linjc16/ctgov huggingface dataset:
Acoustic Radiation Force Impulse Imaging (ARFI) in Patients After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Aims: Prospective evaluation of the applicability of acoustic radiation force impulse(ARFI) imaging to assess liver fibrosis in patients after orthotopic liver transplantation. Material and methods: We prospectively assess the performance of ARFI imaging in planned 100 patients after orthotopic liver transplantation. We evaluate shear wave velocity of the left and right liver lobe with the convex array (6C1HD)ultrasound transducer and compare the results with clinical data and B-mode criteria. ARFI elastometry is an increasingly popular non-invasive method for the assessment of hepatic fibrosis and cirrhosis. To date, ARFI technology has not been applied systematically in patients after orthotopic liver transplantation. Therefore we want to establish standard values in this population.

Official Title
-----------------
Acoustic Radiation Force Impulse Imaging (ARFI) in Patients After Liver Transplantation

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Device: ARFI imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients after orthotopic liver transplantation. Exclusion Criteria: Patients without status after orthotopic liver transplantation.
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 after liver transplantation<br> | Device: ARFI imaging<br> <br> |

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
-----------------
standard, values, share, wave velocity, in ARFI imaging
Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application

Study Overview
=================
Brief Summary
-----------------
This eight-hour kinetic regression clinical study was conducted to assess the ability of MetroGel® 1% to deliver moisture to facial skin after a single application.

Detailed Description
-----------------
This eight-hour kinetic regression clinical study was conducted to assess the ability of MetroGel® 1% to deliver moisture to facial skin after a single application as measured by the Corneometer CM 825.

Official Title
-----------------
MetroGel 1% Hydration Study: A Kinetic Regression Study

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Drug: Metronidazole gel 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of moderate to severe rosacea, defined as the presence of at least moderate erythema with telangiectasia and a minimum of two inflammatory lesions Exclusion Criteria: Individuals with active symptoms of allergy (mild active seasonal allergies are acceptable) or atopic dermatitis

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Metronidazole gel 1%<br>* Applied once to a test site on the right or left cheek (as determined by a randomization design)<br>* Other names: MetroGel® 1%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six replicate Corneometer CM 825 measurements |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 1 day |
Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open surgery according to modified Lichtenstein procedure with light weight mesh.

Official Title
-----------------
Prospective Randomized Study to Evaluate the Recovery of a Hernia Inguinalis by a Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery According to Modified Lichtenstein Procedure With Light Weight Mesh

Conditions
-----------------
Hernia, Inguinal

Intervention / Treatment
-----------------
* Device: Polysoft Mesh
* Device: Light Weight Mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic hernia inguinalis > 18 years

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Light Weight Mesh<br> | Device: Light Weight Mesh<br>* Light Weight Mesh is used.<br>|
| Active Comparator: Polysoft Mesh<br> | Device: Polysoft Mesh<br>* Polysoft Mesh is used.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of relapse |  | Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. | 
| Postoperative pain assessment |  | Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. | 
| Duration to full recovery (able to do all activities) |  | Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hernia Inguinalis
Constructed Intervention by Home and School Diabetes Nurse Visits on Diabetic Control of Children With Type I Diabetes

Study Overview
=================
Brief Summary
-----------------
The investigators assume that an intervention program that includes home visits and trainings of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic balance, a decrease in complications' rate, a reduction of hospitalizations and an economic streamlining.

Detailed Description
-----------------
The investigators assume that during the study, subjects from the intervention group will reach a better metabolic balance than the control group. In this group the following changes will occur: A decrease in HbA1C levels. A decrease in Hypoglycemia events. A decrease in DKA events. A decrease in patients' visits in ER and hospitalizations. An improvement in the knowledge of the patients and their families about the disease.

Official Title
-----------------
The Efficacy of Constructed Intervention by Home and School Visits by Diabetes Nurses on Diabetic Control of Children With Type I Diabetes

Conditions
-----------------
Type 1 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 DM diagnosis from at least 8 months/ HbA1C levels >8 Signed inform consent. Exclusion Criteria: - Children who are not in educational settings and are not hebrew or arabic speakers.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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 |
| --- | --- |
| type 1 DM children- intervention group<br>will have home visits and trainings at school | |
| type 1 DM children- control group<br>will receive the standard care at the clinic | |

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
-----------------
children
Needle Aspiration for Large Cephalohematoma

Study Overview
=================
Brief Summary
-----------------
The cephalohematoma is a common pathology of newborns. Observation is the primary treatment for the most of small uncomplicated cephalohematoma. However large cephalohematoma can lead to calcification with anesthetic local deformation or deformational plagiocephaly. The objective of the study was to evaluate the iatrogenic risk associated with early puncture on local anesthesia.

Detailed Description
-----------------
This is a retrospective study of 67 newborns followed at the University Hospital of Montpellier between 2010 and 2017. Treatment was puncture under local anesthesia between 2 and 4 weeks of life. Any potential complication events were searched retrospectively during the month after the puncture. Analyze of the electronic medical record was made as followed: read of peri-operative and post-operative reports, looking for readmission in Pediatric Emergency department and finally read of the report of the clinical control 1 month after the procedure

Official Title
-----------------
Needle Aspiration for Large Cephalohematoma : a Retrospective Study of Complications

Conditions
-----------------
Cephalohematoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: diagnosis of cephalohematoma was performed by the two senior plastic pediatric surgeon of the study the diagnosis was confirmed by ultrasound examination Exclusion criteria: Skull fracture (seen by ultrasound examination) Intra-cranial complication (ultrasound examination)

Ages Eligible for Study
-----------------
Minimum Age: 15 Days
Maximum Age: 30 Days

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 |
| --- | --- | --- |
| Complication events during the month after the puncture. | retrospective data collection. Analyze of the electronic medical record was made as followed: read of peri-operative and post-operative reports, looking for readmission in Pediatric Emergency department and finally read of the report of the clinical control 1 month after the procedure | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cephalohematoma, Infant, Newborn, Perinatal Care, Plagiocephaly, Nonsynostotic, Skull/pathology
Effect of Sitagliptin on Progression of Coronary Intermediate Lesion

Study Overview
=================
Brief Summary
-----------------
This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on Progression of Coronary Intermediate Lesion.

Official Title
-----------------
Effect of Sitagliptin on Progression of Coronary Intermediate Lesion in Patients With Coronary Heart Disease Complicated With Type 2 Diabetes

Conditions
-----------------
Atherosclerosis, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Sitagliptin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18, < 80 years old, with type 2 diabetes mellitus and angiographically proven Coronary Intermediate Lesion. Exclusion Criteria: Allergy or hypersensitivity to any of the drug's components. Severe liver failure, moderate or severe kidney failure Malignant disease. Active infectious disease. Pregnancy or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Sitagliptin<br>Sitagliptin 100mg QD | Drug: Sitagliptin<br>* 5 mg, 1 tablet per day for 12 months<br>* Other names: JANUVIA;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo,1 tablet per day for 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in late lumen loss of target lesion | A coronary intermediate lesion in Patients with coronary heart disease complicated with Type 2 Diabetes was measure with 3D QCA(3D Quantitative Coronary Angiography). To measure the changes in target lumen at 12 months. | Changes from baseline in late lumen loss of target lesion at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of MACE | MACE include composite of death, myocardial infarction, or target-vessel revascularization. | Incidence rate of MACE from baseline to 12 months |
Cost Effectiveness Analysis of an Ancillary Study of the REMOTEV Study

Study Overview
=================
Brief Summary
-----------------
The implications of the medico-economic impact are essential in the choice of first-line therapists. The economic impact is an important criterion to recommend the privileged use of Direct Oral Anticoagulants (AOD) in first intention.

Official Title
-----------------
Efficacy Cost Analysis: Retrospective Study on the REMOTEV Study's Ancillary Data

Conditions
-----------------
Venous Thromboembolic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Major patient whose age is ≥18 years Patient with a diagnosis of MTEV: pulmonary embolism or deep vein thrombosis diagnosed by the diagnostic reference methods according to the recommendations Major patient included in the REMOTEV registry Patient having accepted that his data recorded in the REMOTEV register be re-used for research and publication purposes Criteria of non-inclusion Refusal to participate in the REMOTEV register Patient who refused to have his data reused for research and publication purposes Pregnant woman Subjects under safeguard of justice Subject under guardianship or 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 |
| --- | --- | --- |
| Cost-effectiveness analysis between 2 therapeutic strategies, Direct Oral Anticoagulants (Rivaroxaban) versus standard anticoagulant (AVK) | Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs. | The period from November 1st, 2013 to July 01, 2015 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous, Thromboembolic, Direct Oral Anticoagulants, AOD, Cost analysis, REMOTEV, AVK, Pulmonary embolism
Acute Glycemic Effects of a Very Low Fat Diet in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
There is some consensus that high fat diets can contribute to the development of obesity and type 2 diabetes in humans and animals. An increase in dietary fat has been shown to produce obesity and diabetes in mice; such diet-induced diabetes can be reversed by reducing the fat in the diet. In humans, there is some evidence that low-fat diets can produce acute improvements in blood sugar control in type 2 diabetes-even in the absence of weight loss. In most human studies, however, dietary fat reduction has been accompanied by a reduction in total calorie intake. It is thus not possible to separate the effects of these 2 metabolic changes. The purpose of this study is to gather preliminary information on the effect of a very-low-fat diet on blood metabolism in persons with type 2 diabetes. The design incorporates controlled feeding procedures, and 30 men and women with type 2 diabetes will be given all foods for 4 weeks--a 2-week diet standardization period (diet composition: 35% fat, 15% protein, 50% carbohydrate), followed by a 2-week experimental diet period. The experimental diet conditions are A) continuation of the moderately-high-fat standardization diet, or B) a very-low-fat diet composed of 10% fat, 15% protein, 75% carbohydrate. Outcomes will be measured after the standardization and the experimental periods. The primary outcome variable is fasting plasma glucose; secondary outcomes are fasting insulin, carbohydrate (meal) tolerance, insulin secretion and blood lipids. In addition, we will gather descriptive data on the potential acceptability and utility of a very-low-fat diet constructed using the fat substitute, olestra (sucrose polyester). There are no results yet.

Conditions
-----------------
Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
-----------------
* Procedure: very low fat diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes, not tightly controlled at present Not using medication (insulin or oral) to control blood sugar Overweight, but generally healthy

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: very low fat diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Regional Anesthesia Practice in Greece

Study Overview
=================
Brief Summary
-----------------
The purpose of this structured questionnaire is to provide useful insight on the practice of regional anesthesia in Greece and depict the result of educational efforts taking place in the country to expand the knowledge and practice of regional anesthesia in the country

Official Title
-----------------
Regional Anesthesia Practice in Greece and Depiction of the Effect of Educational Activities in This Respect

Conditions
-----------------
Questionnaire, Survey

Intervention / Treatment
-----------------
* Procedure: participation in Regional Anesthesia Seminar
* Procedure: no participation in Regional Anesthesia Seminar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: greek anesthesia practitioners Exclusion Criteria: nurses operating department assistants surgeons

Ages Eligible for Study
-----------------
Minimum Age: 24 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 |
| --- | --- |
| participation in Regional Anesthesia Seminar<br>this group consists of anesthesiologists that have attended a Regional Anesthesia Seminar taking place once a year | Procedure: participation in Regional Anesthesia Seminar<br>* this group of anesthesiologists attended the Regional Anesthesia Seminar<br>|
| no participation in Regional Anesthesia Seminar<br>this group consists of anesthesiologists that have not attended a Regional Anesthesia Seminar taking place once a year | Procedure: no participation in Regional Anesthesia Seminar<br>* this group of anesthesiologists did not attend the Regional Anesthesia Seminar<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge and practice of regional anesthesia techniques | this is a 36-item free-text questionnaire, aiming at assessing knowledge and practice of regional anesthesia amongst participants | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
seminar, regional anesthesia practice
Pulmonary and Upper Limb Functions in Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
Although it is known that the functions of pulmonary and upper limb is affected in late stage of Duchenne Muscular Dystrophy (DMD) negatively, the investigators do not have clear information about its early stage. The aim of this study was to investigate the differences in pulmonary and upper limb functions between children with DMD in early stage and healthy peers.

Official Title
-----------------
The Comparison of Pulmonary and Upper Extremity Functions Between Children With Duchenne Muscular Dystrophy and Healthy Peers

Conditions
-----------------
Duchenne Muscular Dystrophy, Upper Limb Function, Respiratory Function Test

Intervention / Treatment
-----------------
* Other: The Performance of Upper Limb Questionnaire (PUL)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with DMD was; age between 5-10 years being on treatment with corticosteroids for more than 6 months being at Level I according to Brooke Upper and Lower Extremity Classification Systems Healthy peers; age between 5-10 years not having any diagnosed disease Exclusion Criteria: • Children has undergo surgery and disease affect upper extremity or pulmonary function in last six months.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient Group<br>Children whose ages between 5-10 years with Duchenne Muscular Dystrophy. | Other: The Performance of Upper Limb Questionnaire (PUL)<br> <br> * Other names: Pulmonary Function Test (PFT);|
| Healthy Group<br>Healthy peers | Other: The Performance of Upper Limb Questionnaire (PUL)<br> <br> * Other names: Pulmonary Function Test (PFT);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function Test (PFT) | The pulmonary function tests of the participants were evaluated with a spirometry. The child was asked to perform the spirometric tests for three times with maximum effort. The child was motivated before each attempt for stronger and longer expiration.The result of Pulmonary function Test were recorded. | 5 minutes | 
| The Performance Upper Limb (PUL) | Upper limb functions of participants were evaluated with The Performance of Upper Limb (PUL) scale. This scale, which was shown to be reliable in DMD, has 22 items in total. It consists of 3 different levels of function: high, mid, and distal. PUL also has four items determining timed performance. | 15 minutes |