TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of Endurance Exercise Training on Cardiovascular Risk Factors Following Radical Prostatectomy Among Men With Localized Prostate Cancer; A Community-Based Intervention
Brief Summary: The primary objective is to determine the feasibility and acceptability of a home-based endurance exercise program among men diagnosed with clinically localized prostate cancer.


Options:
A: Cardiorespiratory Fitness will be determined using a incremental treadmill test with 12-lead ECG monitoring. (6 months)
B: Minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer. (3 months)
C: Changes in gene expression in prostate tissue core biopsy samples as measured before and after a low-fat diet and lifestyle intervention
D: change in physical activity (baseline to 3 months); change in physical activity (3 mos to 6 months); change in physical activity (6 months to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Challenging the Dogma: Topical Proparacaine is Safe and Effective for the Emergency Department Management of Acute Traumatic Corneal Injuries
Brief Summary: Introduction: Traumatic injuries to the outer covering of the eye (the cornea) are a common emergency department complaint. They cause significant patient distress including pain, loss of sleep and missed work days. There is currently no accepted, uniform approach to pain management in this patient population. Emergency medicine and ophthalmology texts state that prolonged use of medications that anesthetize the cornea is not recommended. Several recent publications in the ophthalmology literature show that the outpatient use of dilute local anesthesia in patients after eye surgery is a safe and effective method of pain control. In this study, we used Proparacaine (a local anesthetic), in a similar manner, for the outpatient emergency department management of traumatic corneal injuries.

Methods: We performed a clinical trial on a sample of adult patients presenting with traumatic corneal injuries to two university affiliated emergency departments in London, Canada.

Patients providing signed informed consent to participate in the study received a vial of clear liquid that contained either Proparacaine or plain water (placebo), a pain log, topical antibiotics and oral Acetaminophen (Tylenol) with Codeine for breakthrough pain.

Patients were instructed to use the "study drug" on an "as-needed" basis for the next seven days. Patients completed a pain scale describing their discomfort immediately prior to, and five minutes after self-administration of the study drug. All patients were followed closely in an ophthalmology outpatient clinic on Days 1, 3 and 5 after presentation to the emergency department. At the last ophthalmology clinic visit, the patients' pain logs were collected.

The protocol was approved by the Research Ethics Board for Health Sciences Research Involving Human Subjects at the University of Western Ontario.


Options:
A: Pain assessed with Visual Analog Scale (Up to 24 months)
B: pain control as measured by visual analogue score (at 12 hours post baseline)
C: pain reduction (continuous)
D: Overall Visual Analog Scale score (48 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Challenging the Dogma: Topical Proparacaine is Safe and Effective for the Emergency Department Management of Acute Traumatic Corneal Injuries
Brief Summary: Introduction: Traumatic injuries to the outer covering of the eye (the cornea) are a common emergency department complaint. They cause significant patient distress including pain, loss of sleep and missed work days. There is currently no accepted, uniform approach to pain management in this patient population. Emergency medicine and ophthalmology texts state that prolonged use of medications that anesthetize the cornea is not recommended. Several recent publications in the ophthalmology literature show that the outpatient use of dilute local anesthesia in patients after eye surgery is a safe and effective method of pain control. In this study, we used Proparacaine (a local anesthetic), in a similar manner, for the outpatient emergency department management of traumatic corneal injuries.

Methods: We performed a clinical trial on a sample of adult patients presenting with traumatic corneal injuries to two university affiliated emergency departments in London, Canada.

Patients providing signed informed consent to participate in the study received a vial of clear liquid that contained either Proparacaine or plain water (placebo), a pain log, topical antibiotics and oral Acetaminophen (Tylenol) with Codeine for breakthrough pain.

Patients were instructed to use the "study drug" on an "as-needed" basis for the next seven days. Patients completed a pain scale describing their discomfort immediately prior to, and five minutes after self-administration of the study drug. All patients were followed closely in an ophthalmology outpatient clinic on Days 1, 3 and 5 after presentation to the emergency department. At the last ophthalmology clinic visit, the patients' pain logs were collected.

The protocol was approved by the Research Ethics Board for Health Sciences Research Involving Human Subjects at the University of Western Ontario.


Options:
A: pain reduction (continuous)
B: pain control as measured by visual analogue score (at 12 hours post baseline)
C: Overall Visual Analog Scale score (48 hours)
D: Pain assessed with Visual Analog Scale (Up to 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic Control
Brief Summary: To investigate efficacy, safety and tolerability of BI 1356 versus placebo


Options:
A: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)
B: HbA1c Change From Baseline to Week 24 (Baseline and week 24)
C: HbA1c Change From Baseline at Week 24 (Baseline and week 24)
D: Absolute Change in the Endothelial Progenitor Cell (EPC) Number (V0, V2 (month 4), V4 (12 month))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Gene Expression in Adipose Tissue of Genes Involved in Obesity, Insulin Resistance and Lipid Metabolism Before and After Weight Loss or an Intensive Exercise Period
Brief Summary: Lifestyle and genetic factors interact in the development of obesity and the metabolic syndrome. The molecular mechanisms underlying the beneficial dietary modifications are, however, unclear. We aimed to examine the effect of the long-term 30 moderate weight reduction on gene expression in adipose tissue (AT) and to identify genes and gene clusters responsive to treatment and thereby likely contributing to the development of the metabolic syndrome. Thus, randomized controlled and individualized weight reduction and physical exercise intervention was conducted. In the WR group, glucose metabolism improved that was not seen in other groups. Moreover, an inverse correlation between the change in SI and the change in body weight was found (r =-0.44, p=0.026). Down-regulation of gene expression (p\<0.01) involving gene ontology groups of extracellular matrix, cell death was seen. Such changes did not occur in the other groups.


Options:
A: The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death (Every 12 months, at the end of the study.)
B: Changes in blood pressure levels at 6 and 12 months (It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.)
C: N/A
D: Weight change (Baseline - 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Gene Expression in Adipose Tissue of Genes Involved in Obesity, Insulin Resistance and Lipid Metabolism Before and After Weight Loss or an Intensive Exercise Period
Brief Summary: Lifestyle and genetic factors interact in the development of obesity and the metabolic syndrome. The molecular mechanisms underlying the beneficial dietary modifications are, however, unclear. We aimed to examine the effect of the long-term 30 moderate weight reduction on gene expression in adipose tissue (AT) and to identify genes and gene clusters responsive to treatment and thereby likely contributing to the development of the metabolic syndrome. Thus, randomized controlled and individualized weight reduction and physical exercise intervention was conducted. In the WR group, glucose metabolism improved that was not seen in other groups. Moreover, an inverse correlation between the change in SI and the change in body weight was found (r =-0.44, p=0.026). Down-regulation of gene expression (p\<0.01) involving gene ontology groups of extracellular matrix, cell death was seen. Such changes did not occur in the other groups.


Options:
A: N/A
B: Change in Body Weight (Change from baseline weight to weeks 6, 10, 16, 20, 24.)
C: N/A
D: Serum estrone concentrations as measured by radioimmunoassay (At baseline and 12 months timepoint)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A RCT to Evaluate the Effect of Normal Saline in 5% Dextrose at Maintenance Rate, N/5 Saline in 5% Dextrose at 2/3 Maintenance Rate and N/5 Saline in 5% Dextrose at Maintenance Rate on Incidence of Hyponatremia in Hospitalized Children.
Brief Summary: Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized children.

Hypothesis: Use of normal saline in 5% dextrose or reduced (2/3) volume of N/5 saline in 5% dextrose reduces incidence of hyponatremia (serum sodium 130 mmol/L) by two-thirds when compared to N/5 saline in 5% dextrose at standard maintenance rate in hospitalized children receiving intravenous maintenance fluids.


Options:
A: Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L) (72 hrs)
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: Serum Sodium Levels in Both Groups (first 48 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Use Of Lorazepam For The Treatment Of Pediatric Status Epilepticus: A Randomized, Double-Blinded Trial Of Lorazepam And Diazepam
Brief Summary: Children with seizures are frequently seen in the emergency department. The drug lorazepam, which is commonly used, is not labeled by the US Food and Drug Administration for children for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that a study comparing diazepam, a drug that is labeled by the FDA for this indication, with lorazepam be performed. The study will show whether one drug is more effective and safe than the other.


Options:
A: recurrence of febrile seizure (two years)
B: cessation of convulsions within 10 minutes of the initial administration of the study drug and a sustained absence of convulsions for 30 minutes from the initial administration of the study drug. (30 minutes)
C: Length of Seizure After Study Medication Administration (24 hours)
D: whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia
Brief Summary: The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia


Options:
A: Antibiotic treatment prescriped at initial visit (Within 2 days of initial visit)
B: Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit (5 to 10 days after the last dose of study drug); Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit (5 to 10 days after the last dose of study drug)
C: Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population (8-15 days after last dose of study drug); Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population (8-15 days after last dose of study drug)
D: Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations (8 to 15 days after last dose of study drug); Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population (8-15 days after last dose of study drug)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Duration Pharmacotherapy for Prevention of Relapse to Smoking
Brief Summary: Varenicline (Chantix) is a smoking cessation treatment that was approved in 2006 by the FDA for treatment of nicotine dependence and may be particularly beneficial in smokers with schizophrenia or bipolar disorder. Early experience with varenicline indicates that it will be effective for smoking cessation in schizophrenia and in addition, has the potential to be therapeutic for cognitive dysfunction in this population. In addition, more data is needed to evaluate the safety, tolerability and effectiveness of Varenicline in people with bipolar disorder.

To assess this possibility, we will evaluate the safety and efficacy of 12 months of varenicline in schizophrenia or bipolar disorder patients who are able to quit smoking in the short term with this treatment. To do so, we will enroll 324 smokers with schizophrenia or bipolar disorder from 6 mental health clinics in Massachusetts, New Hampshire, Michigan and Minnesota into an open, 12-week smoking cessation program that includes varenicline added to weekly group cognitive behavioral therapy (CBT). Those who achieve at least 2 weeks of continuous abstinence during the last 2 weeks of the open intervention will be randomized to the relapse prevention phase: a 40-week, double blind, placebo-controlled trial of varenicline at the dose used to quit smoking added to a tapering CBT schedule. Participants will then discontinue study medications and behavioral treatment and enter a 3-month follow up phase.


Options:
A: Smoking cessation maintenance (12 month follow-up)
B: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)
C: smoking, self-report (6 months follow-up)
D: Self Reported Relapse Rate at 2 Months (2 months after joining the groups for the social networking services.); Self Reported Relapse Rate at 6 Months (6-months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Duration Pharmacotherapy for Prevention of Relapse to Smoking
Brief Summary: Varenicline (Chantix) is a smoking cessation treatment that was approved in 2006 by the FDA for treatment of nicotine dependence and may be particularly beneficial in smokers with schizophrenia or bipolar disorder. Early experience with varenicline indicates that it will be effective for smoking cessation in schizophrenia and in addition, has the potential to be therapeutic for cognitive dysfunction in this population. In addition, more data is needed to evaluate the safety, tolerability and effectiveness of Varenicline in people with bipolar disorder.

To assess this possibility, we will evaluate the safety and efficacy of 12 months of varenicline in schizophrenia or bipolar disorder patients who are able to quit smoking in the short term with this treatment. To do so, we will enroll 324 smokers with schizophrenia or bipolar disorder from 6 mental health clinics in Massachusetts, New Hampshire, Michigan and Minnesota into an open, 12-week smoking cessation program that includes varenicline added to weekly group cognitive behavioral therapy (CBT). Those who achieve at least 2 weeks of continuous abstinence during the last 2 weeks of the open intervention will be randomized to the relapse prevention phase: a 40-week, double blind, placebo-controlled trial of varenicline at the dose used to quit smoking added to a tapering CBT schedule. Participants will then discontinue study medications and behavioral treatment and enter a 3-month follow up phase.


Options:
A: Plasma Cotinine Concentration (Measured at the end of the last 3 weeks of randomization trial phase)
B: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Duration Pharmacotherapy for Prevention of Relapse to Smoking
Brief Summary: Varenicline (Chantix) is a smoking cessation treatment that was approved in 2006 by the FDA for treatment of nicotine dependence and may be particularly beneficial in smokers with schizophrenia or bipolar disorder. Early experience with varenicline indicates that it will be effective for smoking cessation in schizophrenia and in addition, has the potential to be therapeutic for cognitive dysfunction in this population. In addition, more data is needed to evaluate the safety, tolerability and effectiveness of Varenicline in people with bipolar disorder.

To assess this possibility, we will evaluate the safety and efficacy of 12 months of varenicline in schizophrenia or bipolar disorder patients who are able to quit smoking in the short term with this treatment. To do so, we will enroll 324 smokers with schizophrenia or bipolar disorder from 6 mental health clinics in Massachusetts, New Hampshire, Michigan and Minnesota into an open, 12-week smoking cessation program that includes varenicline added to weekly group cognitive behavioral therapy (CBT). Those who achieve at least 2 weeks of continuous abstinence during the last 2 weeks of the open intervention will be randomized to the relapse prevention phase: a 40-week, double blind, placebo-controlled trial of varenicline at the dose used to quit smoking added to a tapering CBT schedule. Participants will then discontinue study medications and behavioral treatment and enter a 3-month follow up phase.


Options:
A: The primary endpoint will be 6M of abstinence measured 18M after enrollment. (18M)
B: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)
C: evaluate the abstinence of tobacco consumption (12 months)
D: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.
Brief Summary: Patients undergoing cardiac surgery could develop postoperative acute renal failure requiring renal replacement therapy.

Fenoldopam, already used for patients with hypertensive emergencies, could improve renal function in critically ill patients with or at risk for acute renal failure.


Options:
A: Total Number of Days in Hospital (Within 60 days of randomization)
B: mortality (1 year)
C: Number of patients requiring Renal Replacement Therapy (participants will be followed for the duration of intensive care unit stay, an expected average of one week)
D: Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction (up to 10 days post procedure)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo
Brief Summary: The locoregional anaesthesia is increasingly important in surgical practice, often allowing to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading to a longer hospitalization because of the pain resulting from the surgery. The Levobupivacaïne (Chirocaïne) administered through catheters placed in the caesarean scars, showed its efficiency in post-operative analgesia.

Method : realization of a double blind prospective randomized study, control versus placebo Purpose : to show that the local administration of a unique dose of analgesia reduce the post-operative pain with a little or non-invasive technique


Options:
A: analgesic consumption of level 3 in the two treated groups (24 hours)
B: VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. (six months)
C: Quality of recovery 40(QoR-40) score (24hours after operation day)
D: To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo
Brief Summary: The locoregional anaesthesia is increasingly important in surgical practice, often allowing to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading to a longer hospitalization because of the pain resulting from the surgery. The Levobupivacaïne (Chirocaïne) administered through catheters placed in the caesarean scars, showed its efficiency in post-operative analgesia.

Method : realization of a double blind prospective randomized study, control versus placebo Purpose : to show that the local administration of a unique dose of analgesia reduce the post-operative pain with a little or non-invasive technique


Options:
A: The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period. (24 hours)
B: opiate consumption (hospital discharge/ days 0-7)
C: analgesic consumption of level 3 in the two treated groups (24 hours)
D: To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural (24 months)

Answer: C