cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.25934/00006106
title: A Randomized, Double-Blind, Placebo-Controlled Insulin Tolerance Test Study to Assess the Safety, Tolerability, and Pharmacodynamics OF Pitolisant in Patients With Type 1 Diabetes

description: The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes
DOI: 10.25934/pr00008217
title: A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal

description: Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
DOI: 10.25934/pr00008249
title: Interventional, Randomised, Double-blind, Placebo-controlled, Active Comparator, Four-way Crossover Electroencephalography Study Investigating the Effects of Vortioxetine (Lu AA21004) in Healthy Male Subjects

description: To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine
DOI: 10.25934/pr00010659
title: A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

description: The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.
DOI: 10.3535/ykg-7z3-xd1
title: siliciclastic rocks

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.3535/z4s-ksx-1gc
title: Weissermelia

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.25934/00001402
title: High Risk B-Precursor Acute Lymphoblastic Leukemia

description: RATIONALE: Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium (LCV), work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia.
DOI: 10.25934/00006789
title: A Phase 3, Randomized, Active-controlled Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13vPnC Vaccine Compared With a 7vPnC in Healthy Infants in China

description: This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.
DOI: 10.25934/pr00008733
title: A Randomized, Double-blind, Multicenter Active-controlled Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression

description: The purpose of this study is to evaluate the efficacy of switching adult participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to flexibly dosed intranasal esketamine (56 milligram [mg] or 84 mg) plus a newly initiated oral antidepressant compared with switching to a newly initiated oral antidepressant (active comparator) plus intranasal placebo, in improving depressive symptoms. Efficacy will be assessed by the change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score from Day 1 (before randomization) to the end of the 4-week double-blind treatment phase.
DOI: 10.25934/pr00010189
title: A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN

description: This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.
DOI: 10.3535/1me-89s-qvy
title: sedimentary rocks

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.3535/cca-gah-rme
title: Echinodermata

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.25934/00004637
title: TOPAMAX (Topiramate) Intervention to Prevent Transformation of Episodic Migraine: The Topiramate INTREPID Study

description: The purpose of this study is to determine whether Topiramate is effective in preventing the development of chronic daily headache among patients with episodic migraine headaches.
DOI: 10.25934/00006621
title: A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients With Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia

description: The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the (T)hreonine-315-(I)soleucine (T315I) mutation.
DOI: 10.25934/pr00004396.0
title: Available IPD datapackage for study 'Phase IV Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder'

description: To investigate the effect of atomoxetine hydrochloride in treating adults who have attention deficit hyperactivity disorder with comorbid social anxiety disorder
DOI: 10.3535/e50-x6s-j6d
title: Echinodermata

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.3535/e6y-weq-8qe
title: †Trilobita

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.25934/00001234
title: Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects

description: This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in healthy male and female subjects. This study will confirm the PK and safety profile in Chinese subjects. GSK1605786 is currently in clinical development for the treatment of Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or 500mg twice daily) within 30 minutes after a meal. The study will consist of single and repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.
DOI: 10.25934/00002436
title: A Phase 3, Randomized, Multicenter, Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout.

description: The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.
DOI: 10.25934/00003048
title: A Phase 3, Open-Label Period Followed by a Randomized, Double-blind, Placebo-controlled Study of the Analgesic Efficacy of Extended-release Hydrocodone/Acetaminophen (Vicodin CR) Compared to Placebo in Subjects With Chronic Low Back Pain

description: The primary purpose of the study was to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).
DOI: 10.3535/4xk-tv2-r60
title: Calymenina

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.25934/00005762
title: A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer

description: This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.
DOI: 10.25934/00006124
title: A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

description: The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.
DOI: 10.25934/00007204
title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Aducanumab (BIIB037) in Japanese Subjects With Mild to Moderate Alzheimer'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/pr00004212.0
title: Available IPD datapackage for study 'A Randomized, Double-Blind, Placebo-Controlled Study of Atomoxetine Hydrochloride in Adolescents with Attention-Deficit/Hyperactivity Disorder and Comorbid Depressive Disorder'

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: 10.3535/3f6-6q3-zyd
title: Animalia

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.3535/bef-3ll-64s
title: sedimentary rocks

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.25934/00000532
title: Follow-up Study to Evaluate the Long-term Efficacy of a HPV Vaccine (580299) in Healthy Young Adult Women in Brazil

description: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy, safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in the primary & follow-up study will be enrolled in this long-term follow-up study. Subjects were aged 15-25 years at the time of entry into the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
DOI: 10.25934/00000667
title: A Phase 2 Study of the MET RTK Inhibitor GSK1363089 (Formerly XL880) in Subjects With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck

description: This study is being conducted to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in adult subjects with squamous cell carcinoma of the head and neck (SCCHN). GSK1363089 is a new chemical entity that inhibits multiple receptor tyrosine kinases (RTKs) with growth-promoting and angiogenic properties. The primary targets of GSK1363089 are the HGF and vascular endothelial growth factor (VEGF) RTK families (eg, MET, VEGFR2/kinase insert domain receptor [KDR]). Since MET overexpression has been associated with poorer prognosis and MET tyrosine kinase mutations have been reported in SCCHN, inhibition of MET receptor and VEGFR2/KDR activation by agents such as GSK1363089 may be of therapeutic benefit in this patient population.
DOI: 10.25934/00001015
title: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

description: This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).
DOI: 10.25934/00001034
title: A 24-week Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder Delivered Once-daily Via a Novel Dry Powder Inhaler on Arterial Stiffness Compared With Placebo and Vilanterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

description: The purpose of the study is to investigate the effect of fluticasone furoate/vilanterol Inhalation Powder on arterial stiffness compared with placebo and vilanterol over a 24-week treatment period in subjects with COPD and aortic pulse wave velocity of 11.0 m/s or above.
DOI: 10.25934/00003101
title: A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection (PEARL-IV)

description: The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.
DOI: 10.25934/pr00010591
title: A Phase 2 Placebo-Controlled, Double-Blind, Enriched Enrollment Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 (Vixotrigine) in Treating Pain Experienced by Subjects With Confirmed Small Fiber Neuropathy That is Idiopathic or Associated With Diabetes Mellitus

description: The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or associated with diabetes mellitus. A secondary endpoint that relates to the primary objective is the change from Randomization to Week 12 of the double-blind period in mean average daily pain score.The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient global impression, use of rescue medication, and SFN symptoms in participants treated with BIIB074; to investigate the safety and tolerability of BIIB074 in participants with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.
DOI: 10.3535/cvk-a7v-gl1
title: Brachiopoda Duméril, 1805

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.3535/nnx-rfb-wbb
title: Dolomitic marl

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.25934/00000700
title: Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects

description: This is a multicenter study in which women are planned to receive either the HPV vaccine or control. Study participation will last approximately 72 months and involves a total of thirteen or fourteen scheduled visits. Originally, the study was planned for 24 months. It was then extended for 2 more years with 4 additional visits (study end at Month 48). The protocol posting has been updated as the study will be extended by additional 2 years with two or three additional visits (study end at Month 72) for subjects who consent to participate in the extension.
DOI: 10.25934/pr00009850
title: A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Oral Levetiracetam, in Epilepsy Patients Aged ≥16 Years, With Generalized Tonic-clonic (GTC) Seizures

description: The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.
DOI: 10.3535/cct-gwy-m2m
title: Animalia

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.3535/qx8-5dm-tsc
title: Animalia

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.25934/00001042
title: Antibody Persistence in Children Previously Vaccinated With Three Doses of Infanrix Hexa™ or Infanrix-IPV/Hib™

description: The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
DOI: 10.25934/00001114
title: A Fixed Dose, Dose-response Study of Ropinirole Prolonged Release (PR) as Adjunctive Treatment to L-dopa in Patients With Advanced Parkinson's Disease

description: This is a double blind, fixed dose, parallel group study to characterize the dose response of ropinirole PR as adjunctive therapy to L-dopa in patients with late stage Parkinson's disease. The primary endpoint of this study, mean change from baseline in total awake time spent "off' is the same endpoint as used in the ropinirole PR pivotal study for advanced Parkinson's disease patients. This study includes a wide range of ropinirole doses (4-24mg) with the 8mg, 12mg, and 16mg per day doses powered to detect a 1.7 hour difference in total awake time spent "off" compared with placebo. The dose of Ldopa will remain stable through the study, unless the subject experiences tolerability issues that require an L-dopa dose reduction. Up to three L-dopa dose reductions are allowed, making a total reduction of up to approximately 30%. Keeping the L-dopa dose constant where possible is important to avoid confounding the efficacy data. Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.
DOI: 10.25934/00003094
title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)

description: The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.
DOI: 10.3535/2mg-9az-ynr
title: Dolomite

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.3535/64e-dy5-38b
title: Dalmanites

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.25934/00005865
title: Phase 1/2 Determination of the Dose of Recominant Human Hyaluronidase (rHuPH20) Required Enabling Up to 600 mg/kg Bodyweight of IGIV, 10% to be Administered Subcutaneously in a Single Infusion Site in Subjects With Primary Immunodeficiency (PID)

description: The purpose of the study is to determine the feasibility of infusing a full 4-week dose of Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of recombinant human hyaluronidase needed to infuse that dose with no more than mild local adverse drug reactions.
DOI: 10.25934/pr00009655
title: A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

description: The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.
DOI: 10.3535/d5y-s0d-qay
title: sedimentary rocks

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.3535/gj9-rlv-ng4
title: Animalia

description: Digital Specimen for the physical specimen hosted at Tallinn University of Technology.
DOI: 10.25934/00004419
title: Lilly's Emotional and Physical Symptoms of Depression Study

description: To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting