linjc16/ctgov huggingface dataset:
Expression of TIM-3 on Lymphocytes in Sepsis

Study Overview
=================
Brief Summary
-----------------
The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its role in immunosuppression during sepsis.

Detailed Description
-----------------
Immunosuppression is the leading cause of death in septic patients.Lymphocyte apoptosis has been recognized as an important step in the pathogenesis of sepsis. Previous studies indicated that T cell immunoglobulin and mucin protein 3 (TIM-3) is a type I cell surface protein and was identified as a marker of lymphocyte dysfunction. The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its further role in immunosuppression during sepsis.

Official Title
-----------------
Expression and the Clinical Significance of TIM-3 on Lymphocytes During Sepsis

Conditions
-----------------
Sepsis, Immunosuppression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with severe sepsis patients undergo invasive spine surgery healthy volunteers Exclusion Criteria: patients with immunodeficient diseases patients who accept glucocorticoid or immunosuppressant patients with an age older than 18 years patients providing the informed consent

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 |
| --- | --- |
| Severe sepsis<br>Patients with severe sepsis | |
| SIRS patient<br>Patients after elective surgeries presented with SIRS but without sepsis | |
| Volunteer<br>Volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIM-3 expression on CD4+, CD8+ T cells and CD14+ monocytes | TIM-3 level on T cells was compared between different populations. | within 24h after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality |  | 28 days after diagnosis of sepsis |
Diagnosis of Bone Metastases in Breast Cancer: Bone Scintigraphy, Fluoride-PET and FDG-PET

Study Overview
=================
Brief Summary
-----------------
Breast cancer can metastasize to the bones, which leads to another treatment if bone metastases are detected. The purpose of the study is to determine, if fluoride PET/CT is superior to bone scintigraphy with technetium. On the other side, the investigators would like to see if FDG-PET/CT is a reliable alternative to dedicated bone imaging to detect bone metastases in patients with breast cancer.

Official Title
-----------------
Diagnosis of Sceletal Metastases in c. Mammae: 18F-NaF-PET/Lowdose-CT Versus 99mTc HDP Bone Scintigraphy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven c. mammae clinically suspicion of bone metastases Exclusion Criteria: age under 18 years diabetes mellitus pregnancy other known malignant disease

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

Sexes Eligible for Study
-----------------
Female

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
-----------------
breast cancer, bone metastasis, comparison of diagnostic methods, bone scintigraphy, fluoride PET/CT, FDG-PET/CT
Antibody Levels Associated With Reduced Risk of Invasive Group B Streptococcus Disease in Infants Aged Less Than 90 Days

Study Overview
=================
Brief Summary
-----------------
Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not. Use this comparison to establish antibody levels associated with reductions in risk of GBS disease in infants aged less than 90 days.

Official Title
-----------------
Establishing a Sero-correlate of Protection Against Invasive Group B Streptococcus Disease in Newborns and Young Infants Aged Less Than 90 Days.

Conditions
-----------------
Invasive Group B Streptococcus Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers. Subjects aged ≥18 years. Able to understand and comply with planned study procedures. Provides written informed consent. Exclusion Criteria: Refuses to consent to study participation.

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls<br>Infants born to GBS colonized mother who do not develop GBS disease | |
| Cases<br>Infants with culture confirmed GBS disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early onset Group B Streptococcus Disease due to serotypes Ia or III | Risk of early onset Group B Streptococcus disease (due to serotypes Ia or III) with respect to maternal or newborn anticapsular antibody levels at delivery | 0-6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late onset Group B Streptococcus Disease due to serotype III | Risk of late onset Group B Streptococcus disease (due to serotypes III) with respect to maternal or newborn anticapsular antibody levels at delivery | 7-90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early onset disease, late onset disease, anticapsular antibodies, serotype specific, Group B Streptococcus
Efficiency of Art-therapy in Psychotic Disorders

Study Overview
=================
Brief Summary
-----------------
The main purpose of the protocol is to test the efficiency of art-therapy versus metacognitive rehabilitation on the visual perception disorders observed in patients with schizophrenia.

Official Title
-----------------
Efficiency of Art-therapy in Psychotic Disorders

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: Art therapy
* Behavioral: metacognitive therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: schizophrenia according to DSM IV Exclusion Criteria: addiction problem invalidating visual sensory problems neurological history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Art-therapy<br>16 Art-therapy sessions | Behavioral: Art therapy<br> <br> |
| Active Comparator: Metacognitive therapy<br>16 Metacognitive therapy sessions | Behavioral: metacognitive therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Response times between baseline and after 16 therapy sessions |  | Baseline and after 16 therapy sessions (up to 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical scales (SAPS and SANS) between baseline and after 16 therapy sessions |  | Baseline and after 16 therapy sessions (up to 6 months) | 
| Change in esthetic perception between baseline and after 16 therapy sessions | Esthetic Perception Test | Baseline and after 16 therapy sessions (up to 6 months) | 
| Change in errors in visual organization tasks between baseline and after 16 therapy sessions |  | aseline and after 16 therapy sessions (up to 6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Art-therapy, Visual organization
Taste Reward Processing in Pediatric Obesity

Study Overview
=================
Brief Summary
-----------------
The study aims to provide a better understanding of the neural influence of eating behavior in the development of childhood obesity. Children ages 4-8 will be recruited to examine fMRI brain response to pictures that signal delivery of a chocolate milkshake and to the taste itself. The brain response will be compared to body mass index percentile scores for each child to help us determine whether brain differences present in adolescents and adults with obesity are present in young children.

Official Title
-----------------
Taste Reward Processing in Pediatric Obesity

Conditions
-----------------
Pediatric Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 4-8 parent available to complete surveys in English Exclusion Criteria: no presence of metal in body no claustrophobia no psychiatric or neurological condition that will affect brain function

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 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 |
| --- | --- |
| Overweight/Obese<br>Children with BMI percentile of 85 or above. | |
| Healthy Weight<br>Children with BMI percentile between 15 and 85. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI brain response to taste of chocolate milkshake |  | Baseline | 
| fMRI brain response to picture cue |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Picture food type, Taste type
Role of Oxygen for Vascular Dysfunction

Study Overview
=================
Brief Summary
-----------------
Hypoxemia may contribute increased morbidity and mortality in chronic obstructive pulmonary disease (COPD) patients. We aim to characterize the role of acute and chronic hypoxemia for vascular function. For this purpose we measure capillary oxygen concentration and vascular. Vascular function is assessed by flow-mediated dilation oft he brachial artery, forearm blood flow and laser doppler perfusion imaging. We hypothesize that hypoxemia leads to impaired vascular function.

Official Title
-----------------
Role of Acute and Chronic Hypoxemia for Vascular Function

Conditions
-----------------
FMD, Endothelial Dysfunction, IMT, Microcirculation, Oxygen Pressure, Carbon Dioxide Pressure, Oxygen Saturation, Forced Expiratory Volume After 1 Second

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable coronary artery disease stable chronic obstructive pulmonary disease Exclusion Criteria: acute myocardial infarction within 30 days acute exacerbated COPD within 30 days acute infections severe acute or chronic renal failure severe heart failure atrial fibrillation severe cardiac arrhythmia hypotension active malignant disease active rheumatic disease pulmonary hypertension with vasoactive therapy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CAD patients with COPD<br> | |
| CAD patients without COPD<br> | |
| healthy volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated dilation of the brachial artery |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forearm blood flow |  | Baseline | 
| Laser doppler perfusion |  | Baseline | 
| Intima-media thickness of the brachial artery |  | Baseline | 
| Fractional diameter change of the brachial artery |  | Baseline | 
| Endothelium-independent vasodilation of the brachial artery |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic obstructive pulmonary disease, Coronary artery disease, Endothelial function
Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the efficacy of Iv hyoscine butylbromide in preventing Bradycardia during cesarean section under spinal anaesthesia with local anaesthetic and morphine.

Official Title
-----------------
Prophylactic Use of Iv Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section Under Spinal Anaesthesia. a Randomized Controlled Trial

Conditions
-----------------
Bradycardia, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, Cesarean Section Complications

Intervention / Treatment
-----------------
* Drug: Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule
* Other: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status class I-II. Age: 18 Years to 40 Years. Women scheduled for elective Cesarean section under spinal anesthesia. indications for CS other than fetal or maternal pathology. Exclusion Criteria: Height < 150 or > 180 cm Body mass index (BMI) >35 kg/m2 Contraindication for central neuraxial block Refusal to undergo regional anesthesia Known allergy to any of the study drugs, Infection at the site of injection, Coagulopathy, Indication to general anesthesia Baseline bradycardia (heart rate < 60/min), or any cardiovascular disease Patients taking β-adrenergic blockers or any drugs that may alter normal response to study drugs. Arrhythmia such as atrial fibrillation, supraventricular tachycardia, heart block greater than first degree, left bundle branch block, Hypertension (systolic blood pressure more than 140 mm Hg or diastolic blood pressure more than 90 mm Hg), unstable angina or cardiomyopathy, Associated medical problem with pregnancy (as hypertension, diabetes mellitus, hepatic impairment or renal impairment)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyoscine butylbromide<br> | Drug: Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule<br>* Patients will receive IV study solution which is hyoscine butylbromide 20 mg in 1 ml one minute after spinal anaesthesia<br>|
| Placebo Comparator: Control<br> | Other: Normal saline<br>* Patients will receive 1 ml of IV normal saline as a placebo one minute after spinal anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bradycardia | number of participants who will develop heart rate below 50 BPM. | intraoperative |
THRA_hematologic Variables

Study Overview
=================
Brief Summary
-----------------
Total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.

Official Title
-----------------
Relations Between Hematologic Variables and Postoperative Bleeding in Total Hip Replacement Arthroplasty

Conditions
-----------------
Avascular Necrosis of Hip

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: avascular necrosis of hip total hip replacement arthroplasty Exclusion Criteria: revision operation hematologic disease anticoagulant medication preoperative hemoglobin < 10 g/dl preoperative transfusion of red blood cells

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative bleeding volume |  | at first postoperative day | 
| Hemoglobin |  | preoperative 1 day and postoperative 1 day | 
| hematocrit |  | preoperative 1 day and postoperative 1 day | 
| platelet |  | preoperative 1 day and postoperative 1 day | 
| prothrombin time_international normalized ratio |  | preoperative 1 day and postoperative 1 day | 
| activated partial prothrombin time |  | preoperative 1 day and postoperative 1 day | 
| fibrinogen concentration |  | preoperative 1 day and postoperative 1 day | 
| Rotational thromboelastometry |  | preoperative 1 day and postoperative 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume of infused fluid during operation | Infused total crystalloid and colloid volume during the operation will be recorded. | Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) | 
| intraoperative urine output |  | Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) | 
| transfusion units | Red blood cell | Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) and postoperative first day |
APROVE : Irbesartan in Hypertension

Study Overview
=================
Brief Summary
-----------------
Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan in ambulatory Hypertensive patients

Official Title
-----------------
Efficacy and Tolerability of Posology Adaptation of Irbesartan in Ambulatory Hypertensive Patients

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

Intervention / Treatment
-----------------
* Drug: Irbesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with mild or moderate hypertension defined with arterial diastolic pressure (PAD) at sit position between 90 mmHg and 110 mmHg and arterial systolic pressure (PAS) at sit position between 140 mmHg and 180 mmHg. Patient diagnosed after 3 consultations within 2 months who has never been under treatment and responding to the required conditions for hypertension treatment with irbesartan. This patient must has been under proper but insufficient hygieno dietetic diet Patient who has been under a none satisfied antihypertensive treatment, and for whom this treatment was stopped at least 2 weeks prior to inclusion. Patient with a laboratory analysis (urinary sediment- Na -K- creatinine, total cholesterol) and ECG during the month prior to inclusion. Exclusion Criteria: Severe Hypertension defined by PAS > 180mmHg and/or PAD > 110 mmHg. Isolated systolic Hypertension Secondary Hypertension Arterial stenosis on unique kidney - arterial bilateral kidney stenosis Non-surgically sterilized women or non-menopaused women. Confirmed sodic depletion. Hypersensitivity to Irbesartan. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Tension |  |  | 
| Tolerability |  |  |
Resting Metabolic Rate Reliability

Study Overview
=================
Brief Summary
-----------------
This research is being conducted to study the reliability of a method used to measure resting metabolic rate, or how much energy a person expends while at rest.

Official Title
-----------------
Resting Metabolic Rate Reliability

Conditions
-----------------
Resting Metabolic Rate Reliability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 - 65 years old BMI of 19 - 40 kg/m2 Women must not be pregnant or planning to become pregnant Exclusion Criteria: Age less than 18 or greater than 65 BMI less than 19 or greater than 40 Tobacco use Taking medications that affect metabolic rate (unless weight stable for past 3 months) Any disease that affects the metabolic rate

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Metabolic Rate by Indirect Calorimetry | The within-subject coefficient of variation for resting metabolic rate (RMR) will be less than 10%. Testing will occur on non-consecutive days, with a compliance and menstrual cycle questionnaire prior to testing. | At least 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Quotient Variation | The within-subject coefficient of variation for respiratory quotient (RQ) will be less than 10%. Testing will occur on non-consecutive days, with a compliance and menstrual cycle questionnaire prior to testing. | At least 3 days | 
| Sense Wear Mini Armband verses Indirect Calorimetry | The limits of agreement of Sense Wear Mini Armband (SWA)-estimated resting energy expenditure (REE) with indirect calorimetry measures of REE will be large (+ 500 kcal). Testing will occur on non-consecutive days, with a compliance and menstrual cycle questionnaire prior to testing. | At least 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RMR, Reliability, Obese, Energy Expenditure, Resting Energy Expenditure, Resting Metabolic Rate