TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Does The Combined Use Of Local And Intravenous Tranexamic Acid Offer Better Surgical Field Quality During Functional Endoscopic Sinus Surgery? A Placebo-Controlled Clinical Trial
Brief Summary: Functional Endoscopic Sinus surgery (FESS) is a surgery done for chronic rhinosinusitis after failure of medical treatment. Intraoperative bleeding poses a challenge to both the surgeon and anaesthetist. Although blood loss is not massive during FESS, bleeding may obscure the surgical field prolonging the time of surgery or even leading to incompletion of the surgery.

Different methods have been used to improve the surgical field but none without side effects. The use of diathermy carries the risk of local tissue damage with the risk of subsequent bleeding. Local vasoconstrictors carry the risk of systemic absorption. Induced hypotension may not be suitable for all patients; besides, this may necessitates the use of more anaestheic drugs with their associated side effects. In addition, none of theses methods have provided ideal surgical field for the surgeon.1-3 Tranexamic acid, an antifibrinolytic agent, has been used to decrease surgical field bleeding in different surgeries showing effectiveness in its topical, oral and intravenous use.4-6 The aim of this study is to evaluate the effectiveness of local, intravenous and combined use of tranexamic acid in improving the surgical field quality during functional endoscopic sinus surgery.


Options:
A: The Wormald grading scale, this is a validated instrument used to assess intraoperative bleeding during video endoscopy sinus surgery. (Intraoperatively (as infusion of tranexamic acid or placebo is being infused))
B: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)
C: bleeding during surgery (time of surgery)
D: Intraoperative Visual Field Assessment (Performed intraoperatively at the end of surgical case)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Double-blind, Randomised, Placebo - Controlled Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Inhaled Esketamine in Subject With Treatment-resistant Bipolar Depression
Brief Summary: The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD). The study is to determine the efficacy and dose response of three Esketamine doses, compared with placebo.


Options:
A: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. (60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)
B: Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 0 to week 8 of the study); Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 9 to week 16 of the study); Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 0 to week 8 of the study); Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 9 to week 16 of the study)
C: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 14 (Day 1 and Day 14)
D: To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score (Baseline to week 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Double-blind, Randomised, Placebo - Controlled Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Inhaled Esketamine in Subject With Treatment-resistant Bipolar Depression
Brief Summary: The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD). The study is to determine the efficacy and dose response of three Esketamine doses, compared with placebo.


Options:
A: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 of Double- Blind Induction Phase- Mixed- Effects Model Using Repeated Measures (MMRM) Analysis (Baseline up to Day 28 of Double-blind Induction Phase); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis (Baseline up to Double-blind Endpoint (Day 28))
B: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 14 (Day 1 and Day 14)
C: MADRS Score - Baseline (Baseline); MADRS Score - Day 1 Following Intervention (Day 1)
D: Change in depressive symptoms (After 4th treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.
Brief Summary: A registerbased RCT will investigate whether arthroplasty can decrease the reoperation rate compared to internal fixation for patients with an undisplaced femoral neck fracture (Garden I-II).


Options:
A: Number of Participants With Revision Surgery (Measured 2 years after original surgery)
B: Harris hip score (2 years)
C: Hip related complication rate (2 years); Health-related Quality of Life (2 years)
D: Composite variable comprising reoperation rate and mortality (1 to 2-year post-surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Zambia Common Elements Treatment Approach Pilot Study
Brief Summary: This is a randomized controlled trial (RCT) evaluating the effectiveness of an alcohol brief intervention alone compared to the brief intervention plus an evidence-based psychotherapy (CETA) in reducing alcohol misuse and co-occurring mental health problems among persons with HIV in Zambia.


Options:
A: Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline. (Baseline and 6 months post-baseline)
B: Change in level of aggressive behaviour in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, sub-scale "Aggressive behaviour" (with 19 items (CBCL ½ - 5) and 18 items (CBCL 6-18), continuous sub-scale score (pre: Jan/Feb 2021; post: approx. 4 months after pre assessment (May/June 2021); follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)); Change in prevalence of Externalising Disorders in Children (MINI-KID), binary total score (pre: Jan/Feb 2021; post: approx. 4 months after pre assessment (May/June 2021); follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)); Change in Parent Daily Ratings (PDR): oppositional and aggressive sub scale (12 items), continuous sub-scale score (PLH group: after the first, third and fifth session. lecture: after the lecture, 2 and 4 weeks later)
C: Age-appropriate Social-Emotional Development of Children Under 2 Years (6 months post-intervention); Maternal Depression/Anxiety (6 months post-intervention)
D: Recovery from Common Mental Disorder (defined by ICD10) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Zambia Common Elements Treatment Approach Pilot Study
Brief Summary: This is a randomized controlled trial (RCT) evaluating the effectiveness of an alcohol brief intervention alone compared to the brief intervention plus an evidence-based psychotherapy (CETA) in reducing alcohol misuse and co-occurring mental health problems among persons with HIV in Zambia.


Options:
A: Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline. (Baseline and 6 months post-baseline)
B: Alcohol: change in mean number of heavy drinking days in last month of study period compared with baseline (6 months); TB: successful treatment vs. non-successful treatment as defined by the WHO (6 months)
C: Change in violence against women as measured by Severity of Violence Against Women Scale (SVAWS) (Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)
D: Alcohol use (12 months); HIV viral load (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Systematic Case Series Study Investigating the Effectiveness of Eye Movement Desensitization Reprocessing (EMDR) in the Treatment of Childhood Sexual Abuse in Adolescents and Adult Survivors
Brief Summary: This study investigates the effectiveness of EMDR for survivors of childhood sexual abuse. All participants will undertake a standard course of EMDR via the National Heath Service program, alongside a number of questionnaires and a follow-up interview.


Options:
A: Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores (2 weeks post-treatment)
B: Change in Pittsburgh Sleep Quality Index total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU); Change in Modified PTSD Symptom Scale - Self Report total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU)
C: Impact of Events Scale-Revised 'IESR' (Change from Baseline PTSD symptomology at up to 5 months); The Psychology Experiment Building Language 'PEBL' Test (Change from Baseline neuropsychological functioning at up to 5 months); Generalized Anxiety Disorder 7 (GAD-7) Scale (Change from Baseline anxiety levels at up to 5 months); Patient Health Questionnaire 9 (PHQ-9) Scale (Change from Baseline depression levels at up to 5 months); Weekly Problems Rating Scale (Change from Baseline emotional and behavioural functioning at up to 5 months); Rosenberg Self-Esteem Scale 'RSES' (Change from Baseline levels of self-worth at up to 5 months); The Valued Living Questionnaire 'VLQ' (Change from Baseline quality of life issues at up to 5 months)
D: PTSD (Before session, middle, end, one year follow-up, 18 month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Systematic Case Series Study Investigating the Effectiveness of Eye Movement Desensitization Reprocessing (EMDR) in the Treatment of Childhood Sexual Abuse in Adolescents and Adult Survivors
Brief Summary: This study investigates the effectiveness of EMDR for survivors of childhood sexual abuse. All participants will undertake a standard course of EMDR via the National Heath Service program, alongside a number of questionnaires and a follow-up interview.


Options:
A: Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention (Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).); PTSD Symptom Checklist-5 (PCL-5): Change in Mean Total Score From Baseline to 3-month Post-intervention (Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).)
B: Sleep Latency (SL) (After 8 weeks of study participation); Minutes of Wake After Sleep Onset (WASO) (After 8 weeks of study participation); Sleep Efficiency (SE) (After 8 weeks of study participation)
C: Impact of Events Scale-Revised 'IESR' (Change from Baseline PTSD symptomology at up to 5 months); The Psychology Experiment Building Language 'PEBL' Test (Change from Baseline neuropsychological functioning at up to 5 months); Generalized Anxiety Disorder 7 (GAD-7) Scale (Change from Baseline anxiety levels at up to 5 months); Patient Health Questionnaire 9 (PHQ-9) Scale (Change from Baseline depression levels at up to 5 months); Weekly Problems Rating Scale (Change from Baseline emotional and behavioural functioning at up to 5 months); Rosenberg Self-Esteem Scale 'RSES' (Change from Baseline levels of self-worth at up to 5 months); The Valued Living Questionnaire 'VLQ' (Change from Baseline quality of life issues at up to 5 months)
D: Severity of mental health symptoms (previous 4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: 2018 Intern Health Study Micro-randomized Trial: Developing a Mobile Health App to Improve Mental Health and Maintain Healthy Behaviors During the Internship Year
Brief Summary: The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.


Options:
A: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (Baseline and after 4, 8 weeks later)
B: change in self reported Stress symptoms (Baseline, 1 month, 3 months)
C: Average daily mood (7 days); Patient Health Questionnaire-9 (PHQ-9) (4 months)
D: Stress Mindset Measure - General (SMM-G) (Change from Baseline SMM-G score at 6-months post CAR Training)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Methods for Reducing Obesity Risk in Parents and Children: A Randomized Trial
Brief Summary: The purpose of this study is to test the efficacy of an innovative 6-month smartphone-delivered intervention using simplified monitoring of dietary intake compared to a smartphone-delivered intervention with standard calorie monitoring among parents with overweight or obesity.


Options:
A: Percent weight loss: objective (Baseline, 6 Months); Weight (Baseline, 6 Months)
B: Percent Change in Body Weight From Baseline to 12 Weeks (12 weeks)
C: Mean Change in Weight by Randomized Group (Observed means from baseline weight and at 6 months)
D: Weight loss (3 months, 6 months, 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (The Nudge Study)
Brief Summary: The study plans to learn if sending different text messages, serving as reminders or encouragement, may help patients take their medication more often if they have had trouble keeping up with their medicines.


Options:
A: Medication Adherence (12 months after intervention); Mean Proportion of Days Covered Relative to Usual Care (12 months)
B: systolic blood pressure (change from baseline to 12-month of follow-up)
C: Combined adherence endpoint (at Visit 2 (follow-up visit after 3 months of intervention period))
D: The evaluation of the effect of multifaceted intervention compared to usual outpatient care on the primary endpoint will be performed using the Student's t-Student test of the log ratio of NT-proBNP levels at 6 months baseline. (six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (The Nudge Study)
Brief Summary: The study plans to learn if sending different text messages, serving as reminders or encouragement, may help patients take their medication more often if they have had trouble keeping up with their medicines.


Options:
A: The proportion of subjects who attain the LDL-C levels set as targets by the Guidelines for Management of Dyslipidaemias and CVR (24 months)
B: MEMS Adherence (12 months follow up)
C: Primary composite outcome (4 years)
D: Medication Adherence (12 months after intervention); Mean Proportion of Days Covered Relative to Usual Care (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Additional Core Stability Exercises on Improving Dynamic Sitting Balance, Trunk Control and Functional Rehabilitation for Subacute Stroke Patients: A Randomized Controlled Trial
Brief Summary: This study assess the effectiveness of core stability exercises performed in subacute phase of stroke. Half of participants will receive conventional physiotherapy, while the other half will receive core stability exercises and core stability exercises plus transcutaneous electrical nerve stimulation (TENS).


Options:
A: Subjective Index of Physical and Social Outcome (SIPSO) (Change from baseline to 3 months.); Nottingham Extended Activities of Daily Living (NEADL) (Change from baseline to 3 months.)
B: Change in Upper Extremity Fugl Meyer Assessment (6 weeks from baseline); Percentage of Sessions With Adverse Events (Post treatment (6 weeks from baseline).)
C: Dynamic sitting balance and trunk control (Change from Baseline at week 5); Stepping (Change from Baseline at week 5)
D: Ankle Dorsiflexion Angle. Change From Baseline in Ankle Dorsiflexion Angle During the Swing Phase of Gait (Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial
Brief Summary: The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.


Options:
A: Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours (48 hours)
B: latency period interval between time of tocolysis and delivery (24 hours up to 7 days)
C: Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation (4 years)
D: Perinatal morti-morbidity (Up to discharge from hospital, with a maximum of 24 weeks after birth.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Multicenter, Open-Label, Pilot Study to Investigate Medication Adherence & Patient Reported Symptom Occurrence & Interference w/ Daily Life Comparing Envarsus XR® & Immediate Release Tacrolimus in Adult Renal Transplant Recipients (SIMPLE)
Brief Summary: The purpose of this study is to compare once-daily tacrolimus extended-release (Envarsus XR®) to twice-daily immediate release tacrolimus to find out if people taking tacrolimus extended release (Envarsus XR®) report fewer side effects, increased medication compliance and higher scores on quality of life assessments compared to people taking twice daily tacrolimus immediate release.


Options:
A: Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients? (2013)
B: The primary objective of this study is to compare tacrolimus formulations (Envarsus XR® versus twice a day tacrolimus) based on the difference in mean Calcineurin Inhibitor-Related Symptoms (CIRS) severity score. (12 months)
C: 12-week immunosuppression medication adherence (12 weeks)
D: Kidney recipients'knowledge level (7-8 weeks post kidney transplantation); Kidney recipients'knowledge level (6 months post kidney transplantation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comprehensive Health Informatics Engagement Framework for Pulmonary Rehab
Brief Summary: Previous studies clearly established clinical benefits of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease however uptake and completion rate of pulmonary rehabilitation programs by these patients is limited by multiple barriers. The goal of this project to systematically evaluate impact of Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) in a randomized controlled trial. The main hypothesis is that CHIEF-PR will result in significantly higher rates of completion of a comprehensive pulmonary rehabilitation program.


Options:
A: Dyspnea with ADL (3, 6, and 12 months); Exercise and functional performance (3, 6, and 12 months); Exercise adherence (3, 6, and 12 months); Acute COPD exacerbations (3, 6, and 12 months)
B: 6MWT -12 weeks (12 weeks afte baseline)
C: Percentage of patients who completed the program (3 months)
D: Re-hospitalizations (During the 30days after discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comprehensive Health Informatics Engagement Framework for Pulmonary Rehab
Brief Summary: Previous studies clearly established clinical benefits of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease however uptake and completion rate of pulmonary rehabilitation programs by these patients is limited by multiple barriers. The goal of this project to systematically evaluate impact of Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) in a randomized controlled trial. The main hypothesis is that CHIEF-PR will result in significantly higher rates of completion of a comprehensive pulmonary rehabilitation program.


Options:
A: Combined number of hospitalizations and emergency department presentations (Two years)
B: Training time (3 month)
C: Percentage of patients who completed the program (3 months)
D: Treatment Adherence (10 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Register-based, Randomized, Controlled Trial Comparing Dapagliflozin with Metformin Treatment in Early Stage Type 2 Diabetes Patients by Assessing Mortality and Macro- and Microvascular Complications
Brief Summary: A real-world, nationwide, register-based, randomised trial (RRCT) comparing SGLT2 inhibitors with metformin as standard treatment in early typ 2 diabetes. An open-label trial addressing efficacy with respect to clinically important macro- and microvascular events.


Options:
A: Time to first occurence of a confirmed composite endpoint of death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer. (Time to first event during study period (for each patient 24-48 months, mean 36 months ))
B: Change from baseline in HbA1c at 24 weeks
C: Novel cardiovascular risk factors modification (2 years)
D: Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 Weeks)

Answer: A