linjc16/ctgov huggingface dataset:
Adipokine Genetic Variations in predictingNAFLD Progression to NASH in Egyptian Patients

Study Overview
=================
Brief Summary
-----------------
Due to the limited data concerning Egyptian population. authors aimed to investigate the differentadipokine gene polymorphism related to non alcoholic fatty liver disease incidence, prognosis and progression to steotosis and also to find different related factors including obesitu, diabetes and liver enzymes level

Official Title
-----------------
Genetic Variations in Adipokine to Improve Risk Prediction for NAFLD and Its Progression to NASH in Egyptian Patients

Conditions
-----------------
NAFLD, NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Genetic: DNA extraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Egyptian patients confirmed NAFLD diagnosis diabetic - Exclusion Criteria: Pregnancy and lactation, history of alcohol abuse (as defined by an average daily consumption of alcohol > 30 g/day in men and > 20 g/day women), cirrhosis, autoimmune hepatitis and other causes of liver disease (viral hepatitis, hemochromatosis, Wilson's disease), drug induced hepatitis, chronic enteropathies, Chronic kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br>healthy volunteers with absence of NAFLD | Genetic: DNA extraction<br>* investigation of DNA polymorphism in patients suffering from NAFLD<br>|
| test group<br>patients with confirmed NAFLD diagnosis | Genetic: DNA extraction<br>* investigation of DNA polymorphism in patients suffering from NAFLD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| investigate adipokine dna polymorphism | to investigate adipokine gene polymorphism associated with prognosis of NAFLD patients | 1 months | 
| correlations | to correlate between gene polymorphism and glycated hemoglobin, liver enzyme and obesity | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NASH, DNA extraction, liver enzymes, Egyptian population, NAFLD
TRIAD Project: Qualitative Study of Adolescent Depression and Smoking

Study Overview
=================
Brief Summary
-----------------
It has been shown in the adult literature that smoking is related to depression and visa versa. Not much is known about how this relationship is started or if one perhaps leads to the other. We are performing 1 hour long interviews with adolescents ages 12-19 who meet criteria for major depression and who smoke. They are interviewed along with their parent. Questions center around their view of depression and their history of depression as well as questions around their smoking as well as the interrelationships between the two. Transcripts are made of the interview and are being analyzed for themes.

Official Title
-----------------
TRIAD Project: Qualitative Study of Adolescent Depression and Smoking

Conditions
-----------------
Adolescent - Emotional Problem, Smoking

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-19 years old Major depression Smoke cigarettes Lives with parents No confidentiality issues related to smoking Exclusion Criteria: Non English speaking Suicidal ideation Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 19 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine relationships that exist between smoking and depression in adolescents |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent depression, Adolescent smoking
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.

Detailed Description
-----------------
The study is a retrospective chart review of patients with chronic neurological, emotional, social, and cognitive deficits from mild, moderate, or severe traumatic brain injury who underwent SPECT brain imaging as part of their evaluation and treatment with hyperbaric oxygen therapy in my practice over the last two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical and cognitive testing.

Official Title
-----------------
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

Conditions
-----------------
Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury

Intervention / Treatment
-----------------
* Drug: Hyperbaric oxygen therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults or children with traumatic brain injury at least one year old Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric oxygen therapy-TBI<br>Low pressure hyperbaric oxygen therapy | Drug: Hyperbaric oxygen therapy<br>* Total body exposure to increased atmospheric pressure oxygen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPECT brain imaging | Only for those subjects in which SPECT brain imaging was performed before hyperbaric oxygen therapy | After completion of HBOT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical history and physical exam |  | After completion of HBOT | 
| Cognitive testing | Only for those subjects in which neuropsychological cognitive testing was performed before hyperbaric oxygen therapy | After the final HBOT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
traumatic brain injury
Study of Immediate Start of Progestin Contraceptives in Medical Abortion

Study Overview
=================
Brief Summary
-----------------
This study will compare immediate to post-abortion start of two progestin-based contraceptives (DMPA and etonorgestrel implants) among women having first trimester medical abortion who wish to use that method for post-abortion contraception.

Official Title
-----------------
Immediate Initiation of Progestin Contraceptives in First Trimester Medical Abortion: A Randomized Controlled Trial

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Other: Timing of Contraceptive Initiation in Medical Abortion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women having medical abortion desiring progestin-based contraceptives (injectables or implants)
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quickstart<br>Immediate start | Other: Timing of Contraceptive Initiation in Medical Abortion<br> <br> |
| Active Comparator: Afterstart<br>Delayed start | Other: Timing of Contraceptive Initiation in Medical Abortion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Abortion Failure |  | One month after enrollment | 
| Repeat Pregnancy |  | 6 months after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contraception, Medical Abortion, Implant, Injectable, Quickstart
The Effect of Pre-Operative Transversus Abdominis Plane (TAP) Block in the Post Operative Opioid Consumption in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study

Study Overview
=================
Brief Summary
-----------------
The use of preoperative TAP block in laparoscopic bariatric surgery can improve the postoperative pain and quality of recovery in patients undergoing these procedures.

Official Title
-----------------
TAP) Block in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study

Conditions
-----------------
Pain, Obesity, Surgery

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-65 years BMI >35 Kg/m2 Surgery: laparoscopic gastric bypass surgery ASA status: I, II and III Fluent in English Exclusion Criteria: History of allergy to local anesthetics Chronic opioid use Pregnant patients Patients who remained intubated after surgery Drop-out criteria: Patient or surgeon request Complications related to the procedure or conversion to open route Patient requiring mechanical ventilation after surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>(control group) will receive sterile normal saline in the block | Drug: Placebo<br>* Bilateral TAP block using sterile normal saline.<br>|
| Active Comparator: Active comparator<br>(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. | Drug: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.<br>* (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery 40 Score | Quality of Recovery 40 Score at 24 hours postoperative. | 24 hours post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 Hour Total Opioid Consumption. | 24 Hour total opioid consumption translated into IV morphine equivalents. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAP Block, Pain, Obesity, Surgery, Laparoscopic Banding
The Impact of Material on Microbiota in Association With Tongue and Lip Piercing

Study Overview
=================
Brief Summary
-----------------
Biofilms on oral piercings may serve as a bacterial reservoir and lead to systemic bacteraemia or local transmission of periopathogenic microbiota. The investigators hypothesize that there are microbiological differences in bacterial samples collected from tongue /or lip piercings made of different materials. The investigators also hypothesize that the piercings carry the same characteristic bacteria as found in the piercing channels and that independently the biofilm on the tongue/adjacent teeth is similar to the other study locations. 85 subjects with tongue and 85 subjects with lip piercing will participate. Periodontal clinical parameters, traumata of hard tissues, and characteristics of the stud are evaluated. Sterile piercings of four different materials will be randomly allocated to the study subjects. After two weeks, microbiologic samples are collected and are processed by checkerboard DNA-DNA hybridization methods.

Conditions
-----------------
Bacteremia

Intervention / Treatment
-----------------
* Device: piercings of four different materials


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lip/tongue piercing for at least six month in situ Exclusion Criteria: pregnancy and lactating women medication with known effects on gingival tissues antibiotic medication in the last six months or need for antibiotic prophylaxis chlorhexidine use in the last six months non-plaque induced gingival disease prior diagnosis of periodontitis

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| subjects with lip piercing<br> | Device: piercings of four different materials<br>* randomly assigned sterile piercings are inserted for two weeks<br>* Other names: steel, titanium, polypropylene, polytetrafluoroethylene;|
| subjects with tongue piercing<br> | Device: piercings of four different materials<br>* randomly assigned sterile piercings are inserted for two weeks<br>* Other names: steel, titanium, polypropylene, polytetrafluoroethylene;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiologic findings of piercing samples |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiologic findings in piercing channels, microbiologic findings on the tongue/adjacent teeth |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adolescent, body piercing/adverse effects, tongue piercing, tongue/microbiology
Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

Study Overview
=================
Brief Summary
-----------------
The Nevanac product information insert says that it can cause increase in eye pressure in 5-10% of patients. There is very little published literature on the effect of topical Nepafenac eye drops on eye pressure in normal people. The purpose of our study is to report this effect with a working hypothesis that there is no increase in eye pressure following use of Nepafenac eye drops.

Official Title
-----------------
Effect of Nepafenac Eye Drops on Intraocular Pressure - a Randomized Prospective Study

Conditions
-----------------
Intraocular Pressure

Intervention / Treatment
-----------------
* Drug: nepafenac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Best corrected visual acuity better than 20/80 in both eyes Intraocular pressure ≤21 mmHg in both eyes Open angles on 4 mirror gonioscopy without indentation Normal optic disc on stereoscopic examination and photographs Exclusion Criteria: Change in the systemic medication profile during the course of the study Allergy to nepafenac molecule Corneal thinning/corneal infections Any intraocular surgery in past 3 months Pregnancy or those planning to conceive Breast feeding patients Unwillingness to participate in the trial Concomitant use of any other ocular drug (except artificial tears)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nepafenac<br>Nepafenac 0.1% eye drops, 3 times a day | Drug: nepafenac<br> <br> * Other names: Nevanac;|
| No Intervention: control<br>No intervention in the control arm | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | Intraocular pressure elevation of more than 4 mmHg from baseline | 4 weeks | 
| Intraocular pressure | Intraocular pressure elevation of more than 4 mmHg from baseline | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nepafenac eye drops, intraocular pressure
Sun Protection Factor Assay (SPF Assay 18677)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose.

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY 987517)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF Signed and dated Informed Consent Form Signed and dated HIPAA Form An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY 987517)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2mg/cm*2 test application.(Formulation-SR15-79_Y73-161)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Antimalarial Treatments for Clearing Low Density P. Falciparum and Its Impact on Malaria Transmission

Study Overview
=================
Brief Summary
-----------------
The malaria parasite Plasmodium falciparum remains at sub-patent level throughout the dry season in areas of seasonal malaria transmission. Targeting this parasite reservoir before the transmission season could be a good strategy for malaria control. We are conducting a randomized double blind placebo controlled mass drug administration trial in eight village to clear the dry season low level parasitaemia with an ultimate aim of controlling malaria in eastern Sudan.

Official Title
-----------------
Validation of the Use of Istope-Based Molecular Techniques for Malaria Control

Conditions
-----------------
Plasmodium Falciparum, Asymptomatic Parataemia, Sub Patent Parasitaemia

Intervention / Treatment
-----------------
* Drug: Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)
* Drug: placebo tablet similar to active drug in shape and size


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All residents of the 8 villages Exclusion Criteria: Pregnancy History of allergy to sulfa drugs

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>1:Active comparator sulfadoxine-pyrimethamine plus artesunate | Drug: Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)<br>* Standard three day regimen<br>|
| Placebo Comparator: 2<br>2:placebo comparator | Drug: placebo tablet similar to active drug in shape and size<br>* Dosage similar to active drug(standard three days regimen)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parsitaemia detected during the transmission season among dry season PCR negative persons in the intervention and control villages |  | October to December 2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Malaria prevalence during the transmission season 2. Frequency of mutation in drug resistance genes |  |  |