TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Adding Weight Control to Smoking Cessation Quitlines
Brief Summary: This randomized controlled trial compares the effectiveness for both smoking cessation and weight control of two alternative combined interventions offered via telephone quitline, as compared to standard of care quitline treatment addressing cessation alone. The interventions to be compared are cessation treatment alone versus cessation treatment combined with weight control treatment added either simultaneously or sequentially.


Options:
A: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
B: Change From Baseline in Weight at 24 Weeks (baseline and 24 weeks)
C: To demonstrate an increase in smoking abstinence rate (12 months)
D: 30-day point prevalence tobacco abstinence (6 months); Change in weight (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Proyecto Mama: Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women
Brief Summary: The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.


Options:
A: Maternal weight gain in pregnancy (Measured at the time of delivery); Weight of the newborn (Measured at the time of delivery); Maternal fasting serum glucose level (Measured at gestational week 30); Incidence of operative delivery, both cesarean section and operative vaginal delivery (Assessed following delivery); Maternal body composition (Measured at 36 weeks of gestation)
B: Gestational Weight Gain (delivery); Postpartum Weight Change (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Percent of Participants Meeting Postpartum Weight Goals (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Fasting Glucose (FG) (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Fasting Insulin (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Hemoglobin A1c (HbA1c) (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Adiponectin (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Total Leptin (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Total Cholesterol (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Low Density Lipoprotein Cholesterol (6 weeks postpartum, 6 months postpartum, 12 months postpartum); High Density Lipoprotein Cholesterol. (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Triglycerides (6 weeks postpartum, 6 months postpartum, 12 months postpartum); High Sensitivity C-Reactive Protein (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Compliance With IOM Weight Gain Guidelines for Pregnancy. (delivery); Child Waist Circumference (delivery); Child Head Circumference (delivery); Child Skinfold Thicknesses - Subcapsular and Triceps (delivery); Fetal Growth (delivery); Ponderal Index (delivery); Birthweight (delivery); Child Length (delivery)
C: Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations (Delivery (when the baby is delivered))
D: Gestational Weight Gain (Delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TeleLifestyleCoaching Use of Telemedicine for Weight Loss and Care of Weight Associated Illnesses
Brief Summary: Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching have the potential to support lifestyle change and weight loss. Therefore, the aim of our randomized controlled trial was to examine the effect of telemedicine with and without coaching in comparison to a control group on weight loss in overweight participants.


Options:
A: weight loss (12 weeks)
B: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
C: change in physical activity (4 months)
D: Amount of physical activity at baseline. (at baseline); Amount of Physical activity 1 month after baseline. (1 month after baseline); Amount of physical activity 3 months after baseline. (3 months after baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Masked, Placebo-Controlled, Efficacy And Safety Study Of RV 001, An Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody (Fully Human), Administered Every 3 Weeks (q3W) By Intravenous (IV) Infusion In Patients Suffering From Active Thyroid Eye Disease (TED)
Brief Summary: The primary objective of this study is to investigate the efficacy, safety, and tolerability of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months, in comparison to placebo, in the treatment of participants suffering from active TED.

"Funding Source - FDA OOPD"


Options:
A: Change in Clinical Activity Score (CAS) (baseline, 6 months after the first infusion)
B: Percentage of Participants Who Were Proptosis Responders at Week 24 (Week 24)
C: Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year (When all participants complete the 1 year visit)
D: Responder Status at Week 24 (Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Shoes for Kids on the Island of Pemba (SKIP): A Pragmatic, Cluster Randomised Controlled Trial to Test if Shoes Reduce Hookworm Infection and Transmission in School-aged Children on Pemba Island, Zanzibar
Brief Summary: Small association studies have hypothesised that shoes protect against hookworm infection. The purpose of this pragmatic study was determine, under field conditions, whether school-age children on Pemba Island, Zanzibar, would wear shoes and if shoes protected them against hookworm infection.


Options:
A: Diarrhoea (<5s) (21 months)
B: Reported diarrhoea in children <5 years (7-day recall, assessed 4 times during 3-month follow-up rounds)
C: Reduction in hookworm prevalence and intensity of infection in intervention arm (6 months)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients
Brief Summary: To assess efficacy of bronchoscopic lung volume reduction in Korean emphysema patients


Options:
A: 6-month improvement of the 6-minute walk test (6 months)
B: Difference between responder rates of the treatment & control groups, responders defined as subjects with clinically meaningful improvements in disease-related health status (SGRQ) & regional lung volume changes as measured by quantitative CT scan. (6 months)
C: Occurence of adverse events (serious and non-serious) secondary to the BTVA treatment procedure from initiation of treatment through completion of the six-month follow-up period (6 months)
D: Quantitative change of lung volume on computed tomography (Before procedure and 12 weeks after procedure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in resolving postoperative ileus.


Options:
A: Small bowel transit time (6 hours)
B: Time to flatus (30 days)
C: time to flatus (two days)
D: Time to first bowel movement (patients postoperative in hospital stay (mean 6 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial
Brief Summary: As individuals age, their physical activity decreases and sedentary time increases. Even small changes in these two behaviors can greatly decrease risks for several major health problems, including cardiovascular disease, diabetes, and many cancers. Studies that use pedometers to encourage walking have successfully increased physical activity, but do not address sedentary behaviors such as television watching. The investigators propose to use a novel pedometer-like device (Jawbone Up) that encourages both increased physical activity and decreased sedentary time. First, the investigators will recruit 10 adults to participate in a brief intervention for six weeks. They will wear the wrist-based activity monitor and use a mini-tablet device to see feedback on their activity and sedentary time. They will also receive brief counseling weekly. The investigators will use this first study to investigate the basic feasibility of the intervention materials. Next, the investigators will recruit 20 adults and randomize them to receive the intervention for 12 weeks or to a waiting list. Here, the investigators will test the intervention with refinements made based on participant responses from the first small study. Our primary outcomes will be measures of feasibility and acceptability across all parts of the study. The investigators hypothesize that the intervention will be feasible and acceptable to the participants. The investigators will also measure physical activity, sedentary behavior, fitness, body fat, and psychological feelings of motivation.


Options:
A: Change in Physical Activity From Baseline to 12 Weeks (12 weeks)
B: Time spent being physically active (2 months); Time spent sitting (2 months); Changes in food consumption (2 months)
C: Change in objective total, light and moderate-to-vigorous physical activity (PA) (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in objective sedentary behaviour (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in self-reported total, light and moderate-to-vigorous physical activity (PA) (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in self-reported sedentary behaviour (Pretest, posttest (6 weeks) and follow-up (6 months))
D: Change in Hours of Sitting Time (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis
Brief Summary: Indomethacin for tocolysis for 48 hours vs placebo


Options:
A: Efficacy of MgSO4 as tocolytics : increased interval of uterine contraction, decreased maternal painful sensation, stopping the cervical change (48 hours later)
B: N/A
C: delivery within 48 hours (48 hours after enrollment)
D: gestational age at delivery (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Outcomes in Geriatric Depression: Magnetic Seizure Therapy
Brief Summary: To evaluate the feasibility, tolerability and efficacy of Magnetic Seizure Therapy (MST) in elderly patients with a major depressive episode, who are randomly assigned to receive an acute course of MST or ECT.

The investigators hypothesize:

1. MST and ECT will have similar antidepressant efficacy
2. MST will have less post-treatment amnesia than ECT as reflected in a primary measures of anterograde and retrograde amnesia following the acute treatment phase.
3. At follow up, MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT.


Options:
A: changes of The Positive and Negative Syndrome Scale (PANSS) (At baseline, 4-week, 8-week)
B: Clinical improvement (Hamilton Rating Scale for Depression) (After each treatment and at followups up to 3 months after the treatment course)
C: Clinical improvement (Hamilton Rating Scale for Depression) (After each treatment and at follow-ups up to 6 months after the treatment course)
D: Hamilton Rating Scale for Depression, 24-Item (HRSD-24) (baseline (pre-treatment) and post-treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Shared Decision Making for Patients With First-admission Schizophrenia: a Randomized Controlled Trial
Brief Summary: To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.


Options:
A: Patient satisfaction as measured by the Japanese version of the Client Satisfaction Questionnaire (CSQ-8) (Within 7days before the date of discharge)
B: Shared Decision Making Questionnaire (CollaboRATE) (Level of Shared Decision Making at end of treatment (this will be at approximately week 8))
C: Recruitment Rate (Up to one year from when the study starts enrolling participants)
D: Quality of Decision Making (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.); Knowledge Transfer (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Educational Group Intervention in Primary Care to Maintain Exclusive Breastfeeding. Cluster Randomised Clinical Trial. PROLACT Study.
Brief Summary: Hypothesis: An educational intervention increases the proportion of mother-infant pairs using exclusive breastfeeding


Options:
A: Infant Feeding Questionnaire (4 weeks)
B: Pain Sensitivity (Baseline); Genetic variations in COMT (Baseline)
C: Exclusive breastfeeding (EBF) (six months)
D: Breastfeeding self-efficacy (Change from Baseline Breastfeeding self-efficacy at 6 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Surgical Skin Preps During Cesarean Deliveries
Brief Summary: In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation solutions for best outcome of surgical site infection. The three different solutions are: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Women are prospectively randomized to one of the three groups and followed until thier postpartum visit at 6-8 weeks following delivery.


Options:
A: Bacterial Load (Immediately Post-operative prior to exit from operating room)
B: Cesarean Surgical Site Infection (42 days after delivery)
C: Post-intervention Aerobic Bacterial Colony Counts (From intervention to 7 days post); Post-intervention Anaerobic Bacterial Colony Counts (From intervention to 7 days post)
D: Number of Participants With Surgical Site Infection (up to 6 weeks postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients
Brief Summary: The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.


Options:
A: Cardiac death and rehospitalization for HF (180 days)
B: Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180 (180 days); Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5 (Day 5)
C: Net change in weight (day 1,2,3,4,5)
D: Changes in a composite clinical-lab score (Baseline and 96 h after randomization,precisely:48 h after end of the last UF session in the intervention arm;24 h after end of 72 h infusional drug treatment in the control arm)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Knee Arthroscopy Cohort Southern Denmark (KACS)
Brief Summary: PURPOSE: To investigate the natural time course of patient-reported outcomes after meniscus surgery and identify factors associated with good and bad outcome after surgery.


Options:
A: the Knee Injury and Osteoarthritis Outcome Score (KOOS4) (Primary endpoint: Change from baseline to 12 months.)
B: Knee Injury and Osteoarthritis Outcome Score (KOOS) (PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up)
C: Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) (2 and 10 years postoperatively)
D: WOMAC Functional Status - Difference From Baseline (Baseline and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial
Brief Summary: There are currently over 11 million cancer survivors in the U.S. and survival rates are increasing. Unfortunately, 10-30% of cancer patients are current smokers at the time of diagnosis, and many of these patients have elevated socioeconomic, medical, and psychosocial vulnerabilities. Documented risks associated with continued smoking following cancer diagnosis include decreased survival time; increased complications from surgery, radiation, and chemotherapy; and increased risk of second primary tumors. U.S. Department of Health \& Human Services Public Health Service evidence-based tobacco treatment guidelines exist but have not been integrated into the cancer setting. This is a tremendous missed opportunity to address a modifiable risk factor. In recognition of this treatment gap, the National Cancer Institute (NCI) sponsored a conference in 2009 to address how to increase the readiness and capacity for delivery of tobacco treatment in Cancer Centers. The American Society of Clinical Oncology (ASCO) recommends identification, advice, and counseling of all smokers by their second oncology visit as a core quality indicator; however, currently only half of patients report being asked about tobacco use.

Specific Aim: To conduct a randomized controlled comparative effectiveness trial of two strategies to promote smoking cessation in suspected or newly diagnosed cancer patients.

Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll 295 current smokers with suspected or newly diagnosed melanoma, lymphoma, thoracic, breast, genitourinary, gastrointestinal, head and neck, or gynecologic cancer. Participants will be randomly assigned to receive Intensive Counseling (IC) or "Standard Care" (SC). Both groups will receive an initial motivational counseling session and 3 weekly follow-up counseling sessions with a tobacco treatment counselor, conducted in-person or by telephone. The IC arm has the option to also receive:

* Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication (Varenicline, bupropion, or combination NRT) at no cost to the participant.
* Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts).

All participants will complete 1 baseline and 2 follow-up surveys, at 3 and 6 months. Self-reported abstinence will be biochemically confirmed at 3 and 6 months.


Options:
A: smoking status (six month followup)
B: percent of patients eligible for quality measures (ABCS) (1 year)
C: Results in Abstinence Rates (1 Year)
D: Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 6 Months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: 7% Hypertonic Saline for Acute Bronchiolitis: A Randomized Controlled Trial
Brief Summary: Research suggests that hypertonic saline may improve mucous flow in infants with acute bronchiolitis. Data suggest a trend favoring reduced length of hospital stay and improved pulmonary scores with increasing concentration of nebulized solution to 3% and 5% saline as compared to 0.9% saline mixed with epinephrine. To our knowledge, 7% hypertonic saline has not been previously investigated. OUr hypothesis was that 7% hypertonic saline would improve bronchiolitis severity scores and admission rate.


Options:
A: Change in Bronchiolitis Severity Score (Baseline and up to 24 hours of hospital stay)
B: Length of Stay in the Study-LOS--Intention to Treat Analysis (Time of first study treatment until time of discharge); Length of Stay in the Study-LOS by Per Protocol Analysis (Time of first study treatment until time of discharge)
C: compare the rate of admission to hospital between the study and control groups (1 hour after treatment ends)
D: Admission Rate (1 day); Length of Stay (1 month); Change in RDAI Score (1 Hour)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: 7% Hypertonic Saline for Acute Bronchiolitis: A Randomized Controlled Trial
Brief Summary: Research suggests that hypertonic saline may improve mucous flow in infants with acute bronchiolitis. Data suggest a trend favoring reduced length of hospital stay and improved pulmonary scores with increasing concentration of nebulized solution to 3% and 5% saline as compared to 0.9% saline mixed with epinephrine. To our knowledge, 7% hypertonic saline has not been previously investigated. OUr hypothesis was that 7% hypertonic saline would improve bronchiolitis severity scores and admission rate.


Options:
A: Admission rate (24 hours)
B: Admission Rate (1 day); Length of Stay (1 month); Change in RDAI Score (1 Hour)
C: Change in Bronchiolitis Severity Score (Baseline and up to 24 hours of hospital stay)
D: Time to 'fit for discharge' (This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.)

Answer: C