linjc16/ctgov huggingface dataset:
Randomized Controlled Trial of an Eczema Care Plan

Study Overview
=================
Brief Summary
-----------------
The objectives of this project are to increase families' understanding of eczema and improve eczema management in the primary care setting. We have created an Eczema Care Plan similar to those used in the management of asthma. It gives specific instructions about medications, bathing and moisturizing, as well as when to seek further treatment. We will conduct a randomized controlled trial of the plan in Primary Care at Longwood for a 10 month period. Specifically, we aim to (1) decrease eczema severity (2) improve patient quality of life and (3) increase parental knowledge and confidence about eczema management. We also plan to track provider uptake and documentation of the plan and elicit feedback from parents and providers on the utility and feasibility of the plan.

Official Title
-----------------
Randomized Controlled Trial of an Eczema Care Plan

Conditions
-----------------
Eczema

Intervention / Treatment
-----------------
* Behavioral: Eczema Care Plan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:a) accompanying adult speaks English b) patient has a history of eczema c) patient is between the ages of 1 month and 16 years d) family is coming for an eczema visit or plans to discuss eczema e) accompanying adult is a primary caregiver f) child is not in foster care g) caregiver has not received an eczema care plan previously. - Exclusion Criteria: a) accompanying adult does not speak English b) patient does not have a history of eczema c) patient is younger than 1 month or older than 16 years of age d) eczema will not be discussed at the visit e) accompanying adult is not the primary caregiver f) child is in foster care g) caregiver has received an eczema care plan previously.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Families in the intervention group will receive an Eczema Care Plan | Behavioral: Eczema Care Plan<br> <br> |
| No Intervention: Control<br>Families in the control group will not receive an Eczema Care Plan | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with moderate/severe/very severe eczema |  | 1 month for each patient | 
| quality of life measured via validated survey |  | 1 month for each patient | 
| parental knowledge measured via survey |  | 1 month for each patient |
Helsinki Ultra-acute Stroke Biomarker Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to establish diagnostic and predictive biomarkers for patients with suspected acute stroke, that are transported by EMS as candidates for thrombolytic treatment. The study focuses on the ultra acute phase, <4.5 hours from symptom onset, including the prehospital setting. Analyses will include known biomarkers (e.g. GFAP, NR2 peptide) and a discovery phase for novel markers. Patient outcome will be evaluated at 3 month using the modified Rankin Scale (mRS).

Official Title
-----------------
Helsinki Ultra-acute Stroke Biomarker Study

Conditions
-----------------
Acute Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute stroke suspected by EMS personnel Transport to tertiary hospital as possible candidate for thrombolytic treatment of ischemic stroke Age ≥18 Successful prehospital blood sampling by EMS personnel Exclusion Criteria: Unsuccessful prehospital blood sampling by EMS personnel

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of biomarkers for identifying ischemic stroke, transient ischemic attack, intracerebral hemorrhage and stroke mimics. | Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value | 90 days +/- 5 days | 
| Predictive accuracy of biomarkers for identifying patients not responding to thrombolytic treatment. | Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value | 90 days +/- 5 days | 
| Predictive accuracy of biomarkers for identifying patients facing hemorrhagic complications of thrombolytic treatment | Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value | 90 days +/- 5 days | 
| Predictive accuracy of biomarkers for predicting outcome | Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value | 90 days +/- 5 days |
The Change of Pulmonary Blood Flow During One Lung Ventilation

Study Overview
=================
Brief Summary
-----------------
To investigate the changes of regional pulmonary blood flow in nondependent lung by transesophageal echocardiography during one lung ventilation

Official Title
-----------------
The Changes of Pulmonary Blood Flow in Nondependent Lung During One Lung Ventilation

Conditions
-----------------
One Lung Ventilation

Intervention / Treatment
-----------------
* Procedure: one lung ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (ASA physical status I-III) requiring OLV for selective thoracic surgery. Exclusion Criteria: chronic obstructive pulmonary disease hypertension cardiovascular esophageal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: one lung ventilation|measure the pulmonary blood flow in nondependent lung during 30min one lung ventilation|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine, in healthy controls, whether LED lighting that has a color spectrum similar to that of sunlight is able to differentially impact mood, circadian rhythms, sleep, and behavior, as compared to standard fluorescent lighting.

Official Title
-----------------
The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms

Conditions
-----------------
Sleep, Circadian Dysregulation, Mood

Intervention / Treatment
-----------------
* Device: Light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good self-reported health Normal color vision Exclusion Criteria: No sleep disorders No extreme chronotype Regular smoker Significant hearing loss Depression Alcohol use disorder Use of illegal drugs Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LED - Sunlike<br>LED lighting with spectral pattern similar to that of sunlight | Device: Light<br>* 15 hours of light exposure<br>|
| Active Comparator: Fluorescent<br>Fluorescent light at same illuminance (lux) as LED light | Device: Light<br>* 15 hours of light exposure<br>|
| Placebo Comparator: Dim<br>Dim fluorescent light with same spectrum as Fluorescent condition | Device: Light<br>* 15 hours of light exposure<br>|
| Active Comparator: LED<br>Standard LED lighting | Device: Light<br>* 15 hours of light exposure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alertness | Change in median reaction time score on the auditory psychomotor vigilance test | 15 hours | 
| Melatonin suppression | Amount of reduction in the concentration of salivary melatonin concentrations during an experimental light stimulus | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood | Change in total positive and negative affect scores on the Positive and Negative Affect Schedule (PANAS) | 15 hours |
Inducing Children's Emotional Eating

Study Overview
=================
Brief Summary
-----------------
Background: Children's emotional eating is related to greater BMI and less healthy diet but little is known about the early development of this behavior. Objective: This study aimed to examine the relationships between preschool children's emotional eating and parental feeding practices using experimental manipulation of child mood and food intake in a laboratory setting. Design: 25 3-5 year old children and their mothers sat together and ate a standard meal to satiety. Mothers completed questionnaires about their feeding practices. Children were assigned to a control or negative mood condition. Children's consumption of snack foods in the absence of hunger was measured.

Official Title
-----------------
Inducing Preschool Children's Emotional Eating: Relationships With Parental Feeding Practices.

Conditions
-----------------
Emotional Eating Behaviour

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child age between 3 years and 5 years No disease/disorder affecting eating No learning disability Exclusion Criteria: Any child brought in by a (non-primary care-giving) grandparent Child BMI at extreme of sample Incongruous mood shift to condition Child of non-english speaking/reading parent

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| negative emotion<br>Children experienced induction of mild negative emotion through a jigsaw with a missing piece (negative emotion group) | |
| neutral emotion<br>Vs. Same task with No missing piece (neutral emotion). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eating in the absence of hunger | Child's consumption of kcal from snack foods in the absence of hunger | @ 60 minutes into study, at  4 years of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emotional eating, Eating in the absence of hunger, emotion induction
Novel Hemostatic Cardiac Risk Factors in Framingham

Study Overview
=================
Brief Summary
-----------------
To investigate hemostatic variables in relation to cardiovascular risk in the Framingham Offspring Study cohort.

Detailed Description
-----------------
BACKGROUND: Elevation of platelet reactivity plasminogen activator inhibitor, fibrinogen, von Willebrand's factor, and factor VII have been reported to increase myocardial infarction risk. Myocardial infarction and sudden cardiac death are more frequent in the morning when platelet activity is increased and fibrinolysis is decreased. Reduction of recurrent myocardial infarction by aspirin and coumadin suggests causal roles for platelet activity and coagulation. Increases in viscosity and decreases in anti-thrombin III and Protein C have been linked with increased thrombosis. Despite these findings, a coherent picture of these disparate hemostatic indices as cardiac risk factors has yet to emerge. DESIGN NARRATIVE: Platelet reactivty, plasminogen activatator inhibitor, fibrinogen, von Willebrand's factor, factor VII, and other hemostatic risk factors were measured in all 4,000 subjects of the Framingham Offspring Study. The data were combined with the regularly collected Framingham data to: determine the relationships between hemostatic factors and carotid atherosclerosis as assessed by ultrasound; determine the relationship between hemostatic factors and the traditional cardiac risk factors; and determine if hemostatic risk factors independently predict myocardial infarction and cardiac death. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Death, Sudden, Cardiac, Myocardial Infarction, Thrombosis, Atherosclerosis, Carotid Artery Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Contemporary Transvenous Lead Extraction Outcomes

Study Overview
=================
Brief Summary
-----------------
Presentation of procedural safety and outcomes data from a high volume TLE centre

Detailed Description
-----------------
Transvenous lead extraction is crucial procedure in the longterm management of patients with implanted pacemakers or cardioverter defibrillators. Our study presents the patient and procedural characteristics as well as the outcome data of a cohort undergoing transvenous lead extraction (TLE) with olny mechanical extraction tools at a high-volume TLE centre.

Official Title
-----------------
Contemporary Mechanical Lead Extraction Outcomes From a High-volume Center: Patient Characteristics, Procedural Characteristics and Outcomes.

Conditions
-----------------
ICD, Pacemaker Lead Dysfunction, Pacemaker Electrode Infection, Endocarditis Infective

Intervention / Treatment
-----------------
* Procedure: TLE group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing a lead removal procedure Exclusion Criteria: minors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: TLE group|all patients underwent a transvenous lead extraction/explantation (TLE) procedure|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with complete or clinical successful lead removal | Removal of a lead or retention of a part less than 4cm | acute setting (during the surgical procedure) | 
| Percentage of patients undergoing TLE with major and minor complication | procedure related major and minor complications | acute setting (during the surgical procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long term outcome | survival after TLE | >12months follow up | 
| Percentage of patients encountering a major or minor sedation complication during TLE | Complication of cardiologist-directed sedation during TLE procedures | acute setting (during the surgical procedure) |
A Study of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.

Official Title
-----------------
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: TC-5214
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese healthy elderly male and female ≥65 years old. Have a BMI of ≥18 and ≤27 kg/m2 and weigh ≥ 45 kg. Be able to understand and comply with the requirements of the study as judged by the investigator(s). Exclusion Criteria: History of any clinically significant medical or neurologic disease or disorder. History of gastrointestinal surgery or unintentional rapid weight loss. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TC-5214<br> | Drug: TC-5214<br>* Tablet, Oral, twice daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Tablet, Oral, twice daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the safety and tolerability during single and multiple ascending oral doses by assessment of AEs, brief neurological examinations, vital signs, eye symptoms question, physical examinations, laboratory parameters, and ECGs, and C-SSRS. |  | During the whole study period, ca. 50 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characterise the PK of TC-5214 in plasma and urine during single and multiple ascending oral doses to Japanese healthy elderly volunteers. |  | PK samplings are taken at defined timepoints during residential periods, 4 days for SAD part and/or 9 days for MAD part. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, Japan, Elderly, PK, SAD, MAD
Cardiovascular Fitness and Venous Function in Trained and Untrained Subjects

Study Overview
=================
Brief Summary
-----------------
The primary aim is to study the relationship between vascular function, cardiovascular fitness and age in healthy subjects. Individuals with the highest cardiovascular fitness will have the greatest arterial inflow independent of age.

Official Title
-----------------
Cardiovascular Fitness and Venous Function in Trained and Untrained Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Behavioral: Aerobic Interval Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects, 18-75 years of age Exclusion Criteria: Inability to exercise due to musculoskeletal conditions Known ischemic cardiovascular disease Smoking or tobacco use Acute medical conditions Active infections Pharmacotherapy with known vascular effects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy subjects<br>Men Women Age; 18-75 | Behavioral: Aerobic Interval Training<br>* One interval training session<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Compliance | Echocardiography; Test - retest | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal oxygen uptake | Cardiopulmonary testing | one test at baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Veins, Exercise tests, maximal oxygen uptake, VO2max
Primary Prevention Study: Study on Obesity, Cardiovascular and Psycho-Social Characteristics in the City of Merzig

Study Overview
=================
Brief Summary
-----------------
Cardiovascular risk factors and psycho-social characteristics will be determined in obese and non-obese patients in the setting of primary medical care.

Detailed Description
-----------------
Cardiovascular risk factors and psycho-social characteristics will be determined using a questionnaire in primary care physician offices in the city of Merzig, Germany. We will recruit all people (age>18y) with a body-mass index (BMI) > 30 kg/m2 plus patients in the two following participating physician offices: Praxisnetz and Merzig. Cardiovascular risk will be assessed using the PROCAM (Munster Heart Study), ESC (European Society of Cardiology) and Framingham risk scores. Psycho-social factors will be recorded according to the methodology of the INTERHEART study.

Official Title
-----------------
Cross-Sectional Case-Control Study on Obesity, Cardiovascular and Psycho-Social Characteristics in the City of Merzig

Conditions
-----------------
Obesity, Cardiovascular Disease, Depression, Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or > 18 BMI > 30 kg/m2 Presenting to a participating primary care physician Exclusion Criteria: Age < 18

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, cardiovascular disease, depression, stress