TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Technology and Online Tools to Improve Asthma Control in Adolescents
Brief Summary: This project will preliminarily validate CampAir, an empirically-based dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control. In addition to developing a highly novel product for adolescents with asthma, the research proposed for this project will address unique scientific questions. Despite the high asthma prevalence among adolescents, few interventions have specifically targeted adolescents. This study is innovative in that it is among the few to focus on adolescents, who are often overlooked by the healthcare system. This research will assess factors associated with successful implementation of CampAir, thereby providing new information regarding how e-health interventions can be effectively developed and implemented for use with adolescents with asthma.


Options:
A: Change from Baseline Asthma Control to 3 Month Asthma Control (Post-Refinement Baseline, 3 Months); Change from Baseline Asthma Control to 3 Month Asthma Control (Post-Refinement Baseline, 4 Months)
B: Night Wakenings Due to Asthma (To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up).)
C: Appropriate use of asthma controller medications (Measured at Year 1); Number of asthma symptom days (Measured at Year 1)
D: Change from Baseline in adherence rate to entire treatment period (From baseline to end of participation (up to 3 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Stroke survivors, as a group, are extremely inactive and this has serious consequences for them, including an increased risk of a second stroke and developing other diseases. This study investigates a novel intervention designed to improve everyday activity after stroke by combining walking training to improve walking capacity with a program to encourage more daily walking.


Options:
A: VO2-peak, strength, walking, activities of daily living (baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.)
B: Steps Per Day (Change from Baseline to 3 months (Post)); Steps Per Day (Change from 3 months (Post) to 6 months); Steps Per Day (Change from 3 months (Post) to 12 months)
C: Stroke risk score card (Baseline, within a month after the intervention, 1 year follow-up after baseline.); Healthy Activity patterns (PPR profile) (Baseline, within a month after the intervention, 1 year follow-up after baseline.); Questions of Lifestyle habits (Baseline, within a month after the intervention, 1 year follow-up after baseline.); Canadian Occupational Performance Measurement (COPM) (Baseline, within a month after the intervention, 1 year follow-up after baseline.)
D: Systolic Blood Pressure (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Stroke survivors, as a group, are extremely inactive and this has serious consequences for them, including an increased risk of a second stroke and developing other diseases. This study investigates a novel intervention designed to improve everyday activity after stroke by combining walking training to improve walking capacity with a program to encourage more daily walking.


Options:
A: Change from baseline in Physical activity levels - multisensor monitor (At baseline, 12 weeks post-intervention, and at 4-week follow-up); Change from baseline in Physical activity levels - Human Activity Profile (At baseline, 12 weeks post-intervention, and at 4-week follow-up); Change from baseline in sedentary behavior - multisensor monitor (At baseline, 12 weeks post-intervention, and at 4-week follow-up)
B: Steps Per Day (Change from Baseline to 3 months (Post)); Steps Per Day (Change from 3 months (Post) to 6 months); Steps Per Day (Change from 3 months (Post) to 12 months)
C: Feasibility (6 weeks)
D: modified Rankin Score (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Magnesium Sulfate in Obese Preeclamptic Women
Brief Summary: The purpose of this study is to learn how medications participant will receive in the course of their delivery are metabolized (broken down by the body). The investigators hope to learn more about the way drugs are metabolized by pregnant women, and how those drugs are distributed in the blood and body compartments and cleared in the urine, and how maternal body weight affects the metabolism. With this information the investigators will be able to develop a treatment regimen considering factors in the body that affect magnesium levels so that the investigators can improve treatment of pregnant women. The goal of the study is to understand how different dosing of magnesium sulfate affects blood levels of the magnesium in larger women.


Options:
A: completed course of treatment (24 hours postpartum)
B: Time of magnesium sulfate therapy (minutes); Blood pressure; Maternal symptoms (headaches, blurred vision, chest pain, shortness of breath)
C: Maternal Serum Magnesium Level at 4 Hours After Administration (4 hours)
D: Magnesium concentration (00:00, 00:20; 00:40; 1:20; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Intervention Program for Preterm Infants and Their Parents: Establishing the Impact at 18 Months Corrected Age
Brief Summary: There are several intervention programs involving multisensory and motor stimulations such as, gym, auditory, visual, vestibular and tactile stimulations. We propose to study a continuous program of early intervention involving very preterm infants' families in their first 12 months of life taking the chance of their neuronal plasticity during this period. Preterm infants born in our institution will be included when they complete 48 hours after birth (first intervention). All preterm infants and their mothers will be followed during neonatal period and pre hospital discharge they will have a second intervention ( to measure parental bond ). After discharge they will be conducted to follow up program and we will divided all very low birth weight infants included in the study in two groups according previous randomization:

1. Standard care with motor, and cognition evaluation and intervention according to their needs
2. Program of early intervention with parents' orientation independently of f the standard evaluation and care that will be performed.

All phases of neurodevelopment will be evaluated, and the parents will be oriented to stimulate motor, language and cognition iteratively and continuously at home; this is a innovative method to improve very preterm neurodevelopment outcome.

Randomization: in neonatal period, preterm infants will be sequentially randomized when they completed 48 hours after birth in:

Group 1- conventional group (CG): standard care, according to the routine care of the NICU (skin-to skin care by mother, kangaroo care ).

Group 2- intervention group (IG): skin-to skin care by mother ( kangaroo care ) plus massage therapy by mothers. They will receive the tactile-kinesthetic stimulation by mothers from randomization until hospital discharge. Intervention performed exclusively by the mothers was based on studies regarding the application of skin stimulations and passive exercises in preterm infants.

Both groups will receive skin-to skin care by mother (Kangaroo Care) according to the routine care of the neonatal intensive care unit (NICU).


Options:
A: Peabody Developmental Motor Scales(PDMS-2) (Two years post term age)
B: Birth admission length of stay (Hospital length of stay in days, expected to range between 14 and 24 days; some infants may require a longer admission)
C: neurodevelopmental outcome (one year corrected age)
D: Motor Development. (18 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Collaborative Care Teams to Enhance Service Delivery to Youth With Mental Health and Substance Use Challenges: Protocol for a Pragmatic Randomized-controlled Trial
Brief Summary: Among youth, the prevalence of mental health and addiction (MHA) disorders is roughly 20%, yet youth are challenged to access services in a timely fashion. To address MHA system gaps, this study will test the benefits of an Integrated Collaborative Care Team (ICCT) model for at-risk youth with MHA challenges. In partnership with community agencies, adolescent psychiatry hospital departments, and family health teams, investigators have developed an innovative model of service provision involving rapid access to MHA services. This model will be implemented and compared to the usual treatment youth receive in hospital-based, outpatient, mental health clinics in Toronto. A rapid, systematic, approach to MHA services geared to need in a youth-friendly environment is expected to result in better MHA outcomes for youth. Moreover, the ICCT approach is expected to decrease service wait-times, be more youth- and family-centred, and be more cost-effective.


Options:
A: Youth functioning (One year)
B: Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age (1 year)
C: Change in uptake of shared decision-making from the patients' perspective (All clinics: baseline, 8 months, 16 months, 24 months)
D: Change in Body Mass Index (3 and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Communication About Uncertainty and Hope: A Randomized Controlled Trial Assessing the Efficacy of a Communication Skills Training Program for Physicians Caring for Cancer Patients
Brief Summary: Background: Although previous studies have reported the efficacy of communication skills training programs (CST), specific training addressing communication about uncertainty and hope in oncology has not yet been studied. This paper describes the study protocol of a randomized controlled trial assessing the efficacy of a CST program aimed at improving physician ability to communicate about uncertainty and hope in encounters with cancer patients.

Methods: Physician participants will be randomly assigned in groups (n = 3/group) to a 30-hour CST program (experimental group) or to a waiting list (control group). The training program will include learner-centered, skills-focused, practice-oriented techniques. Training efficacy is assessed in the context of an encounter with a simulated advanced stage cancer patient at baseline and after the CST for the experimental group, and after four months for the waiting-list group. Efficacy assessments will include communicational, psychological and physiological measures. Group-by-time effects will be analyzed using a generalized estimating equation (GEE). A power analysis indicated that a sample size of 60 (30 experimental and 30 control) participants will be sufficient to detect effects.

Discussion: The current study will aid in the development of effective CST programs to improve physician ability to communicate about uncertainty and hope in encounters with cancer patients.


Options:
A: Physicians' acquisition of communication skills addressing uncertainty and hope in encounters with a simulated advanced stage cancer patient through validated tools and questionnaires (4 months)
B: Patient and family ratings on the "End-of-Life domain" of the Quality of Communication Questionaire (QOC) (4/1/2007-3/31/2012)
C: Change in uptake of shared decision-making from the patients' perspective (All clinics: baseline, 8 months, 16 months, 24 months)
D: Mean Patient-centered Communication in Advanced Cancer Score (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study 200622: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Adolescent and Adult Subjects With Severe Hypereosinophilic Syndrome
Brief Summary: Mepolizumab is a humanized monoclonal antibody. In conditions where eosinophilia is considered to play an important part in the pathology, including eosinophilic asthma, HES, and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood eosinophil counts is observed in association with mepolizumab administration, with concomitant clinical improvement. This is a 32-week treatment period, randomized, double-blind, placebo-controlled, parallel group, multicentre study of mepolizumab in adolescent and adult subjects with severe HES receiving standard of care (SoC) therapy. This study will demonstrate the efficacy of mepolizumab compared with placebo based on maintenance of control of HES symptoms during the treatment period. The study will comprise of a screening period of up to approximately 4 weeks followed by a 32-Week study treatment period (subjects will be randomized 1:1 to placebo or mepolizumab) and up to 8-week additional follow-up period (12 weeks after the last dose of study treatment).


Options:
A: Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis (Throughout the study); Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis. (Throughout the study)
B: The prednisone-sparing effect of SB-240563 versus placebo as; indicated by the absolute and percentage dose reduction possible without a clinical exacerbation (as measured by the Juniper ACQ in patients with asthma or by Likert symptom scores +/- FEV1 in patients with eosinophilic bronchitis without asthma).
C: Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period (Up to Week 32)
D: Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control (Week 28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Background: Over 39% of approximately 3,000 doctors (The British Medical Association quarterly survey, 2015) admitted to frequently feeling drained, exhausted, overloaded, tired, low and lacking energy. Such occupational distress may link to psychological and physical difficulties in doctors and have negative outcomes for organization and patients. The aim of the current study is to investigate the impact of an induction programme on occupational distress of doctors.

Methods/design: Doctors will be invited to take part in an online research. Participants will be randomly assigned to the experimental and control groups. Participants in the experimental groups will complete one of the induction topics (about stress at work). Before and after an induction programme participants will be asked to fill in an online survey about their current occupational distress and organizational well-being.

Discussion: The investigators expect that doctors' psychological, physiological and organizational well-being will improve after an induction programme which should serve as a resource for better doctor's own health understanding.


Options:
A: The Anxiety Disorder Scale (A week); The Grief Inventory (A week); The Coping Mechanisms Scale (A week); The Psychiatric Morbidity Scale (A week); The Physical Symptoms Scale (A week); The Insomnia Scale (A week); The Binge Eating Scale (A week); The Burnout Inventory (A week); Alcohol use (A week); Drug use (A week)
B: Return to work (at 6, 12, 24 and 60 months)
C: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
D: The primary outcome variables are mental distress (GHQ12, SCL5 and MBI), student stress (PMSS) and subsequent work stress, subjective wellbeing (SWB), empathy (JPSE), mindfulness (FFMS) (9 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Background: Over 39% of approximately 3,000 doctors (The British Medical Association quarterly survey, 2015) admitted to frequently feeling drained, exhausted, overloaded, tired, low and lacking energy. Such occupational distress may link to psychological and physical difficulties in doctors and have negative outcomes for organization and patients. The aim of the current study is to investigate the impact of an induction programme on occupational distress of doctors.

Methods/design: Doctors will be invited to take part in an online research. Participants will be randomly assigned to the experimental and control groups. Participants in the experimental groups will complete one of the induction topics (about stress at work). Before and after an induction programme participants will be asked to fill in an online survey about their current occupational distress and organizational well-being.

Discussion: The investigators expect that doctors' psychological, physiological and organizational well-being will improve after an induction programme which should serve as a resource for better doctor's own health understanding.


Options:
A: The Anxiety Disorder Scale (A week); The Grief Inventory (A week); The Coping Mechanisms Scale (A week); The Psychiatric Morbidity Scale (A week); The Physical Symptoms Scale (A week); The Insomnia Scale (A week); The Binge Eating Scale (A week); The Burnout Inventory (A week); Alcohol use (A week); Drug use (A week)
B: Stress Mindset Measure - General (SMM-G) (Change from Baseline SMM-G score at 6-months post CAR Training)
C: level of depression (Baseline to 3 months)
D: Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed. (Change from Baseline up to 1 year); Perceived Stress Scale, "change" is being assessed. (Change from Baseline up to 1 year); Resilience Scale for Adults, "change" is being assessed. (Change from Baseline up to 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin, CTEP-Supplied Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin and CTEP-Supplied Bevacizumab in Platinum Resistant Ovarian Cancer
Brief Summary: This phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). Chemotherapy drugs, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.


Options:
A: Radiographic imaging and clinical evaluation will be used for tumor assessment (every 6 weeks)
B: N/A
C: Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens (Up to 28 days); Progression Free Survival (PFS) (Phase II) (From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years); PFS (Phase III) (From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years.); Overall Survival (OS) (Phase III) (From study enrollment to the date of death regardless of the cause, assessed up to 5 years)
D: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin, CTEP-Supplied Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin and CTEP-Supplied Bevacizumab in Platinum Resistant Ovarian Cancer
Brief Summary: This phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). Chemotherapy drugs, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.


Options:
A: ORR (Up to 2 years); PFS (Up to 2 years)
B: Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab (Up to 37 months)
C: Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens (Up to 28 days); Progression Free Survival (PFS) (Phase II) (From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years); PFS (Phase III) (From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years.); Overall Survival (OS) (Phase III) (From study enrollment to the date of death regardless of the cause, assessed up to 5 years)
D: Progression-Free-Survival (2 years)

Answer: C