TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Robotic-assisted Training After Upper Arm Fracture - a Multicentre, Controlled and Randomized Intervention Study
Brief Summary: In this study, patients with upper arm fracture will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks on the injured arm in addition to conventional physio- and occupational therapy. The supportive treatment and execution of specific exercises on the Armeo®Spring should lead to improved recovery of function and mobility of the upper arm compared to conservatively treated patients.


Options:
A: Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender). (12 and 24 months)
B: Quick-DASH (2 years)
C: Constant Shoulder Score (5 years)
D: Change in disability of the arm, shoulder and hand (DASH) (DASH will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months for assessing the change)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Aligned Care Team (PACT) Intensive Management (PIM) Project
Brief Summary: Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while the patient is still in the ambulatory care setting.

Goal:

* Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients
* Improve Veteran and staff satisfaction

Objectives:

* Maintain the patient in the home setting as much as possible
* Secure appropriate home environment to facilitate health and well-being
* Utilize comprehensive team-based care
* Engage appropriate Veteran Health Administration (VHA) programs to provide interdisciplinary, coordinated, and timely management of complex medical issues


Options:
A: number of steps per day (6 months)
B: Daily number of steps (changes from baseline to 3 months)
C: VA health care cost (2 years (two 1-year points))
D: Hospitalization-free Survival - Time to Event (From randomization until date of first hospitalization for COPD, assessed up to 26 months); Hazard Ratio for First COPD Hospitalization (26 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
Brief Summary: Despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a considerable number of patients in cardiac arrest fail to achieve sustained return of spontaneous circulation. The INCEPTION trial is a multicenter, randomized controlled trial that will explore extracorporeal cardiopulmonary resuscitation (ECPR) in patients in refractory out-of-hospital cardiac arrest (OHCA) presenting with ventricular fibrillation or tachycardia. It aims to determine the effect on survival and neurological outcome. Additionally, it will evaluate the feasibility and cost-effectiveness of ECPR.


Options:
A: 30-day survival rate with favorable neurological status (30 days)
B: Achievement of VT reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at VT of 6 mL/kg. (maximum 28 days)
C: Development of ARDS (28 days)
D: All-cause Mortality (Day 30)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
Brief Summary: Despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a considerable number of patients in cardiac arrest fail to achieve sustained return of spontaneous circulation. The INCEPTION trial is a multicenter, randomized controlled trial that will explore extracorporeal cardiopulmonary resuscitation (ECPR) in patients in refractory out-of-hospital cardiac arrest (OHCA) presenting with ventricular fibrillation or tachycardia. It aims to determine the effect on survival and neurological outcome. Additionally, it will evaluate the feasibility and cost-effectiveness of ECPR.


Options:
A: 30-day survival rate with favorable neurological status (30 days)
B: Cardiac index (within 1 hour after device implantation)
C: Responder Analysis - Peak Oxygen Uptake (Peak VO2) (Baseline to 6 months); Responder Analysis - Six (6) Minute Walk (6MW) Distance (Baseline to 6 months); Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score (baseline to 6 months); Number of Participant Deaths (12 months)
D: Death (up to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HeartHab: a Prospective Cross-over Trial Investigating the Effectiveness of an App Based Telerehabilitation Program on Exercise Capacity, Lifestyle and Risk Factors in Patients With Coronary Artery Disease
Brief Summary: The recurrence of major cardiac events after infarction is very high, in some populations up to 20% in the first year. Optimal secondary prevention as organized in cardiac rehabilitation centers is effective in reducing both morbidity and mortality. However, many studies have shown that the participation and adherence rate in CR-programs is low in most European countries. Therefore, novel ways of delivering secondary prevention using information technology and self-monitoring are being explored. Hence, this study will investigate the effectiveness of a mobile, patient tailored, app based multidisciplinary telerehabilitation program (HeartHab app) in improving exercise capacity, lifestyle and risk factors in patients with coronary artery disease in a post-rehabilitation setting.


Options:
A: Percentage of subjects who completed all tasks in the application. (Baseline to 3 months)
B: VO2peak (baseline, after 12 weeks and after 1 year)
C: Change in VO2peak (day1); Change in VO2peak (month 2 + 14 days); Change in VO2peak (month 4 + 14 days)
D: Change in the levels of physical fitness (Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: HeartHab: a Prospective Cross-over Trial Investigating the Effectiveness of an App Based Telerehabilitation Program on Exercise Capacity, Lifestyle and Risk Factors in Patients With Coronary Artery Disease
Brief Summary: The recurrence of major cardiac events after infarction is very high, in some populations up to 20% in the first year. Optimal secondary prevention as organized in cardiac rehabilitation centers is effective in reducing both morbidity and mortality. However, many studies have shown that the participation and adherence rate in CR-programs is low in most European countries. Therefore, novel ways of delivering secondary prevention using information technology and self-monitoring are being explored. Hence, this study will investigate the effectiveness of a mobile, patient tailored, app based multidisciplinary telerehabilitation program (HeartHab app) in improving exercise capacity, lifestyle and risk factors in patients with coronary artery disease in a post-rehabilitation setting.


Options:
A: Reduction of the SCORE Risk Score (6 months after the intervention)
B: Change from baseline aerobic exercise capacity (watts) at 4 months (4 months)
C: Glucometabolic state (12 months); Atherosclerosis (12 months)
D: Change in VO2peak (day1); Change in VO2peak (month 2 + 14 days); Change in VO2peak (month 4 + 14 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HeartHab: a Prospective Cross-over Trial Investigating the Effectiveness of an App Based Telerehabilitation Program on Exercise Capacity, Lifestyle and Risk Factors in Patients With Coronary Artery Disease
Brief Summary: The recurrence of major cardiac events after infarction is very high, in some populations up to 20% in the first year. Optimal secondary prevention as organized in cardiac rehabilitation centers is effective in reducing both morbidity and mortality. However, many studies have shown that the participation and adherence rate in CR-programs is low in most European countries. Therefore, novel ways of delivering secondary prevention using information technology and self-monitoring are being explored. Hence, this study will investigate the effectiveness of a mobile, patient tailored, app based multidisciplinary telerehabilitation program (HeartHab app) in improving exercise capacity, lifestyle and risk factors in patients with coronary artery disease in a post-rehabilitation setting.


Options:
A: Physical Activity (48 weeks); Completing program content (48 weeks)
B: Change in VO2peak (day1); Change in VO2peak (month 2 + 14 days); Change in VO2peak (month 4 + 14 days)
C: Compliance to the exercise programme (9 months); Two Minute Walk Test (9 months)
D: Quality of life (At inclusion (baseline), change from baseline at 3, 6 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transplant Regimen Adherence for Kidney Recipients by Engaging Information Technologies: The TAKE IT Trial
Brief Summary: The investigators will evaluate a technology-enabled strategy designed to promote medication adherence, routinely monitor regimen use, and mobilize appropriate transplant center resources to respond early to kidney transplant recipients demonstrating inadequate adherence.


Options:
A: Time to First Occurrence of Acute Rejection, Failure, Death (1 year post-transplant)
B: Rx Pill Count (1 year - 1.5 years)
C: Difference in adherence to immunosuppressant medications between intervention and control (self-report) (3 months and 12 months after enrolment); Difference in adherence to immunosuppressant medications between intervention and control (immunosuppressant blood levels) (3 months and 12 months after enrolment)
D: Incidence of clinical or subclinical allograft injury at any timepoint as assessed by the appearance of de novo donor specific anti-HLA antibody (dnDSA) OR biopsy proven allograft rejection. (9 months); Change in Patient Reported Transplant Symptoms (Baseline, 2.5 months, 4.5 months, 7 months, 9 months); Change in Patient Reported Medication Adherence and Barriers (Baseline, 2.5 months, 4.5 months, 7 months, 9 months); Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) as a measure of safety (2 weeks, 2.5 months, 4.5 months, 5 months, 7 months, 9 months); Change in Patient Reported Distress (Baseline, 2.5 months, 4.5 months, 7 months, 9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assoziationen Von Leukozyten-Sub-Populationen im Blut kardiovaskulärer Risikopatienten Mit Der Inzidenz Perioperativer kardiovaskulärer Ereignisse
Brief Summary: The potential use of regulatory T cells as preoperative risk stratification tool is evaluated in order to improve clinical risk stratification and reduce perioperative morbidity and mortality.


Options:
A: Cardiovascular Events (30 days postoperative)
B: The change in reactive hyperemia index assessed by EndoPat (The change from 4-24 hours to between day 3 and 5 after surgery); Major adverse cardiovascular events (Within 365 days of surgery); Postoperative non-cardiovascular complications (Within 365 days of surgery)
C: Composite cardiovascular and hemorrhagic postoperative complications (30 days)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Assessor-blinded, Controlled, Randomised, Parallel Group, Superiority, Pragmatic Trial Assessing the Effectiveness of Daily SMS-reminders in Pharmaceutical Care of Older Adults With Hypertension on Improving Patients' Adherence to Blood Pressure-lowering Medication
Brief Summary: By conducting the SPPA trial we try to find out, whether personalized Short Message Service (SMS) reminders of blood pressure-lowering medication can effectively increase patients' adherence to blood pressure-lowering medication. Additionally, we also evaluate their effect on patients' systolic blood pressure control.


Options:
A: Care Transition Measure-3 score (CTM-3) (30-days post discharge)
B: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)
C: Blood pressure at 6 and 12 months of follow up following the educational process (1 year)
D: Combined adherence endpoint (at Visit 2 (follow-up visit after 3 months of intervention period))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Assessor-blinded, Controlled, Randomised, Parallel Group, Superiority, Pragmatic Trial Assessing the Effectiveness of Daily SMS-reminders in Pharmaceutical Care of Older Adults With Hypertension on Improving Patients' Adherence to Blood Pressure-lowering Medication
Brief Summary: By conducting the SPPA trial we try to find out, whether personalized Short Message Service (SMS) reminders of blood pressure-lowering medication can effectively increase patients' adherence to blood pressure-lowering medication. Additionally, we also evaluate their effect on patients' systolic blood pressure control.


Options:
A: Combined adherence endpoint (at Visit 2 (follow-up visit after 3 months of intervention period))
B: Change of medication non-adherence (Participants' medication non-adherence scores were measured at enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)); Change of systolic blood pressure (At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)); Change of diastolic blood pressure (At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)); Change of heart rate (At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up))
C: Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol (Baseline and 12 months); Differences in physiological variables depending on taking medications: Systolic Blood pressure (Baseline and 12 months); Differences in physiological variables depending on taking medications: Heart Rate (Baseline and 12 months)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Assessor-blinded, Controlled, Randomised, Parallel Group, Superiority, Pragmatic Trial Assessing the Effectiveness of Daily SMS-reminders in Pharmaceutical Care of Older Adults With Hypertension on Improving Patients' Adherence to Blood Pressure-lowering Medication
Brief Summary: By conducting the SPPA trial we try to find out, whether personalized Short Message Service (SMS) reminders of blood pressure-lowering medication can effectively increase patients' adherence to blood pressure-lowering medication. Additionally, we also evaluate their effect on patients' systolic blood pressure control.


Options:
A: Combined adherence endpoint (at Visit 2 (follow-up visit after 3 months of intervention period))
B: MEMS Adherence (12 months follow up)
C: Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (Baseline); Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (6 months); Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (12 months)
D: Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among hypertensive study participants. (Baseline and 18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Independence in Self Care - A Program Focused on Nursing Care
Brief Summary: This study is a randomized clinical trial conducted in a medical ward of an acute 580-bedded teaching hospital. One hundred fifty-eight older acute medical patients will be blindly randomly allocated to the control group or intervention group. The intervention will consist of a twice daily walking training, plus privileging trips to the toilet by walking and all daytime meals seated. Differences between groups will be measured at baseline (admission) and discharge. As primary outcomes, we defined the length of stay and the independence level. The independence level will be assessed at baseline (admission) and discharge by two distinct methods: through the Barthel Index and the Patient Classification Systems(PCS).


Options:
A: Changes in functional status after the intervention (Barthel Index) (Baseline (Hospital Admiission), 1 and 3 months later); Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test) (Baseline (Hospital Admiission) and 1 and 3 months later)
B: Independence level in self-care (The level of independence in self-care will be assessed at baseline (admission) and discharge through the Barthel Index)
C: Falls (18 months); Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers (During hospital stay)
D: The Primary Outcome Variable for This Study Will be the Short Form of the Continuous Scale Physical Functional Performance Test (CS-PFP) Called the PFP-10 (1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PREOPTI-POOP: Preoxygenation Optimisation in Obese Patients: High-flow Nasal Cannula Oxygen Versus Non-invasive Ventilation : A Single-centre Randomized Controlled Study. "
Brief Summary: Oro-tracheal intubation in operating room in obese patients with BMI \> 35kg/m2 remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal intubation after crash induction in obese patients


Options:
A: to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask. (4 minutes)
B: Change in arterial carbon dioxide (pCO2) (From start of anaesthesia to end of apnoea oxygenation or max 30 minutes); Change in arterial pH (From start of anaesthesia to end of apnoea oxygenation or max 30 minutes); Change in arterial oxygen tension (pO2) (From start of anaesthesia to end of apnoea oxygenation or max 30 minutes)
C: Reintubation (within 72 hours after extubation or at ICU discharge)
D: Expired fraction of oxygen at the end of intubation (2 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Impact of a Community Health Worker Program in Neno, Malawi: A Stepped-Wedge Cluster Randomized Controlled Trial
Brief Summary: This protocol concerns the implementation and evaluation of an intervention designed to realign the existing cadre of Community Health Workers (CHW) in Neno District, Malawi to better support the care needs of the clients they serve. The proposed intervention is a 'Household Model' where CHWs will be assigned to households, rather than HIV or TB specific patients, and will be trained to provide support for a wider range of conditions including HIV, hypertension, diabetes, and pediatric malnutrition. The new model is designed to improve retention in care for clients with chronic, non-communicable diseases, along with increased uptake of women's health services and treatment for pediatric malnutrition, while sustaining the high retention rates for clients in the HIV program. Eleven sites (health centres and hospitals) were arranged into six clusters by estimated size of the catchment area populations, with a population range of 11,680 to 26,260 and an average population of 20,400. The order in which the intervention will be rolled out across the sites will be randomized so that the intervention can be evaluated in a stepped-wedge cluster randomized controlled trial. These clusters were grouped based mostly on geographic location but also on catchment area sizes, in order to maximize feasibility of training for the CHW team and not overload CHW training sessions with too many trainees.


Options:
A: Difference in the under-five child mortality rate between the two study arms (36 months)
B: HIV (Last 3 months); Hypertension (Last 3 months); Asthma (Last 3 months); Diabetes (Last 3 months); Epilepsy (Last 3 months); Mental Health (Last 3 months); Malnutrition (Last 3 months); Tuberculosis (Last 3 months); Family Planning (Last 3 months); Antenatal Care (Last 3 months)
C: Brief Psychiatric Rating Scale, Expanded Version (BPRS-E) (12 months post-randomisation (18 months for secondary outcome))
D: The coverage of the therapeutic nutritional program in the control and intervention health districts (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Endometrial Scratch Effect on Pregnancy Rates When Performed During the Previous Cycle of Embryo Transfer in Patients Undergoing Egg-donation IVF
Brief Summary: Clinical trial about the effect of endometrial scratch on pregnancy rates in patients undergoing a treatment with in-vitro fertilization with donor eggs, when doing the endometrial biopsy during the cycle prior to the embryo transfer.


Options:
A: pregnancy rates (individual outcome will be evaluated within 8 weeks after IVF treatment. Over all outcome will be evaluated after 3 years.)
B: Pregnancy Rate (12 weeks)
C: Rate of clinical pregnancy (5 weeks after the embryo implantation in an IVF procedure)
D: Positive Pregnancy Test (12 to 14 days after embryo transfer); Clinical Pregnancy (5 weeks of pregnancy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Humeral Component Version on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective Randomized Controlled Trial
Brief Summary: The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.


Options:
A: Difference in Glenoid Component Placement (Inclination and Version) (Two weeks post surgery); Difference in Glenoid Component Placement (AP and SP). (Two weeks post surgery)
B: Migration of resurfacing prostheses (five years); Bone density around the prosthesis (five years); Pain (five years); Activities of Daily Living (ADL) (five years)
C: disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales.; the Western Ontario Osteoarthritis of the Shoulder Index (WOOS); the Constant Score; American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form.; Short Form-12
D: Postoperative External Range of Motion (ROM) (2 years); Postoperative Internal Range of Motion (ROM) (2 years)

Answer: D