linjc16/ctgov huggingface dataset:
Effect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate potential effects of valsartan on lipid subfractions and other parameters in lipid metabolism in patients with essential hypertension and metabolic syndrome.

Official Title
-----------------
A 12 Week Treatment, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Valsartan 160-320 mg With Regard to Effects on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome

Conditions
-----------------
Hypertension, Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: Valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients >= 18 years of age at Visit 1 Hypertension (systolic blood pressure >= 140 mmHg and < 170 mmHg and/or diastolic blood pressure >= 90 mmHg and < 105 mmHg Elevated triglycerides Metabolic syndrome as defined by Adult Treatment Panel III criteria Exclusion Criteria: MSSBP >= 170 mmHg and/or MSDBP >= 105 mmHg at any time between Visit 1 and Visit 2 Diabetes mellitus Patients treated with lipid lowering drugs in the last 6 weeks prior to Visit 1 A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease, heart failure NYHA II - IV Other protocol-defined inclusion/exclusion criteria may apply

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of valsartan 320 mg on small, dense low density lipoprotein (LDL) subfractions in hypertensive patients with metabolic syndrome. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of valsartan 320 mg on further lipid subfractions and enzymes related to the lipoprotein metabolism. |  |  | 
| To evaluate the effect of valsartan 160-320 mg on blood pressure and pulse rate. |  |  | 
| To assess the safety and tolerability of valsartan 160-320mg. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Metabolic Syndrome, lipid subfractions
Retroseptal Transconjunctival Blepharoplasty for GIR

Study Overview
=================
Brief Summary
-----------------
The tear trough deformity is a challenging cosmetic condition.surgical treatment and filling are good treatment options

Detailed Description
-----------------
Procedure is lower eyelid transconjunctival Blepharoplasty associated with stromal vascular fraction gel (SVF-gel) or fat transposition

Official Title
-----------------
Orbital Fat Graft Retroseptal Transconjunctival Blepharoplasty for Treatment of Groove in the Infraorbital Region

Conditions
-----------------
Eyelid Diseases

Intervention / Treatment
-----------------
* Procedure: transconjunctival lower blepharoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: tear trough deformity Exclusion Criteria: Eyelid diseases and previous eyelid surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SVF-gel<br>Transconjunctival blepharoplasty associated with associated with stromal vascular fraction gel (SVF-gel) | Procedure: transconjunctival lower blepharoplasty<br>* transconjunctival lower blepharoplasty associated with stromal vascular fraction gel (SVF-gel)<br>|
| Experimental: fat transposition<br>Transconjunctival blepharoplasty associated with fat transposition | Procedure: transconjunctival lower blepharoplasty<br>* transconjunctival lower blepharoplasty associated with stromal vascular fraction gel (SVF-gel)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin-periosteal depth | measure skin-periosteal depth | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global aesthetic improvement scale | calculate scale score from score 1 (exceptional improvement) to score 5 (worsening patient) | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tear trough, blepharoplasty,orbital fat
The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.

Detailed Description
-----------------
Patients admitted to Aberdeen ICU with severe traumatic brain injury will have a BIS electrode placed and observed for 24 hours. The study team will be blinded to the result, so not to influence treatment. All clinical care is at the discretion of the clinical team.

Official Title
-----------------
The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Device: BIS Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (over 18) Diagnosis of traumatic brain injury Expected to survive Expected to require greater than 24 hours of sedation and mechanical ventilation Exclusion Criteria: Brain injury thought to be unsurvivable by ICU clinical team Frontal decompressive craniectomy Use of ketamine infusion at recruitment or planned use within 24 hours Fractured frontal bone or severe overlying soft tissue injury Simple extradural haemorrhage with no other obvious intracranial injury Pregnant patient

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with TBI<br>Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation. | Device: BIS Monitor<br>* Unilateral BIS electrode<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean BIS | Mean BIS of patients sedated | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean ICP | Mean ICP of sedated patient | 24 hours | 
| Incidence of osmotherapy use | Number of instances of osmotherapy use in sedated patients | 24 hours | 
| Vasopressor dose | Total vasopressor dose for sedated patients | 24 hours | 
| Sedative dose | Total sedative dose for sedated patients | 24 hours | 
| Length of ICU stay | Number of days admitted to ICU | Days to weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bispectral index, Monitoring, Sedation, Traumatic Brain Injury
Long Term Follow up of Scars Formation and Quality of Life Assessment Study

Study Overview
=================
Brief Summary
-----------------
In previous study (MW2004-011-02), patients with burn wounds had their damaged skin removed by either standard of care treatment or by Debrase Gel Dressing (DGD), which is composed of enzymes that dissolve the damaged skin selectively (DGD removes only the damaged skin and not other parts of the skin). The burn wound, like any other wound, heals by the formation of scar at the injured site in order to replace the destroyed tissues. Scarring is not a static process, but rather a dynamic one, changing over time, especially during the first 24 months post-injury. Scars and patients' quality of life from two treatment arms (DGD and SOC) will be compared in order to evaluate the long term influence of damaged skin removal and wound care techniques on scar formation and maturation.

Official Title
-----------------
Scar Formation and Quality of Life Assessment in Subjects (Adults & Children) Following Treatment With Debrase Compared to Standard of Care (SOC)

Conditions
-----------------
Scars Formation, Quality of Life

Intervention / Treatment
-----------------
* Other: Scars assessment & QOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Adults and children who had participated and completed study MW2004-11-02. Subjects must be willing and able to sign a written informed consent prior to study entry (by subject or by a guardian, when applicable).

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 55 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 |
| --- | --- |
| Patients that were treated in MW2004-011-02 study with Debrase<br> | Other: Scars assessment & QOL<br>* Scar assessment and quality of life questionnaires<br>|
| Patients that were treated in MW2004-011-02 with SOC<br> | Other: Scars assessment & QOL<br>* Scar assessment and quality of life questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Scar assessment of target wounds that have been treated by Debrase or SOC during MW2004-11-02 using Modified Vancouver Scar Scale (MVSS) | Assesment of scars will be done using the Modified Vancouver Scar Scale | Approximately 2 years after wound closure | 
| 2. To evaluate and compare the Quality of Life (QoL) in adult and children that their burn wounds were treated with Debrase or SOC in study MW2004-11-02 | 2. A Quality of Life (QoL) assessment will be performed in burn victims using a Short Form 36 (SF-36) and Burn Outcomes Questionnaire (BOQ). | Approximately 2 years after wound closure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QOL
A Trial Examining the Treatment of Common Warts With Combination Liquid Nitrogen (LN2) and Cantharidin

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to see if liquid nitrogen, a commonly used treatment for warts, is more effective if it is used alone, or if it is more effective if combined with cantharidin, a topical treatment also commonly used for warts (verruca vulgaris).

Official Title
-----------------
A Randomized Clinical Trial Examining the Efficacy of Treatment of Cutaneous Verruca Vulgaris in Adult Patients With Combined Liquid Nitrogen Cryotherapy and Topically Applied Cantharidin

Conditions
-----------------
Verruca Vulgaris

Intervention / Treatment
-----------------
* Drug: Liquid nitrogen and cantharidin
* Drug: Liquid nitrogen and topical placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: common warts on non-genital, non-facial skin otherwise healthy between 18-65 and able to give informed consent capable of tolerating treatment Exclusion Criteria: Ill-health Poor tolerance or sensitivity to treatments in study <18 years old; >65 years old verruca plana or condyloma acuminata immunosuppression or immune dysfunction significant peripheral vascular disease significant sensitivity to cold epidermodysplasia verruciformis mosaiform warts or periungual warts

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liquid nitrogen and canthardin<br>Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterwards. | Drug: Liquid nitrogen and cantharidin<br>* Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterward.<br>|
| Placebo Comparator: Liquid nitrogen and placebo<br>Liquid nitrogen applied to wart(s) then placebo vehicle afterwards. | Drug: Liquid nitrogen and topical placebo<br>* Liquid nitrogen applied to wart(s), then placebo vehicle applied thereafter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of common warts cleared | Percentage of treated warts cleared with treatment, as measured with dermatoscopic examination, after 12 weeks. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Warts, Verruca vulgaris, Liquid Nitrogen, Cantharidin, combination treatment
The Influence of Breathing in Writing

Study Overview
=================
Brief Summary
-----------------
Purpose: To examine whether nasal breathing influences the perception of sound causing trade between hard and soft consonants in the writing of children in school age and the incidence of trade.

Detailed Description
-----------------
To achieve the above goal explained, it was used: Methods: The sample was consisted of 200 children, 100 previously diagnosed with oronasal breath (51 females and 49 males) who participated in the study group and 100 nasal breathers (54 females and 46 males) which were the control group. 36 words were dictated as minimal pairs to be written. Then a story was submitted in sequence of six figures from which the subjects produced a text.

Official Title
-----------------
The Influence of Mouth Breathing in the Discrimination of Sonority Perception in Writing

Conditions
-----------------
Mouth Breathing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mouth Breather/Nasal Breather Literate Exclusion Criteria: Hearing trouble Speech trouble

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 13 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 |
| --- | --- |
| Mouth Breather<br>Mouth Breathers Children from 7 to 13 years old | |
| Nasal Breather<br>Nasal breathers children from 7 to 13 years old | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between production written and directed free nose breathers and mouth breathing children |  | up to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiration, Learning, Speech, Language and Hearing Sciences
Subclavian Artery Plug Embolization (SAPE)

Study Overview
=================
Brief Summary
-----------------
This is an observational, no-profit, ambispective study: a retrospective arm will include the cases treated between August 2009 and March 2018, and a prospective arm, investigating patients treated from March 2018 until December 2018. Target study population size is 150 patients between two groups analyzed. Endovascular occlusion of the prevertebral subclavian artery was first used in the Vascular Surgery Department at San Raffaele Hospital in August 2009. During the initial experience (2009-2014) this technique was used with low frequency. Since 2015, the volume of cases receiving this treatment, has increased and the investigators expect to reach the study population target, by the end of 2018. The objective of this study is describe the casuistry of endovascular occlusion of the subclavian artery by means of the Amplatzer Vascular plug in the Vascular Surgery Department at San Raffaele Hospital, and to evaluate the efficacy of such procedure. Moreover, the investigators will evaluate the patency and success rate of the carotid-subclavian bypasses performed at the same time of the analyzed procedure.

Official Title
-----------------
Endovascular Occlusion by Plug of the Prevertebral Subclavian Artery Preparatory to the Surgical or Endovascular Aortic Procedures (SAPE)

Conditions
-----------------
Subclavian Artery Plug Embolization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients aged ≥ 18 years, patients candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug Exclusion Criteria: • none

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | Technical success rate defined as complete occlusion of the left subclavian artery at postoperative CT scan | within 30-day | 
| Major adverse event rate | Any stroke or mortality related to the surgical procedure | within 30-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access site complications requiring secondary adjunctive procedures | Any access site complication requiring open or endovascular adjuctive procedures (ie: surgical embolectomy, echo-guided pseudoaneurysm manual compression) | within 30-day | 
| Supra-aortic vessels patency rate | Patency of the carotid and subaclavian artery at follow-up | within 5-years |
Basic Intermittent Exotropia and Risk Factors for Postoperative Overcorrection and Under Correction

Study Overview
=================
Brief Summary
-----------------
To evaluate preoperative risk factors for overcorrection and undercorrection following surgery for basic intermittent exotropia such as axial length of the globe, refractive error, age and sex

Official Title
-----------------
Basic Intermittent Exotropia; is the Axial Length of the Globe One of the Prognostic Factors for Overcorrection and Undercorrection After Binocular Surgery

Conditions
-----------------
Strabismus

Intervention / Treatment
-----------------
* Procedure: Strabismus surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Basic type intermittent exotropia Exclusion Criteria: previous strabismus surgery restrictive strabismus

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 25 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 |
| --- | --- |
| Other: Basic intermittent exotropia patients<br> | Procedure: Strabismus surgery<br>* Recession and resection of horizontal extra ocular muscles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for postoperative overcorrections and under corrections | as axial length of the globe, age, sex and refractive error | 6 months |
Children Severe Traumatic Skin Lesions and Functional Outcome

Study Overview
=================
Brief Summary
-----------------
Traumatic skin lesions require an adapted and early patient care management

Detailed Description
-----------------
Traumatic skin lesions and in particular the burns which happen to growing children are complex and require an adapted and early patient care management. A child presents physical, psychological, and physiological characteristics which involve a specific functional prognosis. The aim of the study was to evaluate the functional outcome after a mid-term period from a severe skin traumatism occurring during childhood and which had required an initial graft.

Official Title
-----------------
Children Severe Traumatic Skin Lesions and Functional Outcome

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children who were hospitalized for an extensive and deep skin lesion on at least one joint, at CHU Amiens, from April 1999 to December 2014, in the Physical and Rehabilitation Pediatric activity center. And with a serious skin lesion: What the total dermal area is estimated to be less than 25% Taking at least one articulation Dont a part is at least 2nd degree deep or third degree Exclusion Criteria: First degree burns or superficial second degree Burns resulting in death in the acute phase A history of pre-burn disorders affecting growth Escarres

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| skin lesion<br>severe skin traumatism occurring during childhood and which had required an initial graft. | Other: questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| autonomy | for daily life activities (questionnaire) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appearance of contractures | consultation follow-up | 5 years | 
| limited joint mobility | consultation follow-up | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burn, child, graft, development, complications, autonomy