linjc16/ctgov huggingface dataset:
Contribution of Image Fusion in Percutaneous Left Atrial Occlusion procédures (Fusion Image)

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation is the most common rhythm disorder, affecting 2 to 3 percent of the population. One of the major complications is the occurrence of thromboembolic events, the thromboembolic risk can be predicted by the ChadsVasc score. Anticoagulant treatment is therefore almost always indicated, however, in view of the target population, anticoagulant treatment is sometimes contraindicated, justifying the appearance of alternative treatment such as occlusion of the left auricle by surgical or percutaneous means, with the placement of a prosthesis in the left auricle. Image fusion is a new imaging technique aimed at improving the spatial view of 2D images (made during a catheterization session) by repositioning in real time a 3D model obtained by reconstruction from scanner images of the structure of interest. Once the model has been redesigned, it follows all the consequences that the hemodynamicist wants to take and thus guides the gesture as well as possible. The purpose of this project is to evaluate the contribution of image fusion to per cutaneous occlusion procedures of the left atrium. This contribution will be evaluated by comparing the procedure time, the irradiation time, the amount of contrast material used between the procedures performed with the image fusion technique and without this new technique.

Official Title
-----------------
Contribution of Image Fusion in Percutaneous Left Atrial Occlusion Procedures

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

Intervention / Treatment
-----------------
* Other: No interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient Patient with a collegially selected indication of FAG Patient willing to participate in the study Exclusion Criteria: Minors, adults under guardianship and protected persons Presence of contraindications to the procedure, including the presence of a thrombus in the left atrium Procedure combined with another percutaneous gesture at the same time

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No interventional study|No interventional study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the contribution of image fusion to reduce patient irradiation with measurement of the amount of irradiation of the procedure | the cumulative Air KERMA in milligray (mGy) | 3 years | 
| evaluate the contribution of image fusion to reduce patient irradiation with measurement of the amount of irradiation of the procedure | the surface dose product (PDS) in centigray centimetres squared (cGy.cm²) | 3 years |
Expanded Access Protocol of Patisiran for Patients With Hereditary ATTR Amyloidosis (hATTR)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide expanded access of patisiran to patients with hereditary transthyretin-mediated amyloidosis (hATTR).

Detailed Description
-----------------
Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the links provided in More Information.

Official Title
-----------------
Expanded Access Protocol of Patisiran for Patients With Hereditary Transthyretin-Mediated Amyloidosis (hATTR Amyloidosis) With Polyneuropathy

Conditions
-----------------
TTR-mediated Amyloidosis, Amyloidosis, Hereditary, Amyloid Neuropathies, Familial, Familial Amyloid Polyneuropathies, Amyloid Neuropathies, Amyloidosis, Hereditary, Transthyretin-Related

Intervention / Treatment
-----------------
* Drug: patisiran (ALN-TTR02)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female greater than or equal to 18 years of age Have a diagnosis of hATTR Meet Karnofsky performance status and Polyneuropathy Disability (PND) score requirements Have adequate complete blood counts, liver function tests and coagulation tests Exclusion Criteria: Participated in an interventional hATTR amyloidosis clinical trial involving RNA interference (RNAi) therapeutics within the last 12 months Are currently eligible to participate in or currently enrolled in an ongoing interventional hATTR amyloidosis clinical trial Have inadequate cardiac function Known primary amyloidosis (AL amyloidosis) or leptomeningeal amyloidosis Have known serious comorbidities or considered unfit for the program by the investigator Prior or planned liver or heart transplantation

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 |
| --- |
|Drug: patisiran (ALN-TTR02)|patisiran (ALN-TTR02) administered by intravenous (IV) infusion|

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
-----------------
TTR, RNAi therapeutic, FAP, Familial Amyloid Polyneuropathies, Transthyretin, Amyloidosis
miRNA Biomarkers in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Multiple Sclerosis (MS) characterized by demyelination and axonal degeneration is a chronic inflammatory disease of the central nervous system (CNS). Recent studies have shown that dysregulated miRNAs alter immune responses, so they may have roles basis on various genetic diseases such as MS and may be potential targets for biomarkers and new therapeutic approaches. In this study, we evaluated the dysregulation of miRNA expression levels at MS and MS stages. We also discussed the potential of these miRNAs to be biomarkers and/or therapeutic targets in MS.

Official Title
-----------------
The Potential Candidate miRNA Biomarkers in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis, miRNA, Epigenetic, Biomarker

Intervention / Treatment
-----------------
* Genetic: miRNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age of 25 years and above at least one Central Nervous System (CNS) demyelination event Exclusion Criteria: with genetic diseases, hypertension, head trauma, neuropsychiatric disease, diabetes mellitus, hypertension, cardiac failure, hepatic failure, renal failure, Thalassemia, Sickle cell disease, iron deficiency, and B12 deficiency

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- |
| Study group<br>with Multiple sclerosis | Genetic: miRNA<br>* miRNA effect on Multiple sclerosis pathology<br>|
| Control group<br>not Multiple sclerosis | Genetic: miRNA<br>* miRNA effect on Multiple sclerosis pathology<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA expression | peripheral blood miRNA expressions | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple sclerosis, miRNA biomarkers, peripheral blood molecular diagnostics
An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with narcolepsy.

Official Title
-----------------
A 6-Month Multicenter, Open-Labelled Extension of the Clinical Trial NLS-1021 in Narcoleptic Patients With and Without Cataplexy

Conditions
-----------------
Narcolepsy With Cataplexy, Narcolepsy, Narcolepsy Without Cataplexy

Intervention / Treatment
-----------------
* Drug: Mazindol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must complete all Study NLS-1021 study requirements and assessments up to Visit 6; The subject is able, in the opinion of the Investigator, to receive NLS-2 for the 24-week Treatment Phase of this study; Biological females of childbearing potential must agree to use a medically acceptable double-barrier method of contraception for at least 30 days prior to Day 1 and until completion of the study; The subject is able to comply with the open-labelled extension design schedule and other study requirements; The subject provides written informed consent for the open-label extension study. Exclusion Criteria: The subject meets any Exclusion Criteria for Study NLS-1021 at Visit 6 of that study; The subject receives any investigational drug (other than the COVID-19 vaccine) that is not NLS-2.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: NLS-2 (mazindol extended release)<br>NLS-2 (mazindol extended release) administered once a day. | Drug: Mazindol<br>* Drug: NLS-2<br>* Other names: mazindol extended release;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2) | Summaries of the number and percentage of subjects who experienced Treatment Emergent Adverse Events (TEAEs), TEAEs related to study drug, SAEs, or discontinued study drug or withdrew from the study due to an AE. | 24 weeks |
An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.

Official Title
-----------------
A Phase 2a Study of BMS-790052 and BMS-650032 in Combination Therapy With Japanese Subjects With Genotype 1 Chronic Hepatitis C (HCV) Virus Infection

Conditions
-----------------
Hepatitis C Infection

Intervention / Treatment
-----------------
* Drug: BMS-790052
* Drug: BMS-650032


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects chronically infected with HCV Genotype 1 HCV RNA viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening Exclusion Criteria: Subjects with evidence of liver cirrhosis Evidence of HCC Co-infection with hepatitis B virus, HIV

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-790052 + BMS-650032<br> | Drug: BMS-790052<br>* Tablets, Oral, 60 mg, daily, 24 weeks<br>Drug: BMS-650032<br>* Tablets, Oral, 1200 mg, daily, 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: To assess safety and tolerability based on 4 weeks safety data, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs |  | Week 4 | 
| Part 2: To determine the proportion of subjects who achieve SVR12 (i.e., HCV RNA < 15 IU/mL at follow-up Week 12) |  | Post-treatment Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of co-administration of BMS-790052 + BMS-650032 as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities |  | Weeks 4, 12, end of treatment and post-treatment Week 24 | 
| The proportion of subjects who achieve RVR (defined as HCV RNA < 15 IU/mL |  | Week 4 | 
| The proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL |  | at both Weeks 4 and 12 | 
| The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL |  | at follow-up Week 24 | 
| Resistant variants associated with clinical failure |  | Weeks 4, 12, end of treatment and post-treatment Week 24 |
Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications

Study Overview
=================
Brief Summary
-----------------
Single-Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy is a modified and simplified duodenal switch. It is performed on morbid obese patients and severe T2DM patients with obesity, and a proper weight loss is expected as well as a decrease in the cardiac risk and a remission of T2DM. A lower complication rate than for duodenal switch is expected.

Detailed Description
-----------------
A sleeve gastrectomy over a wide bougie is performed. Then the proximal duodenum is divided and anastomosed to the ileum 250 cm from the cecum. The preoperative studies and postoperative follow up is similar to those performed before and after other bariatric procedures.

Official Title
-----------------
Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications

Conditions
-----------------
Morbid Obesity, Diabetes

Intervention / Treatment
-----------------
* Procedure: SADI-S 250


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 30 with T2DM or BMI > 40 Exclusion Criteria: Oncologic patients, alcoholic patients, mentally retarded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Morbid obese, diabetics<br>Patients with morbid obesity or severe metabolic disease | Procedure: SADI-S 250<br>* Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morbid obesity, duodenal switch, diabetes, decrease in cardiac risk, remission of T2DM
Asymmetrical Recovery of Cone Outer Segment Tips and Foveal Displacement After Macular Hole Surgery

Study Overview
=================
Brief Summary
-----------------
Evaluation of asymmetry in recovery of cone outer segment tips and foveal displacement after macular hole surgery

Official Title
-----------------
Asymmetrical Recovery of Cone Outer Segment Tips and Foveal Displacement After Macular Hole Surgery

Conditions
-----------------
Macular Hole

Intervention / Treatment
-----------------
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with macular hole Exclusion Criteria: The patients with follow-up less than 6 months

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 95 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vitrectomy<br> | Procedure: Vitrectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical coherence tomography | Anatomical evaluation detected with optical coherence tomography after surgical intervention | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual recovery | The numbers of the patients with visual recovery after surgical intervention | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cone outer segment tips line, foveal displacement
Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is a form of mastectomy that achieves optimal disease control and facilitates reconstruction. The study aimed to assess the oncological safety and aesthetic outcomes of nipple-sparing mastectomy and immediate breast reconstruction. 35 female patients with breast cancer were included in the study. The investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant.

Official Title
-----------------
Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: nipple sparing mastectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ductal in situ carcinoma or infiltrating ductal carcinoma with a tumor diameter up to 3 cm Distance of the tumor from the nipple ≥ 2 cm Cancer or microcalcifications not localized in the central field. No blood secretions or other (nipple-areola complex) NAC disturbances Absence of skin involvement Indication to mastectomy for multifocal or diffuse microcalcifications Negative intraoperative assessment of NAC-bottom Exclusion Criteria: Tumor or microcalcifications localized in the central quadrant or in the retroareolar region Blood secretions or other NAC alterations Positive intraoperative assessment of NAC-bottom Inflammatory carcinoma Paget's disease of the nipple

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 68 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: nipple sparing mastectomy|The investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients complications after nipple sparing mastectomy | Complete general examination, local examination of the skin, nipple and areola were done to determine whether the patients suffered from any complaints | 2017-2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic results assessed by Tzafetta et al scoring system |  | 2017-2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, mastectomy, breast reconstruction
Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin

Study Overview
=================
Brief Summary
-----------------
Currently, most knee meniscal tears are treated by partial or complete meniscectomy, or by suture repair when it is possible. Recently, the investigators have successfully developed and implanted a novel biomaterial, platelet-rich fibrin (PRF), to treat articular cartilage defect in pigs. The PRF is autogenesis as a natural fibrin-based biomaterial favorable to the development of microvascularization and enables local and progressive delivery of growth factors providing unique properties for tissue remodeling and wound healing. The advantages of using PRF implantation include no transplant rejection and no need to perform second operation. Knee meniscal repair using PRF has not been reported before. The aim of this study is to investigate whether PRF implantation can facilitate regeneration process of meniscectomized knee and T2-map MRI can monitor the process in those patients with meniscal tears. A total of 18 adult patients with torn menisci (outer 1/3, posterior horn, medial meniscus) will be recruited and randomly divided into three groups: A (n=6), implantation of PRF after partial menisectomy; B (n=6), implantation of PRF after partial menisectomy and suture; C (n=6), partial menisectomy only. All studied knee will be scanned on a 1.5-T MRI with surface coil at baseline before surgery, 3 months and 6 months and 12 months after surgery. The investigators believe that PRF enables to facilitate regeneration of meniscectomized knee, and T2-map MRI enables monitoring healing process of meniscal tears.

Official Title
-----------------
Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin

Conditions
-----------------
Meniscal Injuries

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 45 years old; time of injury to surgery within 8 weeks patients who will sign inform consent patients with clinical and MRI diagnosis of meniscal tears who will undergo arthroscopy patients who will make MRI diagnosis at 3, 6, 12 months Exclusion Criteria: major trauma coexist ligamentous rupture knee dislocations

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platelet-rich fibrin, PRF<br> | Other: No PRF<br>* Group B (n=6), implantation of PRF after partial menisectomy and suture; Group (n=6), partial menisectomy only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI T2-map values in healing menisci |  | one-month |