TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blinded, Multi-center Phase III Confirmatory Study to Assess the Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
Brief Summary: This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay). Total of 824 healthy subjects (412 subjects per treatment arm) aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.


Options:
A: Number of Subjects With a Vaccine Response for Anti-gE Antibodies (At Month 3); Anti-glicoprotein E (gE) Antibody Concentrations (At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)); Anti-pneumococcal Antibody Titers (At one month post-dose (Month 1)); Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups (At 1 month after vaccination); Adjusted GMCs Between Groups (At 1 month after last vaccine dose)
B: Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies (Baseline and 6 weeks following vaccine administration); Number of Participants Reporting an Adverse Experience (AE) (Up to 42 days following vaccine administration); Number of Participants Reporting a Serious Adverse Experience (SAE) (Up to 42 days following vaccine administration); Number of Participants Reporting a Serious Adverse Experience (Within 5 days after the blood draw at approximately 20 months following vaccine administration); Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) (Up to 5 days following vaccine administration); Number of Participants Reporting Systemic Adverse Experiences (Up to 42 days following vaccine administration); Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) (Up to 42 days following vaccine administration)
C: GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay) (6 weeks after IP(Investigational Product) vaccination); GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA (6 weeks after IP(Investigational Product) vaccination)
D: Number of Subjects With Vaccine Response to Anti-gE Antibodies (At one month post-dose 2 (Month 3)); Vaccine Response for Anti-gE Humoral Immunogenicity (At one month post-dose 2 (Month 3)); Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies (At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)); FLU Haemagglutination Inhibition (HI) Antibody Titers (At Day 21 post vaccination)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: High-flow Nasal Cannula Oxygen Therapy With or Without Non-invasive Ventilation (NIV) During the Weaning Period: a Multicenter Randomized Controlled Trial
Brief Summary: Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.


Options:
A: Inspiratory muscle effort : oesophageal pressure (Poes) and the oesophageal pressure time product (PTPoes) (Every 30 minutes for 90 minutes)
B: mortality rates (day 28)
C: Failure of the ventilation system (One week)
D: Reintubation at Day 7 (up to 7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: High-flow Nasal Cannula Oxygen Therapy With or Without Non-invasive Ventilation (NIV) During the Weaning Period: a Multicenter Randomized Controlled Trial
Brief Summary: Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.


Options:
A: percentage of patients who developed postoperative hypoxemia (defined as PaO2/FiO2 ratio <300) (1 hour after tracheal extubation (day 1))
B: Post-extubation respiratory failure and Reintubation rate (3 months)
C: All-cause day-28 mortality (28 days)
D: Reintubation at Day 7 (up to 7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepwise Strategy to Improve Cervical Cancer Screening Adherence (SCAN-CC): Automatic Text Messages, Phone Calls and Face-to-face Interviews
Brief Summary: This study aims to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organized cervical cancer screening: step 1a - customized text message invitation; step 1b - customized automatic phone call invitation; step 2 - secretary phone call; step 3 - health professionals face-to-face appointment.

A population-based randomized controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomized (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automatic phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (invitation by written letter).

As primary objectives, we intend to test the superiority of interventions based on step 1 (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, based on intention-to-treat analyses.


Options:
A: Highly-effective contraceptive use (6 months postpartum)
B: Knowledge of Reproductive Health True/False Quiz of 20 questions (5-6 months after baseline and then again 14-16 months after baseline); Sexual behavior (14-16 months after baseline)
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: Adherence to cervical cancer screening (step1) (Up to 20 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepwise Strategy to Improve Cervical Cancer Screening Adherence (SCAN-CC): Automatic Text Messages, Phone Calls and Face-to-face Interviews
Brief Summary: This study aims to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organized cervical cancer screening: step 1a - customized text message invitation; step 1b - customized automatic phone call invitation; step 2 - secretary phone call; step 3 - health professionals face-to-face appointment.

A population-based randomized controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomized (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automatic phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (invitation by written letter).

As primary objectives, we intend to test the superiority of interventions based on step 1 (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, based on intention-to-treat analyses.


Options:
A: Acceptability of at least one method of effective contraception (4 months)
B: Adherence to cervical cancer screening (step1) (Up to 20 months)
C: ART Adherence at 20 Weeks as Determined by VAS, Viral Load (20week [End of study]); ART Adherence at 20 Weeks as Determined by Pill Counts, ACTG Adherence Questionnaire, and VAS Scores (20week [End of study]); ART Adherence at 20 Weeks as Determined by Viral Load Count (20 week [End of study]); ART Adherence at 20 Weeks as Determined by Log of Viral Load Count (20week [End of study])
D: Smoking Abstinence (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepwise Strategy to Improve Cervical Cancer Screening Adherence (SCAN-CC): Automatic Text Messages, Phone Calls and Face-to-face Interviews
Brief Summary: This study aims to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organized cervical cancer screening: step 1a - customized text message invitation; step 1b - customized automatic phone call invitation; step 2 - secretary phone call; step 3 - health professionals face-to-face appointment.

A population-based randomized controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomized (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automatic phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (invitation by written letter).

As primary objectives, we intend to test the superiority of interventions based on step 1 (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, based on intention-to-treat analyses.


Options:
A: On-time Completion of the Human Papillomavirus Vaccine Series (32 weeks after receipt of initial vaccine)
B: fat tissue (6 months)
C: Adherence to cervical cancer screening (step1) (Up to 20 months)
D: Proportion of men failing to return for a post-operative clinic visit at 7 days. (7 days); Proportion of men who report resumption of sexual activity before 42 days post-circumcision. (42 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepwise Strategy to Improve Cervical Cancer Screening Adherence (SCAN-CC): Automatic Text Messages, Phone Calls and Face-to-face Interviews
Brief Summary: This study aims to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organized cervical cancer screening: step 1a - customized text message invitation; step 1b - customized automatic phone call invitation; step 2 - secretary phone call; step 3 - health professionals face-to-face appointment.

A population-based randomized controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomized (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automatic phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (invitation by written letter).

As primary objectives, we intend to test the superiority of interventions based on step 1 (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, based on intention-to-treat analyses.


Options:
A: Proportion of participants self-reporting receipt of Pap test (One month post-intervention)
B: Adherence to cervical cancer screening (step1) (Up to 20 months)
C: Patient Satisfaction in the 2 Interventions (within 6 months of PAP); CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy (within 6 months of PAP)
D: Completing at least one recommended cancer screenings (colorectal, breast, cervical) (At six months and one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepwise Strategy to Improve Cervical Cancer Screening Adherence (SCAN-CC): Automatic Text Messages, Phone Calls and Face-to-face Interviews
Brief Summary: This study aims to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organized cervical cancer screening: step 1a - customized text message invitation; step 1b - customized automatic phone call invitation; step 2 - secretary phone call; step 3 - health professionals face-to-face appointment.

A population-based randomized controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomized (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automatic phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (invitation by written letter).

As primary objectives, we intend to test the superiority of interventions based on step 1 (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, based on intention-to-treat analyses.


Options:
A: Initiation of Long acting reversible contraception method (6 months)
B: 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)
C: 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))
D: Adherence to cervical cancer screening (step1) (Up to 20 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Behavior-based Cognitive-Behavioral Therapy for Obsessive Compulsive Behavior in Children With Autism Spectrum Disorder: A Randomized Controlled Trial
Brief Summary: Individuals with high functioning autism spectrum disorder (ASD) frequently experience obsessions and/or compulsions that are similar to those specified in Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5) criteria for obsessive compulsive disorder (OCD). However, little research exists on effective interventions for OCD symptoms (referred to as OCBs) in ASD. In a randomized controlled trial, a manualized functional behavior-based cognitive-behavior therapy (Fb-CBT) consisting of traditional CBT components (psychoeducation and mapping, cognitive-behavioral skills training, exposure, and response prevention) as well as function-based behavioral assessment will be evaluated. Participants will be assigned randomly to Fb-CBT or treatment as usual (TAU). Primary and secondary outcome measures will be used to evaluate the efficacy of the treatment, and will be administered at pre and post-intervention as well as six month follow-up.


Options:
A: 6-item Pediatric Anxiety Rating Scale (Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.); Clinical Global Impression-Improvement (Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.)
B: Change in Repetitive Behavior Scale (RBS_SCR) (Assessment occurred at baseline and 2 weeks following end of treatment, as well as at follow-up (6 months following the cessation of treatment)); Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) (Assessment occurred at baseline and 2 weeks following end of treatment)
C: Score on anxiety diagnostic interview after treatment or waitlist (post-treatment); Score on anxiety rating scale after treatment or waitlist (post-treatment)
D: Pediatric Anxiety Rating Scale. (Post-treatment, which is an average of 16 weeks after Baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
Brief Summary: This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp.

Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.


Options:
A: Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Baseline and Week 12)
B: Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria (Week 24)
C: N/A
D: Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline (Baseline to Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
Brief Summary: This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp.

Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.


Options:
A: Percentage of Participants With a PASI 75 Response at Week 12 (Baseline and week 12)
B: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)
C: Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline (Baseline to Week 16)
D: Long-term Safety and Tolerability of Secukinumab (Week 268)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
Brief Summary: This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp.

Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.


Options:
A: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)
B: Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline (Baseline to Week 16)
C: Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA]) (Week 12); Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI]) (Week 12)
D: Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Electronic Alert System Combined With a Risk Score Calculation Tool for Improving Appropriate Thromboprophylaxis in Hospitalized Medical Patients: a Randomized Controlled Trial
Brief Summary: The investigators aim to investigate whether a computer-based alert system in the electronic patient chart and order entry system using the Geneva Risk Score as clinical decision support tool to estimate the risk of venous thromboembolism improves the rate of appropriate thromboprophylaxis among hospitalized medical patients.


Options:
A: The outcome measure will be rate of patients falls per 1000 patient days (1/2009-6/2009)
B: Referral Rates to Local Hospitals (Month 7, Month 12); Number of Neonatal Deaths (Month 12)
C: Quality of otitis media care. (18 Months)
D: Rate of appropriate thromboprophylaxis (During hospital stay (expected average duration of 1 week))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Which do You Think is the Best Treatment Choice in Primary Dysmenorrhea?
Brief Summary: Our aim is to evaluate and compare the pain relief of estradiol valerate/dienogest and ethinylestradiol/ drospirenone by using doppler indices.

100 nullipara patients with symptoms of severe primary dysmenorrhea (PD) requesting contraception aged from 18 to 35 were included to the study. Visual analog scale (VAS), the uterine artery doppler indices including systole/diastole rates ( S/D), pulsatility index (PI) and resistance index (RI) values were evaluated and recorded in both uterine vessels before treatment. The 66 PD patients who met the inclusion criteria were divided into 2 groups and 33 healthy controls created Group 1. Group 2 were administered estradiol valerate/dienogest while Group 3 were administered 0.03 mg ethinylestradiol and 3 mg drospirenone. Both VAS scores and doppler indices were repeated after 3 months treatment. The changes in values were recorded.


Options:
A: Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain (baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days))
B: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles)); Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles))
C: Doppler indices of uterine artery blood flows. (up to 10 minutes)
D: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles)); Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Professional Coaching on Early Career Academic Emergency Physician Well-Being, Burnout, Leadership Strengths, and Goal Attainment: A Pilot Randomized, Controlled Trial
Brief Summary: This research study is designed to answer the question: How does professional coaching impact early career academic emergency medicine physician goal attainment, leadership strengths, well-being, and burnout?


Options:
A: Institutional delivery (Up to six months)
B: Supportive leadership behaviour questionnaire for assessing head nurses performance (10 months)
C: Change in team cohesion (Change from baseline to 6 months)
D: Goal Setting and Attainment (18 months (3 measurements at 6-month intervals))

Answer: D