TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy
Brief Summary: This prospective, randomized controlled trial was designed to compare the efficacy of a simple maneuver using lower airway pressure (30 cm H2O) and intraperitoneal instillation of bupivacaine, alone or in combination, to reduce shoulder pain after gynecologic laparoscopy.

Patient aged 15-65 years, scheduled for laparoscopic surgery for benign adnexa disease will be eligible for the study. Patients will be excluded from analysis if the procedure requires conversion to a laparotomy, an operative time \> 3 hours, or interpretation of pain is impossible due to serious adverse effects

240 patients will be randomly assigned to one of four groups Upon completion of surgery, the patient is placed in the Trendelenburg position (30 degrees), and one of four procedures is followed. For group A (control), 50 ml of normal saline is instilled under the diaphragm and CO2 is removed by manual deflation of the abdominal cavity through the cannula; For group B, a mixture of 50ml solution (20ml of 0.5% bupivacaine + 30ml normal saline) is instilled under the diaphragm and CO2 is removed by manual deflation of the abdominal cavity through the cannula; For group C, 50 ml of normal saline is instilled under diaphragm and CO2 was removed by means of a pulmonary recruitment maneuver consisting of five manual inflations of the lung with a maximum pressure of 30 cm H2O. The anesthesiologist holds the fifth positive pressure inflation for approximately 5 seconds. During these maneuvers, the surgeon will be instructed to ensure that the trocar sleeve valve is fully open to allow the CO2 gas to escape. For group D, patients receive an instillation of a mixture of 50ml solution in combination with the clinical maneuver.

Patients will be given a questionnaire with the pain question represented as a visual analog scale (VAS) preoperatively. Patients will be asked to fill out the questionnaires during the first 24 hours after surgery to determine the frequency and severity of their shoulder pain. All patients are instructed to record the pain scores regarding their shoulder pain only. The degree of postoperative shoulder pain will be assessed using VAS at 1, 6, 12, and 24 hours postoperatively. The VAS, with scores ranging from 0 (no pain) to 10 (excruciating pain), is constructed without numeration, thus allowing patients to mark a point along the scale that best represented their pain at that time.

In addition, the following parameters are recorded on the case report form by the investigators: operative time, blood loss, the length of hospital stay, analgesic use, and incidence of postoperative events.


Options:
A: the severity and frequency of shoulder-tip pain after laparoscopic surgery (the first 48 hours after the surgery)
B: The degree of shoulder pain after gynecologic laparoscopy (During the first 24hours after surgery; 1,6, 12, 24hr)
C: Shoulder Pain (within 14 days)
D: pain scores at varying time points pot operatively (48 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis
Brief Summary: This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.


Options:
A: Modified Total Sharp Score (mTSS) at Month 6 (Month 6); Change From Baseline at Month 6 in mTSS (Month 6); Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6 (Month 6); Absolute Blood Pressure (BP) Values (mmHg) (Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24); Change From Baseline in BP Values (mmHg) (Months 1, 2, 3, 6, 9, 12, 15, 18, and 24)
B: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)
C: Change in disease activity. (6 months)
D: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score (76 and 91 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of the Proximate Administration of Oxytocin After a Traumatic Event in Preventing the Development of Post Traumatic Stress Disorder
Brief Summary: This study is designed to test the hypothesis that a single administration of intranasal oxytocin within 6 hours post-trauma facilitates the physiological recovery for the trauma, thereby preventing the development of Post Traumatic Stress Disorder (PTSD) in the months following the event. In the absence of such treatment (i.e., under placebo conditions), we hypothesize that a greater proportion of persons will develop PTSD (i.e., fail to recover from acute effects).


Options:
A: The primary outcome measure is DSM-IV diagnosis of PTSD at the end of the trial. (13 months)
B: Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS) (15 minute measurement intervals on Study Days 7, 9, and 16)
C: Cumulative opioid morphine equivalent dose (The first 24 hours)
D: The primary outcome is symptom severity at the end of the trial .This will be determined using the Clinician Administered PTSD Scale (CAPS), a scale with established reliability and good psychometric properties. (13 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Sensori-motor Integration Balance Training on Balance Disturbances in Patients With Multiple Sclerosis
Brief Summary: Balance impairment is a common and very disabling disturbance in people with Multiple Sclerosis. The efficacy of pharmacotherapy in treating balance impairment in MS is poorly documented in literature. Although literature dealing with the rehabilitation of balance impairment in MS is very scant, the preliminary data reports show very promising results. The present project could have a positive impact on balance and gait ability, disability, fear of falling, risk of falls and quality of life of patients with Multiple Sclerosis.


Options:
A: Difference in mean change in total falls between intervention and control arms (5 months)
B: Change from Baseline in Bergs balance scale (Change from Baseline in Bergs balance scale at 7 weeks)
C: Clinical assessment procedures: - Berg Balance Scale (BBS) - Activities-specific Balance Confidence Scale (ABC) Instrumental assessment procedures: - Stabilometric assessment (At recruitment, after treatment (5 weeks) and in the follow-up (1 month))
D: Fall incidence (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Trichuris Suis Ova in Autism Spectrum Disorders
Brief Summary: The purpose of this study is to determine whether Trichuris Suis Ova (TSO) is safe and effective in treating adults with autism spectrum disorder


Options:
A: ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score (Baseline and 8 weeks)
B: Change From Baseline at Week 24 on the Vineland Adaptive Behavior Scales (Vineland-II) Two-domain Composite (2DC) Score. (Week 24)
C: Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. (Baseline; Week 4)
D: Yale-Brown Obsessive Compulsive Scale (YBOCS): to measure repetitive behaviors (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Aberrant Behavior Checklist (ABC): to measure aggression and irritability (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Clinical Global Impression - Improvement (CGI-I): to measure global functioning (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trichuris Suis Ova in Autism Spectrum Disorders
Brief Summary: The purpose of this study is to determine whether Trichuris Suis Ova (TSO) is safe and effective in treating adults with autism spectrum disorder


Options:
A: Change From Baseline in Social Communication Deficits as Measured by Social Responsiveness Scale 2 (SRS-2) (Baseline, Week 12); Percentage of Participants with Suicidality, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) (Baseline up to Week 12); Percentage of Participants With Adverse Events (From Baseline up to Week 18)
B: Yale-Brown Obsessive Compulsive Scale (YBOCS): to measure repetitive behaviors (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Aberrant Behavior Checklist (ABC): to measure aggression and irritability (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Clinical Global Impression - Improvement (CGI-I): to measure global functioning (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks)
C: Clinical Global Impressions Scale - Improvement - Social (6 Weeks); Repetitive Behavior Scale - Revised (6 Weeks); Diagnostic Analysis of Nonverbal Accuracy, Paralanguage Test (6 Weeks)
D: Children's Psychiatric Rating Scale (Weekly)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Trichuris Suis Ova in Autism Spectrum Disorders
Brief Summary: The purpose of this study is to determine whether Trichuris Suis Ova (TSO) is safe and effective in treating adults with autism spectrum disorder


Options:
A: Mean Conners' Teacher ADHD Index T Score by Dose (Measured at each dosing week of the drug trial (placebo, low, medium, high)); Mean Continuous Performance Test (CPT)-Commission Errors by Dose (Measured at each dosing week of the drug trial (placebo, low, medium, high))
B: Yale-Brown Obsessive Compulsive Scale (YBOCS): to measure repetitive behaviors (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Aberrant Behavior Checklist (ABC): to measure aggression and irritability (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Clinical Global Impression - Improvement (CGI-I): to measure global functioning (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks)
C: Changes in the Autism Diagnostic Observation Schedule (ADOS) (At baseline and after 12 weeks of treatment); Clinical Global Impression Scale (CGI) (At baseline and every 4 week up to 12 weeks)
D: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, 8 Treatments, 4 Periods, Incomplete Crossover Study to Determine the Optimal Free Dose Combination of BI 1744 CL and Tiotropium Bromide (Both Delivered by the Respimat® Inhaler) After 4 Weeks Once Daily Treatment in Patients With COPD
Brief Summary: The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.


Options:
A: Trough FEV1 Response (Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29)
B: Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks (12 weeks)
C: Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity (6 weeks); Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap (6 weeks)
D: FEV1 AUC0-24 on Day 29 (Day 29)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized,Double-blind,Multicenter Phase III Trial to Evaluate the Safety and Efficacy of Icotinib and Gefitinib in Advanced NSCLC Patients Previously Treated With Chemotherapy
Brief Summary: The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.


Options:
A: Progression-Free Survival (PFS) (Baseline to first observation of disease progression or death, 12 weeks up to 31 months)
B: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)
C: Progression Free Survival (2-7 months)
D: Response Rate (average 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Peer Coaching for Low-Income Patients With Diabetes in Primary Care
Brief Summary: Patients with diabetes who are counseled by a peer coach (another patient with diabetes) will have improved glycemic control compared with usual care patients.


Options:
A: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
B: Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein (12 months)
C: HbA1c level (6 months)
D: Blood pressure at target level (140/85 or lower), total cholesterol at target level (4.5 mmol/l or lower), LDL cholesterol at target level (2.5 mmol/l or below), waist circumference at target level (<=94 men, <=80 cm women) (12 months from start of intervention); For patients with diabetes: blood HbA1c at target level (7% or less) (12 months from start of intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
Brief Summary: In 2003, Surgeon General Richard Carmona suggested that low health literacy is "one of the largest contributors to our nation's epidemic of overweight and obesity." Over 26% of preschool children are now overweight or obese, and children who are overweight by age 24 months are five times as likely as non-overweight children to become overweight adolescents. The aim of the study is to assess the efficacy of a low-literacy/numeracy-oriented intervention aimed at teaching pediatric resident physicians to promote healthy family lifestyles and prevent overweight among young children (age 0-2) and their families in under-resourced communities.


Options:
A: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)
B: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)
C: Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life (2 years)
D: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
Brief Summary: In 2003, Surgeon General Richard Carmona suggested that low health literacy is "one of the largest contributors to our nation's epidemic of overweight and obesity." Over 26% of preschool children are now overweight or obese, and children who are overweight by age 24 months are five times as likely as non-overweight children to become overweight adolescents. The aim of the study is to assess the efficacy of a low-literacy/numeracy-oriented intervention aimed at teaching pediatric resident physicians to promote healthy family lifestyles and prevent overweight among young children (age 0-2) and their families in under-resourced communities.


Options:
A: Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life (2 years)
B: Physical Activity Level (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Physical Literacy (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Dietary Intake (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.)
C: BMI variation from baseline (12 months)
D: Provision of flesh-food or vitamin A-rich food (Change from baseline to 5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
Brief Summary: In 2003, Surgeon General Richard Carmona suggested that low health literacy is "one of the largest contributors to our nation's epidemic of overweight and obesity." Over 26% of preschool children are now overweight or obese, and children who are overweight by age 24 months are five times as likely as non-overweight children to become overweight adolescents. The aim of the study is to assess the efficacy of a low-literacy/numeracy-oriented intervention aimed at teaching pediatric resident physicians to promote healthy family lifestyles and prevent overweight among young children (age 0-2) and their families in under-resourced communities.


Options:
A: Exclusive Breastfeeding at Four Months of Age (Six months after the beginning of the study)
B: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)
C: Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life (2 years)
D: Change in glycemic control, change in dietary intake (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
Brief Summary: In 2003, Surgeon General Richard Carmona suggested that low health literacy is "one of the largest contributors to our nation's epidemic of overweight and obesity." Over 26% of preschool children are now overweight or obese, and children who are overweight by age 24 months are five times as likely as non-overweight children to become overweight adolescents. The aim of the study is to assess the efficacy of a low-literacy/numeracy-oriented intervention aimed at teaching pediatric resident physicians to promote healthy family lifestyles and prevent overweight among young children (age 0-2) and their families in under-resourced communities.


Options:
A: Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life (2 years)
B: Growth trajectories (using BMI, waist circumference), body composition (3 months)
C: Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment (0, 3 month)
D: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
Brief Summary: In 2003, Surgeon General Richard Carmona suggested that low health literacy is "one of the largest contributors to our nation's epidemic of overweight and obesity." Over 26% of preschool children are now overweight or obese, and children who are overweight by age 24 months are five times as likely as non-overweight children to become overweight adolescents. The aim of the study is to assess the efficacy of a low-literacy/numeracy-oriented intervention aimed at teaching pediatric resident physicians to promote healthy family lifestyles and prevent overweight among young children (age 0-2) and their families in under-resourced communities.


Options:
A: Summary composite measure of practice performance and exposure (One year)
B: BMI change at 6 month post assessment (Baseline and 6 month post assessment); BMI change at 1 year post assessment (Baseline to 1 year post assessment)
C: Body Mass Index Z-score (0, 6, 12, and 18 months)
D: Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
Brief Summary: In 2003, Surgeon General Richard Carmona suggested that low health literacy is "one of the largest contributors to our nation's epidemic of overweight and obesity." Over 26% of preschool children are now overweight or obese, and children who are overweight by age 24 months are five times as likely as non-overweight children to become overweight adolescents. The aim of the study is to assess the efficacy of a low-literacy/numeracy-oriented intervention aimed at teaching pediatric resident physicians to promote healthy family lifestyles and prevent overweight among young children (age 0-2) and their families in under-resourced communities.


Options:
A: Child BMI
B: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
C: Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life (2 years)
D: Infant weight for height (One year after study entry)

Answer: C