linjc16/ctgov huggingface dataset:
Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)

Study Overview
=================
Brief Summary
-----------------
The research project is part of the evaluation of the therapeutic approaches in mental health. Its framework infant and juvenile units that have developed integrative devices, taking into account recent advances in knowledge and providing care, education and pedagogical approach. The evolution of autistic children receiving these integrative devices is studied to determine the validity of the devices mentioned. The methodology is based on case studies in a natural situation. Clinicians are committed to network among themselves and with researchers in a multicenter study.

Official Title
-----------------
Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Behavioral: Integrative practices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 3 to 6 years with diagnosis F84.0 and F84.1 according to ICD-10. The diagnosis should be made according to the criteria established by the recommendations on the diagnosis (FFP / HAS 2005). Children supported in care units that meet the criteria defined integrative practices. Children receiving a volume of hours of intervention between two and four half-days per week. Written parental consent collection. Exclusion Criteria: Presence of co-morbidities such epilepsia, serious organ damage, somatic and sensory.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Integrative practices<br>Children included in this project are children 3 to 6 years with diagnosis F84.0 F84.1 according to CIM-10. these children must be supported in care units that meet the criteria defined integrative practices. | Behavioral: Integrative practices<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Developmental evolution in the Psycho Educative-Profil 3 (PEP 3) scale between Month 0 and Month 12 | The main objective is to evaluate scare practices in autism for children 3 to 6 years | Month 12 (score : success or failure or emergence) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global evolution of children by ECA-R scale |  | Month 12 (score 0 to 4) | 
| Global evolution thanks to CARS scale |  | Month 12 (score between 15 and 60) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, aged, 3 to 6 years
Russian National Registry of LAAO

Study Overview
=================
Brief Summary
-----------------
The first Russian registry presents data from two hundred consecutive patients with nonvalvular atrial fibrillation, who undergone left atrial appendage occlusion (LAAO) using the Watchman device and the Amplatzer cardiac plug. This government-funded catheter-based LAAO program was started in September 2015 and was completed in December 2017. Data collection was finished in December 2018. Five clinics agreed to participate in the study. Patients' baseline characteristics, procedure, and follow up data were collected according to established registry protocol. Patients were followed at 45 days, 3, 6 and 12 months after enrollment. At each follow-up visit, the data regarding clinical events and healthcare utilization was collected.

Official Title
-----------------
Russian National Registry of Left Atrial Appendage Occlusion

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Catheter-based left atrial appendage occlusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18 years nonvalvular atrial fibrillation, CHA2DS2VASc ≥2, high risk of hemorrhagic events, non-compliance with pharmacological anticoagulant therapy Exclusion Criteria: significant mitral valve disease, left ventricular ejection fraction <35%, the tendency to systemic thrombosis, severe co-morbidities

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Catheter-based left atrial appendage occlusion|Catheter-based implantation of left atrial appendage occluder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related major adverse events (pericardial effusion, cardiac tamponade, device embolization, procedure/device-related death) |  | 12 months | 
| The composite of thromboembolic events, device thrombosis, hemorrhagic events, unexplained death | Primary efficacy endpoint | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure success rate | successful left atrial appendage occluder implantation rate | intraprocedural | 
| Peridevice leakage | incidence rates of significant (≥5mm) leakage | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, left atrial appendage, stroke prevention, occluder, Watchman device, Amplatzer Cardiac Plug
Percutaneous Tracheostomy With COVID-19

Study Overview
=================
Brief Summary
-----------------
Coronavirus disease 2019 (COVID-19) has brought about a requirement of intensive care and mechanical ventilation for a significant portion of patients. Percutaneous tracheostomy is performed in order to reduce the complications that may develop due to prolonged endotracheal intubation.

Detailed Description
-----------------
Different methods are needed for situations in which the potential for producing aerosols is high, such as intubation and tracheostomy. One of these methods is the aerosol box.To share our experiences of percutaneous tracheostomy performed with aerosol box in COVID-19 patients. Patients who underwent percutaneous tracheostomy between March 2020 and June 2020 in the pandemic intensive care unit were evaluated retrospectively.The study is designed as a clinical trial study. This study was performed in faculty of medicine hospital's intensive care unit which is located in Canakkale province Turkey.

Official Title
-----------------
Percutaneous Tracheostomy With Aerosol Box in COVID-19 Positive Patients in Intensive Care Unit: a Clinical Trial

Conditions
-----------------
Tracheostomy

Intervention / Treatment
-----------------
* Procedure: Tracheostomy with aerosol box in COVID-19 positive patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: who underwent percutaneous tracheostomy with COVID-19(+) Exclusion Criteria: Patients who do not give informed consent or do not want to participate in the study Coagulopathy, thrombocytopenia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Tracheostomy with aerosol box in COVID-19 positive patients|Patients who underwent percutaneous tracheostomy with aerosol box in COVID-19 positive patients. The patients age, gender, hospitalization diagnosis, number of intubated days, anesthetic agents used during the procedure, neck ultrasonography data before and during the procedure, and complications were recorded.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications observed in the cases in which we applied percutaneous tracheostomy with aerosol box | Complications | During the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reanimation
Difficult Colon Polypectomies

Study Overview
=================
Brief Summary
-----------------
The investigators aim to define the concept of difficult colonic polypectomy and investigate whether resection methods (hot/cold snare, Endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD)), adjuvant techniques (endoloop, prophylactic hemoclip placement, submucosal injection) and operator experience have an impact on polypectomy outcomes and complication rate.

Official Title
-----------------
An Observational Study of Difficult Colonic Polypectomies

Conditions
-----------------
Colon Polyps

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colonic polyps that are deemed difficult to resect by the endoscopist Exclusion Criteria: patient refusal to participate in the 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate | the advent of hemorrhage or perforation during the 30 days following the endoscopic procedure | 30 days |
Does a Relationship Exist Between Fetal Hiccups and Computerised Cardiotocography Parameters?

Study Overview
=================
Brief Summary
-----------------
BACKGROUND: The physiological function of fetal hiccups and its correlation with fetal well-being is unexplored. No previous study examines the correlation between the maternal perception of the fetal hiccups and the antepartum cardiotocography. OBJECTIVE: To evaluate the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies.

Official Title
-----------------
Does a Relationship Exist Between Fetal Hiccups and Computerised Cardiotocography Parameters?

Conditions
-----------------
Fetal Conditions, Fetal Movement Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: Fetal heart rate (FHR) monitoring through computerized cardiotocography (cCTG) analysis antepartum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physiological nonlaboring term singleton pregnancies Exclusion Criteria: . Gestations complicated by fetal malformations, stillbirth, preterm deliveries or patients with missing data were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| nonlaboring term singleton pregnancies<br>A total of 51 nonlaboring term singleton pregnancies were enrolled. | Diagnostic Test: Fetal heart rate (FHR) monitoring through computerized cardiotocography (cCTG) analysis antepartum<br>* The investigator conducted antepartum surveillance through computerized cardiotocography (cCTG) analysis antepartum. This is a non-invasive method to study fetal well being. For each patient, a cCTG was attended using a computerized cardiotocography machine. External cCTG was practised for no less than 20 min (max 60 min), two transducers were fixed on the maternal abdomen: one above the fetal heart level and the other at the uterine fundus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies. | antepartum computerised cardiotocography parameters are the baseline fetal heart rate (Basal FHR), accelerations and decelerations, long-term FHR variation (LTV), short-term FHR variation (STV), episodes of high/low FHR variation and number of fetal movements for an hour (FM) | pre-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fetal hiccups, fetal movement, computerised cardiotocography, cardiotocography, computerized analysis
Observational Study on Effect of Anesthetic Conditions on Stapling Thickness

Study Overview
=================
Brief Summary
-----------------
Measure anesthetic condition used during laparoscopic sleeve gastrectomy stapling. Measure quality of stapling in resected stomach by measuring staple thickness. Find if any relation exists.

Detailed Description
-----------------
During each staple firing the staple size, time of compression and anesthetic conditions being systolic arterial pressure, fluids transfused and intra abdominal pressure used are recorded. After removal of stapled stomach during surgery, thickness of stomach wall and thickness of staple line are measured and compared to evaluate quality of staple formation. the closer the staple height to the wall thickness the better the quality of stapling. Because no one has ever analyzed this relationship, and certainly not under different anesthetic conditions it is not clear yet if any relationship will be found. the analysis will help to understand the relation and help to start perhaps a randomised trial to learn what conditions are best to improve staple quality.

Official Title
-----------------
Impact of Anesthetic Conditions on Stapling Quality Measured as Staple Thickness During Laparoscopic Sleeve Gastrectomy

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

Intervention / Treatment
-----------------
* Procedure: stapling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary sleeve gastrectomy Exclusion Criteria: stomach disease prior surgery on the stomach

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: stapling|staples are fired through the gastric wall after waiting several seconds for compression without attention to blood pressure, fluids given or intra abdominal pressure, but these might have an impact on quality of stapling. therefore the conditions during stapling will be recorded during stapling.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness of staple line | thickness of staple line measured in micrometers | intra operative on excised stomach before being discarded |
University of Washington Reading & Dyslexia Research Program

Study Overview
=================
Brief Summary
-----------------
Subjects are recruited for a pre-kindergarten education program focusing on early literacy skills. Primary outcomes are improvement in letter knowledge and changes in brain response to text.

Official Title
-----------------
University of Washington Reading & Dyslexia Research Program

Conditions
-----------------
Reading Disability

Intervention / Treatment
-----------------
* Behavioral: preK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Typically developing children enrolled before kindergarten. Typically developing child between 60 and 72 months of age Has not yet begun Kindergarten Exclusion Criteria: Reported neurological or psychiatric condition. Claustrophobia. ADHD

Ages Eligible for Study
-----------------
Minimum Age: 60 Months
Maximum Age: 72 Months

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Letters<br>Education program focuses on learning letters. | Behavioral: preK<br>* Subjects enter and education program that either focuses on learning letters and their corresponding sounds or on language comprehension skills.<br>|
| Language<br>Education program focuses on language comprehension. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Letter Knowledge | Knowledge of letter names and sounds. This is computed as percent correct (out of 52). Each child is shown a flash card with each upper case letter and asked to name it and say its sound | Within 2 weeks post intervention |
Mobile Phone Personalized Intervention for Diabetes

Study Overview
=================
Brief Summary
-----------------
With the development of economy and change of lifestyles, it is characterized that there is a dramatic increase of diabetes in China. Changes in lifestyle/self-care behaviors by diabetes patients are required to improve blood glucose and subsequent outcomes. Mobile phone intervention was a kind of high cost efficiency and high quality health care. Our study evaluated a diabetes coaching system, using mobile phones and patient/provider portals for patient-specific treatment and communication.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Personalized Behavioral Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician diagnosis of type 2 diabetes Age 20 years and more The local resident Exclusion Criteria: Not currently managed by study physicians Pregnant Active substance, alcohol, or drug abuser Psychotic or schizophrenic under activecare Severe hearing or visual impairment No telephone or mobile phone

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Personalized Behavioral Intervention | Behavioral: Personalized Behavioral Intervention<br> <br> |
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in glycated hemoglobin levels | Blood sample would be collected and HbA1C level would be assessed in baseline and 6 months later.Change in glycated hemoglobin levels will be compared between the two group. | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in patient-reported diabetes symptoms | Diabetes symptoms such as polydipsia, polyuria and polyphagia of all participants would be obtained by questionnaire in baseline and 6 months and compared between the two groups. | baseline and 6 months | 
| control of diabetic complications | Blood pressure, blood lipid, weight and sleep quality etc.would be obtained by physical or lab examination or questionnaire in baseline and 6 months. The percentage of patients with well-control of blood pressure (BP≤130/80mmHg),weight (BMI≤24kg/m2) and sleep quality(PSQI score≤5) etc.will be compared between the two groups. | baseline and 6 months |
Refraction Determination Analysis

Study Overview
=================
Brief Summary
-----------------
Correlating the accuracy of a refraction done over telemedicine to that of a standard refraction, with a study hypothesis that the results will be equivalent.

Conditions
-----------------
Myopia,, Hyperopia,, Astigmatism,, Presbyopia,, Eye Strain,

Intervention / Treatment
-----------------
* Device: Telemedicine refraction
* Device: Traditional refraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-40 years old healthy eyes Exclusion Criteria: mid level ocular diseases (glaucoma, hypertension, retinal issues) psychiatric disorders brain tumor or history of under 18, or over 40 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine refraction before traditional refraction<br>We will first refract an individual using telemedicine refraction, and then refract them using a traditional refraction method. | Device: Telemedicine refraction<br> <br> * Other names: Refractive surgery,;Device: Traditional refraction<br> <br> |
| Experimental: Traditional refraction before telemedicine refraction<br>We will first refract an individual using a traditional refraction, and then refract them using a telemedicine refraction method. | Device: Telemedicine refraction<br> <br> * Other names: Refractive surgery,;Device: Traditional refraction<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| refraction in diopters over telemedicine compared standard phoropter refraction |  | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| telemedicine refraction results beyond dioptric readings | to see if there are other uses for telemedicine refraction results | an average of 1 year |