TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress and Adaptation in Rheumatoid Arthritis (SARA)
Brief Summary: Rheumatoid arthritis (RA) is an autoimmune disease that causes long-term inflammation of the joints and occasionally, other body tissues. The purpose of this study is to evaluate two different types of cognitive behavioral therapy (CBT) in reducing RA disease activity and improving mental health of adults with RA.


Options:
A: Pain, physical functioning, coping efficacy, positive and negative emotional affect, and depression (6 months after treatment)
B: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
C: Pain VAS
D: Pain intensity (Measured at Week 4 and Month 6); Pain-related disability (Measured at Week 4 and Month 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress and Adaptation in Rheumatoid Arthritis (SARA)
Brief Summary: Rheumatoid arthritis (RA) is an autoimmune disease that causes long-term inflammation of the joints and occasionally, other body tissues. The purpose of this study is to evaluate two different types of cognitive behavioral therapy (CBT) in reducing RA disease activity and improving mental health of adults with RA.


Options:
A: Pain, physical functioning, coping efficacy, positive and negative emotional affect, and depression (6 months after treatment)
B: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
C: SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability (before intervention)
D: Pain (Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multicenter, Single Blind, Randomized, Comparative and add-on Clinical Trial, in Three Parallel Groups, to Evaluate Efficacy and Safety of a New Therapy With Adipose-derived Autologous Stem Cells for the Treatment of Complex Perianal Fistulas in Patients Without Inflammatory Bowel Disease
Brief Summary: Anal fistula is defined as an abnormal communication between the anal canal and the perianal skin. Adipose-derived stem cells are a new therapy for the closure of these fistulas. This study will test the safety and efficacy of ASCs (adipose stem cells) in the treatment of patients without Crohn´s disease.


Options:
A: Safety and efficacy (fistula closure) (12 weeks)
B: Closure of fistulas defined as absence of suppuration and re-epithelization of the external opening and absence of collections>2 cm directly related to the fistula tract treated, as measured by MRI (healing) (weeks 1, 4, 12 and 24. Week 26 in patients with a second dose)
C: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
D: Clinical healing (6 months after last injection)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Vaginal Mesh for Prolapse
Brief Summary: The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.


Options:
A: Number of Participants With Anatomic Cure at 3 Years (3 year)
B: Mesh attachment interval (Intraoperative placement of mesh - approximately 30 minutes to 2 hours)
C: Operative time for LPS subtotal hysterectomy and sacral colpopexy (participants will be followed for the duration of hospital stay, , an expected average of 5 weeks)
D: Comparison of surgical time (Up to four months (2 weeks before surgery until 3 months post-surgery).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Vaginal Mesh for Prolapse
Brief Summary: The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.


Options:
A: Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative) (12 months postoperatively)
B: Recurrence of anterior vaginal wall prolapse
C: Number of Participants With Anatomic Cure at 3 Years (3 year)
D: Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Vaginal Mesh for Prolapse
Brief Summary: The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.


Options:
A: Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis (2 years)
B: Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom (One year)
C: Number of Participants With Anatomic Cure at 3 Years (3 year)
D: Stress urinary continence (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Vaginal Mesh for Prolapse
Brief Summary: The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.


Options:
A: Primary outcome: operative time from incision to closure. (Primary outcome: will be obtained immediately at the end of each procedure.)
B: anatomic outcomes,graft-related complications between the two materials, changes in pelvic organ prolapse-related quality of life,subjective changes in sexual function,changes in bowel function and the prolapse related pain present after sacral colpopexy (One year)
C: Number of Participants With Anatomic Cure at 3 Years (3 year)
D: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis
Brief Summary: This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were \< 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.


Options:
A: Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) (Baseline (Day 1)); Atopic Dermatitis Severity Index (ADSI) Score at Day 14 (Day 14); Atopic Dermatitis Severity Index (ADSI) Score at Day 28 (Day 28); Atopic Dermatitis Severity Index (ADSI) Score at Day 42 (Day 42); Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28 (Baseline (Day 1), Day 28)
B: Adherence to topical Therapy (12 months)
C: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions (Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)); Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment))
D: Occurrence of systemic or cutaneous malignancy (10 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple Sclerosis
Brief Summary: The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of Glatiramer Acetate \[GA\].

The secondary objectives were:

* to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA on Magnetic Resonance Imaging \[MRI\] parameters, relapse rate and patient-reported fatigue;
* to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA.


Options:
A: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)
B: Confirmed Annualized Relapse Rate (up to 12 months)
C: Overview of Adverse Events (AE] (from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)); Overview of AE With Potential Risk of Occurrence (from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)); Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) (from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max))
D: At least 1 point-reduction on Kurtzke functional scale (28 days after beginning of corticotherapy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device After Vaginal Delivery
Brief Summary: This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal delivery will be higher in women who have immediate postplacental insertion as compared to delayed insertion 6-8 weeks following delivery.


Options:
A: neonatal growth (12 months)
B: Implant utilization as measured by the proportion of women using LNG contraceptive implants at 6 months after delivery in women randomized to insertion within 5 days of delivery (immediate insertion) or 6-8 weeks after delivery (delayed insertion). (6 months)
C: IUD Usage Rate at 6 Months (6 months after delivery)
D: Time to Lactogenesis Stage II (5 days postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device After Vaginal Delivery
Brief Summary: This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal delivery will be higher in women who have immediate postplacental insertion as compared to delayed insertion 6-8 weeks following delivery.


Options:
A: Continuation Rates of the LNG-IUS when placed postpartum at three time periods (at 6 months)
B: Use of the LNG-IUS for Contraception (12 months after cesarean delivery)
C: IUD Usage Rate at 6 Months (6 months after delivery)
D: Time (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device After Vaginal Delivery
Brief Summary: This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal delivery will be higher in women who have immediate postplacental insertion as compared to delayed insertion 6-8 weeks following delivery.


Options:
A: Number of Participants Who Continued to Breastfeed at 6 Months (Baseline to Week 8, Week 8, 2-6 months)
B: IUD Usage Rate at 6 Months (6 months after delivery)
C: Time to Lactogenesis Stage II (5 days postpartum)
D: Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Open, parallel group design. The study has a screening phase and a 12 week treatment phase. Subjects will be randomised to treatment in a 1:1 ration.


Options:
A: Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period (Baseline to 12 weeks)
B: FEV1, (Forced expiratory volume in the 1st second).
C: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 26 weeks); Number of Participants Experiencing at Least One Asthma Exacerbation (From Day 1 up to 26 weeks)
D: Change from start of treatment in evening pre-dose FEV1 (2, 6 and 12 weeks after starting treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Open, parallel group design. The study has a screening phase and a 12 week treatment phase. Subjects will be randomised to treatment in a 1:1 ration.


Options:
A: The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) (Baseline to Week 12)
B: FEV1, (Forced expiratory volume in the 1st second).
C: morning peak expiratory flow (PEF) daily measured by patients
D: Asthma control assessed by asthma exacerbations (Continuosly throughout the treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Open, parallel group design. The study has a screening phase and a 12 week treatment phase. Subjects will be randomised to treatment in a 1:1 ration.


Options:
A: FEV1, (Forced expiratory volume in the 1st second).
B: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 26 weeks); Number of Participants Experiencing at Least One Asthma Exacerbation (From Day 1 up to 26 weeks)
C: Pre-dose morning FEV1 measured at clinic visit 5 (12-week treatment)
D: Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1) (Baseline (Day 1) and Day 15 of each treatment period); Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg (Baseline (Day 1) and Day 15 of each treatment period); Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods (Baseline (Day 1) and Day 15 of each treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study
Brief Summary: This purpose of this study is to test whether a 6-month yoga program improves quality of life and reduces fatigue and weight gain in breast cancer survivors.


Options:
A: quality of life, fatigue, and body weight (baseline, 6 months, 12 months)
B: change in physical activity (baseline to 3 months); change in physical activity (3 mos to 6 months); change in physical activity (6 months to 12 months)
C: Fatigue (immediately before and after the intervention)
D: Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL) (Baseline to up to 6 months); Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months); Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study
Brief Summary: This purpose of this study is to test whether a 6-month yoga program improves quality of life and reduces fatigue and weight gain in breast cancer survivors.


Options:
A: Weight loss maintenance (6 - 18 months)
B: Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c (At week 16); Improvement of physical fitness, cardiorespiratory fitness, and muscle strength (At week 16); Feasibility of a supervised exercise program for cancer survivors (At week 16); Maintain positive benefits of an exercise intervention (12 weeks post-intervention)
C: Fatigue as measured by the Brief Fatigue Inventory (prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.)
D: quality of life, fatigue, and body weight (baseline, 6 months, 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study
Brief Summary: This purpose of this study is to test whether a 6-month yoga program improves quality of life and reduces fatigue and weight gain in breast cancer survivors.


Options:
A: Stimulated ln (TNF-a) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-6) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-1b) (Immediately post-treatment and 3 months post-treatment); MFSI-SF Fatigue (Immediately post-treatment and 3 months post-treatment); Vitality, SF-36 (Immediately post-treatment and 3 months post-treatment); CES-D (Immediately post-treatment and 3 months post-treatment)
B: Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) (2-24 months after surgery, chemotherapy, and/or radiation therapy)
C: quality of life, fatigue, and body weight (baseline, 6 months, 12 months)
D: Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL) (Baseline to up to 6 months); Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months); Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Moderate to Severe Persistent Asthma
Brief Summary: Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.


Options:
A: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 26 weeks); Number of Participants Experiencing at Least One Asthma Exacerbation (From Day 1 up to 26 weeks)
B: Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period (Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12)
C: Pre-dose morning PEF (End of treatment)
D: Change from start of treatment in evening pre-dose FEV1 (2, 6 and 12 weeks after starting treatment)

Answer: C