TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Diabetes Medication Choice Cards Trial in Greece
Brief Summary: A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool will serve as a facilitator for the Shared Decision Making process.


Options:
A: Adverse Drug Events (3 and 6 months)
B: Overall Decisional Comfort (0-100, 100=no Conflict) (Day 1)
C: HbA1c (12month); Blood pressure (12 month); Lipid profile (12 months); quality of life (12month)
D: First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty) (2.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Electronic Alert System for In-Hospital Acute Kidney Injury: A Randomized, Controlled Trial
Brief Summary: This study will randomize hospitalized patients with acute kidney injury (AKI) to usual care, or an electronic alert intervention. The electronic alert will be in the form of a text page that will be sent to the covering clinician and unit pharmacist once per patient with AKI at the time lab results are uploaded. The investigators hypothesize that such an alert will improve outcomes in these patients.


Options:
A: Enhanced goal-consistent care (up to 2 years); PEACE (up to 2 years)
B: Rate of HPV vaccination among girls actively cared for at participating sites (Monthly, up to 1 year)
C: Dialysis Within 7 Days (From start of AKI to 7 days later); Death (7 days of randomization); Relative Maximum Change in Creatinine (7 days of randomization)
D: HbA1c (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Electronic Alert System for In-Hospital Acute Kidney Injury: A Randomized, Controlled Trial
Brief Summary: This study will randomize hospitalized patients with acute kidney injury (AKI) to usual care, or an electronic alert intervention. The electronic alert will be in the form of a text page that will be sent to the covering clinician and unit pharmacist once per patient with AKI at the time lab results are uploaded. The investigators hypothesize that such an alert will improve outcomes in these patients.


Options:
A: Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options. (Up to 19 months)
B: Use of sun protection (6 weeks)
C: Number of patients that start home-based dialysis. (1 year)
D: Dialysis Within 7 Days (From start of AKI to 7 days later); Death (7 days of randomization); Relative Maximum Change in Creatinine (7 days of randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Brief Summary: To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.


Options:
A: Change From Baseline In The Cohen-Mansfield Agitation Inventory (CMAI) Total Score After 12 Weeks Of Brexpiprazole Treatment (Baseline, Week 12/Early Termination (ET))
B: Change From Baseline to Week 12/Early Termination in the Cohen-Mansfield Agitation Inventory (CMAI) Total Score (From screening to week 12/early termination)
C: Antipsychotic Efficacy (Day 43)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Monitoring the Efficacy and Safety of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke
Brief Summary: The goal of this study is to show the efficacy and safety of heparin and nadroparin in the acute phase of ischemic stroke. Therapeutic agents are administered at intervals of 4.5 to 2 hours after onset of clinical signs. Overall administration of anticoagulant agents will test 72 hours.

Randomized patients will be divided into three groups. The first group of patients will receive heparin intravenously at the beginning of 2500 UI bolus intravenously, followed by intravenous pump 1000 UI / h (18-20 IU / kg / hr) to reach 2-2.5 times the baseline aPTT. After 24 hours, patients will receive the group Nadroparin subcutaneously in the therapeutic dose.

Second group of patients will be administered subcutaneously Nadroparin the therapeutic dose as recommended.

The third group of patients are those who will receive placebo intravenously and 24 hours after receiving nadroparin subcutaneously in the therapeutic dose.

All patients will receive after 24 hours of starting treatment 100 mg of aspirin per orally.

For initiation of treatment will be assessed:

* Modified Rankin Scale, National Institutes of Health Stroke Scale, inclusion, exclusion criteria
* Sign the informed consent and patient randomization
* Laboratory parameters: glucose, creatinine, GGT, K, Na, Cl, blood count, basic coagulation
* Women of childbearing age (pregnancy test)
* History, clinical presentation, medical history, basic internal review of the status (blood pressure, pulse, body temperature, etc.).
* Initial CT examination of the brain
* EKG
* USG sections of extracranial carotid and vertebral arteries
* special hematology factors

If a patient meets all the necessary criteria, he may be given the test substance. During the first 24 hours will be monitored at regular intervals vital functions.

After 24 hours, each patient received subcutaneous Nadroparin the therapeutic dose and also 100 mg of aspirin per orally.

In the interval from 24 to 30 hours of starting treatment the patient will be made:

* Control CT brain
* EKG
* Basic coagulation
* Reduction to stop treatment for newly identified haemorrhage or severe and extensive focal cerebral ischemia by CT scan
* special hematology factors

  72 hours, 7, 30 and 90 days after starting treatment, the patient's clinical evaluation using the Modified Rankin Scale, National Institutes of Health Stroke Scale and Barthel Index.

Safety endpoints: mortality, adverse side effects, bleeding


Options:
A: Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism) (10 ± 4 days following acute ischemic stroke)
B: Safety of nadroparine or heparin (DAY 3,7,30,90); Efficacy of nadroparine or heparin (DAY 3,7, 30, 90)
C: Number of Participants With Composite of Stroke/MI/Death (From randomization up to 97 days)
D: Composite of Subsequent Stroke or Death (From randomisation (day 1) to visit 3 (day 30-34))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Sit-Stand Workstations on Physical Activity in Sedentary Office Workers: A Randomized Crossover Trial
Brief Summary: The purpose of this study was to determine whether the installation of sit-stand work stations could lead to decreased sedentary time and increased physical activity during the workday among sedentary office workers.


Options:
A: Acceptability and feasibility (3 weeks)
B: Change in objective measure of degree of physical activity (baseline, 12 weeks, 6 months)
C: Mean Change in Light-intensity Physical Activity at Work From Baseline to 12 Months (1 year); Mean Change in Sitting Time at Work From Baseline to 12 Months (1 year)
D: non-exercise activity (Measured constantly during the entire control period and measured constantly during the entire intervention period and the two periods were compared to determine change in non-exercise activity)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Sit-Stand Workstations on Physical Activity in Sedentary Office Workers: A Randomized Crossover Trial
Brief Summary: The purpose of this study was to determine whether the installation of sit-stand work stations could lead to decreased sedentary time and increased physical activity during the workday among sedentary office workers.


Options:
A: non-exercise activity (Measured constantly during the entire control period and measured constantly during the entire intervention period and the two periods were compared to determine change in non-exercise activity)
B: Change from control week and intervention week in total energy expenditure (TEE) (week 1 and week 2); Resting energy expenditure (REE) (Baseline (day 0)); Change from control week and intervention week in physical activity energy expenditure (PAEE) (week 1 and week 2); Change from control week and intervention week in daily time spent in sedentary (SB) (week 1 and week 2); Change from control week and intervention week in light (LIPA), moderate and vigorous (MVPA) intensity activities (week 1 and week 2); Change from control week and intervention week in number of breaks in sedentary time (BST) (week 1 and week 2); Change from control week and intervention week in time spent sitting (TSS) (week 1 and week 2); Change from control week and intervention week in time spent standing (TSst) (week 1 and week 2); Change from control week and intervention week in time spent walking (TSW) (week 1 and week 2); Change from control week and intervention week in number of steps (week 1 and week 2)
C: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)
D: Change in Occupational Physical Activity From Baseline to 16 Weeks (Baseline and 16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Sit-Stand Workstations on Physical Activity in Sedentary Office Workers: A Randomized Crossover Trial
Brief Summary: The purpose of this study was to determine whether the installation of sit-stand work stations could lead to decreased sedentary time and increased physical activity during the workday among sedentary office workers.


Options:
A: Change from baseline in workplace sitting time at 4 and 8 weeks (Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks))
B: change in physical activity (4 months)
C: non-exercise activity (Measured constantly during the entire control period and measured constantly during the entire intervention period and the two periods were compared to determine change in non-exercise activity)
D: Change from baseline occupational sitting time (minutes/day) at post-intervention (19 weeks) and two months follow-up. (Baseline,19 weeks, two months follow-up); Change from baseline step counts (steps/day) at post-intervention (19 weeks) and two months follow-up (Baseline,19 weeks, two months follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children Aged 6-59 Months in the Mirria District, Niger
Brief Summary: The objective of this study is to determine the efficacity of a community strategy for screening children 06-59 months old for Severe Acute Malnutrition (SAM) conducted by their mothers' compared with a community screening strategy conducted by Community Health Workers.


Options:
A: Product sales and use (coverage) (Every 2 weeks)
B: HIV (Last 3 months); Hypertension (Last 3 months); Asthma (Last 3 months); Diabetes (Last 3 months); Epilepsy (Last 3 months); Mental Health (Last 3 months); Malnutrition (Last 3 months); Tuberculosis (Last 3 months); Family Planning (Last 3 months); Antenatal Care (Last 3 months)
C: Number of death in children aged 6 to 59 months (12 months)
D: The coverage of the therapeutic nutritional program in the control and intervention health districts (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Mode of Therapy in Acute Decompensated Heart Failure:Comparison Between Usual Care Plus Tolvaptan and Ultrafiltration.
Brief Summary: For patients hospitalized with acute decompensated heart failure,volume removal remains the primary therapeutic objective. The current standard of care remains loop diuretics.The high likelihood of readmissions and poor outcomes highlights the need to examine and improve in-hospital protocols for these patients. Ultrafiltration allows for greater volume removal, less neurohormonal stimulation and greater sodium removal.However it is associated with increased costs, line complications, and relative immobility during treatment. Tolvaptan in addition to diuretic therapy has been shown to improve the amount of volume removed compared to diuretic alone.

The study proposes to compare the strategy of adding tolvaptan to usual care with ultrafiltration as primary mode of therapy in acute decompensated HF(ADHF) patients.

Hypothesis: addition of tolvaptan to usual care for hospitalized HF patients will result in:

* greater volume and weight reduction compared with usual care
* similar efficacy outcomes compared with ultrafiltration, with less complications of therapy


Options:
A: Cardiac death and rehospitalization for HF (180 days)
B: Evaluate the number and percentage of eligible patients who are discharged on optimal therapy. Evaluate all HF indicators recommended by JCAHO and CMS.
C: Total weight loss during first 48 hours of randomization; Change in dyspnea score during first 48 hours of randomization
D: Net change in weight (day 1,2,3,4,5)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage
Brief Summary: Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative treatment when Oxytocin isn't available. The aim of this study is to compare the safety and efficacy of Oxytocin and misoprostol for prevention of PPH.


Options:
A: Incidence of PPH (24 hours after birth)
B: Amount of bleeding (1 hour)
C: Mean change in hemoglobin (during 3rd trimester and 1-3 days postpartum)
D: To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section (an expected average 1 week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage
Brief Summary: Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative treatment when Oxytocin isn't available. The aim of this study is to compare the safety and efficacy of Oxytocin and misoprostol for prevention of PPH.


Options:
A: Amount of bleeding (1 hour)
B: Occurrence of post partum hemorrhage > 500mL in 1 hour (1 HOUR)
C: postpartum bleeding in the third stage of labour (participants will be followed for the duration of hospital stay, an expected average of 48 hours)
D: Blood loss =>500 mls within one hour after enrollment

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging
Brief Summary: Prostate cancer has been the most common cancer in men in Finland over the last ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection. Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS) guided biopsy. Due to the low accuracy of TRUS, a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a risk of increase in complications, there is an increasing interest in developing more accurate non-invasive imaging modalities.

This study will enroll 150 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination. Multiparametric magnetic resonance imaging (mpMRI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.


Options:
A: 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)
B: Feasibility of using electromagnetic devices in different cohorts. (Day 1)
C: 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)
D: Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Medicines Advice Service: A Randomised Controlled Trial of a Pharmacy-based Telephone Intervention to Support Patients Taking Medication for a Long-term Condition
Brief Summary: The purpose of this study is to find out whether talking to a pharmacist on the telephone can help to support people taking medicine for a long-term condition.


Options:
A: Medication Adherence (Two months)
B: Mean Severity-weighted Admission Medication History (AMH) Error Score (Attempted to obtain the day after admission)
C: Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins (One year from inclusion)
D: Self-reported medication adherence (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Remote Ischaemic Preconditioning and Glyceryl Trinitrate on Peri-operative Myocardial Injury in Cardiac Bypass Surgery Patients (ERIC-GTN Study)
Brief Summary: The purpose of this study is to determine whether Glyceryl Trinitrate (GTN) reduces injury to the heart during heart-lung bypass surgery in combination with the newer technique of remote ischaemic preconditioning (RIPC).


Options:
A: Troponin T area under the curve (72 hours)
B: Troponin-T release over the perioperative 72-hour period. (3 days)
C: Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure (In-hospital)
D: Major adverse cardiac and cerebral events (One year post-surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol - A Randomized Trial
Brief Summary: The open abdomen is a valid and accepted surgical tactic for the trauma and acute care patient. There have been many mechanisms described for its management, but the most accepted strategy is the vacuum pack. At our hospital the investigators have used for many years a double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial operation. At subsequent surgeries once the abdomen is clean the investigators leave the same subfascial sylo bag and use a prolene mesh attached to the fascia. Every day the investigators try to tighten the mesh with sutures until the abdomen can be closed. This study´s objective is to compare our double sylo bag- mesh protocol with the vacuum pack to determine which is related to a higher fascial closure rate.


Options:
A: The numbers of participants who are survival in hospital stay (90 days after participants enrolled in the study)
B: Indications to open abdomen (Enrollment); Techniques to perform open abdomen (Enrollment); Management of open abdomen (Visit 2); Definitive closure techniques (Visit 4)
C: Systemic inflammatory marker levels and peritoneal fluid inflammatory marker levels (admission to dicharge, expected average of hospital stay 4 weeks.)
D: Fascial Closure Rate (Until hospital discharge Aprox 60 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Post-abortion Care and Contraceptive Counselling by Midwives or Physicians - a Randomized Controlled Trial in Kisumu, Western Kenya
Brief Summary: The aim of this project is to study the safety, efficacy and effectiveness of medical treatment of incomplete abortion provided to women by physicians or midwives in Kisumu, Kenya.

In Kenya, Post Abortion Care (PAC), provided by physicians, nurse-midwives and clinical officers, has been integrated at private reproductive health facilities since 1998. Misoprostol as treatment of incomplete abortion was launched I Nyanza Province in April, 2012. The involvement of midwives in medical (Misoprostol) treatment of incomplete abortion has, however, not been systematically evaluated. There is a need to determine whether midwives and physician can perform medical treatment of incomplete abortion equally safe and effective in Kenya. The results will thus provide evidence-based information that can contribute to the development of strategies to increase women's access to Post Abortion Care in Kenya as well as in other low-income contexts.


Options:
A: Complete abortion without recourse to surgical intervention. (follow up visit 7 days after initial treatment)
B: Complete abortion requiring no further medical or surgical intervention. (7-10 days after intervention)
C: -The main outcome measures will be the induction time, defined as the time from placement of the first dose of misoprostol until the time of delivery of the fetus. (48 hours)
D: Complete abortion (14 days)

Answer: B