linjc16/ctgov huggingface dataset:
Shock Index To DEtect Low Plasma Fibrinogen In Trauma (SIDE)

Study Overview
=================
Brief Summary
-----------------
Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without the need to perform other potentially time consuming investigations.

Detailed Description
-----------------
Hypofibrinogenemia is common in severe trauma and below the threshold of 2.3 g/l is associated with increased mortality. Although guidelines for management of the trauma induced coagulopathy does not recommend any specific timing of fibrinogen substitution, several papers suggest that early substitution might be associated with improved outcome. Laboratory measurement of plasma fibrinogen level, thromboelastometry and/or its estimation based on base excess, hemoglobin level, Injury Severity Score or combinations require diagnostic procedures that are associated with with a certain time delay and prolongs the time to fibrinogen substitution.

Official Title
-----------------
Shock Index To DEtect Low Plasma Fibrinogen In Trauma (SIDE)

Conditions
-----------------
Trauma, Multiple

Intervention / Treatment
-----------------
* Procedure: plasma fibrinogen measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient having / suspected to have severe trauma transported to participating centers by cooperating Emergency Medical System organizations Exclusion Criteria: possible alterations of plasma fibrinogen level in the time of trauma (inflammatory disease, malignant disease, pregnancy) administration of fibrinogen containing products (fresh frozen plasma, fibrinogen concentrate, cryoprecipitate) before sampling blood for fibrinogen level circumstances possibly interfering with plasma fibrinogen level measurement (prior the administration of hydroxyethylstarches)

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 |
| --- | --- |
| Trauma patients<br>All patients having / suspected to have severe trauma injuries admitted to participating centers. | Procedure: plasma fibrinogen measurement<br>* plasma fibrinogen measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects that have plasma fibrinogen <2.3 g.l-1 on admission among those with shock-index >1. |  | On admission |
High Flow Therapy in ICUs Across Ibero America

Study Overview
=================
Brief Summary
-----------------
The study aims to describe the use of Nasal High Flow (NHF) in the intensive care units of participating centers in Iberoamerica. It will describe the indications for the use, the clinical outcome of patients , and the therapeutic failure of NHF therapy in patients staying in an intensive care unit in the participant centers in Iberoamerica.

Official Title
-----------------
High Flow Nasal Cannula Technique in Iberoamerica

Conditions
-----------------
Nasal High Flow Therapy, Intensive Care Unit, Ventilatory Failure, Hypoxia, Hypercapnic Respiratory Failure

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old Admitted to medical or surgical ICU Requirement of high nasal flow therapy Exclusion Criteria: Post-extubation failure Patient unable to protect airway Diagnosed shock Glasgow equal or under 8

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 |
| --- | --- |
| High Nasal Flow Therapy<br>Every patient in the ICU that requires High Nasal Flow Therapy | Other: No intervention<br>* No intervention, observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia | PO2 under 60mmHg, or SatO2 under 80%; that leads to the instauration of invasive ventilation | 15 days | 
| Tachypnea | Respiratory rate over 20; that leads to the instauration of invasive ventilation | 15 days | 
| Hypercapnia | PCO2 over 55mmHg; that leads to the instauration of invasive ventilation | 15 days |
Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the safety and effectiveness of ribavirin, administered as an aerosol, in preventing progression of upper respiratory tract RSV infection to RSV pneumonia in bone marrow and peripheral blood transplant recipients.

Detailed Description
-----------------
The study enrolls 90 transplant recipients with positive nasal/throat culture specimens for Respiratory Syncytial Virus (RSV) infection. Patients are randomized into one of two groups: investigational treatment or standard treatment.

Official Title
-----------------
A Randomized Phase III Study to Evaluate the Safety and Efficacy of Ribavirin Inhaled Solution in Preventing Progression of Upper Respiratory Tract Respiratory Syncytial Virus Infection to RSV Pneumonia in Blood and Bone Marrow Transplant (BMT) Recipient

Conditions
-----------------
Respiratory Syncytial Virus Infections

Intervention / Treatment
-----------------
* Drug: Virazole (Ribavirin) Inhalation Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: 2 years of age or older. Are not pregnant or breast-feeding and agree to use a reliable birth control method for the duration of the study. Are a blood or bone marrow transplant recipient. Have evidence of upper respiratory tract infection. Have nasopharyngeal-throat samples positive for RSV. EXCLUSION CRITERIA: Are known to be HIV positive. Have pneumonia. Require a ventilator to breathe. Are pregnant. Are breast-feeding and are unwilling to stop breast-feeding. Are receiving treatment with certain other drugs for RSV.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Virazole (Ribavirin) Inhalation Solution|nan|

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
-----------------
Ribavirin, RSV
A Study of Docetaxel and Lobaplatin Versus Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.

Official Title
-----------------
A Study of Docetaxel and Lobaplatin vs. Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer

Conditions
-----------------
Recurrent Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 70 years old singed the information consent form Expected survival time >3 months Recurrence for at least 6 months after receiving initial platinum-based chemotherapy and without cytoreductive surgery indications. Exclusion Criteria: Recurrence within 6 months after receiving initial platinum-based chemotherapy without radiographic evidence for tumor recurrence receiving other chemotherapy, hormone therapy, immunotherapy, or radiation therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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 |
| --- | --- | --- |
| Evidence of the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer. | Blood routine, urine routine, hepatic and kidney function, electrolyte, ECG, CT,MRI | from pre-chemotherapy to 4-6 weeks post-chemotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent ovarian cancer, lobaplatin, docetaxel, carboplatin
Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)

Study Overview
=================
Brief Summary
-----------------
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic heart failure (CHF) under real-world use.

Official Title
-----------------
Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients With Chronic Heart Failure in Japan

Conditions
-----------------
Heart Failure

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic heart failure (CHF) failure who are prescribed with JARDIANCE® Tablets in Japan Patients who have never been treated with Empagliflozin (including treatment for type 2 diabetes mellitus (T2DM)) before enrolment Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chronic heart failure (CHF)<br> | Drug: JARDIANCE®<br>* JARDIANCE®<br>* Other names: empagliflozin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Drug Reactions (ADRs) | Focus on hypoglycaemia, the events relevant volume depletion, influence of ketone body increased / ketoacidosis, renal impairment. | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all-cause death |  | Up to 52 weeks | 
| Incidence of cardiovascular (CV) death |  | Up to 52 weeks | 
| Incidence of hospitalizations for heart failure |  | Up to 52 weeks |
Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction

Study Overview
=================
Brief Summary
-----------------
As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the prototype during the weaning of the flap during surgery. Indeed, during weaning the investigators voluntarily interrupt the arterial and venous flow to transfer the flap to the breast. This weaning corresponds to a thrombosis model. The patients will benefit from an improved postoperative monitoring. Indeed, in addition to the classical clinical monitoring, they will benefit from an additional monitoring during 5 days thanks to the realization of an ultrasound of the flap which will be carried out every 6 hours the first 24 hours then every 12 hours. This protocol is therefore a feasibility study for the collection of data of interest.

Official Title
-----------------
Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction

Conditions
-----------------
Breast Reconstruction, Thrombosis, Venous, Bioimpedance Measurement Capacity

Intervention / Treatment
-----------------
* Device: portable prototype of bioimpedance measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman undergoing microsurgical breast reconstruction using a free abdominal flap Age greater than or equal to 18 years Exclusion Criteria: Pregnant patient Patient with an active implantable device such as a pacemaker or an artificial heart Patient refusing to participate in the study Age less than 18 years old

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: portable prototype of bioimpedance measurement|The device will be installed during the patient's operation. It will be attached to the healthy skin of the flap (without wound or scar) by sterile glue. It will then be covered with a self-adhesive tegaderm type dressing. The wound will be isolated from the device with a hermetic silicone dressing of the Mepilex type, for example. There will therefore be no communication between the measuring device and the surgical wound.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of impedence | Impedence measurement during episode of ischemia. | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast reconstruction, Thrombosis, Venous, bioimpedance measurement capacity
Novel SARS-CoV-2 Point-of-care Testing

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to study the feasibility of implementing a novel point-of-care test (POCT) for rapid detection of SARS-CoV-2 infection. A CRISPR-based detection kit would be piloted for testing of suspected SARS-CoV-2 infection in healthcare setting, with the objectives of evaluating the performance of the new test in the detection of SARS-CoV-2, and assessing the practicability of the new test for diagnosing SARS-CoV-2 infection in healthcare settings.

Detailed Description
-----------------
A CRISPR-based lateral flow assay (LFA) detection kit would be designed and developed for testing for the presence of SARS-CoV-2. The aim of the project is to study the feasibility of implementing the novel point-of-care test (POCT) for rapid detection of SARS-CoV-2 infection in health service setting, with the following objectives: (b) Evaluation of the performance of novel POCT in comparison with conventional quantitative PCR in diagnosis SARS-CoV-2 infection and (c) Assessment of the practicability of LFA-CRISPR-based tests in the operating environments in healthcare settings. Patients who are admitted to the isolation wards of Prince of Wales Hospital, Hong Kong would be invited to join the study. A total of 600 persons with suspected SARS-CoV-2 infection presenting with different symptomatology and epidemiological history will be recruited. Nasal, deep saliva and/or mouth gargle samples will be collected from all recruited subjects in accordance with standard clinical protocol. The samples would be tested for SARS-CoV-2 by the new Point-of-care test, in parallel with standard diagnostic testing of the hospital.

Official Title
-----------------
Point-of-care Testing for Improving the Detection of SARS-CoV-2 Infection in Healthcare Setting

Conditions
-----------------
SARS-CoV2 Infection

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients admitted to isolation wards of the hospital who are of age of 18 or above; presentation with symptoms of COVID-19 and/or demonstration of exposure risk to SARS-CoV-2 infection. Exclusion Criteria: inability to communicate in English or Chinese; known history of mental illness; prisoners.

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 |
| --- |
|Other: no intervention|evaluating the performance of a novel point-of-care test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test performance | agreement of point-of-care test result and conventional test | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, point-of-care testing, rapid diagnostics, Hong Kong
Transient Urinary Incontinence After Holmium Laser Enucleation of the Prostate (HoLEP)

Study Overview
=================
Brief Summary
-----------------
In men, urinary incontinence (UI) is relatively uncommon, and usually associated with some forms of prostate surgery. Thus, one of the risks of surgery for benign prostate hyperplasia (BPH) is postoperative UI. The guidelines of the American Urological Association for BPH treatment indicate that UI (2 5%) is relevant complications after transurethral prostatectomy (TURP). Rassweiler et al., based on a review of publications stated that early UI may occur in up to 30-40% of patients after TURP. Rigatti et al. reported that early postoperative urgency UI occurred in 38.6% (TURP) and 44% (holmium laser enucleation of the prostate; HoLEP) of surgically treated patients at 1-month after the surgery. Recently, the follow-up data for patients treated with HoLEP showed that transient stress UI developed in up to 44% after HoLEP. Although this alternative surgical treatment such as HoLEP can be performed safely with minimal complications, patients often face debilitating UI during the postoperative period before any improvement in micturition parameters occurs. Although this symptom ameliorates within a relatively short time, it usually cause significant stress and anxiety to the patient as far as their durations is concerned. In addition to its economic cost, UI is a distressing condition that has major impacts on a patient's quality of life. Social withdrawal, isolation, and depression occur in some patients. Because this problem is usually temporary, there has been little attempt at addressing the issue. Therefore, there has been no research devoted specifically to transient de novo UI associated with HoLEP. 1. The aim of the present study was following: to investigate the incidence of transient de novo UI after HoLEP for BPH determine the predictors of early postoperative transient de novo UI.

Official Title
-----------------
Predictor of Transient Urinary Incontinence Following Holmium Laser Enucleation of the Prostate

Conditions
-----------------
Prostatic Hyperplasia, Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age older than 50 years presence of moderate or severe LUTS (International Prostate Symptom Score [IPSS] greater than 8)or maximum flow rate of less than 10 mL/s Exclusion Criteria: previous prostate surgery urethral stricture prostate carcinoma neurogenic bladder disease

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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 |
| --- | --- | --- |
EFS of the CardioMech MVRS

Study Overview
=================
Brief Summary
-----------------
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.

Detailed Description
-----------------
The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥3+) or severe (≥4+), symptomatic, degenerative mitral regurgitation and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site's multidisciplinary heart team.

Official Title
-----------------
Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)

Conditions
-----------------
Mitral Regurgitation

Intervention / Treatment
-----------------
* Device: CardioMech MVRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eighteen (18) years of age or greater Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail Intermediate or high surgical risk for mitral valve repair Exclusion Criteria: History of rheumatic heart disease History of prior endocarditis History of prior repair or replacement of the mitral valve, annuloplasty or valvuloplasty or has a left atrial appendage closure device Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CardioMech Mitral Valve Repair System (MVRS)<br> | Device: CardioMech MVRS<br>* CardioMech MVRS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure |  | 30 days | 
| Change in MR grade |  | 30 days |