TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.


Options:
A: Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52. (Baseline, Week 52)
B: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
C: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Week 12)
D: Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered Via a SelfDose (TM) Device in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis
Brief Summary: The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.


Options:
A: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
B: Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis (12 weeks)
C: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
D: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16); Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 (Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered Via a SelfDose (TM) Device in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis
Brief Summary: The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.


Options:
A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16)
B: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16); Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 (Week 16)
C: Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) (Week 12)
D: Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest (From Day 169 to Day 729); Short-term Period: Number of Participants With ACR 20 Response at Day 169 (At Day 169 from Baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of an Intervention Delivered by Text Message to Increase the Acceptability of Effective Contraception Among Young Women in Palestine
Brief Summary: This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone text message on the acceptability of effective contraception in Palestine. Woman aged 18-24 will be randomised to receive 0-3 text messages a day for 4 months (intervention) or a monthly text message not about contraception (control). Participants will complete a questionnaire at baseline and 4 month follow-up.


Options:
A: Use of effective contraception (4 months); Acceptability of at least one method of effective contraception (4 months)
B: LARC uptake (at time of intervention (baseline (0 weeks))
C: Uptake of the timed appointment provided by the screening service (Usually within a month (Individual timed appointment is provided by the screening service))
D: Acceptability of at least one method of effective contraception (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of an Intervention Delivered by Text Message to Increase the Acceptability of Effective Contraception Among Young Women in Palestine
Brief Summary: This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone text message on the acceptability of effective contraception in Palestine. Woman aged 18-24 will be randomised to receive 0-3 text messages a day for 4 months (intervention) or a monthly text message not about contraception (control). Participants will complete a questionnaire at baseline and 4 month follow-up.


Options:
A: Acceptability of at least one method of effective contraception (4 months)
B: Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) (3 months); Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) (3 months); Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) (12 months); Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) (12 months); Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) (12 months); Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) (12 months)
C: Exhaled Carbon Monoxide Levels (1 month)
D: The primary outcome will measure the number of children who got vaccinated for routine immunization scheduled at 6, 10 and 14 weeks of life (Vaccination status at 20th week of life of the particpants)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of an Intervention Delivered by Text Message to Increase the Acceptability of Effective Contraception Among Young Women in Palestine
Brief Summary: This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone text message on the acceptability of effective contraception in Palestine. Woman aged 18-24 will be randomised to receive 0-3 text messages a day for 4 months (intervention) or a monthly text message not about contraception (control). Participants will complete a questionnaire at baseline and 4 month follow-up.


Options:
A: Overall MEMS Adherence to Antiretroviral Medication (6 weeks); MEMS Adherence to Antiretroviral Medication Based on Dose Timing (6 weeks)
B: Antiretroviral Therapy (ART) Adherence Levels (real time (for 9 months))
C: Rate of Premature birth (before 37 weeks gestation)
D: Acceptability of at least one method of effective contraception (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of an Intervention Delivered by Text Message to Increase the Acceptability of Effective Contraception Among Young Women in Palestine
Brief Summary: This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone text message on the acceptability of effective contraception in Palestine. Woman aged 18-24 will be randomised to receive 0-3 text messages a day for 4 months (intervention) or a monthly text message not about contraception (control). Participants will complete a questionnaire at baseline and 4 month follow-up.


Options:
A: Acceptability of at least one method of effective contraception (4 months)
B: Improvement in the recall of LMP date among enrolled participants in the intervention arms compared to control arm (12 months after enrollment); Increased accuracy of LMP-based gestational age measurement, as compared to USG (12 months after enrollment)
C: Prevalence of Influenza Vaccination of those who do receive text message reminders compared to those who do not. (Up to 5 months)
D: Percent of children immunized (Up to 12 months of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of an Intervention Delivered by App Instant Messaging to Increase the Acceptability of Effective Contraception Among Young People in Tajikistan
Brief Summary: This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on the acceptability of effective contraception in Tajikistan. Woman and men aged 16-24 will be randomised to have access to the Tajik Family Planning Alliance's sexual and reproductive health app (control) or the app plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a questionnaire at baseline and 4 months.


Options:
A: Acceptability of at least one method of effective contraception (4 months)
B: Use of a Effective Contraceptive Method at Four-months Post-abortion (4 months)
C: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
D: Self-reported completion of a full course of PEP medications and receipt of a final HIV test result from their nPEP provider 12 weeks after the index exposure (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of an Intervention Delivered by App Instant Messaging to Increase the Acceptability of Effective Contraception Among Young People in Tajikistan
Brief Summary: This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on the acceptability of effective contraception in Tajikistan. Woman and men aged 16-24 will be randomised to have access to the Tajik Family Planning Alliance's sexual and reproductive health app (control) or the app plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a questionnaire at baseline and 4 months.


Options:
A: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
B: Acceptability of at least one method of effective contraception (4 months)
C: Measles - 2 Completion (When the participants reach 2 years of age)
D: Initiation of highly effective contraception, as defined by the World Health Organization. (3 months after initial enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of an Intervention Delivered by App Instant Messaging to Increase the Acceptability of Effective Contraception Among Young People in Tajikistan
Brief Summary: This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on the acceptability of effective contraception in Tajikistan. Woman and men aged 16-24 will be randomised to have access to the Tajik Family Planning Alliance's sexual and reproductive health app (control) or the app plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a questionnaire at baseline and 4 months.


Options:
A: Acceptability of at least one method of effective contraception (4 months)
B: Adherence to ART and HIV RNA suppression (6,12 months)
C: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)
D: Exclusive breastfeeding duration (Six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of an Intervention Delivered by App Instant Messaging to Increase the Acceptability of Effective Contraception Among Young People in Tajikistan
Brief Summary: This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on the acceptability of effective contraception in Tajikistan. Woman and men aged 16-24 will be randomised to have access to the Tajik Family Planning Alliance's sexual and reproductive health app (control) or the app plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a questionnaire at baseline and 4 months.


Options:
A: Acceptability of at least one method of effective contraception (4 months)
B: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)
C: Adherence to PrEP (Baseline to Week 48)
D: Unprotected sex, no contraceptive (6-week post-baseline (in the past 6 weeks)); Unprotected sex, no highly effective contraceptive (6-week post-baseline (in the past 6 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of an Intervention Delivered by App Instant Messaging to Increase Use of Effective Contraception Among Young Women in Bolivia
Brief Summary: This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on use of effective contraception in Bolivia. Woman aged 16-24 will be randomised to have access to Centro de Investigacion, Educacion y Servicios's sexual and reproductive health app (control) or the app plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a questionnaire at baseline and 4 month follow-up.


Options:
A: Change in ART Adherence - Clever Cap (Up to 6 months)
B: Use of effective contraception (4 months); Acceptability of at least one method of effective contraception (4 months)
C: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
D: SDCAS (3 months, 6 months, 9 months, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects on Vaginal Health and Quality of Life in Postmenopausal Women Using Ultra Low Topic Estriol Before Vaginal Surgery for Pelvic Statics Disorders
Brief Summary: The purpose of this study is to determine whether the vaginal estriol before vaginal surgery for pelvic statics disorders is more efficacy of no estriol treatment on vaginal health and quality of life.


Options:
A: Vaginal Health Indexes (vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks)
B: Evaluate the histopathological effects on endometrium after each treatment (48 days); Compare the endometrial thickness measured by ultrassound after each treatment (48 days)
C: Vaginal infections (60 weeks)
D: Number of Patients With Bacterial Vaginosis at 3 Months (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Clinic- and Community-Based Pain Self-Care Programs for Low-Income Hispanics on Opioids
Brief Summary: The purpose of this study is to conduct a parallel group, randomized trial of a chronic pain self-management program in clinic or community settings to educate and support low-income, Hispanic patients with chronic pain to adopt evidence-based pain self-care behaviors and activities.


Options:
A: Change in Oswestry Disability Index (ODI) (Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)
B: Lumbar spine flexion changes (baseline (day 1) to post-test (day 5)); Expectation of pain changes (baseline (day 1) to post-test (day 5)); Expectation of harm changes (baseline (day 1) to post-test (day 5))
C: Change in pain Intensity (Baseline and 6 weeks after beginning treatment.); Change in functional disability (Baseline and 6 weeks after beginning treatment.)
D: Five Times Sit-to-stand (5XSTS) (Change from Baseline sit-to-stand at 3 and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Nicotine Patch / Lorcaserin for Smoking Cessation
Brief Summary: This study plans to compare the efficacy of the nicotine patch / lorcaserin combination treatment vs. the nicotine patch alone in terms of leading to a reduction in smoking behavior and withdrawal symptoms.


Options:
A: Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment (7 days at end of treatment); Number of Participants Experiencing Treatment-emergent Adverse Events (26 weeks (12 weeks of treatment plus full post-treatment follow-up))
B: Efficacy: Smoking abstinence rate (1 year); Efficiency: Incremental Cost-Effectiveness Ratio (1 year)
C: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
D: Time-to-lapse (Week 2 pre quit day); Smoking Withdrawal (Week 2 pre quit day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Propess® Versus Double Balloon for Cervical Ripening of Prolonged Pregnancies: a Randomised Controlled Trial
Brief Summary: A pregnancy is considered ''prolonged'' from 41 weeks of gestation. Prolonged Pregnancies (PP) are associated with increased maternal morbidity: emergency caesarean, 3rd and 4th degree perineal lesions and postpartum haemorrhage. Foetuses are at increased risk of oligohydramnios, meconium-staining and Fetal Heart Rate (FHR) anomalies. Around 15% of all pregnancies are prolonged.

A Cochrane review on induction of labour showed that a policy of labour induction at or beyond 41 weeks was associated with significantly fewer perinatal deaths. Thus the French College of Obstetricians and Gynaecologists stated, "induction of labour can be proposed to patients between 41+0 and 41+6 weeks of gestation". In cases where labour is induced and cervix is unfavourable, cervical ripening is advised. Methods of cervical ripening include pharmacological (prostaglandins) and mechanical (Foley catheter or trans-cervical double balloon) methods. Those two methods were compared in the PROBAAT trial among women with term pregnancies (beyond 37+0). The rates of caesarean section with these two strategies were identical, however uterine hyper stimulation with FHR anomalies occurred less when cervical ripening was mechanical.

Considering pharmacological cervical ripening is associated with more uterine hyper stimulation and more FHR anomalies, it may not be the most appropriate in cases of fragile foetuses that include cases of prolonged pregnancies. Considering prolonged pregnancies are associated with a risk of FHR anomalies and that cervical ripening with a pharmacological method is another factor which increases this risk: women with prolonged pregnancies could benefit from a more "gentle" cervical ripening.

At present, no particular method is recommended in cases of cervical ripening and prolonged pregnancies. We hypothesise that, in cases of prolonged pregnancies, mechanical cervical ripening, with less uterine hyperstimulation and fewer FHR anomalies, could be more appropriate and could reduce the rate of caesarean section for suspicion of fetal distress.


Options:
A: Number of Participants With a Need for Cesarean Delivery (Induction to delivery)
B: Delivery rate (proportion) (Within 24 hours)
C: Cesarean Birth Rate (39 weeks gestation)
D: Caesarean section rate for non-reassuring fetal status. (Up to 2 days after cervical ripening)

Answer: D