TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.


Options:
A: SKAMP deportment rating scale (Week 8)
B: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
C: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks (Baseline and up to 7 weeks)
D: Efficacy outcome was change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T) (at 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.


Options:
A: Onset of Effect of Vyvanse (Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.)
B: Change in ADHD and ODD symptoms (Every week for six weeks); Change in attention, motor activity and executive functioning (The neuropsychological tests are administered once on each type of medication during the six week trial); Change in side-effects (Once every week through the six week trial)
C: Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase (2, 4, 8, 10, 12 and 14 hours post-dose on Day 7)
D: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks (Baseline and up to 7 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.


Options:
A: Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3) (From baseline (visit 2) to end of of Double-Blind phase (visit 3))
B: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks (Baseline and up to 7 weeks)
C: N/A
D: CGI -S - ADHD rating scale (Father) (Change from Screening at 8 weeks.); Conners Adult ADHD Rating Scale - Self Report (Father) (Change from Screening at 8 weeks.); Conners Other Report (about Father) (Change from Screening at 8 weeks); Barkley Functional Impairment Rating Scale (Father) (Change from Screening at 8 weeks.); Conners Parent (completed by parent about child) (Change form Screening at 8 weeks.); Conners Teacher Rating Scale (completed by teacher about child) (Change from Screening at 8 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PERL 4: Promoting Effective Recovery From Labor
Brief Summary: The primary goal of this project is to determine the efficacy of an antenatal Bladder Health class to prevent UI in a diverse sample of African American, Caucasian, and Hispanic childbearing women. The determination of efficacy will be made at 12-months post index birth, a time point that is a traditional benchmark of recovery from childbirth, using UI incidence/severity as the primary outcome.


Options:
A: Change from baseline in mean number of micturitions per 24 hours after 8 weeks (8 weeks)
B: Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries. (Every 6 months for 4 years)
C: Urogenital Distress Inventory (UDI-6) (baseline to 6 or 8 weeks); Incontinence Impact Questionnaire (IIQ-7) (baseline to 6 or 8 weeks)
D: UI incidence/severity (12 months - 3 years post-index birth)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet and Omega-3 Intervention Trial on Atherosclerosis
Brief Summary: The study was actuated to evaluate the effects of a 3-year intervention with diet and/or very long chain omega-3 (VLC n-3 PUFA), in a randomized 2x2 factorial design on the progression of atherosclerosis in a high risk population. A total of 563 elderly men were included and randomized to receive usual care and VLC n-3 placebo capsules (control group), dietary advice and VLC n-3 placebo capsules, usual care and VLC n-3 capsules, and finally both VLC n-3 capsules and dietary advice.

The evaluation of atherosclerosis were i) ultrasound measurement of carotid intima media thickening ii) pulse wave propagation time iii) circulating biomarkers of atherosclerosis.


Options:
A: Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers (1997-2010)
B: Change in Liver Fat (baseline and 12 months); Change in Enhanced Liver Fibrosis Score (ELF) (baseline and 12 months); Change in NAFLD Fibrosis Score (baseline and 12 months); Change in Bifidobacterium Spp. (baseline and 12 months)
C: Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm) (one year)
D: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet and Omega-3 Intervention Trial on Atherosclerosis
Brief Summary: The study was actuated to evaluate the effects of a 3-year intervention with diet and/or very long chain omega-3 (VLC n-3 PUFA), in a randomized 2x2 factorial design on the progression of atherosclerosis in a high risk population. A total of 563 elderly men were included and randomized to receive usual care and VLC n-3 placebo capsules (control group), dietary advice and VLC n-3 placebo capsules, usual care and VLC n-3 capsules, and finally both VLC n-3 capsules and dietary advice.

The evaluation of atherosclerosis were i) ultrasound measurement of carotid intima media thickening ii) pulse wave propagation time iii) circulating biomarkers of atherosclerosis.


Options:
A: Cumulative incidence of Major depressive Disorder (12 months)
B: Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers (1997-2010)
C: Time to first relapse of atrial fibrillation (After a three weeks loading phase)
D: Change in Liver Fat (baseline and 12 months); Change in Enhanced Liver Fibrosis Score (ELF) (baseline and 12 months); Change in NAFLD Fibrosis Score (baseline and 12 months); Change in Bifidobacterium Spp. (baseline and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet and Omega-3 Intervention Trial on Atherosclerosis
Brief Summary: The study was actuated to evaluate the effects of a 3-year intervention with diet and/or very long chain omega-3 (VLC n-3 PUFA), in a randomized 2x2 factorial design on the progression of atherosclerosis in a high risk population. A total of 563 elderly men were included and randomized to receive usual care and VLC n-3 placebo capsules (control group), dietary advice and VLC n-3 placebo capsules, usual care and VLC n-3 capsules, and finally both VLC n-3 capsules and dietary advice.

The evaluation of atherosclerosis were i) ultrasound measurement of carotid intima media thickening ii) pulse wave propagation time iii) circulating biomarkers of atherosclerosis.


Options:
A: Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months (12 months)
B: MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.; MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.
C: Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers (1997-2010)
D: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTX
Brief Summary: The Swefot trial was designed to compare two treatment strategies for patients with early rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of traditional antirheumatic medications (DMARDs), versus a combination including a newer "biological" anti-TNF medication. In order to make this trial consistent with current practices in rheumatology, all patients were first given the most commonly used antirheumatic medication, methotrexate (MTX). After 3-4 months those patients who had not responded adequately to this treatment were randomized to receive either MTX plus sulfasalazine plus hydroxychloroquine, or MTX plus infliximab. Again, to be truly life-like, the trial allowed patients who could not tolerate one of the added medications to switch in treatment - but keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin A, and infliximab by etanercept. The primary outcome in this trial was the percentage of patients who, after one year of treatment, achieved a "good response" as defined by Eular.


Options:
A: EULAR individual response (12 months)
B: Percentage of Participants With American College of Rheumatology-ACR20 Response (Baseline, Week 24); Change From Baseline in Modified Total Sharp-Genant Score at Week 52 (Baseline, Week 52); Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52 (Baseline to Week 52); Change From Baseline in the Modified Total Sharp-Genant Score at Week 104 (Baseline, Week 104); Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104 (Baseline to Week 104)
C: Mean 48-week Change in DAS28 (48 weeks after baseline assessment)
D: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTX
Brief Summary: The Swefot trial was designed to compare two treatment strategies for patients with early rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of traditional antirheumatic medications (DMARDs), versus a combination including a newer "biological" anti-TNF medication. In order to make this trial consistent with current practices in rheumatology, all patients were first given the most commonly used antirheumatic medication, methotrexate (MTX). After 3-4 months those patients who had not responded adequately to this treatment were randomized to receive either MTX plus sulfasalazine plus hydroxychloroquine, or MTX plus infliximab. Again, to be truly life-like, the trial allowed patients who could not tolerate one of the added medications to switch in treatment - but keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin A, and infliximab by etanercept. The primary outcome in this trial was the percentage of patients who, after one year of treatment, achieved a "good response" as defined by Eular.


Options:
A: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
B: EULAR individual response (12 months)
C: Dose-Normalized AUC[0-Inf] for MTX (24 Hour period); Dose-Normalized AUC[0-24] for MTX (24 Hour period); Dose-Normalized Cmax for MTX (24 Hour period)
D: Mean 48-week Change in DAS28 (48 weeks after baseline assessment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTX
Brief Summary: The Swefot trial was designed to compare two treatment strategies for patients with early rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of traditional antirheumatic medications (DMARDs), versus a combination including a newer "biological" anti-TNF medication. In order to make this trial consistent with current practices in rheumatology, all patients were first given the most commonly used antirheumatic medication, methotrexate (MTX). After 3-4 months those patients who had not responded adequately to this treatment were randomized to receive either MTX plus sulfasalazine plus hydroxychloroquine, or MTX plus infliximab. Again, to be truly life-like, the trial allowed patients who could not tolerate one of the added medications to switch in treatment - but keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin A, and infliximab by etanercept. The primary outcome in this trial was the percentage of patients who, after one year of treatment, achieved a "good response" as defined by Eular.


Options:
A: Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes (Baseline (Week 3) and Week 8 (5 weeks post-vaccination))
B: EULAR individual response (12 months)
C: Change in disease activity. (6 months)
D: Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTX
Brief Summary: The Swefot trial was designed to compare two treatment strategies for patients with early rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of traditional antirheumatic medications (DMARDs), versus a combination including a newer "biological" anti-TNF medication. In order to make this trial consistent with current practices in rheumatology, all patients were first given the most commonly used antirheumatic medication, methotrexate (MTX). After 3-4 months those patients who had not responded adequately to this treatment were randomized to receive either MTX plus sulfasalazine plus hydroxychloroquine, or MTX plus infliximab. Again, to be truly life-like, the trial allowed patients who could not tolerate one of the added medications to switch in treatment - but keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin A, and infliximab by etanercept. The primary outcome in this trial was the percentage of patients who, after one year of treatment, achieved a "good response" as defined by Eular.


Options:
A: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
B: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
C: EULAR individual response (12 months)
D: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.5 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTX
Brief Summary: The Swefot trial was designed to compare two treatment strategies for patients with early rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of traditional antirheumatic medications (DMARDs), versus a combination including a newer "biological" anti-TNF medication. In order to make this trial consistent with current practices in rheumatology, all patients were first given the most commonly used antirheumatic medication, methotrexate (MTX). After 3-4 months those patients who had not responded adequately to this treatment were randomized to receive either MTX plus sulfasalazine plus hydroxychloroquine, or MTX plus infliximab. Again, to be truly life-like, the trial allowed patients who could not tolerate one of the added medications to switch in treatment - but keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin A, and infliximab by etanercept. The primary outcome in this trial was the percentage of patients who, after one year of treatment, achieved a "good response" as defined by Eular.


Options:
A: ACR 20% response (Week 14)
B: Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169 (Day 169); Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups (Day 253 (short term))
C: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
D: EULAR individual response (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Dietary Protein Source on Phosphaturia, PTH and FGF23 in Patients With CKD 3 and 4
Brief Summary: Phosphorus is a substance in the blood that comes from food and is normally cleared from the body by the kidneys. In patients with kidney disease, excess phosphorus may build up in the body as you eat. This leads to problems with bones and blood vessels over time. In this study, we will compare the blood and urine before and after eating one week of a diet with a protein from plants (soy and grains) and before and after another one week of diet with protein from animals (meat and dairy products). The amount of phosphorus that the kidney puts out in the urine, and the changes in blood hormones in response to the diet will be measured at the beginning and end of each week on the two diets.


Options:
A: To determine if the dietary protein source affects fasting serum and urinary phosphorus excretion in patients with CKD stages 3 and 4. (6 months after baseline)
B: serum phosphorus (change from baseline to mean during 2 weeks active therapy)
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: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Multi Center Study to Evaluate the Efficacy of a Structured Information Program During ICU Stay
Brief Summary: The purpose of this study is to test whether a structured information program at the beginning of the ICU-stay is effective to reduce ICU related anxiety and discomfort.


Options:
A: Hospital Anxiety and Depression Scale (Day 90)
B: Patient self-reported anxiety (First three days on ICU and/or within 24 hours after ICU discharge)
C: Patient Health Questionaire (PHQ-9) (At 3- and 6- months following the death of the patient)
D: length of stay and depression (ICU admission, Day 5, discharge, and 2 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis
Brief Summary: A prospective controlled trial to compare the efficacy and safety of 7-day albendazole, single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand.


Options:
A: cure rate (1 year)
B: Change in TB-score compared to baseline (Wejse et al 2007) (2 months)
C: Change in markers of HIV-1 disease progression (12 weeks); CD4 count (12 weeks); HIV-1 RNA level (12 weeks); Genital HIV-1 RNA levels (12 weeks)
D: CD4 count (every 6 months for 24 months (enrollment and months 6, 12, 18, and 24 )); HIV-1 RNA level (enrollment, 12, and 24 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy: a Double Blinded Randomized Placebo Controlled Trial
Brief Summary: The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone disease.


Options:
A: Pain 'Right Now' (24 hours after the end of surgery); Morphine Equivalents of Concomitant Pain Medication (24 hours after the end of surgery)
B: Pain 'Right Now' (24 hours after the end of surgery); Morphine Equivalents of Concomitant Pain Medication (24 hours after the end of surgery)
C: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
D: Evaluation of analgesic effect by 11-NRS scale (4th postoperative day)

Answer: A