TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Eicosapentaenoic Acid Cerebral Vasospasm Therapy Study (EVAS): Effect of Eicosapentaenoic Acid on Cerebral Vasospasm Following Subarachnoid Hemorrhage
Brief Summary: Cerebral vasospasm following subarachnoid hemorrhage (SAH) is the most common cause of morbidity and mortality. Recent studies indicate that Rho-kinase play an important role in the occurrence of such cerebral vasospasm. Eicosapentaenoic acid (EPA) inhibits sphingosylphosphorylcholine (SPC)-induced Rho-kinase activation in vitro. So this study examines whether EPA prevents cerebral vasospasm occurrence after SAH in patients.


Options:
A: 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)
B: Cerebral vasospasms: Symptomatic vasospasm defined as documented arterial vasospasm consistent with new neurological deterioration. New low-density areas on CT scans associated with vasospasm. (Between 4 and 30 days after the onset of SAH)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Eicosapentaenoic Acid Cerebral Vasospasm Therapy Study (EVAS): Effect of Eicosapentaenoic Acid on Cerebral Vasospasm Following Subarachnoid Hemorrhage
Brief Summary: Cerebral vasospasm following subarachnoid hemorrhage (SAH) is the most common cause of morbidity and mortality. Recent studies indicate that Rho-kinase play an important role in the occurrence of such cerebral vasospasm. Eicosapentaenoic acid (EPA) inhibits sphingosylphosphorylcholine (SPC)-induced Rho-kinase activation in vitro. So this study examines whether EPA prevents cerebral vasospasm occurrence after SAH in patients.


Options:
A: Major coronary events (sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina pectoris including hospitalization for ischemic episodes,events of angioplasty/ stenting or coronary artery bypass grafting)
B: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect (baseline and 12 weeks)
C: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
D: Cerebral vasospasms: Symptomatic vasospasm defined as documented arterial vasospasm consistent with new neurological deterioration. New low-density areas on CT scans associated with vasospasm. (Between 4 and 30 days after the onset of SAH)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo and Active-Controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes


Options:
A: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26); Change in Glycosylated A1c (HbA1c) at Week 104 (week 0, week 104)
B: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)
C: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 (Baseline and Week 52)
D: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 (Baseline and Week 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Symbicort® SMART (160/4.5μg) and Symbicort® Turbuhaler 160/4.5 μg, Plus Terbutaline Turbuhaler 0.4 mg as Needed, for Treatment of Asthma - a 12-month, Randomized, Double-blind, Parallel Group, Active-controlled, Multinational Phase III Study in Asthmatic Patients From 16 Years
Brief Summary: The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy


Options:
A: Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level (Baseline and 12 weeks)
B: The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study (week 52)
C: Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes (60 min)
D: Asthma control assessed by asthma exacerbations (Continuosly throughout the treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Dissemination of Consensus Recommendations on the Management of Canadian Patients With Non Variceal Upper Gastrointestinal Bleeding: A National Cluster Randomized Trial of a Multifaceted Tailored Implementation Strategy
Brief Summary: The purpose of this study is to assess whether adherence to NVUGIB guidelines is improved with implementation of a national, tailored multifaceted intervention. Outcomes include adherence rates to two key endoscopic and pharmacological therapy guidelines together (primary), or adherence to these individually as well as to other recommendations (secondary). Patient outcomes and economic data are also assessed (tertiary).


Options:
A: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
B: Successful completion of follow-up colonoscopy; Number of patients completing colonoscopy during the study period
C: colorectal cancer screening (15 months)
D: Bone mineral density (BMD) testing rates

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Dissemination of Consensus Recommendations on the Management of Canadian Patients With Non Variceal Upper Gastrointestinal Bleeding: A National Cluster Randomized Trial of a Multifaceted Tailored Implementation Strategy
Brief Summary: The purpose of this study is to assess whether adherence to NVUGIB guidelines is improved with implementation of a national, tailored multifaceted intervention. Outcomes include adherence rates to two key endoscopic and pharmacological therapy guidelines together (primary), or adherence to these individually as well as to other recommendations (secondary). Patient outcomes and economic data are also assessed (tertiary).


Options:
A: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
B: The outcome measure will be rate of patients falls per 1000 patient days (1/2009-6/2009)
C: referral to a nephrologist (12 months)
D: Referral for Implantable Cardioverter Defibrillator (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Dissemination of Consensus Recommendations on the Management of Canadian Patients With Non Variceal Upper Gastrointestinal Bleeding: A National Cluster Randomized Trial of a Multifaceted Tailored Implementation Strategy
Brief Summary: The purpose of this study is to assess whether adherence to NVUGIB guidelines is improved with implementation of a national, tailored multifaceted intervention. Outcomes include adherence rates to two key endoscopic and pharmacological therapy guidelines together (primary), or adherence to these individually as well as to other recommendations (secondary). Patient outcomes and economic data are also assessed (tertiary).


Options:
A: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
B: Episiotomies; Oxytocin use in third stage of labor
C: Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls (nine months)
D: Change in t-PA use with assessment of appropriateness of use and complications. (January 2005 to January 2010)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Dissemination of Consensus Recommendations on the Management of Canadian Patients With Non Variceal Upper Gastrointestinal Bleeding: A National Cluster Randomized Trial of a Multifaceted Tailored Implementation Strategy
Brief Summary: The purpose of this study is to assess whether adherence to NVUGIB guidelines is improved with implementation of a national, tailored multifaceted intervention. Outcomes include adherence rates to two key endoscopic and pharmacological therapy guidelines together (primary), or adherence to these individually as well as to other recommendations (secondary). Patient outcomes and economic data are also assessed (tertiary).


Options:
A: Symptomatic venous thromboembolic events and severe haemorrhage (3 months)
B: Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses (2 years)
C: Composite measure representing improvement in cholesterol-related secondary prevention consisting of (1) provision of a statin sample (2) provision of a statin prescription or (3) dosage increase of a statin within the first 6 months post-angiogram.
D: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Epidemiologic Study on Changing HIV Risks Among FSW-IDUs on the Mexico-US Border
Brief Summary: The investigators propose a highly efficient four-arm (factorial) trial to simultaneously test the efficacy of two behavioral interventions aimed at:

* increasing condom use in the context of ongoing drug use and
* decreasing needle and paraphernalia sharing

among female sex workers who also inject drugs in two Mexican-U.S. border cities: Tijuana and Ciudad Juarez.


Options:
A: Frequency of unprotected sexual acts with nonspousal partners (Measured at baseline and Years 1 and 2); Overall observed incidence of sexually transmitted diseases (STDs) (e.g., chlamydia, gonorrhea, syphilis, trichomonas, HIV, or herpes simplex virus-2), as detected by biological specimens (Measured at baseline and Years 1 and 2)
B: Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis. (12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline)
C: HIV-1 seroincidence; HSV2 seroprevalence
D: Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study); All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomised, Placebo Controlled, Double Blind Trial About Safety and Efficacy of Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke
Brief Summary: It should be shown that Cerebrolysin in combination with Alteplase, the medication that should recover the blood flow through the brain, is an effective and save medication to treat ischeamic stroke.


Options:
A: Modified Rankin Scale (90 days after start of treatment); Barthel Index (90 days after start of treatment); NIH Stroke Scale (90 days after start of treatment)
B: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
C: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
D: Global disability on modified Rankin scale at 90 days.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomised, Placebo Controlled, Double Blind Trial About Safety and Efficacy of Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke
Brief Summary: It should be shown that Cerebrolysin in combination with Alteplase, the medication that should recover the blood flow through the brain, is an effective and save medication to treat ischeamic stroke.


Options:
A: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
B: Global disability on modified Rankin scale at 90 days.
C: Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28 (baseline and week 28); Clinical Interview-based Impression of Change (CIBIC+) Score (week 28)
D: National Institutes of Health Stroke Scale Score (At 11-day and 21-day after therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomised, Placebo Controlled, Double Blind Trial About Safety and Efficacy of Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke
Brief Summary: It should be shown that Cerebrolysin in combination with Alteplase, the medication that should recover the blood flow through the brain, is an effective and save medication to treat ischeamic stroke.


Options:
A: Global disability on modified Rankin scale at 90 days.
B: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
C: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
D: National Institutes of Health Stroke Scale Score (At 11-day and 21-day after therapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomised, Placebo Controlled, Double Blind Trial About Safety and Efficacy of Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke
Brief Summary: It should be shown that Cerebrolysin in combination with Alteplase, the medication that should recover the blood flow through the brain, is an effective and save medication to treat ischeamic stroke.


Options:
A: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
B: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)
C: Modified Rankin Scale (mRS) 0-1 (3 months)
D: Modified Rankin Scale (mRS) 0-1 (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomised, Placebo Controlled, Double Blind Trial About Safety and Efficacy of Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke
Brief Summary: It should be shown that Cerebrolysin in combination with Alteplase, the medication that should recover the blood flow through the brain, is an effective and save medication to treat ischeamic stroke.


Options:
A: National Institutes of Health Stroke Scale Score (At 11-day and 21-day after therapy)
B: Global disability on modified Rankin scale at 90 days.
C: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
D: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Facilitating and Inhibiting Factors and Effect of Interventions in Return to Work for Patients With Neck and Low Back Pain
Brief Summary: Low back pain is a usual condition in the western countries and several treatments available for patients with "non-specific low back pain". According to the European guidelines both Brief intervention and exercise/cognitive intervention are effective treatments with regard to pain and function (www.backpaineurope.org), but none have documented effect on return to work.

The challenges for health personnel is not cure of the patients back pain, but to build up rehabilitation programs which focus on disability and work incapacity, in patients which are at risk of loosing their work. Dr. P. Loisel, Montreal, Canada", has since 1995 treated patients with back pain according to the "The PREVICAP model - (PREVention of work handICAP)", where the main purpose with work-related program is to prevent prolonged disability and to help patients back to work. Loisel demonstrated that the PREVICAP models accelerated the "return to work" factor by a factor 2.4 (p=0.01). The PREVICAP model had also been evaluated in Amsterdam, by Dr. Anema with the same results.

At the Back Clinic, Ullevål University Hospital we are presently involved in a randomized controlled trial after the PREVICAP model, where patients are randomized to Brief intervention including a work-related intervention or usual care. All included patients in both groups, will have a clinical examination by specialist in Physical Medicine and Rehabilitation and advice from a physiotherapist. The current study replaces Brief intervention with an exercise - and a work-related program, so patients with non-specific LBP will be randomized to an exercise and work-related program or usual care.

The main purpose of this study

* to investigate if rehabilitation programs specifically focusing on the return to work process will reduce sickness absence and disability pension in patients with neck and low back pain.
* to assess the work-, individual- and health factors and their interrelationship predicting sickness absence and work disability.
* to compare results from the rehabilitation program with results from rehabilitation program in Toronto
* to which extent are the patients met by actions from employers and employment services, and does is influence sickness absence and disability.
* do these actions represent favourable cost benefit for the work places and the society


Options:
A: time until full sustainable return-to-work (RTW) (1 year); Total number of sickness absence days (1 year)
B: Change in Sickness leave 1 year after inclusion (At 12 months after baseline)
C: N/A
D: return to work rate (week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial to Establish the (Cost-)Effectiveness of an Interdisciplinary Community-based COPD Management Program Relative to Usual Care.
Brief Summary: There is growing evidence that COPD is a multi-organ system disease. Besides impaired lung function, skeletal muscle weakness and weight loss are important determinants of impaired exercise performance, decreased quality of life and increased mortality. Based on earlier succesful intervention studies in pulmonary rehabilitation settings, Máxima Medical Centre developed an integrated, inter-disciplinary approach to the management of COPD including physical exercise, nutritional therapy, education, smoking cessation and psychological consultation. This COPD management program consists of a set of protocols that cover patient recruitment, diagnostic testing, treatment, follow-up and communication between professionals.

The exercise program and the nutitional therapy are carried out by local physiotherapists and dieticians working outside but in conjunction with the hospital. A program in such a setting could be substantially less expensive and certainly more easily accessible for many more patients than an inpatient or hospital-based outpatient rehabilitation program, as it is offered close to a patient's home. This study investigates the (cost-)effectiveness of the COPD management program compared to usual care in a randomized controlled trial.

Patients with moderate to severe COPD and a reduced exercise capacity during an incremental exercise test of less than 70% of predicted, are randomised to a treatment or a control group. The treatment group will participate in the COPD management program during the first 4 months after which they will be followed up for the remaining months. Both groups (n=100) are followed for 2 years and outcomes will be assessed at the beginning of the program, after 4, 12 and 24 months by disease-specific and generic measures of health status, body composition, skeletal muscle function and exercise capacity. A cost-effectiveness and cost-utility analysis with a two-year time horizon will be performed. The analysis is conducted from a societal perspectice, including the program costs and all COPD-related direct costs within and outside the healthcare sector ans costs of lost productivity.


Options:
A: disease-specific health-related quality of life (HRQoL) (two years)
B: The number of ED presentations (1 year after randomization.)
C: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)
D: The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations

Answer: D