cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.58020/4nz9-tq14
title: A Cohort Study to Investigate the Value of Exercise in ESRD/Analyses Designed to Investigate the Paradox of Obesity and Survival in ESRD

description: Characteristics associated with the phenotype of frailty include fatigue and reduced physiologic capacity in neurologic control, mechanical performance, and energy metabolism. Studies have shown that there is an increased risk of frailty in chronic disease populations, including patients with chronic kidney disease undergoing hemodialysis. Currently, little is known about the prevalence or the contributing factors of frailty among patients with this condition. The ACTIVE/ADIPOSE (a Cohort Study to Investigate the Value of Exercise in ESRD/Analyses Designed to Investigate the Paradox of Obesity and Survival in ESRD) study is a prospective, multicenter observational study designed to characterize the prevalence and progression of frailty among patients undergoing hemodialysis for end-stage renal disease (ESRD). 

Patients at least 18 years of age who were on hemodialysis for at least three months were enrolled in the study. Participants were assessed using the validated Fried frailty index, which defines frailty as the presence of 3 or more criteria, including recent unintentional weight loss, reported exhaustion, low grip strength, slow walk speed, and low physical activity. Information was collected on participants’ demographics, medical history, activity status, and mood, and physical performance was assessed via tests of grip strength, walk speed, and body composition. Additionally, blood draws were conducted semi-annually for evaluation of nutrition, inflammation, and cardiac markers. All participants were followed for two years. Logistic regression models were used to estimate the association of nutrition, cardiovascular, and rehabilitation parameters with patient frailty. 

Analyses showed that peripheral vascular disease and cardiac diseases, such as dysrhythmia, atrial fibrillation, tachycardia, pericarditis, and cardiac arrest, were associated with higher odds for frailty. In contrast, black race and higher serum albumin concentration were associated with lower odds for frailty. Among patients who met the Fried definition of frailty, 78% scored as frail on walk speed and 56% scored as frail on grip strength, the two measures of physical performance. The association of these sociodemographic and clinical risk factors with wasting in this cohort provides evidence for the prevalence of frailty in hemodialysis patients.
DOI: 10.58020/9n48-q075
title: Acute Liver Failure Study Group: Adult Acute Liver Failure Study

description: Acute liver failure (ALF) affects about 2,000 persons per year in the U.S. Patients with ALF show severe and sometimes devastating disease presentations and require extensive care and resources. Liver transplant is often necessitated as treatment. The Acute Liver Failure Study Group (ALFSG) was established in 1997 to develop a consortium of investigators and clinical centers that could consolidate data and biospecimens for observational and clinical trials concerning ALF.

A Multi-Center Trial to Study Acute Liver Failure in Adults (AALF) is a prospective cohort study currently being conducted by the ALFSG. The study is designed to collect clinical and epidemiological data as well as serum, plasma, urine, tissue and DNA samples on individuals who have ALF and on individuals who have acute liver injury (ALI), a less severe group of patients who have coagulopathy but do not reach the threshold of encephalopathy. Patients with either ALF or ALI who meet the eligibility criteria are enrolled and referred to ALFSG clinical sites by providers. Information concerning clinical history and physical findings, hospital course, and short- and long-term outcomes are collected for all participants who consent to participate in the study.  Patients are followed long-term at 6 and 12 months. Overall survival and outcome data will be assessed to contribute to the understanding of these conditions. Currently, the bioreposity contains more than 75,000 specimens for over 2,000 patients. 

This study is ongoing.
DOI: 10.58020/9y3c-s862
title: Acute Renal Failure Trial Network

description: Acute kidney injury is a common complication of acute illness, affecting approximately 2 to 7% of hospitalized patients and more than 35% of critically ill patients. While renal-replacement therapy is the main treatment method for patients with acute kidney injury, the optimal timing for the initiation, method, and dosing of therapy is uncertain. Given this uncertainty, 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. Participants were randomized to receive intensive (i.e., intermittent hemodialysis and sustained low-efficiency dialysis six times per week and continuous venovenous hemodiafiltration at 35 ml/kg of body weight/hour) or less intensive renal-replacement therapy (i.e., the corresponding treatments were provided three times per week and at 20 ml/kg/hour). The assigned renal-replacement therapy was provided for up to 28 days after randomization or until recovery of kidney function, discharge from acute care, withdrawal of life-sustaining therapy, or death. The primary outcome measure was death from any cause by day 60. Recovery of kidney function (defined as lack of need for continuing dialysis support, with a minimum creatinine clearance of 20 ml/minute), duration of renal-replacement therapy, lengths of stay in the intensive care unit (ICU) and hospital, and days free of nonrenal organ failure were also assessed. 

Results showed that the primary outcome measure, death from any cause by day 60, did not differ between the two groups. Additionally, recovery of renal function and reduction in the rate of nonrenal organ showed no improvement with intensive renal support. The study found no added benefit from an intensive (high-dose) treatment strategy as compared with the more conventional, less-intensive treatment strategy.
DOI: 10.58020/f87q-jn46
title: Adolescent Bariatrics: Assessing Health Benefits & Risks

description: Teen-LABS proposes that bariatric surgery is more beneficial to extremely obese patients when it’s done during the adolescent years instead of adulthood. By using duration of obesity as the moderating variable, the Teen-LABS study will estimate the risks and benefits of bariatric surgery among adolescent patients in comparison with adult patients. At least 200 adolescent bariatric patients will be recruited from four centers and undergo gastric bypass surgery between 2007 and 2012. Post-surgery data and biospecimens will be obtained at pre-determined points during a 24 month period. The assessments of the Teen-LABS subjects will be compared with similar data from the adult subjects of the LABS study. 

The current data package contains data through Year 4.
DOI: 10.58020/7wvm-dg50
title: African American Study of Kidney Disease and Hypertension Cohort Study

description: 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 overall objective of the AASK Cohort Study was to determine prospectively the long-term course of kidney function and risk factors for chronic kidney disease (CKD) progression in African-Americans with hypertension-related CKD receiving antihypertensive therapy and a low blood pressure goal. A secondary objective was to determine the occurrence of cardiovascular disease and assess its risk factors in the setting of hypertension-related CKD.

Of the 1,094 randomized participants of the AASK Trial, 691 individuals who had not yet reached end-stage renal disease (ESRD) enrolled in the AASK Cohort study. Antihypertensive therapy in the cohort study was largely based on AASK trial phase results and prevailing recommendations. Ramipril, a renin-angiotensin system (RAAS)-blocker, was first-line therapy; if ramipril was not tolerated, an angiotensin receptor blocker (ARB) was used. Additional drugs were added as needed if the BP goal of <130/80 mm Hg was not achieved with ramipril. The primary renal outcome measure was a composite clinical outcome defined by doubling of serum creatinine, ESRD, or death. Cardiovascular events were also measured as a major outcome of interest.  The study found that most participants with hypertensive CKD who were treated with the BP therapy continued to progress during the long term.

Note: If requesting access to AASK Cohort data, it is recommended to also request access to the AASK Trial data <a href="https://repository.niddk.nih.gov/studies/aask-trial/">(https://repository.niddk.nih.gov/studies/aask-trial/)</a> which contains participant demographic information.
DOI: 10.58020/jtkq-h450
title: African American Study of Kidney Disease and Hypertension Study (Clinical Trial)

description: The African American Study of Kidney Disease and Hypertension study (AASK Trial) was a multi-center, randomized clinical trial that investigated the effects of blood pressure (BP) control and the use of specific antihypertensive regimens on the progression of chronic kidney disease (CKD).  The study was designed to address the high incidence of CKD in African Americans with hypertension. A two by three factorial study design, including two levels of BP control as defined by mean arterial pressure (MAP) and three different anti-hypertensive regimens, was used. Participants were randomized into two levels of BP control groups, either a goal MAP < 92 mmHg or a goal MAP between 102-107 mmHg inclusive.. The antihypertensive drugs used for treatment were amlodipine, a calcium channel blocker; ramipril, an angiotensin-converting enzyme inhibitor; and metoprolol, a β-blocker. The trial was double-blind (drug administration only). The change in glomerular filtration rate (GFR) as determined by iothalamate clearance was measured as the primary outcome to test the regimens’ efficacy in slowing the rate of decline of kidney function.
 
The study showed that the angiotensin-converting enzyme inhibitor ramipril was more effective than the beta blocker metoprolol or the dihydropyridine calcium channel blocker amlodipine in slowing the rate of GFR decline. The results suggest that reduction in blood pressure to levels below those currently advocated for cardiovascular risk reduction does not provide readily identifiable benefits to African Americans with hypertensive nephrosclerosis.
DOI: 10.58020/dgft-2p11
title: A Multicenter Clinical Trial of Allopurinol to Prevent Kidney Function Loss in Type 1 Diabetes

description: Despite improvements during the past 20 years in blood glucose and blood pressure control, diabetic kidney disease remains one of the leading causes of health problems in patients with diabetes. Novel treatments to complement blood glucose and blood pressure control are urgently needed. The goal of this study was to see whether a medication called allopurinol may help prevent loss of kidney function among people with type 1 diabetes (T1D). Allopurinol has been used for many years to decrease high blood uric acid and treat gout. There is evidence suggesting that allopurinol might also be useful in people with diabetes who have normal or moderately impaired kidney function to decrease the risk of developing advanced kidney disease in the future. To prove this beneficial effect of allopurinol, a double-blinded, international clinical trial was conducted with patients with type 1 diabetes that had an increased risk of developing kidney disease. Participants were randomly assigned to take allopurinol or placebo (inactive pill) for three years, during which they were followed through periodical visits. Kidney function was measured at the beginning and at the end of the treatment period to assess whether patients taking allopurinol experienced a slower loss of kidney function over time compared to those taking the inactive pill.
DOI: 10.58020/khy5-1135
title: Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial

description: Aprepitant is an FDA-approved medication for the treatment of nausea following chemotherapy or surgery. Aprepitant is also used by some doctors to reduce nausea and vomiting in patients with gastroparesis, although the drug is not approved for this use. The Aprepitant for the Relief of Nausea in Patients with Chronic Nausea and Vomiting of Presumed Gastric Origin (APRON) study is a multicenter, randomized, placebo-controlled clinical trial designed to test the safety and efficacy of aprepitant in reducing symptoms among patients with gastroparesis. 

Patients at least 18 years of age who have experienced symptoms of chronic nausea and vomiting related to gastroparesis for at least 6 months are eligible for the study. Participants are randomized to treatment with either aprepitant (125 mg/day) or placebo for 4 weeks. Nausea symptoms are measured daily on a 0 to 100 mm visual analog scale (VAS) for one week at baseline and for four weeks after randomization. The primary outcome measure is improvement in VAS scores from baseline to through the course of treatment, as defined by a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of < 25 mm. Improvement in other gastrointestinal symptoms, including symptoms of fullness, hunger, bloating, and abdominal pain, will be measured using the Gastroparesis Cardinal Symptom Index Daily Diary (GCSIDD), an overall relief of symptom questionnaire, and patient perception of improvement. Safety will be determined through satiety tests, electrogastrography for measuring of EGG dysrhythmias, and monitoring of side effects.
DOI: 10.58020/vwfs-jq54
title: A Prospective Database of Infants With Cholestasis

description: This is a multi-center project to establish a prospective database of clinical information and a repository of blood and tissue samples from children with diagnoses of neonatal liver diseases, such as biliary atresia and neonatal hepatitis, in order to perform research in these liver problems. Children were screened and enrolled at presentation at the participating pediatric liver sites. Subjects diagnosed with biliary atresia were followed intensively for the first year, at 18 months of age, and then annually up to 15 years of age. Other subjects diagnosed with cholestasis were followed on the same schedule; if there was complete (clinical and biochemical) resolution of their underlying liver disease off all therapy, there was one follow up visit within one year (preferably scheduled at the time of the next planned follow up visit or at 12 months of age, whichever was later) for data collection and to obtain blood samples. The development of a serum and tissue bank of specimens from children with various neonatal cholestatic disorders are used for future investigations into the etiology and pathogenesis of hepatobiliary injury in the infant.

The data package available for request includes raw and analysis datasets from multiple publications including combined data from the <a href="https://repository.niddk.nih.gov/studies/basic/">BASIC</a> and  <a href="https://repository.niddk.nih.gov/studies/logic/">LOGIC</a> studies.
DOI: 10.58020/e09y-fr19
title: A Retrospective Study of Biliary Atresia Patients up to 2 Years of Age

description: The Biliary Atresia Research Consortium (BARC) is an NIH-funded network of 9 clinical sites and a data coordinating center whose goal is to study biliary atresia, neonatal hepatitis and other cholestatic diseases in the infant. BARC is preparing a prospective observational study of infants with cholestatic disease and clinical trials related to modalities of treatment.

Biliary atresia is the leading cause of morbidity and mortality from pediatric liver disease, and is the most common indication for pediatric liver transplantation. Despite its clinical importance, little is known of a wide range of fundamental issues regarding biliary atresia and optimal approaches to the medical management are unknown. No prospective randomized trials of important aspects of the care of children with biliary atresia have been performed. The majority of published data regarding biliary atresia is anecdotal and based upon a single center experience. Comprehensive registries of the management and outcome of biliary atresia do not exist.

This retrospective study will be unique and powerful because it analyzes the results of a large cohort of children in the United States from a diverse group of institutions with expertise in the management of children with liver disease. The proposed retrospective study may provide novel information and may lead to insights that can be used in the design of a subsequent 5 year prospective study.
DOI: 10.58020/b0yw-j370
title: Assessment of Inter-Observer Variability in the Histological Diagnosis of Infantile Cholestasis

description: Infants with cholestasis prior to 181 days of age present a challenging diagnostic problem of differentiation between an extra- and intra-hepatic location of the cholestatic process. This assessment is critical, since any evidence of obstruction essentially mandates surgical exploration. Extrahepatic biliary atresia (EHBA) is the most frequent cause of persistent unrelieved infant jaundice amenable to surgical correction.

This is a retrospective multi-center pathology project, which will examine interobserver variability in the histological diagnosis of infantile cholestasis with the aim of establishing reliable histological criteria of extra-hepatic obstruction in infants.
DOI: 10.58020/js2k-9d54
title: Assessment, Serial Evaluation, and Subsequent Sequelae in Acute Kidney Injury

description: The Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study investigates differences in the occurrence of renal and cardiovascular outcomes and death within a diverse, matched cohort of patients with and without acute kidney injury (AKI). This prospective study enrolls a cohort of 1100 adult participants with a broad range of AKI and matched hospitalized participants without AKI at 3 Clinical Research Centers, as well as 100 children undergoing cardiac surgery at 3 Clinical Research Centers. Participants are followed for up to four years, and undergo serial evaluation during the index hospitalization, at three months post-hospitalization, and at annual clinic visits, with telephone interviews occurring during the intervening six-month intervals. Biospecimens are collected at each visit, in addition to information on lifestyle behaviors, quality of life and functional status, cognitive function, receipt of therapies, interim renal and cardiovascular events, electrocardiography, and urinalysis.
DOI: 10.58020/vjvg-pb52
title: ATG-GCSF in New Onset Type 1 Diabetes

description: Type 1 diabetes (T1D) is an autoimmune disease, meaning that the immune system mistakenly attacks the cells in the body that make insulin. These cells, called beta cells, are found in the pancreas. Beta cell destruction starts years before symptoms appear. By the time T1D has been diagnosed, many beta cells have already been destroyed, but some are still left that can produce insulin. People who can continue to make a little insulin may have fewer problems with low blood glucose (hypoglycemia). They may also have an easier time keeping their blood glucose at normal levels. This helps lower the risk of long-term complications. At this time, there is no proven treatment that will protect the remaining beta cells. The body's immune system keeps destroying them. Within a few years after diagnosis, most people with T1D can no longer make their own insulin.

The TrialNet 19 (TN19) study was a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which participants either received active Anti-Thymocyte Globulin (ATG) and Granulocyte Colony Stimulating Factor (GCSF), received ATG alone, or received a placebo alone within 100 days from diagnosis of T1D. TrialNet researchers assessed whether ATG used alone or in combination with GCSF helped participants continue to make some of their own insulin.

The study had a treatment phase and a follow-up phase. The treatment phase was during the first 3 months of the study. During this time, participants had one inpatient stay for 3 days and 2 nights to receive two infusions of low dose ATG or placebo followed by one injection of GCSF or placebo. Participants returned for five additional outpatient visits over the next 10 weeks (every 2 weeks) to receive an injection of GCSF or placebo. After the treatment phase, participants moved to the follow-up phase and returned for outpatient visits every 3 to 6 months. The study had a total participation time of two years.
DOI: 10.58020/sjgp-bq76
title: Behavior Enhances Drug Reduction of Incontinence

description: Urge incontinence, the involuntary urine loss associated with a strong desire to void, is one of several types of urinary incontinence (UI) and has one of the greatest impacts on quality of life. Common treatments for urge incontinence include behavioral training and antimuscarinic medications, but long-term adherence with medication therapy can be difficult to achieve. 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 primary aim of this randomized clinical trial was to determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared to drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing medication. 

Participants with urge incontinence (defined as urge symptom index > stress symptom index on the Medical, Epidemiological, and Social Aspects of Aging Questionnaire) were enrolled in the study and randomly assigned either to drug therapy alone or combined behavioral and drug therapy. Drug therapy was tolterodine tartrate at a dose of 4 mg per day. Combination therapy included drug and behavioral training, which consisted of teaching pelvic floor muscle control and exercises, delayed voiding to increase voiding interval, individualized fluid management, and strategies to diminish urgency, suppress bladder contractions, and prevent both stress and urge incontinence. Treatment was discontinued for both groups after 10 weeks. The primary outcome measure, assessed at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcome measures included reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and health-related quality of life.

Results showed that the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups, although a higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks. The study concluded that the addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence.