TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation. A Comparative, Prospective, Multicenter, Randomized Controlled Trial.
Brief Summary: The purpose of this study is to determine whether individualized ventilatory management combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and postoperative individualized ventilatory support will decrease postoperative complications, unplanned ICU readmissions, ICU and hospital length of stay and mortality compared to a standardized Lung Protective Ventilation (LPV) for all patients at risk.


Options:
A: Surgical wound infection (30 days)
B: Lung cytokines in mechanically ventilated patients (30 months)
C: Incidence of Reperfusion Lung Injury (72 Hours)
D: Reduction of lung and systemic postoperative complications (Up to 7 postoperative days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentric Prospective Randomised Single-blind Controlled Clinical Study Assessing the Effect and the Safety of Primebrain Sensorimotor Stimulation on Neurological Development of Preterm Infants (Born Before 32 Weeks' Gestation) or Infants Born Weighing Less Than 1500 g
Brief Summary: Background : Brain vulnerability is particularly marked in preterm neonates and has long-term consequences. Unlike lesions affecting other organs, those that affect the brain can currently not 'be repaired' by producing new cells. However, exeprience-driven brain plasticity allows the brain to reorganise its connections to compensate (at least partially) the effects of an injury.

Purpose : To evaluate the influence of Primebrain stimulation programme administred by parents until 6 months post-term on motor and neurophysiological development of infants born \<32 weeks' gestation or with birth weight \<1500 g.


Options:
A: Motor development using Bayley Scales of Infant Development (BSID-III) (at 24 months of corrected age.)
B: neurodevelopmental outcome (one year corrected age)
C: Peabody Developmental Motor Scales(PDMS-2) (Two years post term age)
D: Changes in Infant Motor Profile (IMP) (Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the CT/IM period (T1); 8 weeks after the end of CT/IM periods (T2); at 18 mths of post term age (T3))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia): a Cluster-randomised Trial
Brief Summary: The purpose of this study is to determine whether community-based rehabilitation plus facility-based care is superior to facility-based care alone in reducing disability related to schizophrenia in rural Ethiopia.


Options:
A: HSCL 25 (Symptoms were assessed at baseline); HSCL 25 (3-month follow-up); HSCL 25 (Assessment at 12-month-follow-up)
B: Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0) (12 months)
C: Rate of Maternal HIV Viral Suppression (Two months post pregnancy); Mean Maternal Antiretroviral (ART) Adherence (Past 6 months, assessed at 2 months after the completion of pregnancy); Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention (through study completion, an average of 48 weeks); Rate of Delivery in Health Facility (two months post pregnancy); Rate of Infant Use of ART (First 6 weeks of life)
D: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study to Assess the Effect of Diets With Different Protein Composition - Mainly Coming From Lean Red Meat - in Body Weight and Lipid Profile in Overweight and Obese Women
Brief Summary: The objective of the study is to assess the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from animal proteins such as lean red meat, on body weight and lipid profile in overweight and obese women. A dietary intervention is carried out during 3 months in 90 women who are individually randomized to an hypocaloric diet with three types of macronutrient composition: 1) 35% proteins, 30% fat and 35% carbohydrates; 2) 27% proteins, 30% fat and 43% carbohydrates and 3) 20% proteins, 30% fat and 50% carbohydrates. Around 50% of total proteins in diet come from lean red meat (leg or shoulder of lamb) by providing up to 15 different recipes to participants to use them as part of the diet. At the beginning of the study, after 6 weeks and at the end of the intervention, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferrin, ferritin, uric acid, glucose, HbA1c, insulin and adipokines). In 3-months visit, participants will be advised to follow the prescribed diets during the next 3 months. Monitoring visits with the nutritionist will not be performed. A follow-up visit will be done after 3-months of end of intervention (at 6-months after beginning the study) to assess the long-time efficacy on main endpoint of each diet. In this visit only anthropometric parameters (weight, waist circumference, body mass index and body composition) will be determined.


Options:
A: Physical function (Baseline, 4, 6, and 9 months); Lean Mass (Baseline, 4, 6, and 9 months)
B: Change in body weight and lipid profile of diets with different protein composition in overweight and obese women.. (After 3 months of intervention)
C: N/A
D: Liver fat (Sept 2008)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support
Brief Summary: Improving diabetes social support is associated with health improvement benefits. This study is a prospective randomized controlled trial comparing the effects of telephone-based diabetes self-management support (DSMS) compared with usual care, which includes diabetes self-management education (DSME), during a 1-year period. It will determine whether this specific model for providing on-going support to people with diabetes will better enable them to maintain the engagement in self-care behaviors, clinical improvements and diabetes-specific knowledge gained during the course of diabetes self-management education.


Options:
A: This research study may lead to a potentially useful treatment for diabetes management when depression is present. (6 weeks); HbA1c (3-,6-, and 9-months); Depression (3-, 6- and 9-months)
B: 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)
C: Change from baseline HbA1c at 3, 9, 15, and 27 months (0, 3, 9, 15, and 27 months); Change from baseline blood pressure at 3, 9, 15, and 27 months (0, 3, 9, 15, and 27 months); Change from baseline cholesterol at 3, 9, 15, and 27 months (0, 3, 9, 15, and 27 months); Change from baseline BMI at 3, 9, 15, and 27 months (0, 3, 9, 15, and 27 months); Change from baseline weight at 3, 9, 15, and 27 months (0, 3, 9, 15, and 27 months); Change from baseline fasting glucose at 3, 9, 15, and 27 months (0, 3, 9, 15, and 27 months)
D: Participant HbA1c levels (one year); Participant cardiovascular risk index (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial
Brief Summary: Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional anesthesia technique for providing postoperative lower abdominal analgesia. Complications associated with TAPB are very rare and pose a lower overall risk to the patient receiving a TAPB versus a caudal block, which is considered the gold standard for pediatric lower abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to caudal block initially in providing postoperative pain control but would show improved pain relief beyond the anticipated caudal duration.


Options:
A: postoperative pain (from emergence to 24 hrs post-discharge)
B: Surgical Pleth Index (SPI) at the time of start of surgery (intraoperative)
C: time to first use of analgesic (24 hour)
D: Narcotic requirement (24 hours post intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis
Brief Summary: The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.


Options:
A: survival rate at 2 months (at 2 months)
B: 30 day-survival (30 days); Malondialdehyde serum levels (14 and 30 days)
C: Overall Survival (6 months)
D: Survival at one, three and six months (six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Investigator Initiated, International Collaborative, Multicentre, Cluster Crossover, Randomised Controlled Trial to Establish the Effects of Head Positioning on Death or Disability in Patients With Acute Stroke
Brief Summary: This study is an investigator-initiated and conducted, international collaborative, regionally organised, multicentre, prospective, cluster randomised, crossover, blinded outcome assessment study to compare the effectiveness of the lying flat (0°) head position with the sitting up (=30°) head position, in the first 24 hours of admission to hospital for patients with acute stroke, on the poor outcome of death or disability over the subsequent 90 days.


Options:
A: Shift ('improvement') in death or disability according to the modified Rankin Scale (mRS) (90 days)
B: To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score) (3 months)
C: Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK (between day 0 and month 3)
D: modified Rankin Score (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment Strategies in Colorectal Cancer Patients with Initially Unresectable Liver-only Metastases CAIRO5 a Randomized Phase 3 Study of the Dutch Colorectal Cancer Group (DCCG)
Brief Summary: Colorectal cancer patients with initially unresectable liver-only metastases may be cured after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal neoadjuvant induction regimen has not been defined, and no consensus exist on criteria for resectability.

In this study colorectal cancer patients with initially unresectable liver-only metastases, as prospectively confirmed by an expert panel according to predefined criteria, will be tested for RAS and BRAF tumor mutation status and selected by location of primary tumor. Patients with RAS or BRAF mutant and/or right sided tumors will be randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab (schedule 1), and triple chemotherapy (FOLFOXIRI) plus bevacizumab (schedule 2). Patients with RAS AND BRAF wildtype AND left-sided primary tumors will be randomized between doublet chemotherapy (FOLFOX or FOLFIRI) plus either bevacizumab (schedule 1) or panitumumab (schedule 3). Patient imaging will be reviewed for resectability by a central panel, consisting of at least one radiologist and three surgeons every assessment. Central panel review will be performed prior to randomization as well as during treatment, as described in the protocol.


Options:
A: Incidence of Adverse events; Changes in Lab values; Incidence of HAHA formation
B: Progression-free survival (PFS) (2 years after last patient in study)
C: the rate of patients converted to resection for liver metastases (3 years)
D: Overall survival

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity
Brief Summary: The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.


Options:
A: Continuous Nicotine Abstinence (8 weeks)
B: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
C: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
D: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity
Brief Summary: The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.


Options:
A: Smoking Status (at week 48)
B: Days of abstinence following the programmed lapse (7 days)
C: Continuous Nicotine Abstinence (8 weeks)
D: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity
Brief Summary: The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.


Options:
A: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
B: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
C: Number of cigarettes smoked per day (End of 6 week intervention)
D: Continuous Nicotine Abstinence (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity
Brief Summary: The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.


Options:
A: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
B: Continuous Nicotine Abstinence (8 weeks)
C: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)
D: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity
Brief Summary: The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.


Options:
A: A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment. (2 years)
B: Continuous Nicotine Abstinence (8 weeks)
C: Expired-air Carbon Monoxide Confirmed Smoking Abstinence (52 weeks)
D: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity
Brief Summary: The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.


Options:
A: 7-day point prevalence abstinence measured at 6 months (6 months)
B: Will bupropion reduce relapse to smoking compared to placebo (52 weeks and 76 weeks)
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: Continuous Nicotine Abstinence (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity
Brief Summary: The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
C: Continuous Nicotine Abstinence (8 weeks)
D: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity
Brief Summary: The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.


Options:
A: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
B: Continuous Nicotine Abstinence (8 weeks)
C: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
D: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Vitamin E Fortified Whey Drink on Nutritional Status, Inflammatory Markers and Oxidative Stress in Hemodialysis Patients
Brief Summary: The purpose of the study is to evaluate the effect of vitamin E fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients


Options:
A: increase in serum albumin (6 months)
B: Number of patients who correct the state of protein energy wasting in intervention group compared to a control group (at 6 months)
C: Change of physical endurance on bicycle (At months 3 and 15 after inclusion)
D: malnutrition (based on SGA assessment) (2 months (8 weeks)); Malnutrition inflammation score (2 months (8 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants (PROMOTE Birth Cohort 1)
Brief Summary: This will be a double-blinded randomized controlled phase III trial of 300 HIV uninfected pregnant women and the children born to them. The study interventions will be divided into two phases. In the first phase, HIV uninfected women at 12-20 weeks gestation will be randomized in equal proportions to one of three intermittent preventive therapy in pregnancy (IPTp) treatment arms: 1) 3 doses of sulfadoxine-pyrimethamine (SP), 2) 3 doses of dihydroartemisinin-piperaquine (DP), or 3) monthly DP. All three interventions arms will have either SP or DP placebo to ensure adequate blinding is achieved. Follow-up for the pregnant women will end approximately 6 weeks after giving birth. In the second phase of the study, all children born to mothers enrolled in the study will be followed from birth until they reach 36 months of age. Children born to mothers randomized to receive 3 doses of SP during pregnancy will receive DP every 3 months between 2-24 months of age. Children born to mothers randomized to receive 3 doses of DP or monthly DP during pregnancy will receive either DP every 3 months or monthly DP between 2-24 months of age. To ensure adequate blinding, children who will receive DP every 3 months will be given DP placebo during the months they will not be taking DP. Children will then be followed an additional year between 24-36 months of age following the interventions. We will test the hypothesis that IPT with DP will significantly reduce the burden of malaria in pregnancy and infancy and improve the development of naturally acquired antimalarial immunity.


Options:
A: Level of malaria parasitemia in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis for malaria in pregnancy (6 months)
B: Prevalence of Placental Malaria (Delivery); Incidence of Malaria in Pregnant Women (Time at risk will begin after first dose of study drug and will end when study participants deliver or early study termination); Incidence of Malaria in Infants (Time at risk will begin at birth and will end when study participants reaches 24 months of age or early study termination (if prior to 24 months of age)); Incidence of Malaria in Infants (Time at risk will begin at 24 months of age and will end when study participants reaches 36 months of age or termination)
C: Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
D: Proportion of preterm births (once, after delivery); Number of serious adverse events (Cumulative during pregnancy and neonatal period)

Answer: B