linjc16/ctgov huggingface dataset:
Observational Registry on the HARPOON Device

Study Overview
=================
Brief Summary
-----------------
To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.

Detailed Description
-----------------
This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.

Official Title
-----------------
Beating Heart Mitral Valve REPair With the HARPOON™ System: ReaL World Outcomes From a multICenter observATional European Registry

Conditions
-----------------
Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse

Intervention / Treatment
-----------------
* Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are clinically suitable for treatment with the HARPOON™ System, as per the Instructions for Use (IFU), will be evaluated for inclusion in the registry. Exclusion Criteria: N/A

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: Single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HARPOON™ MVRS<br>Subjects who were treated with the HARPOON MVRS. | Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS)<br>* Repair of the chordae tendinae in the mitral valve.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant | Subject's freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant | 1 year post-implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart valve, Mitral valve, Mid-segment posterior leaflet prolapse of the mitral valve, Chordae tendinae, Valve disease, Mitral Regurgitation, Harpoon, Mitral valve repair, Posterior leaflet prolapse, Beating heart intervention, Heart disease, Cardiovascular disease
Fast Versus Slow Application of Vulsellum During Intrauterine Device Insertion

Study Overview
=================
Brief Summary
-----------------
intrauterine device insertion requires use a vulsellum to stabilize the cervix. Patient's often complain that its placement is one of the most uncomfortable parts of this procedure

Official Title
-----------------
the Effect of Slow Versus Fast Application of Vulsellum on Pain Perception During Intrauterine Device Insertion

Conditions
-----------------
Improving Quality of Life

Intervention / Treatment
-----------------
* Procedure: fast application
* Procedure: slow application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women not taken analgesics or anxiolytics in the 24 hours prior insertion Women not taken misoprostol prior to intrauterine device insertion Women who will accept to participate in the study Exclusion Criteria: Any contraindication to intrauterine device placement

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fast vulsellum<br>rapid ratchet of the vulsellum | Procedure: fast application<br> <br> |
| Active Comparator: slow vulsellum<br>Placement of the tenaculum over 7-10 seconds and not allowing the vulsellum to ratchet audibly. | Procedure: slow application<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean Pain score with vulsellum placement |  | 5 minutes |
Study on Susceptibility Genes and Pathogenic Mechanism of Non-syndromic Familial Aortic Dissection

Study Overview
=================
Brief Summary
-----------------
Aortic dissection is dangerous and difficult to predict, so it is particularly important to carry out early prevention, diagnosis and rational treatment for high-risk groups. The related genes found in previous studies can not be detected in all patients with dissection; at present, the pathogenesis of non-syndromic aortic dissection is not clear, of which about 20% of patients have family aggregation and have the general representative characteristics of non-syndromic dissection. In this project, the peripheral blood samples of core family subjects were detected by sequencing technique. analyze disease-related susceptibility genes; 2 determine the effect of susceptibility genes on the incidence of dissection in mice through animal experiments; and 3 explore the effect of susceptibility genes on cell function at the cellular level.

Official Title
-----------------
Study on Susceptibility Genes and Pathogenic Mechanism of Non-syndromic Familial Aortic Dissection

Conditions
-----------------
Aortic Dissection, Family Research, Aortic Dissection, Familial, With or Without Aortic Aneurysm

Intervention / Treatment
-----------------
* Genetic: movement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Family inclusion criteria: 1 at least one person in each generation of a family has aortic dissection, and at least two generations of members can be included; Exclusion Criteria: Pedigree exclusion criteria: pedigree members have marfan syndrome, Loeys-Dietz syndrome, Ehler-Danlos syndrome, aneurysm-Osteoarthritis syndrome and other syndroms
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: movement|aortic dissection or aneurysm patients this is an observation cohort study about a Non-syndromic Familial Aortic Dissection without intervention.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gege | Discovery of known or unknown genes | 2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aortic dissection, pathogenesis, familial inheritance, susceptibility gene
Exploratory Study of Upper and Lower Endoscopic Fuse System

Study Overview
=================
Brief Summary
-----------------
Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology

Detailed Description
-----------------
The investigational devices are EndoChoice gastrointestinal endoscopic systems that are similar in their fit, form, and functions to the corresponding commercially available models with the exception of the EndoChoice's proprietary Optical system that enhances their field of view.

Official Title
-----------------
Exploratory Study of Upper and Lower Endoscopic Fuse System

Conditions
-----------------
Gastrointestinal Diseases

Intervention / Treatment
-----------------
* Device: Fuse® Colonoscope
* Device: Fuse® Gastroscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female patients ages of 18-75 The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance. Signed informed consent form Exclusion Criteria: Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study. Patients who are unable to consent Pregnant female patients of any age.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopy exploratory single arm<br> | Device: Fuse® Colonoscope<br>* Endoscopic diagnostic procedures for lower GI tract<br>Device: Fuse® Gastroscope<br>* Endoscopic diagnostic procedures for upper GI tract<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance, usability and ease of use (performance questionnaire) | The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer | Through study completion, estimate average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse and severe adverse events) | Establish safety of the device by measure of adverse and severe adverse events, if such occur. | Through study completion, estimate average of 1 year |
A Trial of Carboplatin and Gemcitabine Versus Gemcitabine Alone in Patients With Non-Small-Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.

Official Title
-----------------
A Randomized Phase III Trial of Paraplatin (Carboplatin) + Gemzar Versus Gemzar Alone in Patients With Advanced Non-Small Cell Lung Cancer

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

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic or cytologic new diagnosis of NSCLC, Stage IIIB with a cytologically positive pleural or pericardial effusion or Stage IV. No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment of NSCLC. ECOG Performance Status of 2 . Patients must be at least 3 weeks since major surgery. Patients must be at least 1 week since surgery, such as mediastinoscopy, pleuroscopy, or thoracostomy. Patients must have measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than 10 mm with spiral CT scan. Exclusion Criteria: Any prior radiation therapy to the thoracic area. Active and ongoing systemic infection. Prior radiation to greater than 25% of the bone marrow. ECOG PS other than 2 Patients with a known hypersensitivity to gemcitabine and carboplatin.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|nan|
|Drug: Carboplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine and compare the 1-year survival produced by combined Paraplatin (carboplatin) + Gemcitabine versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2 |  |  | 
| To determine the safety of combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2 |  |  | 
| To compare the response rate between treatment groups |  |  | 
| To compare the changes in QOL between treatment groups |  |  |
Evaluation of the Performance of an Adhesive Strip

Study Overview
=================
Brief Summary
-----------------
This study investigated the performance of a new adhesive strip when impacted by output

Official Title
-----------------
A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Output

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Other: New adhesive strip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have had an ileostomy for more than one year Have intact skin on the area used in the evaluation Has an ileostomy with a diameter up to (≤) 35 mm Have a peristomal area accessible for application of test product (assessed by investigator) Exclusion Criteria: Currently receiving or have within the past 2 month received radio- and/or chemotherapy Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. Are pregnant or breastfeeding Having dermatological problems in the peristomal- or abdominal area (assessed by investigator) Participating in other interventional clinical investigations or have previously participated in this investigation

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test of new adhesive strip<br>A new adhesive strip has been developed and will be tested in this investigation | Other: New adhesive strip<br>* This strip is made of a newly developed adhesive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans epidermal water loss | trans epidermal water loss is a measure of the skins barrier function. There is always a oss of water from the skin due to evaporation. However, when the skin barrier is damaged this evaporation increases. Thus, trans epidermal water loss can be used to assess the skins barrier function | 24 hours |
To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol

Study Overview
=================
Brief Summary
-----------------
In this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol.

Official Title
-----------------
Study of the Predictive Value of Airway Obstruction Reversibility on the Effectiveness of Indacaterol (Onbrez® Breezhaler ®) 150 mcg Once Daily in Patients With Moderate to Severe COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: Indacaterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and: Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value Post-bronchodilator FEV1/FVC (forced vital capacity) <70% Smoking history of at least 10 pack-years Exclusion Criteria: Patients who have had a COPD exacerbation in the 6 weeks prior to screening Patients who have had a respiratory tract infection within 4 weeks prior to screening Patients with concomitant pulmonary disease Patients with a history of asthma Patients with diabetes Type I or uncontrolled diabetes Type II Any patient with lung cancer or a history of lung cancer Patients with a history of certain cardiovascular comorbid conditions Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indacaterol<br> | Drug: Indacaterol<br>* Indacaterol 150 µg once-daily via single-dose dry powder inhaler<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficient of correlation between FEV1 and reversibility | Coefficient of correlation between the change from baseline in FEV1 with indacaterol after 1 month and the reversibility to salbutamol at screening | After 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficient of correlation between VQ11 (an assessment of quality of life) and reversibility | Coefficient of correlation between the change from baseline in VQ11 with indacaterol after 5 months and the reversibility to salbutamol at screening | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Indacaterol, COPD, LABA, Reversibility
A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to evaluate the performance of the Medrobotics Flex® Robotic System to visualize and access specific anatomical locations along with evaluation of the safety of the device.

Official Title
-----------------
A Multicenter OUS Post-Market Clinical Follow-Up of the Medrobotics Flex® Robotic System Used for Accessing and Visualizing the Oropharynx, Hypopharynx, and Larynx During Transoral Procedures

Conditions
-----------------
OSA, Oral Disease, Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 22 years of age Candidate for transoral surgery in the oropharynx, hypopharynx and larynx Exclusion Criteria: Less than 22 years of age Not a candidate for transoral surgery in the oropharynx, hypopharynx and larynx

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| Transoral Visualization & Access<br>Subjects ≥ 22 yrs requiring transoral procedures | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access and Visualizaton in Oropharynx, Hypopharynx and Larynx | Ability to access and visualize all the following anatomical locations in the oropharynx, hypopharynx and larynx via transoral only approach. Palatine tonsils, base of tongue, epiglottis, posterior pharyngeal wall, false vocal cords. | Intra-Operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic Transoral, Transoral, Oropharynx, Hypopharynx, Endoscopic, TORS, Larynx
Intravitreal Anti-vascular Endothelial Growth Factor Administration and Its Influence on Vitreomacular Interface- and Retinal Morphology in Eyes With Neovascular Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Purpose: To assess the influence of intravitreal anti-vascular endothelial growth factor (anti-VEGF) administration on vitreomacular interface- and retinal morphology in eyes with neovascular age-related macular degeneration (AMD) and to identify morphological markers potentially influencing disease prognosis. Methods: 43 patients (51 eyes) with treatment naïve neovascular AMD subsequently treated with Bevacizumab 1.25mg (in 0.05ml of solution) were monitored until month 12 of follow-up. Following a loading dose of 3 monthly intravitreal anti-VEGF injections, patients were treated as-needed [pro re nata (PRN)]. Functional and morphological changes were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT).

Detailed Description
-----------------
This retrospective study included 43 treatment-naive patients (51 eyes) with neovascular AMD over the course of 12 months. Patients were treated with a loading dose of 3 initial monthly anti-VEGF injections (Bevacizumab 1.25mg in 0.05ml of solution-Avastin®) and were followed monthly until year 1. Re-treatment was performed if needed (pro re nata-PRN) as previously reported.

Official Title
-----------------
Influence of Intravitreal Anti-vascular Endothelial Growth Factor Administration on Vitreomacular Interface- and Retinal Morphology in Eyes With Neovascular Age-related Macular Degeneration

Conditions
-----------------
Vitreomacular Interface

Intervention / Treatment
-----------------
* Device: OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - diagnosis of treatment-naive neovascular AMD Exclusion Criteria: any treatment with other anti-VEGF agents than Bevacizumab in the follow-up period any other diseases leading to macular edema prior vitrectomy uveitis retinal or corneal laser surgery high myopia (>6dpt) preceding eye trauma

Ages Eligible for Study
-----------------
Minimum Age: 66 Years
Maximum Age: 98 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OCT<br>only optical coherence tomography and visual acuity testing at each visit, patients were recruited retrospectively, only data analysis | Device: OCT<br>* only OCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | visual acuity testing was performed | 12 months |