TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo- Controlled Study Of Atorvastatin As Prevention Of Cerebrovascular Events In Patients With A Previous Transient Ischemic Attack (TIA) Or Stroke
Brief Summary: To determine whether Lipitor reduces stroke, compared to placebo in patients who have had a previous stroke or transient ischemic attack.


Options:
A: Change in intima media thickness as measured by carotid ultrasound
B: N/A
C: Time to occurrence of fatal or non-fatal stroke
D: Morphological carotid plaque stabilization (Six months); Carotid plaque regression (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo- Controlled Study Of Atorvastatin As Prevention Of Cerebrovascular Events In Patients With A Previous Transient Ischemic Attack (TIA) Or Stroke
Brief Summary: To determine whether Lipitor reduces stroke, compared to placebo in patients who have had a previous stroke or transient ischemic attack.


Options:
A: Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX) (Baseline and 16 weeks)
B: Brachial Artery Flow-mediated Dilation (FMD) (baseline and 6 weeks)
C: The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin. (visit 4 (day 1) to visit 16 (day 148))
D: Time to occurrence of fatal or non-fatal stroke

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled, Four Arm (Placebo, Tolterodine ER, Tamsulosin, and Tolterodine ER Plus Tamsulosin) Study To Evaluate The Clinical Efficacy And Safety Of Tolterodine ER 4 mg In Men Who Have Frequency and Urgency, With Or Without Urinary Urge Incontinence, With Or Without Bladder Outlet Obstruction
Brief Summary: The primary objective of the trial is to evaluate the effect of tolterodine ER plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, with or without urinary urge incontinence (UUI), with or without bladder outlet obstruction (BOO).


Options:
A: Patient Perception of Treatment Benefit at Week 12:; Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12
B: Patient Perception of Bladder Condition at 12 weeks of treatment
C: Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) (Baseline and Week 12); Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) (Baseline and Week 12)
D: Change From Baseline to End of Treatment in Total International Prostate Symptom Score (Baseline and Week 12); Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS]) (Baseline and Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double Blind Placebo Controlled Trial of Effects of Long Term Low Dose Oral Erythromycin Therapy in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this study is to determine whether long term treatment with oral erythromycin is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease (COPD) by reducing the number of exacerbations and the degree of airway inflammation.


Options:
A: Exacerbation Frequency; Airway Inflammation
B: reduction of number of exacerbations; reduction of number of hospitalisations
C: Mean change in the Leicester Cough Questionnaire (LCQ) scores. (2 years)
D: Reduction in number of exacerbations (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double Blind Placebo Controlled Trial of Effects of Long Term Low Dose Oral Erythromycin Therapy in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this study is to determine whether long term treatment with oral erythromycin is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease (COPD) by reducing the number of exacerbations and the degree of airway inflammation.


Options:
A: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)
B: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
C: Identifying new patient subtypes and endpoints for COPD (3 years)
D: Exacerbation Frequency; Airway Inflammation

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double Blind Placebo Controlled Trial of Effects of Long Term Low Dose Oral Erythromycin Therapy in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this study is to determine whether long term treatment with oral erythromycin is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease (COPD) by reducing the number of exacerbations and the degree of airway inflammation.


Options:
A: Progression to Clinically Significant Lower Respiratory Tract Symptoms (14 days after initiation of APRIL therapy); OCELOT: Pediatric Respiratory Assessment Measure (36-72 hours after initiation of OCELOT therapy)
B: Exacerbation Frequency; Airway Inflammation
C: Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations) (5 to 8 months)
D: To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo (Week 14 post treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Monotherapy or Metformin Therapy in Combination With Other Oral Anti-Diabetic Agents
Brief Summary: The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in combination with other anti-diabetic drugs.


Options:
A: To evaluate the effect of 8 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method, i.e., placebo-corrected change from baseline in M-value. (8 weeks)
B: To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
D: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Sulfonylurea Monotherapy or Sulfonylurea Therapy in Combination With Other Oral Anti-Diabetic Agents
Brief Summary: The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in combination with other anti-diabetic drugs.


Options:
A: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
B: To assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
D: - To assess the additional lowering of HbA1c achieved by; addition of WelChol® to current antidiabetic therapy

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Patient Decision Aids for Faecal Occult Blood Test Screening
Brief Summary: This project has been completed and consisted of a randomised trial of six tailored decision aids giving patients evidence-based information about faecal occult blood test screening for bowel cancer. 314 Australians aged between 50-74 years were recruited from five general practices and randomised to received either the tailored decision aid with age-gender and family history specific information and values clarification exercise or a standard government information sheet.

The decision aid significantly increased the proportion of people who were informed participants in the screening program.


Options:
A: Feasibility of Data Collection at Month 12 (Data collection occurred at month 12)
B: Quality of Decision Making (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.); Knowledge Transfer (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.)
C: Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant - Randomised Withdrawal of Mycophenolate Mofetil (CellCept®) or Cyclosporine A (Sandimmun Neoral®)
Brief Summary: To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy


Options:
A: 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)
B: Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection (12 months)
C: Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR) (Baseline and Month 6)
D: The primary efficacy endpoint is the absolute change in renal function from inclusion to 12 months post drug withdrawal, evaluated as GFR estimated from Nankivell's formula B and normalised for 1.73 m2 body-surface.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Multicenter, Randomized, Double-Blind Study Comparing Safety and Efficacy of Norepinephrine Plus Dobutamine Versus Epinephrine Alone in Septic Shock.
Brief Summary: Catecholamines infusion is a major component of septic shock management. International guidelines recommend that norepinephrine should be preferred to epinephrine, though phase III trials are lacking. The present study aimed at comparing the efficacy and safety of norepinephrine plus dobutamine to that of epinephrine in adults with septic shock.


Options:
A: The primary outcome measure for the study is death from all causes (90 days)
B: Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI) (over a period of 6 hrs from the time of randomization); Oxygen transport variables (over a period of 6 from the time of randomization)
C: Efficacy and Safety of Dopamine Versus Norepinephrine in Septic Shock (28 days)
D: 28 Day mortality (28 Day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label Extension of the Phase II/III Clinical Trial of Intravitreal Triamcinolone on the Effects and Safety of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment
Brief Summary: This open label extension will treat all the eyes of study participants with active study medication (intravitreal triamcinolone) as well as standard laser treatment where appropriate.

The specific aims will be to test the following hypotheses:

* That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment remains efficacious over five years
* That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment retains a manageable and acceptable safety profile over five years


Options:
A: Increase of ≥5 letters at the 5-year study visit on a LogMAR chart compared with (a) the initial baseline level and (b) the level at the 2-year study visit. (3 year extension, total 5 years study from baseline); Incidence of moderate or severe adverse events over the 3 years of the open-label extension (3 year extension study, total 5 year study from baseline)
B: Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years. (Baseline to 2 Years); Median Change in Visual Acuity Baseline to 2 Years (Baseline to 2 Years); Distribution of Change in Visual Acuity Baseline to 2 Years (baseline to 2 years)
C: Visual Acuity (36 months)
D: Visual acuity gain (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Electrical Stimulation for Footdrop in Hemiparesis
Brief Summary: The objective of this research is to determine if electrical stimulation can improve the strength and coordination of the lower limb muscles, and the walking ability of stroke survivors.

The knowledge gained from this study may lead to enhancements in the quality of life of stroke survivors by improving their neurological recovery and mobility. The results may lead to substantial changes in the standard of care for the treatment of lower limb hemiparesis after stroke.


Options:
A: Gait Velocity (6 months); Stroke Impact Scale (SIS) Composite Score (6 months); Device Related Serious Adverse Events (6 months)
B: Change in Action Research Arm Test (ARAT) Score (Baseline and 12 weeks)
C: Change in Fugl-Meyer Assessment Scale after training (1) up to 7 weeks, 2) 3 months after participants finish the training); Change in Modified Ashworth Scale after training (1) up to 7 weeks, 2) 3 months after participants finish the training)
D: Fugl-Meyer Motor Assessment (FMA) (Weeks 0, 12, 24, 36)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of Asthma Patient Education (TAPE)
Brief Summary: The purpose of this research study is to investigate the way that educational approaches and presentation of a drug may affect the response to montelukast and placebo (an inactive medication) in subjects with asthma.


Options:
A: Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16); Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16)
B: Morning peak expiratory flow
C: Symptom-free days; Quality of Life Questionnaire (AQLQ, PAQLQ); Rate of asthma-related hospitalizations over 18 months of enrollment; Rate of asthma-related emergency room (ER) visits over 18 months of enrollment
D: FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of 2 TeleComputer Diet Change Maintenance Programs
Brief Summary: The purpose of this study is to test two different approaches to helping individuals who have recently starting eating a healthful diet maintain those healthy changes. This study will deliver a health program using an automated telephone system. The programs will be designed to help individuals maintain a healthy diet change for a lifetime.


Options:
A: Smoking Abstinence (12 weeks); Smoking Abstinence (2 weeks)
B: Fasting Insulin (Baseline); 3 Month Fasting Insulin (3 month); 12 Month Fasting Insulin (12 months); Fasting Glucose (Baseline); 3 Month Fasting Glucose (3 months); 12 Month Fasting Glucose (12 Months)
C: Depressive symptoms (Pre-, post-monitoring, 6-week follow up & 6 month follow-up); Emotional Self Awareness (Pre-, post-, 6-weeks post- and 6-months post-test)
D: The study hypothesis is that the goal systems intervention will out perform the social cognitive intervention and that both of these interventions will outperform the control group for fruit and vegetable consumption. (July 2006-July 2009)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC.
Brief Summary: The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who did not received prior chemotherapy. Overall survival will be taken as primary measure of efficacy.


Options:
A: Progression-free Survival (Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168)
B: Overall Survival Time (OS) (Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007)
C: Progression free survival (12 months)
D: Median Progression Free Survival (PFS) Time (Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective,Randomised, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Bilateral Globus Pallidus Internus - in Patients With Medically Refractory Primary Cervical Dystonia
Brief Summary: The purpose of this study is to investigate the efficacy and safety of bilateral pallidal stimulation in patients with medically refractory primary cervical dystonia.


Options:
A: relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
B: Improvement in neck postures/movements; Improvement in quality of life
C: Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group) (3 months)
D: The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline. (at six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: "The CHRONOS Study: Can the Sleep-deprivation Induced Antidepressive Effect in Patients With Major Depression be Sustained by Correction of Diurnal Rhythms, Long Term Light Treatment and Duloxetine Treatment?"
Brief Summary: The primary objective of the present study is to examine whether the combination of the antidepressant duloxetine and chronotherapeutic methods (including sleep deprivation, light therapy, and maintaining a regular sleep-wake rhythm) in patient with major depression, will induce an immediate improvement from depression and whether this antidepressive effect will be maintained in the long term (29 weeks). Patient will be randomised to the above mentioned treatment or to an active group receiving exercise.


Options:
A: HAM-D17 (Before and after 3 months intervention)
B: Hamilton Depression Rating Scale (Measured at 16 weeks)
C: Measured at Week 16 and Months 6 and 12 post-treatment: Post-treatment recovery from MDD; Post-treatment depression scores on the Hamilton Depression Rating Scale
D: Hamilton score during the 29 weeks trial (1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Low-dose Hydrocortisone in the Treatment of the Shock of Burned Patients
Brief Summary: Major burns trigger the release of circulating mediators, as cytokines and endotoxin that induces a systemic inflammatory response syndrome. The cardiovascular effects are similar to those seen in septic shock. After the initial hypovolemic phase, patients with extensive burns often present a shock with increased cardiac output and reduced systemic vascular resistances. As described in septic shock, we test the hypothesis that low-dose hydrocortisone could decrease the duration of the shock period.


Options:
A: All cause mortality at 90 days after randomisation (90 days after randomisation)
B: Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock
C: 28-day Mortality (28 days)
D: Septic shock (14 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Low-dose Hydrocortisone in the Treatment of the Shock of Burned Patients
Brief Summary: Major burns trigger the release of circulating mediators, as cytokines and endotoxin that induces a systemic inflammatory response syndrome. The cardiovascular effects are similar to those seen in septic shock. After the initial hypovolemic phase, patients with extensive burns often present a shock with increased cardiac output and reduced systemic vascular resistances. As described in septic shock, we test the hypothesis that low-dose hydrocortisone could decrease the duration of the shock period.


Options:
A: Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock
B: Time to clinical stability (30 days)
C: 90-day mortality (90 day)
D: 28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH) (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Comparison of LY2140023, Olanzapine, and Placebo in the Treatment of Patients With Schizophrenia
Brief Summary: Assess the efficacy of a new drug (a receptor agonist that modulates the glutamatergic activity) in the treatment of schizophrenia.

The primary objective of this study is to determine if a mGlu2/3 agonist dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score.


Options:
A: Efficacy of combined risperidone and quetiapine groups versus placebo based on change in psychotic symptoms scale from baseline to two weeks.
B: To determine if a mGlu2/3 agonist (LY2140023) dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score (28 days)
C: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline, Week 6)
D: Positive and Negative Syndrome Scale (PANSS) total score (over 4 weeks of treatment)

Answer: B