linjc16/ctgov huggingface dataset:
Efficacy of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy with intensive medical management on weight and metabolic parameters.

Detailed Description
-----------------
Intensive medical management will include VLCD Physical activity Exenatide Metformin Insulin detemir

Official Title
-----------------
Effect of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Obesity

Intervention / Treatment
-----------------
* Procedure: Sleeve gastrectomy
* Drug: Intensive medical management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetics with BMI ≥ 27.5 kg/m2 HbA1c 7-10% Age 20-70 years Exclusion Criteria: Prior gastric surgery Pregnancy and lactation renal disease (GFR < 60 ml/min) Pancreatitis Symptomatic gallstone disease Active malignancy Secondary causes of obesity ( Cushing's syndrome, uncontrolled Hypothyroidism) Severe psychiatric illness Allergic reaction to exenatide

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleeve gastrectomy<br>Will undergo laparoscopic sleeve gastrectomy | Procedure: Sleeve gastrectomy<br>* Sleeve gastrectomy<br>* Other names: Laparoscopic sleeve gastrectomy;|
| Active Comparator: Intensive medical management<br>Will receive VLCD, exenatide, metformin, insulin detemir | Drug: Intensive medical management<br>* Exenatide 10 mcg BD, Metformin 2-3 gm/day, 800 Kcal diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | weight loss at 6 months after the start of intervention | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control | HbA1c and glucose profile | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleeve gastrectomy, Intensive medical management
Sonographic Features of Normal Soft Tissues of the Feet

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study normal sonographic(ultrasound)anatomy of the soft tissues of the foot in normal volunteers.

Detailed Description
-----------------
To study normal sonographic anatomy of soft tissues of the foot [which include Extensor retinaculum, sinus tarsi, ligaments and tendons, spring ligament and their attachments to underlying bones] in asymptomatic individuals/volunteers.

Official Title
-----------------
Sonographic Features of Normal Soft Tissues of the Feet

Conditions
-----------------
Foot Disease, Healthy

Intervention / Treatment
-----------------
* Procedure: Ultrasound of the foot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older no disease or abnormality of the feet Exclusion Criteria: abnormality of the feet

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normals<br>Normal volunteers having Ultrasound scan of foot. | Procedure: Ultrasound of the foot<br>* These volunteers will have one ultrasound scan of each foot<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical relevance of understanding the anatomy will help in early and accurate identification of pathology. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anatomy, Foot, Sonography, Medical
High-flow Nasal Cannula Oxygen Therapy With or Without NIV During the Weaning Period

Study Overview
=================
Brief Summary
-----------------
Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.

Official Title
-----------------
High-flow Nasal Cannula Oxygen Therapy With or Without Non-invasive Ventilation (NIV) During the Weaning Period: a Multicenter Randomized Controlled Trial

Conditions
-----------------
Acute Respiratory Failure Requiring Reintubation

Intervention / Treatment
-----------------
* Device: HFNC
* Device: NIV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duration of mechanical ventilation prior to extubation at least 24h Planned extubation decided by the physician in charge of the patient after success of a weaning trial Patients at high risk of reintubation according to the following criteria: patients older than 65 years, or those having any underlying chronic cardiac or lung disease. Exclusion Criteria: Patient admitted for traumatic brain injury Periphal neuromuscular disease as reason for intubation Usual lon-term treatment with NIV for chronic desease Usual lon-term treatment with CPAP for obstructive apneas syndrome Contraindication to NIV Unplanned extubation Do-not-reintubated order at time of extubation Terminal extubation for end of life People under legal protection Opposition to participate

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HFNC alone<br>Control group | Device: HFNC<br>* Gas flow of 50 l/min and FiO2 adjusted to obtain SpO2 ≥ 92%<br>|
| Experimental: HFNC and NIV<br> | Device: HFNC<br>* Gas flow of 50 l/min and FiO2 adjusted to obtain SpO2 ≥ 92%<br>Device: NIV<br>* Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cm H2O with FiO2 adjusted to obtain SpO2 ≥ 92%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintubation at Day 7 | The rate of reintubation will be assessed within the 7 days following planned extubation | up to 7 days |
Plasma Oxalate in Patient With Short Bowel

Study Overview
=================
Brief Summary
-----------------
Hyperoxaluria due to fat malabsorption is seen in patients suffering from short bowel and can lead to stones and nephrocalcinosis. Not all patients are prone to these renal complications. only urinary oxaluria is measured in practice. Plasma oxalate shouldn't increase theoretically in these patients. However recent report showed an increase of plasma oxalate in patient with enteric hyperoxaluria. The aim of this study is to assess the plasma oxalate distribution in this specific population to have a new tool to predict renal complication of these patients.

Official Title
-----------------
Plasma Oxalate in Patient With Short Bowel

Conditions
-----------------
Short Bowel Syndrome, Hyperoxaluria, Hyperoxalemia

Intervention / Treatment
-----------------
* Biological: Blood sampling
* Biological: Urine sampling
* Procedure: Pulse Wave Velocity (PWV) measurement
* Procedure: central pressure measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Type II short bowel for more than 6 months Affiliated to a social health care Exclusion Criteria: Primary hyperoxaluria Other type of short bowel than type II Minor patient or major patient protected by the law

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

| Intervention/Treatment |
| --- |
|Biological: Blood sampling|blood sampling will be used to perform oxalemia and FGF23 quantitative analysis|
|Biological: Urine sampling|urine sampling will be used to measure glycolate urinary rate (glycolaturia) and to perform urinary inflammation markers quantitative analysis|
|Procedure: Pulse Wave Velocity (PWV) measurement|PWV will be measured thank to the Complior® device|
|Procedure: central pressure measurement|central pressure will be measured thank to the Complior® device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma oxalate rate (oxalemia) | this sample measures the plasma oxalate rate | at inclusion |
Abraxane in Treatment of Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This observational project is collecting tolerability, safety and efficacy data with the routine use of Abraxane in the treatment of metastatic breast cancer. Additionally data on the dosage of Abraxane and general data on the disease and the health status of the patient will be collected.

Detailed Description
-----------------
This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labelled indication in metastatic breast cancer. Additionally data on real life dosing in daily clinical routine will be analyzed. A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy. This data might also be supportive for further treatment optimization of Abraxane in Metastatic Breast Cancer (MBC).

Official Title
-----------------
Assessment of Abraxane in Metastatic Breast Cancer in a Real-life Setting

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: nab-paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metastatic breast cancer (according to European Summary of Product characteristics (SmPC) Signed Informed Consent Participants > 18 Years of Age Exclusion Criteria: Pregnant or lactating females Neutrophils <1.5 X 10^9/L Hypersensivity to nab-paclitaxel

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 |
| --- | --- |
| nab-paclitaxel<br>nab-paclitaxel 260mg/m^2 in intravenous (IV) infusion every 3 weeks until progression or toxicity | Drug: nab-paclitaxel<br>* nab-paclitaxel by IV infusion every 3 weeks until progression or toxicity<br>* Other names: ABI-007;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Includes the number of participants with adverse events | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response | Number of participants who achieve a response | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Breast Cancer, nab-paclitaxel, Abraxane
Importance of Patient Selection for Treatment of Infected Total Knee Prosthesis

Study Overview
=================
Brief Summary
-----------------
The infection of a total knee replacement often imposes changing implants. The change in two step is currently considered the gold standard. The change in one step is a much debated attitude: strictly contra-indicated for some professionals, but others agree to reserve these for favorable suspected cases selected. Several criteria have been proposed in the literature: age, condition, duration of infection, known bacterium responsible, not virulent and sensitive to antibiotics, no fistula, no significant bone destruction. But these criteria are poorly validated, standing over an experience of surgical teams rather than high-level scientific studies. Some authors have proposed to achieve change in one step systematically. The results of these cohorts on healing the infection does not seem very different from the changes in two steps. But it is most often single-center series, uncontrolled, with small numbers.

Official Title
-----------------
Does the Selection of Patients Helps Healing the Infection After Change in One Step of a Knee Replacement?

Conditions
-----------------
Knee Infection

Intervention / Treatment
-----------------
* Other: restrospective study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years Patient having surgery for the management of knee infection after change in one step of a knee replacement prothesis in the participating services between 2000 and 2010. Exclusion Criteria: Patients under 18 years

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

| Intervention/Treatment |
| --- |
|Other: restrospective study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery from the infection measured visually | show that the selection process of patients used improve treatment outcomes of infection in total knee replacement | for the duration of hospital stay, up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee replacement, Infection, Knee
The Role of High Resolution-Computed Tomography (CT) in Tuberculosis (TB) Outbreak Investigation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the role of high-resolution computed tomography of the chest (HRCT) in the investigation of an outbreak of TB that developed in the South Korean army.

Detailed Description
-----------------
Outbreak investigation including tuberculin skin test (TST), QuantiFERON® TB Gold In-Tube (QFT), and simple chest radiography (CXR) will be performed. For participants with any abnormal findings in these tests, HRCT will be carried out. Active pulmonary TB is diagnosed based on sputum studies or HRCT findings. In addition, participants with positive results both in TST and QTF will be treated as having a latent TB infection (LTBI). TST and QTF were repeated in participants with positive result in one of these tests. CXR will be repeated in all participants at 3 and 6 months of follow-up.

Official Title
-----------------
The Role of Addition of High Resolution-CT in Outbreak Investigation of Tuberculosis

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All soldiers who assigned to the military battery where a tuberculosis outbreak occurred Exclusion Criteria: Soldiers who could not complete study
Sexes Eligible for Study
-----------------
Male

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberculosis, Outbreaks
Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine

Study Overview
=================
Brief Summary
-----------------
Anticholinergic drugs have traditionally been used for their antisialagogue properties. But use of anticholinergic drugs can interfere with thermoregulation via inhibition of the parasympathetically mediated sweat secretion. Sweating inhibition can reduce heat elimination, and children's thermoregulation depend more on sweating than adults and they can become hyperthermic when given these agents. The investigators evaluated the fever-causing effects of adjunctive anticholinergics in children under general anesthesia using ketamine.

Official Title
-----------------
Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine

Conditions
-----------------
Fever

Intervention / Treatment
-----------------
* Drug: Glycopyrrolate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) Physical Status classification I underwent surgery between 8 to 9 am undergoing ambulatory anesthesia with ketamine Exclusion Criteria: who required endotracheal intubation who were administered with medications other than ketamine

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 8 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anticholinergic premedication<br>Premedication with 0.005mg/Kg of glycopyrrolate | Drug: Glycopyrrolate<br>* Intravenously administered 0.005mg/Kg of glycopyrrolate in intervention group<br>|
| No Intervention: Control group<br>Same volume of normal saline | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature | measured body temperature at three times in both ears and the highest value was selected. | every 30 minutes from base line ( up to 90min ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral secretion (VAS) | Oral secretion during the whole procedure was recorded by the researcher | up to operative end | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child, outpatient, premedication
Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19

Study Overview
=================
Brief Summary
-----------------
Approximately 15% of patients with SARS-CoV-2 infection / COVID-19 develop a severe clinical course. This leads to hospitalization and potentially life threatening complications such as pneumonia and respiratory failure. Predictors for early detection and risk stratification are urgently needed. Moreover, only scarce information is available for long-term follow-up and late complications associated with infection. We therefore aimed to find predictors for severe courses of the novel disease as well as to establish strategies for therapeutic monitoring and follow-up.

Official Title
-----------------
Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19

Conditions
-----------------
SARS-CoV2, COVID

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SARS-CoV-2 infection / COVID 19 Exclusion Criteria: invasive ventilation respiratory failure at admission

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 |
| --- | --- | --- |
| TLCO | Transfer factor for carbon monoxide | 3-5 days intervals (inpatients) | 
| TLCO | Transfer factor for carbon monoxide | 1-6 months (outpatients, follow up) | 
| D5-20 | frequency dependence of resistance as measured by oscillometry | 3-5 days intervals (inpatients | 
| D5-20 | frequency dependence of resistance as measured by oscillometry | 1-6 months (outpatients, follow up) | 
| FEV1/FVC | forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry) | 3-5 days intervals (inpatients) | 
| FEV1/FVC | forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry) | 1-6 months (outpatients, follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comorbidities | structured questionnaire | at hospital admission and each follow (every 1-6 months) | 
| clinical symptoms | structured qualitative questionnaire | 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up) | 
| St. George's Respiratory Questionnaire total score | validated questionnaire (scores range from 0 to 100, with higher scores indicating more limitations) | 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up) |