedation, miosis, respiratory depression, nausea and vomiting produce a general reluctance for their use in neurosurgery. Therefore, all patients were closely observed to detect opioid related side effects in the intensive care unit for 24 hours following surgery in the previous study. The Integrated Pulmonary Index (IPI) is a new tool that calculates respiratory and hemodynamic parameters noninvasively. In the present study the investigators will use different doses of morphine based PCA and the IPI system to determine more effective and safer morphine dose for postoperative analgesia following supratentorial craniotomy. |
NCT03124277 | ALL | CHILD, ADULT, OLDER_ADULT | Disability Physical | DIETARY_SUPPLEMENT: Fortifit®|OTHER: Control Group | Functional status - distance walked during the six minutes walking test, Change in the distance walked during the six minutes walking test, 30 days | This randomized, trial will tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium would increase the efficacy of physical rehabilitation in old adults suffering from Parkinson's disease o parkinsonism |
NCT02347046 | MALE | ADULT, OLDER_ADULT | Renal Insufficiency|Healthy | DRUG: FYU-981, (Oral single dosing) | Pharmacokinetics (Cmax: Maximum plasma concentration), 48 hours|Pharmacokinetics (Tmax: Time to reach the peak plasma concentration), 48 hours|Pharmacokinetics (T1/2: Elimination half-life of plasma concentration), 48 hours|Pharmacokinetics (AUC: Area under the plasma concentration-time curve), 48 hours|Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed), 48 hours|Pharmacokinetics (kel: Elimination rate constant), 48 hours|Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed), 48 hours|Pharmacokinetics (MRT: Mean residence time), 48 hours|Pharmacokinetics (Ae: Amount of drug excreted in urine), 48 hours|Pharmacokinetics (fe: Fraction of dose excreted in urine), 48 hours | The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with renal insufficiency and with normal renal function. |
NCT01867879 | ALL | ADULT, OLDER_ADULT | Advanced Solid Tumors (Excluding Breast Cancer) | DRUG: TAS-102|DRUG: Placebo | QTc interval, Predose (Day -2) to post-dose changes and absolute values in QTc interval after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1), Days -2, -1, 1, and 12 of Cycle 1 | The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors. |
NCT03099382 | ALL | ADULT, OLDER_ADULT | Esophageal Carcinoma | BIOLOGICAL: camrelizumab|DRUG: Docetaxel|DRUG: Irinotecan | Overall Survival (OS), approximately 24 months | In this study, participants with advanced or metastatic squamous cell carcinoma of the esophagus that has progressed after first-line standard therapy will be randomized to receive either single agent SHR-1210 or the Investigator's choice of standard therapy with docetaxel or irinotecan. The primary study hypothesis is that treatment with SHR-1210 will prolong overall survival (OS) as compared to treatment with standard therapy. |
NCT04773483 | ALL | ADULT, OLDER_ADULT | Overweight and Obesity | DIETARY_SUPPLEMENT: Quorn Foods products|DIETARY_SUPPLEMENT: Meat/fish products | Postabsorptive blood cholesterol (free, total, LDL, HDL) concentrations, Test for intervention vs control differences in postabsorptive blood cholesterol levels (mMol) pre and post intervention, 4 weeks | In overweight individuals (BMI \> 27.5 kg/m2), does daily consumption of mycoprotein containing Quorn Food products lower blood cholesterol compared with daily meat/fish consumption? |
NCT00799864 | ALL | CHILD | HIV-1 | DRUG: Rilpivirine|DRUG: Zidovudine|DRUG: Abacavir|DRUG: Tenofovir disoproxil fumarate|DRUG: Lamivudine|DRUG: Emtricitabine | Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Plasma Concentration (Cmax), Up to 48 weeks|Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve (AUC24), AUC24 is defined area under the plasma concentration time curve from 0 to 24 hours post dosing of rilpivirine., Up to 48 weeks | The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\], or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\] in antiretroviral (ARV) treatment-naïve adolescents and children aged greater than or equal to (\>=) 6 to less than (\<) 18 years. |
NCT01686724 | ALL | CHILD | Attention Deficit Hyperactivity Disorder Symptoms | BEHAVIORAL: Collaborative Life Skills Intervention (CLS)|OTHER: Business As Usual | Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V., change from baseline on ADHD symptoms at 12 weeks | This study tests the effectiveness of a newly developed integrated school-home behavioral intervention for behaviors related to Attention Deficit Hyperactivity Disorder (ADHD). The intervention is implemented by school-based mental health professionals within school settings. |
NCT01595347 | ALL | ADULT, OLDER_ADULT | Pressure Ulcer | DRUG: Hyper-oxigenated fatty acid|OTHER: Olive oil's cream | Appearance grade II pressure ulcers, The primary outcome or result is the appearance of grade II pressure ulcers in patients under study during the 9 months follow up. This will be confirmed by observation of the areas where we did the intervention (sacrum, hips and heels)., 48 months | Pressure ulcers (UPP) represent an important sanitary problem affecting mostly elderly immobilized persons, increasing the burden of care to professionals in the health system, as well as pharmaceutical spending. There are studies of the effectiveness of various products in the prevention of the UPP, most made in hospitals and using fundamentally composed based on oily hyperbecome oxygenated acids (AGHO).
There do not exist studies realized specifically with cream of olive oil.
AIMS:
Principal: To verify the efficiency of a new intervention of UPP's prevention in immobilized patients consisting in the application of cream of olive oil. Secondary: To evaluate the cost - efficiency of this new intervention opposite to AGHO's application.
To value the degree of satisfaction of the patient and his keeper with regard to the use of cream of olive oil.
METHODOLOGY DESIGN: clinical Test randomized with two parallel branches. AREA: Population consultant of the health centers in the province of Malaga. SUBJECTS OF STUDY: Patients immobilized at the risk of developing UPP. INTERVENTION: Administration of cream of olive oil to the group of intervention and AGHO's administration to the group control. Follow-up for one year. VARIABLES. Principal variable: UPP's appearance. Secondary: Demographic and clinical data, presence of technical supports, information of the caragiver and questionnaire of satisfaction. STATISTICAL ANALYSIS: Test. Exact of Fischer. Odds's calculation ratio. Shapiro-Wilk's test. Parametric test t- student or test U of Mann-Whitney. Reason of the increase cost efficiency (ICER). Logistic regression model multivariant. |
NCT01190540 | ALL | CHILD, ADULT, OLDER_ADULT | Capacity Building|Support for Midlevel Health Professionals|Diagnostic Training | BEHAVIORAL: Training and supervision|BEHAVIORAL: Training and Supervision|BEHAVIORAL: Integrated Management of Infectious Disease (IMID)|BEHAVIORAL: Integrated Management of Infectious Disease (IMID) | Model of Integrated Capacity Building Program, The principal output of this evaluation will be a proven model of an integrated capacity-building package for the care and prevention of infectious disease in Africa. The package will include a single curriculum for MLP and a portfolio of on-site support services founded on Accordia Global Health Foundation's considerable experience in training clinicians in North America and Africa., monthly over 3 years|Competence of individual clinicians, Competence of individual clinicians will be measured by scores on 12 written case scenarios or vignettes. Three blocks of 4 scenarios each covered different aspects of HIV/AIDS, tuberculosis, malaria, and other infectious diseases and included cases involving children, adults, and pregnant women. Each case scenario addressed 6 principal domains: emergency or danger signs, history and physical examination, laboratory testing, diagnosis or classification of patients' medical problems; initial treatment or referral plan, and evolution of the case over time., 3 observations at pre/post IMID and final|Practice of individual clinicians, Clinical assessments will be conducted by mobile team faculty who will observe individual clinicians during five outpatient visits with children under five years and five HIV clinic visits. Clinical practice will be assessed on history, physical examination, review of medical records (HIV clinic only), laboratory investigations ordered, diagnosis, treatment prescribed and patient education., Baseline and Endline (9 months)|Clinical performance indicators, 54 clinical performance indicators used by the Ministry of Health, the Uganda Malaria Surveillance Program or recommended by international organizations will be used to measure performance in general areas: 1) HIV prevention, 2) HIV care, 3) Antiretroviral therapy, 4) TB/HIV care, 5) Case management of respiratory infections, 6) Case Management of Fever, and 7) Emergency Triage and Treatment., Monthly beginning 5 months before OSS | This evaluation aim is to investigate a cost-effective way to build capacity for the care and prevention of infectious diseases among mid-level practitioners (MLP) in sub-Saharan Africa. Classroom based training continues to be the dominant form of training, despite evidence that suggests that on-site support (OSS) is more beneficial. Definitive evidence that on-site support is the most effective way to deliver the required outputs and related outcomes is still lacking. IDCAP will provide two interventions that integrate training in TB, HIV/AIDS and malaria as well as other infectious diseases, and the effects will be studied: 1) Integrated Management of Infectious Disease (IMID) training program for individual MLP, and 2) On-site support (OSS) for team of health professionals. This study employs a mixed design with pre/post and cluster randomized trial components. Interventions are at the level of the individual participant for IMID and at the level of the site (health facility) for OSS. All participants attend a 3-week course, followed by two 1-week booster courses over a six month period. After the 3-week course, a randomized arm of half the sampled facilities also received OSS every month for 9 months and bi-monthly for 6 additional months. |
NCT02395718 | ALL | OLDER_ADULT | Geriatric Disorder | OTHER: QDU|OTHER: DIM | All cause mortality, Number of participants that die by any cause within 90 days after the day of admission, data will be retrieved from The Danish Civil Registration system 90 days after admission. Accounted as dead or alive., 90 days | To evaluate differences in health outcomes among elderly patients (age ≥ 75 years) treated in a Quick Diagnostic Unit (QDU) compared to the Department of Internal Medicine (DIM). A QDU is a medical Short Stay Unit (SSU). |
NCT00309283 | ALL | ADULT, OLDER_ADULT | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | DRUG: Long-acting somatostatin|OTHER: Saline solution | Change over baseline of the total kidney volume at 1 and 3 years follow-up (estimated by gadolinium contrast enhanced and T2-weighted magnetic resonance imaging, MRI)., Basal, 1 and 3 years follow-up | Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common hereditary renal disease, responsible for 8% to 10% of the cases of end stage renal disease (ESRD) in Western countries. At comparable levels of blood pressure control and proteinuria, patients with ADPKD have faster decline in glomerular filtration rate than those with other renal diseases and do not seem to benefit to the same extent of ACE inhibitor therapy. A reasonable explanation for the above findings is that in ADPKD progression is largely dependent on the development and growth of cysts and secondary disruption of normal tissue. Thus, renoprotective interventions in ADPKD - in addition to achieve maximal reduction of arterial blood pressure and proteinuria and to limit the effects of additional potential promoters of disease progression such as dyslipidemia, chronic hyperglycemia or smoking - should also be specifically aimed to correct the dysregulation of epithelial cell growth, secretion, and matrix interactions characteristic of the disease.
Evidence that specific receptors for somatostatin are present in the kidney tissue, arises the possibility that somatostatin treatment in patients with ADPKD might inhibit fluid formation and eventually induce the shrinking of renal cysts.To evaluate the tolerability and the safety of long-acting somatostatin in ADPKD patients, a prospective cross-over controlled study has been recently performed. This pilot study demonstrated the safety of six month treatment of long-acting somatostatin in patients with ADPKD. Moreover, the percent increase of total kidney volume was significantly lower in patients on somatostatin than in placebo. Overall, these findings provide the basis for designing a long-term study in ADPKD patients aimed to document the efficacy of the somatostatin treatment in preventing further increase or even reducing the total kidney volume and the renal volume taken up by small cysts, eventually halting kidney disease progression. |
NCT03624946 | ALL | ADULT | Zika Virus Infection|Zika Virus Disease | BIOLOGICAL: Zika Virus Immune Globulin (ZIKV-IG)|OTHER: Placebo | Number of Subjects With Adverse Events., Number of subjects with of adverse events by severity., Up to Day 85 | Currently, there are no licensed therapeutics against Zika virus infection. Due to this unmet medical need, Zika Virus Immune Globulin (ZIKV-IG) is being developed as a therapeutic intervention against Zika virus infection. In this first-in-human study, evaluation of ZIKV-IG safety and pharmacokinetics (absorption, metabolism and excretion) will be conducted in healthy adult volunteers. |
NCT01800942 | FEMALE | ADULT | Neonatal Infection | DRUG: Azithromycin and Placebo | the prevalence of nasopharyngeal carriage of the newborn of any of the following bacteria: 1) Group B Streptococci (GBS) , 2) S.pneumoniae and 3) S.aureus, The primary outcome is the prevalence of nasopharyngeal carriage of the newborn at the age of six days for any of the following bacteria: 1) Group B Streptococci, 2) S.pneumoniae and 3) S.aureus., 6 days | The last decade has witnessed an important reduction of the mortality in children under 5 years but such reduction has not impacted in neonates. Mortality in neonates contributes 40% of all deaths occurring in children below 5 years of age.
Severe bacterial disease is among the leading causes of neonatal deaths. Bacterial disease follows bacterial infection. Individuals can be infected without developing disease (carriage stage) but infection is needed to subsequently develop disease. In sub-Saharan Africa, bacterial carriage (i.e. in the birth canal and/or nasopharyngeal tract) is very common in all age groups, with the consequence that occurrence of bacterial disease is one of the highest in the world.
Newborns can be infected during labour - when passing through the birth canal - and during the first days/weeks of life, as a consequence of the close physical contact with the mother, if the latter carries bacteria in the nasopharyngeal tract.
If the mother is an important source of bacterial infection to the newborn, treating mothers with a powerful antibiotic during labour should decrease bacterial carriage and therefore diminish the risk of bacterial transmission to the newborn during the first days/weeks of life, which should in turn result in the lower occurrence of severe bacterial disease and hence lower mortality.
The purpose of this trial is to evaluate the impact of a single oral dose of azithromycin given to women in labour on bacterial carriage of the newborn as well as the women during the first month after delivery.
The investigators have selected an antibiotic (azithromycin) that in sub-Saharan Africa has already shown both a strong impact on bacterial nasopharyngeal carriage and on all-cause mortality when administered to everybody in a community (mass drug administration). This specific antibiotic has several advantages for being deployable as a simple intervention in rural Africa, i.e. it requires a single oral administration, it has no special storage requirements and it has the potential to eliminate many of the bacteria commonly causing severe disease in newborn.
This clinical trial will be conducted in a peri-urban health facility in Western Gambia. If an impact is shown, the next step would be to conduct a larger study aiming at establishing if the intervention, implemented at a lower level of care (most African women deliver at home assisted by traditional birth assistants), decreases the occurrence of neonatal bacterial disease |
NCT04690257 | ALL | CHILD | Venipuncture|Pain|Anxiety|Fear | OTHER: Trace Image and Coloring for Kids-Book (TICK-B) | Pain Intensity Measure, Wong-Baker faces scale (WBFS). Used to measure the pain severity during the procedure, the WB-FBRS is a series of six cartoon faces positioned side-by-side from the greatest pain to the mildest one (0-5)., Immediately after venipuncture (1-2 min) | Venipuncture is one of the most common stressful procedures in children. Managing pain and fear of venipuncture procedure recommended strongly because it may change children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses.
There was clear evidence that the distraction method is the most performed as a psychological technique performed to decrease venipuncture-related pain and distress and supporting its efficacy in children.
The aim of this study to investigate the effectiveness of TICK-B on children's pain and anxiety during venipuncture procedure. |
NCT02839343 | ALL | ADULT, OLDER_ADULT | Pancreatic Adenocarcinoma|Borderline Resectable Adenocarcinoma of the Head of the Pancrease | RADIATION: radiation therapy|PROCEDURE: surgery|DRUG: mFOLFIRINOX|DRUG: FOLFOX | Overall Survival (OS) Rate, Defined as the percentage of patients who are alive at 18 months after randomization divided by the total number of evaluable patients in each arm. An evaluable patient is defined as any patient who signed informed consent, deemed eligible by central review and received any protocol-defined treatment. 95% confidence interval will be estimated based on standard method. Chi-squared test (or Fisher's exact test if the data in contingency table is sparse) will be used to compare 18 month OS rates among treatment arms. OS within each arm will be summarized by Kaplan-Meier method. Median, 1-year and 2-year rates will be estimated based on Kaplan-Meier curves., 18 months | This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with or without hypofractionated radiation therapy before surgery works in patients with pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is more effective with or without hypofractionated radiation therapy before surgery in treating patients with pancreatic cancer. |
NCT01599650 | ALL | ADULT, OLDER_ADULT | Branch Retinal Vein Occlusion | DRUG: Ranibizumab|PROCEDURE: Laser | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO), Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)
-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model., Baseline, 6 Months | This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication. |
NCT02176278 | ALL | CHILD, ADULT, OLDER_ADULT | Diabetic Kidney Disease | OTHER: Telephone Reminder|OTHER: Doctor-Nurse Follow Up|OTHER: Personalized Risk Report for Patient Empowerment | Attainment of at least 3 treatment targets, Attainment of at least 3 treatment targets of
* A1c\<7%
* BP\<130/80 mmHg
* LDL-C\<1.8 mmol/L
* Triglyceride\<1.7 mmol/L
* Persistence with RAS inhibitors taking into consideration safety and tolerability (e.g. hypoglycemia, hypotension, changes in electrolytes), 1 year | In this quality improvement program (DKD-TMT), patients will be recruited from multiple sites across Asia, with each site recruiting at least 300 type 2 diabetic patients with Diabetic Kidney Disease (DKD). After explanation by trained doctors and nurses, and with written informed consent, patients will be randomized to the UC (n=100, usual care) group, the EC (n=100, empowered care) group, or the TEC (n=100, team-based, empowered care) group. Patients in all 3 groups will undergo a comprehensive assessment (CA) guided by the templates in the Joint Asia Diabetes Evaluation (JADE) portal at baseline and at month 12. They will also self-administer a set of questionnaires for assessing quality of life and psychological distress during the CA at both time points.
During the 12 months between the 2 CAs:
* Patients in the UC group will receive UC in accordance to the practice of the health institution.
* Patients in the EC group will receive a JADE summary report with personalized risk prediction, treatment targets and decision support with explanation from the doctor and nurse. In addition to receiving UC in accordance to the practice of the health institution, the nurse will telephone the patient 3-monthly to remind them to adhere to treatment, provide support and empower them to discuss with their doctors about their treatment needs and any concerns.
* Patients in the TEC group will be followed by a doctor-nurse team at least 3 monthly to achieve multiple targets, but tailored to patients' risk profile. The patients will receive telephone reminders and also be given a JADE follow up report 3-monthly.
The primary composite endpoint is attainment of treatment goals and/or control of risk factors. The secondary composite endpoint is all-diabetes related clinical endpoints. The tertiary changes are behavioral changes, psychological well-being and quality of life. |
NCT01804959 | ALL | ADULT, OLDER_ADULT | Systemic Sclerosis | DIETARY_SUPPLEMENT: Vivomixx probiotics | mean difference between probiotics group versus placebo group in gastrointestinal change score from baseline to day 60 of treatment., After 60 days of either placebo treatment or active drug treatment | SSc-associated gastrointestinal (GI) involvement is common, with no effective treatment. Probiotics may have beneficial effects on symptoms as supported by one small open-label study (n=10) that demonstrated decreased bloating symptoms in SSc patients after 2 months of probiotics. This study aims to determine (i) whether 60 days of Vivomixx probiotics result in greater GI symptom improvement than placebo in SSc outpatients, assessed using an interview-administered 34-item Gastrointestinal Tract (GIT) questionnaire and (ii) whether 60 days versus 120 days of probiotics result in greater GI symptom improvement in SSc outpatients, assessed using the GIT questionnaire. |
NCT00117663 | FEMALE | ADULT, OLDER_ADULT | Breast Cancer | OTHER: temporary discontinuation of hormone therapy for 1 month|OTHER: temporary discontinuation of hormone therapy for 2 months | Mammogram Recall for Additional Imaging, Mammography recall was defined as any assessment requiring additional imaging or evaluation of either breast (BI-RADS assessment of 0 for either or both breasts)(30) determined exclusively from the study radiologists' interpretation., 4 years|Mammographic Breast Density, Breast density (Mean, SE) and Change in Breast density by Randomization Group, 4 years | The purpose of this study is to determine whether cessation of hormone replacement therapy for one or two months before a screening mammogram will improve its performance by decreasing breast density. |
NCT01926223 | FEMALE | CHILD, ADULT | Adolescent Parenting | OTHER: Home visiting | Child abuse and neglect, 24 months post-enrollment | Massachusetts Healthy Families Evaluation is a randomized controlled trial of a statewide home visiting program for first time parents aged 20 years and under. The evaluation uses a mixed-method design to assess participant outcomes in five program goal areas: 1) prevention child abuse and neglect; 2) optimal child development; 3) educational achievement and economic self-sufficiency; 4) parental well-being; and 5) prevention of repeat teenaged births. |
NCT01470820 | ALL | CHILD, ADULT, OLDER_ADULT | Neonatal Hyperbilirubinemia | OTHER: Phototherapy with blue light | 24 hours decrease of TsB expressed in percent., TsB was measured before and after 24 hours of phototherapy and irradiance every 8th hour. Main outcome was 24 hours decrease of TsB expressed in percent (∆ TsB0-24(%)., Baseline and 24 hours | Background: Using light emitting diodes (LED's) during conventional phototherapy it is possible to reduce the distance from light source to infant, thereby increasing light irradiance.
Objective: To examine the relation between light irradiance and the rate of decrease in total serum bilirubin concentration (TsB) and to see if the investigators can identify a "saturation point", i.e. an irradiation level above which there is no further decrease in TsB.
Design: Prospective randomised study. Setting: Neonatal Intensive Care Unit, Pediatric Department, Aalborg Hospital, Aarhus University Hospital, Denmark.
Material and method: 151 infants with gestational age ≥ 33 weeks and uncomplicated hyperbilirubinaemia are randomised to one of 4 different distances from phototherapy device to mattress (20, 29, 38 and 47 cm). TsB is measured before and after 24 hours of phototherapy and irradiance every 8th hour. Main outcome measure is 24 hours decrease of TsB expressed in percent (∆ TsB0-24 (%)). |
NCT04383613 | ALL | ADULT, OLDER_ADULT | Covid-19|ARDS | OTHER: Prone positioning | Composite outcome of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, or need for FiO2 of 60% or more, From date of randomization until the date of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, need for FiO2 of 60% or more, or date of hospital discharge, whichever came first, assessed up to 4 weeks | COVID-PRONE is a multicenter, pragmatic, unblinded, 2-arm, parallel, randomized controlled trial seeking to compare the pre-emptive prone positioning (i.e. encouraging patients to adopt a prone position before they require mechanical ventilation) to the control arm of standard care alone. Randomization will be stratified by site. |
NCT03478501 | ALL | ADULT, OLDER_ADULT | Suicide|Emergencies | BEHAVIORAL: Decision Aid | Acceptability of Lethal Means Decision Aid, This will be assessed using the Ottawa Acceptability Questionnaire that captures the patient's feedback on the design, presentation, quality, and information presented in the decision aid through both survey and open ended questions. Questions include likert scale responses (range of responses are specific to each question's content). There are also a series of yes/no/don't know questions related to content presented. Each "no" response asks the participant to elaborate in an open ended response. The participant also has the ability to provide general feedback in open ended feedback format. There are no subscales to this measure., Baseline|Decision Making Quality in Emergency Department (ED), The Decisional Conflict Scale (DCS), low literacy 10 item scale, measures decision quality, uncertainty, personal perceptions and satisfaction. A total score is computed through sum of items 1-10 (Yes=1; unsure=2; no=4) divided by 10, and multiplied by 25. Scores range from 0 (no decision conflict) to 100 (extreme decision conflict). The sum of items 1, 2, 3, divided by 3 and multiplied by 25 is the informed decision subscale (1 extremely informed) to 100 extremely uninformed). The sum of items 4 and 5, divided by 2 and multiplied by 25 is the values clarity (0 feels extremely clear to 100 feels extremely unclear). The sum of items 9 and 10, divided by 2 and multiplied by 25 is the uncertainty subscale (0 feels extremely certain about best choice to 100 feels extremely uncertain about best choice). The sum of items 6, 7, 8, divided by 3 and multiplied by 25 is the support subscale (0 feels extremely supported in decision making to 100 feels extremely unsupported in decision making)., Baseline|Home Firearm Storage, At both baseline and one week follow up, participants will complete a study specific survey that asks about how they currently store their firearms or current plans to change how they store their firearms to measure change in storage., Baseline and 1 week follow up|Decision Making Quality - Follow up, The Decisional Conflict Scale (DCS), low literacy 10 item scale, measures decision quality, uncertainty, personal perceptions and satisfaction. A total score is computed through sum of items 1-10 (Yes=1; unsure=2; no=4) divided by 10, and multiplied by 25. Scores range from 0 (no decision conflict) to 100 (extreme decision conflict). The sum of items 1, 2, 3, divided by 3 and multiplied by 25 is the informed decision subscale (1 extremely informed) to 100 extremely uninformed). The sum of items 4 and 5, divided by 2 and multiplied by 25 is the values clarity (0 feels extremely clear to 100 feels extremely unclear). The sum of items 9 and 10, divided by 2 and multiplied by 25 is the uncertainty subscale (0 feels extremely certain about best choice to 100 feels extremely uncertain about best choice). The sum of items 6, 7, 8, divided by 3 and multiplied by 25 is the support subscale (0 feels extremely supported in decision making to 100 feels extremely unsupported in decision making)., 1 week follow up|Suicidal Ideation and Behavior at One Month, While this pilot trial is not powered to detect a change in mental health outcomes, as part of the feasibility for a larger trial, the investigators will attempt to track suicide attempts and outcomes through medical record chart review., 1 month post baseline|Suicidal Ideation and Behavior at Three Months, While this pilot trial is not powered to detect a change in mental health outcomes, as part of the feasibility for a larger trial, the investigators will attempt to track suicide attempts and outcomes through medical record chart review., 3 months post baseline|Vital Statistics (Suicide death), While this pilot trial is not powered to detect a change in suicide outcomes, as part of the feasibility for a larger trial, the investigators will attempt to track suicide death outcomes through state vital statistics reporting., 3 months post baseline | This study will test a patient decision aid about safe firearm storage during suicidal crisis. The investigators hypothesize that participants with higher quality decisions after the decision aid will be more likely to change their firearm storage to reduce access during the time of crisis. |
NCT01082874 | ALL | ADULT, OLDER_ADULT | Cardiovascular Disease | DRUG: Active Clonidine|DRUG: Placebo Clonidine|DRUG: Active ASA|DRUG: Placebo ASA | Composite of All-cause Mortality and Nonfatal MI, 30 days|All-cause Mortality and Nonfatal MI, 1 year | Major surgeries not involving the heart are common, and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested. There is encouraging data suggesting that small doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems. The POISE-2 Trial is a large international study to test if ASA and Clonidine can prevent heart attacks and deaths from heart problems around the time of surgery. |
NCT00126100 | ALL | ADULT, OLDER_ADULT | Myocardial Infarction | DRUG: G-CSF Granulocyte-Colony Stimulating Factor|OTHER: Placebo | Reduction of infarct size (measured by Tc-sestamibi scintigraphy), measured by Tc-sestamibi scintigraphy baseline, 4 and 6 months | The purpose of this study is to determine whether stem cell mobilization by granulocyte colony-stimulating factor (G-CSF) therapy in patients with acute myocardial infarction after successful mechanical reperfusion reduces infarct size. |
NCT01730534 | ALL | ADULT, OLDER_ADULT | Diabetes Mellitus, Non-Insulin-Dependent|High Risk for Cardiovascular Event | DRUG: Dapagliflozin 10 mg|DRUG: Placebo tablet | Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke, Safety and co-primary efficacy, up to 5.2 years|Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure., Co-primary efficacy, up to 5.2 years | This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors. |
NCT01900262 | ALL | ADULT | Running|Leg Injuries | OTHER: Strengthening|OTHER: Balance Training|OTHER: Stretching | Change in Strength, Strength of the muscles crossing the ankle, knee and hip joint will be assessed at baseline and after 8 weeks of training in order to assess the change in strength following training., Week 0, Week 8|Change in Running Mechanics, Running kinematics and kinetics will be measured using 3D motion capture technology at baseline and after 8 weeks of training in order to assess the change in running mechanics following training., Week 0, Week 8|Change in Postural Control, Postural control will be assessed using single leg stance and the star excursion balance test at baseline and after 8 weeks of training in order to assess the change in postural control following training., Week 0, Week 8 | The purpose of this study is to understand the effects of muscle strengthening and balance exercise interventions on muscle strength, running mechanics and postural control in novice recreational runners. Participants will be assessed before and after they engage in an 8-week exercise intervention program. |
NCT00409188 | ALL | ADULT, OLDER_ADULT | Non-small Cell Lung Cancer | BIOLOGICAL: Tecemotide (L-BLP25)|DRUG: Single low dose cyclophosphamide|DRUG: Placebo | Overall Survival, Overall survival time was defined as the time from randomization to death. Participants without events were censored at the last date they were known to be alive or the clinical cut-off date, whatever was earlier., Up to 66 months | The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.
A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination. |
NCT02058459 | ALL | ADULT, OLDER_ADULT | Chronic Obstructive Pulmonary Disease (COPD) | DEVICE: Holaira™ Lung Denervation System with energy delivery|DEVICE: Holaira™ Lung Denervation System without energy delivery | AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months, Respiratory adverse events is defined as: worsening bronchitis, worsening dyspnea, common cold, COPD exacerbation, influenza, pneumonia, respiratory infection, respiratory failure, tachypnea and wheezing. Subjects may have reported more than one type of respiratory adverse event., 3-6.5 months | The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control. |
NCT02708745 | ALL | CHILD, ADULT, OLDER_ADULT | Preventive Health Services | BEHAVIORAL: Intervention Survey|BEHAVIORAL: Placebo Survey | Child's Mean Percent Days Under-immunized, Mean percent days under-immunized among children of parents who received (vs. did not receive) the intervention, Child's immunization status at 8 months of age | The overall goal of this project is to determine whether integrating a novel parent-report measure of vaccine hesitancy into pediatric primary care is effective in improving acceptance of childhood vaccines among vaccine-hesitant parents. |
NCT01225302 | ALL | ADULT, OLDER_ADULT | Non-Small Cell Lung Cancer | DRUG: Linifanib|DRUG: Linifanib|DRUG: Carboplatin|DRUG: Paclitaxel | Safety (Number of patients with adverse events and/or dose-limiting toxicities), Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring., At each treatment visit (weekly for 6 weeks, then every 3 weeks) | The primary objective of this study is to assess the safety and pharmacokinetics of linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor activity in the subjects as first-line treatment. |
NCT01877772 | ALL | ADULT, OLDER_ADULT | Rotator Cuff Tear | PROCEDURE: Bone Trephination|PROCEDURE: Control | High-resolution ultrasound, High-resolution ultrasound will be used as the primary outcome measure to determine the re-tear rate at 6 and 24 months following repair. Ultrasound was chosen as it has been shown to have a high degree of accuracy for the diagnosis of rotator tears that is equivalent but less expensive than MRI.
The interpretation of the high-resolution ultrasound is based on healing status and will be carried out by a trained MSK radiologist. Healing status will be documented at both 6 and 24 months as either completely healed, partially healed, or not healed. For tendons partially healed or not healed, the size of the defect will be compared with the size of the tear pre-operatively., 6 and 24 months post op | This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff repair; bone trephination."Trephination" is a procedure that involves making small perforations in the bone that the tendon is repaired to.The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon. The control group will undergo the standard repair for rotator cuff tears.
It is the investigators' hypothesis that healing rates in patients who undergo bone trephination will be higher compared with surgery without trephination in arthroscopic rotator cuff repair at 24 months post-operatively. |
NCT00265096 | ALL | ADULT, OLDER_ADULT | Arthritis, Psoriatic | BIOLOGICAL: golimumab|BIOLOGICAL: Placebo; golimumab|BIOLOGICAL: golimumab | American College of Rheumatology (ACR) 20 Response at Week 14, ACR 20 response is an improvement of \>= 20% from baseline (baseline measurement is defined as the closest measurement taken prior to or at the time of the initiation of study medication administration) in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale \[VAS\], Health Assessment Questionnaire \[HAQ\] and C-reactive protein \[CRP\]), Baseline (Week 0), Week 4, Week 8 and Week 14|Change From Baseline in Total Radiographic Scores of the Hands and Feet at Week 24, Summary of change from baseline in total van der Heijde-Sharp (vdH-S) score of the hands and feet, as modified for psoriatic arthritis, at Week 24. The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 to 528 with higher scores indicating more joint damage. For the change from baseline, positive values show an increase in damage., Baseline and Week 24 | The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and symptoms of active PsA, including effects on joint pain and swelling, changes on x-ray related to joint damage, psoriasis skin lesions, physical function, and quality of life. |
NCT02229903 | ALL | ADULT, OLDER_ADULT | Obsessive Compulsive Disorder | DEVICE: Active DTMS Treatment|DEVICE: Sham Treatment | Yale Brown Obsessive Compulsive Scale (YBOCS) score, The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the 6 week (post-randomization) visit, between the two treatments groups., 6 Weeks | The purpose of the study is to evaluate the safety and efficacy of the Deep TMS (DTMS) treatment in subjects with OCD. The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a predetermined frequency. The Brainsway DTMS study is a randomized, 10 week, double blind, multi-center trial comparing active DTMS treatment to sham treatment. |
NCT01873365 | ALL | ADULT, OLDER_ADULT | Herpes Zoster | OTHER: Data collection | Total number of HZ cases reported in the study area, overall and within a specific age-group and gender. The following age-groups will be considered: 60-69, 70-79 and ≥ 80 years of age., Approximately 1 year|Occurrence of HZ-associated PHN pain, persisting between 90 and 270 days after the initial visit for this study., Day 90 - Day 270 | The study aims to estimate the incidence of herpes zoster (HZ), proportion of postherpetic neuralgia (PHN) and the economic burden and impact on quality of life, in Japanese adults greater than or equal to sixty years of age. |
NCT00139347 | ALL | CHILD | Infections, Rotavirus | BIOLOGICAL: 2-dose oral live attenuated G1P[8] human rotavirus vaccine | Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old. | The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age. |
NCT01114555 | ALL | CHILD, ADULT, OLDER_ADULT | Neuroblastoma | DRUG: Bevacizumab, Irinotecan and Temozolomide | Overall Responses, To evaluate tumor responses to combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB., 15-35 days after cycle 2 | The purpose of this study is to find how good and how safe the combination of irinotecan, temozolomide and bevacizumab is for patients with resistant or recurrent neuroblastoma. These drugs have each been given separately to patients, but they have never been given all together. Irinotecan and temozolomide are two drugs that have been used together to treat neuroblastoma in many people. These drugs are considered chemotherapy. Bevacizumab is another drug used to treat cancer. It is made by a company called Genentech. Bevacizumab is an antibody. Antibodies are proteins that are found in the blood and can attach themselves to bacteria and viruses. Bevacizumab attaches itself to a special protein in the bloodstream. This protein helps tumors grow new blood vessels. Blood vessels carry nutrients to feed the tumor. Bevacizumab is thought to block this growth of new blood vessels and starve tumors. It has been used for the treatment of many cancers in adults. It is approved by the FDA for the treatment of adults with colon cancer and other cancers but not for people with neuroblastoma. There is only a small amount of information known on using this drug in children. It has been used with irinotecan before to treat cancer but not in children with neuroblastoma. |
NCT01032668 | ALL | ADULT, OLDER_ADULT | Coronary Artery Disease | DRUG: Clopidogrel | Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths, 6 months. | Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac events in patients with clopidogrel resistance |
NCT03406078 | ALL | ADULT, OLDER_ADULT | Asthma | BIOLOGICAL: Tezepelumab|OTHER: Placebo | Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control, Categorized percent reduction from baseline at Week 48. Percent change from baseline is defined as {final dose-baseline dose)/baseline dose}\*100, and the categories of percent change from baseline in daily OCS dose are defined as: ≥90% to ≤100% reduction, ≥75% to \<90% reduction, ≥50% to \<75% reduction, \>0% to \<50% reduction, and, no change or any increase., Baseline to Week 48 | Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma |
NCT03965936 | FEMALE | ADULT, OLDER_ADULT | Skin Rejuvenation|Lipofilling | PROCEDURE: lipofilling|PROCEDURE: lipofilling enriched with adipose tissue derived stem cells | Assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness, serial photography for assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness, 3 months, 6 months | this research is to study the effect of Adipose Derived Stem Cells on Survival of Fat as Filler |
NCT04080765 | ALL | CHILD, ADULT, OLDER_ADULT | Hiv | BEHAVIORAL: HIV-ASSIST|BEHAVIORAL: DHHS guidelines | Proportion of appropriate ARV selections, Median score (out of 100%) on survey of 10 standardized case scenarios, as scored in comparison to a reference panel of HIV experts., Up to one hour | HIV-ASSIST is an online decision support tool created by Johns Hopkins faculty that utilizes standard patient variables, and provides treatment recommendations and tailored educational content to assist providers learn HIV treatment principles and support decision-making.
The research goal is to determine the difference in percentage of appropriate antiretroviral therapy (ART) selection (based upon a reference standard of HIV experts and guidelines) for a set of hypothetical patient scenarios, comparing a group of trainees with access to current national DHHS guidelines (control), and a group using HIV-ASSIST (intervention) in addition to guidelines.
The investigators proposed a randomized study design, in which an electronic survey/questionnaire with 10 HIV case vignettes are presented to study participants. Medical and nursing students and internal medicine residents will be eligible to participate.
Participants providing informed consent will be randomized to receiving access to either online Department of Health and Human Services (DHHS) HIV guidelines, or the HIV-ASSIST online tool to support participants' decision making. Participants will be asked to indicate participants' ART regimen of choice for each case scenario. The proportion of appropriate ART selections will be evaluated comparing the intervention and control arms. The investigators will additionally report the time required for trainees to complete ART selections for the presented clinical vignettes. |
NCT00992823 | ALL | CHILD | Anemia | DRUG: iron supplementation|BIOLOGICAL: iron supplementation | Initial and final blood hemoglobin concentration, 10 months | Aim: To evaluate the efficacy of iron supplements given at intervals corresponding to the mean life of red blood cells compared to weekly supplementation, in reducing the prevalence of preschool anemia.
Method: Ninety-nine children from public day care centers with ages from 24 to 59 months old were randomly divided into two groups. All the children received 40 doses of 30 mg of ferrous sulfate during a 10-month intervention period. Group 1 received once weekly supplementation and Group 2 received supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation. |
NCT01705756 | ALL | ADULT, OLDER_ADULT | Familial Mediterranean Fever | DRUG: Kineret | Number of patients with less than a mean of one FMF attack per month, Total number of FMF attacks in abdominal, thoracic, skin or joint locations during the observational period (4 months) as recorded in the patient diary, devided by 4 for each patient will result in number of attacks per one month. The number of patients with less than 1 attack per month will be compared between the 2 study groups, 4 months | FMF is the most common periodic fever with a worldwide patient population estimated as 150,000, mainly located in the Eastern Mediterranean basin. colchicine is the established therapy of choice ,however, around 20.000 patients worldwide fail to respond or cannot tolerate therapeutic doses, thereby suffering from recurrent debilitating, severe, painful attacks of peritonitis, pleuritis and synovitis and are at risk to die from reactive amyloidosis .Mutation-induced reduction in pyrin/ marenostrin activity is thought to underlie the disease by leading to NALP3 inflammasome activation ,and thereby to IL-1β related burst of inflammation.
The IL-1 receptor antagonist Kineret (Anakinra), seems to be the most appropriate response to the uncontrolled IL-1β elevation. Indeed, an increasing number of reports over the last few years indicate a good response to Kineret (Anakinra), in colchicine-resistant FMF ,also in children ,however, no controlled study has thoroughly evaluated the efficacy and safety of this treatment.
Study outline:
The study aims to run at the FMF centre in Sheba Medical Center, covering more than 10,000 patients. The study will evaluate the effect of recombinant IL-1 receptor antagonist, Kineret (Anakinra), on the frequency of FMF attacks in patients that, despite maximum tolerable dose of colchicine, present with more than one attack per month.
The study is designed as a randomised, placebo-controlled, double-blind study. 50 patients will be randomised to treatment with either Kineret (Anakinra), or placebo treatment for 4 months. |
NCT01551095 | ALL | ADULT, OLDER_ADULT | GERD | DEVICE: PEGJ tube | Safety: Number of Participants With Adverse Events, One week after the procedure patients were called by one of the study investigators and were asked whether or not they had Abdominal pain, Nausea or Vomiting after the procedure., From date of PEGJ placement up to 3 weeks | This research is being done to study the safety of an investigational percutaneous endoscopic gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of the J tube prevents it from slipping back into the stomach. |
NCT02415400 | ALL | ADULT, OLDER_ADULT | Acute Coronary Syndromes | DRUG: Apixaban|DRUG: vitamin K antagonist|DRUG: Acetylsalicylic acid|OTHER: Acetylsalicylic acid placebo | The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period, Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA.
N is the number of participants treated with Apixaban or VKA.
n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.
Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year., Approximately 6 months|The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period, Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo.
N is the number of participants with aspirin or placebo.
n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment.
Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year., Approximately 6 months | The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin. |
NCT01413178 | ALL | ADULT, OLDER_ADULT | Myeloma | DRUG: Busulfan|DRUG: Melphalan|OTHER: Questionnaire|DRUG: G-CSF|DRUG: High Dose Melphalan|PROCEDURE: Stem cell transplant | Progression-Free Survival (PFS), Participants that are still alive and without Multiple Myeloma 3 years after Stem cell Transplantation., 3 years after transplant | The goal of this clinical research study is to compare Busulfex (busulfan) with or without Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in patients who will receive an autologous stem cell transplant. The safety of this combination therapy will also be studied.
Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die. |
NCT00842712 | ALL | ADULT, OLDER_ADULT | Carcinoma, Non-Small-Cell Lung | DRUG: Cilengitide|DRUG: Cilengitide|DRUG: Cetuximab|DRUG: Cisplatin|DRUG: Cisplatin|DRUG: Gemcitabine|DRUG: Vinorelbine|DRUG: Cilengitide|DRUG: Cilengitide|DRUG: Cetuximab|DRUG: Chemotherapy | Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs), Up to Week 3|Randomized Part: Progression Free Survival (PFS) Time - Independent Read, The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC)., Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013) | Primary objective of the study's Safety run-in:
- To determine the maximum tolerated dose (MTD) of cilengitide in combination with cetuximab, and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine).
Primary objective of the study's Randomization Part:
- To assess the efficacy of cilengitide in combination with cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine) compared to cetuximab and platinum-based chemotherapy alone in terms of progression-free survival (PFS) time.
Study design and plan:
This is a multicenter, open-label, randomized, controlled Phase II study with a safety run-in part in subjects with advanced non-small cell lung cancer (NSCLC).
During the safety run-in, the regimen was intensified stepwise by cohort (cilengitide intravenous \[i.v.\] 1000 milligram \[mg\] to 2000 mg twice a week) in a classical 3+3 subjects (for each platinum-based chemotherapy regimens separately) approach with predefined dose- and schedule reduction rules.
In the safety run-in 12 subjects were included and evaluated for safety and feasibility of different escalating doses of cilengitide administered twice weekly in combination with cetuximab, cisplatin and vinorelbine or gemcitabine.
After completion of the safety run-in, the randomized part will be started, during which all subjects will receive cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine).
Subjects will be centrally randomized on a 1:1 basis to either Group A or C; Group B will be closed with implementation of Amendment No. 4 (dated 20 December 2010):
• Group A: Cilengitide 2000 mg once weekly (Days 1, 8, and 15 of every 3-week chemotherapy cycle) in combination with cetuximab and platinum-based chemotherapy that will consist of the following:
* Cetuximab once weekly (Days 1, 8, and 15), plus cisplatin on Day 1 and vinorelbine on Days 1 and 8 of every 3-week chemotherapy cycle, or
* Cetuximab once weekly (Days 1, 8, and 15), plus cisplatin on Day 1 and gemcitabine on Days 1 and 8 of every 3-week chemotherapy cycle.
The decision which of the 2 chemotherapy regimens will be applied for a given subject is at the discretion of the treating investigator.
• Group B: Cilengitide 2000 mg twice weekly (Days 1, 4, 8, 11, 15, and 18 of every 3-week chemotherapy cycle) in combination with cetuximab and platinum-based chemotherapy as described for Group A.
Group B will be closed with implementation of Amendment No. 4 (global, dated 20 December 2010). Subjects randomized to Group B before implementation of Amendment No 4 will continue to be treated as planned.
• Group C: Cetuximab and platinum-based chemotherapy as described for Group A
Chemotherapy will be given until radiographically documented progressive disease (PD) or unacceptable toxicity but for no more than 6 cycles.
Cilengitide and cetuximab will be given until radiographically documented PD or unacceptable toxicity.
Randomization will be performed centrally using an interactive voice/web response system (IXRS). A stratified block randomization procedure will be employed using chosen first-line chemotherapy (cisplatin/vinorelbine versus cisplatin/gemcitabine) as stratification criterion. |
NCT03145220 | ALL | ADULT, OLDER_ADULT | Systemic Inflammatory Response Syndrome|Coronary Artery Bypass Grafting | DRUG: EA-230|OTHER: Placebo (NaCl) | Safety and tolerability (treatment related (serious) adverse events), Safety and tolerability expressed in treatment related (serious) adverse events, Total (serious) adverse events related to treatment at day 90 after treatment|Interleukin-6 (IL-6), Blood plasma levels IL-6, 1 day: at baseline, start of the cardiopulmonary bypass (CPB), stop of CPB, 2h after stop of CPB, 4h after stop of CPB, 6h after stop of CPB and first post-operative day. | EA-230 is a newly developed synthetic compound with anti-inflammatory properties, it is a linear tetrapeptide derived from the human chorionic gonadotropin hormone (hCG). Recently, its immunomodulatory effects in humans were confirmed in a phase I trial and an optimal dose was established. To establish this anti-inflammatory effect in a selected patient population and assess clinical outcome, a combined phase IIa/IIb trial will be conducted with patients undergoing cardiac surgery. |
NCT04414891 | ALL | CHILD, ADULT, OLDER_ADULT | Acute Exacerbation of COPD | DEVICE: Non invasive ventilation | Rate of NIV failure, NIV failure will be considered in case of
• Endotracheal intubation, From initiation of NIV to either intubation or re-initiation of NIV or successful weaning | Non invasive ventilation is the standard of care in managing patients with exacerbation of chronic obstructive pulmonary disease. However no optimal mode of NIV delivery is established; failure rates remain high, attributed to asynchrony and leak associated with NIV. Neurally adjust ventilator assist is a new mode that may improve patient ventilator interactions, improve synchrony and contribute to improved outcomes. Likewise ASV is a mode principled on the closed loop system and is associated with reduction of work associated with breathing and improved outcomes. In this randomised, non-blinded trial, we study these two modes of NIV delivery in patients of AECOPD with hypothesis being that better synchrony with NAVA may translate to better clinical outcomes. |
NCT00190320 | FEMALE | ADULT | Fetal Macrosomia | PROCEDURE: Induction of labor vs waiting | reduction of neonatal traumatism risk, 52 months | Aim of the study :The major aim is to evaluate the effectiveness of the induction of labor in case of fetal macrosomia on the reduction of neonatal traumatism risk. The secondary aims are to evaluate maternal morbidity and the risk of Caesarean in case of induction of labor, compared to a spontaneous labor. |
NCT00094302 | ALL | ADULT, OLDER_ADULT | Cardiovascular Diseases|Heart Diseases|Heart Failure, Congestive | DRUG: Spironolactone|DRUG: Placebo | Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First, Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function. |
NCT00910858 | ALL | ADULT, OLDER_ADULT | Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS) | DRUG: Lenalidomide|DRUG: Recombinant human erythropoietin | PK Phase: Area-under-the Concentration-time Curve (AUC0-24) for Lenalidomide, Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose for lenalidomide after a single dose, calculated using the log-linear trapezoidal method., On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.|Monotherapy Phase: Area-under-the Concentration-time Curve (AUC0-5) for Lenalidomide, Area under the plasma concentration-time curve from Time 0 to 5 hours postdose for lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days, calculated using the log-linear trapezoidal method., On Day 14 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, and 5 hours postdose. | The purpose of this study is to assess pharmacokinetic and pharmacodynamic characteristics of oral lenalidomide monotherapy administered to patients with Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS). |
NCT01471522 | ALL | ADULT, OLDER_ADULT | Cardiovascular Diseases|Coronary Disease|Coronary Artery Disease|Heart Diseases|Myocardial Ischemia | PROCEDURE: cardiac catheterization|PROCEDURE: coronary artery bypass graft surgery|PROCEDURE: percutaneous coronary intervention|BEHAVIORAL: Lifestyle|DRUG: Medication | Primary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest, 3.2 year follow-up (median)|Cumulative Event Rate of Primary Composite Outcome (Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest), This measure represents the estimated cumulative probability of experiencing the primary endpoint within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur)., 5 years|Number of Participants That Experienced Death From Cardiovascular Causes or Myocardial Infarction, 5 years|Cumulative Event Rate of Death From Cardiovascular Causes or Myocardial Infarction, This measure represents the estimated cumulative probability of experiencing Death from cardiovascular causes or myocardial infarction within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur)., 5 years|Number of Participants That Experienced Death From Any Cause, 5 years|Cumulative Event Rate of Death From Any Cause, 5 years|Number of Participants That Experienced Myocardial Infarction, 5 years|Cumulative Event Rate of Myocardial Infarction, 5 years|Estimated Difference in Cumulative Event Rate ( %) of Primary Composite Outcome: Invasive Minus Conservative, The primary composite outcome includes death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest., 5 years|Estimated Difference in Cumulative Event Rate of Death From Cardiovascular Causes: Invasive Minus Conservative or Myocardial Infarction Between Invasive and Conservative Strategies, 5 years|Estimated Difference in Cumulative Event Rate of Death From Any Cause: Invasive Minus Conservative, 5 years|Estimated Difference in Cumulative Event Rate of Myocardial Infarction: Invasive Minus Conservative, 5 years | The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter randomized controlled trial with 5179 randomized participants with moderate or severe ischemia on stress testing. A blinded coronary computed tomography angiogram (CCTA) was performed in most participants with eGFR ≥60 mL/min/1.73m2 to identify and exclude participants with either significant unprotected left main disease (≥50% stenosis) or those without obstructive CAD (\<50% stenosis in all major coronary arteries). Of 8518 participants enrolled, those that had insufficient ischemia, ineligible anatomy demonstrated on CCTA or another exclusion criterion, did not go on to randomization. Eligible participants were then assigned at random to a routine invasive strategy (INV) with cardiac catheterization followed by revascularization, if feasible, plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cardiac catheterization and revascularization reserved for those who fail OMT.
SPECIFIC AIMS
A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure in participants with SIHD and moderate or severe ischemia over an average follow-up of approximately 3.5 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT.
B. Secondary Aims Secondary aims are to determine whether an initial invasive strategy compared to a conservative strategy will improve: 1) the composite of CV death or MI; 2) angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire; 3) all-cause mortality; 4) net clinical benefit assessed by including stroke in the primary and secondary composite endpoints; and 5) individual components of the composite endpoints.
Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III per NIH
Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III per NIH
Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III per NIH |
NCT00890929 | ALL | ADULT, OLDER_ADULT | Acute Myeloid Leukemia (AML)|Adult Acute Myeloblastic Leukemia | DRUG: Lenalidomide|DRUG: Azacitidine | Compete Remission (CR) Rate, Compete Remission (CR) includes subjects with CR but incomplete recovery of blood counts (CRi). CR was assessed according to the European LeukemiaNet (ELN) guidelines, and is defined as the absence of clonal lymphocytes in the peripheral blood., 12 months | This study has a phase 1 and a phase 2 component.
In phase 1, the objective is to determine the maximum tolerated dose (MTD) of lenalidomide when after azacitidine.
In phase 2, the objective is to determine the efficacy of the combination treatment. |
NCT00970710 | ALL | CHILD | Childhood Obesity Pevention | BEHAVIORAL: Vaasa Childhood Obesity Primary Prevention Study | Preventing childhood obesity, Difference in offspring weight gain compared to control group, Offspring age until six years | This study aims to prevent childhood obesity with early life (pregnancy) intensified counselling. The recruited intervention group is pregnant mothers who are at risk to get gestational diabetes. Lifestyle intervention (nutritional and physical activity) begins during pregnancy in maternity clinics and continues in child wellfare clinics until the child is 5 years of age. |
NCT00686491 | ALL | CHILD, ADULT | Asthma|Cardiovascular Diseases|Metabolic Diseases | null | null | Eleven National Sports Teams are located in the Quebec Metropolitan Area. In these groups, many athletes are aiming for Olympic medals in Beijing 2008 and Vancouver 2010 Olympic Games. A consultation of the coaches of these National Teams revealed that although a large proportion of these athletes present various cardio-respiratory symptoms, they do not have a rapid access to a systematic medical evaluation and follow-up. Furthermore, little is done in regard to prevention and optimization of treatment of pulmonary and cardiac conditions in the elite athlete's population of the Quebec area.
Cardiorespiratory problems are therefore commonly found in high-level athletes. However, these pathologies are not well characterized in athletes and the associated symptoms often not well perceived. These problems can be serious and it is important to detect them before they appear1 while setting up a systematic medical follow-up. Health professionals should monitor health of the young athletes and help to reduce the risks associated with high level exercise. The following project is an evaluation and follow-up program of high-level athletes, aiming at gathering key-information on long-term effects of high-level training on cardio-respiratory and metabolic parameters. Our aims will be
1. to establish a long-term program of systematic evaluation and follow-up of cardiorespiratory health and performance of high elite athletes.
2. to evaluate the prevalence of respiratory, circulatory and metabolic problems among high-level athletes
3. to evaluate the effects of treatments on cardiorespiratory conditions and exercise performance in athletes who need asthma medication. |
NCT04320979 | FEMALE | ADULT, OLDER_ADULT | Breast Cancer | RADIATION: internal mammary nodal irradiation|RADIATION: no internal mammary nodal irradiation | disease-free survival, failure: relapse of ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal or distant metastasis or contralateral invasive breast cancer or death due to any cause., 5 years | The purpose of this study is to evaluate the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients treated with mastectomy. |
NCT01660100 | ALL | ADULT, OLDER_ADULT | Atrial Fibrillation | PROCEDURE: Pulmonary vein antrum isolation (PVAI)|PROCEDURE: PVAI plus left atrial posterior wall (LAPW) isolation | Outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation or proven pulmonary vein antrum plus left atrial posterior wall isolation, "Procedure success" is defined as freedom from atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) off antiarrhythmic drug during follow-up after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven.
"Procedure failure" is defined as atrial arrhythmia recurrence during follow-up after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven., 12 months after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven by a repeat procedure | Objective: This prospective study aims to examine the outcome of atrial fibrillation (AF) ablation after permanent pulmonary vein antrum isolation or pulmonary vein antrum isolation plus left atrial posterior wall isolation is proven by a repeat procedure. The study will be conducted in patients with different types of AF: paroxysmal AF (PAF) and non-PAF (Persistent AF and Long Standing Persistent AF).
Hypothesis: In addition to permanent pulmonary vein antrum isolation, proven isolation of left atrial posterior wall is associated with more freedom from atrial arrhythmia at long-term follow-up after atrial fibrillation ablation, especially in non-PAF patients. |
NCT00133692 | ALL | ADULT, OLDER_ADULT | Hypertension|Coronary Artery Disease | DRUG: Verapamil SR/Trandolapril/Hydrochlorothiazide (HCTZ)|DRUG: Atenolol/HCTZ/Trandolapril | First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke | Because blood pressure affects the heart, blood vessels, kidneys, and the entire body, it is important to keep it as normal as possible. There are several different ways to control blood pressure and to prevent or limit the development of heart disease due to high blood pressure. The purpose of this study is to compare two treatments to see how well they work and the difference in their side effects. One treatment includes the use of a calcium antagonist drug (Isoptin sustained release \[SR\] or Verapamil SR). The other treatment excludes the calcium antagonist and may include a non-calcium antagonist drug called a beta blocker (Tenormin or Atenolol). Both treatments may also include medication called angiotensin converting enzyme (ACE) inhibitors and water pills. None of the drugs in this study are experimental, they are all approved by the Food and Drug Administration (FDA). |
NCT00672620 | ALL | ADULT, OLDER_ADULT | Major Depressive Disorder | DRUG: Vortioxetine|DRUG: Duloxetine|DRUG: Placebo | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8, The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with terms for treatment and center as factors and the Baseline rank value as a covariate., Baseline and Week 8 | The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder. |
NCT00626717 | ALL | CHILD, ADULT, OLDER_ADULT | Keratoconus | PROCEDURE: Riboflavin/UVA crosslinking|PROCEDURE: Sham treatment | Keratoconus progression, 3 years|Endothelial cell loss, 3 years | Background: Corneal cross linking is a procedure that induces collagen cross linking of the corneal stroma due to release of reactive oxygen radicals upon activation of topically applied riboflavine A by UVA exposure. This procedure might be capable of reducing keratocouns progression.
Purpose: Although there are no randomised controlled trials on the effectiveness of corneal cross linking for the treatment of keratoconus it gains more and more importance in the general clinical setting. Therefore, the investigators started such randomised, placebo controlled, double blinded, multicenter trial to find out if this treatment is as effective as it promises to be.
Methods: Randomised, placebo controlled, double blinded, multicenter trial. |