linjc16/ctgov huggingface dataset:
AHC Ballana Heart Study

Study Overview
=================
Brief Summary
-----------------
This Study is designed to assess CVD incidence, prevalence, progression and related risk factors, including genetic background. It will provide an important base for all cardiovascular research activities in our centre and help in designing future studies and guide policy.

Detailed Description
-----------------
Background Population-based longitudinal studies are a cornerstone in understanding current disease landscapes affecting communities and collecting reliable data to guide prevention and treatment strategies. In Egypt there is pressing need of collecting reliable data on cardiovascular disease (CVD) in defined populations. Objectives Defining the cardiovascular phenotype, genotype as well as OMICS and risk factors for CVD in a defined population in Egypt with follow up for up to 30 years Methods As a first step, a random representative sample of 1,200 households from the Ballana population will be created. Following inclusion, patients will be screened for their cardiovascular profile and followed up for changes in their profile and cardiovascular events continuously every year in high risk patients and every 3 years for the rest of the participants for a period of 30 years.

Official Title
-----------------
Aswan Heart Centre - Ballana Heart Study

Conditions
-----------------
Genetic Predisposition to Disease

Intervention / Treatment
-----------------
* Other: Risk assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Residents of Ballana from the 1,200 randomly selected households Participants must have a valid National ID card Written informed consent Exclusion criteria: • Residents who are younger than 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| BHS<br>Residents of Ballana from the 1,200 randomly selected households | Other: Risk assessment<br>* Collect clinical, laboratoary and genetics data from the participants after informed consent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk assessment |  | 30 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genetics, Cardiovascular risks
Natural History of Cherubism Observational Study

Study Overview
=================
Brief Summary
-----------------
To observe the natural history of cherubism.

Detailed Description
-----------------
The investigators will take a history and examine patients with cherubism to determine the natural history of the disease. The investigators also may take skin or blood samples (IRB approved 7256) from patients to learn more about this disorder.

Official Title
-----------------
Natural Hisotry of Cherubism Observational Study

Conditions
-----------------
Cherubism

Intervention / Treatment
-----------------
* Other: no interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with cherubism Exclusion Criteria: patients without cherubism
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 |
| --- | --- |
| cherubism patients<br>no interventions | Other: no interventions<br>* no interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression | We will take a history and examine patients with cherubism and look for disease progression. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient growth | We will measure height and weight | 10 years | 
| bone abnormalities | We will take panorex radiographs. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cherubism, bone tumors
Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn

Study Overview
=================
Brief Summary
-----------------
Ocular chemical burn is one of the causes of vision loss in China, and there are no satisfactory treatment. Human umbilical cord mesenchymal stem cells(UC-MSCs) have the biological characteristics of self-renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rabbits, the UC-MSCs can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access the efficacy and safety of UC-MSCs in the treatment of corneal burn in human.

Official Title
-----------------
Placebo-Controlled,Randomized,Double-blind Trial of Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn

Conditions
-----------------
Ocular Corneal Burn

Intervention / Treatment
-----------------
* Biological: human umbilical cord mesenchymal stem cells
* Biological: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be ocular burns including chemically burned or the thermally burned; the subjects are willing to accept this research, and promise to coordinate with the researchers during the follow up period; the subjects should abide by the laws and rules of the study. Exclusion Criteria: the visual acuity is blind in any of the eye; have corneal perforation or have the corneal perforation tendency; have been accepted surgery on eyeball after trauma; IOP>=25 mmHg even after antiglaucoma; have the history of other corneal disease or surgery; have the history of radiotherapy or surgery in the eyeball; associated with corneal ulcer or endoophthalmitis; uncontrolled hypertension(>=150/95 mmHg); abnormal liver and renal function; the pregnant women.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br> | Biological: human umbilical cord mesenchymal stem cells<br>* human UC-MSCs: 0.2ml(about 2*10^6 cells) subconjunctival injection<br>|
| Active Comparator: group 2<br> | Biological: placebo<br>* Saline injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percent of cornea perforation |  | 3 months |
Far Infrared Radiation Treatment for Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the possibility of using far infrared radiation to manage pain due to osteoarthritis.

Detailed Description
-----------------
Arthritis consists of more than 100 different conditions. These conditions range from relatively mild forms such as tendonitis and bursitis to crippling forms as rheumatoid arthritis. Pain syndromes include fibromyalgia and arthritis-related disorders as lupus erythematosus that involve every part of the body. There are forms of the disease, such as gout that almost nobody connects with arthritis. Osteoarthritis is the most common form of arthritis. The objective for the study is to access the possibility of using far infrared radiation for pain management.

Official Title
-----------------
Phase 1 Study to Determine the Efficacy of Using Energy Specific Far Infrared (FIR) Radiation for the Treatment of Arthritis and Other Related Diseases

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Radiation: Far Infrared


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1 year old and above Exclusion Criteria: None
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Far infrared radiation | Radiation: Far Infrared<br>* Far Infrared Radiation (5μm to 20μm wavelength). Duration is 30 to 40 minutes per session<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point is to determine the therapeutic effects of far infrared radiation on osteoarthritis |  | 2 years and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The therapeutic effects of far infrared radiation on all forms of arthritis |  | 2 years and 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, Degenerative, Osteoarthrosis, Osteoarthrosis Deformans
Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners

Study Overview
=================
Brief Summary
-----------------
Interest and demand for sound amplifiers are increasing due to the burden of purchasing hearing aids and technological advances in healthcare products, and the demand is expected to increase rapidly. For sensorineural hearing loss patients, who are subject to wearing hearing aids, it aims to compare the effect of hearing aid application and personal sound amplification product (PSAPs) compared to the hearing aids

Official Title
-----------------
Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners

Conditions
-----------------
Hearing Disorders

Intervention / Treatment
-----------------
* Device: personal sound amplification product, hearing aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over the age of 20 who speak Korean as their mother tongue and have no mental or physical limitations in conducting test. Hearing loss patients with a hearing threshold of 26 dB or higher in the four frequency (0.5, 1, 2, 4 kHz) Those who do not have a history of neurological disease, cognitive disorder, learning disorder, or language disorder at the time of recruitment Exclusion Criteria: In case that communication is difficult, equipment cannot be handled, or it is difficult to cooperate with the inspection Acoustic nerve lesions or central nervous system disease Those suspected of having false hearing loss Those who have secondary benefits related to clinical trials

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unaided<br> | Device: personal sound amplification product, hearing aid<br>* the device for hearing gain in sensorineural hearing loss<br>|
| Active Comparator: Aided<br> | Device: personal sound amplification product, hearing aid<br>* the device for hearing gain in sensorineural hearing loss<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The hearing level threshold (decibel) after each treatment | The comparison of hearing threshold, which is calculated as mean decibel on four frequencies, among different treatments | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hearing aid, Personal sound amplification product, Hearing aid application, Hearing loss
Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and Hypertension

Study Overview
=================
Brief Summary
-----------------
Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure

Official Title
-----------------
A Randomized, Double-blind, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administration for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Men With Arterial Hypertension and Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, Arterial hypertension adequately controlled Stable sexual relationship for > 6 month Exclusion Criteria: Primary hypoactive sexual desire History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month Nitrate therapy

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

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

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: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 5mg, 10mg or 20mg taken 1h before sexual intercourse<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Encounter Profile (SEP), questions 2 and 3 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function (IIEF) - EF (Erectile Function) domain |  | 12 weeks | 
| Global Assessment Questionnaire (GAQ) |  | 12 weeks | 
| Safety and tolerability |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, Arterial hypertension, Vardenafil
Ovarian Reserve in Women With Cystic Fibrosis and the Correlation With Demographic and Clinical Parameters

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to assess the ovarian reserve of CF patients via measurement of AMH and AFC. Secondly, we aim to correlate between the ovarian reserve and demographic and clinical characteristics of these patients. Outcomes measured will be levels of AMH and AFC, as compared to standard means in the general population. There is no need for a control group in this study since the standardized means of AMH and AFC in the general population are a more accurate comparable measure, which is based on data collected from large-scale populations, and thus accounts for confounding age factor in a more complete manner than can be obtained via a control group (Almog et al., 2011, La Marca et al., 2012, Penzias et al., 2020).

Official Title
-----------------
Ovarian Reserve in Women With Cystic Fibrosis and the Correlation With Demographic and Clinical Parameters

Conditions
-----------------
Cystic Fibrosis, Infertility, Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients diagnosed with CF according to genetic testing. Age 18-45 years old. Routinely attended the CF Center at Hadassah Medical Center. Exclusion Criteria: Refusal to participate in the study. Age under 18 or above 45. Use of hormonal contraceptives (for the purpose of AFC).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- | --- |
| AMH levels | Levels of Anti-Mullerian hormone | 24 hours | 
| Antral follicular count | Antral follicular count as assessed by ultrasound | Through study completion, an average of 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antral follicular count, Anti-Mullerian hormone
Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether enalapril or antioxidant therapy (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell disease and and its progression to sickle nephropathy

Official Title
-----------------
A Phase 2 Study of the Efficacy of Antioxidant Therapy Compared With Enalapril in Slowing the Progression of Sickle Nephropathy in Children

Conditions
-----------------
Microalbuminuria, Sickle Cell Nephropathy

Intervention / Treatment
-----------------
* Drug: Enalapril
* Drug: N-Acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Homozygous S sickle cell disease Diagnosed by newborn screening determined to have persistent microalbuminuria satisfied criteria for microalbuminuria screening parental consent Exclusion Criteria: Asymptomatic bacteriuria on screening urine cultures On Hydroxyurea therapy Pre-existing complications of SCD which would meet local criteria for HU therapy

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Active Comparator: Enalapril<br> | Drug: Enalapril<br>* 0.25-0.35 mg/kg/day<br>|
| Active Comparator: N-Acetylcysteine<br> | Drug: N-Acetylcysteine<br>* N-Acetylcysteine 0.5 mmol/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary albumin excretion rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular filtration rate | Measurement of glomerular filtration rate by iohexol | 12 months |
Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.

Study Overview
=================
Brief Summary
-----------------
The post operative routine after Oculoplastic Surgery includes usage of cold compressions for symptomatic relief and decreasing of the edema and local hematomas in the first few days after the surgery. Khat (Catha edulis) is a plant that is used mainly for chewing and has a known stimulating effect, some patients report major improvement after including these leaves in the compressions they use after surgery. Khat contains the chemical ingredients Cathine and Cathinone, which are amphetamine-like alkaloids and probably the main contributors for its active effects. Our main goal is to use compressions that include the Khat leaves and check their effect on reducing the edema and hematomas after oculoplastic surgery.

Official Title
-----------------
Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.

Conditions
-----------------
Hematoma, Surgical Wound, Surgery, Eye Bruise, Edema

Intervention / Treatment
-----------------
* Biological: Khat leaves


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent blepharoplasty and/or ptosis repair Exclusion Criteria: Patients who were operated on one eye only Patients who underwent a different surgery in each eye

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Interventional Model Description: Each participant is his own control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients after Oculoplastic surgery<br>Each participant will use one compression with Khat leaves and another standard compression and will decide on which eye to use which compression. The compressions will be used for 10 minutes per every waking hour in the first 2 days post-op. The patient will take pictures of both his eyes in days 1,3 and 7 post operative days. | Biological: Khat leaves<br>* One of the two compressions (one per each eye) the patient will use will contain the Khat leaves.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edema | Improvement in edema in the Khat compression in comparison to standard compression by clinical evaluation. | 7 days post op | 
| Hematoma | Improvement in hematomas in the Khat compression in comparison to standard by compression by clinical evaluation. | 7 days post op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oculoplastic Surgery, Khat leaves, Post operative care, Edema, Hematoma