TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events
Brief Summary: This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.


Options:
A: Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia (Baseline to Month 6)
B: Change From Baseline in HbA1c to Week 24 (Baseline, Week 24)
C: Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
D: Hemoglobin A1c Change From Baseline (Baseline to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE III, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF L GLUTAMINE THERAPY FOR SICKLE CELL ANEMIA AND SICKLE ß0-THALASSEMIA
Brief Summary: The purpose of this research is to evaluate the effects of L-glutamine as a therapy for Sickle Cell Anemia or Sickle ß0 Thalassemia as evaluated by the number of occurrences of sickle cell crises.


Options:
A: Number of Occurrences of Painful Sickle Cell Crises (From Week 0 through Week 48 (cumulative))
B: The Number of Occurrences of Sickle Cell Crises (48 weeks)
C: Gardos Channel Activity (12 weeks after randomization); Nitric Oxide (12 weeks after randomization); Mean Corpuscular Hemoglobin Concentration (12 weeks after randomization)
D: Mean change in total serum 25-hydroxyvitamin D levels (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Interaction Study to Evaluate Changes in Blood Pressure Following 1, 1.5, 2, and 2.5 mg Riociguat Tid (Dose Titration) Compared to Placebo Treatment on the Background of Stable Sildenafil Pretreatment in Subjects With Symptomatic Pulmonary Arterial Hypertension
Brief Summary: Pulmonary Arterial Hypertension (PAH) is a severe progressive disease with a high mortality. Although several drugs are available for the treatment of PAH none offer a cure, therefore there is still a high medical need for new treatments.

Soluble guanylate cyclase (sGC) is one of the chemicals involved in the pathways controlling vascular tone, which is impaired in patients with PAH. This causes constriction and thickening of the blood vessels wall in the lungs and increase of blood pressure in the lungs. This can lead to the very debilitating symptoms of PAH such as tiredness, shortness of breath on exertion, collapse and often the inability of the patient to perform their daily life activities.

Inhalation of Nitric Oxide, which activates sGC is used to treat PAH, but its effect wears off as soon as inhalation stops. Direct stimulation of sGC using this new compound Riociguat may be a new approach for the treatment of PAH.

The phosphodiesterase 5 (PDE5)-inhibitor Sildenafil is one of licensed treatments for PAH. The Patent Plus is a double-blind, placebo-controlled safety study, designed to investigate the effect of Riociguat on blood pressure in patients with PAH when given in combination with Sildenafil.


Options:
A: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12 (Baseline and week 12)
B: Number of Participants With Treatment-emergent Adverse Events (TEAE) (From administration of first dose of study medication in PATENT-2 up to 2 days after end of treatment with study medication, up to 10 years and 5 months.); Number of Participant With Death (From baseline to end of safety follow-up visit, up to 10 years and 6 months (1 month more than End of study visit))
C: Safety and tolerability (12 weeks treatment)
D: Maximum Change From Baseline in Supine Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12) (Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Interaction Study to Evaluate Changes in Blood Pressure Following 1, 1.5, 2, and 2.5 mg Riociguat Tid (Dose Titration) Compared to Placebo Treatment on the Background of Stable Sildenafil Pretreatment in Subjects With Symptomatic Pulmonary Arterial Hypertension
Brief Summary: Pulmonary Arterial Hypertension (PAH) is a severe progressive disease with a high mortality. Although several drugs are available for the treatment of PAH none offer a cure, therefore there is still a high medical need for new treatments.

Soluble guanylate cyclase (sGC) is one of the chemicals involved in the pathways controlling vascular tone, which is impaired in patients with PAH. This causes constriction and thickening of the blood vessels wall in the lungs and increase of blood pressure in the lungs. This can lead to the very debilitating symptoms of PAH such as tiredness, shortness of breath on exertion, collapse and often the inability of the patient to perform their daily life activities.

Inhalation of Nitric Oxide, which activates sGC is used to treat PAH, but its effect wears off as soon as inhalation stops. Direct stimulation of sGC using this new compound Riociguat may be a new approach for the treatment of PAH.

The phosphodiesterase 5 (PDE5)-inhibitor Sildenafil is one of licensed treatments for PAH. The Patent Plus is a double-blind, placebo-controlled safety study, designed to investigate the effect of Riociguat on blood pressure in patients with PAH when given in combination with Sildenafil.


Options:
A: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16 (Baseline and week 16)
B: Number of Participants With Adverse Events (AEs) (Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period))
C: Maximum Change From Baseline in Supine Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12) (Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12))
D: Endurance time (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (10 and 15 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.


Options:
A: Change From Baseline in MADRS Total Score After 6 Weeks of Treatment (Baseline and Week 6)
B: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline and Week 8)
C: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline and Week 8)
D: Change From Baseline in MADRS Total Score After 8 Weeks of Treatment (Baseline and Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Confronting Unequal Eye Care in Pennsylvania
Brief Summary: Pt. 1 Diabetic retinopathy is a common eye condition among diabetic adults and can lead to severe vision impairment and even blindness. African Americans are more likely to have vision loss from diabetic retinopathy due to a variety of factors, including cultural barriers to care. The investigators aim to increase the rates of eye exams in diabetic African American adults by providing culturally relevant home-based interventions. These interventions will increase the knowledge about diabetes and the eyes and the awareness of ocular risks due to diabetes.

206 African American adults, over the age of 65, with diabetes will be recruited from primary care clinics at Thomas Jefferson and Temple University. Eligible patients who consent to participate will have baseline information taken about medical and ocular history, understanding of diabetes and a hemoglobin A1C level obtained. The subjects will then be randomized to one of two treatment conditions: Behavioral Activation or Supportive Therapy, each of which will be delivered over 4 sessions. Behavioral Activation will consist of educational materials, referral assistance for eye clinics, and addressing patient specific barriers to care. Supportive Therapy will consist of supportive but non-directional interaction with the patient exploring the impact of aging and diabetes on the patient's life. The investigators hypothesize that more patients who receive Behavioral Activation will have a dilated fundus exam (the primary outcome variable), understand the risks of diabetic complications and feel less depression then subjects who receive Supportive Therapy.


Options:
A: Pt. 1 Dilated Fundus Exam (DFE) (6-month follow-up assessment)
B: Outcome and process measures from the danish diabetes guideline (1/3 2007-1/6 2008)
C: Change From Baseline in Glycosylated Hemoglobin (%) (Baseline to 12 months)
D: Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Confronting Unequal Eye Care in Pennsylvania
Brief Summary: Pt. 1 Diabetic retinopathy is a common eye condition among diabetic adults and can lead to severe vision impairment and even blindness. African Americans are more likely to have vision loss from diabetic retinopathy due to a variety of factors, including cultural barriers to care. The investigators aim to increase the rates of eye exams in diabetic African American adults by providing culturally relevant home-based interventions. These interventions will increase the knowledge about diabetes and the eyes and the awareness of ocular risks due to diabetes.

206 African American adults, over the age of 65, with diabetes will be recruited from primary care clinics at Thomas Jefferson and Temple University. Eligible patients who consent to participate will have baseline information taken about medical and ocular history, understanding of diabetes and a hemoglobin A1C level obtained. The subjects will then be randomized to one of two treatment conditions: Behavioral Activation or Supportive Therapy, each of which will be delivered over 4 sessions. Behavioral Activation will consist of educational materials, referral assistance for eye clinics, and addressing patient specific barriers to care. Supportive Therapy will consist of supportive but non-directional interaction with the patient exploring the impact of aging and diabetes on the patient's life. The investigators hypothesize that more patients who receive Behavioral Activation will have a dilated fundus exam (the primary outcome variable), understand the risks of diabetic complications and feel less depression then subjects who receive Supportive Therapy.


Options:
A: Proportion of Participants that Receive Annual Eye Exam (Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study))
B: HbA1c, LDL-cholesterol, Systolic Blood Pressure (Visit 1; Visit 2 (after approximately 4 months after visit 1); Visit 3 (after approximately 8 months after visit 1); Visit 4 (after approximately 12 months after visit 1))
C: Pt. 1 Dilated Fundus Exam (DFE) (6-month follow-up assessment)
D: Patient is receiving a statin (July 2009 to April 2010)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China: Duloxetine Versus Placebo
Brief Summary: The purpose of this trial is to assess the efficacy of duloxetine 60 milligrams (mg) once daily (QD) compared with placebo, on the change in pain severity from baseline to 12 weeks as measured by the weekly mean of the daily pain scores recorded in the participant's diary in participants with diabetic peripheral neuropathic pain.


Options:
A: Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score (Baseline, 12 weeks)
B: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
C: Average Joint Pain According to BPI-SF (Weeks 2, 6, 12, and 24; Week 12 reported)
D: Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits (at end of treatment, 15 weeks from baseline assessment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label, Randomized Study of the Impact of Diet on Gut Microbiota, Inflammageing and Oxidative Stress in Elderly People. Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene. German Part of a Multicentric European Study
Brief Summary: Ageing of the population is a major event in the world. Gerontological/geriatric literature unanimously indicate that physical exercise and diet are at present the two available fundamental approaches to contrast/prevent most of the age associated alterations. In the elderly the inflammageing, the oxidative stress and the alteration of the intestinal microbiota can be influenced by nutritional status and possibly corrected by an appropriate dietetic intervention:

Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve the quality of individual diet for specific needs


Options:
A: High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk) (2 months)
B: 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)
C: The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. (24 weeks)
D: The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein) (2 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2 Study of E6005 in Japanese Patients With Atopic Dermatitis
Brief Summary: The safety and pharmacokinetics of topical application with E6005 ointment compared to vehicle will be evaluated in Japanese male patients with atopic dermatitis. Additionally, the efficacy of topical application with E6005 ointment will be explored in Japanese male patients with atopic dermatitis.


Options:
A: The incidence of atopic dermatitis (Measure will be reported annually by year from 2008-2018); The prevalence of atopic dermatitis (Measure will be reported annually by year from 2008-2018); The prevalence of diagnosed co-morbidities in people with and without atopic dermatitis (Prevelence reported annually by year from 2008-2018); Annual rates of service utilisation (number of primary and secondary care visits) in people with atopic dermatitis (Measures will be reported annually by year from 2008-2018); Annual prescription rates for atopic dermatitis related treatments (Measures will be reported annually by year from 2008-2018)
B: Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID (Baseline and Week 4)
C: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29 (Baseline, Day 29); Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) (Baseline up to Day 60); Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters (Baseline up to Day 29); Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs (Baseline up to Day 29)
D: Pharmacokinetic parameter Cmax will be calculated (Until Day 13); Pharmacokinetic parameter tmax will be calculated (Until Day 13); Pharmacokinetic parameter AUC(0-t) will be calculated (Until Day 13); Pharmacokinetic parameter t1/2 will be calculated (Until Day 13)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: "A Randomized Controlled Trial of Rituximab Versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN)"
Brief Summary: The primary outcome of this study is to determine whether or not the B cell targeting with Rituximab is non-inferior or more effective than Cyclosporine in inducing long term remission of proteinuria.


Options:
A: change in probability of complete remission (proteinuria < 0.3 g/day) Primary Outcome Measures The primary outcome measure is the change in probability of complete remission (proteinuria < 0.3 g/day) at one year (see Design and power considerations). (1 year)
B: Remission Status (24 months after randomization)
C: N/A
D: Evaluation of efficacy of Rituximab associated with Non Immunosuppressive Symptomatic Treatment (NIST) in (IMN) in reducing the rate of proteinuria (patients with persistent urinary protein excretion rate ≥3,5g/24 h and albuminemia < 30g/l ) (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy: A Randomized Trial
Brief Summary: The aim of this study was to evaluated the advantages of routine application of the anterior approach in patients scheduled to right hepatectomy or extended right hepatectomy, without infiltration of segment 1, inferior vena cava or main bile duct.


Options:
A: Intraoperative blood loss (2.5 hours)
B: OVERALL BLOOD LOSS (UP TO 7 DAYS)
C: To determine if ANH reduces the requirement for allogeneic red cell transfusions in patients undergoing major hepatic resection or pancreaticoduodenectomy compared to standard intraoperative management (All patients will have their blood checked every 30 minutes during surgery)
D: Postoperative Complications (30 days post procedure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: SUUBI MAKA ("Hope for Families"): A Family-Based Economic Empowerment Model for Orphaned Children in Uganda
Brief Summary: The overall goal of SUUBI-MAKA is to further develop and preliminarily examine a family economic empowerment intervention that creates economic opportunities (specifically Children Development Accounts) for families in Uganda who are caring for children orphaned due to the AIDS pandemic, and to lay groundwork for a bigger study with practice and policy implications for Sub-Saharan Africa.


Options:
A: Remission (i.e. recovery from depression) (6 months post child birth)
B: Eyberg Child Behavior Inventory (Baseline, post- intervention and 12-month post-intervention follow-up); Parenting Young Children Scale (Supporting Positive Behaviour subscale; Setting Limits subscale) (Baseline, post- intervention and 12-month post-intervention follow-up); Sinovuyo Observational Coding System (Baseline, post- intervention and 12-month post-intervention follow-up)
C: Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) (Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI)
D: Savings and asset-accumulation (12-month post-intervention); Educational outcomes (12-month post-intervention); Sexual risk taking (12-month post-intervention); Savings and asset-accumulation (24-month post-intervention); Educational outcomes (24-month post-intervention); Sexual risk taking (24-month post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Probiotics in Childhood Abdominal Pain
Brief Summary: The purpose of this study is to assess the effect of probiotics in childhood recurrent abdominal pain. Patients will be randomly assigned to receive L. reuteri or placebo for 4 weeks with a follow up phase of additional 4 weeks.


Options:
A: Intensity of abdominal pain (3 months); Severity of chronic constipation (3 months)
B: Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms (baseline and 4 week)
C: Abdominal Pain Frequency (16 weeks from the enrollment)
D: Frequency and intensity of abdominal pain (Eight weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Probiotics in Childhood Abdominal Pain
Brief Summary: The purpose of this study is to assess the effect of probiotics in childhood recurrent abdominal pain. Patients will be randomly assigned to receive L. reuteri or placebo for 4 weeks with a follow up phase of additional 4 weeks.


Options:
A: Frequency and intensity of abdominal pain (Eight weeks)
B: The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention. (12 weeks and 20 weeks)
C: number of patients with no abdominal pain at the end of the study (4 weeks (study period))
D: Improvement in pain and stooling symptoms (The last two weeks of treatment and up to 18 months after treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.


Options:
A: Average actual change in percent predicted forced expiratory volume at 1 second (FEV1) from Day 1 to Day 14 (14 days)
B: Time to an Exacerbation (Baseline to end of study (up to 59 days))
C: Clinically Significant Laboratory Abnormalities. (28 Days)
D: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score (Day 0 to Day 28)

Answer: B