TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Active Controlled, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Mycophenolate Mofetil (MMF) in Inducing Response and Maintaining Remission in Subjects With Lupus Nephritis.
Brief Summary: This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in maintaining remission and renal function. Patients were randomized to receive either MMF (1.5 g twice daily \[bid\]) or cyclophosphamide (0.5-1.0 g/m\^2 in monthly pulses) in the induction phase. Those patients meeting criteria for response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g bid) or azathioprine (2 mg/kg/day).


Options:
A: Assessment of Primary Renal Response (12 months)
B: To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN (18 months)
C: Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response (At Week 52)
D: Induction Phase: Number of Patients Showing Treatment Response (24 weeks); Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval (From the start of the Maintenance Phase to Month 36)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-Based Patient-Centered Asthma Management System
Brief Summary: Asthma is a respiratory condition that affects millions of children. It can be controlled, however, with the proper medications and treatment. AsthmaNet, an internet-based asthma management system, aims to improve the asthma care of children by providing their parents and doctors with appropriate tools and feedback related to asthma management. The purpose of this study is to evaluate the effectiveness of AsthmaNet at improving quality of care and controlling asthma symptoms in children.


Options:
A: Appropriate use of asthma controller medications (Measured at Year 1); Number of asthma symptom days (Measured at Year 1)
B: Asthma control - as measured by the Asthma Control Test (Measured at Year 1)
C: Percentage Changed in Adherence Score (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores); Number of Symptom-free Days (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores)
D: Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Primary Care to Prevent Childhood Obesity
Brief Summary: To determine the extent to which a clinical intervention based on the Chronic Care Model (CCM), compared with the usual care control condition, results in a smaller age-associated increase in body mass index (BMI) over a 1 year intervention (primary outcome) and a 1 1/2-year follow-up period.


Options:
A: Feasibility (1 year); Efficacy (1 year)
B: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)
C: Primary - Body Mass index (2 years)
D: Body mass index (BMI) at 1 year.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Primary Care to Prevent Childhood Obesity
Brief Summary: To determine the extent to which a clinical intervention based on the Chronic Care Model (CCM), compared with the usual care control condition, results in a smaller age-associated increase in body mass index (BMI) over a 1 year intervention (primary outcome) and a 1 1/2-year follow-up period.


Options:
A: Daily physical activity > 60 minutes (4 years)
B: Body height and weight (Sept 2006- May 2009); Healthy Start Knowledge Quiz (Sept 2006- May 2009); 24-hour diet observation and recall (Sept 2006- May 2009); Physical activity (Sept 2006- May 2009); Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Nutrition and exercise knowledge (Sept 2006- May 2009); Self-efficacy for eating and exercise behaviors (Sept 2006- May 2009); Score on Nutrition Attitudes Scale (Sept 2006- May 2009); Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009)
C: Body mass index (BMI) at 1 year.
D: Body mass index (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Primary Care to Prevent Childhood Obesity
Brief Summary: To determine the extent to which a clinical intervention based on the Chronic Care Model (CCM), compared with the usual care control condition, results in a smaller age-associated increase in body mass index (BMI) over a 1 year intervention (primary outcome) and a 1 1/2-year follow-up period.


Options:
A: weight change over 6 months (Baseline, 6 months); weight change over 12 months (Baseline, 12 months)
B: Change in BMIz score (Baseline to 6 months)
C: Body mass index (BMI) at 1 year.
D: Weight (baseline, 1, 2, 3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimisation d'un Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans l'ischémie Critique Des Membres inférieurs liée à l'athérosclérose
Brief Summary: This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).


Options:
A: Survival without major amputation (6 months after implantation)
B: AE and symptomatic relief (6 months)
C: Ankle brachial index (6 months); Healing (1 year); Amputation rate (1 year)
D: Ankle brachial index (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimisation d'un Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans l'ischémie Critique Des Membres inférieurs liée à l'athérosclérose
Brief Summary: This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).


Options:
A: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)
B: Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.
C: Survival without major amputation (6 months after implantation)
D: Ankle brachial index (6 months); Healing (1 year); Amputation rate (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Joint Attention Intervention in Young Children With Autism - a Randomized Study
Brief Summary: The purpose of this study is to investigate the effectiveness of an intervention aimed to increase joint attention in 2-4 year old children with autism. The study will be conducted in mainstream preschools in Norway. The intervention will be implemented by preschool teachers and paraprofessionals supervised by trained counselors.


Options:
A: Receptive language skills (Pre-tx, Post-tx, and 6 month follow up); Expressive language skills (Pre-tx, Post-tx, and 6 month follow up)
B: N/A
C: childrens score on measures of joint attention (pre, post, follow up 6 months and 1 year)
D: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures (Measured at Year 2)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Joint Attention Intervention in Young Children With Autism - a Randomized Study
Brief Summary: The purpose of this study is to investigate the effectiveness of an intervention aimed to increase joint attention in 2-4 year old children with autism. The study will be conducted in mainstream preschools in Norway. The intervention will be implemented by preschool teachers and paraprofessionals supervised by trained counselors.


Options:
A: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures (Measured at Year 2)
B: childrens score on measures of joint attention (pre, post, follow up 6 months and 1 year)
C: Cognitive Assessment - Mullen Scales of Early Learning (MSEL) (Before treatment begins and at the 6 month follow up); Language Assessment - Reynell Developmental Language Scales (Before treatment begins and at 6 month follow up)
D: Behavioral profiles (6 to 12 months); Immune markers (6 to 12 months); Sleep/EEG findings (6 to 12 months); Neuroimaging findings (6 to 12 months); Other laboratory findings (6 to 12 months); Genetic abnormalities (6 to 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Joint Attention Intervention in Young Children With Autism - a Randomized Study
Brief Summary: The purpose of this study is to investigate the effectiveness of an intervention aimed to increase joint attention in 2-4 year old children with autism. The study will be conducted in mainstream preschools in Norway. The intervention will be implemented by preschool teachers and paraprofessionals supervised by trained counselors.


Options:
A: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures (Measured at Year 2)
B: N/A
C: childrens score on measures of joint attention (pre, post, follow up 6 months and 1 year)
D: Receptive language skills (Pre-tx, Post-tx, and 6 month follow up); Expressive language skills (Pre-tx, Post-tx, and 6 month follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Open-Label, Rater Blinded Assessment of Optimal Treatment Change Strategy to Risperidone for Patients Intolerant of Olanzapine
Brief Summary: The purpose of this study is to compare three strategies for switching patients with schizophrenia or schizoaffective disorder to the atypical antipsychotic, risperdone, after they have been unsuccessfully treated with another atypical antipsychotic, olanzapine. In the second phase of this study, investigators will assess the effectiveness of behavioral therapy in reducing body weight in risperdone-treated patients who are overweight or have problems with diabetes or blood sugar.


Options:
A: The primary objective of this study is to assess the fixed dose response relationship for efficacy between standard and higher doses of olanzapine (10, 20, and 40 mg/day) in patients with schizophrenia or schizoaffective disorder.
B: Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.; The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
C: Neurocognitive function (12 weeks)
D: The change in total Positive and Negative Syndrome Scale (PANSS) score from baseline at week 14 of Phase 2.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ullevål PersonalityProject. A Randomized Controlled Trial of Intensive Daytreatment Followed by Outpatient Long-term Combined Treatment Compared With Eclectic Individual Therapy for Patients With Personality Disorders
Brief Summary: Ullevål PersonalityProject is a ranomized controlled trial of treatment of patients with personality disorder. It's main purpose is to test the effect of a long-term combined treatment program compared with eclectic individual therapy for patients with personality disorders.

The main study hypothesis is that long-term combined treatment is superior to eclectic individual therapy with respect to improvement in personality functioning, psychosocial functioning, symptoms, interpersonal problems, and self destructive behavior for poorly functioning patients with personality disorders.


Options:
A: Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up (Pre-assessment and post-assessment (after intervention or two weeks from baseline))
B: To assess the efficacy of olanzapine therapy (5.0-10.0 mg/day) compared with placebo in patients with BPD,as defined by DSM-IV-TR criteria,; in improving overall symptomatology as measured by the last observation carried forward (LOCF) mean change from baseline to endpoint in the ZAN-BPD total score for up to 12 weeks of double-blind treatment.
C: Psychosocial functioning (The outcomes will be assessed after 8, 18, 36, and 72 months:); symptom distress (after 8, 18, 36 and 72 months); self esteem (after 8, 18, 36 and 72 months); interpersonal problems, (after 8, 18, 36 and 72 months); self destructive behavior, (after 8, 18, 36 and 72 months); personality pathology, (after 36 and 72 months); quality of life, (after 8, 18, 36 and 72 months); health care utilization after (after 8, 18, 36 and 72 months)
D: Beck scale for suicidal ideation (six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Ullevål PersonalityProject. A Randomized Controlled Trial of Intensive Daytreatment Followed by Outpatient Long-term Combined Treatment Compared With Eclectic Individual Therapy for Patients With Personality Disorders
Brief Summary: Ullevål PersonalityProject is a ranomized controlled trial of treatment of patients with personality disorder. It's main purpose is to test the effect of a long-term combined treatment program compared with eclectic individual therapy for patients with personality disorders.

The main study hypothesis is that long-term combined treatment is superior to eclectic individual therapy with respect to improvement in personality functioning, psychosocial functioning, symptoms, interpersonal problems, and self destructive behavior for poorly functioning patients with personality disorders.


Options:
A: Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008) (one year); Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010) (one year); Coping Styles and Strategies Scale (COPE) (Crespo 1997) (one year)
B: Psychosocial functioning (The outcomes will be assessed after 8, 18, 36, and 72 months:); symptom distress (after 8, 18, 36 and 72 months); self esteem (after 8, 18, 36 and 72 months); interpersonal problems, (after 8, 18, 36 and 72 months); self destructive behavior, (after 8, 18, 36 and 72 months); personality pathology, (after 36 and 72 months); quality of life, (after 8, 18, 36 and 72 months); health care utilization after (after 8, 18, 36 and 72 months)
C: Borderline Symptom Checklist (BSL-23) (Changes in scores of BSL-23 before treatment, and at 4, 8, 12 months after starting the treatment)
D: Suicide Attempt Behavior (12-month observation period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Ullevål PersonalityProject. A Randomized Controlled Trial of Intensive Daytreatment Followed by Outpatient Long-term Combined Treatment Compared With Eclectic Individual Therapy for Patients With Personality Disorders
Brief Summary: Ullevål PersonalityProject is a ranomized controlled trial of treatment of patients with personality disorder. It's main purpose is to test the effect of a long-term combined treatment program compared with eclectic individual therapy for patients with personality disorders.

The main study hypothesis is that long-term combined treatment is superior to eclectic individual therapy with respect to improvement in personality functioning, psychosocial functioning, symptoms, interpersonal problems, and self destructive behavior for poorly functioning patients with personality disorders.


Options:
A: Psychosocial functioning (The outcomes will be assessed after 8, 18, 36, and 72 months:); symptom distress (after 8, 18, 36 and 72 months); self esteem (after 8, 18, 36 and 72 months); interpersonal problems, (after 8, 18, 36 and 72 months); self destructive behavior, (after 8, 18, 36 and 72 months); personality pathology, (after 36 and 72 months); quality of life, (after 8, 18, 36 and 72 months); health care utilization after (after 8, 18, 36 and 72 months)
B: The primary outcome will be the composite outcome of the number of in-patient psychiatric hospitalisations, the number of A& E contacts, and the number of suicidal acts. (At both 12 and 24 months post randomisation.)
C: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)
D: Suicide Attempt Behavior (12-month observation period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Ullevål PersonalityProject. A Randomized Controlled Trial of Intensive Daytreatment Followed by Outpatient Long-term Combined Treatment Compared With Eclectic Individual Therapy for Patients With Personality Disorders
Brief Summary: Ullevål PersonalityProject is a ranomized controlled trial of treatment of patients with personality disorder. It's main purpose is to test the effect of a long-term combined treatment program compared with eclectic individual therapy for patients with personality disorders.

The main study hypothesis is that long-term combined treatment is superior to eclectic individual therapy with respect to improvement in personality functioning, psychosocial functioning, symptoms, interpersonal problems, and self destructive behavior for poorly functioning patients with personality disorders.


Options:
A: CAPS-5 (Clinician Administered PTSD Scale) (12 months)
B: CGI scale for use in borderline personality disorder (CGI-BPD) (12 weeks)
C: Borderline Symptoms (6 weeks)
D: Psychosocial functioning (The outcomes will be assessed after 8, 18, 36, and 72 months:); symptom distress (after 8, 18, 36 and 72 months); self esteem (after 8, 18, 36 and 72 months); interpersonal problems, (after 8, 18, 36 and 72 months); self destructive behavior, (after 8, 18, 36 and 72 months); personality pathology, (after 36 and 72 months); quality of life, (after 8, 18, 36 and 72 months); health care utilization after (after 8, 18, 36 and 72 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions
Brief Summary: The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.


Options:
A: In-stent Neointimal volume; In-stent Late lumen loss; Semi-Quantitative evaluation of infarcted size of myocardium
B: Glasgow Outcome Scale (at 6 months after injury)
C: Decrease in Delayed Graft Function
D: Infarct Size in the Territory of the Infarct Related Artery (performed 2 to 6 days after study medication administration (first CMR))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for IgAN. Both ACEi/ARB and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects. However, there is no evidence from RCT on the question of whether combined use of steroid with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of patients with IgAN.


Options:
A: Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 (Baseline (Day 1) and at Week 36)
B: Change in 24-h proteinuria from baseline after treatment (Baseline(week 0), week 4, week 12, week 24, week 36, week 48)
C: Serum creatinine; 24 hour urinary protein excretion
D: change in the degree of proteinuria (16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for IgAN. Both ACEi/ARB and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects. However, there is no evidence from RCT on the question of whether combined use of steroid with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of patients with IgAN.


Options:
A: Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio) (Week 0, week 12 and week 16)
B: Change from baseline in urine protein creatinine ratio (9 months)
C: Serum creatinine; 24 hour urinary protein excretion
D: Patients reaching full clinical remission of their disease (at the end of the 3 year study period.); GFR loss of 15 ml/min or higher from baseline GFR (at the end of the 3 year study period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The BeST Trial: A Randomized Phase II Study of VEGF, RAF Kinase, and mTOR Combination Targeted Therapy (CTT) With Bevacizumab, Sorafenib, and Temsirolimus in Advanced Renal Cell Carcinoma
Brief Summary: This randomized phase II trial studies different combinations of bevacizumab, temsirolimus, and sorafenib tosylate to see how well they work compared with bevacizumab alone in treating patients with kidney cancer that has spread to other places in the body. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab and sorafenib tosylate may stop the growth of tumor cells by blocking blood flow to the tumor. Temsirolimus and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving different combinations of bevacizumab, sorafenib tosylate, and temsirolimus may be more effective than bevacizumab alone in treating metastatic kidney cancer.


Options:
A: To evaluate if progression-free survival from randomization to progression or death during second-line therapy (Total PFS) of sorafenib followed by pazopanib is non-inferior compared to pazopanib followed by sorafenib. (4 years)
B: Progression-free Survival (Randomization until progression (up to 2 years))
C: Disease-free Survival (DFS) (Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry)
D: Progression-free Survival (PFS) (Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years)

Answer: D