linjc16/ctgov huggingface dataset:
The Effect of EGD Scope Insertion on the Intracuff Pressure of a New, Modified LMA in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this current study is to compare changes of the intracuff pressure in the newly designed LMA with the older design LMA after insertion of an esophagogastroduodenoscopy (EGD) probe in pediatric patients and adolescents.

Official Title
-----------------
The Effect of Esophagogastroduodenoscopy Scope Insertion on the Intracuff Pressure of a New, Modified Laryngeal Mask Airway in Children

Conditions
-----------------
Intracuff Pressure

Intervention / Treatment
-----------------
* Device: Ambu LMA
* Device: Gastro LMA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who weigh more than 30 kg Patients undergoing an EGD Patients getting an LMA Exclusion Criteria: Patients who weigh less than 30 kg Use of an EGD probe with an OD greater than 14 mm Decision not to use an LMA for the procedure Tracheomalacia, bronchomalacia, or any other airway issues
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| New LMA or Old LMA<br>newly designed LMA or older designed LMA | Device: Ambu LMA<br>* Will be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured<br>* Other names: old LMA;Device: Gastro LMA<br>* Will be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured<br>* Other names: new LMA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excessive intracuff pressure | Our primary goal is to compare the incidence of excessive intracuff pressure after EGD probe insertion between the newly designed LMA and the older version LMA. For this primary outcome, we will define excessive intracuff pressure as ≥40 cmH2O. | as long as the LMA is in place in the OR with usually a max amount of time of 45 minutes |
Intravitreal Bevacizumab for Inflammatory Neovascular Membranes

Study Overview
=================
Brief Summary
-----------------
Intravitreal injection of Bevacizumab in patients with Neovascular Membranes secondary to intraocular inflammation. We injected a single injection of Bevacizumab (2.5 mg/0.1 ml) and evaluate visual acuity , Fluorescein angiogram and retinal thickness by Optical Coherence Tomography (OCT) in 4 patients with Vogt Koyanagi Harada disease, 1 patient with Serpiginous Choroidopathy and 1 patient with Multifocal Choroiditis.

Official Title
-----------------
Intravitreal Bevacizumab for the Treatment of Neovascular Membranes in Patients With Intraocular Inflammation

Conditions
-----------------
Vogt Koyanagi Harada Disease, Serpiginous Choroiditis, Multifocal Choroiditis

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Procedure: Intravitreal Injection of Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Diagnose Patient Consent Chronic stage of inflammation Exclusion Criteria: only eye age lower than 30 yo. Systemic condition

Ages Eligible for Study
-----------------
Minimum Age: 25 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bevacizumab|nan|
|Procedure: Intravitreal Injection of Bevacizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity |  |  | 
| Retinal thickness by OCT |  |  | 
| Leakage in Fluorescein angiogram |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neovascular Membrane, Uveitis, Bevacizumab
Puberty Suppression and Cardiometabolic Health

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the effect of puberty suppression on insulin sensitivity, metabolic rate and vascular health among transgender female youth at baseline and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched cisgender male controls.

Official Title
-----------------
Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health

Conditions
-----------------
Transgenderism, Insulin Sensitivity/Resistance, Endothelial Dysfunction, Vascular Stiffness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Identify as a transgender female or cisgender male Age 9-14 years at the time of enrollment Tanner Stage 2-3 baseline pubertal development Plan to start gonadotropin releasing hormone analogue clinically in < 2 months (for transgender females only) Exclusion Criteria: Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures Type 1 or 2 diabetes (by medical history) On any medications that affect insulin sensitivity (e.g. metformin, antipsychotics) Hypertension (resting BP ≥ 140/90 mm/Hg) Weight > 400 lbs On estrogen- or progesterone-containing medications at baseline >3 hours of moderate-to-vigorous physical activity on the 3DPAR at the screening visit

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transgender females<br>Transgender females who plan to start a gonadotropin releasing hormone agonist clinically in the next 2 months | |
| Cisgender males<br>Cisgender male controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin sensitivity | Insulin sensitivity assessed by the oral minimal model | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body composition (fat mass, fat-free mass) | Body composition measured by DXA | Baseline, 6 months | 
| Change in resting metabolic rate | Resting metabolic rate assessed by indirect calorimetry | Baseline, 6 months | 
| Change in endothelial function | Endothelial function assessed by brachial artery flow mediated dilation | Baseline, 6 months | 
| Change in large elastic artery stiffness | Large elastic assessed by carotid ultrasound | Baseline, 6 months | 
| Change in cerebrovascular function | Middle cerebral artery blood flow assessed using bilateral transcranial Doppler | Baseline, 6 months |
Effects of Therapeutic Plasmaexhange on Viscoelastic Tests in Non-coagulopathic Patients

Study Overview
=================
Brief Summary
-----------------
Therapeutic plasma exchange is widely performed in patients with autoimmune disease. The exact effects of fresh frozen plasma on coagulation in this group of patients remains unknown. In order to investigate this issue the present study monitors periprocedural coagulation status with the aid of standard coagulation tests and rotational thromboelastometry. Four thromboelastometric tests will be performed: ExTEM, InTEM, FibTEM and ApTEM. The following parameters will be recorded from each test: CT (sec), CFT (sec) and MCF (mm) one hour before and one hour after plasmaechange was performed.

Official Title
-----------------
Effects of Therapeutic Plasmaexhange on Viscoelastic Tests in Non-coagulopathic Patients

Conditions
-----------------
Transfusion Related Complication

Intervention / Treatment
-----------------
* Diagnostic Test: dynamics of coagulation parameters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing therapeutic plasma exchange for autoimmune disease Exclusion Criteria: previous coagulation disorders anticoagulant or antiplatelet therapy within the last 7 days

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: dynamics of coagulation parameters|the effects of fresh frozen plasma administered during a plasma exchange therapy on viscoelastic tests|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in clotting time - CT (%) | change in CT determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant. | one hour before compared to one hour after plasmaexchange | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change clot formation time - CFT (%) | change in CFT determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant. | one hour before compared to one hour after plasmaexchange | 
| change maximum clot firmness - MCF (%) | change in MCF determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant. | one hour before compared to one hour after plasmaexchange |
Electrical Acupuncture and Laser Therapy for Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This is a treatment for low back pain using electrical stimulation and laser for 6 weeks.

Detailed Description
-----------------
The purpose of the study is to investigate the effects of electroacupuncture and laser therapy to treat chronic low back pain.

Official Title
-----------------
Electrical Acupuncture and Laser Therapy for Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Device: Electrical acupuncture
* Device: Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain for over 6 weeks Exclusion Criteria: Individuals with cancer Tuberculosis Pacemakers Pregnancy Osteoporosis Heart disease Kidney failure Thyroid disorders Diabetes Chronic disease Neurological diseases Skin or bleeding disorders Currently taking drugs or medications A health history questionnaire will be used to screen subjects

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Treatment by electrical acupuncture | Device: Electrical acupuncture<br>* Treatment by electrical acupuncture<br>|
| Experimental: Group 2<br>Treatment by laser | Device: Laser<br>* Treatment by laser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Low Back Pain Disability Index, VAS Questionnaire, Revised Oswestry Pain Questionnaire |  | Before treatment and every two weeks for six weeks. |
Continuous EMG Measurements in Children With Asthma During Sleep

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate whether electromyography of the diaphragm during sleep in asthmatic children can be used to objectively monitor asthma control.

Official Title
-----------------
Continuous EMG Measurements in Children With Asthma During Sleep

Conditions
-----------------
Asthma in Children, Electromyography, Sleep-Disordered Breathing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paediatrician diagnosed asthma or bronchial hyperresponsiveness Aged 4 till 18 Admitted to the paediatric ward of Medisch Spectrum Twente Exclusion Criteria: Admittance to the ICU Patient has ICD or pacemaker Parents and/or patient cannot understand or speak Dutch Does not fit in one of the available Hexoskin shirts

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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 |
| --- | --- | --- |
| Breathing registration in sleep using electromyography | Amplitude of the EMG signal will be used to obtain breathing waveforms. | From admittance to the ward, up to 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of asthma exacerbations | A machine learning model will be applied to be able to predict an asthma exacerbation before it occurs | After inclusion of all subjects, up to 3 months |
Active Older Adult Program on Health and Well-being

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a structured 12-week program designed for older adults will improve physical function and, in parallel, circulating biomarkers of aging

Official Title
-----------------
The Effects of an Active Older Adult Program at the Dan Abraham Healthy Living Center on Health and Well-being

Conditions
-----------------
Older Adult

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women age 55 years or older. Membership at the DAHLC. New to AOA (Active Older Adult) Program and commitment to full participation in the twelve-week program. Must be able to get down and off the floor with little assistance. Exclusion Criteria: Inability to provide informed consent. Previous participation in the AOA Program at the DAHLC.

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- | --- |
| Change in repeated chair rise time | Chair stand test where participants will perform a chair rise movement for five repetitions. The series of 5 repetitions will be timed and measured in seconds. | Baseline to end of study, approximately 14 weeks | 
| Change in plasma protein levels reflective of biological age | Blood samples will be obtained at baseline and at 12 weeks. The concentration of target proteins (pg/mL) in the plasma will be measured and compared between baseline and week 12. | Baseline, week 12 | 
| Change in expression of senescence-related genes in blood cells | Blood samples will be obtained at baseline and at 12 weeks. The expression of senescence-related genes (arbitrary units) will be measured in immune cells isolated from whole blood and compared between baseline and week 12. | Baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-reported Physical Function | Measured using the Physical Component Scale (PCS) from the 12-Item short form general health survey (SF-12). | Baseline, week 12 | 
| Change in Performance-based Physical Function | Measured using the timed up-and-go test (seconds to complete). | Baseline, week 12 | 
| Change in Mental Function | Measured using the Mental Component Scale (MCS) from the 12-Item short form general health survey (SF-12) | Baseline, week 12 | 
| Change in self-assessment of well-being | Measured using a linear analogue self-assessment scale of well-being from 0 (as bad as it can be) to 10 (as good as it can be) of mental, physical, emotional, and spiritual well-being, level of social activity, and overall quality of life during the past week | Baseline, week 12 |
Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over

Study Overview
=================
Brief Summary
-----------------
The main objective of this non-interventional, single-center study is to assess survival and associated factors at 1 year in patients aged 65 and over who received liver transplantation

Detailed Description
-----------------
The expected benefits of this study are to identify the preoperative risk factors of mortality from liver transplant failure in patients aged 65 and over (90-day mortality and 1 and 3-year survival) will allow better selection. candidates for this age group. In the current context of organ shortage, this study should make it possible to reduce the number of risky transplants and thus improve the allocation of grafts.Inclusion of patients who meet the inclusion criteria will be carried out during their hospitalization in the surgical department of the hepato-bilary center. Included patients will receive a standardized geriatric assessment in addition to the usual assessment for a liver transplant. The geriatric assessment will be carried out and conducted as follows: geriatric scores and quality of life questionnaires. Two geriatricians will perform the physical examination and blindly estimate each other's probability of survival at 90 days using a Likert scale. Geriatricians will be blinded to hepatic data (reasons for transplantation). The consultation as well as the completion of the questionnaire will be carried out during the pre-transplantation assessment. Survival and quality of life will be assessed at 3 and 12 months post-transplantaion.

Official Title
-----------------
Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over

Conditions
-----------------
Patients Suitable for a Liver Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidates for liver transplantation Having expressed non-oppostion to his participation in study and documented in his medical file With social coverage Exclusion Criteria: Emergency transplant patients Patient already included in another study Patient under guardianship or curatorship Expressing his opposition to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Assessment of survival and quality of life after liver transplantation according to the quality of life score |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detecting depression in the elderly according the Geriatric Depression Scale (GDS) |  | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver transplant
Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae

Study Overview
=================
Brief Summary
-----------------
Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification assay based on kPCR technology. The assay is intended for the diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC).

Detailed Description
-----------------
The study was terminated This clinical trial protocol outlines the analytical and clinical performance characteristics that will be evaluated to demonstrate equivalency of the VERSANT CT/GC DNA 1.0 (kPCR) Assay for product registration. The Gen-Probe APTIMA Combo 2 Assay will be used as the CE-marked comparative method. The studies conducted during the clinical trial are intended to provide data to support the safety and effectiveness, as well as the labeling claims for the VERSANT CT/GC Assay. The study objectives are as follows: To demonstrate concordance with the Gen-Probe APTIMA Combo 2 Assay; To estimate the positive and negative predictive values for each specimen type included in the study; To estimate the indeterminate rate for each specimen type included in the study; To estimate the equivocal rate for each specimen type; and To assess reproducibility of the VERSANT CT/CG DNA 1.0 Assay (kPCR) using the VERSANT kPCR Molecular System. Two (2) studies will be conducted to validate the analytical and clinical performance characteristics of the CT/GC DNA 1.0 (kPCR) Assay. Table 1 provides an overview of these studies.

Official Title
-----------------
Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae

Conditions
-----------------
Chlamydia, Gonorrhea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18 years of age or older. Subject signed an IRB approved informed consent form. Subject is able to follow verbal and written instructions. Exclusion Criteria: Subject has been on antibiotic therapy within 21 days prior to study enrollment. Subject urinated within one hour prior to sample collection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| male/female<br>Symtomatic and asymptomatic males and females attending STD, family planning, public health and women's health clinics, or other applicable centers, who are being screened for CT or GC. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of CT and/or GC disease by clinical site |  | Study terminated | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CT, GC, NG, chlamydia, gonorrhoeae