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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

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://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html

A listing of NIH supported data sharing repositories that make data accessible for reuse. Most accept submissions of appropriate data from NIH-funded investigators (and others), but some restrict data submission to only those researchers involved in a specific research network. Also included are resources that aggregate information about biomedical data and information sharing systems. The table can be sorted according by name and by NIH Institute or Center and may be searched using keywords so that you can find repositories more relevant to your data. Links are provided to information about submitting data to and accessing data from the listed repositories. Additional information about the repositories and points-of-contact for further information or inquiries can be found on the websites of the individual repositories.

Proper citation: NIH Data Sharing Repositories (RRID:SCR_003551) 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

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/camus/camus.aspx

Randomized, multicenter, double blind, placebo controlled clinical trial of phytotherapy for benign prostate symptoms among men. The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the CAMUS trial will be given one out of two possible treatments at random. One out of every two men would get an inactive placebo treatment. One out of every two men would get Saw palmetto pills. This kind of scientific study is the best way to find out if the plant extracts really work to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study, men will not know which of the two treatments they are assigned to. They will be followed very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial will be studied over 72 weeks. Ten clinical centers will participate in the trial. They are located at: Columbia University, NY, NY; New York University, NY, NY; University of Texas Southwestern Medical Center, Dallas, Texas; University of Colorado, Denver, CO; Washington University, St. Louis, MO; Yale University, New Haven, CT; Queens University, Hamilton, Ontario, Canada; Northwestern University, Chicago, IL; University of Maryland, Baltimore, MD; University of California at San Francisco, San Francisco, CA.

Proper citation: Complementary and Alternative Medicine for Urological Symptoms (RRID:SCR_007131) 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

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

Randomized clinical trial to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride. The study has been terminated. (Inability to recruit required sample size.)

Proper citation: Minimally Invasive Surgical Therapies Treatment Consortium for Benign Prostatic Hyperplasia (RRID:SCR_007126) Copy   

•   Source: SciCrunch Registry

http://www.med.upenn.edu/idom/drc/cores/cellbio.html

Core that gives support including experimental design, islet isolation, and performance of and training in an expansive range of assays for physiological and morphometric assessment of pancreatic islet function and growth. It contributes to the basic and translational research activities of the Institute of Diabetes, Obesity and Metabolism (IDOM) at the Perelman School of Medicine of the University of Pennsylvania. Its services include perform individual islet and single cell fluorescence imaging, respirometry with islet batches using a Seahorse Extracellular Flux Analyzer, perifusion coupled with respirometry, and closed respirometry experiments for our investigators.

Proper citation: University of Pennsylvania School of Medicine Penn Diabetes Research Center Pancreatic Islet Cell Biology Core Facility (RRID:SCR_008265) Copy   

•   Source: SciCrunch Registry

http://www.med.upenn.edu/idom/drc/cores/transmouse.html

Mouse core which generates transgenic and gene-targeted mouse lines for diabetes research.

Proper citation: Penn Diabetes Research Center Transgenic and Chimeric Mouse Core Facility (RRID:SCR_010036) Copy   

•   Source: SciCrunch Registry

https://labnodes.vanderbilt.edu/community/profile/id/1133

THIS RESOURCE IS NO LONGER IN SERVICE. Documented on October 30,2023. Core facility that provides training and expertise in nutrition/diet methodology to obtain valid and reliable assessment and analyses of dietary intakes, nutritional status, body composition and metabolism.

Proper citation: Vanderbilt Diabetes Research and Training Center Vanderbilt Diet Body Composition and Metabolism Core Facility (RRID:SCR_010191) Copy   

•   Source: SciCrunch Registry

http://www.t1diabetes.nih.gov/t1d-raid/index.shtml

NOTE: The T1D-RAID program is not currently accepting applications. Cooperative program that makes available, on a competitive basis, NCI resources for the pre-clinical development of drugs, natural products, and biologics to facilitate translation to the clinic of novel, scientifically meritorious therapeutic interventions for type 1 diabetes and its complications. A partial listing of those services includes: high-throughput screening, studies in animal models, formulation, pharmacology and toxicology studies, and bulk substances acquisition. Requests to T1D-RAID are brief (20 pages or less), and should clearly outline the resources required to ready the proposed therapeutic agent for clinical trials. T1D-RAID should enable entry into the clinic of promising molecules that are not otherwise likely to receive an adequate and timely clinical test. T1D-RAID is designed to accomplish the tasks that are rate-limiting in bringing discoveries from the laboratory to the clinic. Once a project has been approved, NIDDKstaff interact directly with the Principal Investigator (PI). NCI contractors perform the T1D-RAID-approved tasks under the direction of NIDDKand NCI staff. The required tasks will vary from project to project. In some cases T1D-RAID will support only one or two key missing steps necessary to bring a compound to the clinic; in other cases it may be necessary to supply the entire portfolio of development requirements needed to file an IND. Examples of tasks that can be supported by T1D-RAID include, but are not limited to: * Definition or optimization of dose and schedule for in vivo activity * Development of pharmacology assays * Conduct of pharmacology studies with a pre-determined assay * Acquisition of bulk substance (GMP and non-GMP) * Scale-up production from lab-scale to clinical-trials lot scale * Development of suitable formulations * Development of analytical methods for bulk substances * Production of dosage forms * Stability assurance of dosage forms * Range-finding initial toxicology * IND-directed toxicology, with correlative pharmacology and histopathology * Planning of clinical trials * Regulatory affairs, so that FDA requirements are likely to be satisfied by participating investigators seeking to test new molecular entities in the clinic * IND filing advice The output of T1D-RAID activities will be both products and information that will be made fully available to the originating investigator for support of an IND application and clinical trials. T1D-RAID does not sponsor clinical trials.

Proper citation: Type 1 Diabetes - Rapid Access to Intervention Development (RRID:SCR_000203) Copy   

•   Source: SciCrunch Registry

http://ods.od.nih.gov/Research/CARDS_Database.aspx

Database of federally funded research projects pertaining to dietary supplements. CARDS contains projects funded by the United States Department of Agriculture (USDA), the Department of Defense (DOD) and the Institutes and Centers (ICs) of the National Institutes of Health (NIH) beginning with fiscal year 1999, the first year that NIH ICs began reporting research related to dietary supplements. Projects funded by other Federal agencies will be added to CARDS as they become available. The Office of Dietary Supplements (ODS) will post notices on its website and listserv when CARDS updates are completed. Codes assigned to each research project allow the CARDS user to identify: * research related to specific dietary supplement ingredients; for example, vitamin E or St. John''''s wort * the type of study; for example, a Phase III study or an animal study * health outcomes or biological effects; for example, osteoporosis or antioxidant function * whether the research is directly related or indirectly related to dietary supplements. For example, a clinical trial comparing bone density in women given a daily calcium supplement versus a placebo would be classified as directly related to dietary supplements. A study examining the activation of steroid hormone receptors by supplemental vitamin D in cell culture would be classified as indirectly related to dietary supplements because the direct physiological or health effects of vitamin D supplementation are not being studied. A search of the CARDS database can be used to sort and tabulate information for a variety of purposes. For example, a researcher may want to know which ICs at the NIH fund research on herbal supplement ingredients. A consumer may want to know if the Federal government is supporting research on a popular dietary supplement ingredient such as vitamin C.

Proper citation: CARDS Database (RRID:SCR_009011) 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://www.clinicaltrials.gov/study/NCT00360646

Prospective and retrospective registry of well-characterized cases of drug-induced liver disease. The goals of Network include the development of standardized procedures to identify and fully characterize bona fide cases of drug- and complementary and alternative medicines (CAM)-induced liver injury, and to conduct controlled, clinical studies that will include extensive collection of data, serum, DNA, and tissue specimens. Cases of liver injury due to herbal medications are also included. The network will also develop terminology and standardized definitions for DILI, and to develop causality assessment instruments that are sensitive, specific, and reproducible. DILIN is funded by a cooperative agreement and includes five clinical centers and a central data coordinating center. The research goals of DILIN are to: * Create a registry of carefully documented DILI cases * Identify clinical, immunological, and environmental risk factors for drug- and CAM-mediated hepatotoxicity * Create a bank of biological specimens consisting of DNA, plasma, and immortalized lymphocytes to facilitate detailed genetic analyses * Characterize the natural history of drug- and CAM-induced DILI for at least six months following enrollment * Develop the capability to recontact these individuals over an extended period of time so that additional studies exploring DILI mechanisms can be performed Two studies are being initiated by the network. In the Retrospective Study, the implicated drugs are restricted to isoniazid, phenytoin, combination clavulanic acid/amoxicillin, and valproic acid (Depakote), Nitrofurantoin, Trimethoprim-sulfamethoxazole, Minocycline, and Quinolone antibiotics. These drugs were chosen because they are frequently administered to patients not receiving other hepatotoxic drugs, making it easier to establish causality. Patients must be alive, and the date of onset of the DILI episode must be on or after January 1, 1994. In the Prospective Study, all incident cases of drug- and CAM-induced liver injury are being considered. Initial presentation to a healthcare professional must be within the previous six months. A detailed medication history of the implicated DILI drug together with all prescription, OTC, and herbal medications is being recorded. Liver and serological tests are being performed to characterize the injury and to exclude competing causes of liver injury. A blood sample is also being drawn for plasma storage and DNA isolation. These cases will be followed longitudinally to characterize the long-term effects of the DILI episode. For both studies, documented, clinically significant DILI must be recorded in the patient's medical charts so that a causal determination can be made. Patients will be excluded if they are unwilling or unable to provide a blood sample or participate in the genetics component. Children under two years of age at the time of enrollment are excluded due to blood-volume requirements. If you have patients who are eligible to participate in either study, please contact one the DILIN clinical sites. As a general policy, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites investigator-initiated research project applications for ancillary studies to ongoing, large-scale clinical trials, epidemiological studies, and disease databases supported by the Institute. These studies are focused on a wide range of diseases and conditions including diabetes, obesity, acute and chronic liver disease, chronic kidney disease, and benign prostatic hyperplasia, among others.

Proper citation: Drug-Induced Liver Injury Network (RRID:SCR_001524) Copy   

•   Source: SciCrunch Registry

http://www.prostatitis.org/symptomindex.html

Questionnaire developed by physicians in NIDDK's Chronic Prostatitis Collaborative Research Network that can help physicians to accurately measure the severity of prostatitis symptoms and their impact on a patient's lifestyle. The CPSI questionnaire assesses pain, urination, and the effect of chronic prostatitis on daily activities. With this information, researchers and physicians can reliably evaluate whether potential treatments are working. The questionnaire was originally published in the Journal of Urology in August 1999 (Vol. 162, pages 369-375). It is available as a PDF document in English, Spanish, German and Korean.

Proper citation: NIH Chronic Prostatitis Symptom Index (RRID:SCR_001482) Copy   

•   Source: SciCrunch Registry

https://ncats.nih.gov/grdr/rdhub

A database of biospecimens collected, stored, and distributed by biorepositories in the United States and around the globe. Its goals are: To help and assist interested parties and investigators search, locate, and identify desired biospecimens needed for their research; to facilitate collaboration and sharing of material and data among investigators across the globe; to accelerate research to facilitate the discovery of new treatments, therapeutics and eventually cures for rare diseases as well as common diseases; to identify, locate and increase the awareness of existing biorepositories across the globe; and to link the RD-HUB with the Global Rare Diseases Patient Registry and Data Repository (GRDR).

Proper citation: Biospecimens/Biorepositories: Rare Disease-HUB (RD-HUB) (RRID:SCR_004327) Copy   

•   Source: SciCrunch Registry

https://biolincc.nhlbi.nih.gov/home/

Repository that serves to coordinate searches across data and biospecimen collections from participants in numerous clinical trials and epidemiologic studies and to provide an electronic means for requests for additional information and the submission of requests for collections. The collections, comprising data from more than 80 trials or studies and millions of biospecimens, are available to qualified investigators under specific terms and conditions consistent with the informed consents provided by the individual study participants. Some datasets are presented with studies and supporting materials to facilitate their use in reuse and teaching. Datasets support basic research, clinical studies, observational studies, and demonstrations. Researchers wishing to apply to submit biospecimen collections to the NHLBI Biorepository for sharing with qualified investigators may also use this website to initiate that process.

Proper citation: Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) (RRID:SCR_013142) Copy   

•   Source: SciCrunch Registry