linjc16/ctgov huggingface dataset:
EtCO2 Monitoring in Acute Self-poisoning

Study Overview
=================
Brief Summary
-----------------
There is no consensus on monitoring criteria in acute self poisoning. Clinical scores, vital signs or lactatemia have failed to prove good predictive value. The main acute self poisoning complication is decreased consciousness level with consequent increased risk of hypoxemia and aspiration pneumonitis. Several clinical studies have recently shown that EtCO2 monitoring can be valuable in procedural sedation in the emergency department. It is able to predict hypoxemia before any SaO2 decrease and any complications related to these procedures. We therefore hypothesized that EtCO2 could help in acute self poisoning patients' monitoring in the ED.

Official Title
-----------------
Continuous EtCO2 Monitoring in Acute Self Poisoned Patients Admitted in an Emergency Department

Conditions
-----------------
Acute Intentional Overdose

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18y/o acute self poisoning patients patients requiring monitoring according to physician's opinion patients not requiring invasive ventilation at ED admission Exclusion Criteria: Pregnant woman patients deprived of liberty

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 |
| --- | --- |
| Acute poisoning<br>Consecutive acute drug self poisoned patients admitted in the ED. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROC curve of maximal EtCO2 to predict poisoning complication | Poisoning complications are defined as: Hypoxia (Spo2<93%) and/or Respiratory rate <10/min or >25/min and/or ICU admission and/or Oro tracheal intubation | During the first 2 hours of ED admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intoxication, overdose, poisoning, EtCO2, emergency medicine
Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy

Study Overview
=================
Brief Summary
-----------------
The aim of this Phase II trial is to evaluate safety and efficacy of Hyalospine in patients undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk herniation. The device is used as an adjunct in lumbar spine surgery to prevent post- surgical fibrosis and adhesions, and improve patient outcomes.

Official Title
-----------------
A Multi-center Prospective Randomized Phase II Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy

Conditions
-----------------
Degenerative Spinal Stenosis, Disk Herniation

Intervention / Treatment
-----------------
* Device: Hyalospine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for elective single- or two-level lumbar laminectomy or laminotomy procedure for treatment of spinal stenosis and/or disk herniation. Subjects who have failed conservative care for at least 6 weeks. Exclusion Criteria: Contraindication to MRI Instrumented fusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control group consists of subjects randomized to the control arm who will receive lumbar decompression surgery (laminotomy or laminectomy) alone | |
| Experimental: Hyalospine<br>Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine. | Device: Hyalospine<br>* Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events |  | 6 months | 
| Extent of epidural fibrosis |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results |  | 12 months |
The Effect of Sifrol® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions

Official Title
-----------------
The Effect of SIFROL® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease Patients.

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Sifrol®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with idiopathic Parkinson's disease with tremor and/or depression requiring therapy with Sifrol® or change of therapy to Sifro®l and not under medication with neuroleptics were allowed to be observed during the study Exclusion Criteria: Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SPC) for Sifrol® Patients under treatment with neuroleptics should not be observed during this study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Idiopathic Parkinson's Disease Patients<br> | Drug: Sifrol®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parkinson signs and symptoms by means of a 4-point rating scale |  | up to 6 weeks | 
| Occurrence of tremor (rest and postural) by means of a 4-point rating scale | Short Parkinson's Evaluation Scale (SPES) | up to 6 weeks | 
| Change in severity of kinetic tremor assessed by tremor spiral test |  | up to 6 weeks | 
| Occurrence of depression by means of a 4-point SPES rating scale |  | up to 6 weeks | 
| Change in severity of depression by means of an 8-point rating scale | Clinical Global Impression (CGI) rating scale | up to 6 weeks | 
| Self-Assessment of depression by patient by means of six different visual analogue scales (VAS) | VAS (10 cm) | up to 6 weeks | 
| Assessment of efficacy by investigator on a 5-point rating scale |  | after 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse drug reactions |  | up to 6 weeks | 
| Assessment of tolerability by investigator on a 5-point scale |  | after 6 weeks | 
| Assessment of tolerability by patient on a 5-point scale |  | after 6 weeks |
Superior Vena Caval Obstruction (SVCO) - Management and Outcome

Study Overview
=================
Brief Summary
-----------------
All patients with symptomatic malignant SVCO deemed suitable for treatment either with radiation therapy or by stenting will be eligible. They will receive whichever treatment is deemed most clinically appropriate. Symptomatic response, time to onset of palliation, duration of symptom control and survival will be assessed.

Official Title
-----------------
A Prospective Longitudinal Study of the Management and Outcome of Superior Vena Caval Obstruction (SVCO)

Conditions
-----------------
Superior Vena Cava Syndrome

Intervention / Treatment
-----------------
* Behavioral: Management and Outcome of SVCO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic clinical and radiological diagnosis of superior vena caval obstruction. Underlying histological diagnosis deemed appropriate for palliative radiotherapy as treatment by investigator. Patients with chemosensitive tumours such as small cell lung cancer (both untreated and recurrent), lymphoma and testicular tumours, will be eligible if radiation is deemed to be appropriate treatment.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Management and Outcome of SVCO|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in an index symptom at 4 weeks as recorded by a daily symptom diary |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of palliation |  |  | 
| Duration of symptom control |  |  | 
| Survival |  |  | 
| Number of days spent in hospital |  |  | 
| Requirement for further treatment |  |  |
Myocardial Injury After BNT162b2 mRNA COVID-19 Fourth Dose Vaccination Among Israeli Health Care Workers

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.

Detailed Description
-----------------
Population-based retrospective studies suggest an association between BNT162b2 (Pfizer-BioNTech) vaccination against coronavirus disease 2019 (COVID-19) and myocarditis. While the overall incidence of myocarditis is estimated to be 2.13 per 100,000 persons, the incidence of myocardial injury and subclinical myocarditis may be higher. Adult health care workers who received the BNT162b2 vaccine in two Israeli hospitals (SZMC and Shamir) during the fourth dose campaign had blood samples taken for high-sensitivity cardiac troponin (hs-cTn) measurement at the time of vaccine administration and after 2-4 days. Post-vaccine myocardial injury was defined as hs-cTn elevation above the 99th percentile upper reference limit and >50% increase from the first measurement. Participants with evidence of myocardial injury underwent assessment for possible myocarditis including electrocardiogram and echocardiography.

Official Title
-----------------
A Prospective Study for Myocardial Injury After BNT162b2 mRNA COVID-19 Fourth Dose Vaccination Among Israeli Health Care Workers

Conditions
-----------------
Myocardial Injury, Vaccine Adverse Reaction, COVID-19

Intervention / Treatment
-----------------
* Biological: BNT162b2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult health care workers (≥18 years old) Exclusion Criteria: Acute coronary syndrome, peri/myocarditis, cardiac catheterization, cardiac surgery, cardiac ablation, or any other invasive cardiac procedure within 14 days prior to study enrollment. Chronic renal failure (creatinine clearance ≤30 mL/min), or dilated or hypertrophic cardiomyopathy

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

| Intervention/Treatment |
| --- |
|Biological: BNT162b2|Administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Injury | Myocardial injury was defined as high sensitivity cardiac troponin elevation above the 99th percentile upper reference limit and >50% increase from baseline measurement | 2-4 days after vaccine administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial injury, vaccine, COVID-19
Medium-term Venous Access in Congenital Heart Surgery

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate medium-term central venous catheter placement in infants undergoing complex cardiac surgery using a new technique. This technique involves placement of the catheter into the inferior vena cava through a subcutaneous tunnel and through a tunnel between pericardium and diaphragm.

Official Title
-----------------
A Medium-term Venous Access Alternative in Infants Undergoing Congenital Heart Surgery

Conditions
-----------------
Congenital Heart Surgery

Intervention / Treatment
-----------------
* Procedure: Placement of transthoracic catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants undergoing surgical correction or palliation of congenital heart disease via sternotomy Age 0-365 days Anticipated intensive care stay over 10 days Need for central venous access or prolonged venous access Exclusion Criteria: Presence of access that is likely to last more than 10 days at time of operation Septic shock Known inferior vena cava thrombosis Operations not approached by sternotomy

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 365 Days

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 |
| --- | --- |
| Experimental: Catheter<br>Cohort undergoing catheter placement using the new technique being studied | Procedure: Placement of transthoracic catheter<br>* Placement of transthoracic catheter into the inferior vena cava<br>* Other names: transthoracic catheter;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of complication-free use. Morbidity (infection, malposition, bleeding, thrombosis, need for removal for catheter-related complication). Need for additional catheter placement or reintervention. |  | Until catheter no longer needed; it is not anticipated that these remain longer than 2 weeks. Prior to discharge all will have been removed and final assessment of primary outcome will be obtained |
Mood and Subthalamic Nucleus (STN) Deep Brain Stimulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to investigate any changes seen in mood or behavior following deep brain stimulation for movement disorders.

Official Title
-----------------
Mood and STN Deep Brain Stimulation

Conditions
-----------------
Movement Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic PD diagnosed by a movement disorders neurologist Approved by a movement disorders neurologist as clinically needing a DBS device Absence of significant cognitive dysfunction (Mattis Dementia Rating Scale Score of greater than or equal to 116) MRI without evidence of structural abnormality (stroke, tumor, malformation, etc) No prior neurosurgical intervention Exclusion Criteria: None

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Staged Bilateral STN DBS<br> | |
| Simultaneous Bilateral STN DBS<br> | |

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
-----------------
Staged versus Simultaneous Bilateral DBS
Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor

Study Overview
=================
Brief Summary
-----------------
A single arm dose optimization study in which all patients are given a fixed dose of Cytoxan (4 x 50 mg/kg) plus ATG (3 x 30 mg/kg) and the TBI dose starting at 3 x 200 cGy is escalated or de-escalated dependent upon engraftment and toxicity.

Official Title
-----------------
Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor

Conditions
-----------------
Anemia, Aplastic

Intervention / Treatment
-----------------
* Procedure: Bone marrow transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Life-threatening marrow failure of nonmalignant etiology; failure to respond to the best available immunosuppressive treatment; lack of a HLA-identical family member Exclusion Criteria: Severe disease other than aplastic anemia that would severly limit the probability of survival during the graft procedure; HIV seropositive patients; clonal abnormalities or myelodysplastic syndrome;

Ages Eligible for Study
-----------------
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bone marrow transplant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained engraftment; survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute and chronic GVHD |  |  |
Database of Tissue Samples to Understand the Inflammatory Response After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to collect non-individual related blood samples for the compelling of a unique database of tissue samples to understand the inflammatory responds after cardiac surgery on an on-going basis. This includes especially protein analyses and genetic testing for certain neurotransmitters in the blood and tissues to understand disease markers related to heart disease. The study is designed as an openly recruiting biobank with the purpose to later serve multiple study purposes. Outcomes refer to protein analyses and genetic testing for neurotransmitters in the blood and tissues.

Official Title
-----------------
Non-individual Related Ongoing Collection of Blood Samples for the Compilation of a Unique Database of Tissue Samples to Understand the Inflammatory Response After Cardiac Surgery

Conditions
-----------------
Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cardiac surgery Exclusion Criteria: None.
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 |
| --- | --- | --- |
| Inflammatory Cytokines |  | Perioperatively until 7 days after cardiac surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac surgery, Tissue sample database, Inflammatory responds
Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon

Study Overview
=================
Brief Summary
-----------------
Recent studies reports feasibility, effectiveness and even less complications of using NIV for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate same results or even more in that conditions.

Detailed Description
-----------------
This trial will compare classical preoxygenation strategy with unidirectional valve autofilling balloon versus NIV.

Official Title
-----------------
Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon. A Multicenter Randomized Controlled Trial in Mobile Medical Emergency Rescue Service

Conditions
-----------------
Preoxygenation

Intervention / Treatment
-----------------
* Device: Non invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients needing chest tube intubation Exclusion Criteria: Cardiac arrest Children Pregnancy Incompetents

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NIV preoxygenation<br> | Device: Non invasive ventilation<br>* Non invasive ventilation<br>|
| No Intervention: Classical preoxygenation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hypoxemia | SpO2 below 85% | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chest tube, preoxygenation, NIV, out-of-hospital, patients needing tracheal chest tube managed by Medical Mobile Emergency rescue services