cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.25934/00007377
title: An Observer-blind, Dose Ranging Safety and Immunogenicity Study of GSK Biologicals' GSK1557484A Vaccine in Children 6 to Less Than 36 Months of Age

description: The purpose of this study is to assess the safety and immunogenicity of different formulations of GSK Biologicals' influenza candidate vaccine GSK1557484A, in children 6-35 months of age.
DOI: 10.25934/pr00004988.0
title: Available IPD datapackage for study 'A trial to assess the effectiveness and tolerance of paroxetine by double-blind comparison with amitriptyline in the treatment of depressed patients in General Practice'

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/pr00005143.1
title: Available IPD datapackage for study 'A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (≥ 16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or Generalized Tonic-clonic Seizures.'

description: Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).
DOI: 10.25934/pr00007117.0
title: Available IPD datapackage for study 'A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer'

description: The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS).
DOI: 10.25934/pr00007946
title: Antimicrobial Response to Oral Vitamin D3 in Patients with Psoriasis (CATH 03) {NCT00789880}

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/pr00008256
title: An Open Label Phase 3 Trial to Evaluate the Safety of ALD403 Administered Intravenously in Patients With Chronic Migraines

description: An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine
DOI: 10.25934/pr00008306.0
title: Available datapackage for dataset 'Vivli Test Dataset - do not request tis'

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 in Eastern Europe
DOI: 10.25934/00001141
title: An Interaction Study to Assess the Effect of the Ezogabine/Retigabine and the Main Metabolite NAMR on the Pharmacokinetics of Digoxin in Healthy Volunteers

description: An interaction study to assess the effect of the ezogabine/retigabine and the main metabolite NAMR on the pharmacokinetics of digoxin in healthy volunteers
DOI: 10.25934/00006014
title: Specific Use-Result Surveillance of Spiriva Respimat in Asthmatics (Patients With Mild and Moderate Persistent Asthma)

description: The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use
DOI: 10.25934/00006429
title: An open phase II study of ZD1839 (Iressa) plus best supportive care (BSC) in chemotherapy-naiive patients ineligible for chemotherapy with advanced  (stage IIIB or IV) non-small cell lung 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/pr00004780.1
title: Available IPD datapackage for study 'A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy'

description: The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.
DOI: 10.25934/pr00007516
title: Immunogenicity, Reactogenicity and Safety Study of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) When Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age

description: MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries. The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by storage at 2-8ºC.
DOI: 10.25934/pr00008278
title: Reactogenicity, Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults

description: The purpose of this study is to assess the reactogenicity, safety and immunogenicity of different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted) in 18 to 39 year-old healthy subjects. Subjects will be enrolled and vaccinated with one or 2 primary dose(s) followed by a booster dose one year later.
DOI: 10.25934/00001219
title: Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Versus Intramuscularly in Adults Aged 50 Years or Older

description: The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC) as compared to intramuscularly (IM) to people 50 years of age and older.
DOI: 10.25934/pr00005106.1
title: Available IPD datapackage for study 'A Multicenter, Double-blind, Randomized, Parallel Group, Positive-controlled Trial Comparing the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) to Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy for up to a Maximum of 121 Weeks in Subjects (≥ 16 Years) Newly or Recently Diagnosed as Suffering From Epilepsy, and Experiencing Partial or Generalized Tonic-clonic Seizures'

description: A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized tonic-clonic seizures.
DOI: 10.25934/pr00007933
title: SMART EngageZone - data request

description: Global surveillance; resistance trend analysis; fulfilment of regulatory commitments.
description: Specimens are collected, as per hospital protocol, from patients suspected with having an infectious disease. Specimens are sent to the microbiology lab for identification, and susceptibility testing, of suspected pathogen.
Clinical isolates collected for clinical practice are then submitted to the surveillance program if they fit the criteria (first isolate per patient; sources included UTI, IAI, RTI or BSI). Isolates are sent to the central lab for further workup.
Inclusion: first gram negative (GN) isolate (and only one isolate) per patient from UTI, IAI, RTI and (from 2018) BSI. Isolates are from hospitalized patients. Exclusion: more than 1 isolate per patient or from sources other than above; no gram-positive isolates. Participating labs indicate on form whether isolate collected =<48h prior to admission to the hospital or >48h after admission.
DOI: 10.25934/pr00008060
title: Systemic availability of budesonide inhaled as suspension aerosol with metered dose inhaler and as dry powder  with Turbuhaler.

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/pr00008133
title: with Mild to Moderate Plaque Psoriasis or Atopic Dermatitis.

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: 10.25934/00005457
title: Multicenter, Open-label, Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial Hypertension

description: This study enrolls patients with pulmonary arterial hypertension (PAH) treated with inhaled treprostinil. During the study, the treatment with inhaled treprostinil will be tapered off and simultaneously replaced with an oral treatment (selexipag) targeting the disease in a similar way. The purpose of the study is i) to investigate the safety and tolerability of oral selexipag in patients who transition from inhaled treprostinil, ii) to investigate the effects of oral selexipag on PAH severity and exercise ability before and after transition, and iii) to gain new information about the patients experience taking oral selexipag compared to inhaled treprostinil. Study participants may stay in the study until the FDA has granted marketing authorization.
DOI: 10.25934/pr00008077
title: Pharmacokinetics of roflumilast after single oral dose administration of 0.25 mg to patients with liver cirrhosis Child Pugh A in comparison to healthy subjects\n

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/pr00008078
title: Pharmacokinetics of roflumilast after single oral dose administration of 0.5 mg to patients suffering from severe renal impairment

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/pr00008306
title: Vivli Test Dataset - do not request tis

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 in Eastern Europe
DOI: 10.25934/00005824
title: Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Children in Africa

description: The purpose of this study is to assess the safety and reactogenicity of a single IM dose of the GSK3390107A (ChAd3 EBO-Z) vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years, separately. Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational GSK3390107A (ChAd3-EBO-Z) vaccine to afford at least partial protection, all children in the study will receive the investigational GSK3390107A (ChAd3 EBO-Z) vaccine. The children in the Group GSK3390107A+Nimenrix will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine at Day 0 of the study, whereas the children in the Group Nimenrix+GSK3390107A will receive Nimenrix at Day 0 (as a control). At Month 6, the children in the Group Nimenrix+GSK3390107A will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine (provided that no safety concerns are raised), whereas the children in the Group GSK3390107A+Nimenrix will receive Nimenrix.
DOI: 10.25934/pr00008095
title: Withdrawal of 500/mg roflumilast after 12 weeks of treatment versus continued treatment for 24 weeks versus placebo 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: 10.15468/dl.k98n84
title: Occurrence Download

description: A dataset containing 7391080 species occurrences available in GBIF matching the query:
{
 "and" : [
 "HasGeospatialIssue is one of (FALSE)",
 "OccurrenceStatus is one of (Present)",
 "HasCoordinate is one of (TRUE)",
 "Geometry POLYGON ((-74.00598329181811 40.80567069444212, -74.01801704966867 40.805222584342076, -74.02993443277991 40.80388258763908, -74.04162020584276 40.801663662690714, -74.05296140070753 40.798587265749454, -74.0638484208529 40.794683140968154, -74.07417611131521 40.78998902942976, -74.08384478321402 40.78455030018015, -74.09276118254998 40.7784195070314, -74.1008393936099 40.771655875647845, -74.1080016680777 40.7643247261183, -74.11417917180724 40.75649683684905, -74.11931264214957 40.74824775617574, -74.12335294972807 40.739657068584414, -74.12626155960555 40.73080762284685, -74.12801088787131 40.72178472971162, -74.12858455078114 40.712675337045845, -74.12797750469156 40.703567190495036, -74.12619607613075 40.694547987817835, -74.12325788242899 40.68570453506088, -74.11919164437978 40.67712191266851, -74.11403689341147 40.66888265947455, -74.10784357670552 40.66106598230363, -74.10067156460161 40.65374699861936, -74.09259006546809 40.64699601930321, -74.08367695399204 40.64087787823275, -74.07401801954816 40.63545131485941, -74.06370614194121 40.6307684154657, -74.05284040237935 40.62687411821844, -74.04152513802774 40.62380578653085, -74.02986894891025 40.62159285460947, -74.0179836662752 40.62025654839548, -74.00598329181811 40.619809684421284, -73.99398291736102 40.62025654839548, -73.98209763472599 40.62159285460947, -73.97044144560849 40.62380578653085, -73.95912618125688 40.62687411821844, -73.94826044169503 40.6307684154657, -73.93794856408806 40.63545131485941, -73.92828962964418 40.64087787823275, -73.91937651816814 40.64699601930321, -73.91129501903461 40.65374699861936, -73.90412300693072 40.66106598230363, -73.89792969022477 40.66888265947455, -73.89277493925646 40.67712191266851, -73.88870870120725 40.68570453506088, -73.88577050750548 40.694547987817835, -73.88398907894467 40.703567190495036, -73.88338203285508 40.712675337045845, -73.88395569576491 40.72178472971162, -73.88570502403067 40.73080762284685, -73.88861363390815 40.739657068584414, -73.89265394148667 40.74824775617574, -73.89778741182899 40.75649683684905, -73.90396491555853 40.7643247261183, -73.91112719002632 40.771655875647845, -73.91920540108624 40.7784195070314, -73.92812180042222 40.78455030018015, -73.93779047232101 40.78998902942976, -73.94811816278333 40.794683140968154, -73.95900518292869 40.798587265749454, -73.97034637779346 40.801663662690714, -73.98203215085631 40.80388258763908, -73.99394953396757 40.805222584342076, -74.00598329181811 40.80567069444212))"
 ]
}

 The dataset includes 7391080 records from 310 constituent datasets; see https://api.gbif.org/v1/occurrence/download/0012453-241126133413365/datasets/export for details.
 
Data from some individual datasets included in this download may be licensed under less restrictive terms.
DOI: 10.25934/00001194
title: A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

description: This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of FF/VI Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on lung function in COPD subjects. Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to evaluate the subject's adherence with study treatment, study procedures and assessment of disease stability. At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the Randomization Criteria will be randomized to double-blind study medication (12-week treatment period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1 inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return to the clinic at the end of the treatment period. A follow-up phone contact will be performed approximately 7 days after the last clinic visit. The overall study duration (Screening to Follow-up) for each subject is approximately 15 weeks.
DOI: 10.6084/m9.figshare.27284166
title: Efficient Sampling From the Watson Distribution in Arbitrary Dimensions

description: In this article, we present two efficient methods for sampling from the Watson distribution in arbitrary dimensions. The first method adapts the rejection sampling algorithm from <i>Kent, Ganeiber, and Mardia</i>, originally designed for Bingham distributions, using angular central Gaussian envelopes. For the Watson distribution, we derive a closed-form expression for the parameters that maximize sampling efficiency, which is further investigated and bounded by asymptotic results. This approach avoids the curse of dimensionality through a smart matrix inversion, enabling fast runtimes even in high dimensions. The second method, based on <i>Saw</i>, employs adaptive rejection sampling from a projected distribution. This algorithm is also effective in all dimensions and offers rapid sampling capabilities. Finally, our simulation study compares the two main methods, revealing that each excels under different conditions: the first method is more efficient for small samples or large dimensions, while the second performs better with larger samples and more concentrated distributions. Both algorithms are available in the R package watson on CRAN. Supplementary materials for this article are available online.
DOI: 10.6084/m9.figshare.27284166.v1
title: Efficient Sampling From the Watson Distribution in Arbitrary Dimensions

description: In this article, we present two efficient methods for sampling from the Watson distribution in arbitrary dimensions. The first method adapts the rejection sampling algorithm from <i>Kent, Ganeiber, and Mardia</i>, originally designed for Bingham distributions, using angular central Gaussian envelopes. For the Watson distribution, we derive a closed-form expression for the parameters that maximize sampling efficiency, which is further investigated and bounded by asymptotic results. This approach avoids the curse of dimensionality through a smart matrix inversion, enabling fast runtimes even in high dimensions. The second method, based on <i>Saw</i>, employs adaptive rejection sampling from a projected distribution. This algorithm is also effective in all dimensions and offers rapid sampling capabilities. Finally, our simulation study compares the two main methods, revealing that each excels under different conditions: the first method is more efficient for small samples or large dimensions, while the second performs better with larger samples and more concentrated distributions. Both algorithms are available in the R package watson on CRAN. Supplementary materials for this article are available online.
DOI: 10.25934/00004968
title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Renally-Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-5)

description: This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.