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http://clinicaltrials.gov/

Registry and results database of federally and privately supported clinical trials conducted in United States and around world. Provides information about purpose of trial, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.Offers information for locating federally and privately supported clinical trials for wide range of diseases and conditions. Research study in human volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings. ClinicalTrials.gov contains trials sponsored by National Institutes of Health, other federal agencies, and private industry. Studies listed in database are conducted in all 50 States and in 178 countries.

Proper citation: ClinicalTrials.gov (RRID:SCR_002309) Copy   

•   Source: SciCrunch Registry

http://www.nimh.nih.gov/trials/index.shtml

NIMH supports research studies on mental health and disorders. Participate, refer a patient or learn about results of studies in ClinicalTrials.gov, the NIH/National Library of Medicine''''s registry of federally and privately funded clinical trials for all disease. Find NIH-funded studies currently recruiting participants in the following mental health topics: * Anxiety Disorders ** Generalized Anxiety Disorder ** Obsessive-Compulsive Disorder (OCD) ** Panic Disorder ** Post-traumatic Stress Disorder (PTSD) ** Social Phobia (Social Anxiety Disorder) * Attention Deficit Hyperactivity Disorder (ADHD, ADD) * Autism Spectrum Disorders (Pervasive Developmental Disorders) * Bipolar Disorder (Manic-Depressive Illness) * Borderline Personality Disorder * Depression * Eating Disorders * HIV/AIDS * Schizophrenia * Suicide Prevention Information Resources for NIMH Researchers Conducting Clinical Trials * Limited Access Datasets from NIMH-Supported Clinical Trials * NIMH Policy for Recruitment of Participants in Clinical Research * NIMH Policy on Data and Safety Monitoring in Extramural Investigator-Initiated Clinical Trials * Register a study with ClinicalTrials.gov

Proper citation: NIMH Clinical Trials (RRID:SCR_005613) Copy   

•   Source: SciCrunch Registry

http://www.nimh.nih.gov/funding/clinical-trials-for-researchers/practical/tordia/treatment-of-ssri-resistant-depression-in-adolescents-tordia.shtml

A multi-site, clinical research study examining treatment options for teens whose depression has not improved after one adequate trial of a selective serotonin reuptake inhibitor (SSRI), a type of antidepressant. The purpose of the study is to determine how best to treat adolescents with depression that is resistant to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy. The TORDIA study aims to develop useful clinical guidelines for the care and management of adolescent depression. Adolescents ages 12 to 18, currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) and still experiencing depression, participate in a 12-week randomized treatment study that includes one of four conditions: (1) switching to an alternative SSRI, (2) switching to a different non-SSRI antidepressant, (3) switching to an alternative SSRI and receiving cognitive behavioral therapy (CBT), or (4) switching to a different non-SSRI antidepressant and receiving CBT. This is a double-blind study, which means that neither the participant nor the clinical staff will know which of the three possible medications has been assigned. Participants who respond to the assigned treatment will receive 12 additional weeks of the same treatment. Those who do not appear to be getting better will be offered 12 weeks of an alternative, individualized treatment plan based on each participant''s particular needs. All participants will receive follow-up psychiatric evaluations for 12 months after the 12-week continuation phase of the study, regardless of treatment adherence. For more information visit, http://www.clinicaltrials.gov/ct2/show/NCT00018902?term=clinical+trial+AND+treatment+of+ssri-resistant+AND+depression+AND+TORDIA+AND+study&rank=1

Proper citation: Treatment of SSRI-resistant Depression in Adolescents (TORDIA) (RRID:SCR_008831) Copy   

•   Source: SciCrunch Registry

http://clinicaltrials.gov/show/NCT00143949

Randomized, multicenter, double-blind study to determine if renin angiotensin medications, either losartan (angiotensin II blocker) or enalapril (converting enzyme inhibitor), can prevent or delay the onset of diabetic kidney disease in patients with type 1 diabetic patients who do not have hypertension, diabetic nephropathy, or predictive levels of microalbuminuria. Two hundred eight five patients ages 16-61 with 2-20 yrs of Type 1 Diabetes Mellitus and no renal functional abnormalities were randomized into a parallel, double-blind, placebo-controlled study involving 3 groups (95 patients/group). Each group received an angiotensin-converting enzyme inhibitor (ACEI) (enalapril), or an angiotensin II receptor blocker (Losartan), or placebo. All patients had their usual Diabetes Mellitus (DM) management. Baseline studies included measures of glomerular filtration rate (GFR), urinary albumin excretion rate (UAE), blood pressure (BP), and a percutaneous renal biopsy. Patients were followed by quarterly measures of BP, HbA1C, UAE, and drug compliance. There were annual measures of GFR and a repeat renal biopsy after 5 yrs in the study. The main endpoint is kidney structural changes over time, especially mesangial fractional volume (v(Mes/glom)). Secondary endpoints will be other DN structural measures and measures of kidney function (UAE, GFR). These studies will determine whether rennin angiotensin system blockage in the early stages of DN can prevent the early kidney structural changes in this important disorder. Ancillary studies will evaluate the effects of treatment group on the development and progression of diabetic retinopathy and will develop predictors of study participants'''' compliance. Baseline, 2.5 and 5 year retinal fundus photographs in the RASS patients were obtained.

Proper citation: Renin Angiotensin System Study (RRID:SCR_013385) Copy   

•   Source: SciCrunch Registry

http://clinicaltrials.gov/show/NCT00100659

Multi-center, randomized controlled trial that studied peginterferon therapy, with or without ribavirin, in children with chronic hepatitis C. Approximately 120 children were randomly assigned to receive peginterferon alfa-2a alone or peginterferon with ribavirin for 48 weeks. Samples of blood, genomic DNA, and liver tissue are stored in the NIDDKrepositories. A long-term follow up study of the clinical trial participants is underway.

Proper citation: Peginterferon and Ribavirin for Pediatric Patients with Chronic Hepatitis C (RRID:SCR_006787) Copy   

•   Source: SciCrunch Registry

https://trialweb.dcri.duke.edu/tads/index.html

THIS RESOURCE IS NO LONGER IN SERVICE. Documented on August 16,2023. Multi-site clinical research study examining the short- and long-term effectiveness of an antidepressant medication and psychotherapy alone and in combination for treating depression in adolescents ages 12 to 17. For teens treated in TADS, the trial is designed to provide best-practice practical care for depression.

Proper citation: TADS - Treatment for Adolescents with Depression Study (RRID:SCR_000037) Copy   

•   Source: SciCrunch Registry

http://clinicaltrials.gov/ct2/show/NCT00248651

Multi-center, randomized, placebo-controlled trial evaluating the tricyclic antidepressant, amitriptyline and the selective serotonin reuptake inhibitor (SSRI), escitalopram to placebo in patients with functional dyspepsia. The purpose of this study is to determine whether amitriptyline and escitalopram are more efficacious than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidities.

Proper citation: Functional Dyspepsia Treatment Trial (RRID:SCR_006691) Copy   

•   Source: SciCrunch Registry

http://clinicaltrials.gov/show/NCT00237081

Clinical study that investigated several hundred families with two or more blood relatives with interstitial cystitis in order to understand the molecular genetic basis of this condition. The study sought to find changes in genes that are found far more commonly in family members who have interstitial cystitis than in those who do not have the disease. Identifying these genes should lead to a better understanding of the cause of interstitial cystitis. This is a national study which is conducted by telephone and mail, and in which participants could participate entirely from their home.

Proper citation: Maryland Genetics of Interstitial Cystitis (RRID:SCR_006992) Copy   

•   Source: SciCrunch Registry

http://clinicaltrials.gov/show/NCT00059202

Multi-center, placebo-controlled trial of ursodiol in primary sclerosing cholangitis (PSC). A total of 150 patients with previously untreated PSC without cirrhosis were randomly assigned to receive high doses of ursodiol (20-25 mg/kg/day) or placebo for two years. Patients underwent medical evaluation, endoscopic retrograde cholangiography, and liver biopsy before randomization and again at two-year intervals. The endpoints of therapy were progression of hepatic fibrosis, liver decompensation, liver transplantation, or death. The treatment phase of the study was stopped for futility in June 2008; however, patients continue to be followed. Ongoing mechanistic studies are underway.

Proper citation: High-dose Ursodiol Therapy of Primary Sclerosing Cholangitis (RRID:SCR_006772) Copy   

•   Source: SciCrunch Registry

http://www.nimh.nih.gov/funding/clinical-trials-for-researchers/practical/step-bd/index.shtml

A long-term outpatient study designed to find out which treatments, or combinations of treatments, are most effective for treating episodes of depression and mania and for preventing recurrent episodes in people with bipolar disorder. This study has been completed. (2005) STEP-BD is evaluating all the best-practice treatment options used for bipolar disorder: mood-stabilizing medications, antidepressants, atypical antipsychotics, and psychosocial interventions - or talk therapies - including Cognitive Behavioral Therapy, Family-focused Therapy, Interpersonal and Social Rhythm Therapy, and Collaborative Care (psychoeducation). There are two kinds of treatment pathways in STEP-BD, and participants may have the opportunity to take part in both. The medications and psychosocial interventions provided in these pathways are considered among the best choices of treatment for bipolar disorder in everyday clinical practice. In the Best Practice Pathway, participants are followed by a STEP-BD certified doctor and all treatment choices are individualized. Everyone enrolled in STEP-BD may participate in this pathway. Participants and their doctors work together to decide on the best treatment plans and to change these plans if needed. Also, anyone who wishes to stay on his or her current treatment upon entering STEP-BD may do so in this pathway. Adolescents and adults age 15 years and older may participate in the Best Practice Pathway. For adults age 18 and older, another way to participate is in the STEP-BD Randomized Care Pathways. Depending on their symptoms, participants may be offered treatment in one or more of these pathways during the course of the study. The participants remain on mood-stabilizing medication. However, because doctors are uncertain which of several treatment strategies work best for bipolar disorder, another medication and/or talk therapy may be added. Each Randomized Care Pathway involves a different set of these additional treatments. Unlike in the Best Practice Pathway, the participants in the Randomized Care Pathways are randomly assigned to treatments. Also, in some cases, neither the participant nor the doctor will be told which of the different medications is being added. This is called a double-blind study and is done so that the medication effects can be evaluated objectively, without any unintended bias that may come from knowing what has been assigned. Participants will not be assigned medications that they have had bad reactions to in the past, that they are strongly opposed to, or that the doctor feels are unsuitable for them. The medication(s) participants may be randomly assigned to in the Randomized Care Pathways are free of charge. There are other treatment options for participants if they do not respond well to the treatment assigned to them. Also, participants may return to the Best Practice Pathway at any time. About 1,500 individuals will be enrolled in at least one Randomized Care Pathway during their period of participation in STEP-BD. It is important to note that STEP-BD provides continuity of care. For example, if a participant starts out in the Best Practice Pathway and later chooses to enter one of the Randomized Care Pathways, he or she continues with the same STEP-BD doctor and treatment team. Then, after completing the Randomized Care Pathway, the participant may return to the Best Practice Pathway for ongoing, individually-tailored treatment. Follow the link to view study info at Clinicaltrials.gov, http://www.clinicaltrials.gov/ct/show/NCT00012558?order=1

Proper citation: Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) (RRID:SCR_008844) Copy   

•   Source: SciCrunch Registry

https://repository.niddk.nih.gov/study/36

Data set and biosepecimens of a multi-center clinical trial to determine if treatment with beta-cell antigens can delay the onset of Type 1 Diabetes Mellitus (Type 1 DM) in non-diabetic relatives of persons with Type 1 DM. Insulin is a well characterized antigen specifically produced by beta-cells, and it was used for this purpose in the initial DPT-1 studies. The protocol for high risk subjects uses daily subcutaneous insulin injections and an annual course of intravenous insulin treatment, while the protocol for intermediate risk subjects uses daily doses of insulin administered orally. Neither injected nor oral insulin at the doses used were observed to delay or prevent diabetes, although further studies are needed to test whether oral insulin can delay diabetes in people in the intermediate risk group with high titers of insulin autoantibodies.

Proper citation: Diabetes Prevention Type 1 (RRID:SCR_001467) Copy   

•   Source: SciCrunch Registry

https://edic.bsc.gwu.edu

Publications from a multi-center, longitudinal, observational study examining the risk factors associated with the long-term complications of type 1 diabetes. The study began in 1994 and follows the 1441 participants previously enrolled in the Diabetes Control and Complications Trial (DCCT), http://diabetes.niddk.nih.gov/dm/pubs/control/index.aspx. The primary aim of EDIC is to examine the long-term effects of conventional vs. intensive diabetes treatment received during the DCCT on the subsequent development and progression of microvascular, neuropathic and cardiovascular complications. This involves studying the influence of genetic factors and other factors such as HbA1c, blood pressure, lipid levels, and treatment modalities on the development and progression of these complications. Annual or biennial measurements (using DCCT methods, standardized protocols and central laboratories) of vascular events, albumin excretion, GFR, ECG, ankle-brachial BP index, serum lipids and HbA1c allows the following analyses: 1) continuation of intention-to-treat analyses to determine long-term effects of prior separation of glycemic levels; 2) risk factors for macrovascular outcomes; 3) correlation of progression of micro- and macrovascular outcomes. The current updated version of the EDIC Protocol is available for download. EDIC is made up of 28 clinical centers, one data coordinating center and one clinical coordinating center.

Proper citation: Epidemiology of Diabetes Interventions and Complications (RRID:SCR_001468) Copy   

•   Source: SciCrunch Registry

https://repository.niddk.nih.gov/study/119

Multi-center randomized clinical trial to determine if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will make it possible to discontinue the drug and still maintain a reduced number of accidents. The most popular treatments for urge incontinence are drug therapy and behavior therapy, each with its own limitations. In this clinical study, the Urinary Incontinence Treatment Network (UITN) aims to determine differences with the addition of behavioral treatment to drug therapy alone.

Proper citation: Behavior Enhances Drug Reduction of Incontinence (RRID:SCR_001495) Copy   

•   Source: SciCrunch Registry

http://www.healthystudy.org/

Primary prevention trial conducted in 42 middle schools at 7 locations across the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at the start of 6th grade (fall 2006) and followed to the end of 8th grade (spring 2009). Half of the schools were randomized to receive an intervention that integrated four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.

Proper citation: HEALTHY study (RRID:SCR_001530) Copy   

•   Source: SciCrunch Registry

http://todaystudy.org/

Randomized, double blind, nationwide clinical trial to compare the efficacy and safety of three interventions to treat adolescents and youth with type 2 diabetes (T2D): (1) metformin alone, (2) metformin plus rosiglitazone, and (3) metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program (TLP). The secondary aims are to: compare and evaluate the safety of the three treatment arms; compare the effects of the three treatments on the pathophysiology of type 2 diabetes (T2D) with regards to beta cell function and insulin resistance, body composition, nutrition, physical activity and aerobic fitness, cardiovascular risk factors, microvascular complications, quality of life, and psychological outcomes; evaluate the influence of individual and family behaviors on treatment response; and compare the relative cost effectiveness of the three treatment arms. The study recruits patients over a three-year period and follows patients for a minimum of two years. Patients are randomized within two years of the diagnosis of T2D. Materials that were used for the study are made publicly available: * The TODAY Standard Diabetes Education (TSDE) program, developed especially for youth with type 2 diabetes. (All participants received the TSDE program) * The TODAY Lifestyle Program (TLP) that was among the treatments tested.

Proper citation: Treatment Options for type 2 Diabetes in Adolescents and Youth (RRID:SCR_001547) Copy   

•   Source: SciCrunch Registry

https://jhuccs1.us/gpcrc/

Perform clinical, epidemiological, and therapeutic research in gastroparesis and provide an infrastructure that can rapidly and efficiently design and conduct clinical trials for effective medical, surgical, or other interventions to improve treatment of patients with gastroparesis. The GpCRC studies comprise well characterized individuals with diabetic, surgical, and idiopathic gastroparesis.

Proper citation: Gastroparesis Clinical Research Consortium (RRID:SCR_006673) Copy   

•   Source: SciCrunch Registry

https://scicrunch.org/scicrunch/data/source/nlx_154697-5/search?q=*

A virtual database currently indexing clinical trials databases including EU Clinical Trials Register and Clinicaltrials.gov.

Proper citation: Integrated Clinical Trials (RRID:SCR_005969) Copy   

•   Source: SciCrunch Registry

http://www.bsc.gwu.edu/dpp/protocol.htmlvdoc

Observational clinical trial studying the long term effect of diet and exercise and the diabetes medication, metformin, on the delay of type 2 diabetes in participants of the Diabetes Prevention Program (DPP). The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. The DPPOS is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest IGT population ever studied. Clinically important research questions remain that focus on 1)durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding CVD, CVD risk factors and atherosclerosis and microvascular disease, 3)close examination of these topics in men vs women and in minority populations. More than 87% of the original surviving DPP cohort has joined DPPOS as of December, 2007 and, to date, after 5 years of DPPOS and 10 years of combined DPP/DPPOS, 93% of the DPPOS cohort continue to attend annual follow-up visits. Interim analyses performed after 5 years of DPPOS have demonstrated a durable effect of diabetes prevention associated with the lifestyle and metformin interventions with 34 and 19% reductions in diabetes incidence, respectively, compared with the placebo group. Interim analyses also reveal significant reductions from baseline in CVD risk factors in the lifestyle intervention group, but with decreased utilization of glucose-lowering and lipid-lowering medications. Analyses of the participants in the placebo group who have developed diabetes during DPP/DPPOS, compared with those who have remained non-diabetic, reveal an increased frequency of retinopathy and microalbuminuria. The current, updated protocol describes the DPPOS including the revisions incorporated to complete the second five-years of the study. DPPOS participants have blood samples stored at the time of each annual visit. Specimens are stored at the study CBL until after the primary study outcomes are reported. DNA samples were previously collected and are stored at the NIDDKsample repository for DPP participants.

Proper citation: Diabetes Prevention Program Outcomes Study (RRID:SCR_001502) Copy   

•   Source: SciCrunch Registry

https://repository.niddk.nih.gov/study/44

Randomized controlled clinical trial to understand how increasing hemodialysis to six times a week from the standard of three times a week may result in improved heart health. Subjects were recruited from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 1 year. Subjects will be randomized to either conventional hemodialyis Daily HD delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week, or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week. The study has two co-primary outcomes: 1) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life scale. In addition, main secondary outcomes have been designated for each of seven outcome domains: 1) cardiovascular structure and function (change in LV mass), 2) health-related quality of life/physical function (change in the PHC), 3) depression/burden of illness (change in Beck Depression Inventory), 4) nutrition (change in serum albumin), 5) cognitive function (change in the Trail Making Test B), 6) mineral metabolism (change in average predialysis serum phosphorus), and 7) clinical events (rate of non-access hospitalization or death). Hypertension and anemia are also main outcome domains, but without designation of single first priority outcomes.

Proper citation: Frequent Hemodialysis Network Daily Trial (RRID:SCR_001527) Copy   

•   Source: SciCrunch Registry

https://repository.niddk.nih.gov/study/47

Study designed to test the hypothesis that African-Americans respond less well to combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not previously treated with either interferon or ribavirin. Reasons for differences in response, regardless of race, will be studied. All patients were treated with combination therapy of pegylated interferon and ribavirin for 48 weeks, and were followed for an additional 48 week safter cessation of therapy. 400 patients, half African-American and half Caucasian American, from 8 clinical centers with the goals of establishing rates of response to optimal current therapy in the two ethnic groups, identify factors predictive of response, establish patterns of viral kinetics in response to antiviral therapy, and test hypotheses concerning viral and host factors determining response to therapy. Four ancillary studies designed to elucidate biological and virological basis for non-response are also included in Virahep-C. Additionally, the study has central facilitates for pathology, the virological testing laboratory and a serum/tissue repository.

Proper citation: Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (RRID:SCR_001553) Copy   

•   Source: SciCrunch Registry