TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Treatment of Patients With Pulmonary Embolism Based on Pro-BNP Levels
Brief Summary: The aim of this study is to investigate the safety of treatment of pulmonary embolism in an outpatient setting based on normal pro-BNP levels. The mortality rate and the incidence of hemodynamic instability as well as major bleeding and recurrent venous thromboembolism (VTE) in the outpatient group will be studied.


Options:
A: 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE (90 Days)
B: Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
C: Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) (within 3 months of randomization)
D: -Thromboembolic recurrences; -Bleeding Complications; -Deaths

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Treatment of Patients With Pulmonary Embolism Based on Pro-BNP Levels
Brief Summary: The aim of this study is to investigate the safety of treatment of pulmonary embolism in an outpatient setting based on normal pro-BNP levels. The mortality rate and the incidence of hemodynamic instability as well as major bleeding and recurrent venous thromboembolism (VTE) in the outpatient group will be studied.


Options:
A: Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
B: -Thromboembolic recurrences; -Bleeding Complications; -Deaths
C: Rate of home discharge from the emergency department following treatment for pulmonary embolism (8 months post-implementation compared to 8 months pre-implementation)
D: 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE (90 Days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Latently Infected With Mycobacterium Tuberculosis.
Brief Summary: This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who are latently infected with M.tb. A single vaccination with MVA85A, when administeredat a dose of 5 x 107pfu intradermally, is safe in both mycobacterially naïve individuals and those previously vaccinated with BCG. We will use the same vaccination regime in this study. Subjects will be defined as being latently infected if they have a positive elispot response to ESAT6 or CFP10. Subjects will be identified from TB contact clinics.


Options:
A: Safety of a single intradermal injection of 5 x 107pfu MVA85A (One year)
B: Percentage of Participants With Adverse Events (Adverse Events (AEs) are recorded for 28 days post vaccination, Serious Adverse Events (SAEs) for at least 6 months post second vaccination.)
C: Culture and RT-PCR quantification of BCG in challenge site biopsy (10 weeks post biopsy)
D: T cell immunogenicity by gamma-interferon ELISPOT of Ag85A response. (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)
Brief Summary: We hypothesize that Family Dietary Coaching for one school year will allow a nutritional shift towards following recommendations and improve health indicators in free-living children and adults.


Options:
A: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
B: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
C: changes in body mass index throughout the intervention
D: To test the role of European genetic admixture on measures of insulin action and response in a multiethnic group of prepubertal children. (5 years); To investigate whether the impact of energy intake, energy expenditure and socioeconomic status on proxy measures of insulin sensitivity and/or action differ as a function of European ADM in prepubertal children (5 years); To test phenotype-genotype associations between each one of the AIMs and measures of FI, SI and AIRg after adjusting for body composition in a sample of AA, HA and EA prepubertal children. (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)
Brief Summary: We hypothesize that Family Dietary Coaching for one school year will allow a nutritional shift towards following recommendations and improve health indicators in free-living children and adults.


Options:
A: Change in body mass index (BMI) z-score (Up to 2 years)
B: Change in Infant Growth (Baby is less than 2 months; baby is 3 months; baby is 6 months)
C: changes in body mass index throughout the intervention
D: Overweight and obesity according to IOTF references (0-1-2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)
Brief Summary: We hypothesize that Family Dietary Coaching for one school year will allow a nutritional shift towards following recommendations and improve health indicators in free-living children and adults.


Options:
A: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
B: changes in body mass index throughout the intervention
C: To test the role of European genetic admixture on measures of insulin action and response in a multiethnic group of prepubertal children. (5 years); To investigate whether the impact of energy intake, energy expenditure and socioeconomic status on proxy measures of insulin sensitivity and/or action differ as a function of European ADM in prepubertal children (5 years); To test phenotype-genotype associations between each one of the AIMs and measures of FI, SI and AIRg after adjusting for body composition in a sample of AA, HA and EA prepubertal children. (5 years)
D: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
Brief Summary: The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.


Options:
A: Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population (Intended Treatment Period); Incidence of Major Bleeding During the Treatment Period in Treated Participants (Day 1, first dose of study drug, to last dose of study drug plus 2 days); Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants (Day 1, first dose of study drug, to last dose of study drug plus 2 days); Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants (Day 1, first dose of study drug, to last dose of study drug plus 2 days); Incidence of All Bleeding During the Treatment Period in Treated Participants (Day 1, first dose of drug to last dose of drug plus 2 days)
B: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (20 days)
C: Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days (Up to Day 35 + 6 days); Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days (Up to Day 10 + 5 days)
D: During double blind treatment : Cumulative occurrence of VTE assessed by ultrasound for all patients at 28±4 days after randomization (or earlier if symptomatic VTE) and/or V/Q lung scan for symptomatic patients ; Major hemorrhagic complications.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: PREPIC 2 : Interruption of Inferior Vena Cava by a Retrievable Filter for the Prevention of Recurrent Pulmonary Embolism : a Randomised, Open Label Study
Brief Summary: The purpose of this study is to assess efficacy and safety of optional vena cava filter implanted 3 months in prevention of recurrent pulmonary embolism in patients presenting with acute pulmonary embolism associated with thrombotic risk factors


Options:
A: at 3 months, combined criteria including recurrent PE confirmed by objective tests and fatal PE confirmed by autopsy and death which can not be attribuated to a documented cause and for which PE/DVT can't be ruled out (3 months)
B: Clinical composite endpoint of all-cause mortality or haemodynamic collapse within 7 days (Day 7); Haemodynamic collapse is defined as: need for cardiopulmonary resuscitation; or systolic blood pressure < 90 mm Hg for at least 15 min or drop of syst (Day 7)
C: Incidence of chronic thromboembolic pulmonary hypertension (within 3 years)
D: Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy (Baseline, within 48 +/- 6 hours of initiation of therapy); Number of Participants With Major Bleeding (From start of study drug infusion up to 72 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hypothermia After In-hospital Cardiac Arrest
Brief Summary: ILCOR Recommendations "On the basis of the published evidence to date, the Advanced Life Support (ALS) Task Force of the International Liaison Committee on Resuscitation (ILCOR) made the following recommendations in October 2002: Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32°C to 34°C for 12 to 24 hours when the initial rhythm was ventricular fibrillation (VF).Such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest" (Circulation. 2003;108:118-121). This study ist to investigate the efficacy of mild therapeutic hypothermia on mortality and neurological outcome in patients after in-hospital cardiac arrest.


Options:
A: Number Alive at Hospital Discharge (at hospital discharge)
B: all cause mortality at 6 months (6 months)
C: Mortality (180 days)
D: All-cause mortality (Maximum follow-up with a minimum of 180 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Effectiveness of BI Given to Injured MVC ED Patients Who Use Alcohol Harmfully and Hazardously
Brief Summary: The purpose of this study is to determine if a brief counseling intervention, delivered by telephone, is more effective than standard ED care, to reduce future alcohol related injuries and alcohol related negative consequences, among patients treated in the ED for injuries from an MVC and other injury mechanisms.


Options:
A: Reduction in injury recidivism (August 2011); Reduction in alcohol intake (August 2011); Reduction in alcohol problems (August 2011)
B: Drinks per drinking day (6 months); Rate of effective contraception (6 months)
C: N/A
D: Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent. (6 and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression.


Options:
A: Global Self-Worth Scale from the Self-Perception Profile for Children (3 years)
B: the change in spherical equivalent (SE) (SE measured at 3, 6, 9, 12 months.)
C: the progression of myopia degree, axial length elongation of eye
D: Spherical equivalent refraction determined by cycloplegic autorefraction

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression.


Options:
A: Global Self-Worth Scale from the Self-Perception Profile for Children (3 years)
B: Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (Baseline to 3 years); Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (3 years)
C: the progression of myopia degree, axial length elongation of eye
D: Myopia progression, measured by cycloplegic autorefraction (Every 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression.


Options:
A: the progression of myopia degree, axial length elongation of eye
B: the change in spherical equivalent (SE) (SE measured at 3, 6, 9, 12 months.)
C: Spherical Equivalent Refractive Error (Baseline and every 6 months post-baseline for 2 years)
D: Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Rapamycin Therapy of Angiomyolipomas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis
Brief Summary: The purpose of this study was to determine if rapamycin reduced angiomyolipomata volume in patients with tuberous sclerosis complex or lam.


Options:
A: Objective Response Rate (On treatment, patients were evaluated radiologically for response to therapy up to 52 weeks.)
B: List Learning test (from the BIRT Memory and Information Processing Battery) (6 months); Complex Figure test (from the BIRT Memory and Information Processing Battery) (6 months); CANTAB - Stockings of Cambridge (SOC) (6 months); CANTAB - Spatial Working Memory (SWM) (6 months); Telephone search dual task (from the Test of Everyday Attention) (6 months)
C: Volume of Angiomyolipomata
D: Number With Observed Adverse Side Effects (During the entire study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rapamycin Therapy of Angiomyolipomas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis
Brief Summary: The purpose of this study was to determine if rapamycin reduced angiomyolipomata volume in patients with tuberous sclerosis complex or lam.


Options:
A: Volume of Angiomyolipomata
B: Rapamycin level (6 months); Complete blood count (6 months); Total cholesterol (6 months); Dermatologic sensitivity at site of application (pain, erythema, edema, pruritis) (6 months)
C: Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response (End of core period (Week 48), and end of extension period (up to 4 years))
D: Objective Response Rate (On treatment, patients were evaluated radiologically for response to therapy up to 52 weeks.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects With Genotype G551D
Brief Summary: The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.


Options:
A: Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (primary nasal parameters: obstruction of nasal breathing, sneeze stimulus, permanent nose running, thick-mucous nasal discharge, earaches) (day 1, 29, 57 and 85)
B: Changes in the Sino-nasal-outcome test SNOT-20 adapt CF (days 1, 29, 57 and 85)
C: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
D: Number of Subjects With Adverse Events (Combined Part 1 and Part 2) (Baseline to Follow-up); Number of Adverse Events (Combined Part 1 and Part 2) (Baseline to Follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects With Genotype G551D
Brief Summary: The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.


Options:
A: Percentage of Predicted Function (Percent-Predicted) of Forced Expiratory Volume in One Second (FEV1) at Baseline (Baseline (Week 1)); Percentage Change From Baseline in Percent-Predicted of FEV1 at Week 48 (End of Treatment (EOT) (Week 48))
B: Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs (Part A: Up to 93 Days); Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs (Part B: Up to 28 Weeks); Part A: Plasma Concentration of Ivacaftor and Its Metabolites (Part A: up to 24 hours post-dose on Day 4)
C: Number of Subjects With Adverse Events (Combined Part 1 and Part 2) (Baseline to Follow-up); Number of Adverse Events (Combined Part 1 and Part 2) (Baseline to Follow-up)
D: exercise capacity (one month, 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects With Genotype G551D
Brief Summary: The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.


Options:
A: Changes in the Sino-nasal-outcome test SNOT-20 adapt CF (days 1, 29, 57 and 85)
B: Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (primary nasal parameters: obstruction of nasal breathing, sneeze stimulus, permanent nose running, thick-mucous nasal discharge, earaches) (day 1, 29, 57 and 85)
C: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
D: Number of Subjects With Adverse Events (Combined Part 1 and Part 2) (Baseline to Follow-up); Number of Adverse Events (Combined Part 1 and Part 2) (Baseline to Follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy: A Pilot Randomized Trial
Brief Summary: Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have serious complications. It has recently been suggested that isotonic saline may be a more appropriate choice of maintenance IV fluid. This pilot and feasibility study aims to compare isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support in order to:

Aim 1: To determine the feasibility of conducting a double-blind, randomized controlled trial comparing these solutions.

Aim 2a: To compare the rate of change in serum Na (mmol/L/hr) and the incidence of hyponatremia (Na \<136 mmol/L) between patients receiving isotonic and hypotonic intravenous fluids at at least 50% of the traditional maintenance rate for an interval of at least 8 hours.

Aim 2b: To compare the incidence of adverse events between the two IV fluid treatment groups.


Options:
A: Serum Sodium Levels in Both Groups (first 48 hours)
B: rate of change in serum sodium (8 to 20 hours)
C: Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia) (During the treatment and follow-up period.); Hyponatremia (during the study intervention)
D: Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L) (72 hrs)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Middle-School Based Primary Prevention Trial (HEALTHY)
Brief Summary: HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the schools were randomized to receive an intervention that integrated four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.


Options:
A: Change from baseline in physical activity as assessed by Actigraph accelerometer (Baseline, 6 months and 1 year)
B: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
C: Physical activity level (one school week); Time on task (change in time on task from baseline to 15 minutes post academic lesson); Acute academic achievement (change in math and language arts scores from Baseline to 2 weeks); Long-term math achievement (Change in math achievement scores from Baseline to 7 months); Long-term language arts achievement (Change in language arts achievement from Baseline to 7 months)
D: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)

Answer: B