linjc16/ctgov huggingface dataset:
Development of Workshop for Lifestyle Changing for Crohn's Disease Patients and Its Affect on the Disease's Indexes

Study Overview
=================
Brief Summary
-----------------
Subjects that participate in the practical workshop will improve their quality of life and will stay longer in remmision , in compare to the participants that will continue their regular threatment

Detailed Description
-----------------
Participants will be randomly assigned to a regular threatment (control group) or to a lifestyle changing workshop. The workshop will consist of 11 meetings with behavioral lessons in nutrition, cooking, stress realese and physical activity. The study population will include 100 crohn's disease patients in remmision that will be recruited and will be randomly divided into two groups: an intervention group of 50 will commence the workshop during 2007 and a control group of 50 who will continue their regular threatment. an IBDQ , CDAI and blood samples for metabolic index will be taken from the participant in the staudy before entering the study and every half a year for three years.

Official Title
-----------------
Development of Workshop for Lifestyle Changing for Crohn's Disease Patients and Its Affect on the Disease's Indexes

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Behavioral: lifestyle changing workshop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years of age diagnosed with CD Crohn's Disease Activity Index (CDAI) of under 170 a minimum of 75% of the meetings Exclusion Criteria: patients with a stoma and patients with a planned admission to the hospital for surgery or other treatment.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: lifestyle changing workshop|nan|

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
-----------------
crohns, quality of life, lifestyle changing, remmision
Incidence of Delirium in Critically Ill Patients in a Dutch University Hospital

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the incidence of delirium in adults patients who are admitted at the critical care unit of a Dutch University Hospital. The primary aim is to determine the incidence of delirium and to determine risk factors for this group of patients to develop a prediction model. A secondary aim is to find differences between delirious patients and non-delirious patients on different aspects of diagnostics, treatment and care, outcome, length of stay, and inflammation. According to Dutch law, the need to obtain informed consent was waived by the Committee on Research Involving Human Subjects (CMO) of Nijmegen for this observational study (2007/283).

Official Title
-----------------
Incidence of Delirium in Critically Ill Patients in a Dutch University Hospital

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adult patients (18 years and older) admitted at the critical care unit of our hospital Exclusion Criteria: not able to understand Dutch patients with serious hearing and visibility disabilities mentally retarded patients

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 |
| --- | --- |
| delirious patients<br>minimal one positive CAM-ICU score during ICU admission | |
| non-delirious patients<br>without any positive CAM-ICU scores during ICU admission | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delirium |  | during admission at the critical care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| markers of inflammation |  | within 24 hours of delirium diagnosis | 
| biomarkers |  | within 24 hours of delirium diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
delirium, critical care, risk factors, prediction
Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique

Study Overview
=================
Brief Summary
-----------------
Accurate cardiac output determination is a commonly used and important index of myocardial performance. The thermodilution method using a pulmonary artery catheter is the most common approach to cardiac output determination; however, placement of the pulmonary artery catheter is not without risk and at times can be problematic. Ultrasound dilution measurement has been shown to correlate with measured cardiac output in animal models and adults, but it has not been validated in pediatric patients. This study will validate the accuracy of ultrasound dilution measurements of cardiac output to thermodilution measurements of cardiac output in pediatric patients.

Official Title
-----------------
Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique

Conditions
-----------------
Cardiac Output

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transplant patients undergoing hemodynamic evaluation in the catheterization laboratory that are less than 18 years of age and have structurally normal hearts. Exclusion Criteria: Patient's age greater than 18 years, and any structural abnormality of the heart.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Validation of cardiac output measured by ultrasound dilution with cardiac output measured by thermodilution. |  | 5-8 minutes minimum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound Dilution, Cardiac Output, Validation of measured ultrasound dilution cardiac output
Neurologic and Immunologic Characteristics of CTLA-4 and LRBA Hereditary Deficiency

Study Overview
=================
Brief Summary
-----------------
CTLA4 and LRBA deficiencies are rare genetic disorders, recently described, and associated with multiple clinical features. It ranges from recurrent infections, auto-immunity, and organ infiltration with lymphocytes. Neurologic syndroms are described in up to 30% of patients, yet they are poorly defined to date. Early recognition of a specific pattern can be important, given that there is a targeted therapy in this situation.

Official Title
-----------------
Neurologic and Immunologic Characteristics of CTLA-4 and LRBA Hereditary Deficiency

Conditions
-----------------
CTLA4 Haploinsufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Patients diagnosed with CTLA4 or LRBA mutation Exclusion criteria: - Age < 12 years

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
| Number of Neurologic impairment | Neurologic signs and symptoms (headaches, seizures…), cerebral MRI features, lumbar puncture, histopathology | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of reccurent infections | Presence of reccurent infections and type, granulomatous disease, cancer predisposition, immunologic biological tests, type of treatments and effectiveness | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LRBA deficiency, Primary immunodeficiency, Neuroinflammation, Genetic diseases, Autoimmune diseases
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

Study Overview
=================
Brief Summary
-----------------
The present study aims to evaluate safety and immunogenicity of one dose of a commercially available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, in non-elderly adult and elderly subjects.

Official Title
-----------------
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Commercially Available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, When Administered to Non-Elderly Adult and Elderly Subjects

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: influenza surface antigen inactivated vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects 18 years of age or older Exclusion Criteria: any auto-immune disease or other serious acute, chronic or progressive disease hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: influenza surface antigen inactivated vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection. |  |  | 
| Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection. |  |  | 
| Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
flu, influenza, influenza vaccine, vaccination, immunogenicity
MATCh Parents' Supplemental Survey

Study Overview
=================
Brief Summary
-----------------
Primary Objectives: To collect data on health behaviors in the parents of MATCh study participants To collect and/or update risk factor data from the parents of the MATCh study participants.

Detailed Description
-----------------
This research project is for the parents of study participants in the Predictors of Smoking in Mexican American Youth, also known as the MATCh study. This research project has three objectives. These include: collecting data on your health behaviors. Researchers are interested in this information because your health behaviors may influence your children's health behavior; learning about the types of interventions that would be of most use and interest to you and your family; and learning about the most convenient and useful way in which these interventions would be delivered. Researchers are interested in knowing about the types of interventions that would benefit you and your family because they would like to design future intervention studies that meet your needs and the needs others in your community.

Official Title
-----------------
MATCh Parents' Supplemental Survey: Predictors of Smoking in Mexican American Youth

Conditions
-----------------
Epidemiology

Intervention / Treatment
-----------------
* Behavioral: Supplemental Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The parent or legal guardian of the child participating in UT MDACC Protocol 2004-0616. Parents/legal guardians will be identified and enrolled after their child is enrolled in protocol 2004-0616. Participants who speak English, Spanish or are bilingual are eligible to participate. Exclusion Criteria: None
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 |
| --- | --- |
| MATCh Parents' Supplemental Survey<br>Parent/Guardian Survey | Behavioral: Supplemental Survey<br>* Questionnaire give during home visit to collect behavioral, risk factors and other smoking status data on MATCh parents/guardians.<br>* Other names: Questionnaire;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection on health behaviors in the parents of MATCh study participants. |  | 4 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection and/or update risk factors from the parents of the MATCh study participants. |  | 4 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidemiology, Cancer Prevention, Questionnaire, MATCh, Survey
Prospective Comparison Between TE, SWE and MRE (FULLFIBRO01)

Study Overview
=================
Brief Summary
-----------------
The main purpose of the present study is to compare the diagnostic performance of three non-invasive stiffness imaging methods (TE, SWE and MRE) in a consecutive cohort of patients with chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV).

Detailed Description
-----------------
Primary Endpoint: Verify if Transient Elastography, Shear Wave Elastography, Magnetic Resonance Elastography (MRE) get comparable results in the measurement of liver fibrosis Secondary Endpoint: To evaluate if the level of liver iron overload and steatosis may act as a confounding factor in stiffness measurements by MRE. Tertiary Endpoint: to provide information about the prevalence and grade of steatosis in a consecutive cohort of patients with chronic viral C hepatitis, and to verify if the presence and grade of parenchymal steatosis may affect the correlation between the different non-invasive stiffness imaging modalities. Subject: consecutive 100 patients affected by chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV).

Official Title
-----------------
Prospective Comparison Between Transient Elastography (TE), Shear Wave Elastography (SWE) and Magnetic Resonance Elastography (MRE) for Non-invasive Assessment of Liver Fibrosis in Patients Affected by Chronic Viral Hepatitis

Conditions
-----------------
Liver Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enrollment of a consecutive cohort of at least 100 patients affected by chronic C virus hepatitis (HCV) or co-infected by HCV+ Human Immunodeficiency Virus (HIV). Exclusion Criteria: contraindications to undergo MRI examination. Impossibility to obtain a valid TE measurement (e.g. narrow intercostal spaces; obese patients)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| liver stiffness | liver stiffness is indicated in kPa | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver iron overload | liver iron concentration (LIC) is indicated in mg/g dw | 18 months | 
| liver steatosis | liver steatosis | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV, HIV, Liver Fibrosis, Liver Iron Overload
Role of Ultrasonography in the Diagnosis of Carpal Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
This prospective study aims to evaluate the median nerve in Carpal Tunnel Syndrome by high-frequency ultrasound and color Doppler in comparison with clinical and Nerve conduction studies.

Detailed Description
-----------------
This prospective study aims to evaluate the median nerve anatomical changes in Carpal Tunnel Syndrome by high-frequency ultrasound and color Doppler in comparison with clinical and Nerve conduction studies physiological changes to determine the efficacy of ultrasound to diagnose and determine the severity of carpal tunnel syndrome.

Official Title
-----------------
Role of Ultrasonography in the Diagnosis of Carpal Tunnel Syndrome and Detection of Its Severity

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any Age Group with symptoms, clinical signs and NCS consistent with CTS Exclusion Criteria: Uncooperative Patients . Patients with History of previous wrist surgery, fracture or traumatic nerve injury
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 |
| --- | --- |
| patients<br>those with symptoms of CTS | Diagnostic Test: imaging<br>* imaging by ultrasonography and nerve conduction studies will be done for both grups<br>* Other names: nerve conduction studies;|
| control group<br>normal people those with no symptoms of CTS | Diagnostic Test: imaging<br>* imaging by ultrasonography and nerve conduction studies will be done for both grups<br>* Other names: nerve conduction studies;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anatomical changes in the median nerve in carpal tunnel syndrome | compare the anatomical changes observed by ultrasonography in patients diagnosed with carpal tunnel syndrome and comparing the results with clinical and nerve conduction studies results | imaging within 24 hours from the nerve conduction studies and clinical assessment of the patient |
Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants

Study Overview
=================
Brief Summary
-----------------
Children with a torticollis are usually referred for physiotherapy where they are evaluated, and given exercises as well as education to treat the condition. This study is being done in order to compare 2 methods of sharing information with parents of children with torticollis.

Detailed Description
-----------------
160 children of less than 6 months of age will be recruited for the study and divided in 2 groups. Children of both groups will receive the same physiotherapy evaluation and exercises but parents will receive information handouts with one of two different types of illustrations and written instructions for home exercises.

Official Title
-----------------
Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants

Conditions
-----------------
Torticollis

Intervention / Treatment
-----------------
* Other: Booklet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged newborn to 6 months at initial visit in physiotherapy, A diagnosis of PT made by a physician, At least 37 weeks of gestational age at delivery Exclusion Criteria: Congenital muscular torticollis with fibrosis (confirmed diagnosis): because this is a rare condition that has a different rate of recovery, Presence of craniosynostosis (confirmed diagnosis made by a neurosurgeon), APGAR score of less than 7 at 5 minutes, Prescription of a Tubular Orthosis for Torticollis (TOT) collar or Botox intervention for the torticollis, Confirmed diagnosis of syndrome or neurological condition.

Ages Eligible for Study
-----------------
Maximum Age: 6 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Booklet<br> | Other: Booklet<br>* booklet given to parents for home exercises<br>|
| Active Comparator: 2 standard<br> | Other: Booklet<br>* booklet given to parents for home exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck range of motion measurements |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital muscular torticollis