linjc16/ctgov huggingface dataset:
Non-invasive Evaluation of Hepatic Fibrosis in Patients With the Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Non-alcoholic fatty liver disease (NAFLD) is now recognised as the hepatic complication of the metabolic syndrome of insulin resistance. In some patients, the disease can progress into steatohepatitis (NASH) which associates fatty liver, hepatocellular damage, chronic inflammation and variable and progressive fibrosis. The latter can evolve into cirrhosis and end-stage liver disease. Thus the presence of fibrosis sign the severity of the disease, and therefore its accurate detection is crucial for the identification of patients in need of treatment and appropriate follow-up. To date, histological examination of a biopsy of the liver is the gold standard in the diagnosis of fibrosis. the procedure is however associated with significant complication in 0.01 to 0.1% of cases and with sampling errors because it analyses only a minimal portion fo the liver. The aim of the study is to evaluate, in a population of patients with the metabolic syndrome, whether non-invasive tests may identify those with hepatic fibrosis. At inclusion, serum tests, fibroscan (elastography of the liver by ultra-sounds) and elastography by MRI will be performed. Those tests will be repeated within 2 months. A liver biopsy will be performed if 2 out of the 3 (serum test, fibroscan or elastography) tests are suggestive of hepatic fibrosis. This study will allow to determine whether hepatic fibrosis may be detected by non-invasive means in patients with NAFLD/NASH. whether there is a correlation between non-invase tests and liver biopsy for assessment of fibrosis and it severity whether the presence of fatty liver interfere with the results of the fibroscan and the elastography. whether there are metabolic factors associated with an increased risk of fibrosis in this population.

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metabolic syndrome with 3 out of 5 criteria (ATP III definition) Exclusion Criteria: alcohol intake > 20g/day (women), > 30g/day (men) chronic liver disease of other cause: viral hepatitis (HBV, HCV), Wilson's disease, haemochromatosis, alpha1 anti-trypsin deficiency, drug-induced, ... decompensated cirrhosis (Child-Pugh 3) body weight > 120 Kg

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic syndrome, insulin resistance, NASH, hepatic fibrosis, Fibroscan, elastography by MRI
Unnoticed Gloves Perforation

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to investigate the incidence of glove perforation in cannulation of blood vessels (CBV) during resuscitation and compare perforation rates between single and double-gloves.

Detailed Description
-----------------
Exposure to blood pathogens among medical staff is a serious problem that should be first and foremost prevented . The risk of acquiring a virus from one percutaneous needle stick is 0.3% to 0.4% for human immunodeficiency virus (HIV), 6% to 30% for hepatitis B (HBV), and 2.7% to 10% for hepatitis C (HCV). The prevention of blood-borne infections is particularly important during cases when emergency medical attention is needed. Emergency Response Personnel that work in this profession have taken medical rescue courses to prepare for situations of sudden health threats, hence the majority of procedures is associated with direct contact with body fluids of the patient.

Official Title
-----------------
Double Gloves: A Randomized Trial to Evaluate a Simple Strategy to Reduce Contamination During Resuscitation

Conditions
-----------------
Catheterization, Contamination

Intervention / Treatment
-----------------
* Procedure: single-gloving system
* Procedure: double-gloving system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Give voluntary consent to participate in the study Medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians) Exclusion Criteria: Not meet the above criteria Wrist or low back diseases

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheterization<br>Blood vessel Catheterization during resuscitation with single and double - gloving system. Catheterization was performed using simulation mannikin | Procedure: single-gloving system<br>* single-gloving system was used during Catheterization<br>Procedure: double-gloving system<br>* double-gloving system was used during Catheterization. inner and outer gloves were the same size<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visible puncture | Checking gloves for visible damage in the course of cannulation during resuscitation | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WLT | Water leak test was used to checking unnoticed gloves damage | 1 day |
Comparison of Different Inspiratory to Expiratory Ratios on Respiratory Mechanics and Oxygenation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum

Study Overview
=================
Brief Summary
-----------------
The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Previous studies have proposed that a prolonged I:E ratio ventilation improved respiratory mechanics and gas exchange. Therefore, the aim of this study is to evaluate whether a prolonged I:E ratio ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.

Conditions
-----------------
General Anesthesia Using Endotracheal Intubation

Intervention / Treatment
-----------------
* Other: prolonged inspiratory to expiratory (I:E) ratio (1:1)
* Other: conventional I:E ratio (1:2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male patients (20-90 years of age) scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia Exclusion Criteria: Patients with an abnormal airway anatomy, reactive airway diseases, chronic respiratory diseases, a history of coronary artery diseases, or heart failure BMI > 30 kg/m 2

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prolonged I:E ratio (1:1) group<br> | Other: prolonged inspiratory to expiratory (I:E) ratio (1:1)<br>* 80 patients are randomly allocated into two groups : prolonged I:E ratio (1:1) (n=40) and conventional I:E ratio (1:2) group (n=40). In the prolonged I:E ratio (1:1), mechanical ventilation is maintained with during I:E ratio 1:1 during steep trendelenburg with pneumoperitoneum.<br>|
| Active Comparator: conventional I:E ratio (1:2) group<br> | Other: conventional I:E ratio (1:2)<br>* 80 patients are randomly allocated into two groups : prolonged I:E ratio (1:1) (n=40) and conventional I:E ratio (1:2) group (n=40). In the conventional I:E ratio (1:2) group (n=40), mechanical ventilation is maintained with during I:E ratio 1:2 during steep trendelenburg with pneumoperitoneum.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The peak inspiratory pressure | The peak inspiratory pressure during mechanical ventilation with endotracheal intubation under general anesthesia | before 10 minutes after anesthesia induction, 30 and 60 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position and CO2 desufflation |
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment.

Official Title
-----------------
A Randomized, Double-blind, Placebo Controlled, Phase IIA Study to Assess the Effect on Gastroesophageal Reflux Disease (GERD) Symptoms, Pharmacokinetics, Safety and Tolerability of 4 Weeks Treatment With AZD3355 65 mg Bid as add-on Treatment to a Proton Pump Inhibitor (PPI) in Patients With an Incomplete Response to PPI.

Conditions
-----------------
Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
-----------------
* Drug: AZD3355


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent At least 6 months history of Gastroesophageal reflux disease (GERD) symptoms Continuous treatment with Proton Pump Inhibitor (PPI) Ability to read and write Exclusion Criteria: Prior surgery of the upper gastrointestinal (GI) tract History of clinically significant diseases other than GERD Need for concomitant medication with drugs that may influence gastrointestinal symptoms

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD3355|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment | Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary | Twice daily during the last seven days on treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule |  | An interval of one to two hours after the first intake of AZD3355 65 mg capsule | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heartburn, Patient reported symptoms, Proton pump inhibitor
Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate

Study Overview
=================
Brief Summary
-----------------
Aspirin is very common in older patients. Therefore many of the investigators patients have aspirin. The aim of the study is to proof that Transurethral Surgery of the bladder or the prostate can be performed with aspirin.

Official Title
-----------------
Prospektive Doppel-Blind-randomisierte Studie Zur Verwendung Von Aspirin Bei Transurethralen Operationen

Conditions
-----------------
Blood Loss, Surgical, Intraoperative Complications, Re-operation Rates in Patients With Aspirin Treatment

Intervention / Treatment
-----------------
* Drug: transurethral surgery with or without aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transurethral surgery of the bladder or prostate, informed consent, age over 18 Exclusion Criteria: Oral anticoagulation,

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>aspirin 100mg | Drug: transurethral surgery with or without aspirin<br>* aspirin 100mg once a day, transurethral surgery with or without aspirin<br>* Other names: Asprin cardio 100mg;|
| Placebo Comparator: 2<br>empty capsule | Drug: transurethral surgery with or without aspirin<br>* aspirin 100mg once a day, transurethral surgery with or without aspirin<br>* Other names: Asprin cardio 100mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss |  | intraoperative, 6 hours post op, 3 days postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation rates |  | during hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aspirin, blood loss, transurethral surgery
French Observatory of Rare Malignant Tumors of the Ovary

Study Overview
=================
Brief Summary
-----------------
To take charge of the treatment in rare adult ovarian tumors with an homogenous manner (germinal and sexual cords tumors), at different stages of the disease.

Detailed Description
-----------------
to establish prognosis factors for the disease to proceed in a centralised examination of histologic laminas to reach in the long-term and homogenous follow-up of the patients to follow-up the long-term toxicities of the treatments given to analyse and follow-up the later fertility of the patients to evaluate the interest of setting a multi-disciplinary discussion forum on the Web

Official Title
-----------------
Observatoire Francophone Des Tumeurs Malignes Rares de l'Ovaire : Protocole de Prise en Charge Chez l'Adulte (Tumeurs Germinales et Des Cordons Sexuels)

Conditions
-----------------
Ovarian Tumors

Intervention / Treatment
-----------------
* Drug: chemotherapies protocols


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years old germinal or sexual cords ovary tumors histologically proven first line or relapse treatment written informed consent Exclusion Criteria: mental ineptitude to understand and follow the study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chemotherapies protocols|Cisplatine 20 mg/m² IV Etoposide 100 mg/m² IV Bléomycine 30 mg IV|

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
-----------------
ovarian tumors, rare ovarian tumors, germinal tumors, sexual cords tumors, observatory, forum
Human Epidemiology of Newly Identified Arboviruses

Study Overview
=================
Brief Summary
-----------------
A local network is being set up to study the impact of arboviruses in our region. It is committed to a one-health approach, in particular with research without a priori for new viruses hosted among vectors and wildlife. The candidates identified by high throughput sequencing approaches will serve as a basis for the development of serological and molecular tools for their detections. These tools will be used to assess the possible circulation of these new viruses in humans in biological collections created within the framework of this project Arbodocc .

Official Title
-----------------
Epidemiology in Humans of New Arbovirusus Sorted Out From Metagenomic Screen in Local Vectors and Animal Hosts.

Conditions
-----------------
Arbovirus Infections, SARS-CoV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Patients admitted at the Monpellier University Hospital for any infectious syndrome compatible with an arboviral infection with samples available Exclusion criteria: - Informed consent non obtain for samples used

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- | --- |
| Seroprevalence | Detection of antibodies targeting specific antigens of newly identified arboviruses | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular detection | Detection of newly identified arboviruses genome | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with arboviral infection compatible signs, Unexplained isolated fever, Neurological infection conditions without any identified etiology, Arbovirus, Arboviral like infectious disease
Clinical and Paraclinical Characteristics of the Systemic Scleroderma Cohort According to the Criteria ACR 2013 and the History of Professional Exposure or of Agricultural Environment

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the exposure to environmental and professional toxics by patients with systemic scleroderma and by patients not achieved by this pathology.

Detailed Description
-----------------
This study is based on a questionnaire. The data will be collected according a retrospective and prospective design : at diagnostic of the disease at the inclusion in the systemic scleroderma cohort during the annual visit (in 2017-2018-2019-2020)

Official Title
-----------------
Clinical and Paraclinical Characteristics of the Systemic Scleroderma Cohort According to the Criteria ACR 2013 and the History of Professional Exposure or of Agricultural Environment

Conditions
-----------------
Systemic Scleroderma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with systemic scleroderma Exclusion Criteria: -

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 |
| --- | --- | --- |
| Questionnaire to evaluate the exposition of environmental and professional toxics | clinical, personal and professional data | once a year up to 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
systemic scleroderma, environmental and professional toxics
The Efficacy and Safety of PEG-rhG-CSF in Neutropenia After Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of the trail is to evaluate the efficacy and safety of PEG-rhG-CSF in primary prophylaxis and secondary prophylaxis of neutropenia after chemotherapy.

Conditions
-----------------
Mammary Cancer, Lymphoma, Bone Tumour, Gynecological Tumors

Intervention / Treatment
-----------------
* Drug: PEG-rhG-CSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with age between 18 and 70 years. Breast cancer, lymphoma, bone tumor or Gynecologic tumor patients. With multi-cycle chemotherapy. With III/IV degree neutropenia after the last cycle of chemotherapy and plans to use the same regimen in the subsequent cycles.FN risk of the chemotherapy regimens is ≥20%，or 10%≤FN risk<20% and has high risk factors associated with FN. KPS score≥ 70. Expected to survive more than 3 months. No hematologic system disease and ANC≥1.5×10E9/L, PKT≥80×10E9/L, Hb≥ 75g/L, WBC≥3×10E9/L, and no bleeding tendency. Written informed consent are acquired. - Exclusion Criteria: With infection or systemic antibiotic therapy 72h before chemotherapy. With any abnormal hematopoietic function. Received transplantation within 3 months. Suffered from other malignant tumor or brain metastases. TBIL, ALT,AST > 2.5×ULN; if it were caused by liver metastases, TBIL, ALT,AST >5×ULN. Cr >1.5 ×ULN. Sensitive to the product or other genetically engineered biological products from Escherichia coli strains. Mental or nervous system disorders. Refused to accept contraceptive measures. Other situations that investigators consider as contra-indication for this study. -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF<br> | Drug: PEG-rhG-CSF<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of febrile neutropenia (FN) |  | 30days after PEG-rhG-CSF administration |