cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.25934/pr00004839.0
title: Available datapackage for study 'An Open-Label Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Subjects With Metastatic Castration-Resistant Prostate Cancer'

description: The purpose of this study is to establish the safety profile of oral (by mouth) abiraterone acetate and oral prednisone following short-term administration after standardized low-fat or high-fat meals to patients with metastatic (spreading) castration-resistant prostate cancer (mCRPC).
DOI: 10.25934/pr00004876.0
title: Available IPD datapackage for study 'A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer'

description: The purpose of this registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments, there is a need for a current and improved understanding of how these treatments fit into the current treatment paradigm for mCRPC, how they are combined and sequenced, and how their relative effectiveness profiles emerge outside of a clinical trial setting. This will be based on documentation and description of sequencing of treatment initiation, termination, and duration; relative effectiveness of treatments; defined medical resource utilization (MRU) and quality-of-life parameters and follow-up for survival.
DOI: 10.25934/pr00005173.0
title: Available IPD datapackage for study 'A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy'

description: The purpose of this study is to assess the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer (a disease in which cells in the prostate gland [a gland in the male reproductive system found below the bladder and in front of the rectum] become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane (docetaxel)-based chemotherapy.
DOI: 10.25934/pr00007735
title: Multicentre, Single-arm, Open Label Clinical Trial Intended to Provide Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen and to Document Safety of Cabazitaxel in These Patients

description: The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or after docetaxel and to document the overall safety of cabazitaxel in these patients. Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.
DOI: 10.25934/pr00007750.0
title: Available IPD datapackage for study 'A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)'

description: The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).
DOI: 10.25934/pr00008416.0
title: Available datapackage for study 'A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study of Regorafenib in Patients With Hepatocellular Carcinoma (HCC) After Sorafenib'

description: The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.
DOI: 10.25934/pr00008918
title: Interventional, Open-label Effectiveness Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder Comorbid With Generalized Anxiety Disorder

description: This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder.
DOI: 10.25934/00000661
title: Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.

description: The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
DOI: 10.25934/00001007
title: Comparative Efficacy of Dutasteride Plus Tamulsoin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice With Step-up Therapy to Tamsulosin in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement.

description: Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic benign prostate hyperplasia (BPH). Once consented, each subject will undergo screening procedures to ensure the prostate volume and post void residual are within eligible range. If all entry criteria are met, subjects will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation will be initiated when no improvement from baseline is scored using the International Prostate Symptom Score (version 2) (IPSS) questionnaire. After randomisation, the subjects return to site at one month, then every 13 weeks until two years of treatment is complete or they are withdrawn. Key assessments, such as Adverse Events (AE's) and concomitant medication monitoring and completion of the quality of life questionnaires are performed at each visit and the data recorded.
DOI: 10.25934/00004683
title: Galantamine in the Treatment of Alzheimer's Disease: Flexible Dose Range Trial

description: The purpose of this study is to evaluate the safety and effectiveness of galantamine (a drug for treating dementia) versus placebo in the treatment of patients with Alzheimer's disease using a flexible dose design.
DOI: 10.25934/00005135.0
title: Available IPD datapackage for study 'A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis'

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: 10.25934/00005808
title: Postmarketing Surveillance Study: A Randomized, Open-Label, 3-Month Interventional Study of Tadalafil Effectiveness (2.5 mg and 5 mg) and Long-Term Safety Administered Once Daily in Chinese Men With Erectile Dysfunction

description: The purpose of this study is to evaluate the safety and effectiveness of the study drug, taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED). The study will last about up to 25 months for each participant.
DOI: 10.25934/00006840
title: Randomised Double Blind, Controlled, Parallel Group, Multicentre Study of a Subcutaneous Formulation of Icatibant Versus Oral Tranexamic Acid for the Treatment of Hereditary Angioedema (HAE)

description: Primary Outcome Measures: The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase. H0: λ icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ tranexamic acid ≠1 Where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid refers to the hazard rate under tranexamic acid. Secondary Outcome Measures:   -  Additional efficacy assessments (Time to Almost Complete Symptom Relief)   -  Safety and tolerability   -  Pharmacoeconomics
DOI: 10.25934/pr00007468
title: 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/pr00008726
title: Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

description: Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions
DOI: 10.25934/pr00010726
title: Usage Tracking Test Data Set 6 - 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: 10.7483/opendata.delphi.pqnn.zrwn
title: DELPHI simulation data xs_kk2f4146sigmaqlowqq_e91.25_c98_1l_e1
DOI: 10.25934/00000397
title: PD of Hydrofluoroalkane Propellant of Inhaled Fluticasone Propionate Following Administration in Pediatric Subjects 6-12 Months of Age With Asthma

description: The purpose of this study is to address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to <12 months, following administration of fluticasone propionate HFA.
DOI: 10.25934/00000766
title: OM6X: An Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Lovaza (Previously Omacor®) and Simvastatin Therapy in Hypertriglyceridemic Subjects

description: In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza® (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin plus placebo to simvastatin plus Lovaza® for lowering non-High Density Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at 12 and 24 months.
DOI: 10.25934/00001367
title: Long Term Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine 1437173A and Assessment of Re-vaccination With 2 Additional Doses, in Healthy Subjects Aged 60 Years of Age and Older

description: The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine as well as safety up to 10 years after the first dose of initial vaccination course. This study will also assess immune responses after re-vaccination with 2 additional doses of the HZ/su administered at ten years after first dose of initial vaccination course from study Zoster-003 (NCT00434577).
DOI: 10.25934/00001875
title: SMART: A Double-Blind, Randomized, Placebo-Controlled Surveillance Study of Asthma Event Outcomes in Subjects Receiving Either Usual Pharmacotherapy of Asthma or Usual Pharmacotherapy Plus Salmeterol 42mcg Twice 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: 10.25934/00003671
title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single 50 mg Dose of BI 10773 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Type 2 Diabetes and Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase 1 Trial

description: Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773
DOI: 10.25934/00003806
title: Study of GSK1203486A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

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: 10.25934/00004716
title: Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared With Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute Manic and Mixed Episodes in Bipolar Disorder

description: The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone ER on global functioning, and will compare the effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks.
DOI: 10.25934/00004907
title: Phase 2 study of ET-743 as second or third line therapy in advanced and/or metastatic soft tissue sarcoma patients

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: 10.25934/00005864
title: Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human) 10% (IGIV, 10%) Administered Intravenously or Subcutaneously in Subjects With Primary Immunodeficiency Diseases

description: The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with IGIV, 10% in subjects with primary immunodeficiency (PID) disorders.
DOI: 10.25934/pr00008000
title: Vaccine Safety and Placebo Groups Arm 1C & 1D with CHMI: Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium falciparum NF54

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/pr00009226
title: Study 200894: A Double-blind, Double-dummy, Randomized, Parallel Group, Placebo-controlled Superiority Study to Evaluate the Efficacy and Safety of Tafenoquine (SB-252263, WR238605) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax Malaria

description: Tafenoquine (TQ) is an 8-aminoquinoline anti-malarial drug which is in development as a single-dose treatment for the radical cure of P.vivax malaria when given with standard doses of chloroquine. Currently, the only available drug for radical cure is primaquine (PQ) which requires administration over 14 days, resulting in poor compliance. In Indonesia, chloroquine has been replaced by artemisinin-based combination therapy (i.e. ACTs) due to widespread chloroquine resistance. This study will evaluate the efficacy and safety of a single dose of tafenoquine when co-administered with an ACT (i.e. DHA-PQP). This single-center, double-blind, double-dummy, randomized study will test the superiority of DHA-PQP plus TQ against DHA-PQP alone in the prevention of P. vivax malaria relapse at 6 months. The study will be conducted in male Indonesian soldiers diagnosed with P.vivax malaria on return from deployment to a malarious region of Indonesia. A PQ plus DHA-PQP comparator arm is included to provide an informal comparison against the standard 14 day treatment for P.vivax malaria in Indonesia. Subjects who are glucose-6-phosphate dehydrogenase deficient (G6PD deficient) will be excluded due to the risk of acute hemolysis following dosing with 8-aminoquinolines drugs. Subjects who have a recurrence of P.vivax malaria during the study will be treated with an ACT plus PQ (0.5mg/kg for 14 days), in line with local treatment guidelines. At the end of the 6 month follow up period, any subject who has not relapsed will be given open label PQ (0.5mg/kg daily for 14 days) to minimize the likelihood of relapse after the study. Approximately 200 subjects will be screened to achieve 150 randomized subjects. The total duration of study for each subject will be 180-195 days. This study is being carried out to support registration of TQ in Indonesia and other countries where ACTs are first line therapy.
DOI: 10.25934/00001485
title: Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic as Post-consolidation Therapy in Adult Patients With Acute Myeloid Leukemia

description: This study is being done to evaluate the safety of a WT1 Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-consolidation therapy in adult patients with WT1-positive Acute Myeloid Leukemia in first complete remission. It will also be analyzed to what extent this treatment induces an immune response, specific to the malignancy.
DOI: 10.25934/00002945
title: Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients

description: To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
DOI: 10.25934/00003501
title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Weeks Treatment With Three Oral Doses of BI 10773 as Tablets in Female and Male Patients With Type 2 Diabetes

description: Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773
DOI: 10.25934/00004013
title: Persistence study of GSK Biologicals’ Tdap vaccine (776423), 1, 3, 5 and 9 years following administration as a single dose in NCT00346073 study and to evaluate the immunogenicity and safety of Boostrix as a second dose of Tdap, when administered at Year 9 {NCT00489970}


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: 10.25934/00006378
title: Pharmacokinetics of roflumilast after single dose oral administration of 0.5 mg to healthy elderly 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/pr00009799
title: Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation in patients with chronic heart failure and left ventricular systolic dysfunction. A 6 to 12-month randomised double blind parallel groups multicentre 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: 10.25934/00002723
title: TAK-375 Clinical Phase I Study (Multiple dose 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: 10.25934/00005210
title: Special Survey Long-term Treatment

description: Since Spiriva Inhalation Capsules 18mcg (hereinafter this product) are indicated for treatment of patients with chronic obstructive pulmonary disease (i.e. patients with chronic bronchitis or pulmonary emphysema) and usually intended for long-term use, the present survey is conducted to collect safety and effectiveness information on the use of this product for long period of time in daily clinical settings, and to obtain proper drug use information.