linjc16/ctgov huggingface dataset:
Effects of Video-Assisted Surgery on Ventilatory Parameters

Study Overview
=================
Brief Summary
-----------------
The study investigates the effects of induced pneumoperitoneum during surgery on ventilatory parameters including peak inspiratory pressure, lung compliance, end-tidal CO2 at specific time-points: after induction of anaesthesia, after induction of surgery, one-hour and two-hours during surgery, end of surgery. The effects of pneumoperitoneum are compared between two groups of patients: patients undergoing laparoscopic surgery and patients undergoing robotic-assisted surgery. No intervention was performed in this study and the decision for type of surgery performed was made by the attending surgeon prior to study inclusion

Official Title
-----------------
Effects of Pneumoperitoneum on Ventilatory Parameters in Patients Undergoing Video-assisted Surgery

Conditions
-----------------
Surgery--Complications

Intervention / Treatment
-----------------
* Procedure: mechanical ventilation during video-assisted surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent video-assisted surgery by either classic laparoscopy or robotic-assisted surgery. Exclusion Criteria: refusal to participate conversion of surgery to laparotomy need of vasopressure support preoperative severe respiratory dysfunction

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 |
| --- | --- |
| Video-assisted surgery<br>Patients undergoing video-assisted major abdominal surgery (VAS) in Trendelenburg position. The decision regarding the type of VAS was made by the attending surgeon prior to study inclusion. Twenty-five consecutive patients undergoing classic laparoscopic surgery and twenty-five patients undergoing robotic-assisted surgery will be included in the study. | Procedure: mechanical ventilation during video-assisted surgery<br>* observed variation of ventilatory parameters during video-assisted surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung compliance | change in lung compliance (mL/cmH2O) before and after induction of pneumoperitoneum in patients undergoing VAS. Lung compliance is automatically calculated by the anesthesia machine during surgery. The study compares the magnitude in change associated with VAS. | one-hour and two-hours after induction of pneumoperitoneum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial to end-tidal CO2 difference | difference in arterial to end-tidal CO2 (mmHg) during surgery. Arterial blood samples and end-tidal CO2 were simultanously obtained at the specific time-points. | one-hour and two-hours after induction of pneumoperitoneum |
Search of Protein Biomarkers in Order to Achieve a Molecular Classification of Gliomas

Study Overview
=================
Brief Summary
-----------------
The aim is to classify high grade glioma by matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI MSI). In order to provide more specific informations for the diagnosis and the prognosis of high grade glioma.

Official Title
-----------------
Search of Protein Biomarkers in Order to Achieve a Molecular Classification of Gliomas

Conditions
-----------------
Glioblastoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion criteria: Patients with grade III or IV glioma newly diagnosed with histological evidence Surgical indication Tumor tissue available at biobank of Lille Men and women aged ≥ 18 years Informed Consent signed by the patient or his legal representative. Main exclusion criteria: Antecedents of other cancers except basal cell skin cancer or carcinoma in situ of the uterus cervix Previous history of brain radiotherapy Anti-tumor systemic treatments (chemotherapy or targeted therapy) prior to surgery of glioma Genetic disease that may cause brain tumor, potentially radiation-induced tumor History of degenerative neurological disease prior to diagnosis contraindication to MRI

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 |
| --- | --- | --- |
| To evaluate the correlation between the WHO classification 2007 only established standard diagnostic and classification by mass spectrometry gliomas (lipids, peptides, proteins) |  | 2.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proteomics, High Grade Glioma, MALDI-MSI
Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome

Study Overview
=================
Brief Summary
-----------------
Sjogren's syndrome is an autoimmune chronic disease. It has two forms Primary Sjogren's syndrome charactrized by dry eyes and dry mouth. Secondary Sjogren's syndrome characterized by rheumatoid diseases as rheumatoid arthritis, scleroderma and lupus erythematosus. SS patients are most liable to oral candidiasis , so they need prophylaxis aganist oral candidiasis. Probiotic bacteria are live microorganisms that when administered in adequate amounts confer benefits to health.Probiotics are commonly used as a prophylaxis aganist oral candidosis.

Official Title
-----------------
Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome

Conditions
-----------------
Sjogren's Syndrome

Intervention / Treatment
-----------------
* Drug: Probiotic Product - Cap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary or scondary Sjogren's syndrome Exclusion Criteria: allergy to milk derivatives previous intake of antifungals

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic group<br>Probiotic complex capsule taken twice daily for 5weeks | Drug: Probiotic Product - Cap<br>* probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus<br>|
| Placebo Comparator: Placebo group<br>Placebo capsule taken twice daily for 5 weeks | Drug: Probiotic Product - Cap<br>* probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | Numerical Rating Scale ( NRS) | 5 WEEKS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Candidal load | colony forming unit CFU/ml | 5 weeks |
Study to Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis.

Official Title
-----------------
A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center Phase III Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: M518101
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Who are able and willing to give signed informed consent Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator. Who have up to 20% of body surface area (BSA) afflicted with plaques Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study. Exclusion Criteria: Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity. Who are pregnant or lactating. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease. Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests. Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study. Whose serum calcium levels exceed the upper limit of reference range Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization. Who have been treated with systemic therapy within 30days of randomization. Who have treated with biologics within 5 half-lives of the biologics before the day of randomization Who have been treated with topical therapy within 14days before the day of randomization.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Proper quantity twice a day | Drug: Vehicle<br> <br> |
| Experimental: M518101<br>Proper quantity twice a day | Drug: M518101<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment |  | 8 weeks after dosing |
Role of Volatile Anesthetics for Hepatic Protection

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the attenuation of ischemic-reperfusion injury in the liver after sevoflurane preconditioning. In the presence of sevoflurane, an attenuation of liver injury is hypothesized (diminished increase of liver enzymes, reduced production of inflammatory mediators).

Detailed Description
-----------------
Organ protection; preconditioning; volatile anesthetics; ischemia reperfusion

Official Title
-----------------
Role of Volatile Anesthetics for Hepatic Protection in Ischemia-reperfusion

Conditions
-----------------
Reperfusion Injury

Intervention / Treatment
-----------------
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years of age Patients undergoing liver resection (benign or malignant tumors) Exclusion Criteria: Laparoscopic liver resection coagulopathy (platelets < 50,000/ml, Quick < 50%) Liver cirrhosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery with Pringle maneuver needed for liver resection
Digital Occlusal Analysis of Ultra Suction Retained Complete Denture

Study Overview
=================
Brief Summary
-----------------
Bite testing using T-Scan allows the evaluation of occlusal contacts prior to making a bite adjustment. The T-Scan can indicate premature contact and the load distribution on teeth, and provide measurable force and time information that ensures proper occlusal adjustment.

Detailed Description
-----------------
Prior to employing T-Scan occlusal analyzer to assess the occlusion on the complete denture, complete denture was seated and checked for fitness, stability, pressure areas with pressure indicating paste and border evaluation and extension. The peripheral seal should be evident so that the denture-maintained suction against maxillary tissues. Upon completion of these fit and stability assessments, the occlusion could then be addressed. The method considered for the occlusal analysis was a computerized system . The system was composed of a computer with a specific board and software capable of converting information recorded by the sensor to visual and numerical information on tooth contact. For Tekscan system to function properly, computer system must meet or exceed specified system requirements. The Tekscan USB handle, does not require an additional interface card or parallel box in order tobe connected to computer. When inserted into computer, the computer's operating system will automatically detect and configure the hardware for use. The T-Scan sensor was an ultra-thin (.004, 0.1 mm), flexible printed circuit that detected the patient's occlusal parameters.

Official Title
-----------------
Digital Occlusal Analysis of Ultra Suction Retained Complete Denture

Conditions
-----------------
Complete Edentulism

Intervention / Treatment
-----------------
* Device: T scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All implant indicated. Exclusion Criteria: All implant contraindicated
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Complete denture<br>Conventional complete denture without supporting devices | Device: T scan<br>* Occlusal load analysis<br>|
| Experimental: Ultra suction retained complete denture<br>Conventional complete denture with ultra suction device | Device: T scan<br>* Occlusal load analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusal load analysis | occlusal load analysis of the ultra suction system in complete denture being evaluated by T-scan system | One year |
Inspiratory Muscle Training With Normocapnic Hyperpnea in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
Many studies suggest that inspiratory muscles training by means of normocapnic hyperpnea improves exercise tolerance in healthy subjects. No information is available about the use of this training in COPD patients even if other methods (such as threshold loading and resistive loading) have been shown to be effective in terms of Inspiratory Muscle Function, Health-Related Quality of Life and Exercise Tolerance. This study is designed to evaluate the effects of normocapnic hyperventilation by means of Spirotiger®, an instrument training the respiratory muscles, avoiding hypocapnia (using the methodology of isocapnic hyperpnoea)in COPD patients.

Official Title
-----------------
Efficacy of Inspiratory Muscle Training by Means of Spirotiger® in COPD Patients.

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Device: Spirotiger®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients. All patients are at stable state, free from an exacerbation from at least 3 months. Exclusion Criteria: COPD patients with a recent history of cardiovascular disease, neurologic disease and other diseases that would interfere with the training.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respiratory muscle training<br>Patients assigned to this arm train the respiratory muscles by means of normocapnic hyperpnea. | Device: Spirotiger®<br>* training session :10 minutes twice a day X 4 weeks<br>* Other names: Pulmonary rehabilitation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Capacity |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, inspiratory muscles training
Magnetic Resonance Imaging at Different Levels of Magnetic Intensity

Study Overview
=================
Brief Summary
-----------------
Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the human body without the use of X-ray (radiation). MRI uses different levels of magnetic fields to create images of the body and organs. Occasionally, researchers will give patients undergoing a MRI an injection of a substance called gadolinium. Gadolinium works by brightening areas of the magnetic resonance image, thereby improving the contrast. In this study researchers will use magnetic resonance imaging and contrast substances, like gadolinium, on normal volunteers in order to evaluate different aspects of its performance. Information gathered from this study may be used to develop more specific research studies involving MRI.

Detailed Description
-----------------
Technical evaluation of magnetic resonance imaging and spectroscopy will be performed on normal volunteers. These studies will be conducted in the MRI systems located at the NIH. These studies may involve the intravenous administration of commercially available MR contrast media and exercise. The results will be used to evaluate the performance of various pulse sequences, gradient coils, and RF coils on human subjects and will provide essential ground work for specific patient protocols.

Official Title
-----------------
Magnetic Resonance at 1.5 and 3 Tesla

Conditions
-----------------
Cardiovascular Disease, Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Any normal volunteer greater than or equal to 18 who is capable of giving informed consent. EXCLUSION CRITERIA: A subject will be excluded if he/she has a contraindication to MR scanning such as: Brain aneurysm clip Implanted neural stimulator Implanted cardiac pacemaker or defibrillator Cochlear or ear implant Ocular foreign body (e.g. metal shavings) Insulin pump Pregnant women (when uncertain, subject will undergo urine or blood testing). Claustrophobia Any condition in the Principal Investigator's judgement which present unnecessary risk EXCLUSION CRITERIA FOR GADOLINIUM ENHANCED STUDIES: Lactating Women Renal or hepatic disease

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?
-----------------
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
-----------------
Normal Volunteer, Imaging, MRI, Spectroscopy, Cardiovascular, Technical Development, Heart, Safety, Toxicity, Gadolinium, Adverse Events
Double-blind Comparative Study of TAK-875

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: TAK-875
* Drug: TAK-875
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant is an outpatient. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease. The participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.

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

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

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

Design Details

Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAK-875 25 mg<br> | Drug: TAK-875<br> <br> |
| Experimental: TAK-875 50 mg<br> | Drug: TAK-875<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Therapy