linjc16/ctgov huggingface dataset:
Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)

Study Overview
=================
Brief Summary
-----------------
Epilepsy is the second commonest chronic neurological disorder in developed countries ,comorbidity refers to the co-occurrence of two conditions with greater frequency than found in the general population

Official Title
-----------------
Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary epilepsy. Aged above 18 years old. Exclusion Criteria: patient diagnosed as secondary epilepsy or epilepsy syndromes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Find out comorbidities of epilesy and its treatment |  | 1 year |
Epidural Block Impairs HPV During One-lung Ventilation: an EIT- Based Prospective Observation Study

Study Overview
=================
Brief Summary
-----------------
Define the effect of epidural block on HPV by EIT.

Detailed Description
-----------------
Epidural block may affect the physiological mechanism of hypoxic pulmonary vasoconstriction, which is still poorly understood. Electrical impedance tomography might be helpful in establishing the hypoxemia etiology at bedside via combining regional ventilation and perfusion information.

Official Title
-----------------
Epidural Block Impairs Hypoxic Pulmonary Vasoconstriction During One-lung Ventilation: an Electrical Impedance Tomography- Based Prospective Observation Study

Conditions
-----------------
Epidural Block, Electrical Impedance Tomography

Intervention / Treatment
-----------------
* Device: Electrical impedance tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 - 80 years Existing central venous and arterial access Chest circumference 70 - 150 cm Exclusion Criteria: Contraindication to central venous injection of 5 % sodium chloride (NaCl) Contraindications of PulmoVista 500: Patients with pacemakers, defibrillators or other electrically active implants Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings Patients where the attachment of the patient belt could pose a risk to the patient, e.g. patients with spinal lesions or fractures Patients with uncontrolled body movements Extremely obese patients (BMI>50) Patients during pregnancy Patients with massive lung edema Use during electricity-based therapies, such as electrosurgery or electrocautery Use in the presence of strong magnetic fields Use in conjunction with other bioimpedance measurement devices

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Electrical impedance tomography|A bolus of 10ml 10% NaCl was injected during a respiratory pause (≥10s) through the central venous catheter.The results of arterial blood gas analysis and the data of EIT were collected before the first prone session (time baseline), the end of prone positioning (time P).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess regional distribution of pulmonary perfusion | To evaluate the effect of epidural block on pulmonary blood flow distribution. | within 24 hours | 
| Assess oxygenation status | To evaluate the effect of epidural block by assessing regional distribution of pulmonary perfusion based on indicator dilution and changes at different points in time during varying states of regional ventilation will be evaluated. | within 24 hours |
Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery

Study Overview
=================
Brief Summary
-----------------
To study the safety and effectiveness of several doses of PD 0348292 compared to enoxaparin in preventing blood clots in the lungs or deep leg veins of patients after knee surgery

Official Title
-----------------
A Phase 2B, Randomized, Multicenter, Dose-Ranging Study Assessing the Safety and Efficacy of PD 0348292 in the Prevention of Venous Thromboembolic Events (VTE) in Subjects Undergoing an Elective, Unilateral Total Knee Replacement

Conditions
-----------------
Venous Thrombosis

Intervention / Treatment
-----------------
* Drug: PD 0348292
* Drug: Enoxaparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult men or women scheduled for an elective, unilateral total knee replacement who are otherwise healthy. Exclusion Criteria: History of deep vein thrombosis or pulmonary embolism, suspected postthrombotic state, bleeding or clotting disorders, or cardiovascular, renal or liver disease within the past year

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PD 0348292|nan|
|Drug: Enoxaparin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint is the incidence of total venous thromboembolism (including all proximal and distal deep vein thrombosis [DVT] and pulmonary embolism [PE]) |  |  | 
| The primary safety endpoint is the incidence of total bleeding. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy endpoints are incidence of proximal DVT, distal DVT, and PE. |  |  | 
| Secondary safety endpoints are incidence of major and minor bleeding, all-cause mortality, abnormal liver function test elevation, adverse events and serious adverse events, and changes in clinical laboratory parameters. |  |  |
Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplant from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated transplants. More effective prevention and treatment strategies are needed. The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in animal models of various inflammatory diseases including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis. Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and immunosuppressive effects. As such, it may reduce the incidence and severity of GVHD after allogeneic stem cell transplantation.

Official Title
-----------------
Safety and Efficacy of Oral Cannabidiol for GVHD Prophylaxis in Allogeneic Stem Cell Transplantation

Conditions
-----------------
Graft Versus Host Disease

Intervention / Treatment
-----------------
* Drug: Oral Cannabidiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing allogeneic stem cell transplantation. No previous history of psychosis. - Exclusion Criteria: Previous history of psychosis. Consumption of cannabis during the last 2 moths before transplantation. -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Cannabidiol<br>Oral Cannabidiol 10 mg twice daily will be given from conditioning starting day and until day +30 after allogeneic transplantation. Dose can be doubled every 7 days if no significant side effects documented. | Drug: Oral Cannabidiol<br>* Cannabidiol will be dissolved in oil to a predefined concentration. Patients will be given oral cannabidiol 10 mg twice daily from conditioning starting day and until day +30 after allogeneic transplantation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall percentage of patients with acute GVHD at day 100 post-transplant |  | day 100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant |  | day 100 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cannabidiol, GVHD, Allogeneic transplantation, Prophylaxis
Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents

Study Overview
=================
Brief Summary
-----------------
The main objective of this research is to demonstrate the possible use of erythroferrone (ERFE) as a potential marker of recombinant human erythropoietin (rHuEpo) use to be included in the Athlete Biological Passport (PBA) developed by the World Anti-Doping Agency (WADA).

Official Title
-----------------
Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents

Conditions
-----------------
Sports Drug Abuse

Intervention / Treatment
-----------------
* Drug: EPREX
* Drug: sodium chloride AGUETTANT 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man between 18 and 49 years old Beneficiary of a social protection scheme Able to sign informed consent Exclusion Criteria: Hematocrite>50% or Hemoglobin> 17d/dl or Ferritin<30 ug/l Hypersensitivity to the active substance or to any of the excipients ofEPREX Erythroblastopenia already reported following treatment with erythropoietin Uncontrolled hypertension Any medication taken as part of a chronic treatment Absence of stable or evolutionary pathology without treatment History of convulsion or epilepsy History of thrombotic vascular events Large blood loss due to an accident, pathological condition or other similar situation. Donation of blood or blood transfusion within three months prior to inclusion in the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 different conditions: Eprex 20 UI/kg Eprex 50 UI/kg Placebo
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eprex 20 UI/kg<br>6 doses at 20 IU/kg in subcutaneous use | Drug: EPREX<br>* 6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use<br>|
| Experimental: Eprex 50 UI/kg<br>6 doses at 50 IU/kg in subcutaneous use | Drug: EPREX<br>* 6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use<br>|
| Placebo Comparator: Placebo<br>6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9% | Drug: sodium chloride AGUETTANT 0.9%<br>* 6 injections at 1ml in subcutaneous use<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythroferrone | dosage Erythroferrone from blood samples | 12 measures in 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hbmass | Measure of the total mass of hemoglobin | 2 measures in 29 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antidoping
Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Propofol has been routinely used for general anesthesia during pediatric cardiopulmonary bypass at our institution without complications. However, propofol may cause propofol infusion syndrome (PRIS), a rare, but often fatal complication mainly defined by bradycardia with progress to asystolia. Metabolic acidosis is regarded as an early warning sign of PRIS. Due to the preconditioning effects of sevoflurane and its availability for cardiopulmonary bypass, propofol has recently been substituted by sevoflurane during pediatric cardiopulmonary bypass at our institution. In this study the effect of substituting propofol by sevoflurane on metabolic acidosis and outcome are examined.

Detailed Description
-----------------
In this retrospective and partially prospective observational study the charts of 200 children anesthetised for pediatric heart surgery are analysed since September 2007. 100 children received propofol and up to now 80 children received sevoflurane during cardiopulmonary bypass. Blood gas analysis, laboratory results and vital parameters are compared before and after cardiopulmonary bypass for each group. Duration of intensive care treatment and time to dismission from hospital are compared between groups. Changes relative to baseline are analysed by paired t-Test with correction for multiple testing. Differences between groups are analysed by unpaired t-Test with correction for multiple testing

Official Title
-----------------
Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass: Effect on Metabolic Acidosis and Clinical Outcome

Conditions
-----------------
Metabolic Acidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children scheduled for heart surgery including cardiopulmonary bypass

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- |
| Propofol<br>Patients receiving Propofol during cardiopulmonary bypass. | |
| Sevoflurane<br>Patients receiving sevoflurane during cardiopulmonary bypass | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic acidosis during cardiopulmonary bypass | Changes of pH, base excess and lactate relative to baseline are analysed. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome parameter | Duration of intensive care treatment and time to dismission from hospital are compared between groups. | 1 month |
Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines

Study Overview
=================
Brief Summary
-----------------
An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines

Conditions
-----------------
Glabellar Frown Lines

Intervention / Treatment
-----------------
* Biological: AbobotulinumtoxinA
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe glabellar lines at maximum frown Understands the study requirements and signs an informed consent form Exclusion Criteria: Botulinum toxin treatment in the face within 6 months prior to study treatment

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>AbobotulinumtoxinA | Biological: AbobotulinumtoxinA<br>* Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Treatment of glabellar facial lines with placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo | Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA) | Month 1 after treatment |
Urine Biomarker for Kidney Transplant Rejection

Study Overview
=================
Brief Summary
-----------------
An adaptive sample collection to support biomarker evaluation for kidney transplant rejection.

Official Title
-----------------
An Adaptive Sample Collection to Evaluate a Biomarker for Kidney Transplant Rejection

Conditions
-----------------
Graft Rejection

Intervention / Treatment
-----------------
* Diagnostic Test: Urine Biomarker for Kidney Transplant Rejection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide informed consent Kidney Transplant Exclusion Criteria: Pediatric patients, under 18 years of age

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Urine Biomarker for Kidney Transplant Rejection|Biomarker for active kidney transplant rejection.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biospecimen collection |  | 3 years after last enrollment |
Study on Normal Ranges of Lipids in Breast Milk of Healthy Mothers

Study Overview
=================
Brief Summary
-----------------
This trial is undertaken to better understand the ranges of functional components normally found in human milk. This will strengthen the scientific knowledge on breast-milk composition as a gold standard.

Conditions
-----------------
Healthy Mothers

Intervention / Treatment
-----------------
* Other: minimum 4 months of breastfeeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age between 37 and not above 42 weeks 18 years old ≤ Mother ≤ 40 years old 18.5 ≤ pre-pregnancy BMI ≤ 29 Mothers willing to breastfeed for the first 4 months Exclusion Criteria: Gestational diabetes HTA < 140/90 Mothers who are smokers while breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| 50 healthy mothers<br> | Other: minimum 4 months of breastfeeding<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of lipids | The primary objective of this trial is to determine the levels of lipids normally found in the breast-milk of healthy lactating mothers | After 1 month of Breastfeeding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| profile and quantity of sugars | Secondary objectives include the measure of the profile and quantity of sugars found in human milk | After 1 month of breastfeeding |
The Study of Regional Lung Ventilation-perfusion by EIT

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational trial. The purpose of this study is to explore the feasibility of EIT monitoring pulmonary blood flow and the consistency and difference between EIT monitoring pulmonary local ventilation blood flow and SPECT and CTPA monitoring methods

Official Title
-----------------
The Study of Regional Lung Ventilation-perfusion by EIT

Conditions
-----------------
Pulmonary Ventilation, Pulmonary Perfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to ICU was less than 72 hours; Age ≥ 18 years old and ≤ 80 years old; Volunteer to participate after communicating with patients' family members; Exclusion Criteria: The patients with heart implants could not be monitored by EIT; Patients or their families refused to participate in the study; Hypernatremia

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EIT group<br>patients went through EIT detection | |
| CTPA group<br>patients went through CTPA detection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional pulmonary perfusion by EIT | Using EIT to measure the regional pulmonary perfusion and calculate ventilation/perfusion ratio | 1 Day | 
| Regional pulmonary perfusion by CTPA | Using CTPA to measure the regional pulmonary perfusion and calculate ventilation/perfusion ratio | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional pulmonary ventilation index by EIT | Regional pulmonary ventilation index by EIT, including GI: global inhomogeneity CoV: center of ventilation, ROI: region of interest | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EIT, pulmonary perfusion