linjc16/ctgov huggingface dataset:
EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors

Study Overview
=================
Brief Summary
-----------------
Background: Preoperative pathologic diagnosis of subepithelial tumor (SET) can improve clinical decision making. Although EUS-guided fine needle aspiration (FNA) is currently considered the standard method for sampling SET, its diagnostic yield is generally suboptimal. EUS-guided fine needle biopsy (FNB) of SET is safe and feasible with adequate histology obtained. Objective: To compare the diagnostic accuracy of EUS-FNA and EUS-FNB.

Conditions
-----------------
Gastrointestinal Subepithelial Tumors

Intervention / Treatment
-----------------
* Procedure: Device: 22G FNA needle
* Procedure: Device: 20G FNB needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Esophageal, gastric, or duodenal SET over 2 cm Hypoechoic lesion including 4th layer on EUS Exclusion Criteria: SET with characteristic findings such as lipoma, vessels, or ectopic pancreas bleeding or rupture of SET platelet count <50,000 or prothrombin time INR > 1.3

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EUS-FNA<br>Device: 22G FNA needle | Procedure: Device: 22G FNA needle<br> <br> |
| Experimental: EUS-FNB<br>Device: 20G FNB needle | Procedure: Device: 20G FNB needle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy (proportion of correctly classified subjects (ture positive + true negative) among all subjects ) , compared to the gold standard diagnosis | Gold standard diagnosis is defined as; in operated patients; histological assessment of the surgical resection specimen in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of FNA and FNB samples and imaging studies) | 12 months |
Music and Sounds for ECV

Study Overview
=================
Brief Summary
-----------------
This international study is looking to see if the addition of music and sound on the maternal abdomen encourages fetal position change from breech to vertex in near term women.

Official Title
-----------------
Use of Music and Sounds for the External Cephalic Version of Breech Fetuses Near Term.

Conditions
-----------------
Breech Presentation, Vertex Presentation

Intervention / Treatment
-----------------
* Other: Music and Sound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women near term with breech presentation. Exclusion Criteria: women with a contraindication for vaginal birth

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music and Sound<br>Music and Sound applied to maternal abdomen through a special device for pregnant women. | Other: Music and Sound<br> <br> |
| No Intervention: no music and sound<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vertex position |  | 3 days post intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breech presentation, vertex presentation
Intravitreal Avastin in Proliferative Retinopathies

Study Overview
=================
Brief Summary
-----------------
The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes

Detailed Description
-----------------
Proliferative retinopathies due to different causes represent important causes for the visual acuity loss. Conventional treatments may sometimes improve the visual function, whereas other times, the visual acuity continue to decrease, in spite of all the medical, surgical or laser treatments. Intravitreal injections with anti-VEGF agents (ex. Avastin for our trial) seem to be an important tool for certain difficult situations in which at the ocular fundus, out of different reasons (advanced age, diabetes mellitus, retinal veins occlusions, etc)new pathologic vessels appear, causing devastating changes in the posterior and anterior segment as well.

Official Title
-----------------
Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes

Conditions
-----------------
Retinal Neovascularization

Intervention / Treatment
-----------------
* Drug: Avastin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of a proliferative retinopathy (AGE RELATED MACULAR DEGENERATION,DIABETIC PROLIFERATIVE RETINOPATHY, etc) distance acuity < 0.5 age > 20 years Exclusion Criteria: noncooperative patients ocular infections / inflammations

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A,1, II<br> | Drug: Avastin<br>* 2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively<br>* Other names: Bevacizumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The following parameters will be assessed in order to evaluate the Avastin effect: visual acuity, lesions's area at the ocular fundus |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intraocular pressure will be measured during the whole study in order to assess the possible side effects of Avastin injections |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antiVEGF therapy
To Evaluate Compliance to Treatment Regimen (Rate of Deviations From the Prescribed Regimen) in Polish Females Treated With Different Low Dose Oral Contraceptives

Study Overview
=================
Brief Summary
-----------------
Adherence to the dosing scheme is the principal element of Combined Oral Contraceptives efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral treatment. The aim of the study is to evaluate in everyday practice the relation between dosage errors and indicated factors, potentially influencing the compliance with the dosing scheme.

Official Title
-----------------
Prospective, Open-label Observational Survey Evaluating Patients Compliance to Administration Regimen During Low Dose Combined Oral Contraceptive Use in Everyday Praxis Data on Oral Contraceptives Compliance - DOC Study

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: EE/DRSP (Yasmin Product Family)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at the age of over 18 requiring contraception. The decisions would be made at the discretion of the attending physician. Exclusion Criteria: According to official Summary of Product Characteristics (SmPC) contraindications.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: EE/DRSP (Yasmin Product Family)<br>* One tablet per day, orally, 21 tablets followed by 7 days, during three consecutive cycles.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of users showing noncompliant behaviors |  | 3 consecutive cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The characteristics of noncompliant behavior |  | 3 consecutive cycles | 
| The relation between noncompliant behavior and selected factors |  | 3 consecutive cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contraception, Compliance
Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)

Study Overview
=================
Brief Summary
-----------------
The hyperglycemic response to surgery and the added effect of low-dose steroids (dexamethasone 4 to 8mg), and whether these differ in diabetics and nondiabetics remain unclear. Therefore, we prospectively evaluate the intraoperative and postoperative serum glucose concentrations in diabetics and nondiabetics that received intravenous steroid administration. This multicentre study include > 250 patients.Primary endpoiunt was glucose concentration at H6 after surgery. Secondary endpoints were glucose concentration at H12 and at H24 and effect of anesthesia (regional anesthesia)

Official Title
-----------------
Hyperglycemic Response to Steroid Administration After Noncardiac Surgery in Patients With and Without Diabetes

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: Steroid Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery under anesthesia Exclusion Criteria: < 50 kg emergency insulin therapy cardiac surgery refusal hyperglycemia> 2g/L

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diabetes<br>Patient with non insulin diabetes | Drug: Steroid Drug<br>* mesure of the glucose concentration<br>|
| control<br>Patient without diabete | Drug: Steroid Drug<br>* mesure of the glucose concentration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose concentration |  | 6-8 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose concentration |  | 12 hour | 
| glucose concentraion |  | 24 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, anesthesia, surgery, glucose
Large-Scale Metabolomic Profiling for the Diagnosis of Inborn Errors of Metabolism

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to determine the efficacy of a global metabolomic approach in testing for and diagnosing inborn errors of metabolism as opposed to traditional testing methods.

Detailed Description
-----------------
Residual samples will be tested for a variety of biomarkers that may lead to better understanding of these disorders and help develop treatment options.

Official Title
-----------------
Large-Scale Metabolomic Profiling for the Diagnosis of Inborn Errors of Metabolism

Conditions
-----------------
Congenital Disorders of Glycosylation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All individuals with specimens in Biochemical Genetics Laboratory and from patients collected under another IRB who have agreed to share samples/data Exclusion Criteria: None
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 |
| --- | --- | --- |
| Quantify N-linked glycan intermediates in plasma and urine | Measure N-linked glycan intermediates in plasma and urine from PMM2-CDG patients. | length of study, up to 5 years | 
| Develop quantitative biomarkers for PGM1-CDG patients to monitor the efficacy of galactose therapy. | Measure the 41 plasma N-glycan levels in 9 PGM1-CDG patients before and after galactose therapy. | length of study, up to 5 years | 
| Develop quantitative biomarkers for SLC35A2-CDG patients and monitor galactose therapy efficacy. | Measure levels of plasma N-glycans from 10 SLC35A2-CDG patients before and after galactose therapy. | length of study, up to 5 years | 
| Validate biomarker to diagnose and follow NGLY1 deficiency and monitor N-acetylglucosamine (GlcNAc) therapy response. | Measure the level of Sia-Gal-GlcNAc-Asn biomarker excretion during GlCNAc therapy. | length of study, up to 5 years | 
| Validate novel diagnostic biomarkers for ALG13-CDG | Measure GlcNAc-β-Asn on glycoproteins in the cells from the already available fibroblast of 9 ALG13 patients. | length of study, up to 5 years |
A Study to Evaluate Clinical Characteristics of Lung Cancer in Patients With Surgeries and Adjuvant Therapies

Study Overview
=================
Brief Summary
-----------------
The study was designed to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors

Detailed Description
-----------------
The trial is a multi-centre real-world non-interventional observational study to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors via a retrospectively review method on the study data on patient demographic/tumor biological characteristics and clinical treatments.

Official Title
-----------------
A Multi-centre Real-world Non-interventional Observational Study to Evaluate Clinical Characteristics of the Chinese Patients With Lung Malignant Tumors Who Received Surgeries or Surgeries Plus Adjuvant Therapies

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Surgeries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years old; Pathologically diagnosed lung malignant tumors after surgeries; Patients with lung surgeries; Patients with complete medical health records and follow-up visit information (at least one follow-up visit); Exclusion Criteria: Patients who were not performed with surgeries; Pathologically diagnosed patients with benign diseases after surgeries;

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 |
| --- | --- |
| Surgeries and adjuvant therapies<br>Surgeries or surgeries plus adjuvant therapies | Procedure: Surgeries<br>* Surgeries or surgeries plus adjuvant therapies<br>* Other names: Adjuvant therapies;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics of the patients with lung malignant tumors who received surgeries | Demographic characteristics of the patients with lung malignant tumors who received surgeries of thoracotomy, video-assistant thoracic surgery or robotic thoracic surgery as measured by: Age Gender Payment types Insurance types Smoking history Complications and symptoms of complications Respiratory functions Type of diagnoses | 2014 - 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location of tumors and tumor sizes | Location of tumors and tumor sizes | 2014 - 2017 | 
| Tumor clinical/pathological staging | Tumor clinical/pathological staging | 2014 - 2017 | 
| Type of biomarkers | Type of biomarkers | 2014 - 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, Chinese, surgeries, adjuvant therapies
Hepatitis E Infection : Emergence Mechanisms in North-Eastern France of Polymorphic Clinical Forms.

Study Overview
=================
Brief Summary
-----------------
The present research aims to collect virological and clinical data on hepatitis E virus (HEV) infections, either in acute or chronic forms of HEV infection in North-Eastern France, with liver- or non liver-related symptoms, plus data on HEV circulation in the outside environment. The purpose of this study is to improve the diagnosis and care of HEV-infected patients, as well as the preventive features to take into account in order to avoid food- and environment-borne infections. At last, we will investigate HEV molecular characteristics, with the hypothesis that some advantageous HEV strains coul be more pathogenic for some tissues and/or organs.

Official Title
-----------------
Hepatitis E Infection : Emergence Mechanisms in North-Eastern France of Polymorphic Clinical Forms.

Conditions
-----------------
Hepatitis E Infection in Humans and in Environment

Intervention / Treatment
-----------------
* Other: Only advice for diagnosis and prevention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HEV-infected patients, with hepatitis and/or neurological and/or renal symptoms Exclusion Criteria: Patients, with hepatitis and/or neurological and/or renal symptoms, infected by other viruses leading to hepatitis (hepatitis B, hepatitis C, hepatitis A ...)

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 |
| --- | --- |
| HEV-infected patients with hepatitis<br> | Other: Only advice for diagnosis and prevention<br>* Only advice for diagnosis and prevention<br>|
| HEV-infected patients with neurological features<br> | Other: Only advice for diagnosis and prevention<br>* Only advice for diagnosis and prevention<br>|
| HEV-infected patients with kidney features<br> | Other: Only advice for diagnosis and prevention<br>* Only advice for diagnosis and prevention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HEV IgM (qualitative assay); | Guidelines to improve HEV detection by using the 2 virological assays | 2 years | 
| HEV RNA (quantitative PCR assay) | Guidelines to improve HEV detection by using the 2 virological assays | 2 years |
Evaluation of Gastric Juice Samples During Standard Gastroscopy Procedure

Study Overview
=================
Brief Summary
-----------------
Development of a new diagnostic detection tool for gastrointestinal bleeding.

Detailed Description
-----------------
Literature does not support enough data/knowledge regarding stomach bleeding Hb levels in pathological situations and/or stomach bleeding levels following biopsy. It is important to understand the approximate concentration level of stomach bleeding before proceeding with technology development to insure this technology is capable of detecting such blood levels.

Conditions
-----------------
Gastrointestinal Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects ≥ 18 years old. Subject is scheduled for EGD endoscopy which includes biopsy, or, Subject is scheduled for EGD endoscopy following a bleeding event. Exclusion Criteria: Subject is either not competent or not willing to provide written informed consent.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric juice, Stomach, GI, Gastric juice samples with presence of blood.
Vancomycin in the Target Site Treatment of Intracranial Infection

Study Overview
=================
Brief Summary
-----------------
Vancomycin, a novel intravenously administered antibiotic, currently plays a key role in the management of complicated multi-organism infections. However,current LC-MS/MS methods briefly describe parameters and the only reported internal standard was sometimes difficult to obtain. In our study,an updated LC-MS/MS method for the quantitative analysis of vancomycin in human serum was developed.

Official Title
-----------------
Vancomycin in the Target Site Treatment of Intracranial Infection : a New Strategy for PK/PD Treatment

Conditions
-----------------
Vancomycin

Intervention / Treatment
-----------------
* Drug: Vancomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In ICU; ventricle drainage was carried out; renal function is normal, namely creatinine clearance rate is >60ml/min; Exclusion Criteria: women in pregnancy or lactation;in patients with renal insufficiency, the creatinine clearance rate (Clcr) is less than 60ml/min.

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: Vancomycin 1g q12h<br> | Drug: Vancomycin<br>* Vancomycin, a novel intravenously administered glycylcycline antibiotic, currently plays a key role in the management of complicated multi-organism infections.<br>|
| Experimental: Vancomycin 1g q8h<br> | Drug: Vancomycin<br>* Vancomycin, a novel intravenously administered glycylcycline antibiotic, currently plays a key role in the management of complicated multi-organism infections.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancomycin concentration change in serum and cerebrospinal fluid | Quantitative analysis of vancomycin in serum and cerebrospinal fluid after treatment by an updated LC-MS/MS method. | 0.5h, 1h, 1.5h, 3h, 5h, 7h, 9h, and 12h after treatment |