linjc16/ctgov huggingface dataset:
Three Dimensional Morphology of Upper Respiratory Tract and Mandibular Position on Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Oral appliances, which can maintain patients' jaw forwards during sleep, become more popular in treating obstructive sleep apnea (OSA). However, the exact mechanism of mandible forward on upper airway is not completely known. In this study we will use both static and dynamic MRI to study the 3D morphological changes and dynamic behavior of the upper respiratory tract at different mandible posits. Because in asian society non-obese OSA patients are not uncommonly seen, in this study we focus only on non-obese severe OSA patients.

Detailed Description
-----------------
The aim of this study is to analyze upper airway morphology changes and dynamic movement at different sections affected by mandible position by using dynamic and static magnet resonance imaging technique. The study also discusses the formation mechanism of obstructive sleep apnea syndromes and function mechanism of the oral appliance, as well as the evaluation of the clinical results of the oral appliance on non-obese male patients with severe obstructive sleep apnea in Taiwan. 10 non-obese (BMI<25) severe OSA (AHI>30) male patients between the age of 20 to 60 and 10 gender, BMI and age matched control (AHI<5) were recruited for this study. Nine bite index were made for the different mandible positions of the subjects. Upper airway was imaged by using static and dynamic MRI of each subject wearing the bite index while lying on the MRI scanning table. This study also measures the circumference and takes the lateral cephalometric imaging of each subject. Oral appliances were made and fitted for the experimental group subjects, who wore them for three months, after which they transferred to the Sleep Center and underwent PSG examination to evaluate therapeutic effects of the appliances.

Conditions
-----------------
Sleep Apnea, Obstructive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe obstructive sleep apnea (AHI>=30/hr) age, sex, BMI match control subject Exclusion Criteria: Patients were excluded when: (1) refused to participate in this study, (2) had severe obstructive pulmonary disease or active neurological events, (3) enrolled in other studies at the same time

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder (PDD)

Study Overview
=================
Brief Summary
-----------------
This study will examine the effects of low-dose naltrexone (LDN) on children with autistic spectrum disorders. The investigators hope to show a positive effect on social functioning and language.

Detailed Description
-----------------
Fifty children aged three to six years will be recruited for the study. They will be randomly assigned to receive either LDN or placebo for two months after which the treatment groups will be switched over. Assessments of functioning will be obtained from a video-taped play session, and by parent and teacher questionnaires at baseline, after two months and after four months.

Official Title
-----------------
Randomized Double-Blind Trial of Low-Dose Naltrexone for Children With PDD

Conditions
-----------------
Pervasive Developmental Disorder

Intervention / Treatment
-----------------
* Drug: low dose naltrexone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PDD

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 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

| Intervention/Treatment |
| --- |
|Drug: low dose naltrexone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| play observation |  |  | 
| Autism Behavior Checklist (ABC) questionnaire |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autism, PDD, LDN, naltrexone
Use of Onepiece Suit or Forced Warm Air for Perioperative Temperature Conservation.

Study Overview
=================
Brief Summary
-----------------
To study if a one piece body suite (T-balance, Telespro, Finland) is equally effective in maintaining peri-operative body temperature as forced air warming, during open low-back surgery of medium duration.

Official Title
-----------------
Use of Onepiece Suit or Forced Warm Air for Perioperative Temperature Conservation.

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: Anaesthesia, Teles Pro, Body suit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1-3 Approved consent Expected duration of open back surgery of 60-120 min Prestudy core temperature (oral) of at least 36 degrees C Exclusion Criteria: Known diabetes mellitus Any known illness or use of pre-op drugs which may interfere with normal temperature regulation Body mass index less than 17 or more than 35 Pregnancy Any contraindication for warming device or temperature monitor

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Body suit<br>The patients will receive a body suit at least 30 min before start of general anaesthesia, and will keep the suit on until warm and comfortable in the post-operative unit. The suit is supplied with multiple snap openings to allow for draping, washing and surgery. | Device: Anaesthesia, Teles Pro, Body suit<br> <br> |
| Active Comparator: Forced warm air<br>The patients will receive forced warm air on their lower body when placed on operating table, ready for surgery. | Device: Anaesthesia, Teles Pro, Body suit<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body core temperature | SpotOn (3M) measurement in the forehead | 30 minutes after anaesthesia induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body core temperature |  | 1 hr before - intraoperative - 3 hrs postoperative | 
| Patient termal satisfaction | patient interview | 1 hr before - intraoperative - 3 hrs postoperative |
Dexcom G6 for Total Pancreatectomy With Islet Autotransplantation (TPIAT) Patients

Study Overview
=================
Brief Summary
-----------------
A single-center prospective trial on the effects of standard of care radiation exposure on the Dexcom G6 continuous glucose monitoring (CGM) device.

Detailed Description
-----------------
To determine if standard of care radiation exposure longitudinally effects the accuracy and precision of the G6 transmitter in the post TPIAT in-patient population. Reduce burden for patients to remove and waste a functional and expensive Dexcom G6 CGM for radiologic procedures.

Official Title
-----------------
Accuracy of Dexcom G6 After Radiation Exposure-A Cross Sectional and Longitudinal Analysis

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: Uncovered CGM during radiologic procedures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned TPIAT at CCHMC Staying in-patient at CCHMC post TPIAT Planned to receive a Dexcom G6 CGM Exclusion Criteria: • Hemo- or peritoneal dialysis

Ages Eligible for Study
-----------------
Minimum Age: 11 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uncovered<br>Dexcom G6 CGM will be uncovered during standard of care radiologic procedures. | Other: Uncovered CGM during radiologic procedures<br>* Dexcom G6 CGM will not be covered during radiologic procedures.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dexcom G6 accuracy post radiation exposure | Dexcom G6 transmitter readings will be compared to glucometer readings until the transmitter is changed. | 3 months | 
| Post radiation Dexcom G6 transmitter functional duration | Data will be collected on participant procedures resulting in radiation exposure and transmitter change date. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexcom G6
Telemedicine and Forensic Odontology

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify the expectations of experts in forensic odontology on telemedicine. This study could improve, in multiple cases post mortem body identification.

Detailed Description
-----------------
Experts in forensic odontology will have to complete a questionnaire that will reveal their expectations and knowledge on telemedicine.

Official Title
-----------------
National Evaluation of the Expectations of Experts in Forensic Odontology on Telemedicine

Conditions
-----------------
Dental Caries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Experts in forensic odontology members of the AFIO or UIO association Exclusion criteria: - Dentist who not practicing forensic odontology

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 |
| --- | --- |
| Experts on forensic odontology<br>Experts on forensic odontology, members of AFIO (French Association of odontological identification) and UIO (Odontological identification Unit) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the knowledge | Evaluate the knowledge expectations on telemedicine among experts on forensic odontology | 1 day | 
| Evaluate the expectations | Evaluate the expectations on telemedicine among experts on forensic odontology | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highlight the key points to work in legal teleodontology | Highlight the key points to work in legal teleodontology according to the expectations of experts | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Public Health, Forensic odontology, Telemedicine, Identification post mortem, dentist who is an forensic odontology expert, member of the AFIO or UIO
Phase 3 Study of KHK7580

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate efficacy and safety of KHK7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week extension period to evaluate long-term safety and efficacy.

Official Title
-----------------
Phase 3 Study of KHK7580 (A Clinical Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Peritoneal Dialysis)

Conditions
-----------------
Secondary Hyperparathyroidism

Intervention / Treatment
-----------------
* Drug: KHK7580


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Personally submitted written voluntary informed consent to participate in the study Stable chronic renal disease treated with peritoneal dialysis for at least 16 weeks before screening Intact PTH level of > 240 pg/ml at screening Exclusion Criteria: Treatment with cinacalcet hydrochloride within 2 weeks before screening; Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening; Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening; Severe heart disease; Severe hepatic dysfunction; Uncontrolled hypertension and/or diabetes; Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening; Primary hyperparathyroidism; Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: KHK7580<br> | Drug: KHK7580<br>* Oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects in the evaluation period achieving a mean intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL |  | Weeks 30-32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects in the evaluation period achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline |  | Weeks 30-32 | 
| Mean percent change in the evaluation period in intact PTH level from baseline |  | Weeks 30-32 |
Micra Accelerometer Sensor Study 2

Study Overview
=================
Brief Summary
-----------------
The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future enhancements in device functionalities.

Conditions
-----------------
Bradyarrhythmia

Intervention / Treatment
-----------------
* Device: Investigational Software loaded on Micra device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is ≥ 18 years old Subject is implanted with a Micra device Subject or witness (if applicable as per local regulation) is able and willing to provide Informed Consent Exclusion Criteria: Subject is in atrial fibrillation Subject is not able to perform study requirements

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Software<br>Investigational Software loaded on Micra device | Device: Investigational Software loaded on Micra device<br>* Subject will receive an investigational software loaded on subject's Micra device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waveform and Components of Accelerometer Signal | Accelerometer signal was measured using the 3 axis Micra accelerometer (Vector 1 was labelled as V1, Vector 2 as V2, Vector 3 as V3). Components of the accelerometer signals (unit (g) represent acceleration)were identified and labelled as A1 (acceleration associated with ventricular systole), A2 (ventricular diastole), A3 (early passive filling), and A4 (active filling). The A4 signal is associated with atrial contraction and active filling. | For approximately two hours after software download |
Treatment of Dentin Hypersensitivity Using Different Desensitizing Agents

Study Overview
=================
Brief Summary
-----------------
Treatment of Dentin Hypersensitivity Using Theobromine , Remin Pro , and Combination of Both Materials

Official Title
-----------------
The Effect of Using Two Desensitizing Agents Alone and In Combination on Dentin Permeability and Hypersensitivity

Conditions
-----------------
Dentin Sensitivity

Intervention / Treatment
-----------------
* Other: Theobromine
* Other: Remin Pro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that aged 18-50 years. Patients in good general health. Patients that have accessible teeth demonstrating signs of sensitivity. Exclusion Criteria: • Any chronic debilitating disease that could influence study outcomes. Partial dentures, orthodontic appliances, implants or restorations in a poor state of repair that could influence study outcomes. Intolerance or hypersensitivity to the study desensitizing agents or their ingredients. Desensitising treatment or tooth bleaching within 8 weeks of screening. Daily use of medications that might influence the perception of pain.(

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theobromine<br>Natural extract from Cocoa | Other: Theobromine<br>* Natural extract from Cocoa<br>|
| Active Comparator: Remin Pro<br>Fluoride , Hydroxyapatite , and Xylitol | Other: Remin Pro<br>* Remin Pro<br>|
| Experimental: Combination<br>Remin Pro and Theobromine | Other: Theobromine<br>* Natural extract from Cocoa<br>Other: Remin Pro<br>* Remin Pro<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale pain score | 0 = no pain to 10=severe exagerated pain | 1 month |
Pre-operative Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome. Does it Affect The Operative Procedure?

Study Overview
=================
Brief Summary
-----------------
Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome to assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS.

Detailed Description
-----------------
Abstract Objective: To assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS. Methods: The study was conducted on thirty patients with CTS with electrophysiological confirmation; twelve males and eighteen females with mean age 43.93±4.51 (range 35-52y), and another thirty normal subjects; fifteen males and fifteen females, with their mean age 36.7±4.86 (range 29-45y). The cross sectional area (CSA) and flattening ratio (FR) at different levels were measured on both groups. Data from the study and control groups were compared. The accuracy of the ultrasonographic diagnostic criteria for CTS was evaluated using receiver operating characteristic (ROC) analysis. All the patients had surgical carpal tunnel release and the operative details were correlated with the ultrasonographic data.

Official Title
-----------------
Pre-operative Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome. Does it Affect The Operative Procedure?

Conditions
-----------------
CTS

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Carpal tunnel syndrome Exclusion Criteria: bifid median nerve, carpal tunnel mass lesions, persistent median artery
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 |
| --- | --- |
| ultrasonography<br>diagnostic tool | Diagnostic Test: ultrasonography<br>* ultrasonography of median nerve<br>|
| operative release<br> | Diagnostic Test: ultrasonography<br>* ultrasonography of median nerve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cross sectional area |  | three minutes | 
| flattening ratio |  | three minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cross sectional area difference |  | three minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasonography, carpal tunnel syndrome