cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.27941622
title: Exploring meaning in life as a potential target for early intervention – results from a randomized trauma analogue study

description: <b>Background:</b> Previous studies in individuals exposed to stressors, including traumatic ones, have shown inverse relations between life meaning and distress. Furthermore, meaning-related treatments can benefit (traumatic) stressor-exposed individuals. However, the evidence regarding the effect of life meaning interventions on PTSD symptoms is limited. Moreover, early post-stressor interventions preventing distress are needed. This study investigated the effects of a short, online life meaning intervention after an analogue traumatic stressor on intrusions and anxiety following the intervention, intrusions over a week, and explored distress and life meaning differences after a week. <b>Method:</b> Following an analogue traumatic stressor (i.e. an aversive film), <i>N</i> = 237 participants were randomized to a life meaning intervention, an active or inactive control condition. Participants completed questionnaires in the laboratory, in an online seven-day diary, and at one-week follow-up. <b>Results:</b> The intervention resulted in significantly lower post-intervention state anxiety and higher life meaning, but not significantly less severe wait-period intrusions than the control conditions. Intrusions in the subsequent week as well as depression, anxiety, PTSD, and life meaning after a week did not significantly differ between the conditions. <b>Conclusion:</b> This intervention showed promising temporary effects on anxiety and life meaning after a trauma analogue, but no significant longer-term effects and no effects on PTSD symptoms including intrusions. Meaning-related interventions for PTSD target stressor-related meaning-making rather than life meaning. Thus, future studies may benefit from implementing more intense interventions to extend effects on general distress, as well as stressor-addressing meaning interventions to elicit stressor-related meaning-making. Meaning in life may counteract psychological distress in the context of (traumatic) stressors.The current study investigated the effect of a short life meaning intervention on psychological distress after an analogue traumatic stressor.Compared to control conditions, individuals who received the life meaning intervention reported greater state meaning in life and lower state anxiety. However, the intervention did not result in significantly less severe intrusions. Meaning in life may counteract psychological distress in the context of (traumatic) stressors. The current study investigated the effect of a short life meaning intervention on psychological distress after an analogue traumatic stressor. Compared to control conditions, individuals who received the life meaning intervention reported greater state meaning in life and lower state anxiety. However, the intervention did not result in significantly less severe intrusions.
DOI: 10.25934/pr00007726
title: A Phase 2 Randomized, Open Label Clinical Trial in High Risk Percutaneous Coronary Intervention (PCI) Patients Receiving Standard Antithrombotic Treatment Plus Either ALX-0081 or GPIIb/IIIa Inhibitor (ReoPro®) Over a Period of 24 Hours

description: This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients. Patients will receive standard treatment with acetylsalicylic acid (ASA) plus clopidogrel and heparin. Eligible patients will be randomly assigned to receive open-label study treatment with either ALX-0081 or ReoPro®. Patients will be stratified according to PCI type (elective or ad-hoc) and stent type (bare metal stent or drug eluting stent).
DOI: 10.6084/m9.figshare.27941622.v1
title: Exploring meaning in life as a potential target for early intervention – results from a randomized trauma analogue study

description: <b>Background:</b> Previous studies in individuals exposed to stressors, including traumatic ones, have shown inverse relations between life meaning and distress. Furthermore, meaning-related treatments can benefit (traumatic) stressor-exposed individuals. However, the evidence regarding the effect of life meaning interventions on PTSD symptoms is limited. Moreover, early post-stressor interventions preventing distress are needed. This study investigated the effects of a short, online life meaning intervention after an analogue traumatic stressor on intrusions and anxiety following the intervention, intrusions over a week, and explored distress and life meaning differences after a week. <b>Method:</b> Following an analogue traumatic stressor (i.e. an aversive film), <i>N</i> = 237 participants were randomized to a life meaning intervention, an active or inactive control condition. Participants completed questionnaires in the laboratory, in an online seven-day diary, and at one-week follow-up. <b>Results:</b> The intervention resulted in significantly lower post-intervention state anxiety and higher life meaning, but not significantly less severe wait-period intrusions than the control conditions. Intrusions in the subsequent week as well as depression, anxiety, PTSD, and life meaning after a week did not significantly differ between the conditions. <b>Conclusion:</b> This intervention showed promising temporary effects on anxiety and life meaning after a trauma analogue, but no significant longer-term effects and no effects on PTSD symptoms including intrusions. Meaning-related interventions for PTSD target stressor-related meaning-making rather than life meaning. Thus, future studies may benefit from implementing more intense interventions to extend effects on general distress, as well as stressor-addressing meaning interventions to elicit stressor-related meaning-making. Meaning in life may counteract psychological distress in the context of (traumatic) stressors.The current study investigated the effect of a short life meaning intervention on psychological distress after an analogue traumatic stressor.Compared to control conditions, individuals who received the life meaning intervention reported greater state meaning in life and lower state anxiety. However, the intervention did not result in significantly less severe intrusions. Meaning in life may counteract psychological distress in the context of (traumatic) stressors. The current study investigated the effect of a short life meaning intervention on psychological distress after an analogue traumatic stressor. Compared to control conditions, individuals who received the life meaning intervention reported greater state meaning in life and lower state anxiety. However, the intervention did not result in significantly less severe intrusions.
DOI: 10.25934/00003719
title: A Phase I Open Label Dose Escalation Study of Oral Treatment With BIBF 1120 in Combination With Standard Treatment of Paclitaxel and Carboplatin in Patients With Advanced Gynaecological Malignancies

description: The primary objectives of this trial were to determine the safety, tolerability, and MTD of BIBF 1120 when added to standard therapy with carboplatin and paclitaxel
DOI: 10.25934/00000503
title: A Multicentre Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine (GSK1674330A) in Healthy Female Subjects Aged 18-25 Years.

description: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals' HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control vaccine. There will be different levels of blinding in the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
DOI: 10.25934/pr00007514
title: A Phase 2b Open-Label Multi-Center Study Assessing the Immunological Persistence of Antibodies at Approximately 2 Years After the Last Meningococcal Vaccination in Study V102_15 (NCT02212457) and the Response to a Booster Dose of GSK MenABCWY or Meningococcal Serogroup B Vaccines, in Healthy Adolescents

description: The purpose of this study is to compare the persistence of 2 or 3 doses of the GSK MenABCWY vaccine, or 2 doses of GSK rMenB+OMV vaccine (Bexsero) administered to healthy adolescents at approximately 24 months after the last meningococcal vaccination in the parent study V102_15(NCT02212457), compared with baseline antibody levels in vaccine naïve subjects at similar age at enrolment.
DOI: 10.25934/00001718
title: A Randomized, Double-Blind, Multicenter Study Comparing the Glycemic Control Characteristics of Carvedilol and Metoprolol in Hypertensive Patients with Type II Diabetes Mellitus (Protocol 346) and A Randomized, Double-Blind, Multicenter Study Comparing the Effects of Carvedilol and Metoprolol on Glycemic Control in Hypertensive Patients with Type II Diabetes Mellitus (Protocol 347)

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/pr00007337.0
title: Available IPD datapackage for study 'A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects With Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath'

description: This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called pexidartinib for the treatment of certain tumors for which surgical removal could cause more harm than good. The main purpose of this study is to gather information about the investigational drug pexidartinib, which may help to treat tumors of pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS). The study consists of two parts with a follow-up period. In Part 1, eligible study participants will be assigned to receive either pexidartinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Some subjects, assigned to placebo in Part 1 transitioned to pexidartinib for Part 2. Then a protocol amendment was written to allow only pexidartinib patients to continue into Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label pexidartinib. There was also a follow-up period added to Part 2.
DOI: 10.25934/00001550
title: A placebo-controlled pharmacokinetic and safety study of twice daily SRT501 in type 2 diabetic human male subjects

description: Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform to serve all elements of the international research community. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. The Vivli platform includes an independent data repository, in-depth search engine and a cloud-based, secure analytics platform.
DOI: 10.25934/00006772
title: STRIVE: A MULTICENTER PHASE 2, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE VS. BICALUTAMIDE IN MEN WITH PROSTATE CANCER WHO HAVE FAILED PRIMARY ANDROGEN DEPRIVATION THERAPY

description: The purpose of this study is to determine the safety and efficacy of enzalutamide vs bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.
DOI: 10.25934/00006906
title: A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer

description: The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.
DOI: 10.25934/pr00008222
title: A Randomized, Double-blind, Two Treatment, Two Period, Chronic Dosing (4 Weeks), Crossover, Multi-center Pilot Study to Evaluate the Effects of Budesonide/Glycopyrronium/Formoterol Fumarate and Glycopyrronium/Formoterol Fumarate on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

description: This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.
DOI: 10.25934/00000410
title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Anti-inflammatory and Metabolic Effects of Rosiglitazone XR, 8mg Once Daily, in Subjects With Rheumatoid Arthritis

description: To assess whether the anti-inflammatory effects of rosiglitazone result in improvements in Rheumatoid Arthritis symptoms in patients for whom their existing Disease Modifying Anti-Rheumatic Drug (DMARD) treatment does not give adequate relief.
DOI: 10.25934/pr00003656.1
title: Available IPD datapackage for study 'LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy'

description: This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.
DOI: 10.25934/pr00006776.0
title: Available IPD datapackage for study 'A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis'

description: The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.
DOI: 10.25934/pr00007117.1
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/pr00007740.0
title: Available IPD datapackage for study 'An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMATM) Versus Placebo in Subjects With Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer'

description: The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.
DOI: 10.25934/00004899
title: A double-blind, placebo-controlled study of risperidone in children and adolescents with autistic 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: 10.25934/00006106.0
title: Available IPD datapackage for study '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: 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: 10.25934/00007043
title: Randomized, double-blind, cross-over trial to evaluate the efficacy of inhaled budesonide in patients with stable chronic obstructive pulmonary disease (COPD) responsive to steroids.

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/pr00004470.0
title: Available IPD datapackage for study 'A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer (NSCLC)'

description: The research study is testing the investigational drug necitumumab in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and pemetrexed will be more effective in improving participant disease than the standard chemotherapy combination alone.
DOI: 10.25934/pr00005765.3
title: Available IPD datapackage for study 'A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer'

description: This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.
DOI: 10.25934/pr00007615.0
title: Available IPD datapackage for study 'A Multi-Centre, Parallel, Double-Blind, Blinded Evaluator, Randomised, Placebo-Controlled Evaluation of the Efficacy and Safety of a Single Dose of 6 mL of Synvisc in Patients With Symptomatic Osteoarthritis of the Knee'

description: This clinical study is to evaluate the safety and efficacy of hylan G-F 20 (Synvisc) in patients with symptomatic knee osteoarthritis (OA). Patients will be given 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control), with a possible repeat treatment with Synvisc after the week 26 visit.
DOI: 10.25934/00000379
title: A Randomized, Double-blind Placebo-controlled Study of Treatments With Salmeterol, Fluticasone Propionate and Their Combination to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease

description: This study will last for approximately 14 weeks and will involve 5 visits. The study is being carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient. The effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your COPD is responding. In this study we therefore want to look at new and more sensitive ways of measuring COPD. The results of this research will help in the assessment of new drugs for COPD in the future.
DOI: 10.25934/00001696
title: An Extended, Observational Study in Pediatric Patients with Chronic Hepatitis B Who Have Previously Received Long-Term Lamivudine Treatment


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/pr00003603.0
title: Available IPD datapackage for study 'LUX-Lung 6: A Randomized, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation'

description: To investigate the efficacy and safety of BIBW 2992 compared to standard first-line chemotherapy in patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR activating mutation
DOI: 10.25934/00000765
title: A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients With Cystic Fibrosis.

description: The purpose of this study is to determine whether the safety, tolerability and pharmacodynamics of SB656933 in patients that have cystic fibrosis