linjc16/ctgov huggingface dataset:
Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to test the feasibility of using gene expression from saliva to identify patients with early-stage non-small cell lung cancer (NSCLC). The primary objective of this study is to compare gene expression profiles from saliva from healthy controls and patients with early-stage non-small cell lung cancer. To be eligible, patients with non-small cell lung cancer, must not yet have received treatment for their cancer (surgical removal, chemotherapy, or radiation therapy). Health control participants may participate if they meet eligibility criteria listed below. Eligible enrollees will be asked to submit a one time saliva sample and complete a study questionaire.

Official Title
-----------------
Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening

Conditions
-----------------
Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with untreated stage I-II NSCLC OR Healthy control subjects: with a > 20 pack year history of cigarette smoking OR Never smokers (defined as less than 100 cigarettes over subject's lifetime) The investigators recognize that pathologic confirmation is not always available prior to surgical resection of a lung mass. To account for this, subjects with a suspicious lung mass concerning for lung cancer, can be enrolled on this trial, and submit a saliva sample prior to surgical resection (ideally within 45 days of planned surgery). Adults age 40-79 Ability to understand the investigational nature of the study and sign the informed consent in accordance with institutional and FDA guidelines Exclusion Criteria: No active pulmonary infection, i.e. bronchitis or pneumonia for 6 months No use of steroid inhalers for > 6 months No other prior malignancy is allowed except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancers from which the patient has been disease-free for 5 years

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 79 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>Non-small cell lung cancer patients | |
| 2<br>Healthy control subjects | |

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
-----------------
non-small cell lung cancer, screening, saliva, gene expression, healthy control subject
Cardiac Deformation: Correlation With Conventional Echocardiographic Hemodynamic Variables (An Intraoperative Study)

Study Overview
=================
Brief Summary
-----------------
The aim of this research is to apply cardiac tissue characterization in order to assess left ventricular function in cardiac surgical patients pre and post cardiopulmonary bypass. The procedures to be used include a retrospective review of transesophageal images obtained during conventional intraoperative transesophageal echocardiography (TEE) for cardiac surgery, as well as a secondary analysis with Tissue Doppler. The results will be compared with hemodynamic data obtained from a pulmonary artery catheter (PAC).

Detailed Description
-----------------
Patients included in this study are between the ages of 18 to 99 years of age, who presented to the operating room for cardiac surgery, and received both a pulmonary artery catheter and a routine intra-operative TEE. We will only be looking at patients whose TEE images were of good quality. Subjects underwent cardiac surgery and received both a PAC and a routine TEE exam. We will review the data from the PAC, the images from the conventional TEE exam, and a secondary analysis with Tissue Doppler. A potential benefit to society is a novel means for assessing left ventricular function. Our research will not benefit our subjects directly. There is no additional risk to our subjects beyond the insertion of the PAC and the TEE probe, which are routinely placed in our patients under-going cardiac surgery.

Official Title
-----------------
Cardiac Deformation: Correlation With Conventional Echocardiographic Hemodynamic Variables. An Intraoperative Study.

Conditions
-----------------
Cardiac Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients >18 years of age Patients scheduled for cardiac surgery and will receive both a pulmonary artery catheter and a routine intra-operative TEE Exclusion Criteria: TEE images that are of poor quality

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| assess left ventricular function in cardiac patients pre and post cardiopulmonary bypass |  | 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac deformation, Cardiopulmonary bypass, TEE, Cardiac Surgery, Left ventricular function, Pulmonary Artery catheter, Tissue Doppler, Left ventricular function in cardiac surgery
Belgian Real Life Non-interventional Study (NIS) on Xarelto in Non-valvular Atrial Fibrillation (AF) Patients Treated for the Prevention of Stroke and Systemic Embolism

Study Overview
=================
Brief Summary
-----------------
The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with non-valvular AF treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.

Official Title
-----------------
Belgian Real Life Non-interventional Study (NIS) on Xarelto® in Non-valvular Atrial Fibrillation (AF) Patients Treated for the Prevention of Stroke and Systemic Embolism (BOX-AF)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients ≥ 18 years old with a confirmed diagnosis of non-valvular atrial fibrillation Patients must in addition present with at least one of following risk factors: prior stroke, TIA (transient ischemic attack) or non-CNS (central nervous system) systemic embolism left ventricular ejection fraction of < 40% symptomatic heart failure, New York Heart Association class 2 or higher age ≥75 years age ≥65 years in combination with either diabetes, coronary disease or arterial hypertension Exclusion Criteria: Patients who do not fulfil the Belgian reimbursement criteria

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 |
| --- | --- |
| Rivaroxaban<br> | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* 15 mg OD or 20 mg OD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with major bleedings |  | 1 year or 30 days after end of rivaroxaban | 
| Number of patients with symptomatic thromboembolic events |  | 1 year or 30 days after end of rivaroxaban | 
| All-cause mortality |  | 1 year or 30 days after end of rivaroxaban | 
| Adverse events |  | 1 year or 30 days after end of rivaroxaban | 
| Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS) |  | 1 year or 30 days after end of rivaroxaban | 
| Quantities of resource use consumption |  | 1 year or 30 days after end of rivaroxaban | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-valvular atrial fibrillation, Stroke, Systemic embolism, Oral anticoagulation, Real-life setting, Preventive measure
A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)

Study Overview
=================
Brief Summary
-----------------
Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.

Detailed Description
-----------------
Patients with Severe Pneumonia caused by SARS-CoV-2 infection are enrolled to the study. Adipose-derived mesenchymal stem cells (AD-MSCs) are administered once a week, total four times intravenously. Safety and efficacy of AD-MSCs are evaluated for 12 weeks after first administer.

Official Title
-----------------
An Phase2 Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection

Conditions
-----------------
SARS-CoV-2 Infection( COVID-19 )

Intervention / Treatment
-----------------
* Biological: Mesenchymal stem cell
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SARS-CoV-2 infection is confirmed on antigen test or PCR test Pulmonary infiltrative shadow is confirmed on chest X-ray test PaO2/FiO2 <=200mmHg at the time of screening Exclusion Criteria: Continue treatment for Pneumonia before SARS-CoV-2 infection SOFA score >= 15 Infection type on DIC diagnosis criteria >= 4 Deep Venous Thrombosis

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cell<br>4 times dose of Mesenchymal stem cell | Biological: Mesenchymal stem cell<br>* 1*10^8 cells are administered once a week, total four times intravenously.<br>|
| Placebo Comparator: Placebo<br>Saline | Biological: Placebo<br>* Commercially available saline.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator Free Days | Ventilator Free Days which appear in subjects with ADR-001 treatment are evaluated. | Day 28 |
Mechanical Ventilation in Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
To identify risk factors for mortality in patients with interstitial lung disease receiving mechanical ventilation.

Official Title
-----------------
Risk Factors for Mortality in Patients With Interstitial Lung Disease Receiving Mechanical Ventilation: A Retrospective, Observational Cohort Study

Conditions
-----------------
Interstitial Lung Disease, Mechanical Ventilation, Risk Factors, Morality

Intervention / Treatment
-----------------
* Device: Mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They were clearly diagnosed as interstitial lung disease in hospital; They had progressive worsening of dyspnea and their oxygenation indexes were less than 300 in ICU; They received at least 48 hours of mechanical ventilation after being admitted into ICU. Exclusion Criteria: We excluded patients who were admitted into ICU because of postoperative monitoring.

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

| Intervention/Treatment |
| --- |
|Device: Mechanical ventilation|Noninvasive and/or invasive mechanical ventilation were performed when patients had respiratory failure.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Mortality |  | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality |  | 7 years | 
| Noninvasive mechanical ventilation failure |  | 7 years | 
| Invasive mechanical ventilation failure |  | 7 years |
Position HTO Multicenter NIS

Study Overview
=================
Brief Summary
-----------------
Evaluation of the Position HTO system in patients with unicompartmental medial arthrosis after open wedge high tibial osteotomy

Official Title
-----------------
Study on Quality of Life in Patients With Unicompartmental Arthrosis After High Tibial Osteotomy With the Position HTO(R) System

Conditions
-----------------
Medial Monocompartmental Osteoarthritis of the Knee

Intervention / Treatment
-----------------
* Device: Position HTO system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Varus deformity between 0 - 20°, Isolated medial arthrosis ≥ level 2 (K&L) OR a congenital deformity OR chondromalacia ≥ level 2 (ICRS), Lateral cartilaginous tissue damage ≤ level 1(K&L), Intact lateral meniscus, Age ≥ 18 years, Range of Motion at least 0° - 0° - 130°, Patella/ sliding plane without signifikant signs of arthrosis, Stable joint OR possibility of intraoperative balancing of the tendon tension; Exclusion: Clinically relevant disorders of bone metabolism, Aktive infection, Adipositas (BMI ≥ 35), Rheumatoid arthritis, Osteomyelitis in the tibia, No availibility for follow-up examinations

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 |
| --- | --- |
| A<br>HTO cohort | Device: Position HTO system<br>* open wedge high tibial osteotomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient health status improvement assessed by IKDC 2000 subjective knee score |  | 1 year after HTO | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of further scores: Tegner Activity Score, Lysholm-Gillquist Score, Cincinnati-Sportsmedicine and Orthopaedic Center-Score, IKDC 2000 objective knee score, Hospital for Special Surgery Score (HSS) |  | 1 year after HTO | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HTO, high tibial osteotomy, open wedge, medial arthritis
Dumping Syndrome and Quality of Life After Vagus Nerve-preserving Distal Gastrectomy

Study Overview
=================
Brief Summary
-----------------
There is no consensus on what type of function-preserving gastrectomy can provide the best patient quality of life (QOL). This study aims to evaluate the incidence of dumping syndrome after vagus nerve-preserving distal gastrectomy (VPNDG).

Detailed Description
-----------------
The study is designed as a prospective observational phase II study with a follow-up period of 12 months. Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach who are planned to undergo laparoscopic VPNDG with Roux-en Y gastrojejunostomy will be enrolled. Primary endpoint is incidence of dumping syndrome defined by Sigstad score 7 after a 3-month interval. Other outcomes include operative data, early complication, and patient QOL using the European Organization for Research and Treatment of Cancer C-30 and STO22 modules.

Official Title
-----------------
Incidence of Dumping Syndrome After Laparoscopic Vagus Nerve-preserving Distal Gastrectomy for Early Gastric Cancer

Conditions
-----------------
Stomach Neoplasm

Intervention / Treatment
-----------------
* Procedure: Vagus nerve-preserving distal gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach planned to undergo laparoscopic vagus nerve-preserving distal gastrectomy Exclusion Criteria: Sacrificed vagus nerve Anastomosis other than Roux-en Y gastrojejunostomy or uncut Roux-en Y gastrojejunostomy conversion to an open procedure combined resection of other organs

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 |
| --- | --- |
| Vagus nerve preserving group<br>Patients who underwent vagus nerve-preserving distal gastrectomy for early gastric cancer | Procedure: Vagus nerve-preserving distal gastrectomy<br>* Laparoscopic distal gastrectomy with the preservation of the celiac and hepatic branch of the vagus nerve.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dumping syndrome | Sigstad score of equal or more than 7 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC C-30/STO22 | Quality of life surveys | 3 months, 6 months, 1 year | 
| Postoperative complication | incidence of postoperative complication | 3 months, 6 months, 1 year | 
| Incidence of gallstones | Found in follow-up CT or ultrasound | 1 year |
Chevron Osteotomy Versus SCARF Osteotomy in the Treatment of Hallux Valgus

Study Overview
=================
Brief Summary
-----------------
Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data. All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone surgery CHU Limoges : Scarf or Jonhson (chevron) osteotomy Experienced surgeon : Pr ARNAUD, Pr MABIT or Pr CHARISSOUX.

Detailed Description
-----------------
Prospective assessmentfor all patients with an average follow up of 5 years : Groulier score scale (similar to AOFAS score rating) X-rays data Clinical evaluation Pedoscopic data.

Official Title
-----------------
Chevron Osteotomy Versus SCARF Osteotomy in the Treatment of Hallux Valgus

Conditions
-----------------
Hallux Valgus

Intervention / Treatment
-----------------
* Procedure: Chevron osteotomy versus Scarf osteotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone surgery CHU Limoges. Scarf or Johnson (Chevron) osteotomy, Experienced surgeon : Pr MABIT, Pr ARNAUD, Pr CHARISSOUX. Age of Patients > 18 years. Exclusion Criteria: Hallux valgus wich wasn't operated by these surgeons. No consentment

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Chevron osteotomy versus Scarf osteotomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extension of chevron osteotomy indication. Check of results for one-year more operated patients by chevron osteotomy. |  |  | 
| Comparaison of both techniques concerning post-operative complication. |  |  | 
| Search of significative difference about satisfaction of patients. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scarf Osteotomy, Chevron Osteotomy, Comparison
Association of the Optic Nerve Sheath Diameter With Eyeball Transverse Diameter in Robot-assisted Prostatectomy

Study Overview
=================
Brief Summary
-----------------
Robot-assisted laparoscopic radical prostatectomy (RALRP) is becoming a popular procedure due to its unique advantages. Despite these advantages, pneumoperitoneum and steep trendelenburg position are associated with hemodynamic instability and elevated intracranial pressures (ICP). Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is an indirect but also a generally accepted reliable and noninvasive measurement of elevated ICP. However, optimal cut-off values are highly inconsistent due to multiple factors (gender, height, weight). To eliminate the effects of these factors on the results; a ratio should be established in patients known to have elevated ICPs. In a recent study ONSD/ eyeball transverse diameter(ETD) in healthy volunteers in a specific population was established. 60 patients without any history of ICP undergoing RALRP will be enrolled to the study. Ultrasonographic measurement of ONSD and ETD will be performed 10 minutes after induction of general anesthesia, 10 minutes after CO2 pneumoperitoneum with trendelenburg positioning and measurements will be repeated hourly and at last after returning to supine position without CO2 pneumoperitoneum at the end of the procedure. Hemodynamic variables and BIS values on this specific times will be recorded and an arterial sample will be obtained.

Official Title
-----------------
Ultrasonographic Measurement of the Optic Nerve Sheath Diameter and Its Association With Eyeball Transverse Diameter in Robot-assisted Laparoscopic Radical Prostatectomy

Conditions
-----------------
Elevated Intracranial Pressure, Optic Nerve Sheath Diameter, ONSD /ETD Ratio

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19-75 years patients undergoing RALP Exclusion Criteria: a history of corneal surgery, open-angle or closed-angle glaucoma intraocular surgery history of elevated ICPs

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RALPD<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of the Optic Nerve Sheath Diameter With Eyeball Transverse Diameter in Robot-assisted Prostatectomy | To determine a cut off value for ratio of ONSD to ETD in a group known to have elevated ICPs | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
robot assisted laparoscopic prostatectomy, optic nerve sheath diameter