TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. Participants had monthly laboratory tests and comprehensive testing every 3 months.


Options:
A: Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients
B: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)
C: Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study (Baseline to Month 12)
D: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. Participants had monthly laboratory tests and comprehensive testing every 3 months.


Options:
A: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan (Weeks 12 to 36)
B: The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24. (Weeks 12, 16, 20, and 24)
C: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)
D: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate (Core treatment period between 48 - 152 weeks depending on time of enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. Participants had monthly laboratory tests and comprehensive testing every 3 months.


Options:
A: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.
B: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit (Up to 98 weeks); Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks))
C: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 (Month 3 and Month 6)
D: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Oral Iron Supplementation With Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent - A Non-Inferiority Safety Trial
Brief Summary: The purpose of this study is to determine the safety profile of oral iron supplementation (OIS) with Sprinkles in a pediatric population with high prevalence of Iron deficiency (ID) and moderate or severe malnutrition (MSM); the efficacy profile will also be investigated.


Options:
A: Dual Sugar Absorption Test (12 weeks); Dual Sugar Absorption Test (24 weeks)
B: Birth weight (Within 48 hours (or back calculated from later measurements).); Birth length (Within 48 hours (or back calculated from later measurements)); Child linear growth status at 24 months (24 months)
C: Product sales and use (coverage) (Every 2 weeks)
D: A composite score based on the sum of all distinct episodes of diarrhea, dysentery and lower respiratory tract infections (2 distinct and consecutive phases of 6 months each)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
Brief Summary: Obesity is a serious and increasing health problem in the Western World with about one third of all pregnant women in Denmark being overweight. Among these are more than 11% severe obese.

Obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and mortality. Observational studies indicate that the rate of pregnancy complications among obese pregnant women can be limited if weight gain during pregnancy is restricted.

Aims of the trial is to study the effects of diet and physical training during pregnancy among Danish obese women. Also to describe the metabolic effects of lifestyle intervention during pregnancy.

360 obese pregnant women with Body Mass Index (BMI) \> 30 are randomized to lifestyle intervention group or control group. The intervention is composed of individual dietician counselling and physical training. The physical training includes weekly aerobic exercises in a fitness center and lifestyle coaching in small groups.

Both groups will be examined during pregnancy with extra ultrasound scanning of the fetus, blood pressure, and metabolic markers. All women receive vitamin supplementation to assure sufficient intake.


Options:
A: Weight loss (6 months)
B: 1: Differences in Change in Weight between Groups - Body Weight (kg) (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Weight between Groups - waist circumference (cm) (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Kcal intake (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Weekly minutes moderate or greater intensity activity (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Pressure (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Lipids (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)
C: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)
D: First Occurrence of a Severe Cardiovascular Event (up to 11 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
Brief Summary: Obesity is a serious and increasing health problem in the Western World with about one third of all pregnant women in Denmark being overweight. Among these are more than 11% severe obese.

Obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and mortality. Observational studies indicate that the rate of pregnancy complications among obese pregnant women can be limited if weight gain during pregnancy is restricted.

Aims of the trial is to study the effects of diet and physical training during pregnancy among Danish obese women. Also to describe the metabolic effects of lifestyle intervention during pregnancy.

360 obese pregnant women with Body Mass Index (BMI) \> 30 are randomized to lifestyle intervention group or control group. The intervention is composed of individual dietician counselling and physical training. The physical training includes weekly aerobic exercises in a fitness center and lifestyle coaching in small groups.

Both groups will be examined during pregnancy with extra ultrasound scanning of the fetus, blood pressure, and metabolic markers. All women receive vitamin supplementation to assure sufficient intake.


Options:
A: Change from Baseline in oral glucose tolerance test at variable time frames (1) Baseline (group 1= planning a pregnancy; group 2=at gest.week 10-14); 2) at gest.week 10-14 (group 1) and 3) at gest.week 24-28; 4) 6 weeks and 12 months post partum)
B: Number of at risk participants developing GDM during pregnancy
C: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)
D: Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations (Delivery (when the baby is delivered))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
Brief Summary: Obesity is a serious and increasing health problem in the Western World with about one third of all pregnant women in Denmark being overweight. Among these are more than 11% severe obese.

Obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and mortality. Observational studies indicate that the rate of pregnancy complications among obese pregnant women can be limited if weight gain during pregnancy is restricted.

Aims of the trial is to study the effects of diet and physical training during pregnancy among Danish obese women. Also to describe the metabolic effects of lifestyle intervention during pregnancy.

360 obese pregnant women with Body Mass Index (BMI) \> 30 are randomized to lifestyle intervention group or control group. The intervention is composed of individual dietician counselling and physical training. The physical training includes weekly aerobic exercises in a fitness center and lifestyle coaching in small groups.

Both groups will be examined during pregnancy with extra ultrasound scanning of the fetus, blood pressure, and metabolic markers. All women receive vitamin supplementation to assure sufficient intake.


Options:
A: Diet; Physical Activity
B: Birth weight as assessed by z-scores (At birth)
C: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)
D: Child body mass standard deviation score (On average 2.9 years of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
Brief Summary: Obesity is a serious and increasing health problem in the Western World with about one third of all pregnant women in Denmark being overweight. Among these are more than 11% severe obese.

Obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and mortality. Observational studies indicate that the rate of pregnancy complications among obese pregnant women can be limited if weight gain during pregnancy is restricted.

Aims of the trial is to study the effects of diet and physical training during pregnancy among Danish obese women. Also to describe the metabolic effects of lifestyle intervention during pregnancy.

360 obese pregnant women with Body Mass Index (BMI) \> 30 are randomized to lifestyle intervention group or control group. The intervention is composed of individual dietician counselling and physical training. The physical training includes weekly aerobic exercises in a fitness center and lifestyle coaching in small groups.

Both groups will be examined during pregnancy with extra ultrasound scanning of the fetus, blood pressure, and metabolic markers. All women receive vitamin supplementation to assure sufficient intake.


Options:
A: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
B: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)
C: Percentage of women above the Institute of Medicine Guidelines for gestational weight gain (40 weeks)
D: Birth weight as assessed by z-scores (At birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to investigate the effects of robot-assisted gait training on active walking in the patients with stroke.


Options:
A: change of functional ambulation category point (baseline, during training (2weeks), post training (4weeks) & followed for 2months after training)
B: N/A
C: Fugl-Meyer Assessment (FMA) (An expected average of 4 weeks)
D: Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention (Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
Brief Summary: In this study, we will determine whether treating pregnant and breastfeeding women co-infected with human immunodeficiency virus type 1 (HIV-1) and herpes simplex virus type 2 (HSV-2) with daily valacyclovir will reduce HIV-1 levels in plasma, genital, and breast milk and will decrease the risk of mother-to-child HIV-1 transmission (MTCT).


Options:
A: Plasma HIV-1 levels and HIV-1 mucosal shedding (18 weeks)
B: Difference of HIV-1 RNA and DNA shedding assessed by performing cervicovaginal lavage (CVL) HIV viral load, among groups; Difference of HSV-2 DNA shedding among groups
C: Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation (4 weeks)
D: Sequence-verified HIV-transmission from index to partner participant (March 2009)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Effectiveness and Preventive Impact of Home Zinc Treatment for Acute Diarrhea in Children: A Cluster-randomized Field Trial in Rural Western Kenya
Brief Summary: Background. Zinc deficiency is common in Africa. It has been shown in Asia that zinc as treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent future episodes. The use of zinc at home to treat diarrhea in an African setting, where malaria, HIV and malnutrition are common, has not been well-studied.

Objective. To evaluate if zinc treatment for diarrhea given at home in Kenyan children will decrease the community prevalence of diarrhea more than zinc given only in the clinic Work planned. We propose to do a community-randomized intervention study of 10 days of dispersible zinc tablets given in the home, in addition to ORS, to treat diarrhea in children under-5 years of age living in a rural part of Bondo District. The comparison group will be children who receive zinc and ORS in the clinic only. The primary outcome will be a comparison of the prevalence of diarrhea in home zinc versus nonhome zinc villages. Secondary outcomes will be the incidence of repeat episodes of diarrhea, the duration of diarrheal illness, the prevalence of acute respiratory infection, and the effect of malaria infection on treatment with zinc. Thirty-three villages (approximately 1300 children) will be enrolled and children will be followed for 1 year.

Significance of results. If this study shows zinc given at home to be effective, this might be considered by the Kenyan MOH as an essential component of the treatment of diarrhea in children at the community level.


Options:
A: all cause hospitalizations in comparison to infants receiving placebo. (November 2004 to August 2007); illnesses requiring visits to healthcare providers. (November 2004 to August 2007)
B: N/A
C: To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic leads to a greater reduction in the prevalence of diarrhea than giving zinc for treatment of diarrhea in the clinic only (One year)
D: Incidence acute diarrheal disease and acute respiratory infection (Up to 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Inhalation of a Free Combination of Tiotropium Once Daily 18 Mcg and Salmeterol Twice Daily 50 Mcg Versus a Fixed Combination of Fluticasone and Salmeterol Twice Daily (500/50 Mcg) on Static Lung Volumes and Exercise Tolerance in COPD Patients (a Randomised, Double-blind, Double Dummy, 16 (2 x 8) Weeks, Crossover Study).
Brief Summary: The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD.

The secondary objective includes assessment of safety.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Week 12)
B: Post-dose TGV(FRC) (After 8 Weeks) (8 weeks); Endurance Time (After 8 Weeks) (8 weeks)
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
D: Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169 (Baseline and Day 169)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Inhalation of a Free Combination of Tiotropium Once Daily 18 Mcg and Salmeterol Twice Daily 50 Mcg Versus a Fixed Combination of Fluticasone and Salmeterol Twice Daily (500/50 Mcg) on Static Lung Volumes and Exercise Tolerance in COPD Patients (a Randomised, Double-blind, Double Dummy, 16 (2 x 8) Weeks, Crossover Study).
Brief Summary: The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD.

The secondary objective includes assessment of safety.


Options:
A: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84 (Baseline and Day 84)
B: Moderate and severe COPD exacerbation rate over 52 weeks of treatment (1 year)
C: Post-dose TGV(FRC) (After 8 Weeks) (8 weeks); Endurance Time (After 8 Weeks) (8 weeks)
D: Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Week 12 (Visit 4)); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Day 1 (baseline) and week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Inhalation of a Free Combination of Tiotropium Once Daily 18 Mcg and Salmeterol Twice Daily 50 Mcg Versus a Fixed Combination of Fluticasone and Salmeterol Twice Daily (500/50 Mcg) on Static Lung Volumes and Exercise Tolerance in COPD Patients (a Randomised, Double-blind, Double Dummy, 16 (2 x 8) Weeks, Crossover Study).
Brief Summary: The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD.

The secondary objective includes assessment of safety.


Options:
A: Post-dose TGV(FRC) (After 8 Weeks) (8 weeks); Endurance Time (After 8 Weeks) (8 weeks)
B: Change From Baseline in 24-hour Weighted-mean Serial FEV1 on Treatment Day 84 (Baseline and Day 84)
C: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84 (Baseline and Day 84)
D: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84 (Baseline and Day 84)

Answer: A