TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: McFlu2 COLD3 Prevention: A Randomized, Placebo-controlled, Double Blind Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections in McMaster University Students
Brief Summary: The specific objectives of this investigation are to assess the effectiveness of daily gargling and vitamin D supplementation as preventative measures against incident upper respiratory tract infection (URTI) in students attending McMaster University. Investigators hypothesize that

1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.


Options:
A: The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: (1 month); The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: (1 month); The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: (1 month)
B: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
C: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)
D: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: McFlu2 COLD3 Prevention: A Randomized, Placebo-controlled, Double Blind Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections in McMaster University Students
Brief Summary: The specific objectives of this investigation are to assess the effectiveness of daily gargling and vitamin D supplementation as preventative measures against incident upper respiratory tract infection (URTI) in students attending McMaster University. Investigators hypothesize that

1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.


Options:
A: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
B: Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes (every month)
C: RT-PCR confirmed COVID-19 infection (10 weeks)
D: the incidence rates of influenza infection (Until 3 months gargling)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: McFlu2 COLD3 Prevention: A Randomized, Placebo-controlled, Double Blind Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections in McMaster University Students
Brief Summary: The specific objectives of this investigation are to assess the effectiveness of daily gargling and vitamin D supplementation as preventative measures against incident upper respiratory tract infection (URTI) in students attending McMaster University. Investigators hypothesize that

1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.


Options:
A: Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1 (Day 14 after dosing through end of surveillance period (approximately 7 months))
B: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
C: Reduction of rhinovirus-induced common colds. (9 weeks)
D: Safety and tolerability assessed through diaries for local and systemic tolerability and with follow up for occurrence of any adverse event (7 days post each dose / 57 days post prime)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Intensive Treatment Regimens and Standard Treatment Regimen for Tuberculous Meningitis: Pharmacokinetics, Pharmacodynamics and Tolerability Study
Brief Summary: Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, and is diagnosed in approximately 5-10% of TB patients. The incidence of TBM has increased considerably during the last decade, partly due to the HIV epidemic. Without treatment, virtually all patients with TB meningitis will die. With the current treatment regimens, TBM is fatal in approximately 30-50% of cases, and responsible for severe disability in a similar proportion of survivors.

Worldwide, Indonesia the third highest case load of tuberculosis with an estimated 500,000 new patients / year. Representative data are lacking, but it is clear that TBM is a growing problem. For instance, in Hasan Sadikin Hospital, the top-referral hospital for West Java Province (population 40 million), Indonesia, 40-50 cases of TBM were treated yearly in the late 90's compared to approximately 100 in recent years.

There is very little evidence for the current treatment regimen for TBM, which dates back to the late 60's. Therefore, there is an urgent need to evaluate intensified treatment of TBM in randomized trials. We hypothesize that higher dose rifampicin, moxifloxacin (possibly also at high dose), or both will improve outcome of TBM. To determine the experimental regimen(s) which should be compared with current regimen in phase 3 trials, we want to evaluate pharmacokinetic aspects and toxicity of candidate regimens in a phase 2 clinical trial in 60 patients with TBM in Indonesia.


Options:
A: Rifampicin and Moxifloxacin concentration in plasma and CSF (Plasma drug concentration samplings at 0, 1, 2, 4, 6 and 24h post dose (6 time points). CSF samples at 2 time points.)
B: The Time to Sputum Culture Conversion at Week 8 (Stage 1) (Week 8, Stage 1); The Time to Sputum Culture Conversion at Week 24 (Stage 2) (Week 24, Stage 2)
C: • To compare the culture-conversion rate at the end of the intensive phase of therapy of the moxifloxacin regimen vs. that of the isoniazid regimen (8 weeks)
D: Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14). (14 consecutive days of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Omega-3 Intake During Pregnancy on Maternal Stress and Infant Outcome
Brief Summary: This will be the first study of the effect of essential fatty acid supplementation in pregnant women living in inner-city poverty on the stress response system during pregnancy. The investigators proposed that essential fatty acid supplementation will be associated with reductions in the experience of stress, more modulated hormonal response to stress, and more optimal regulation of emotion and attention in the infant, even within the context inner-city poverty.


Options:
A: Occurrence of Early Preterm Birth (<34 weeks gestation) (Baseline to 34 Weeks); Occurrence of Early Preterm Birth (<34 weeks gestation) (Baseline to 34 weeks); Maternal and infant adverse and serious adverse events (Enrollment to 30 days past last birth)
B: Maternal Cortisol Levels (Baseline (pre-stressor)); Maternal Cortisol Levels (20 minutes post-stressor); Maternal Cortisol Levels (45 minutes post stressor); Infant Cortisol Levels (4 months post-partum); Infant Cortisol Levels (4 months post-partum); Infant Cortisol Levels (4 months post-partum)
C: Decreased inflammation during human pregnancy (enrollment (8-16 weeks) to delivery)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Health Information Technology to Improve Healthcare Quality in Primary Care Practices and in Transitions Between Care Settings
Brief Summary: This study will test the effectiveness of clinician-focused health IT-based decision support, family-focused health IT-based decision support, and a combination of both efforts, in increasing HPV and other adolescent vaccine rates among adolescent girls. We hypothesize that a combination of clinician-focused clinical decision support and family-focused decision support will be most effective.


Options:
A: Referral Rates to Local Hospitals (Month 7, Month 12); Number of Neonatal Deaths (Month 12)
B: Rate of HPV vaccination among girls actively cared for at participating sites (Monthly, up to 1 year)
C: The outcome measure will be rate of patients falls per 1000 patient days (1/2009-6/2009)
D: Quality of otitis media care. (18 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III, Open-Label, Multicenter, Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Neonates Ages ≥28 Weeks to ≤44 Weeks Gestational Age
Brief Summary: The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).


Options:
A: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)
B: Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion (During study drug administration (6 to 24 hours))
C: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required (RASS score will be assessed approximately 2 hourly during the treatment period and during the 48-hour follow-up period); Duration of mechanical ventilation the number of days the patient receives mechanical ventilation will be recorded (This variable will be dependent on the individual patient and the number of days they require mechanical ventilation .)
D: Percent of Subjects Requiring Rescue Midazolam for Sedation (During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness Based Relapse Prevention: Efficacy and Mechanisms
Brief Summary: The broad, long-term objective of the proposed randomized clinical trial is to evaluate the efficacy, moderators and mechanisms of change of two cognitive-behavioral aftercare treatments for alcohol and other drug (AOD) use disorders in preventing AOD relapse compared to treatment as usual (TAU) offered in the community. The two cognitive-behavioral aftercare treatments are relapse prevention (RP) and Mindfulness-Based Relapse Prevention (MBRP), which integrates mindfulness meditation and RP aftercare components.


Options:
A: Change in number of alcohol use days from baseline to 6 months (Baseline, 1, 3, and 6 months)
B: Proportion Days Abstinent (PDA) (Every 3 months out to 2 years)
C: Drug abstinence
D: Mean Number of Alcohol and Drug Use Days Out of Past 30 (30 days previous, assessed at 12-month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness Based Relapse Prevention: Efficacy and Mechanisms
Brief Summary: The broad, long-term objective of the proposed randomized clinical trial is to evaluate the efficacy, moderators and mechanisms of change of two cognitive-behavioral aftercare treatments for alcohol and other drug (AOD) use disorders in preventing AOD relapse compared to treatment as usual (TAU) offered in the community. The two cognitive-behavioral aftercare treatments are relapse prevention (RP) and Mindfulness-Based Relapse Prevention (MBRP), which integrates mindfulness meditation and RP aftercare components.


Options:
A: Mean Number of Alcohol and Drug Use Days Out of Past 30 (30 days previous, assessed at 12-month follow-up)
B: Change in pain symptoms (Change from baseline through study completion (9 months post-treatment)); Change in aberrant drug-related behaviors (Change from baseline through study completion (9 months post-treatment))
C: Addiction Severity Index (ASI) - Alcohol (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Addiction Severity Index (ASI) - Drugs (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Change on Urine Drug Test (change) (Baseline, 2 months, 4 months, 6 months, 12 months)
D: Smoking Abstinence (2 weeks post quit day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Observational Study Evaluating Efficacy and Costs of Secondary Prophylaxis vs On-demand Therapy With Kogenate Bayer in Patients With Severe Haemophilia A. POTTER
Brief Summary: The project is a controlled observational, multicenter, prospective data collection on secondary prophylaxis with Kogenate Bayer in adolescents and adults with severe haemophilia A (FVIII \< 1%).

The observational period will cover at least 5 years per patient.

The long-term secondary prophylaxis group will be compared versus on-demand treatment group by the assessment of orthopedic status progression and pharmacoeconomics evaluation.


Options:
A: Evaluate the efficacy, safety and pharmacoeconomic of long-term secondary prophylaxis with Kogenate Bayer in comparison to on-demand treatment with Kogenate Bayer in terms of joint bleeding episodes per year (Every 6 months)
B: The Number of Bleeding Episodes (During at least 24 weeks from treatment onset (week 0))
C: Occurrence of FVIII Inhibitor Development (Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26)
D: Number of adverse events (AEs) (From first trial drug administration (day 1) to 11 weeks after the first trial product administration)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double-dummy, Placebo Controlled (With Rescue Medication), Multicenter Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.
Brief Summary: A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.


Options:
A: Total Number of Asthma Exacerbations (52 Weeks)
B: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF (Baseline to Endpoint (12 weeks)); Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F (26-week Treatment Period)
C: Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period (Baseline and Week 24)
D: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double-dummy, Placebo Controlled (With Rescue Medication), Multicenter Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.
Brief Summary: A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.


Options:
A: Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period (Baseline and Week 24)
B: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
C: Peak expiratory flow (PEF) (28 days)
D: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The study purpose is to evaluate the effect of a small group discussion based intervention on physician well-being, job satisfaction, and professionalism. Participants will be put in one of 3 groups by chance (as in the flip of a coin). A computerized selection process will be used to assign participants to the study groups. There is a 1 in 3 chance of being assigned at random to either of the 3 groups.

The first study group will meet once every two weeks for 9 months (from September 2010 through June 2011) from 12:30 pm until 2:00 pm. These meetings will be small group discussion sessions with groups of no more than 15 participants. Lunch will be provided for the first 30 minutes, and group discussion during the next 1 hour will be guided by the session facilitator around such topics as work-life balance, meaning in work, medical mistakes, spirituality, and unmet patient needs. However, the discussions will be open forums, and the groups themselves will help decide on topics relevant to the group. The 1 hour of protected non-clinical time every other week required for this group will be funded by the study.

The second study group will also have 1 hour of protected non-clinical time provided every other week for the same 9 months. This study group will not participate in small group discussions, but may use the protected time for professional tasks as they wish.

Participants in the third study group will continue with their current work practices, but will be provided with protected time to complete study surveys. If group sizes are too small after recruitment to allow a complete study of all three groups, the third study group will be removed and participants will be randomly assigned to one of the first two study groups only.

Participants in all groups will be asked to complete a quarterly survey on well-being, job satisfaction, and professionalism. Follow-up surveys will also be administered 3 months and 1 year after the conclusion of the small group sessions. Each survey is expected to take approximately 20-30 minutes to complete.


Options:
A: level of depression (Baseline to 3 months)
B: Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up. (It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.)
C: Professional identity (We will measure the score of professional identity before intervention and immediately after intervention.); Career self-efficacy (We will measure the score of career self-efficacy before intervention and immediately after intervention.)
D: Physician burnout (September 2010 - June 2012)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The study purpose is to evaluate the effect of a small group discussion based intervention on physician well-being, job satisfaction, and professionalism. Participants will be put in one of 3 groups by chance (as in the flip of a coin). A computerized selection process will be used to assign participants to the study groups. There is a 1 in 3 chance of being assigned at random to either of the 3 groups.

The first study group will meet once every two weeks for 9 months (from September 2010 through June 2011) from 12:30 pm until 2:00 pm. These meetings will be small group discussion sessions with groups of no more than 15 participants. Lunch will be provided for the first 30 minutes, and group discussion during the next 1 hour will be guided by the session facilitator around such topics as work-life balance, meaning in work, medical mistakes, spirituality, and unmet patient needs. However, the discussions will be open forums, and the groups themselves will help decide on topics relevant to the group. The 1 hour of protected non-clinical time every other week required for this group will be funded by the study.

The second study group will also have 1 hour of protected non-clinical time provided every other week for the same 9 months. This study group will not participate in small group discussions, but may use the protected time for professional tasks as they wish.

Participants in the third study group will continue with their current work practices, but will be provided with protected time to complete study surveys. If group sizes are too small after recruitment to allow a complete study of all three groups, the third study group will be removed and participants will be randomly assigned to one of the first two study groups only.

Participants in all groups will be asked to complete a quarterly survey on well-being, job satisfaction, and professionalism. Follow-up surveys will also be administered 3 months and 1 year after the conclusion of the small group sessions. Each survey is expected to take approximately 20-30 minutes to complete.


Options:
A: Presence of job stain evaluated by the French version of the Karasek scale (6 months)
B: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (Baseline and after 4, 8 weeks later)
C: Physician burnout (September 2010 - June 2012)
D: ICU length of stay (Up to 32 weeks)

Answer: C