TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
Brief Summary: Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma.

Secondary Objectives:

* To evaluate the safety and tolerability of dupilumab.
* To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life.
* To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.


Options:
A: Peak expiratory flow rate. (12 weeks)
B: Progression to Clinically Significant Lower Respiratory Tract Symptoms (14 days after initiation of APRIL therapy); OCELOT: Pediatric Respiratory Assessment Measure (36-72 hours after initiation of OCELOT therapy)
C: Symptom scoring (1 to 3 years of age); Duration in days of each asthmatic episode from randomisation start (1 to 3 years of age)
D: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population (Baseline to Week 52); Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population (Baseline, Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
Brief Summary: Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma.

Secondary Objectives:

* To evaluate the safety and tolerability of dupilumab.
* To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life.
* To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.


Options:
A: Mucosal thickness on CT scan (after 6 months of treatment)
B: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population (Baseline to Week 52); Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population (Baseline, Week 12)
C: Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (Baseline, Week 24); Change From Baseline at Week 24 in Nasal Polyp Score (Baseline, Week 24)
D: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Month 12); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Month 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
Brief Summary: Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma.

Secondary Objectives:

* To evaluate the safety and tolerability of dupilumab.
* To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life.
* To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.


Options:
A: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Month 12); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Month 12)
B: Mucosal thickness on CT scan (after 6 months of treatment)
C: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population (Baseline to Week 52); Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population (Baseline, Week 12)
D: Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (Baseline, Week 24); Change From Baseline at Week 24 in Nasal Polyp Score (Baseline, Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis
Brief Summary: For elective abdominal surgery preoperative administration of 8 mg dexamethasone reduces the incidents of postoperative nausea and vomiting (PONV). Whether preoperative administration of 8 mg dexamethasone reduces PONV for patients having acute abdominal surgery has not been established. The investigators wish to see if preoperative administration of 8 mg dexamethasone minimum 30 minutes prior to a diagnostic laparoscopy for suspected appendicitis will reduce the incidents of PONV by 50%. Of secondary interest the investigators want to see if 8 mg dexamethasone preoperative can reduce pain, reduce opioid consumption, postoperative fatigue, duration of time until resumption of work and resumption of normal daily activities, and enhanced the quality of recovery.


Options:
A: Postoperative nausea and vomiting (PONV) (24-32 hours postoperative)
B: Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively (within 24h after operation)
C: Rates of vomiting and retching (after surgery)
D: incidence and severity of postoperative nausea and vomiting (upto 2 days after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis
Brief Summary: For elective abdominal surgery preoperative administration of 8 mg dexamethasone reduces the incidents of postoperative nausea and vomiting (PONV). Whether preoperative administration of 8 mg dexamethasone reduces PONV for patients having acute abdominal surgery has not been established. The investigators wish to see if preoperative administration of 8 mg dexamethasone minimum 30 minutes prior to a diagnostic laparoscopy for suspected appendicitis will reduce the incidents of PONV by 50%. Of secondary interest the investigators want to see if 8 mg dexamethasone preoperative can reduce pain, reduce opioid consumption, postoperative fatigue, duration of time until resumption of work and resumption of normal daily activities, and enhanced the quality of recovery.


Options:
A: Evaluation of analgesic effect by 11-NRS scale (4th postoperative day)
B: Major Perioperative Morbidity (30 day after surgery)
C: Pain score by numeric rating scale (At 8 hours postoperatively)
D: Postoperative nausea and vomiting (PONV) (24-32 hours postoperative)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis
Brief Summary: For elective abdominal surgery preoperative administration of 8 mg dexamethasone reduces the incidents of postoperative nausea and vomiting (PONV). Whether preoperative administration of 8 mg dexamethasone reduces PONV for patients having acute abdominal surgery has not been established. The investigators wish to see if preoperative administration of 8 mg dexamethasone minimum 30 minutes prior to a diagnostic laparoscopy for suspected appendicitis will reduce the incidents of PONV by 50%. Of secondary interest the investigators want to see if 8 mg dexamethasone preoperative can reduce pain, reduce opioid consumption, postoperative fatigue, duration of time until resumption of work and resumption of normal daily activities, and enhanced the quality of recovery.


Options:
A: Pain score by numeric rating scale (At 8 hours postoperatively)
B: Major Perioperative Morbidity (30 day after surgery)
C: Postoperative nausea and vomiting (PONV) (24-32 hours postoperative)
D: Evaluation of analgesic effect by 11-NRS scale (4th postoperative day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
Brief Summary: The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.


Options:
A: The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke (From the time of randomization (Day 1) up to completion of the treatment phase (Month 6))
B: Percentage of Participants With Clinically Significant Bleeding (Up to Month 12)
C: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)
D: The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period (Approximately 6 months); The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period (Approximately 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'URSA SOFT CAP. (UDCA-003)' in fatigue patients with liver dysfunction


Options:
A: Grade of steatosis as judged by repeat biopsy (6 mo)
B: The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months. (baseline and 12 months)
C: Regression of white matter lesion load in terms of numbers and size in the brain (1 to 2 years)
D: Rate of subjects whose CIS score has improved under 76 at week 8 (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Child Protective Effects of Economic Strengthening and Child Rights Interventions Among Ultra-poor Families in Burkina Faso
Brief Summary: This study tests the effects of family-based economic empowerment intervention, alone and in combination with child rights sensitization component, on child protective outcomes among ultra-poor families in Nord Region, Burkina Faso.


Options:
A: Change in Child Protection (Baseline, 12 months, 24 months); Change in Exposure to Child Abuse (Baseline, 12 months, 24 months)
B: physical violence (Assessed at 10-week follow-up)
C: Change from baseline in Bayley III Language scale (Baseline and 11 months)
D: Change in Reach (implementation) (Change from Baseline in Reach at 12 months); Cost (Cost of implementing each arm will be calculated through study completion, an average of 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes
Brief Summary: The purpose of this study is to develop and test a series of booklets designed to assist smokers of tobacco cigarettes who are also using e-cigarettes (dual users) in quitting smoking and remaining smoke-free.


Options:
A: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
B: Rate of Smoking Abstinence (18 months & 24 months post study enrollment)
C: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
D: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes
Brief Summary: The purpose of this study is to develop and test a series of booklets designed to assist smokers of tobacco cigarettes who are also using e-cigarettes (dual users) in quitting smoking and remaining smoke-free.


Options:
A: Change in Metabolic Syndrome Prevalence (Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)
B: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 30 days after last dose of study treatment or up to Week 16); Number of Participants With Psychiatric Adverse Events (Baseline up to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) (Baseline to Week 12); Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) (Baseline to Week 24); Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase (Week 1 to Week 12 (Treatment phase)); Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase (Week 13 to Week 24 (Post treatment phase)); Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline (Bsl) to Week 12); Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline to Week 24); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 (Baseline, Week 1); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 (Baseline, Week 12); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 (Baseline, Week 24)
C: Rate of Smoking Abstinence (18 months & 24 months post study enrollment)
D: Smoking abstinence at 6 months after inclusion (yes/no) (6 months after inclusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes
Brief Summary: The purpose of this study is to develop and test a series of booklets designed to assist smokers of tobacco cigarettes who are also using e-cigarettes (dual users) in quitting smoking and remaining smoke-free.


Options:
A: Smoking abstinence at 6 months after inclusion (yes/no) (6 months after inclusion)
B: Number of Participants With Smoking Cessation (12 WEEK)
C: Rate of Smoking Abstinence (18 months & 24 months post study enrollment)
D: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes
Brief Summary: The purpose of this study is to develop and test a series of booklets designed to assist smokers of tobacco cigarettes who are also using e-cigarettes (dual users) in quitting smoking and remaining smoke-free.


Options:
A: Change in Weight (Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up); Change in the 6 minute walk test (Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up); Change in Days of Abstinence-Timeline follow back interview for tobacco smokers (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up); Change in Carbon Monoxide Level (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up)
B: Toxicant Exposure (6 weeks)
C: Continuous smoking abstinence rate (Weeks 9 to 12)
D: Rate of Smoking Abstinence (18 months & 24 months post study enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tampostat: A Low-cost, Self-regulating Tamponade for Management of Postpartum Hemorrhage in Bangladesh
Brief Summary: The purpose of the study is to evaluate the safety, feasibility and applicability of a new device 'Tampostat' in the management of primary postpartum hemorrhage and compare the efficacy of 'Tampostat' in terms of arresting primary PPH with that of the conventional condom catheter.


Options:
A: Safety of Tampostat as measured by number of serious adverse events in primary PPH management (2 months); Efficacy of Tampostat as measured by number of successful cases in arresting bleeding in Primary PPH (12 months); Comparison of the efficacy of Tampostat as measured by number of successful cases in arresting primary PPH and the time takes to arrest the bleeding with that of the condom catheter tamponade (12 months)
B: Maternal death due to PPH or invasive procedures due to PPH (After delivery and before discharge from facility (usually within 48 hours after delivery)); Treatment of postpartum infection among women diagnosed with PPH (Within 4 weeks after delivery)
C: Estimation of blood loss: (during the operation)
D: Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon. (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SystemCHANGE: An Intervention for Medication Adherence in Transplant Recipients
Brief Summary: With kidney transplant (KT) recipients as our exemplar population, our goal is to develop and test interventions that increase medication adherence (MA) in chronically ill adults. Among adult KT recipients, non-adherence to immunosuppressive medications (MNA) is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of KT patients experience MNA even though the problem is preventable. Adherence intervention studies have proven marginally effective for those with acute and chronic illnesses and ineffective for adult KT recipients. Using a randomized controlled trial design with an attention-control group, this R01 will test an innovative 6-month SystemCHANGE intervention to enhance immunosuppressive MA in adult non-adherent KT recipients. This intervention shows great promise for increasing MA with a large effect size of 1.4 in our pilot study. Grounded in the socio-ecological model, SystemCHANGE seeks to systematically improve MA behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-lead experiments to change and maintain behavior. The Medication Event Monitoring System cap, which contains microelectronics that record the date and time of the cap removal, will be used to measure MA. Persistence of the MA behavior change will be examined by evaluating the difference in MA between the two groups during the 6-month maintenance phase. Mediators and moderators of MA will be examined. Health outcomes will be compared and a cost-effectiveness analysis will be conducted.


Options:
A: medication adherence (5 months)
B: Medication Adherence Change from Baseline to 6 Months (6 months); Medication Adherence Change from 6 Months to 12 Months (12 months); Medication Adherence Change from Baseline to 12 Months (12)
C: basal assessment of adherence with immunosuppressive medication scale (12 months)
D: Occurrence of adverse events (composite endpoint) (at month 60)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: SystemCHANGE: An Intervention for Medication Adherence in Transplant Recipients
Brief Summary: With kidney transplant (KT) recipients as our exemplar population, our goal is to develop and test interventions that increase medication adherence (MA) in chronically ill adults. Among adult KT recipients, non-adherence to immunosuppressive medications (MNA) is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of KT patients experience MNA even though the problem is preventable. Adherence intervention studies have proven marginally effective for those with acute and chronic illnesses and ineffective for adult KT recipients. Using a randomized controlled trial design with an attention-control group, this R01 will test an innovative 6-month SystemCHANGE intervention to enhance immunosuppressive MA in adult non-adherent KT recipients. This intervention shows great promise for increasing MA with a large effect size of 1.4 in our pilot study. Grounded in the socio-ecological model, SystemCHANGE seeks to systematically improve MA behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-lead experiments to change and maintain behavior. The Medication Event Monitoring System cap, which contains microelectronics that record the date and time of the cap removal, will be used to measure MA. Persistence of the MA behavior change will be examined by evaluating the difference in MA between the two groups during the 6-month maintenance phase. Mediators and moderators of MA will be examined. Health outcomes will be compared and a cost-effectiveness analysis will be conducted.


Options:
A: Taking Adherence (12 months); Timing Adherence (12 months)
B: Medication Adherence Change from Baseline to 6 Months (6 months); Medication Adherence Change from 6 Months to 12 Months (12 months); Medication Adherence Change from Baseline to 12 Months (12)
C: Drug adherence (at 6 months after enrollment)
D: medication adherence (5 months)

Answer: B