TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular, Pulmonary and Skeletal Muscle Evaluation in Patients With Univentricular Physiology in the Late Postoperative Period of the Fontan Surgery: Effects of Exercise Training
Brief Summary: Introduction: The Fontan operation is the surgical treatment in most patients with either anatomic or functional single ventricles. In this operation, the subpulmonary ventricle is bypassed, connecting the systemic veins directly to the pulmonary arteries. The lack of a subpulmonary ventricle is associated with a nonpulsatile pulmonary flow and triggers a sequence of adaptive mechanisms along the life of these patients. The most frequent consequence of these adaptative mechanisms is the reduction in functional capacity, objectively measured by the decrease in peak oxygen consumption (VO2). So, cardiovascular and pulmonary functioning and skeletal muscle alterations can explain exercise intolerance in these patients.

Objectives: 1. To compare the cardiovascular, pulmonary, and musculoskeletal system variables in clinically stable Fontan patients with Healthy subjects; 2. To correlate the variables of the cardiovascular, pulmonary, and skeletal muscle with the functional capacity in Fontan patients; 3. To identify predictors of low functional capacity in this population; 4. To evaluate four-month aerobic exercise and inspiratory muscle training on functional capacity, pulmonary function, and autonomic control in patients after Fontan operation and compare to the group with no exercise training.

Methods: All subjects were submitted to cardiovascular, pulmonary, and skeletal muscle evaluation at baseline to perform a cross-sectional study comparing Fontan Patients (FP) with Healthy Controls (HC). In addition, the FP accepted to participate in the longitudinal clinical trial to evaluate exercise programs were randomized into three groups: Aerobic Exercise Training (AET), Inspiratory Muscle Training (IMT), and Non-exercise Training Group (NET, a control group). All patient groups (AET, IMT, NET) were reassessed after four months of training or under usual care.

Expected Outcomes: This study expects to demonstrate that impaired pulmonary function, altered neurovascular control, and reduced skeletal muscle could be an additional potential mechanism for reducing functional capacity in clinically stable Fontan patients. And this impairment could be diminished by exercise training, enhancing physical capacity, and exercise tolerance.


Options:
A: Improvement exercise tolerance and physical capacity (Baseline and 4 months)
B: Cardiac disease knowledge (12 months)
C: Moderate to Vigorous Physical Activity (MVPA) (From baseline to follow-up (approximately 22 weeks).)
D: Consent rate (1 year); Enrolment rate (1 year); Adherence rate (1 year); Completion rate (1 year); Attrition rate (1 year); Acceptability questionnaire (Investigator-generated satisfaction questionnaire) (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular, Pulmonary and Skeletal Muscle Evaluation in Patients With Univentricular Physiology in the Late Postoperative Period of the Fontan Surgery: Effects of Exercise Training
Brief Summary: Introduction: The Fontan operation is the surgical treatment in most patients with either anatomic or functional single ventricles. In this operation, the subpulmonary ventricle is bypassed, connecting the systemic veins directly to the pulmonary arteries. The lack of a subpulmonary ventricle is associated with a nonpulsatile pulmonary flow and triggers a sequence of adaptive mechanisms along the life of these patients. The most frequent consequence of these adaptative mechanisms is the reduction in functional capacity, objectively measured by the decrease in peak oxygen consumption (VO2). So, cardiovascular and pulmonary functioning and skeletal muscle alterations can explain exercise intolerance in these patients.

Objectives: 1. To compare the cardiovascular, pulmonary, and musculoskeletal system variables in clinically stable Fontan patients with Healthy subjects; 2. To correlate the variables of the cardiovascular, pulmonary, and skeletal muscle with the functional capacity in Fontan patients; 3. To identify predictors of low functional capacity in this population; 4. To evaluate four-month aerobic exercise and inspiratory muscle training on functional capacity, pulmonary function, and autonomic control in patients after Fontan operation and compare to the group with no exercise training.

Methods: All subjects were submitted to cardiovascular, pulmonary, and skeletal muscle evaluation at baseline to perform a cross-sectional study comparing Fontan Patients (FP) with Healthy Controls (HC). In addition, the FP accepted to participate in the longitudinal clinical trial to evaluate exercise programs were randomized into three groups: Aerobic Exercise Training (AET), Inspiratory Muscle Training (IMT), and Non-exercise Training Group (NET, a control group). All patient groups (AET, IMT, NET) were reassessed after four months of training or under usual care.

Expected Outcomes: This study expects to demonstrate that impaired pulmonary function, altered neurovascular control, and reduced skeletal muscle could be an additional potential mechanism for reducing functional capacity in clinically stable Fontan patients. And this impairment could be diminished by exercise training, enhancing physical capacity, and exercise tolerance.


Options:
A: Maximal inspiratory pressure in kilopascal (12 weeks)
B: Cardiac Rehabilitation Enrollment (12 weeks after patient is discharged from hospital)
C: Improvement exercise tolerance and physical capacity (Baseline and 4 months)
D: Quality of life score (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life. (follow up of patients over 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Cannabis Extract as Anaesthetic Premedication on Postoperative Pain, Nausea-vomiting and Perioperative Anxiety
Brief Summary: Clinical evidence about the effects of cannabis in a perioperative setting or for the management of acute pain is rather scarce, mostly consisting of case report-based opinions on adverse events during or after general anesthesia after smoking cannabis, experimental pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages and routes of administration. It is difficult to draw strong conclusions from the available evidence, that may seem sometimes even contradictory, mainly due -the investigators believe- to the many sources of variability in the study designs (e.g.: heterogeneity of the study samples, underpowered, unblinding, lack of randomization, timing of the therapeutic intervention, different experimental pain models, inclusion of different kind of surgical pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that cannabis and cannabinoids may have a beneficial role in the management of acute post-operative pain and nausea, at least for a selected group of patients and through an appropriate therapeutic intervention.

Therefore, it seems to us pertinent to carry out an investigation in order to re-evaluate the issue of perioperative cannabis use through a sufficiently powered and controlled clinical trial. Some of cannabis effects such as sedation, bronchodilation, dryness of respiratory secretions, vein dilation, and increase of heart rater without producing hypertension, make of it an attractive option for pre-medication; while its antiemetic properties and its analgesic potential without causing respiratory depression may be profitable for the post-operative period.

Cannabis oil seem to be most suitable to our investigation. The co-administration of tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic benefits with an attenuation of adverse effects. The investigators expect to obtain less sedation, milder "high", lower incidence of anxiety, tachycardia, and hyperalgesia, as compared with THC-only acute pain trials.


Options:
A: Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9). (12-hours from 8:00 am to 8:00 pm)
B: Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR (Baseline to Month-2)
C: Postoperative pain - VAS (24 hours); Postoperative pain - PCA (24 hours)
D: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points (0.75 up to 13 hours post-dose)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation
Brief Summary: The purpose of this study is to evaluate if Apixaban will decrease the complication of having another stroke for people who have atrial fibrillation if initiated earlier than standard of care.


Options:
A: Number of Participants With 0 or 1 on Modified Rankin Scale (90 days); Number of Participants With Symptomatic Intracranial Hemorrhage Within 48 Hours of tPA Administration (48-hours)
B: Percentage of Participants With Composite of Venous Thrombotic Event (VTE) or Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period. (From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.)
C: Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality (90 days)
D: Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA (180 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Teams Advancing Patient Experience: Strengthening Quality (TAPESTRY): A Randomized Controlled Trial Using the Health TAPESTRY Approach to Care for Older Adults
Brief Summary: Health TAPESTRY is a delayed intervention pragmatic randomized control trial promoting interprofessional team collaboration, facilitating connection to the community through system navigation and trained community volunteers, enhancing communication and improving care through the use of technology to better understand and assist older adult patients in achieving their health goals and to enable them to have optimal aging.


Options:
A: Progress attaining health goals (12 months)
B: Health-related quality of life as measured with 15D (16 weeks)
C: Hospitalizations: rates of first hospitalization, number and reason (Three years)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS)
Brief Summary: This Phase 2 study is intended to serve as a proof of concept for potential treatment with laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod in this population.


Options:
A: Time to Confirmed Disease Progression (CDP) (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)); Percentage of Participants With CDP (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression))
B: Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT) (Up to 96 weeks (2 years)); Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (218 weeks)
C: Percent Brain Volume Change (PBVC) From Baseline to Week 48 Using a Repeated Measures ANCOVA Model (Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48 and including early termination visits); Percent Brain Volume Change (PBVC) From Baseline to Weeks 24 and 48 (Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48)
D: Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) (Baseline, every 3 month up to the maximum of approximately 3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS)
Brief Summary: This Phase 2 study is intended to serve as a proof of concept for potential treatment with laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod in this population.


Options:
A: Confirmed Annualized Relapse Rate (up to 12 months)
B: Percent Brain Volume Change (PBVC) From Baseline to Week 48 Using a Repeated Measures ANCOVA Model (Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48 and including early termination visits); Percent Brain Volume Change (PBVC) From Baseline to Weeks 24 and 48 (Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48)
C: Cumulative Number of New Gadolinium-enhancing (GdE) T1 Lesions at Week 12 (Week 12)
D: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) (From Baseline until the end of the study (up to a maximum duration of 5.6 years)); Number of Participants With Infusion-Associated Reactions (IAR) (Within 24 hours of any alemtuzumab infusion); Number of Participants With Adverse Events of Special Interest (AESI) (From Baseline until the end of the study (up to a maximum duration of 5.6 years)); Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (From Baseline until the end of the study (up to a maximum duration of 5.6 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Contribution of Ultrasound for Peripheral Intravenous Catheter Placement by Intensive Care Nurses
Brief Summary: Peripheral intravenous access is a major intervention in patients admitted to an intensive care unit. Systematically performed by nurses, it is also an essential intervention when the central venous access has to be removed. However, in the intensive care unit, patient centered-characteristics such as previous history of intravenous drug abuse, obesity, history of multiple vascular punctures or fluid overload most often affect the success rate of this procedure. For these patients, failure consequences are numerous: 1) delayed discharge from the intensive care unit, 2) increased pain and dissatisfaction, 3) increased incidence of catheter-related bloodstream infections. The use of ultrasound has gained increasing popularity particularly for obtaining central venous access. We hypothesize that, among trained nurses, ultrasound-guided peripheral venous access could represent an attractive alternative compared to the traditional anatomical method in order to increase the success rate.


Options:
A: Grade 1 and Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique (9 months after patient recruitment begins)
B: Patient's experience of pain during the procedure (up to 5 minutes.); Patient's experience with the method used to obtain venous access (1/2) (up to 5 minutes.); Patient's experience with the method used to obtain venous access (2/2) (up to 10 minutes.)
C: number of peripheral venous catheterization attempts (up to day 2)
D: Reducing the use of CVC and PVC (through study completion, an average of 7 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Basal Cell Carcinoma Using a One-stop-shop With Reflectance Confocal Microscopy: a Randomized Controlled Multicenter Trial
Brief Summary: The purpose of this study is to assess the efficacy and safety of the one-stop-shop concept, using real-time in vivo reflectance confocal microscopy as diagnostic tool, prior to surgical management of new primary basal cell carcinoma


Options:
A: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)
B: Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report. (Within the first week after surgical excision of suspected BCC lesion)
C: Sensitivity and Specificity (Within 120 days of Data Lock)
D: The number of correctly identified basal cell carcinoma and the subtype by Reflectance confocal microscopy validated by histopathological examination of the excision specimen (Through study completion, an average of 3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Basal Cell Carcinoma Using a One-stop-shop With Reflectance Confocal Microscopy: a Randomized Controlled Multicenter Trial
Brief Summary: The purpose of this study is to assess the efficacy and safety of the one-stop-shop concept, using real-time in vivo reflectance confocal microscopy as diagnostic tool, prior to surgical management of new primary basal cell carcinoma


Options:
A: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)
B: Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report. (Within the first week after surgical excision of suspected BCC lesion)
C: Sensitivity and Specificity (Within 120 days of Data Lock)
D: To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. (10 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent End-Stage Renal Disease (ESRD) (SPin-D) Trial
Brief Summary: The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal disease.


Options:
A: risk of hyperkalemia (6 months)
B: Peritoneal fibrosis (6 months)
C: The time to onset of the first incident :non-fatal MI or acute coronary syndrome or hospitalization for heart failure or nonfatal stroke or cardiovascular (CV) death (25 months)
D: Safety - Number of Participants With Serum Potassium >6.5 mEq/L (0 - 40 weeks); Safety - Participants With Serious Hypotension (0 - 40 weeks); Study Drug Tolerability (0 - 36 weeks); Efficacy - Change in Mitral Annular E' Velocity (Baseline to 36 weeks); Feasibility of Conducting a Full-scale Mortality-powered Trial (0 - 40 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Addition of Virtual Reality Training to a Standard Program of Inpatient Rehabilitation Improve Sitting Balance Ability and Function After Stroke? A Blinded Randomized Controlled Trial.
Brief Summary: The purpose of this study is to determine if the addition of 10 to 12 sessions of sitting balance exercises using virtual reality training will provide additional gains in balance ability and function over standard inpatient rehabilitation in stroke patients.


Options:
A: Fugl Meyer Assessment Scale (four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up)
B: Change in the Function In Sitting Test (FIST) from baseline to after 10-12 treatment sessions (baseline, immediately after 10-12 treatments); Change in the Function In Sitting Test (FIST) from baseline to 1 month after second assessment (baseline,1 month after second assessment)
C: Rating Scale Score (1 day)
D: Physical activity of the lower and upper extremities (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Addition of Virtual Reality Training to a Standard Program of Inpatient Rehabilitation Improve Sitting Balance Ability and Function After Stroke? A Blinded Randomized Controlled Trial.
Brief Summary: The purpose of this study is to determine if the addition of 10 to 12 sessions of sitting balance exercises using virtual reality training will provide additional gains in balance ability and function over standard inpatient rehabilitation in stroke patients.


Options:
A: The change in Tinetti Performance Oriented Mobility Assessment (week 0, week 5, and week 9)
B: Barthel Index (up to 6 months)
C: Recruitment (Through study completion, an average of 1.5 months.); Retention (Through study completion, an average of 1.5 months.); Participation (Through study completion, an average of 1.5 months.); Adherence (Through study completion, an average of 1.5 months.); Acceptability and enjoyment (Through study completion, an average of 1.5 months.); Safety and Adverse events (Through study completion, an average of 1.5 months.); Device development or modifications (Through study completion, an average of 1.5 months.); Fatigue (Through study completion, an average of 1.5 months.); Patient Global Impression of Change (Through study completion, an average of 1.5 months.)
D: Change in the Function In Sitting Test (FIST) from baseline to after 10-12 treatment sessions (baseline, immediately after 10-12 treatments); Change in the Function In Sitting Test (FIST) from baseline to 1 month after second assessment (baseline,1 month after second assessment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Life-Stress Interview for Women With Chronic Urogenital Pain Conditions
Brief Summary: The goal of this study is to test the efficacy, feasibility, and acceptability of providing an experiential assessment interview that targets health, and emotional and stressful experiences in a tertiary care setting specializing in women's urology.


Options:
A: Change From Baseline in Mean Average Daily Pain Score at Week 8 (Baseline, Week 8)
B: Net change of Patient Perception of Visual Analogue Scale (VAS) (Baseline and 8 weeks)
C: Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire (Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported)
D: Symptom Interpretation Questionnaire (SIQ) (Change from baseline symptom attribution at 6-weeks); Brief Pain Inventory (BPI) (Change from baseline pain at 6-weeks)

Answer: D