TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Brief Summary: The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.


Options:
A: Modified Rankin Scale (mRS) (12 months post)
B: Myocardial Injury (Upto 60 days)
C: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
D: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Brief Summary: The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.


Options:
A: Reduction in the incidence of Post-Operative Delirium (%) (Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first))
B: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
C: Recruitment rate (Up to 12 months)
D: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Brief Summary: The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.


Options:
A: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
B: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
C: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
D: Mortality (90 day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Electroacupuncture for Major Depression: A Pilot Study
Brief Summary: This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression.


Options:
A: Self-rated sleep quality score measured by Insomnia Severity Index questionnaire (Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.); Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy (Baseline, 1-week posttreatment, and 4-week posttreatment.); Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log. (Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.)
B: N/A
C: Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10 (Change from Baseline to Post-Intervention Endpoint)
D: MDI depression score (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Van Gogh-extension Trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006
Brief Summary: Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.

In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.

Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.


Options:
A: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
B: Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) (From randomization up to the end of the treatment period (minimum of 6 months))
C: Symptomatic recurrent PE/DVT during the 6-month study treatment period.
D: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Van Gogh-extension Trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006
Brief Summary: Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.

In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.

Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.


Options:
A: The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
B: Symptomatic recurrent PE/DVT during the 6-month study treatment period.
C: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
D: Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Van Gogh-extension Trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006
Brief Summary: Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.

In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.

Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.


Options:
A: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)
B: Symptomatic recurrent PE/DVT during the 6-month study treatment period.
C: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)
D: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6- or 12-month study treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure
Brief Summary: The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).


Options:
A: Change in VO2max measured by CPEX (After 2 weeks of intervention)
B: N/A
C: Primary Composite Endpoint (From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.)
D: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date (Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)); Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) (Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure
Brief Summary: The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).


Options:
A: N/A
B: To assess the efficacy and safety of lixivaptan treatment in congestive heart failure (CHF) patients with volume expansion. (8 weeks)
C: Time to repeat therapeutic paracentesis (12 weeks)
D: EFFICACY:Serum Sodium; SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry; PHARMACOKINETICS:Plasma SR121463B concentrations

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Idiopathic Pulmonary Fibrosis, Open Label Extension
Brief Summary: Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis.

Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic pulmonary fibrosis (IPF), a condition for which no established treatment is available.

The present trial investigates a possible use of bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a new category of patients suffering from IPF.

It was decided to offer Open Label treatment (bosentan) for patients willing to continue in the BUILD 1 study.


Options:
A: exercise capacity (Baseline to end of study); cardiac hemodynamics (Baseline to end of study)
B: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
C: Change in 6-minute walk distance (Baseline to End-of-Period 1)
D: Exercise Capacity; Pulmonary artery systolic pressure

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.


Options:
A: To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE. (Days 0-105)
B: SLE Responder Index (SRI) Response Rate at Week 52 (Baseline, 52 weeks)
C: Percentage of Participants With a State of Disease Control at Week 52 (Week 52)
D: Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. (Baseline, 24 weeks); Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index) (0 to 52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.


Options:
A: change of DASH questionnaire (Baseline, 6, 12, 24 weeks)
B: Change in physiological measures (At baseline and after 10 weeks of HIIT)
C: Lipid profile - Plasma levels of total cholesterol (mg/dl), VLDL-chol (mg/dl) HDL-chol (mg/dl), LDL-chol (mg/dl), triglycerides (mg/dl), Apolipoprotein AI and AII (mg/dl) and Apolipoprotein B (mg/dl) (3 months); Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp (3 months); Cytokine response - Plasma levels of TNF-α (pg/ml), IL-6 (pg/ml), IFN-type I (pg/ml), IL-10 (pg/ml)and IL-1ra (pg/ml) (3 months)
D: Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. (Baseline, 24 weeks); Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index) (0 to 52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Youth Support Team Intervention for Suicidal Adolescents
Brief Summary: This study will attempt to improve treatment adherence and reduce suicide risk among adolescents who are at risk for attempting suicide.


Options:
A: Columbia Suicide-Severity Rating Scale (C-SSRS; Posner et al., 2006; Posner et al. 2008). (Baseline and 1, 3, and 6 month follow-up assessments)
B: Non-suicidal self-harm (6 months); Suicidal ideation (6 months); suicide attempts (6 months)
C: suicidal ideation - Suicidal Ideation Questionnaire-JR (3 month)
D: Change in Autonomous and Controlled Motivation (From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 3 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Youth Support Team Intervention for Suicidal Adolescents
Brief Summary: This study will attempt to improve treatment adherence and reduce suicide risk among adolescents who are at risk for attempting suicide.


Options:
A: suicidal ideation - Suicidal Ideation Questionnaire-JR (3 month)
B: Change in the Intensity of Suicidal Ideation Between Intake and End of Treatment (16 weeks (end of treatment)); Change in the Severity of Depression Symptoms Between Intake and End of Treatment (16 weeks (end of treatment))
C: Number of suicidal behaviours (12 months)
D: Suicide attempts (Measured at 18 months from Baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Youth Support Team Intervention for Suicidal Adolescents
Brief Summary: This study will attempt to improve treatment adherence and reduce suicide risk among adolescents who are at risk for attempting suicide.


Options:
A: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (Baseline to end of week 8)
B: Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm (16 weeks and 68 weeks); Severity of suicidal ideation, level of depressive symptoms (16 weeks and 68 weeks)
C: Suicidal Ideation Questionnaire - JR (SIQ-JR) (Baseline, 6 weeks, 12 weels, 24 weeks); Beck Depression Inventory - II (BDI-II) (Baseline, 6 weeks, 12 weeks, 24 weeks); Scale for Suicidal Ideation (SSI) (baseline, 6 weeks, 12 weeks, 24 weeks)
D: suicidal ideation - Suicidal Ideation Questionnaire-JR (3 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Post-Stroke Depression - Treatment Strategy
Brief Summary: This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.


Options:
A: Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes (The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).)
B: Feasibility - enrollment of 1-2 participants per month (One year)
C: Depression (4 months)
D: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Post-Stroke Depression - Treatment Strategy
Brief Summary: This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.


Options:
A: Fugl Meyer Motor Scale score (Baseline and 90 days)
B: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)
C: Occurrence rate of depression (3 months)
D: Peak treadmill speed (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Post-Stroke Depression - Treatment Strategy
Brief Summary: This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.


Options:
A: Vascular death, Transient Ischemic Attack (TIA)/stroke and myocardial infarction (combined) (6 months); Functional status at 6-months (6 months)
B: Progression in the Fugl-Meyer Motor Scale (M3 (3 months))
C: Occurrence rate of depression (3 months)
D: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Post-Stroke Depression - Treatment Strategy
Brief Summary: This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.


Options:
A: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)
B: length of non-essential Internet use in hours/week as well as CGI-Improvement (baseline and biweekly for 10 weeks)
C: Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Valproate to Attenuate the Progression of Alzheimer's Disease (AD)
Brief Summary: The purpose of this trial is to demonstrate whether valproate therapy delays the emergence of agitation and/or psychosis in outpatients with probable Alzheimer's disease (AD) who have not experienced agitation and psychosis in their illness. A secondary aim is to determine whether valproate therapy delays the progression of cognitive and functional measures of the illness. This trial will also assess the tolerability and safety of low-dose, long-term valproate therapy. Valproate, an anticonvulsant drug, was selected because of its possible symptomatic efficacy for agitation in AD, known safety profile in numerous clinical populations, and in view of recent data supporting its neuroprotective potential in AD.


Options:
A: Apathy Evaluation Scale Score at 12 Weeks (At 12 weeks)
B: N/A
C: Presence of Agitation and/or Psychosis Measured by the Neuropsychiatric Inventory (NPI) Combined With an Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician (24 months)
D: Relapse by Study Week 32 (0-16 weeks in Phase B (16-32 weeks in study))

Answer: C