linjc16/ctgov huggingface dataset:
MitraClip in Acute Mitral Regurgitation

Study Overview
=================
Brief Summary
-----------------
Acute MR may develop in the setting of an acute myocardial infarction (AMI) as a result of papillary muscle dysfunction or rupture, and these patients are grossly underrepresented in MitraClip registries. Our group has recently published the Spanish experience with MitraClip in acute MI, but only 5 patients could be collected. However, the results of our initial experience are highly encouraging since patients performed well in such life-threatening condition. In order to expand the information of the device in this condition, our aim is to start a multinational registry in Europe.

Official Title
-----------------
European Registry of MitraClip in Acute Myocardial Infarction

Conditions
-----------------
Mitral Regurgitation, Acute Myocardial Infarction

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient ≥ 18 year-old Transmural myocardial infarction in the previous 4 weeks (managed under current guideline's recommendations). Symptomatic severe mitral regurgitation diagnosed by left ventriculography, transthoracic echo or trans-oesophageal echo. Symptoms may vary form heart failure to cardiogenic shock. Symptoms should be stabilized by medical management: iv diuretics, inotropic support, LV assistance devices Considered by heart team at high risk for conventional surgery Exclusion Criteria: Anatomy not suitable for MitraClip implantation Technical contraindication for access to left atrium Patient candidate for emergent heart transplant Uncontrolled infection

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: MitraClip|MitraClip consists in two clip arms and opposing grippers, which can be opened and closed against each other in order to grasp and gain cooptation of MV leaflets at the origin of the regurgitant jet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite primary end point | death from cardiac causes, readmission due to heart failure and mitral regurgitation >2+ | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MitraClip, Acute mitral regurgitation, Acute myocardial infarction
Advance® 18PTX® Balloon Catheter Study

Study Overview
=================
Brief Summary
-----------------
The Advance® 18 PTX® Balloon Catheter study is a clinical trial to study the safety and effectiveness of the Advance 18® PTX® Balloon Catheter in the treatment of lesions in the superficial femoral artery and popliteal artery.

Official Title
-----------------
Advance® 18PTX® Balloon Catheter Study: Treatment of Lesions in Superficial Femoral Artery/Popliteal Artery With a Paclitaxel-coated Balloon

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: Advance® 18PTX® Balloon Catheter
* Device: Advance® 18LP Balloon Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Age >18 years. Able to provide informed consent. Has at least one de novo or restenotic lesion(s) with > 70% stenosis documented angiographically of the SFA or popliteal artery. If more than one lesion requires intervention, only one should be treated as a study lesion. Key Exclusion Criteria: Has significant stenosis (> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure. Lack of at least one patent runoff vessel with < 50% stenosis throughout its course. Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PTX-coated balloon | Device: Advance® 18PTX® Balloon Catheter<br> <br> |
| Active Comparator: 2<br>Bare balloon | Device: Advance® 18LP Balloon Catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Late Lumen Loss |  | 6 months |
Postural Changes in Lung Volumes in Obesity

Study Overview
=================
Brief Summary
-----------------
Postural changes are known to affect normal lung volumes. A reduction in sitting to supine functional residual capacity (FRC) is well-described in non-obese subjects adopting a supine position. However, postural changes in lung volumes in the obese require further exploration. We aimed to longitudinally address the effects of weight loss on postural changes in lung volumes and pulmonary function, in obesity. We tested the hypothesis that supine reduction in FRC would be absent in morbid obesity and recovered upon weight loss.

Official Title
-----------------
Effect of Weight Loss on Postural Changes in Pulmonary Function : a Longitudinal Study in Morbidly Obese to Obese Subjects Following Gastroplasty

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Postural change in lung volumes: sitting to Supine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects scheduled for bariatric surgery (BMI over or equal to 40 kg/m2) Exclusion Criteria: Subjects with respiratory and cardiac history (asthma, COPD, heart failure) were excluded.

Ages Eligible for Study
-----------------
Maximum Age: 60 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 |
| --- | --- |
| Morbidly obese<br>Consecutive morbidly obese adults (BMI over or equal to 40 kg/m2) scheduled for bariatric surgery were prospectively recruited.Subjects with respiratory and cardiac history (asthma, Chronic obstructive pulmonary disease, heart failure) were excluded. | Other: Postural change in lung volumes: sitting to Supine<br>* Pulmonary function and arterial blood gases were assessed both prior to and after weight loss as part of pre-operative and 12-month follow-up evaluations. Pulmonary function tests were performed both in the sitting and then in the supine position.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional residual capacity |  | baseline and one year after bariatric surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung volumes and flows |  | at baseline and after bariatric surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, lung volumes, postural changes
Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets

Study Overview
=================
Brief Summary
-----------------
X-linked hypophosphatemic rickets (XLH) is characterized by rickets, disproportionate short stature, impaired renal phosphate reabsorption and vitamin D metabolism. Despite oral phosphate and vitamin D treatment, most children with XLH demonstrate reduced adult height. The main objective of the study is to determine the beneficial effects of recombinant human growth hormone (rhGH) therapy on body proportions after 36 month in these patients. Secondary objective is to monitor side effects of the therapy.

Official Title
-----------------
Effects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic Rickets

Conditions
-----------------
Hypophosphatemic Rickets, Growth Disorders, Somatropin Therapy

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tanner stages of puberty B1, G1 body height < 2,5 SDS growth velocity < 75% confirmed diagnosis of XLHR conservative treatment for at least 1 year (phosphate, vitamin D) informed consent, written agreement Exclusion Criteria: growth hormone deficiency hypothyreosis severe rickets severe physical deformities severe hyperparathyreoidism chronic renal failure complex syndrome involving failure to thrive chronic disease with failure to thrive impairment of glucose tolerance Tanner stages of puberty greater than B1, G1 medical history of malignancy therapy with growth hormone, glucocorticoides, anabolica attending another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: somatropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of body proportion and final height |  | within 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects of therapy with rhGH |  | within 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
X-linked dominant hypophosphatemic rickets, growth disorders, anthropometry, human growth hormone
Study Evaluating Genotypes Using Lucentis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms

Detailed Description
-----------------
Treatment naive exudative AMD patients will receive Lucentis treatment as standard of care, and followed monthly for 12 months. Standard ophthalmologic exams will be performed, along with ETDRS visual acuity and optical coherence tomography (OCT). A blood sample will be obtained for DNA analysis. The primary outcome measure is change in visual acuity at 4 months after initial Lucentis treatment. Secondary outcomes are change in visual acuity and retinal thickness at 12 months.

Official Title
-----------------
VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis

Conditions
-----------------
Age-Related Maculopathy

Intervention / Treatment
-----------------
* Drug: Lucentis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment naive AMD patients; At least 50 years of age; Visual acuity between 20/40 and 20/320 Exclusion Criteria: Pregnancy; Prior enrollment in a ranibizumab clinical trial; Previous therapy in either eye for AMD; Concurrent eye disease that could compromise visual acuity

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 1<br>Active approved treatment | Drug: Lucentis<br>* 0.05 mg intravitreal injection<br>* Other names: ranibizumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exudative age-related macular degeneration
1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism

Study Overview
=================
Brief Summary
-----------------
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Baseline Visit at which informed consent will be obtained and eligibility will be assessed.

Official Title
-----------------
1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Ultra for Astigmatism Contact Lenses

Conditions
-----------------
Myopia, Astigmatism

Intervention / Treatment
-----------------
* Device: kalifilcon A Daily Disposable Toric
* Device: Ultra for Astigmatism Contact Lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have the capacity to read, understand and provide written voluntary informed consent. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Have no active ocular disease or allergic conjunctivitis. Not be using any topical ocular medications. Be willing and able to follow instructions. Have signed a statement of informed consent. Exclusion Criteria: Participating in a conflicting study. Considered by the Investigator to not be a suitable candidate for participation.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kalifilcon A Daily Disposable Toric<br>kalifilcon A Daily Disposable Toric | Device: kalifilcon A Daily Disposable Toric<br>* kalifilcon A Daily Disposable Toric<br>|
| Active Comparator: Ultra for Astigmatism Contact Lenses<br>Ultra for Astigmatism Contact Lenses | Device: Ultra for Astigmatism Contact Lenses<br>* Ultra for Astigmatism Contact Lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Mean Binocular logMAR Visual Acuity | One week |
An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus

Study Overview
=================
Brief Summary
-----------------
This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to these subjects

Official Title
-----------------
An Open Label, Expanded Access Protocol to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus

Conditions
-----------------
Super-Refractory Status Epilepticus

Intervention / Treatment
-----------------
* Drug: SAGE-547


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects six (6) months of age and older Subjects who have: Failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment), according to the institution's standard of care, and; Failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AEDs), according to the institution's standard of care, and; Not previously been administered a third-line agent but have been admitted to an intensive care unit with the intent of administering at least one third-line agent for at least 24 hours; or who have previously failed zero, one or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agents and in an EEG burst or seizure suppression pattern; or who have previously failed one or more wean attempts from third-line agents and are now either not on at least one continuous infusion of a third-line agent or are on one or more continuous infusions of third-line agents but not in an EEG burst or seizure suppression pattern. Exclusion Criteria: Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/ malignant EEG features Children (subjects aged less than 18 years) with an encephalopathy due to an underlying progressive neurological disorder Subjects who have any of the following: a GFR low enough to warrant dialysis for whatever reason, but dialysis is not planned or non-continuous dialysis is planned; severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use; fulminant hepatic failure; no reasonable expectation of recovery or life-expectancy of less than 30 days. Subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed per protocol

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SAGE-547|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Viscontour® Serum Med in Hydration of Facial Skin

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to confirm the clinical safety and efficacy of Viscontour® Serum Med in the hydration of facial tissue.

Official Title
-----------------
Viscontour® Serum Med in Hydration of Facial Skin

Conditions
-----------------
Sodium Hyaluronate

Intervention / Treatment
-----------------
* Device: Viscontour® Serum Med


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females ≥ 18 years of age and in good general health condition Signed informed consent Existing Viscontour® Serum Med recommendation (i.a. for hydration, soothing, nourishing and refreshing the complexion and for use in combination with a day cream) Exclusion Criteria: Known hypersensitivity to one of the Viscontour® Serum Med components Known pregnancy or lactating females Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Viscontour® Serum Med|Viscontour® Serum Med is a CE-certified preservative-free isotonic solution containing 5.0 mg sodium hyaluronate.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Skin Parameters compared to Baseline | Routine Evaluation of the Overall Skin Condition | 20 Minutes, Day 7 and Day 28 | 
| Change of Subjective Therapy Evaluation (Questionnaire) compared to Baseline |  | 20 Minutes, Day 7 and Day 28 | 
| Incidence of Treatment-Emergent Adverse Events |  | Up to Day 28 |
Comparison of NOSE and Conventional Methods in Laparoscopic Right Colon Surgery

Study Overview
=================
Brief Summary
-----------------
Laparoscopic right hemicolectomy (LRH) is an accepted surgical procedure for several right sided colonic pathologies. Recently the advantages of the intracorporeal ileotransversostomy over the extracorporeal anastomosis is appearing in the literature. Additionally, specimen extraction through the natural orifices is an emerging method when combined with the totally laparoscopic procedures. Our observations on natural orifice surgery was promising . In our daily surgical practice, investigators prefer the intracorporeal anastomosis and this study was conducted to compare the specimen extraction sites after LRH. Here investigators aimed to compare the results of conventional and natural orifice specimen extractions (NOSE) after totally LRHs.

Detailed Description
-----------------
compare the patient-selected NOSE method and conventional method in laparoscopic right colon cancer surgery

Official Title
-----------------
Comparison of NOSE and Conventional Methods in Laparoscopic Right Colon Surgery

Conditions
-----------------
Surgical Incision

Intervention / Treatment
-----------------
* Procedure: natural orifice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laparoscopic right hemicolectomy patients Exclusion Criteria: no

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: natural orifice<br>Patients who underwent laparoscopic surgery and removed the specimen from the natural orifice will be gathered. demographic data and perioperative results will be compiled | Procedure: natural orifice<br>* laparoscopic right colon surgery and patients who are removed from the natural orifice and conventional will gather<br>* Other names: conventional;|
| No Intervention: conventional<br>patients who underwent laparoscopic surgery and removed specimen with conventional will be gathered. demographic data and perioperative results will be compiled. (conventional extraction is suprapubic or median incision) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS control | Visual Analog Score for pain (1-10 score) | 6 years |