TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Descending Age Double-blinded Randomized Placebo-controlled Dose Escalation Study to Examine the Safety Reactogenicity Tolerability & Immunogenicity of the P2-VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers & Infants
Brief Summary: This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study will examine the safety and immunogenicity of this vaccine first in healthy South African toddlers. If the safety profile is deemed appropriate, the study will continue to explore the safety and immunogenicity of the vaccine in healthy South African infants.

The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated in healthy toddlers and infants. The primary immunogenicity hypothesis is that the P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response in at least 80% of participants in at least one of the study groups.


Options:
A: Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.
B: Hospitalization for gastroenteritis (2 years)
C: Number of Participants With Vaccine Induced Reactions (7 days following each dose); Number of Participants With Serious Adverse Events (within 28 days of a study dose and at any time); Number of Participants Reporting Any Non-Serious Adverse Event (6 mo following first vaccination); Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse. (Baseline to day 84); Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses (Baseline to day 84); Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8]) (Baseline to Day 84)
D: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Descending Age Double-blinded Randomized Placebo-controlled Dose Escalation Study to Examine the Safety Reactogenicity Tolerability & Immunogenicity of the P2-VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers & Infants
Brief Summary: This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study will examine the safety and immunogenicity of this vaccine first in healthy South African toddlers. If the safety profile is deemed appropriate, the study will continue to explore the safety and immunogenicity of the vaccine in healthy South African infants.

The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated in healthy toddlers and infants. The primary immunogenicity hypothesis is that the P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response in at least 80% of participants in at least one of the study groups.


Options:
A: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (Within the 15-day solicited follow-up period after any dose)
B: 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)
C: Number of Participants With Vaccine Induced Reactions (7 days following each dose); Number of Participants With Serious Adverse Events (within 28 days of a study dose and at any time); Number of Participants Reporting Any Non-Serious Adverse Event (6 mo following first vaccination); Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse. (Baseline to day 84); Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses (Baseline to day 84); Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8]) (Baseline to Day 84)
D: Number of Subjects Reporting Any Serious Adverse Events (SAEs). (From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Descending Age Double-blinded Randomized Placebo-controlled Dose Escalation Study to Examine the Safety Reactogenicity Tolerability & Immunogenicity of the P2-VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers & Infants
Brief Summary: This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study will examine the safety and immunogenicity of this vaccine first in healthy South African toddlers. If the safety profile is deemed appropriate, the study will continue to explore the safety and immunogenicity of the vaccine in healthy South African infants.

The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated in healthy toddlers and infants. The primary immunogenicity hypothesis is that the P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response in at least 80% of participants in at least one of the study groups.


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: Number of Participants With Vaccine Induced Reactions (7 days following each dose); Number of Participants With Serious Adverse Events (within 28 days of a study dose and at any time); Number of Participants Reporting Any Non-Serious Adverse Event (6 mo following first vaccination); Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse. (Baseline to day 84); Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses (Baseline to day 84); Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8]) (Baseline to Day 84)
C: Immunogenicity (7 months)
D: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Prevention of Childhood Obesity: an Active Pregnancy
Brief Summary: The main aim of this study was to examine the effect of a supervised physical exercise program on the prevention of childhood obesity and its impact on the motor development of the offspring.


Options:
A: Urinary incontinence score assessed with ICIQ-SF questionnaire (one year post partum)
B: Urinary Incontinence (Prevalence) (6 months postpartum (end of intervention))
C: Body mass index of the offsprings (0-24 postpartum months); Fetus body composition (0-24 postpartum months); Change from baseline in Maternal gestational weight gain (40-42 weeks of gestation); Changes in Baby motor development (0-24 postpartum months); Recovery time to pre-gestational weight (6-12 postpartum months); Glycemia level of the offsprings (0-24 postpartum months); Postpartum depression (0-12 postpartum months); Change from baseline in Body image satisfaction (up to 36 weeks); Changes from baseline in maternal quality of life (up to 36 weeks); Placenta measurements (At delivery)
D: Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. (week 36-38 of pregnancy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: a Controlled, Randomized Study Evaluating the Immediate Effect of One tDCS Session on Quadriceps Strength in Hemiparetic Patients.
Brief Summary: Previous studies show that one session of tDCS allow to improve muscle strength in hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale stimulation opposite to the cortical representation area of the injured hemisphere and a simultaneous stimulation opposite to the homonyme the cortical representation area of the healthy hemisphere. This approach seems to be the best relevant electrods configuration in order to restore the inter-hemispheric balance.

We hypothesis that one session of tDCS with this electrods configuration allow to improve paretic quadriceps strength in hemiparetic patients after stroke.


Options:
A: Jebsen-Taylor Hand Function Test (Baseline, Treatment days 1,5,10, Follow Up); Motor Activity Log Rating Scale (Baseline, Treatment Days 1,5,10 and Follow Up); Beck Depression Inventory (Baseline, Treatment days 1,5,10 and Follow up); Visual Analogue Scale for Anxiety (Baseline, Treatment days 1,5,10 and Follow Up)
B: Fugl-Meyer Assessment (FMA) (At baseline and immediately after the completion of intervention); Motor Status Scale (MSS) (At baseline and immediately after the completion of intervention); Modified Ashworth Scale (MAS) (At baseline and immediately after the completion of intervention); MyotonPRO (At baseline and immediately after the completion of intervention); Muscle metabolism (NIRS) (At baseline and immediately after the completion of intervention); Box and Block Test (BBT) (At baseline and immediately after the completion of intervention); Revised Nottingham Sensory Assessment (RNSA) (At baseline and immediately after the completion of intervention); Functional Independence Measure (FIM) (At baseline and immediately after the completion of intervention); Motor Activity Log (MAL) (At baseline, immediately after the completion of intervention, at a 6-month follow up); ABILHAND Questionnaire (At baseline, immediately after the completion of intervention, at a 6-month follow up); Adelaide Activities Profile (AAP) (At baseline, immediately after the completion of intervention, at a 6-month follow up); EQ-5D-5L (At baseline and immediately after the completion of intervention); Accelerometers (At baseline, immediately after the completion of intervention, at a 6-month follow-up.); Functional magnetic resonance imaging (fMRI) (At baseline and immediately after the completion of intervention); Kinematic analysis (At baseline and immediately after the completion of intervention); Inflammatory markers (At baseline and immediately after the completion of intervention); Oxidative stress markers (At baseline and immediately after the completion of intervention); Erythrocyte deformability (At baseline and immediately after the completion of intervention); Blood glucose indicators (At baseline and immediately after the completion of intervention)
C: Motor Skill Retention (Day 9)
D: maximum voluntary isometric strength of knee extensors (2 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: a Controlled, Randomized Study Evaluating the Immediate Effect of One tDCS Session on Quadriceps Strength in Hemiparetic Patients.
Brief Summary: Previous studies show that one session of tDCS allow to improve muscle strength in hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale stimulation opposite to the cortical representation area of the injured hemisphere and a simultaneous stimulation opposite to the homonyme the cortical representation area of the healthy hemisphere. This approach seems to be the best relevant electrods configuration in order to restore the inter-hemispheric balance.

We hypothesis that one session of tDCS with this electrods configuration allow to improve paretic quadriceps strength in hemiparetic patients after stroke.


Options:
A: maximum voluntary isometric strength of knee extensors (2 hours)
B: Total score in a neglect test battery (Change from baseline at Day 8 (post-treatment)); Functional independence score (Change from baseline at Day 8 (post-treatment))
C: Functional Independence measured by Barthel Index (Change for functional independence at 4 months)
D: Change of TMS (transcranial magnetic stimulation) measurement of cortical excitability (within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
Brief Summary: The goal of this research study is to better understand current treatment practices for pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient Registry (CFFNPR)can be used for this type of study.


Options:
A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
B: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))
C: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)
D: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
Brief Summary: The goal of this research study is to better understand current treatment practices for pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient Registry (CFFNPR)can be used for this type of study.


Options:
A: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))
B: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)
C: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
D: Time to a Protocol-defined Pulmonary Exacerbation (Over the 18-month study period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
Brief Summary: The goal of this research study is to better understand current treatment practices for pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient Registry (CFFNPR)can be used for this type of study.


Options:
A: Clinically Significant Laboratory Abnormalities. (28 Days)
B: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)
C: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
D: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score (Day 0 to Day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
Brief Summary: The goal of this research study is to better understand current treatment practices for pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient Registry (CFFNPR)can be used for this type of study.


Options:
A: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization (Measured over the 18 month study)
B: to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination. (up to 48 weeks)
C: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)
D: Average actual change in percent predicted forced expiratory volume at 1 second (FEV1) from Day 1 to Day 14 (14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
Brief Summary: The goal of this research study is to better understand current treatment practices for pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient Registry (CFFNPR)can be used for this type of study.


Options:
A: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)
B: Time to an Exacerbation (Baseline to end of study (up to 59 days))
C: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))
D: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
Brief Summary: The goal of this research study is to better understand current treatment practices for pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient Registry (CFFNPR)can be used for this type of study.


Options:
A: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
B: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
C: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))
D: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis to Determine Choice Between Antibiotics Alone vs. Appendectomy
Brief Summary: The purpose of this study is to determine if a patient activation tool (PAT) can improve decision making and patient centered outcomes in pediatric patients with appendicitis and their caregivers choosing between antibiotics alone and appendectomy.


Options:
A: Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching (30 months)
B: Decisional conflict (within 1 week after consult)
C: Decision Self-Efficacy Scale (1 hour following decision); PedsQL 3.0 Healthcare Satisfaction Generic Module (Parent Report) (1 day from enrollment); Disability Days (1 year folow-up)
D: Predicted 10-year CHD risk (4-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Brief Summary: This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.


Options:
A: Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events (6 months)
B: Time to AVF Primary Unassisted Patency (Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year); Kaplan-Meier Estimate of Secondary AVF Patency (Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year)
C: Change to diameter of vein (Initial assessment and 6 weeks after surgery)
D: To assess the safety of a single topical dose of PRT-201. (Day of AVG creation and 4 weeks After surgery.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: DREAM-GLOBAL: Diagnosing hypeRtension - Engaging Action and Management in Getting LOwer Bp in Aboriginal and LMIC - A Research Proposal
Brief Summary: Heart disease and stroke are the number one killers world-wide. When someone has hypertension, the constantly elevated blood pressure damages their blood vessels and the organs that they supply blood to. This causes stroke, heart attack, heart failure, kidney failure and dementia. Finding and lowering high blood pressure to normal with lifestyle changes and if necessary medications, lowers the risk of these outcomes. Canada has high rates of blood pressure control compared to other countries in the world, due in large part to the successful dissemination of hypertension guidelines. However remote and disadvantaged communities have not been as successful and need additional measures to help achieve the same level of blood pressure control as the rest of the country. The DREAM-GLOBAL team has extensive experience working with Canada's Aboriginal Communities and a large community in Tanzania. The DREAM-GLOBAL project will integrate innovations in technology with the implementation of guidelines-based blood pressure control and through partnerships with experts in government and industry, overcome barriers to lowering blood pressure in Canada's Aboriginal Communities, and in a community in Tanzania. Tools will be developed and tested that will close the circle of care around people with hypertension by bringing measurement data to the medical record and health care provider and also sending useful medical feedback to the person with hypertension via secure data servers and routine SMS messaging on cell phones. The system will be tested for effectiveness of diagnosing and also for managing hypertension. To begin the process of preventing hypertension, the team will also explore with an Aboriginal community how to create policies to reduce the sodium content in their food. If proven effective, DREAM-GLOBAL can also become a platform for managing other chronic diseases.


Options:
A: Blood Pressure and Hemaglobin A1c
B: MEMS Adherence (12 months follow up)
C: Medication Adherence (12 months after intervention); Mean Proportion of Days Covered Relative to Usual Care (12 months)
D: Blood Pressure (one year)

Answer: D