TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Open Label Trial to Investigate the Effect of Schistosoma Mansoni (Sm) Infection on the Immunogenicity of a Candidate TB Vaccine, MVA85A, in BCG-vaccinated African Adolescents
Brief Summary: Mycobacterium tuberculosis (M. tb) is a pathogen with worldwide distribution which infects humans causing tuberculosis (TB), a transmissible disease resulting in very high mortality and morbidity; development of an effective vaccine is a global health priority.

Over a billion people worldwide are infected with one or more helminths. Helminths are parasitic worms, of which Schistosoma mansoni is one species. There is some evidence that helminth infection may affect a person's response to a vaccine. In this trial the investigators hope to investigate whether Schistosoma mansoni infection affects adolescents' responses to a candidate TB vaccine called MVA85A, as adolescents are a crucial target group for an effective TB vaccine.


Options:
A: T cell immunogenicity by gamma-interferon ELISPOT of Ag85A response. (8 weeks)
B: Safety of MVA85A (Six months)
C: The occurence and severity of local side-effects The occurence and severity of systemic side-effects (1 year)
D: Safety of the Vaccine. This will be determined by the degree and number of adverse events reported.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HealthMap: a Cluster Randomised Trial of Interactive Health Plans and Self-management Support to Prevent Cardiovascular Disease in People With HIV
Brief Summary: The purpose of this study is to improve the health status of people living with HIV in Australia. The overall goal is to rigorously evaluate the impact of interactive health plans and self-management support on chronic condition outcomes in people with HIV.

The specific aims are to:

Aim 1: Using a doctor-level cluster randomised trial, evaluate the effect of interactive health plans and self-management support on coronary heart disease risk and other chronic condition outcomes in people living with HIV.

Aim 2: Evaluate patient and health care provider experiences and acceptability of interactive health plans and self-management support.

Aim 3: Evaluate intervention cost-effectiveness and effect on health service utilisation.


Options:
A: Hemoglobin A1c
B: Hemoglobin A1C (Baseline, 6 months and 12 months)
C: The primary study endpoint is 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by the Framingham risk equation (12 months)
D: 1. ADEs; 2. duration of ameliorable medication side effects; 3. health goal adherence rates; 4. diabetes outcomes; 5. familial risk factor documentation rates; 6. user satisfaction surveys; 7. user metrics

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Pre- and Probiotics on P-cresol Plasma Levels in Patients Bearing a Kidney Allograft
Brief Summary: The purpose of this study is to establish whether a short treatment with the synbiotic combination Probinul neutro® may decrease the plasma concentration of the uremic toxin p-cresol in patients bearing a kidney allograft. The effect of this treatment on plasma levels of immunosuppressant drugs will be evaluated as well.


Options:
A: Change in p-cresol plasma concentration (one month)
B: To maintain normal bowel function and significantly moderate or obviate Immunosuppression Associated Diarrhea following kidney transplantation, utilizing a daily questionnaire, stool cultures and C. Difficile. (5 months)
C: Evaluate the effect of synbiotic on postoperative infection after liver transplantation (15 days)
D: All-cause postoperative mortality (90 days after the date of liver transplantation); Postoperative infection (30 days from the date of liver transplantation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the Lab-score on Antibiotic Prescription Rate in Children Aged 7 Days to 3 Years Old With Fever Without Source.
Brief Summary: Detecting serious bacterial infections (SBI) in children presenting to the Pediatric Emergency Department (PED) with fever without source (FWS) is a frequent diagnostic challenge. The recently described Lab-score, based on the combined determination of Procalcitonin, C-Reactive Protein (CRP) and urine dipstick results, has been shown an accurate tool for SBI prediction on retrospective cohorts. The investigators aimed to assess the usefulness of the Lab-score in safely decreasing unnecessary antibiotic prescriptions in children with FWS, and to prospectively determine the diagnostic characteristics of the Lab-score compared to other classically used SBI biomarkers (white blood cell (WBC) count, band count and CRP).


Options:
A: Antibiotic Prescription Rate (at PED (Pediatric Emergency Department) presentation)
B: Duration of antibiotic therapy for the first episode of infection (28 days); Total antibiotic exposure days per 1,000 days (28 days); Days alive without antibiotics (28 days)
C: Change in performance between hospitals in the intervention and hospitals in the control group on the proportion of prophylaxis administered within the recommended timeframes.
D: Proportion of Appropriateness of Antimicrobial Prescriptions in each group. (10-month period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin to Augment Low Milk Supply in Pre-diabetic Mothers, a Phase I/II Randomized Clinical Trial
Brief Summary: Most new mothers in the United States will start off breastfeeding. For some mothers, despite following best practices, they are not able to meet their breastfeeding goals due to unexplained low milk supply. At the same time, nearly 1 in 4 new mothers are pre-diabetic (elevated blood sugar, but not yet diabetic). My progression of research suggests that the same metabolic factors causing pre-diabetes may also be causing low milk supply. Metformin is a widely prescribed drug to treat high blood sugar. This study is a preliminary, small scale randomized trial designed to test for a trend in the hypothesis that metformin is safe and potentially effective in treating low milk supply in insulin resistant and pre-diabetic mothers.


Options:
A: Quality of life (4 weeks); Quality of life (4 weeks); Quality of life (4 weeks); Quality of life (4 weeks)
B: Percentage of mothers who exclusively breastfeed their child (At 6 weeks postpartum)
C: Peak Change in Milk Output (baseline and 4 weeks post-intervention)
D: The Main Outcome Variable of This Study is the Quantity of Milk Produced. ("Day 0" , "Day 8")

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis
Brief Summary: Pulmonary rehabilitation is well established as a treatment in COPD. After exacerbations of COPD, rehabilitation is associated with reduced frequency of exacerbations and improved exercise capacity. No data are available in bronchiectasis.

This study will randomly assign patients with bronchiectasis exacerbations to pulmonary rehabilitation or standard care. The hypothesis is that exercise capacity will be improved by pulmonary rehabilitation at 8 weeks.


Options:
A: Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire (July 2011)
B: 6 minute walk distance (8 weeks post exacerbation)
C: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)
D: Distance, in meters, performed in the Incremental Shuttle Walk Test (up to 9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reduce Nonsteroidal Antiinflammatory Drugs Doses for Analgesia After Sternotomy
Brief Summary: Currently, the management of pain after cardiac surgery is based on the concept of multimodal analgesia: Combined use of non-opioid analgesics associated with morphine intravenous analgesia by a system controlled by the patient (patient-controlled analgesia-PCA).

The combination of paracetamol and morphine PCA is very effective on pain at rest, but is limited on pain mobilization and causes the problem of side effects associated with opioid (overdose, sedation, respiratory depression, gastrointestinal intolerance, urinary retention ...) which are contributing factors to increase the length of stay in Intensive Care Unit, an additional cost of care and an increase postoperative morbidity and mortality.

Methods that have proved their effectiveness on pain and mobilization used in postoperative cardiac surgery are: anti-inflammatory drugs (NSAIDs) and / or loco-regional analgesia techniques. NSAIDs enhance analgesia produced by PCA Morphine and allow a reduction in morphine consumption, improved postoperative pain, decreased sedation and decreased postoperative morbidity and mortality.

Adverse effects of NSAIDs are commensurate with their time and exposure dose. Consequently, NSAIDs, in the absence of against-indications, should always be prescribed and used at the lowest effective dose and for the shortest possible time.

Some studies have suggested that lower doses of NSAIDs didn't appear to affect their effectiveness. At present, the investigators have no studies that address the hypothesis from which minimum dose of ketoprofen analgesic effect is obtained.

The investigators hypothesis is that lower dose ketoprofen may have efficacy on pain in the postoperative mobilization of cardiac surgery. The investigators want to find, in their study, this "optimal" ketoprofen dose which would be the minimum dose for clinical efficacy demonstrated dose.

This optimal dose could reduce the number of adverse effects of NSAIDs, but their study will probably not have enough power to prove it. NSAID use at these low doses, in postoperative cardiac surgery, could be extended to patient populations most at risk or for a duration longer than 48 hours.


Options:
A: Pain at the mobilization (At the first 48 hours postoperatively)
B: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
C: Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery (24 Hours)
D: Evaluation of analgesic effect by 11-NRS scale (4th postoperative day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation of Telemonitoring in the Management of Acute Exacerbations of Chronic Heart Failure and Respiratory Failure/Chronic Obstructive Pulmonary Disease
Brief Summary: The aims of the study are to:

1. Implement a telemonitoring programme in heart failure and obstructive pulmonary disease (COPD) /chronic respiratory patients by assessing the real world impact of on readmissions, consults, home visits, quality of life and economic endpoints.
2. Explore the effects of telemonitoring across heart and respiratory groups with respect to i) factors that influence how patients integrate telemonitoring into their daily routines and self care behaviour and ii) how healthcare professionals use telemonitoring to aid decision- making.
3. Understand the impact of telemonitoring on a variety of care pathways.


Options:
A: Improvement tolerance capacity (4 months and 6 months)
B: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)
C: Time to first event (at 6 months)
D: Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation of Telemonitoring in the Management of Acute Exacerbations of Chronic Heart Failure and Respiratory Failure/Chronic Obstructive Pulmonary Disease
Brief Summary: The aims of the study are to:

1. Implement a telemonitoring programme in heart failure and obstructive pulmonary disease (COPD) /chronic respiratory patients by assessing the real world impact of on readmissions, consults, home visits, quality of life and economic endpoints.
2. Explore the effects of telemonitoring across heart and respiratory groups with respect to i) factors that influence how patients integrate telemonitoring into their daily routines and self care behaviour and ii) how healthcare professionals use telemonitoring to aid decision- making.
3. Understand the impact of telemonitoring on a variety of care pathways.


Options:
A: disease-specific health-related quality of life (HRQoL) (two years)
B: Time to first event (at 6 months)
C: Number of hospital admissions for exacerbations of COPD
D: Number of unscheduled hospital days (up to 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing and Testing a Culturally-Tailored Stroke Risk Factor Reduction Intervention in Community Senior Centers
Brief Summary: Stroke is a cruel disease that disproportionately kills and disables African-Americans, Latinos, Chinese-Americans and Korean-Americans; seniors with high blood pressure are at particularly high risk. There is a higher incidence of hemorrhagic stroke in African Americans, Latinos, and Chinese Americans relative to non-Latino whites. Asian-Americans have up to 1.4 higher relative risk of stroke death compared to U.S. non-Latino whites. A critical need therefore exists for a sustainable and scalable mechanism to disseminate culturally-tailored stroke knowledge/prevention education in community-based settings where large numbers of these high-risk ethnic minority older adult groups are regularly served, such as in federally funded Multipurpose Senior Centers (MPCs) that exist across the nation (16 of which are in Los Angeles alone).

The overall objective of the proposed study is to develop and test the implementation of a training program for case managers at senior centers to implement a stoke knowledge/prevention education program among four high-risk ethnic minority older adult groups--Korean-American, Chinese-American, African-American, Latinos. We propose to develop a culturally-tailored case manager training curriculum, implement the training at 4 community-based sites, and evaluate the training model using a randomized wait-list controlled trial (n=244) testing the hypothesis that training case managers will decrease older adult participants' stroke risk in a sustainable fashion through increasing their preventative behavior (i.e. increasing their physical activity--mean steps/day--at 1 and 3 months).

Findings will inform similar community-academic partnership efforts around stroke and other disease-specific prevention research/interventions; they will also determine next steps in terms of whether this case manager-centric model can be scaled up and deployed in other community-based settings.


Options:
A: Percent of Participants That Scheduled an Appointment for PrEP Consultation. (3 months); Percent of Participants That Attended an Appointment for PrEP Consultation. (3 months); Percent of Participants That Received a PrEP Prescription. (3 months); Percent of Participants That Filled Their PrEP Prescription. (3 months); Percent of Participants That Initiated PrEP Use. (3 months); Percent of Participants That Adhered to PrEP Over the Past Seven Days for Participants That Initiated PrEP (3 months); Percent of Participants That Attended PrEP Follow-up Appointment. (3 months)
B: Beck Depression Inventory- II (Assessed at every session and at the 1-month follow-up)
C: Change from Baseline in Mean steps/day at 3 months (3 months); Change from Baseline in Mean Steps/day at 1 month (1 month)
D: Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Pre Test) (Baseline); Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Post Test) (Up to 8-weeks post-treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer Tailored Education Program to Reduce Disparities in Living Donor Kidney Transplant
Brief Summary: Because of the deceased donor organ shortage, more kidney patients are considering whether to receive kidneys from family and friends, a process called living donor kidney transplantation (LDKT). Although Blacks are 3.4 times more likely to develop end stage renal disease, they are less likely to receive LDKTs. To address this disparity, this randomized controlled trial will assess whether Black and White transplant patients' knowledge and receipt of LDKTs can be increased when they receive access to the Your Path to Transplant computerized Expert System (YPT). This trial will also examine how other known patient, family, and healthcare system barriers to LDKT impact YPT's effectiveness.

Nine hundred (900) Black,White and Hispanic ESRD patients presenting for transplant medical evaluation at University of California-Los Angeles Kidney and Pancreas Transplant Program (UCLA-KPTP) in Los Angeles, California will be stratified by race and randomly assigned to one of two education conditions (YPT vs. Usual Care Education). As they undergo transplant evaluation, patients in the YPT condition will receive individually-tailored feedback reports, coaching, and socioeconomic resource guidance associated with reducing barriers to access to LDKT. Control patients will receive usual care transplant education provided by UCLA-KPTP. Changes in knowledge, readiness to pursue LDKT, pros/cons to LDKT, and self-efficacy will be assessed at four time points: prior to presenting at the transplant center (baseline), during transplant evaluation (approximately 2 months post-baseline), and 4- and 8-months post-baseline. Completion of transplant evaluation and receipt of LDKTs will be assessed 18-months post-baseline.

At the conclusion of the study, we will have developed an innovative and cost-effective YPT Computerized Expert System that could be utilized to tailor LDKT discussion and education in different medical settings based on the needs of individual patients of different races.


Options:
A: Knowledge about Living Kidney Donation (3 weeks)
B: Pursuit of Living Related Transplantation (6 months)
C: Patient LDKT Attitude & Decision-Making Measure: Readiness (up to 8 months post-Baseline)
D: enhancing rates of family communication, donor evaluations, and transplantation (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer Tailored Education Program to Reduce Disparities in Living Donor Kidney Transplant
Brief Summary: Because of the deceased donor organ shortage, more kidney patients are considering whether to receive kidneys from family and friends, a process called living donor kidney transplantation (LDKT). Although Blacks are 3.4 times more likely to develop end stage renal disease, they are less likely to receive LDKTs. To address this disparity, this randomized controlled trial will assess whether Black and White transplant patients' knowledge and receipt of LDKTs can be increased when they receive access to the Your Path to Transplant computerized Expert System (YPT). This trial will also examine how other known patient, family, and healthcare system barriers to LDKT impact YPT's effectiveness.

Nine hundred (900) Black,White and Hispanic ESRD patients presenting for transplant medical evaluation at University of California-Los Angeles Kidney and Pancreas Transplant Program (UCLA-KPTP) in Los Angeles, California will be stratified by race and randomly assigned to one of two education conditions (YPT vs. Usual Care Education). As they undergo transplant evaluation, patients in the YPT condition will receive individually-tailored feedback reports, coaching, and socioeconomic resource guidance associated with reducing barriers to access to LDKT. Control patients will receive usual care transplant education provided by UCLA-KPTP. Changes in knowledge, readiness to pursue LDKT, pros/cons to LDKT, and self-efficacy will be assessed at four time points: prior to presenting at the transplant center (baseline), during transplant evaluation (approximately 2 months post-baseline), and 4- and 8-months post-baseline. Completion of transplant evaluation and receipt of LDKTs will be assessed 18-months post-baseline.

At the conclusion of the study, we will have developed an innovative and cost-effective YPT Computerized Expert System that could be utilized to tailor LDKT discussion and education in different medical settings based on the needs of individual patients of different races.


Options:
A: Patient LDKT Attitude & Decision-Making Measure: Readiness (up to 8 months post-Baseline)
B: efficacy of PC-ACP
C: Referral for Kidney Transplantation (One Year)
D: Change in Anxiety and Depression (HADS) scores from baseline (Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Psoriatic Arthritis
Brief Summary: The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with psoriasis).


Options:
A: Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria (Week 24)
B: Proportion of patients achieving an ACR20 response. (48 weeks)
C: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)
D: Dose-Normalized AUC[0-Inf] for MTX (24 Hour period); Dose-Normalized AUC[0-24] for MTX (24 Hour period); Dose-Normalized Cmax for MTX (24 Hour period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of a Multimodal Rehabilitation Programme (MRP) for Adolescents With Chronic Musculoskeletal Pain (12-21 Years) Compared to Care as Usual (CAU); a Randomized Clinical Trial (2B Active)
Brief Summary: The purpose of this study is to evaluate whether a multimodal rehabilitation program effectively reduces functional disability in adolescents with chronic musculoskeletal pain, compared to care as usual.


Options:
A: Pain Diary - Average Daily Pain (Baseline,12 weeks, and 26 weeks); Pain Diary - Average Daily Activity Limitations (Baseline,12 weeks, and 26 weeks); Adaptive Coping - Coping Attempts (Baseline,12 weeks, and 26 weeks)
B: Change in Functional Disability (Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
C: PATIENT-RATED LOW BACK PAIN (3 and 12 months)
D: Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (Baseline (prior to randomization) and 3 months after intervention)

Answer: B