TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluid Shift in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest, and How do They Manage Life Afterwards?
Brief Summary: Therapeutic hypothermia after cardiac arrest har shown to improve the rate of survival in a significant way. However hypothermia also causes leak of fluid into the surrounding tissue. This edema could lead to damage to the same tissue, not beneficial for the patients. We therefore try to evaluate if hyperosmolar, hyperoncotic fluid as an alternative to std. treatment (NaCl/RA)could affect the edema in a positive way, and result to a better outcome neurological for the patients.


Options:
A: Mortality; Quality of Life
B: Sublingual microcirculation (24 hour)
C: Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization (until hemodynamic stabilization (up to 48 hours))
D: All cause mortality (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluid Shift in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest, and How do They Manage Life Afterwards?
Brief Summary: Therapeutic hypothermia after cardiac arrest har shown to improve the rate of survival in a significant way. However hypothermia also causes leak of fluid into the surrounding tissue. This edema could lead to damage to the same tissue, not beneficial for the patients. We therefore try to evaluate if hyperosmolar, hyperoncotic fluid as an alternative to std. treatment (NaCl/RA)could affect the edema in a positive way, and result to a better outcome neurological for the patients.


Options:
A: All cause mortality (90 days)
B: Sublingual microcirculation (24 hour)
C: Mortality; Quality of Life
D: Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization (until hemodynamic stabilization (up to 48 hours))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of the Effectiveness of Base-in Prism Reading Glasses Vs. Placebo Reading Glasses for Symptomatic Convergence Insufficiency in Children
Brief Summary: This study is designed to compare the use of special prism glasses to placebo treatment for children with symptomatic convergence insufficiency.


Options:
A: Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey (12 weeks)
B: The change in the Wechsler Individual Achievement Test-III (WIAT-III) reading comprehension score as measured after the completion of 16 weeks of assigned treatment (OBVAT or OBPT). (After 16 weeks of treatment)
C: Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU (12 weeks after randomization (baseline)); Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-P (12-weeks after randomization (baseline))
D: Symptom score on the Convergence Insufficiency Symptom Survey

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies for the Control of Blinding Trachoma: Effect of Fly Spray
Brief Summary: The purpose of this community-based randomized trial was to determine, in trachoma hyper-endemic communities of Tanzania, the added value of intensive spraying to control flies on the fly population and on trachoma and ocular chlamydia infection at 6 months and one year after mass antibiotic treatment.


Options:
A: All-cause Mortality Rate in Children Aged 1-60 Months (24 Months); All-cause Mortality Rate in Children Aged 1-60 Months (36 months)
B: The prevalence of ocular chlamydia infection in a village as determined by PCR
C: clinical trachoma (1 year)
D: Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline (At baseline); Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of Antibiotics to Reduce Recurrent Trichiasis (STAR)
Brief Summary: Trachoma, an ocular infection caused by C. trachomatis, is the second leading cause of blindness worldwide.Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma, which includes surgery to correct trichiasis. Despite this encouraging news, under the best of circumstances the recurrence rate of trichiasis following surgery is disappointingly high. The objective of our project is to conduct a randomized, controlled clinical trial of post-surgical antibiotic treatment, comparing oral azithromycin to topical tetracycline, for trichiasis surgical patients in Ethiopia with the goal of determining the impact of treatment on rates of trichiasis recurrence at one and two years.


Options:
A: Trichiasis (One and two years)
B: Number of Eyelids With Presence of Recurrent Trichiasis (2 years); Number of Eyelids With Pyogenic Granuloma (2 years); Number of Eyelids Experiencing an Unfavorable Outcome (2 years); Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities (2 years)
C: Recurrent Trichiasis in Tetracycline and Azithromycin Groups (Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery); Recurrent Trichiasis Between Two Azithromycin Arms (Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery)
D: Recurrent trichiasis (One and two years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.
Brief Summary: Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.


Options:
A: Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9) (Visit 3 - day 8 or 9); Eradication of Baseline Pathogens (Day 8 or 9) (Visit 3 - Day 8 or day 9)
B: Clinical Cure at the Day 4 (EOT)/Exit Visit (Day 4)
C: Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 5 +/- 1 day); Microbial Eradication of Baseline Bacterial Infection (Day 5 +/- 1 day)
D: Participants Who Achieved Clinical Resolution (Visit 3 (Days 6-7))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Pencil Push-Ups Versus Office Based Vision Therapy For the Treatment of Convergence Insufficiency
Brief Summary: The Convergence Insufficiency Treatment Trial (CITT) is a multi-center, placebo-controlled, single-masked, clinical trial designed to compare the benefits of two commonly used treatment approaches for patients with convergence insufficiency (CI)


Options:
A: Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey (12 weeks)
B: Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU (12 weeks after randomization (baseline)); Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-P (12-weeks after randomization (baseline))
C: The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey
D: symptomatic convergence insufficiency (one month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Effects of SB-742457, Donepezil and Placebo on Cognition in Subjects With Mild to Moderate Alzheimer's Disease
Brief Summary: The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate Alzheimer's Disease. SB-742457 is a new treatment which is thought to increase the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's Disease.


Options:
A: Cohen Mansfield Agitation Inventory
B: Polysomnography parameters: sleep structure, respiratory, limb movements (onset, 3 and 6 months of treatment)
C: Change in cognition and function after 24 weeks.
D: Change From Baseline to Week 24 in SIB Total Score (Baseline and Week 24); Overall Change From Baseline in Modified CIBIC+ to Week 24 (Baseline and Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare whether there is the difference in the effect of insulin therapy by the number of times of insulin injection.


Options:
A: mortality
B: HbA1c; daily profile of blood glucose
C: Mortality; Sternal wound infections; Stroke; Cardiac arrhythmias; Renal failure
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 Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients
Brief Summary: Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients.


Options:
A: Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery (3 Months)
B: N/A
C: Percentage of patients who develop macular edema within 90 days following cataract surgery (Time to event)
D: The incidence of CME was evaluated by retinal foveal thickness on optical coherence tomography (OCT) (After 1 week, 4 weeks, 12 weeks after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
Brief Summary: The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.


Options:
A: Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year (one year)
B: Endoscopic recurrence of disease (18 months)
C: Number of Subjects Without Mucosal Ulceration at Week 12 (Week 12)
D: Percentage of Participants With Mucosal Healing and No Deep Ulcerations (48 weeks after Randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
Brief Summary: The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.


Options:
A: Number of Subjects Without Mucosal Ulceration at Week 12 (Week 12)
B: Clinical remission (CDAI score of <150) (Week 11)
C: Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments (Baseline, Week 10); Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments (Baseline, Week 10)
D: To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.
Brief Summary: The primary objective of the study is to compare the efficacy of levosimendan and dobutamine on all-cause mortality in the 180 days following randomization.


Options:
A: N/A
B: All-cause mortality in the 180 days following randomization.
C: All cause mortality at 30 days post randomization
D: Number of Dual Efficacy Endpoint Events (30 days); Number of Quad Efficacy Endpoint Events (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effects of a Water Cure on Gonarthrosis: Randomized Clinical Study Including Water Cure Versus Continuation of the Usual Treatment
Brief Summary: The main objective of this study is to evaluate the therapeutic effect of a thermal treatment on gonarthrosis, with an increase of the number of patients presenting a clinically significant improvement.


Options:
A: N/A
B: Pain (Baseline and 12-month follow-up)
C: the more small change clinically relevant of the WOMAC indice and/or of pain. (at 6 months)
D: Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 (baseline and 4 weeks); Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4 (baseline and 4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects
Brief Summary: Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions.

The duration of the current study is 36 weeks.


Options:
A: Reduction of brain lesions in the last 4 months of the study (36 weeks)
B: Cumulative Number of New Gadolinium-enhancing (GdE) T1 Lesions at Week 12 (Week 12)
C: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
D: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate (Core treatment period between 48 - 152 weeks depending on time of enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy
Brief Summary: The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy


Options:
A: Safety Will be Evaluated by Number of AE (Total AEs and SAEs within 450 days post-infusion)
B: increase of the ejection fraction of the left ventricle (1 year)
C: Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation (one month post-catheterization)
D: Longitudinal change in left ventricular function (ejection fraction) (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With B-cell Chronic Lymphocytic Leukemia Who Have Failed Fludarabine and Alemtuzumab
Brief Summary: The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.


Options:
A: Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines (Start of treatment (Week 0 of Visit 2) until Week 24)
B: Progression-free survival (randomization until disease progression or death)
C: Progression-Free Survival (Up to 17 months)
D: Overall response rate (ORR) (84 days after start of the last induction cycle)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With B-cell Chronic Lymphocytic Leukemia Who Have Failed Fludarabine and Alemtuzumab
Brief Summary: The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.


Options:
A: Number of Participants (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion (Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)); Number of Participants (Par.) Who Were Classified as Responders and Non-responders (From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32))
B: Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines (Start of treatment (Week 0 of Visit 2) until Week 24)
C: Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC) (From randomization to the date of first documented disease progression or death due to any cause, whichever occured first, reported between day of first patient randomized up to about 49 months)
D: Progression-free Survival (PFS) (Median observation time at time of analysis was approximately 21 months); Final Analysis: Time to Progression-free Survival Event (Median observation time was approximately 66.4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Trial to Increase t-PA Use in Stroke Treatment
Brief Summary: The purpose of this study is to evaluate a standardized, system-based, barrier assessment and interactive educational intervention to increase appropriate t-PA use for stroke.


Options:
A: Changes in a set of predefined quality indicators measuring appropriateness of prescriptions for elderly out-patients (1 year)
B: Hospital rate of permanent colostomy; Hospital rate of local recurrence
C: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
D: Change in t-PA use with assessment of appropriateness of use and complications. (January 2005 to January 2010)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of ANCA-Associated Vasculitides : Corticosteroids and Pulse Cyclophosphamide Followed by Maintenance Therapy With Methotrexate or Azathioprine: a Prospective Multicenter Randomized Trial
Brief Summary: Remission of ANCA-associated vasculitis can be obtained in approximately 80% of the patients with a combination of corticosteroids and cyclophosphamide. However, relapses are frequent. This point warrants the prescription of a maintenance treatment with a less toxic immunosuppressant for several months to years. The optimal drug in this indication is not determine. We decided therefore to compare the 2 most used drugs in this indication. Induction therapy consists in the combination of corticosteroids and intravenous cyclophosphamide pulses. Corticotherapy consisted first in one daily methylprednisolone pulse, for 1 to 3 days, followed by oral prednisolone at the dose of 1 mg/kg/d for 3 weeks, then progressively tapered and stopped at the 18th month from the diagnosis. Cyclophosphamide is administered every 2 weeks for the first 3 bolus (0.6 g/m2 - D1, 15 and 30), then every 3 weeks (0.7 g/m2). Once remission is achieved, patients receive 3 additional bolus (0.7 g/m2). At that time, patients are randomized for a maintenance treatment with azathioprine (2 mg/kg/d, orally) or oral methotrexate (starting at the dose of 0.3 mg/kg/wk, then progressively increased every weeks by 2.5mg, if necessary, to a maximum and optimal dose of 25 mg/wk) for 12 months.


Options:
A: Disease Remission (6 months post-randomization)
B: Remission rates at 6 months (6 months)
C: Renal recovery (Three months)
D: Safety/Efficacy; Frequency of severe adverse events in each arm. Hypothesis based upon NIH data was a rate of 6% severe adverse event with methotrexate compared to 30% with azathioprine (24% in one study on RA and 46% in one study on Sjögren syndrome).; Evaluation was planned after the last included patient has completed the assigned trial regimen (after 12 months of maintenance regimen or because of drug withdrawal).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of ANCA-Associated Vasculitides : Corticosteroids and Pulse Cyclophosphamide Followed by Maintenance Therapy With Methotrexate or Azathioprine: a Prospective Multicenter Randomized Trial
Brief Summary: Remission of ANCA-associated vasculitis can be obtained in approximately 80% of the patients with a combination of corticosteroids and cyclophosphamide. However, relapses are frequent. This point warrants the prescription of a maintenance treatment with a less toxic immunosuppressant for several months to years. The optimal drug in this indication is not determine. We decided therefore to compare the 2 most used drugs in this indication. Induction therapy consists in the combination of corticosteroids and intravenous cyclophosphamide pulses. Corticotherapy consisted first in one daily methylprednisolone pulse, for 1 to 3 days, followed by oral prednisolone at the dose of 1 mg/kg/d for 3 weeks, then progressively tapered and stopped at the 18th month from the diagnosis. Cyclophosphamide is administered every 2 weeks for the first 3 bolus (0.6 g/m2 - D1, 15 and 30), then every 3 weeks (0.7 g/m2). Once remission is achieved, patients receive 3 additional bolus (0.7 g/m2). At that time, patients are randomized for a maintenance treatment with azathioprine (2 mg/kg/d, orally) or oral methotrexate (starting at the dose of 0.3 mg/kg/wk, then progressively increased every weeks by 2.5mg, if necessary, to a maximum and optimal dose of 25 mg/wk) for 12 months.


Options:
A: Disease free period, time from remission to relapse or study end.
B: Number of events (failures, relapses and/or deaths) occurring in each group, defining the disease-free survival rate, measured at study end (mean follow-up of 5 years)
C: the remission rate after 9 months of therapy with intravenous immunoglobulins,; in relapsing patients with ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome); during 6 months, after relapse
D: Safety/Efficacy; Frequency of severe adverse events in each arm. Hypothesis based upon NIH data was a rate of 6% severe adverse event with methotrexate compared to 30% with azathioprine (24% in one study on RA and 46% in one study on Sjögren syndrome).; Evaluation was planned after the last included patient has completed the assigned trial regimen (after 12 months of maintenance regimen or because of drug withdrawal).

Answer: D