TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: TIPS (With Coated Stents) OR PARACENTESIS + ALBUMIN ADMINISTRATION FOR THE TREATMENT OF REFRACTORY ASCITES IN PATIENTS WITH CIRRHOSIS : A RANDOMIZED TRIAL COMPARING SURVIVAL, QUALITY OF LIFE AND NUTRITIONAL STATUS
Brief Summary: The main end point of the study is to assess survival in cirrhotic patients with refractory ascites treated by TIPS (using PTFE covered stents) vs patients treated by paracentesis + albumin infusion.


Options:
A: Number of patients with control of ascites (3 months)
B: Survival at one year (one year)
C: Mortality (18 months)
D: To evaluate complications (renal failure, hepatic encephalopathy, hyponatremia, infection and gastrointestinal bleeding) in patients with cirrhosis awaiting for liver transplant. (When 97 patients are included (% of the whole population))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Early Intervention Prevent Developmental Disturbances/Delays and Improve the Health of Children Born Prematurely
Brief Summary: The purpose of this study is to examine whether an early intervention program may improve cognitive and behavioral short and longterm outcome in preterm infants.


Options:
A: Length of Stay (From Infant's birth to discharge from NICU)
B: Cognitive and behavioral outcome; Parenting Stress
C: Motor Development. (18 Months)
D: Parent-child interaction (12 months corrected age.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Early Intervention Prevent Developmental Disturbances/Delays and Improve the Health of Children Born Prematurely
Brief Summary: The purpose of this study is to examine whether an early intervention program may improve cognitive and behavioral short and longterm outcome in preterm infants.


Options:
A: Peabody Developmental Motor Scales(PDMS-2) (Two years post term age)
B: Cognitive and behavioral outcome; Parenting Stress
C: Changes on Infant Motor Profile (IMP) (T0(baseline, 1week before beginning of Study period);T1 (within 1 week after the end of the first training/control period; before the cross-over); T2 (within 1 week after the end of the second training/control 2nd period, after cross-over), T3: 18 months)
D: Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan. (In-hospital, 6, 12, 18 and 24 months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind and Placebo Controlled Assessment of Depakote ER in Borderline Personality Disorder
Brief Summary: This study examines the effect of Depakote ER versus placebo in a randomized trial of borderline personality disorder. Patients all participate in DBT therapy and those who are not responsive are assigned to either Depakote ER or placebo for up to 12 weeks. Borderline Personality Symtoms are measured and side-effects are assessed.


Options:
A: Symptom Checklist 90
B: Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010) (12 weeks); Self-harm and related hospital use as reported in National Health Service patient records (12 weeks)
C: To assess the efficacy of olanzapine therapy (5.0-10.0 mg/day) compared with placebo in patients with BPD,as defined by DSM-IV-TR criteria,; in improving overall symptomatology as measured by the last observation carried forward (LOCF) mean change from baseline to endpoint in the ZAN-BPD total score for up to 12 weeks of double-blind treatment.
D: PTSD Symptoms (CAPS, SCID, PDS, IESR) (1.5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind and Placebo Controlled Assessment of Depakote ER in Borderline Personality Disorder
Brief Summary: This study examines the effect of Depakote ER versus placebo in a randomized trial of borderline personality disorder. Patients all participate in DBT therapy and those who are not responsive are assigned to either Depakote ER or placebo for up to 12 weeks. Borderline Personality Symtoms are measured and side-effects are assessed.


Options:
A: assessing change in number of suicide attempts/self-harming acts (baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment)
B: Symptom Checklist 90
C: Number of days with hospital admission (Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)
D: Reduction of dissociative symptoms (End of 3rd week treatment of naltrexon)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Deworming and Enhanced Vitamin A Supplementation DEVTA Project
Brief Summary: Randomisation of 72 large rural areas ("blocks") into a 2 x 2 trial of six- monthly treatment of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or neither. The placebo group get no trial treatment at all and do not receive physical placebos.


Options:
A: childhood mortality rate at age 1-6
B: N/A
C: L:M ratio at 1.5 months (1.5 months)
D: Pregnancy-related mortality and all cause mortality (Continuous)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Deworming and Enhanced Vitamin A Supplementation DEVTA Project
Brief Summary: Randomisation of 72 large rural areas ("blocks") into a 2 x 2 trial of six- monthly treatment of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or neither. The placebo group get no trial treatment at all and do not receive physical placebos.


Options:
A: - Proportion of intestinal parasitic re-infection rates among intervention and control groups (six months); - Proportion of intestinal parasite load (mean eggs per gram) among intervention and control groups (six months)
B: childhood mortality rate at age 1-6
C: Combined prevalence of bacterial and protozoan enteric infections (12 month follow-up)
D: Reduction in hookworm prevalence and intensity of infection in intervention arm (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Deworming and Enhanced Vitamin A Supplementation DEVTA Project
Brief Summary: Randomisation of 72 large rural areas ("blocks") into a 2 x 2 trial of six- monthly treatment of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or neither. The placebo group get no trial treatment at all and do not receive physical placebos.


Options:
A: childhood mortality rate at age 1-6
B: Pregnancy-related mortality and all cause mortality (Continuous)
C: Naïve T-cells in peripheral blood (measured once at 52 - 104 weeks of age)
D: intestinal parasitic infections (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clopidogrel Or Metoprolol in Myocardial Infarction Trial
Brief Summary: COMMIT/CCS2 is a large randomised trial of the effects of clopidogrel plus Aspirin versus Aspirin alone in acute heart disease. Patients presenting within 24 hours of the onset of suspected acute MI were potentially eligible provided they were thought to have ST elevation or other ischaemic ECG abnormality with no clear indication for, or contraindication to, trial treatment. All patients were to be given 162 mg ASA daily and, in addition, 75 mg clopidogrel daily or matching placebo for 4 weeks or until prior discharge or death. (Patients were also randomised separately in a 2 X 2 factorial design between metoprolol versus placebo.) The two main study endpoints are death and the composite outcome of death, non-fatal reinfarction or stroke during the scheduled treatment period in hospital.


Options:
A: Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date (9 months)
B: Death and the composite outcome of death, non-fatal reinfarction or stroke
C: All cause mortality (6-year); Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization (6-year)
D: Occurrence of myocardial infarction,stroke or cardiovascular death.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clopidogrel Or Metoprolol in Myocardial Infarction Trial
Brief Summary: COMMIT/CCS2 is a large randomised trial of the effects of clopidogrel plus Aspirin versus Aspirin alone in acute heart disease. Patients presenting within 24 hours of the onset of suspected acute MI were potentially eligible provided they were thought to have ST elevation or other ischaemic ECG abnormality with no clear indication for, or contraindication to, trial treatment. All patients were to be given 162 mg ASA daily and, in addition, 75 mg clopidogrel daily or matching placebo for 4 weeks or until prior discharge or death. (Patients were also randomised separately in a 2 X 2 factorial design between metoprolol versus placebo.) The two main study endpoints are death and the composite outcome of death, non-fatal reinfarction or stroke during the scheduled treatment period in hospital.


Options:
A: Death and the composite outcome of death, non-fatal reinfarction or stroke
B: Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke (Randomization up to 12 months); Participants With Any Major Bleeding Event (First dosing up to 12 months)
C: Occurrence of myocardial infarction,stroke or cardiovascular death.
D: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clopidogrel Or Metoprolol in Myocardial Infarction Trial
Brief Summary: COMMIT/CCS2 is a large randomised trial of the effects of clopidogrel plus Aspirin versus Aspirin alone in acute heart disease. Patients presenting within 24 hours of the onset of suspected acute MI were potentially eligible provided they were thought to have ST elevation or other ischaemic ECG abnormality with no clear indication for, or contraindication to, trial treatment. All patients were to be given 162 mg ASA daily and, in addition, 75 mg clopidogrel daily or matching placebo for 4 weeks or until prior discharge or death. (Patients were also randomised separately in a 2 X 2 factorial design between metoprolol versus placebo.) The two main study endpoints are death and the composite outcome of death, non-fatal reinfarction or stroke during the scheduled treatment period in hospital.


Options:
A: MACE events (6 months)
B: Death and the composite outcome of death, non-fatal reinfarction or stroke
C: Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose (At 2 hours after first dose of study drug); Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug (4 to 72 Hours after last dose of study drug)
D: Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke (Within 30 days following the onset of acute atherothrombotic stroke)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clopidogrel Or Metoprolol in Myocardial Infarction Trial
Brief Summary: COMMIT/CCS2 is a large randomised trial of the effects of clopidogrel plus Aspirin versus Aspirin alone in acute heart disease. Patients presenting within 24 hours of the onset of suspected acute MI were potentially eligible provided they were thought to have ST elevation or other ischaemic ECG abnormality with no clear indication for, or contraindication to, trial treatment. All patients were to be given 162 mg ASA daily and, in addition, 75 mg clopidogrel daily or matching placebo for 4 weeks or until prior discharge or death. (Patients were also randomised separately in a 2 X 2 factorial design between metoprolol versus placebo.) The two main study endpoints are death and the composite outcome of death, non-fatal reinfarction or stroke during the scheduled treatment period in hospital.


Options:
A: Death and the composite outcome of death, non-fatal reinfarction or stroke
B: All causes mortality at each follow-up period (6 months, each year)
C: Infarct size evaluated primarily by area of delayed enhancement on cardiac magnetic resonance imaging. (5-7 days after reperfusion)
D: All cause mortality (6-year); Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization (6-year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Blinded Cross-Over Clinical Trial Investigate the Interactions Between Influenza Vaccination and Oral Anticoagulant Therapy
Brief Summary: The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination


Options:
A: The primary study endpoint was the comparison of efficacy of CAIV-T versus placebo against culture-confirmed influenza-illness caused by community-acquired influenza subtypes that were antigenically similar to those contained in the vaccine.
B: Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1) (At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)); Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1) (At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)); Number of Subjects With Any Solicited Local Symptoms. (During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration); Number of Subjects With Any Solicited General Symptoms. (During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration); Number of Subjects With Any Unsolicited Adverse Events (AEs). (During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)); Number of Subjects With Serious Adverse Events (SAEs) (From Day 0 through Day 182 and through Day 379.); Number of Subjects With Medically Attended Events (MAEs) (From Day 0 through Day 182 and through Day 364.)
C: Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. (After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))); Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups. (At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study)
D: 1.Variations in INR value and in OAT weekly dosage after IV

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Single Bolus i.v. Tenecteplase Versus Placebo in Normotensive Patients With Pulmonary Embolism and Right Ventricular Dysfunction
Brief Summary: To assess the efficacy and safety of Tenecteplase versus Placebo in normotensive patients with sub-massive Pulmonary Embolism and Right Ventricular Dysfunction (RVD) all receiving unfractionated heparin (UFH)


Options:
A: Number of Patients With Cardiogenic Shock or Respiratory Failure From Pulmonary Embolism and Number of Patietnts With Major Hemorrhage (1,2,3,4, and 5 days); Number With Functional Cardiopulmonary Limitations Assessed With a Composite Measurement (Six Minute Walk Distance, Right Ventricular Function and Quality of Life Score on the SF-36) (90 days); Number With Recurrent Venous Thromboembolism and/or Severe Post-phlebitic Syndrome (90 days)
B: The improvement of the right ventricular function , perfusion defect score on lung V/Q scans or quantitative computed tomographic pulmonary angiography (CTPA) score. (14d)
C: Clinically relevant reduction of RVD (24 hours from Tenecteplase or Placebo injection)
D: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Single Bolus i.v. Tenecteplase Versus Placebo in Normotensive Patients With Pulmonary Embolism and Right Ventricular Dysfunction
Brief Summary: To assess the efficacy and safety of Tenecteplase versus Placebo in normotensive patients with sub-massive Pulmonary Embolism and Right Ventricular Dysfunction (RVD) all receiving unfractionated heparin (UFH)


Options:
A: Clinically relevant reduction of RVD (24 hours from Tenecteplase or Placebo injection)
B: Reduction of RV/LV Ratio (24 hours); Major Bleeding and Intracranial Bleeding at 30 Days. (30 days)
C: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
D: The improvement of the right ventricular function , perfusion defect score on lung V/Q scans or quantitative computed tomographic pulmonary angiography (CTPA) score. (14d)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Single Bolus i.v. Tenecteplase Versus Placebo in Normotensive Patients With Pulmonary Embolism and Right Ventricular Dysfunction
Brief Summary: To assess the efficacy and safety of Tenecteplase versus Placebo in normotensive patients with sub-massive Pulmonary Embolism and Right Ventricular Dysfunction (RVD) all receiving unfractionated heparin (UFH)


Options:
A: Clinically relevant reduction of RVD (24 hours from Tenecteplase or Placebo injection)
B: Exercise Limitation (1 month); Exercise Limitation (12 months)
C: Resolution of hypoxia (Post-procedure and 3 months); Survival from acute PE (Post-procedure and 3 months); Stabilization of hemodynamics (Post-procedure and 3 months)
D: Incidence of chronic thromboembolic pulmonary hypertension (within 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Aspirin After Six Months or One Year of Oral Anticoagulants for the Prevention of Recurrent Venous Thromboembolism in Patients With Idiopathic Venous Thromboembolism. The WARFASA Study.
Brief Summary: To determine whether aspirin is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for at least two years after the initial 6-12 month of oral anticoagulant therapy in patients with idiopathic venous thromboembolism


Options:
A: the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism (28 days)
B: recurrence of VTE and/or VTE related death (at least 24 months per patient)
C: Mortality (30 Days post intervention)
D: To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery. (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Aspirin After Six Months or One Year of Oral Anticoagulants for the Prevention of Recurrent Venous Thromboembolism in Patients With Idiopathic Venous Thromboembolism. The WARFASA Study.
Brief Summary: To determine whether aspirin is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for at least two years after the initial 6-12 month of oral anticoagulant therapy in patients with idiopathic venous thromboembolism


Options:
A: Combined endpoint: all-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism (42 days)
B: hospitalizations (30 days); all-cause death (30 days)
C: To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery. (2 years)
D: recurrence of VTE and/or VTE related death (at least 24 months per patient)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Aspirin After Six Months or One Year of Oral Anticoagulants for the Prevention of Recurrent Venous Thromboembolism in Patients With Idiopathic Venous Thromboembolism. The WARFASA Study.
Brief Summary: To determine whether aspirin is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for at least two years after the initial 6-12 month of oral anticoagulant therapy in patients with idiopathic venous thromboembolism


Options:
A: Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation (Day 1 up to 12 Months); Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation (Day 1 up to 12 months)
B: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
C: recurrence of VTE and/or VTE related death (at least 24 months per patient)
D: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Aspirin After Six Months or One Year of Oral Anticoagulants for the Prevention of Recurrent Venous Thromboembolism in Patients With Idiopathic Venous Thromboembolism. The WARFASA Study.
Brief Summary: To determine whether aspirin is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for at least two years after the initial 6-12 month of oral anticoagulant therapy in patients with idiopathic venous thromboembolism


Options:
A: Improvement of Total EKOS Thrombus Score, a specifically developed venographic scoring system (After 15 hours of CDT)
B: recurrence of VTE and/or VTE related death (at least 24 months per patient)
C: Bleeding (28 days); Thrombosis (28 days); Mortality (28 days)
D: Hospital Admission (21 days); Hospital Admission (50 days); Hospital Admission (90 days); Death (21 days); Death (50 days); Death (90 days)

Answer: B