TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers
Brief Summary: Studies have shown that ethnic-racial minority elders are more likely to be neglected from appropriate dementia care in time than the white counterparts. Among minorities group, Korean Americans (KAs) are the 4th largest and one of the most rapidly growing Asian subpopulations and have been characterized as under-resourced and underserved population of dementia care. This research is being done to understand how an education and navigation support program led by trained community health workers (CHWs) helps Korean American elders with probable dementia and the Korean American elders' caregivers. In a 2-arm randomized controlled trial (RCT) with 288 dyads, the investigators' aims are to (1) test the effect of a community-based intervention delivered by trained CHWs for undiagnosed KA elders with probable dementia and the KA elders' caregivers, (2) evaluate the effect of the PLAN on improving caregiver's dementia literacy, self-efficacy in dementia care and service use, social support, depression, and quality of life at 6 months in comparison to usual care, and (3) examine whether the effect of PLAN differs across age, sex, English proficiency and education caregiver subgroups. Exploratory Aim 1 is to test the effect of PLAN on Korean elders with probable dementia and caregiver development of a plan regarding dementia care at 6 months in comparison to usual care. The other two Exploratory Aims are to test the applicability of this study in another environment: Exploratory Aim 2: Using an equity-informed human-centered design framework, scale PLAN for implementation in ethnic daycare and Exploratory Aim 3: Pilot test the feasibility and acceptability of PLAN in ethnic adult daycare.

Aim 1 and Exploratory Aim test the following hypotheses: (1) Korean elders with probable dementia who receive the PLAN will have higher rates of linkage to medical service for dementia than those in the control group (Aim 1) and (2) Korean elders with probable dementia and the KA elders' caregivers who receive the PLAN will have higher rates of having a plan for dementia care than those in the control group (Exploratory Aim). Aim 2 tests the following hypothesis: Caregivers in the PLAN group will have higher dementia literacy, self-efficacy in dementia care and service use, social support, and quality of life, and lower depression than those in the control group.


Options:
A: Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention (1 month)
B: Number of participants linked to medical service for dementia measured by medical record verification (6 months)
C: Hemoglobin A1C (6 months)
D: Change from Baseline in Mean steps/day at 3 months (3 months); Change from Baseline in Mean Steps/day at 1 month (1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized-Controlled Trial to Determine the Effects on Blood Pressure of A Reduced-sodium Added-potassium Salt Substitute Among Adults With Hypertension in India
Brief Summary: Blood pressure is a key modifiable risk factor for cardiovascular disease in India. Drug therapies are highly effective and are recommended by local guidelines to reduce the risks of serious cardiovascular complications. Behavioural approaches to blood pressure control based upon sodium reduction are also recommended but there are no interventions proven effective in India.

Mean sodium intake in India is about 5g/day (equivalent to about 12.5g salt) which is, more than double World Health Organization (WHO) recommendations. Reduced sodium, added potassium salt substitutes have favourable effects on blood pressure in settings where discretionary salt use is high, but have not been tested in India. This single-site, Salt Substitute on blood pressure in India Study will investigate the effects of reduced sodium added potassium salt substitution on blood pressure in rural areas where hypertension is a prevalent disease problem and additional, scalable and affordable interventions are required. The primary objective is to assess the effects of salt substitute on SBP at 3 months follow-up. The secondary objectives are to determine effects on DBP, urinary sodium and potassium levels and to determine acceptability of the salt substitute.

The study will be a double-blinded, randomized-controlled trial done in the Hyderabad region amongst adult volunteers with a history of hypertension diagnosed by a health professional. The main exclusion criteria will be known serous kidney disease or use of potassium containing medications by the individual or others living in the household. Written informed consent will be obtained from potential participants followed by baseline data collection. Eligible individuals will then be assigned at random to receive double-blind salt or salt substitute which will be used to replace all dietary salt used for cooking and seasoning over the next 3 months. Follow-up will be at one and three months after randomisation for blood pressure, urinary electrolytes and acceptability of the intervention.


Options:
A: Stroke (5 years)
B: Change in Baseline Mean Systolic Blood Pressure (mmHg) at 6 months ((Baseline compared to 6 months after start of intervention))
C: Systolic Blood Pressure (three months)
D: The modified Rankin scale (mRs) (6 months); The National Institute of Health Stroke Scale (NIHSS) (6 months); The Barthel index (BI) (6 months); The "good neurological performance" (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Do Dual Mobility Cups Prevent Dislocation After Total Hip Arthroplasty Performed Due to Femoral Neck Fracture? a Registry-based, Pragmatic, Randomized Controlled Trial Comparing Dual Mobility with Standard Cups
Brief Summary: Our aim is to develop a strategy that reduces the risk of dislocations after total hip arthroplasty surgery performed due to femoral neck fracture. We therefore perform a register-nested, pragmatic, randomized controlled trial to investigate the safety and efficacy of dual mobility cups that were designed to minimize the risk of dislocation in the large and fragile group of elderly patients with femoral neck fractures.


Options:
A: Number of Participants With Revision Surgery (Measured 2 years after original surgery)
B: Hip related complication rate (2 years); Health-related Quality of Life (2 years)
C: Harris hip score (2 years)
D: Dislocation (1 year after index surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Do Dual Mobility Cups Prevent Dislocation After Total Hip Arthroplasty Performed Due to Femoral Neck Fracture? a Registry-based, Pragmatic, Randomized Controlled Trial Comparing Dual Mobility with Standard Cups
Brief Summary: Our aim is to develop a strategy that reduces the risk of dislocations after total hip arthroplasty surgery performed due to femoral neck fracture. We therefore perform a register-nested, pragmatic, randomized controlled trial to investigate the safety and efficacy of dual mobility cups that were designed to minimize the risk of dislocation in the large and fragile group of elderly patients with femoral neck fractures.


Options:
A: Dislocation (1 year after index surgery)
B: hip function score (1 year)
C: visual analog scale (36 months); Harris hip score (36 months); Eq-5d index scores (36 months)
D: Hip related complication rate (2 years); Health-related Quality of Life (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Vehicle Controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment to the Vehicle in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)
Brief Summary: To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).


Options:
A: Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing (3 days)
B: Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 (Baseline and Week 4)
C: VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 (Baseline to Week 8)
D: Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity (At Week 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of PUSH Notifications From a Mobile App for Improving the Body Composition of Overweight or Obese Women. Protocol of a Three-armed Clinical Assay
Brief Summary: A clinical three-armed assay has been established to permit an evaluation of the effectiveness of implementing PUSH notifications in the actions orientated towards improving body composition through the establishment of dietary patterns and an increase in physical activity.


Options:
A: Weight reduction (1 year)
B: Change in weight (12 weeks)
C: 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)
D: Changes from baseline BMI (At baseline (0 years) and followed for 2 years); Changes from baseline Fatty mass (At baseline (0 years) and followed for 2 years); Changes from baseline Free-fatty mass (At baseline (0 years) and followed for 2 years); Changes from baseline Muscular Mass (At baseline (0 years) and followed for 2 years); Changes from baseline Corporal Water (At baseline (0 years) and followed for 2 years); Adherence to dietary pattern will be also measured through personal interview (At baseline (0 years) and followed for 2 years); Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire) (At baseline (0 years) and followed for 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.


Options:
A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 12)
B: Treatment Period: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 196)
C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Baseline (Day 1) up to end of study (Week 196)); Number of Participants With Clinically Significant Laboratory Abnormalities (Baseline (Day 1) up to end of study (Week 196))
D: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis
Brief Summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis (CF).


Options:
A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Baseline up to Week 100)
B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Day 1 Through Safety Follow-up (up to Day 75 for Part 1 and up to Day 85 for Part 2)); Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline Through Day 29)
C: Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)
D: Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites (From Day 1 through Day 15); Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Day 43); Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis
Brief Summary: Pulmonary sarcoidosis (PS) is defined as a multisystem granulomatous disorder of unknown cause affecting different vital organs, especially the lungs.

PS manifest in reduction of pulmonary function. Overall symptoms lead to poor physical conditioning contributing to a vicious cycle of more physical inactivity.

Treatment of sarcoidosis is usually limited to patient symptoms. Progressive fibrosis sometimes can lead to respiratory failure and ultimately, pulmonary transplantation.

Physical training shows promising evidence of a positive effect on PF. No defined training program with regard to exercise frequency, duration or intensities exists.

PS is a relatively rare disease and patients are scattered in great geographically areas,.It is difficult to organize targeted group training with supervised physical training, convenient for patients and affordable for the public health sector. Tele-rehabilitation (TR) seems to be a good approach to reach patients in low inhabited areas, going from health care to self-care, empowering patient's awareness of their disease and increasing the flexibility patients need to acquire healthier behaviors.

Preliminary evaluations from TR initiatives in Scotland showed tele-rehabilitation to be more cost effective with patients living in remote areas than with the outreach- or centralized model.

No studies on the feasibility effect of TR in PS exists. The study is a prospective randomized controlled trial investigating the effects of tele-rehabilitation in patients with PS compared to standard practice. 24 patients with PS will be randomized in two groups, trained by tele-rehabilitation for 12 weeks and afterwards followed for 6 months. The control group will follow the usual control program for PS patients that only involves outpatient visits approximately every 3rd month. No specific PS rehabilitation program exists. The intervention group will receive TR in the form of video consultations- and chat sessions with a real physiotherapist and workout sessions with a virtual physiotherapist agent. They will also train with virtual reality glasses or tablets that show the actual exercises in the training program.

Patients will be tested with pulmonary function, physical, anxiety and quality of life parameters, all at baseline, after 12 weeks of intervention, 3 and 6 months after cessation of the program.


Options:
A: Change in the distance walked at a 6MWT measured at week 12 (12 weeks)
B: 6MWT -12 weeks (12 weeks afte baseline)
C: Number of Participants with Hospital Readmission at 6 months (6 months)
D: COPD Assessment Test (CAT) (Baseline and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis
Brief Summary: Pulmonary sarcoidosis (PS) is defined as a multisystem granulomatous disorder of unknown cause affecting different vital organs, especially the lungs.

PS manifest in reduction of pulmonary function. Overall symptoms lead to poor physical conditioning contributing to a vicious cycle of more physical inactivity.

Treatment of sarcoidosis is usually limited to patient symptoms. Progressive fibrosis sometimes can lead to respiratory failure and ultimately, pulmonary transplantation.

Physical training shows promising evidence of a positive effect on PF. No defined training program with regard to exercise frequency, duration or intensities exists.

PS is a relatively rare disease and patients are scattered in great geographically areas,.It is difficult to organize targeted group training with supervised physical training, convenient for patients and affordable for the public health sector. Tele-rehabilitation (TR) seems to be a good approach to reach patients in low inhabited areas, going from health care to self-care, empowering patient's awareness of their disease and increasing the flexibility patients need to acquire healthier behaviors.

Preliminary evaluations from TR initiatives in Scotland showed tele-rehabilitation to be more cost effective with patients living in remote areas than with the outreach- or centralized model.

No studies on the feasibility effect of TR in PS exists. The study is a prospective randomized controlled trial investigating the effects of tele-rehabilitation in patients with PS compared to standard practice. 24 patients with PS will be randomized in two groups, trained by tele-rehabilitation for 12 weeks and afterwards followed for 6 months. The control group will follow the usual control program for PS patients that only involves outpatient visits approximately every 3rd month. No specific PS rehabilitation program exists. The intervention group will receive TR in the form of video consultations- and chat sessions with a real physiotherapist and workout sessions with a virtual physiotherapist agent. They will also train with virtual reality glasses or tablets that show the actual exercises in the training program.

Patients will be tested with pulmonary function, physical, anxiety and quality of life parameters, all at baseline, after 12 weeks of intervention, 3 and 6 months after cessation of the program.


Options:
A: 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)
B: 6MWT -12 weeks (12 weeks afte baseline)
C: Quality of Care (36 months)
D: Number of hospital admissions for exacerbations of COPD

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Robotic Neurorehabilitation Plus Virtual Reality on Attention Process and Executive Functions in Patients With Chronic Stroke: a Randomized Controlled Trial
Brief Summary: Stroke can be classified as ischemic, i.e. due to the lack of blood flow, and haemorrhagic, caused by bleeding. Stroke results in focal signs and symptoms, with a devastating impact on a patient and his family. Although robotic rehabilitation is very useful in improving motor function, there is no a clear evidence on its role in improving cognitive abilities, which are often compromised in stroke patients.

To this end, the investigators designed a randomized controlled experimental study on stroke patients, with the aim of evaluating the effects of robotic neurorehabilitation using Lokomat with and without virtual reality on cognitive functioning in stroke patients, compared to traditional therapy.


Options:
A: Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time (Baseline, rehabilitation discharge, month 3, month 6)
B: Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time (Baseline, rehab discharge, month 3, month 6, month 12)
C: Frontal Assessment Battery (3 months)
D: Patient Participation (12 and 36 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Nurse-Led Intervention Programme on Compassion Fatigue, Burnout, Compassion
Brief Summary: Nurses are at risk in terms of burnout and empathic fatigue. Therefore, efforts to protect the mental health of nurses are very important. It is stated that the studies conducted are mostly descriptive and not interventional.

In addition, the evidence levels of interventional studies are low.


Options:
A: level of depression (Baseline to 3 months)
B: ICU length of stay (Up to 32 weeks)
C: Change from baseline compassion fatigue at 1 and 6 months assessed by compassion fatigue subscale of Professional quality of life scale (Data collected before the program starts and one months after the end of the program and six months); Change from baseline burnout at 1 and 6 months assessed by burnout subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months); Change from baseline compassion satisfaction at 1 and 6 months assessed by compassion satisfaction subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months)
D: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Nurse-Led Intervention Programme on Compassion Fatigue, Burnout, Compassion
Brief Summary: Nurses are at risk in terms of burnout and empathic fatigue. Therefore, efforts to protect the mental health of nurses are very important. It is stated that the studies conducted are mostly descriptive and not interventional.

In addition, the evidence levels of interventional studies are low.


Options:
A: Resilience - Brief Resilience Scale (BRS) (20 weeks); General Health - General Health Questionnaire (GHQ-12). (20 weeks)
B: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (Baseline and after 4, 8 weeks later)
C: Change from baseline compassion fatigue at 1 and 6 months assessed by compassion fatigue subscale of Professional quality of life scale (Data collected before the program starts and one months after the end of the program and six months); Change from baseline burnout at 1 and 6 months assessed by burnout subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months); Change from baseline compassion satisfaction at 1 and 6 months assessed by compassion satisfaction subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months)
D: Change in level of stress per Perceived Stress Scale (PSS) (Baseline and at 2 months (immediately post-intervention))

Answer: C