TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
Brief Summary: Some individuals with autism spectrum disorders (ASD) also demonstrate irritability or aggression, which can interfere with functioning. The purpose of this pilot study is to test whether transdermal nicotine is effective for irritability and/or aggression in adults with ASD using a double-blind, placebo-controlled clinical trial. Subjects will participate in three visits. At the first visit, subjects are screened for eligibility and enrolled. Baseline measures include rating scales and a frustrative computerized task. They will then wear seven days of transdermal nicotine or placebo. Visit two is on day seven and the study measures are repeated, vital signs and side effects monitored. Subjects will return for a third and final visit on day 21 to repeat the study measures performed during visit two.


Options:
A: Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain (16 weeks)
B: Social Responsiveness Scale (SRS) Change (Completed at Baseline and Week 11); Social Responsiveness Scale (SRS) at Follow-Up (Completed at Week 22)
C: Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I) (Baseline and 7 days.)
D: Aberrant Behavior Checklist - Social Withdrawal Subscale (Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Brain Computer Interface and Brain-Controlled Stroke Rehabilitation Method Utilizing Electroencephalography in Hemiparetic and Hemiplegic Stroke Patients to Achieve Thought Control of Machines and a Better Understanding of Brain Function
Brief Summary: The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. This ultimate goal will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device.


Options:
A: Ten Meter Walk Test (10mWT) (Week 30)
B: Change in Fugl-Meyer Assessment Scale after training (1) up to 7 weeks, 2) 3 months after participants finish the training); Change in Modified Ashworth Scale after training (1) up to 7 weeks, 2) 3 months after participants finish the training)
C: Change in Action Research Arm Test (ARAT) Score (Baseline and 12 weeks)
D: Gait Velocity (6 months); Stroke Impact Scale (SIS) Composite Score (6 months); Device Related Serious Adverse Events (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis Among Very Low Birth Weight Infants With Formula-feeding
Brief Summary: The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.


Options:
A: NEC onset (6 weeks)
B: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)
C: Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). (6 months post-pullthrough); Severity of Clinical Episodes of HAEC (6 months)
D: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis Among Very Low Birth Weight Infants With Formula-feeding
Brief Summary: The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.


Options:
A: NEC onset (6 weeks)
B: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
C: To assess gut microbiome composition (meta genome sequencing) of preterm infants receiving probiotics versus preterm infants not receiving probiotics (4 time points: 7 days of age, 4 weeks of age, 4 months corrected age and 12 months corrected age)
D: Time to reach full feeds (First 40 days after birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis Among Very Low Birth Weight Infants With Formula-feeding
Brief Summary: The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.


Options:
A: Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). (6 months post-pullthrough); Severity of Clinical Episodes of HAEC (6 months)
B: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)
C: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
D: Time to reach full feeds (First 40 days after birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis Among Very Low Birth Weight Infants With Formula-feeding
Brief Summary: The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.


Options:
A: Time to reach full feeds (First 40 days after birth)
B: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
C: Human milk glycans (Change from day 2 to day 366)
D: Feeding tolerance (Change from Full Enteral Feeding (FEF) Day 1 (start of FEF defined as achieving 150ml/day/kg of enteral feeding and discontinuation of parenteral feeding) and FEF Day 21 (approximately 5 weeks after enrollment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis Among Very Low Birth Weight Infants With Formula-feeding
Brief Summary: The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.


Options:
A: Number of days alive and receiving full enteral feeding (birth to 28 days)
B: incidence of feeding intolerance (28 days); time to reach full enteral feedings sustained for 72 hours. (72 hours)
C: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
D: Time to reach full feeds (First 40 days after birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Development and Piloting of 'Power Up': a Tool for Young People with Internalising/emotional Disorders to Make Shared Decisions in Child and Adolescent Mental Health Services (CAMHS)
Brief Summary: Patients should be able to have a say in their care and treatment, but how this should work for children and young people with mental health difficulties is unknown. For example, how and when do young people want to be involved in decision making, and what is important to them, their parents/guardians and healthcare professionals? This project will address these questions and will develop a tool known as 'Power Up' to help young people with mental health difficulties make decisions about their own care and treatment.

This project will run for 24 months and will:

1. Understand the beliefs, experiences, and values of young people, their parents/guardians and clinicians around shared decision making (SDM) in mental health.
2. Use these responses to develop 'Power Up'; a tool to help young people make decisions about their care or treatment in mental health services.
3. Pilot 'Power 'Up' in child and adolescent mental health services to estimate the number of patients who would want to use Power Up and to see whether patients can be recruited and followed up with measures. The pilot study would investigate randomisation, see how clinicians cooperate, and identify barriers to collaboration and ways of overcoming these.

Forty five young people, parents and clinicians will be recruited for interviews and focus groups to inform tool development. Sixty young people aged 1116 will be recruited for the pilot/feasibility study. Measurements will be collected at baseline, session by session, and at the end of treatment.


Options:
A: Shared Decision Making Questionnaire (CollaboRATE) (Level of Shared Decision Making at end of treatment (this will be at approximately week 8))
B: Recruitment Rate (Up to one year from when the study starts enrolling participants)
C: Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation (6 months after inclusion)
D: Number of Participants Who Adhered to Physician Recommended Treatment (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Development and Piloting of 'Power Up': a Tool for Young People with Internalising/emotional Disorders to Make Shared Decisions in Child and Adolescent Mental Health Services (CAMHS)
Brief Summary: Patients should be able to have a say in their care and treatment, but how this should work for children and young people with mental health difficulties is unknown. For example, how and when do young people want to be involved in decision making, and what is important to them, their parents/guardians and healthcare professionals? This project will address these questions and will develop a tool known as 'Power Up' to help young people with mental health difficulties make decisions about their own care and treatment.

This project will run for 24 months and will:

1. Understand the beliefs, experiences, and values of young people, their parents/guardians and clinicians around shared decision making (SDM) in mental health.
2. Use these responses to develop 'Power Up'; a tool to help young people make decisions about their care or treatment in mental health services.
3. Pilot 'Power 'Up' in child and adolescent mental health services to estimate the number of patients who would want to use Power Up and to see whether patients can be recruited and followed up with measures. The pilot study would investigate randomisation, see how clinicians cooperate, and identify barriers to collaboration and ways of overcoming these.

Forty five young people, parents and clinicians will be recruited for interviews and focus groups to inform tool development. Sixty young people aged 1116 will be recruited for the pilot/feasibility study. Measurements will be collected at baseline, session by session, and at the end of treatment.


Options:
A: Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores (Follow-up assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Patient Version) (End-of-intervention Assessment (5 months)); Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version (Follow-up Assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Provider Version) (Follow-up Assessment (2 months)); Perceptions of Care Survey - Global Evaluation of Care Scale (PoC) (End-of-intervention Assessment (5 months)); Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version (End-of-intervention Assessment (5 months))
B: The choice of primary surgical treatment (1 year)
C: Shared Decision Making Questionnaire (CollaboRATE) (Level of Shared Decision Making at end of treatment (this will be at approximately week 8))
D: Number of Participants Who Used Dual Contraception or Safer Conception Method (Month 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adaptive Computerized COPD Exacerbation Self-management Support (ACCESS): A Randomized Controlled Trial
Brief Summary: Aim is to test the effect of ACCESS ("Adaptive Computerized COPD Exacerbation Self-management Support"), a software application designed to support patients with COPD in self-management of exacerbations.


Options:
A: 6 minute walk test (measured at week 8)
B: 6MWT -12 weeks (12 weeks afte baseline)
C: To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged with oxygen and/or home mechanical ventilation (HMV) with high risk of hospital readmission. (3 years)
D: Number of exacerbation-free weeks (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Comprehensive Cancer Screening Among Vulnerable Patients Using Patient Navigation as Part of a Population-Based Health IT System: A Randomized Control Trial
Brief Summary: Patient navigation (PN) has been shown to improve rates of cancer screening in vulnerable populations. Most cancer PN programs are located in community health centers and focus on a single cancer. The investigators will evaluate the impact of PN program on breast, cervical, and/or colorectal cancer screening in vulnerable patients receiving care in a large, academic, primary care network using a population-based IT system.


Options:
A: Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months. (Baseline, 6 months, and 12 months)
B: Patient-centered Outcome Measure = Self-reported Hunger (12 months follow-up); Medical Outcome Measure = Body Weight (12 months follow-up); Meal Satisfaction Yesterday (12 months follow-up); Feeling Full After Last Meal Yesterday (12 months follow-up)
C: Percentage of Cancer Screening Tests Completed - Intention to Treat (8 months); Percentage of Cancer Screening Tests Completed - As Treated (8 Months)
D: HbA1c (12month); Blood pressure (12 month); Lipid profile (12 months); quality of life (12month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Short Educational Video on OSA Patient Satisfaction, Knowledge and Outcomes
Brief Summary: The purpose of this study is to determine how satisfied patients are when undergoing an overnight polysomnogram (sleep study), what their knowledge about sleep apnea is, and what factors affect obstructive sleep apnea (OSA) treatment use.


Options:
A: Incidence of hypertension; Incidence of cardiovascular events
B: proportion using CPAP within 48-hours of stroke onset (72 hours)
C: CPAP Therapy Adherence (30 days post in-lab split night polysomnogram)
D: proportion of patients using Continuous Positive Airway Pressure for more than 3 hours per night in the 2 groups (CPAP use was evaluated for 4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double Blind, Placebo Controlled Study of the Safety, PK, and PD of Multiple Doses of ISIS 416858 (ISIS-FXI RX), Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis
Brief Summary: Evaluation of safety, tolerability, PK and PD of ISIS 416858 in patients with end-stage renal disease (ESRD) receiving chronic hemodialysis.


Options:
A: Prothrombin time (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis); Activated partial thromboplastin time (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis); Anti-Xa level (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis; 24 hours after administration of LMWH); Dialyser urea and creatinine clearances (At 15 mins after starting hemodialysis and 15 mins before the end of hemodialysis); Dialyser thrombus score (At the end of hemodialysis (8th hour))
B: Effect of citrate dialysate on acid base status in hemodialysis patients measured by pH, BEecf and Bicarbonate at the end of HD session. (32 weeks)
C: Assess the safety of the factor Xa inhibitor apixaban versus a vitamin-K antagonist phenprocoumon in patients with NVAF and ESKD on hemodialysis. (1-60 months)
D: Safety and Tolerability - evaluated by reviewing frequency and severity of Adverse events (including bleeding events) and use of concomitant medications, changes in vital signs and laboratory evaluations for all patients (For the PK Cohort: Patients will be followed for 72 days. For Cohorts A and B: Patients will be followed for 162 days.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness Improving Medication Adherence in Heart Transplant Management
Brief Summary: The purpose of this study is to improve medication adherence, engagement and support to heart transplant patients through implementation of a new clinical care programme conducted by the clinical pharmacy service in cooperation with the heart transplant team and supported by mobile health (mHealth).


Options:
A: Medication Adherence (six months)
B: Time to First Occurrence of Acute Rejection, Failure, Death (1 year post-transplant)
C: Medication adherence measured on validated scales and questionnaires (6 months)
D: Self-reported Medication Adherence From Baseline to 6 Months. (6 months post conversion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma
Brief Summary: The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary function testing, and effects on asthma control


Options:
A: 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation (FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period)
B: Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26 (26 weeks)
C: Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period (Baseline to 12 weeks)
D: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 26 weeks); Number of Participants Experiencing at Least One Asthma Exacerbation (From Day 1 up to 26 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma
Brief Summary: The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary function testing, and effects on asthma control


Options:
A: 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))
B: Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. (7 assessments within 12 month treatment period)
C: Time to First Serious Asthma Exacerbation (Up to 21 months)
D: Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26 (26 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism
Brief Summary: The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.


Options:
A: Event Free Survival (6 years)
B: Event free survival for all patients (January 2014); GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage) (January 2014)
C: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)
D: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) (Up to Day 180); Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) (From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism
Brief Summary: The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.


Options:
A: disease response (up to day 1 of cycle 6)
B: first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) (7 months)
C: DVT/TVE event rate (After 12 events and after 24 events or after 540 pts recruited)
D: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) (Up to Day 180); Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) (From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))

Answer: D