cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.25934/pr00007765
title: A Multi-centre, One-arm Prospective Study to Evaluate Efficacy and Safety of Switching From Entecavir (ETV) to Tenofovir Disoproxil Fumarate (TDF) in Japanese Chronic Hepatitis B HBeAg-positive and HBV-DNA Undetectable Subjects

description: Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits Hepatitis B Virus (HBV) growth, and is marketed in Japan with an indication for inhibition of HBV growth in subjects with chronic hepatitis B associated with HBV growth and abnormal liver function. This study has been planned to evaluate the virological effects and safety of switching from ETV to TDF in chronic hepatitis B (hepatitis B e-antigen [HBeAg])-positive and HBV- deoxyribonucleic acid (DNA) undetectable subjects. This study is designed as a multi-center, one-arm, post-marketing clinical study to investigate the HBsAg reduction in subjects who have not achieved the long-term goal, the loss of hepatitis B surface antigen (HBsAg). The study will be conducted in HBeAg-positive and HBV-DNA undetectable subjects treated with ETV. After switching ETV to TDF, TDF will be administered for 96 weeks. Approximately 80 subjects will be screened to achieve 65 evaluable subjects.
DOI: 10.25934/pr00007935.0
title: Available datapackage for dataset 'SOAR.201818'

description: Data generation for antibiotic resistance of the main community-acquired respiratory tract infection pathogens such as Streptococcus pneumoniae and Haemophilus influenzae.
description: Results from the Survey of Antibiotic Resistance (SOAR) 2014-2016 in Bulgaria, Romania, Serbia, Croatia, Russia, Czech Republic, Ukraine, the Slovak Republic and Greece
DOI: 10.25934/pr00007920.0
title: Available datapackage for dataset 'SOAR.201818'

description: Data generation for antibiotic resistance of the main community-acquired respiratory tract infection pathogens such as Streptococcus pneumoniae and Haemophilus influenzae.
description: Results from the Survey of Antibiotic Resistance (SOAR) 2014-2016 in Bulgaria, Romania, Serbia, Croatia, Russia, Czech Republic, Ukraine, the Slovak Republic and Greece
DOI: 10.25934/00006795
title: A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Pregabalin (Bid) In Subjects With Post-traumatic Peripheral Neuropathic Pain

description: This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
DOI: 10.25934/pr00007935
title: SOAR.201818

description: Data generation for antibiotic resistance of the main community-acquired respiratory tract infection pathogens such as Streptococcus pneumoniae and Haemophilus influenzae.
description: Results from the Survey of Antibiotic Resistance (SOAR) 2014-2016 in Bulgaria, Romania, Serbia, Croatia, Russia, Czech Republic, Ukraine, the Slovak Republic and Greece
DOI: 10.25934/pr00007920
title: SOAR.201818

description: Data generation for antibiotic resistance of the main community-acquired respiratory tract infection pathogens such as Streptococcus pneumoniae and Haemophilus influenzae.
description: Results from the Survey of Antibiotic Resistance (SOAR) 2014-2016 in Bulgaria, Romania, Serbia, Croatia, Russia, Czech Republic, Ukraine, the Slovak Republic and Greece
DOI: 10.25934/pr00007952
title: B and T Cell Determinants of Influenza Vaccine Responses in the Elderly SLVP015 2009 (see companion study SDY460) {NCT01827462}

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/pr00007964
title: Systems Biology Analysis of the response to  Licensed Hepatitis B Vaccine (Engerix-B) (see companion study SDY690) {NCT02117934}

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/pr00007956
title: Plasmablast response to inactivated and live attenuated influenza vaccines (TIV3/TIV3 ID) SLVP021 2012 {NCT02141581}

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/pr00007960
title: Safety, Tolerability, and Immunogenicity of Plasmodium falciparum Sporozoite Vaccine Administered by Direct Venous Inoculation to Infants and Young Children {NCT02687373}

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/pr00007947
title: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination (TIV) SLVP015 2010 (See companion studies SDY315 2012 / SDY312 2009 / SDY314 2008 / SDY112 2011) {NCT01827462}

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: 10.25934/00001524
title: A Microdose Study to Describe the Intravenous Pharmacokinetics of GSK3191607 in Healthy Male Subjects Following Administration of [14C]-GSK3191607

description: This is an open-label, single-centre, non-randomized study to investigate the pharmacokinetics of GSK3191607, administered as a single intravenous (IV) dose in healthy male subjects. Six subjects will be administered an IV microdose of radio-labeled [14C]-GSK3191607. The study will provide an early readout on human pharmacokinetic parameters. The results of this study will be used to estimate the potential duration of anti-parasite effect in humans, define predicted clinical oral doses, and hence inform about the compound's potential safety margin. Each subject will participate in the study for up to 8 weeks, and will have a screening visit, one treatment period, eight outpatient visits, and a follow-up visit.
DOI: 10.25934/pr00008086
title: 12 weeks treatment with 0.1 mg or 0.25 mg or 0.5 mg roflumilast in patients with asthma (dose range finding 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/pr00008089
title: 12 weeks treatment with 500 mg roflumilast versus 400 mg beclomethasone dipropionate in patients with asthma. A double-blind, double dummy, randomized parallel group 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/pr00008094
title: 26 weeks treatment with 500 /mg roflumilast in patients with chronic obstructive pulmonary disease.

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: 10.25934/00007330
title: A Randomised Double Blind (Sponsor Unblinded), Single and Repeat Ascending Dose First Time in Human Study in Healthy Subjects, Cold Urticaria and Chronic Spontaneous Urticaria Subjects to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK2646264

description: This First Time in Human (FTIH) study, which will be performed in three parts, is designed to investigate the safety, local tolerability, pharmacokinetics and pharmacodynamics after single and repeat topical applications of up to 2 strengths of GSK2646264 and corresponding placebo within the same subject, in healthy adult subjects (Part A), subjects with cold urticaria (CU, Part B) and subjects with chronic spontaneous urticaria (CsU, Part C). The study will also measure short term effects of GSK2646264 on the number and size of weals in subjects with CsU, and in healthy subjects and subjects with CU following provocation tests.
DOI: 10.25934/pr00008128
title: A Randomised, Open-Label, Crossover, Phase I Study to Assess the Effect of Itraconazole, a CYP3A4 Inhibitor, on the Pharmacokinetics of ZD1839 at Doses of 250 and 500 mg in Healthy Male 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: 10.25934/00006652
title: A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab+Herceptin+Docetaxel Versus Placebo+Herceptin+Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

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/pr00007916
title: A Phase IIIb, Multi-center Open-label, Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With Methotrexate in Patients With Active Rheumatoid Arthritis Who Participated in C87077.

description: The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).
DOI: 10.25934/pr00008106
title: A Relative Bioavailability Study of the Fixed Dosed Combination of 2.5 mg Saxagliptin/1000 mg Metformin XR Relative to Coadministration of 2.5 mg Saxagliptin (Onglyza, Bristol-Myers Squibb and AstraZeneca) and 1000 mg Metformin IR (Glucophage, Merck-Serono) or 1000 mg Metformin XR (Glucophage XR, Merck-Serono) in Fed Conditions, and the Effect of a High Fat Meal on Fixed Dose Combination of 2.5 mg Saxagliptin/1000 mg Metformin XR in 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/pr00008221
title: A Phase I, Randomised, Two-Period, Single-Dose, Single-Centre, Crossover Gamma Scintigraphy Study to Assess the Pulmonary Deposition of Technetium-99m Radiolabelled Budesonide, Glycopyrronium and Formoterol Fumarate MDI, Following 3 s and 10 s Breath-Hold, in Healthy Male Subjects

description: This study is a 2 treatment period, single dose crossover, gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler. This study will be investigating how the drug (known as PT010) is distributed in the lungs following a 10 second or 3 second breath hold. The study will involve the following visits: 1 screening visits, 2 treatment visits, each separated by around 7 days (each with 1 overnight stay; from the evening before dosing until a minimum of 4 hours post-dose on the morning of Day 1) and a post-study follow up phone call. The study population will be 10 healthy males, aged between 28 and 50 years of age.
DOI: 10.25934/00006898
title: A Phase I/II Study of ZD1839 (Iressa) Given Concurrently With Radiotherapy in Patients With Non-Metastatic Prostate Cancer

description: To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer
DOI: 10.25934/pr00008110
title: A Phase I trial to assess the effect of rifampicin on the pharmacokinetics of a single intravenous dose of ICI 182,780 (ZD9238) in healthy male 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/pr00008119
title: A Randomised, Open-Label, 2-Way Crossover, Phase I Trial to Assess the\\r\\nEffect of Itraconazole, a CYP3A4 Inhibitor, on the Pharmacokinetics of\\r\\nZD1839 in Healthy Male 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/pr00008135
title: A Randomized, Single-blind, Two-treatment, Single-dose, Singlecenter, Placebo-controlled, Crossover Gamma Scintigraphy Study  to Assess the Pulmonary Deposition of 99mTc Radiolabeled  Glycopyrronium and Formoterol Fumarate MDI and Placebo MDI  in Healthy Male 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/pr00008274
title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial in
Subjects with Type 1 Diabetes Mellitus to Assess Safety and Changes in Insulin
Sensitivity and Daily Insulin Requirements in Response to ALD403

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: 10.25934/00005022
title: A Phase IV, Open-Label, Multi-Center Study to Evaluate the Safety and the 1-year Persistence of Antibody Response Among Children Who Received 4 Doses of the GSK MenACWY Conjugate Vaccine at 2, 4, 6 and 12 Months of Age in South Korea

description: This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian will be provided information about the trial. If interested and if eligible, they will then be asked to provide signed informed consent. The initial study visit can occur immediately after signed informed consent has been obtained. Approximately 135 subjects will be enrolled to receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.
DOI: 10.25934/pr00008111
title: A Phase I Trial to Assess the Metabolism, Excretion and Pharmacokinetics of a Single Intramuscular Dose of 18 mg [14C]-ICI 182,780 (ZD9238), Short-acting Formulation, in Healthy Male and Healthy Post-menopausal Female 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: 10.25934/00003679
title: A Retrospective Cohort Study With Chart Review to Assess the Management of Major Bleeding Events in NVAF Patients Treated With Dabigatran Etexilate

description: This study is being conducted to collect data on the management of major bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.
DOI: 10.25934/pr00003640.1
title: Available IPD datapackage for study 'A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control'

description: The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.
DOI: 10.25934/pr00004986.0
title: Available IPD datapackage for study 'Early Clinical Evaluation of a New Antidepressant: A Double-Blind Parallel Study Comparing Paroxetine 30mg Daily with Amitriptyline 150mg Daily'

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/pr00007230.1
title: Available IPD datapackage for study 'Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization'

description: This is a multi-center, double-blinded study of COVID-19 infected patients requiring inpatient hospital admission randomized 1:1 to daily Losartan or placebo for 7 days or hospital discharge.
DOI: 10.25934/pr00008153
title: A Single-centre, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects Under Fed Conditions

description: The primary objective of this study is to assess the pharmacokinetic parameters of saxagliptin and metformin in healthy male Chinese subjects.
DOI: 10.25934/00001909
title: A randomised, double-blind, triple-dummy, placebo-controlled, five-way crossover study to investigate the bronchoprotective effects against methacholine challenge and the bronchodilatory effects of single doses of salmeterol (25, 50 and 200 µg) and salbutamol (200 µg) over a 24-hour period in atopic non-asthmatic 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: 10.25934/00002209
title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety And Preliminary Efficacy of Neoadjuvant Therapy With GI198745 in Subjects With Localized Prostate Cancer Undergoing Radical Prostatectomy.

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: 10.25934/00006611
title: Incidence of Symptomatic Venous Thromboembolic Events and Major Bleeding Events After Dabigatran Etexilate in Patients Subject to Subject to Elective Total Hip or Knee Replacement Surgery.

description: Open, prospective, uncontrolled, observational cohort study.