cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.25934/pr00004737.0
title: Available IPD datapackage for study 'A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis'

description: The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).
DOI: 10.25934/pr00004789.0
title: Available IPD datapackage for study 'A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Aanti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis'

description: The purpose of this study is to evaluate the effectiveness (improvement of signs and symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.
DOI: 10.25934/pr00010405
title: Insulin Lispro versus Humulin R in Adolescent Patients with Type 1 Diabetes

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/pr00010692
title: Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)

description: The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the primary vaccination and 12 months after the booster dose will also be evaluated in these subjects.In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV). These subjects will be followed for safety and immunogenicity for 12 months after vaccination in study V102_03E1.
DOI: 10.3886/icpsr08250
title: Specific Deterrent Effects of Arrest for Domestic Assault: Minneapolis, 1981-1982
title: Archival Version

description: This data collection contains information on 330 incidents of domestic violence in Minneapolis. Part 1, Police Data, contains data from the initial police reports filled out after each incident. Parts 2-5 are based on interviews that were conducted with all parties to the domestic assaults. Information for Part 2, Initial Data, was gathered from the victims after the incidents. Part 3, Follow-Up Data, consists of data from follow-up interviews with the victims and with relatives and acquaintances of both victims and suspects. There could be up to 12 contacts per case. Suspect interviews are the source for Part 4, Suspect Data. An experimental section, Part 5, Repeat Data, contains information on repeat incidents of domestic assault from interviews with victims. Parts 2-5 include items such as socioeconomic and demographic data describing the suspect and the victim, relationship (husband, wife, boyfriend, girlfriend, lover, divorced, separated), nature of the argument that spurred the assault, presence or absence of physical violence, and the nature and extent of police contact in the incident. The collection also includes police records, which are the basis for Parts 6-9. These files record the date of the crime, ethnicity of the participants, presence or absence of alcohol or drugs and weapons, and whether a police assault occurred.
description: All calls between March 17, 1981, and August 1, 1982, to the Minneapolis police concerning misdemeanant domestic violence incidents where both parties were present were included. Cases involving life-threatening or severe injury were excluded.
description: Datasets: DS0: Study-Level Files DS1: Police Data DS2: Initial Data DS3: Follow-Up Data DS4: Suspect Data DS5: Repeat Data DS6: CCNlog Data DS7: Recaplog Data DS8: Dispatch Data DS9: Rapsheet Data DS10: Codebook for All Parts DS11: SAS Control Cards for Police Data DS12: SAS Control Cards for Initial Data DS13: SAS Control Cards for Follow-Up Data DS14: SAS Control Cards for Suspect Data DS15: SAS Control Cards for Repeat Data DS16: SAS Control Cards for CCNlog Data DS17: SAS Control Cards for Recaplog Data DS18: SAS Control Cards for Dispatch Data DS19: SAS Control Cards for Rapsheet Data
description: Domestic assault incidents in Minneapolis.
DOI: 10.25934/00003836
title: An Open-label Study of the Ease of Use and Correct Use of Placebo ELLIPTA Dry Powder Inhaler in Subjects With Asthma

description: Asthma is a chronic disease of the lungs characterized by airway inflammation, bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the delivery of medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study is designed to assess the correct use of the ELLIPTA inhaler in subjects with asthma and also to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of asthma and receiving asthma therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2. ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.
DOI: 10.25934/00005030
title: A Two Part, Multicenter Phase IIa, Placebo Controlled Study, to Examine the Safety, Tolerability, and Effects of GSK256073 on Lipids in Subjects With Dyslipidemia

description: This is a two part study (Part A and Part B) that will first aim to establish the PK/PD relationship between exposure and lipid effects (Part A: 75 subjects), and will then confirm the effect using the most relevant dose(s) (Part B: ~90 subjects). Doses of 5mg, 50mg and 150mg of GSK256073 will be administered in Part A, and the dose(s) for Part B will be based on the PK/PD data from Part A. Data from Part A and Part B will be combined to decrease overall subject numbers needed in part B. Part B of the study will include a niaspan arm for relative comparison of the effects of GSK256073 and niacin on lipids and flushing
DOI: 10.25934/00005882.0
title: Available IPD datapackage for study 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Once Daily Oral Lu AA21004 in Patients With Major Depressive Disorder'

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/00006603
title: Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

description: The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease.
DOI: 10.25934/pr00001997.0
title: Available datapackage for study 'A multi-center, double blind, placebo-controlled flexible dose study to evaluate the efficacy and safety of Paroxetine in children with major depression.'

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/pr00010136.0
title: Available datapackage for study 'A Randomized, Multicenter, International, Open-label Study of Infliximab Plus Methotrexate Versus Methotrexate (MTX) Alone for the Treatment of MTX naïve Subjects With Active Psoriatic Arthritis'

description: This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients.
DOI: 10.25934/00003308
title: CS-747S PhaseIII trial - Double-blinded comparative study for evaluation of efficacy and safety of CS-747S versus clopidogrel bisulfate in subject with acute coronary syndromes who are to undergo percutaneous coronary intervention.

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/00005877.0
title: Available IPD datapackage for study 'A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Duloxetine-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (15 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder'

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/pr00003462.0
title: Available datapackage for study 'JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme, Phase III Study to Compare the Preventive Effect of Recurrent Brain Infarction and Safety of Aggrenox (Combination Drug Containing Sustained-release Dipyridamole 200 mg/Acetylsalicylic Acid 25 mg) Twice Daily vs. Acetylsalicylic Acid 81 mg Once Daily'

description: Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily
DOI: 10.25934/pr00009461
title: Efficacy and safety of 3 doses of S 38093 (2, 5 and 20 mg/day) versus placebo in patients with mild to moderate Alzheimer’s diseaseA 24-week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study followed by a 24-week extension period

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/pr00010533
title: Phase II/III Study of S-877503 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/pr00010697
title: Phase 3b, Open Label, Uncontrolled, Single-arm, Single-centre Study to Evaluate the Safety of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Healthy Adults From 18 to 50 Years of Age and to Collect Blood Donations to Develop Vaccines Against Neisseria Meningitidis

description: The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.
DOI: 10.25934/00000965
title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Pneumococcal Vaccine 1024850A When Administered to Children Between 8 Weeks and 2 Years of Age

description: The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A. Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.
DOI: 10.25934/00003921
title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs {NCT00343915}

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/00004479
title: The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)

description: GeNeSIS is an open-label, multinational, multicenter, observational study to evaluate the safety and effectiveness of Humatrope treatment. GeNeSIS is a modular program that includes:   -  Core study: Evaluating the safety and effectiveness of Humatrope in the observational setting   -  Genetic Analysis Sub-study: Investigating the genetic defects underlying growth hormone (GH) deficiency and non-GH-deficient growth disorders   -  Growth Prediction Sub-study: Working to validate and refine specific models to accurately predict growth response to GH   -  Short Stature Homeobox containing gene (SHOX) Deficiency Sub-study: Elucidating the clinical, endocrine and radiological features of participants with SHOX deficiency due to loss of, or mutation in the SHOX gene (including participants with Turner syndrome)   -  Neoplasia Sub-study: To characterize the natural history of neoplastic disease, especially in relation to recurrence/progression of primary neoplasia or development of secondary neoplasia in children with a history of neoplasia
DOI: 10.25934/00005369
title: Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® IND# 103, 331) During Consolidation

description: This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
DOI: 10.25934/pr00001532.0
title: Available datapackage for study 'A Multi-center, Double-blind, Placebo-Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression - Acute Phase'

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/pr00005876.0
title: Available IPD datapackage for study 'A Randomized, Double-blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder'

description: The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.
DOI: 10.25934/00006458
title: Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy

description: The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in postmenopausal women with estrogen receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after treatment with letrozole or anastrozole.
DOI: 10.25934/pr00008587
title: Validation of a transcriptome-based assay for classifying cancers of unknown primary origin

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/pr00010945.0
title: Available datapackage for study 'Usage Tracking Test Data Set 11 - do not request'

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/00001057
title: Open Label Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil)

description: Study to Assess the Pharmacokinetics of GSK1278863A Coadministered with a High Fat Meal or an Inhibitor of CYP2C8 (gemfibrozil),]
DOI: 10.25934/00002376
title: Evaluation of the Effect of a Low- and High-Fat Breakfast of the Oral Bioavailability and Pharmacokinetics of BMS-201038 Given as a 50 MG Capsule to Normal Healthy Volunteers

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/00004411.0
title: Available IPD datapackage for study 'Duloxetine Versus Placebo in the Long-Term Treatment of Patients With Late-Life Major Depression'

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/00005741
title: Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies

description: This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.
DOI: 10.25934/00006286
title: Systemic availability and pharmacokinetics of budesonide (Pulmicort) nebulizing suspension when administered by a jet nebulizer (Pari LC Jet Plus) in young asthmatic children

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/00006919
title: Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia

description: The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance Phase.