Look AHEAD (Action For Health in Diabetes) is a multi-center randomized clinical trial to examine the effects of a lifestyle intervention designed to achieve and maintain weight loss over the long term through decreased caloric intake and exercise. Look AHEAD is focusing on the disease most affected by overweight and obesity, type 2 diabetes, and on the outcome that causes the greatest morbidity and mortality, cardiovascular disease.
This NHLBI study is 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 two additional issues: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 Acute Liver Failure Study Group is collecting biosamples and information on the natural history, causes and outcomes of Acute Liver Failure in the United States. In addition to the database, a clinical trial conducted to test whether the drug N-acetylcysteine (NAC) improves outcome (survival) for patients with Acute Liver Failure not caused by acetaminophen overdose has recently been completed.
The Acute Renal Failure Trial Network (ATN) study was established to determine whether more intensive renal replacement therapy decreases mortality among critically ill patients with acute kidney injury. The study was a multicenter, prospective, randomized trial of two strategies for renal-replacement therapy in patients with acute kidney injury.
The primary goal of A2ALL is to provide valuable information on the outcomes of both potential and actual recipients and their donors who have been evaluated for adult-to-adult living donor liver transplantation.
The African American Study of Kidney Disease and Hypertension Cohort Study (AASK Cohort) is a prospective, observational study that is an extension of the AASK Clinical Trial, which investigated the effects of two levels of blood pressure (BP) control and the use of three antihypertensive drug regimens on the progression of chronic kidney disease.
The centers that make up the ACE program conduct clinical trials and basic research on new immune-based therapies for autoimmune diseases. This program is designed to enhance interactions between scientists and clinicians in order to accelerate the translation of research findings into medical applications.
The Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study was a multicenter, randomized clinical trial that combined behavioral training and pharmacological treatment with the goal of improving patient outcomes.
The BACH Survey was established by the NIDDK to survey residents in the Boston metropolitan area about their urologic symptoms and how those symptoms affect their daily lives. The BACH Survey was designed to estimate the prevalence of urologic symptoms typical of interstitial cystitis (IC), urinary incontinence, benign prostatic hyperplasia, prostatitis, hypogonadism, and impaired sexual function by race/ethnicity, age, sex, and socioeconomic status (SES).
The BrIDGs program assists researchers in advancing promising therapeutic agents through late-stage pre-clinical development toward an Investigational New Drug (IND) application and clinical testing. Investigators do not receive grant funds through this program. Instead, selected researchers partner with NCATS experts to generate pre-clinical data and clinical-grade material through government contracts for use in Investigational New Drug (IND) applications to a regulatory authority such as the Food and Drug Administration (FDA). In general, BrIDGs provides synthesis, formulation, pharmacokinetic and toxicology expertise and resources to its collaborators.
The NHLBI-led BARI-2D study aims to determine the best therapies for people with type 2 diabetes and moderately severe cardiovascular disease.
The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).
The objectives of CRIC are to improve understanding of the relationship between CKD and CVD and to examine traditional and non-traditional ("uremia-related")) risk factors for progression of CKD and CVD among patients with reduced kidney function. The study, which started in 2001, is a prospective observational cohort study of approximately 3,000 men and women with CKD. This is the largest cohort study of CKD undertaken. A wide range of measurements are performed on CRIC Study participants including creatinine clearance and iothalamate measured glomerular filtration rate. Cardiovascular measures include blood pressure, ECG, ABI, ECHO, and EBCT. Clinical CV outcomes include MI, ischemic heart disease-related death, acute coronary syndromes, congestive heart failure, cerebrovascular disease, peripheral vascular disease, and composite outcomes.
The CKiD Study is a NIH-funded, multicenter, prospective cohort study of children aged 6 months to 16 years with mild to moderate impaired kidney function. The specific aims of the CKiD study are to: (1) identify novel and traditional renal disease risk factors for the progression of CKD (i.e., decline of GFR) in children; (2) characterize the impact of a decline in kidney function on neurodevelopment, cognitive abilities, and behavior; (3) identify the prevalence and evolution of cardiovascular disease risk factors in children with CKD, and; (4) examine the effects of declining GFR on growth and the treatment of growth failure, and to assess the consequences of growth failure on morbidity in children with CKD.
The Clinical Islet Transplantation (CIT) Consortium is a network of clinical centers and a data coordinating center conducting studies of islet transplantation in patients with type 1 diabetes. Studies conducted by the CIT Consortium will focus on improving the safety and long-term success of methods for transplanting islets, the insulin-producing cells of the pancreas, in people whose own islets have been destroyed by the autoimmune process that characterizes type 1 diabetes.
The Clinical Outcomes Research Initiative, CORI, provides gastrointestinal physicians, nurses and researchers with software, research data and tailor-made services aimed to advance the overall practice of endoscopy.
TThe Clinical Trials in Organ Transplantation (CTOT) project is a cooperative research program sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). CTOT is an investigative consortium for conducting clinical and associated mechanistic studies that will lead to improved outcomes for transplant recipients. The purpose of these studies is to improve short and long-term graft and patient survival.
The mission of the Collaborative Islet Transplant Registry (CITR) is to expedite progress and promote safety in islet/beta cell transplantation through the collection, analysis, and communication of comprehensive and current data on all islet/beta cell transplants performed in North America, as well as some European and Australian centers.
An 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).
The fundamental aim of GoKinD is to facilitate investigator-driven research into the genetic basis of diabetic nephropathy by collecting, storing, and distributing genetic samples from cases and controls of type 1 diabetes and diabetic nephropathy.
The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) is a long-term study of different treatments for type 2 diabetes. The goal of the GRADE Study is to determine which combination of two diabetes medications is best for achieving good glycemic control, has the fewest side effects, and is the most beneficial for overall health in long-term treatment for people with type 2 diabetes.
The ITN is an international consortium of scientists and physicians dedicated to the clinical evaluation of novel tolerogenic approaches for the treatment of autoimmune diseases, asthma and allergic diseases, and the prevention of graft rejection.
The goals of the National Gene Vector Biorepository and Coordinating Center (NGVB) are to provide the following: (1) maintain a database of pre-clinical pharmacology and toxicology studies (Pharm/Tox database) to support Investigational New Drug (IND) submissions to the Food and Drug Administration (FDA); (2) provide a reagent repository to support pre-clinical and clinical gene therapy studies; (3) provide biorepository and archiving services; (4) provide educational material about gene therapy; (5) provide IND-enabling testing services; and (6) conduct research related to gene therapy safety.
The goals of the nPOD initiative are to maintain a network of procuring and characterizing, in a collaborative manner, pancreata and related tissues (spleen, lymph node, pancreatic lymph node, peripheral blood, thymus and bone marrow) from cadaveric organ donors with type 1 diabetes as well as those whom are islet autoantibody positive.
The U.S. Organ Procurement and Transplantation Network (OPTN) maintains a registry of human tissues in order to ensure the success and efficiency of the U.S. organ transplant system.
PERL is a clinical trial for people with type 1 diabetes who have early signs of kidney problems. Our goal is to test a new way to reduce loss of kidney function using a safe and inexpensive medicine. Over 1500 people with type 1 diabetes volunteered to participate in the PERL study, and 530 were eligible and enrolled in the study.
The Restoring Insulin Secretion RISE Study is recruiting adults and children with early type 2 diabetes or who are at risk for type 2 diabetes. RISE includes 3 studies examining whether aggressive glucose lowering will lead to recovery of pancreas function (known as ß-cell function) in those with prediabetes and early type 2 diabetes.
The TEDDY consortium is looking for the causes of type 1 diabetes mellitus (T1DM), including genetic and genetic-environmental interactions and childhood infections or other environmental factors predisposing to development of Type I Diabetes Mellitus (T1DM). The consortium of six centers will recruit and enroll children, including obtaining informed consent from parents prior to or shortly after birth, obtain genetic and other samples from neonates and parents, and prospectively follow selected neonates throughout childhood or until development of islet autoimmunity or T1DM. Biological samples collected from the TEDDY study will be placed in the Central NIDDK Repository for access by interested investigators.
The ChiLDReN Network was developed to support the discovery of new diagnostics, etiologic, and treatment options for ChiLDReN with liver disease, and those who undergo liver transplantation. The Network also supports training for the next generation of investigators in rare, pediatric liver diseases. One of the primary goals of the Network is to provide a way for patients to join with doctors and researchers by participating in research studies.
Type 1 Diabetes TrialNet is an international network of researchers who are exploring ways to prevent, delay and reverse the progression of type 1 diabetes. TrialNet is conducting clinical trials with researchers in the United States, Canada, Finland, United Kingdom, Italy, Germany, Australia and New Zealand. Studies are available for people newly diagnosed with type 1 diabetes, as well as for relatives of people with type 1 diabetes who are at greater risk of developing the disease.