TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
Brief Summary: The study investigated the clinical efficacy and safety of a 10-day course of therapy with daily intravenous administration of 30mL Cerebrolysin based on a comparison with Placebo in patients with acute ischemic stroke. 1070 patients were randomized in this trial in 2 parallel groups, one receiving Cerebrolysin, the control group receiving Placebo. Study drug will be given once daily by intravenous infusion for 10 consecutive days. Acetylsalicylic acid will be given orally, once daily throughout the study duration of 90 days as basic treatment. The clinical observation period for each patient will be 3 months and will include six clinical evaluation visits at Baseline (day 1) and on study days 2, 5, 10, 30 and 90.


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

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
Brief Summary: The study investigated the clinical efficacy and safety of a 10-day course of therapy with daily intravenous administration of 30mL Cerebrolysin based on a comparison with Placebo in patients with acute ischemic stroke. 1070 patients were randomized in this trial in 2 parallel groups, one receiving Cerebrolysin, the control group receiving Placebo. Study drug will be given once daily by intravenous infusion for 10 consecutive days. Acetylsalicylic acid will be given orally, once daily throughout the study duration of 90 days as basic treatment. The clinical observation period for each patient will be 3 months and will include six clinical evaluation visits at Baseline (day 1) and on study days 2, 5, 10, 30 and 90.


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: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Macronutrient Relations on Body Weight, Body Composition, and Cardiovascular Risk Markers in Overweight Patients Attending a Telemedically Guided Weight Loss Program
Brief Summary: The burden of overweight and obesity has dramatically increased during the last decades. High carbohydrate intake, particularly refined carbohydrates, probably increase the risk of obesity, type 2 diabetes, and metabolic syndrome. There is evidence that energy-restricted low-carbohydrate diets show greater weight loss and better improvement of cardiovascular risk markers compared to energy-restricted low-fat diets. Beside macronutrient relations, efficacy of weight loss programs depends on care and control. The investigators aim to investigate whether or not a carbohydrate-restricted telemedically guided weight loss program results in a more pronounced weight loss and influences metabolic risk markers more beneficial than a fat-restricted diet.


Options:
A: weight loss (4 and 12 month)
B: body weight (12 months)
C: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
D: weight loss (3 months); Weight loss (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Macronutrient Relations on Body Weight, Body Composition, and Cardiovascular Risk Markers in Overweight Patients Attending a Telemedically Guided Weight Loss Program
Brief Summary: The burden of overweight and obesity has dramatically increased during the last decades. High carbohydrate intake, particularly refined carbohydrates, probably increase the risk of obesity, type 2 diabetes, and metabolic syndrome. There is evidence that energy-restricted low-carbohydrate diets show greater weight loss and better improvement of cardiovascular risk markers compared to energy-restricted low-fat diets. Beside macronutrient relations, efficacy of weight loss programs depends on care and control. The investigators aim to investigate whether or not a carbohydrate-restricted telemedically guided weight loss program results in a more pronounced weight loss and influences metabolic risk markers more beneficial than a fat-restricted diet.


Options:
A: body weight (12 months)
B: Physical function (Baseline, 4, 6, and 9 months); Lean Mass (Baseline, 4, 6, and 9 months)
C: The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
D: Cardiovascular Disease Prevention based on dietary approach. (Two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Study to Evaluate the Effects of Patiromer in Heart Failure Patients
Brief Summary: The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.


Options:
A: Exponential Rate of Change in Serum Potassium (S-K) Values During the Initial 48 Hours of Study Drug Treatment (From 0 to 48 hours.)
B: Percentage of Responders (Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.)
C: Percentage of Responders (Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.); Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data (Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.)
D: Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period. (Baseline and Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the first line treatment policy in Tanzania. AL is an efficacious drug that also has the capacity to reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the development of parasite resistance against AL and there have been very few clinical trials that compared different ACT regimens. A recent clinical trial shows that the combination of dihydroartemisinin-piperaquine (DP) may be more efficacious than AL and may have a more pronounced beneficial effect on post-treatment malaria transmission. Screening for molecular markers that are related to parasite susceptibility to ACT drugs and to post-ACT treatment malaria transmission can assist in preventing the development and spread of ACT resistance.

In the current study, the investigators compared AL and DP for the treatment of uncomplicated malaria. The investigators endpoints are

* clinical efficacy
* post-treatment gametocytaemia by molecular techniques
* post-treatment malaria transmission.


Options:
A: Adequate Clinical and parasitological response (Day 63)
B: PCR unadjusted treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping. (Day 28); PCR adjusted treatment failure up to day 28 (TF28A): all early failures before day 14 plus the recurrent parasitaemias detected at day 14 or later and classified by genotyping as recrudescence. (Day 28)
C: Incidence of clinical episodes of malaria (over entire course of follow-up); Risk of treatment failure at Day 28 defined as any early treatment failure or late clinical/parasitological failure adjusted and unadjusted by genotyping to distinguish recrudescence (treatment failure due to drug resistance) and new infections (28 days following each malaria treatment)
D: To determine the clinical efficacy of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) in the treatment of uncomplicated falciparum malaria in children living in north-western Tanzania and in western Kenya. (during 42 day follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Calcium, Vitamin D, Magnesium, and Zinc Absorption in Healthy Children 4 to 8 Years of Age
Brief Summary: The goal of our research is to provide data to enhance the development of nutritional guidelines, especially as related to mineral nutrition, in children. Using human experimentation, we are studying methods of delivering the key minerals of calcium, zinc and iron in the diet so as to optimize health outcomes. We will conduct a controlled trial of vitamin D supplementation to assess the effects of vitamin D status on calcium absorption in small children. We will evaluate the effects of differing intakes of zinc on zinc and copper absorption. These studies will utilize stable isotope techniques so as to provide accurate, practically applicable information which may be obtained from the study populations in a safe manner. These data will have global application and provide a strong basis for evidence-based nutritional recommendations to be developed.

Objective #1: To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age.

Objective #2: Assess the absorption of magnesium and zinc in healthy children 4 to 8 yrs of age.


Options:
A: To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age. (End of the study)
B: Number of asthma exacerbations per child treated with rescue oral corticosteroids (7 months)
C: Gene Expression (Baseline and Final Visits)
D: serum Vitamin D (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease - A Randomized Controlled Trial
Brief Summary: Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in affluent countries. It may progress to cirrhosis and liver cancer. At present, there is no approved drug for NAFLD. Although healthy diet and exercise is often recommended, there is little supportive evidence. Therefore, the investigators plan to conduct a randomized controlled trial comparing a low glycemic index dietary intervention program and simple lifestyle advice in NAFLD patients. The primary endpoint is resolution of NAFLD. Non-invasive tests will be used to assess the study subjects. Proton-magnetic resonance spectroscopy is used to quantify hepatic triglyceride content, and transient elastography is used to quantify liver fibrosis.


Options:
A: Change in intrahepatic triglyceride content (6 weeks)
B: Change in hepatic lipid assessed via magnetic resonance imaging (MRI and magnetic resonance spectroscopy (MRS). (8 weeks after baseline)
C: Change of intrahepatic triglyceride contents (12 months)
D: Resolution of NAFLD by proton-magnetic resonance spectroscopy (Month 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain
Brief Summary: The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department. It compares types of cardiac tests performed while receiving treatment in an observation unit. Patients will either undergo cardiac MRI testing or conventional care testing. Patients treated in the conventional care testing group will undergo the testing their doctor determines is best for them. All patients will undergo follow up to find out if they have had any heart related events.


Options:
A: Therapeutic efficacy: Length of stay (Duration of Initial Hospitalization)
B: Cost of Index Hospitalization (Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours)
C: The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. (Index Hospitalization through 90 days)
D: Objective cardiac testing (stress testing or cardiac imaging) within 30 days (30 Days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The investigators' aim is to determine whether probiotic and prebiotic treatment plus lifestyle advice is more effective in reducing hepatic fat content than lifestyle advice alone in patients with Nonalcoholic Fatty Liver Disease (NAFLD).


Options:
A: Improved metabolic parameters(glucose, lipid, liver enzymes, etc.) (16 weeks)
B: Improvement of laboratory markers of inflammation and oxidative stress, such as concentrations of TNF-alpha, lipopolysaccharide (LPS), adiponectin, catepsin D, cytokeratin-18. (4 months); Improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile, transaminases serum levels (4 months)
C: The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. (24 weeks)
D: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The investigators' aim is to determine whether probiotic and prebiotic treatment plus lifestyle advice is more effective in reducing hepatic fat content than lifestyle advice alone in patients with Nonalcoholic Fatty Liver Disease (NAFLD).


Options:
A: Time To The First Breakthrough Overt HE Episode (Baseline up to 6 Months (168 days))
B: The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein) (2 months)
C: The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. (24 weeks)
D: The primary end point will be development of overt HE or completion of a follow-up of 6 months after enrollment (6 months after enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adenovirus-Mediated Delivery of Herpes Simplex Virus Thymidine Kinase Administration Improves Outcome of Recurrent High-Grade Glioma
Brief Summary: Malignant gliomas are the most common primary brain tumor in adults, but the prognosis for patients with these tumors remains poor despite advances in diagnosis and standard therapies such as surgery, radiation therapy, and chemotherapy. The advantages of ADV-TK gene therapy highlight its efficacy and safety for glioma patients. This clinical trial was conducted to assess the anti-tumor efficacy and safety of intraarterial cerebral infusion of replication-deficient adenovirus mutant ADV-TK, in combination with systemic intravenous GCV administration in patients with recurrent high-grade glioma.


Options:
A: Progression Free Survival (up to 142 weeks)
B: Progression Free Survival (PFS) (Baseline at 6 weeks and then every 6 weeks to discontinuation)
C: The primary end point was 6-month progression-free survival rate (PFS-6) (6 months)
D: Progression-free Survival (from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Study of a Computer Stop Order Versus Routine Practice When Trimethoprim/Sulfamethoxazole is Ordered Concurrently With Warfarin
Brief Summary: To determine if a computerized stop order will reduce the number of concurrent trimethoprim/sulfamethoxazole and warfarin orders accepted through the inpatient electronic ordering system while a patient is hospitalized.


Options:
A: Proportion of visits to primary care clinic associated with antibiotic prescriptions (30 days)
B: Change in screening and assessment of childhood obesity at the point of care, including BMI, blood pressure, and laboratory screening, and provision of nutrition and physical activity counseling (Baseline and 1 Year)
C: Number of Re-hospitalizations at 30 and 60 Days (30 days, 60 days post discharge); The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days. (30 days, 60 days post discharge)
D: Reduce concomitant orders for warfarin and tmp/smx (7 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Study of a Computer Stop Order Versus Routine Practice When Trimethoprim/Sulfamethoxazole is Ordered Concurrently With Warfarin
Brief Summary: To determine if a computerized stop order will reduce the number of concurrent trimethoprim/sulfamethoxazole and warfarin orders accepted through the inpatient electronic ordering system while a patient is hospitalized.


Options:
A: Antibiotic use; Length of stay in hospital
B: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
C: Duration of antibiotic therapy for the first episode of infection (28 days); Total antibiotic exposure days per 1,000 days (28 days); Days alive without antibiotics (28 days)
D: Reduce concomitant orders for warfarin and tmp/smx (7 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study of Carisbamate in the Treatment of Neuropathic Pain in Diabetic Peripheral Neuropathy Followed by a Blinded Extension Phase
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of carisbamate (800 and 1200 mg/day) in patients with diabetic neuropathic pain.


Options:
A: Mean of the last 7 daily average diabetic peripheral neuropathy (DPN) pain scores (Through 15 weeks)
B: Onset meaningful pain reduction
C: Duration Adjusted Average Change (DAAC) of Mean Pain Score (Baseline, Week 16)
D: Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS) (Up to Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis
Brief Summary: To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.


Options:
A: ACR 20% response (Week 14)
B: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 (Month 3); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)
D: Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 (Baseline, Week 26)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis
Brief Summary: To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.


Options:
A: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
B: Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR (Day 85); Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A (Length of study (through Day 85))
C: Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 (Baseline, Week 26)
D: MRI synovitis, bone edema and erosions score (baseline, week 18 and 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis
Brief Summary: To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.


Options:
A: Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 (Baseline to Week 24)
B: EULAR Good Response (at 24 weeks); ACR50 Response Rate (at 24 weeks); Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score (at 52 weeks)
C: Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 (Baseline, Week 26)
D: Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 (Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis
Brief Summary: To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.


Options:
A: Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 (Week 78)
B: Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28) (Month 6 (randomization) and Month 12)
C: Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 (Baseline, Week 26)
D: ACR 20% response (Week 14)

Answer: C