TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Refinement and Evaluation of a Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial)
Brief Summary: South Africa has one of the highest rates of violence towards women globally. However, little is known about how to prevent men's use of violence. The Sonke CHANGE Trial tests an intervention that targets men as individuals, groups, and community members in a peri-urban setting in South Africa. Eighteen neighborhoods will be randomly assigned to either the intervention condition or a control group. By speaking to men at baseline, 12 months, and 24 months, investigators will learn whether violence and other health behaviors shift over time. Alongside the trial, qualitative research will explore how the intervention took place and why participants may change attitudes or behaviors.


Options:
A: Change in PTSD symptom severity with the PSS-I the Post-traumatic Stress Disorder Scale- Interview (PSS-I) post-treatment at 6- and 12-month follow-up (8, 18 and 25- month follow-up); Change in Attraction to violence with the Appetitive Aggression Scale (AAS) post-treatment at 6- and 12-month follow-up (8, 18 and 25- month follow-up); Change in Methylation Pattern of the Glucocorticoid Receptor promoter region via saliva samples (8, 18 and 25- month follow-up); Change in Self-committed violence with the AAS offense list (8, 18 and 25- month follow-up); Influence of Social Acknowledgement with Social Acknowledgement Questionnaire (SAQ) (8, 18 and 25- month follow-up); Influence of drug abuse related to violence on number of offenses with the offense checklist (from the AAS) (8, 18 and 25- month follow-up); Change in Epigenetic Markers (methylation patterns) of violence in the androgen receptor promoter region via saliva samples (8, 18 and 25- month follow-up)
B: Change in intimate partner violence (12 months, 24 months)
C: Feasibility as assessed through the John Hopkins Implementation and Dissemination Science Scale (Immediately after the intervention); Acceptability as assessed through the John Hopkins Implementation and Dissemination Science Scale (Immediately after the intervention)
D: Patient Health Questionnaire (PHQ-9) (8 weeks); WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smart Walk: A Physical Activity Program for African American Women
Brief Summary: The purpose of this project is to test an 8-month, culturally relevant, Smartphone-delivered PA program to improve and maintain high physical levels and reduce cardiometabolic disease risk among obese AA women.


Options:
A: Weight (Baseline to 6-Months)
B: Change in physical activity from baseline to 8-months (three assessment periods: baseline, 4-months, and 8-months); Feasibility and acceptability of the Smartphone delivered physical activity program (4-months)
C: Change in Body Mass Index z-score (youth) (Baseline, 3 months, 6 months); Change in health behaviour knowledge (youth) (Baseline, 3 months, 6 months); Change in objective dietary behaviour (youth) (Baseline, 3 months, 6 months); Change in number of daily steps (youth) (Baseline, 3 months, 6 months); Change in screen behaviour (youth) (Baseline, 3 months, 6 months)
D: Fat mass (0, 3, and 12 months); Energy intake (0, 3 months); Body weight (0, 3, 12 months); Insulin resistance (HOMA-IR) (0, 3, 12 months); Glucose levels (0, 3,12 months); Glucose variability (0, 3,12 months); Sleep assessment (0, 3,12 months); Adherence (0, 3,12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-Celiac Wheat Sensitivity: Permanent or Transient Condition? A Follow-up Study
Brief Summary: Non-Celiac Gluten Sensitivity (NCGS) has been recently included among the gluten-related diseases. Patients suffering from NCGS are diagnosed after carefully excluding celiac disease (CD), and immunoglobulin E (IgE)-mediated wheat allergy. Then, in the absence of sensitive and specific diagnostic biomarkers for NCGS, a monitoring of the patient during elimination and re-introduction of wheat by a double-blind placebo controlled (DBPC) challenge method has been suggested as diagnostic hallmark. Some studies seem to suggest that wheat components other than gluten can cause the symptoms, and therefore the term "non-celiac wheat sensitivity" (NCWS) has been proposed instead of NCGS. While it is well known that CD is a long-life condition and a strict adherence to the gluten-free diet must be maintained, it is unknown whether this is valid for NCWS. On the year 2012, the researchers published a retrospective study, including 276 patients with irritable bowel syndrome (IBS)-like symptoms who had been diagnosed with NCWS using a DBPC challenge during a ten-years period (2001-2011). The present prospective study aimed to evaluate: A) how many of these patients are still following a wheat-free diet, and B) which percentage was still suffering from NCWS, diagnosed by DBPC wheat challenge, in a subgroup of that cohort.


Options:
A: How many patients were still following a gluten-free or a wheat-free diet (Between July and November 2016)
B: The changes in Montgomery-Åsberg Depression Rating Scale(MADRS) total score to measure the severity of depression symptoms (from the date of randomization until the end of the study up to 12 weeks); The changes in Beck Depression Inventory (BDI) total score to measure the severity of depression symptoms (from the date of randomization until the end of the study up to 12 weeks); The changes in Symptom Checklist-90 (SCL-90) total score to measure the severity of psychopathological impairment (from the date of randomization until the end of the study up to 12 weeks); The changes in the 36-Item Short Form Survey (SF-36) total score to measure the quality of life (from the date of randomization until the end of the study up to 12 weeks); The changes in the Perceived Stress Scale (PSS-10) total score to measure the stress levels (from the date of randomization until the end of the study up to 12 weeks)
C: Change in the presence and severity of overall and individual gastrointestinal symptoms (daily diary cards via a 100-mm VAS to score) (These will be assessed daily during baseline week (0), treatment week (1, 4, 7 and 10) and washout week (3, 6 and 9))
D: The extent of autistic symptoms based on the Autism Diagnostic Observation Schedule - 2 (ADOS-2) (Change over time - 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial
Brief Summary: This study evaluates if motivational interviewing sessions aiming to motivate recently discharged patients with either chronic obstructive pulmonary disease or congestive heart failure to be active in post-discharge self-management can reduce re-hospitalization rates.


Options:
A: Systolic Blood Pressure (12 months)
B: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)
C: Re-hospitalization (90 days)
D: Patients with confirmed DRA after discharge from the index hospitalisation (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial
Brief Summary: This study evaluates if motivational interviewing sessions aiming to motivate recently discharged patients with either chronic obstructive pulmonary disease or congestive heart failure to be active in post-discharge self-management can reduce re-hospitalization rates.


Options:
A: Change in HADS-A score from baseline to three months follow-up (Three months)
B: Number of unscheduled hospital days (up to 12 months)
C: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)
D: Re-hospitalization (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial
Brief Summary: This study evaluates if motivational interviewing sessions aiming to motivate recently discharged patients with either chronic obstructive pulmonary disease or congestive heart failure to be active in post-discharge self-management can reduce re-hospitalization rates.


Options:
A: Identifying new patient subtypes and endpoints for COPD (3 years)
B: 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)
C: Physical activity (Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)); Physical activity (Change between T1 and T2: 3 months follow up)
D: Re-hospitalization (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mid-term Effect of a Novel Sit-to-stand Workplace (ACTIVE OFFICE) on Cognitive and Physiological Parameters
Brief Summary: Prolonged sitting is a risk factor for cardiovascular and musculoskeletal diseases, diabetes, several types of cancer and all-cause mortality. In combination with static and awkward postures, the prevalence of musculoskeletal diseases can increase further. Although the implementation of sit-to-stand or active workstations can help to reduce sitting time, improve physical activity at work and promote health benefits, it might also lead to changes in cognitive functions such as productivity The purpose of this study is to evaluate the mid-term effect of a novel two desk sit-to-stand workplace on sitting time as well as physiological and cognitive parameters for healthy people of working age in comparison to their traditional workplace.


Options:
A: Change in objective measure of degree of physical activity (baseline, 12 weeks, 6 months)
B: Physical Activity (Measured 5 times over 13 months, for seven days each time. Time points = baseline, 1-2weeks, 3 months, 6 months and 12 months)
C: Daily sitting time (baseline and 23 weeks)
D: Change from control week and intervention week in total energy expenditure (TEE) (week 1 and week 2); Resting energy expenditure (REE) (Baseline (day 0)); Change from control week and intervention week in physical activity energy expenditure (PAEE) (week 1 and week 2); Change from control week and intervention week in daily time spent in sedentary (SB) (week 1 and week 2); Change from control week and intervention week in light (LIPA), moderate and vigorous (MVPA) intensity activities (week 1 and week 2); Change from control week and intervention week in number of breaks in sedentary time (BST) (week 1 and week 2); Change from control week and intervention week in time spent sitting (TSS) (week 1 and week 2); Change from control week and intervention week in time spent standing (TSst) (week 1 and week 2); Change from control week and intervention week in time spent walking (TSW) (week 1 and week 2); Change from control week and intervention week in number of steps (week 1 and week 2)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mid-term Effect of a Novel Sit-to-stand Workplace (ACTIVE OFFICE) on Cognitive and Physiological Parameters
Brief Summary: Prolonged sitting is a risk factor for cardiovascular and musculoskeletal diseases, diabetes, several types of cancer and all-cause mortality. In combination with static and awkward postures, the prevalence of musculoskeletal diseases can increase further. Although the implementation of sit-to-stand or active workstations can help to reduce sitting time, improve physical activity at work and promote health benefits, it might also lead to changes in cognitive functions such as productivity The purpose of this study is to evaluate the mid-term effect of a novel two desk sit-to-stand workplace on sitting time as well as physiological and cognitive parameters for healthy people of working age in comparison to their traditional workplace.


Options:
A: muscle strength (3 months); Aerobic capacity (3 months)
B: Weight loss (~1-2 years post baseline)
C: Daily sitting time (baseline and 23 weeks)
D: Change in Body Mass Index (BMI) (Baseline to 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mid-term Effect of a Novel Sit-to-stand Workplace (ACTIVE OFFICE) on Cognitive and Physiological Parameters
Brief Summary: Prolonged sitting is a risk factor for cardiovascular and musculoskeletal diseases, diabetes, several types of cancer and all-cause mortality. In combination with static and awkward postures, the prevalence of musculoskeletal diseases can increase further. Although the implementation of sit-to-stand or active workstations can help to reduce sitting time, improve physical activity at work and promote health benefits, it might also lead to changes in cognitive functions such as productivity The purpose of this study is to evaluate the mid-term effect of a novel two desk sit-to-stand workplace on sitting time as well as physiological and cognitive parameters for healthy people of working age in comparison to their traditional workplace.


Options:
A: duration of prolonged sitting (5 days)
B: Change in Occupational Physical Activity From Baseline to 16 Weeks (Baseline and 16 weeks)
C: Daily sitting time (baseline and 23 weeks)
D: Average steps per day (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Conventional and Ultrasound Guided Techniques of Radial Artery Cannulation in Different Hemodynamic Subsets: a Randomized Controlled Study
Brief Summary: Purpose Two techniques of radial artery cannulation, ultrasound guided (USG) and conventional method (CM) were compared to find the better technique in general and in different hemodynamic subsets of patients.

Method This is a prospective randomized, single center study of 100 patients. The details of the primary cannulation technique, number of attempts, time taken, failure and cross-over technique were recorded for three different hemodynamic subsets with Systolic blood pressure \<80 mm hg, 80-100 mm hg and \> 100 mm hg.


Options:
A: First pass success rate (1 year); Final/ultimate success rate of an intervention (1 year)
B: Number of Attempts (Immediately during procedure. (up to 30 minutes))
C: Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100) (1 year); Thumb and Forefinger Pinch Strength Test (1 year); Hand Grip Strength Test (1 month)
D: Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5) (Evaluations will occur up to 30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Conventional and Ultrasound Guided Techniques of Radial Artery Cannulation in Different Hemodynamic Subsets: a Randomized Controlled Study
Brief Summary: Purpose Two techniques of radial artery cannulation, ultrasound guided (USG) and conventional method (CM) were compared to find the better technique in general and in different hemodynamic subsets of patients.

Method This is a prospective randomized, single center study of 100 patients. The details of the primary cannulation technique, number of attempts, time taken, failure and cross-over technique were recorded for three different hemodynamic subsets with Systolic blood pressure \<80 mm hg, 80-100 mm hg and \> 100 mm hg.


Options:
A: Success rate (at first attempt, as average 5 min)
B: First pass success rate (1 year); Final/ultimate success rate of an intervention (1 year)
C: Duration of Use of Arterial Cannula (During Procedure)
D: Only one attempt at arterial puncture was necessary (yes/no) (Day 0 - end of procedure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Conventional and Ultrasound Guided Techniques of Radial Artery Cannulation in Different Hemodynamic Subsets: a Randomized Controlled Study
Brief Summary: Purpose Two techniques of radial artery cannulation, ultrasound guided (USG) and conventional method (CM) were compared to find the better technique in general and in different hemodynamic subsets of patients.

Method This is a prospective randomized, single center study of 100 patients. The details of the primary cannulation technique, number of attempts, time taken, failure and cross-over technique were recorded for three different hemodynamic subsets with Systolic blood pressure \<80 mm hg, 80-100 mm hg and \> 100 mm hg.


Options:
A: First pass success rate (1 year); Final/ultimate success rate of an intervention (1 year)
B: Only one attempt at arterial puncture was necessary (yes/no) (Day 0 - end of procedure)
C: Incidence of major vascular complications (up to 30 days post-procedure)
D: success rate of radial artery cathertrization (postoperate 72 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Swallowing Function, Oral Health, and Food Intake in Old Age
Brief Summary: The purpose of this study is to determine whether a specific rehabilitation program with oral screen used in an elderly population with dysphagia can improve elderly's swallowing capacity.


Options:
A: Change in plaque scores over course of trial (Three week in-hospital rehabilitation period)
B: Pneumonia (2.5 years)
C: Swallowing function (Baseline, 5 weeks and 6 months post-intervention)
D: Pneumonia (Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vaginal Hysterectomy Versus Laparoscopically Assisted Hysterectomy for Large Uteri ( A Pilot Randomized Clinical Trial)
Brief Summary: The investigators compare between Vaginal Hysterectomy and Laparoscopically assisted vaginal hysterectomy in cases of large uteri weighing more than 280 gm regarding operative and Postoperative outcomes


Options:
A: Insulin resistance (3 weeks)
B: Operative time of the procedure (Range from 90 minutes to 210 minutes)
C: To assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The pain score and morbidity associated with surgery will be noted. (1 year)
D: Safety of hysterectomy (1.1-31.12.2006)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.


Options:
A: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 (Week 12); Participants With IGA Mod 2011 0 or 1 at Week 12 (Week 12)
B: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (At Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16 (At Week 16)
C: The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) (Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]))
D: Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 (Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.


Options:
A: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)
B: Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16 (Week 16); Number of Participants Experiencing Adverse Events (Up to 72 weeks); Number of Particpants Discontinuing Study Treatment Due to Adverse Events (Up to 52 weeks)
C: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 (Week 12); Participants With IGA Mod 2011 0 or 1 at Week 12 (Week 12)
D: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.


Options:
A: Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52. (Baseline, Week 52)
B: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
C: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 (Week 12); Participants With IGA Mod 2011 0 or 1 at Week 12 (Week 12)
D: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.


Options:
A: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)
B: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)
C: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 (Week 12); Participants With IGA Mod 2011 0 or 1 at Week 12 (Week 12)
D: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 (Week 16)

Answer: C