cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.25934/00006018
title: Non-interventional Study Describing Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)

description: Describe patient and physician assessed factors for patient well-being when treated with Pradaxa for stroke and embolism prevention in atrial fibrillation either compared to previous antithrombotic treatment (switcher)
DOI: 10.25934/00006837.0
title: Available IPD datapackage for study 'Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized 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: 10.25934/00006928
title: An Open-Label, Multi-Center, Dose Indicator Study of Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) in Adult Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

description: This is an open-label, multi-center study to evaluate the accuracy, reliability and functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment Period.
DOI: 10.25934/pr00009085.0
title: Available datapackage for study 'Effect of LY2062430, an Anti-Amyloid Beta Monoclonal Antibody, on the Progression of Alzheimer's Disease as Compared With Placebo'

description: Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized by progressive decline in cognitive function and ability to perform activities of daily living, and ultimately can lead to death due to complications of the disease. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase clearance, might be expected to slow the progression of AD. LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1) monoclonal antibody being developed for the treatment of AD. The primary hypothesis being tested is that LY2062430 will slow cognitive and functional decline in AD as compared with placebo. Each patient's participation will last approximately 19 months. Patients taking approved AD medications may participate in this study and continue taking these medications during the study.
DOI: 10.25934/00000259
title: A Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Efficacy of Controlled-release Ropinirole (CR) (1-24 mg) Administered Once Daily for 12 Weeks in Subjects With Fibromyalgia

description: A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in particular the widespread pain associated with this condition. A total 160 subjects (80 per treatment arm) are being recruited from approximately 25 centres in 9 European countries. Male and female subjects greater than 18 years of age with a diagnosis of primary fibromyalgia, as defined by the American College of Rheumatology (ACR) criteria, are eligible for study entry. Subjects will receive either ropinirole (1-24mg) or placebo, depending upon a statistically defined allocation to treatment. The primary endpoint is improvement in pain score by 12 weeks of treatment. An 11 point numerical rating scale for the assessment of the subject's pain is being collected on a daily diary. In addition, the overall improvement in quality of life for the subject will be assessed by means of a number of subject-completed questionnaires during the treatment period. Safety of the treatment regimen will be assessed throughout the study.
DOI: 10.25934/00001001
title: A Randomized Cross-over Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Twice Daily Oral Administration of GSK1325756, Compared to Placebo, in Healthy Subjects; and the Pharmacokinetic Profile of Twice Daily Oral Administration of GSK1325756 in Healthy Fed and Fasted Elderly Subjects

description: This study will invite two groups of volunteers to participate. The data from one group of volunteers will be used to find out how much study drug, known as GSK1325756, is in the blood after taking the drug twice in one day. Data will also collected to find out if the level of cetain blood cells, known as neutrophils, change significantly after taking the study drug twice in one day. This group of volunteers will be aged 40 to 64 years of age. The data from the other group of volunteers will be used to find out if taking the study drug, GSK1325756, twice in one day with or without food, makes a difference to the level of study drug in the blood. This group of volunteers will also provide data to find out if any study drug metabolites are present in the bile, a fluid secreted by the liver. This group of volunteers will be aged 65 to 80 years of age.
DOI: 10.25934/00004442.0
title: Available IPD datapackage for study 'Effect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer's Disease as Compared With Placebo'

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: 10.25934/00004631
title: An Open-label Study of the Safety and Efficacy of Topiramate for Migraine Prophylaxis: Extension Study to CAPSS-277

description: The purpose of this study is to assess the long-term safety and effectiveness of topiramate for the prevention of migraine headaches in adults. Topiramate has been approved to prevent migraine headaches in adults.
DOI: 10.25934/00004782
title: An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)

description: Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antirheumatic drug (DMARD) regimens used in daily rheumatology practice. Subsequently, Part 2 will study if a strategy of intravenous (IV) golimumab to induce remission followed by SC golimumab to retain remission is superior to continuing a SC regimen.
DOI: 10.25934/00005014
title: Extension to Study MALARIA-055 PRI (NCT00866619) for Evaluation of Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine (SB257049) in Infants and Children in Africa

description: The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following a primary vaccination series (NCT00866619). No new subjects will be enrolled in this extension study.
DOI: 10.25934/00001770
title: An open, 3.5 year, immunogenicity follow-up of subjects who previously received GSK Biologicals’ dTpa vaccine or GSK Biologicals’ DTPa vaccine or Chiron Behring’s Td vaccine + either Pasteur Merieux’s Pa vaccine or GSK Biologicals’ pa vaccine, administered as a booster dose at age 4-6 years in study 208355/118 (APV-118)

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: 10.25934/00001838
title: A 4-week, randomized, double-blind, placebo run-in, parallel-group study in pediatric subjects with asthma aged 4-11 years to examine the pharmacodynamics and pharmacokinetics of the fluticasone propionate (FP) and salmeterol (SALM) combination product administered twice daily via the Diskus (FP 100mcg/SALM 50mcg) and the FP Diskus (FP 100mcg)

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: 10.25934/00000132
title: A Multicenter, Open-Label Conversion of Valproate Monotherapy to Lamotrigine Monotherapy in Patients With Epilepsy

description: This study includes patients 16 years of age or older with a confident diagnosis of epilepsy who are currently treated with an antiepileptic drug (AED) monotherapy but require a change in therapy due to inadequate seizure control and/or unacceptable side effects.
DOI: 10.25934/00000608
title: Long-term Follow-up Study to Assess Antibody Persistence in Children Previously Vaccinated With Four Doses of Pneumococcal Conjugate Vaccine in Primary Vaccination Study (105553) and Booster Vaccination Study (107046)

description: This protocol posting deals with objectives & outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in order to comply with the FDA AA (Sep 2007).
DOI: 10.25934/00001410
title: A Phase III, Observer-blinded Randomised, Multi-centre Clinical Study of the Safety, Immunogenicity and Consistency of Three Manufacturing Lots of GSK Biologicals' Candidate Tdap Vaccine as Compared to a US-licensed Td Vaccine When Given as a Booster Dose to Healthy Adolescents (10-18 Years of Age)

description: This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).
DOI: 10.25934/00000415
title: An Open-label Extension to Study 49653/461, to Assess the Long-term Safety of Rosiglitazone (Extended Release Tablets) in Subjects With Mild to Moderate Alzheimer's Disease

description: This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease.
DOI: 10.25934/00003155
title: A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg Once-Daily) Compared to AG-1749 (15 mg Once-Daily) in a 24-week Maintenance Treatment in Patients With Healed Erosive Esophagitis (EE).

description: The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared to lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the clinical dose.
DOI: 10.25934/00003747
title: An Open-label Study to Determine the Pharmacokinetics of Single-dose and/or Steady-state TPV/r 500/200 mg in Subjects With Mild and Moderate Hepatic Insufficiency

description: To determine the pharmacokinetics of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) 500/200 mg in subjects with mild to moderate hepatic insufficiency
DOI: 10.25934/00004434.0
title: Available IPD datapackage for study 'Effect of γ-Secretase Inhibition on the Progression of Alzheimer's Disease: LY450139 Versus Placebo'

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: 10.25934/00004959
title: A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1)

description: This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis
DOI: 10.25934/00002154
title: Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Seven Years and Older (209762)

description: The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR (Priorix®), comparing it to Merck"s MMR vaccine (M-M-R®II), which is approved for use in the US.
DOI: 10.25934/00002438
title: Phase II, Dose-Response, Safety and Efficacy Study of Oral TMX-67 in Subjects With Gout.

description: The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.
DOI: 10.25934/00002474
title: Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease

description: This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.
DOI: 10.25934/00002517
title: A Phase 3, Open-Label, Randomized, Long-Term Comparison of the Safety and Tolerability of the TAK-491 Plus Chlorthalidone Fixed-Dose Combination vs. Olmesartan Medoxomil-Hydrochlorothiazide Fixed-Dose Combination in Subjects With Essential Hypertension

description: The purpose of this study is to compare the safety and tolerability of azilsartan medoxomil plus chlorthalidone, once daily (QD), versus olmesartan medoxomil-hydrochlorothiazide in adults with essential hypertension.
DOI: 10.25934/00006192
title: Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Stage I-IIIB Breast Cancer and Oestrogen Receptor (ER) and/or Progesterone (PgR) Positive Tumours

description: The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.
DOI: 10.25934/00007291.0
title: Available IPD datapackage for study 'Attrition of TEAEs: Post Hoc Pooled Analysis'

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/pr00007616.0
title: Available IPD datapackage for study 'Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen'

description: Primary Objective: - To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen. Secondary Objectives:   -  To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was better tolerated than Cabazitaxel 25 mg/m².   -  To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:   -  Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or death due to any cause;   -  PSA Progression;   -  Pain progression;   -  Tumor response in participants with measurable disease (RECIST 1.1);   -  PSA response;   -  Pain response in participants with stable pain at baseline.   -  To compare Health-related Quality of Life (HRQoL).   -  To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.
DOI: 10.25934/pr00008422
title: Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16µg/24h Dose Group (LCS16 Arm) up to 5 Years

description: This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years
DOI: 10.25934/00000325
title: Demonstrate the Lot-to-lot Consistency of 3 Consecutive Production Lots of an Adjuvanted Influenza Vaccine Candidate and Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate Versus Fluarix™ Administered Intramuscularly in Elderly

description: The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
DOI: 10.25934/00000359
title: A Study to Evaluate Immunogenicity and Safety of Boostrix Compared to Adacel When Administered as a Booster Vaccination in Adults Aged 19 to 64 Years of Age

description: GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.
DOI: 10.25934/00001187
title: Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Quadrivalent Seasonal Influenza Candidate Vaccine GSK2321138A, Administered to Children Who Previously Participated in Study 115345

description: The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals' investigational vaccine GSK2321138A in children who previously participated in study 115345 (FLU D-QIV-004 PRI) (NCT01439360).
DOI: 10.25934/00001711
title:  multicenter, double-blind, placebo-controlled trial evaluating oral 256U87 for the treatment of herpes zoster in immunocompetent patients less than 50 years old

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: 10.25934/00002183
title: Identification of Migraine Headache Among Self-Described and/or Physician Diagnosed Sinus Headache Sufferers and Treatment with IMITREX† 50mg Tablets

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/pr00007231.0
title: Available IPD datapackage for study 'Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization'

description: This is a multi-center, double-blinded study of COVID-19 infected patients randomized 1:1 to daily losartan or placebo for 10 days or treatment failure (hospital admission).
DOI: 10.25934/pr00007468.0
title: Available IPD datapackage for study 'Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoC-2 Virus Infection (COVID-19). A Pilot, Randomized, Simple Blind, Placebo-controlled, Parallel-group Study'

description: Evaluation of the efficacy and safety of NTX in adult patients (≥18 years and <60 years), with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm. 135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Simple blind design. Primary endpoint: eradication of virus from patients' respiratory tract secretions by the 7th day of treatment.
DOI: 10.25934/00000561
title: Safety and Immunogenicity Study of an Additional Dose of HPV Vaccine (580299) in Young, Adult Women in North America.

description: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This study will further evaluate induction of immune memory and anamnestic responses in women who previously took part in the primary study (580299/001) and follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the primary study and participation in the follow-up study lasted approximately 6 years. In the primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints and had sustained antibody responses to both vaccine types over at least 5.5 years of follow-up. All subjects from North American study sites that completed the follow-up study will be invited to take part in the current study. The study will evaluate the safety and immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been immunologically primed in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.