linjc16/ctgov huggingface dataset:
Scoring Systems in ICU and Malnutrition

Study Overview
=================
Brief Summary
-----------------
The objective of the present study was to compare the ability of acute physiology and chronic health evaluation (APACHE) scoring systems with the combination of an anthropometric variable score adductor pollicis muscle (APM) thickness to the APACHE systems in predicting mortality in the ICU. Three hundred and four patients enrolled in this prospective observational study. The APM thickness in dominant hand and APACHE II and III scores were measured for each patient upon admission. Given scores for the APM thickness, were added to APACHE score systems to make two composite scores of APACHE II- APM and APACHE III- APM. The accuracy of the two composite models and APACHE II and III systems in predicting mortality of patients was compared using area under the ROC curve. Based on the study results, the area under the ROC curves improved in composite models. Therefore, it seemed that considering anthropometric variables may improve prediction of mortality in APACHE systems.

Detailed Description
-----------------
The baseline medical history, physical examination, Acute Physiology and Chronic Health Evaluation score II and III (APACHE) were recorded for all patients. All data were collected by a single physician. The APACHE II and III scores were gathered using the method presented by Knaus. The dominant hand APM thickness (as reported by the patient, or the relative) was assessed by Caliper (Vogel, Germany) in the emergency room or at the time of the ICU admission. To estimate weight for the APM thickness, multivariate logistic regression analysis was used to determine the relation between mortality and the APM thickness while controlling for other physiologic variables (12 physiologic variables for APACHE II and 18 physiologic variables for APACHE III).The area under the receiver-operating curves (ROC curve) to predict mortality was used to compare APACHE II, APACHE III, APACHE II- APM and APACHE III- APM systems.

Official Title
-----------------
Combination of APACHE Scoring Systems With Adductor Pollicis Muscle Thickness for the Prediction of Mortality in ICU

Conditions
-----------------
Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 16 years of age Exclusion Criteria: Splints, in the upper extremities Casts in the upper extremities Edema in the upper extremities Patients with readmission during the study period Those transferred from other ICUs

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of Mortality | Mortality prediction by APACHE -APM | First day of ICU admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anthropometry, Mortality, Nutrition Assessment, Caliper
A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether sivelestat will reduce the amount of time a patient must spend on a ventilator and/or increase the chance of survival of patients with acute lung injury.

Detailed Description
-----------------
Acute lung injury often develops as a result of severe infection, sepsis, severe injuries, inhalation of foreign substances into the lungs, or pneumonia. The tissues and blood vessels in the lungs become inflamed, and the body does not receive enough oxygen. Patients with this condition are placed on a ventilator to assist with breathing. Patients entered into this study will be randomly assigned to one of two treatment groups: a sivelestat group or a placebo group. Once entered into the study, patients are monitored for up to 6 months.

Official Title
-----------------
A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury

Conditions
-----------------
Respiratory Distress Syndrome, Adult, Acute Lung Injury

Intervention / Treatment
-----------------
* Drug: Sivelestat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria show evidence of acute lung injury be on mechanical ventilation Exclusion Criteria have undergone certain organ transplants have severe underlying medical problems be unlikely to survive be pregnant or breast-feeding

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

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

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
-----------------
Sivelestat, acute lung injury
Caloric Restriction and Body Weight in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the role of dietary calcium in fecal fat loss and the association between lactose maldigestion, dietary calcium level and source, and weight loss induced by caloric restriction. caloric restriction on biomarkers of inflammation and oxidative stress

Official Title
-----------------
Effect of Dietary Calcium on Body Weight Regulation in Adults

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: Dietary calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 -65 years old Healthy Exclusion Criteria: Body weight more than 300 lbs (body composition measurement instrument limit) diabetes Heart disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dairy calcium<br>Diet with dairy calcium sources | Dietary Supplement: Dietary calcium<br>* Dairy and non-dairy calcium provided as a part of diet in the amounts of 500 mg/day and 1500 mg/day. Diet contained 70% of daily caloric requirements.<br>|
| Experimental: Non-dairy calcium<br>Diet with non-dairy calcium sources | Dietary Supplement: Dietary calcium<br>* Dairy and non-dairy calcium provided as a part of diet in the amounts of 500 mg/day and 1500 mg/day. Diet contained 70% of daily caloric requirements.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat in stool as a percentage of fat intake |  | 3 months of diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change |  | 3 months of diet | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dietary calcium, weight loss
Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the safety and feasibility of gene transfer with the third generation adenovirus H5.001CBCFTR in patients with cystic fibrosis.

Detailed Description
-----------------
PROTOCOL OUTLINE: H5.001CBCFTR, an adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, is administered endobronchially. Cohort of 2 patients receive 1 of 6 H5.001CBCFTR concentrations. There is no intrapatient dose escalation.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Genetic: H5.001CBCFTR


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Cystic fibrosis diagnosed as follows: Sweat sodium or chloride greater than 60 mEq/L by pilocarpine iontophoresis or cystic fibrosis genotype Clinical manifestations Estimated 2-year survival greater than 50%, i.e.: FEV1 at least 30% of predicted PaO2 greater than 55 mm Hg on room air PaCO2 less than 50 mm Hg on room air --Prior/Concurrent Therapy-- At least 2 months since systemic glucocorticoids At least 90 days since participation in investigational therapeutic study --Patient Characteristics-- Pulmonary: No pneumothorax within 12 months No asthma or allergic bronchopulmonary aspergillosis requiring glucocorticoids within 2 months No sputum pathogens unless sensitive to at least 2 antibiotics No hemoptysis of more than 250 mL blood over 24 hours within 1 year Other: No active adenoviral infection Ad5 (or similar type) antibody seropositive No other contraindication to protocol participation, e.g.: Drug abuse Alcoholism Psychiatric instability Inadequate motivation Documented azoospermia (men) Bilateral tubal ligation or hysterectomy (women) Screening exams within 4 weeks prior to registration

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: H5.001CBCFTR|nan|

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
-----------------
cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
Collection of Blood Specimens for Circulating Tumor Cell Analysis

Study Overview
=================
Brief Summary
-----------------
Objective: To test the sensitivity of a proprietary novel filtration device designed to capture and concentrate circulating tumor cells (CTCs).

Official Title
-----------------
Collection of Blood Specimens for Circulating Tumor Cell Analysis

Conditions
-----------------
Breast Cancer, Prostate Cancer, Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years of age Written informed consent obtained Confirmed diagnosis of stage 2-4 breast, prostate, or colorectal cancer, (OR) no prior history of cancer Stage 2-4 treatment naive, metastatic, secondary, and recurrent cancer patients Able to undergo blood collection prior to initiation of chemotherapy treatment, (OR) able to provide blood sample if subject is a non-cancer control subject Exclusion Criteria: Patients unable to understand the research protocol and/or provide informed consent. Patients with known immunodeficiency, or pregnancy.

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 |
| --- | --- |
| Cancer or no prior history of cancer<br>Confirmed patients with breast, prostate, or colorectal cancer (OR) subjects with no prior history of cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of circulating tumor cells (CTCs) per milliliter of whole blood. Reported unit of measure will be the number of CTCs/milliliter. | Blood samples will be collected from study subjects and analyzed for the number of circulating tumor cells (CTCs) within 96 hours of blood collection. | Analysis will be performed within 96 hours following blood sample collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Prostate cancer, Colorectal cancer, Circulating tumor cell (CTC)
Hemi-diaphragmatic Paresis and Erector Spinae Plane Block

Study Overview
=================
Brief Summary
-----------------
To assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane (ESP) block

Detailed Description
-----------------
The aim of the study is to assess the effect of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane block.

Official Title
-----------------
The Effect of Erector Spinae Plane Block on Hemidiaphragm Paresis in Shoulder Surgery

Conditions
-----------------
Anesthesia, Regional, Shoulder

Intervention / Treatment
-----------------
* Other: ESP block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 85 years American Society of Anesthesiology (ASA) I-III elective shoulder surgery Exclusion Criteria: patient's refusal under 18 years of age or over 65 years of age ASA IV and above known allergy to local anaesthetic drugs the block cannot be applied due to bleeding disorders or localized skin infection at the injection site history of neurological and/or neuromucular disease history of severe bronchopulmonary disease a moderate to severe decrease in preoperative pulmonary function, or abnormality in preoperative chest radiography data (pleural effusion, pneumothorax, or hemidiaphragm elevation)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| ESP block group<br>Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre. | Other: ESP block<br>* ESP block performed using ultrasound guidance. Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hemi-diaphragmatic paresis | Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative opioid consumption | intraoperative opioid consumption will be recorded | 2 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erector Spinae Plane Block, Regional Anesthesia, Shoulder Surgery, Hemidiaphragmatic Paresis
Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying coronary artery disease

Conditions
-----------------
Hypercholesteremia, Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: atorvastatin, Lipitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hypercholesteremia The indication of coronary angiography, coronary angioscopy and intravascular ultrasound are expected Exclusion Criteria: Patients who has current administration of Lipitor or history of discontinued administration of Lipitor Acute cardiac infarction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: atorvastatin, Lipitor|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plaque characteristics as observed by coronary angioscopy |  |  | 
| (the amount of yellow plaque and grade shall be determined by the coronary angioscopic findings evaluation committee) |  |  | 
| Changes in the volume and the echogenicity as observed by intravascular ultrasound |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change in serum lipid level |  |  | 
| Changes in the surface character and size of plaque as observed by coronary angioscopy (determined by the angioscopic findings evaluation committee) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lipitor, atorvastatin, Hypercholesteremia, yellow coronary plaque
Identification of New Markers in the Hypereosinophilic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose is to characterize new hypereosinophilic syndrome biomarkers more informative and more accessible compared to those that we have already thanks to a proteomic approach. This will help the investigators to diagnose the this disease.

Official Title
-----------------
Identification of New Markers in the Hypereosinophilic Syndrome

Conditions
-----------------
Hypereosinophilic Syndrome

Intervention / Treatment
-----------------
* Biological: biologie sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dated and signed informed consent virale serology negative or negative result less than 6 months virale serology negative for HBV or vaccinated patient insured virale serology negative or negative result less than 6 months negative pregnancy test or female menopause for at least 1 year Exclusion Criteria: subject enable adult, under guardianship or under protective measures of justice Refusal or inability to give informed consent The hypereosinophilic syndrome explained origin other than than atopy, bullous pemphigoid, the Churg-Strauss syndrome and DRESS

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypereosinophilic syndrome unexplained<br> | Biological: biologie sample<br>* comparison of biomarkers between HES, HE biomarkers data and control arms<br>|
| Active Comparator: Hypereosinophilic syndrome explained<br> | Biological: biologie sample<br>* comparison of biomarkers between HES, HE biomarkers data and control arms<br>|
| Sham Comparator: Normal rate of eosinophilic<br> | Biological: biologie sample<br>* comparison of biomarkers between HES, HE biomarkers data and control arms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aim is to characterize, through an approach immunoprotéomique, new HES biomarkers more informative and easier access than those currently available to us. These biomarkers will help to the diagnosis of HES, compared with other causes of eosinophilia. |  | one month after patient inclusion |
Airway Management With Simulated Microgravity Using a Submerged Model

Study Overview
=================
Brief Summary
-----------------
Trained anesthesiologist- or emergency physician-divers will perform an airway management in simulated microgravity on a submerged model.

Detailed Description
-----------------
Trained anesthesiologist- or emergency physician-divers participate in the study. Simulated microgravity during spaceflight is obtained by using a submerged model. Full-torso manikins is going to be used for performing airway management. Each diver attempted airway management with each device (laryngeal mask, laryngeal tube, orotracheal intubation with video-assisted laryngoscope. The time for airway protection will be measured as well as the success rate.

Official Title
-----------------
Airway Management With Simulated Microgravity Using a Submerged Model

Conditions
-----------------
Airway Management, Emergency Medicine

Intervention / Treatment
-----------------
* Device: Airway management with a submerged model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anaesthesiologist with diver licence or Emergency physician with diver license Exclusion Criteria: All other

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: Other
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Airway device placement<br>airway device is placed during the dive | Device: Airway management with a submerged model<br>* Airway management with a submerged manikin using different airway devices in randomized order<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of inserts | Summarizing the number of Intubation attempts or attempts to place the supraglottic airway | after 5 minutes | 
| Time to first ventilation | Time from beginning with the airway manoeuvre (taking the decice) until successful airway secure and first ventilation | after 5 minutes |