linjc16/ctgov huggingface dataset:
Fetal Alcohol Damage Prevention Study

Study Overview
=================
Brief Summary
-----------------
The goal of this study was to determine whether a series of blood markers of alcohol use obtained from alcohol using pregnant women could help them to change their behavior.

Detailed Description
-----------------
This study involved screening pregnant women with an alcoholism screening questionnaire and obtaining blood from those women who screened positive and a subset of women who screened negative. Each woman who had blood drawn were informed of their results, educated about alcohol use in pregnancy and had a brief intervention about their alcohol use, if appropriate. They were monitored throughout the pregnancy with additional blood tests obtained, depending upon their stage in pregnancy. After birth the babies were examined for any signs of alcohol exposure.

Official Title
-----------------
Prevention of Fetal Alcohol Damage Using Maternal Blood Markers

Conditions
-----------------
Fetal Alcohol Syndrome, Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: Brief motivational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women seen at one of the obstetric clinics in the study and willing to give a blood sample Exclusion Criteria: over 36 week gestation

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

Sexes Eligible for Study
-----------------
Female

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: I<br>Pregnant women are recruited and screened for alcohol use using a validated alcoholism screening questionnaire. Those who screen positive are then entered into the next phase of the study. | Behavioral: Brief motivational intervention<br>* The women who have positive alcohol screening questionnaires and a random sample of women who screen negative are entered into the next phase of the study. They have blood drawn for the markers of alcohol use, are told of the results and are given brief intervention about alcohol use.<br>* Other names: Brief Intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in drinking |  | during the pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved infant size |  | after pregnancy finished | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fetal alcohol exposure, blood markers of alcohol use, brief intervention
Is Phonophoresis Treatment Effective?

Study Overview
=================
Brief Summary
-----------------
The specimens from patients as knee osteoarthritis diagnosed who was applied ibuprofen phonophoresis will be analyzed.

Official Title
-----------------
Is Phonophoresis Treatment Effective? Determination of Ibuprofen Levels by Microextraction and HPLC (High Liquid Pressure Chromatography) Method in the Tissues of the Patients With Knee Osteoarthritis?

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Other: Ibuprofen phonophoresis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having diagnosed as osteoarthritis Exclusion Criteria: surgery at knee trauma at knee
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: phonophoresis in knee osteoarthritis<br>Ibuprofen phonophoresis in patients with knee osteoarthritis | Other: Ibuprofen phonophoresis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of ibuprofen in bone by Microextraction and HPLC (High Liquid Pressure Chromatography) | Effectiveness and safety | 1 year | 
| level of ibuprofen in synovial membrana by Microextraction and HPLC (High Liquid Pressure Chromatography) | Effectiveness and safety | 1 year | 
| level of ibuprofen in synovial fluid by Microextraction and HPLC (High Liquid Pressure Chromatography) | Effectiveness and safety | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | VAS score after phonophoresis treatment | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ibuprofen phonophoresis, High performance liquid chromatography
Study to Determine if Tetrix Cream is Removed From the Hands by Gentle Washing With Soap and Water

Study Overview
=================
Brief Summary
-----------------
To determine if Tetrix Cream remains on the hands after gentle washing with soap and water

Official Title
-----------------
A Study of the Substantivity of Tetrix Cream

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

Intervention / Treatment
-----------------
* Device: Tetrix
* Device: Tetrix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal subjects Male and Female Exclusion Criteria: Under the age of 18 years

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single topical application | Device: Tetrix<br>* single topical application<br>|
| Active Comparator: 2<br>Single topical application | Device: Tetrix<br>* Single topical application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of Tetrix remaining on the skin compared to control, after gentle washing with soap |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tetrix cream, substantivity, resistance to a gentle wash, Tetrix Cream remaining on hands after gentle washing with soap and water.
Interest of the Donor-specific Antibodies After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The study is a prospective observational mono center study Primary objective : Study the anti-HLA antibodies frequency preformed before liver transplantation and the kinetic of appearance of DSA and de novo complement-binding anti-HLA antibodies after liver transplantation. Secondary objective : Risk factor of de novo DSA appearance (Immunosuppressive therapy, liver aetiology) Impact of DSA on: Graft and patients survivals Onset of allograft rejection (acute, late-onset, chronic) Unexplained liver graft dysfunction Unexplained liver enzymes abnormalities Liver fibrosis development (liver stiffness study using fibroscan©)

Official Title
-----------------
Interest of the Donor-specific and Complement-binding Anti-HLA Antibodies (C1q) Assays for the Management and the Monitoring After Liver Transplant

Conditions
-----------------
Liver Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver transplanted patients older than 18, transplanted in Lille University Hospital. Written consent by the patient or his/her legal representative (especially patient with hepatic encephalopathy). Patients with health insurance Exclusion Criteria: Minor patients. Pregnant women or during lactation. Patient under curatorship.

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 |
| --- | --- | --- |
| Prevalence DSA positivity (or anti-HLA). | The positivity is defined as a fluorescence ≥ 1000. | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescence quantification |  | at 3 months, 1 year and 2 years after transplantation | 
| Presence of C1q binding-complement anti-HLA antibodies |  | at 3 months, 1 year and 2 years after transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DSA
Lung Scintigraphy for Pulmonary Embolism Diagnosis in COVID-19 Patients.

Study Overview
=================
Brief Summary
-----------------
A frequent complication of COVID-19 disease is pulmonary embolism (PE). Lung ventilation/perfusion (V/P) scintigraphy is a well-established test for PE diagnosis. The test is interpreted based on the recognition of wedge shaped perfusion mismatched defects. However, the ventilation procedure increases the potential risk of contamination by the aerosol secretion and the expired air. A variety of strategies have been proposed in the nuclear medicine literature regarding performance of lung ventilation scintigraphy in COVID-19 patients with suspected acute PE. However, there is currently no factual data in this specific population to support recommendations to the nuclear medicine community. The aim of this study was to assess the role of ventilation imaging when performing lung scintigraphy for suspected PE in COVID-19 patients.

Official Title
-----------------
Lung Scintigraphy for Pulmonary Embolism Diagnosis in COVID-19 Patients: a Multicenter Observational Study.

Conditions
-----------------
Pulmonary Embolism, COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected COVID-19 disease Referred for lung scintigraphy for suspected acute PE Exclusion Criteria: Patient under guardianship or curatorship Patient deprived of liberty by an administrative or judicial decision Inability or refuse to give consent

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PE diagnosis on lung scintigraphy without the ventilation scan. | Percentage of scans for which the diagnostic conclusion of the lung scan would have been different when omitting the ventilation scan | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung scintigraphy
Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare healthy children to children who have systemic lupus erythematosus (SLE). SLE is a childhood disease that has high risk for low bone mass and vertebral compression fractures.

Detailed Description
-----------------
The purpose of this research study is to measure bone mass in children with SLE using different measurement techniques. Children with chronic illnesses are at risk of bone fragility. This is important because bone fragility can result in childhood fractures especially children with SLE. Therefore better diagnosis technique can lead to better management of bone health.

Official Title
-----------------
Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children

Conditions
-----------------
Systemic Lupus Erythematosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For SLE subjects: Subjects age 5-21 drawn from rheumatology clinic at Children's Hospital of Philadelphia diagnosed with SLE for at least 1 month. Also subjects with no known vertebral compression fracture of L2. For Control subjects: Subjects age 5-21. Controls will be a 50% male/female. Exclusion Criteria: For SLE subjects: Subjects with SLE will be excluded if they have conditions or drug exposure unrelated to SLE and known to impact growth or bone health. For Control subjects: Chronic disease or syndrome known to affect growth or bone health, prematurity (<37 weeks gestation), or use of any medication known to affect growth.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 21 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 |
| --- | --- | --- |
| Age and sex specific z-scores for lumbar spine (L2) volumetric bone mineral density (BMD) (trabecular and total) and vertebral volume. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean lumbar spine stiffness and strength in children with SLE and healthy controls correlation between standard and low dose lumbar spine. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic Lupus Erythematosus, SLE, Lupus, children with SLE
Bariatric Surgery vs. Lifestyle Modification for NASH

Study Overview
=================
Brief Summary
-----------------
Randomized Controlled Trial comparing the effects of Bariatric Surgery vs. Lifestyle modification on NASH resolution.

Detailed Description
-----------------
Patients with biopsy-proven NASH will be randomized to either bariatric surgery or lifestyle interventions. After 1-year follow-up a liver biopsy will be done to evaluate NASH resolution

Official Title
-----------------
Bariatric Surgery vs. Lifestyle Modification: Effects Against Nonalcoholic Steatohepatitis Randomized Trial

Conditions
-----------------
NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Procedure: Bariatric Surgery
* Behavioral: Lifestyle modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 30 and 45 with biopsy-proven NASH with or without type 2 diabetes that fit for bariatric surgery. Exclusion Criteria: borderline NASH ou cirrhosis; alcohol consumption (> 20 g/day for men and > 10 g/day for women, for the last 2 years); other hepatic diseases (such as viral hepatitis, autoimmune hepatitis, drug-induced hepatic disease, Wilson's disease, hemochromatosis); HIV infection; unable to provide informed consent; previous foregut or bariatric surgery; malignancy; patients that unfit for bariatric surgery.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bariatric Surgery<br>Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to either laparoscopic Roux-en-Y Gastric Bypass or laparoscopic Sleeve Gastrectomy | Procedure: Bariatric Surgery<br>* laparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy<br>|
| Active Comparator: Lifestyle Modification<br>Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to guided diet and physical activity. | Behavioral: Lifestyle modification<br>* guided low-calorie diet and physical activity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NASH resolution | NASH resolution evaluated by liver biopsy | 12 months |
Preoperative Ultrasonographic Evaluation of the Right Common Femoral Vein Diameter for Predicting Spinal Anesthesia-induced Hypotension in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
In this study we will determine the ability of preoperative ultrasonographic evaluation of the right common femoral vein diameter to predict spinal anesthesia-induced hypotension in elderly patients.

Official Title
-----------------
Preoperative Ultrasonographic Evaluation of the Right Common Femoral Vein Diameter for Predicting Spinal Anesthesia-induced Hypotension in Elderly Patients. A Prospective Observational Study.

Conditions
-----------------
Spinal Anesthesia-induced Hypotension

Intervention / Treatment
-----------------
* Diagnostic Test: preoperative ultrasonographic evaluation of right common femoral vein diameter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years of age or more. ASA score I & II. Patients scheduled for surgeries under spinal anesthesia. Exclusion Criteria: Negative consent. pre-existing hypertension Diabetes mellitus or autonomic neuropathy. Emergency operations. Absolute contraindications or failure to perform spinal anesthesia.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: preoperative ultrasonographic evaluation of right common femoral vein diameter|preoperative ultrasonographic evaluation of right common femoral vein diameter to predict spinal anesthesia-induced hypotension in elderly patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity of the transverse diameter (mm) value of the right common femoral vein as measured by ultrasound before anesthesia to predict spinal aneshesia-induced hypotension in elderly patients. |  | 30 minutes after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of spinal anesthesia-induced hypotension in elderly |  | 30 minutes after spinal anesthesia | 
| The sensitivity of the peak velocity of blood flow (mm/s) in the right common femoral vein as measured by ultrasound before anesthesia to predict spinal anesthesia-induced hypotension in elderly patients |  | 30 minutes after spinal anesthesia |
The Expression of Serum Angiogenesis Marker in Patients Presenting With Hemoptysis

Study Overview
=================
Brief Summary
-----------------
Vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) are major mediators of angiogenesis and are induced by tissue inflammation and hypoxia. While elevated serum VEGF levels have been reported in inflammatory lung diseases, especially with hemoptysis, there was no study to evaluate the Ang-2 levels in lung inflammatory diseases according to the presence of hemoptysis, inflammatory biomarker and hypoxia.

Official Title
-----------------
The Expression of Serum Angiogenesis Marker in Patients Presenting With Hemoptysis

Conditions
-----------------
Inflammatory Lung Diseases, Hemoptysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients visited Samsung Medical Center for the treatment of benign inflammatory disease such as bronchiectasis, aspergilloma, pneumonia and post-tuberculosis destroyed lung Exclusion Criteria: patients with tumorous condition including lung cancer, vasculitis and the lung disease associated with collagen vascular disease on the point of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| patients with hemoptysis within 2 weeks<br> | |
| patients without hemoptysis within 2 years<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum VEGF and Ang-2 level in lung inflammatory disease according to the presence of hemoptysis | We'll measure the serum VEFG and Ang-2 level of enrolled patients within a week from the moment that patients agree to enroll this study. Therefore, Comparison of the serum VEGF and Ang-2 level (measured within a week from enrollment) according to the presence of hemoptysis will be primary outcome. | up to 7 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to investigate association between angiogenesis factors and other factors such as inflammatory biomarker and hypoxia. | We'll measure the serum VEFG, Ang-2 level, and other factors such as inflammatory biomarkers and PaO2 of enrolled patients within a week from the moment that patients agree to enroll this study. Therefore, Investigating association between angiogensis factors and other factors such as inflammatory biomarker and hypoxia, which were measured within a week from enrollment, will be secondary outcome. | up to 7 days after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vascular endothelial growth factor, angiopoietin-2