linjc16/ctgov huggingface dataset:
VITRO-Trial. B Vitamins and the Secondary Prevention of Venous Thrombosis

Study Overview
=================
Brief Summary
-----------------
The VITRO (Vitamins and Thrombosis) study investigated the effect of homocysteine lowering by daily supplementation of B-vitamins on the risk reduction of deep-vein thrombosis and pulmonary embolism. Patients between 20 to 80 years old with a first objectively confirmed proximal deep-vein thrombosis or pulmonary embolism in the absence of major risk factors and a homocysteine concentration above the 75th percentile of a reference group were asked to participate (hyperhomocysteinemic group). A similar study was conducted in a random sample of patients with a homocysteine below the 75th percentile of the reference group (normohomocysteinemic group). After informed consent patients were randomized to daily multivitamin supplementation (5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin) or placebo and were followed for 2.5 years. End-points were objectively diagnosed recurrent deep-vein thrombosis or pulmonary embolism.

Official Title
-----------------
Homocysteine Lowering by B Vitamins and the Secondary Prevention of Deep-Vein Thrombosis and Pulmonary Embolism. A Randomized, Placebo-Controlled, Double Blind Trial.

Conditions
-----------------
Deep-Vein Thrombosis, Pulmonary Embolism

Intervention / Treatment
-----------------
* Drug: 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: objectively confirmed proximal deep-vein thrombosis or pulmonary embolism idiopathic thrombosis (i.e. absence of major risk factors (major surgery, known malignant disease, pregnancy and puerperium or immobility for more than three weeks) age between 20 to 80 years Exclusion Criteria: obligatory use of vitamin B

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent symptomatic DVT or recurrent PE. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous thrombosis, Deep-vein thrombosis, Pulmonary embolism, Homocysteine, B-vitamins, Folate, Vitamin B12, Vitamin B6
The Effect of Ketanserin on the Microcirculation in Sepsis

Study Overview
=================
Brief Summary
-----------------
This study is an evaluation of the effect of ketanserine on sublingual microcirculation in intensive care patients with severe sepsis.

Detailed Description
-----------------
This is a pilot study, including 10 ICU patients with severe sepsis with MFI < 2,5 after fulfillment of a strict resuscitation protocol. At the start of the study, a baseline SDF measurement is made, when MFI < 2,5 inclusion in the study is permitted and intravenous ketanserin administration is started and subsequently increased, guided by the effect on sublingual MFI, until a safe maximum dosage is reached. Safety margins for hypotension are defined in the study protocol.

Official Title
-----------------
Evaluation of the Effect of Ketanserine on Sublingual Microcirculation by SDF Imaging in Septic Patients on the Intensive Care

Conditions
-----------------
Severe Sepsis, Septic Shock

Intervention / Treatment
-----------------
* Drug: ketanserin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe sepsis and MFI < 2,5 after resuscitation Exclusion Criteria: age < 18 year old pregnant participation other trials prolonged Qt interval

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: administration of ketanserin<br> | Drug: ketanserin<br>* ketanserin administration is started and increase, guided by the effect on sublingual MFI, dosage is 0,03mg/kg/hr<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microcirculation | achievement of a microvascular flow index >2,9 | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ketanserine dosage | obtaining a global indication of the ketanserin dosage needed to achieve a MFI >2,9 and the incidence of hypotension | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SDF, microcirculation, ketanserin, severe sepsis
Evaluation of Muscle Activation Efficiency in Challenging Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether muscle activation can be accomplished more effectively and comfortably in challenging subjects using novel configurations of an activation device. A novel device will be compared side by side with a market leading device.

Official Title
-----------------
Evaluation of Muscle Stimulation Efficiency in Challenging Subjects: A Pilot Study

Conditions
-----------------
Obesity, COPD

Intervention / Treatment
-----------------
* Device: Muscle Activation with Niveus and Intelect Devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 30 (Wing 1 of study) Non-hospitalized with confirmed diagnosis of COPD (Wing 2 of study) Exclusion Criteria: Age < 18 years Subject has an implanted pacemaker/defibrillator Subject diagnosed with epilepsy Subject has implanted metallic femoral rods Subject is chair- or bed-bound Subject has neuromuscular disease or abnormalities Subject BMI > 45 Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obese<br>Subjects with BMI > 30 | Device: Muscle Activation with Niveus and Intelect Devices<br>* Subjects will receive muscle activation technology from the Niveus device on one leg and from the Intelect (commercially-available third-party) device on the other. The order of use and the leg applied to will be randomized.<br>|
| Experimental: COPD<br>Non-hospitalized COPD patients | Device: Muscle Activation with Niveus and Intelect Devices<br>* Subjects will receive muscle activation technology from the Niveus device on one leg and from the Intelect (commercially-available third-party) device on the other. The order of use and the leg applied to will be randomized.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity Required | Intensity required to achieve target levels of muscle contraction | During treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Comfort of stimulation will be assessed at various intensity levels using a widely-used discomfort scale | During treatment |
The Immune Tolerance Mechanism Induced by IL-17-producing Regulatory T Cells in the Orthotopic Liver Transplant Recipients With Aspergillosis

Study Overview
=================
Brief Summary
-----------------
Infection accounted for the first cause of death in patients after liver transplantation, and 2 / 3 of the cause of death was fungal infections. The investigators group early found that T cell subsets playing a role of inducing immune tolerance were significantly increased in vivo of liver transplantation patients with aspergillus infection, which may be a kind of Treg cells expressing IL-17. To explore the immune tolerance mechanism induced by the immune balance cells is important to liver transplantation patients for improving efficacy and reducing the mortality. Therefore, the investigators are going to get the blood sample and liver tissue of the liver transplantation patients before and after treatment of aspergillus infection, flow cytometry analysis of blood T cell subsets, Cytometric Bead Array to detect changes in blood cytokines, laser capture microdissection to obtain liver biopsies of inflammatory cells in portal area and further for analysis of T cell subsets and protein. And the investigators are also to investigate the characteristics of CCR6 + CD4 + FOXP3 + Treg cell clones secreting IL-17 and the capacity of which suppressing conventional T cell proliferation. This study may find new methods, such as certain types of T cell subsets or cytokines for the treatment of liver transplant patients, which not only to anti-rejection but also to reduce fungal infection.

Conditions
-----------------
Liver Transplantation, Aspergillus, Interleukin-17, Treg Cell, Immune Tolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver transplantation patients Exclusion Criteria: Psychopath

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?
-----------------
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
-----------------
liver transplantation, aspergillus infection, interleukin-17, Treg cell, immune tolerance
Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity

Study Overview
=================
Brief Summary
-----------------
This project seeks to develop a standardized technique for simultaneous capturing bi-planar images of patients against a standard background with a grid that can be used later for the quantitative determination of global balance and thoracic symmetry. We hypothesize that patients who are successfully managed with surgery will demonstrate an improvement in global balance and thoracic symmetry that can be accurately measured. This measurement station will be specifically developed to provide a standardized, reproducible means to compare clinical assessments of surgical and non-surgical outcomes, and establish normative data for comparison. This standardized tool can be established at multiple centers for use in multicenter trials.

Official Title
-----------------
Tools for Objective Clinical Assessment of Pediatric Spinal Deformity and the Results of Surgical Intervention--Simultaneous Measurement of Sagittal and Coronal Balance and Symmetry With Digital Photography.

Conditions
-----------------
Thoracic Insufficiency Syndrome, TIS

Intervention / Treatment
-----------------
* Other: Digital Photography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female participants from 1- skeletal maturity Exclusion Criteria: no specific disease related exclusion criteria

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| 1<br>We intend to photograph male and female subjects from age 1 through skeletal maturity. Healthy children will be photographed to determine the normative characteristics of thoracic function using this technique. We will also enroll patients with thoracic pathology to determine how digital imaging can document thoracic dysfunction. There are no specific disease related exclusion criteria. Participation is voluntary. | Other: Digital Photography<br>* Digital Photography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in overall global balance following surgical intervention |  | Dec 2005-Dec 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in overall global balance |  | Dec 2005-Dec 2008 |
Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effects in terms of gas exchange, respiratory mechanics and comfort of breathing, of different assisted mechanical ventilation in ALI/ARDS patients.

Detailed Description
-----------------
ALI/ARDS patients (during assisted ventilation) will be ventilated with different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation) and gas exchange, comfort of breathing, respiratory mechanics and pattern of breathing will be measured.

Official Title
-----------------
Effects of Different Assisted Mechanical Ventilation in ALI/ARDS Patients

Conditions
-----------------
Respiratory Distress Syndrome, Adult

Intervention / Treatment
-----------------
* Other: Mechanical Ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ALI/ARDS Exclusion Criteria: COPD patients Barotrauma Hemodynamic instability Age less than 18

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ALI/ARDS patients | Other: Mechanical Ventilation<br>* Four different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gas exchange and respiratory mechanics |  | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, ALI, respiratory mechanics, gas exchange, assisted ventilation
Optical Tomographic Scanner for Skin Lesions

Study Overview
=================
Brief Summary
-----------------
Optical coherence tomography is technology widely used in medicine. In this study, the investigators will use an optical tomographic scanner to scan skin tissue image.

Detailed Description
-----------------
The investigators will use optical tomographic scanner to scan skin specimen and obtain tissue images. Part of skin specimen obtained from skin biopsy or surgery will be scanned.

Official Title
-----------------
Optical Tomographic Scanner for Skin Lesions

Conditions
-----------------
Skin Cancer, Benign Skin Tumor, Inflammatory Skin Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Patient who receive skin biopsy or surgery due to skin cancers, benign skin diseases, or inflammatory skin diseases.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Skin tissue image obtained. | Part of the skin specimen from surgery or biopsy will be scanned. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin histopathology | The skin specimen will be stained with hematoxylin and eosin. Histopathological pictures (or findings) will be obtained and correlate with the scanned images. | 2 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
optical coherence tomography
Electric Impedance Tomography

Study Overview
=================
Brief Summary
-----------------
Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when compared to reference measurements performed via right heart thermodilution

Official Title
-----------------
Electric Impedance Tomography

Conditions
-----------------
Stroke Volume

Intervention / Treatment
-----------------
* Device: Stroke Volume estimation using electrical impedance tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cardiac surgery which requires placement of pulmonary catheter Patients with right heart catheterization for diagnostic or therapeutic reasons Exclusion Criteria: Patient unable to understand the study Patient unable to provide written consent or refusing his/her participation Patient suffering from a severe valvular insufficiency Patient allergic to ECG electrodes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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: Tomographie par impédance électrique<br>Tomographie par impédance électrique | Device: Stroke Volume estimation using electrical impedance tomography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of stroke volume values measured via pulmonary catheter compared to EIT-derived stroke volume estimates. |  | 12 months |
Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
To assess whether vulnerable coronary plaques have more uptake of 68Ga-Dotatate than non-vulnerable plaques.

Official Title
-----------------
Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction

Conditions
-----------------
Atheroscleroses, Coronary

Intervention / Treatment
-----------------
* Other: 68Ga-Dotatate PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 50 years and older Underwent CCTA imaging within 78 weeks from the screening visit Either CAD-RADS 4 or higher or 0/1 on CCTA. Able to provide written informed consent Exclusion Criteria: History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of < 45 ml/min/1,73m2. CVD events/revascularization in history Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator. Chronic or recent (< 1 month) infections and/or clinical signs of acute infection. History of auto-immune diseases. Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study. Elevated liver enzymes (> 2 ULN of liver transaminases), acute liver failure or known liver disease.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: 68Ga-Dotatate PET/CT<br>These patients will undergo a 68Ga-Dotatate PET/CT scan. | Other: 68Ga-Dotatate PET/CT<br>* One 68Ga-Dotatate PET/CT to determine uptake of tracer in the arterial wall.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in TBRmax | Difference of target to background ratio (TBR)max in the coronary arteries between groups. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between TBRmax and FAI. | Correlation of TBRmax with fat attenuation index, a specific CCTA parameter of vascular inflammation. | 1 day |
Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine risk factors for relapse of bipolar disorder during pregnancy and the postpartum period. The main goal of this study is to find the risks that may make it more likely for a woman with bipolar disorder to experience a depressive, manic, or hypomanic episode during her pregnancy and the postpartum period.

Official Title
-----------------
Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity

Conditions
-----------------
Bipolar Disorder, Psychiatric Morbidity, Neonatal Outcome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for bipolar disorder of any type (1 or 2) who are currently pregnant within 14 weeks gestation dated by last menstrual period; euthymic at the time of conception; able to give informed consent and comply with study procedures; have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45 Exclusion Criteria: active suicidality or homicidality; active substance use disorder with 6 months prior to enrollment, or positive urine drug screen at enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| H<br>Pregnant women with bipolar disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychiatric morbidity |  | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| obstetrical outcomes |  | 6 months |