TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-masked, Multicenter, Controlled Study of Photodynamic Therapy in Patients With Central Serous Chorioretinopathy
Brief Summary: The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin dose in the treatment of CSC.


Options:
A: Serial changes in ETDRS letterscore (3 months)
B: Change from baseline in BCVA (1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year)
C: Safety of Intravitreal Aflibercept Injection (6 months)
D: Absence of subretinal fluid on OCT scan (6-8 weeks after treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary: Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.


Options:
A: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: Rating of urges to smoke 1-week after the target quit (1 week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary: Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.


Options:
A: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
B: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: Change in lung function values in smokers without previous respiratory disease (2 years)
D: Summarization of safety data in smokers treated with either varenicline or placebo.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary: Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.


Options:
A: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: Biochemically-verified point-prevalence abstinence (7, 11, 16, and 30 weeks post-quit); Likelihood of progression to a relapse (e.g., return to baseline smoking) following a slip at any time in study. (At any point following the quit date.); Treatment completion. (Weeks 7 and 30.); Daily cigarette smoking rate. (Weekly); Frequency and severity of bupropion and naltrexone side effects. (Weekly during treatment)
D: 6 Month Self-reported Abstinence From Smoking (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary: Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.


Options:
A: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
B: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
C: Tobacco use abstinence (26 week)
D: Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. (Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quit); Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence (Changes in log withdrawal symptoms from baseline through 66 days of abstinence)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases
Brief Summary: The purpose of this study is to evaluate the efficacy of Aerosal® compared to a placebo treatment in the prognosis of sub-obstructive adenotonsillar hypertrophy present for at least six months.


Options:
A: Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months. (The primary endpoint measure will occur at 7 months following the baseline visit.)
B: Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25% (2 weeks (10 sessions), 14 weeks)
C: The percentage of children converting from needing T&A surgery before treatment with montelukast to not needing surgery after treatment will be examined. (Duration of Study)
D: Change in the number of apnea/hypopnea episodes during a sleep study (Start of study, 6 weeks after drug treatment started and 6 weeks after placebo treatment started.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients
Brief Summary: In this study the investigators aim to investigate the effects of two different types of non-invasive brain stimulation techniques -- repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) on motor function in stroke. This is a cross-over study where subjects will receive 5 sessions of stimulation (each separated by 1 week) -- with either active tDCS and sham rTMS, sham tDCS and active rTMS or both sham tDCS and rTMS.


Options:
A: Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months)
B: Ambulatory function measured by the Six Minute Walk Test (Rehabilitation discharge (average 4-5 weeks post admission))
C: Changes in cortical excitability measures (Measured for approximately 6 weeks)
D: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients
Brief Summary: In this study the investigators aim to investigate the effects of two different types of non-invasive brain stimulation techniques -- repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) on motor function in stroke. This is a cross-over study where subjects will receive 5 sessions of stimulation (each separated by 1 week) -- with either active tDCS and sham rTMS, sham tDCS and active rTMS or both sham tDCS and rTMS.


Options:
A: Changes in cortical excitability measures (Measured for approximately 6 weeks)
B: Motor Skill Retention (Day 9)
C: Motor learning improvement with tDCS (Improvement on motor learning were recorded from baseline to 4 weeks after the intervention)
D: Safety of the intervention as assessed by frequency of adverse events (2 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity of the Human Rotavirus Vaccine (Rotarix™) at Varying Schedules, Doses, and Ages in Rural Ghana
Brief Summary: The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.


Options:
A: Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group.
B: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules (4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))
C: Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus (Up to 2 years of age)
D: Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (6, 10, 14 and 18 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity of the Human Rotavirus Vaccine (Rotarix™) at Varying Schedules, Doses, and Ages in Rural Ghana
Brief Summary: The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.


Options:
A: Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.
B: Immunogenicity (7 months)
C: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules (4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))
D: Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody (28 days post-vaccination); Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody (28 days post-vaccination)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity of the Human Rotavirus Vaccine (Rotarix™) at Varying Schedules, Doses, and Ages in Rural Ghana
Brief Summary: The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.


Options:
A: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules (4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))
B: Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group.
C: Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.
D: Number of Participants With Any Severity of Rotavirus Gastroenteritis (From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity of the Human Rotavirus Vaccine (Rotarix™) at Varying Schedules, Doses, and Ages in Rural Ghana
Brief Summary: The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.


Options:
A: Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups (Day 0 to Day 56); Assessment of Safety (Day 0 to Day 182)
B: Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load (Twice daily on Day 2 through Day 11 and once on Day 12)
C: To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children (Day 28); Reactogenicity evaluations (REs) from administration of study vaccine through 28 days post-dosing (Day 28 post final vaccination); Adverse events (AEs) from administration of study vaccine through 28 post-dosing (Day 28 post final vaccination); Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing (Day 180)
D: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules (4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nasal High-flow Oxygen Therapy vs Standard Oxygen Therapy Via Venturi Mask in the Post-extubation Period
Brief Summary: The aim of the study is to compare two devices for oxygen therapy, nasal high-flow and Venturi mask, in critically ill patients in the post-extubation period. The hypothesis is that nasal high-flow may be superior to the Venturi mask in terms of oxygenation


Options:
A: Oxygenation failure (2 hours)
B: Inspiratory muscle effort : oesophageal pressure (Poes) and the oesophageal pressure time product (PTPoes) (Every 30 minutes for 90 minutes)
C: mortality rates (day 28)
D: Oxygenation (PaO2/FiO2 ratio) (Up to 48 hours after extubation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nasal High-flow Oxygen Therapy vs Standard Oxygen Therapy Via Venturi Mask in the Post-extubation Period
Brief Summary: The aim of the study is to compare two devices for oxygen therapy, nasal high-flow and Venturi mask, in critically ill patients in the post-extubation period. The hypothesis is that nasal high-flow may be superior to the Venturi mask in terms of oxygenation


Options:
A: Respiratory failure after extubation (72 hours)
B: mortality rates (day 28)
C: Oxygenation (PaO2/FiO2 ratio) (Up to 48 hours after extubation)
D: The decrease of diaphragmatic workload (thickening fraction of the diaphragm) (30 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Brief Summary: The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis


Options:
A: Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip (One Year (at baseline and one year))
B: Number of Participants With New Vertebral Fractures (36 months)
C: Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) (Baseline and 9 months)
D: Percentage of Participants With New Vertebral Fracture Through Month 12 (12 Months); Percentage of Participants With New Vertebral Fracture Through Month 24 (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fp Spiromax® (Fluticasone Propionate Inhalation Powder) Administered Twice Daily Compared With Placebo in Adolescent and Adult Subjects With Severe Persistent Asthma Uncontrolled on High Dose Inhaled Corticosteroid Therapy
Brief Summary: The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high dose ICS therapy.


Options:
A: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks. (Baseline and 12 weeks)
B: Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12 (Baseline and Week 12)
C: Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period (Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12)
D: Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12 (Baseline and Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Hatha Yoga Exercises in Pelvic and Lumbar Back Pain in Pregnant Woman
Brief Summary: The aim of this study is to identify evaluate the effectiveness of stretching exercises of Hatha Yoga method in pregnant women with back pain and posterior pelvic City Paulínia. -There will be a randomized clinical trial with 60 pregnant women with these symptoms. They will be randomly divided into 2 groups. The group A will perform the exercises of Hatha Yoga for ten weeks, once a week group B postural follow the guidelines recommended for the treatment of these pains, for ten weeks. Will be used as a technique for evaluating the Visual Analogue Scale to measure pain intensity and confirmation tests of the lumbar and posterior pelvic pain in order to differentiate them. A descriptive statistical analysis of univariate and bivariate distributions will be made through frequency and graphical representation. The association between the variables will be tested by statistical tests: \[chi-square (X ²)\], Fisher's exact test, Student's t test or Mann-Whitney, \[Student's t test to compare means\], ANOVA for the analysis of effects between the groups. \[The significance level is predetermined to 5%\]. The data will be analyzed in EPI-INFO 2000. SAS 9.0 and from the database created .


Options:
A: Pain Visual Analog Scale (VAS) (10 weeks); confirmatory low back pain test (10 weeks); Confirmatory pelvic pain test (10 weeks)
B: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)
C: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
D: Roland Morris Disability Index (Last study visit prior to birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week, Multinational, Multicentre, Randomised, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of CHF 1535 200/6µg Versus Beclomethasone Dipropionate in Adult Asthmatic Patients Not Adequately Controlled on High Dose of Inhaled Corticosteroids or on Medium Dose of Inhaled Corticosteroids Plus Long-acting β2 Agonists
Brief Summary: The purpose of this study is to show the superiority of CHF 1535 (BDP/FF) pMDI over BDP HFA pMDI in terms of lung function considering change from baseline to the entire treatment period in average pre-dose morning PEF in adult asthmatic patients not adequately controlled on high doses of ICS or on medium dose of ICS+LABA.


Options:
A: 'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No) (Weekly, up to 52 weeks)
B: Pre-dose morning PEF (12 weeks)
C: Morning Peak Expiratory Flow (AM PEF) (Baseline (run-in) and throughout 12 weeks)
D: Change in evening PEF (Daily throughout the 12 week treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Utility of Indomethacin as Support Treatment in Women With Preterm Labor With Intact Membranes and High Risk of Intraamniotic Inflammation
Brief Summary: To demonstrate if indomethacin associated to conventional treatment for preterm labor is useful to delay delivery and to improve neonatal morbimortality in women with preterm labor with high risk of intraamniotic inflammation


Options:
A: Number of participants with successful prolongation of pregnancy for a period of 48 hours following administration of the studied drug. (48 hours prolongation of pregnancy after starting the studied drug)
B: Gestational age at delivery (before than 42 weeks of gestation)
C: Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Participants will be followed for the duration of pregnancy, an expected average of 10 weeks); Number of women undelivered 48 hrs and seven days of initiation of therapy (Participants who are not delivered within seven days of initiation of therapy); Number of Babies with Adverse Events as a Measure of Safety and Tolerability (participants will be followed for the duration of hospital stay, an expected average of 7 weeks)
D: delaying labor (for more than 48 hours after starting treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Generic Protocol for the Collection of Early Pregnancy Urines
Brief Summary: Female volunteers, wishing to become pregnant will be offered the use of Clearblue ovulation prediction products to help identify their most fertile time and aid conception. Volunteers will provide SPD with a daily urine sample throughout the study period, which will be used for the development and validation of SPD products related to pregnancy and fertility.


Options:
A: Unintended Pregnancies (1, 3, 6, and 12 months)
B: Ultrasound (Participants will be followed for one menstrual cycle, anticipated average of four weeks.)
C: Collection of early pregnancy urine samples. (60 days)
D: Difference in pregnancy rates across 2 cycles of use between volunteers trying to conceive in the home setting using (i) COTS, (ii) no intervention. (2 months)

Answer: C