linjc16/ctgov huggingface dataset:
Validation of a Wearable Sensor for Stress Response in a Virtual Reality Environment

Study Overview
=================
Brief Summary
-----------------
Monitor stress response in a virtual reality environment using a wearable sensor to analyze and track heart rate variability (HRV).

Detailed Description
-----------------
Wearable sensor technology is being developed that may allow, for the first time, the ability for individuals to better recognized their level of stress in any given situation on a continuous basis. A major focus of many of these wearable sensors is being able to accurately analyze and track heart rate variability (HRV), which is indicative of primarily parasympathetic/vagal tone and emotional state.3 However there is a need to validate the reliability of this measured response and understand any inter-individual variability. The present study will take advantage of virtual reality scenarios to expose healthy volunteers to controlled stressful situations during monitoring with several standardized lab-based non-invasive physiological sensors as well as a novel wrist band sensor device to track individual response to stress.

Official Title
-----------------
Validation of a Wearable Sensor for Stress Response in a Virtual Reality Environment

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over age 18 Exclusion Criteria: History of seizures History of vertigo or other vestibular abnormalities History of a chronic anxiety disorder History of cardiovascular disease or heart disease

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in heart rate variability (HRV) as detected by the wristband sensor relative to measures of stress noted by lab-based physiologic monitoring equipment. | Collect continuous physiological data in real-time from participants undergoing a set of standardized stress exposure experiences. |  Four hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress, Virtual Reality, Wearable Sensor, Wellness
Percutaneous Endoscopic Gastrostomy in Hands of ORL-HN Surgeon

Study Overview
=================
Brief Summary
-----------------
PEG tubes are commonly used to provide nutritional support to patients with head and neck cancer. PEG insertions are typically carried out by gastroenterologists, but also otorhinolaryngologist - head and neck surgeons perform the procedure in some countries. Prospective studies on PEG tube placements in an ORL - HNS service are lacking. The investigators aim was to prospectively evaluate the preformance of ORL - HN surgeons in PEG tube insertions, and analyze the time gains and cost effectiveness achieved of the independency from other specialities.

Official Title
-----------------
Prospective Experience of Percutaneous Endoscopic Gastrostomy Tubes in an Otolaryngologist Service - Safety and Benefits

Conditions
-----------------
Complication, Head and Neck Cancer, Percutaneous Endoscopic Gastrostomy

Intervention / Treatment
-----------------
* Procedure: percutaneous endoscopic gastrostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: head and neck cancer as a underlying disease Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 31 Years
Maximum Age: 89 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: percutaneous endoscopic gastrostomy|PEG tube inserted with pull technique|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications |  | 1 year | 
| mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delay | delay from the decision to insert PEG to the procedure | 1 year |
The Mechanism of TCF7L2 and SLC30A8 on Antipsychotic-induced Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Almost all of antipsychotics can induce metabolic syndrome,Genetic factors play a key role in the development of metabolic syndrome,TCF7L2 and SLC30A8 are strongestly correlated with metabolic syndrome.Moreover,Antipsychotics have an effect on the expression of TCF7L2 and SLC30A8 genes.It indicates the variations of TCF7L2 and SLC30A8 play an important part in the development of antipsychotics-induced metabolic syndrome.

Detailed Description
-----------------
In this study, we will determine the effect of olanzapine on the expression of TCF7L2 and SLC30A8. The relationship of the polymorphism of TCF7L2 and SLC30A8 with antipsychotic-induced metabolic syndrome in schizophrenia patients.

Official Title
-----------------
The Mechanism of TCF7L2 and SLC30A8 on Antipsychotic-induced Metabolic Syndrome

Conditions
-----------------
Schizophrenia, Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of first episode schizophrenia Must be able to swallow tablets Take only one antipsychotics Exclusion Criteria: liver or renal or cardiovascular diseases pregnant or lactating women drug and alcohol dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| olanzapine<br>15-25mg/day for 24 weeks | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight and blood glucose |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the blood pressure and blood lipid |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic Syndrome
Stitch Closure of PFO and Septal Repair

Study Overview
=================
Brief Summary
-----------------
The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of Atrial Septal Aneurysm (ASA) and rate of recurrent neurologic embolic events in patients with cryptogenic stroke and PFO.

Official Title
-----------------
Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System

Conditions
-----------------
Foramen Ovale, Patent, Septal Defect, Atrial, Septal Defect, Heart

Intervention / Treatment
-----------------
* Device: PFO Closure Rate
* Device: Published PFO Device Closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PFO ASD (less than 1 cm with redundant septal tissue) Trans Septal Puncture Sites ASA (when an appropriate PFO or small ASD defect is present) Stroke Trans ischemic Attack (TIA) Platypnea Orthodeoxia Syndrome Decompression Illness Exclusion Criteria: Patients under 18 and over 65 Patients who are not fluent in English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Non-randomized, single-center, observational study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PFO Closure Rate<br>Evaluate closure rate of clinically relevant septal defects including PFO, ASD (less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of ASA (when an appropriate PFO or small ASD defect is present) and rate of recurrent neurologic embolic event in patients with cryptogenic stroke and PFO | Device: PFO Closure Rate<br>* Suture Mediated PFO Closure and Septal Repair<br>Device: Published PFO Device Closure<br>* Suture Mediated PFO Closure and Septal Repair<br>|
| Other: Published PFO Device Closure<br>Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials. | Device: PFO Closure Rate<br>* Suture Mediated PFO Closure and Septal Repair<br>Device: Published PFO Device Closure<br>* Suture Mediated PFO Closure and Septal Repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure Rates of PFO and ASD | Saline Contrast Echo | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent Stroke Rate | Rate of which Patient Experiences Recurrent Stroke | 4-6 weeks, 6 months, 1 year and annually up to five years |
Follow-Up After Surgical Treatment of Peri-implantitis

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective clinical study was to evaluate the 3-year outcomes of anti-infective surgical treatment of peri-implantitis when a regular supportive peri-implant therapy (SPIT) programme was followed.

Detailed Description
-----------------
The patients enrolled in this prospective study all received surgical treatment for peri-implantitis at one of 2 treatment centres (specialist periodontal practice, Molndal and Gothenburg, Public Dental Health Services, Region Vastra Gotaland, Sweden) and were enrolled between October 2010 and December 2013.). All were treated by experienced periodontists. Details of the peri-implantitis treatment protocol have been described in a previous publication reporting on the 12-month clinical and radiographic treatment outcomes, registered at ClinicalTrials.gov (NCT01857804) and approved by the Regional Ethical Committee, Gothenburg, Sweden (Dnr. 654-10).

Official Title
-----------------
Follow-Up After Surgical Treatment of Peri-implantitis

Conditions
-----------------
Peri-Implantitis

Intervention / Treatment
-----------------
* Procedure: 3 years follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients who received surgical treatment for peri-implantitis for 3 years ago Exclusion Criteria: -
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 |
| --- | --- |
| 3 years follow-up<br>all patients who received surgical treatment for peri-implantitis during a Randomized and Controlled Trial registered in ClinicalTrials.gov NCT NCT01857804 | Procedure: 3 years follow-up<br>* Examination 3 years after surgical treatment of peri-implantitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in treatment success at 3 years post-op | treatment success is defined by pocket closure, no bleeding on probing, bone loss ≤0.5 mm between baseline and 3 years | baseline (1 year post-op) and 3 years post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peri-Implantitis, Surgical therapy, Follow-up, Supportive peri-implant therapy
Plasma Metanephrines in Patients With Cyanotic and Acyanotic Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to compare plasma metanephrines in patients with cyanotic and acyanotic congenital heart disease and possible association with chronic hypoxic stress.

Official Title
-----------------
Plasma Metanephrines in Patients With Cyanotic and Acyanotic Congenital Heart Disease

Conditions
-----------------
Acyanotic Congenital Heart Disease, Cyanotic Congenital Heart Disease, Pheochromocytoma, Paraganglioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with congenital heart disease attending regular follow up Exclusion Criteria: missing main data in medical documentation

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 cyanotic Congenital Heart Disease<br> | |
| Patients with acyanotic Congenital Heart Disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma metanephrine level | Level of plasma metanephrine | baseline, one point of time in a cross-sectional study | 
| Plasma normetanephrine level | Level of plasma normetanephrine | baseline, one point of time in a cross-sectional study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia | Length of hypoxemia presence in years | baseline, one point of time in a cross-sectional study |
Reducing Pain Intensity During Spinal Needle Insertion: Valsalva Maneuver vs. Control Technique

Study Overview
=================
Brief Summary
-----------------
This study was aimed to observe the efficacy of Valsalva maneuver in reducing pain intensity during spinal needle insertion.

Detailed Description
-----------------
Spinal anesthesia is one of the regional anesthesia techniques needed to provide motor, sensory, and autonomic blocks specifically for lower limbs by delivering local anesthetics into subarachnoid space. This technique is not difficult to perform and relatively inexpensive. However, spinal anesthesia may cause an intense pain during needle insertion. Valsalva maneuver is an attempt to force expiration by pushing a closed airway, such as covering nose or mouth. This maneuver can lead to anti-nociceptive stimulation and may decrease the pain. Thus, this study was aimed to observe the efficacy of Valsalva maneuver in reducing pain intensity during spinal needle insertion.

Official Title
-----------------
Comparison of Valsalva Maneuver and Control Technique in Reducing Pain Intensity During Spinal Needle Insertion

Conditions
-----------------
Undefined

Intervention / Treatment
-----------------
* Behavioral: Valsalva Maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective patients having spinal anesthesia Patients with no previous history of spinal anesthesia Patients with criteria of American Society of Anaesthesiologist (ASA) I-II Patients willing to participate in the study and signing informed consent form Exclusion Criteria: Patients with contraindications of spinal anesthesia Patients with difficulty in blowing 30 mmHg for 20 seconds Patients having allergic reactions due to local anesthetics and opioid

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Valsalva Maneuver<br>Patients who undergo spinal anesthesia and perform Valsalva maneuver to reduce the pain intensity | Behavioral: Valsalva Maneuver<br>* Performing Valsalva maneuver will reduce the pain intensity during spinal needle insertion.<br>|
| No Intervention: Group Control<br>Patients who undergo spinal anesthesia and perform nothing to reduce the pain intensity | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Pain Intensity | Pain Measurement by Visual Analog Scale or Numeric Rating Scale with Range 1-10 | 15 minutes |
Montelukast as a Controller of Atopic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.

Official Title
-----------------
Montelukast as a Controller of Atopic Syndrome

Conditions
-----------------
Atopic Eczema, Seasonal Allergic Rhinitis, Allergic Conjunctivitis, Asthma

Intervention / Treatment
-----------------
* Drug: montelukast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Wheal diameter at least 4 mm in skin-prick test for both birch and timothy Allergic symptoms in both upper airways (allergic rhinitis) and lower airways (asthma-like symptoms or diagnosed asthma) and at least one of the following: Allergic conjunctivitis Atopic eczema Oral symptoms from vegetables or fruits by cross reactivity to birch Urticaria in allergen exposure Exclusion Criteria: Need for regular treatment with glucocorticoids Current smoking Other major disease or need for regular drug treatment Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>3 weeks of Montelukast and 3 weeks of placebo treatment | Drug: montelukast<br>* 10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner<br>|
| Active Comparator: 2<br>3 weeks of placebo and 3 weeks of montelukast treatment | Drug: montelukast<br>* 10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergic symptoms |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for antihistamines or inhaled beta-2-agonists to relieve symptoms |  | 3 weeks | 
| Exhaled nitric oxide concentration |  | 3 weeks |
Outcomes of Geriatric Hip Fractures in Assiut University Hospital

Study Overview
=================
Brief Summary
-----------------
hip fractures are common problem specially in elderly population the incidence is increasing nowadays because of increased incidence of motor vehicle accidents

Detailed Description
-----------------
hip fractures are a common problem specially in elderly population the incidence is increasing nowadays because of increased incidence of motor vehicle accidents the incidence of morbidity and mortality is increasing today and the mortality rate is about 30% the aim of the study is follow up of the patients aged 65 years and older who experienced hip fractures for one year to evaluate the outcome of different ways of intervention in elderly population.

Official Title
-----------------
Outcomes of Geriatric Hip Fractures in Assiut University Hospital

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Procedure: Arthroplasty or open reduction and internal fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 65 years and older with fractures acetabulum , neck of femur , trochanteric , subtrochanteric and reverse trochanteric fractures Exclusion Criteria: no patient will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 110 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 |
| --- | --- |
| open reduction and internal fixation<br>outcome of open reduction and internal fixation of fractures of proximal femur and acetabulum in patients aged 65 years and older | Procedure: Arthroplasty or open reduction and internal fixation<br>* fixation of proximal femoral fractures or replacement with prosthesis<br>|
| Arthroplasty<br>outcome of arthroplasty of fractures of proximal femur and acetabulum in patients aged 65 years and older | Procedure: Arthroplasty or open reduction and internal fixation<br>* fixation of proximal femoral fractures or replacement with prosthesis<br>|
| conservative management<br>outcome of conservative management of fractures of proximal femur and acetabulum in patients aged 65 years and older | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the outcome of geriatric hip fractures | determine the morbidity and mortality of surgery of hip fractures in elderly patients aged 65 years and older | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine magnitude of geriatric hip fractures | determine incidence of hip fractures which is increasing nowadays | one year |