linjc16/ctgov huggingface dataset:
20- Versus 23- Gauge System for Pars Plana Vitrectomy

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to compare the functional and clinical differences and advantages between a standard operating system and a newly developed even smaller system for pars plana vitrectomy. The present study may work out the possible advantages and disadvantages between the routinely used 20-gauge vitrectomy system and the newly developed 23-gauge device.

Detailed Description
-----------------
60 patient randomized into 2 groups of 30 each. All of them operated in general anesthesia, vitrectomized and cataract extracted by phacoemulsification if indicated. Preoperative and postoper5ative controls at days 1,2,3 and week 1, month 1,3 and 12 performed. Parameters of interest are: postoperative conjunctival injection, pain, eye pressure, complications intra- and postoperative as well as the durations of surgery divided into opening time, vitrectomy time, retinal manipulation time, closing time.

Official Title
-----------------
20- Versus 23- Gauge System for Pars Plana Vitrectomy: A Prospective Randomized Clinical Study

Conditions
-----------------
Diabetic Retinopathy, Macular Edema, Postoperative Complications, Vitreous Hemorrhage

Intervention / Treatment
-----------------
* Device: 20- and 23 gauge vitreoretinal surgery systems


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age Written form of consent Vitreous and retinal pathologies requiring surgery Exclusion Criteria: Previous history of vitreous or retinal surgery Pregnant or breastfeeding women Prohibiting general medical conditions or diseases No informed consent signed Under 18 years of age

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 20- and 23 gauge vitreoretinal surgery systems|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival Injection |  |  | 
| Subjective postoperative recovery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery time |  |  | 
| Intraocular pressure |  |  | 
| Visual acuity |  |  | 
| Technically successful surgery (from surgeon's view) |  |  | 
| Intra- and postoperative complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
23 gauge pars plana vitrectomy, conjunctival erythema and injection, 20 gauge pars plana vitrectomy, vitreous and retinal surgery
The Study of Pharmacological Treatment Pattern for Cannabis-induced Psychosis

Study Overview
=================
Brief Summary
-----------------
A cross-sectional and retrospective chart review study was conducted at the Princess Mother National Institute on Drug Abuse Treatment (PMNIDAT), Thailand. All patients who admitted at PMNIDAT from October 2013 to September 2019 were included. Patients aged 18-65 years who met the International Classification of Disease-10 (ICD-10) criteria of CIP and Had a positive urine test of cannabis were included. Cannabis use is a component cause of psychosis.More than half of symptoms of cannabis-induced psychosis (CIP) were hallucination, delusion, irritable and anxiety. Antipsychotic drug was still a key psychotropic drugs for treatment of CIP. However, antidepressants and benzodiazepines were commonly used for treatment of other symptoms beyond psychotics

Official Title
-----------------
The Study of Pharmacological Treatment Pattern for Cannabis-induced Psychosis

Conditions
-----------------
Cannabis

Intervention / Treatment
-----------------
* Other: cannabis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 12 years of age Patients who had been diagnosed as Cannabis-induced psychosis by International statistical Classification of Disease and Related Health problem (ICD-10) on 2016 code F12.5 Patients had history of use of cannabis in medical chart Patients had the positive urine screening test of cannabis at the first day of admission Exclusion Criteria: Patients had psychosis from organic psychosis, defined by diagnosis by ICD-10 code F09.6 Unavailable data for evaluate of outcome especially data of drug use, content of drug use or urine screening test Patients who cancel of medical treatment before 7 day after admission.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cannabis-induced psychosis<br> | Other: cannabis<br>* This study is observational study, we recorded history of substance used, symptoms and medication in a medical chart.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacological treatment pattern for cannabis-induced psychosis | Pharmacological treatment pattern for cannabis-induced psychosis during admission | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Brief psychiatric rating scale (BPRS) form the first day of admission | A high BPRS score is more severe of symptoms than a lower score | Day1, Day 8, Day 15 and Day 22 |
Use of Mobile Teledermatology in the Care of Acne Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to determine whether a mobile teledermatology care model can achieve better clinical outcomes as compared to conventional, outpatient care for the management of severe acne treated with isotretinoin. The superiority of mobile care in comparison to conventional, outpatient care will be investigated regarding effectiveness: Global evaluation Acne (GEA) score -response at week 24 safety: drop out rates and medication side effects overall patient satisfaction with acne care and therapy overall physician satisfaction with mobile acne care

Official Title
-----------------
Use of Mobile Teledermatology in the Care of Acne Patients - A Randomized Controlled Trial

Conditions
-----------------
Acne

Intervention / Treatment
-----------------
* Other: Mobile Teleconsultation Arm (MTA)
* Other: Outpatient Consultation Arm (OCA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male, aged 12 to 30 years with facial acne requiring systemic isotretinoin treatment (GEA-Score: 3-5) with basic handy skills with a signed consent form Exclusion Criteria: Pregnancy or lactation period Withdrawal of informed consent Non-compliance, failure to comply with protocol requirements

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Outpatient Consultation Arm (OCA)<br>Conventional in Office Care | Other: Outpatient Consultation Arm (OCA)<br>* Patients will receive routine outpatient care at the clinic according to the treatment guidelines, and will be scheduled for outpatient visits every 4 weeks.<br>* Other names: Health Care Service Modality;|
| Experimental: Mobile Teleconsultation Arm (MTA)<br>Mobile Teledermatology Care | Other: Mobile Teleconsultation Arm (MTA)<br>* In addition to a face-to-face visit at baseline, patients will conduct mobile visits at home every two weeks. The general practitioner of choice will perform examinations, such as laboratory or occasionally pregnancy tests every 4 weeks according to the treatment guidelines.<br>* Other names: Health Care Service Modality;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global evaluation Acne score (GEA) | Change from Baseline in the median GEA score at week 24 | week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mobile Teledermatology, Telemedicine, Acne
Comparison of 6-fluoro-[18F]-L-dihydroxyphenylalanine (18F-DOPA) Positron Emission Tomography (PET) and Multiparametric Resonance Magnetic Imagery (RMI) in Initial Exploration of Glial Tumors

Study Overview
=================
Brief Summary
-----------------
For patient having a brain tumor, RMI is the standard exam for tumor characterization and determines initial surgery. The aim of this study is to assess if PET could provide additional information that could have an impact on surgery (indication and planification)

Official Title
-----------------
Diagnostic Assessment Study, Single Site and Prospective, comparing18F-DOPA PET and Multiparametric RMI in Initial Exploration of Diffuse Glial Tumors

Conditions
-----------------
Brain Neoplasms, Adult Brain Tumor

Intervention / Treatment
-----------------
* Diagnostic Test: PET imagery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected glial resectable tumor Free and informed consent Affiliated to French social security Exclusion Criteria: Suspected high grade glioma Surgical emergency Pregnant or breastfeeding woman Patient deprived of their liberty or under guardianship Patient not able to follow study medical monitoring for geographical, social or psychological reasons Treated with carbidopa, catechol-O-methyl transferase inhibitor, haloperidol, reserpine within 2 weeks before PET imagery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET Arm<br> | Diagnostic Test: PET imagery<br>* Every patients will have a PET imagery in addition to standard MRI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET pictures and MRI sequences comparison | Comparison of PET pictures and MRI sequences will be done in order to assess concordance between both imagings | Imagings performed up to 29 days after inclusion (before brain surgery) |
A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media

Study Overview
=================
Brief Summary
-----------------
The study will be conducted in infants and children with acute otitis media, 6 months to less than 7 years old, in Costa Rica and Israel. The primary objective of this trial will be to describe bacteriologic efficacy in those with initial culture positive specimens with different dosages of faropenem

Detailed Description
-----------------
The study will be conducted in infants and children with acute otitis media, 6 months to <7 years old, in Costa Rica and Israel. Faropenem is to be used as therapy for both simple and complicated AOM.

Official Title
-----------------
Prospective, Randomized, Investigator-Blind Trial to Evaluate the Bacteriologic Eradication, Safety and Tolerability, and Pharmacokinetics of Different Dosages of Faropenem Medoxomil BID for 10 Days in the Treatment of Acute Otitis Media

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Drug: Faropenem Medoxomil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Otis Media Exclusion Criteria: Any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 7 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

| Intervention/Treatment |
| --- |
|Drug: Faropenem Medoxomil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate bacteriologic efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe investigator assessment of clinical response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AOM
Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)

Study Overview
=================
Brief Summary
-----------------
This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.

Official Title
-----------------
A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women

Conditions
-----------------
HPV, Cervical Cancer, Premalignancy Anogenital Warts

Intervention / Treatment
-----------------
* Biological: Comparator: Gardasil
* Biological: Comparator: octavalent HPV Vaccine - dose formulation 1
* Biological: Comparator: octavalent HPV Vaccine - dose formulation 2
* Biological: Comparator: octavalent HPV Vaccine - dose formulation 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lifetime history of 0-4 sexual partners Exclusion Criteria: History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 23 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Gardasil | Biological: Comparator: Gardasil<br>* 0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6<br>|
| Experimental: 2<br>HPV VLP vaccine -Dose regimen 1 | Biological: Comparator: octavalent HPV Vaccine - dose formulation 1<br>* 0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6<br>|
| Experimental: 3<br>HPV VLP vaccine -Dose regimen 2 | Biological: Comparator: octavalent HPV Vaccine - dose formulation 2<br>* 0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6<br>|
| Experimental: 4<br>HPV VLP vaccine -Dose regimen 3 | Biological: Comparator: octavalent HPV Vaccine - dose formulation 3<br>* 0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay. |  | 4 weeks post dose 3 injection |
Artificial Intelligence-assisted Diagnosis and Prognostication in Low Ejection Fraction Using Electrocardiograms

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.

Official Title
-----------------
Artificial Intelligence-assisted Diagnosis and Prognostication in Low Ejection Fraction Using Electrocardiograms

Conditions
-----------------
Left Ventricular Systolic Dysfunction (Disorder)

Intervention / Treatment
-----------------
* Other: AI-enabled ECG-based Screening Tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with EF>50% or without Transesophageal Echocardiography (TEE) Exclusion Criteria: Patients with a history of heart failure or an EF<= 35%.

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients randomized to intervention will have access to the screening tool. | Other: AI-enabled ECG-based Screening Tool<br>* Primary care clinicians in the intervention group had access to the report, which displayed whether the AI-ECG result was positive or negative.The system will send a message to corresponding physicians if positive finding.<br>|
| No Intervention: Control<br>Patients randomized to control will continue routine practice. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Diagnosis of Low Ejection Fraction(defined as ejection fraction ≤35%) | Ejection fraction obtained by echocardiography | Within 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality(death) | After performing an electrocardiogram, the patient's survival is tracked. | Within 365 days | 
| Cardiovascular cause mortality(death) | After performing an electrocardiogram, the patient's survival is tracked. | Within 365 days | 
| Transesophageal Echocardiography (TEE) | After performing the ECG examination, perform theTransesophageal Echocardiography examination | Within 90 days |
Effectivity of Dermatix in Promoting Scar Maturation

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to demonstrate effectivity of Dermatix in promoting maturation of the scar, versus a control region that will be treated with an indifferent cream.

Detailed Description
-----------------
The healing of deep thermal injuries is always associated with scarring. The healing process can lead to the formation of large scar bundles (e.g. hypertrophic scars). The scars can be discomforting, disfiguring and restrict motion if situated over or near joints. Evidence for effectivity of treatment for reduction of hypertrophic scars or the prevention of them is limited. Different treatments are used such as intralesional injected steroids, topically used oily creams, silicone sheets or occlusive dressings. Compression garments are also frequently used. There is some evidence as to the effectivity of silicone sheets for recuction of hypertrophic scarring, however, these sheets cannot be used easily on all anatomical locations. Valeant Pharmaceuticals International has developed a silicone based scar remodelling gel, Dermatix®, which has been empirically shown by others to have potential to reduce hypertrophic scars. Primary objectives are to demonstrate effectivity of Dermatix in promoting maturation of the scar, versus a control region that will be treated with an indifferent cream.

Official Title
-----------------
Dermatix; A Randomized Controlled Trial Measuring Effectivity of Dermatix in Promoting Scar Maturation of Hypertrophic Scars.

Conditions
-----------------
Hypertrophic Scars

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hypertrophic scarring and/or ropes, stable for at least 3 months before inclusion. Written informed consent Scar size enabling the definition of two distinct scar areas, with similar scar characteristics at inclusion, preferably symmetric scars. Patients of 18 years or older Exclusion criteria: Known sensitivity for occlusive dressings or silicone containing products Any patient condition that may influence the compliance of the treatment negatively.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertrophy, scarring, scar treatment, silicone