TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Double-blind, Placebo-controlled, Multiple Intravenous, Ascending-Dose Study of CNTO 136 to Evaluate Safety and Pharmacokinetics in Subjects With Cutaneous Lupus Erythematosus and to Evaluate Safety and Pharmacokinetics in a Cohort of Subjects With Systemic Lupus Erythematosus
Brief Summary: The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the action of a drug in the body over a period of time) of multiple intravenous (IV) administrations of CNTO 136 in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). The secondary goal of this study was to assess the pharmacodynamics (biochemical and physiological effects of a drug and the mechanisms of action), immune response, and clinical response.


Options:
A: Safety and tolerability of MEDI-545 will be assessed primarily by summarizing adverse events. (Day 84)
B: SLE response (Various timepoints through Week 52)
C: Number of participants with adverse events (Up to 26 weeks); Pharmacokinetic profile of CNTO 136 (Up to 22 weeks); Physical examinations (Up to 26 weeks); Electrocardiograms (ECGs) (Up to 26 weeks); Sitting blood pressure (Up to 26 weeks); Heart rate (Up to 26 weeks); Respiration rate (Up to 26 weeks); Oral temperature (Up to 26 weeks); Hemoglobin (Up to 26 weeks); Hematocrit (Up to 26 weeks); Platelets and total white blood cells (WBC) (Up to 26 weeks); Albumin and total protein (Up to 26 weeks); Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) (Up to 26 weeks); Blood urea nitrogen (BUN), calcium, creatinine, and total bilirubin (Up to 26 weeks); Chloride, potassium, and sodium (Up to 26 weeks); Bicarbonate (Up to 26 weeks); Creatine kinase (Up to 26 weeks); Gamma-glutamyl-transferase (Up to 26 weeks); Glucose (Up to 26 weeks); Lymphocytes and neutrophils (Up to 26 weeks); Inorganic phosphate (Up to 26 weeks); Fasting Lipid Panel (Up to 8 weeks)
D: A change in CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) activity score (from baseline (at visit 2) to 16 weeks treatment (at visit 6))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers - Randomized, Double Blind, Placebo Controlled Study
Brief Summary: Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common infections (gastrointestinal and respiratory) in healthy children who attend day care centre

This study is a prospective, randomized, double blind, placebo- controlled parallel study in healthy children attending day care centers.

The study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections and absence from day care due to infections.

The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is an identical product except for the absence of probiotics.

The study includes 3 months (90 days) of intervention period. The study product will be consumed daily in the evening together with a meal.

The consumption of the study products will be taken under the surveillance of the parents.

During the entire intervention period the subjects are not allowed to consume any probiotic products other than the study products supplied to them by the study personnel.

Data on infections will be recorded in a diary, filled in and administered by the parents and diary recorded by referring physician (on-call log).

All infections are to be diagnosed by the local physician. The incidence of infections will be analyzed based on the information recorded in the diaries (parent's \& physician's).


Options:
A: Common infections
B: average weight gain (4 months)
C: Common infections in children
D: Incidence of infectious diseases

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers - Randomized, Double Blind, Placebo Controlled Study
Brief Summary: Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common infections (gastrointestinal and respiratory) in healthy children who attend day care centre

This study is a prospective, randomized, double blind, placebo- controlled parallel study in healthy children attending day care centers.

The study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections and absence from day care due to infections.

The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is an identical product except for the absence of probiotics.

The study includes 3 months (90 days) of intervention period. The study product will be consumed daily in the evening together with a meal.

The consumption of the study products will be taken under the surveillance of the parents.

During the entire intervention period the subjects are not allowed to consume any probiotic products other than the study products supplied to them by the study personnel.

Data on infections will be recorded in a diary, filled in and administered by the parents and diary recorded by referring physician (on-call log).

All infections are to be diagnosed by the local physician. The incidence of infections will be analyzed based on the information recorded in the diaries (parent's \& physician's).


Options:
A: The Number (Rate) of Patients With Acute Respiratory Infections (first 28 days of life)
B: Common infections
C: Natural killer cell activity (At baseline); Natural killer cell activity (At 12-week follow-up); Change from baseline natural killer cell activity at 12-week (At baseline and 12-week follow-up)
D: The mean number of episodes and duration of acute diarrheal disease (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be defined as infections which develop more than 48 hours after admission and they are not present or incubating on admission

This study is a prospective, randomized, double blind, placebo- controlled parallel study in children hospitalized at Children's hospital Zagreb.

The study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections.

The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) probiotic per serving.

The placebo product is an identical product except for the absence of probiotics.

The study includes an intervention period lasting the length of the hospital stay.

The study product will be consumed daily in the morning together with breakfast.

The consumption of the study products will be taken under the surveillance of the physician.

Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of infections will be analyzed based on the information recorded in the CRF.


Options:
A: N/A
B: Common infections in children
C: N/A
D: average weight gain (4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be defined as infections which develop more than 48 hours after admission and they are not present or incubating on admission

This study is a prospective, randomized, double blind, placebo- controlled parallel study in children hospitalized at Children's hospital Zagreb.

The study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections.

The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) probiotic per serving.

The placebo product is an identical product except for the absence of probiotics.

The study includes an intervention period lasting the length of the hospital stay.

The study product will be consumed daily in the morning together with breakfast.

The consumption of the study products will be taken under the surveillance of the physician.

Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of infections will be analyzed based on the information recorded in the CRF.


Options:
A: Acute respiratory infections and diarrheal disease (28 weeks)
B: To examine if the consumption of two different probiotic strains added to milk at the point of consumption could reduce the "flu-like" symptoms and other symptoms of illness of preschool-age children in day care centers. (Daily for six months)
C: The mean number of episodes and duration of acute diarrheal disease (24 weeks)
D: Common infections in children

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion of Prematures (TOP) Trial: Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy?
Brief Summary: The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized assessments by Bayley.


Options:
A: Occurrence of a composite endpoint (90 days)
B: Quality of Life (QOL)/Function based on the FACT-BMT scale (3 years)
C: Death or Neurodevelopmental Impairment (Birth to 22-26 months corrected age); Death (Birth to 22-26 months corrected age); Neurodevelopmental Impairment (at 22-26 months corrected age); Cognitive Delay (at 22-26 months corrected age); Moderate or Severe Cerebral Palsy (at 22-26 months corrected age); Severe Vision Impairment (at 22-26 months corrected age); Severe Hearing Impairment (at 22-26 months corrected age)
D: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion of Prematures (TOP) Trial: Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy?
Brief Summary: The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized assessments by Bayley.


Options:
A: Absolute hemoglobin concentration (24 hours of life); Percent change in hemoglobin concentration from baseline (24 hours of life)
B: Bayley III Composite Cognitive Score (22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlier)
C: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)
D: Death or Neurodevelopmental Impairment (Birth to 22-26 months corrected age); Death (Birth to 22-26 months corrected age); Neurodevelopmental Impairment (at 22-26 months corrected age); Cognitive Delay (at 22-26 months corrected age); Moderate or Severe Cerebral Palsy (at 22-26 months corrected age); Severe Vision Impairment (at 22-26 months corrected age); Severe Hearing Impairment (at 22-26 months corrected age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment With MK-3102 in Subjects With Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to evaluate the cardiovascular (CV) safety profile of omarigliptin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with omarigliptin 25 mg once weekly is non-inferior to treatment with placebo and active comparators across the omarigliptin program with regard to the risk of developing a confirmed event in the primary CV composite endpoint.


Options:
A: Change in Left ventricular function from visit 1 to week 24, measured by Ecco (24 weeks)
B: Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke (Up to approximately 8 years)
C: Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) (From randomisation until completion of the planned treatment period, up to 1040 days.)
D: Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina) (Up to 156 weeks); Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) (Up to 179 weeks); Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) (Up to 179 weeks); Change From Baseline in Hemoglobin A1C (A1C) at Week 18 (Baseline and Week 18); Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin) (Baseline and Week 18); Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change (Up to Week 18); Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change (Up to Week 18)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Brief Summary: There has been an alarming increase in the incidence and severity of Clostridium difficile infection (CDI) in North America over the past decade. Relapsing infection is a common problem in patients treated for CDI, often requiring prolonged and expensive courses of oral vancomycin with limited alternative treatment options. This study will determine if fecal microbiota transplantation, which involves administering fecal flora from a healthy stool donor to a patient with relapsing CDI, is an effective and safe treatment.


Options:
A: Cure of C. difficile infection (8 weeks)
B: Change in subjective symptom score (at 0 and 3 months)
C: Clinical Cure (8 weeks)
D: Safety (up to 6 mo post FMT)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Brief Summary: There has been an alarming increase in the incidence and severity of Clostridium difficile infection (CDI) in North America over the past decade. Relapsing infection is a common problem in patients treated for CDI, often requiring prolonged and expensive courses of oral vancomycin with limited alternative treatment options. This study will determine if fecal microbiota transplantation, which involves administering fecal flora from a healthy stool donor to a patient with relapsing CDI, is an effective and safe treatment.


Options:
A: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
B: diversity and steady state of the stool (6 months)
C: Safety (up to 6 mo post FMT)
D: Clinical Cure (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Brief Summary: There has been an alarming increase in the incidence and severity of Clostridium difficile infection (CDI) in North America over the past decade. Relapsing infection is a common problem in patients treated for CDI, often requiring prolonged and expensive courses of oral vancomycin with limited alternative treatment options. This study will determine if fecal microbiota transplantation, which involves administering fecal flora from a healthy stool donor to a patient with relapsing CDI, is an effective and safe treatment.


Options:
A: clinical remission (12 weeks)
B: The primary outcome of the randomized trial is remission of UC defined as a Mayo score < 3 with an endoscopic Mayo score = 0 at the end of the trial Transplant Therapy in Ulcerative Colitis (9 weeks)
C: Clinical Cure (8 weeks)
D: Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Kenya: A Cluster Randomized Controlled Trial of the Benefits of Sanitation, Water Quality, Handwashing, and Nutrition Interventions on Child Health and Development
Brief Summary: The purpose of this study is to measure the independent and combined effects of interventions that improve sanitation, water quality, handwashing, and nutrition on child health and development in the first years of life.


Options:
A: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
B: Validation of the performance of FECPAKG2 to assess drug efficacy (up to 12 months); In depth evaluation of the FECPAKG2 technique to assess drug efficacy (up to 12 months); Validation of b-tubulin gene as a molecular marker for benzimidazole resistance (up to 24 months)
C: Mean (± standard deviation) weight gain (kg) (from 12 to 24 months of age)
D: CD4 count (every 6 months for 24 months (enrollment and months 6, 12, 18, and 24 )); HIV-1 RNA level (enrollment, 12, and 24 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Kenya: A Cluster Randomized Controlled Trial of the Benefits of Sanitation, Water Quality, Handwashing, and Nutrition Interventions on Child Health and Development
Brief Summary: The purpose of this study is to measure the independent and combined effects of interventions that improve sanitation, water quality, handwashing, and nutrition on child health and development in the first years of life.


Options:
A: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
B: 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))
C: Direct observation of hand washing prior to eating a snack (8 weeks)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Kenya: A Cluster Randomized Controlled Trial of the Benefits of Sanitation, Water Quality, Handwashing, and Nutrition Interventions on Child Health and Development
Brief Summary: The purpose of this study is to measure the independent and combined effects of interventions that improve sanitation, water quality, handwashing, and nutrition on child health and development in the first years of life.


Options:
A: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
B: Diarrhea prevalence of children under five years old (Measured 24 months after the baseline survey (12 months after intervention complete))
C: Infant length at 18 months (18 months of age. Protocol and Statistical Analysis Plan are available at https://osf.io/w93hy.); Infant hemoglobin at 18 months (18 months)
D: Diarrhoea (<5s) (21 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Kenya: A Cluster Randomized Controlled Trial of the Benefits of Sanitation, Water Quality, Handwashing, and Nutrition Interventions on Child Health and Development
Brief Summary: The purpose of this study is to measure the independent and combined effects of interventions that improve sanitation, water quality, handwashing, and nutrition on child health and development in the first years of life.


Options:
A: Reported diarrhoea in children <5 years (7-day recall, assessed 4 times during 3-month follow-up rounds)
B: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
C: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
D: Combined prevalence of bacterial and protozoan enteric infections (12 month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Kenya: A Cluster Randomized Controlled Trial of the Benefits of Sanitation, Water Quality, Handwashing, and Nutrition Interventions on Child Health and Development
Brief Summary: The purpose of this study is to measure the independent and combined effects of interventions that improve sanitation, water quality, handwashing, and nutrition on child health and development in the first years of life.


Options:
A: Duration of diarrhea (within the first 72 hours during hospitalization)
B: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
C: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
D: Diarrhoea (<5s) (21 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Kenya: A Cluster Randomized Controlled Trial of the Benefits of Sanitation, Water Quality, Handwashing, and Nutrition Interventions on Child Health and Development
Brief Summary: The purpose of this study is to measure the independent and combined effects of interventions that improve sanitation, water quality, handwashing, and nutrition on child health and development in the first years of life.


Options:
A: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
B: Diarrhea in Children Under 5 (one year after the intervention)
C: Post neonatal under-five all cause mortality (1 year)
D: Incidence of Diarrhea (2 weeks)

Answer: A