TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Omega-3 Fatty Acids in the Treatment of Non-Alcoholic Steatohepatitis in Patients With Type 2 Diabetes Mellitus
Brief Summary: Non-alcoholic steatohepatitis (NASH), the most severe form of liver injury in the spectrum of non-alcoholic fatty liver disease (NAFLD), has emerged as the major cause of chronic liver disease in developed countries. Among adults in the United States, the prevalence is between 5.7% and 17%. These rates are expected to increase concurrent with the epidemics of obesity and type 2 diabetes mellitus, which are the major risk factors for NAFLD and NASH. In addition to its high prevalence, NASH is also a progressive fibrotic disease that advances to cirrhosis and liver related death in 20% and 12% of patients, respectively. Among NASH patients with cirrhosis, 40% have liver related death. Diabetics are particularly prone to experience these poor outcomes. No therapy has been proven effective for patients with NASH.

The purpose of this study is to find out whether treatment with polyunsaturated fatty acids (eicosapentaenoic acid \[EPA\] combined with docosahexaenoic acid \[DHA\] called Opti-EPA) improves NASH compared to treatment with placebo pills. The placebo pills will contain corn oil and will be contained in a capsule, but have no medical effect on the body. The investigators will determine improvement in NASH from microscopic changes in the subject's liver tissue during 48 weeks of treatment. This means that the subject will need to have a liver biopsy before and after the treatment.

Omega-3 fatty acids are a form of polyunsaturated fats, one of the four basic types of fat that the body gets from food. (Cholesterol, saturated fat, and monounsaturated fat are the others.) One's body does not make this type of fat; it comes from food sources. These fats are found in foods like cold water fish (tuna, salmon, and mackerel), and vegetable products like flaxseed oil and walnuts.

Research shows that polyunsaturated fats are good for people. Studies have shown that it is good for heart health by playing a role in keeping blood cholesterol levels low, keeping irregular heart rhythms stable, and reducing blood pressure.

The drug being studied, Opti-EPA, is a nutritional supplement. They do not have to be reviewed by the Food and Drug Administration (FDA) like medicines do. Opti-EPA is considered experimental in this study. This means that the United States Food and Drug Administration (FDA) has not approved it for use in people with nonalcoholic fatty liver disease.


Options:
A: Change of intrahepatic triglyceride contents (12 months)
B: Liver status by liver biopsy (steatosis and fibrosis) (months 24)
C: Change in Liver Fat (24 weeks); Change in Liver Fibrosis (24 weeks); Change in Liver Injury (24 weeks)
D: Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS) (48 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Very Low Protein Diet Supplemented With Ketoanalogs on Renal Death in Phase 4/5 Chronic Kidney Disease (CKD) - ERIKA Study
Brief Summary: The purpose of this study is to determine whether the use of a very low protein diet is effective in delaying the start of chronic dialysis treatment in patients affected by chronic kidney disease (CKD).


Options:
A: Primary composite endpoint (15 months after randomization)
B: annual change of GFR; annual change of Ccr; annual change of 1/Cr; incidence rate of the doubling of sCr; time to the doubling of sCr
C: Time to renal death, defined as the first event between start of renal replacement therapy or patient death (Months)
D: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind, Placebo Controlled, Crossover Study of Extended Release Methylphenidate for Treatment of ADHD in Children With Epilepsy
Brief Summary: This study will evaluate the safety and effectiveness of extended release methylphenidate (XR-MPH) in treating attention deficit hyperactivity disorder (ADHD) in children with both ADHD and epilepsy.


Options:
A: Seizure occurence (Measured between Weeks 1 and 4); Clinical administered scores on the ADHD Rating Scale IV Parent Version (Measured between Weeks 1 and 4)
B: Change in ADHD RS-IV total score (Baseline, month 4, and month 6)
C: Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA); Blood lipids profile
D: Conners Rating Scale - School Version (change from baseline in conners raiting scale at 15 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy. Effects on Recurrent Respiratory Infections, Inflammatory Parameters and Bacterial Persistence
Brief Summary: Aims of the study

* to evaluate the rate of enteric gram negative bacteria colonization in tracheotomised COPD patients
* to evaluate the effect of azithromycin long-term treatment on Pseudomonas aeruginosa colonization and colony counts, and on reduction of the number of exacerbations/hospitalisations, antibiotic courses and steroid use.
* to evaluate the Quality of Life of patients treated and not treated with azithromycin, using a validate Italian version of St George questionnaire
* to evaluate the rate of chronic colonization with atypical pathogens
* to evaluate the safety and tolerability of a long-term treatment with azithromycin, including a survey on possible bacterial antibiotic resistance pattern variations


Options:
A: myeloperoxidase in induced sputum (3 weeks)
B: reduction of number of exacerbations; reduction of number of hospitalisations
C: Exacerbation Frequency; Airway Inflammation
D: Inflammatory markers (outcome will be assessed up to two months post initial bronchoscopy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy. Effects on Recurrent Respiratory Infections, Inflammatory Parameters and Bacterial Persistence
Brief Summary: Aims of the study

* to evaluate the rate of enteric gram negative bacteria colonization in tracheotomised COPD patients
* to evaluate the effect of azithromycin long-term treatment on Pseudomonas aeruginosa colonization and colony counts, and on reduction of the number of exacerbations/hospitalisations, antibiotic courses and steroid use.
* to evaluate the Quality of Life of patients treated and not treated with azithromycin, using a validate Italian version of St George questionnaire
* to evaluate the rate of chronic colonization with atypical pathogens
* to evaluate the safety and tolerability of a long-term treatment with azithromycin, including a survey on possible bacterial antibiotic resistance pattern variations


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

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open, Randomised, Multicentre Study to Compare Buprenorphine Transdermal Delivery System (BTDS) With Standard Treatment in Elderly Subjects With OA of the Hip and/or Knee
Brief Summary: The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).


Options:
A: Number of Participants With Treatment-emergent Adverse Events (TEAE) (52 weeks)
B: 5-Day Sum of Pain Intensity Difference (SPID5) (Day 1 to Day 5); Spontaneous Bowel Movements Per Week (SBMs/Week) (Week 1 to Week 2)
C: Average Daily Pain Scores - BS11 Pain Scores. (every day over a 12 week study duration.)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Glycemic Index, Body Weight and Health
Brief Summary: The purpose of this study is to investigate the effect of a diet with either high or low glycemic index (GI) on ad libitum (free) food intake, body weight, fat mass and fat-free mass, risk markers for diabetes and cardiovascular diseases, energy expenditure and substrate oxidation after 10 weeks´ intake in slightly overweight subjects.


Options:
A: Body weight; Fat mass and fat-free mass; Food intake
B: Insulin sensitivity (IVGTT and minimal model)
C: N/A
D: Change in insulin sensitivity between the two dietary arms (at 3-, 12- and 24 months); Change in BMI z-score between the two dietary groups (3-, 12-, and 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Glycemic Index, Body Weight and Health
Brief Summary: The purpose of this study is to investigate the effect of a diet with either high or low glycemic index (GI) on ad libitum (free) food intake, body weight, fat mass and fat-free mass, risk markers for diabetes and cardiovascular diseases, energy expenditure and substrate oxidation after 10 weeks´ intake in slightly overweight subjects.


Options:
A: Body Weight (4 months); Body Weight (7 Months)
B: Change in Hemoglobin A1c (6 months); Change in Fasting Glucose (6 months)
C: Body weight; Fat mass and fat-free mass; Food intake
D: For adults: body weight loss maintenance (6 Month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo
Brief Summary: The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration \[FDA\]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine


Options:
A: Overall Survival (OS) (From the date of randomization until date of death due to any cause (up to approximately 6 years))
B: Adverse Events (5 years)
C: Overall Survival (OS) (Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months)
D: Progression-Free Survival (PFS) as Assessed by the Investigator (From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo
Brief Summary: The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration \[FDA\]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine


Options:
A: Overall Survival (OS) (Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months)
B: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))
C: Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants (6 months); Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression (6 months)
D: Overall Survival (OS) (From the date of randomization until date of death due to any cause (up to approximately 6 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo
Brief Summary: The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration \[FDA\]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine


Options:
A: Frequency of BRAF Mutations Among Nevi (up to 30 months)
B: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
C: To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. (10 years)
D: Overall Survival (OS) (Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo
Brief Summary: The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration \[FDA\]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine


Options:
A: Disease-free survival
B: Overall Survival (OS) (Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months)
C: 2-month Progression-free Survival Rate (Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.)
D: Overall Survival (OS) (From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.); Overall Survival (OS) Rate (From randomization to 6 months and or to 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Brief Summary: A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences:

1. sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals
2. sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.


Options:
A: Change in Serum Phosphorus Levels From Week 24 to Week 27 (Week 24, Week 27)
B: Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values.
C: Correlation between fasting salivary phosphorus and estimated glomerular filtration rate (single value between 7-11 am); Correlation between post meal salivary phosphorus and estimated glomerular filtration rate (single value after meal between 1-4 pm)
D: Calcium Balance (2 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Open and Sequential Study to Evaluate the Efficacy and Safety of Bemiparin Administration on the Response to Treatment in Patients Diagnosed With Limited Small Cell Lung Cancer
Brief Summary: Main objective:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT), delays tumoral spread and increases progression-free survival.

Secondary objectives:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting with the onset of chemotherapy, increases global survival, improving the response rates to treatment with CT + RT (radiotherapy) and reduces the incidence of venous thromboembolism (VTE).


Options:
A: Thromboembolic events (during study treatment)
B: first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) (7 months)
C: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
D: efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (efficacy); safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. (safety)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Open and Sequential Study to Evaluate the Efficacy and Safety of Bemiparin Administration on the Response to Treatment in Patients Diagnosed With Limited Small Cell Lung Cancer
Brief Summary: Main objective:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT), delays tumoral spread and increases progression-free survival.

Secondary objectives:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting with the onset of chemotherapy, increases global survival, improving the response rates to treatment with CT + RT (radiotherapy) and reduces the incidence of venous thromboembolism (VTE).


Options:
A: Progression free survival (5 years)
B: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)
C: efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (efficacy); safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. (safety)
D: Overall 3-year mortality (overall 3-years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Open and Sequential Study to Evaluate the Efficacy and Safety of Bemiparin Administration on the Response to Treatment in Patients Diagnosed With Limited Small Cell Lung Cancer
Brief Summary: Main objective:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT), delays tumoral spread and increases progression-free survival.

Secondary objectives:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting with the onset of chemotherapy, increases global survival, improving the response rates to treatment with CT + RT (radiotherapy) and reduces the incidence of venous thromboembolism (VTE).


Options:
A: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)
B: efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (efficacy); safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. (safety)
C: Significant increase of overall survival (At follow up 1 year after treatment)
D: Incidence of venous thromboembolism reduction

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Open and Sequential Study to Evaluate the Efficacy and Safety of Bemiparin Administration on the Response to Treatment in Patients Diagnosed With Limited Small Cell Lung Cancer
Brief Summary: Main objective:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT), delays tumoral spread and increases progression-free survival.

Secondary objectives:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting with the onset of chemotherapy, increases global survival, improving the response rates to treatment with CT + RT (radiotherapy) and reduces the incidence of venous thromboembolism (VTE).


Options:
A: efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (efficacy); safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. (safety)
B: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
C: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (20 days)
D: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)

Answer: A