linjc16/ctgov huggingface dataset:
Prospective Observational Study Comparing the Use of Circular (Orvil) and Linear Stapler for Intracorporeal Esophagojejunostomy

Study Overview
=================
Brief Summary
-----------------
Prospective observational study comparing the use of circular (Orvil) and linear stapler for intracorporeal esophagojejunostomy. Patients with adenocaricinoma involving the esophagogastric junction or the gastric cardia are observed. The two methods of esophagojejunostomy are compared.

Official Title
-----------------
Prospective Observational Study Comparing the Use of Circular (Orvil) and Linear Stapler for Intracorporeal Esophagojejunostomy

Conditions
-----------------
Stomach Neoplasm

Intervention / Treatment
-----------------
* Procedure: Esophagojejunostomy type


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as gastric adenocarcinoma Involving the esophagogastric junction or gastric cardia Age 18 - 80 years Anticipated to undergo laparoscopic total or proximal gastrectomy cT1-T4a Exclusion Criteria: Previous history of gastrectomy Neoadjuvant chemotherapy or radiotherapy for gastric cancer Invasion to other organs Open conversion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Orvil Group<br>Group that used the Orvil (circular stapler) for esophagojejunostomy | Procedure: Esophagojejunostomy type<br>* Use of either circular or linear stapler<br>|
| Linear Group<br>Group that used the linear stapler for esophagojejunostomy | Procedure: Esophagojejunostomy type<br>* Use of either circular or linear stapler<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomosis complication | including anastomosis leakage, stenosis, bleeding of the esophagojejunostomy | within 1 year |
Renal Denervation in Patients With Refractory Hypertension

Study Overview
=================
Brief Summary
-----------------
To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.

Official Title
-----------------
Renal Denervation in Patients With Refractory Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: Symplicty(TM) Catheter System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 years of age a systolic blood pressure of 160mmHg or more receiving and adhering to full doses of at least three antihypertensive drugs estimated glomerular filtration rate (eGFR) of ≥45mL/min agrees to have the study procedure(s) performed and additional procedures and evaluations is competent and willing to provide written, informed consent to participate in this clinical study Exclusion Criteria: hemodynamically or anatomically significant renal artery stenosis has a history or prior renal artery angioplasty has experienced MI, unstable angina pectoris, or CVA within 6 months has hemodynamically significant valvular heart disease has Type 1 diabetes has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI) requires respiratory support is pregnant, nursing, or planning to be pregnant has known, unresolved history of drug use or alcohol dependency. is currently enrolled in another investigational drug or device trial.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Symplicty(TM) Catheter System|Renal denervation using the Symplicity Catheter System|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To document the physiologic effects of renal denervation in patients with refractory hypertension. |  | 3 years |
Reference Values for Respiratory Resistance Measured by the Interrupter Technique in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose is to obtain reference values of respiratory resistance (a technique widely used in children), in adults. The interest is that this technique needs only little co-operation and would be particularly adapted in subjects in whom co-operation is insufficient for other measurements.

Official Title
-----------------
Reference Values for Respiratory Resistance Measured by the Interrupter Technique in Adults

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: EFR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult non smokers, without any disease interfering with pulmonary function

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: EFR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| References values obtained once |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of short-term reproductibility |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interrupter technique, Respiratory resistance, Normal adults
Incidence of Ocular Antibodies in Patients With Sturge - Weber Syndrome (SWS)

Study Overview
=================
Brief Summary
-----------------
Sturge-Weber Syndrome (SWS) is a neurological disorder characterized at birth by seizures and a large port-wine stain birthmark on the forehead and upper eyelid of one side of the face. SWS is also accompanied by an increased pressure within the eye (glaucoma) which can develop very early in life. Glaucoma represents a group of ocular disorders that are characterized by the loss of retinal ganglion cells and their axons, damage to the optic nerve, and gradual loss of visual field. Recently, several studies provided evidence that there is a potential role of the immune system in the pathogenesis of glaucoma. These findings suggest that there might be changes in systemic humoral immunity possibly underlying the optic neuropathy in at least some glaucoma patients.

Detailed Description
-----------------
The ocular antibody profile in patients with SWS is unknown.The researchers want to study on blood and tear drop samples from patients with SWS to determine the incidence of ocular antibodies in patients with this syndrome.

Official Title
-----------------
Incidence of Ocular Antibodies in Patients With Sturge - Weber Syndrome (SWS)

Conditions
-----------------
Sturge - Weber Syndrome (SWS)

Intervention / Treatment
-----------------
* Other: blood sample tear drop sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female volunteers with SWS of all ages Exclusion Criteria: Volunteers without SWS
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| blood sample tear drop sample<br>blood sample tear drop sample | Other: blood sample tear drop sample<br>* blood sample tear drop sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring

Study Overview
=================
Brief Summary
-----------------
This pilot study aims to assess the feasibility and safety of using an ILR to identify the incidence of recurrent AF after an episode of newly diagnosed AF. The study further aims to assess the risk of AF recurrence in this low risk population based on left atrial and left atrial appendage anatomic and functional indices in addition to the standardized clinical CHA2DS2-Vasc score.

Detailed Description
-----------------
There is a significant incidence of recurrent AF following initial diagnosis of AF. Inclusion of left atrial (LA) and left atrial appendage (LAA) abnormalities together with risk prediction of CVA using CHA2DS2-Vasc score will identify patients at low or high risk for adverse cardiovascular events in patients with manifest and silent AF. Patients requiring cardioversion have higher risk of recurrent AF in follow up.

Official Title
-----------------
Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring and Cardiac Imaging in Patients at Low Risk for Cardiovascular Events Following Direct Current Cardioversion for New Onset Atrial Fibrillation

Conditions
-----------------
New Onset Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Newly diagnosed AF Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule Exclusion Criteria: Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint Patient received an organ transplant, or is on a waiting list. Patient is not able to follow instructions for remote monitoring 4 Prior history of AF

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 |
| --- | --- |
| Subjects with new onset atrial fibrillation<br>Subjects with new onset atrial fibrillation who may or may not require electrical cardioversion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to AF recurrence | Time to AF recurrence based on clinical or ILR monitoring | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death | Composite endpoint of all-cause death | 30 days; 6 months; 1 year; 2 years; 3 years | 
| AF related re hospitalizations | any hospitalization related to AFib | 3 years | 
| Occurrence of CVA | Stroke mRs>1 or TIA | 3 years | 
| Major and minor bleeding | events of major and minor bleeding | 3 years |
A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study

Study Overview
=================
Brief Summary
-----------------
This study tests novel technology using computer vision and remote clinical review to reduce falls for residents with dementia in assisted living communities.

Official Title
-----------------
A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Device: SafelyYou
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living in a participating assisted living facility and suffering from dementia Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Waitlist control
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Cameras<br>active cameras in the room | Device: SafelyYou<br>* technology to detect and prevent falls<br>|
| Sham Comparator: Inactive Cameras<br>camera in the room, not activated | Other: Control<br>* technology present but not activated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opt-in rate | participants enrolling | through study completion, an average of 1 year | 
| Number of falls | fall incidents | through study completion, an average of 1 year | 
| Number of ER visits | fall incidents requiring emergency transportation | through study completion, an average of 1 year |
Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar

Study Overview
=================
Brief Summary
-----------------
The Lubo cervical collar is a device that simultaneously maintains cervical spine control and keeps an open airway in a non-invasive manner. The purpose of the device is to manage cervical spine control and airway protection in the trauma patient.

Detailed Description
-----------------
Cervical spine stabilization is usually achieved by a semi-rigid collar. While these collars achieve the goal of supporting the cervical spine, they limit the possibilities for jaw thrust or other airway manipulations. Definitive airway protection usually must be achieved by orotracheal intubation. Thee Lubo collar is a device that simultaneously maintains cervical spine control and keeps an open airway in a non-invasive manner that is simple to operate. The objective of the study is to test the safety of the collar volunteers. The study is composed of two stages:1.healthy volunteers that will not undergo any intervention except testing the LCC.2. second group of patients scheduled to undergo an operation under general anesthesia with endotracheal intubation or laryngeal mask airway.

Official Title
-----------------
Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar

Conditions
-----------------
Elective Surgical Procedure

Intervention / Treatment
-----------------
* Device: Lubo cervical collar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Males or females. Age 18-60. Normal airway anatomy, with expected easy ventilation and intubation. Anesthetic risk- class 1or 2 by the American Society of Anesthesiologists (ASA) criteria. Patients scheduled for an elective operation at the lower part of the body in supine position not supposed to last more then 2 hours. Anesthetic plan- general anesthesia Exclusion criteria Known problems of the cervical spine. Known problems of the temporomandibular joint. Suspected difficult intubation or difficult mask ventilation. High risk of gastric content aspiration. Morbid obesity (BMI >32). Pregnancy Psycho- social problems Any cerebrovascular or cardiovascular disease Known hypersensitivity reactions to fabrics or plastics Any rash, eruption, wounds or sores at the upper torso, the neck and the head. No participation in other clinical trail at the time of the trail

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Lubo cervical collar|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Clamping the Indwelling Urethral Catheter Before Removal From Patients After Type III Radical Hysterectomy

Study Overview
=================
Brief Summary
-----------------
The effect of clamping the indwelling urethral catheter before removal is an unsettled issue in clinical practice. No studies have done before in the patients with gynecologic cancers who received radical hysterectomy. We hypothesized that clamping the catheter would decrease the rate of recatheterization. In addition, the feeling of urination during clamping is correlated with lower rate of recatheterization after removal.

Conditions
-----------------
Gynecologic Cancer

Intervention / Treatment
-----------------
* Procedure: to clamp or release the catheter for 2 days before removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients receiving Piver III radical hysterectomy catheterization over 7 days Exclusion Criteria: catheterization shorter than 7 days
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clamping<br>to clamp or release the catheter for 2 days before removal | Procedure: to clamp or release the catheter for 2 days before removal<br> <br> |
| No Intervention: no clamping<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of recatheterization |  | 12 months |
Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection

Study Overview
=================
Brief Summary
-----------------
This prospective observational study will evaluate predictors of response to Invirase (saquinavir) treatment in treatment-naïve patients with HIV infection. Data will be collected during 48 weeks of treatment.

Official Title
-----------------
Prospective Multicentre Noninterventional Observational Study on Predictors of Treatment Response in a Cohort of Treatment naïve HIV-infected Patients Treated With Saquinavir (PROSPECTOR)

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age HIV infection Treatment-naïve Initiation of treatment with Invirase Exclusion Criteria: Contraindications according to Invirase Summary of Product Characteristics

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of baseline CD4 count and HIV RNA on virological and immunological response at 12, 24 and 48 weeks of treatment |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Host- and virus-related factors influencing virological and immunological response at 12, 24 and 48 weeks of treatment |  | 48 weeks |
Videoendoscopic Pilonidal Sinus Surgery

Study Overview
=================
Brief Summary
-----------------
This study examines performing pilonidal sinus surgery minimal invasively with videoendoscopic approach.

Detailed Description
-----------------
Lots of surgical techniques are performing on pilonidal sinus disease treatment. Lately large flap techniques are popular but causing anatomical distortions and bad cosmesis. In this new approach the investigators concluded that two 1cm diameter holes are enough to surgical treatment. One hole is for videoendoscopic camera and the other one for grasper to extract piluses and granulation tissues.

Official Title
-----------------
Videoendoscopic Pilonidal Sinus Surgery. A New Technique

Conditions
-----------------
Recurrence, Postoperative Complication

Intervention / Treatment
-----------------
* Procedure: videoendoscopic resection of pilonidal sinus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic pilonidal sinus disease primer pilonidal sinus disease noncomplicated pilonidal sinus disease Exclusion Criteria: Asymptomatic pilonidal sinus disease Recurrence pilonidal sinus disease complicated pilonidal sinus disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control<br>excision and primer repair surgical technique will be perform | Procedure: videoendoscopic resection of pilonidal sinus<br>* Resection of pilonidal sinus tissue with videoendoscopic approach.<br>* Other names: Procedure/Surgery: Videoendoscopic: Group-2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rates | primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications, wound healing | Postoperative complications such as bleeding and infection are important outcome measurements. Wound healing time is the other important one. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pilonidal sinus, new technique, videoendoscopic