linjc16/ctgov huggingface dataset:
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if pumosetrag is effective in treating Gastroesophageal Reflux Disease (GERD) symptoms in patients who have a history of GERD symptoms and are currently taking an acid suppression therapy, such as a Proton Pump Inhibitor (PPI).

Official Title
-----------------
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Multiple Dose Levels of Pumosetrag in Patients With Symptoms Associated With Gastroesophageal Reflux Disease (GERD) Receiving a Standard Refluxogenic Meal

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: Pumosetrag
* Drug: Pumosetrag
* Other: Placebo
* Drug: Pumosetrag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with history of Gastroesophageal Reflux Disease (GERD) symptoms (heartburn, regurgitation, acid taste in mouth). Between ages of 18 - 70 inclusive. Develop GERD symptoms following ingestion of a refluxogenic meal. Able to take a stable Proton Pump Inhibitor (PPI) regimen for duration of study. Understand and sign the informed consent form. Exclusion Criteria: Pregnant or lactating women. Allergic to pumosetrag or formulation excipients.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.2mg Pumosetrag<br> | Drug: Pumosetrag<br> <br> |
| Experimental: 0.5mg Pumosetrag<br> | Drug: Pumosetrag<br> <br> |
| Experimental: 0.8mg Pumosetrag<br> | Drug: Pumosetrag<br> <br> |
| Placebo Comparator: Placebo<br> | Other: Placebo<br> <br> |

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symptoms of Gastroesophageal Reflux Disease (GERD)
Using EEG to Study Coma in the Neurocritical Care Unit

Study Overview
=================
Brief Summary
-----------------
Despite its clinical significance, the pathophysiology of coma is still under investigation and the physiology of emergence from coma remains a mystery. Furthermore, predictors of emergence from coma, despite their obvious clinical value, remain un-established. Because of its low arousal state and hypothesized parallel neurophysiological mechanisms, sleep has been studied as both an animal and human model of coma, and awakening from sleep has likewise been studied as a surrogate of coma emergence. In this study, we will determine whether certain electrographic patterns, known as spectral shifts, which have correlates in normal sleep, are predictive of eventual awakening from coma and the time course of this emergence. To detect spectral shifts in comatose patients, EEG monitoring must be performed for several days. Quick, simple, and reliable EEG recording in the ICU will be enhanced by a small device that can be easily and properly positioned on the head by hospital personnel and which lacks cumbersome cables or receivers. Traditional EEG monitoring requires placement of up to 25 wires, which can impede efficient intensive patient care. Our hypothesis is that we can detect a difference in spectral shifts in comatose patients who will eventually emerge from coma as compared to comatose patients who do not wake up and that a wireless EEG patch-type device can effectively make this distinction.

Official Title
-----------------
A Wireless EEG Patch Device for Continuous Electrographic Monitoring and Study of Coma in the Neurocritical Care Unit

Conditions
-----------------
Coma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with brain injuries admitted to the neurocritical care unit will be screened for enrollment. The estimated enrollment will be for 100 patients. 90 patients will be comatose with Glascow Coma Scale < 9. The other 10 patients will be control, non-comatose patients for quality control of the device. Consent for inclusion will be obtained from the patient or next of kin for all enrolled patients. Exclusion Criteria: None

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 |
| --- | --- |
| Coma Patients<br>Observation of EEG patterns in coma patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence from coma |  | 1 year post admission |
Comparative Study of the Link Between the Practice of Gambling and Money and Materialism Among Problem Gamblers and Non-problem Gamblers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to to explore the link between materialism and addiction to gambling and money

Official Title
-----------------
GAMbling and MAterialism

Conditions
-----------------
Gambling

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ( specific to problem gamblers) subject having at least four diagnostic criteria in Trouble linked to gambling and money DSM-5 (APA 2013) subject who had written consent for participation in the EVALADD cohort Subject who has started treatment for a problem with the practice of gambling and money in the addictology and psychiatric department ( specific to non-problem gamblers) Subject playing games of chance and money at least once a year Subject playing games of chance and money less than once per week OR less than € 500 per year Subject having a score of 0-2 at ICJE questionnaire Exclusion Criteria: Subject having difficulty reading or writing of the French language Subject having Parkinson's Disease Subject under guardianship

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 |
| --- | --- |
| Problem glambers<br>The group of problem gamblers will consist of patients already included in the cohort EVALADD [favorable opinion of GNEDS 06/09/2012; CNIL authorization No. 912631 of 10.09.2013], and the data will be extracted directly from the database EVALADD | Other: questionnaire<br> <br> |
| Non-problem gamblers<br>The subjects of this group will be matched on sex, age and education level with the group problem gamblers. They will be recruited over the Internet and using the volunteer base [normal declaration with the CNIL: No. 1761543 of 21/05/2014]. | Other: questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Materialism level among problem gamblers compared to non-problem gamblers | To assess the total score of materialism by the Material Value Scale in 15 items (MVS-15), among a group of non-problem gamblers and a group of problem gamblers. | 1 year |
Glivec in Pediatric Chronic Myeloid Leukemia (CML)

Study Overview
=================
Brief Summary
-----------------
It is a phase 4 study, not randomised and multicentric. Within 2 months after the diagnosis, the patients daily receive imatinib by oral way during at least 1 year (260mg/m² once a day), i.e. until the cytogenetic analysis. Beyond 1 year of treatment, if a haematological relapse or a loss of the cytogenetic response is observed, the nature of the treatment suggested to the patient is left with the appreciation of the investigator. Later on, discontinuation of imatinib is discussed if a molecular remission (negative RT-PCR) is obtained and maintained for at least 2 years.

Conditions
-----------------
Chronic Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Imatinib mesylate 100 mg (Glivec)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Old < 18 years, male or female. Chronic myeloid leukaemia confirmed on the cytogenetic level by the presence of the translocation t(9; 22) (q34; q11) or by the presence of transcript BCR-ABL in the event of absence of description of the translocation t(9; 22) (q34; q11). Chronic phase of a chronic myeloid leukaemia Absence of extra-medullary disease (except for a hepatomegaly and/or of a splenomegaly). Absence of any former treatment of chronic myeloid leukaemia except for hydroxyurea. Stop of hydroxyurea at least week before the beginning of the imatinib mesylate. Diagnosis of chronic myeloid leukaemia in chronic phase recent (less than 2 months). Score of Lansky ≥ 60. Effective contraception among patients in age to procreate. Written voluntary informed consent of the two parents or the legal guardian. Exclusion Criteria: Patients with grade 3 / 4 cardiac disease. Pathology cardiac, pulmonary, hepatic, renal or neurological of grade > 2 (WHO). Participation in a clinical trial in the 28 days preceding the beginning by the treatment. Impossible Follow-up during at least 2 years, patient not compliant. Expectant mother or nursing.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imatinib<br> | Drug: Imatinib mesylate 100 mg (Glivec)<br>* 260 mg/m2/day tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Using Telmisartan Alone or Combination of Telmisartan -HCTZ in the Treatment of Mild to Moderate Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
The aim of this therapeutic observation is to demonstrate the efficacy and safety of telmisartan or telmisartan and HCTZ in the treatment of patients with mild-to-moderate essential hypertension under normal conditions of use after market launch.

Detailed Description
-----------------
Study 502.465(NCT00638911) was planned and conducted as 6 independent substudies with varying country participation. One study database, a data management plan or a TSAP were not planned and do not exist which precludes baseline and outcome analyses.

Official Title
-----------------
PMS Assessing the Safety and Efficacy of Telmisartan in Patients With Mild-to-moderate Essential Hypertension

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 1. Male or female patients over the age of 18 years, with mild-to-moderate essential hypertension with values of mean morning seated diastolic BP more than 90 mmHg and less than 109 mmHg and or mean morning seated systolic BP more than 140 mmHg and less than 180 mmHg newly diagnosed patients patients failing to reach target blood pressure of less than 140 on 90 on their current antihypertensive treatment Exclusion criteria: Pre-menopausal women who do not use adequate contraception who are pregnant or nursing Cholestasis and biliary obstructive disorders Severe hepatic impairment Severe renal impairment creatinine clearance less than 30 ml pro min Refractory hypokalaemia hypercalcaemia Known hypersensitivity to any component in the formulation of Micardis/Micardis Plus

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 |
| --- | --- |
| Patients with hypertention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoints will be the change from baseline in mean systolic blood pressure. |  | 4-24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoints are clinical control of the BP and response rate. |  | 4-24 Weeks | 
| Other secondary Endpoints will be discontinuations and tolerability. |  | 4-24 Weeks |
Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution

Study Overview
=================
Brief Summary
-----------------
This study investigates the safety and feasibility of performing laparoscopic surgery for colorectal and gastric cancer inside versus outside the primary registered medical institution under multi-sites practice (MSP) policy. This is a single practitioner, retrospective comparative study. The endpoints are peri-operative outcomes, pathological results, and medical costs.

Official Title
-----------------
Safety and Feasibility of Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution Under Multi-sites Practice (MSP) Policy, a Retrospective Comparative Study

Conditions
-----------------
Colorectal Cancer, Gastric Cancer

Intervention / Treatment
-----------------
* Other: surgery inside the primary institution
* Other: surgery outside the primary institution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 100 years diagnosed as colorectal cancer or gastric cancer undergoing laparoscopic surgery between 2016-2020 performed by Dr Feng Exclusion Criteria: Emergency procedure without histopathological result of malignancy conventional open surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| inside group<br>laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution | Other: surgery inside the primary institution<br>* to perform laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution<br>|
| outside group<br>laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution | Other: surgery outside the primary institution<br>* to perform laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall postoperative complication rate | postoperative complications evaluated according to Clavin-Dindo classification | 30 days after surgery |
Interest of the OSA (Obstructive Sleep Apnea) Predictive Scores in the Prognosis of Postoperative Mortality of Femoral Neck Fractures

Study Overview
=================
Brief Summary
-----------------
Interest of the four major OSA Predictive Scores (STOP-BANG, P-SAP, DES-OSA, OSA50) in the prognosis of postoperative mortality after femoral neck fracture.

Detailed Description
-----------------
All patients incoming at the Saint-Luc Bouge Hospital with a femoral neck fracture Study between 15/09/2014 and 15/10/2015 The four OSA predictive scores will be collected Evaluation of mortality at 1 month

Official Title
-----------------
Interest of the OSA (Obstructive Sleep Apnea) Predictive Scores in the Prognosis of Postoperative Mortality of Femoral Neck Fractures.

Conditions
-----------------
Femoral Neck Fracture

Intervention / Treatment
-----------------
* Other: OSA Scoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with femoral neck fractures Incoming at the Saint-Luc Bouge Hospital Between 15/09/2014 and 15/10/2015 Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>OSA Scoring | Other: OSA Scoring<br>* Comparison of the preoperative OSA scoring (STOP-BANG, DES-OSA, P-SAP and OSA50) with the postoperative mortality at one month.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact OSA predictive scores on mortality prognosis | Impact of the four major OSA predictive scores (STOP-BANG, P-SAP, OSA50 et DES-OSA) on the mortality prognosis after surgery for femoral neck fracture | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femoral Neck Fractures, Obstructive Sleep Apnea, Perioperative Complications
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction Angiography（DSA）for pancreatic cancer.

Detailed Description
-----------------
By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction Angiography（DSA）for pancreatic cancer.

Official Title
-----------------
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Cancer: Clinical Trial

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: interventional therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age:18-80 Karnofsky performance status >60 Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive interventional therapy Life expectancy: Greater than 3 months Patients' routine blood test, liver function and kidney function have no obvious abnormalities Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: Patients with other primary tumor except pancreatic cancer History of coagulation disorders or anemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HepaSphere<br>pancreatic cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA） | Procedure: interventional therapy<br>* pancreatic cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）<br>|
| No Intervention: control<br>pancreatic cancer patients did not receive any interventional therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse events |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of lesions that show no sign of recurrence 12 months after interventional therapy |  | 1 year | 
| Progress free disease (PFS) |  | 1 year | 
| Overall survival (OS) |  | 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic Cancer, HepaSphere
Difficult Intubation With Glidescope Video Laryngoscope

Study Overview
=================
Brief Summary
-----------------
A prospective observational study on predictors available and on variables of difficult intubation adopting Gliscope video laryngoscope routinely. Primary hypothesis of the current study is that the rate of difficult intubation with Glidescope is low and multiple predictors interact favorably in anticipating difficulties.

Detailed Description
-----------------
All possible factors involved in difficult intubations were included in this prospective analysis. Main predictors were considered: time to Cormack Lane using Glidescope intubation, Cormack Lane score, experience of the operator (staff or resident), number of bag mask ventilation, number of intubation attempts.

Official Title
-----------------
Incidence and Predictors of Difficult Intubation Adopting an Institutional Algorithm Glidescope Based: a Cohort Study

Conditions
-----------------
Difficult Intubation, Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient up to ASA4 eligible for intubation for neurosurgical procedures any anesthesiologist in charge for GA Exclusion Criteria: children patient not suitable for clinical evaluation of predictors for difficult intubation (ie. Parkinson's disease)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| incidence of difficult intubation using Adnet score modified | Difficult intubation in the current study is measured using Adnet score including the number of laryngoscopies | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of difficult intubations in novices vs experts and complication in the overall cohort |  | 3 years |