TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management
Brief Summary: The investigators aim to study the clinical efficacy of a mobile health application, AsthmaCare, and it's impact on long term health outcomes for asthma. AsthmaCare is a novel application developed by members of the study team that was previously studied in a pilot study of 21 children/teenagers 9-16 years old. During the 30 day pilot study, there was universal usage and acceptance by all participants of this novel form of technology and asthma management. This current study aims to measure clinical outcomes for users of the app.


Options:
A: Time to Next Asthma or COPD Exacerbation up to 182 Days (182 days)
B: Night Wakenings Due to Asthma (To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up).)
C: Number of Emergency Room Visits Secondary to Asthma Exacerbation (6 months)
D: Change from Baseline Asthma Control to 3 Month Asthma Control (Post-Refinement Baseline, 3 Months); Change from Baseline Asthma Control to 3 Month Asthma Control (Post-Refinement Baseline, 4 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Long-axis/In-plane and Short-axis/Out-of-plane Methods During the Ultrasound-guided Arterial Cannulation in Pediatric Patients
Brief Summary: Investigators designed a prospective randomized controlled study to compare the long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial catheterization in pediatric patients younger than 5 years old.


Options:
A: Incidence of major vascular complications (up to 30 days post-procedure)
B: Arterial catheterization time (Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average of 200 seconds)
C: Number of Attempts (Immediately during procedure. (up to 30 minutes))
D: Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5) (Evaluations will occur up to 30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Long-axis/In-plane and Short-axis/Out-of-plane Methods During the Ultrasound-guided Arterial Cannulation in Pediatric Patients
Brief Summary: Investigators designed a prospective randomized controlled study to compare the long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial catheterization in pediatric patients younger than 5 years old.


Options:
A: Number of Attempts (Immediately during procedure. (up to 30 minutes))
B: Arterial catheterization time (Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average of 200 seconds)
C: Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography (Immediately, during procedure.)
D: Time Needed to Correctly Insert the Arterial or Midline Catheter. (Immediately following intervention (within 2 hours))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Open-label Trial Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Subjects With Pulmonary Infection of Either Extensively Drug-resistant Tuberculosis (XDR-TB) or Treatment Intolerant / Non-responsive Multi-drug Resistant Tuberculosis (MDR-TB).
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for participants who remain culture positive at month 4) in participants with either pulmonary extensively drug resistant tuberculosis (XDR-TB), treatment intolerant or non-responsive multi-drug resistant tuberculosis (MDR-TB).


Options:
A: Time to TB treatment initiation (8 weeks follow up)
B: Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay (Day 1)
C: Proportion of Treatment Failure (Unfavorable Outcome), Defined as Bacteriologic Failure or Relapse or Clinical Failure (Derived) Through Follow-up Until 6 Months After the End of Treatment. (6 Months post End of Treatment)
D: Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases (2 months after enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Mental Health First-Aid Training in Denmark. A Randomized Controlled Trial With a Six-Month Follow-Up Supplemented With a Qualitative Study
Brief Summary: The purpose of the study is evaluate the effect of the Mental Health First-aid training course on a Danish population of employees.


Options:
A: Changes in mental health service utilization (baseline, 2 months)
B: Change in Employees' help-seeking behaviour (6, 12 and 24 months.)
C: Change from baseline in help-seeking behavior (Baseline, post-intervention, 3 month follow-up); Change from baseline in help-outreach behavior (Baseline, post-intervention, 3 month follow-up)
D: Increased confidence in help-giving behaviour as measured by comparing the intervention group after having attended the training course with the control group. (questionnaire) (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Interim Methadone and Patient Navigation Initiated in Jail
Brief Summary: The purpose of this study is to determine which of three approaches started in jail is more effective in treating opioid use disorder: (1) methadone treatment without counseling (termed interim methadone) coupled with case management (termed patient navigation); (2) interim methadone without patient navigation; (3) or an enhanced treatment as usual including opioid detoxification, overdose prevention and drug treatment information and referral.


Options:
A: Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time (1, 3, 6, and 12 months post-release from incarceration); Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form (30 days post-release from incarceration)
B: treatment adherence (six months); Any illicit opioid used (1,2,3,4,5,6,7 and 12-months following release from prison); re-arrest (12-months following release from prison); re-incarceration (12-months following release from prison); criminal activity (1,2,3,4,5,6,7 and 12-months following release from prison); Injection drug use and HIV sexual risk factors (6 and 12-months following release from prison)
C: Service Cascade: % Referred to Substance Use Treatment (120 weeks); Staff Perception: Value of Evidenced Based Substance Use Treatment (120 weeks)
D: Treatment Progress (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Brief Summary: To evaluate the safety for the combination of Rivaroxaban and Ticagrel versus triple antithrombotic regimen (Vitamin K Antagonist (VKA), Clopigogrel and Aspirin) in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention (PCI).


Options:
A: Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition (6 Months)
B: Percentage of Participants With Clinically Significant Bleeding (Up to Month 12)
C: Major or clinically relevant non-major bleeding (12 months)
D: Composite Safety Endpoint (one year); Primary Efficacy Endpoint (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bump on the Ball: Impact of a Prenatal Exercise & Education Program on Birth Outcomes & Maternal Quality of Life
Brief Summary: Operative vaginal delivery (with forceps or vacuums) is frequently performed secondary to maternal exhaustion, which leads to an inability to push effectively; 40% of operative vaginal deliveries at Prentice are for maternal exhaustion. The risk of severe birth trauma is increased three to four fold with operative delivery. This randomized, controlled trial will compare rates of operative vaginal delivery and severe birth trauma in two groups of women: (1) an intervention group who will participate in the antepartum Total Control® fitness and education program modified for pregnancy; and (2) a control group. Women will be recruited and followed from the second trimester until 6 weeks postpartum; all will complete validated questionnaires regarding their (1) level of worry and knowledge about their birthing experience (2) pelvic floor symptoms and quality of life (3) sexual function (4) satisfaction with their birthing experience and (5) level of depressive symptoms at various time points during and after their pregnancy. Obstetrical data will also be collected.


Options:
A: Incidence of fecal and/or flatal incontinence (3 months (1st trimester)); Incidence of fecal and/or flatal incontinence (6 months (2nd trimester)); Incidence of fecal and/or flatal incontinence (9 months (3rd trimester))
B: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))
C: Contraction strength (Change of contraction strength is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )); Contraction pressure (Change of contraction pressure is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ))
D: Predomination of type of birth, operative vaginal delivery versus natural spontaneous vaginal delivery (At time of delivery (~6 months after baseline)); Indication for operative vaginal delivery (if applicable) (At time of delivery (~6 months after baseline))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid in Major Vascular Surgery. A Randomized Placebo-controlled Trial.
Brief Summary: The purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair


Options:
A: Blood loss (milliliters) (intraoperative (from skin incision to skin closure))
B: Success in achieving hemostasis.
C: Attainment of hemostasis at following randomization.
D: Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes (10 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Incision Transumbilical Laparoscopic Varicocelectomy: Comparison With the Conventional Laparoscopic Approach.
Brief Summary: Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of varicocele in our department since the nineties. However, the relatively several trocar wounds represent a big challenge against its acceptance by many of our patients who prefer the open approach with one or at least two wounds.

Single incision laparoscopic surgery (SILS), since its introduction in 2007, has been proven to be feasible and effective, with high patient satisfaction rates regarding improved cosmotic outcomes, reduced postoperative pain, and rapid return to normal activities. (10, 11) SILS for varicocelectomy has been reported to be safe and effective alternative to conventional laparoscopic varicocelectomy in a few studies.


Options:
A: number of patients with improvement in semen parameters and resolution of testicular pain (2 years)
B: pain score (Postoperative first 24 hours); Intraoperative complications (Average of 70 minutes)
C: Post-operative pain scores (visual analogue pain scale from 0-10) (Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery)
D: Pain After Surgery (12 hours post-surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects With Advanced/Unresectable or Metastatic Urothelial Cancer
Brief Summary: This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. The primary study objective is to determine the objective response rate (ORR) in all participants and by programmed cell death ligand 1 (PD-L1) status.

With Amendment 4, once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.


Options:
A: Progression-free Survival (PFS) (Calculated after a median follow-up time of 12.9 months)
B: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants (Up to approximately 80.5 months); Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% (Up to approximately 80.5 months); Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10% (Up to approximately 80.5 months)
C: Pembro Combo vs Chemo: Progression-free Survival (PFS) Using Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) (Up to approximately 42 months); Pembro Combo vs Chemo: Overall Survival (OS) (Up to approximately 42 months); Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10% (Up to approximately 42 months); Pembro vs Chemo: OS (Up to approximately 42 months)
D: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); Overall Survival (OS) - All Participants (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); OS - Participants With PD-L1 Positive Tumors (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); OS - Participants With Strongly PD-L1 Positive Tumors (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multimedia Internet-Based Program for Workers With Subthreshold Depression
Brief Summary: Depression is one of the most prevalent mental disorders to afflict adults. It seriously impacts role functioning and often takes a recurrent or chronic course. Because most adults who suffer from depression never receive treatment, there is a critical need to develop interventions that can be easily implemented and widely disseminated. Interventions that reduce the performance-impairing symptoms of subclinical depression and prevent the onset of major depression can improve employee well-being, while reducing healthcare costs and improving productivity. This project produced a mobile-web program to activate cognitive behavioral skills in workers with subthreshold depression, reduce depression symptoms, improve functioning in the workplace, and potentially reduce the risk for escalation to full-syndrome depression.


Options:
A: Depression symptoms as assessed by the Patient Health Questionnaire-9 (PHQ-9) (10 week follow-up)
B: Improvement in Work Related Disability Post Intervention (4 months post randomization)
C: At-work performance deficits and productivity loss as measured by the Work Limitations Questionnaire (4 months post-randomization); Absenteeism and productivity loss as measured by the Work Limitations Questionnaire Absence Module (4 months post-randomization)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Text Messaging to Improve the Hospital-community Transition and Prevent Readmission in Patients With Cardiovascular Disease (Txt2Prevent)
Brief Summary: Participants will be recruited during their hospitalization for either heart attack or unstable angina and will be randomly assigned to either a text message program (Txt2Prevent) or usual care. They will be texted for the first 60-days after discharge. Texts will include topics regarding self-management and discharge protocols such as reminders to make an appointment with their general practitioner or to refill medication prescriptions. After 60 days, the two groups will be compared for hospital readmission rates, quality of life, medication adherence, and self-management.


Options:
A: systolic blood pressure (change from baseline to 12-month of follow-up)
B: Change in medication adherence over 12 months (12 months); Change in medication adherence over 12 months (12 months); Change in medication adherence at 12 months (12 months); Change in medication adherence at 12 months (12 months); Change in medication adherence at 12 months (12 months)
C: Change in systolic blood pressure obtained in office during each interview (Baseline; 6months)
D: Self-management as measured by the Health Education Impact Questionnaire by Osborne et al. (Pre- and post-study period (0 and 60 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Das Verhaltenstherapeutische Therapiemanual "Smoke_less" Zur Reduktion Des Tabakkonsums: Eine Evaluationsstudie Mit Ambulanten Patienten
Brief Summary: The aim of this study is to evaluate a new cognitive behavioral smoking reduction program for ambulant patients in a three-armed study design. Study participants will be randomized to one of the following three study groups: experimental group: 5-week lasting cognitive behavioral reduction program ("smoke_less"); active comparator: 15 minutes counseling interview; waiting group: no intervention.

The three follow-up measures take place after the reduction program in week 6, 17 an 29. After the finalisation of the last follow-up, participants from the active comparator and waiting group get the chance to take part at the smoking reduction program at no charge.


Options:
A: Change from baseline in number of smoked cigarettes/day at 6, 17 and 29 weeks (6, 17 and 29 weeks); Change from baseline in percentage of carbon monoxide in exhalation air at 6, 17 and 29 weeks (6, 17 and 29 weeks)
B: Tobacco cessation, defined as quit rate at 30 days, as measured by self-reported abstinence from tobacco use (30-days)
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: Continuous Abstinence From Smoking at Ten Weeks Post-quit (May 2009)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Growth Hormone Adjuvant Therapy With Long Down Regulation Protocol in Poor Responders Undergoing In Vitro Fertilization Cycles: a Randomized Control Trial
Brief Summary: The long down regulation protocol is widely used in the in vitro fertilization cycles, now it will be assessed regarding its efficacy, in poor responder females undergoing in vitro fertilization cycles, alone and after the addition of growth hormone.


Options:
A: Numbers of oocytes retrieved and number of fertilized oocytes (2 years)
B: Live birth rate (12 months)
C: Clinical pregnancy rates (15 months)
D: Live birth rate (Up to 9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Psycho-Social Well Being Following Stroke - A Randomized Controlled Trial
Brief Summary: Multicenter randomized controlled trial (RCT) testing the effect of a dialogue-based psychosocial intervention for stroke acute survivors in primary care one to six months poststroke. Primary outcome is psycho-social health and wellbeing, measured by GHQ28 (primary outcome) and SAQoL (secondary outcome). 400 stroke survivors are randomized into intervention group or control group. Patients are followed up for 12 months.


Options:
A: Feasibility of recruitment (ability to recruit dyads) (Baseline); Feasibility of intervention delivery (ability to deliver intervention to dyads) (Feasibility of program delivery will be measured at 6 weeks); Credibility and expectancy questionnaire (Baseline); Client Satisfaction Questionnaire (post intervention (6 weeks after baseline))
B: response rate (baseline, 2nd and 4th week); remission rate (baseline, 2nd and 4th week)
C: Occurrence rate of depression (3 months)
D: General Health Questionnaire (GHQ 28) (T2 (6 months poststroke))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Psycho-Social Well Being Following Stroke - A Randomized Controlled Trial
Brief Summary: Multicenter randomized controlled trial (RCT) testing the effect of a dialogue-based psychosocial intervention for stroke acute survivors in primary care one to six months poststroke. Primary outcome is psycho-social health and wellbeing, measured by GHQ28 (primary outcome) and SAQoL (secondary outcome). 400 stroke survivors are randomized into intervention group or control group. Patients are followed up for 12 months.


Options:
A: TMS Symptom Checklist (Adminstered at testing session, 2-4 years after intervention.)
B: General Health Questionnaire (GHQ 28) (T2 (6 months poststroke))
C: Progression in the Fugl-Meyer Motor Scale (M3 (3 months))
D: Hamilton Rating Scale for Depression (HRSD) (1 year post-treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Integrated E-learning Intervention, Focused on Comprehensive Geriatric Assessment to Improve the Quality of Drug Prescribing in Hospitalized Elderly Patients
Brief Summary: This randomized controlled pragmatic study is aimed to set-up, assess and implement an integrated e-learning program of medical education in an hospital setting, focused on teaching and implementing CGA added to geriatric pharmacological notions (GPNs) to improve the quality of drug prescribing in elderly patients


Options:
A: Model of Integrated Capacity Building Program (monthly over 3 years); Competence of individual clinicians (3 observations at pre/post IMID and final); Practice of individual clinicians (Baseline and Endline (9 months)); Clinical performance indicators (Monthly beginning 5 months before OSS)
B: Clinical behaviour on the A&E department, self-efficacy of the nurse in the detection of child abuse and assessment of the individual performance on screening child abuse. (2-3 months)
C: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)
D: Knowledge; Learning efficiency

Answer: C