TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double Blind Trial to Compare the Efficacy and Safety of Escitalopram With Placebo in Patients With Acute Stroke for the Prevention of Poststroke Depression and Related Symptoms (Emotional Incontinence, Anger Proneness), and for Improvement of Neurologic, Cognitive Function and Quality of Life
Brief Summary: Through this study, the investigators are to demonstrate the superiority of Escitalopram over placebo for the prevention of poststroke depression in patients with acute stroke

The primary hypothesis of this study is;

This study will prove the superiority of Escitalopram on the prevention of poststroke depression in patients with acute stroke against placebo


Options:
A: Efficacy (90 day after stroke); Safety (90 day after stroke)
B: Occurrence rate of depression (3 months)
C: Hamilton Rating Scale for Depression (HRSD) (1 year post-treatment)
D: response rate (baseline, 2nd and 4th week); remission rate (baseline, 2nd and 4th week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double Blind Trial to Compare the Efficacy and Safety of Escitalopram With Placebo in Patients With Acute Stroke for the Prevention of Poststroke Depression and Related Symptoms (Emotional Incontinence, Anger Proneness), and for Improvement of Neurologic, Cognitive Function and Quality of Life
Brief Summary: Through this study, the investigators are to demonstrate the superiority of Escitalopram over placebo for the prevention of poststroke depression in patients with acute stroke

The primary hypothesis of this study is;

This study will prove the superiority of Escitalopram on the prevention of poststroke depression in patients with acute stroke against placebo


Options:
A: Functional status, measured with the modified Rankin scale. (6 months)
B: Peak treadmill speed (4 weeks)
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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double Blind Trial to Compare the Efficacy and Safety of Escitalopram With Placebo in Patients With Acute Stroke for the Prevention of Poststroke Depression and Related Symptoms (Emotional Incontinence, Anger Proneness), and for Improvement of Neurologic, Cognitive Function and Quality of Life
Brief Summary: Through this study, the investigators are to demonstrate the superiority of Escitalopram over placebo for the prevention of poststroke depression in patients with acute stroke

The primary hypothesis of this study is;

This study will prove the superiority of Escitalopram on the prevention of poststroke depression in patients with acute stroke against placebo


Options:
A: General Health Questionnaire (GHQ 28) (T2 (6 months poststroke))
B: Hamilton Rating Scale for Depression (HRSD) (1 year post-treatment)
C: Treatment response (Week 4 after tenth day of tDCS)
D: Occurrence rate of depression (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double Blind Trial to Compare the Efficacy and Safety of Escitalopram With Placebo in Patients With Acute Stroke for the Prevention of Poststroke Depression and Related Symptoms (Emotional Incontinence, Anger Proneness), and for Improvement of Neurologic, Cognitive Function and Quality of Life
Brief Summary: Through this study, the investigators are to demonstrate the superiority of Escitalopram over placebo for the prevention of poststroke depression in patients with acute stroke

The primary hypothesis of this study is;

This study will prove the superiority of Escitalopram on the prevention of poststroke depression in patients with acute stroke against placebo


Options:
A: Occurrence rate of depression (3 months)
B: Fugl Meyer Motor Scale score (Baseline and 90 days)
C: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)
D: Vascular death, Transient Ischemic Attack (TIA)/stroke and myocardial infarction (combined) (6 months); Functional status at 6-months (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Investigate the Impact of a Low Glycemic Index (GI) Diet on Body Mass Index and Obesity Related Cardiovascular and Hormonal Factors in Chinese Adolescents
Brief Summary: Epidemiological studies suggest a role for a low glycemic index (GI) diet in the management of obesity and associated metabolic risks including diabetes. However, evidence from long-term, randomized controlled trials exploring the relationship between low GI diet, weight reduction and glycemia, particularly in children and adolescents, is lacking. Modern food-processing technology has produced many food products with high GI which may contribute to the burgeoning epidemic of obesity worldwide. Since dietary habits are shaped in early life, adolescence is a critical period to educate our young people to acquire a healthy eating habit to prevent obesity.

The investigators hypothesized that, in Chinese adolescents, low GI diet results in greater reduction in body mass index and body fat percentage, enhanced insulin sensitivity and favorable changes of cardiometabolic risk factors compared to conventional diet after 12 months of intervention.

This study is a randomized controlled trial of a low GI (\<55) versus conventional Chinese diet (GI\>/=70) in adolescents (12-month intervention followed by a 6-month observational period) to study; 1) the changes in body mass index and obesity associated changes in cardiometabolic profile; 2) the underlying hormonal factors associated with these changes.


Options:
A: Weight; measured at each study visit; Percent body fat; measured at each study visit
B: Systolic blood pressure (SBP), Low Density Lipoproteins (LDL) cholesterol, High Density Lipoproteins (HDL) cholesterol, triglycerides, and insulin sensitivity (Measured at Week 5 of each dieting period)
C: body mass index (change from baseline to 12 months)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Investigate the Impact of a Low Glycemic Index (GI) Diet on Body Mass Index and Obesity Related Cardiovascular and Hormonal Factors in Chinese Adolescents
Brief Summary: Epidemiological studies suggest a role for a low glycemic index (GI) diet in the management of obesity and associated metabolic risks including diabetes. However, evidence from long-term, randomized controlled trials exploring the relationship between low GI diet, weight reduction and glycemia, particularly in children and adolescents, is lacking. Modern food-processing technology has produced many food products with high GI which may contribute to the burgeoning epidemic of obesity worldwide. Since dietary habits are shaped in early life, adolescence is a critical period to educate our young people to acquire a healthy eating habit to prevent obesity.

The investigators hypothesized that, in Chinese adolescents, low GI diet results in greater reduction in body mass index and body fat percentage, enhanced insulin sensitivity and favorable changes of cardiometabolic risk factors compared to conventional diet after 12 months of intervention.

This study is a randomized controlled trial of a low GI (\<55) versus conventional Chinese diet (GI\>/=70) in adolescents (12-month intervention followed by a 6-month observational period) to study; 1) the changes in body mass index and obesity associated changes in cardiometabolic profile; 2) the underlying hormonal factors associated with these changes.


Options:
A: body mass index (change from baseline to 12 months)
B: weight (6 months and 1 year); body mass index (6 months and 1 year); % body fat (6 months and 1 year); lipids (6 months and 1 year); blood pressure (6 months and 1 year); glucose (6 months and 1 year); insulin (6 months and 1 year); HOMA index (6 months and 1 year)
C: BMI Z score (12 months)
D: Body mass index (BMI) (Change through 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Treatment of Dyslipidemia for Hemodialysis
Brief Summary: The purpose of this study is to determine Effect of oral L-carnitine supplement on lipid profile, anemia, and quality of life.


Options:
A: The primary outcome measure is the number of intradialytic complications in each of the three study groups, only during the first study phase. (4 weeks for one study phase)
B: Change in weight (Baseline and 6 months); Change in fat free body mass (Baseline and 6 months); Change in serum albumin concentration (Baseline and 6 months); Change in serum prealbumin concentration (Baseline and 6 months)
C: lipid profile (at sixteen weeks after admission)
D: To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp (time 0, 4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economics.
Brief Summary: Is thoracoscopic surgery better than traditional open surgery for lung cancer?

Video assisted thoracoscopic surgery for lung cancer (VATS) is presumed to be less traumatic than traditional open surgery for lung cancer but this has never been documented in a randomized trial. Some surgeons hesitate to use VATS because it is technically more demanding, others question if the two methods are oncologically equal. Regardless, VATS has been implemented as a routine method for lung cancer surgery several places around the world including Odense University Hospital. The investigators have launched the first randomized controlled trial in the world comparing the two surgical methods to investigate any differences in length of hospitalization, postoperative pain, life quality within the first year, and health economics.

The investigators include patients with stage I and II lung cancer, and randomize between VATS and open surgery in a design where both the patient and doctors doing general rounds in the ward are blinded until discharge because the dressing on the surgical wound is identical, regardless of the surgical method. The surgeon cannot influence clinical decisions including time to discharge, which is decided by other specialist surgeons. Pain evaluation is performed 6 times daily using the VAS-score, life quality is evaluated continuously during the first 12 months using EQ5D and EORTC QLQC-30 questionnaires, and the consumption of analgetics in both groups are monitored via the national prescription database.

Parallel to this trial a similar clinical study, which is also the first of its kind in the world, has been launched for patients with lung cancers not eligible for VATS. They are randomized between the two traditional open surgical methods (anterolateral and posterolateral thoracotomy) - this is also blinded to both patient and doctors doing rounds until discharge from hospital, and endpoint are similar in the two studies.

206 patients have been randomized in the first substudy (VATS vs. open) and 88 in the second substudy (posterolateral vs. anterolateral).


Options:
A: Change in inspiratory muscle strength (Before surgery, 5.postoperative day, 2 weeks after surgery)
B: Change in Maximal oxygen uptake (VO2max) from baseline (An expected average of two weeks before surgery (baseline), four to six weeks after surgery, after six months and after 5 years)
C: Postoperative pain (12 months)
D: Systemic inflammation measured by c-reactive protein. (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cervical Foley Plus Vaginal Misoprostol Versus Vaginal Misoprostol for Cervical Ripening and Labor Induction: A Randomized Trial
Brief Summary: The purpose of this study is to compare the efficacy of the combination of the supracervical foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter induction to delivery time.


Options:
A: Rate of vaginal delivery within 24 hours (within 24 hours)
B: Time From Start of Labor Induction to Vaginal Delivery (72 hours)
C: The Time Interval From Induction to Delivery: All Participants (Day 1); Time (Hours) From Induction to Delivery: Nulliparous (Day 1); Time (Hours) From Induction to Delivery: Multiparous (Day 1); Time From Induction to Delivery: VD (Day 1); Time From Induction to Delivery: CD (Day 1); Per Treatment Protocol: Time (Hours) From Induction to Delivery (day 1)
D: Average Time in Hours From Insertion of the Catheter Until Delivery (At the end of the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cervical Foley Plus Vaginal Misoprostol Versus Vaginal Misoprostol for Cervical Ripening and Labor Induction: A Randomized Trial
Brief Summary: The purpose of this study is to compare the efficacy of the combination of the supracervical foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter induction to delivery time.


Options:
A: Time From Induction of Labor Until Delivery (Time from induction to delivery (average 14.2 hours))
B: Time from treatment start to delivery (At delivery)
C: Delivery Rate (Within 24 hours)
D: Time From Start of Labor Induction to Vaginal Delivery (72 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: EFFECTIVENESS OF A MULTIFACTORIAL INTERVENTION PROGRAM TO REDUCE FALLS INCIDENCE AMONG COMMUNITY-LIVING ELDERLY PEOPLE
Brief Summary: The purpose of this study is to determine the effectiveness of a multifactorial intervention program to prevent falls among the elderly as compared to a brief intervention.


Options:
A: Falls events (6-months)
B: Falls incidence rate (6 months)
C: fall incidence rate
D: Rate of falls and rate of undernutrition risk as MNA < 23,5

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Active Malaria Epidemiology Cohort Study With Evaluation of a 2 Day Versus 3 Day Treatment Regimen of Dihydroartemisinin (DHA)-Piperaquine for Patients With Uncomplicated Malaria
Brief Summary: An observational cohort and malaria treatment study in Cambodia.


Options:
A: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)
B: P.falciparum parasitaemia detected by PCR on days 3,7 and 14. (14 days from start of treatment)
C: Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment.
D: Adequate clinical and parasitological response to a treatment regimen of DHA-PIP for Plasmodium falciparum (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial
Brief Summary: The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin discoloration, is 5-10% in general population. Often conventional measures such as warming up or minimizing exposure to cold are not enough and many patients require treatment with a vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil, a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP.

Here, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5 inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment of secondary RP in Korean patients.


Options:
A: Change in the Raynaud's Condition Score (daily for 18 weeks)
B: Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo. (7 days)
C: RP Attacks Per Day (baselin and 4 weeks)
D: The primary outcome variables will be frequency and duration of Raynaud's attacks, evolution of trophic digital lesions (6 weeeks and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Applying Mobile Persuasive Technologies to Increase Physical Activity in Women
Brief Summary: The primary purpose of this study is to assess the efficacy of the mobile phone-based physical activity intervention on increasing physical activity compared to the control group.


Options:
A: 7-Day Physical Activity Recall (7-Day PAR) (6 months)
B: Physical activity measured by accelerometry. (3 months post-randomisation)
C: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)
D: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Applying Mobile Persuasive Technologies to Increase Physical Activity in Women
Brief Summary: The primary purpose of this study is to assess the efficacy of the mobile phone-based physical activity intervention on increasing physical activity compared to the control group.


Options:
A: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)
B: Physical activity measured by accelerometry. (3 months post-randomisation)
C: Reduction in incidence of diabetes at 3 years (3 years from entry into the study)
D: smoking status (six month followup)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Applying Mobile Persuasive Technologies to Increase Physical Activity in Women
Brief Summary: The primary purpose of this study is to assess the efficacy of the mobile phone-based physical activity intervention on increasing physical activity compared to the control group.


Options:
A: Physical activity level
B: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)
C: Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
D: Self-Reported physical activity (Baseline, 3 months, and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Applying Mobile Persuasive Technologies to Increase Physical Activity in Women
Brief Summary: The primary purpose of this study is to assess the efficacy of the mobile phone-based physical activity intervention on increasing physical activity compared to the control group.


Options:
A: Physical activity measured by accelerometry. (3 months post-randomisation)
B: Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
C: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
D: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Multicenter, Open Label, Phase II Study to Access Efficacy and Safety of Lucentis® Monotherapy (Ranibizumab 0.5 mg Intravitreal Injections) Compared With Lucentis® Plus Panretinal Photocoagulation (PRP) and PRP (Monotherapy) in the Treatment of Patients With High Risk Proliferative Diabetic Retinopathy
Brief Summary: The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of ranibizumab (0.5 mg) plus panretinal photocoagulation, versus panretinal photocoagulation alone in the regression of retinal neovascularization in eyes with high-risk proliferative diabetic retinopathy.


Options:
A: Treatment or "Failure" Defined as Vitrectomy (within 112 days of randomization); Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) (Baseline to 16 weeks)
B: Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG (12 months)
C: Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive Participants (Baseline, Week 24)
D: Regression of neovascularization (12-month treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis
Brief Summary: The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).


Options:
A: Composite Assessment of Function and Survival (CAFS) at 12 Months (12 months); Death up to 12 Months (CAFs Individual Component) (12 months); Change From Baseline in ALSFRS-R at 12 Months (CAFs Individual Component) (12 months)
B: Validated 7-day point prevalence tobacco abstinence (6 months after discharge)
C: Rate of all-cause hospital readmission or death during the 6-month follow-up period. (6 months)
D: Body Mass Index BMI (change in body mass index at baseline); BMI (change in body mass index at 6 months); BMI (change in body mass index at 12 months); BMI (change in body mass index at 18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Education Interventions Model for Rational Drug Use
Brief Summary: The purpose of this study is to develop, implement and evaluate an economically viable and efficient interventions education model for rational drug use, adaptable to different pathological situations and should be implemented into Brazil Heath Care System.


Options:
A: The percentage of selected (=undertreated) patients receiving at least one prescription for lipid-lowering medication. (six months after the general practitioner received the list with selected patients)
B: Knowledge of Asthma (6 months after the first evaluation)
C: Rate of adherence (2 months and 6 months)
D: Proportion of patients achieving hypertension control (6 months after enrollment); change in systolic and diastolic blood pressure (6 months after enrollment)

Answer: B