TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents: a Cluster-randomized Controlled Trial
Brief Summary: Background and objective:

There is an alarming increase in obesity and unhealthy lifestyles in adolescents. This issue threatens to have a highly negative health and socioeconomic impact in the near future. The only way to tackle this epidemic is to implement effective preventive strategies able to positively impact on youth lifestyle behaviours. The school is the most appropriate environment for such an intervention. The main objective of this study is to evaluate the efficacy of a comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles. The project consortium constitutes a unique framework of research groups at the forefront of novel and successful approaches aiming to healthier behaviours and dietary habits.

Methodology:

A cluster-randomized controlled trial involving 24 secondary schools in Spain will be carried out. Schools will be 1:1:1 randomized to receive a short-term (2-year) or a long-term (4-year) comprehensive educational program, or to receive the usual curriculum (control). Participants will be evaluated at baseline, and after 2 and 4 years with the following: weight scale, circumference measuring tape, bioelectrical impedance, dual energy X-ray absorptiometry, sphygmomanometer, blood analysis, saliva and urine analysis, accelerometers, and questionnaires. The primary outcome is the change in obesity and other health parameters from baseline to year 2 and 4, as assessed by the Ideal Cardiovascular Health score. Secondary outcomes include the change in adiposity, anthropometry and body composition parameters, physical activity and dietary habits, polyphenol and carotenoid intake, metabolomics and attitudes. Participants will be measured again when they reach 20 years old.

Expected results:

The investigators expects to show that a school-based educational intervention induces favorable lifestyle changes and improves cardiovascular health among Spanish adolescents, including obesity/adiposity and metabolic profiles. If successful, this strategy could be widely adopted having a meaningful effect on obesity and cardiovascular health promotion. Additionally, associations between health parameters and bioactive dietary compounds intake and metabolic profiles will be stablished.


Options:
A: Changes in the composite ICH score of adolescents from baseline to year 2 and 4 (2 and 4 years)
B: Improved dietary quality (Baseline- 24 months); Increased physical activity (Baseline- 24 months)
C: standardized body mass index (zbmi)
D: Change in Body Mass Index from to baseline to 1 and 2 years (0-1-2 years); Change in overweight and obesity status according to IOTF norms (up to 2 years); Change in BMI Z score from baseline to one and two years (up to 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mind/Body Interventions for Chronic Low Back and Neck Pain in Military Personnel
Brief Summary: Our primary aim is to assess the feasibility of conducting yoga research among active-duty military personnel with Chronic Low Back Pain (CLBP) and/or Chronic Neck Pain (CNP). In addition, we will evaluate the yoga intervention preferences and refine an existing yoga intervention to address those needs. The study will prepare us for a R01 funded pragmatic clinical trial of yoga for CLBP and CNP in active-duty military.


Options:
A: Change from baseline in low back pain (Baseline, 6 weeks, 12 weeks, 24 weeks); Change from baseline in back-related function (Baseline, 6 weeks, 12 weeks, 24 weeks)
B: Pain Interference (assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported)
C: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)
D: Client Satisfaction Questionnaire (3 months); Credibility Expectancy Questionnaire (CEQ) (1 month); Participant adherence (3 months); Participant homework adherence (3 months); Instructor manual fidelity checklist (3 months); Systematic Assessment of Treatment-Emergent Events - General Inquiry (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multicenter Study Assessing Short and Long-term Efficacy, Safety, and Tolerability of Sub-cutaneous Secukinumab in Subjects of Body Weight 90 kg or Higher With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: The purpose of this study is to assess secukinumab high dose (every 2 weeks) vs standard dose (every 4 weeks) in heavy body weight subjects with moderate to severe plaque psoriasis.


Options:
A: Percentage improvement of PASI from baseline to Week 16 (Week 16)
B: Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set) (16 weeks)
C: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
D: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1) (Week 16); The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75) (Baseline and Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension
Brief Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).


Options:
A: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) (Baseline (Visit 1) to week 12)
B: ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase) (8 weeks)
C: Change From Baseline at Week 24 on the Vineland Adaptive Behavior Scales (Vineland-II) Two-domain Composite (2DC) Score. (Week 24)
D: Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. (Baseline; Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PeriOperative ISchemic Evaluation-3 Trial
Brief Summary: This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.


Options:
A: The amount of blood loss in the third and fourth stages (the fourth stage of labor begins with delivery of the placenta and ends 2 hours after delivery) of labor. (2 hours)
B: o compare the estimated blood loss (EBL) during cesarean delivery among the three groups (Intraoperative and within the first 24 hours postoperative.)
C: A composite of life-threatening bleeding, major bleeding, and critical organ bleeding (30 days after randomization); A composite of MINS, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism. (30 days after randomization); For patients in the blood pressure management arm: A composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest. (30 days after randomization)
D: Number of patients receiving study intervention (At time of delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PeriOperative ISchemic Evaluation-3 Trial
Brief Summary: This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.


Options:
A: Success in achieving hemostasis.
B: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
C: A composite of life-threatening bleeding, major bleeding, and critical organ bleeding (30 days after randomization); A composite of MINS, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism. (30 days after randomization); For patients in the blood pressure management arm: A composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest. (30 days after randomization)
D: Blood loss (milliliters) (intraoperative (from skin incision to skin closure))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone Twice for Pain Treatment of Total Knee Arthroplasty - A Randomized Blinded Placebo-controlled Clinical Trial
Brief Summary: Dexamethasone twice for pain treatment after total knee arthroplasty - A Placebo-controlled, randomised, parallel 3-group multicentre trial of one and two doses of dexamethasone for postoperative treatment


Options:
A: The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40). (up to 20-24 hours after surgery)
B: Cumulative usage of morphine 0-48 hours postoperatively (0-48 hours postoperatively)
C: Pain 6 hours postoperatively (6 hours postoperatively); Pain 3 hours postoperatively (3 hours postoperatively); Pain 24 hours postoperatively (24 hours postoperatively); Pain (2-7 days postoperatively)
D: The average depths of hypnosis as assessed by the BIS and the cAAI between skin incision and start of closure. (During anaesthesia); Postoperative nausea as assessed by a verbal rating scale (VRS) ranging between 0 and 10. (After anesthesia at 5, 10, 15, 30, 45, 60, and 90 min. At 2, 6 and 24 h after anesthesia the maximum nausea will be rated for the 30-120 min, 2-6 h, and 6-24 h interval.); Reduction of VRS nausea immediately at 2, 5, 7.5, 10, 15, 20 and 30 min after rescue treatment administration. (Maximum nausea will be rated at 2, 6 and 24 hours after treatment for the 30-120 min, 2-6 h and 6-24 h interval.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke. Randomized Study
Brief Summary: The aim of this study is to determine the impact of an m-health based intervention on long term adherence to a rehabilitation program for stroke survivors.


Options:
A: Adherence (8 weeks)
B: Feasibility (6 weeks)
C: Ambulatory Activity Profile (6 months)
D: Incident Cancer (12/31/2030); All cause and disease specific mortality (12/31/2030); Chronic diseases (12/31/2030)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke. Randomized Study
Brief Summary: The aim of this study is to determine the impact of an m-health based intervention on long term adherence to a rehabilitation program for stroke survivors.


Options:
A: The number of steps taken per day by participants in each group (at baseline & at 6 weeks post randomisation)
B: Change in the Reintegration to Normal Living Index (RNL) from baseline (baseline, 12 weeks, 24 weeks)
C: Adherence (8 weeks)
D: Rate of recruitment to the studies (12 weeks (pilot study))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Mulligan Mobilization Technique in Older Adults With Neck Pain: A Randomized Controlled, Double-Blind Study
Brief Summary: When the literature is examined, there is study investigating the effect of mulligan mobilization technique on older adults with neck pain. This study aims to investigate the effect of mulligan mobilization technique on pain, range of motion, functional level, kinesiophobia, fear of movement, depression and quality of life in older adults with neck pain.


Options:
A: Change in Neck pain intensity as measured by Visual Analog Scale (Change from baseline neck pain intensity at 4 weeks)
B: Visual Analogue Scale (5 months)
C: The intensity of cervical pain (Baseline)
D: Pain Pressure Threshold (6 sessions)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Disruptive Behaviors in Fragile X Syndrome
Brief Summary: Disruptive behaviors such as self-injury, aggression, and property destruction pose significant health-related issues to children diagnosed with fragile X syndrome (FXS), impacting the child's quality of life and causing significant distress to families.

Access to appropriate treatment for families is severely limited by factors such as cost of care, shortages of qualified treatment providers, and geographic spread of children with FXS across the country. To address these potential issues, the effectiveness of administering a standardized function-based behavioral treatment for problem behaviors in FXS will be evaluated using telemedicine. The proposed study intervention therefore offers a tremendous step forward in clinical research both in the field of FXS and in the field of developmental disabilities more broadly, and thus will have a significant impact on public health.


Options:
A: Challenging Behaviour (12 months)
B: Change from baseline level of problem behavior at 4, 8, 12 and 16 weeks (0, 4, 8, 12, 16 weeks)
C: Aberrant Behavior Checklist scale (6 months)
D: Clinical Global Impression--Improvement score (Every two weeks); Affective Reactivity Index (ARI) (Every two weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects Among Smokers Who Use and Do Not Use E-Cigarettes
Brief Summary: This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.


Options:
A: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))
B: Number of cigarettes smoked per day (End of 6 week intervention)
C: Toxicant Exposure (6 weeks)
D: Days of abstinence following the programmed lapse (7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects Among Smokers Who Use and Do Not Use E-Cigarettes
Brief Summary: This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.


Options:
A: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)
B: Toxicant Exposure (6 weeks)
C: Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD). (6 months following quit day.)
D: Continuous smoking abstinence rate (Weeks 9 to 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects Among Smokers Who Use and Do Not Use E-Cigarettes
Brief Summary: This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.


Options:
A: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
B: 4-week continuous quit rate (CQR) for Weeks 9-12
C: Smoking Status (at week 48)
D: Toxicant Exposure (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects Among Smokers Who Use and Do Not Use E-Cigarettes
Brief Summary: This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.


Options:
A: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)
B: Toxicant Exposure (6 weeks)
C: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)
D: Rate of Smoking Abstinence (18 months & 24 months post study enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects Among Smokers Who Use and Do Not Use E-Cigarettes
Brief Summary: This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.


Options:
A: smoking cessation (52 weeks)
B: Toxicant Exposure (6 weeks)
C: Continuous smoking abstinence rate (Weeks 9 to 12)
D: Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (Up to 1 year); Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (Up to 1 year); Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (up to 1 year); Changes in withdrawal symptoms (up to 1 year); Subjective nicotine effect will be analyzed (up to 1 year); Changes in feelings and emotions (up to 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Midwife-coordinated, Individualized, and Specialized Maternity Care Intervention (ChroPreg) in Addition to Standard Care in Pregnant Women With Chronic Disease: a Parallel Randomized Controlled Trial
Brief Summary: The number of pregnant women affected by chronic diseases such as epilepsy, hypertension and thyroid disease is rising, and in the Danish population 15 % of all pregnant women had a chronic disease in 2016. Chronic disease increase the risk of complications during pregnancy such as preterm birth and caesarian section, while children born of mothers with chronic disease have an increased risk of low birthweight, prematurity and birth effects. Moreover, pregnant women with chronic disease have an increased risk of post-natal depression and report higher rates of anxiety during pregnancy and have described dissatisfaction with the communication with care providers about issues such as breastfeeding, lack of coherence during the course of pregnancy and after delivery.

The purpose of this study is to examine the effect of an increased, interdisciplinary, coordinated and specialized maternity care multimodal intervention for pregnant women with chronic disease on the length of hospitalization (during pregnancy and after delivery). Secondarily, the purpose is to examine the effect of the intervention on psychological well-being and patient satisfaction.

The investigators hypothesis is that the delivery of an increased interdisciplinary, coordinated and specialized intervention targeted pregnant women with pre-existing chronic disease will be beneficial for this group of pregnant women's' length of hospitalization during pregnancy and after delivery due to improved maternity care and improved self-care. Also, the investigators hypothesize that the effect of the intervention will be improved psychological well-being and satisfaction with care during pregnancy and after delivery.


Options:
A: Parenting self-efficacy (Up to 24 months of age, from 6 weeks after birth until 24 months of age); Parenting self-efficacy (Up to 24 months of age, from 6 weeks after birth until 24 months of age)
B: Antenatal visits (0-9 months before delivery)
C: Expectant mothers satisfaction of prenatal care (36 weeks)
D: Hospitalization, length of stay (LOS) (2 weeks post-partum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The AMOR Method: Resilience Training for Parents of Children With Autism
Brief Summary: We will evaluate whether a resilience training program which includes group and individual parent training will be effective in improving optimism and resiliency in parents of young children with autism spectrum disorders (ASD). By observing the level of parent optimism and resiliency before and after intervention, we will be able to determine whether the intervention is effective in improving parent resilience.


Options:
A: Feasibility of Making Mindfulness Matter© (M3) as a family treatment for children with epilepsy and their parents (Throughout the study enrollment period and over the 8 weeks of intervention.)
B: Change in Connor-Davidson Resilience Scale (CDRISC) from Baseline to week 8 (Baseline, week 8)
C: Change from Baseline in parent-rated self-control of the child (Baseline, 3, 5 and 9 months)
D: Attendance (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Impact of Infant Formulas With Different Protein Content on Growth, Gastrointestinal Tolerance, and B-casomorphin Concentration of Infants.
Brief Summary: Human milk (HM) is the gold standard of early infant nutrition. The World Health Organization (WHO) recommend that newborns be exclusively breastfed for the first 6 months of life. It has beed reported that an exclusive breast feeding at 6 months of age range from 10 to 46%. Thus, the intake of infant formulas (IF) is quite widespread, including infants that have less than 6 months that are not receiving breast milk. Most of the commercial IF are cow's milk-based formulas that have a higher concentration of protein than breast milk and have a different protein composition. Commercial IF have a low proportion of alpha lactoalbumin, and A1 β-casein; during its digestion, a β-casomorphin 7 peptide is produced. In addition, it has a high concentration of β-lactoglobulin. Both, β-casomorphin 7 and β-lactoglobulin have been associated with a higher risk of diabetes obesity and allergies. Human β-casein does not produce β-casomorphin 7 during its digestion, it has a high concentration of alpha-lactoalbumin and does not have β-lactoglobulin.

The purpose of this study is to evaluate growth, gastrointestinal tolerance, and β-casomorphin 7 in urine of infants that are exclusively breastfed compared to infants fed three IF with different proteint content.


Options:
A: Body weight measured at each study visit (12 months)
B: Change in weight (Baseline to 4 months of age)
C: mean weight gain (3 months)
D: MR Imaging (365 days of age)

Answer: B