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https://www.clinicaltrials.gov/study/NCT00064753
Multi-center, randomized, double blind controlled clinical trial to determine whether treatment with a standard multivitamin augmented with high doses of folic acid, vitamin B6 and vitamin B12 reduces the rate of cardiovascular disease outcomes in renal transplant recipients relative to participants receiving a similar multivitamin that contains no folic acid. This study hopes to show that by reducing the level of homocysteine in the body, the risk of heart disease is also reduced among kidney transplant patients.
Proper citation: Folic Acid for Vascular Outcome Reduction in Transplantation (RRID:SCR_001505) Copy
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
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
Network of centers to conduct studies of islet transplantation in patients with type 1 diabetes to improve the safety and long-term success of methods for transplanting islets. It is the aim of this trial to improve methods of isolating islets, to improve techniques for the administering those transplanted islets; and to develop approaches to minimize the toxic effects of immunosuppressive drugs required for transplantation.
Proper citation: Clinical Islet Transplantation Study (RRID:SCR_001515) Copy
https://sites.cscc.unc.edu/cscc/projects/RIVUR%20
Multicenter, randomized, double-blind, placebo-controlled trial is designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrence of urinary tract infection (UTI) in children with vesicoureteral reflux (VUR). The basic eligibility criteria are: (1) age at randomization of at least 2 months, but less than 6 years, (2) a diagnosed first febrile or symptomatic UTI within 42 days prior to randomization that was appropriately treated, and (3) presence of Grade I-IV VUR based on voiding cystourethrogram (VCUG). Patients will be randomly assigned to treatment for 2 years with daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo. The study is designed to recruit 600 children (approximately 300 in each treatment group) over an 18-24 month period. The primary endpoint is recurrence of UTI. In addition, patients will be evaluated for secondary endpoints related to renal scarring and antimicrobial resistance. Scarring will be determined based on renal scintigraphy by 99mTc dimercaptosuccinic (DMSA) scan. Quality of life, compliance, safety parameters, utilization of health resources, and change in VUR will be assessed periodically throughout the study.
Proper citation: RiVuR (RRID:SCR_001539) Copy
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
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
https://www.accordtrial.org/public
Study testing whether strict glucose control lowers the risk of heart disease and stroke in adults with type 2 diabetes. In addition the study is exploring: 1) Whether in the context of good glycemic control the use of different lowering lipid drugs will further improve these outcomes and 2) If strict control of blood pressure will also have additional beneficial effects on reducing cardiovascular disease. The design was a randomized, multicenter, double 2 X 2 factorial trial in 10,251 patients with type 2 diabetes mellitus. It was designed to test the effects on major CVD events of intensive glycemia control, of fibrate treatment to increase HDL-cholesterol and lower triglycerides (in the context of good LDL-C and glycemia control), and of intensive blood pressure control (in the context of good glycemia control), each compared to an appropriate control. All 10,251 participants were in an overarching glycemia trial. In addition, one 2 X 2 trial addressed the lipid question in 5,518 of the participants and the other 2 X 2 trial addressed the blood pressure question in 4,733 of the participants. The glycemia trial was terminated early due to higher mortality in the intensive compared with the standard glycemia treatment strategies. The results were published in June 2008 (N Eng J Med 2008;358:2545-59). Study-delivered treatment for all ACCORD participants was stopped on June 30, 2009, and the participants were assisted as needed in transferring their care to a personal physician. The lipid and blood pressure results (as well as the microvascular outcomes and eye substudy results) were published in 2010. All participants are continuing to be followed in a non-treatment observational study.
Proper citation: ACCORD (RRID:SCR_009015) Copy
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
http://clinicaltrials.gov/ct2/show/study/NCT00248638
Multi-center, double-blind, placebo-controlled, intent-to-treat Phase III trial, designed to determine the effect of parenteral glutamine (GLN) dipeptide on important clinical outcomes in patients requiring surgical intensive care unit (SICU) care and parenteral nutrition (PN) after cardiac, vascular, or intestinal surgery. Patients who required PN and SICU care will receive either standard glutamine (GLN)-free PN (STD-PN) or isocaloric, isonitrogenous alanyl-glutamine dipeptide (AG)-PN until enteral feedings are established. The study will determine whether AG-PN decreases hospital mortality, nosocomial infection and other important indices of morbidity and will obtain mechanistically relevant observational data in the subjects on whether AG-PN a) increases serial blood concentrations of glutathione (GSH), heat shock proteins (HSP)-70 and -27, and glutamine; b) decreases the serum presence of the bacterial products flagellin and lipopolysaccharide (LPS) and the adaptive immune response to these mediators; and c) improves key indices of innate and adaptive immunity.
Proper citation: Efficacy and Mechanisms of Glutamine Dipeptide in the Surgical Intensive Care Unit (RRID:SCR_006806) Copy
http://clinicaltrials.gov/show/NCT00271999
Randomized controlled clinical trial where subjects will be randomized to conventional hemodialysis delivered three days per week home arm or to the six times per week nocturnal home hemodialysis arm which will follow any dialysis prescription provided their prescribed standardized Kt/V is at least 4.0 and treatment time is at least 6.0 hours, six times per week. Subjects were recruited from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 12 months. Primary Outcome Measures: * composite of 12 month mortality and the change over 12 months in left ventricular mass by cine-MRI, * a composite of 12 month mortality and the change over 12 months in the SF-36 RAND physical health composite Secondary Outcome Measures: * cardiovascular structure/funct (change in LV mass over 12 mos), health-related QoL/phys funct (change over 12 mos in PHC), * depression / dis burden (change over 12 mos in Beck Depression Inv.), nutrition (change over 12 mos in serum albumin, cognitive funct (change over 12 mos in TrailMaking Test B), mineral metabolism (change over 12 mos in aveg pre-dialysis serum phosphorus), * clin events (rate of non-access hospital or death * hypertension, anemia
Proper citation: Frequent Hemodialysis Network Nocturnal Trial (RRID:SCR_007014) Copy
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
Multidisciplinary data generation project which aims to create and share multimodal dataset optimized for artificial intelligence research in type 2 diabetes. At each release of the AI-READI dataset, two sets will be made available: public access and controlled access set. The public set will be stripped of Protected Health Information (PHI) as well as information related to the sex and race/ethnicity of the participants.
Proper citation: AI-READI (RRID:SCR_027031) Copy
http://www.niddkrepository.org/studies/hapo-fus/
The goal of this follow-up study of mothers who participated in the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study is to determine the levels of blood sugar during pregnancy that are linked to increased body fat in the child, as well as to determine the chances of a mother developing diabetes 8-12 years after the pregnancy. The original study examined 23,316 mother-child pairs, and researchers determined that the hyperglycemia of a mother was linked to newborn birth weight and body fat. HAPO-FUS will enroll 7,000 or the original HAPO mother-child pairs for one follow-up visit to assess body composition, blucose metabolism, medical history, and other metabolic parameters.
Proper citation: Hyperglycemia and Pregnancy Outcomes Follow-Up Study Consortium (HAPO-FUS) (RRID:SCR_014377) Copy
https://www.niddkrepository.org/studies/neptune/
A consortium of researchers conducting a cohort study that investigates the underlying disease mechanisms of pro non-inflammatory glomerular diseases. The aim is to elucidate pathogenesis and identify therapeutic targets for clinical trials. The study participants will be classified according to the kidney biopsy results into one of three subcohorts, including Minimal change disease/Focal segmental glomerulosclerosis; Membranous nephropathy; and other conditions.
Proper citation: Nephrotic Syndrome Study Network (NEPTUNE) (RRID:SCR_014380) Copy
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
Trans-NIH program encouraging and facilitating the study of the underlying mechanisms controlling blood vessel growth and development. Other aims include: to identify specific targets and to develop therapeutics against pathologic angiogenesis in order to reduce the morbidity due to abnormal blood vessel proliferation in a variety of disease states; to better understand the process of angiogenesis and vascularization to improve states of decreased vascularization; to encourage and facilitate the study of the processes of lymphangiogenesis; and to achieve these goals through a multidisciplinary approach, bringing together investigators with varied backgrounds and varied interests.
Proper citation: Trans-Institute Angiogenesis Research Program (RRID:SCR_000384) Copy
http://www.icpsr.umich.edu/icpsrweb/NAHDAP/
Archive that acquires, preserves and disseminates data relevant to drug addiction and HIV research. Collection of data on drug addiction and HIV infection in United States. Most of datasets are raw data from surveys, interviews, and administrative records. They were originally gathered in research projects and for administrative purposes. Some datasets have been used in published studies. Bibliographies of these studies are available . Provides access to research data and technical assistance for data depositors. Provides e-workshops on data preparation and data systems.
Proper citation: National Addiction and HIV Data Archive Program (NAHDAP) (RRID:SCR_000636) Copy
https://repository.niddk.nih.gov/study/21
Data and biological samples were collected by this consortium organizing international efforts to identify genes that determine an individual risk of type 1 diabetes. It originally focused on recruiting families with at least two siblings (brothers and/or sisters) who have type 1 diabetes (affected sibling pair or ASP families). The T1DGC completed enrollment for these families in August 2009. They completed enrollment of trios (father, mother, and a child with type 1 diabetes), as well as cases (people with type 1 diabetes) and controls (people with no history of type 1 diabetes) from populations with a low prevalence of this disease in January 2010. T1DGC Data and Samples: Phenotypic and genotypic data as well as biological samples (DNA, serum and plasma) for T1DGC participants have been deposited in the NIDDKCentral Repositories for future research.
Proper citation: Type 1 Diabetes Genetics Consortium (RRID:SCR_001557) Copy
THIS RESOURCE IS NO LONGER IN SERVICE. Documented on September 23,2022. Consortium to advance the understanding of intestinal epithelial stem cell biology during development, homeostasis, regeneration and disease. Its immediate goals are to isolate, characterize, culture and validate populations of intestinal stem cells; answer major questions in stem cell biology of the intestinal epithelium; and accelerate research by making information and resources available to the research community. Resources include data sets, protocols, and a resource catalog. Long-term goals include: 1) laying the ground work for therapeutic manipulation of the intestinal epithelium 2) contributing to the greater understanding of stem cell biology through knowledge of the intestine as a model stem cell-driven system. Research Projects are housed at 8 institutions across the nation: Oregon Health & Science University, Stanford University, Stowers Institute for Medical Research, University of California, Los Angeles School of Medicine (UCLA) (partnered with the VA Greater Los Angeles), University of North Carolina, Chapel Hill (UNC), University of Oklahoma, University of Pennsylvania, and University of Pittsburgh.
Proper citation: Intestinal Stem Cell Consortium (RRID:SCR_001555) Copy
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