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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

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://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

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

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/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

https://www.clinicaltrials.gov/study/NCT00392678?term=SALSALATE&viewType=Table&rank=8

Nationwide, randomized, double blind, multi-center research study to determine whether the drug salsalate, a member of the commonly used Non-Steroidal Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2 diabetes. The study is conducted in two stages. The primary objective of the first stage is to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The primary objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and cardiac risk.

Proper citation: TINSAL-T2D (RRID:SCR_001546) Copy   

•   Source: SciCrunch Registry

https://www.clinicaltrials.gov/study/NCT00580749

Randomized multi-center clinical trial designed to test whether duodenojejunal (DJ) feeding is more effective than nasogastric (NG) feeding in providing enteral nutrition to patients with severe acute pancreatitis. SNAP will enroll participants with severe acute pancreatitis admitted to the intensive care unit at eight clinical centers. Upon enrollment, participants are assigned to NG or DJ feeding and managed for up to 28 days or until weaned on to solid food. Follow-up continues until participants are discharged from the hospital or for a maximum of 60 days. Outcomes relate to feeding tolerance and failure, nutritional status, risk for life-threatening pancreatic/systemic complications, and hospital mortality.

Proper citation: Study of Nutrition in Acute Pancreatitis (RRID:SCR_001544) Copy   

•   Source: SciCrunch Registry

http://clinicaltrials.gov/ct2/show/NCT00688662

A prospective, double-blind, randomized, sham-controlled, multi-center clinical trial that enrolls subjects who have received a prior cholecystectomy and are diagnosed with the clinical syndrome of Sphincter of Oddi Dysfunction III (SOD III) as defined by the Rome III criteria. The goal of the study is to asses the value of endoscopic sphincterotomy as a treatment for adult subjects categorized as SOD III suffering from pain after cholecystectomy and to define the role of manometry in treating these patients.

Proper citation: Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (RRID:SCR_006897) Copy   

•   Source: SciCrunch Registry

http://archives.niddk.nih.gov/patient/fsgs/fsgs.aspx

Network of collaborative research centers that tested the effects of treatment with cyclosporine to treatment with mycophenalate mofetil combined with oral pulse dexamethasone in children and young adults with focal segemental glomerulosclerosis. Efficacy was assessed in terms of induction of remission of proteinuria after 52 weeks of treatment and sustained remission after 26 weeks off treatment. The clinical sites were State University of New York, Stony Brook; Montefiore Medical Center; Seattle Children''''s Medical Center; Medical City Dallas Hospital; and the University of North Carolina. The Cleveland Clinic is the data-coordinating center, and NephCure will fund ancillary studies.

Proper citation: Focal Segmental Glomerulosclerosis in Children and Young Adults Interventional Study (RRID:SCR_007130) Copy   

•   Source: SciCrunch Registry

https://clinicaltrials.gov/study/NCT00325039

Study that compared the outcomes of two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The procedures insert a mesh sling or hammock to support the bladder neck so that urine does not leak. Both procedures have been approved by the FDA and have been shown to be safe and successful in treating stress urinary incontinence. However, it is not known if one is better than the other. This study answers that question. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and the need for other treatments(s) after surgery. Follow-up will be a minimum of two years. Stress urinary incontinence is the accidental leakage of urine during activities such as coughing, laughing, sneezing, or lifting heavy objects.

Proper citation: TOMUS (RRID:SCR_001549) Copy   

•   Source: SciCrunch Registry

http://teddy.epi.usf.edu/

International consortium of six centers assembled to participate in the development and implementation of studies to identify infectious agents, dietary factors, or other environmental agents, including psychosocial factors, that trigger type 1 diabetes in genetically susceptible people. The coordinating centers recruit and enroll subjects, obtaining informed consent from parents prior to or shortly after birth, genetic and other types of samples from neonates and parents, and prospectively following selected neonates throughout childhood or until development of islet autoimmunity or T1DM. The study tracks child diet, illnesses, allergies and other life experiences. A blood sample is taken from children every 3 months for 4 years. After 4 years, children will be seen every 6 months until the age of 15 years. Children are tested for 3 different autoantibodies. The study will compare the life experiences and blood and stool tests of the children who get autoantibodies and diabetes with some of those children who do not get autoantibodies or diabetes. In this way the study hopes to find the triggers of T1DM in children with higher risk genes.

Proper citation: TEDDY (RRID:SCR_000383) Copy   

•   Source: SciCrunch Registry

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

Multicenter clinical research study aimed at discovering whether modest weight loss through dietary changes and increased physical activity or treatment with the oral diabetes drug metformin (Glucophage) could prevent or delay the onset of type 2 diabetes in study participants. At the beginning of the DPP, all 3,234 study participants were overweight and had blood glucose levels higher than normal but not high enough for a diagnosis of diabetesa condition called prediabetes. In addition, 45 percent of the participants were from minority groups-African American, Alaska Native, American Indian, Asian American, Hispanic/Latino, or Pacific Islander-at increased risk of developing diabetes. The DPP found that participants who lost a modest amount of weight through dietary changes and increased physical activity sharply reduced their chances of developing diabetes. Taking metformin also reduced risk, although less dramatically. In the DPP, participants from 27 clinical centers around the United States were randomly divided into different treatment groups. The first group, called the lifestyle intervention group, received intensive training in diet, physical activity, and behavior modification. By eating less fat and fewer calories and exercising for a total of 150 minutes a week, they aimed to lose 7 percent of their body weight and maintain that loss. The second group took 850 mg of metformin twice a day. The third group received placebo pills instead of metformin. The metformin and placebo groups also received information about diet and exercise but no intensive motivational counseling. A fourth group was treated with the drug troglitazone (Rezulin), but this part of the study was discontinued after researchers discovered that troglitazone can cause serious liver damage. The participants in this group were followed but not included as one of the intervention groups. In the years since the DPP was completed, further analyses of DPP data continue to yield important insights into the value of lifestyle changes in helping people prevent type 2 diabetes and associated conditions. For example, one analysis confirmed that DPP participants carrying two copies of a gene variant, or mutation, that significantly increased their risk of developing diabetes benefited from lifestyle changes as much as or more than those without the gene variant. Another analysis found that weight loss was the main predictor of reduced risk for developing diabetes in DPP lifestyle intervention group participants. The authors concluded that diabetes risk reduction efforts should focus on weight loss, which is helped by increased exercise.

Proper citation: Diabetes Prevention Program (RRID:SCR_001501) Copy   

•   Source: SciCrunch Registry

http://coordinatingcenter.ucsf.edu/pride/

Randomized controlled trial being conducted at two clinical centers in the United States to learn more about the effects of weight loss on urinary incontinence. About 330 overweight women aged 30 or older will participate and will be followed for 18 months. Efficacy of weight reduction as a treatment for urinary incontinence will be examined at 6 months following the intensive weight control program, and the sustained impact of the intervention will be examined at 18 months. To increase the maintenance of weight reduction and facilitate evaluation of the enduring impact of weight loss on urinary incontinence, they propose to study a motivation-based weight maintenance program. At the end of the intensive weight control program, women randomized to the weight loss program will be randomized to either a 12-month skill-based maintenance intervention or to a motivation-based maintenance intervention. The maintenance interventions maximize the potential for sustained weight loss and will allow them to determine if long-term weight reduction will produce continued improvement in urinary incontinence.

Proper citation: Program to Reduce Incontinence by Diet and Exercise (RRID:SCR_009018) Copy   

•   Source: SciCrunch Registry

https://clinicaltrials.gov/study/NCT00342927?term=AREA%5BBasicSearch%5D(NIDDK%20endocrine%20and%20diabetes)%20AND%20AREA%5BSponsorSearch%5D(NIDDK)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING%20OR%20ACTIVE_NOT_RECRUITING)&rank=1

Multicenter observational study designed to identify genetic determinants of diabetic nephropathy. It is conducted in eleven U.S. clinical centers and a coordinating center, and with four ethnic groups (European Americans, African Americans, Mexican Americans, and American Indians). Two strategies are used to localize susceptibility genes: a family-based linkage study and a case-control study using mapping by admixture linkage disequilibrium (MALD). In the family-based study, probands with diabetic nephropathy are recruited with their parents and selected siblings. Linkage analyses will be conducted to identify chromosomal regions containing genes that influence the development of diabetic nephropathy or related quantitative traits such as serum creatinine concentration, urinary albumin excretion, and plasma glucose concentrations. Regions showing evidence of linkage will be examined further with both genetic linkage and association studies to identify genes that influence diabetic nephropathy or related traits. Two types of MALD studies are being done. One is a case-control study of unrelated individuals of Mexican American heritage in which both cases and controls have diabetes, but only the case has nephropathy. The other is a case-control study of African American patients with nephropathy (cases) and their spouses (controls) unaffected by diabetes and nephropathy; offspring are genotyped when available to provide haplotype data. The specific goals of this program: * Delineate genomic regions associated with the development and progression of renal disease(s) * Evaluate whether there is a genetic link between diabetic nephropathy and diabetic retinopathy * Improve outcomes * Provide protection for people at risk and slow the progression of renal disease * Help establish a resource for genetic studies of kidney disease and diabetic complications by creating a repository of genetic samples and a database * Encourage studies of the genetics of progressive renal disease

Proper citation: Family Investigation of Nephropathy of Diabetes (RRID:SCR_001525) Copy   

•   Source: SciCrunch Registry

https://clinicaltrials.gov/study/NCT01885559

Consortium established to design and implement clinical trials of treatments that might slow the progressive loss of renal function in Polycystic Kidney Disease (PKD). Two multicenter randomized, double-blind, placebo controlled clinical trials are running concurrently to study the efficacy of renin-angiotensin-aldosterone system blockade on the progression of cystic disease (kidney volume) and on the decline in renal function in autosomal dominant polycystic kidney disease (ADPKD). Study A is to study whether intensive ACE-I/ARB blockade decrease the progression of cystic disease compared to ACE-I monotherapy patients with early disease, relatively preserved renal function, and high-normal BP or hypertension. Study B is to study whether intensive ACE-I/ARB blockade as compared to ACE-I monotherapy slow the decline in kidney function, end-stage of renal disease, or death in the setting of standard blood pressure control in hypertensive patients with moderately advanced disease.

Proper citation: HALT PKD (RRID:SCR_001529) Copy   

•   Source: SciCrunch Registry