TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial
Brief Summary: This study assesses the effectiveness of a nutrition advice programme - The ten steps for healthy feeding of children under two years old - on nutritional status, diet, and morbidity history of children. This is a randomized controlled trial in mostly socioeconomic deprived families (intervention=200; controls=300). Mothers of the intervention group received dietary counseling in the first year of life. Both groups received routine care by their paediatricians and research assessment at 6 and 12 months, 4 years, 8 years and 12 years of age.


Options:
A: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
B: Blood Glucose, levels of glucose in blood (Postprandial 0-180 min after breakfast); Insulin, levels of insulin in blood (Postprandial 0-180 min after breakfast); Appetite hormones, levels of Peptide YY (PYY) in blood (Postprandial 0-180 min after breakfast); Markers of colonic fermentation, levels of hydrogen in breath (Postprandial 0-180 min after breakfast); Inflammation markers, levels of Interleukin-6 (IL-6) in blood (Postprandial 0-180 min after breakfast)
C: Exclusive Breastfeeding Rates in Burkina Faso (at 3 months of age); Infant Morbidity, 2 Week Diarrhoea Prevalence (at 3 months of age); Exclusive Breastfeeding Rates in Uganda (at 3 months of age); Exclusive Breastfeeding Rates in South Africa (at 3 months of age)
D: new decayed surfaces (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial
Brief Summary: This study assesses the effectiveness of a nutrition advice programme - The ten steps for healthy feeding of children under two years old - on nutritional status, diet, and morbidity history of children. This is a randomized controlled trial in mostly socioeconomic deprived families (intervention=200; controls=300). Mothers of the intervention group received dietary counseling in the first year of life. Both groups received routine care by their paediatricians and research assessment at 6 and 12 months, 4 years, 8 years and 12 years of age.


Options:
A: Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.
B: Children's height and weight (HAZ,WAZ and BAZ) (6 months)
C: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
D: Exclusive Breastfeeding at Four Months of Age (Six months after the beginning of the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg Once Daily) Against Placebo and Oxybutynin Hydrochloride (5 mg Three Times Daily) in the Treatment of Subjects With Neurogenic Detrusor Overactivity
Brief Summary: A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder symptoms due to spinal cord injury or multiple sclerosis


Options:
A: Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants (Baseline (BL); Week 12); CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants (Baseline; Week 12)
B: Baseline Average Number of Daily Incontinence Episodes (Baseline); Change From Baseline in Average Daily Number of Incontinence Episodes (Baseline to Week 12)
C: Change from baseline in maximum cystometric capacity (4 Weeks)
D: Hopkins Verbal Learning Test - Revised (Week 4); Hopkins Verbal Learning Test - Revised (Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.


Options:
A: Prenatal test use (9 months)
B: Severity of Violence Against Women (6 months); Women's Experience with Battering (6 months); Safety Behavior Checklist (6 months); Decisional Conflict Scale (6 months)
C: Men's understanding that prostate cancer screening requires a decision (baseline, post intervention, post clinical visit); Men's knowledge about prostate cancer and prostate cancer screening (baseline, post intervention, post clinical visit); Men's participation in the decision about prostate cancer screening with their clinician at their preferred level (baseline, post intervention, post clinical visit)
D: Participant-reported most important attribute from survey (1 day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.


Options:
A: Men's understanding that prostate cancer screening requires a decision (baseline, post intervention, post clinical visit); Men's knowledge about prostate cancer and prostate cancer screening (baseline, post intervention, post clinical visit); Men's participation in the decision about prostate cancer screening with their clinician at their preferred level (baseline, post intervention, post clinical visit)
B: Overall Screening Adherence (12 months)
C: Shared Decision Making Questionnaire (CollaboRATE) (Level of Shared Decision Making at end of treatment (this will be at approximately week 8))
D: Decision Self Efficacy (post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.


Options:
A: Mean Patient-centered Communication in Advanced Cancer Score (3 years)
B: Men's understanding that prostate cancer screening requires a decision (baseline, post intervention, post clinical visit); Men's knowledge about prostate cancer and prostate cancer screening (baseline, post intervention, post clinical visit); Men's participation in the decision about prostate cancer screening with their clinician at their preferred level (baseline, post intervention, post clinical visit)
C: Decisional Conflict Scale (3 months)
D: Decisional quality (knowledge, decisional conflict, and satisfaction) (Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Observer-Blind, Placebo-Controlled, Multicenter Study to Assess Clinical Efficacy of a Cell-Derived Subunit Influenza Vaccine and an Egg-Derived Subunit Influenza Vaccine in the 2007-2008 Influenza Season in Healthy Adult Subjects
Brief Summary: The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in healthy adults 18 to 49 years of age.


Options:
A: Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment.
B: Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years (Pre-vaccination (Day 0) and day 21 post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years (Pre-vaccination (Day 0) and Day 21 post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years (Days 0 to 7 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years (Days 0 to 7 post-vaccination)
C: Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains (6 Months)
D: The appearance among patients of symptomatic laboratory-confirmed influenza. (Influenza season Nov-Apr. Within 72 hours of illness onset throat swab specimens will be obtained from participants with influenza like illness (ILI).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study
Brief Summary: The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.


Options:
A: Change in Absolute FEV1 From Baseline Over 26 Weeks (26 weeks)
B: Interview #1 (to be conducted at the time of enrollment (post SIMPLIFY study)); Interview #2 (to be conducted 4 months following the date of the first interview)
C: Number of patients in both treatment groups with adverse events (AEs) and serious adverse events (SAEs) (during the 52 week treatment period)
D: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study
Brief Summary: The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.


Options:
A: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control (6 months)
B: Change in Absolute FEV1 From Baseline Over 26 Weeks (26 weeks)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: FEV1

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study
Brief Summary: The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.


Options:
A: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase (12 weeks)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Change in Absolute FEV1 From Baseline Over 26 Weeks (26 weeks)
D: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)
Brief Summary: Prospective, randomized, controlled trial to test if post-operative administration of probiotics in HD patients will lead to a reduction in the occurrence of HAEC.


Options:
A: Time to reach full feeds (First 40 days after birth)
B: Composition of the Fecal Microbiota (Final stool sample at 6 weeks)
C: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)
D: Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). (6 months post-pullthrough); Severity of Clinical Episodes of HAEC (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)
Brief Summary: Prospective, randomized, controlled trial to test if post-operative administration of probiotics in HD patients will lead to a reduction in the occurrence of HAEC.


Options:
A: NEC onset (6 weeks)
B: Probiotics Prevent Hirschsprung's Disease Associated Entercolitis (two years)
C: Time to reach full feeds (First 40 days after birth)
D: Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). (6 months post-pullthrough); Severity of Clinical Episodes of HAEC (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Importance of Increasing Intake of Essential Fatty Acids During Complementary Feeding on Infant Growth and Body Composition, Intestinal Health, Immune Function and Risk Markers for Later Metabolic Complications.
Brief Summary: The objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and body composition, intestinal health and microbiotic composition, immune function and risk markers for later diseases in 9-18 months old infants and toddlers.


Options:
A: Growth; Body composition; Intestinal microbiota; Blood pressure; Plasma lipid profile; Insulin - glucose; Erythrocyte fatty acid composition; Ex vivo cytokine production; IGF-1 and IGFBP-3; Adipokines; Plasma CRP; Plasma IgE
B: 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)
C: Calcium absorption (18 days)
D: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Translating Research Into the Prevention of Diabetes Mellitus (TRIP DM)
Brief Summary: The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized trial designed to test the effectiveness of a lay-health counselor led community-based diabetes prevention program in reducing blood glucose in people at risk for developing diabetes mellitus.


Options:
A: Fasting Glucose (Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization)
B: Weight loss (12 months)
C: Change in the number of incontinent episodes (6 months)
D: weight loss

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Translating Research Into the Prevention of Diabetes Mellitus (TRIP DM)
Brief Summary: The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized trial designed to test the effectiveness of a lay-health counselor led community-based diabetes prevention program in reducing blood glucose in people at risk for developing diabetes mellitus.


Options:
A: Fasting Glucose (Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization)
B: Changes in weight (6, 12, 19 and 24 months from baseline)
C: Progression to diabetes (6 monthly intervals for 2 years)
D: Change in weight from baseline (12- and 24-months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma
Brief Summary: Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.


Options:
A: Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab (Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.)
B: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)
C: Progression-Free Survival (PFS): Independent-Assessment (Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))
D: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma
Brief Summary: Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.


Options:
A: Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab (Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.)
B: Progression Free Survival (2 3/4 years)
C: progression-free rate (at 48 weeks post-treatment)
D: Progression-Free Survival (PFS): Independent-Assessment (Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma
Brief Summary: Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.


Options:
A: Percentage Change From Baseline in Tumour Size at 12 Weeks (Baseline to Week 12)
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: Progression-Free Survival (PFS): Independent-Assessment (Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))
D: Overall Survival (OS) at Primary Endpoint (Randomization until 398 deaths, up to May 2015 (approximately 30 months))

Answer: C