TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)
Brief Summary: There is currently considerable interest in both improving academic achievement (No Child Left Behind) and reducing the rates of obesity and its associated negative health consequences in elementary school students. Increased physical activity (PA) offers a potential intervention to address both issues. Evidence is available which suggests an association of PA with both academic achievement and obesity, and an association between obesity and academic achievement.

To provide increased PA while maintaining academic instruction time, we developed a program we call "Physical Activity Across the Curriculum" (PAAC) in which regular classroom teachers were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA) for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between students in elementary schools that participate in academic lessons taught through MVPA (PAAC) to students that do not (CON).


Options:
A: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)
B: Change in Weight Status (baseline and 2 year follow-up)
C: BMI percentile at 3 years (3 years)
D: Weight for Length Body Mass Index (BMI will be assessed at three years of age for the study participants)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Growth of Infants Fed an Elemental Medical Food
Brief Summary: Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.


Options:
A: Practical handling,ease of use and safety information (number of participants with adverse events) (measurements were taken on day 0-5 and up to day 10 on preterms and through 2 days after the last infusion of study product)
B: Study to assess the allergic symptoms, using a questionnaire. (5 months)
C: Concentrations of immune cells and cytokines of IL-6, IL-10, and IL-12 in infant's blood samples will be measured to evaluate immune functions. (1, 4, and 6 postnatal months)
D: Weight (14 days of age to 112 days of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.
Brief Summary: The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure rates comparable to those obtained by retropubic suburethral tape, becoming the first line treatment for stress urinary incontinence (SUI) in many cases. The TOT procedure is not exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. In addition it is commonly performed under general or regional anesthesia1-3. The single-incision mini-slings (SIMS) were developed to reduce the risk of complications by avoiding the blind passage of the trocars through the obturator space. In addition, the use of SIMS could enable surgeons to perform the procedure truly under local anesthesia.

Different devices for SIMS procedure are available. However, the evidence about their efficacy is controversial4-7. The main limitation of these devices could be the predetermined length of the mesh and the weakness on its fixation. The design of the SIMS Ajust® allows adjusting the length of the sling to each individual woman and provides a robust fixation into the obturator membrane. Recent prospective studies on the efficacy and safety of the sling Ajust® have obtained promising results8,9. Even so, the NICE guidelines advise to use SIMS in the context of research studies10.

The objective of this study is to establish if the effectiveness of the SIMS Ajust® is non-inferior to that of a standard TOT, as well as to compare the comorbidity of both procedures. Owing to the new appearance and fast evolution of these procedures, randomized comparative studies with SIMS are required in order to determine its place in the treatment of SUI.


Options:
A: The absence of stress incontinence at 6 weeks ascertained by direct questioning and from the Kings Quality of life questionnaire and the absence at 6 months by the same criteria and by urodynamics. (6 weeks and 6 months)
B: Subjective Cure of Urinary Incontinence at 12 Months After Surgery (12 months)
C: Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes. (Up to one year)
D: • Feasibility of the single incision sub-urethral tape to be done under local anaesthesia (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Single-dose Study to Assess the Effect of the QAB149 and NVA237 Combination Versus QAB149 Alone on Inspiratory Capacity in Patients With Moderate or Severe COPD.
Brief Summary: The study purpose is to evaluate the effect of QAB149

* NVA237 vs. QAB149 on static lung hyperinflation.


Options:
A: Inspiratory Capacity (IC) Peak Value (Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours)
B: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment); Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment)
C: Trough FEV1 Response (Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29)
D: Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose (Day 43, 60 minutes post-dose after 6 weeks of each treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: In the present study the investigators intend to investigate analgesic and sensory effects of a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory abnormalities in the skin.


Options:
A: Percent change from baseline in "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2 to 12, compared to baseline)
B: Percent change from baseline in the "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2-12, compared to baseline)
C: Percent change from baseline in "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2 to 8, compared to baseline) in the active group compared to the control group
D: Pain change capsaicin vs. placebo patch treatment (Pain intensity assessed at baseline and at 1,2,3 months follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Predictors of Poor Immune Response to Rotavirus Vaccine in Infants
Brief Summary: This will be a randomized study with the primary objective of assessing the impact of withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.

Enrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14 weeks. The subjects will be randomized into one of the two study arms. In one of the group caregivers will be advised to breastfeed immediately prior to and after each dose of the vaccine while in the other group caregivers will be advised to withhold breastfeeding for 30 minutes before and after each dose of the vaccine. The other childhood vaccines i.e. OPV and Pentavalent will be administered at least 30 minutes after administration of Rotarix®, The enrolled subjects will be followed up for 4 weeks after the 2nd dose of Rotarix®.


Options:
A: Safety of Rotavin-M1 vaccine in healthy adult volunteers (3 months)
B: 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))
C: Seroprotection for each polio serotype 1 month after the 3rd dose.
D: Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. (14-18 weeks of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Predictors of Poor Immune Response to Rotavirus Vaccine in Infants
Brief Summary: This will be a randomized study with the primary objective of assessing the impact of withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.

Enrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14 weeks. The subjects will be randomized into one of the two study arms. In one of the group caregivers will be advised to breastfeed immediately prior to and after each dose of the vaccine while in the other group caregivers will be advised to withhold breastfeeding for 30 minutes before and after each dose of the vaccine. The other childhood vaccines i.e. OPV and Pentavalent will be administered at least 30 minutes after administration of Rotarix®, The enrolled subjects will be followed up for 4 weeks after the 2nd dose of Rotarix®.


Options:
A: Occurrence of RV GE
B: Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. (14-18 weeks of age)
C: Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose (At least 14 days following the third vaccination)
D: Safety of Rotavin-M1 vaccine in healthy adult volunteers (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Predictors of Poor Immune Response to Rotavirus Vaccine in Infants
Brief Summary: This will be a randomized study with the primary objective of assessing the impact of withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.

Enrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14 weeks. The subjects will be randomized into one of the two study arms. In one of the group caregivers will be advised to breastfeed immediately prior to and after each dose of the vaccine while in the other group caregivers will be advised to withhold breastfeeding for 30 minutes before and after each dose of the vaccine. The other childhood vaccines i.e. OPV and Pentavalent will be administered at least 30 minutes after administration of Rotarix®, The enrolled subjects will be followed up for 4 weeks after the 2nd dose of Rotarix®.


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: Percentage of Participants Developing New Grade >=3 Adverse Events (From study entry until at least 42 days after third vaccination); Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1. (Prior to first vaccination and at least 14 days after third vaccination)
C: Immunogenicity (7 months)
D: Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. (14-18 weeks of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma (Protocol No. P05607/001)
Brief Summary: The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in children and adults.

The primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).


Options:
A: Use of inhaled corticosteroid (ICS).
B: Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24 (Week 24)
C: determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo (September 2009)
D: Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment (Last 8 weeks of treatment (Weeks 44 to 52)); Number of Participants Who Experience At Least One Adverse Event (AE) (Up to 54 weeks); Number of Participants Who Discontinue Study Drug Due to an AE (Up to 52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The effect of axillary lavage with a gentamicin solution before wound closure will reduce the drainage volume and subsequently day of drainage removal.


Options:
A: N/A
B: Drainage volume (7 days)
C: Intra-operative nausea (intra-operative)
D: Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing. (within 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The effect of axillary lavage with a gentamicin solution before wound closure will reduce the drainage volume and subsequently day of drainage removal.


Options:
A: Surgical Site Infection (as defined by the Centers for Disease Control and Prevention) (Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days)
B: Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group). (1 month)
C: Drainage volume (7 days)
D: Surgical Site infection (365 days after the procedure)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial to Improve Support Services for Caregivers of Patients With Alzheimer Disease in Italy by UPgrading Quality of Care Through the Integration of Services and the Use of New TECHnologies (The UP-TECH Project)
Brief Summary: The UP-TECH project aims at developing an UPgrading quality of care for Alzheimer's disease patients through the integration of services and the use of new TECHnologies in order to also improving the quality of life of their family caregivers.


Options:
A: Perceived stress (every 3 months (between 0 and 6 months))
B: Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12) (3 months)
C: Effects of the WeCareAdvisor Tool on Caregiver Upset (4 weeks); Effect of the WeCareAdvisor Tool on Caregiver Confidence (4 weeks)
D: Caregiver Burden Inventory (one year); Proportion of days spent at home by the AD patient in the past year (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial to Improve Support Services for Caregivers of Patients With Alzheimer Disease in Italy by UPgrading Quality of Care Through the Integration of Services and the Use of New TECHnologies (The UP-TECH Project)
Brief Summary: The UP-TECH project aims at developing an UPgrading quality of care for Alzheimer's disease patients through the integration of services and the use of new TECHnologies in order to also improving the quality of life of their family caregivers.


Options:
A: Caregiver Burden Inventory (one year); Proportion of days spent at home by the AD patient in the past year (one year)
B: Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12) (3 months)
C: Change from baseline in subjective burden using the Zarit Burden Interview (ZBI) (Baseline, Month 3, Month 6)
D: Center for Epidemiological Studies Depression scale (Pre- and post-training, 3 months and 6 months); Spielberger State-Trait Anger and Anxiety Scales (Pre-and post-training, 3 months and 6 months); Perceived Stress Scale (Pre- and post-training, 3 months and 6 months); Pittsburgh Sleep Quality Index (Pre-and post-training, 3 months and 6 months); Heart rate and blood pressure at rest and during recall of caregiver situation (Pre-and post-training, 3 months and 6 months); Salivary cortisol upon awakening, 30 minutes later, and prior to going to bed at night (Pre-and post-training, 3 months and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh
Brief Summary: The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of \>=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.


Options:
A: 116E rotavirus vaccine (6,10 and 14 weeks)
B: Hospitalization for gastroenteritis (2 years)
C: Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies (8 weeks post vaccination); Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG) (8 weeks post vaccination)
D: Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. (2 months post-Dose 2 (at study Month 4))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh
Brief Summary: The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of \>=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.


Options:
A: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)
B: Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies (8 weeks post vaccination); Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG) (8 weeks post vaccination)
C: Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. (14-18 weeks of age)
D: Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody (At Month 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh
Brief Summary: The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of \>=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.


Options:
A: Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody (At Month 3)
B: Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. (2 months post-Dose 2 (at study Month 4))
C: Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies (8 weeks post vaccination); Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG) (8 weeks post vaccination)
D: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay (3-6 weeks after the last vaccination); Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay (3-6 weeks after the last vaccination); Geometric Mean Serum Anti-rotavirus IgA Titer (3-6 weeks after the last dose of vaccine)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Ketamine vs. Midazolam: Testing Rapid Relief of Suicide Risk in Depression
Brief Summary: This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from depression.

The first drug, Ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts.


Options:
A: Change in Scale for Suicidal Ideation (Day 1 (24 hours) post-treatment)
B: Hamilton Rating Scale for Depression - 6 Items (A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1, & 3)
C: Change in 24 item Hamilton Depression Rating Scale (HAMD) scores. Safety measures: UKU scale, vital signs assessments, laboratory parameters (SMA-20, CBC, UA) (6 weeks); Change in Hamilton Rating Scale for Anxiety (HAMA) scores. (6 weeks)
D: Change From Baseline to Day 1: 4-Hour Post-dose in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Double-blind Phase) (Baseline (Day 1-Predose) to Day 1: 4-hours post-dose)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study
Brief Summary: The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in patients undergoing selective nasal sinus surgery and mammaplasty.


Options:
A: N/A
B: the mean infusion rate of intraoperative remifentanil and propofol (during operation)
C: Postoperative nausea and vomiting
D: Postoperative nausea and vomiting (24 hours)

Answer: B