TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Encouragement-induced Movement Therapy in Daily Life - a Randomized Controlled, Assessor-blinded Multi-center Trial in Stroke Patients With a Unilateral Hemiparesis, Using a Wrist-worn Tracking and Feedback Device
Brief Summary: Stroke places a major burden on health care and society. It often leads to a hemiparesis. Intensive stroke rehabilitation speeds up recovery. In daily practice, the financial and/or human resources to provide this intensive rehabilitation are often lacking. Applying modern-day tracking and feedback technology to encourage a self-administered, context specific training is expected to offer significant potential to increase intensity of practice. Up until now, there has been no randomized trial examining the effect of such an intervention on daily arm usage.

The primary objective of this study is to determine the effect of wearing an activity tracking and multimodal feedback device for six weeks on self-reported daily life use of the paretic arm after stroke, when compared to control group stroke subjects wearing a hardware-wise identical sham device providing no feedback. The secondary aim is to examine compliance to use the device and the quantitative, qualitative and functional improvement of the paretic arm. It is hypothesized that participants in the experimental group show a higher change in self-reported daily life use of the paretic arm when compared to the control group both post intervention and at 6-week follow-up.

ISEAR is a multicenter, assessor-blinded randomized controlled trial of 62 subjects beyond the first 3 months poststroke.


Options:
A: Wolf Motor Function Test (0 to 1 months); Motor Activity Log Quality of Movement Scale (0 to 1 months)
B: Jette Late Life Functional and Disability Instrument (LLFDI) (3 months)
C: physical scale of the Stroke Impact Scale 3.0 (before discharge from acute care, four weeks after discharge from the hospital or rehabilitation (in case of referral to a medical rehabilitation) immediately before randomization (baseline assessment), and 12 months after randomization)
D: Motor Activity Log - 14, Amount of Use sub scale (Post-intervention (6 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Socio-health Impact of a Multifactorial Program of Hand Hygiene on Respiratory and Gastrointestinal Infections in Children Attending in Day-care Centres
Brief Summary: It is well known that attending Day Care Centres (DCCs) can lead to an increase in the frequency of infections, due to the high incidence at this age and also the ease of transmission among children. This high incidence respiratory tract infections (RTIs) and acute gastroenteritis can also have a significant impact on the cost of health care systems, increasing the number of medical visits, hospitalizations and prescribing medications as symptomatic drugs or unnecessary antibiotics in some cases.The aim of the study was to determine whether a multifactorial hand-hygiene program (handwashing with soap and water vs hand sanitizer vs control group) reduce episodes due to RTIs and gastroenteritis in children attending DCCs. In addition, analyze the cost-effectiveness of these interventions.


Options:
A: the episodes due to respiratory tract infections (8 moth); The episodes due to gastroenteritis (8 month)
B: To compare the overall survival of patients at high risk for developing peritoneal carcinomatosis from colorectal cancer who undergo mandatory second look surgery + HIPEC and CRS (if applicable) vs. similar patients who receive standard of care. (Follow-up will occur every 3 months for two years, every six months for three ye)
C: Duration of diarrhea (within the first 72 hours during hospitalization)
D: To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh (17 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Socio-health Impact of a Multifactorial Program of Hand Hygiene on Respiratory and Gastrointestinal Infections in Children Attending in Day-care Centres
Brief Summary: It is well known that attending Day Care Centres (DCCs) can lead to an increase in the frequency of infections, due to the high incidence at this age and also the ease of transmission among children. This high incidence respiratory tract infections (RTIs) and acute gastroenteritis can also have a significant impact on the cost of health care systems, increasing the number of medical visits, hospitalizations and prescribing medications as symptomatic drugs or unnecessary antibiotics in some cases.The aim of the study was to determine whether a multifactorial hand-hygiene program (handwashing with soap and water vs hand sanitizer vs control group) reduce episodes due to RTIs and gastroenteritis in children attending DCCs. In addition, analyze the cost-effectiveness of these interventions.


Options:
A: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
B: RT-PCR analysis (two weeks)
C: Symptomatic SARS-CoV2 infection (12 weeks)
D: the episodes due to respiratory tract infections (8 moth); The episodes due to gastroenteritis (8 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Pan-Asian Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology Programme
Brief Summary: To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.


Options:
A: Ongoing Pregnancy Rate (10-11 weeks after blastocyst transfer); Ongoing Implantation Rate (10-11 weeks after blastocyst transfer)
B: Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles (Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose)
C: Ongoing Pregnancy Rate (10-11 weeks after transfer)
D: Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage); Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing Alcohol Misuse SBIRT in a National Cohort of Pediatric Trauma Centers
Brief Summary: The goal of this study is to conduct a fully powered Type III hybrid effectiveness-implementation trial to test the effectiveness of a comprehensive implementation strategy in increasing the implementation of SBIRT for alcohol and other drug use in pediatric trauma centers. Our implementation strategy is based on the Science to Service Laboratory (SSL), an approach developed by the SAMHSA-funded Addiction Technology Transfer Centers (ATTCs) that consists of the same three core elements (i.e., didactic training + performance feedback + leadership coaching) used in our Centers for Disease Control and Prevention (CDC) study. Based on feedback from the CDC study, two enhancements were made to the SSL strategy: 1) integration of the intervention into the electronic medical record as a means of improving SBIRT adherence; and 2) development of separate training tracks for nurses, social workers and organizational leaders to meet the unique needs of each group. In addition, we integrate counseling around the use of prescription pain relievers into the SBIRT intervention as an Exploratory Aim, since most pediatric trauma center patients are discharged on pain medication and patients with a history of AOD use are at elevated risk of opioid misuse. Utilizing a stepped wedge design, a national cohort of 10 pediatric trauma centers will receive the SSL implementation strategy. Data collection for this study relies on multiple sources. At six distinct time points, each of the 10 sites will provide retrospective data from EMR charts. A subset of adolescents will also report on fidelity of intervention delivery and linkage to care (i.e., continued AOD discussion and/or treatment with a primary care provider) 1 month post hospital discharge. In addition, nurses, social workers, and leaders from each pediatric trauma center will report on organizational readiness for implementation at three distinct time points. Results of this study will demonstrate that a highly scalable implementation strategy, adapted for pediatric trauma centers from the results of our mixed-methods implementation trial, will improve the fidelity (i.e., the consistency and quality) of SBIRT delivery in pediatric trauma centers.


Options:
A: Proportion of COX-2 inhibitors prescribed within the entire NSAID class (18 months); Proportion of omeprazole prescribed within the entire proton pump inhibitors class (18 months)
B: Proportion of admitted injured adolescents receiving each element of the alcohol screening, brief intervention and referral to treatment (SBIRT) protocol (54 months)
C: Hospital rate of permanent colostomy; Hospital rate of local recurrence
D: Number of LTC residents on vitamin D (16 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Change in Mindfulness in Borderline Personality Disorder After Dialectic-behavioural Therapy (DBT): A Pre-post-comparison
Brief Summary: The current study aims to investigate the effect of dialectical behavioral therapy on mindfulness in patients with Borderline Personality Disorder. A treatment group will be compared to a waitlist control group.


Options:
A: MHS heavy use (2 years)
B: N/A
C: Change in mindfulness (Baseline and after 12-weeks); Change in borderline symptom severity (Baseline and after 12-weeks); Change in overall psychiatric symptom severity (Baseline and after 12-weeks); Change in severity in symptoms of depression (Baseline and after 12-weeks)
D: Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Change in Mindfulness in Borderline Personality Disorder After Dialectic-behavioural Therapy (DBT): A Pre-post-comparison
Brief Summary: The current study aims to investigate the effect of dialectical behavioral therapy on mindfulness in patients with Borderline Personality Disorder. A treatment group will be compared to a waitlist control group.


Options:
A: The acceptability of the intervention to patients (within 6 months of study completion); The feasibility of intervention delivery at the ER setting (within 6 months of study completion); Patient recruitment (Baseline); The proportion of participating patients who can be reached by telephone contact at the 3-month follow-up. (3 months); The proportion of participating patients who can be reached by telephone contact at the 6-month follow-up. (6 months); The proportion of participating patients who can be traced from the hospital record at the 3-month. (3 months); The proportion of participating patients who can be traced from the hospital record at the 6-month. (6 months); The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 6-month. (6 months); The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 3-month. (3 months); Change in scores on a self-report suicidal behaviors assessment from baseline to 3 months (Baseline, 3 months); Change in scores on a self-report suicidal behaviors assessment from baseline to 6 months (Baseline, 6 months); Number of repeat self-harm episodes per person in 3 months after intervention based on hospital records (3 months); Number of repeat self-harm episodes per person in 3 months after intervention recorded in the nationwide self-harm registry (3 months); Number of repeat self-harm episodes per person in 6 months after intervention based on hospital records (6 months); Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry (6 months); Time to next self-harm repetition (in days) following randomization (6 months)
B: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)
C: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)
D: Change in mindfulness (Baseline and after 12-weeks); Change in borderline symptom severity (Baseline and after 12-weeks); Change in overall psychiatric symptom severity (Baseline and after 12-weeks); Change in severity in symptoms of depression (Baseline and after 12-weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Change in Mindfulness in Borderline Personality Disorder After Dialectic-behavioural Therapy (DBT): A Pre-post-comparison
Brief Summary: The current study aims to investigate the effect of dialectical behavioral therapy on mindfulness in patients with Borderline Personality Disorder. A treatment group will be compared to a waitlist control group.


Options:
A: Borderline Symptom Checklist (BSL-23) (Changes in scores of BSL-23 before treatment, and at 4, 8, 12 months after starting the treatment)
B: Change in mindfulness (Baseline and after 12-weeks); Change in borderline symptom severity (Baseline and after 12-weeks); Change in overall psychiatric symptom severity (Baseline and after 12-weeks); Change in severity in symptoms of depression (Baseline and after 12-weeks)
C: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
D: Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview (Assessed at baseline, and at 8, 16 and 24 months post-randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Change in Mindfulness in Borderline Personality Disorder After Dialectic-behavioural Therapy (DBT): A Pre-post-comparison
Brief Summary: The current study aims to investigate the effect of dialectical behavioral therapy on mindfulness in patients with Borderline Personality Disorder. A treatment group will be compared to a waitlist control group.


Options:
A: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)
B: Suicidal thoughts or attempts (Measured at Year 2)
C: Change in mindfulness (Baseline and after 12-weeks); Change in borderline symptom severity (Baseline and after 12-weeks); Change in overall psychiatric symptom severity (Baseline and after 12-weeks); Change in severity in symptoms of depression (Baseline and after 12-weeks)
D: Days/skill (Daily measurements up to 1 year. (minimum 8 months.))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Different Incentive Models in Booster up the Second Follow up Response Rate
Brief Summary: Aim to test the effectiveness of different incentive models for increasing the follow-up response rate in the current smoker subject.


Options:
A: Proportion of respondents who will complete the 3-month follow-up (Finish all telephone survey by Jan 2018)
B: Change in Cardiorespiratory Fitness from Baseline (Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2))
C: Women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out. (90 days)
D: Surgical Failure (6 months and 1, 2, 3, 4, and 5 years); Recruitment Into E-OPTIMAL (At 24 Months post OPTIMAL Treatment); Retention in E-OPTIMAL (3, 4, and 5 Years Post OPTIMAL Treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Different Incentive Models in Booster up the Second Follow up Response Rate
Brief Summary: Aim to test the effectiveness of different incentive models for increasing the follow-up response rate in the current smoker subject.


Options:
A: Knowledge of Consent Information (At baseline (time zero))
B: Proportion of respondents who will complete the 3-month follow-up (Finish all telephone survey by Jan 2018)
C: Change in Rolland Morris Disability Questionnaire (Change from baseline to 52 weeks)
D: The proportion of clinics that have satisfied each of the structure criteria. (Five years); The proportion of patients who have complied with the criterion process of care. (Five years); The proportion of patients who have achieved the target of outcomes of care (Five years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Structural Phonation Training on Respiratory Muscle Function in Patients With Structural Heart Disease - HeartChoir
Brief Summary: Most patients with complex congenital heart disease and cardiomyopathy from acquired heart disease have reduced exercise capacity. Exercise capacity is associated with respiratory muscle strength and function. If structured respiratory muscle training positively influences respiratory muscle function in patients with structural heart disease is not well known. The aim of this study is to investigate whether regular singing lessons and breathing exercises improve respiratory muscle strength in patients with congenital or acquired structural heart disease.


Options:
A: Improvement exercise tolerance and physical capacity (Baseline and 4 months)
B: Maximal inspiratory pressure in kilopascal (12 weeks)
C: Change in muscle strength (Newton, N) (Change from baseline muscle strength at 12 weeks follow-up)
D: Cardiopulmonary exercise capacity (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Study on Tocolysis in Prevention of Preterm Labour
Brief Summary: Preterm birth is defined as birth before 37 completed weeks of gestation .it occurs in 11.1%of birth globally affecting an estimated 14.9 million babies every year . It is generally accepted that approximately 65%-70%of preterm births are spontaneous,40%-45% of them due to spontaneous preterm labor and 25%-30%following preterm rupture of membranes.preterm birth represents the single largest cause of morbidity and mortality for newborn and is estimated for 29%of deaths in the first four weeks of life and also is estimated for of major cause of morbidity for pregnant women .

Tocolytic agents include a wide range of drugs that can slow or suppress uterine contractions . Tocolytic are considered advantages in spontaneous preterm labor to : (a) allow time for the fetus to mature ,potentially avoiding deleterious effects of pre-maturity . (b)allow time for antenatal corticosteroids to be administered and have clinical effect. (c) allow time for intrauterine transfer to higher-care center where neonatal intensive care facilities are available . the ideal Tocolytic agent should be effective , easy to administer , without significant material ,fetal or neonatal side effects and permit time for antenatal corticosteroids to be administered and take effect . a variety of Tocolytic treatments have been used to inhibit uterine activity in women in spontaneous preterm labor , including betamimetics , calcium channel blockers , magnesium sulfate , prostaglandin inhibitors and oxytocin receptor antagonists however there is considerable global variation in types , doses and regimens of tocolytic agents uses to manage preterm labor .

A comparison study between Ritodrine, magnesium sulfate and Nifedipine in terms of effect and morbidity will be conducted.


Options:
A: The present study aims to evaluate the efficacy of these tocolytic drugs for maintenance tocolysis in the management of threatened preterm delivery. (12 months)
B: In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures (At delivery)
C: The time of delivery (6 months)
D: latency period interval between time of tocolysis and delivery (24 hours up to 7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Interventions for Chronic Pain and Opioid-Related Problems
Brief Summary: The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain.


Options:
A: Mean Number of Alcohol and Drug Use Days Out of Past 30 (30 days previous, assessed at 12-month follow-up)
B: Change in pain symptoms (Change from baseline through study completion (9 months post-treatment)); Change in aberrant drug-related behaviors (Change from baseline through study completion (9 months post-treatment))
C: Smoking Abstinence (2 weeks post quit day)
D: Addiction Severity Index (ASI) - Alcohol (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Addiction Severity Index (ASI) - Drugs (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Change on Urine Drug Test (change) (Baseline, 2 months, 4 months, 6 months, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Non-severe Male Infertility: a Randomized Controlled Trial
Brief Summary: A multicenter, parallel-controlled(1:1 treatment ratio), open-label, randomized clinical trials regarding fertilization and pregnancy outcomes between ICSI and conventional IVF among couples with no-severe male-factor infertility in China.


Options:
A: Ongoing pregnancy leading to live birth after the first cycle with embryo transfer (After 22 weeks of gestation)
B: Ploidy state: euploid or aneuploid (7 days)
C: Cumulative live birth rate from first live birth episode of a study cycle (Minimum follow-up time is one year after inclusion)
D: Ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle. (At 12 weeks of gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Active Thyroid Eye Disease
Brief Summary: The overall objective is to investigate the efficacy, tolerability, and safety of teprotumumab (a fully human monoclonal antibody \[mAb\] inhibitor of the insulin-like growth factor-1 receptor \[IGF-1R\]) administered once every 3 weeks (q3W) for 21 weeks with a final assessment at Week 24, in comparison to placebo, in the treatment of participants with moderate-to-severe active thyroid eye disease (TED).


Options:
A: Drug efficacy will be established as a decrease in CAS (clinical activity score) by 2 or more points in a scale of 10. (It will be measured before treatment (week -4 / 0), after treatment (week 16) and after the end of the follow-up (week 40).)
B: Change in Clinical Activity Score (CAS) (baseline, 6 months after the first infusion)
C: Percentage of Participants Who Were Proptosis Responders at Week 24 (Week 24)
D: Responder Status at Week 24 (Week 24)

Answer: C