TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Procalcitonin-Guided Antimicrobial Discontinuation Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Sepsis
Brief Summary: The current study aims to validate the diagnostic use of PCT assessing its capability to individualize and shorten the duration of antibiotic therapy in critically ill patients with suspected or confirmed sepsis.

In particular, no well-designed intervention study has properly examined the following hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic treatment duration in critically ill patients with suspected or documented sepsis, without harming patient safety.


Options:
A: Proportion of patients who achieve a C(max) for amikacin in tracheal aspirates at least 25 times greater than the reference MIC for hospital-acquired organisms and an AUC (0-24 hr) / MIC ratio that is 100 or greater on Day 1 (Day 1)
B: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
C: Cure of respiratory infection (21 days after inclusion)
D: mortality/survival (28 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
Brief Summary: To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription


Options:
A: Time (days) to disappearance of middle ear effusion (Within 60 days)
B: Proportion of each group that filled the antibiotic prescription
C: The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment (The first 7 days on therapy); The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment (The first 7 days on therapy); The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment (During the first 7 days of therapy)
D: Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo (During the first 8 days of follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
Brief Summary: To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription


Options:
A: Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo (During the first 8 days of follow-up)
B: The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment (The first 7 days on therapy); The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment (The first 7 days on therapy); The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment (During the first 7 days of therapy)
C: Proportion of each group that filled the antibiotic prescription
D: Time (days) to disappearance of middle ear effusion (Within 60 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety Study Comparing Concentration-controlled Everolimus in Two Doses (1.5 and 3.0 mg/Day Starting Doses) With Reduced Cyclosporine Versus 1.44 g Mycophenolic Acid (as Sodium Salt) With Standard Dose Cyclosporine in de Novo Renal Transplant Recipients
Brief Summary: The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.


Options:
A: Incidence of CMV disease (1 year)
B: Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis (12 months); Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints (12 months)
C: Observation of G.I. toxicity (nausea, vomiting, or diarrhea). One year patient and graft survival after initiation of study agent.Incidence of biopsy-proven acute rejection (vide infra). 4. Incidence of chronic allograft nephropathy (vide infra). (1 year)
D: Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. (Month 12 is Primary, Month 24 secondary)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety Study Comparing Concentration-controlled Everolimus in Two Doses (1.5 and 3.0 mg/Day Starting Doses) With Reduced Cyclosporine Versus 1.44 g Mycophenolic Acid (as Sodium Salt) With Standard Dose Cyclosporine in de Novo Renal Transplant Recipients
Brief Summary: The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.


Options:
A: renal function as measured by serum creatinine at 6 months post-transplant
B: GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation
C: Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis (12 months); Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints (12 months)
D: Reduced Exposure Cyclosporine in Renal Transplant Recipients (12 months after the time of kidney transplantation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: OMEGA: A Prospective, Randomised, Double-Blind, Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters (Ω-3FAE) Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death.
Brief Summary: Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.


Options:
A: Sudden cardiac death (12 months)
B: Survival free of atrial fibrillation (12 months)
C: Cumulative incidence of Major depressive Disorder (12 months)
D: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: OMEGA: A Prospective, Randomised, Double-Blind, Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters (Ω-3FAE) Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death.
Brief Summary: Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.


Options:
A: Sudden cardiac death (12 months)
B: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)
C: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)
D: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: OMEGA: A Prospective, Randomised, Double-Blind, Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters (Ω-3FAE) Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death.
Brief Summary: Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.


Options:
A: Sudden cardiac death (12 months)
B: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)
C: Optical density of macular pigment (12 months)
D: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: OMEGA: A Prospective, Randomised, Double-Blind, Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters (Ω-3FAE) Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death.
Brief Summary: Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.


Options:
A: Sudden cardiac death (12 months)
B: Survival free of atrial fibrillation (12 months)
C: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
D: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: OMEGA: A Prospective, Randomised, Double-Blind, Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters (Ω-3FAE) Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death.
Brief Summary: Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.


Options:
A: Sudden cardiac death (12 months)
B: Number of ventilator-free days (VFD) (Measured at Day 28); Mortality before hospital discharge, with unassisted breathing (Measured at Days 60 and 90)
C: Infectious complications (POD+1 to POD+14)
D: Ventilator-free days (day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: OMEGA: A Prospective, Randomised, Double-Blind, Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters (Ω-3FAE) Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death.
Brief Summary: Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.


Options:
A: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
B: Sudden cardiac death (12 months)
C: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
D: Death, all-cause (Up to 7 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: OMEGA: A Prospective, Randomised, Double-Blind, Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters (Ω-3FAE) Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death.
Brief Summary: Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.


Options:
A: The Composite of Major Adverse Cardiovascular Events (MACE) (From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure)
B: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization. (Total follow-up time of up to approximately 6 years.)
C: Cardiovascular mortality (From entry into the study (baseline: 2002-2006) through study completion); All-cause mortality (From entry into the study (baseline: 2002-2006) through study completion); Major cardiovascular events (From entry into the study (baseline: 2002-2006) until November 2009)
D: Sudden cardiac death (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: OMEGA: A Prospective, Randomised, Double-Blind, Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters (Ω-3FAE) Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death.
Brief Summary: Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.


Options:
A: Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers (1997-2010)
B: time to clinical relapse (52 weeks)
C: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization. (Total follow-up time of up to approximately 6 years.)
D: Sudden cardiac death (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Teen Alcohol and Violence Prevention in the ER
Brief Summary: This study is designed to address both alcohol misuse and violence among adolescents ages 14-18 seeking care in an urban emergency department (ED). The study is a randomized controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing and Skills Training intervention, delivered either by a computer or by a counselor, and an informational handout control condition.


Options:
A: Change in the number of drinks per week and the number of drinks per drinking day (Baseline, 3 months & 12 months)
B: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
C: Reduction in injury recidivism (August 2011); Reduction in alcohol intake (August 2011); Reduction in alcohol problems (August 2011)
D: Drinks per drinking day (6 months); Rate of effective contraception (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Teen Alcohol and Violence Prevention in the ER
Brief Summary: This study is designed to address both alcohol misuse and violence among adolescents ages 14-18 seeking care in an urban emergency department (ED). The study is a randomized controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing and Skills Training intervention, delivered either by a computer or by a counselor, and an informational handout control condition.


Options:
A: Reduction of 15% in alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the PFI group . In the self-help material group we expect that 5 - 10% will reduce their consumption equivalent. (12 months)
B: Alcohol Use Disorders Identification Test - Consumption scale (AUDIT-C scale) (6 weeks)
C: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
D: Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care (5 months); Number of brief interventions for excessive alcohol consumption delivered in primary health care settings (5 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Teen Alcohol and Violence Prevention in the ER
Brief Summary: This study is designed to address both alcohol misuse and violence among adolescents ages 14-18 seeking care in an urban emergency department (ED). The study is a randomized controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing and Skills Training intervention, delivered either by a computer or by a counselor, and an informational handout control condition.


Options:
A: Linkage to alcohol assistance; Change in drinks per day
B: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
C: Discontinuation of consumption of prescription drugs (one year); Reduction of consumption of prescription drugs (one year); Utilization of formal help (one year)
D: alcohol use (6 months); HIV risk taking (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Teen Alcohol and Violence Prevention in the ER
Brief Summary: This study is designed to address both alcohol misuse and violence among adolescents ages 14-18 seeking care in an urban emergency department (ED). The study is a randomized controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing and Skills Training intervention, delivered either by a computer or by a counselor, and an informational handout control condition.


Options:
A: marijuana use (12 months)
B: Alcohol use (3 months); Alcohol use (6 months); Alcohol use (12 months)
C: Condom use (one year)
D: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Teen Alcohol and Violence Prevention in the ER
Brief Summary: This study is designed to address both alcohol misuse and violence among adolescents ages 14-18 seeking care in an urban emergency department (ED). The study is a randomized controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing and Skills Training intervention, delivered either by a computer or by a counselor, and an informational handout control condition.


Options:
A: Time to onset and severity of drug use (2 years); Frequency and Quantity of Drinking (2 years); Problem drinking symptoms (2 years)
B: Rearrest
C: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
D: alcohol use, alcohol related consequences (3 -12 month period)

Answer: C