TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial
Brief Summary: The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment with aspirin alone after cerebral ischemia of arterial origin.


Options:
A: The combined event of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happens first during follow-up
B: 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)
C: Any stroke at 90 days; Stroke severity
D: acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke (30 months intake; 12-42 months follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Randomized Controlled Trial of Antibiotic Treatment in Children With Urinary Tract Infections: Oral Amoxicillin/Clavulanic Acid vs Initial iv Ceftriaxone.
Brief Summary: The main objectives of the study are

1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI
2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)


Options:
A: 1. Duration of fever (>38°),; 2. Sterilization of the urine,; 3. Reduction of the blood inflammatory indices,; 4. Incidence of renal scarring documented at 12 month.
B: Recurrence of pyelonephritis (up to 4 years after enrollment)
C: Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up (2 years)
D: The primary end-point is UTI Recurrence Rate during the 12-month observation period and the Development of renal damage (parenchymal scar) after 12 months.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Randomized Controlled Trial of Antibiotic Treatment in Children With Urinary Tract Infections: Oral Amoxicillin/Clavulanic Acid vs Initial iv Ceftriaxone.
Brief Summary: The main objectives of the study are

1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI
2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)


Options:
A: The primary end-point is UTI Recurrence Rate during the 12-month observation period and the Development of renal damage (parenchymal scar) after 12 months.
B: Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up (2 years)
C: 1. Duration of fever (>38°),; 2. Sterilization of the urine,; 3. Reduction of the blood inflammatory indices,; 4. Incidence of renal scarring documented at 12 month.
D: Recurrence of pyelonephritis (up to 4 years after enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents
Brief Summary: In this study, an intervention is tested that is designed to reduced risky sexual behaviors in adolescent females. Study design:

* randomized, controlled study
* participants: 640 girls aged 15-19 years old
* length of follow-up: 1 year after the intervention is completed

Study hypothesis: The experimental condition will significantly reduce risky sexual behaviors in adolescent females as measured by:

* lower incidence of STI's at 6 and 12 months, as compared to baseline
* decreased incidence of risky sexual behaviors
* increased knowledge of the level of risk of certain behaviors
* increased knowledge of safer sexual behaviors that can prevention HIV infection
* increased motivation to reduce sexual risk
* increased behavioral skills to reduce risk of HIV infection


Options:
A: N/A
B: Incidence of vaginal sexual intercourse measured (Measured at Months 3 and 12 post-treatment)
C: HIV incidence
D: rates of STIs (Baseline, 6 and 12 months); computer-assisted survey results (baseline, 1 week, 3, 6, & 12 months); - score on self-report of frequency of risky sexual and substance use behaviors (baseline, 1 week, 3, 6, & 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents
Brief Summary: In this study, an intervention is tested that is designed to reduced risky sexual behaviors in adolescent females. Study design:

* randomized, controlled study
* participants: 640 girls aged 15-19 years old
* length of follow-up: 1 year after the intervention is completed

Study hypothesis: The experimental condition will significantly reduce risky sexual behaviors in adolescent females as measured by:

* lower incidence of STI's at 6 and 12 months, as compared to baseline
* decreased incidence of risky sexual behaviors
* increased knowledge of the level of risk of certain behaviors
* increased knowledge of safer sexual behaviors that can prevention HIV infection
* increased motivation to reduce sexual risk
* increased behavioral skills to reduce risk of HIV infection


Options:
A: Use of very effective contraception (up to 3 months after termination of pregnancy appointment)
B: Re-infection with a non-viral sexually transmitted infection (1 year)
C: Unprotected vaginal and anal sex (Baseline); Unprotected vaginal and anal sex (6 month follow-up); Unprotected vaginal and anal sex (12-month follow-up)
D: rates of STIs (Baseline, 6 and 12 months); computer-assisted survey results (baseline, 1 week, 3, 6, & 12 months); - score on self-report of frequency of risky sexual and substance use behaviors (baseline, 1 week, 3, 6, & 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents
Brief Summary: In this study, an intervention is tested that is designed to reduced risky sexual behaviors in adolescent females. Study design:

* randomized, controlled study
* participants: 640 girls aged 15-19 years old
* length of follow-up: 1 year after the intervention is completed

Study hypothesis: The experimental condition will significantly reduce risky sexual behaviors in adolescent females as measured by:

* lower incidence of STI's at 6 and 12 months, as compared to baseline
* decreased incidence of risky sexual behaviors
* increased knowledge of the level of risk of certain behaviors
* increased knowledge of safer sexual behaviors that can prevention HIV infection
* increased motivation to reduce sexual risk
* increased behavioral skills to reduce risk of HIV infection


Options:
A: HIV sero-incidence (24 months post-baseline)
B: Contraceptive use at time of last sexual intercourse (18 months)
C: Unprotected vaginal and anal sex (Baseline); Unprotected vaginal and anal sex (6 month follow-up); Unprotected vaginal and anal sex (12-month follow-up)
D: rates of STIs (Baseline, 6 and 12 months); computer-assisted survey results (baseline, 1 week, 3, 6, & 12 months); - score on self-report of frequency of risky sexual and substance use behaviors (baseline, 1 week, 3, 6, & 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility
Brief Summary: The purpose of this study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples.


Options:
A: Change in sexual functioning over the course of one year (T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later])
B: Collection of early pregnancy urine samples. (60 days)
C: Cortisol Measurement (Twice monthly)
D: Time to Pregnancy (Up to one year.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Trial of Pentoxifylline Administration Versus Placebo on Survival in Patients With Cirrhosis and Severe Liver Failure
Brief Summary: In patients with cirrhosis and liver failure, pro-inflammatory cytokines (TNF alpha) might be responsible of severe complications and death. Thus, the prevention of cytokine production should prevent complications and mortality.

The aim of this study is to study the 2 months survival rate in patients with severe cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6 month mortality, the proportion of transplanted patients, the occurrence of complications (bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding), plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a multicenter double blind randomized trial with a placebo.

All adult patients with severe cirrhosis might be randomized after written consent. Patients with severe carcinoma, intolerance or contraindication to pentoxifylline will not be included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.


Options:
A: Overall Survival (6 months)
B: survival rate at 2 months (at 2 months)
C: 30 day-survival (30 days); Malondialdehyde serum levels (14 and 30 days)
D: Survival at one, three and six months (six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
Brief Summary: To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.


Options:
A: Postoperative Functional mobility; Restricting factors for functional mobility
B: Hemoglobin Concentration (In-hospital up to 30 days post randomization); Red Blood Cell Transfusion (In-hospital up to 30 days post randomization)
C: Myocardial Injury (Upto 60 days)
D: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
Brief Summary: To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.


Options:
A: Postoperative Functional mobility; Restricting factors for functional mobility
B: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
C: Glasgow Outcome Scale (at 6 months after injury)
D: 90-day mortality (after 90 days from study enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
Brief Summary: To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.


Options:
A: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)
B: Postoperative Functional mobility; Restricting factors for functional mobility
C: Modified Rankin Scale (mRS) (12 months post)
D: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
Brief Summary: To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.


Options:
A: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))
B: Postoperative Functional mobility; Restricting factors for functional mobility
C: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
Brief Summary: To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.


Options:
A: Postoperative Functional mobility; Restricting factors for functional mobility
B: Randomization Rate (12 months)
C: Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction (Within 30 days of randomization)
D: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
Brief Summary: To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.


Options:
A: Timed Up and Go-test (TUG)in seconds. (30 days)
B: Mortality (90 day)
C: Postoperative Functional mobility; Restricting factors for functional mobility
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Antidepressant Maintenance for Major Depression Following Mild Traumatic Brain Injury
Brief Summary: The purpose of the study is to explore to what extent continuing the antidepressant medication citalopram (Celexa), after depression has responded to treatment, helps prevent the return of depressive symptoms in patients with recent traumatic brain injury (TBI).


Options:
A: Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) (Through month 18 of treatment); Number of Participants in Recovery According to the LIFE and HRSD (Through 36 months of treatment); Number of Participants in Recurrence According to the LIFE and HRSD (Measured up to Month 36 from recovery)
B: recurrence of major depression by administering the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impressions Scale (CGI) every 4 weeks for 40 weeks (40 weeks)
C: N/A
D: Percentage of Participants With Depressive Recurrence After Time (t) in Days (Every Visit from Week 34 up to Week 86 (Maintenance Phase))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Antidepressant Maintenance for Major Depression Following Mild Traumatic Brain Injury
Brief Summary: The purpose of the study is to explore to what extent continuing the antidepressant medication citalopram (Celexa), after depression has responded to treatment, helps prevent the return of depressive symptoms in patients with recent traumatic brain injury (TBI).


Options:
A: Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).
B: N/A
C: Scores on Hamilton Depression Rating Scale (8 time points through 6 weeks)
D: recurrence of major depression by administering the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impressions Scale (CGI) every 4 weeks for 40 weeks (40 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Prospective, Double-Blinded, Placebo-Controlled (Sham-Controlled) Study to Evaluate the Safety and Effectiveness of the Adacolumn Apheresis System for the Treatment of Moderate to Severe Crohn's Disease
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohn's disease.


Options:
A: Number of Patients Reporting Side Effects (8 weeks or 16 weeks)
B: Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. (12 week)
C: Clinical Remission (Baseline to Week 12); Frequency and Severity of Adverse Events Through Week 12 (Baseline through Week 12 Visit)
D: Percentage of Participants With Mucosal Healing and No Deep Ulcerations (48 weeks after Randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children
Brief Summary: The purpose of this study is to find out if young children have more benefit of the combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent otitis media.


Options:
A: Number of visits to health clinic (Two years after randomisation)
B: Non B type tympanogram (one month)
C: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
D: - number of acute otitis media; - quality of life issues

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children
Brief Summary: The purpose of this study is to find out if young children have more benefit of the combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent otitis media.


Options:
A: Number of visits to health clinic (Two years after randomisation)
B: - number of acute otitis media; - quality of life issues
C: Treatment response (1 months)
D: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lacunar-Brain Infarction Cerebral Hyperactivity And Atorvastatin Trial. A Placebo-Controlled Trial Of High-Dose Atorvastatin In Patients With Cerebral Small Vessel Disease.
Brief Summary: The main purpose of this study is to evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients.


Options:
A: Evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients. CVR, humeral and carotid vasoreactivity will be measured in all patients at M0 and M3.
B: N/A
C: Percentages changes of the hs-CRP between baseline (means between week-2 to -1 and week 0 (V2) values) and week 26 (V5).
D: Time of Atrial Fibrillation Recurrence (Upon recurrence, up to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Lacunar-Brain Infarction Cerebral Hyperactivity And Atorvastatin Trial. A Placebo-Controlled Trial Of High-Dose Atorvastatin In Patients With Cerebral Small Vessel Disease.
Brief Summary: The main purpose of this study is to evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients.


Options:
A: Evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients. CVR, humeral and carotid vasoreactivity will be measured in all patients at M0 and M3.
B: From the 48 hour holter monitoring the number of ischemic episodes will be assessed at baseline (week 1), week 18 and at the final visit (week 26).
C: Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy (Baseline, Week 12); Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy (Baseline, Week 12)
D: Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX) (Baseline and 16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized Double-Blind Study Comparing The Pleiotropic Effects Of Atorvastatin 10 Mg And 80 Mg Over A 26-Week Period In Subjects With Coronary Atherosclerosis
Brief Summary: The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease.


Options:
A: Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 (Baseline (Week 6), Week 12)
B: Evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients. CVR, humeral and carotid vasoreactivity will be measured in all patients at M0 and M3.
C: Percentages changes of the hs-CRP between baseline (means between week-2 to -1 and week 0 (V2) values) and week 26 (V5).
D: Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy (baseline(randomization) to 12 weeks)

Answer: C