cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.25934/pr00008257
title: A Double-Blind, Randomized, Placebo and Active-Controlled, Six-Period Crossover Study to Evaluate the Likeability, Safety, and Abuse Liability of NRP104 in Healthy Adult Volunteers With Histories of Stimulant Abuse

description: This research is being done to evaluate if NRP104 is a safe drug. The other purpose is to learn if NRP104 produces a high and any other effects like amphetamine and other stimulant drugs that are abused. This information will give some indication if NRP104 can be abused. NRP104 is an investigational drug. This means that it has not been approved by the U.S. Food and Drug Administration (FDA). Healthy people, between the ages of 18 and 55 with histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to treat narcolepsy (excessive sleepiness) and for weight loss.
DOI: 10.25934/pr00010669
title: A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

description: The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.
DOI: 10.25934/pr00010710
title: A Phase II Study Using ACP-196 (Acalabrutinib) in Patients With Relapsed/Refractory and Treatment-naïve Deletion 17p CLL/SLL: Pharmacodynamic Assessment of BTK Inhibition and Antitumor Response.

description: This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
DOI: 10.25934/00004368
title: Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

description: The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.
DOI: 10.25934/00005620
title: A randomized, open-label study of the effect of different doses of pertuzumab on treatment response in patients with metastatic breast cancer with low HER2 expression

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: 10.25934/00006057
title: A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

description: This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
DOI: 10.25934/pr00004147.0
title: Available IPD datapackage for study 'A Fixed-Dose Range Safety and Efficacy Study of Olanzapine Versus Haloperidol in the Treatment of Schizophrenia'

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/pr00004767.0
title: Available IPD datapackage for study 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis'

description: The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the treatment of patients with moderate to severe psoriasis in South Korea and Taiwan.
DOI: 10.25934/pr00009341
title: A Phase 1, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Hormone Therapy-Resistant Prostate Cancer Subjects

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: 10.25934/00003055
title: A Randomized, Multicenter, Single-blind, Placebo-controlled Study Comparing the Analgesic Efficacy and Safety of Hydrocodone/ Acetaminophen Extended-release Tablets and Hydrocodone/Acetaminophen (NORCO) to Placebo in Subjects With Acute Pain Following Third Molar Tooth Extraction

description: The purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction.
DOI: 10.25934/00004396
title: Phase IV Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder

description: To investigate the effect of atomoxetine hydrochloride in treating adults who have attention deficit hyperactivity disorder with comorbid social anxiety disorder
DOI: 10.25934/00004591
title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Anti-TNF a Monoclonal Antibody (Infliximab) to Treat Cancer-Related Cachexia in Subjects With Pancreatic Cancer.

description: The purpose of this study is to evaluate the effectiveness and safety of infliximab, the active ingredient in Remicade, for the treatment of cachexia in pancreatic cancer patients who are receiving chemotherapy with gemcitabine.
DOI: 10.25934/00006228
title: A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of MEDI4736 in Combination With Tremelimumab in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

description: This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.
DOI: 10.25934/pr00011019
title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

description: Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied.Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.
DOI: 10.25934/00003514
title: STREAM (Strategic Reperfusion Early After Myocardial Infarction). Comparison of the Efficacy and Safety of a Strategy of Early Fibrinolytic Treatment With Tenecteplase and Additional Antiplatelet and Antithrombin Therapy Followed by Catheterisation Within 6-24 Hours or Rescue Coronary Intervention Versus a Strategy of Standard Primary PCI in Patients With Acute Myocardial Infarction Within 3 Hours of Onset of Symptoms

description: This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B. The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated. All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.
DOI: 10.25934/00005558
title: Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy

description: The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.
DOI: 10.25934/00005966
title: Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104

description: The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).
DOI: 10.25934/pr00007642
title: Safety and Immunogenicity Trial Among Adults Administered Quadrivalent Influenza Vaccine

description: The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the investigational TIV containing the alternate B strain in adult subjects. Primary Objective:   -  To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among subjects 65 years of age and older Observational Objective:   -  To describe the safety profiles of TIV among subjects 18 years of age and older and QIV in subjects 65 years and older, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.
DOI: 10.25934/pr00009333
title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

description: A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.
DOI: 10.25934/pr00009775
title: A Phase 2b/3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Japanese Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

description: This is a randomized, double-blind study comparing ABT-494 to placebo in Japanese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response. Following marketing approval of upadacitinib for rheumatoid arthritis in Japan, this study will become a post-marketing clinical study and include a long-term extension period.
DOI: 10.25934/00001245
title: An Open-Label Exploratory Study to Investigate the Feasibility of Administering Exenatide by Continuous Subcutaneous Infusion to Healthy Subjects

description: This is an open-label study to investigate the feasibility of administering exenatide by continuous subcutaneous infusion to healthy subjects. Study will consist of two parts i.e. Part A and B. In Part A 2 healthy subjects will receive exenatide infusion over 24 hours followed by a follow-up visit 10 to 14 days after discharge from clinic. In Part B approximately 6 healthy subjects will receive subcutaneous infusions of exenatide for maximum of 7 days followed by a follow-up visit 10 to 14 days after discharge from clinic.
DOI: 10.25934/00002479
title: A Phase III Safety Study to Evaluate the Long-term Effects of TAK-375 on Endocrine Function in Adult Subjects With Chronic Insomnia

description: The purpose of this study is to determine the long-term effects of Ramelteon, once daily (QD), on endocrine function values.
DOI: 10.25934/00003613
title: A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

description: The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug. The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF). As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.
DOI: 10.25934/00004709
title: A 2-year, Prospective, Blinded-rater, Open-label, Active-controlled, Multicenter, Randomized Study of Long-term Efficacy and Effectiveness Comparing Risperdal® Consta® and Abilify® (Aripiprazole) in Adults With Schizophrenia

description: The purpose of this study is to compare the effectiveness of two antipsychotic medications, RisperdalÂ® ConstaÂ® versus AbilifyÂ®, over a 2-year treatment period in the long-term maintenance of patients with schizophrenia.
DOI: 10.25934/00005734
title: A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma

description: This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
DOI: 10.25934/pr00009260
title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients

description: Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE). A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.
DOI: 10.25934/00003007
title: A Randomized, Multi-center, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen and Placebo in Subjects With Osteoarthritis

description: The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen with placebo over a 5-week dosing period in patients with osteoarthritis.
DOI: 10.25934/00003434
title: Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)

description: The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
DOI: 10.25934/00004323
title: Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

description: A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in pre-menopausal women.
DOI: 10.25934/00004406.0
title: Available IPD datapackage for study 'A Randomized, Open-label Study Comparing the Effects of Olanzapine Pamoate Depot With Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia'

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: 10.25934/00007294
title: A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia

description: This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia.
DOI: 10.25934/pr00008338.0
title: Available datapackage for study 'A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered Via a SelfDose (TM) Device in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis'

description: The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.
DOI: 10.25934/00000122
title: A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma

description: The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
DOI: 10.25934/00000955
title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Compare GW766944 (an Oral CCR3 Receptor Antagonist) Versus Placebo in Patients With Asthma and Sputum Eosinophilia.

description: GW766994 is a selective, competitive antagonist of the human CC chemokine receptor-3 (CCR3). It is proposed that the inhibition of the CCR3 receptor may provide a treatment for airway inflammation such as in asthma. This will be a double-blind, placebo controlled, parallel group study being conducted to evaluate the effects of GW766994 in subjects with mild-moderate asthma who have high sputum eosinophilia. The primary objective is to compare the effects of GW766994 to placebo on sputum eosinophils.
DOI: 10.25934/00003108.0
title: Data Package for study.

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: 10.25934/00004506
title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis

description: This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.
DOI: 10.25934/00004565
title: Dose Response Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

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.