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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://www.t1diabetes.nih.gov/T1D-PTP/
THIS RESOURCE IS NO LONGER IN SERVICE, documented August 22, 2016. Investigator access is provided to the established facilities and expertise needed to extend, enhance and validate preclinical studies of promising new therapeutics in cases where additional preclinical testing is needed to validate potential therapies under disease-specific conditions and in multiple animal models before therapeutics can enter the Type 1 Diabetes Rapid Access to Intervention Development (T1D-RAID) development pipeline. The T1D-RAID program provides resources for pre-clinical development of drugs, natural products, and biologics that will be tested as new therapeutics in type 1 diabetes clinical trials. The T1D-RAID program is not currently accepting applications. The T1D-PTP program currently supports two contracts, which are separate from each other and from the T1D-RAID NCI contract resources, to assist in preclinical development of therapeutics for T1D: * Agents to be tested for Preclinical Efficacy in Prevention or Reversal of Type 1 Diabetes in Rodent Models. Type 1 Diabetes Preclinical Testing Program (T1D-PTP) (NOT-DK-09-006) * Needs for Preclinical Efficacy Testing of Promising Agents to Prevent or Reverse Diabetic Complications (NOT-DK-09-009) The T1D-RAID and T1D-PTP are programs intended to remove the most common barriers to progress in identification and development of new therapies for Type 1 Diabetes. The common goal of these programs is to support and provide for the preclinical work necessary to obtain proof of principle establishing that a new molecule or novel approach will be a viable candidate for expanded clinical evaluation.
Proper citation: Type 1 Diabetes Preclinical Testing Program (RRID:SCR_006861) 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
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://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
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
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
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
https://hddc.hms.harvard.edu/core-b
Core facility that provides service for paraffin embedding, sectioning, staining, and frozen sectioning; shared equipment and service for confocal, widefield, photodocumentation, electron microscopy, and digital image processing; and an immunostaining service.
Proper citation: Harvard Digestive Diseases Center Biomedical CORE B: Microscopy and Histopathology (RRID:SCR_009836) Copy
https://joslinresearch.org/drc-cores/Flow-Cytometry-Core
THIS RESOURCE IS NO LONGER IN SERVICE. Documented on October 27,2023. Core that provides cell sorting and flow cytometry services. Specific services include cell analysis, large object sorting,magnetic cell enrichment, and automatic cell counting.
Proper citation: Joslin Diabetes Center Flow Cytometry Core Facility (RRID:SCR_009878) Copy
https://joslinresearch.org/drc-cores/Animal-Physiology-Core
THIS RESOURCE IS NO LONGER IN SERVICE. Documented on October 27,2023. Core that provides technically advanced physiological evaluation of metabolism in diabetes, obesity, and their associated complications in rodents for DRC investigators and outside users. It also provides training of investigators and trainees in several physiological procedures.
Proper citation: Joslin Diabetes Center Animal Physiology Core Facility (RRID:SCR_009876) Copy
https://joslinresearch.org/drc-cores/Advanced-Microscopy-Core
THIS RESOURCE IS NO LONGER IN SERVICE. Documented on October 27,2023. Core that provides services for performing specific morphological procedures, providing training and access to equipment, maintaining the specialized microscopes, and giving advice and interpretation.
Proper citation: Joslin Diabetes Center Advanced Microscopy Core Facility (RRID:SCR_009875) Copy
https://joslinresearch.org/drc-cores/Advanced-Genomics-and-Genetics-Core
THIS RESOURCE IS NO LONGER IN SERVICE. Documented on October 27,2023. Core that provides services for genetic and genomic analysis, including DNA extraction from blood, access to DNA collections from the Core?s repository, SNP genotyping, and support for gene expression studies based on both high-density oligonucleotide arrays and real-time quantitative PCR.
Proper citation: Joslin Diabetes Center Advanced Genomics and Genetics Core Facility (RRID:SCR_009873) Copy
https://hddc.hms.harvard.edu/gnotobiotics-microbiology-and-metagenomics
Core facility that assists investigators evaluating host microbiota and its role in normal physiology and disease. It includes a number of resources for groups studying the role of the microbiota in human health and disease.
Proper citation: Harvard Digestive Diseases Center Biomedical CORE D: Gnotobiotic Mice, Microbiology and Metagenomics (RRID:SCR_012319) Copy
http://sph.unc.edu/norc/norc-diet-and-physical-activity-core/
Core that provides diet, physical activity, or statistical analysis consultation, as well as consultation for the design and development of diet and physical activity data collection protocols.
Proper citation: University of North Carolina at Chapel Hill Nutrition and Obesity Research Center Diet and Physical Activity Core (RRID:SCR_012588) Copy
Core services include consultation, technical support and training and mentoring in clinical and translational research methods that are specifically applicable to diabetes, its complications and related metabolic disorders. Personel provides expertise in first-in-human and mechanistic studies in integrative physiology, in clinical trials of diabetes and obesity, and in application of new technologies.
Proper citation: Einstein-Mount Sinai Diabetes Research Center Translational Research Core Facility (RRID:SCR_015068) Copy
https://www.baderc.org/cores/cbmcore/
Services provided include tissue preparation, embedding and sectioning for electron microscopy, use of electron microscope and photography of thin sections, immunogold staining for electron microscopy, preparation and incubation of samples (cells and tissues) for immunofluorescence microscopy, confocal microscopy and digital imaging.
Proper citation: Boston Area Diabetes Endocrinology Research Center Cell Biology and Morphology Core Facility (RRID:SCR_015069) Copy
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