cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.17632/ydx4d365rw.1
title: MRI and Computational Modelling of Current Flow for taVNS Dataset

description: We performed a high-resolution T1 and T2 weighted magnetization prepared gradient echo (MPRAGE) MRI scans at the Advanced Science Research Center (ASRC), The Graduate Center, City University of New York (CUNY), using a 3-T Siemens Prisma scanner (Siemens Healthineers, Germany). Ear scan was acquired using ZOOMit technology for high-resolution zoomed FOV imaging allowing high contrast and less artifact for region of interest with 0.47 voxel size. Based on optimized high-resolution (0.47 mm) T1 and T2 weighted images from a single healthy adult female (age: 30) subject, we developed an anatomical model of the left ear and the surrounding head tissues including brain/grey-matter, CSF/meninges skull, muscle, blood vessels, fat, cartilage, and skin, included here as RAW files, we developed an anatomical model of the left ear and the surrounding head tissues including brain, CSF/meninges, skull, muscle, blood vessels, fat, cartilage, and skin. 

Six regions of interest (ROIs): cavum concha, cymba concha, crus of helix, tragus, antitragus, and earlobe were also segmented and are all within the folder 'Segmentation Masks Raw Files'. A range of taVNS electrode montages were reproduced spanning varied electrodes sizes and placements over the tragus, cymba concha, earlobe, cavum concha, and crus of helix. Electric field across the ear (for both skin and cartilage) for each montage at 1 mA or 2 mA taVNS, assuming an activation threshold of 6.15 V/m, 12.3 V/m or 24.6 V/m, was predicted using a Finite element method (FEM). These are also included here in 'STL and MPHTXT Files of Montage FE Models'. 

Relative targeting was robust across assumptions of activation threshold and tissue properties. 

Computational models provide additional insight on how details in electrode shape and placement impact sensitivity, current density distribution, selectivity, and location, thereby supporting analysis of existing approaches and optimization of new devices. Our result suggest taVNS current patterns and relative target are robust across individuals, through (variance in) axon morphology were not represented.

Also included here is the full Simpleware ScanIP (Synopsys, CA, USA) file containing all of the FE models and tissue masks. RAW files of the tissue masks and STL and MPHTXT files are included within their respective folders. All files are labeled for their MRI sequence description, what tissue is contained within the mask, and what montage is within the STL or MPHTXT respectively in their folders.
DOI: 10.25934/00000816
title: Immunogenicity and Safety of GSK Biologicals' Pandemic Influenza Candidate Vaccine GSK2340272A

description: The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.
DOI: 10.25934/00003224
title: Open-Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine SR in Canadian Subjects With Multiple Sclerosis Who Participated in Acorda Extension Trials

description: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple sclerosis (MS) who previously participated in the registrational and extension studies conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT) and NCT00649792 (MS-F204EXT).
DOI: 10.25934/00005121.0
title: Available IPD datapackage for study 'Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's 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/pr00000140.0
title: Available IPD datapackage for study 'An International Randomized Study Evaluating the Efficacy and Safety of Fondaparinux Versus Control Therapy in a Broad Range of Patients With ST Segment Elevation Acute Myocardial Infarction.'

description: This is a randomized, double blindcontrolled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI (ST segment myocardial infarction) randomized within 24 hours of the onset of symptoms.
DOI: 10.25934/pr00000339.0
title: Available datapackage for study 'A Parallel Group Study to Evaluate the Efficacy and Safety of Ropinirole for 26 Weeks and to Further Evaluate the Incidence of Augmentation and Rebound for a Further 40 Weeks Open-label Extension Treatment Period in Subjects Suffering From Moderate to Severe Restless Legs Syndrome.'

description: This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.
DOI: 10.25934/pr00000727.0
title: Available IPD datapackage for study 'A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.'

description: A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.
DOI: 10.25934/pr00001275.0
title: Available datapackage for study 'A Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) -Study 1'

description: After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.
DOI: 10.25934/pr00001316.0
title: Available datapackage for study 'A Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) -Study 2'

description: After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.
DOI: 10.25934/pr00007665.0
title: Available IPD datapackage for study 'Safety and Immunogenicity of Different Formulations of a Clostridium Difficile Toxoid Vaccine Administered at Three Different Schedules in Adults Aged 40 to 75 Years at Risk of C. Difficile Infection'

description: This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility. Primary Objectives:   -  To describe the safety profile of subjects in each of the study groups.   -  To describe the immune responses elicited by toxoid A and toxoid B of subjects in each of the study groups. Observational Objective:   -  To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.
DOI: 10.25934/00004609.0
title: Available IPD datapackage for study 'A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis'

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: 10.25934/00005120.0
title: Available IPD datapackage for study 'Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Adult-Onset Active and Progressive Psoriatic Arthritis (PsA)'

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/pr00000169.0
title: Available datapackage for study 'A Phase III, 18 Month, Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Trial to Compare Rosiglitazone Versus Glipizide on the Progression of Atherosclerosis in Subjects With Type 2 Diabetes Mellitus and Cardiovascular Disease (APPROACH)'

description: The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.
DOI: 10.25934/pr00000172.0
title: Available datapackage for study 'A 4 Week Randomized, Double Blind, Placebo Controlled Study of GW685698X Aq Nasal Spray 100mcg QD in Adults and Adolescents With Vasomotor Rhinitis'

description: The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).
DOI: 10.25934/pr00000312.0
title: Data Package for study.

description: Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks
DOI: 10.25934/pr00000598.0
title: Available datapackage for study 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110mcg in Adult and Adolescent Subjects 12 Years of Age and Older With Perennial Allergic Rhinitis (PAR)'

description: The purpose of this study is to compare the effects (effectiveness and safety) of an intranasal corticosteroid (fluticasone furoate nasal spray [FFNS]), with a placebo nasal spray for the treatment of perennial (year-round) allergic rhinitis.
DOI: 10.25934/pr00000952.0
title: Available datapackage for study 'A Randomised, Double-blind, Double-dummy, Placebo Controlled (With Rescue Medication), Multicenter Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.'

description: A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.
DOI: 10.25934/pr00001087.0
title: Available datapackage for study 'A Randomised, Double-blind, Double-dummy, Placebo Controlled Multi-centre Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Inhalation Powder and Fluticasone Propionate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents Not Currently Treated With Inhaled Corticosteroids'

description: A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids
DOI: 10.25934/pr00001212.0
title: Available datapackage for study 'A Multicenter, Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of the Addition of Umeclidinium Bromide (62.5mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily, Umeclidinium Bromide (125mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Versus Placebo to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Over 12 Weeks With COPD'

description: The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.
DOI: 10.25934/pr00002548.0
title: Available IPD datapackage for study 'A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375SL as an Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar I Disorder in Adult Patients'

description: The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.
DOI: 10.25934/pr00004399.0
title: Available IPD datapackage for study 'Bipolar Depression Assessment Study on Tx Response'

description: The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale (MADRS).
DOI: 10.15468/dl.cpucdn
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/0012477-241126133413365/datasets/export for details.
 
Data from some individual datasets included in this download may be licensed under less restrictive terms.
DOI: 10.25934/pr00000200.0
title: Available datapackage for study 'An International, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-segment Elevation MI Acute Coronary Syndromes'

description: Study Objectives PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9 in the acute treatment of patients with unstable angina/non ST-segment elevation myocardial infarction concurrently managed with standard medical therapy. SECONDARY OBJECTIVE: If non inferiority of fondaparinux is established on initial statistical analysis in a second step, superiority of fondaparinux to enoxaparin will be evaluated statistically.   -  To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at Day 9   -  To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding events up to Day 9   -  To determine whether the relative effect on the primary end point of fondaparinux versus enoxaparin is sustained at Day 14, Day 30, Day 90 and Day 180 Study Drug: Patients will be randomized to receive either:   -  Fondaparinux 2.5 mg once and placebo-enoxaparin twice daily by subcutaneous injection or   -  Enoxaparin (1mg/kg) twice and fondaparinux-placebo once daily by subcutaneous injection Duration of Therapy:   -  Fondaparinux 2.5mg daily for 8 days or hospital discharge (whichever is earlier)   -  Enoxaparin 1mg/kg b.i.d. x 2-8 days or until clinically stable.   -  Patients should receive an ASA and all other standard medical therapies. Substudy:   -  A substudy comparing routine early coronary angiography immediately or as soon as possible (but no later than 24 hours after randomization) and intervention versus delayed (>48 hrs) coronary angiography and intervention. Primary Outcome: The first occurence of any component of the following composite up to Day 9:   -  Death   -  Myocardial Infarction   -  Refractory Ischemia
DOI: 10.25934/pr00004437.0
title: Available datapackage for study 'Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis'

description: To study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.
DOI: 10.25934/pr00007433.0
title: Available IPD datapackage for study 'The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea'

description: The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers.
DOI: 10.25934/pr00008981
title: Phase 2, Open-label, Multiple-dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Delamanid (OPC-67683) in Pediatric Multidrug-resistant Tuberculosis Patients on Therapy With an Optimized Background Regimen of Anti-tuberculosis Drugs Over a 6-Month Treatment Period

description: The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in pediatric participants who completed Study 242-12-232 (NCT01856634).
DOI: 10.25934/00000967
title: Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine FluarixTM in Adolescents Previously Vaccinated With GSK Biologicals' H1N1 Vaccine PandemrixTM

description: This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been vaccinated with one dose of PandemrixTM at the age of 10-17 years.
DOI: 10.25934/00002007
title: Phase IV, single-blind, randomised, multicenter study to evaluate immediate post-vaccination pain, reactogenicity and tolerance of GSK Biologicals' Measles-Mumps-Rubella vaccine (Priorix) administered as a second dose compared to Aventis-Pasteur-MSDs Measles-Mumps-Rubella vaccine (ROR Vax)

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: 10.25934/00000903
title: Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Ethnic Japanese Adults

description: The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in healthy ethnic Japanese adults.