TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study
Brief Summary: The purpose of the study was to demonstrate the safety and feasibility of early intranasal cooling prior to return of spontaneous circulation (ROSC) in the emergency medical services (EMS) environment. It was hypothesized that cooling during the resuscitation attempt would increase ROSC and subsequent survival. The study was not powered to demonstrate statistically-significant differences in any outcome parameter, but was intended as an exploratory study only.


Options:
A: Achieve Return of Spontaneous Circulation (ROSC) (1-hour after arrest); Survived to Hospital Discharge (30 days after arrest); Survived Neurologically-Intact (30-days after arrest)
B: All-cause mortality (Maximum follow-up with a minimum of 180 days)
C: Number Alive at Hospital Discharge (at hospital discharge)
D: Neurologically intact survival (CPC-cerebral performance categories scale 1-2) (90 days after cardiac arrest)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity
Brief Summary: Preventing the onset of pediatric obesity and diabetes in Latino families

The investigators will conduct a randomized controlled trial of a family-based community centered intervention. One-hundred Latino families with children ages 3-5 will be randomly allocated to either the intervention group (a 3-month skills building program to improve nutrition and aerobic activity for child-parent dyads) or a control group (literacy promotion). Through an active partnership with Nashville Metro Parks and Recreation and the Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will: 1) Implement an intervention for Latino families with young children that includes parent training, behavior modification training, nutrition education, and physical activity promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3) Evaluate how this intervention affects parenting practices for Latino families to improve nutrition and physical activity; and 4) Evaluate the ability to link families into a pediatric medical home if they have none identified. By developing innovative family-focused interventions, finding solutions to health conditions such as obesity and diabetes could be realized-con la familia.


Options:
A: Change in Percentage of Children Meeting Physical Activity Policy (Spring of Year 1, Year 2, and Year 3)
B: Intake of vegetables and fruit (One month)
C: Growth trajectories (using BMI, waist circumference), body composition (3 months)
D: Physical Activity Level (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Physical Literacy (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Dietary Intake (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity
Brief Summary: Preventing the onset of pediatric obesity and diabetes in Latino families

The investigators will conduct a randomized controlled trial of a family-based community centered intervention. One-hundred Latino families with children ages 3-5 will be randomly allocated to either the intervention group (a 3-month skills building program to improve nutrition and aerobic activity for child-parent dyads) or a control group (literacy promotion). Through an active partnership with Nashville Metro Parks and Recreation and the Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will: 1) Implement an intervention for Latino families with young children that includes parent training, behavior modification training, nutrition education, and physical activity promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3) Evaluate how this intervention affects parenting practices for Latino families to improve nutrition and physical activity; and 4) Evaluate the ability to link families into a pediatric medical home if they have none identified. By developing innovative family-focused interventions, finding solutions to health conditions such as obesity and diabetes could be realized-con la familia.


Options:
A: Vegetable Intake in Preschool Children (1 year 11 months)
B: Stunting in Children at 18 mo (18 months of age)
C: Growth trajectories (using BMI, waist circumference), body composition (3 months)
D: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity
Brief Summary: Preventing the onset of pediatric obesity and diabetes in Latino families

The investigators will conduct a randomized controlled trial of a family-based community centered intervention. One-hundred Latino families with children ages 3-5 will be randomly allocated to either the intervention group (a 3-month skills building program to improve nutrition and aerobic activity for child-parent dyads) or a control group (literacy promotion). Through an active partnership with Nashville Metro Parks and Recreation and the Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will: 1) Implement an intervention for Latino families with young children that includes parent training, behavior modification training, nutrition education, and physical activity promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3) Evaluate how this intervention affects parenting practices for Latino families to improve nutrition and physical activity; and 4) Evaluate the ability to link families into a pediatric medical home if they have none identified. By developing innovative family-focused interventions, finding solutions to health conditions such as obesity and diabetes could be realized-con la familia.


Options:
A: Vegetable Intake in Preschool Children (1 year 11 months)
B: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.
C: Growth trajectories (using BMI, waist circumference), body composition (3 months)
D: Child BMI

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity
Brief Summary: Preventing the onset of pediatric obesity and diabetes in Latino families

The investigators will conduct a randomized controlled trial of a family-based community centered intervention. One-hundred Latino families with children ages 3-5 will be randomly allocated to either the intervention group (a 3-month skills building program to improve nutrition and aerobic activity for child-parent dyads) or a control group (literacy promotion). Through an active partnership with Nashville Metro Parks and Recreation and the Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will: 1) Implement an intervention for Latino families with young children that includes parent training, behavior modification training, nutrition education, and physical activity promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3) Evaluate how this intervention affects parenting practices for Latino families to improve nutrition and physical activity; and 4) Evaluate the ability to link families into a pediatric medical home if they have none identified. By developing innovative family-focused interventions, finding solutions to health conditions such as obesity and diabetes could be realized-con la familia.


Options:
A: Stunting in Children at 18 mo (18 months of age)
B: Child anthropometry (Baseline. Up to 12 months. Up to 24 months.); Child food intake (Baseline. Up to 12 months. Up to 24 months.); Child health (Baseline. Up to 12 months. Up to 24 months.); Distribution of food intake within the household (Baseline. Up to 12 months. Up to 24 months.); Household food security (Baseline. Up to 12 months. Up to 24 months.); Maternal nutrition knowledge (Baseline. Up to 12 months. Up to 24 months.)
C: Body fat (At the end of the intervention and at a six month follow-up)
D: Growth trajectories (using BMI, waist circumference), body composition (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity
Brief Summary: Preventing the onset of pediatric obesity and diabetes in Latino families

The investigators will conduct a randomized controlled trial of a family-based community centered intervention. One-hundred Latino families with children ages 3-5 will be randomly allocated to either the intervention group (a 3-month skills building program to improve nutrition and aerobic activity for child-parent dyads) or a control group (literacy promotion). Through an active partnership with Nashville Metro Parks and Recreation and the Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will: 1) Implement an intervention for Latino families with young children that includes parent training, behavior modification training, nutrition education, and physical activity promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3) Evaluate how this intervention affects parenting practices for Latino families to improve nutrition and physical activity; and 4) Evaluate the ability to link families into a pediatric medical home if they have none identified. By developing innovative family-focused interventions, finding solutions to health conditions such as obesity and diabetes could be realized-con la familia.


Options:
A: Growth trajectories (using BMI, waist circumference), body composition (3 months)
B: Blood pressure (6 months)
C: Change in Fruit and Vegetable Consumption at School Lunch (assessed 4 times each 9-month school year; once prior to intervention beginning (i.e., September), approximately 10 weeks and then 20 weeks later, and finally once after the intervention ends (i.e., May).); Change in Student Activity Level (assessed 3 times over 1 year; initially prior to the intervention beginning (i.e., September), a 2nd time once the intervention ends (i.e., May), and then again at the beginning of the following school year (i.e., September))
D: Change in fruits and vegetables and dairy products (Before and after the intervention (0 and 6 wk))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity
Brief Summary: Preventing the onset of pediatric obesity and diabetes in Latino families

The investigators will conduct a randomized controlled trial of a family-based community centered intervention. One-hundred Latino families with children ages 3-5 will be randomly allocated to either the intervention group (a 3-month skills building program to improve nutrition and aerobic activity for child-parent dyads) or a control group (literacy promotion). Through an active partnership with Nashville Metro Parks and Recreation and the Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will: 1) Implement an intervention for Latino families with young children that includes parent training, behavior modification training, nutrition education, and physical activity promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3) Evaluate how this intervention affects parenting practices for Latino families to improve nutrition and physical activity; and 4) Evaluate the ability to link families into a pediatric medical home if they have none identified. By developing innovative family-focused interventions, finding solutions to health conditions such as obesity and diabetes could be realized-con la familia.


Options:
A: BMI and aerobic fitness (1 schoolyear)
B: Growth trajectories (using BMI, waist circumference), body composition (3 months)
C: Food intake (1 month)
D: Provision of flesh-food or vitamin A-rich food (Change from baseline to 5 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission (ADMIRE)
Brief Summary: The purpose of this pilot study is to investigate the possibility of discontinuing adalimumab therapy in patients with rheumatoid arthritis who are in stable remission after treatment with adalimumab in combination with methotrexate.


Options:
A: Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring (Week 104 in RA0055 Period 2)
B: Percentage of Participants in Remission at Week 28 (Week 28); Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2) (Week 28)
C: Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 (Week 88)
D: Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52. (Baseline and Week 52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of High Dose Atorvastatin Loading in ST Elevation Myocardial Infarction
Brief Summary: Although statin prior to PCI has favorable effects in stable angina and ACS except ST elevation MI (STEMI), there have been few studies for STEMI. Celik T et al. reported in patients with STEMI that prior statin use may improve coronary blood flow after PCI in patients with AMI, possibly by its beneficial effects on microvascular function. But this study was retrospective, non-randomized study and evaluated the effects for chronic statin therapy not acute high dose effect. Therefore, the investigators investigated whether acute high-dose statin prior to primary PCI in ST segment elevation myocardial infarction can have beneficial effect or not for periprocedural period and 30 days-cardiac events.


Options:
A: To evaluate the effect of high dose atorvastatin in STEMI - 30 Days MACE(death, myocardial infarction, target vessel revascularization) (30 days)
B: Change in serum creatinine from baseline to peak level (within first two-seven postoperative days)
C: plasma troponin T level (within the first 7 days after surgery)
D: the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG (in-hospital period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis
Brief Summary: The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.


Options:
A: Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal (7, 14, 21, 28, 56 days)
B: Rate of clinical remission
C: To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). (6 weeks)
D: Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) (week 8 (LOCF))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis
Brief Summary: The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.


Options:
A: Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal (7, 14, 21, 28, 56 days)
B: Clinical and Endoscopic Remission. (8 weeks)
C: To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). (6 weeks)
D: Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score less than or equal to 1 (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation of Clinical Tolerance, Cardio-respiratory Response and Muscle Fatigue During Electrostimulation
Brief Summary: The study was designed to test the following hypothesis

Patients with high cardio-respiratory response to electrostimulation (ES), high perception of pain during ES and high ES-induced muscle fatigue, have low tolerance to ES (more difficulties to increase intensity during training).


Options:
A: Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity) (1 week)
B: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)
C: Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks (Baseline and 12 weeks post-intervention); Change From Baseline in Quadriceps Strength at 12 Weeks (Baseline and 12 weeks following the intervention)
D: Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively (Baseline through 3.5 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation of Clinical Tolerance, Cardio-respiratory Response and Muscle Fatigue During Electrostimulation
Brief Summary: The study was designed to test the following hypothesis

Patients with high cardio-respiratory response to electrostimulation (ES), high perception of pain during ES and high ES-induced muscle fatigue, have low tolerance to ES (more difficulties to increase intensity during training).


Options:
A: VE/VCO2 slope (Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.)
B: Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity) (1 week)
C: Incremental shuttle walk test (10 weeks)
D: oxygen uptake (VO2) (during 30 minutes exercise)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Randomized Clinical Trial of the Efficacy of IM Midazolam Versus IV Lorazepam in the Pre-hospital Treatment of Status Epilepticus by Paramedics
Brief Summary: The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.


Options:
A: Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given (Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes).)
B: recurrence of febrile seizure (two years)
C: whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration
D: Length of Seizure After Study Medication Administration (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
Brief Summary: The systemic treatments for moderate to severe atopic dermatitis (AD) are limited to phototherapy and cyclosporine with the risks respectively of either carcinoma, or hypertension or nephropathy.

Methotrexate was effective in 75% of moderate to severe AD patients with good tolerance in an open retrospective study.

We want to confirm our observations: a non inferiority multicenter clinical trial, methotrexate versus cyclosporine, will be conducted in 100 patients for 24 weeks.


Options:
A: Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16 (Baseline to Week 16)
B: proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment (36 months)
C: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 (Week 16)
D: Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16 (Baseline to Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention Development and Pilot for Foster Care Youth
Brief Summary: The purpose of this study is to develop, standardize and provide a preliminary test of a novel intervention for preadolescent maltreated youth in out-of-home care. It is hypothesized that the preventive intervention, which is known as Fostering Healthy Futures (FHF) and which consists of therapeutic skills groups and mentoring, will improve mental health, social, academic and behavioral functioning and reduce youths' initiation of, and participation in, problem behaviors.


Options:
A: Evaluation of Child mental health, social & behavioral functioning and quality of life as measured from multiple informants and sources. (Immediately post-intervention and 6-months post intervention)
B: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
C: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)
D: Time Line Follow Back and urine screen (Pre and post-treatment, 3 and 6 month follow-ups)

Answer: A