TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial to Assess the Efficacy of Real-Time Continuous Glucose Monitoring (RT-CGM) in the Management of Type 1 Diabetes
Brief Summary: Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0% in 3 age groups (\>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring (CGM) group or control group. The primary outcome is change in HbA1c after 26 weeks. A parallel randomized trial is being conducted for a second cohort with HbA1c \<7.0% that will follow an identical protocol to that of the first cohort with HbA1c \>=7.0%.

The \>=7.0% trial was specifically designed and statistically powered to compare separately the impact of continuous versus standard intensive glucose monitoring in the three age groups. Both trials used standardized treatment algorithms and equivalent frequent contacts with subjects in both the CGM and control group.

After completion of the 26-week trial, the CGM group continues to use CGM for another 26 weeks to evaluate whether any beneficial effect seen in the first 6 months is sustained with longer-term use and less intensive contact and the control group initiates CGM use with less intensive contact after the first month than was provided at initiation of CGM use in the CGM group in the randomized trial.


Options:
A: Daily time spent in the hypoglycemic glucose range during continuous glucose measurement with and without real time access to glucose values and glucose alarms (during the 48 hours of using blind vs. unblind continuous glucose monitoring)
B: Clinical effectiveness: percentage of time spent in euglycaemia (3-6 days)
C: Change in A1c From Baseline to 52 Weeks (Baseline and 52 weeks)
D: Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort) (Baseline and 26 weeks); Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%) (Baseline and 26 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date. Moreover, the safety of repeated treatments with ACT has been little studied. This study aims to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.


Options:
A: N/A
B: Overall Cure Rate at Day 42
C: Adequate Clinical and parasitological response (Day 63)
D: adequate clinical and Parasitological response (ACPR)by day 28.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Hyperbaric Oxygen Therapy on Behavioral Measures of Short Term Memory, Learning, and Behavior in Children With Autism
Brief Summary: PURPOSE

The purpose of this investigation is to evaluate the cognitive and behavioral effects of Hyperbaric Oxygenation Therapy in children who present with a diagnosis of autism spectrum disorder.

HYPOTHESIS

1. Hyperbaric Oxygenation Therapy will be safe to use with children with autism.
2. Hyperbaric Oxygenation Therapy will have a statistically significant effect on the symptoms of autism.
3. Hyperbaric Oxygenation Therapy will have a clinically significant observable effect on the overt symptoms of autism.
4. The decreases in the symptoms of autism will correlate positively with the number of Hyperbaric Oxygenation Therapy sessions.
5. Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up, post 40 treatment sessions.

SPECIFIC AIMS

1. Provide further evidence for the safety of Hyperbaric Oxygenation Therapy in children with autism.
2. To quantitatively assess the effects of Hyperbaric Oxygenation Therapy on behavioral and cognitive symptoms of autism before, during, and after treatment.
3. Identify number of treatments required to reach therapeutic effects.
4. Identify the length and durability of treatment effect and maintenance.


Options:
A: Scores on autism rating scales before and after HBOT; Measure of inflammation before and after HBOT; Measures of oxidative stress before and after HBOT
B: Standardized Measures; In addition to the direct measures of behavior described above, standardized intelligence and adaptive assessments will be conducted prior to the initiation of HBOT. These will include:; ADI/ADOS; WPPSI-III (2-6 years) /WASI (6+ years); Vineland Adaptive Behavior Scale (VABS); Subjective Questionnaires; Aberrant Behavior Checklist; Clinical Global Impression; ATEC; Selected sections of the APEQ; BRIEF; Parenting Stress Index; Repetitive Behavior Scale; A side effect questionnaire; Thoughtful House Caregiver diary
C: Neurologic evaluation (2 and 4 months)
D: Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score (Baseline, 8 Weeks from baseline, and 20 Weeks from baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biologicals' Priorix® & Varilrix®.
Brief Summary: Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany \& Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 \& 3). No new subjects will be enrolled in these follow-up phases of the study.


Options:
A: Phase A: Number of Subjects With Confirmed Varicella Case (From 42 days post dose 2 until the end of Phase A)
B: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series (1 Month after the infant series (7 Months of age)); Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series (1 month after the infant series (7 months of age)); Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series (1 month after the infant series (7 months of age)); Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series (1 month after the infant series (7 months of age))
C: Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year; Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination
D: Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series (One month after the 3-dose infant series (7 months of age)); Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose (1 Month After the Toddler Dose); Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series (One Month After the Infant Series (7 months of age)); Percentage of Participants Reporting Pre-specified Systemic Events (Within 7 days after each dose); Percentage of Participants Reporting Pre-specified Local Reactions (Within 7 days after each dose)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rubeosis Anti-VEGF (RAVE) Trial for Ischemic Central Retinal Vein Occlusion
Brief Summary: The RAVE (Rubeosis Anit-VEgf) trial, utilizes monthly intravitreal Ranibizumab (Lucentis) injections for 9 months to see if total VEGF blockade will prevent neovascular glaucoma and eliminate the need for panretinal photocoagulation in patients with ischemic central retinal vein occlusion.


Options:
A: N/A
B: Mean Visual Acuity; Total number of treatments
C: Preservation of 5Ve isopter Goldmann visual field versus baseline at 1 year (12 and 24 months); Estimate the % of subjects progressing to neovascular glaucoma requiring pan-retinal photocoagulation or glaucoma surgery after treatment with ranibizumab (comparing 0.3mg to 0.5mg doses) (12 and 24 mponths)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Literacy Intervention for Korean Americans With High Blood Pressure (HBP)
Brief Summary: Many Korean Americans are at risk for developing high blood pressure. Low health literacy levels may play a role in this risk. The purpose of this study is to evaluate a literacy-focused program aimed at reducing blood pressure levels in older Korean Americans.


Options:
A: Combined adherence endpoint (at Visit 2 (follow-up visit after 3 months of intervention period))
B: Medication possession ratio (MPR), gaps and persistence in medicines use (Seven months after recruitment)
C: HbA1c (12month); Blood pressure (12 month); Lipid profile (12 months); quality of life (12month)
D: Health literacy levels (Measured at Week 6 and Months 6, 12, 18, and 24); Blood pressure control (Measured at Week 6 and Months 6, 12, 18, and 24); Reduction in blood pressure (Measured at Month 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Literacy Intervention for Korean Americans With High Blood Pressure (HBP)
Brief Summary: Many Korean Americans are at risk for developing high blood pressure. Low health literacy levels may play a role in this risk. The purpose of this study is to evaluate a literacy-focused program aimed at reducing blood pressure levels in older Korean Americans.


Options:
A: Health literacy levels (Measured at Week 6 and Months 6, 12, 18, and 24); Blood pressure control (Measured at Week 6 and Months 6, 12, 18, and 24); Reduction in blood pressure (Measured at Month 24)
B: New advance care planning documentation in the medical record (15 months after study enrollment)
C: Change in HIV viral suppression (Assessed at 4 month follow up (FU), 12 month FU)
D: self-reported status of the series of HBV vaccinations by follow-up calls in seven months after mailing the results verified by the medical records (Seven months after mailing the results)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Crohn's Disease (CD) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy
Brief Summary: The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.


Options:
A: The Proportion of Patients Responders to Dex 21-P vs Placebo (From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients))
B: Clinical Response at Week 8 Based on Mayo Score (Eight week treatment period)
C: Induction Period (IP); Number of Participants With Crohn's Disease Activity Index (CDAI)-Defined Clinical Response at Both Day IP-57 and Day IP-85 (At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).); Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months) (Day MP-365 (12 months) of maintenance therapy); Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs (Between Day OL-1 and Day OL-617); OL; Number of Participants With Adverse Events (AEs) of Special Interest (Between Day OL-1 and Day OL-617)
D: Percentage of Participants With Clinical Response (Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4 Randomized, Double-Blind, Placebo Controlled Methodology Study to Evaluate the Time of Onset of AntiDepressant Response in Subjects With Major Depressive Disorder
Brief Summary: Purpose of the study is to evaluate use of electronic diaries and voice acoustics for use in future depression clinical trial. Focus is on increased precision of measurement.


Options:
A: Change in the International Cooperative Ataxia Rating Scale (ICARS) From Baseline Assessment to Week 24 (baseline and 6 months)
B: The primary endpoint is time to treatment response and difference in time to response for the two data collection methods - daily patient electronic assessment versus weekly assessments measured in clinic.
C: Change in Disposition Index of Glucose Regulation, determined by Frequent Sampling IV Glucose Tolerance Test (Baseline, Day 14 and Day 28)
D: To examine the change in the level of oxidative stress by measuring the oxidative marker 8-hydroxy-2-deoxyguanosine from baseline and after 6 months of treatment with placebo or varying doses of idebenone (baseline and after 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multicenter, Randomized Controlled Study of the Effect of Lotepredol Etabonate on The Initiation of Dry Eye Treatment With Topical Cyclosporine
Brief Summary: To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry eye.

It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the stinging with cyclosporine administration and the dry eye signs and symptoms experienced during the initiation of therapy.


Options:
A: Conjunctival hyperemia (5 minutes)
B: Ocular Surface Disease Questionnnaire Results; Lissamine green staining; Fluorescein Staining; Schirmer testing
C: Changes of inflammatory cytokines in the tears of moderate and severe MGD (1 second before using topical loteprednol etabonate, after 1 month, and after 2 months of using topical loteprednol etabonate)
D: Bulbar Conjunctival Hyperemia (Visit 6 (Day 29)); Ocular Discomfort (Visit 6 (Day 29))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Brief Summary: This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.


Options:
A: Time to first occurrence of uveitis in the study eye. (2 years)
B: Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis (24 months)
C: N/A
D: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Brief Summary: This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.


Options:
A: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)
B: Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero (Week 8)
C: Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis (24 months)
D: Time to first occurrence of uveitis in the study eye. (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Brief Summary: This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.


Options:
A: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)
B: N/A
C: Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis (24 months)
D: Time to first occurrence of uveitis in the study eye. (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Different Immunosuppression Protocols in Highly Sensitized Renal Transplant Recipients: Campath Induction With Tacrolimus Monotherapy vs Thymoglobulin Induction With Triple Drug Protocol.
Brief Summary: Comparison between Campath induction and monotherapy with Tacrolimus vs Thymoglobulin induction and triple drug maintenance using Tacrolimus, mycophenolate, and steroids.


Options:
A: Incidence and severity of biopsy-proven acute rejection at 1 year. (1 year)
B: graft survival (1 year)
C: Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification) (Month 6)
D: Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function (During first 7 days after kidney transplantation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Quetiapine (Seroquel) in the Treatment of Social Phobia: Effects on Cue Reactivity in Response to Virtual Reality Public Speaking Environment
Brief Summary: This is a pilot study that will focus on the collection of preliminary data to determine the efficacy of quetiapine for individuals with social phobia. We hypothesize that individuals will react with less self-reported anxiety and physiological reactivity in the drug condition than in the placebo condition. If true, this would constitute a strong signal for a significant treatment effect for quetiapine in social phobia. A positive treatment effect in this study would provide rationale for further investigation of the efficacy of quetiapine for cue reactivity for individuals with social phobia. Further study would include increased sample size in order to obtain statistical power and replication of findings. We will utilize the IR formulation of quetiapine.


Options:
A: Superiority is defined as a statistically greater reduction of the mean change from baseline to endpoint (after 12 weeks of treatment) in the Liebowitz Social Anxiety Scale (LSAS) total score.
B: To assess, by mean of Positron Emission Tomography, the degree of regional Cerebral Blood Flow in different brain regions involved in the emotional brain circuit during public speaking task before treatment and after eight weeks of treatment.
C: Personal Report of Confidence as a Speaker (PRCS)
D: Change in Liebowitz Social Anxiety Scale (LSAS) - total score (Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Ranibizumab for Edema of the Macula in Diabetes: a Phase 2 Study ( The Read-2 Study)
Brief Summary: This study is being done to see if the investigational drug Ranibizumab (RBZ) given by injection into the eye, is safe and effective to use in people with diabetic macular edema (DME). The investigators want to compare RBZ to laser treatment which is the current standard way to treat DME.

RBZ blocks a growth factor that is thought to be involved in the formation of abnormal blood vessels that cause loss of vision in patients with DME.


Options:
A: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12 (Baseline through the end of study (Month 12))
B: Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6 (6 months)
C: Visual acuity; Central macular thickness
D: Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year (Baseline to 1-year); Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 (Baseline to 1-year); Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69 (Baseline to 1-year)

Answer: B