TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Music in Improving Gait Abnormalities in Parkinson Disease
Brief Summary: Neurologic Music Therapy (NMT) sensorimotor techniques are increasingly used to improve spatio-temporal gait parameters and postural stability in the course of Parkinson's Disease and following stroke. Nonetheless, the neurophysiological underpinnings of NMT-mediated gait recovery is still poorly understood.

The aim of the study was to investigate the central mechanisms of connectivity related to the application of Rhythmic Auditory Stimulation (RAS) in PD gait rehabilitation. The investigators will enroll 30 patients with PD. They will be randomized into two groups: (A) gait training with Music; (B) conventional treadmill gait training. The experimental group will perform training by means of GT3 (Biodex), where the patient is able to walk (on a treadmill) following specific musical beets and rhythms. The control group will perform only gait treadmill training.

Subjects will attend 3 sessions a week for at least 4 weeks. Each session will last 45-min.


Options:
A: Percentage of "Off" Time During Waking Hours at End of Study (22 weeks)
B: Changes from baseline Balance Systems Evaluation Test total and subsection scores at post 4-week training, post 8-week training, 6- and 12-month follow-ups (12 months after intervention)
C: Ten meters walking test (about 4 weeks)
D: Change of Berg Balance Scale (BBS) (15 minutes/session; measured at weeks 0, 6, and 12 of the experiment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintenance of Occupational Therapy for Patients With Alzheimer: A Pragmatic Randomized Trial
Brief Summary: France put a massive effort for improving dementia care through a national Alzheimer plan in 2008 and this effort was confirmed by the next government (Neurodegenerative Diseases Plan 2014-2019). Some new care models and interventions have been implemented such as Alzheimer specialized teams offering occupational therapy. The teams intervene at home with medical prescription. A recent pilot study demonstrated that occupational therapy has the potential to bring clinical benefits for both dementia patients and their caregivers. Nevertheless, occupational therapy has been designed as a short-term intervention and the end of intervention is challenging for therapists and patients. We aim to test the clinical and economic efficacy of maintaining occupational therapy over supplementary 4 months in a pragmatic randomized controlled trial.


Options:
A: Behavioral occurrence; Care recipient depressive mood; Caregiver upset
B: Neuropsychiatric inventory (NPI) score (NPI score will be measured at 7 months)
C: Functional dependence (Change in functional dependence score between baseline (pre-randomization) and 4 months post-randomization)
D: 1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);; 2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);; 3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Piloting At-birth Point of Care HIV Testing Strategies in Kenya
Brief Summary: Innovative strategies to expedite HIV diagnosis among exposed infants, including at-birth testing and two portable point-of-care (POC) diagnostic systems, will be piloted using an implementation framework. The programmatic impact of these tools on early infant diagnosis (EID) will be measured in comparison with parallel standard of care (SOC) HIV DNA PCR testing initiated at 6 weeks of age.


Options:
A: The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection (up to 6 months); the proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up. (3 months after treatment initiation)
B: Accessibility and availability (Three months)
C: Specificity of PoC HIV test (Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID); Sensitivity of PoC HIV test (Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID)
D: Proportion of infants tested at birth (0-4 weeks); Proportion of infants tested at 6-weeks (4-12 weeks postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Active School. A School-based Intervention to Increase Childrens Daily Physical Activity and Its Effect on Childrens Self-regulation
Brief Summary: This study seeks to explore whether increased physical activity in school affects children's executive function, aerobic Fitness and childrens self-regulation. The "Active school" study was a 10-month randomized controlled trial. The sample included 449 children (10-11 years old) in five intervention and four control schools. The weekly interventions were 2×45 minutes physically active academic lessons, 5×10 minutes physically active breaks, and 5×10 minutes physically active homework. Aerobic fitness was measured using a 10-minute interval running test. Executive function was tested using four cognitive tests (Stroop, verbal fluency, digit span, and Trail Making). A composite score for executive function was computed and used in analyses.

Self-regulation was measured by the Child Behavior Rating Scale.


Options:
A: Inhibition (8 months intervention); Working memory (8 months intervention); Cognitive flexibility (8 months intervention); Aerobic fitness (8 months intervention); Physical activity (8 months intervention)
B: Change in knowledge score (One school year); Change in dietary habits (One school year); Change in self-efficacy score (One school year)
C: School-time and total daily MVPA (5 months and 1.5 years)
D: Moderate-to-vigorous physical activity (MVPA) time during activity breaks (Year 3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
Brief Summary: This is a randomized, controlled, parallel study to determine the efficiency of oral antibiotics in reduction of surgical site infection (SSI) in rectal cancer surgery.


Options:
A: Surgical site infection (CDC criteria) (30 days from operation)
B: The primary endpoint of the study was anastomotic failure.
C: Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak (Up to 30 days post operation)
D: Rate of Surgical Site Infection (0 to 30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Pharmacotherapeutic Education on Medication Adherence and Adverse Outcomes in Type 2 Diabetes Mellitus Patients: Prospective, Randomized Study
Brief Summary: Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that affects more than 400 million people worldwide. There are a few studies evaluating ADRs in diabetics. Many patients experience ADRs soon after hospital discharge which can be attributed to the changes in the pharmacotherapy during hospitalization. Education and counseling of diabetic patients has been shown to improve medication adherence and clinical outcomes. Studies that included medical patients revealed that education can significantly reduce risk of ADRs after hospital discharge. Pharmacotherapeutic education is a part of comprehensive education of diabetics that is focused on a proper use of medications, prevention and early detection of ADRs.


Options:
A: Safety: All-cause mortality (6 weeks); Safety: Readmission for any of CHF, unstable angina, arrhythmia, re-infarction, revascularization, stroke, or major bleeding requiring transfusion (6 weeks); Feasibility: Proportion of patients in the intervention group discharged within 72 hours ("feasible" if >= 70%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 3 days of discharge ("feasible" if >= 80%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 5 days of discharge ("feasible" if >= 90%)
B: Whether patient obtained medications prescribed at their discharge from ED (5-8 days after discharge from ED); Whether patient is using medications that were prescribed at their ED discharge correctly (5-8 days after discharge from ED); Whether the patient arranged a follow-up appointment with their primary care provider (5-8 days after discharge from ED); Whether patient attended visit with their primary care provider after discharge from the ED (30-35 days after discharge from ED)
C: Medication adherence assessment method (one month)
D: HbA1c (12month); Blood pressure (12 month); Lipid profile (12 months); quality of life (12month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomized, Investigator-blind, Active-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Ceftobiprole Versus Intravenous Standard-of-care Cephalosporin Treatment With or Without Vancomycin in Pediatric Patients Aged From 3 Months to Less Than 18 Years With Hospital-acquired Pneumonia or Community-acquired Pneumonia Requiring Hospitalisation
Brief Summary: This was a study of the safety and efficacy of ceftobiprole medocaril compared with intravenous (IV) standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients with either hospital-acquired bacterial pneumonia (HAP) or community-acquired bacterial pneumonia (CAP) requiring hospitalization, and requiring intravenous (IV) antibiotic therapy.


Options:
A: Adverse Events (Analysis of AEs assessed during the first 3 days of IV therapy and while on IV, a median of 7 days)
B: Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) (7 to 14 days after the end of therapy (EOT))
C: Clinical success (14 days)
D: Clinical Cure Rate at the End-of-treatment (EOT) Visit (End-of-treatment (Day 10 or Day 11))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double Blind, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Brief Summary: For hemodialysis subjects currently receiving ESAs with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548.


Options:
A: Change from baseline in the average Hemoglobin (Hb) (Baseline and Weeks 18 to 24)
B: Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) (Baseline; Week 10 to Week 12); Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Up to Week 24); Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values (Up to Week 24); Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values (Up to Week 24); Number of Participants Classified as Hb Outliers (Weeks 13 - 20)
C: Mean Hb Level of Week 20 and Week 24 (Up to Week 24)
D: Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 (Baseline (Day 1, Week 0), Week 28 to 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older
Brief Summary: The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.


Options:
A: Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group (One month post-dose 2 (Month 3)); Anti-gE Antibody Concentrations (One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).); Anti-pneumococcal Antibody Titers (At one month post-dose 1 (Month 1)); Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody (One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).); Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies (At one month post-dose 1 (Month 1))
B: Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Anti-glycoprotein E (gE) Antibody Concentrations (One month after the second vaccination (Month 3)); Anti-VZV Antibody Concentrations (One month after the second vaccination (Month 3))
C: GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay) (6 weeks after IP(Investigational Product) vaccination); GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA (6 weeks after IP(Investigational Product) vaccination)
D: Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations (One month after dose 2, at Month 3); Number of Subjects With Solicited Local Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Days With Solicited Local Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Subjects With Solicited General Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Days With Solicited General Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) (During the 30-day (Days 0-29) period after each dose.); Number of Subjects With Any and Related Serious Adverse Events (SAEs) (From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)); Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) (From first vaccination (Month 0) up to 30 days post last vaccination (Month 3))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Evaluation of a Novel Mindful-Compassion Art Therapy (MCAT) Supervision for Self-Care and Collegial Support Among End-of-Life Care Professionals in Singapore
Brief Summary: Background: The need for empathy and the difficulties of coping with morality when caring for the dying and the bereaved pose great psychological and spiritual strains. End-of-Life (EoL) care professionals including doctors, nurses and social workers are particularly prone to burnout given the intense emotional and existential nature of their work. Supervision is one important way to provide adequate support that focuses on both professional and personal competencies in working with death and loss. Previous research has provided strong evidence that support the inclusion of art therapy within supervision for it had effectively reduced burnout and enhanced emotional regulation. Combining the practice of mindfulness in art-therapy based supervision has immense potential to create a dynamic platform for self-care and collegial support, of which could ultimately cultivate sustained resilience, compassion and growth among those immersed the fields of hospice and palliative care.

Methods/Design: A randomized wait-list control trial design. 60 EoL care professionals were randomly allocated into one of two groups: (i) Intervention group (MCAT Supervision), and (ii) Control group (MCAT Supervision will be provided after the intervention group completed all supervision sessions). Both quantitative and qualitative outcomes were assessed at baseline, immediately after intervention, and four weeks post intervention. Primary outcome measure included level of burnout. Secondary outcomes included death attitude and fear of death, emotional awareness and regulation, resilience, compassion, and overall quality of life. Qualitative data were analyzed using Framework method.

Discussion: The integration of art and mindfulness practice to process the needs of professional EoL caregivers for self-care is a scarcely explored area in the field of hospice and palliative care in Singapore and in the international context. This pilot study proposes to develop and test a novel Mindful-Compassion Art Therapy (MCAT) Supervision for professional EoL caregivers. The expected outcome would generate new knowledge contributing to advancements in both theories and practice in hospice and palliative care for Singapore and across the globe.


Options:
A: Change in Maslach Burnout Inventory score (6 month); Change in Physician Job Satisfaction Scale score (6 month); change in Empowerment at Work Scale score (6 month); change in Utrecht Work Engagement score (6 months)
B: change in self reported Stress symptoms (Baseline, 1 month, 3 months)
C: Work limitations (One year); Work engagement (One year)
D: Change from Baseline 'Maslach Burnout Inventory- General Survey (MBI-GS)' at immediate after intervention [T2] and 4 weeks follow-up [T3]. (It will be assessed at baseline [T1], immediately after intervention [T2], and four weeks post intervention [T3].)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Superior Venous Access, Midline vs Ultrasound IVs: A Randomized Clinical Trial
Brief Summary: Obtaining intravenous access (IVA) is the most common procedure performed in the emergency department (ED). Placement of IVA allows for blood work and delivery of intravenous fluids and medications. The implementation of ultrasound guided peripheral IVs (UGPIV) have allowed for ultrasound to be used to place an IV into patients with difficult vein access (DVA). An alternative device to place is a midline catheter (MC). The use of MCs against UGPIV has not been compared in a randomized study. Aim 1: To determine if UGPIVs have a higher failure rate than midline catheters within 72 hours of placement. Aim 2: To collect information to perform a direct cost analysis of UGPIV against that of the midline catheter. Aim 3: Assess patient satisfaction.


Options:
A: Probability of occurrence of a significant adverse event related to the central venous device (37 weeks)
B: Length of canalization (Four weeks); Number of punctures (Four weeks); Phlebitis (Four weeks)
C: Device Failures Within 72 Hours (72 hours after device placement)
D: Grade 1 and Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique (9 months after patient recruitment begins)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Superior Venous Access, Midline vs Ultrasound IVs: A Randomized Clinical Trial
Brief Summary: Obtaining intravenous access (IVA) is the most common procedure performed in the emergency department (ED). Placement of IVA allows for blood work and delivery of intravenous fluids and medications. The implementation of ultrasound guided peripheral IVs (UGPIV) have allowed for ultrasound to be used to place an IV into patients with difficult vein access (DVA). An alternative device to place is a midline catheter (MC). The use of MCs against UGPIV has not been compared in a randomized study. Aim 1: To determine if UGPIVs have a higher failure rate than midline catheters within 72 hours of placement. Aim 2: To collect information to perform a direct cost analysis of UGPIV against that of the midline catheter. Aim 3: Assess patient satisfaction.


Options:
A: Initial success rate (immediatetely after first attempt, average attempt takes 15 minutes)
B: Reduction in number of minor surgical procedures that may be required to deliver fluids into the blood of critically ill patients by using the ultrasound guided technique (1 Day)
C: Device Failures Within 72 Hours (72 hours after device placement)
D: Post insertion failure rates (Duration of catheter dwell time (up to 168 hours)); Overall utility (Up to 168 hours (1 week))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction
Brief Summary: This study evaluates the effect of a specific, multidisciplinary and personalized rehabilitation program compared to usual care, on motor control and functional disability in patients with neuralgic amyotrophy.

Half of the participants will start with the 17-week specific rehabilitation program while the other half will first continue their usual care for 17 weeks, after which they will also receive the 17-week specific rehabilitation program.


Options:
A: Change in Shoulder Rating Questionnaire (SRQ) score from baseline (Baseline (0 weeks) and post-intervention (17 weeks)); Change in brain activity related to central motor control from baseline (Baseline (0 weeks) and post-intervention (17 weeks))
B: Change in weight-bearing physical activity (steps/day) (Baseline, 3, 6 and 12 months post-enrollment)
C: Weekly minutes spent in aerobic and strengthening activity (Baseline, 12, 26 and 52 weeks)
D: Change in Intraepidermal Nerve Fiber Density (IENFD) (Baseline, 9 months, and 18 months); Change in Quality of Life (NQOL-DN) Questionnaire Results (Baseline, 9 months, and 18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Use fo Antiseptic Solution for Vaginal Wash Before Cesarean Section in Patients With Premature Rupture of Membranes. A Randomized, Double Blind, Controlled Trial.
Brief Summary: To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).


Options:
A: Number of cases of endometritis after cesarean section (15 days)
B: Number of Patients With Surgical Site Infection (4 weeks after cesarean delivery)
C: Post-intervention Aerobic Bacterial Colony Counts (From intervention to 7 days post); Post-intervention Anaerobic Bacterial Colony Counts (From intervention to 7 days post)
D: Composite Postoperative Infectious Morbidity (30 days postoperatively)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children
Brief Summary: Dental caries (tooth decay) is the most prevalent childhood disease in the world. Multiple interventions are available to treat and prevent caries. The aim of the proposed study is to compare the benefit of silver diamine fluoride (SDF) and fluoride varnish versus fluoride varnish and glass ionomer sealants. This study is a five-year, cluster randomized, pragmatic controlled trial conducted in public elementary schools in New York City.


Options:
A: Proportion of Subjects With All Caries Arrested (Two years); Prevalence of Dental Caries as Measured by a Clinical Oral Examination (Participants were evaluated biannually over a total of four years or until lost to follow-up, whichever occurred first.)
B: Pulp sensitivity (Once a year during at least five years)
C: Number of lesions that evidence progression by a higher ICDAS code. The score will be expressed as percentage of progression among all the treated lesions. (24 months)
D: Failure Rate of the Three Treatment Arms Judged Clinically (2 years)

Answer: A