TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis
Brief Summary: The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 (Month 3); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)
B: Achievement of a clinical response (according to the ACR criteria) at the 30-week follow-up visit. (30-week follow-up visit.)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (Week 12)
D: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis
Brief Summary: The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)


Options:
A: Change from baseline in the Mayo score at Week 8 (Week 8)
B: Number of Participants With Remission Based on Modified Mayo Score at Month 6 (Month 6)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (Week 12)
D: Percentage of Participants With Remission at Week 8 (Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis
Brief Summary: The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)


Options:
A: Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 (Baseline, Week 26)
B: N/A
C: Number of Subjects Experiencing Any Adverse Event (throughout entire study (61 +/- 28.9 weeks on average)); Number of Subjects Experiencing Serious Adverse Event (throughout entire study (61 +/- 28.9 weeks on average)); Number of Subjects Experiencing Any Infection (throughout entire study (61 +/- 28.9 weeks on average))
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IIA Trial of 1% Topical Cidofovir for Treatment of High-Grade Perianal Squamous Intraepithelial Lesions in HIV-Infected Men and Women
Brief Summary: RATIONALE: High-grade squamous intraepithelial lesions of the skin near the anus are caused by the human papillomavirus (HPV). Antiviral drugs,, such as cidofovir, act against viruses and may stop these lesions from becoming cancer.

PURPOSE: This phase II trial is studying the side effects and how well topical cidofovir works in treating HIV-infected patients with high-grade squamous intraepithelial lesions of the skin near the anus.


Options:
A: Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer (Follow-up through end of study (4 years)); Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] (Follow-up through end of study (4 years))
B: Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study (Up to 4 years); Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study (Up to 14 years since Vaccine Dose 1); Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study (up to 22 years post Vaccination Dose 1)
C: Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL) (6 weeks after treatment discontinuation); Safety and Tolerability of Topical Cidofovir as Assessed by NCI CTCAE v3.0 (Every 2 weeks on study, 6 weeks after treatment discontinuation)
D: recurrence rate

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Neuropsychological Validity of Attention-Deficit Hyperactivity Disorder in Adulthood
Brief Summary: This study aims to establish the psychometric properties of the Adult ADHD Quality of Life Scale (AAQoL) and to validate the diagnosis of adult ADHD by ADHD symptoms, other clinical psychiatric symptoms, neuropsychological functioning, social/family/occupational functioning, and intervention effect.


Options:
A: Number of Participants With Adverse Events, Serious Adverse Events and Deaths. (Week 40 - Week 66)
B: Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks); Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint (DB baseline, DB endpoint)
C: N/A
D: Number of days of use of cannabis (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Neuropsychological Validity of Attention-Deficit Hyperactivity Disorder in Adulthood
Brief Summary: This study aims to establish the psychometric properties of the Adult ADHD Quality of Life Scale (AAQoL) and to validate the diagnosis of adult ADHD by ADHD symptoms, other clinical psychiatric symptoms, neuropsychological functioning, social/family/occupational functioning, and intervention effect.


Options:
A: N/A
B: ADHD Severity (baseline and 20 weeks); Substance Use (20 weeks)
C: Change in pain ratings (0-100) to a suprathreshold heat pain stimulus (3.5 Minutes after end of infusion)
D: CGI -S - ADHD rating scale (Father) (Change from Screening at 8 weeks.); Conners Adult ADHD Rating Scale - Self Report (Father) (Change from Screening at 8 weeks.); Conners Other Report (about Father) (Change from Screening at 8 weeks); Barkley Functional Impairment Rating Scale (Father) (Change from Screening at 8 weeks.); Conners Parent (completed by parent about child) (Change form Screening at 8 weeks.); Conners Teacher Rating Scale (completed by teacher about child) (Change from Screening at 8 weeks.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Neuropsychological Validity of Attention-Deficit Hyperactivity Disorder in Adulthood
Brief Summary: This study aims to establish the psychometric properties of the Adult ADHD Quality of Life Scale (AAQoL) and to validate the diagnosis of adult ADHD by ADHD symptoms, other clinical psychiatric symptoms, neuropsychological functioning, social/family/occupational functioning, and intervention effect.


Options:
A: The change from Baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score as assessed by the Investigator at the Final Visit/2 Week Efficacy Assessment Visit
B: Change from baseline in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale at the end of the double-blind phase (5 weeks) compared with placebo.
C: Prolonged Abstinence (Weeks 7-10)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
Brief Summary: This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms \[mcg\] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.


Options:
A: The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range (Weeks 16-28)
B: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)
C: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) (Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24)
D: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) (Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]
Brief Summary: This research project pretends to demonstrate that a psychoeducative program implemented in the context of PC can produce a significant increase in the quality of life of patients with FM, as well as a decrease in the use of sanitary and social services, compared to usual care.


Options:
A: Change in Pain intensity (Change from baseline pain intensity at 12 months); Change in Depression (Change from baseline depression at 12 months); Change in Catastrophizing (Change from baseline catastrophizing at 12 months); Change in Acceptance (Change from baseline acceptance at 12 months); Change in Disability (Change from baseline disability at 12 months)
B: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
C: Change from baseline in pain severity at 3 and 6 months after admission (from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)); Change from baseline in pain disability at 3 and 6 months after admission (from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission))
D: Quality of life is measured with the FIQ and the EuroQol-5D. (1, 2, 6 and 12 months later)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]
Brief Summary: This research project pretends to demonstrate that a psychoeducative program implemented in the context of PC can produce a significant increase in the quality of life of patients with FM, as well as a decrease in the use of sanitary and social services, compared to usual care.


Options:
A: Quality of life is measured with the FIQ and the EuroQol-5D. (1, 2, 6 and 12 months later)
B: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
C: Fibromyalgia Impact Questionnaire (Assessed following 12 week intervention)
D: Ambulatory Pain (Higher Values Indicate Greater Pain) (Baseline and after 12-weeks); Ambulatory Fatigue, Higher Values Indicate Greater Fatigue (Baseline and after 12-weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Bicalutamide Monotherapy Preserves Bone Mineral Density, Muscle Strength and Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer
Brief Summary: The aim of this study is to comprehensively monitor the effects of a nonsteroidal antiandrogen in patients requiring hormone manipulation for prostate cancer


Options:
A: Quality of life (using Rand 36-Item Health Survey SF-36) (3 monthly for 1 year)
B: Time to clinical progression (Throughout study period); Tolerability in terms of adverse events and laboratory parameters (Throughout study period)
C: Survival (Throughout study period); Time to clinical progression (Throughout study period)
D: Time to clinical progression (Throughout study period); Overall patient survival (Throughout study period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Efficacy Trial of a Computer Decision Support System Compared to Usual Care for Depression Treatment in Primary Care
Brief Summary: The purpose of this study was designed to test the feasibility and effectiveness of implementing a Computerized Decision Support System for depression (CDSS-D) during acute care in a primary care setting.


Options:
A: Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score (24 weeks)
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: Evidence of success of decision aid to providers and patients, which leads to improved knowledge, reduced decisional conflict and enhanced satisfaction with the decision, and enhanced adherence to medication. (Directly following intervention.)
D: Decision to Receive an ICD (1 week post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Efficacy Trial of a Computer Decision Support System Compared to Usual Care for Depression Treatment in Primary Care
Brief Summary: The purpose of this study was designed to test the feasibility and effectiveness of implementing a Computerized Decision Support System for depression (CDSS-D) during acute care in a primary care setting.


Options:
A: poor asthma control (2006-2009)
B: a designated health care proxy (12 months after intervention made available); initial bone density scan (12 months after intervention made available); administration of annual influenza vaccine (12 months after intervention started); administration of pneumococcal vaccine (12 months after the start of the intervention)
C: Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score (24 weeks)
D: Number of Re-hospitalizations at 30 and 60 Days (30 days, 60 days post discharge); The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days. (30 days, 60 days post discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blinded, Tolerability and Immunogenicity Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered Concomitantly With GARDASIL to 16- to 26- Year-Old Women
Brief Summary: The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.


Options:
A: Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) (4 weeks post-vaccination 3 (Month 7)); Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) (4 weeks post-vaccination 3 (Month 7)); Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) (4 weeks post-vaccination 3 (Month 7)); Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs) (Up to 5 days after any vaccination); Base Study: Percentage of Participants With Systemic AEs (Up to 15 days after any vaccination); Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) (Up to 5 days after any vaccination); Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine (Up to ~Month 126); Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine (Up to ~Month 126)
B: Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection (Month 7); Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion (Month 7); Anti-HPV-16/18 Antibody Titres (Month 7)
C: Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
D: Geometric mean titers (GMTs) to HPV types contained in the administered vaccines (4 weeks post dose 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial
Brief Summary: Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of women with prenatal pelvic floor exercises and a control group.

Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.


Options:
A: pain (6 weeks); Disability (6 weeks); Pelvic Floor Muscle activity (6 weeks); Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness (6 weeks); Multifidus muscle thickness and crass section area(S1 level) (6 weeks)
B: Urinary incontinence score assessed with ICIQ-SF questionnaire (one year post partum)
C: Difference in scores on a pelvic floor knowledge questionnaire at 6 weeks postpartum between intervention and control groups (At 6 weeks post-partum)
D: Maternal gestational weight gain (40-42 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial
Brief Summary: Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of women with prenatal pelvic floor exercises and a control group.

Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.


Options:
A: Urinary incontinence score assessed with ICIQ-SF questionnaire (one year post partum)
B: UI incidence/severity (12 months - 3 years post-index birth)
C: Change in number of micturition episodes per 24 hours (Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up))
D: UI reduction (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial
Brief Summary: Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of women with prenatal pelvic floor exercises and a control group.

Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.


Options:
A: UI reduction (12 months)
B: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)
C: Urinary incontinence score assessed with ICIQ-SF questionnaire (one year post partum)
D: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.


Options:
A: Initiation of long term contraception with 6 month postpartum (6 month)
B: Pregnancy (efficacy) (until follow-up about one week after next menses)
C: Pregnancy rates in first month after IUD insertion (4 weeks)
D: Number of Participants With Pregnancy (Within 72 hours of unprotected Intercourse)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.


Options:
A: Initiation of long term contraception with 6 month postpartum (6 month)
B: Number of Participants With Pregnancy (Within 72 hours of unprotected Intercourse)
C: Pregnancy rates in first month after IUD insertion (4 weeks)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-term Infants
Brief Summary: The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow-up.


Options:
A: Participant's survival without CLD ((measured at 36 weeks after birth))
B: Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress (21 days)
C: Survival without chronic lung disease (CLD) (36 weeks)
D: Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality (Week 36 or earlier, if participants are discharged from the hospital); Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight (Randomization to discharge)

Answer: B