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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/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   

•   Source: SciCrunch Registry

http://diabetes.niddk.nih.gov/dm/pubs/control/index.aspx

Clinical study that showed that keeping blood glucose levels as close to normal as possible slows the onset and progression of eye, kidney, and nerve diseases caused by diabetes. EDIC is a follow-up study of people who participated in DCCT. The DCCT involved 1,441 volunteers, ages 13 to 39, with type 1 diabetes and 29 medical centers in the United States and Canada. Volunteers had to have had diabetes for at least 1 year but no longer than 15 years. They also were required to have no, or only early signs of, diabetic eye disease. The study compared the effects of standard control of blood glucose versus intensive control on the complications of diabetes. Intensive control meant keeping hemoglobin A1C levels as close as possible to the normal value of 6 percent or less. The A1C blood test reflects a person''''s average blood glucose over the last 2 to 3 months. Volunteers were randomly assigned to each treatment group. DCCT Study Findings * Intensive blood glucose control reduces risk of ** eye disease: 76% reduced risk ** kidney disease: 50% reduced risk ** nerve disease: 60% reduced risk When the DCCT ended, researchers continued to study more than 90 percent of participants. The follow-up study, called Epidemiology of Diabetes Interventions and Complications (EDIC), is assessing the incidence and predictors of cardiovascular disease events such as heart attack, stroke, or needed heart surgery, as well as diabetic complications related to the eye, kidney, and nerves. The EDIC study is also examining the impact of intensive control versus standard control on quality of life. Another objective is to look at the cost-effectiveness of intensive control. EDIC Study Findings * Intensive blood glucose control reduces risk of ** any cardiovascular disease event: 42% reduced risk ** nonfatal heart attack, stroke, or death from cardiovascular causes: 57% reduced risk

Proper citation: Diabetes Control and Complications Trial (RRID:SCR_006805) Copy   

•   Source: SciCrunch Registry

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   

•   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://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   

•   Source: SciCrunch Registry

https://www.baderc.org/cores/metaboliccore/

Core in BADERC that provides services in consultation and teaching, use of DEXA scanner for determination of body fat and/or bone density, and use of Coulter Counter to measure cell number and cell size distribution.

Proper citation: Boston Area Diabetes Endocrinology Research Center Metabolic Physiology and Energy Balance Core Facility (RRID:SCR_008293) Copy   

•   Source: SciCrunch Registry

https://aireadi.org

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   

•   Source: SciCrunch Registry

https://www.researchallofus.org

Portal stores health data from participants from across the United States. Provides interactive Data Browser where anyone can learn about the type and quantity of data that All of Us collects. Users can explore aggregate data including genomic variants, survey responses, physical measurements, electronic health record information, and wearables data.

Proper citation: All of Us (RRID:SCR_027032) Copy   

•   Source: SciCrunch Registry

https://dpcpsi.nih.gov/onr/nrcc

Coordinates nutritional sciences-related research and research training across the National Institutes of Health (NIH) and among Federal Agencies by providing mechanisms to communicate research, research training, policy, and education initiatives. The DNRC facilitates the exchange of information, coordinates workshops and seminars on critical issues, encourages national and international research collaborations, and serves as the NIH primary point of contact for the Department of Health and Human Services (DHHS) and other agencies, departments, and organizations in matters pertaining to nutritional sciences and physical activity. Through its dedicated efforts to promote scientific policy reviews, innovative research, interagency collaboration, and technical advancements, the DNRC strives to define the increasing roles of nutritional sciences and physical activity in health promotion and disease prevention and treatment.

Proper citation: NIH Division of Nutrition Research Coordination (RRID:SCR_001469) 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://clinicaltrials.gov/study/NCT01619475

Study consisting of nine liver transplant centers with expertise in adult living-donor liver transplantation (LDLT) and a central data coordinating center to provide valuable information on the outcomes of adult to adult living donor liver transplantation (AALDLT) to aid decisions made by physicians, patients, and potential donors. The study will establish and maintain the infrastructure required to accrue and follow sufficient numbers of patients being considered for and undergoing AALDLT to provide generalizable data from adequately powered studies. The major aims of A2ALL are as follows: * Quantify the impact of choosing LDLT on the candidate for transplantation * Characterize the difference between LDLT and deceased donor liver transplant (DDLT) in terms of post-transplant outcomes, including patient and graft survival, surgical morbidity, and resource utilization on the recipient of a transplant * Determine the short- and long-term health and quality of life (QOL) impact of donation, including (a) morbidity after liver donation and (b) long-term health-related QOL of donors. * Standardize and assess the role of informed consent in affecting the decision to donate and satisfaction after living liver donation * Other aims include comparison of the severity of recurrence of hepatocellular carcinoma for DDLT versus LDLT, the systematic characterization of liver regeneration and function in donors and recipients, the evaluation of the differences in the immune response to LDLT versus DDLT, and the establishment of a robust data and sample repository on liver transplantation that may be used to study clinical and biological questions as new technologies and resources become available. Patients enrolled in the study will be followed and managed in a standardized fashion.

Proper citation: Adult to Adult Living Donor Liver Transplantation Cohort Study (RRID:SCR_001494) 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://pathology-anatomy.missouri.edu/research/diabetes.html

Standardization of c-peptide by calibrating C-peptide measurement to a reference method can increase comparability between laboratories. The C-peptide standardization program is supported to establish reliability in results and facilitate the conduct of international clinical trials. For c-peptide, purified or processed material shows significant matrix effects and cannot be used for calibration. The C-peptide program has evaluated the use of single donor and pooled specimens for use by manufacturers in the calibration of these assays and determined that this strategy will reduce C-peptide variability among different assay methods. The standardization process through manufacturer re-calibration is ongoing.

Proper citation: Standardization of C-peptide measurements (RRID:SCR_001499) 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://drcrnet.jaeb.org/

A collaborative network to facilitate multicenter clinical research of diabetic retinopathy, diabetic macular edema and associated conditions. It supports the identification, design, and implementation of multicenter clinical research initiatives focused on diabetes-induced retinal disorders. Principal emphasis is placed on clinical trials, but epidemiologic outcomes and other research may be supported as well. It currently includes over 109 participating sites (offices) with over 320 physicians throughout the United States. Closed and active studies are listed along with the associated protocols, public datasets, and publications.

Proper citation: Diabetic Retinopathy Clinical Research Network (RRID:SCR_001514) Copy   

•   Source: SciCrunch Registry

http://direcnet.jaeb.org/

Network of clinical centers and a coordinating center that investigate the potential use of glucose monitoring technology and its impact on the management of type 1 diabetes in children. Specific goals for the network include the following: * Assess the accuracy of continuous monitoring devices in order to determine if these devices are useful in improving glycemic control and preventing hypoglycemia in children with T1DM. * Determine the optimal utilization of continuous glucose monitors in the management of T1DM in children. * Assess the impact of continuous glucose monitoring on quality of life for the child and family. * Develop tools for the child and parents to use for incorporating continuous glucose monitors into diabetes self-management. * To assess possible changes in neurocognitive function and how it relates to frequency of hypoglycemia in young children with type 1 diabetes. * Evaluate and develop distinct, age-appropriate treatment approaches to T1DM in children. * Use continuous glucose monitoring to characterize the glycemic profile of nondiabetic children. * Develop statistical methods for the analysis of continuous glucose monitoring data. Closed and active studies are listed along with the associated protocols, public datasets, and publications.

Proper citation: Diabetes Research in Children Network (RRID:SCR_001512) 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://repository.niddk.nih.gov/network/284

Group of collaborating investigators who conduct long-term studies and clinical trials of the most commonly used surgical, pharmacological, and behavioral approaches for management of urinary incontinence in women diagnosed with stress and mixed incontinence.

Proper citation: Urinary Incontinence Treatment Network (RRID:SCR_001543) Copy   

•   Source: SciCrunch Registry

https://www.searchfordiabetes.org/

National multi-center study aimed at understanding more about diabetes among children and young adults in the United States less than 20 years of age in six geographically dispersed populations that encompass the ethnic diversity of the United States. SEARCH has been helping to find answers about the types of diabetes, its complications, and how having diabetes affects the lives of children and young adults. There are more than 20,000 study participants representing all different racial and ethnic backgrounds who have helped SEARCH determine the extent of diabetes in the community and its impact on different populations. The SEARCH Study invites Investigators interested in childhood Diabetes Research to collaborate on matters of interest to the field of childhood Diabetes.

Proper citation: SEARCH for Diabetes in Youth (RRID:SCR_001540) Copy   

•   Source: SciCrunch Registry