linjc16/ctgov huggingface dataset:
Hydrolyzed Egg and Tolerance Induction

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to assess the effect of hydrolyzed egg orally administered on oral tolerance induction to egg in children allergic to egg as compared to a placebo.

Official Title
-----------------
Assessment of the Effect of an HA Egg Administration for 6 Months on the Tolerance Induction to Egg in Children Allergic to Egg as Compared to a Placebo

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Dietary Supplement: HA egg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child of any ethnicity aged between 12 and 66 months at the time of enrolment Positive Skin Prick Test (SPT) to egg white within the last 3 months Either positive oral challenge OR convincing history, defined as an immediate (<1h) reaction following isolated ingestion of egg, positive SPT to egg white and positive sIgE (> 0.35 kU/L) for at least one of the following: egg, egg white, ovalbumin, ovomucoid, within the last 12 months Having obtained his/her signed legal representative's informed consent. Exclusion Criteria: History of severe anaphylaxis to egg Significant pre-natal and/or post-natal disease Child on systemic drugs (e.g. antihistamines, beta-agonists, ACE-inhibitors) according to half-life at time of enrolment Congenital illness or malformation that may affect normal growth (especially immunodeficiency) Child whose parents / caregivers cannot be expected to comply with treatment Child currently participating in another interventional clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 66 Months

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: HA egg<br>* Daily dose of HA egg or placebo for 6 months<br>|
| Active Comparator: HA egg<br> | Dietary Supplement: HA egg<br>* Daily dose of HA egg or placebo for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive or negative result (objective and subjective symptoms) of a challenge test with egg |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance (product taken) |  | 6 months | 
| skin prick test (sensitization to egg; size of wheal and flare) |  | 6 months | 
| Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation |  | 6 months | 
| Morbidity / Adverse Events |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergy, Egg
DSME or DSME + MI in T1DM on Glycemic Control

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of diabetic knowledge and self care behavior (DSME) alone or DSME plus motivational interviewing on glycemic control among children and adolescents with DM type 1. Half of participants will receive DSME along, while the other half will receive DSME plus MI.

Official Title
-----------------
A Randomized Control Trial Compare Between Diabetic Knowledge and Self-care Behaviors (DSME) With and Without Motivational Interviewing, on Glycemic Control Among Children and Adolescents With Diabetes Mellitus Type 1

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Motivational interviewing
* Drug: DSME participants in this arm will receive standard care for diabetes (DSME) at the beginning of the study and 3 months later


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T1DM age more than 10 years old HbA1C more than 8% Exclusion Criteria: other types of DM receive medications that may effect blood glucose mental retardation

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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 |
| --- | --- |
| Active Comparator: DSME<br>participants in this arm will receive standard care for diabetes (DSME) at the beginning of the study and 3 months later | Drug: DSME participants in this arm will receive standard care for diabetes (DSME) at the beginning of the study and 3 months later<br> <br> |
| Experimental: DSME+MI<br>participants in this arm will receive standard care for diabetes plus motivation interviewing (MI) sessions at the beginning of the study and 3 months later, will also receive motivation interviewing sessions by phone at 1, 2, 4, 5 month after the beginning of the study | Behavioral: Motivational interviewing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C |  | at the beginning of the study, 3 month and 6 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre and post test scores for Diabetic knowledge |  | at the beginning and 6 months later | 
| Diabetic self-care behavior score |  | at the beginning and 6 months later |
Comparison of Two Different Dosages of Low-molecular Weight Heparin in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
In a prospective, randomized, double-blind trial, the effects of two different dosages of LMWH (5000 anti-Xa U od sc and 10 000 anti-Xa U od sc daily) on markers of hemostatic system and thrombin generation will be investigated in non-surgical cancer patients will be investigated.

Official Title
-----------------
Prevention of Venous Thrombosis in Cancer Patients: A Prospective, Randomized, Double-blind Study Comparing Two Different Dosages of Low-molecular Weight Heparin

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: enoxaparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (> 18 years) with active cancer and at least one of the following indications for thromboprophylaxis with LMWH: Immobilization History of VTE Acute inflammation Heart failure (NYHA class III or IV) Respiratory failure Exclusion Criteria: Indication for LMWH or UFH at therapeutic dosages Treatment with antithrombotics (vitamin K antagonists, acetylsalicylic acid, clopidogrel) for reasons other than prevention of VTE (e.g. atrial fibrillation, myocardial infarction) Contraindication for the treatment with LMWH Major surgery within the last 4 weeks; minor surgery within the last week Thrombocytopenia (< 100.000/μl) Prolonged prothrombin time Prolonged activated partial thromboplastin time (aPTT) History of heparin-induced thrombocytopenia Bodyweight < 50 kg or > 100 kg Renal insufficiency (creatinine > 2 mg/dl)

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: enoxaparin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Immune Status of Elderly Population Admitted in an Acute Geriatric Unit

Study Overview
=================
Brief Summary
-----------------
Ageing is associated with vulnerability against infections leading to increased morbidity with risk of death. Innate and adaptive immunities are altered with ageing responsible of deficits in immune response against pathogens and after vaccination, and favouring the elderly vulnerability against a new pathogen with increased bacterial, viral, and fungal infections. If immunity has been widely studied in immunosenescence, there are few prospective, comparative studies with elderly ill patients. Moreover among these studies, pathologies are not well defined. The main objective of our project is to compare the immune state of elderly hospitalised subjects in an acute geriatric unit to the immune state of elderly healthy subjects selected with strict criteria, in order to precise the impact of polypathology and of various pathologies on immunity state.

Official Title
-----------------
Immune Status of Elderly Population Admitted in an Acute Geriatric Unit

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Other: Blood test and clinical test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject of 75 or more years old, female or male Subject admitted in the service of short stay gériatrique of the hospital Holy Marguerite, whatever is the motive for admittance Subject not being under supervision(guardianship), nor guardianship Subject benefiting from a benefit system Subject having given its assent of participation or for which the reliable person gave her assent in the case of vulnerable person Exclusion Criteria: Subject of less than 75 years old Subject refusing to participate in the study or for whom(which) the reliable person refuses the participation of the subject

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pathological group<br>pathological group | Other: Blood test and clinical test<br>* Blood test and clinical test<br>|
| Experimental: healthy aged<br>healthy aged | Other: Blood test and clinical test<br>* Blood test and clinical test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the immune state of elderly hospitalised subjects in an acute geriatric unit to the immune state of elderly healthy subjects |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ELDERLY POPULATION
Treatment of M.Graves With Radioactive Iodine: Follow-up Study

Study Overview
=================
Brief Summary
-----------------
Hypothesis: What is the natural course after treatment with radioactive iodine in patients with hyperthyroidism? What are the determinants for the development of acute hypo- or hyperthyroidism after treatment with radioactive iodine without antithyroid drugs?

Conditions
-----------------
Hyperthyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients wth hyperthyroidism who are eligible for treatment with radioactive iodine Age > 18 years Exclusion Criteria: Severe ophthalmopathy Pregnancy or wish to pregnancy on short term Breastfeeding Patients already treated with radioactive iodine Known cardiovascular diseases or other severe comorbidity

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with hyperthyroidism who are will be treated with radioactive iodine. | |

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
-----------------
hyperthyroidism, radioactive iodine, antithyroid drugs, Hyperthyroidism, treatment with radioactive iodine without antithyroid drugs
Hemodynamic Monitoring of Newborn Infants With Impedance Cardiography Versus Echocardiography; a Validation Study

Study Overview
=================
Brief Summary
-----------------
Background: Impedance cardiography (ICG) is a noninvasive method for continuous left cardiac output monitoring based on measurement of thoracic electrical bioimpedance. The objective of this study is to validate an ICG device by investigating the agreement in cardiac output (CO; left ventricular output x heart rate) measurements performed by ICG and echocardiography. The ICG device (PhysioFlow) has a new filter technology reducing signal noise and enabling measurements in patients who are moving freely. Material and Methods Design: Prospective observational study. Inclusion: 30 healthy term infants between 24 and 48 hours of age, after parental consent Methods: Continuous measurement with ICG over a 30 min period and point of care echocardiography Primary outcome: Agreement (bis and precision) between measurement of CO with ICG and echocardiography. Secondary outcomes: Agreement between other echocardiographic indices of myocardial function and ICG parameters (early diastolic filling ratio, cardiac index, ventricular ejection time and left cardiac work index). Statistics: Agreement between ICG and echocardiography data will be evaluated using Bland-Altman statistics, including the calculation of mean bias (average difference between measurements) with corresponding standard deviation and lower and upper limits of agreements (95% confidence interval).

Official Title
-----------------
Hemodynamic Monitoring of Newborn Infants With Impedance Cardiography Versus Echocardiography; a Validation Study

Conditions
-----------------
Hemodynamics

Intervention / Treatment
-----------------
* Device: Non-invasive hemodynamic monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborn infants Exclusion Criteria: Infants > 1 month of age

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Non-invasive hemodynamic monitoring|Impedance cardiography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output | Stroke volume x heart rate | one hour |
Formalizing a Conceptual Framework of Work Domain Knowledge

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn the daily activities of nutrition management software users through an improved informed consent process and develop a conceptual model to describe these activities. The investigators will gather information from nutrition management software users, and design and test a new prototype of nutrition management software.

Official Title
-----------------
Formalizing a Conceptual Framework of Work Domain Knowledge

Conditions
-----------------
Knowledge Representation, Knowledge Modeling

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be over 21 years old Subjects must be a student or employee in University of Texas Subjects must be able to read and write in English Subjects must be able to give signed informed consent

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Magnetic Resonance Imaging Study of Patients With Cervical Spondylosis

Study Overview
=================
Brief Summary
-----------------
This study aims at evaluating spinal cord structure using diffusion tensor imaging in patients with cervical spondylosis.

Detailed Description
-----------------
Diffusion tensor imaging (DTI) of the cervical spinal cord will be performed in patients with cervical spondylosis with varying degrees of symptoms and in healthy control subjects. Fibre tracking of main spinal tracts will be performed. Regions of interest will also be identified. Diffusion parameters will be extracted. This will allow quantification of degree of damage in of the spinal cord. The findings will be related to motor function measures and comprehensive clinical tests of sensory and motor function.

Official Title
-----------------
Structural Spinal Cord Integrity in Patients With Cervical Spondylosis in Relation to Clinical Status

Conditions
-----------------
Cervical Spondylosis

Intervention / Treatment
-----------------
* Device: DTI - Diffusor Tensor Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years old Sufficiently cooperative Cognitively understands study and implications Signed informed consent Symptomatic cervical spondylosis Exclusion Criteria: MRI contraindications (e.g., pacemaker, metal implants, claustrophobia) Previous pathology that would impact behavioural measures Anxiety and poor cooperation Previous neurological condition Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healty volunteers<br> | Device: DTI - Diffusor Tensor Imaging<br>* Radiology intervention<br>|
| Experimental: Patients<br> | Device: DTI - Diffusor Tensor Imaging<br>* Radiology intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DTI parameters in cervical spinal cord |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity, and Motor function (dexterity test), grip strength | Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity Motor function (dexterity test), grip strength | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal cord, cervical spondylosis, myelopathy
Preoperative Biochemical Predictors of Outcome in Patients With Hip Fracture

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to identify biochemical predictors of morbidity and mortality in patients suffering from hip fracture. For this purpose blood samples are collected prehospitally or in the emergency department in patients with a suspected hip fracture. During the hospital stay medical history, anesthesiological management recorded. In addition, american society of anesthesiology physiological score (ASA), revised cardiac risk index (RCRI), and POSSUM score is calculated. Morbidity and mortality is recorded  in house, after 30 days, after 4 months and after 1 year. Biochemical predictors of outcome will be evaluated with logistic regression analysis. Biochemical predictors include pro-brain natriuretic peptide, lactate, pro-calcitonin, adrenomedullin, copeptin, cystatin c. The predictive value of the potential markers will be compared to that of ASA, RCRI and POSSUM.

Official Title
-----------------
Can Biochemical Tests Predict Outcome in Patients With Hip Fracture?

Conditions
-----------------
Hip Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with out of hospital hip fracture at University Hospital Lund Sweden Informed consent Blood sampling within 3 hrs of first contact with healthcare Exclusion Criteria: No consent can be obtained Non-operative management Followup through the Swedish National Quality for Hip fracture patients not possible High energy trauma

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 |
| --- | --- | --- |
| Mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Infectious complications Cardiovascular complications Thromboembolic complications Respiratory complications Renal complications Surgical complications | 30 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Predictor, outcome, biochemical