linjc16/ctgov huggingface dataset:
Prevalence of Chronic Venous Disease in General Population

Study Overview
=================
Brief Summary
-----------------
This study is designed to find prevalence and risk factors for chronic venous disease (CVD) in the general population. All the resident, who live in a single rural settlement will be invited to participate.

Detailed Description
-----------------
The study has cross-sectional design. All the residents aged 10 and more, living in the single rural settlement located in Central Russia will be invited to participate in the study. Those who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Possible factors that may influence CVD development will be registered. Signs and symptoms of CVD will be registered. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.

Official Title
-----------------
Cross-Sectional Population Based Study on Prevalence and Risk Factors for Chronic Venous Disease in General Population

Conditions
-----------------
Chronic Venous Insufficiency

Intervention / Treatment
-----------------
* Other: No intervention will be administered


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: residents living in the rural settlement where study will be conducted both female and male age 10 years and more agree to participate signed infromed consent Exclusion Criteria: age 9 years and less not signed informed consent

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| Residents of the single rural settlement<br>No interventions will be administered | Other: No intervention will be administered<br>* No intervention will be studied. Clinical and ultrasound examinations will be used to find the prevalence of CVD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of chronic venous disease | As a disease positive subjects with any morphological and functional abnormalities of the venous system of long duration manifested either by symptoms and/or signs indicating the need for investigation and/or care will be considered | up to Sept. 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic venous disease, prevalence, risk factors
Redistribution of Fat and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn whether HIV-infected patients have blood abnormalities which could lead to heart attack or stroke, and to find out what factors may contribute to these abnormalities.

Detailed Description
-----------------
This research is being done to learn whether HIV-infected patients have abnormalities in their blood vessels that could eventually lead to heart attack or stroke (atherosclerosis), in how fat is distributed in their body and in how their body handles fat and sugars. If there are abnormalities, this study will also try to find out what factors may contribute to those abnormalitites. People who participated in FRAM 1 may join FRAM 2.

Official Title
-----------------
Redistribution and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)

Conditions
-----------------
Human Immunodeficiency Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old previous FRAM 1 participant HIV positive Exclusion Criteria: Artificial knee or hip replacement or Harrington rod Metal objects in the body.Pregnancy Breastfeeding or less than 3 months after breastfeeding Weight more than 300 pound On insulin, pancreatic enzymes, or thioridazine.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV Positive FRAM 1 Participant<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
-----------------
Human Immunodeficiency Virus, FRAM 1
Corneal Versus Conjunctival Delivery Using a Delivery Device

Study Overview
=================
Brief Summary
-----------------
Compare the antihypertensive efficacy of three methods for installing Xalatan

Official Title
-----------------
Effect Of Corneal Versus Conjunctival Delivery On The Corneal Safety, Tolerability, and Antihypertensive Efficacy Of The Xalatan Ophthalmic Delivery Device

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Xalatan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary open angle glaucoma or ocular hypertension in 1 or both eyes Exclusion Criteria: History of closed/barely open anterior chamber angle or a history of angle closure

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xalatan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP level in the study eye |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ocular safety assessments. Ocular and systemic adverse events throughout the study period |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Open Angle Glaucoma
GLP-1 Receptors in Normal Skin and Skin From Patients With Psoriasis

Study Overview
=================
Brief Summary
-----------------
To examine GLP-1 receptors in skin of psoriasis patients compared with the skin of humans with no skin disease

Conditions
-----------------
Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQI

Intervention / Treatment
-----------------
* Drug: Liraglutide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
4.3 Inclusion Criteria Caucasians above 18 years of age Plaque psoriasis PASI score >10 No treatment or stable treatment of psoriasis during at least 3 months before inclusion Steady weight through 3 months with a body mass index (BMI) above 27 kg/m2 Normal blood pressure Spiral or hormonal birth control for fertile women during the entire treatment period and at least 3 days after the end of the treatment period ( 5 times the plasma half-life) 4.4 Exclusion Criteria Psoriasis arthritis Fasting plasma glucose > 7.5 mmol/L or HbA1c > 7.5% Type 1 diabetes Treatment for type 2 diabetes with GLP-1-based medicine (DDP-4-inhibitors or GLP-1-receptor-agonists) Heart failure, NYHA class III-IV Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine >150 µM and/or albuminuria Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) >2 x upper normal serum levels) Anaemia Acute or chronic pancreatitis Struma or thyroid cancer Pregnancy or breast feeding Inability to complete the study

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Psoriasis<br> | Drug: Liraglutide<br>* Victoza® is supplied in pens for injection containing 18 mg of the GLP-1 agonist liraglutide in 3 mL sterile water with disodiumphosphate and propylene glycol, and phenol for conservation (pH 8.15). Commercial pens will be used and the information given in the packaging will be applicable. The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period. The injection is administered once daily in the morning. The maximal plasma concentration is reached 8-12 hours after subcutaneous injection. The half-life in plasma is approximately 13 hours. The duration of effect is 24 hours.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* The placebo pens contain saline and are administered in the same way and volume as Victoza. The placebo pens are specially prepared for this study and will be used in the study only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in PASI and DLQI |  | 2 months |
Treatment of Cutaneous Ulcers With a Novel Biological Dressing

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. The dressing is a reconstructed skin substitute made with the patients own cells.

Detailed Description
-----------------
The hypothesis of this trial is that the cutaneous model SASS, a dermal epidermal skin substitute, created by the LOEX could be as high-performant, or even better, than the one's already existent in North America for the wound care. We anticipate showing on 6 patients that ulcer that did not close with conventional treatment, will heal or at least improve with this treatment.

Official Title
-----------------
Treatment of Cutaneous Ulcers With a Novel Biological Dressing

Conditions
-----------------
Venous Ulcers

Intervention / Treatment
-----------------
* Device: self assembled skin substitute (SASS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women from 18 to 85 years old Have a venous ulcer or a mixed ulcer Exclusion Criteria: Diabetes Mental deficiency Hepatitis holder (A-B-C) HIV positive Pregnancy or lactation Corticosteroids therapy Radiotherapy Chemotherapy

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: self assembled skin substitute (SASS)|Wound care with self assembled skin substitute (SASS)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound closure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of healing at 6 months of treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care
The Effect of ICON Treatment on WPL With Patients After Fixed Orthodontic Appliances

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effect of ICON on White spot lesions compared to CPP-ACPF plus.

Detailed Description
-----------------
The participants were categorized to either group (group1) receiving ICON treatment method (Icon, DMG, Germany), or (group 2) who shall be receiving CPP-ACPF treatment method (Tooth Mousse plus).

Official Title
-----------------
The Effect of ICON Treatment on WPL With Patients After Fixed Orthodontic Appliances: A Randomized Controlled Trial

Conditions
-----------------
White Spot Lesion

Intervention / Treatment
-----------------
* Drug: ICON Remineralization
* Drug: CPP-ACPF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: permanent dentition, in good general health and without systemic diseases, who had received fixed orthodontic treatment. Exclusion Criteria: Patients with primary dentition, enamel hypoplasia, dental fluorosis or tetracycline pigmentation and carious cavity were excluded.

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

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 |
| --- | --- |
| Experimental: ICON Remineralization<br>Firstly, Conditioning of the WSL surface by 15% HCL gel (Icon-Etch, DNG) and subsequent application of the drying solution (Icon-Dry, DMG), Numbers of additional etching intervals have been determined by visual assessment after each of the etch/dry intervals to achieve individual, customized intensities of WSL surface conditioning. | Drug: ICON Remineralization<br>* A material used for the Remineralization of white spot lesions.<br>|
| Active Comparator: CPP-ACPF<br>Participants in group 2 (CPP-ACPF) were treated with applying a pea sized amount of ACC-ACPF plus on a gloved finger of the examiner and rubbed the surface of the labial tooth for 4 minutes with advising the patient to avoid drinking and eating for the next 30 minutes of application. | Drug: CPP-ACPF<br>* Casein phosphopeptide-Amorphous calcium phosphate fluoride used for the remineralization of white spot lesions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remineralization | Using DIAGNOdent Laser device. | 3 Months |
Reconstruction of Extensive Upper Extremity Long Bone Defects With a Microvascular Fibula Flap

Study Overview
=================
Brief Summary
-----------------
This study assesses the long-term functional outcomes of upper extremity long bone defects treated with the free fibula bone transfer.

Detailed Description
-----------------
The study design entails a retrospective review of hospital records and a cross-sectional assessment using patient-reported outcome measures. The purpose of this study is to evaluate the reliability, complications and flap survival rate as well as the long-term functional and health-related quality of life results in patients with upper extremity long bone defect reconstructed using a microvascular fibula bone transfer.

Official Title
-----------------
Reconstruction of Extensive Upper Extremity Long Bone Defects With a Microvascular Fibula Flap: a Cross-sectional Study of Long-term Outcomes

Conditions
-----------------
Limb Salvage

Intervention / Treatment
-----------------
* Procedure: Microvascular fibula bone transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients of upper extremity long bone bone defect treated with a microvascular fibula transfer in Helsinki University Central Hospital. Exclusion Criteria: No upper extremity free fibular transfer

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Microvascular fibula bone transfer|Reconstructive surgery with a microvascular bone flap|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The long-term results are good | The long-term outcomes are assessed and good results gained. | 10-20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm, Shoulder and Hand questionnaire | Assesses the function of the reconstructed limb | 10-20 years | 
| the 15-Dimensions health-related quality of life instrument | The 15-Dimensions assesses the health-related quality of life | 10-20 years | 
| Lower Extremity Functional Scale | Assesses the function of the donor site | 10-20 years |
Corneal Endothelial Cell Injury Induced by Mitomycin-C

Study Overview
=================
Brief Summary
-----------------
our study will investigate the effecacy of Mitomycin-C in TransEpi single step photorefractive keratectomy (PRK) and alcohol assisted PRK

Official Title
-----------------
Corneal Endothelial Cell Injury Induced by Mitomycin-C in TransEpi Single Step and Alcohol Assisted Photorefractive Keratectomy PRK: A Comparative Study

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Procedure: Transepithelial PRK/MMC
* Procedure: Alcohol-Assisted PRK/MMC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years. Primary myopia or compound myopic astigmatism. Preoperative manifest refraction spherical equivalent (MRSE) within the range of -1.0 to 8 D Stable refractive error for at least 12 months before the surgery. Contact lens discontinuation for at least 3 weeks. Estimated corneal stromal bed thickness of more than 300mm at the thinnest point Exclusion Criteria: Unwilling to participate in the study. Previous ocular surgery Any diagnosed ocular disease History of ocular trauma

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 50 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 |
| --- | --- |
| Active Comparator: TransEpi single step PRK<br> | Procedure: Transepithelial PRK/MMC<br>* transepithelial photorefractive keratectomy (PRK) and mitomycin C addition<br>|
| Active Comparator: alcohol assisted PRK<br> | Procedure: Alcohol-Assisted PRK/MMC<br>* photorefractive keratectomy (PRK) assisted by alchol and mitomycin C addition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell Density | will be measured by Specular microscopy | Base line | 
| Endothelial cell Density | will be measured by Specular microscopy | at 1st month | 
| Endothelial cell Density | will be measured by Specular microscopy | at 3rd month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mytomycin
A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis

Study Overview
=================
Brief Summary
-----------------
Recurrent Respiratory Papillomatosis (RRP) causes wart-like lesions along the throat area and can obstruct the airway or become malignant. The cause has been related to specific types of Human Papillomavirus (HPV). The purpose of the study is to assess the clinical effectiveness of a trial drug, SGN-00101, in children with RRP and also assess its safety.

Official Title
-----------------
A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis

Conditions
-----------------
Papilloma, Recurrent Respiratory Papillomatosis

Intervention / Treatment
-----------------
* Drug: SGN-00101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between 2 and 18 yrs old, inclusive, who has documented RRP. Patients with documented RRP Subject is surgically debulked within 7 days before the first dose of SGN-00101. Subject has had at least 4 debulking surgeries for RRP, had no intersurgical intervals greater than 84 days during the period of the last 4 surgeries. Subject is free of life threatening or serious concomitant disorders other than the disease under study. Females of childbearing potential must have a negative pregnancy test and must be practicing an effective/appropriate method of birth control as determined by the Investigator. Exclusion Criteria: Subject has disease or status that causes compromise of the immune system. Subject has a history of ionizing radiation therapy to the respiratory tract. Patient has used concomitant medications that may suppress the immune system. Subject has received any specific or non-specific immunotherapy intended as treatment for their RRP (i.e. mumps vaccine injected intralesionally) within 9 months prior to Week 0 of this study. Subject has participated in a past study with SGN-00101 Pregnancy and lactation.

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SGN-00101|nan|

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
-----------------
HPV, Papilloma
Safety and Efficacy of AGN 203818 for Pain Associated With Painful Bladder Syndrome/Interstitial Cystitis

Study Overview
=================
Brief Summary
-----------------
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with painful bladder syndrome/interstitial cystitis

Conditions
-----------------
Cystitis, Interstitial

Intervention / Treatment
-----------------
* Drug: AGN 203818


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of painful bladder syndrome/interstitial cystitis Moderate or severe bladder pain Exclusion Criteria: Any other uncontrolled disease Pregnant or nursing females

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

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

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: AGN 203818|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in daily pain scores |  |  |