cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.58020/6y8c-jz44
title: Folic Acid for Vascular Outcome Reduction in Transplantation Trial

description: The Folic Acid for Vascular Outcome Reduction in Transplantation Trial (FAVORIT) investigated if lowering homocysteine levels in renal transplant recipients with a multivitamin reduced the occurrence of cardiovascular disease (CVD) outcomes. In response to observational studies of patients with chronic kidney disease that suggested increased homocysteine is a risk factor for CVD, the study hypothesized that treatment with a high dose combination of folic acid, vitamin B6, and vitamin B12 would reduce the rate of pooled arteriosclerotic CVD outcomes among renal transplant recipients relative to treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement amounts of vitamin B6, vitamin B12. Stable kidney transplant recipients were randomized in a double-blind controlled trial to a multivitamin that included either a high dose or low-dose of folic acid, vitamin B6, and vitamin B12. Events such as recurrent or de novo arteriosclerotic CVD, renal graft failure, mortality, and creatinine-based estimates of renal function were monitored as outcome measures. The study found that treatment with a high-dose folic acid, B6, and B12 multivitamin in kidney transplant recipients did not significantly reduce a composite cardiovascular disease outcome, all-cause mortality, or dialysis-dependent kidney failure despite significant reduction in homocysteine level.  The trial was double-blind.

Additional stability testing was also conducted on a subset of serum and urine samples where fructosamine, glycolated albumin, and uromodulin levels were assessed after multiple freeze-thaw cycles.
DOI: 10.58020/4n3d-cq71
title: FONT 2 Study: Novel Therapies for Resistant FSGS Phase II Clinical Trials

description: Standard treatment for primary focal segmental glomerulosclerosis (FSGS) includes administration of corticosteroids and immunosuppressive therapy, with the goals of achieving complete remission of proteinuria and preservation of renal function.  When standard treatments fail to induce remission, a number of agents are used as renoprotective therapy to delay progression of chronic kidney disease (CKD) to end stage renal disease (ESRD); however, there is a need for the development of new therapies that are safe and effective for patients with FSGS, particularly those for whom standard therapy fails. The Novel Therapies for Resistant FSGS (FONT II) trial was a randomized, multicenter Phase I/II clinical trial designed to investigate the potential efficacy of novel therapies for resistant FSGS. Two different therapies, adalimumab (a human anti-TNF-α antibody) and galactose, were evaluated against standard conservative therapy for resistant FSGS, which consists of the combination of lisinopril, losartan, and atorvastatin. Additional aims of the study included identification of one or more novel agents as candidates for evaluation in a future Phase III trial and creation of an infrastructure for the timely completion of clinical trials in patients with rare glomerular diseases such as FSGS. 

Individuals with primary FSGS confirmed by renal biopsy who failed to respond to prior immunosuppressive therapy were eligible for the study. Participants were required to complete a run-in period in which they were taken off all immunosuppressive medications, including corticosteroids, for 30 days. Participants who achieved an estimated GFR ≥ 30 mL/min/1.73 m2 at the end of the run-in period were randomized to treatment with adalimumab, galactose, or standard conservative therapy. The primary outcome measure, evaluated at 6 months, was a composite of two end points, a reduction of proteinuria by 50% from the baseline value and an estimated GFR (eGFR) that was either ≥ 75% of the value at time of randomization or that was persistently ≥ 75 mL/min/1.73 m2 in those whose renal function was ≥ 75 mL/min/1.73 m2. Adverse effect profile, patient satisfaction score using the TSQM questionnaire, percent change in proteinuria (evaluated as a continuous variable) and change in or time to doubling of eGFR were also assessed as secondary outcome measures.
DOI: 10.58020/bx72-p494
title: Frequent Hemodialysis Network Daily Trial

description: The FHN Daily Trial was a randomized controlled trial which recruited subjects from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 1 year. Subjects were randomized to either conventional hemodialysis delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week (120 patients), or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week (125 patients). The study had 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.

Note: The available data do not contain digital raw ECG recordings. Please review the Data Dictionary for a listing of available datasets and variables.
DOI: 10.58020/prfs-az64
title: Frequent Hemodialysis Network: Nocturnal Study

description: Prior observational studies have shown multiple benefits of both frequent hemodialysis (HD) and frequent nocturnal HD compared to conventional three times per week treatments for patients with end-stage renal disease (ESRD). To test these hypotheses, the Frequent Hemodialysis Network (FHN) Trials Group conducted two multicenter randomized trials to compare conventional tree times weekly HD with (1) in-center daily and (2) home nocturnal HD. Specifically, the FHN Nocturnal trial was designed to assess the effects of frequent nocturnal home HD six times per week compared with conventional three times per week HD.

Participants with ESRD requiring maintenance dialysis were recruited from 19 clinical centers. A total of 87 subjects were enrolled, underwent baseline assessment, and were randomized to treatment, either to three times per week conventional HD or to nocturnal HD six times per week, all with single-use high-flux dialyzers. Participants were followed for 14 months. The composite of mortality with change in (1) left ventricular mass index (LVMI) by magnetic resonance imaging (MRI), and (2) SF-36 RAND Physical Health Composite (PHC) were used as co-primary outcomes to assess the efficacy of treatment.  Secondary outcomes included cognitive performance, self-reported depression, laboratory markers of nutrition, mineral metabolism and anemia, blood pressure and rates of hospitalization, and vascular access interventions.

The FHN Nocturnal trial found no significant effect of nocturnal hemodialysis for either of the two co-primary outcomes. Results showed that patients in the nocturnal arm had improved control of hyperphosphatemia and hypertension, but there was no significant benefit to frequent nocturnal hemodialysis among the other main secondary outcomes. While the nocturnal study was unable to demonstrate a definitive benefit of more frequent nocturnal hemodialysis for either co-primary outcome, these results differ from the FHN Daily Trial, which showed a statistically significant benefit of more frequent hemodialysis for both co-primary outcomes.
The primary objective of the FHN Nocturnal trial was to compare the effects of conventional (three times per week) and frequent (six times per week) hemodialysis treatment for patients with ESRD, specifically to assess the safety, efficacy, and cost-effectiveness of the two treatments.
DOI: 10.58020/98dv-gq66
title: Functional Dyspepsia Treatment Trial

description: Functional dyspepsia (FD) is a common problem affecting up to 10-25% of individuals, and accounts for significant health care costs and affects quality of life. Currently there is no definitive treatment for FD, though antidepressants are used in the treatment of FD, but are considered unsatisfactory.  The Functional Dyspepsia Treatment Trial (FDTT) aims to test whether treatment with an antidepressant (amitriptyline or escitalopram) leads to improvement of symptoms in patients with moderate to severe FD.
DOI: 10.58020/na8s-5602
title: Gastroparesis Registry

description: Gastroparesis, a syndrome in which patients experience delayed gastric emptying, is characterized by symptoms such as nausea, vomiting, bloating, abdominal pain, and early satiety. While gastroparesis can present as a complication of diabetes and gastric surgery, the underlying cause is unknown in many cases. Despite the significant morbidity of the condition, research and characterization of the clinical features of gastroparesis are limited, hindered by challenges such as single centers and small study populations. The Gastroparesis Registry is an observational study created by the Gastroparesis Clinical Research Consortium (GpCRC) to enroll a sufficiently large number of patients to elucidate the etiology and clinical features of the condition. 

Individuals with symptoms of gastroparesis of at least 12 weeks duration, delayed gastric emptying on scintigraphy, and no abnormality causing obstruction on upper endoscopy were enrolled. Data was collected on medical history, physical examinations, upper endoscopy results, and 4 hour gastric emptying scintigraphy results. Symptoms of gastroparesis and psychological functioning were assessed using patient-completed questionnaires, including the Patient Assessment of Upper Gastrointestinal Disorders Symptoms Severity Index (PAGI-SYM), the Beck Depression Inventory (BDI), and the State-Trait Anxiety Inventory (STAI). Laboratory tests were obtained to measure complete blood count with erythrocyte sedimentation rate (ESR) and C reactive protein (CRP).

Analyses were done to examine such baseline characteristics as demographics, lifestyle, co-morbidities, laboratory values, psychological evaluation test scores, gastroparesis-specific medical history, gastric emptying scintigraphy results, and symptom severity among all patients and among various patient sub-groups. Comparisons were also done to evaluate the similarities and differences of the diabetic and idiopathic presentations of gastroparesis. Results showed that IG is a diverse syndrome that varies by sex, body mass, symptom onset, and delay in gastric emptying. Following conclusion of the GpR study, a follow-up study was initiated to expand the registry (GpR 2).
DOI: 10.58020/fg9w-2023
title: Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma

description: Previous studies have shown an aggregation of Barrett’s esophagus (BE) and esophageal adenocarcinoma (EAC) (including esophagastric junctional adenocarcinoma [EGJAC]) in families, a syndrome that has been termed Familial Barrett’s esophagus (FBE). This aggregation, which suggests a biological relationship between BE and EAC, may be caused by common environmental exposures in family members, a genetic predisposition to disease, or both. For complex diseases such as BE and cancer, genetic influences may be more evident in pedigrees that have 3 or more affecteds. Thus, the Familial Barrett’s Esophagus study was established by the Familial Barrett’s Esophagus Consortium (FBEC) to determine whether cancers develop at an earlier age in multiplex Familial Barrett’s Esophagus (FBE) kindreds, defined as 3 or more members affected by Barrett’s esophagus (BE) or esophageal adenocarcinoma (EAC). Ultimately, the study aims to identify putative susceptibility genes for BE and its associated cancers. 

 Individuals with BE, EAC, or EGJAC were recruited at 8 academic care centers participating in the FBEC. After providing informed consent, participants were enrolled and given a self-administered FBE questionnaire. Information was collected on gastroesophageal reflux symptoms; risk factors such as age, gender, race, and self-reported obesity measures; and family history of BE, EAC, stomach and throat cancer (which may be incorrect ways of reporting esophageal cancer). Probands, defined as the first known affected member in a family, had the opportunity to discuss and clarify family history with their relatives before mailing back the questionnaire. Pedigrees were constructed from the questionnaire.  Differences in the age of diagnosis and other variables of interest, such as gender, obesity, race, acid regurgitation, heartburn, smoking and alcohol consumption, were assessed between the three family groups (non-familial, duplex and multiplex). Only probands and kindreds with a confirmed diagnosis were included in the analysis.

The study found that EAC is diagnosed at a significantly earlier age in multiplex FBE kindreds when compared to duplex and non-familial kindreds. Findings suggest that individuals who are members of multiplex FBE pedigree may be considered for screening at an earlier age than the general population. Following that earlier age of disease onset is considered an indicator of genetic susceptibility to disease, these results support a genetic basis for FBE. Future investigations into the genetic basis of FBE are needed and should focus on FBE kindreds with 3 or more members affected with defined BE and EAC phenotypes.
DOI: 10.58020/yn29-2g56
title: Hemodialysis Fistula Maturation Consortium

description: In patients undergoing hemodialysis for end-stage renal disease, a large number of fistulas fail to mature adequately to support the hemodialysis blood circuit and cannot be used for dialysis. Currently, hemodialysis access using fistulas is hindered by a lack of predictors of and therapies for arteriovenous fistula (AVF) failure.  The Hemodialysis Fistula Maturation Study was a prospective, multicenter observational study that was established by the Hemodialysis Fistula Maturation Consortium (HFMC) to identify the clinical and biological factors associated with AVF maturation outcomes. The primary objectives of the study included improving prediction of AVF maturation and exploring the mechanism of AVF failure by examining the relationship between clinical usability and anatomy, biology, clinical attributes, and processes of care.

The study enrolled patients nearing or with end-stage renal disease who are undergoing AVF creation for hemodialysis. Data were collected pre-operatively, peri-operatively, and post-operatively. Medical history, demographics, and physical examination information were collected prior to surgery at baseline. Participants undergone preoperative ultrasound arterial and venous mapping, flow-mediated and nitroglycerin-mediated brachial artery dilation, arterial pulse wave velocity, and venous distensibility; additionally, ultrasounds will be administered at 1 day, 2 weeks, 6 weeks, and prior to fistula intervention and initial cannulation. Information were collected peri-operatively on surgical personnel, surgical procedures, and clinical observations. Outcome data on AVF usability and other dialysis-related data were collected post-operatively. In addition to these measurements, tissue and blood specimens were collected for analyses of histology, morphometry, immunohistochemistry, and gene expression.
DOI: 10.58020/fmgh-4d37
title: Hemodialysis Study

description: The Hemodialysis (HEMO) Study was a multi-center, randomized clinical trial designed to test whether the mortality and morbidity of hemodialysis (HD) patients can be reduced by modifying the dialysis procedure for the removal of toxins from the blood. The study examined two factors, the dose of dialysis delivered and the size of the molecules removed, to determine the effect on the survival or morbidity among hemodialysis patients. A two-by-two factorial design was used to assign 1846 patients randomly to either a standard or high dose of dialysis and to either a dialyzer with a low-flux or high-flux membrane for dialysis three times a week. The primary outcome, death from any cause, was not significantly influenced by the dose or flux assignment. The relative risk of death was not significantly different in the high-dose group compared to the standard-dose group, or the high-flux group as compared with the low-flux group. The main secondary outcomes, including first hospitalization, did not differ significantly for either the dose groups or the flux groups. Patients undergoing hemodialysis three times a week appear to have no major benefit from either a higher dialysis dose than that recommended by current U.S. guidelines or from the use of a high-flux membrane.
DOI: 10.58020/4wma-qa41
title: Hepatitis B Research Network Adult Cohort Study

description: Hepatitis B, a significant cause of cirrhosis and hepatocellular carcinoma worldwide, affects an estimated 800,000 to 1.4 million people in the United States. While progress has been made in the prevention, diagnosis, and treatment of chronic hepatitis B, challenges remain in identifying persons affected by the virus and in determining recommendations for management and treatment. The Hepatitis B Research Network (HBRN) is a multicenter network that was established by the NIDDK to investigate the etiology and progression of the disease and to test the safety and efficacy of current treatment approaches. The HBRN Adult Cohort Study (HBRN Cohort A), one of many studies conducted by the HBRN, was designed to describe participants with hepatitis B virus (HBV) infection and identify predictors of disease activation and progression. The relationship of HBV genotype to clinical, biochemical, and histological characteristics and to pregnancy is also explored.  

Individuals of at least 18 years of age who are hepatitis B surface antigen (HBsAg) positive are enrolled in the HBRN Adult Cohort study. Baseline data is collected on demographics, medical history, family history of liver disease, and health behaviors. Participants are categorized into various phases of HBeAg-positive and HBeAg-negative HBV infection and stages of HBV disease for monitoring of changes in HBV infection status and quantitative HBsAg levels. The rate of various clinical outcomes—including hepatitis exacerbation marked by alanine aminotransferase (ALT) flare, antigen loss of HBsAg or HBeAg, cirrhosis, development of hepative decompensation, heptaocellular carcinoma (HCC), death, and liver transplantation—and the factors associated with these outcomes are assessed as primary outcome measures, evaluated at up to 288 weeks. Analyses will be done to determine whether a baseline HBsAg below 1,000 IU/mL and HBV DNA below 1,000 IU/mL are accurate predictors of people who are, or who will become, inactive carriers (defined as people who are HBsAg positive, HBeAg negative, have normal ALT and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months with HBV DNA under 1,000 IU/mL). Additionally, biospecimens are collected from participants to create a repository of resources for future studies.

Currently, only data from the baseline visit are available for request.
DOI: 10.58020/1yer-mr66
title: Hepatitis B Research Network Pediatric Cohort Study

description: will become, inactive carriers (defined as people who are HBsAg positive, HBeAg negative, and have normal ALT and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months with HBV DNA under 1,000 IU/mL). Additionally, biospecimens are collected from participants to create a repository of resources for future studies.

This study is ongoing.


Currently, only data from the baseline visit are available for request.
DOI: 10.58020/92hk-qq44
title: Hyperglycemia and Adverse Pregnancy Outcome Follow-Up Study

description: While diabetes during pregnancy is associated with a significant risk of adverse perinatal outcomes, there is no consensus on the risks of adverse outcomes resulting from abnormal glucose levels below the established threshold for gestational diabetes. In response to this controversy, the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study was established to clarify unanswered questions concerning the association of glucose with risks of adverse pregnancy outcomes.

The prospective, observational HAPO Study enrolled 23,316 pregnant women who had no prior diagnosis of diabetes during or antedating pregnancy. Participants underwent a standard 75 g 2-hour oral glucose tolerance test (OGTT) between 24 and 32 weeks’ gestation. Neonatal anthropometrics were obtained following delivery, and follow-up data, including hospital readmissions, were collected at 4-6 weeks post-delivery. The primary outcome measures assessed in relation to maternal glycemia included primary cesarean delivery, increased birthweight (defined as > 90th percentile for gestational age), neonatal hypoglycemia, and fetal hyperinsulinism. The study found that increased maternal glycemia was associated with both birthweight and cord serum C-peptide > 90th percentile. Greater maternal glucose levels were also associated with increased risk of primary cesarean delivery and clinical neonatal hypoglycemia.

Subsequent to the conclusion of the HAPO Study, a follow-up study (HAPO-FUS) was initiated to determine whether elevated blood sugar during pregnancy, below the threshold for gestational diabetes, influences either development of type 2 diabetes mellitus in mothers or adiposity and disorders of glucose metabolism in offspring at 8-12 years of age. The HAPO Follow-Up Study enrolled 4800 mother-child pairs who originally participated in the HAPO Study. Mothers and children were required to undergo a single study visit for measurement of height, weight, blood pressure, body fat, insulin, and blood sugar and lipid levels. The primary outcome measures assessed in relation to maternal glycemia during pregnancy included development of diabetes in mothers, and obesity and altered glucose metabolism in children, as well as other metabolic abnormalities in both mothers and offspring.
DOI: 10.58020/1khv-nq41
title: Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus

description: The TrialNet (TN20) study was a two-arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).

Participants were from the TrialNet Natural History/Pathway to Prevention (TN01) study, had a relative with T1D, and were positive for insulin autoantibodies and at least one other autoantibody. All participants received an active treatment of recombinant insulin in capsules of either 67.5 mg daily or 500 mg every other week. Participants visited the study site up to 11 times over one year for blood tests and other study procedures. During the beginning treatment phase, there were two visits one month apart for those given the 67.5 mg dose, and three visits two weeks apart to titrate the dose for those in the 500 mg treatment group. There were three additional treatment visits at months 2, 3, and 6, as well as four additional visits for follow-up at months 7, 8, 9, and 12. The primary outcome was the change in immune function as assessed by change in level or quality of T-lymphocyte or autoantibody biomarkers measured between 13 and 26 weeks compared to the baseline.
DOI: 10.58020/t40h-p748
title: Inflammatory Bowel Disease Genetics

description: The NIDDK Inflammatory Bowel Disease Genetics Consortium (IBDGC) and cell line repository was created in 2002 by the National Institute of Diabetes, Digestive and Kidney diseases (NIDDK) to advance knowledge on the inflammatory bowel diseases, specifically Crohn’s Disease and Ulcerative Colitis. The Consortium consists of six genetic research centers (GRC) and a data coordinating center (DCC) that prospectively recruits a combination of cases, controls, and trios to gather a large collection of samples and linked phenotype information. Phenotyping is performed using a standardized protocol, and lymphoblastoid cell lines are established for each subject. The resulting DNA samples are used to conduct genetic linkage and association studies. The IBDGC is involved with independent genetic research studies and actively works with members of the IBD and genetic communities on collaborative projects.