cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.58020/mvyb-pd38
title: Interstitial Cystitis cohort study

description: The Interstitial Cystitis Data Base (ICDB) cohort study was a prospective, multicenter clinical study of patients with Interstitial Cystitis (IC). The study gathered data to investigate the treated history of IC and identify patient subgroups with specific symptoms, physical findings, histopathologic findings from bladder biopsies, and treatment responses. Data was collected on patients at baseline and longitudinally concerning demographic and diagnostic information, medical history, dietary intake, urinary symptoms, and treatments and their outcomes. Additionally, bladder tissue specimens were stored in a specimen bank.  Initial analyses on patient data supported the clinical observation that IC is a chronic symptom complex and showed that no current treatments had a significant impact on symptoms over time.
DOI: 10.58020/7xqs-6v33
title: Intraprostatic Injection of Botulinum Toxin for the Management of Benign Prostatic Hyperplasia (MIST)

description: Benign prostatic hyperplasia (BPH) and lower urinary tract symptoms are bothersome and costly conditions affecting nearly half of men older than age 50 years and 90% of men older than age 80. In the search for more effective noninvasive therapies, the role of the neural activity in BPH has been studied. Botulinum toxin injection has been used for several urological conditions including voiding dysfunction, and studies have shown that intraprostatic injection may be beneficial in lower urinary tract symptoms secondary to BPH.

Eligible men were randomized in a 1:1 ratio to a 100 or a 300 U dose of onabotulinum toxin A. The study was double-blind as to the toxin dose. The drug was injected transrectally into the prostatic peripheral transitional zone with ultrasound guidance. It was administered as 2 cc per lobe in 1 ml aliquots at 2 injection sites for a total of 4 sites. 

Men were contacted by telephone at 1 week after treatment, and evaluated in person at 1, 2, 3, 6, 9 and 12 months. Uroflowmetry, vital signs, AUASI and medical conditions were collected or performed at baseline and each visit; transrectal ultrasound and questionnaires on the impact of BPH, bladder function, erectile function and ejaculatory function were administered at baseline, and 3 and 12 months; bladder ultrasound was performed at baseline and 12 months; and physical and digital rectal examination, and prostate specific antigen were determined at baseline, and at 3, 6 and 12 months.
DOI: 10.58020/waer-b554
title: Irritable Bowel Syndrome Outcome Study

description: Irritable bowel syndrome (IBS) is a condition which affects the large intestine, with symptoms that include varying degrees of abdominal pain, bloating, constipation and diarrhea.  Medications and lifestyle changes are generally prescribed for IBS, but medical treatments for the full range of symptoms are inadequate.  Cognitive behavior therapy (CBT), a psychological treatment where therapists teach patients how to use behavioral skills to manage IBS and relieve unresolved symptoms, has been associated with improvements in symptom severity and quality of life in other clinical trials.  However, CBT has certain economic and feasibility limitations that prevent the therapy from being incorporated into routine clinical settings.

The Irritable Bowel Syndrome Outcome Study (IBSOS) sought to address the limitations of standard therapist-administered CBT by developing an effective self-administered version of the treatment method.  IBSOS participants were randomized into one of three treatment groups and underwent four weeks of symptom monitoring.  One group received the standard ten sessions of clinic-based CBT, one group received four sessions of minimal-contact CBT, and the remaining group received four sessions of supportive counseling and education without any prescribed behavior changes.  Following the symptom monitoring phase, patients underwent treatment and follow-up phases.  Assessments were regularly conducted during the study and the results were evaluated between the groups.
DOI: 10.58020/qx8b-gk69
title: Islet Transplantation in Type 1 Diabetes

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 is 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 CIT07, a single arm Phase 3 license-enabling study, received induction and maintenance immunosuppression in an open-label fashion consisting of rabbit anti-thymocyte globulin (ATG; basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), etanercept, sirolimus and low-dose tacrolimus.
DOI: 10.58020/c22t-jh71
title: Islet Transplantation in Type 1 Diabetes with LEA29Y (Belatacept) Maintenance Therapy

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. The focus of CIT04 was to evaluate the effectiveness of an IS regimen that included belatacept. For immunosuppression, CIT04 subjects received belatacept, basiliximab, and mycophenolate mofetil in an open-label fashion.
DOI: 10.58020/3rma-wx55
title: Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients: Efficacy of Islet After Kidney Transplantation

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. Unlike the other studies, subjects in CIT06 had previously received a kidney transplant and were receiving maintenance immunosuppression. CIT06 was a single arm Phase 3 license-supporting study. At the time of islet transplant, subjects in CIT06 received induction therapy in an open-label fashion with rabbit anti-thymocyte globulin (ATG, 5 doses; daclizumab or basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable) and etanercept. Subjects remained on their calcineurin-based maintenance immunosuppression regimen already in place for their renal allograft.
DOI: 10.58020/scct-xr14
title: JDRF Follow-up of Children Diagnosed with Diabetes

description: The Environmental Determinants of Diabetes in the Young (TEDDY) study enrolled over 8,000 infants identified to have an increased genetic risk for type 1 diabetes (T1D) and were followed prospectively for 15 years for the development of T1D and islet cell antibodies. There were 400 children projected to develop T1D over the course of the study, and follow-up of these children stopped upon development of T1D. The JDRF Follow-up of Children Diagnosed with Diabetes (JDRF-TEDDY Follow-Up) study sought to understand whether these children were diagnosed at an earlier stage of T1D compared to children not enrolled in prospective studies, and to identify if they maintained the ability to produce C-peptide longer than children diagnosed through standard clinical care in the community. The JDRF-TEDDY Follow-Up study analyzed the preservation of C-peptide over time in children diagnosed with T1D through prospective studies and compared them to a group of age matched controls identified from the community. Furthermore, the JDRF-TEDDY Follow-Up study collected samples to investigate immunological changes occurring after diagnosis and how these changes may relate to earlier T1D diagnoses.
DOI: 10.58020/cdrd-9105
title: Liver Transplantation Database

description: The NIDDK Liver Transplantation Database was established to prospectively investigate questions related to the experience of patients evaluated for and undergoing liver transplantation. The LTD contains data for 1563 patients referred and evaluated for orthotopic liver transplantation (OLT) at three large liver transplant centers in the United States; of these patients, 916 underwent transplantation and were followed for 1 to 5 years. 

All patients referred for OLT were screened for eligibility to be entered in the database, which required informed consent, no prior liver transplant, and availability to be followed. For each participant, standardized data was collected on demographics, medical history, preoperative and post-transplant symptoms and quality of life, post-transplant complications, and mortality. Liver biopsies and serum samples were also obtained pre- and post-transplantation at intervals specified in the study protocol. 

Following primary data collection, which occurred from April 1990 to June 1994, the Liver Transplantation Database Follow Up (LTD2) study was conducted to prospectively generate detailed survival data from a large multicenter cohort of liver transplant recipients. This study observed the long-term outcomes of transplantation to examine adverse effects, assess risk factors, and determine long-term mortality rates and causes of death post-transplant. 

Follow-up data was obtained for 798 transplant patients from 1998 to 2003 at 3 clinical centers. Cause of death was captured in the early (≤ 1 year) and late (> 1 year and > 5 years) post-transplant periods. Patient-related risk factors were analyzed for overall deaths as well as for each major cause of death in the late post-transplant period. Adverse events, including complications of transplantation and recurrence or development of disease, were monitored. 

The follow-up study identified common etiologies and risk factors that contributed to the morality of liver transplant patients at various stages post-transplantation. Results showed that hepatic etiologies were the most frequent cause of death in the late post-transplant setting. In addition to malignancy and cardiovascular disease, renal failure was found to be an important and escalating cause of death in the late post-transplant setting. Ancillary studies have also been performed on LTD data to evaluate pathology reliability and cost of liver transplantation, as well as examine various characteristics or biomarkers of collected serum.
DOI: 10.58020/dbbh-rt92
title: Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis

description: Cholestasis, a rare condition involving a reduction or obstruction of bile flow from the liver to the small intestine, can cause significant growth problems, liver complications, the need for liver transplantation, and death. The four rare genetic disorders Alagille syndrome (ALGS), alpha-1 antitrypsin (a-1AT) deficiency, bile acid synthesis defects, and progressive familial intrahepatic cholestasis (PFIC) account for approximately 20% to 30% of all infant cases of cholestasis. Current knowledge concerning the etiology and outcomes of these diseases is limited. The Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC) study is a longitudinal cohort study that was established by the Childhood Liver Disease Research and Education Network (ChiLDReN) to investigate the natural history and progression of these four genetic disorders.  

Children and adults ages 6 months through 25 years who have been diagnosed with ALGS, a-1AT deficiency, bile acid synthesis defects, and PFIC are enrolled. Individuals who are siblings of a-A1T participants and have underlying disease with no evidence of liver involvement may also be enrolled. Participants will complete a baseline visit and give annual follow-up visits. Study visits involve review of clinical information, family history, and any treatments and their outcomes. A physical exam, laboratory tests, and radiologic and imaging evaluations will also be performed. In addition to these standard of care evaluations, participants will undergo neurodevelopment evaluations, DEXA scanning, hearing exams, and liver histology studies. The primary outcome measure is the evaluation of disease progression for each condition, which includes assessment of growth failure, worsening liver functions, developmental complications of portal high blood pressure, liver transplantation, and death. Jaundice, listing for liver transplantation, calculated pediatric end-stage liver disease (PELD) score or model for end-stage liver disease (MELD) score, health-related quality of life, growth, bone mineral density, and presence of hearing loss are assessed as secondary outcome measures. 

The data package now includes analysis datasets from multiple publications.
DOI: 10.58020/w3gs-0421
title: Long-Term Investigative Follow-Up in TrialNet Study

description: The LIFT Study is available nationwide to TrialNet participants who either: 

- Developed diabetes while being monitored in the Pathway to Prevention Study or during participation in any prevention trial. The purpose is to study people early in the disease process

- Participated in any new onset studies.  The purpose is to learn more about diabetes and if there are any long-term effects—good or bad—from the treatments used in these studies
 
Participants will be asked to return to a TrialNet site annually or semi- annually, based on their ongoing ability to produce insulin. Visits will include metabolic testing (i.e., Oral Glucose Tolerance Test and/or Mixed Meal Tolerance Test), HbAc1, and possibly other blood or urine tests.
DOI: 10.58020/wr3g-1218
title: Look AHEAD: Action for Health in Diabetes

description: Short-term studies have shown numerous benefits of weight loss in overweight or obese patients, including improvements in glycemic control, risk factors for cardiovascular disease, quality of life, and other obesity-related coexisting illnesses. The Look AHEAD study was designed to test whether weight loss similarly improved cardiovascular morbidity and mortality in patients with type 2 diabetes. The study is a multicenter, randomized clinical trial that examines the long-term effects of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity.

Eligible patients with type 2 diabetes and a body-mass index (BMI) of 25.0 or more were enrolled and randomly assigned either to participate in an intensive lifestyle intervention (intervention group) or to receive diabetes support and education (control group). The intensive lifestyle intervention, which included both group and individual counseling sessions, was aimed at achieving and maintaining weight loss of at least 7% by focusing on reduced caloric intake and increased physical activity. The diabetes support and education program featured sessions focusing on diet, exercise, and social support. Both the intervention and control programs occurred with decreasing frequency as the trial progressed. The primary outcome measure is the first occurrence of a composite cardiovascular outcome, which consists of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for angina. Participants will be followed for a planned period of 13.5 years.

An ancillary study, Look AHEAD Brain, was conducted to assess whether participation in the 10-year lifestyle intervention, as part of Look AHEAD, had an impact on white matter hyperintensity and loss of brain tissue among individuals with type 2 diabetes. A subset of Look AHEAD study participants underwent standardized brain magnetic resonance imaging in conjunction with tests assessing cognitive function 10-12 years post-randomization.

The Look AHEAD intensive lifestyle intervention ended in September, 2012. Participants continued to be followed to determine the long-term effects of the intervention on health outcomes.

The Look AHEAD Continuation Study (Look AHEAD-C) builds on the Look AHEAD study to determine the long-term impact of an intensive lifestyle intervention on 1) physical function and mobility disability, and 2) cognitive function and cognitive impairment. Collection of cognitive function measures began in Year 8 of the study and continued through Year 13. 

The current data package contains data through the end of the post intervention program.
DOI: 10.58020/akda-0m02
title: Maryland Genetics of Interstitial Cystitis Study

description: The Maryland Genetics of Interstitial Cystitis Study (MaGIC) collected information on several hundred families with two or more blood relatives with interstitial cystitis (IC) to investigate the genetic basis of the condition. The study sought to find genetic variants that are more prevalent in family members who have interstitial cystitis than in those who do not have the disease. Participants who had IC and at least one blood relative with the condition were enrolled. Information was collected via interview by phone, mail, or website.
DOI: 10.58020/b3ns-nq56
title: Medical Therapy of Prostatic Symptoms

description: The Medical Therapy of Prostatic Symptoms (MTOPS) study was a multi-center, randomized, double-blind placebo controlled clinical trial that tested whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or in combination, could delay or prevent the worsening of symptoms in men with benign prostatic hyperplasia (BPH). Doxazosin is an α-adrenergic receptor agonist (α-blocker) that reduces muscle tone of the prostate and bladder neck, and finasteride is a 5-α-reductase inhibitor that reduces prostate volume by inducing epithelial atrophy. The MTOPS study hypothesized that these two classes of drugs may act synergistically to delay or prevent the clinical progression of BPH.
 
Participants were randomly assigned, in a double-blind fashion, to one of the following 4 treatment groups: placebo, doxazosin, finasteride, or combination therapy. The primary outcome measure was time to overall clinical progression of BPH, defined as either a confirmed 4 point or greater increase from baseline in the American Urological Association (AUA) symptom score, acute urinary retention, incontinence, renal insufficiency, or recurrent urinary tract infection. The progression of BPH was also assessed using digital rectal examination, serum PSA measurement, urinalysis, transrectal ultrasound, biopsies, urinary flow, and change in the AUA score. 
The study found that combination therapy with doxazosin and finasteride was more effective than either therapy alone in the preventing the clinical progression of BPH.
DOI: 10.58020/jdxy-7k23
title: Middle-School Based Primary Prevention Trial of Type 2 Diabetes

description: The HEALTHY study is a randomized prevention trial that investigated the effectiveness of an integrated intervention in middle schools that aimed to moderate risk for type 2 diabetes in children. The trial was conducted at 7 field centers in 42 middle schools, randomly assigned to intervention or control. Student recruitment and baseline data collection occurred during in the first semester of 6th grade (2006); the intervention was implemented the following semester (2007) and continued through 8th grade (2007-2009). For schools that received intervention, the program consisted of four integrated components targeting nutrition, physical education, behavior change initiatives, and educational communications activities that were designed to impact the environment and lifestyle choices of middle school children. The intervention was implemented either school-wide or grade-wide, so all students were exposed; those who provided appropriate informed consent participated in data collection and evaluation. The primary outcome measure was the combined prevalence of overweight and obesity (BMI ≥ 85th percentile). The study found that the combined prevalence of overweight and obesity decreased in both intervention and control schools, with no significant difference between school groups. However, the intervention did result in significantly greater reductions in various indexes of adiposity, including obesity.

Detailed information about the HEALTHY study, including the protocol, intervention materials, and publications, is available at www.healthystudy.org.
DOI: 10.58020/emxg-8065
title: Multidisciplinary Approach to the Study of Pelvic Pain

description: The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network was established to focus on a broader approach to the study of Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men. Participants with some form or symptoms of IC or CP were asked to join the Trans-MAPP Epidemiology and Phenotyping (EP) Study. Participants with no Urologic Pelvic Pain Syndromes as well as participants with specific conditions (Fibromyalgia (FM), Irritable Bowel Syndrome (IBS), Chronic Fatigue Syndrome (CFS)) were recruited for the Trans-MAPP Control Study. These participants were a reference/control group for the Trans-MAPP EP Study.

Full study data are available for request.
DOI: 10.58020/8s7b-gg06
title: National Analgesic Nephropathy Study

description: It has been proposed that the chronic, long-term ingestion of analgesics leads to specific renal pathology and renal failure. Previous studies suggested that the non–contrast-enhanced computerized tomography (CT) scan is a highly reliable tool for the diagnosis of analgesic-associated renal disease. The National Analgesic Nephropathy Study (NANS) is a case control study that was established to examine the association between heavy analgesic use and renal insufficiency and to investigate the ability of the CT scan to detect heavy analgesic use in the US population with end-stage renal disease (ESRD).

Patients with ESRD without a clear nonanalgesic cause for renal failure who had begun dialysis within the previous 3 months were enrolled in the study. A non-contract enhanced CT scan was performed using a standardized protocol. Three parameters—size, indentations, and calcifications—were used to identify patients who might have analgesic-induced kidney disease. Additionally, an interview was conducted to obtain information from patients concerning analgesic use, pre-dialysis signs and symptoms of renal disease, medical history, and demographics. 

The study concluded that findings of small indented calcified kidneys (SICK) did not occur with sufficient frequency in US patients with ESRD and heavy analgesic exposure to render the non-contrast-enhanced CT scan a sensitive tool to identify such individuals. Although the conclusion concerning the lack of diagnostic value of the CT scan is clear, the study did not address the overall relationship between analgesics and the progression of renal disease. Results showed an association between heavy analgesic ingestion and findings of SICK in incident US patients with ESRD, which seemed to be accounted for mostly by phenacetin-containing products; however, future studies are needed to learn whether there is an association in the US population between currently available analgesics and ESRD and whether the ingestion of NSAID or cyclooxygenase-2 inhibitors contribute to the development of ESRD.