linjc16/ctgov huggingface dataset:
NGS Strategy Effectiveness in Molecular Diagnosis

Study Overview
=================
Brief Summary
-----------------
The coming out of Next Generation Sequencing (NGS) technologies, with documented advantages and reduced costs respect to Sanger sequencing, has provided new appealing approaches to diagnostic testing. Despite this, its use for routine diagnostic purposes requires certification in terms of reliability, as well as a cost-effectiveness evaluation. To test the feasibility of using the Ion Torrent Personal Genome Machine (PGM) in clinical diagnosis, we assessed its performance to detect point mutations and big rearrangements previously identified with standard techniques. The diagnostic accuracy and the cost-effectiveness will be evaluated by Health Technology Assessment (HTA) analyses.

Conditions
-----------------
Multiple Osteochondroma, Osteogenesis Imperfecta

Intervention / Treatment
-----------------
* Diagnostic Test: NGS molecular screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Multiple Osteochondroma Clinical diagnosis of Osteogenesis Imperfecta
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MO patients<br> | Diagnostic Test: NGS molecular screening<br> <br> |
| OI patients<br> | Diagnostic Test: NGS molecular screening<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the accuracy of the Ion Torrent PGM platform for genetic variant detection (Diagnostic sensitivity evaluation) | The accuracy of the Ion Torrent Personal Genome (PGM) to identify disease-causing mutations in patients affected by Multiple Osteochondromas (MO) and Osteogenesis Imperfecta (OI) needs to be validated for its routine diagnostic clinical use. To asses this, we will compare results obtained with the new NGS approach with those previously obtained with standard techniques (DHPLC/Sanger + MLPA) in a number of MO and OI patients. | at 30 months | 
| HTA analysis to assess the cost-effectiveness, organizational and social implications of a screening strategy based on the IonPGM platform | To demonstrate the pertinence in the use of this innovative technology in health care, we will examine the medical, social and economic implications according with Health Technology Assessment (HTA), a multi-disciplinary field of policy analysis applied to many different health care technologies before their diffusion and use. HTA aims at evaluating the real effectiveness of medical interventions, their proper use, access criteria and qualitative improvements, the clinical and organizational benefits, therefore suggesting how to manage, promote and discourage them. | at 36 months |
the Association Between Obesity and Early Puberty

Study Overview
=================
Brief Summary
-----------------
childhood obesity and early puberty are closely related, but existing reports usually focus on their relationship from the perspective of phenotype. This study was designed to investigate the association between obesity-related genic polymorphisms and the risk of early puberty in Chinese Han girls.

Detailed Description
-----------------
the genotypes of obesity-related SNPs were determined and the unstimulated luteinizing hormone, follicle stimulating hormone and estradiol levels were also detected.

Official Title
-----------------
Polymorphisms in Obesity-related Genes Are Associated With Risk of Early Puberty in Han Chinese Girls

Conditions
-----------------
Early Puberty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of central precocious puberty or early and fast puberty. Exclusion Criteria: The participants who were not the first visit to the hospital and had been treated before. The participants who were with endocrine disorders.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 10 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 |
| --- | --- |
| cases<br>early puberty girls of Han Chinese | |
| controls<br>normal development girls of Han Chinese | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genotypes of SNPs in the obesity-related genes | the obesity-related SNPs in the LRRN6C, MAF, CYP27A1 and ETV5 genes are selected and the genotypes of these SNPs are determined with a MassARRAY system. | 3 months |
Pharmacogenetic of Salbutamol in Pediatric Asthma Crisis

Study Overview
=================
Brief Summary
-----------------
this study is designed to identify the genetic factors which can be implicated in the salbutamol responsiveness for asthmatic children in pediatric emergency department

Detailed Description
-----------------
Patients from 6 to 16 years old consulting for an acute asthma exacerbation and receiving a treatment by salbutamol according to the usual care could be recruited.Saliva from patient were collected using Oragen®.DNA OG-500 kit or swabs.Based on literature review, four SNP were chosen:ADBR2 gene), ARG gene, and GSNOR gene.

Official Title
-----------------
Pharmacogenetic of the Salbutamol Efficacy in Asthma Crisis for Children in Emergency Department

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children 6-16 years old asthmatic patients consulting for an exacerbation in a pediatric emergency department parental informed consent Exclusion Criteria: comorbidity peak flow no available pneumonia

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 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 |
| --- | --- |
| salbutamol<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1) | comparison of acute response to salbutamol calculated as the percentage difference between the pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1) between the different polymorphism | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polymorphism on the response delay |  | Day 0 |
Jugular Venous Oxygen Saturation During Therapeutic Hypothermia After Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand what happens to cerebral metabolism during therapeutic hypothermia for hypoxic brain injury following cardiac arrest.

Detailed Description
-----------------
Latest international guidelines recommend the use of therapeutic hypothermia in patients who have had cardiac arrest and remain in coma after return of spontaneous circulation. This is recommended essentially to limit the cerebral injury caused by cardiac arrest and possibly amplified upon reperfusion. At times, although a spontaneous circulation has returned, cerebral oxygenation may remain inadequate due to inadequate perfusion pressure, and hypothermia, by reducing cardiac output and cerebral blood flow could actually aggravate this phenomenon. The rewarming period is thought to be at greatest risk of inadequate oxygenation for the increase in metabolic demand. With this study we aim to understand what happens to cerebral oxygenation and metabolism during therapeutic hypothermia for cardiac arrest through cerebrovenous oxygen saturation monitoring and in particular, to see whether through this type of monitoring we could recognize otherwise unnoticed periods of inadequate cerebral oxygenation.

Official Title
-----------------
Cerebral Metabolism During Therapeutic Hypothermia for Cardiac Arrest

Conditions
-----------------
Hypoxic Brain Injury, Hypothermia

Intervention / Treatment
-----------------
* Procedure: retrograde jugular venous cannulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients in coma after cardiac arrest undergoing therapeutic hypothermia Exclusion Criteria: Age < 18 Pregnancy Traumatic brain injury Contraindications to cannulation as severe coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: retrograde jugular venous cannulation|Retrograde cannulation of jugular vein and intermittent sampling of venous blood from cerebral circulation before, during and after hypothermia.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
jugular venous oxygen saturation, hypothermia
PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400 tablets from the same drug product batch.

Official Title
-----------------
An Open-Label, 2-Period Pharmacokinetic Study to Evaluate the Intra-Subject Variability in Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400 Tablets

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

Intervention / Treatment
-----------------
* Drug: PN400


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature Exclusion Criteria: Standard inclusion criteria for a study of this nature

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PN400|500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile following dosing with PN400 |  | 24-hour PK on Day 1 & Day 10 of each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of PN400 |  | Day 1-10 of each treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics study
Infectious Complications After Cystectomy: A Prospective Observational Study

Study Overview
=================
Brief Summary
-----------------
In this study, we evaluate peri- and postoperative parameters of patients undergoing a cystectomy and try to find risk factors for infectious complications. In detail, we analyze their medical history, demographic data, lab values, microbiological tests as well as histological and radiological findings. Furthermore, after discharging our patients, we send them several follow-up questionnaires at regular intervals and offer them free follow-up examinations.

Official Title
-----------------
Infectious Complications After Cystectomy: A Prospective Observational Study

Conditions
-----------------
Infection Wound, Urinary Tract Infections, Urinary Bladder Diseases, Urinary Tract Disease, Bladder Cancer, Infections, Infection, Bacterial, Infection, Hospital

Intervention / Treatment
-----------------
* Procedure: Cystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Disease which requires removal of the urinary bladder Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cystectomy|Removal of the urinary bladder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious Complications |  | 1 year |
Study of PRN and Every 2months Intravitreal Aflibercept for Age Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Evaluate a treatment result of every two months versus as needed (PRN) after 3 initial monthly intravitreal aflibercept for the Japanese age related macular degeneration.

Official Title
-----------------
Study of PRN and Every 2months Intravitreal Aflibercept After 3 Initial Monthly Injection for Age Related Macular Degeneration

Conditions
-----------------
Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Aflibercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of age-related macular degeneration Exclusion Criteria: Any treatment before intravitreal Aflibercept for age-related macular degeneration. Visual acuity above 0.1 in decimal visual acuity

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PRN injection of aflibercept<br>Intravitreal aflibercept | Drug: Aflibercept<br> <br> |
| Active Comparator: Two months injection of aflibercept<br>Intravitreal afilibercept | Drug: Aflibercept<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity after treatment by PRN or 2 months intravitreal Aflibercept |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aflibercept, intravitreal injection
Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of anecortave acetate depot when administered for the treatment of elevated IOP following treatment with steroids.

Official Title
-----------------
A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation

Conditions
-----------------
Eye Diseases

Intervention / Treatment
-----------------
* Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
* Drug: Anecortave Acetate Suspension Depot, 30 mg/mL
* Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL
* Other: Anecortave Acetate Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Either gender 18 years of age or older IOP elevation caused by steroid usage Other protocol-defined inclusion criteria may apply Exclusion Criteria: Under 18 years of age Other protocol-defined exclusion criteria may apply

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anecortave Acetate 3 mg Depot<br>One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye | Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL<br>* One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye<br>|
| Experimental: Anecortave Acetate 15 mg Depot<br>One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye | Drug: Anecortave Acetate Suspension Depot, 30 mg/mL<br>* One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye<br>|
| Experimental: Anecortave Acetate 30 mg Depot<br>One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye | Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL<br>* One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye<br>|
| Other: Anecortave Acetate Vehicle<br> | Other: Anecortave Acetate Vehicle<br>* One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in IOP at Week 4 from Baseline |  | Week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elevated IOP due to intravitreal triamcinolone therapy
Clinical Trial of Electro-Acupuncture Preconditioning in Patients Underwent Heart Valve Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the protective effect of electro-acupuncture preconditioning in patients underwent cardiac surgery.

Detailed Description
-----------------
Heart valve replacement surgery has been proved to be an effective method in treating both regenerative and rheumatic valve disease. Current studies showed that cardiopulmonary bypass (CPB) and operation related myocardial injury, as indicated by the release of perioperative cardiac enzymes, is associated with worse patient morbidity and mortality after elective valve replacement surgery. Although the actual mechanism is still unclear, it has been shown that ischemic preconditioning is one potential strategy for reduction of myocardial injury in open heart surgery. Recently, Electro- acupuncture (EA) was proved to produced cerebral protective and antiarrhythmic effects by mimicking ischemic preconditioning. This study aims to assess whether electroacupuncture preconditioning is also effective in reducing myocardial injury in adults with acquired heart valve disease undergoing elective valve replacement surgery.

Official Title
-----------------
Clinical Trial of The Myocardial Protective Effects of Repeated Electroacupuncture Preconditioning in Heart Valve Replacement Surgery

Conditions
-----------------
Rheumatic Valve Disease

Intervention / Treatment
-----------------
* Device: Electro-acupuncture preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have the indication for aortic or mitral valve replacement patients would like to accept the follow-up and sign the informed consent patients with heart function of NYHA I-III degree. Exclusion Criteria: pregnant or nursing women comorbid with coronary artery disease patients with heart function of NYHA IV degree renal dysfunction with serum creatinine level>or=2mg/dl(177umol/L) anticipated life span < 12 months enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 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 |
| --- | --- |
| 1<br>electro-acupuncture preconditioning group | Device: Electro-acupuncture preconditioning<br>* electro-acupuncture<br>* Other names: Type SDZ-II;|
| 2<br>control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late loss |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial protection, cardiac surgery, heart valve replacement