TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Persistent MRSA Eradication Protocol (PMEP)
Brief Summary: The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests that persistent infection with MRSA may result in an increased rate of decline in Forced Expiratory Volume (FEV)1 and shortened survival. Currently there are no conclusive studies demonstrating an effective aggressive treatment protocol for persistent MRSA respiratory infection in CF. Data demonstrating an effective and safe method of clearing persistent MRSA infection are needed.

The purpose of this study is to evaluate the safety and efficacy of a 28-day course of vancomycin for inhalation, 250 mg twice a day, (in combination with oral antibiotics) in eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA infection. Subjects will be assigned in a 1:1 ratio to either vancomycin for inhalation (250 mg twice a day) or taste matched placebo and will be followed for 3 additional months. In addition, both groups will receive oral rifampin, a second oral antibiotic (TMP-SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Forty patients with persistent respiratory tract MRSA infection will be enrolled in this trial.


Options:
A: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture (Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol)
B: MRSA Culture Status (Day 28)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Multi-Centre, Phase II, Dose-ranging Clinical Study to Assess the Safety and Efficacy of Fixed Dose, Orally Administered Pyronaridine and Artesunate (3:1) in Adult Patients With Acute Uncomplicated Plasmodium Falciparum Malaria
Brief Summary: The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa. Secondary trial objectives are to determine the safety of once-daily dosing for 3 days of PA and to explore possible ethnic differences in safety or efficacy.


Options:
A: PCR-Corrected ACPR at Day 28 (Day 28)
B: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
C: result of PCR (42 day)
D: Percentage of Patients With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Multi-Centre, Phase II, Dose-ranging Clinical Study to Assess the Safety and Efficacy of Fixed Dose, Orally Administered Pyronaridine and Artesunate (3:1) in Adult Patients With Acute Uncomplicated Plasmodium Falciparum Malaria
Brief Summary: The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa. Secondary trial objectives are to determine the safety of once-daily dosing for 3 days of PA and to explore possible ethnic differences in safety or efficacy.


Options:
A: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
B: PCR-Corrected ACPR at Day 28 (Day 28)
C: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
D: parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) (June 2008)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Multi-Centre, Phase II, Dose-ranging Clinical Study to Assess the Safety and Efficacy of Fixed Dose, Orally Administered Pyronaridine and Artesunate (3:1) in Adult Patients With Acute Uncomplicated Plasmodium Falciparum Malaria
Brief Summary: The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa. Secondary trial objectives are to determine the safety of once-daily dosing for 3 days of PA and to explore possible ethnic differences in safety or efficacy.


Options:
A: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
B: Crude Cure Rate on Day 14 (Day 14)
C: PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 (Day 28)
D: PCR-Corrected ACPR at Day 28 (Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Olive Oil's Cream Effectiveness in Prevention of Pressure Ulcers in Immobilized Patients in Primary Care.A Cluster Randomized Clinical Trial.
Brief Summary: Pressure ulcers (UPP) represent an important sanitary problem affecting mostly elderly immobilized persons, increasing the burden of care to professionals in the health system, as well as pharmaceutical spending. There are studies of the effectiveness of various products in the prevention of the UPP, most made in hospitals and using fundamentally composed based on oily hyperbecome oxygenated acids (AGHO).

There do not exist studies realized specifically with cream of olive oil.

AIMS:

Principal: To verify the efficiency of a new intervention of UPP's prevention in immobilized patients consisting in the application of cream of olive oil. Secondary: To evaluate the cost - efficiency of this new intervention opposite to AGHO's application.

To value the degree of satisfaction of the patient and his keeper with regard to the use of cream of olive oil.

METHODOLOGY DESIGN: clinical Test randomized with two parallel branches. AREA: Population consultant of the health centers in the province of Malaga. SUBJECTS OF STUDY: Patients immobilized at the risk of developing UPP. INTERVENTION: Administration of cream of olive oil to the group of intervention and AGHO's administration to the group control. Follow-up for one year. VARIABLES. Principal variable: UPP's appearance. Secondary: Demographic and clinical data, presence of technical supports, information of the caragiver and questionnaire of satisfaction. STATISTICAL ANALYSIS: Test. Exact of Fischer. Odds's calculation ratio. Shapiro-Wilk's test. Parametric test t- student or test U of Mann-Whitney. Reason of the increase cost efficiency (ICER). Logistic regression model multivariant.


Options:
A: Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion) (Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
B: Appearance grade II pressure ulcers (48 months)
C: rate of pressure injury from nasogastric tube (Each participant will be followed for 18 days)
D: Rate of any type of pressure ulcer in the sacral area. (On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Postoperative Hydrocortisone on Cardiovascular and Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass
Brief Summary: This protocol is designed to offer insight into critical illness related corticosteroid insufficiency and steroid supplementation in neonates undergoing cardiac surgery with cardiopulmonary bypass by administering exogenous steroids in the immediate post-operative period.


Options:
A: Mortality at 30 days (30 days post-randomization); Composite (30 days post-randomization)
B: Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome (Until hospital discharge, up to 4 months)
C: Incidence of Low Cardiac Output Syndrome (LCOS) (first 48 hours after cardiac intensive care unit (CICU) admission post-op)
D: Difference in occurrence of postoperative cognitive dysfunction between control and intervention group at six days after surgery as determined by using a validated battery of cognitive tests (9 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Autologous Immunomagnetic Selected cd133+ Cells in the Treatment of No-option Critical Limb Ischemia: Clinical and Ceus Assessed Results.
Brief Summary: Aim: to value the safety and efficacy of local intramuscular administration of immunoselected autologous endothelial progenitor cells in the treatment of critical limb ischemia in patients without revascularization options.

Primary goal: to value the feasibility of mobilization, harvesting, immunoselection and auto transplantation of endothelial progenitor cells.

Secondary goal: to value the efficacy of local administration of autologous endothelial progenitor cells in the treatment of critical limb ischemia


Options:
A: Therapy Success (6 months)
B: The safety of MultiGeneAngio will be assessed by monitoring adverse events (Up to 15 years after treatment)
C: Contrast enhanced ultrasound (CEUS) (3-6-12 months)
D: side effects (3months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adding Liraglutide to the Backbone Therapy of Biguanide in Patients With Coronary Artery Disease and Newly Diagnosed Type-2 Diabetes
Brief Summary: The purpose of this study is to investigate the effect of combined glucagon-like-peptide-1 (GLP-1) analogue and metformin therapy on glucose metabolic and cardiovascular endpoints compared to metformin monotherapy in patients with coronary artery disease (CAD) and newly diagnosed type 2 diabetes (T2D).

It is hypothesized that GLP-1 analogue added to backbone therapy of metformin in CAD patients with T2D will improve beta-cell function, left ventricular ejection fraction (LVEF), heart rate variability and lower 24h blood pressure among other selected endpoints.

The present study on CAD patients with newly diagnosed T2D will address these selected endpoints during an investigator initiated, randomized, double blind, crossover, placebo-controlled 12 + 12 weeks intervention study with a 2 week wash-out period.


Options:
A: Beta-cell function (after 12 weeks of intervention); LVEF (after 12 weeks of intervention)
B: Change in low-density lipoprotein cholesterol (52-weeks); Change in glycated hemoglobin (52-weeks)
C: Confirmed Clinical Neuropathy (CCN) (18 Months)
D: The First 3-point Major Adverse Cardiovascular Events (3P-MACE) (From randomization until individual day of trial completion, up to 432 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization
Brief Summary: The purpose of this study is to test if an early appointment (within 10 days) when compared to a standard appointment (5 weeks) will affect attendance at the Cardiac Rehabilitation orientation and subsequent enrollment into cardiac rehabilitation.


Options:
A: Health-related Quality of Life (SF-36v2-acute Form) (9 weeks)
B: Mortality rate (10-year)
C: Cardiopulmonary function (Measured at Week 8)
D: Attendance at the free orientation session for Cardiac Rehabilitation (within 5 weeks of randomized apointment date)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment
Brief Summary: Previous studies about cognitive intervention targeting older adults revealed that cognitive training had effects on the improvement of cognitive function.However, researches are rare that investigated direct changes of brain structures after cognitive training.

The advanced scientific technique allowed us to develop service robots designed to assist human work, which can be important with an increase in the aging population and high costs of elderly care. In this regard, the investigators considered robots for elderly's cognitive training and developed 17 cognitive programs in collaboration with Center for Intelligent Robotics at Korea Institute of Science and Technology.

The purposes of this study were to demonstrate the effects of the investigators newly developed robot assisted group cognitive training programs on the brain in older adults and to identify whether they can help to improve cognitive function or mood in the elderly compared to the conventional cognitive training or control group that were not involved in any cognitive training.


Options:
A: Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests. (Changes from baseline at 4 months in z-scores.)
B: Aggregate Cognitive Performance (Baseline to 10 weeks)
C: the change in cortical thickness between the baseline and the post-intervention assessment. (between the baseline and the post-intervention assessment (12 week training))
D: Activity Compliance (Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment
Brief Summary: Previous studies about cognitive intervention targeting older adults revealed that cognitive training had effects on the improvement of cognitive function.However, researches are rare that investigated direct changes of brain structures after cognitive training.

The advanced scientific technique allowed us to develop service robots designed to assist human work, which can be important with an increase in the aging population and high costs of elderly care. In this regard, the investigators considered robots for elderly's cognitive training and developed 17 cognitive programs in collaboration with Center for Intelligent Robotics at Korea Institute of Science and Technology.

The purposes of this study were to demonstrate the effects of the investigators newly developed robot assisted group cognitive training programs on the brain in older adults and to identify whether they can help to improve cognitive function or mood in the elderly compared to the conventional cognitive training or control group that were not involved in any cognitive training.


Options:
A: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)
B: Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (Comparison in the change of RBANS total score from baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group)
C: the change in cortical thickness between the baseline and the post-intervention assessment. (between the baseline and the post-intervention assessment (12 week training))
D: Global cognitive functioning (26 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment
Brief Summary: Previous studies about cognitive intervention targeting older adults revealed that cognitive training had effects on the improvement of cognitive function.However, researches are rare that investigated direct changes of brain structures after cognitive training.

The advanced scientific technique allowed us to develop service robots designed to assist human work, which can be important with an increase in the aging population and high costs of elderly care. In this regard, the investigators considered robots for elderly's cognitive training and developed 17 cognitive programs in collaboration with Center for Intelligent Robotics at Korea Institute of Science and Technology.

The purposes of this study were to demonstrate the effects of the investigators newly developed robot assisted group cognitive training programs on the brain in older adults and to identify whether they can help to improve cognitive function or mood in the elderly compared to the conventional cognitive training or control group that were not involved in any cognitive training.


Options:
A: the change in cortical thickness between the baseline and the post-intervention assessment. (between the baseline and the post-intervention assessment (12 week training))
B: STROOP-Negative Priming (Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks); ODDBALL (Change from Baseline oddball task at 15 weeks and 30 weeks); N-BACK (Change from Baseline N-back task at 15 weeks and 30 weeks); CORSI BLOCK (Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks)
C: Useful Field of View Test (12 months)
D: cognition: MMSE, ADAS-cog. (month 0, 6, 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment
Brief Summary: Previous studies about cognitive intervention targeting older adults revealed that cognitive training had effects on the improvement of cognitive function.However, researches are rare that investigated direct changes of brain structures after cognitive training.

The advanced scientific technique allowed us to develop service robots designed to assist human work, which can be important with an increase in the aging population and high costs of elderly care. In this regard, the investigators considered robots for elderly's cognitive training and developed 17 cognitive programs in collaboration with Center for Intelligent Robotics at Korea Institute of Science and Technology.

The purposes of this study were to demonstrate the effects of the investigators newly developed robot assisted group cognitive training programs on the brain in older adults and to identify whether they can help to improve cognitive function or mood in the elderly compared to the conventional cognitive training or control group that were not involved in any cognitive training.


Options:
A: the change in cortical thickness between the baseline and the post-intervention assessment. (between the baseline and the post-intervention assessment (12 week training))
B: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
C: sleep measures (3-6 months)
D: Changes in Cognitive Abilities of Memory From Baseline to Year 10 (Up to 10 years); Changes in Cognitive Abilities of Reasoning From Baseline to Year 10 (Up to 10 years); Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10 (Up to 10 years); Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10 (Up to 10 years); Changes in Everyday Problem Solving From Baseline to Year 10 (Up to 10 years); Changes in Everyday Speed of Processing From Baseline to Year 10 (Up to 10 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Controlled Clinical Trial of Standard Compared to Goal-directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
Brief Summary: The purpose of this study is to help us learn what is the best amount of fluid to administer to patients during liver surgery. Patients will receive either an amount for this surgery based on weight, blood pressure, heart rate and urine output or an amount guided by a computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on real time information like blood pressure, pulse and the ability of the heart and blood vessels to maintain normal vital signs.


Options:
A: Postoperative Complications (30 days post procedure)
B: The volume of crystalloid solutions administered intraoperatively. (Start of Anesthesia until the doppler is removed at the end of surgery, approximately 8 hours)
C: Length of Stay (Up to 180 days.)
D: Mean indexed cardiac output (J1 to J12 (Within the surgical hospital length of stay))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Controlled Clinical Trial of Standard Compared to Goal-directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
Brief Summary: The purpose of this study is to help us learn what is the best amount of fluid to administer to patients during liver surgery. Patients will receive either an amount for this surgery based on weight, blood pressure, heart rate and urine output or an amount guided by a computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on real time information like blood pressure, pulse and the ability of the heart and blood vessels to maintain normal vital signs.


Options:
A: OVERALL BLOOD LOSS (UP TO 7 DAYS)
B: Postoperative Complications (30 days post procedure)
C: N/A
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Effect of Ready-cooked Meals Containing Cocoa Extract, as a Potential Functional Ingredient, on Cardiovascular Risk Markers in Older Population
Brief Summary: Obesity prevalence in elderly populations has increased in the last years, and the reduction of overweight and obesity is a priority target in populations of all age ranges worldwide. Obesity is a disease frequently accompanied by a pro-inflammatory state, in which metabolic functions may be compromised, and therefore there is a risk of developing comorbidities such as type-2 diabetes, hyperlipidemias, hypertension, atherosclerosis, etc. In this context, plant extracts are a good source of antioxidant compounds. Among these compounds, polyphenols have been shown to have an important antioxidant effect. Scientific evidence based on epidemiological studies suggest that flavonoids from the diet play an important role on the prevention of cardiovascular disease. Cocoa and related products are an important source of flavonoids, providing even more than tea or wine. Generally, benefits associated to cocoa consumption are related to the ability for improving lipid profile and insulin sensitivity, reducing blood pressure, platelet activity and improving endothelial dysfunction. Some studies have also shown an improvement of inflammatory conditions, mainly due to the capacity of the polyphenols contained to modify cellular transcription, and the secretion of proinflammatory cytokines in peripheral blood mononuclear cells, macrophages and lymphocytic strains. Therefore, the hypothesis of this study is that the consumption of cocoa extract-enriched prepared meals, within a hypocaloric diet, will help to reduce body weight and to improve cardiovascular risk factors compared to the same diet with standard prepared meals.


Options:
A: percentage reduction of women with metabolic syndrome (at baseline and after 6 months.)
B: Change from baseline of Plasma Oxidized LDL (Baseline and 4 weeks)
C: Blood lipids (after 4 weeks intervention)
D: N/A

Answer: B