TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Brief Summary: To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.


Options:
A: Proportion of patients willing to undertake cardiac rehabilitation following TAVR. (6 months)
B: Change in physical capacity (1,4,12 months)
C: chest x-ray mobility of the diaphragm (6 and 12 months)
D: All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure) (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatments for Fathers With Attention Deficit/Hyperactivity Disorder (ADHD) and Their At-Risk Children (Fathers Too)
Brief Summary: In contrast to mothers with Attention Deficit/Hyperactivity Disorder (ADHD), the impact of paternal ADHD in families and children with ADHD symptoms has not been studied, despite the prevalence of ADHD in males. Thus, the investigators do not know the feasibility, impact on treatment on the family and child, and effects of treating fathers relative to mothers with ADHD. Paternal ADHD is associated with negative parenting and child conduct problems.

The investigators hypothesize that successfully treating parental ADHD in fathers will have a beneficial effects on the family that will extend to the child. Specifically, the investigators believe that stimulant medication ((Lisdexamfetamine (LDX) or a different ADHD medication if poor response to LDX) with fathers will reduce father's ADHD symptoms and improve parenting. Effects of stimulant treatment of fathers will be compared to Behavioral Parent Training (BPT) on parenting, and paternal and child outcomes in fathers with ADHD who have children between the ages of 3 -8.

As in the investigator's previous work, the investigators will bank paternal and child DNA and RNA for later examination of pharmacogenetic and epigenetic effects (i.e. RNA) of stimulant response.


Options:
A: Number of days of use of cannabis (12 weeks)
B: Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR (Baseline to Month-2)
C: N/A
D: CGI -S - ADHD rating scale (Father) (Change from Screening at 8 weeks.); Conners Adult ADHD Rating Scale - Self Report (Father) (Change from Screening at 8 weeks.); Conners Other Report (about Father) (Change from Screening at 8 weeks); Barkley Functional Impairment Rating Scale (Father) (Change from Screening at 8 weeks.); Conners Parent (completed by parent about child) (Change form Screening at 8 weeks.); Conners Teacher Rating Scale (completed by teacher about child) (Change from Screening at 8 weeks.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatments for Fathers With Attention Deficit/Hyperactivity Disorder (ADHD) and Their At-Risk Children (Fathers Too)
Brief Summary: In contrast to mothers with Attention Deficit/Hyperactivity Disorder (ADHD), the impact of paternal ADHD in families and children with ADHD symptoms has not been studied, despite the prevalence of ADHD in males. Thus, the investigators do not know the feasibility, impact on treatment on the family and child, and effects of treating fathers relative to mothers with ADHD. Paternal ADHD is associated with negative parenting and child conduct problems.

The investigators hypothesize that successfully treating parental ADHD in fathers will have a beneficial effects on the family that will extend to the child. Specifically, the investigators believe that stimulant medication ((Lisdexamfetamine (LDX) or a different ADHD medication if poor response to LDX) with fathers will reduce father's ADHD symptoms and improve parenting. Effects of stimulant treatment of fathers will be compared to Behavioral Parent Training (BPT) on parenting, and paternal and child outcomes in fathers with ADHD who have children between the ages of 3 -8.

As in the investigator's previous work, the investigators will bank paternal and child DNA and RNA for later examination of pharmacogenetic and epigenetic effects (i.e. RNA) of stimulant response.


Options:
A: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)
B: Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) (Hour 4 of the of the Lab School Day during Double-Blind Assessment Period); Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) (Hour 4 of the Lab School Day During the Double-Blind Assessment Period)
C: CGI -S - ADHD rating scale (Father) (Change from Screening at 8 weeks.); Conners Adult ADHD Rating Scale - Self Report (Father) (Change from Screening at 8 weeks.); Conners Other Report (about Father) (Change from Screening at 8 weeks); Barkley Functional Impairment Rating Scale (Father) (Change from Screening at 8 weeks.); Conners Parent (completed by parent about child) (Change form Screening at 8 weeks.); Conners Teacher Rating Scale (completed by teacher about child) (Change from Screening at 8 weeks.)
D: Change in ADHD and ODD symptoms (Every week for six weeks); Change in attention, motor activity and executive functioning (The neuropsychological tests are administered once on each type of medication during the six week trial); Change in side-effects (Once every week through the six week trial)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatments for Fathers With Attention Deficit/Hyperactivity Disorder (ADHD) and Their At-Risk Children (Fathers Too)
Brief Summary: In contrast to mothers with Attention Deficit/Hyperactivity Disorder (ADHD), the impact of paternal ADHD in families and children with ADHD symptoms has not been studied, despite the prevalence of ADHD in males. Thus, the investigators do not know the feasibility, impact on treatment on the family and child, and effects of treating fathers relative to mothers with ADHD. Paternal ADHD is associated with negative parenting and child conduct problems.

The investigators hypothesize that successfully treating parental ADHD in fathers will have a beneficial effects on the family that will extend to the child. Specifically, the investigators believe that stimulant medication ((Lisdexamfetamine (LDX) or a different ADHD medication if poor response to LDX) with fathers will reduce father's ADHD symptoms and improve parenting. Effects of stimulant treatment of fathers will be compared to Behavioral Parent Training (BPT) on parenting, and paternal and child outcomes in fathers with ADHD who have children between the ages of 3 -8.

As in the investigator's previous work, the investigators will bank paternal and child DNA and RNA for later examination of pharmacogenetic and epigenetic effects (i.e. RNA) of stimulant response.


Options:
A: Number of days of use of cannabis (12 weeks)
B: Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment (Baseline 1 to End of Period 1 (Week 9)); Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment (Baseline 1 to End of Period 1 (Week 9)); Percentage of Participants With Treatment Failures During Period 3 (Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40)
C: Wender Reimherr Adult Attention Deficit Disorder Scale (Double-blind endpoints during MTS and placebo arms)
D: CGI -S - ADHD rating scale (Father) (Change from Screening at 8 weeks.); Conners Adult ADHD Rating Scale - Self Report (Father) (Change from Screening at 8 weeks.); Conners Other Report (about Father) (Change from Screening at 8 weeks); Barkley Functional Impairment Rating Scale (Father) (Change from Screening at 8 weeks.); Conners Parent (completed by parent about child) (Change form Screening at 8 weeks.); Conners Teacher Rating Scale (completed by teacher about child) (Change from Screening at 8 weeks.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Implementation Optimisation Intervention Aimed at Increasing Parent Engagement in HENRY, a Childhood Obesity Prevention Programme: a Cluster Randomised Controlled Trial
Brief Summary: This study will test whether parent engagement (recruitment, attendance) in a Childhood obesity prevention programme (HENRY) can be improved in local authorities randomised to receive an Optimisation intervention (in addition to standard HENRY) compared to those continuing to deliver the programme as standard.


Options:
A: Vegetable Flavor Acceptance [Infants' Intake] (6- to 10-month-old weaned infants (3 separate test days )); Taste Liking Ratings of Vegetable Flavors [Mothers]. (Monthly, 0.5 to 4.5 months); Vegetable Flavor Acceptance (Infants' Rate of Feeding) (6- to 10-month-old weaned infants (3 separate test days))
B: Number of parents engaging with the HENRY programme measured using Centre level process data (12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).)
C: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
D: Very low food security among children according to the U.S. Household Food Security Survey Module, 30-day reference period (Between 30 and 120 days after SEBTC benefits were issued)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Implementation Optimisation Intervention Aimed at Increasing Parent Engagement in HENRY, a Childhood Obesity Prevention Programme: a Cluster Randomised Controlled Trial
Brief Summary: This study will test whether parent engagement (recruitment, attendance) in a Childhood obesity prevention programme (HENRY) can be improved in local authorities randomised to receive an Optimisation intervention (in addition to standard HENRY) compared to those continuing to deliver the programme as standard.


Options:
A: Mother BMI (Baseline, 6 months, 12 months); Infant Weight (Baseline, 6 months, 12 months)
B: Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment (0, 3 month)
C: Proportion of small consumers of fruits and vegetables among children (12 months)
D: Number of parents engaging with the HENRY programme measured using Centre level process data (12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Implementation Optimisation Intervention Aimed at Increasing Parent Engagement in HENRY, a Childhood Obesity Prevention Programme: a Cluster Randomised Controlled Trial
Brief Summary: This study will test whether parent engagement (recruitment, attendance) in a Childhood obesity prevention programme (HENRY) can be improved in local authorities randomised to receive an Optimisation intervention (in addition to standard HENRY) compared to those continuing to deliver the programme as standard.


Options:
A: Change in child adiposity from baseline measured via BMI z-score (Enrollment, 6 months, 12 months, 18 months, 24 months); Change in adult adiposity from baseline measured via BMI (Enrollment, 12 months, 24 months)
B: Number of parents engaging with the HENRY programme measured using Centre level process data (12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).)
C: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
D: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Implementation Optimisation Intervention Aimed at Increasing Parent Engagement in HENRY, a Childhood Obesity Prevention Programme: a Cluster Randomised Controlled Trial
Brief Summary: This study will test whether parent engagement (recruitment, attendance) in a Childhood obesity prevention programme (HENRY) can be improved in local authorities randomised to receive an Optimisation intervention (in addition to standard HENRY) compared to those continuing to deliver the programme as standard.


Options:
A: Nighttime self-regulated sleep duration at 6, 12 and 24 months of age (Up to 24 months)
B: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
C: Number of parents engaging with the HENRY programme measured using Centre level process data (12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).)
D: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Implementation Optimisation Intervention Aimed at Increasing Parent Engagement in HENRY, a Childhood Obesity Prevention Programme: a Cluster Randomised Controlled Trial
Brief Summary: This study will test whether parent engagement (recruitment, attendance) in a Childhood obesity prevention programme (HENRY) can be improved in local authorities randomised to receive an Optimisation intervention (in addition to standard HENRY) compared to those continuing to deliver the programme as standard.


Options:
A: Change from baseline in energy dense food consumption at 12 months (12 months); Change from baseline in nutrient dense food consumption at 12 months (12 months)
B: Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment (0, 3 month)
C: Number of parents engaging with the HENRY programme measured using Centre level process data (12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).)
D: Vitamin D plasma concentrations (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 2-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 100/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 100/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) IN PATIENTS WITH ASTHMA UNCONTROLLED ON MEDIUM DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WITH LONG ACTING ß2 AGONISTS
Brief Summary: The purpose of this study is to evaluate the superiority of CHF 5993 100/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronum bromide) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate), in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.


Options:
A: Number of Patients With Drug-related Adverse Events (after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409)
B: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)
C: Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period (Day 28 of the relevant treatment period (up to Study Day 112))
D: Pre-dose FEV1 (Forced Expiratory Volume in the first second) (at Week 26); Reduction of moderate and severe asthma exacerbations rate (Week 0 to Week 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 3-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 200/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 200/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) ALONE OR ON TOP OF OPEN-LABEL TIOTROPIUM 2.5 µg RESPIMAT® IN PATIENTS WITH ASTHMA UNCONTROLLED ON HIGH DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WITH LONG-ACTING ß2-AGONISTS
Brief Summary: The purpose of this study is to evaluate the superiority of CHF 5993 200/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) versus CHF 1535 200/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate) and to compare the effect of CHF 5993 200/6/12.5 µg pMDI vs CHF 5993 200/6/12.5 µg plus open-label Tiotropium 2.5µg, in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.


Options:
A: Pre-dose FEV1 (Forced Expiratory Volume in the first second) (Week 26); Reduction of moderate and severe asthma exacerbations rate (Week 0 to Week 52)
B: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
C: Percentage of subjects who have an asthma control test (ACT) total score of >=20 (Up to 24 weeks); Percentage of subjects with an increase from Baseline of >=3 in ACT total score (Baseline and up to 24 weeks)
D: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The ENRGISE (ENabling Reduction of Low-Grade Inflammation in SEniors) Pilot Study
Brief Summary: ENRGISE Pilot Study will test the ability of anti-inflammatory interventions for preventing major mobility disability by improving or preserving walking ability.


Options:
A: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
B: Changes in the Interleukin-6 Level Between Groups (Changes from baseline to month 12); Number of Participants Experiencing Major Mobility Disability (12 months)
C: N/A
D: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Study of Combined ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT
Brief Summary: The purpose of this study is to determine the efficacy and safety of combined ATG （antithymocyte globulin ） regimen for aGVHD(acute graft-versus-host disease ) prophylaxis in matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).


Options:
A: Primary: Early treatment failure defined by the occurrence of severe acute GvHD (°III-°IV) or early mortality within 100 days post transplantation. (100 days)
B: Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups (180 days after HCT)
C: Number of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria) (three years)
D: Incidence of Epstein-Barr virus(EBV) viremia (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of General vs Local Anesthesia on Neurological Function in Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment
Brief Summary: Recent observational studies have found an association between general anaesthesia and increased post-operative mortality in acute ischemic stroke patients undergoing endovascular treatment. It is unknown whether there is a causal relationship in this observation. The investigators are performing a large randomised trial of general versus local anaesthesia to definitively answer the question of whether anaesthetic type alters perioperative outcome.


Options:
A: Number of Participants With a Score of 5 or 6 on the Modified Rankin Scale (mRS) (90 days)
B: composite of functional independence at 3 months and absence of medical complication occurring by day 7 after endovascular therapy for anterior circulation AIS (Day 90)
C: modified Rankin score (post-procedural 30 days)
D: National Institutes of Health Stroke Scale (NIHSS) after 24 hours (24 hours)

Answer: C