linjc16/ctgov huggingface dataset:
Relationship Between Polymorphism of Heat Shock Protein 70 Gene and Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Polymorphisms of HSP70 and tumor necrosis factor-alpha promoter in patients with hepatocellular carcinoma, chronic liver disease and healthy controls will be measured by PCR-RFLP or direct sequencing. The clinical relevance of patients will be compared in those with polymorphism and those without.

Detailed Description
-----------------
Heat shock protein 70 (HSP 70) may be involved in various aspects of immune system including infection, autoimmunity, and tumor immunity. The relationship between HSP70 expression, disease activity and cancer prognosis varied according to type of cancer. The overexpression of HSP70 by tumor cells contributes to tumor behavior. HSP70 is present in normal and abnormal hepatocytes, and was reported to be over-expressed in both hepatoma cell lines and human hepatocellular carcinoma (HCC) tissue. Recent study indicated that HSP70 is a molecular marker during early hepatocarcinogenesis. It is also involved in anti-tumor immunity in HCC.We also investigate the polymorphism of tumor necrosis factor-alpha promoter, and correlated to clinical relevance.

Official Title
-----------------
Relationship Between Polymorphism of Heat Shock Protein 70 Gene and Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Genetic: Polymorphisms of HSP70 and TNF promoter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History proven HCC patients Exclusion Criteria: No-definite diagnosed patients
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSP70 and TNF polymorphisms<br> | Genetic: Polymorphisms of HSP70 and TNF promoter<br>* To assess the relationship between clinical relevance and polymorphisms of HSP70 and tumor necrosis factor-alpha with PCR_RFLP<br>* Other names: polymorphism of tumor necrosis factor-alpha promoter;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical relevance |  | year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical relevance |  | year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heat shock protein70, tumor necrosis factor-alpha promoter, polymorphism
A Comparison of Insulin Drip Protocols in Labor: A Randomized Trial

Study Overview
=================
Brief Summary
-----------------
To assess which of two commonly utilized insulin drip protocols has better outcomes when used during the labor process.

Official Title
-----------------
A Comparison of Insulin Drip Protocols in Labor: A Randomized Trial

Conditions
-----------------
Diabetes, Pregnancy

Intervention / Treatment
-----------------
* Procedure: Insulin drip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a. Pregnant patients with either pre-existing diabetes or gestational diabetes type A2 who require insulin for euglycemia during labor and delivery Exclusion Criteria: a. Those patients who decline participation b. Patients less than age 18 at the time of enrollment will be excluded to protect this vulnerable patient population c. Those patients who cannot be consented d. Patients scheduled for cesarean delivery

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Protocol A<br>Our current standard during labor | Procedure: Insulin drip<br> <br> |
| Active Comparator: Protocol B<br>Another commonly accepted alternative for insulin drip management during labor | Procedure: Insulin drip<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean maternal glucose |  | Labor | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin drip, labor
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To compare the efficacy and safety of DVS-233 SR versus placebo treatment in reducing the relapse rate of depressive symptoms in subjects with major depressive disorder (MDD), and to compare the percentages of relapse in terms of time to relapse between DVS-233 SR and placebo treatment groups by using survival analysis. Secondary Objective: To assess the response of subjects on DVS-233 SR versus placebo for the clinical global evaluation, functionality, general well-being, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] < 7).

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: DVS-233 SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria in the open-label phase: Outpatients Men and women 18 to 75 years of age, inclusive. Sexually active women participating in the study must use a medically acceptable form of contraception (Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception) Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features (If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present.) Exclusion Criteria: Treatment with DVS-233 SR at any time in the past Treatment with venlafaxine (immediate release [IR] or ER) within 90 days of study day 1 Known hypersensitivity to venlafaxine (IR or ER)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DVS-233 SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical and Histological Features of Head and Neck Melanoma

Study Overview
=================
Brief Summary
-----------------
The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. Among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse prognosis than melanomas at other sites. The question whether head and neck melanomas could be a distinct entity has been debated.

Detailed Description
-----------------
Aim of the study was to compare clinical and histological characteristics between head and neck melanomas and melanomas at other sites.

Official Title
-----------------
Clinical and Histological Features of Head and Neck Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with melanoma melanoma diagnosed between January 2004 and December 2011 patients living in Champagne-Ardenne
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| melanoma<br>Patients with melanoma. | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location of melanoma | Location of melanoma was classified in head and neck (scalp, forehead, temples, ears, neck, eyelids, nose, cheeks and area around mouse/chin) or other location (upper limb, lower limb, trunk, hand and foot). | Day 0 |
Work of Breathing in Premature Infants at Discharge

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not require oxygen for at least 28 days during their time in the NICU.

Detailed Description
-----------------
Work of breathing tests will be performed on premature infants who required oxygen for at least 28 days during their time in NICU. These same work of breathing tests will be performed in another group of premature infants who did not require oxygen for at least 28 days during their time in the NICU. The two groups will be compared.

Official Title
-----------------
Work of Breathing and Oxygen Saturation Stability in Premature Infants With History of Respiratory Insufficiency Prior to Discharge

Conditions
-----------------
Bronchopulmonary Dysplasia, Very Low Birth Weight Infant, Prematurity

Intervention / Treatment
-----------------
* Other: Enrollment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born at greater than 26 weeks gestation, weighing less than 1500 grams at birth. Infants with diagnosis of BPD and without diagnosis of BPD Exclusion Criteria: Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 7 Months

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 |
| --- | --- |
| Infants WITH diagnosis of bronchopulmonary dysplasia (BPD)<br>Preterm infants who were on oxygen at 28 days of life. | Other: Enrollment<br>* All infants whose families consent will be enrolled and will all receive the same treatment which included measurements of work of breathing.<br>|
| Infants WITHOUT diagnosis of bronchopulmonary dysplasia (BPD<br>Preterm infants who were not on oxygen at 28 days of life. | Other: Enrollment<br>* All infants whose families consent will be enrolled and will all receive the same treatment which included measurements of work of breathing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work of breathing indices | Respiratory Inductance Plethysmography (RIP) measurements will be taken and Phase Angle will be measured. | 25 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intermittent Hypoxia | Oxygen saturation will be measured using a high resolution pulse oximeter. | 25 minutes |
The Investigation of a Fluorescence/Elastic Scattering Spectroscopy (F-ESS) Device for Oral Tissue Characterization

Study Overview
=================
Brief Summary
-----------------
The overall objective of this work is to identify changes in the optical properties of oral tissues to develop a non-invasive tool for the detection, diagnosis and screening of oral pathology so that treatment can be provided at the earliest possible time.

Detailed Description
-----------------
Specifically, we will be obtaining optical spectroscopic data using a fiber optic contact probe that exploits elastic-scattering spectroscopy and fluorescence spectroscopy. Both of these technique have independently shown to provide signatures for the onset of cancer, with varied success. The purpose of this effort is to combine the two techniques and develop and understanding of the signatures obtained in both normal and abnormal oral tissue with simultaneous collection of these optical signatures.

Official Title
-----------------
a Non-invasive Device for the Detection, Diagnosis and Screening of Oral Pathology

Conditions
-----------------
Other Lesions of Oral Mucosa

Intervention / Treatment
-----------------
* Device: Fluorescence/Elastic Scattering Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult over 18 years of age Exclusion Criteria: younger than 18 years of age

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 |
| --- | --- |
| Oral Tissue measurement<br>Fluorescence/Elastic Scattering Spectroscopy Oral tissue measurement | Device: Fluorescence/Elastic Scattering Spectroscopy<br>* Fluorescence/Elastic Scattering Spectroscopy Oral tissue measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Tool | Fluorescence/Elastic Scattering Spectroscopy Oral tissue measurement | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral tissue
Foresight Intracardiac Echocardiography (ICE) System

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy of 2D forward-looking and 3D Intracardiac Echocardiography (ICE) to guide septal punctures during Atrial Fibrillation ablation procedures.

Detailed Description
-----------------
This study is part of a multiphase study. Phase 1 involves 10 patients at a single centre. Phase 2 will be done a multi centre study.

Official Title
-----------------
Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac Echocardiography (ICE) System

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Foresight ICE System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years old. Patient is undergoing an atrial fibrillation ablation procedure. Patient has a transesophageal echocardiogram (TEE) within the 48 hours prior to ablation procedure to rule out left atrial thrombus. Patient provides informed, written consent for participation in the study. Exclusion Criteria: Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician performing the procedure). Patients in whom transseptal puncture is relatively contraindicated. Patients in whom left atrial clot or dense spontaneous contrast is identified on TEE, which would increase thromboembolic risk. Women of child bearing potential, in whom pregnancy cannot be excluded. Patients unable to grant informed, written consent for participation in the study.

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm- Foresight ICE System<br>This open label feasibility study will evaluate the Foresight ICE system for imaging chambers of the heart and guiding transseptal puncture during an atrial fibrillation (AF) ablation procedure. | Device: Foresight ICE System<br>* The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird Console.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device |  | During ablation procedure (2-4 h) |
Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Asthma

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of QAV680 in patients with mild to moderate asthma

Official Title
-----------------
A Randomized, Double-blind, Parallel Group Study to Compare the Pharmacodynamics/Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Moderate Persistent Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: QAV680
* Drug: QAV680 Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate persistent asthma Exclusion Criteria: Smokers Any significant disease or illness, other than asthma Other protocol-defined inclusion/exclusion criteria may apply

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QAV680<br> | Drug: QAV680<br>* QAV680 500 mg (5 x 100 mg capsules) four times per day<br>|
| Placebo Comparator: QAV680 Placebo<br> | Drug: QAV680 Placebo<br>* Placebo to QAV680 5 capsules four times per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 assessments at various timepoints including time of peak drug concentration |  | 28 days | 
| Measure the change in exhaled Nitric Oxide (FeNO) |  | 28 days | 
| Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma. |  | 28 days | 
| Total serum IgE levels |  | 28 days | 
| Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline. |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild, Moderate, Asthma
Comparison of Safety and Efficiency of 20w and 30w Holmium Laser Device in Management of 2-3 cm Diameter Kidney Stones With Retrograde Intrarenal Surgery

Study Overview
=================
Brief Summary
-----------------
To compare safety and efficiency of 20w 30w holmium laser device in treatment of 2-3 cm diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).

Conditions
-----------------
Nephrolithiasis

Intervention / Treatment
-----------------
* Procedure: Retrograde Intrarenal Surgery
* Procedure: Retrograde Intrarenal Surgery
* Procedure: Retrograde Intrarenal Surgery
* Device: Holmium laser device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have 2-3 cm kidney stones patients who are between 18-90 years old Exclusion Criteria: patients who have congenital urogenital abnormalities patients who have previous surgery history for urinary stones

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: first group<br>Patients undergoing Retrograde Intrarenal Surgery with 20w Holmium laser device who have 2-3 cm kidney stones | Procedure: Retrograde Intrarenal Surgery<br>* endoscopic stone treatment with flexible ureteroscopy and 20w holmium laser device<br>* Other names: RIRS;Device: Holmium laser device<br> <br> |
| Active Comparator: second group<br>Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power) who have 2-3 cm kidney stones | Procedure: Retrograde Intrarenal Surgery<br>* Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power)<br>* Other names: RIRS;Device: Holmium laser device<br> <br> |
| Active Comparator: third group<br>Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power) who have 2-3 cm kidney ston | Procedure: Retrograde Intrarenal Surgery<br>* Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power)<br>* Other names: RIRS;Device: Holmium laser device<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Complications according to clavien system) | Complications according to clavien system | 1 day | 
| Efficiency (visual analog score) | visual analog score | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficiency (stone free rate) | stone free rate/ | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Holmium Laser, Kidney Stones, RIRS