linjc16/ctgov huggingface dataset:
Introduction of Protein S100 in Diagnostics in Minor Brain Injury Patients at Our Hospital

Study Overview
=================
Brief Summary
-----------------
In Patients with minor head injury measurement of protein S100 will be introduced to the emergency departement as another tool to rule out intracerebral bleeding.

Detailed Description
-----------------
Severe intracerebral bleeding is still a complication even in obvious minor head injury (MHI) that makes the use of CT scanning necessary in patients with only few signs of intracerebral injury. To reduce the number of cerebral CT scans without pathologic findings measurement of protein S100 level in serum will be used in the emergency departement (ED) at our hospital. Our hypothesis: with measurement of S100 levels cCT scans and inpatient treatment can be reduced, radiation and costs can be reduced. From January 1st 2010 for 3-6 months all patients with head injury (all GCS) will be tested for their initial S100 level. Cut off level is set at 0,105ng/ml. During this period test results will be blinded. Decisions for further diagnostics (x-ray, cCT) and inpatient vs. outpatient treatment are made on clinical impressions as they are made now. The test results will be monitored and compared with clinical cases. Sensitivity, specificity, positive and negative predictive values will be measured. The aim is to identify patients without risk for intracerebral bleeding (ie S100 level lower than 0,105ng/ml). Those can be managed in an outpatient way. All other patients will be diagnosed and treated as it is now. If the test will not miss one intracranial bleeding and will save cCT scans and inpatient treatment, measurement of protein S100 will become a routine diagnostic in our ED for patients with MHI.

Official Title
-----------------
Introduction of Protein S100 in the Routine Diagnostics in Patients With Minor Head Injury

Conditions
-----------------
Intracerebral Hemorrhage

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: history of MHI during last 6 hours older than 3 years Exclusion Criteria: more than 6 hours after MHI younger than 4 years informed consent not given

Ages Eligible for Study
-----------------
Minimum Age: 4 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
-----------------
intracerebral hemorrhage, ct scans, protein s100, inpatient treatment
Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the effect of aerosolized antibiotics on respiratory infection in mechanically ventilated patients.We hypothesize that aerosolized antibiotics , which achieve high drug concentrations in the airway, would more effectively treat respiratory infection, decrease the need for systemic antibiotics and decrease antibiotic resistance.

Detailed Description
-----------------
In patients requiring mechanical ventilation, signs of respiratory infection often persist despite treatment with powerful antibiotics given through the patient's vein. In this trial, patients with purulent secretions were assigned aerosolized antibiotics or placebo by a randomizing protocol. Neither the patients or their doctors knew what the patient was receiving.Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between placebo and study drug for their effects on pneumonia, respiratory signs of infection, ability to wean patients from the ventilator, systemic(given in the vein) antibiotic use and the development of organisms that were resistant to antibiotics.

Official Title
-----------------
Aerosolized Antibiotics in Mechanically Ventilated Patients

Conditions
-----------------
Ventilator Associated Pneumonia, Respiratory Infection, Tracheobronchitis

Intervention / Treatment
-----------------
* Drug: aerosolized vancomycin or gentamicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be on mechanical ventilation greater than 3 days greater than or equal to 18 years of age survival greater than 14 days greater than 2 ccs of tracheal secretions/4 hours Exclusion Criteria: allergy to drugs, pregnancy

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: aerosolized vancomycin or gentamicin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator associated pneumonia Systemic Antibiotic use Clinical pulmonary infection score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning from mechanical ventilation Bacterial resistance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aerosolized antibiotics, ventilator associated pneumonia, clinical pulmonary infection score, bacterial resistance
A Prospective Observational Study of Sepsis

Study Overview
=================
Brief Summary
-----------------
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection and is associated with high morbidity and mortality. Sepsis3 gives sepsis a broad definition, reflecting the heterogeneity of the disease. So we need a precise treatment with a stratification of patient prognosis in order to reduce mortality in patients with sepsis.

Official Title
-----------------
A Prospective Observational Study of Clinical Efficacy, Complications, and Prognosis in Patients With Sepsis in ICU

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who met the Sepsis3 diagnostic criteria. Exclusion Criteria: Absence of laboratory test items (blood routine examination, coagulation function, liver function, biochemistry, urine routine examination, urine renal function, urine protein, etc.) >20%. Admission in ICU less than 48 hours. Patient with psychiatric disorders. Under 18 years of age.

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 |
| --- | --- |
| high exposure level<br>Patients have a high level of exposure factors | Other: no intervention<br>* no intervention<br>|
| low exposure level<br>Patients have a low level of exposure factors | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate | all-cause deaths that occurred in 28 days | 28 days after diagnosis of sepsis |
Effect of Vitamin D3 on Cardiovascular Risk Factors

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether a supplementation of Vitamin D3 can be used to reduce atherosclerotic risk factors.

Detailed Description
-----------------
It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 can lower blood pressure in mildly hypertensive subjects who are naive to antihypertensive medication, whether Vitamin D reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids. major outcomes: - decrease of systolic blood pressure in the treatment group in comparison with the placebo group

Official Title
-----------------
Effect of Vitamin D3 on Cardiovascular Risk Factors: a Randomized Trial in Human

Conditions
-----------------
Hypertensive Disease, Deficiency of Vitamin D3

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D3
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: human volunteers with mild hypertension Exclusion Criteria: use of antihypertensive medication use of vitamin d or calcium supplements known renal, inflammatory or malignant diseases hypercalcemia or hypercalciuria participation in other clinical studies use of tanning booths during the study

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin d<br> | Dietary Supplement: Vitamin D3<br>* daily dosage of 50 µg Vitamin D3 for 8 weeks<br>* Other names: cholecalciferol;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* daily intake of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | major outcome variable is the decrease oy systolic blood pressure in the treatment group in comparison with the placebo group. | after 8 weeks of supplementation |
Ultrasonography for Nutritional Assesment in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
Ultrasonography of Rectus Femoris and Anterior Tibialis muscles for nutritional assesment in cirrhotic patients undergoing major abdominal surgery

Detailed Description
-----------------
in the study, the investigator will use ultrasound to assess the nutritional state of cirrhotic patients after major abdominal surgery,The investigator aim to assess reliability of ultrasound as a bedside,non invasive tool,The investigator will enroll 72 patients for or study which is an observational study

Official Title
-----------------
Ultrasonography of Rectus Femoris and Anterior Tibialis Muscles for Nutritional Assesment in Cirrhotic Patients

Conditions
-----------------
Nutrition Assessment

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hepatic patients classified as child A, B undergoing major abdominal surgery (liver resection,whipple,Splenectomy,colectomy, Common Bile Duct exploration,By pass surgery) 18-60 yrs old no past history of nutritional problems,chronic use of drugs,patients with no orthopedic issues such as skeletal fractures or immobilization Exclusion Criteria: Refusal of the patient to share in the study, relevant comorbidities (renal, heart disease or COPD) previous immune abnormalities including treatment with corticosteroids neuromuscular diseases laparoscopic surgery patients on parenteral nutrition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ultrasound|Ultrasound is a type of imaging. It uses high-frequency sound waves to look at organs and structures inside the body.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the diameters of the Rectus Femoris and Anterior Tibialis muscles using the ultrasound in cm and the change of these diameters over the postoperative period till the 7th day to assess nutrition status in cirrhotic patients | observational prospective study | perioperative days 1,3,5,7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutrition,cirrhosis
iPS Cells of Patients for Models of Retinal Dystrophies

Study Overview
=================
Brief Summary
-----------------
The investigators are focused on inherited retinal dystrophies with an aim to further understand disease pathophysiology and to elaborate novel treatments, as, to date, there is no effective treatment to prevent blindness. The main goal of this study is to generate human cellular models of healthy and disease retinas and perform studies to evaluate the efficiency of gene therapy approaches for different diseases. Skin biopsies of volunteers are cultured to isolate fibroblasts that are then reprogrammed into iPS cells. Healthy and disease-specific iPS cells are then differentiated into retinal models. This study should help to elucidate disease pathways and to provide proof-of-concept for various therapeutic approaches.

Official Title
-----------------
iPS Cells of Patients for Models of Retinal Dystrophies

Conditions
-----------------
Retinal Dystrophies

Intervention / Treatment
-----------------
* Other: Skin biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Signed informed consent and Choroideremia : Males CHM mutation With multimodal Imaging anomalies in line with CHM All other presumed inherited retinal dystrophies with bilateral and symmetrical involvement with identified mutations in one of the Retnet gene All presumed inherited optic neuropathy with bilateral and symmetrical involvement with identified mutations And in all cases or pattern Age from 5 to 70 with appropriate health insurance Exclusion criteria : Patient under tutorship or curatorship

Ages Eligible for Study
-----------------
Minimum Age: 5 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Skin biopsy<br> | Other: Skin biopsy<br>* Skin biopsy on a location preliminarily anesthetized Disinfection protocol Combined required blood tests (HIV, Hepatitis B)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of human cell models obtained |  | 10 years |
Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

Study Overview
=================
Brief Summary
-----------------
Acute bronchiolitis is a common viral infection in infants mainly due to RSV and rhinovirus. Biomarkers can be useful for predicting its severity. The serum CC16 is a marker of epithelial aggression. Its rate increase during RSV bronchiolitis in infants less than 7 months. It could be an early predictive biomarker of the severity of acute bronchiolitis, and secondarily for the development of asthma. Two other markers of airway aggression seem to increase during acute bronchiolitis: serum SP-D protein and serum soluble receptor sRAGE.

Detailed Description
-----------------
Prospective, monocentric, case-control and study Primary end-point: correlation between serum CC16 level and severity of the bronchiolitis, evaluated by a clinical scoring system established at the time of the admission in Paediatric Emergency Unit. Secondary end-points: correlation with urinary CC16; correlation with risk factors for bronchial epithelial aggression, viruses, immediate morbidity and mortality. Study of serum SP-D and sRAGE levels.

Official Title
-----------------
Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

Conditions
-----------------
Acute Bronchiolitis

Intervention / Treatment
-----------------
* Drug: Protein CC16


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants under 1 year old hospitalized for acute bronchiolitis Exclusion Criteria: Broncho dysplasia Preterm under 34 weeks Cystic fibrosis Immune deficiency Suspicion of primary ciliary dyskinesia Congenital heart disease Acute renal failure

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Year

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acute bronchiolitis<br>Prospective, monocentric, case-control and study Primary end-point: correlation between serum CC16 level and severity of the bronchiolitis, evaluated by a clinical scoring system | Drug: Protein CC16<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum CC16 rate |  | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary CC16 rate |  | at day 1 | 
| SP-D rates |  | at day 1 | 
| sRAGE rates |  | at day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute bronchiolitis, RSV, CC16, SP-D, sRAGE, Severity, Biomarkers
An Assessment on Current Outcomes of Peritoneal Dialysis in Korea

Study Overview
=================
Brief Summary
-----------------
In this study, the recent trends in outcomes according to the dialysis modality in Korea since 2009, the effect of the use of peritoneal dialysis solutions containing icodextrin or high-glucose on various outcomes, the usefulness of 'PD first strategy', and the economic burden according to the dialysis modality will be investigated retrospectively using the Korean Health Insurance Review and Assessment Service (HIRA) database.

Detailed Description
-----------------
This study is designed as an observational and retrospective cohort study, thus there will be no intervention or specified prescription. For the comparison of outcomes according to dialysis modality, we will adopt an intention-to-treat analysis, and consider the dialysis modality at day 90 to be the initial dialysis modality. However, the investigators will also regard the dialysis modality at day 30 as the initial dialysis modality in order to evaluate and compare earlier mortality.

Official Title
-----------------
An Assessment on Current Outcomes of Peritoneal Dialysis in Korea

Conditions
-----------------
Kidney Failure, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who started dialysis during the study period and remained on the dialysis therapy for at least 90 days Exclusion Criteria: Patients who were younger than 18 years of age Patients who survived for less than 90 days from the date of dialysis initiation
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 |
| --- | --- | --- |
| Survival rate according to dialysis modality |  | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis, peritoneal dialysis
MMF After Pediatric Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The use of CNIs (CSA or FK) as primary immunosuppressive drugs after pediatric liver transplantation is one of the main causes of chronic kidney disease in these patients in the long term. The study objective is the evaluation of safety of a modification in immunosuppression from a dual-immunosuppression (CSA or FK plus steroids) to a triple immunosuppression (MMF plus CSA (reduced dosage) plus steroids.

Conditions
-----------------
Liver Transplantation, Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: MMF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients after pediatric liver transplantation no acute rejections for the last half year Exclusion Criteria: concomitant malign disease (e.g. ptld) neutropenia (granulocytes <1000/µl) systemic infection thrombopenia (<80/nl)

Ages Eligible for Study
-----------------
Maximum Age: 17 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: MMF|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections |  | 1, 3, 6, 9, 12, 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of chronic kidney disease |  | 12, 24 month | 
| incidence of infections |  | 1, 3, 6, 9, 12, 24 month | 
| incidence of ptld (post transplant lymphoproliferative disease) |  | 1, 3, 6, 9, 12, 24 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver transplantation, children, immunosuppression, mycophenolatmofetil, calcineurin inhibitor, kidney disease