TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes - A Pilot Cluster Randomized Controlled Trial
Brief Summary: Diabetes care is complicated for people with diabetes as well as for health care providers: they have to watch their diet, exercise, take medications, checking blood sugars and blood pressure, get tests and see multiple doctors. On top of that, many with diabetes have other health problems, such as high blood pressure or arthritis, that make care even more complicated. Guidelines for improving the care of people with diabetes try to help by summarizing the best practices for care, but because diabetes care is so complicated, it is hard for them to be put into practice. One solution to this is a tool that can help people with diabetes set health care goals that are important to them, and participate actively in decisions about their own health care, together with health care providers. This tool would have an information booklet for patients with facts that can help them make a decision, a worksheet to help spell out what their goals are and how they want to get there, and a cheat-sheet for health care providers that gives them tips on how to do this. The purpose of this project is to find out if a tool like this would be helpful, how to make it more helpful and usable, and what the best way would be to make sure that people use it.

An interprofessional (IP) shared decision-making (SDM) and goal-setting tool kit, including a 1-page provider enabler, a point-of-care worksheet and a patient workbook, can be implemented successfully in clinical practice and will reduce decisional conflict and diabetes distress and improve chronic care delivery and quality of life in patients with type 1 or type 2 diabetes and 2 other comorbid chronic diseases. The investigators hypothesize that patients in the intervention arm of the study will have reduced decisional conflict and diabetes distress, and improved decision-making satisfaction, chronic care delivery and quality of life.


Options:
A: Decisional Conflict in Patients With Diabetes (This outcome is measured at 0, 6 and 12 months.)
B: Medication start/stop, knowledge, and patient involvement. (Baseline and at 6 months)
C: The between groups difference in the proportion of patients which achieve the treatment goals for HbA1c, blood pressure, and total cholesterol (after 12 months)
D: Decision to Receive an ICD (1 week post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
Brief Summary: Polypharmacy increases the risk of adverse drug effects, interactions and other drug-related problems, and several studies indicate that inappropriate drug use is a major reason for poor health and impaired function in the elderly. A majority of interventions for improvement of drug treatment in the elderly have been evaluated by the use of surrogate outcomes such as drug-related problems, number of prescribed drugs or prevalence of potentially inappropriate prescriptions - and it is so far unclear whether such interventions can result in clinical significant improvements. The primary objective of this trial is therefore to evaluate the effect upon patients, relatives and local health care service of a structured cooperation between a hospital-based geriatrician and family physicians on complex drug regimens in home-dwelling frail elderly patients.


Options:
A: Progress attaining health goals (12 months)
B: Functional status; health status; hospitalization and nursing home placement
C: Health-related quality of life as measured with 15D (16 weeks)
D: Health care utilization including EMR, hospital admissions, care days, out patient hospital or primary care (Change from 1 year before inclusion to 1 year follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
Brief Summary: Polypharmacy increases the risk of adverse drug effects, interactions and other drug-related problems, and several studies indicate that inappropriate drug use is a major reason for poor health and impaired function in the elderly. A majority of interventions for improvement of drug treatment in the elderly have been evaluated by the use of surrogate outcomes such as drug-related problems, number of prescribed drugs or prevalence of potentially inappropriate prescriptions - and it is so far unclear whether such interventions can result in clinical significant improvements. The primary objective of this trial is therefore to evaluate the effect upon patients, relatives and local health care service of a structured cooperation between a hospital-based geriatrician and family physicians on complex drug regimens in home-dwelling frail elderly patients.


Options:
A: Proportion of older ED patients who receive a potentially inappropriate medication (During discharge home from the ED)
B: The primary outcome measure will be the "improvement" of prescribing for efficacious therapies in patients with a chronic cardiovascular disease within six months of the intervention.
C: Number of patients with at least one preventable medication error (Day 1 (medical prescription at hospital admission)); Number of patients with at least one preventable medication error (Phase 2 (maximum 105 days))
D: Health-related quality of life as measured with 15D (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
Brief Summary: Polypharmacy increases the risk of adverse drug effects, interactions and other drug-related problems, and several studies indicate that inappropriate drug use is a major reason for poor health and impaired function in the elderly. A majority of interventions for improvement of drug treatment in the elderly have been evaluated by the use of surrogate outcomes such as drug-related problems, number of prescribed drugs or prevalence of potentially inappropriate prescriptions - and it is so far unclear whether such interventions can result in clinical significant improvements. The primary objective of this trial is therefore to evaluate the effect upon patients, relatives and local health care service of a structured cooperation between a hospital-based geriatrician and family physicians on complex drug regimens in home-dwelling frail elderly patients.


Options:
A: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)
B: Number of patients with medications discontinued, reduced dose or changed. (baseline, 3, 6 and 12 months); Number of discontinued medications, changed or changing doses. (baseline, 3, 6 and 12 months)
C: Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 3 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 6 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 12 months); Change from baseline in fall rate (Change from baseline in fall rate at 3 months); Change from baseline in fall rate (Change from baseline in fall rate at 6 months); Change from baseline in fall rate (Change from baseline in fall rate at 12 months)
D: Health-related quality of life as measured with 15D (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Home-based or Center-based Aerobic Exercise on Physical Function, Nutritional Status Ans Cardiopulmonary Parameters in Patients With Chronic Kidney Disease
Brief Summary: Patients will be randomly assigned to perform the training program in center or home-based . The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine. All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes). The program will consist of 24 weeks with three sessions per week on alternate days. The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks. The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways. The intensity control was done by means of the heart rate value obtained at ventilatory threshold.

Both groups receive the same intervention. However, a group exercise held in the center on a treadmill with the direct supervision of a physical education teacher. The other group will exercise at home with telephone follow-up weekly and once a month will be held at the training center under the supervision of a physical education teacher.

It will also constituted a control group remain without performing any activity during the study period. After 24 weeks patients receive the same advice the team conducting the training at home.


Options:
A: Change in Proteinuria (12 weeks minus baseline); Change in Proteinuria (52 weeks minus baseline)
B: Weight in kgs will be obtained using a single, calibrated scale (Change from baseline in weight at 6 months); Serum phosphorus will be evaluated from a venipuncture sample (Change from baseline in Serum Phosphourous at 6 months); Urinary sodium will be determined from a time 24-hour urine sample (Change from baseline in Urinary sodium at 6 months); Weight in kgs will be obtained using a single, calibrated scale (Change from baseline in weight at 12 months); Serum phosphorus will be evaluated from a venipuncture sample (Change from baseline in Serum phosphorus at 12 months); Urinary sodium will be determined from a time 24-hour urine sample (Change from baseline in Urinary sodium at 12 months)
C: Cardiopulmonary capacity (24 weeks); Functional capacity (walk, sit-stand, arm curl, sit-reach, back scratch, timed up and go) (24 weeks)
D: Percentage change of 24-hour proteinuria (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Analgesic Efficacy of Preoperative Oral Administration of Dexketoprofen Trometamol in Third Molar Surgery, Compared to Postoperative Administration
Brief Summary: The purpose of the present investigation is to evaluate the effectiveness of the preoperative administration of Dexketoprofen Trometamol, employing the third molar surgery model, when compared to postoperative administration of the same drug. It was hypothesized that preoperative oral Dexketoprofen trometamol will reduce the intensity of pain by 30% after 8 hours of the surgery, when compared with post-operative administration.


Options:
A: Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing. (6 hours)
B: SPID8 (Sum of Pain Intensity Differences Over 8 Hours) (over 8 hours after the first dose)
C: Postoperative pain measurement employing a previous validated visual analogue scale of pain (VAS). (72 hours)
D: SPID8 (Sum of Pain Intensity Differences Over 8 Hours) (over 8 hours after the first dose)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Analgesic Efficacy of Preoperative Oral Administration of Dexketoprofen Trometamol in Third Molar Surgery, Compared to Postoperative Administration
Brief Summary: The purpose of the present investigation is to evaluate the effectiveness of the preoperative administration of Dexketoprofen Trometamol, employing the third molar surgery model, when compared to postoperative administration of the same drug. It was hypothesized that preoperative oral Dexketoprofen trometamol will reduce the intensity of pain by 30% after 8 hours of the surgery, when compared with post-operative administration.


Options:
A: Total morphine consumption (At 48 hour postoperative)
B: Morphine consumption the first 24 hours postoperatively (0-24 hours postoperatively); Serious adverse events (0-90 days postoperatively)
C: Cumulative use of morphine as assessed within first 48 hours after surgery (first 48 hours)
D: Postoperative pain measurement employing a previous validated visual analogue scale of pain (VAS). (72 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Trans-rectal Ultrasound Guided Biopsy for the Diagnosis of Prostate Cancer in Men Without Prior Biopsy
Brief Summary: This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each participant will be randomly allocated to one of the biopsy tests.

We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS biopsy.


Options:
A: Detection of "clinically significant cancer" (using definition A, i.e. Gleason ≥7 cancers) in at least one core of SB or TB. (Between 1 and 4 months after the enrollment)
B: Proportion of men with clinically significant detected (When histology results available, at an expected average of 30 days post-biopsy)
C: Safety of multiparametric magnetic resonance imaging (MP-MRI); Recruitment; Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values; Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values
D: Number of men who could avoid repeat biopsy as determined by the Negative predictive value and specificity of mp-MRI for Clinically significant disease. (18 months); Number of men who could avoid repeat biopsy as determined by the negative predictive value and specificity of Prostate HistoScanning for Clinically significant disease. (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Educational Intervention to Improve Effectiveness in the Detection, Treatment and Control of Patients With High Cardiovascular Risk in Low-resource Settings in Argentina: Rationale and Study Design of a Cluster Randomized Controlled Trial.
Brief Summary: Hypercholesterolemia, a major cause of disease burden in both the developed and developing world, is estimated to cause 2.6 million deaths annually (4.5% of all deaths) and one third of ischemic heart diseases., and result in 29.7 million DALY lost. In Argentina, the prevalence of hypercholesterolemia increased between 2005 and 2013 from 27.9% to 29.8%, whereas the rate of non-optimal LDL-C, was 28.0%. The rate of high cholesterol awareness was 37.3 % and the proportion of those who are under pharmacological treatment was dismally low: only 11.1%. Furthermore, only one out of four subjects with a self-reported diagnosis of coronary heart disease (CHD) is taking statins. and most individuals with CHD who are on statins have sub-optimal LDL-C levels. Although other antihypertensive, antidiabetic and low-dose aspirin were available free-of-charge at the primary care clinics of the public sector, statins had not been included until recently. As of 2014, statins (simvastatin 20mg) were incorporated into the package of drugs provided free-of-charge for patients with high cholesterol, according to CVD risk stratification. The goal of this study is to test whether a multifaceted educational intervention targeting physicians and pharmacist assistants, improves detection, treatment and control of hypercholesterolemia among uninsured patients with moderate to high cardiovascular risk in Argentina. Specifically, the intervention will test whether a multifaceted educational intervention program lowers LDL-cholesterol levels and CVD risk in moderate to high cardiovascular risk patients, improves physician compliance with clinical practice guidelines, and improves patient care management and adherence to medication. A cost-effectiveness study will be conducted to compare the intervention to the usual standard of care. This randomized cluster trial will enroll 350 patients from 10 public primary care clinics who will be assigned to receive either the intervention or the usual care. This study is timely and will generate urgently needed data on effective and, practical and sustainable intervention programs aimed at the prevention and control of CVD risk that can be directly used in other primary care settings and health care systems in LMICs.


Options:
A: Difference in Change in Systolic Blood Pressure- 12 Months (12 months)
B: Medication Adherence (12 months)
C: Cholesterol Level (1 year)
D: Change in Mean Systolic Blood Pressure (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcranial Magnetic Stimulation and/or Neurofunctional Electrical Acupuncture in the Rehabilitation of Patients With Myofascial Chronic Pain
Brief Summary: To evaluate the hypothesis: the effects of repetitive transcranial magnetic (rTMS) stimulation and/or peripheral stimulation (neurofunctional electrical acupuncture) treatments are more effective in pain relief than placebo-sham in patients with myofascial chronic pain.


Options:
A: Change From Baseline in Visual Analogue Scale (VAS) for Pain Change From Baseline (On a weekly basis: 1) Day 1 (first day of tDCS). 2) Day 8 (after first week with post 5 consecutive sessions of tDCS followed by 2 consecutive days without tDCS). 3) Day 15 (after second week post another 5 sessions of tDCS followed by 2 consecutive days)
B: Change in Pain Scale (Measured for approximately 6 months)
C: Change in pain Scores as measured by the Visual Analog Scale (2 months)
D: Pain severity (up to three months after the end of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcranial Magnetic Stimulation and/or Neurofunctional Electrical Acupuncture in the Rehabilitation of Patients With Myofascial Chronic Pain
Brief Summary: To evaluate the hypothesis: the effects of repetitive transcranial magnetic (rTMS) stimulation and/or peripheral stimulation (neurofunctional electrical acupuncture) treatments are more effective in pain relief than placebo-sham in patients with myofascial chronic pain.


Options:
A: Pain severity (up to three months after the end of treatment)
B: Analgesic efficiency (36 months)
C: Average Pain (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up); THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up); THE HAMILTON DEPRESSION RATING SCALE (HRDS) (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up)
D: Change in pain Scores as measured by the Visual Analog Scale (2 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Ultrasound Guided Femoral Nerve Blockade and Standard Parenteral Opioid Pain Management Alone in Patients With Hip Fracture in the Emergency Department
Brief Summary: The goal of the study is to evaluate whether pain control achieved by Ultrasound Guided Femoral Nerve Blockade (USFNB) is equal in efficacy to standard pain management practice of parenteral injection of opioid pain medication in patients presenting to the emergency department (ED) with hip fracture.


Options:
A: Pain level (Pre operatively); Pain medication requirement (Pre operatively); Pain level (Four hours after surgery); Pain medication requirement (Four hours after surgery); Pain level (One day after surgery); Pain medication requirement (One day after surgery); Pain level (Two days after surgery); Pain medication requirement (Two days after surgery); Pain level (Three days after surgery); Pain medication requirement (Three days after surgery)
B: pain intensity reduction (4 hours after initiation of study proceduure)
C: Postoperative Pain Score at Resting (Postoperative 48 hours); Postoperative Pain Score With Movement (Postoperative 48 hours)
D: Respiratory complications (During hospital stay, up to 1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension
Brief Summary: 24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.


Options:
A: change from baseline in 6-min-walk distance (6-MWD) (12 weeks)
B: Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. (From baseline to Week 16)
C: Relative Change From Baseline to Week 12 in Pulmonary Vascular Resistance (PVR). (From enrollment/baseline to Week 12 in the Double Blind (DB) treatment period)
D: exercise capacity (Baseline to end of study); cardiac hemodynamics (Baseline to end of study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction
Brief Summary: Proven treatments exist that improve quality of life and reduce the risk of repeat heart attacks or death amongst persons who have already had one heart attack. These treatments include medications and supervised cardiac rehabilitation programs. Unfortunately, research shows that many people who have had a heart attack do not stick with these treatments and therefore cannot benefit. This quality improvement research program seeks to understand the impact of interventions that could be readily implemented at scale by entire health systems or organizations wishing to improve adherence to proven treatments. Specifically, the trial will test whether providing Ontario-based patients (and their health professionals) with repeated educational reminders delivered via post and phone will help improve the use of medications or attendance at cardiac rehabilitation. During the project, the types of patients who are most responsive will be identified as will the most cost-effective strategy for delivering reminders. The trial team are partnering in this project with health system decision makers who have an interest in using the results to create standard operating procedures that could benefit patients across the province.


Options:
A: the percentage change from baseline to 6 months (%Δ) in echocardiographic LV end-diastolic volume index (LVEDVi) (baseline and 6 months)
B: Medication adherence (12 months post-MI); Cardiac rehabilitation completion (12 months post-MI)
C: flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN (6 months)
D: Peripheral blood gene expression (baseline); Peripheral blood gene expression (6wks after starting 12week exercise training (or conventional care)); peripheral blood gene expression (12 weeks after exercise training (or conventional care)); Peripheral blood gene expression (24 weeks after starting 12 weeks exercise training programme)

Answer: B