linjc16/ctgov huggingface dataset:
Investigational Performance Evaluation of the Nanomix eLab® COVID-19 Rapid Antigen Panel With Samples From COVID-19 Positive and Negative Human Subjects

Study Overview
=================
Brief Summary
-----------------
Prospective samples will be collected to evaluate the agreement between a EUA RT-PCR test as the comparator method against the Nanomix eLab® system.

Official Title
-----------------
An Investigational Performance Evaluation of the Nanomix eLab® COVID-19 Rapid Antigen Panel With Samples From COVID-19 Positive and Negative Human Subjects

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Male or Female Willing and able to provide informed consent Symptomatic or asymptomatic The EUA RT-PCR sample must be collected within one (1) day of the sample collected for testing by the Nanomix eLab® COVID-19 Rapid Antigen Panel. Exclusion Criteria: Subjects without both a valid EUA RT-PCR test result and a valid Nanomix eLab® COVID-19 Rapid Antigen results will be excluded Subjects not being able to provide 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 |
| --- | --- |
| EUA RT-PCR positive<br> | Diagnostic Test: Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)<br>* COVID-19 Rapid Antigen Diagnostic Test<br>|
| EUA RT-PCR negative<br> | Diagnostic Test: Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)<br>* COVID-19 Rapid Antigen Diagnostic Test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate clinical agreement between an EUA RT-PCR methodology and the Nanomix eLab® COVID-19 Rapid Antigen Panel | An analysis of the result from subjects who have been or will be tested by EUA RT-PCR will be performed to establish the sensitivity by positive percent agreement (PPA) and the specificity by negative percent agreement (NPA) of the Nanomix eLab® COVID-19 Rapid Antigen Panel and a confirmatory EUA RT-PCR method. | Up to 1 year |
Prospective Cohort Study With Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the incidence of central nervous system (CNS) relapse or metastasis in patients with diffuse large B-cell lymphoma.

Detailed Description
-----------------
We dichotomize patients according to the risk of CNS involvement. Then, we perform CNS evaluation in patients at risk of CNS involvement. We prospectively monitor whether CNS relapse or metastasis occurs in patients with diffuse large B-cell lymphoma

Official Title
-----------------
Prospective Cohort Study With Risk-adapted Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma

Conditions
-----------------
Diffuse Large B-cell Lymphoma

Intervention / Treatment
-----------------
* Procedure: CSF analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed patients with diffuse large B cell lymphoma > 20 years life expectancy more than 6 months Written informed consent Exclusion Criteria: Refusal to informed consent Lymphomas other than diffuse large B cell lymphoma Primary CNS lymphoma

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DLBCL with risk factor<br>Patients have any of risk factors for secondary CNS involvement | Procedure: CSF analysis<br>* The cerebrospinal fluid will be evaluated via lumbar puncture.<br>* Other names: Brain MRI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNS relapse/involvement | After enrollment, patients will be monitored to check the CNS relapse or involvement | Up to 2 years after participants are enrolled. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | The survival outcome of patients will be monitored. | Up to 2 years after participants are enrolled | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diffuse large B cell lymphoma, central nervous system, prognosis
A Translational Study of Tumor Antigen-pulsed DC Vaccine for ESCC

Study Overview
=================
Brief Summary
-----------------
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-pulsed DC vaccine( OCDC and NeoDC) for postoperative adjuvant treatment of ESCC

Official Title
-----------------
A Translational Study of Tumor Antigen-pulsed Dendritic Cell Vaccine for Esophageal Squamous Cell Carcinoma

Conditions
-----------------
Esophageal Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Biological: OCDC vaccine; NeoDC vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed diagnosis of esophageal squamous cell carcinoma no preoperative adjuvant therapy Karnofsky performance status 0-2; The postoperative pathological stage is pT2-4 and / or N + M0 according to AJCC 8th Function of the main organs is normal; Edition Patient's written informed consent Exclusion Criteria: Tumor emergencies; Abnormal coagulation function; Contagious diseases, such as HIV, HBV, HCV infection; Mental disorders; Concomitant tumors; Immunological co-morbidities

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Autologous DCs pulsed with HOCl-oxidized autologous tumor lysate (OCDC) vaccine is administered in prime phase and personal neoantigen-sensitized DC(NeoDC) vaccine is administered in boost phase. | Biological: OCDC vaccine; NeoDC vaccine<br>* OCDC vaccine and NeoDC vaccine are administered in a prime-boost regimen by subcutaneous injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of treatment-related adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From the first administration of vaccine to 3 months after the last administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival | Number of participants with Disease-free Survival as assessed by RECIST1.1 | from the study start to 1 year after the study completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal cancer, tumour cell lysate, neoantigen, prime-boost, dendritic cell vaccine
Closed-loop Anaesthesia for Liver Transplantation: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Automated titration of propofol and remifentanil guided by the bispectral index (BIS) has been used for numerous surgical procedures. Orthotopic liver transplantation (OLT) uniquely combines major volaemic changes, an anhepatic phase, and ischaemia-reperfusion syndrome. We assessed the behaviour of this automated controller during OLT

Official Title
-----------------
Closed-loop Anaesthesia for Liver Transplantation: a Pilot Study

Conditions
-----------------
Anesthesia, Liver Transplant

Intervention / Treatment
-----------------
* Device: Automated titration of propofol and remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for OLT Exclusion Criteria: age younger than 18 years, pregnancy, allergy or hypersensitivity to propofol or remifentanil, a medical history of psychiatric illness, and supraspinal neurological disorders

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 |
| --- | --- |
| Experimental: Orthotopic liver transplantation<br> | Device: Automated titration of propofol and remifentanil<br>* Calculation of Consumption of propofol and remifentanil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of time spent in the BIS interval [40-60] |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Consciousness Monitor, Clinical Pharmacology
Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone (PDB).

Official Title
-----------------
A 6 Months, Open-Label Phase IV Study to Confirm the Safety and Efficacy of Single Intravenous Dose of 5 mg Zoledronic Acid for the Patients of Paget's Disease of Bone (PDB) in China

Conditions
-----------------
Paget's Disease of Bone

Intervention / Treatment
-----------------
* Drug: Zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of PDB by radiological reports Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN) Exclusion Criteria: History of hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates; History of malignancy of any organ system Severe liver or bladder disease; Calculated creatinine clearance < 35 mL/min at baseline; Hypocalcaemia; Patients with pre-existing dental diseases or who predict to have dental surgeries during the study; Evidence of vitamin D deficiency. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Experimental: 1<br> | Drug: Zoledronic acid<br>* 5mg, i.v. single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who achieve therapeutic response (a reduction of at least 75% from baseline in total Serum Alkaline Phosphatase (SAP) excess or normalization of SAP. |  | at the end of 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change from baseline in total Serum Alkaline Phosphatase (SAP). |  | at the end of 3 months and 6 months | 
| The percent change from baseline in serum cross-linked C-telopeptide of type I collagen (CTX). |  | at the end of 3 months and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paget's Disease of Bone, Serum Alkaline Phosphatase
Comparison of Two Techniques for Placement of Perineural Femoral Catheters.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of femoral perineural catheters in comparison with stimulating catheters. A non inferiority trial.

Detailed Description
-----------------
The investigators will randomize patients that will undergo anterior cruciate ligament reconstruction. Each patient will receive a subgluteal single shot nerve block and a continuous femoral nerve block with placement of a catheter either with the hydrolocalization technique (group HLOC) or a neurostimulating catheter (group NS).

Official Title
-----------------
Comparison of Ultrasound Hydrolocalization Technique Versus Neurostimulation for Placement of Continuous Femoral Catheters.

Conditions
-----------------
Postoperative Pain, Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
-----------------
* Procedure: Placement of a femoral catheter with the hydrolocalization technique
* Procedure: Placement of a femoral neurostimulating catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults BMI less than 30 Exclusion Criteria: known allergies to local anesthetics or other drugs used patient refusal any local or systemic contraindication to the use of popliteal block

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HLOC<br>Placement of a femoral catheter with the hydrolocalization technique | Procedure: Placement of a femoral catheter with the hydrolocalization technique<br>* Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%<br>* Other names: Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%;|
| Active Comparator: NS<br>Placement of a femoral neurostimulating catheter | Procedure: Placement of a femoral neurostimulating catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local anesthetic consumption |  | 36 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores with a VAS scale |  | 36 hours postoperatively |
Right Ventricular Damage in Cardiovascular Magnetic Resonance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the predictors of right ventricular damage (RVD) assessed by wall motion abnormalities, edema, myocardial salvage and delayed enhancement (DE)cardiac magnetic resonance imaging in acute ST-elevation myocardial infarction (STEMI) and its prognostic significance. The investigators hypothesize that ischemia related changes of the myocardium are also visible in the right ventricle and that they have an impact on patient outcome.

Official Title
-----------------
Right Ventricular Damage in ST-Elevation Myocardial Infarction. Risk Stratification by Visualization of Wall Motion, Edema and Delayed Enhancement Cardiovascular Magnetic Resonance

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Onset of symptoms <12 h before angioplasty. ST-segment elevation of at least 0.1 mV in ≥2 extremity leads or at least 0.2 mV in ≥2 precordial leads. Exclusion Criteria: Contraindications to CMR as implanted defibrillators, pacemakers, ferromagnetic intracranial metallic implants or pulmonary metallic splints and claustrophobia. A further exclusion criterion was prior fibrinolysis.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Major Adverse Cardiac Event |  | 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myocardial infarction, Right ventricular infarction, Cardiovascular Magnetic Resonance, Prognosis
Regisry of the Stroke Patients in Assiut University Hospital

Study Overview
=================
Brief Summary
-----------------
• Aim of the work To register all type of acute stroke admitted in Assiut university Hospital and assessment of their risk factor, morbidity and Mortality

Official Title
-----------------
Regisry of the Stroke Patients in Assiut University Hospital

Conditions
-----------------
All Patients With Ischemic Cerebrovascular Stroke Aged ≥18 Years of Both Sex

Intervention / Treatment
-----------------
* Drug: tissue plasminogen activator
* Procedure: thrombectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with stroke aged ≥18 years of both sex Written consent was taken for all patient either from the patient himself of closes relative after explaning to them the type of treatment benefits and possible risks Exclusion Criteria: Stroke due to metabolic causes as hypoglycemia liver, Renal failure and other metabolic causes Stroke due to Brain tumors

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tissue plasmnogen activator<br> | Drug: tissue plasminogen activator<br>* role of tissue plasminogen activator in patient with acute ischemic stroke having selective criteria for rTPA<br>* Other names: rtpa;|
| Active Comparator: thrombectoy<br> | Procedure: thrombectomy<br>* role of thrombectomy in patient with acute ischemic stroke<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Registry of the stroke Patients in Assist University Hospital |  | one year |
Mutation of the LEPR Gene at Reunion Island: Involvement in Pediatric Obesity

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to estimate the proportion of the recurrent deletion Δ6-8 of the LEPR gene in the homozygous and heterozygous state in pediatric cases with severe and early ( before the age of 6) obesity (BMI ≥ IOTF-30) on Reunion Island.

Detailed Description
-----------------
The study of the deletion Δ6-8 of the LEPR gene starts with a saliva sample using a swab in children aged between 3 to 18 years old. The DNA from this sample will then be analyzed by the PCR technique. If the deletion of the LEPR gene is confirmed in the patient, his adult family members will also be screened using the same procedure.

Official Title
-----------------
Mutation of the LEPR Gene at Reunion Island: Involvement in Pediatric Obesity GRÉOL (Génétique Réunion Obésité LEPR)

Conditions
-----------------
Obesity, Childhood

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with early severe and non syndromic obesity (BMI> IOTC-30) (before 6 years old) adult family members with deletion of LEPR gene informed consent form signed by participants or parents affiliation to social security scheme Exclusion Criteria: patient with syndromic obesity patient Under guardianship or Under judicial protection

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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 |
| --- | --- |
| Pediatric population<br>Children between 3 to 18 years old with severe (BMI> IOTF-30) and early (before the age of 6) obesity. A Saliva sample for screening of the deletion Δ6-8 of LEPR gene will be performed for each child. | |
| Adult member family<br>The screening of the same deletion according the same procedure will be proposed to the adult family member if the child presents the deletion Δ6-8 of LEPR gene. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of the Δ6-8 deletion of the LEPR gene in paediatric population | Presence of the deletion of the LEPR gene | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of the Δ6-8 deletion of the LEPR gene in adult family members | Presence of the deletion of the LEPR gene | 6 months after inclusion of the paediatric population |