TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Lactbacillus GG on Wheeze and Allergic Sensitization in Infants at Risk
Brief Summary: Given that asthma results from a complex interaction between genetic susceptibility and environmental factors and rates of childhood asthma are increasing, primary prevention has to focus on modifiable aspects such as nutrition. There a implications from epidemiology that food supplementation with probiotics given to atopic mothers in pregnancy and during lactation can prevent the development allergies in the offspring. Children with atopic dermatitis are at increased risk (up to 80%) of developing persistent respiratory tract disease. Our trial examined whether probiotics are able to prevent allergic sensitization and allergic asthma when given to 6-24 month old infants at an increased risk of allergies.


Options:
A: Prevalence of atopic disease in infant (two years)
B: episodes of wheezing, drug use (inhalative steroids and betamimetics), hospital treatment (October 2002 - October 2004)
C: The Effects of probiotics in improving life quality and symptomatic severity (2 years)
D: severity of atopic dermatitis (March 2007 - July 2008)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing the Transmission of Influenza by Face Masks
Brief Summary: Pharmaceutical interventions, particularly vaccination, have been the principal public health method of preventing and controlling seasonal influenza. Other less invasive non-pharmaceutical interventions include the use of face masks and hand hygiene. In Asia, masks are used extensively, especially in Japan, but with only circumstantial evidence of efficacy. Although there are numerous studies that support hand hygiene as an effective measure for decreasing transmission of enteric infections, there are fewer data assessing the effect of hand hygiene on respiratory illnesses. Therefore it is proposed that a study be conducted on the use of face masks with and without the use of hand hygiene in comparison to no intervention in residence housing units of the University of Michigan. The interventions will be carried out during a period of influenza transmission that is defined by surveillance conducted at the University Health Service. Data will be collected on use of the interventions and the occurrence of influenza and other illnesses. When illness occurs meeting a case definition, specimens for viral isolation will be collected in all intervention settings. Face masks could theoretically lead to a large reduction in transmission frequency of influenza, especially if most transmission occurs by the airborne (large or small droplet) route. Even a modest reduction could have a major effect during an influenza pandemic.


Options:
A: To compare the overall survival of patients at high risk for developing peritoneal carcinomatosis from colorectal cancer who undergo mandatory second look surgery + HIPEC and CRS (if applicable) vs. similar patients who receive standard of care. (Follow-up will occur every 3 months for two years, every six months for three ye)
B: The number of household contacts who will develop within 7 days of the inclusion of the index patient a respiratory syndrome defined by fever> = 37.8 ° C and a cough or a sore throat. (during the study)
C: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
D: the incidence rates of influenza infection (Until 3 months gargling)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing the Transmission of Influenza by Face Masks
Brief Summary: Pharmaceutical interventions, particularly vaccination, have been the principal public health method of preventing and controlling seasonal influenza. Other less invasive non-pharmaceutical interventions include the use of face masks and hand hygiene. In Asia, masks are used extensively, especially in Japan, but with only circumstantial evidence of efficacy. Although there are numerous studies that support hand hygiene as an effective measure for decreasing transmission of enteric infections, there are fewer data assessing the effect of hand hygiene on respiratory illnesses. Therefore it is proposed that a study be conducted on the use of face masks with and without the use of hand hygiene in comparison to no intervention in residence housing units of the University of Michigan. The interventions will be carried out during a period of influenza transmission that is defined by surveillance conducted at the University Health Service. Data will be collected on use of the interventions and the occurrence of influenza and other illnesses. When illness occurs meeting a case definition, specimens for viral isolation will be collected in all intervention settings. Face masks could theoretically lead to a large reduction in transmission frequency of influenza, especially if most transmission occurs by the airborne (large or small droplet) route. Even a modest reduction could have a major effect during an influenza pandemic.


Options:
A: Secondary infection with influenza of the household members who are healthy at the start of the study
B: Reduction of rhinovirus-induced common colds. (9 weeks)
C: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
D: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (At the end of the entire study period (16 months)); Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm (At the end of the study period (16 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing the Transmission of Influenza by Face Masks
Brief Summary: Pharmaceutical interventions, particularly vaccination, have been the principal public health method of preventing and controlling seasonal influenza. Other less invasive non-pharmaceutical interventions include the use of face masks and hand hygiene. In Asia, masks are used extensively, especially in Japan, but with only circumstantial evidence of efficacy. Although there are numerous studies that support hand hygiene as an effective measure for decreasing transmission of enteric infections, there are fewer data assessing the effect of hand hygiene on respiratory illnesses. Therefore it is proposed that a study be conducted on the use of face masks with and without the use of hand hygiene in comparison to no intervention in residence housing units of the University of Michigan. The interventions will be carried out during a period of influenza transmission that is defined by surveillance conducted at the University Health Service. Data will be collected on use of the interventions and the occurrence of influenza and other illnesses. When illness occurs meeting a case definition, specimens for viral isolation will be collected in all intervention settings. Face masks could theoretically lead to a large reduction in transmission frequency of influenza, especially if most transmission occurs by the airborne (large or small droplet) route. Even a modest reduction could have a major effect during an influenza pandemic.


Options:
A: Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events (60 weeks)
B: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
C: Physical health symptoms (1 day); Lack of physical health symptoms (1 day)
D: To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh (17 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing the Transmission of Influenza by Face Masks
Brief Summary: Pharmaceutical interventions, particularly vaccination, have been the principal public health method of preventing and controlling seasonal influenza. Other less invasive non-pharmaceutical interventions include the use of face masks and hand hygiene. In Asia, masks are used extensively, especially in Japan, but with only circumstantial evidence of efficacy. Although there are numerous studies that support hand hygiene as an effective measure for decreasing transmission of enteric infections, there are fewer data assessing the effect of hand hygiene on respiratory illnesses. Therefore it is proposed that a study be conducted on the use of face masks with and without the use of hand hygiene in comparison to no intervention in residence housing units of the University of Michigan. The interventions will be carried out during a period of influenza transmission that is defined by surveillance conducted at the University Health Service. Data will be collected on use of the interventions and the occurrence of influenza and other illnesses. When illness occurs meeting a case definition, specimens for viral isolation will be collected in all intervention settings. Face masks could theoretically lead to a large reduction in transmission frequency of influenza, especially if most transmission occurs by the airborne (large or small droplet) route. Even a modest reduction could have a major effect during an influenza pandemic.


Options:
A: Laboratory-confirmed Influenza Infection (one year)
B: Absenteeism rate due to gastrointestinal or respiratory illness during the study period. (8 weeks)
C: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
D: To compare the overall survival of patients at high risk for developing peritoneal carcinomatosis from colorectal cancer who undergo mandatory second look surgery + HIPEC and CRS (if applicable) vs. similar patients who receive standard of care. (Follow-up will occur every 3 months for two years, every six months for three ye)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing the Transmission of Influenza by Face Masks
Brief Summary: Pharmaceutical interventions, particularly vaccination, have been the principal public health method of preventing and controlling seasonal influenza. Other less invasive non-pharmaceutical interventions include the use of face masks and hand hygiene. In Asia, masks are used extensively, especially in Japan, but with only circumstantial evidence of efficacy. Although there are numerous studies that support hand hygiene as an effective measure for decreasing transmission of enteric infections, there are fewer data assessing the effect of hand hygiene on respiratory illnesses. Therefore it is proposed that a study be conducted on the use of face masks with and without the use of hand hygiene in comparison to no intervention in residence housing units of the University of Michigan. The interventions will be carried out during a period of influenza transmission that is defined by surveillance conducted at the University Health Service. Data will be collected on use of the interventions and the occurrence of influenza and other illnesses. When illness occurs meeting a case definition, specimens for viral isolation will be collected in all intervention settings. Face masks could theoretically lead to a large reduction in transmission frequency of influenza, especially if most transmission occurs by the airborne (large or small droplet) route. Even a modest reduction could have a major effect during an influenza pandemic.


Options:
A: the episodes due to respiratory tract infections (8 moth); The episodes due to gastroenteritis (8 month)
B: Symptomatic SARS-CoV2 infection (12 weeks)
C: The number of household contacts who will develop within 7 days of the inclusion of the index patient a respiratory syndrome defined by fever> = 37.8 ° C and a cough or a sore throat. (during the study)
D: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing the Transmission of Influenza by Face Masks
Brief Summary: Pharmaceutical interventions, particularly vaccination, have been the principal public health method of preventing and controlling seasonal influenza. Other less invasive non-pharmaceutical interventions include the use of face masks and hand hygiene. In Asia, masks are used extensively, especially in Japan, but with only circumstantial evidence of efficacy. Although there are numerous studies that support hand hygiene as an effective measure for decreasing transmission of enteric infections, there are fewer data assessing the effect of hand hygiene on respiratory illnesses. Therefore it is proposed that a study be conducted on the use of face masks with and without the use of hand hygiene in comparison to no intervention in residence housing units of the University of Michigan. The interventions will be carried out during a period of influenza transmission that is defined by surveillance conducted at the University Health Service. Data will be collected on use of the interventions and the occurrence of influenza and other illnesses. When illness occurs meeting a case definition, specimens for viral isolation will be collected in all intervention settings. Face masks could theoretically lead to a large reduction in transmission frequency of influenza, especially if most transmission occurs by the airborne (large or small droplet) route. Even a modest reduction could have a major effect during an influenza pandemic.


Options:
A: Frequency of vaccine-related reaction events and other adverse events in each cohort (Throughout study); Amount of vaccine virus shed by each participant (Throughout study); Amount of serum antibody and mucosal antibody induced by the vaccine in each participant (Throughout study)
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: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
D: Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains (28 days after vaccination (Day 29)); Post-dose 1: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic Adverse Events (AEs) (Up to 7 days post-dose 1 on Day 1 (Day 8)); Post-dose 2: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic AEs (Up to 7 days post-dose 2 on Day 29 (Day 36)); Post-dose 1: Percentage of Participants With Unsolicited AEs (Up to 28 days post-dose 1 on Day 1 (Day 29)); Post-dose 2: Percentage of Participants With Unsolicited AEs (Up to 28 days post-dose 2 on Day 29 (Day 57)); Post-dose 1: Percentage of Participants With Serious Adverse Events (SAEs) (Up to 6 months post-dose 1 (Day 183)); Post-dose 2: Percentage of Participants With SAEs (Up to 6 months post-dose 2 (Day 211))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of the Efficacy and Safety of Sirolimus(Rapamycin)Therapy for Renal Angiomyolipmoas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis
Brief Summary: The purpose of this study is to determine the safety and efficacy of the mTOR inhibitor sirolimus as a treatment for renal angiomyolipomas in patients with tyberous sclerosis complex or sporadic lymphangioleiomyomatosis.


Options:
A: Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response (End of core period (Week 48), and end of extension period (up to 4 years))
B: List Learning test (from the BIRT Memory and Information Processing Battery) (6 months); Complex Figure test (from the BIRT Memory and Information Processing Battery) (6 months); CANTAB - Stockings of Cambridge (SOC) (6 months); CANTAB - Spatial Working Memory (SWM) (6 months); Telephone search dual task (from the Test of Everyday Attention) (6 months)
C: Change From Baseline in the Facial Angiofibroma Grading Scale (AGS) Score (baseline, 6 months)
D: longest diameter of renal angiomyolipomas assessed by MRI scan, toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (assessments at baseline and 2,6,12 and 24 months); toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events (throughout study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of the Efficacy and Safety of Sirolimus(Rapamycin)Therapy for Renal Angiomyolipmoas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis
Brief Summary: The purpose of this study is to determine the safety and efficacy of the mTOR inhibitor sirolimus as a treatment for renal angiomyolipomas in patients with tyberous sclerosis complex or sporadic lymphangioleiomyomatosis.


Options:
A: longest diameter of renal angiomyolipomas assessed by MRI scan, toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (assessments at baseline and 2,6,12 and 24 months); toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events (throughout study)
B: Number With Observed Adverse Side Effects (During the entire study)
C: Objective Response Rate (On treatment, patients were evaluated radiologically for response to therapy up to 52 weeks.)
D: Volume of Angiomyolipomata

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intranasal Oxytocin in the Treatment of Autism
Brief Summary: The purpose of this study is to learn whether or not the drug called oxytocin is helpful in improving mood and social functioning in adults with autism.


Options:
A: N/A
B: Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least Mean Squares Double-blind phase: change from baseline to week 24); Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least mean squares for Open Label: Change between weeks 24-48)
C: Clinical Global Impressions Scale - Improvement - Social (6 Weeks); Repetitive Behavior Scale - Revised (6 Weeks); Diagnostic Analysis of Nonverbal Accuracy, Paralanguage Test (6 Weeks)
D: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6 (Baseline to 6 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Hydrocortisone on Humoral and Cellular Immunologic Markers in High Risk Patients After Cardiac Surgery
Brief Summary: Hydrocortisone has been shown to improve the early outcome of high risk patients after cardiac surgery. A potential mechanism resulting in this effect may be its immunomodulatory action. In this prospective interventional study this hypothesis is to be proven.


Options:
A: Incidence of Low Cardiac Output Syndrome (LCOS) (first 48 hours after cardiac intensive care unit (CICU) admission post-op)
B: Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome (Until hospital discharge, up to 4 months)
C: Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery. (36 hours)
D: immunologic markers, health care related quality of life, PTSD (one and a half year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center, Randomized, Double-blind, Placebo-controlled With Open Label run-in Study Assessing Efficacy, Tolerability, Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects With Moderate to Severe, Chronic Low Back Pain
Brief Summary: The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.


Options:
A: The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.
B: Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase. (Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.)
C: Change in pain intensity from baseline (pre-randomization) to last assessment.
D: Change From Baseline to Week 12 in Mean Pain Intensity (Baseline, Week 12 (or final visit))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction
Brief Summary: Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion criteria computerized randomization is performed to either PCI plus intraaortic balloon pump (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration.

The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be 30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.


Options:
A: 30-day mortality (30 day)
B: Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms. (At 5 days)
C: B-type natriuretic peptide (7 days)
D: APACHE II SCORE (4 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction
Brief Summary: Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion criteria computerized randomization is performed to either PCI plus intraaortic balloon pump (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration.

The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be 30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.


Options:
A: APACHE II SCORE (4 days)
B: 30-day mortality (30 day)
C: death, myocardial infarction or refractory (up to and including Day 9); major bleeding (Up to Day 9)
D: Cardiac index (within 1 hour after device implantation)

Answer: B