linjc16/ctgov huggingface dataset:
Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management

Study Overview
=================
Brief Summary
-----------------
Increased indications for transplantation continue to worsen the shortage of organs and need the extension of graft sampling criteria and the search for new potential sources of organs. Despite undeniable success in the short term, due to major advances in surgery, medicine and research, transplant recipients continue to face the risk of chronic rejection and long-term complications. The University Hospital Federation (UHF) SUPORT was created to optimize the chances of success of the organ transplant and improve the quality of life of the transplanted patient. UHF SUPORT 's ambition is based on a translational strategy that presents two priority areas: Axis 1: Optimization, evaluation, conditioning of the donor, graft, recipient Axis 2: Personalized follow-up of the transplanted patient in the short and long term Identifying factors for long-term graft and patient survival through translational research from a common cohort and biological collection will predict transplant rejection, prolong graft function, or improve the patient's care.

Official Title
-----------------
Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management

Conditions
-----------------
Organ Transplantation

Intervention / Treatment
-----------------
* Other: blood and urine samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female over 18 (no age limit) affiliated to a social security organization Recipient (s) of a kidney, liver or heart transplant followed by at least one of the UHF SUPORT centers (Tours, Poitiers, Limoges) having given informed consent to participate in the cohort. Exclusion Criteria: Patient unable to understand the information given by the investigator People under the protection of justice

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: various blood and urine samples will be collected from the recipient at D0, D7, D14, M1, M3, M6 and M12
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blood and urine samples<br>blood and urine samples at D0, D7, D14, M1, M3, M6 and M12 | Other: blood and urine samples<br>* various blood and urine samples will be collected from the recipient at D0, D7, D14, M1, M3, M6 and M12.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of the graft |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
organ transplantation, graft, biological collection.
Comparing Human and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to assess the utility of the automatic stenosis index quantification using 3D Slicer software (Computer-based Quantification). We will recruit three physicians to perform a similar analysis using video images of the same bronchoscopes images (Human-based Quantification). This study relates to the latter data collection.

Official Title
-----------------
Comparing Human and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images

Conditions
-----------------
Airway Obstruction

Intervention / Treatment
-----------------
* Other: Human-based Quantification of Airway Stenosis
* Device: Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physicians who are trained in bronchoscopy. Physicians who are willing and able to understand the scope of the study. Exclusion Criteria: Physicians who are not trained in bronchoscopy. Physicians who are unwilling and unable to understand the study procedure Employees under the direct supervision of the investigators conducting the research

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: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Physicians enrolling the study are exclusively assigned to Human-based Quantification.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Human-based Quantification<br>No intervention. No support tool will be used for quantifying airway stenosis from the bronchoscopic images collected previously. | Other: Human-based Quantification of Airway Stenosis<br>* Human-based Quantification of Airway Stenosis From Bronchoscopic Images.<br>|
| Active Comparator: Computer-based Quantifiction<br>Computer based support tool will quantifying airway stenosis from the bronchoscopic images collected previously. | Device: Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.<br>* Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stenosis index quantified [0-100%] | The stenosis index quantified subjectively by the physician, defined ration between cross-sectional area of the obstructed airway and that of a normal airway. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Airway Stenosis, Stenosis Index Quantification
Evaluation of Prealbumin Levels in Men With Low-T

Study Overview
=================
Brief Summary
-----------------
This is a single-center study intended to evaluate prealbumin (transthyretin), a marker of anabolic metabolism, in men with androgen deficiency (Low-T). There is emerging evidence that prealbumin is an indicator of anabolic, versus catabolic, metabolism, and that lower levels may be associated with hypogonadism.

Official Title
-----------------
Prealbumin (Transthyretin) Levels in Men With Low-T

Conditions
-----------------
Testosterone Deficiency

Intervention / Treatment
-----------------
* Diagnostic Test: Men presenting with low-T


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide responses to standard questionnaires administered to subjects Written Informed Consent obtained Male sex at birth ≥ 40 and ≤ 75 years of age Presentation to the clinic with symptoms suggestive of low testosterone such as loss of libido, erectile dysfunction, cognitive or mood disturbances, etc. Able and willing to provide blood specimens and follow study schedule A final diagnosis can be established (androgen deficient versus not androgen deficient) Exclusion Criteria: Previous exposure to exogenous T, DHEA, clomiphen citrate, or other Selective Estrogen Receptor Modulators, or OTC or herbals (Treatment Naïve) Use of opioid medication within 3 months prior to enrollment Serious psychiatric disease or uncontrolled medical illness, as suspected from medical history or clinical examination Use of any sex hormones or steroidal anabolic drug supplements (OTC or prescribed)(Treatment Naïve) Incapable of giving informed consent or complying with protocol or unwilling to comply with protocol requirements Diagnosis of prolactinoma

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Men presenting with low-T<br>Men presenting with low-t will undergo a blood draw for evaluation of prealbumin levels. | Diagnostic Test: Men presenting with low-T<br>* Evaluation of prealbumin levels.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prealbumin Levels | Evaluation of prealbumin levels in subjects presenting for evaluation of possible late onset adult hypogonadism diagnosed with and without Androgen Deficiency (AD) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prealbumin
Percutaneous Mitral Valve Repair in Cardiogenic Shock: Mitra-Shock Study

Study Overview
=================
Brief Summary
-----------------
Cardiogenic shock (CS) is a medical emergency and a frequent cause of death. CS can be complicated and/or precipitated by mitral regurgitation (MR). The efficacy of percutaneous treatment of MR in patients with cardiogenic shock is unknown. The aims of the study will be to analyse the efficacy of MitraClip therapy on early (30 days) and midterm mortality (6 months) as well as the predictors of outcomes. Investigators will also report the rate of periprocedural complications such as minor and major bleeding, vessel injury and Acute Kidney Injury (AKI). It is a multicenter retrospective observational study on CE marked medical device (MitraClip® System). Retrospective time range: from 01/01/2012 to 01/01/2020

Official Title
-----------------
Use of Percutaneous Mitral Leaflet Approach for Severe Mitral Regurgitation in Cardiogenic Shock: Results From a Multicenter Observational Italian Experience (the Mitra-Shock Study).

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

Intervention / Treatment
-----------------
* Device: MitraClip implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years old Exclusion Criteria: multiorgan failure, VA-ECMO, inadequate peripheral access because of vascular disease, not suitable mitral valve anatomy.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MitraClip implantation|The MitraClip® procedure is performed under general anesthesia and orotracheal intubation. The procedure is usually guided by 2 and 3-dimensional transesophageal echocardiography and fluoroscopy. This catheter-based technology is inserted through femoral venous access and advanced in the left atrium through the transseptal puncture. The MitraClip® is provided by 2 arms able to grasp the anterior and posterior mitral leaflets. The goal is to approximate both leaflets creating a double orifice mitral valve mimicking the edge-to-edge surgical repair procedure (Alfieri stitch).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 30 days | 
| Mortality |  | 6 months |
Postpartum Thyroid Measures and Mood

Study Overview
=================
Brief Summary
-----------------
Women with abnormal serum thyroid antibody levels or abnormal TSH and/or T4 values are more likely than their normal counterparts to have higher scores on a common postpartum depression screening test.

Detailed Description
-----------------
This small pilot study was an attempt to corroborate a relationship between quantified mood and thyroid measures, using the numerical scores obtained from a common depression screen, the Edinburgh Postnatal Depression Scale (EPDS), as a continuum. Mood scores were compared with presence of thyroid autoantibodies and plasma concentrations of free T4 and TSH.

Official Title
-----------------
Postpartum Thyroid Measures and Mood

Conditions
-----------------
Postpartum Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age In third trimester of pregnancy when recruited Negative for the following drugs detected by a urine drug screen: Amphetamines Barbiturates Benzodiazepines Cocaine Opiates Phencyclidine metabolites (PCP), and tricyclic antidepressants Vaginal delivery Screened negative for major depressive disorder on the Edinburgh Postnatal Depression Scale (EPDS) at her prenatal enrollment in the study Receiving a score of 12 or lower out of a possible 30 Exclusion Criteria: Under age 18 Positive for any of the following drugs: Amphetamines Barbiturates Benzodiazepines Cocaine Opiates Phencyclidine metabolites (PCP), and tricyclic antidepressants Cesarean delivery EPDS score over 12 at prenatal screening test

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical score on the Edinburgh Postnatal Depression Scale |  | seven weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpartum depression, thyroxine, thyroid antibodies, thyroid stimulating hormone, Edinburgh Postnatal Depression Scale (EPDS)
NIR Fluorescence Imaging With ICG for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours

Study Overview
=================
Brief Summary
-----------------
This is an open-label pilot study including 10 GIST patients scheduled for an elective open or laparoscopic resection at Leiden University Medical Center (LUMC) and Erasmus Medical Center (EMC), Rotterdam. Patients will receive a single dose injection of 10mg ICG at a given moment during the 24 hours prior to surgery or during surgery. The timing of administration will be determined according to a step-up, step-down procedure. Standard of care surgery will be performed and a NIR fluorescence imaging system will be used to record the GIST under fluorescence.

Official Title
-----------------
Near-infrared Fluorescence Imaging With IndoCyanine Green for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours: a Pilot Study

Conditions
-----------------
GIST

Intervention / Treatment
-----------------
* Procedure: Intraoperative near-infrared fluorescence imaging using indocyaninegreen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with GIST by histology or cytology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection. 18 years Exclusion Criteria: History of an allergy or hypersensitivity to sodium iodide, iodine or ICG Patients with hyperthyroidism and patients with an autonomous thyroid adenoma Patients pregnant or breastfeeding Patients with severe renal insufficiency (eGFR <30)

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
Interventional Model Description: Open-label pilot study
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Intraoperative near-infrared fluorescence imaging using indocyaninegreen|ICG administration before/during surgery and using near-infrared fluorescence imaging for intra-operative detection and identification of GISTs|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary tumor detection | Tumor detection perceived by the surgeon with and without NIR-imaging | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of peritoneal tumor depositions | Detection of peritoneal tumor depositions by the surgeon with and without NIR-imaging | Intra-operative | 
| Tumor to background ratio | Pixel intensity ratio on static images | Through study completion, estimated to be 6 months |
The CUSA Clarity Soft Tissue Removal Study

Study Overview
=================
Brief Summary
-----------------
To investigate the clinical performance and surgeon preferences of the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgical procedures. This will be evaluated through the effectiveness of soft tissue removal per surgeon assessment and Incidence of Adverse Device Effects.

Official Title
-----------------
Clinical Performance Investigation of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Soft Tissue Removal During Urological and General Surgery

Conditions
-----------------
Benign, Malignant Tumors or Other Soft Tissue Removal, Nephrectomy or Partial Nephrectomy With Parenchyma Removal

Intervention / Treatment
-----------------
* Device: CUSA Clarity Ultrasonic Surgical Aspirator System use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years of age Subject requires removal of soft tissue with an ultrasonic aspirator during urological or general surgery Subject is an appropriate candidate to receive use of the CUSA® Clarity Ultrasonic Surgical Aspirator System product for soft tissue removal during surgery, per the study surgeon Subject signed the IRB/EC-approved informed consent form demonstrating that the subject is willing and able to participate in this clinical study and to comply with all study procedures, if applicable. Exclusion Criteria: Subject is currently pregnant or plans to become pregnant prior to the study index surgery Subject has any significant medical condition that in the opinion of the investigator will interfere with protocol evaluation and participation Subject's surgical plan includes utilizing CUSA® Clarity Ultrasonic Surgical Aspirator System for the removal of uterine fibroids Subject is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or ethics committee. Intra-operative exclusion criteria : Surgeon does not utilize the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgery.

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: CUSA Clarity Ultrasonic Surgical Aspirator System use|Assessment of the CUSA® Clarity Ultrasonic Surgical Aspirator System use during urological or general surgery for soft tissue removal|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of soft tissue removal per surgeon assessment. | Multifactorial 5-point Likert scale (1 (worst) to 5 (best)) | During the surgery |
The Microbiologic Profile of Diabetic Foot Infections in Turkey - TURK-DAY

Study Overview
=================
Brief Summary
-----------------
To determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.

Detailed Description
-----------------
Recent studies have demonstrated substantial variation in the etiology of DFIs (Diabetic Foot Infections) in different regions of the world . In contrast to Western countries, studies from Asia and Africa have demonstrated that aerobic gram-negative organisms, particularly Pseudomonas aeruginosa, are far more common . The majority of current guidelines for the management of DFIs have been prepared in Western countries . Based on the results of more recent studies from the Asian continent, however, empiric antibiotic therapy for DFIs may need to be directed at organisms with substantially different antibiotic susceptibility patterns than those recommended in current guidelines. Thus, suggested antibiotic regimens for DFIs should be optimized for local clinical practice. The aim of the current trial is to provide an up-to-date view of the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.

Official Title
-----------------
The Microbiologic Profile of Diabetic Foot Infections in Turkey (TURK-DAY): Prospective Multicenter Cohort Study

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established diagnosis of Diabetes Mellitus Diabetic foot wound clinically diagnosed as infected Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Diabetic foot infection<br>Patients with DM (Diabetes Mellitus) presenting with a diabetic foot infection will be enrolled in the current trial to determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey. | Questionnaire | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic foot infections, microorganisms