TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label, Randomized, Multicenter Phase II Study of a Combination of Torisel® (Temsirolimus) and Avastin® (Bevacizumab) Versus Sutent® (Sunitinib) and Versus a Combination of Avastin® (Bevacizumab) and Roféron® (Interferon Alpha-2a) in First-line Treatment of Patients With Metastatic Renal Cell Carcinoma.
Brief Summary: The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a combination of Torisel® and Avastin® given at first-line treatment in patients with metastatic renal cancer.

Eligible patients will be randomly assigned, in a 2:1:1 ratio, to either Avastin® + Torisel®, or Sutent® or IFN+Avastin®.


Options:
A: progression-free rate (at 48 weeks post-treatment)
B: Duration of Progression-Free Survival (PFS) per RECIST 1.1 as determined by blinded independent radiology committee (BIRC) (Up to 23 months after first subject randomized)
C: Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years))
D: Overall Survival (OS) at Primary Endpoint (Randomization until 398 deaths, up to May 2015 (approximately 30 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Cisplatin Chemotherapy
Brief Summary: The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.


Options:
A: A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). (Overall (in the 120 hours following initiation of cisplatin chemotherapy).)
B: efficacy (24 to 160 hours); tolerability (24 to 160 hours); cost-effectiveness (24 to 160 hours)
C: The primary efficacy endpoint is the overall complete response rate (no emesis and no use of rescue medication from 0 through 120 hours following initiation of cisplatin-based chemotherapy). (Days 1 through 6.)
D: The Percentage of Participants With No Vomiting - Overall Stage (Hour 0 on Day 1 to Day 5 (approximately 120 hours))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study PXN110748: An Efficacy and Safety Study of XP13512 Compared With a Concurrent Placebo Control in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN)
Brief Summary: The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with post-herpetic neuralgia (PHN).


Options:
A: Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine (baseline, 12 weeks)
B: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data (Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
C: Area of pin-prick hyperalgesia (Change from baseline visit to day 14 of treatment sessions); Area of touch-evoked allodynia (Change from baseline visit to day 14 of treatment sessions)
D: Alteration of pain intensity after treatment (5 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT
Brief Summary: This is a randomized, controlled, single-center, single-blind, 2x2 factorial design trial of routine provider, primary care-based interventions to increase breastfeeding intensity up to 6 months in low-income multiethnic women, with stratification for maternal country of birth. The Best Infant Nutrition for Good Outcomes (BINGO) trial will randomize women into one of four treatment groups: (a) Prenatal Care Provider (PNC); (b) Lactation Consultant (LC); (c) PNC + LC, or; (d) Control. Thus, the separate and synergistic effects of the interventions will be tested, compared to a Control standard of care. The intervention and design build upon our prior trial of an LC intervention alone.

PNCs- certified nurse midwives and ob/gyns-- will use a brief, electronically prompted protocol with women in the PNC, and PNC + LC groups throughout pregnancy. An LC will arrange pre-natal one-on-one meetings, daily hospital, and home visits with women in the LC and PNC+LC groups. Descriptive data on infant health visits, and participant/provider experiences will be collected as secondary outcomes. Interviews at 1,3 and 6 months post-partum will collect infant feeding, and health visit data outside the medical center. Medical center visit data will be obtained from MIS data.

Primary Outcomes (Hypotheses): Breastfeeding

1. Breastfeeding Intensity at 1,3, and 6 Months
2. Exclusive Breastfeeding at 1,3, and 6 Months

   Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience
3. To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses
4. To describe participant and provider (LC and PNC) experience of the interventions.


Options:
A: Postpartum weight retention (no more than 1.5 years)
B: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
C: Breastfeeding intensity at 1,3, and 6 months (1,3, and 6 months after birth of the baby)
D: Breastfeeding duration and intensity (Assessed at 1,3, and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double Blind, Placebo Controlled Parallel Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation b.i.d Dosing in Children Aged 1 to < 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin
Brief Summary: The purpose of this study is to determine the safety of the oral formulation of levocetirizine in children ages 1 to less than 6 years old who suffer from allergic rhinitis or chronic urticaria of unknown origin.


Options:
A: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) (Baseline, 14 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) (7 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) (14 days)
B: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) (Baseline, 14 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) (7 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) (14 days)
C: Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography. (5 hours)
D: Change From Baseline in the Weekly Itch Severity Score at Week 12 (Baseline, Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis
Brief Summary: This study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease rate of hospital admission, decrease clinical severity scores, and decrease length of stay.


Options:
A: Admission Rate (1 day); Length of Stay (1 month); Change in RDAI Score (1 Hour)
B: compare the rate of admission to hospital between the study and control groups (1 hour after treatment ends)
C: Change in Bronchiolitis Severity Score (Baseline and up to 24 hours of hospital stay)
D: Respiratory Assessment Change Score (RACS) (Baseline and 1 hour)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis
Brief Summary: This study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease rate of hospital admission, decrease clinical severity scores, and decrease length of stay.


Options:
A: Admission Rate (1 day); Length of Stay (1 month); Change in RDAI Score (1 Hour)
B: Mean Change in Clinical Severity Score (2 hours)
C: Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered (Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h))
D: Admission rate (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Double-blind, Placebo-controlled, 2-period Crossover, Multicenter Study to Assess the Effect of Indacaterol (300 μg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study compared the effect of indacaterol (300 μg once daily \[od\]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease.


Options:
A: Proactive tool (clinical visit version) (7 days)
B: Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period (End of each 3 week treatment period (last day of Weeks 3 and 9))
C: Daily step count (90 days)
D: The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). (14 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Telephone Interventions for Pediatric Obesity in School Age Children
Brief Summary: In this study, we evaluate whether dietary advice based on two healthy nutritional programs can be effectively delivered to families over one month by telephone. We hypothesize that among overweight school age children, a one-month telephone intervention will result in specific dietary changes consistent with the randomly assigned dietary intervention.


Options:
A: Change in diet (1 month)
B: N/A
C: Body weight; Fat mass and fat-free mass; Food intake
D: Blood Flow in Brain Areas of Intake Control. (4 hours postprandial)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Lactobacillus GG to Enhance the Immunogenicity of Influenza Vaccine in Healthy Adults - Proof of Concept Study
Brief Summary: The purpose of this study is to determine whether the food supplement called Lactobacillus rhamnosus GG (LGG) may help boost the effectiveness of the nasal flu vaccine. Preliminary data from several studies of healthy volunteers suggest that LGG boosts the immune response to vaccines. Fifty-two subjects will be recruited into the study, all will receive the nasal flu vaccine. Twenty-six will receive capsules that contain LGG, 26 will receive placebo capsules. Blood and nasal specimens will be collected weekly for four weeks and at eight weeks to evaluate the initial mucosal and systemic immune response to the immunization. This study will provide preliminary data on whether the immune response of healthy adults to the nasal influenza vaccine can be boosted by LGG.


Options:
A: Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age; local and systemic reactions within 2 weeks of vaccination
B: To measure anti-influenza systemic and mucosal antibody responses 4 weeks after administration of influenza vaccine (LAIV) to healthy subjects aged 18-49 and to compare responses in subjects receiving Lactobacillus GG (LGG) versus placebo (4 weeks)
C: Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain (At Day 0); Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 0); Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Number of Subjects With Any and Grade 3 Solicited Local Symptoms (During the 7-day (Days 0-6) post-vaccination period following each dose and across doses); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (During the 7-day (Days 0-6) post-vaccination period following each dose and across doses); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 30-day (Days 0-29) follow-up period after the first vaccination); Number of Subjects With Serious Adverse Events (SAEs) (During the entire study period (From Day 0 up to Month 24))
D: Safety and tolerability of FLU-v (Measurements will be taken at screening, then up to 21 days post-vaccination)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: To Compare Measures of Central Nervous System Maturity of Visual Acuity, Language, Mental and Motor Skill Development in Term Infants Following Maternal Supplementation Wit the n-3 Fatty Acid Docosahexaenoic Acid (DHA) During Gestation.
Brief Summary: Polyunsaturated fatty acids known as n-3 fatty acids are essential dietary nutrients for humans, and are known to be important to reducing the risk of certain diseases, particularly those related to neural system, cardiovascular system and immune system. Among the different n-3 fatty acids, docosahexaenoic acid (DHA) is present in particularly high amounts in the brain and retina, and is accumulated in large amounts in these organs during the last trimester of fetal development and first few months after birth. The n-3 fatty acids are present in the diet as linolenic acid which is found in vegetable and seed oils, and as DHA which is only found in animal tissue fats, with fatty fish being the richest dietary source. Humans are able to convert linolenic acid to DHA, but the conversion is believed to be slow in human and possibly inadequate to support the needs for DHA for the developing brain. Information from our work and those of others has suggested that DHA is important during pregnancy, however specific evidence is lacking to show that the DHA status of pregnant women in low, or that improvement in the DHA status of Canadian women during pregnancy will have benefit to early infant an child development. There is no evidence that infants of vegans and vegetarians, or women who do not eat DHA are at risk for developmental delays. The purpose of this study is to investigate whether a dietary supplement of DHA during pregnancy has any effect on infant birth weight, or indices of infant growth, visual, mental and motor skill development.


Options:
A: Maternal Cortisol Levels (Baseline (pre-stressor)); Maternal Cortisol Levels (20 minutes post-stressor); Maternal Cortisol Levels (45 minutes post stressor); Infant Cortisol Levels (4 months post-partum); Infant Cortisol Levels (4 months post-partum); Infant Cortisol Levels (4 months post-partum)
B: total score of the Hamilton Rating Scale for Depression (HAMD) (Twelve weeks)
C: Primary outcome is measuring of infant CNS maturity to 18 months of age (18 months)
D: Persistent wheeze 0 to 3 years of age (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: To Compare Measures of Central Nervous System Maturity of Visual Acuity, Language, Mental and Motor Skill Development in Term Infants Following Maternal Supplementation Wit the n-3 Fatty Acid Docosahexaenoic Acid (DHA) During Gestation.
Brief Summary: Polyunsaturated fatty acids known as n-3 fatty acids are essential dietary nutrients for humans, and are known to be important to reducing the risk of certain diseases, particularly those related to neural system, cardiovascular system and immune system. Among the different n-3 fatty acids, docosahexaenoic acid (DHA) is present in particularly high amounts in the brain and retina, and is accumulated in large amounts in these organs during the last trimester of fetal development and first few months after birth. The n-3 fatty acids are present in the diet as linolenic acid which is found in vegetable and seed oils, and as DHA which is only found in animal tissue fats, with fatty fish being the richest dietary source. Humans are able to convert linolenic acid to DHA, but the conversion is believed to be slow in human and possibly inadequate to support the needs for DHA for the developing brain. Information from our work and those of others has suggested that DHA is important during pregnancy, however specific evidence is lacking to show that the DHA status of pregnant women in low, or that improvement in the DHA status of Canadian women during pregnancy will have benefit to early infant an child development. There is no evidence that infants of vegans and vegetarians, or women who do not eat DHA are at risk for developmental delays. The purpose of this study is to investigate whether a dietary supplement of DHA during pregnancy has any effect on infant birth weight, or indices of infant growth, visual, mental and motor skill development.


Options:
A: Percentage of Total Fatty Acids by Weight (at time of birth); Gestational Age (at time of birth); Birth Weight (at time of birth); Birth Length (at time of birth)
B: Primary outcome is measuring of infant CNS maturity to 18 months of age (18 months)
C: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
D: Omega-3 fatty acid status in maternal and umbilical cord plasma (Weeks 20, 34 and 38 of pregnancy and at birth (in cord))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial
Brief Summary: The objective of our study is to determine the clinical utility related to the maintenance oral nifedipine therapy in patients with symptomatic placenta previa. This study is a prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of hospitalized patients with symptomatic placenta praevia. All patients may initially receive oral nifedipine therapy with steroid prophylaxis for 48 hours. After then, patients are randomly assigned to receive either oral nifedipine (20 mg every 8 hours) or placebo (one every 8 hours) until 37 weeks of gestation.

The primary outcome for the trial is the length of pregnancy in days after the enrollment. A sample size calculation is designed to detect at least a 14 -day difference in time gained in patients with maintenance oral nifedipine therapy. A sample size of about 52 patients per group would have a 80 % chance of detecting this difference at the 5 % level of significance.


Options:
A: Prolongation of pregnancy (From allocation to the delivery)
B: Time of Delivery (Delivery)
C: Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization (Two weeks after enrolled and randomized, up to 37 weeks of pregnancy)
D: Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours (48 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Insomnia Therapy For Those With Insomnia and Depression
Brief Summary: This study is a randomized clinical trial to test the efficacy of Cognitive-Behavioral Insomnia Therapy when used in isolation or in combination with antidepressant medication (escitalopram) among patients with Major depressive disorder and insomnia.


Options:
A: Percent days abstinent from alcohol (PDA) (12 and 24 weeks)
B: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
C: Number of Awakenings After Sleep Onset (NAASO) (4-Week maintenance treatment with milnacipran and placebo); Sleep Efficiency (SE) (4-Week maintenance treatment with milnacipran and placebo); Wake After Sleep Onset (WASO) (4-Week maintenance treatment with milnacipran and placebo)
D: Mean two-week sleep log estimate of post-treatment sleep continuity (An average of two-weeks post-treatment)

Answer: D