TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Brief Summary: This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).


Options:
A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls. (baseline and 6 months)
D: Change in FEV1 (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Brief Summary: This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).


Options:
A: Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline Forced Vital Capacity (FVC) at 8 weeks (Eight weeks); Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks (Eight weeks); Change from baseline Peak Expiratory Flow (PEF) at 8 weeks (Eight weeks); Change from baseline maximum inspiratory pressure at 8 weeks (Eight weeks); Change from baseline maximum expiratory pressure at 8 weeks (Eight weeks); Change from baseline distance covered in six-minute walk test at 8 weeks (Eight weeks)
B: Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls. (baseline and 6 months)
C: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
D: Change from baseline Posture at 4 weeks (Baseline and after 4 weeks of training); Change from baseline Health-related quality of life at 4 weeks (Baseline and after 4 weeks of training)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Brief Summary: This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).


Options:
A: Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)
B: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
C: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)
D: Safety assessments based on clinical evaluations, laboratory assessments, and adverse events. (28 Days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Brief Summary: This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).


Options:
A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
B: Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline Forced Vital Capacity (FVC) at 8 weeks (Eight weeks); Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks (Eight weeks); Change from baseline Peak Expiratory Flow (PEF) at 8 weeks (Eight weeks); Change from baseline maximum inspiratory pressure at 8 weeks (Eight weeks); Change from baseline maximum expiratory pressure at 8 weeks (Eight weeks); Change from baseline distance covered in six-minute walk test at 8 weeks (Eight weeks)
C: Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24 (Baseline, Week 24)
D: The six-minute walking distance (0, 1, 2 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
Brief Summary: This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)


Options:
A: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in treatment period up to safety follow-up (up to 28 days)); Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)); Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29)
B: Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 1 (4 hours post-morning dose on Day 1); Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 14 (4 hours post-morning dose on Day 14); Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to End of Dosing Interval (AUCtau) of Lumacaftor (LUM) and Ivacaftor (IVA) (Day 14 (pre-morning dose, 4, 6, 12, and 24 hours post-morning dose for LUM; pre-morning dose, 2, 4, 6, 12 hours post-morning dose for IVA)); Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 26)
C: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
Brief Summary: This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)


Options:
A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
B: Change in forced expiratory volume in 1 second (FEV1) (%predicted) (Baseline to 3 months and Baseline to 6 months); Change in peak oxygen uptake (% predicted) (Baseline to 3 months and Baseline to 6 months); Change in number of steps per day (Baseline to 3 months and Baseline to 6 months)
C: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
D: Change in FEV1 (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
Brief Summary: This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)


Options:
A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
B: Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values (On Study Day 14)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Number of Participants With Treatment-Emergent Adverse Events (First administration (Day 1) through Follow-up (Day 43))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
Brief Summary: The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation


Options:
A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Baseline up to Week 100)
B: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
C: Treatment Period: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 196)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
Brief Summary: The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation


Options:
A: Treatment Period: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 196)
B: Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites (From Day 1 through Day 15); Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Day 43); Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 28)
C: Cohort 1: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)); Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs (Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21 (Cohort 1: Day 14, Day 21); Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56 (Cohort 2 and 3: Day 28, Day 56); Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56 (Cohort 4: Baseline, Day 56)
D: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Baseline up to Week 100)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Fascia Iliaca Block on Pain Outcomes and Opioid Consumption for Hip Fracture Patients-A Prospective, Randomized Study
Brief Summary: The study is a prospective randomized examining the impact of fascia iliaca block on perioperative pain control and post operative ambulation in patients with hip fractures.


Options:
A: Pain level (Pre operatively); Pain medication requirement (Pre operatively); Pain level (Four hours after surgery); Pain medication requirement (Four hours after surgery); Pain level (One day after surgery); Pain medication requirement (One day after surgery); Pain level (Two days after surgery); Pain medication requirement (Two days after surgery); Pain level (Three days after surgery); Pain medication requirement (Three days after surgery)
B: Respiratory complications (During hospital stay, up to 1 month)
C: Pain scores (For 24 hours after performance the blockade)
D: Number of Participants Reporting at Least One NRS Rating (30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Alternate Day Fasting Combined With a High Protein Background Diet for Weight Loss and Weight Maintenance in Adults With Obesity
Brief Summary: The aims of this study are as follows: AIM 1: To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance).


Options:
A: Measure of plasma glucose (5 weeks)
B: Progression-free-survival (6 months)
C: Body weight (Change from baseline to week 24)
D: Change in body weight (Baseline and weeks 2, 4 and 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Commercial Video Games in Subacute Stroke Rehabilitation: Randomized Clinical Trial
Brief Summary: Stroke creats dependancy of patients due to various associated impairments. The use of low-cost technologies for neurological rehabilitation may be beneficial for the treatment of these patients.


Options:
A: Timed get up and go (eight weeks)
B: Recruitment (Through study completion, an average of 1.5 months.); Retention (Through study completion, an average of 1.5 months.); Participation (Through study completion, an average of 1.5 months.); Adherence (Through study completion, an average of 1.5 months.); Acceptability and enjoyment (Through study completion, an average of 1.5 months.); Safety and Adverse events (Through study completion, an average of 1.5 months.); Device development or modifications (Through study completion, an average of 1.5 months.); Fatigue (Through study completion, an average of 1.5 months.); Patient Global Impression of Change (Through study completion, an average of 1.5 months.)
C: Change in the Function In Sitting Test (FIST) from baseline to after 10-12 treatment sessions (baseline, immediately after 10-12 treatments); Change in the Function In Sitting Test (FIST) from baseline to 1 month after second assessment (baseline,1 month after second assessment)
D: Barthel Index (up to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cell Therapy in Patients With Relapsed or Refractory CD19-positive Non-Hodgkin's Lymphoma
Brief Summary: n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy.


Options:
A: Occurrence of study related adverse events (Until week 24)
B: Occurrence of study related adverse events (2 years)
C: Event-free survival (EFS) (Approximately 3 years)
D: Treatment-related adverse events (AEs) (2 years); Dose-limiting toxicities of JWCAR029 (28 days after JWCAR029 infusion); Objective response rate (ORR) (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: for Infection Prevention in Sickle Cell Anemia (ZIPS)
Brief Summary: A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in Ugandan children with sickle cell anemia (SCA).


Options:
A: To determine whether supplementation with LOVAZA will exert an anti-inflammatory effect by decreasing levels of the inflammatory biomarker high sensitivity C Reactive Protein (hsCRP) in children and adolescents with Sickle Cell Disease (SCD). (6 months)
B: The Number of Occurrences of Sickle Cell Crises (48 weeks)
C: Number of Occurrences of Painful Sickle Cell Crises (From Week 0 through Week 48 (cumulative))
D: Incidence of infection (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial Evaluating the Efficacy of an Adapted Physical Activity Program Using a Connected Device With Activity Trackers and a Therapeutic Education Program Among Women With Localized Breast Cancer
Brief Summary: The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.


Options:
A: Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (Baseline); Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (Four weeks); Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (10 weeks); Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (18 weeks); Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (52 weeks)
B: Number of patients achieving the internationally recommended level of physical activity of at least 150 minutes per week of moderate-to-vigorous physical activity (intensity ≥3 METs) (6 months)
C: Health related quality of life (Change from Baseline HRQoL at 6 months)
D: Mental condition (from baseline until 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: In-home Obesity Prevention to Reach Low-income Infants Through Maternal and Social Transmission
Brief Summary: Existing obesity prevention efforts have had limited success among underserved, low-income children. This study capitalizes on the strengths of a nationwide ongoing Home Visitation Program (HVP), which serves at-risk, low-income, ethnically/racially diverse mothers and their infants, to test the effectiveness of delivering obesity prevention as part of their weekly, in-home services. The study will evaluate whether the integration of an obesity prevention enhancement module into existing HVP services, reduces the risk and incidence of obesity and associated risk factors in mothers and infants, compared to the provision of standard home visitation services. The study also focuses on the role of maternal factors (maternal diet, physical activity, food insecurity and feeding practices) and social factors (social network support) as mechanisms operating on infant outcomes.


Options:
A: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
B: 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)
C: change in adiposity (baseline, 6 month follow-up)
D: Mother BMI (Baseline, 6 months, 12 months); Infant Weight (Baseline, 6 months, 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: In-home Obesity Prevention to Reach Low-income Infants Through Maternal and Social Transmission
Brief Summary: Existing obesity prevention efforts have had limited success among underserved, low-income children. This study capitalizes on the strengths of a nationwide ongoing Home Visitation Program (HVP), which serves at-risk, low-income, ethnically/racially diverse mothers and their infants, to test the effectiveness of delivering obesity prevention as part of their weekly, in-home services. The study will evaluate whether the integration of an obesity prevention enhancement module into existing HVP services, reduces the risk and incidence of obesity and associated risk factors in mothers and infants, compared to the provision of standard home visitation services. The study also focuses on the role of maternal factors (maternal diet, physical activity, food insecurity and feeding practices) and social factors (social network support) as mechanisms operating on infant outcomes.


Options:
A: Mother BMI (Baseline, 6 months, 12 months); Infant Weight (Baseline, 6 months, 12 months)
B: Growth trajectories (using BMI, waist circumference), body composition (3 months)
C: Eating habits (3 years); Physical activity (3 years); Nature relatedness (3 years)
D: body mass index (three years)

Answer: A