TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia
Brief Summary: To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia


Options:
A: Brief pain inventory (6 weeks)
B: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
C: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
D: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia
Brief Summary: To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia


Options:
A: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
B: Composite Syndrome Responder Status (At the end of the three-month stable dose treatment phase); Composite Pain Responder Status (At the end of three-month stable dose treatment phase)
C: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
D: To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia
Brief Summary: To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia


Options:
A: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
B: Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test (Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS); Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test (Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
C: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
D: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia
Brief Summary: To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia


Options:
A: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
B: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
C: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
D: Area of pin-prick hyperalgesia (Change from baseline visit to day 14 of treatment sessions); Area of touch-evoked allodynia (Change from baseline visit to day 14 of treatment sessions)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia
Brief Summary: To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia


Options:
A: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
B: Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 (Baseline, week 6); Change from Baseline in Pain Pressure Threshold (PPT) at week 6 (Baseline, week 6); Change from Baseline Brain-derived neurotrophic factor at week 6 (Baseline, week 6)
C: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
D: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia
Brief Summary: To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia


Options:
A: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
B: Composite Syndrome Responder Status (At the end of the three-month stable dose treatment phase); Composite Pain Responder Status (At the end of three-month stable dose treatment phase)
C: Composite responder analysis based on pain and patient global status, with or without physical function.
D: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia
Brief Summary: To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia


Options:
A: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
B: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
C: last observation carried forward (LOCF) mean change from baseline to week 8 on the Hamilton Depression Scale (HAM-D) total score. (8 weeks)
D: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and STIs Among Adolescent Females Receiving Family Planning Clinic Services
Brief Summary: The New Generation Health Center/University of California, San Francisco (UCSF) will implement an intervention to impact contraceptive behavior and reduce unintended pregnancy and sexually transmitted infections (STIs) among adolescent females who receive services at the New Generation Health Center (NGHC)/UCSF in San Francisco. Study subjects will be randomized into either standard reproductive health services or standard services plus follow-up motivational counseling telephone calls. Outcomes will be evaluated by ETR (Education, Training, Research)Associates, who will conduct follow-up surveys with all study participants at baseline, 6 months, 12 months and 18 months.


Options:
A: pregnancy
B: Sequence-verified HIV-transmission from index to partner participant (March 2009)
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: Contraceptive use at time of last sexual intercourse (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and STIs Among Adolescent Females Receiving Family Planning Clinic Services
Brief Summary: The New Generation Health Center/University of California, San Francisco (UCSF) will implement an intervention to impact contraceptive behavior and reduce unintended pregnancy and sexually transmitted infections (STIs) among adolescent females who receive services at the New Generation Health Center (NGHC)/UCSF in San Francisco. Study subjects will be randomized into either standard reproductive health services or standard services plus follow-up motivational counseling telephone calls. Outcomes will be evaluated by ETR (Education, Training, Research)Associates, who will conduct follow-up surveys with all study participants at baseline, 6 months, 12 months and 18 months.


Options:
A: Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS (Participants will receive counseling before admission and at 12 months after)
B: Contraceptive use at time of last sexual intercourse (18 months)
C: Average number of missed pills per cycle (3 months)
D: contraceptive continuation (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and STIs Among Adolescent Females Receiving Family Planning Clinic Services
Brief Summary: The New Generation Health Center/University of California, San Francisco (UCSF) will implement an intervention to impact contraceptive behavior and reduce unintended pregnancy and sexually transmitted infections (STIs) among adolescent females who receive services at the New Generation Health Center (NGHC)/UCSF in San Francisco. Study subjects will be randomized into either standard reproductive health services or standard services plus follow-up motivational counseling telephone calls. Outcomes will be evaluated by ETR (Education, Training, Research)Associates, who will conduct follow-up surveys with all study participants at baseline, 6 months, 12 months and 18 months.


Options:
A: contraception (past 3 months)
B: Contraceptive use at time of last sexual intercourse (18 months)
C: Use of very effective contraception (up to 3 months after termination of pregnancy appointment)
D: Re-infection with a non-viral sexually transmitted infection (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and STIs Among Adolescent Females Receiving Family Planning Clinic Services
Brief Summary: The New Generation Health Center/University of California, San Francisco (UCSF) will implement an intervention to impact contraceptive behavior and reduce unintended pregnancy and sexually transmitted infections (STIs) among adolescent females who receive services at the New Generation Health Center (NGHC)/UCSF in San Francisco. Study subjects will be randomized into either standard reproductive health services or standard services plus follow-up motivational counseling telephone calls. Outcomes will be evaluated by ETR (Education, Training, Research)Associates, who will conduct follow-up surveys with all study participants at baseline, 6 months, 12 months and 18 months.


Options:
A: HIV-1 seroincidence; HSV2 seroprevalence
B: rates of STIs (Baseline, 6 and 12 months); computer-assisted survey results (baseline, 1 week, 3, 6, & 12 months); - score on self-report of frequency of risky sexual and substance use behaviors (baseline, 1 week, 3, 6, & 12 months)
C: HIV sero-incidence (24 months post-baseline)
D: Contraceptive use at time of last sexual intercourse (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Load Diet Compared With a Standard National Nutrition Council-recommended Diet: a Randomized Trial
Brief Summary: Overweight and obesity is increasing in most countries, including Norway, and the optimal diet for reducing weight is under discussion. The present study in overweight and moderate obese individuals compares a low glycemic load diet with a standard low-fat diet (as recommended from the National Nutrition Council) in an open, randomized trial over 12 months, with changes in weight loss and changes in cardiovascular risk markers as endpoints.


Options:
A: Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group (12 months); Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group (12 Months); Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group (12 months); Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group (12 Months); Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group (12 Months); Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group (12 Months)
B: The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
C: N/A
D: Change in body weight (measured at Year 2)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Load Diet Compared With a Standard National Nutrition Council-recommended Diet: a Randomized Trial
Brief Summary: Overweight and obesity is increasing in most countries, including Norway, and the optimal diet for reducing weight is under discussion. The present study in overweight and moderate obese individuals compares a low glycemic load diet with a standard low-fat diet (as recommended from the National Nutrition Council) in an open, randomized trial over 12 months, with changes in weight loss and changes in cardiovascular risk markers as endpoints.


Options:
A: Change from baseline in weight at 12 months (Baseline and 12 months)
B: N/A
C: The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
D: Body weight; Fat mass and fat-free mass; Food intake

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Load Diet Compared With a Standard National Nutrition Council-recommended Diet: a Randomized Trial
Brief Summary: Overweight and obesity is increasing in most countries, including Norway, and the optimal diet for reducing weight is under discussion. The present study in overweight and moderate obese individuals compares a low glycemic load diet with a standard low-fat diet (as recommended from the National Nutrition Council) in an open, randomized trial over 12 months, with changes in weight loss and changes in cardiovascular risk markers as endpoints.


Options:
A: Body mass index (BMI); Glycated Haemoglobin (HbA1c); Triglycerides; Dietary intake as measured by 3-day weighed diet records; All measures to be compared at end of study (6 months)
B: The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
C: Hemoglobin A1c (22 weeks)
D: weight loss

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Load Diet Compared With a Standard National Nutrition Council-recommended Diet: a Randomized Trial
Brief Summary: Overweight and obesity is increasing in most countries, including Norway, and the optimal diet for reducing weight is under discussion. The present study in overweight and moderate obese individuals compares a low glycemic load diet with a standard low-fat diet (as recommended from the National Nutrition Council) in an open, randomized trial over 12 months, with changes in weight loss and changes in cardiovascular risk markers as endpoints.


Options:
A: body weight (prior to and after 4, 8, and 12 months of dieting)
B: Dietary intake (6 month)
C: The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
D: Change in body mass at 12 weeks (12 weeks from baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.
Brief Summary: Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion.

This is a randomized controlled, open clinical trial with two groups.

* first group, 100 patients : control group, patients followed with no add-on intervention
* Second group, 100 patients : rehabilitation group with education, oral supplements, exercise and androgenic steroids.


Options:
A: The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations
B: An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.
C: 6-Minute walk distance (Six months)
D: Number of hospital admissions for exacerbations of COPD

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)
Brief Summary: The objective of this randomized, double blind, sham-controlled study is to demonstrate the safety and effectiveness of the Alair System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting β2-agonists.

The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from the 6-, 9-, and 12-month follow-up visits.

All other outcome measures assessed at 12 months post-treatment.

This will be a multicenter, randomized, double-blind, sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA).

A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 2:1 (two Alair Group Subjects for every one Control Group Subject).


Options:
A: Mild Exacerbation Rate (OFF-LABA) (Change From Baseline) (Baseline, 12 Months)
B: Respiratory Adverse Events Per Subject (Baseline, 12 Months)
C: Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments (2-year, 3-year, 4-year and 5-year follow up post procedure); Respiratory Adverse Events (2-year, 3-year, 4-year and 5-year follow up post procedure)
D: Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) (Baseline, 12 Months)

Answer: D