TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Local Endometrial Injury on Pregnancy Outcomes During Ovulation Induction Cycles
Brief Summary: The aim of this study is to detect whether or not performing an endometrial sampling in the cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in the next cycle.


Options:
A: Compare Pipelle and Explora Curette Groups With Respect to Patient Perception of Pain Associated With the Procedure as Rated by a 100mm Visual Analog Scale (VAS). (2 minutes after biopsy procedure)
B: Clinical pregnancy rate (6 months)
C: Clinical pregnancy rate (10 month)
D: Clinical pregnancy rate. (one year); Miscarriage rate. (one year); Multiple pregnancy rates (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by GA101 and Ibrutinib (BIG) Followed by GA101 and Ibrutinib Maintenance in CLL Patients (CLL2-BIG Protocol)
Brief Summary: A prospective, open-label, multicenter Phase-II trial to evaluate the efficacy and safety of a sequential regimen of Bendamustine followed by GA101 and Ibrutinib followed by Ibrutinib and GA101 maintenance in CLL patients.


Options:
A: Overall response rate (ORR) (84 days after first dose of last induction cycle)
B: Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study (Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months)); Percentage of Participants With Best Overall Response in Phase II of the Study (by Cutoff Date: 31 March 2012 (within 3 years, 4 months))
C: Progression-Free Survival (Up to 17 months)
D: Overall Survival (OS) (Up to approximately 11 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects With Moderate to Very Severe COPD After 4 Weeks of Treatment With PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo
Brief Summary: Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo.


Options:
A: Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24 (Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29)
B: Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks (12 weeks)
C: Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo (Baseline, day 22, baseline day 36, day 57); Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level (Baseline, day 22, baseline day 36, day 57)
D: Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169 (Baseline and Day 169)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects With Moderate to Very Severe COPD After 4 Weeks of Treatment With PT003 and Placebo MDI
Brief Summary: Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003 and Placebo MDI


Options:
A: Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap (6 weeks); Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap (6 weeks)
B: FEV1 AUC0-24 on Day 29 (Day 29)
C: Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks (12 weeks)
D: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Oral Health Among Tobacco Quitline Callers
Brief Summary: The current study will test the effectiveness of a multi-modal behavioral intervention (the Oral Health 4 Life program) targeted to smokers who are ready to quit smoking and seeking services through tobacco quitlines.

The investigators hypothesize that, compared to people in the control arm, participants in the enhanced intervention will:

1. Be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates at 6 month follow-up \[primary outcome\] and at 2 month follow-up \[secondary outcome\].
2. Be more likely to see a dental care professional in the past 6 months at 6 month follow-up \[primary outcome\].
3. Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes (e.g., self-efficacy, motivation) that could influence future behavior change.


Options:
A: 7 Day Point Prevalent Abstinence (PPA) (6 month post-enrollment); Professional Dental Care Utilization in Past 6 Months (6 months post-enrollment)
B: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
C: Primary Patient Acceptability A: Rate of Patient Wanting Provider to Use QA-DDS (Immediately Post-Consultation up to 1 week); Primary Patient Acceptability B: Rate of Patient Wanting to Use QA-DDS Patient Portal (1-Month Follow-Up); Primary Patient Feasibility A: Rate of Patient Completion of 1-Month Follow-Up Survey (1-Month Follow-Up)
D: Rating of urges to smoke 1-week after the target quit (1 week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Tralokinumab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis
Brief Summary: The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis


Options:
A: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 (Baseline (Day 1) and Week 12); Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12 (Week 12)
B: Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12 (Baseline (Day 1) and Week 12)
C: Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 (baseline to Week 12)
D: The primary endpoint in the study is the incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN668 or Placebo from baseline through week 12. (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Indigestible Carbohydrates in an Over-night Design as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
Brief Summary: The experimental model is a semi-acute, over-night, study where the purpose is to evaluate food factors related to colonially derived regulation and satiety in healthy subjects.


Options:
A: new decayed surfaces (1 year)
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: Incidence of dental caries (Baseline and 3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Brief Summary: This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene 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: 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)
C: Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 (From Baseline to Week 48)
D: Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24 (Day 1, Through Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Brief Summary: This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Safety as Determined by Adverse Events (AEs) (Start of study drug through the Follow-up Visit (Up to Day 56)); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 1-5b (Baseline through Day 28); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 6 (Baseline through Day 28); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 7 (Baseline through Day 28)
C: Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24 (Day 1, Through Week 24)
D: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Brief Summary: This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.


Options:
A: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
B: Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24 (Day 1, Through Week 24)
C: Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values (On Study Day 14)
D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma
Brief Summary: This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, Cohort 5 and Cohort 6).

The primary objectives of this study are:

* Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens
* Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel
* Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities

Subjects who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.


Options:
A: Event Free Survival (EFS) Per Blinded Central Assessment (From randomization date up to a median follow-up: 24.9 months)
B: Event-free Survival (EFS) Per Blinded Independent Review Committee (BIRC) Assessment (appro. 24 months)
C: Adverse events attributed to Tcm adoptive transfer as reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Up to 15 years); MTD of CD19-CAR-specific/truncated EGFR lentiviral vector-transduced autologous T cells based on dose limiting toxicities (Up to day 28)
D: Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) (First infusion date of axicabtagene ciloleucel up to 30 days); Phase 2 Pivotal Study (Cohorts 1 and 2): Overall Response Rate (ORR) as Assessed by Investigator Per Revised International Working Group (IWG) Response Criteria for Malignant Lymphoma (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 7.7 years)); Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 6.8 years)); Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 5.4 years)); Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.4 years)); Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.1 years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Myofascial Release Therapy in the Treatment of Occupational Mechanical Neck Pain: a Randomized Parallel Group Study.
Brief Summary: Mechanical neck pain is a musculoskeletal disorder usually associated with work absenteeism. Myofascial release therapy (MRT) is currently under development and has the treatment of mechanical neck pain as one of its main focal points. However, there is a paucity of studies reporting its effectiveness. For that purpose a randomized single-blind parallel group study was designed to compare the effectiveness of MRT with manual therapy (MT) for treating occupational mechanical neck pain. The sample (n=59) was randomly assigned to two therapeutic intervention programs. Group I patients were treated with MT and Group II patients were treated with MRT. Variables studied were intensity of neck pain, cervical disability, quality of life (QoL), craniovertebral angle and ranges of cervical motion.


Options:
A: Neck Pain (Baseline)
B: Improvement in neck related dysfunction (4 weeks); Improvement in pain levels (4 weeks)
C: Change in functionality assessment NDI (Neck Disability Index) & SPADI (Shoulder Pain and Disability Index) (at baseline, one week after the end of the treatment sessions, at 3 months); Pain assessment 0-10 (at baseline); Change in Pain assessment (at baseline, one week after the end of the treatment sessions, at 3 months)
D: Neck Disability Index (NDI) (baseline and post intervention 2 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Evaluation of Dabigatran Etexilate Compared to warfarIn in pulmonaRy Vein Ablation: Assessment of an Uninterrupted periproCedUral alntIcoagulation sTrategy (The RE-CIRCUIT Trial)
Brief Summary: The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study.

Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting.

It is not intended to assess confirmatory hypothesis, this is an exploratory study.


Options:
A: Number of participants with newly onset of symptomatic venous thromboembolism (VTE) (Up to 12 months); Number of clinically relevant bleedings (Up to 2 days after last dose)
B: Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH) (during and up to 2 months post-ablation)
C: Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month)); Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)); Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period (During extended treatment period: up to month 12.); Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication) (More than 2 and up to 30 days after stop of study medication); Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)); Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period (During extended treatment period: up to month 12.)
D: Symptomatic DVT (3 months); Symptomatic PE (3 months); Unsuspected PE and DVT (3 months); Worsening of pulmonary vascular or venous obstruction (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Health Intervention to Improve Perinatal Continuum of Care in Guatemala
Brief Summary: The purpose of the study is to explore ways to improve maternal and child outcomes in the ethnic Maya speaking the Kaqchikel language population, which experiences wide disparities in health care access and outcomes when compared to other inhabitants of Guatemala who are not ethnically Maya and live in other parts of the country.


Options:
A: Referral Rates to Local Hospitals (Month 7, Month 12); Number of Neonatal Deaths (Month 12)
B: Receipt of colorectal cancer screening exam (fecal occult blood test, flexible sigmoidoscopy, or colonoscopy) within 4 months following delivery of an electronic message within the personal health record
C: Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) (12-months)
D: poor asthma control (2006-2009)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Health Intervention to Improve Perinatal Continuum of Care in Guatemala
Brief Summary: The purpose of the study is to explore ways to improve maternal and child outcomes in the ethnic Maya speaking the Kaqchikel language population, which experiences wide disparities in health care access and outcomes when compared to other inhabitants of Guatemala who are not ethnically Maya and live in other parts of the country.


Options:
A: Referral Rates to Local Hospitals (Month 7, Month 12); Number of Neonatal Deaths (Month 12)
B: %patients at ATP III goals (one year after intervention)
C: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
D: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus
Brief Summary: The gold standard corneal crosslinking (CXL) technique involves the initial step of epithelial removal, in order to achieve a sufficient treatment effect (meaning: stabilisation of progressive keratoconus (KC). Our aim is to evaluate the effects of transepithelial CXL (TE-CXL), whereby the epithelium is left intact and the cornea is instead treated by a solution composed of 0.1% riboflavin, combined with enhancers, after which standard CXL is performed. This solution seems to facilitate riboflavin penetration into the corneal stroma through the intact epithelium. The investigators expect to achieve a similar effect of TE-CXL with the advantage of a faster healing time and less risk of infections.


Options:
A: Clinical stabilisation of keratoconus one year after CXL (1 year)
B: Time to Re-epithelialization (Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete)
C: Microbiological Cure on Repeat Culture (4 to 24 hours after enrollment)
D: Time From Surgery to Device Loss or Replacement (2 years)

Answer: A