linjc16/ctgov huggingface dataset:
Effects of Photobiomodulation on Postoperative Pain After Primary Endodontic Therapy in Molars With Symptomatic Apical Periodontitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of photobiomodulation (PBM) on postoperative pain after endodontic treatment in mandibular molar teeth diagnosed with symptomatic apical periodontitis.

Official Title
-----------------
Effects of Photobiomodulation on Postoperative Pain After Primary Endodontic Therapy in Molars With Symptomatic Apical Periodontitis

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Device: PBM Therapy
* Device: PBM Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Posterior mandibular molars No previous root canal therapy on the tooth in question Able to complete the endodontic treatment in one visit Exclusion Criteria: Maxillary teeth, mandibular anteriors and premolars Infection (swelling, sinus tract) on the tooth in question Periodontal disease on the tooth in question Dental trauma Crown/ root fractures Systemic diseases Immunocompromised patients

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBM Therapy<br> | Device: PBM Therapy<br>* After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .<br>|
| Sham Comparator: PBM Sham<br> | Device: PBM Sham<br>* For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as Assessed by the Visual Analog Scale | This scale ranges form 0(no pain) to 10(worst pain) | 72 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as Assessed by the Visual Analog Scale | This scale ranges form 0(no pain) to 10(worst pain) | 0 hours, 6 hours, 12 hours and 24 hours hours after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endodontic treatment, mandibular molar teeth, apical periodontitis.
Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to screen for hepatitis B, hepatitis C and AIDS viruses using a Dried Blood Spot in drug users

Official Title
-----------------
Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot

Conditions
-----------------
Hepatitis B, Hepatitis C, AIDS

Intervention / Treatment
-----------------
* Diagnostic Test: Blood collection using Dried Blood Spot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Former or active intravenous and/or nasal drug user Person on opiate substitution therapy Exclusion Criteria: Person with known active viral infection(s)

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: Drug user<br>Drug users will be screened for Hepatitis C, Hepatitis B and AIDS using Dried Blood Spot for blood collection | Diagnostic Test: Blood collection using Dried Blood Spot<br>* Drug users will be screened for Hepatitis C, Hepatitis B and AIDS using Dried Blood Spot for blood collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of person with an active hepatitis C infection |  | Day 1 | 
| Number of person with an active hepatitis B infection |  | Day 1 | 
| Number of person with an active AIDS infection |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dried Blood Spot
Long Term Metformin in Women With Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
The investigators analyzed collection data of 10 years for the efficacy of metformin on body mass, menstrual frequencies, metabolic and hormonal outcomes in women with polycystic ovary syndrome (PCOS) and BMI ≥ 25kg/m2. Each patient's age and height were recorded at baseline. In addition each patient weight, waist circumference, menstrual regularity, fasting glucose, glucose after 120 minute oral glucose tolerance test, luteinizing hormone, follicle stimulating hormone , free and direct testosterone, androstenedione, sex hormone binding globulin, dehydroepiandrosterone sulfate were identified at baseline and at the every follow up visit where available.

Official Title
-----------------
Effects of Long Term Treatment With Metformin on Clinical, Metabolic and Endocrine Parameters in Women With Polycystic Ovary Syndrome And Increased Metabolic Risk

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCOS phenotype A BMI≥ 25kg/m2 metformin 1000mg twice a day for at least one year Exclusion Criteria: PCOS phenotype B, C, D BMI <25kg/m2 had been treated with spironolactone or oral contraceptives alone or in combination with metformin had history of bariatric surgery became pregnant during the observation period had inability to tolerate metformin, leading to the cessation of drug therapy within first follow up year

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

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

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 |
| --- | --- | --- |
| body weight | Primary outcome was change in body weight. | The measurement is assessed in kilograms at the beginning and after every year of taking metformin for 10 years. | 
| menstrual frequency | Primary outcome was change in menstrual frequency. | The measurement is assessed in number of bleeds per year at the beginning and after every year of taking metformin for 10 years. | 
| free testosterone | Primary outcome was change in levels of free testosterone. | The measurement is assessed in nmol/L at the beginning and after every year of taking metformin for 10 years. | 
| diabetes mellitus | Primary outcome was development of diabetes mellitus. | The measurement of glucose in blood is assessed in mmol/L at the beginning and after every year of taking metformin for 10 years. |
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients

Study Overview
=================
Brief Summary
-----------------
Evaluation of the aqueous concentrations of 2 topical NSAIDS as well as the PGE2 inhibition in human patients.

Official Title
-----------------
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: ketorolac 0.4%, bromfenac 0.09%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male/Female 21 years of age of older. Patient understands and is willing to sign the written informed consent form Likely to complete the entire course of the study. Patient is scheduled to undergo cataract surgery Female patients of childbearing potential must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation). Patient is willing and able to administer eye drops and record the times the drops were instilled Exclusion Criteria: Patient has been using a topical NSAID within 1 week of study entry Patient has a known sensitivity to any of the ingredients in the study medications Patient has sight in only one eye Patient has a history of previous intraocular surgery Patient's doctor has determined they have a condition (i.e., UNCONTROLLED systemic disease) or are in a situation that may put them at significant risk, confound the study results or may interfere significantly with their participation in the study Female patients who are pregnant, nursing an infant or planning a pregnancy Patients who are currently involved in another investigational study or have participated in one within the 30 days prior to entering this study

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- |
|Drug: ketorolac 0.4%, bromfenac 0.09%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of Clinical Types and Surgical Out Come of Pediatric Exotropia

Study Overview
=================
Brief Summary
-----------------
study aiming to evaluate all children presented to strabismus clinic in ophthalmology department at sohag university hospital with divergent squint (exotropia) and to record surgical outcome of those who underwent strabismus surgery in our hospital

Detailed Description
-----------------
A hospital-based, prospective, interventional study include infants and children up to the age of 15 years with Primary Concomitant divergent squint (1ry concomitant exotropia),Candidate for surgical correction of squint. Each patient will be subjected to Detailed history and Full preoperative ophthalmic & orthoptic evaluation including: Visual acuity , ocular motility in the 6 cardinal directions, Hirschberg test & angle of deviation. ,Cover test & prism cover test for distant & near fixation,Cycloplegic refraction , Anterior segment examination, fundus examination. _ post operative Follow-up regimen: Children will be examined after surgery on: 1st postoperative day, 1st week, 1st month, 3rd month, and 6 months postoperatively. The following will be recorded for each patient: Visual acuity, cover test, ocular motility testing, cover test and prism cover test, the degree of postoperative eye position, presence of over-correction or under-correction, and presence of any other complications.

Official Title
-----------------
Study of Clinical Types and Surgical Out Come of Pediatic Exotropia

Conditions
-----------------
Exotropia

Intervention / Treatment
-----------------
* Procedure: Squint surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants and children up to the age of 15 years. Primary Concomitant divergent squint (1ry concomitant exotropia) Candidate for surgical correction of squint Exclusion Criteria: Children with: Paralytic squint Consecutive exotropia Any neurological disorder History of previous squint surgery History of previous other ocular surgery (e.g. congenital cataract & glaucoma) Children who missed follow up.

Ages Eligible for Study
-----------------
Maximum Age: 15 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: Children with exotropia<br>squint surgery | Procedure: Squint surgery<br>* Lateral rectus recession and /or medial rectus resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of children who become corrected post operatively | Results of exotropia surgeries in children in sohag university hospital | Six months | 
| The number of children with post operative residual squint | Results of exotropia surgeries in children in sohag university hospital | Six months |
A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is for investigation and collection of Aricept safety information with a dose increase on Alzheimer's disease patients.

Detailed Description
-----------------
This is an observational study to systematically investigate domestic patients with Alzheimer's disease to figure out the safety under a situation of the use of Donepezil HCl 23mg. Additionally, if the dose of Donepezil HCl increase, there is need to examine the safety of Donepezil HCl 23mg in depth for patients with Alzheimer's disease by comparing aspects of occurring adverse events by the type of Donepezil HCl increase.

Official Title
-----------------
A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Aricept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients who admitted the reading and using of his/her biographical and medical data by word Patients who maintained Aricept dosage for at least 3 months before involved in the study Exclusion Criteria Hypersensitivity to the active substance or to any of the excipients Breast feeding Pregnancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aricept Group 1<br>Subjects starting at 5 mg Aricept and increasing their dose to 10 mg Aricept | Drug: Aricept<br>* 5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept<br>|
| Aricept Group 2<br>Subject starting at 10 mg Aricept and increasing their dose to 23 mg Aricept | Drug: Aricept<br>* 5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability due to an increase of Aricept in patients with Alzheimer's disease. | The aspects of adverse events between those who have increased Aricept dosage from 5mg to 10mg and those who have increased Aricept dosage from 10mg to 23mg will be compared. The subjects will be observed at least more than 12 weeks after Aricept administration. The patients who have obtained safety information through a visit after Aricept administration at least once will be selected as the subjects who can be assessed under the status of use. | Up to 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease
SEEQ™ Performance Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the Medtronic SEEQ™ Performance study is to build further evidence on the clinical and economic benefit of the Medtronic market-released SEEQ™ Mobile Cardiac Telemetry System/External Cardiac Monitor System (MCT/ECM).

Official Title
-----------------
SEEQ™ Performance Study

Conditions
-----------------
Arrhythmia Type Unknown

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is indicated for a SEEQ™ MCT/ECM System for approved indications Patient is 18 years of age or older Patient is willing and able to provide consent and authorize the use and disclosure of health information Patient is willing and able to comply with the protocol Exclusion Criteria: Patient has known allergy and/or hypersensitivity to adhesives or hydrogel. Patient has suspected potential life-threatening arrhythmias, or requires in-subject/in-hospital monitoring. Patient will undergo a medical procedure that would preclude full participate during the prescribed duration of the SEEQ™ Patient has an implanted cardiac device, (e.g., pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy)

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 |
| --- | --- |
| SEEQ™ MCT/ECM System<br>SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Yield of the SEEQ™ MCT/ECM System |  | 120 Days |
Rheumatoid Arthritis DMARD Intervention and UtilizationStudy

Study Overview
=================
Brief Summary
-----------------
To systematically collect and document use patterns, effectiveness and safety of DMARD treatments currently used in the management of rheumatoid arthritis. The primary purpose of this study is to estimate the incidence of serious adverse experiences and adverse experiences of interest in patients with rheumatoid arthritis (RA) treated with ENBREL®.

Official Title
-----------------
Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2)

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: ENBREL®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfillment of the 1987 American Rheumatism Association criteria for RA Currently requiring the addition of ENBREL® therapy (to be taken alone or in addition to their current DMARD therapy) Exclusion Criteria: Currently or previously enrolled in RADIUS 1 Currently enrolled in a clinical trial where treatments or patient visits are imposed by a protocol Active infections Known allergy to ENBREL® or any of its components Current treatment with ENBREL® Patients who have previously been demonstrated to be intolerant of or refractory to ENBREL® therapy Nursing or pregnant women

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 |
| --- | --- |
| Drug<br>etanercept 50 mg/wk SC | Drug: ENBREL®<br>* 50 mg/wk SC<br>|

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
-----------------
Rheumatoid Arthritis, DMARD
An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of the OMNI® Surgical System in subjects who have undergone canaloplasty and trabeculotomy using OMNI® Surgical System without any concomitant surgery in pseudophakic eyes with mild to moderate primary open angle glaucoma (POAG) at least 150 days prior to enrollment.

Official Title
-----------------
An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0)

Conditions
-----------------
Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Device: OMNI® Surgical System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated with OMNI® Surgical System as a standalone procedure in pseudophakic eye with mild to moderate primary open angle glaucoma at least 150 days prior to enrollment. Exclusion Criteria: Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits. Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications or contraindicate washout, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eyes receiving OMNI intervention after medication washout<br> | Device: OMNI® Surgical System<br>* The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.<br>|
| Eyes receiving OMNI intervention without medication washout<br> | Device: OMNI® Surgical System<br>* The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in intraocular pressure (IOP) | Decrease in unmedicated mean diurnal IOP (DIOP) | 12 months | 
| Decrease in number of medications | Mean change in the number of ocular hypotensive medications. | 12 months |