TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Course of Intralesional Antimony for Bolivian Cutaneous Leishmaniasis
Brief Summary: Intralesional injection of antimony has been used for L major from Iran with a modest cure rate \[56%: Asilian 2004\]. However, this therapeutic approach has been used for L braziliensis from Brazil, with an attractive cure rate after 3 months of 80% \[Oliveira-Neto 1997\]. Because intralesional Sb injections is the local therapy with the best reported cure rate for South American L braziliensis disease, the species that causes disease in Bolivia, this pilot study of local therapy for bolivian L braziliensis disease will evaluate intralesional Sb therapy.


Options:
A: Complete reepithelization (three months after the beginning of the treatment)
B: Complete clinical cure (six months)
C: Number of Participants Who Obtained Final Clinical Cure of Index Lesion (168 days)
D: Change of Lesion size (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects With Dyslipidemia, Followed by a 40-Week Safety Extension Study
Brief Summary: A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.


Options:
A: Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir (12 weeks)
B: Thiobarbituric acid reactive substance; high sensitive C-reactive protein (12 weeks)
C: Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks (12 weeks minus baseline)
D: Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks (Baseline to 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects With Dyslipidemia, Followed by a 40-Week Safety Extension Study
Brief Summary: A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.


Options:
A: Number of Participants Who Stated (by Self-report) That They Had Side Effects (4 months); Number of Participants Who Took >90% of Their Doses (by Pill Count) (4 months); Change From Baseline to Month 4 in the Framingham Risk Score (FRS) (Change from baseline to 4 months)
B: Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks (12 weeks minus baseline)
C: serum LDL-C (at week 12); ALT value
D: Total Cholesterol (-2, 0, 4, 6 weeks); LDL Cholesterol (-2, 0, 4, 6 weeks); HDL Cholesterol (-2, 0, 4, 6 weeks); Triglycerides (-2, 0, 4, 6 weeks); C-reactive protein (-2, 0, 4, 6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Controlled, Double Blinded, Clinical Trial: 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
Brief Summary: The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration.


Options:
A: Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L) (72 hrs)
B: Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia) (During the treatment and follow-up period.); Hyponatremia (during the study intervention)
C: rate of change in serum sodium (8 to 20 hours)
D: Serum Sodium Levels in Both Groups (first 48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Bilateral Study of the Safety and Efficacy of Topically Applied AN2898 and AN2728 in the Treatment of Patients With Mild-to-Moderate Atopic Dermatitis
Brief Summary: The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).


Options:
A: Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) (Baseline (Day 1)); Atopic Dermatitis Severity Index (ADSI) Score at Day 14 (Day 14); Atopic Dermatitis Severity Index (ADSI) Score at Day 28 (Day 28); Atopic Dermatitis Severity Index (ADSI) Score at Day 42 (Day 42); Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28 (Baseline (Day 1), Day 28)
B: Atopic Dermatitis (AD) Disease Control Over 36 Months (36 months); Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age (6 years)
C: Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing (3 days)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Virtual Reality Augmented Balance Training for Postural Control in Patients With Parkinson's Disease
Brief Summary: Background and Objective: Postural instability is common in patient with Parkinson's disease (PD). The purpose of this study was to investigate the effects of virtual reality (VR) balance training on sensory and cognitive domains of postural control.

Setting: Balance Performance Laboratory. Participants: A total of 42 patients (Hoehn and Yahr stage II-III) were recruited and assigned into three groups randomly.

Intervention: Participants in the virtual reality (VR) group and conventional balance training (CB) group received a 6 weeks balance training program. The control group (CG) did not receive any training.

Outcome Measures: The sensory organization tests (SOT) of computerized dynamic posturography with single and dual tasks (i.e. with backward subtraction of number) were examined pre-, post-training and follow-up. The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded.

Results: (1) Only VR significantly increased ES of SOT-6 (i.e., vestibular function at visual and somatosensory conflicting condition) post-training more than CG post-training in either single or dual task. (2) Only CB training significantly increased SOT-5 (i.e., vestibular function without visual conflict) and vestibular sensory ratio (i.e., SOT-5/SOT-1) more than CG post-training in either single or dual task. (3) (3) Neither VR nor CB training reduced VRT significantly under six sensory conditions at post-training and follow-up.

Conclusion: Both VR training and CB training can improve sensory organization for postural control by enhancing utilization of vestibular information, but VR could enhance vestibular function with conflicting proprioceptive and visual information under single and dual tasks in patients with mild to moderate PD.


Options:
A: Functional Reach (baseline, 4, 10, 16 months)
B: The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded. (6 weeks)
C: Balance (3 time points)
D: Level of Physical Activity based on the LAPAQ questionnaire (Average of 6, 12, 18 and 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Virtual Reality Augmented Balance Training for Postural Control in Patients With Parkinson's Disease
Brief Summary: Background and Objective: Postural instability is common in patient with Parkinson's disease (PD). The purpose of this study was to investigate the effects of virtual reality (VR) balance training on sensory and cognitive domains of postural control.

Setting: Balance Performance Laboratory. Participants: A total of 42 patients (Hoehn and Yahr stage II-III) were recruited and assigned into three groups randomly.

Intervention: Participants in the virtual reality (VR) group and conventional balance training (CB) group received a 6 weeks balance training program. The control group (CG) did not receive any training.

Outcome Measures: The sensory organization tests (SOT) of computerized dynamic posturography with single and dual tasks (i.e. with backward subtraction of number) were examined pre-, post-training and follow-up. The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded.

Results: (1) Only VR significantly increased ES of SOT-6 (i.e., vestibular function at visual and somatosensory conflicting condition) post-training more than CG post-training in either single or dual task. (2) Only CB training significantly increased SOT-5 (i.e., vestibular function without visual conflict) and vestibular sensory ratio (i.e., SOT-5/SOT-1) more than CG post-training in either single or dual task. (3) (3) Neither VR nor CB training reduced VRT significantly under six sensory conditions at post-training and follow-up.

Conclusion: Both VR training and CB training can improve sensory organization for postural control by enhancing utilization of vestibular information, but VR could enhance vestibular function with conflicting proprioceptive and visual information under single and dual tasks in patients with mild to moderate PD.


Options:
A: Parkinson's Disease Quality of Life Questionnaire (PDQL) (8 months); AMC Linear Disability Score (ALDS) (8 months)
B: Falls rate (6 months post intervention)
C: The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded. (6 weeks)
D: UNIFIED PARKINSON'S DISEASE RATING SCALE (08/2011 (up to 2 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutritional Status of Iodine in the Pregnant Population of Catalonia: a Study of Dietary Habits and Urinary Iodine
Brief Summary: The purpose of this study is to assess the effectiveness of individual education versus group education about dietary habits and iodine supplementation to decrease iodine deficiency in pregnant women


Options:
A: Improved understanding of preeclampsia (one week)
B: Increase in parent knowledge, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Increase in parent skills, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Decrease in parental high-risk behaviors, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Increase in parental-child involvement, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
C: Iodine deficiency (36 weeks of pregnancy); Iodine deficiency (24 weeks of pregnancy)
D: Sexually transmitted disease (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Rapid repeat pregnancy (Measured at Month 12 postpartum); Sexual risk behavior (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Perinatal outcomes (e.g., birth weight, gestational age) (Measured at Months 6 and 12 postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis
Brief Summary: "Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis " has begun in October 2008 at the Laboratory of Leishmaniasis Surveillance at Evandro Chagas Clinical Research Institute (IPEC), FIOCRUZ, aiming to compare efficacy and safety of the standard recommended schedule with an alternative dosage scheme of meglumine antimoniate in the treatment of American tegumentary leishmaniasis (ATL). It is a study with blind evaluation by the doctors and the responsible for statistical analysis. Patients diagnosed with ATL, eligible for the trial are randomly allocated into one of the schemes with meglumine antimoniate and monitored before, during and after it. There is no single regimen applicable to all forms of leishmaniasis around the world. Therapeutic regimens applied to treat people living in other geographic areas result in mixed outcomes. Ideally, the most appropriate regimens should be established for each endemic area, based on its efficacy, toxicity, difficulties of administration and cost. Given the problems and limitations of the use of pentavalent antimonials (Sb5+) at 20 mg Sb5+ / kg / day, less toxic alternative regimens, i.e. 5mg Sb5+/kg/day, deserve to be better evaluated. The treatment of ATL must heal skin lesions and prevent late mucosal lesion development. The indication of high doses of Sb5+ is based on the evidence that there could be induction of resistance with use of subdoses. However, clinical studies with extended follow-up in Rio de Janeiro have suggested that regular low doses (5mg Sb5+ / kg / day) may constitute an effective scheme, achieving cure rates similar to higher doses, with lower toxicity, ease of implementation and lower cost. Published studies on efficacy and safety of alternative dosage schemes with meglumine antimoniate failed to provide conclusive results so far, for various methodological biases. The need to compare the effectiveness and safety between the standard treatment scheme with meglumine antimoniate currently recommended in Brazil for the treatment of ATL and an alternative scheme with low doses of antimony is the motive for this study in Rio de Janeiro.


Options:
A: Final Clinical Cure for Index Lesions (Initial clinical cure by day 63 and no relapse by day 168)
B: Effectiveness of meglumine antimoniate treatment (6 years)
C: Number of Participants Who Obtained Final Clinical Cure of Index Lesion (168 days)
D: Complete reepithelization (three months after the beginning of the treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).
Brief Summary: Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.


Options:
A: Total number of urinary incontinence episodes per week
B: Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours (Baseline, Week 12); Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (Baseline, Week 12)
C: Percent Change in Urgency Urinary Incontinence Episodes (Baseline and 2 month follow-up)
D: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 (Baseline, Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.
Brief Summary: This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.


Options:
A: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. (Week 12)
B: Total number of urinary incontinence episodes per week
C: Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
D: Change From Baseline to Week 12 in Bladder Wall Thickness (Baseline and Week 12); Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12 (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Multicenter, Randomized, Adaptive, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Year Old Spinal Muscular Atrophy (SMA) Patients.
Brief Summary: Assess the efficacy and the safety of olesoxime in SMA type 2 or type 3 non ambulant patients aged 3-25 years


Options:
A: Motor Function Measure (every 6 months)
B: Percentage of Motor Milestones Responders (assessed at the later of the Day 183, Day 302, or Day 394 study visits); Time to Death or Permanent Ventilation (Day 91, Day 182, Day 273, Day 364, Day 394)
C: Number of Participants That Experienced One Grade III or Higher Unanticipated, Treatment-related Toxicity That Presents With Clinical Symptoms and Requires Medical Treatment (2 years)
D: Laboratory Safety Data (-2 weeks, + 2 weeks, 3 months, 6 months); Anthropometric Measures of Nutritional Status (Body Mass Index [BMI] Z-scores, Weight for Length Ratios, Lean/Fat Mass Via DEXA, Growth Parameters, and Triceps Skinfold Measures) (-2 weeks, time 0, 3 months, 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Multicenter, Randomized, Adaptive, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Year Old Spinal Muscular Atrophy (SMA) Patients.
Brief Summary: Assess the efficacy and the safety of olesoxime in SMA type 2 or type 3 non ambulant patients aged 3-25 years


Options:
A: Number of Participants That Experienced One Grade III or Higher Unanticipated, Treatment-related Toxicity That Presents With Clinical Symptoms and Requires Medical Treatment (2 years)
B: Safety Labs (-4 wks, 0, 2 wks, 3 mo, 6 mo, 9 mo, 12 mo for safety labs; throughout for AEs); Efficacy, Measured Through Motor Function Assessments (-4wks, 0, 3 mo, 6 mo, 12 mo); Modified Hammersmith Change From Baseline to 6 Months (0 months, 6 months)
C: Manual Muscle Test (Medical Research Council scale-MRC), the Hammersmith Motor Ability Score (one year)
D: Motor Function Measure (every 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploratory, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Center, Web-Based Phase IV Pilot Methodology Trial To Evaluate The Efficacy And Safety Of Tolterodine ER In Subjects With Overactive Bladder
Brief Summary: To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative web-based trial design


Options:
A: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (Baseline, Week 12)
B: Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.
C: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 (Baseline, Week 12)
D: Change in the total weekly number of incontinence episodes (Baseline to Treatment Week 12/Premature Discontinuation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIb Randomized Study to Evaluate the Efficacy of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer
Brief Summary: The purpose of the study is to evaluate the efficacy of the combination of gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in patients with metastatic pancreatic cancer.


Options:
A: Progression free survival (4 years)
B: Overall Survival (From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months))
C: Survival rate at 6 months (6 months)
D: Progression-free survival rate at 6 months

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial
Brief Summary: The aim of this study is to assess the effectiveness and safety of dexamethasone for transforaminal epidural steroid injection. A secondary aim of this study is to obtain data on the lowest most effective dose of dexamethasone for this treatment and the effective duration of effect.


Options:
A: Procedural Pain score (NRS) (Immediately after the procedure)
B: Numerical Rating Leg Pain Score (1 month)
C: To evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment (1,3,6,12 months)
D: Radicular Pain Visual Analogue Scale (VAS) Score change from baseline (Baseline, 4 weeks, 8 weeks, 12 weeks post injection)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: 7-day Point Prevalence Quit Rate (Week 12)
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: 7-Day Point Prevalence Smoking Abstinence (24 weeks); Continuous Smoking Abstinence (24 weeks)
D: Summarization of safety data in smokers treated with either varenicline or placebo.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: 4-week continuous quit rate (CQR) for Weeks 9-12
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
D: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)

Answer: B