TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation: Determining the Balance Between Benefits and Risks
Brief Summary: Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment during cast immobilization of the lower leg. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.

Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.


Options:
A: Clinically important venous thromboembolism at 3 months
B: To evaluate the effect of LMWH (Fragmin, dalteparin) versus UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound (While in ICU to a maximum of 90 days)
C: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
D: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
Brief Summary: This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug (Up to 12 weeks)
B: Number of Participants With Sustained Virologic Response (SVR) (From follow-up week (FW) 24 up to end of follow-up (EOF))
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate (12 weeks after last dose of study drug)
D: Percentage of Participants Achieving SVR12 (Post-treatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of TPF (Docetaxel, Cisplatin, 5-fluorouracil) Induction Chemotherapy Followed by Surgery and Radiotherapy in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma
Brief Summary: Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radical surgery and/or radiotherapy. However, there are still debates on the clinical value of induction chemotherapy for patients with advanced and resectable oral squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival rate, local control, and safety.


Options:
A: Quality of Life (1-year post treatment)
B: Survival rate (Up to 5 years)
C: Opreation Duration (1 day)
D: Overall Survival (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of TPF (Docetaxel, Cisplatin, 5-fluorouracil) Induction Chemotherapy Followed by Surgery and Radiotherapy in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma
Brief Summary: Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radical surgery and/or radiotherapy. However, there are still debates on the clinical value of induction chemotherapy for patients with advanced and resectable oral squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival rate, local control, and safety.


Options:
A: Survival rate (Up to 5 years)
B: Opreation Duration (1 day)
C: Quality of Life (1-year post treatment)
D: Overall Survival (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Lost a Satisfactory Response to Adalimumab
Brief Summary: This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.


Options:
A: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 (Week 12); Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status (Week 12)
B: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) (Week 12 (or end of trial if prior to Week 12)); Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study) (Baseline and Week 12 (or end of trial if prior to Week 12)); Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) (Up to 12 weeks)
C: Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 (Week 12)
D: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Lost a Satisfactory Response to Adalimumab
Brief Summary: This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.


Options:
A: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
B: Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT (112 and 140 days)
C: Change in Vascular Inflammation (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Total Cholesterol (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Cholesterol Efflux (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Insulin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Adiponectin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Leptin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log C-reactive Protein (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Interleukin 6 (Baseline - Week 12); Change in Cardiometabolic Biomarkers: GlycA (Baseline - Week 12)
D: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 (Week 12); Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Lost a Satisfactory Response to Adalimumab
Brief Summary: This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20]) (Week 24)
B: Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12 (Week 12); Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12)
C: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)
D: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 (Week 12); Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Lost a Satisfactory Response to Adalimumab
Brief Summary: This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.


Options:
A: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)
B: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 (Week 12); Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status (Week 12)
C: Change in PASI score from baseline in the two groups (12 weeks)
D: Long-term Safety and Tolerability of Secukinumab (Week 268)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD
Brief Summary: The aim of this study is to reduce the number of subsequent hospital admissions and/or emergency department (ED) visits for hospitalized patients with chronic obstructive pulmonary disease (COPD) by utilizing a respiratory care practitioner-led disease management (RCP-DM) program compared to standard discharge instructions and planning.


Options:
A: The combined number of hospital admissions and ED visits for a COPD exacerbation (6-month follow-up period)
B: "Quality of care process" (one year)
C: Cardiovascular risk and diabetes testing (During the first year of the trial); Systolic blood pressure (During the first year of the trial)
D: Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources. (14 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD
Brief Summary: The aim of this study is to reduce the number of subsequent hospital admissions and/or emergency department (ED) visits for hospitalized patients with chronic obstructive pulmonary disease (COPD) by utilizing a respiratory care practitioner-led disease management (RCP-DM) program compared to standard discharge instructions and planning.


Options:
A: Hospital Readmission (12 months)
B: QUAL-E - Preparation Sub-scale (Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)); QUAL-E Life Completion Sub-scale (Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64))
C: The combined number of hospital admissions and ED visits for a COPD exacerbation (6-month follow-up period)
D: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD
Brief Summary: The aim of this study is to reduce the number of subsequent hospital admissions and/or emergency department (ED) visits for hospitalized patients with chronic obstructive pulmonary disease (COPD) by utilizing a respiratory care practitioner-led disease management (RCP-DM) program compared to standard discharge instructions and planning.


Options:
A: The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). (14 Months)
B: Evaluation of effects (T1: Initial evaluation; T2: after three months; T3: one year after T1)
C: Combined number of hospitalizations and emergency department presentations (Two years)
D: The combined number of hospital admissions and ED visits for a COPD exacerbation (6-month follow-up period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD
Brief Summary: The aim of this study is to reduce the number of subsequent hospital admissions and/or emergency department (ED) visits for hospitalized patients with chronic obstructive pulmonary disease (COPD) by utilizing a respiratory care practitioner-led disease management (RCP-DM) program compared to standard discharge instructions and planning.


Options:
A: COPD hospitalization rates (1 year (study inclusion - 12 months of follow-up))
B: CCQ-recovery time in the event of an exacerbation(Health status recovery time) (6-months)
C: The combined number of hospital admissions and ED visits for a COPD exacerbation (6-month follow-up period)
D: Quality of Life of chronic obstructive pulmonary disease patients after a 1-year téléherabilitaion versus standard care program, after an initial short-term pulmonary rehabilitation program (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis
Brief Summary: The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. These biologic drugs have been registered for human therapy from a few years, thereby the investigators miss long-term data for safety and efficacy. Aim of this study is to register all the clinical data of patients with rheumatoid arthritis and spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term safety and efficacy in the real life.


Options:
A: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)
B: Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports (Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug); Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) (Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)); Extension Period: Number of Participants With Laboratory Test Abnormalities (Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)); Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis (Includes AEs for every visit and up to 999 days after last dose of study drug); Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib (Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period)
C: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis
Brief Summary: The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. These biologic drugs have been registered for human therapy from a few years, thereby the investigators miss long-term data for safety and efficacy. Aim of this study is to register all the clinical data of patients with rheumatoid arthritis and spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term safety and efficacy in the real life.


Options:
A: Percentage of patients with ACR 20 response (Week 24)
B: Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28) (Month 6 (randomization) and Month 12)
C: EULAR individual response (12 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis
Brief Summary: The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. These biologic drugs have been registered for human therapy from a few years, thereby the investigators miss long-term data for safety and efficacy. Aim of this study is to register all the clinical data of patients with rheumatoid arthritis and spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term safety and efficacy in the real life.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 (Baseline, Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 (Month 6)
B: N/A
C: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)
D: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) (Baseline to Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Well-Being Therapy for Psychological Distress and Enhancing Healthy Behaviors With Personalized Mobile Technology in Cardiac Patients: a Randomized Controlled-trial Study Protocol
Brief Summary: The WELL-ME study is a three-arm randomized controlled clinical trial (RCT). The aim of this RCT is to compare the effectiveness of the Well Being Web Based Therapy (WBT-Web) with the gold standard CBT (Cognitive Behavior Therapy) and standard clinical procedure of patients' management (CM) for psychological distress and promotion of healthy behaviors in Cardiac Patients.


Options:
A: Hamilton Rating Scale for Depression (HAM-D-17) (12 weeks post-randomization)
B: Psychological distress (Within one year after the treatment)
C: Hamilton Rating Scale of Depression (HAM-D) (Baseline, Week 4, Week 8, Week 12)
D: Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of "Tailored Physical Activity" on the Number of Sick Days: a Randomized Controlled Trial in Health Care Workers That Have Experienced Pain Related to the Spine or Upper Body
Brief Summary: The purpose of this study is to test the effect of "Tailored Physical Activity" on the number of sick-days.

The hypothesis is that "Tailored Physical Activity" is superior in efficacy on sick-days.


Options:
A: Self-reported number of sick-days (3 months)
B: Change from baseline in experienced community of practice at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in well-being at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in dietary behaviors at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in exercise behaviors at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in safety behavior counts at 6 and 12 months, Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline safety behavior consistency at 6 and 12 months, Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months)
C: Change in Body Weight (Change from baseline weight to weeks 6, 10, 16, 20, 24.)
D: Weight Loss (1 year)

Answer: A