cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.58020/7nt7-nf08
title: Beta Cell Restoration Through Fat Mitigation

description: Obesity is one of the key risk factors in the development of type 2 diabetes.  Research has shown that excess body mass is linked to insulin resistance and loss of beta-cell function, which are precursors of type 2 diabetes. Clinical studies indicate medication and weight loss attained through lifestyle changes are both effective at slowing the progression of the disease by mitigating the effects of obesity on beta-cell function. The Beta Cell Restoration Through Fat Mitigation (BetaFat) Study was created to determine if weight loss through gastric banding surgery would be more effective than metformin medication at sustaining or improving beta-cell function in individuals with prediabetes or early type 2 diabetes, who are also mildly to moderately obese. 

BetaFat, a component of the Restoring Insulin Secretion (RISE) Consortium, was a two-arm, unblinded clinical trial. Study participants were recruited at the University of Southern California and randomized into two intervention groups.  One group received gastric banding surgery and the other group was treated with metformin. Patients underwent assessments at baseline and at predetermined intervals during the 24-month study period. Beta-cell function, insulin sensitivity, and blood glucose levels were regularly evaluated during the study period. Participants were also monitored for adverse effects to the interventions.
DOI: 10.58020/agds-b607
title: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR)

description: Sodium bicarbonate may help prevent kidney failure in people with chronic kidney disease. However, the dose to prescribe in order to test this possibility in a clinical trial is uncertain. The BASE pilot clinical trial will help determine the best dose of sodium bicarbonate to prescribe in a future study that will test the long-term safety and efficacy of sodium bicarbonate as a treatment to preserve kidney function in individuals with chronic kidney disease.
DOI: 10.58020/2jbe-2m91
title: Biliary Atresia Research Consortium

description: The BARC study was a retrospective study that analyzed the results of a large cohort of patients with biliary atresia from US institutions with expertise in management of children with liver disease. The study consisted of a comprehensive retrospective chart review of clinical data and outcomes for all patients with biliary atresia undergoing HPE between January 1, 1997 and December 31, 2000 at 9 clinical centers. All children included in the study were followed for 2 years or until loss of the native liver as a result of transplantation or death. The data showed that there was no standard approach to the diagnosis of biliary atresia and that postsurgical management varied considerably among the BARC centers; nevertheless, the outcomes at age 2 years for the 9 centers were comparable to the best outcome data published from other countries and in large single-center reports. The study also showed that total bilirubin in early follow-up after HPE was highly predictive of outcome.

Data from the P001 and P002 protocols are now available.
DOI: 10.58020/t68y-hk43
title: B-Lymphocyte Immunotherapy in Islet Transplantation: Toward Calcineurin-Inhibitor Free Immunosuppression

description: The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population was individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. Subjects in CIT05 received, in an open label-fashion, the anti-CD20 agent rituximab in combination with rabbit anti-thymocyte globulin (ATG; daclizumab or basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable) for induction and sirolimus alone for maintenance, a calcineurin-inhibitor free regimen.
DOI: 10.58020/e5cx-za20
title: Boston Area Community Health Survey

description: In response to a lack of basic descriptive epidemiology of urologic symptoms in the general populationthe Boston Area Community Health (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 survey created a random community-based sample of racially and ethnically diverse men and women across a broad age range, between 30 and 79 years.  The cohort consisted of 5502 participants, approximately equally divided between African American, Hispanic, and Caucasian individuals.   A substantial proportion of the originally recruited cohort was followed-up.

The investigators conducted a two-hour, in-home, bilingual field interview of all eligible participants, in which they examined symptoms and asked questions about lifestyle, physical activity, alcohol use, nutrition, demographics, and morbidity. They also conducted a detailed inventory of medications, both prescribed and over-the-counter, and took two non-fasting blood samples for hormone, cholesterol, and lipid levels. While the initial BACH study focused on urologic symptoms and conditions as its main outcomes of interest, two follow-up and a number of sub-studies were subsequently initiated on the BACH cohort with a focus on other health conditions in addition to urologic symptoms.

The BACH study contributed greatly to knowledge of the prevalence of urologic conditions, which was shown to be greater than previously estimated. The study succeeded in creating a large, racially-diverse sample to provide cross sectional, longitudinal data to explore urologic questions. This data has been used by researchers to identify gender, racial/ethnic, and socioeconomic disparities in a number of health conditions and is available for future studies.
DOI: 10.58020/6gqa-cn96
title: Careful Urinary Tract Infection Evaluation

description: Urinary tract infections (UTIs) are the most common serious bacterial infections in young children. When accompanied by a fever, there is an increased likelihood of a UTI also infecting the kidneys; between 15 and 52% of these children will develop kidney scarring as a result.

The Careful Urinary Tract Infection Evaluation (CUTIE) study is an observational study designed to determine why some children develop kidney scars after UTIs. Ultimately, the study was aimed at understanding which children are at the greatest risk of developing renal scarring following a UTI, so physicians can provide targeted therapies and appropriate interventions. Children between 2 months and 6 years of age who had a first or second UTI in the past 4 months were eligible for enrollment in the study. Participants were followed for 2 years through the course of five study visits, during which they were required to undergo a physical exam and provide information about recent medical history and quality of life via a questionnaire completed by parents. Additionally, blood and urine biospecimens were collected to monitor kidney function, and renal scans were performed to assess the development of kidney damage.
 
The CUTIE study is ancillary to the RIVUR (Randomized Intervention for Children with Vesicoureteral Reflux) study, which compared antibiotic prophylaxis to placebo in a cohort of children with a history of UTI and vesicoureteral reflux.  The CUTIE study focused specifically on children with a history of UTI who did not have vesicoureteral reflux. More information about the RIVUR study is available on the NIDDK repository website.
DOI: 10.58020/801k-fj90
title: Chronic Prostatitis Collaborative Research Network Clinical Trial- Alfuzosin

description: The second phase of the Chronic Prostatitis Collaborative Research Network (CPCRN chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) was established to conducted randomized clinical trials of promising therapies for this syndrome. In men with CP/CPPS , treatment with alpha-adrenergic receptor blockers early in the course of the disorder has been reported to be effective in some, but not all, relatively small randomized trials. In response to the findings of these previous trials, the CPCRN conducted a multicenter, randomized, placebo-controlled trial of alfuzosin to determine whether the symptoms CP/CPPS could be reduced in men who had recently received a diagnosis of CP/CPPS and who had not previously been treated with this class of drug.

Men with CP/CPPS were enrolled at 11 recruitment centers and randomly assigned in a 1:1 ratio to receive either 10 mg of alfuzosin or placebo once daily for 12 weeks. The trial was double-blind.  There were four research-clinic visits during which data for the primary and secondary outcome measures were collected. The primary outcome measure was a decrease (improvement) in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) of at least 4 points from baseline to 12 weeks, which is the minimal clinically significant difference in the score. Secondary outcome measures included evaluations of pain, urinary urgency, medical outcomes, mental health, and erectile dysfunction. Adverse events associated with treatment was assessed for each subject both overall and within each body system. 

Results showed no difference between the placebo and the alfuzosin groups in the proportion of men with in an improvement of the NIH-CPSI score and a clinically meaningful reduction of symptoms. Similarly, there was no significant difference between the alfuzosin and placebo groups in multiple secondary outcomes, including the results of the global response assessment and measures of quality of life, depression, sexual function, and pain. These findings do not support the use of alfuzosin to reduce the symptoms of CP/CPPS in men who have not received prior treatment with an alpha-blocker.
DOI: 10.58020/g34k-9585
title: Chronic Prostatitis Collaborative Research Network Clinical Trial- Ciprofloxacin and  Tamsulosin

description: The Chronic Prostatitis Collaborative Research Network (CPCRN), which consists of six clinical centers and one data coordinating center, was established to study all aspects of chronic prostatitis with the hope of improving diagnosis and treatment. Because the cause of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is unknown, affected men receive many empirical therapies. The two most common treatments prescribed by physicians are antimicrobial agents (including quinolones such as ciprofloxacin) and α-adrenergic receptor antagonists (such as tamsulosin), although there is little objective evidence to support their use. Based on these common clinical practices, the CPCRN conducted a randomized, two-by-two factorial design double-bind, clinical trial (CPCRN RCT#1) to evaluate whether ciprofloxacin or tamsulosin reduces symptoms of long-standing CP/CPPS of at least moderate severity. 

Men with CP/CPPS from 11 clinical centers were enrolled and randomly assigned in equal proportions to receive placebo; ciprofloxacin alone, 500 mg twice daily; tamsulosin alone, 0.4 mg once daily; or a combination of both drugs. Patients were treated for 6 weeks, at which time the primary endpoint was assessed. Symptoms at 9 and 12 weeks after randomization (3 and 6 weeks after completion of treatment) were also assessed to evaluate longer-term treatment response. The primary outcome measure was the change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score from baseline to 6 weeks. Secondary outcome meaures included changes in the pain, voiding, and quality-of-life subscales of the NIH-CPSI; physical and mental summary scores on the Medical Outcomes Study 12-Item Short-Form Health Survey; and a 7-point patient-reported global response assessment. All adverse events were monitored and analyzed.

The study found that neither ciprofloxacin nor tamsulosin significantly reduced the NIH-CPSI total score over 6 weeks compared with placebo. Moreover, neither treatment showed a significant benefit among a wide range of secondary outcomes related to symptoms and quality of life. Findings do not support the use of these agents as empirical therapy for men with long-standing CP/CPPS and at least moderate symptoms.
DOI: 10.58020/hamh-fh56
title: Chronic Prostatitis Collaborative Research Network Clinical Trial- Pregabalin

description: The Chronic Prostatitis Collaborative Research Network (CPCRN) was established to conduct randomized controlled clinical trials of promising therapies for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in order to treatment of this syndrome. While the pathogenesis of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is not known, there is some evidence to suggest that the urogenital pain of CP/CPPS may be neuropathic. The CPCRN conducted a randomized clinical trial to investigate whether a drug found to be effective for treating neuropathic pain, pregabalin, could be beneficial in treating the symptoms of CP/CPPS. 

Men with CP/CPPS form 10 clinical centers were enrolled and randomly assigned 2:1 in each clinical site to receive treatment with either pregabalin or matching placebo (the trial was double-blind). Treatment was for six weeks.  Dose was escalated from 150 mg/d (50 mg orally 3 times daily) for 2 weeks, to 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then to 600 mg/d (200 mg orally 3 times daily) for 2 weeks; participants in the placebo group underwent a similar dose escalation. The primary outcome measure was a decrease (improvement) in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 6 points from baseline to week 6. Several secondary outcome measures were assessed, including the subscores of the NIH-CPSI, the Global Response Assessment (a self-reported assessment that measures perception of change in symptoms), the Medical Outcomes Study 12-Item Short Form Health Survey, the Hospital Anxiety and Depression Scale, and the Sexual Health Inventory for Men. 

The study found no a clinically significant (6-point) decrease in the NIH-CPSI in men treated with pregabalin compared to those assigned to placebo.
DOI: 10.58020/4tmh-xc10
title: Clinical Outcomes Research Initiative

description: The Clinical Outcomes Research Initiative (CORI) was established in 1995 under the American Society for Gastrointestinal Endoscopy (ASGE) to study outcomes of gastrointestinal (GI) endoscopic procedures in clinical settings. Physicians participating in the CORI consortium produce GI endoscopy reports using an electronic health record developed specially for the project. CORI practice sites include hospitals, ambulatory care centers, private practices, universities, and Veteran's hospitals. The practice data are stripped of most patient and physician identifiers before transmitting to a central data repository, where they are tested for completeness and accuracy. Data from all participating practices are merged and stored in the National Endoscopic Database (NED).

Data from the NED has been analyzed to examine endoscopic practice patterns, including endoscopic utilization, frequency and severity of endoscopic findings, and endoscopic treatment and medical management. The data also serve as a resource to develop research hypotheses and to support quality measure reporting.  CORI data has already been utilized to support many research initiatives, many of which have resulted in publications in medical journals and presentations at GI conferences. 

In addition to availability in through the CORI consortium, the data collected in the NED since 2000 is been contributed to the NIDDK Repository and is available for request through the NIDDK Repository site. 

The current data package contains data from the v3 warehouse from 2000 through 2010.
DOI: 10.58020/zv2g-cy49
title: Comprehensive Dialysis Study

description: The Comprehensive Dialysis Study (CDS) is a special data collection study in which physical activity, health-related quality of life, and work/disability data were requested from patients identified as initiating maintenance dialysis during 2005 to 2007. The CDS study aimed to understand factors contributing to physical, functional, and nutritional health status among patients starting dialysis. The study was coordinated in part by the United States Renal Data System (USRDS), which maintains an extensive database that facilitates biomedical and economic research on end-stage renal disease (ESRD) in the U.S. population. In a subset of participants, dietary intake and nutritional status were also evaluated. The study represents one of few cohorts in which laboratory proxies of nutrition and inflammatory status were measured simultaneously. The study successfully gathered information and samples from participants and generated baseline characteristics for patients undergoing maintenance dialysis. Information reported by CDS participants was linked with patient-specific modality history, mortality, hospitalization, and cost information in USRDS files.
DOI: 10.58020/j1jk-ct53
title: Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis

description: For diabetics with gastroparesis, unpredictable gastric emptying rates and uncertainties in nutrient absorption can lead to difficulties in managing glycemia. The utility of continuous glucose monitoring (CGM), which quantifies real time glucose excursions, in planning periprandial insulin dosing for diabetic patients with gastroparesis has not been explored. The Safety, Feasibility, and Potential Efficacy of Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG) study is a multicenter, uncontrolled clinical trial that was established by the Gastroparesis Clinical Research Consortium (GpCRC) to assess the safety and utility of CGM in guiding insulin pump therapy in patients with type 1 and type 2 diabetes and gastroparesis. 

Individuals with symptoms of gastroparesis, a Gastroparesis Cardinal Symptom Index (GCSI) score of 18, and diabetes for at least 2 years are enrolled in the study. Participants are treated using a combination of CGM and insulin pump therapy. The primary outcome measure, the frequency of mild and moderate (glucose level < 70 mg/dL) and severe hypoglycemic episodes while undergoing therapy, is assessed at 12 and 24-week follow-up visits. CGM data are related to finger stick levels and HbA1c values to test comparability of CGM and finger stick values. The efficacy of CGM-guided insulin pump therapy on symptoms of gastroparesis, quality of life, satiety, gastric myoelectrical activity, and autonomic function are also evaluated as a secondary outcome measures.
DOI: 10.58020/9g61-6226
title: Cure Glomerulonephropathy

description: Glomerular diseases are chronic diseases that cause damage to the filters, glomeruli, in the kidneys. Damaged glomeruli allow red blood cells and protein to leak into the urine, cause waste products to build up in the blood, and can lead to kidney failure. Glomerular diseases affect individuals of all ages and tend to progress slowly in many patients. Due to lengthy follow-up periods and challenges with patient recruitment, previous efforts to study glomerular diseases have been difficult.


Cure Glomerulonephropathy Network (CureGN) is a multi-center consortium that seeks to establish an infrastructure for the advancement of glomerular disease studies. CureGN recruits and maintains a large and diverse population of glomerular disease patients. The study established a database of patients diagnosed with the following conditions: minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), membranous nephropathy (MN), and immunoglobulin A nephropathy (IgAN). 

Currently, data from one analysis dataset is available for request.
DOI: 10.58020/637v-9r95
title: Cysteamine Bitartrate Delayed-Release for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Children

description: The CyNCh (Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children) study is a prospective, multicenter, double-blind clinical trial designed by the NASH Clinical Research Network to determine whether treatment with cysteamine improves disease severity in children diagnosed with NAFLD.  Children between the ages of 8 and 17 years with biopsy-confirmed moderate to severe NAFLD were eligible for the CyNCh study. Participants were enrolled and randomized to treatment with either delayed-release cysteamine bitartrate capsules or placebo capsules. Improvement in NAFLD at 52 weeks, defined as a decrease in NAFLD Activity Score (NAS) of at least 2 and no worsening of fibrosis, was assessed as the primary outcome measure. Secondary outcome measures, assessed at 52 weeks, included reduction in serum aminotransferase and gamma-glytamyl transpeptidase, reduction in MRI-determined hepatic fat fraction, changes in markers of oxidation and anti-oxidant status, changes in histology and symptoms, and self-reported quality of life.
DOI: 10.58020/brsr-hp55
title: Diabetes Autoimmunity Study in the Young

description: Children determined to be at an increased risk for development of type 1 diabetes (T1D), either due to known genetic markers or due to family history of T1D, are followed from birth and monitored on an annual basis for development of T1D-related autoimmunity. At annual clinic visits, participants are tested for development of these autoantibodies and data are collected related to environmental exposures. In addition to blood collection for determination of autoantibodies, serum and plasma are frozen and stored for future analyses, along with other biological samples such as throat swabs, rectal swabs, saliva, and urine. If T1D-related autoantibodies are detected, the participant is asked to increase the frequency of clinic visits to 2-4 visits per year in order to monitor for the onset of disease more closely. The endpoint of the study is diagnosis of T1D per the American Diabetes Association (ADA) criteria.