cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.25934/00001119
title: An Open-label, Randomized, Single Dose, Multi-stage, Cross-over Study to Determine the Relative Bioavailability of Fixed Dose Combination Products Containing a 3-oblong Dutasteride Soft Gel Capsule and Tamsulosin (0.5 mg Dutasteride /0.2 mg Tamsulosin HCl) Pellets Having a Range of Tamsulosin Release Rates Produced by Different Mixtures of Enteric Coated and Uncoated Pellets Relative to Harnal-D Tablets, in Healthy Male Subjects of North East Asian Ancestry.

description: This study is an open-label, randomized, single dose, multi-stage, cross-over study in healthy male subjects of North East Asian ancestry. The aims are to:   -  evaluate the pharmacokinetic parameters of several formulations of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.2 mg tablets in the fasted state in order to define a formulation which is bioequivalent to a 0.2 mg orally disintegrating tamsulosin tablet, (Harnal-D Tablets)   -  determine the effect of food on the relative bioavailability of tamsulosin in the FDC product which is assessed to be bioequivalent to Harnal-D Tablets in the fasted state   -  assess the effect of water on the relative bioavailability of tamsulosin in Harnal-D Tablets in the fasted state   -  assess the safety and tolerability of dosing with the different FDC capsule formulations Subjects will receive single oral doses in at least one treatment period; treatment periods will be separated by a 5-10 day washout period. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate and review of adverse events. Each stage of the study will enrol 18 subjects to ensure 16 complete. Subjects may consent to participate in more than one stage.
DOI: 10.25934/00003653
title: A Prospective, Open Label Study Evaluating the Efficacy of Two Management Strategies (Pantoprazole 40 mg q.a.m. and Taking Pradaxa® With Food (Within 30 Minutes After a Meal) on Gastrointestinal Symptoms (GIS) in Patients Newly on Treatment With Pradaxa® 150 mg b.i.d., 110 mg b.i.d. or 75 mg b.i.d. for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation (NVAF)

description: This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125 sites in North America will be recruited. Patients who report GIS during the 3 month treatment period will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.
DOI: 10.25934/00005230
title: A 12-week, Randomised, Placebo-controlled, Double-blind, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Tiotropium Bromide (18 µg) Delivered Via the HandiHaler® in Patients With Newly Diagnosed and/or Maintenance Treatment naïve Chronic Obstructive Pulmonary Disease (COPD) Experiencing an Acute Respiratory Infection (TICARI 1: Tiotropium In COPD Patients With an Acute Respiratory Infection 1)

description: The aim of the study is to investigate whether the early introduction of maintenance bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on the recovery of symptoms. It also represents an opportunity to identify COPD patients earlier in their disease state and start maintenance therapy, if appropriate.
DOI: 10.15468/dl.h38fxx
title: Occurrence Download

description: A dataset containing 6767 species occurrences available in GBIF matching the query:
{
 "and" : [
 "Country is one of (Spain, Portugal)",
 "HasCoordinate is true",
 "HasGeospatialIssue is false",
 "TaxonKey is Canis lupus Linnaeus, 1758"
 ]
}

 The dataset includes 6767 records from 41 constituent datasets; see https://api.gbif.org/v1/occurrence/download/0002166-241125135418005/datasets/export for details.
 
Data from some individual datasets included in this download may be licensed under less restrictive terms.
DOI: 10.25934/00001109
title: A Randomized, Double-blind, Placebo-controlled First Time Into Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intranasal Dosing With GSK2245035, a TLR7 Agonist, in Healthy Volunteers and Allergic Rhinitics

description: GSK2245035 is a highly selective Toll-like Receptor 7(TLR7) agonist capable of preferentially inducing the production of interferon alpha (IFNα) versus tumor necrosis factor alpha (TNFα). The aim of this FTIH study is to collect tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) information to enable the identification of appropriate safe doses of intranasal (i.n) GSK2245035, associated with up-regulation of TLR7-mediated genes in the nasal milieu, for use in subsequent clinical drug development studies. There will be two parts to the study: Healthy Volunteers will be dosed in escalating single doses in Part 1, followed by Allergic Rhinitis (AR) subjects dosed similarly in Part 2.
DOI: 10.25934/00001107
title: Two Part Study to Investigate Pharmacokinetics (PK) & Pharamcodynamics (PD) of SB-705498 in Cough. Part A:Open Label Study in Healthy Subjects to Determine Exposure to SB-705498. Part B:Double-blind, Placebo Controlled, Cross Over Study to Investigate Effect of SB-705498 on Capsaicin Induced Cough and 24 Hour Cough Counts in Cough Patients

description: This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled capsaicin challenge
DOI: 10.25934/00001106
title: A Two-part, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamicsof Single and Repeat Doses of Intravenously Infused GSK1995057 in Healthy Subjects.

description: The main purpose of the study is to see how safe GSK1995057 is and how well it is tolerated after dosing. The study will also investigate how GSK1995057 is taken up, metabolised (chemically broken down), distributed through the body and excreted, and what some of the effects of the study drug are.
DOI: 10.15468/dl.gx488f
title: Occurrence Download

description: A dataset containing 0 species occurrences available in GBIF matching the query:
{
 "and" : [
 "HasGeospatialIssue is false",
 "HasCoordinate is true",
 "OccurrenceStatus is Present",
 {
 "not" : {
 "BasisOfRecord" : [
 "is one of (Fossil, Living Specimen)"
 ]
 }
 },
 "TaxonKey is one of (Platycarya longzhouensis S.Ye Liang & G.J.Liang)"
 ]
}

 The dataset includes 0 records from 0 constituent datasets; see https://api.gbif.org/v1/occurrence/download/0002167-241125135418005/datasets/export for details.
DOI: 10.25934/00001104
title: An Open-label, Randomized, Single Dose, Four-Period Crossover Study to Compare the Bioavailability of Fixed Dose Combination Capsule Formulations of Dutasteride and Tamsulosin Hydrochloride (0.5 mg/0.2 mg) With 10% and 15% of Enteric Coated Pellets With Harnal-D Tablets and Harnal Capsules Co-administered With Dutasteride (0.5 mg) Soft Gel Capsules in Healthy Male Subjects of North East Asian Ancestry

description: This study aims to determine the relative bioavailability of tamsulosin hydrochloride in a fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.2 mg tablets or capsules. Two fixed dose combination capsules will be tested; one will contain tamsulosin hydrochloride pellets with a 15% enteric coating, and the other tamsulosin hydrochloride pellets with a 10% enteric coat. In addition, two formulations of tamsulosin hydrochloride will be tested in the co-administration with dutasteride 0.5 mg; a 0.2 mg oral disintegrating tablet and a 0.2 mg hard shell capsule. This will be an open-label, randomized, single dose, four-period crossover in healthy male subjects of North East Asian ancestry. Subjects will receive single oral doses in four treatment periods, each separated by a 5-10 day washout period. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate and review of adverse events. The study will enrol approximately 30 healthy male subjects to ensure that 24 complete the study.
DOI: 10.11583/dtu.27684813
title: NordTank NTK 500/41 Wind Turbine Definition along with Noise and SCADA Measurement Data

description: This repository contains a collection of data related to the NordTank wind turbine, model NTK 500/41, with a rated power of 500 kW and a 41 m diameter rotor. These data consist of:The definition of this stall-regulated wind turbine, including its overall geometry, its blade aerodynamic properties, and its main operational conditions.Field measurement data of its acoustic emission during three periods of time (of the order of one hour each), including the simultaneously acquired turbine SCADA data. The latter also include data acquired from sensors on a nearby met mast.A numerical model set-up for this turbine in order to run the aeroelastic simulation code HAWC2, including its aerodynamic noise module.Further information about how to extract, interpret, and use this dataset can be found in the README_MAIN(.md or pdf) file in the main repository folder.<b><i>Copyright notices:</i></b><i>All data available in the present repository are covered by license CC BY-NC-SA 4.0.</i><i>For software codes, different licenses apply:</i><i>read_ntk_data.py © Josephine Pockelé, 2024. License MIT (Technische Universiteit Delft hereby disclaims all copyright interest in the program “read_ntk_data.py” written by the Author(s). Henri Werij, Faculty of Aerospace Engineering, Technische Universiteit Delft).</i><i>read_tim_file.f90 © Technical University of Denmark, 2024. License MIT.</i><b><i>Version:</i></b><i>This is Version 2 of the dataset, for which a corrupted file (in Version 1) has been corrected.</i><br>
DOI: 10.11583/dtu.27684813.v1
title: NordTank NTK 500/41 Wind Turbine Definition along with Noise and SCADA Measurement Data

description: This repository contains a collection of data related to the NordTank wind turbine, model NTK 500/41, with a rated power of 500 kW and a 41 m diameter rotor. These data consist of:The definition of this stall-regulated wind turbine, including its overall geometry, its blade aerodynamic properties, and its main operational conditions.Field measurement data of its acoustic emission during three periods of time (of the order of one hour each), including the simultaneously acquired turbine SCADA data. The latter also include data acquired from sensors on a nearby met mast.A numerical model set-up for this turbine in order to run the aeroelastic simulation code HAWC2, including its aerodynamic noise module.Further information about how to extract, interpret, and use this dataset can be found in the README_MAIN(.md or pdf) file in the main repository folder.<b><i>Copyright notices:</i></b><i>All data available in the present repository are covered by license CC BY-NC-SA 4.0.</i><i>For software codes, different licenses apply:</i><i>read_ntk_data.py © Josephine Pockelé, 2024. License MIT (Technische Universiteit Delft hereby disclaims all copyright interest in the program “read_ntk_data.py” written by the Author(s). Henri Werij, Faculty of Aerospace Engineering, Technische Universiteit Delft).</i><i>read_tim_file.f90 © Technical University of Denmark, 2024. License MIT.</i><br>
DOI: 10.25934/00004841
title: Comparative Study of the Effect on Acne With Norgestimate Containing Triphasic Oral Contraceptive and Biphasic Preparation Containing Desogestrel

description: The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment of female participants with mild to moderate acne vulgaris (pimples).
DOI: 10.25934/00003651
title: LUX-Lung 7: A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung

description: This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.
DOI: 10.25934/00001101
title: An Open-label, Randomised, Crossover Study to Assess the Relative Bioavailability of Different 2mg Formulations of GSK2018682(S1P1 Agonist) in Healthy Volunteers

description: GSK2018682 is a potent and selective agonist for the sphingosine-1- phosphate receptor subtype 1 (S1P1) with the potential to be an effective treatment for multiple sclerosis (MS). The immunomodulatory properties of GSK2018682 are related to functional antagonism of S1P1 on lymphocytes, resulting in sequestration of lymphocytes within the lymphoid organs, rendering them incapable of migrating to sites of inflammation and leading to lymphopenia. Orally administered GSK2018682 is very effective in murine experimental autoimmune encephalomyelitis (EAE), an animal model of human MS. This study will assess the relative bioavailability of different oral formulations of GSK2018682 in healthy volunteers. A tablet formulation is desired for progression into future clinical safety and efficacy studies as the current capsule formulation is not suited to large scale manufacture. The information obtained in this study will help to establish the optimal dosing form for future studies, and also determine the effect of food on the pharmacokinetics of GSK2018682.
DOI: 10.25934/00001099
title: A Single-centre. Double-blind, Placebo Controlled Three Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single and Repeat Doses of Nebulised GSK2269557 in Healthy Male Subjects

description: The study will comprise three Parts: Part A will consist of two cohorts of healthy male volunteers to assess the safety, tolerability and pharmacokinetics of ascending single doses of nebulised GSK2269557. Blinded safety and available PK data will be reviewed before each dose escalation. Part B will be one cohort to examine the safety, tolerability and pharmacokinetics of a repeated dose of GSK2269557 given by nebuliser for 7 days in healthy male volunteers. The total daily dose will be the same as, or lower than, doses that are well tolerated in Part A. Part C will consist of two cohorts of single nebulised doses in healthy male smokers, to assess pharmacodynamic endpoints in sputum and bronchoalveolar lavage.
DOI: 10.15468/dl.s3e8pt
title: Occurrence Download

description: A dataset containing 4 species occurrences available in GBIF matching the query:
{
 "and" : [
 "HasGeospatialIssue is false",
 "HasCoordinate is true",
 "OccurrenceStatus is Present",
 {
 "not" : {
 "BasisOfRecord" : [
 "is one of (Fossil, Living Specimen)"
 ]
 }
 },
 "TaxonKey is one of (Akebia longisepala (H.N.Qin) Christenh.)"
 ]
}

 The dataset includes 4 records from 1 constituent datasets; see https://api.gbif.org/v1/occurrence/download/0002168-241125135418005/datasets/export for details.
 
Data from some individual datasets included in this download may be licensed under less restrictive terms.
DOI: 10.25934/00003165
title: A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

description: The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.
DOI: 10.25934/00003164
title: A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Low-dose Aspirin

description: The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant low-dose aspirin therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.
DOI: 10.25934/00002546
title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 mg and 50 mg Compared With Placebo in Subjects With Type 2 Diabetes

description: The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).
DOI: 10.25934/00002545
title: A Phase-3 Randomized, Double-Blind, Efficacy and Safety Study Evaluating the Fixed Dose Combinations of TAK-491 Plus Chlorthalidone (40/12.5 mg and 40/25 mg) in Subjects With Grades 2 or 3 Essential Hypertension, Who Do Not Achieve Target Blood Pressure Following Treatment With TAK-491 40 mg Monotherapy

description: The purpose of this study is to evaluate the efficacy and safety of the fixed dose combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily, in participants with grades 2 or 3 essential hypertension who do not reach target blood pressure following treatment with 40 mg azilsartan medoxomil monotherapy after 4 weeks.
DOI: 10.25934/00001094
title: A Single Centre, 5-Period, Randomized Study To Evaluate The Relative Bioavailability Of An Immediate Release Tablet Formulation And Prototype Bioenhanced Formulations Of GSK1325756 In Healthy Elderly Subjects During Suppression Of Gastric Acid Secretion

description: This is a Phase I study to assess the combined effects of food and suppression of gastric acid secretion on the relative bioavailability of an immediate release (IR) tablet formulation and prototype bioenhanced formulations of GSK1325756, an oral interleukin 8 receptor (IL8R also known as CXCR2) antagonist. The objectives are to understand if the co-administration of food enhances absorption and the inter-subject variability for the current GSK1325756 IR tablet under fed state proton pump inhibitor (PPI) conditions and secondly to assess whether two proposed bioenhanced formulations offer any improvement over the current GSK1325756 IR formulation under PPI conditions. This open-label, randomized, 5-period crossover study will be completed in a single cohort of subjects, with an interim analysis after completion of Treatment Period 4. During Treatment Periods 1 to 4, subjects will be randomized to receive GSK1325756 50 mg IR in the fed state, GSK1325756 50 mg IR in the fasted state, GSK1325756 Bioenhanced Formulation 1 in the fasted state, and GSK1325756 Bioenhanced Formulation 2 in the fasted state. Progression to Treatment Period 5 and the choice of bioenhanced formulation for dosing in this treatment period will be dependent on the findings of an interim analysis of the pharmacokinetic profile and relative bioavailability of each formulation following completion of Treatment Periods 1 to 4. In Treatment Period 5, subjects will receive the selected GSK1325756 bioenhanced formulation in the fed state.
DOI: 10.25934/00002888
title: An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers

description: This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.
DOI: 10.25934/00001093
title: A Randomized, Double-blind, Placebo-controlled, Two-way Crossover 7-day Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Dose Inhaled GW642444 25 μg (Micrograms) in Children Aged 5-11 Years With Persistent Asthma.

description: This study will investigate the effect of dosing paedeatric asthmatic subjects with GW642444, an orally inhaled long-acting agonist of the β2-adrenoceptor.
DOI: 10.25934/00002137
title: A Randomized, Double-blind, Repeat Dose, Two Period Crossover Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Inhaled Fluticasone Furoate/Vilanterol 100/25 Micrograms in Children Aged 5 to 11 Years With Persistent Asthma

description: This study will investigate the safety and tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the novel dry powder inhaler in children aged 5 to 11 years with persistent asthma.
DOI: 10.25934/00003160
title: A Phase 3, Randomized, Single-Blind, Multicenter Study to Evaluate the Safety of TAK-438 (10 and 20 mg Once-daily) in a 52-week Maintenance Treatment in Patients With Healed Erosive Esophagitis (EE)

description: The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.
DOI: 10.25934/00003149
title: A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (20 mg Once-Daily) Compared to AG-1749 (30mg Once-Daily) in Patients With Erosive Esophagitis

description: The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.
DOI: 10.25934/00003650
title: A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt

description: To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.
DOI: 10.25934/00001092
title: A Randomised, Double-blind, Double-dummy, Single Dose, Four Way Cross-over Study to Compare the Pharmacokinetics and Pharmacodynamics of GSK961081 and Fluticasone Propionate When Administered Alone, Concurrently and as a Combination Blend in Healthy Subjects

description: In the current study GSK961081 and fluticasone propionate will be administered in a blended formulation from a single device and compared with GSK961081 and fluticasone propionate administered alone and concurrently. This is a single centre, randomized, double-blind, double dummy, single dose, four way cross-over study investigating the pharmacokinetics and pharmacodynamics of GSK961081 and fluticasone propionate when administered alone, concurrently and as a combination blend in healthy subjects.
DOI: 10.25934/00006128
title: Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)

description: To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
DOI: 10.15468/dl.6mgb65
title: Occurrence Download

description: A dataset containing 5287 species occurrences available in GBIF matching the query:
{
 "and" : [
 "HasGeospatialIssue is false",
 "HasCoordinate is true",
 "OccurrenceStatus is Present",
 {
 "not" : {
 "BasisOfRecord" : [
 "is one of (Fossil, Living Specimen)"
 ]
 }
 },
 "TaxonKey is one of (Platycarya strobilacea Siebold & Zucc.)"
 ]
}

 The dataset includes 5287 records from 97 constituent datasets; see https://api.gbif.org/v1/occurrence/download/0002169-241125135418005/datasets/export for details.
 
Data from some individual datasets included in this download may be licensed under less restrictive terms.