linjc16/ctgov huggingface dataset:
Hemostatic Textile to Control Bleeding at Donor Graft Sites

Study Overview
=================
Brief Summary
-----------------
The rationale underlying the study is that donor site bleeding is common and often problematic when presenting to the burn surgeon or staff. Frequently, gauze wound dressings are not sufficiently hemostatic to control a donor site bleed thereby leading to administration of vasoconstrictive agents and repeated application of wound dressing/pressure. The hemostatic textile Stasilon™ has proven superior to gauze in reducing bleeding from anesthetized pigs undergoing standardized surgically-induced trauma. Also, observational case reports have noted cessation of bleeding in a limited number of human patients with difficult to control bleeds.

Official Title
-----------------
Use of a HemostaticTextile (StasilonTM) to Control Bleeding at Skin Graft Donor Sites (Randomized, Single-Blind)

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Device: Stasilon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >/= 18 years old burn injury requiring allografting from donor site Exclusion Criteria: < 18 years unable to give consent due to mental or emotional instability

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 |
| --- | --- |
| 1<br>Each donor site will act as it own control - both dressings will be applied to the donor site and assessments will be made | Device: Stasilon<br>* Stasilon and gauze will be applied to donor site. Dressings will be collected and evaluated for amount of shed blood.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of a new hemostatic textile named Stasilon™ against standard wound dressings in controlling burn patient donor graft site bleeding. |  | At the time of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allografting
Metabolic Syndrome and Leptin Level Associated With Fructose Consumption in Spain

Study Overview
=================
Brief Summary
-----------------
A Food Frequency Questionnaire (FFQ), will be provided to 800 adults to assess overall fructose intake and this will be related to a number of features related to the metabolic syndrome, including serum leptin, characteristic features of metabolic syndrome (body mass index, waist circumference, plasma lipids, blood pressure, HOMA index,fasting glucose and fasting insulin levels) and other as: CRP, fibrinogen, homocysteine and uric acid.

Official Title
-----------------
Prevalence of Cardiovascular Risk Factors in Minorca - Spain

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, 18-70 years of age Exclusion Criteria: Diabetes Kidney Failure Heart Failure Cancer

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum leptin levels as it relates to fructose intake |  | Epidemiological association | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of metabolic syndrome features with fructose intake. This includes measuring all 5 components of metabolic syndrome, assessing insulin resistance by HOMA, and measuring some markers of inflammation (CRP, fibrinogen, homocysteine) |  | Epidemiological | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fructose, leptin, metabolic syndrome, blood pressure, inflammation, Relationship of fructose intake to leptin levels, Relationship of fructose to metabolic syndrome, Relationship of fructose to inflammation parameters, Relationship of fructose to blood pressure
Volumetric Monitoring in Major Lung Surgery

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this observational single-center clinical study was to explore the volumetric hemodynamic monitoring in the perioperative period in major and risky thoracic intervention. The investigators monitored the changes in the volumes of blood in the central vessels and heart chambers as well as a volume of fluid in pulmonary tissue (i. e. extravascular lung water).

Detailed Description
-----------------
The goal of this observational study is to investigate into changes in volumetric hemodynamic parameters obtained with a technique of transpulmonary indicator dilution after major thoracic intervention, including pneumonectomy and lobar resections. The important parameters of hemodynamics were monitored throughout the intervention and 48 hrs postoperatively, including extravascular lung water index, global end-diastolic volume index, etc.

Official Title
-----------------
Pulmonary Edema Following Major Thoracic Resections: a Value of Perioperative Volumetric Monitoring

Conditions
-----------------
Pneumonectomy, Acute Pulmonary Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Age above 18 and below 80 Confirmed malignant bronchial neoplasm or Destructive pulmonary infection Exclusion Criteria: Pregnant Severe pulmonary hypertension Pulmonary tuberculosis Severe occlusive atherosclerosis of lower extremities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpneumonectomy pulmonary edema, extravascular lung water
STA-21 Topical Efficacy on Psoriasis

Study Overview
=================
Brief Summary
-----------------
The clinical assessment of patients with plaque-type psoriasis is performed by open, intrapatient comparison of 0.2% STA-21 with vehicle(Vaseline) alone within a 2 week period.

Detailed Description
-----------------
Two discrete psoriatic lesions with a similar size (approximately coin-sized) and clinical severity are selected in each patient. Clinical assessment of psoriatic lesion severity is performed at the baseline and at 1 and 2 (end of treatment) using the scores of erythema, induration, scaling on a scale of 0-4 by two observers. Since STA-21 inhibits Stat3 activation, which is essential for disease activity of psoriasis, topical application of 0.2% STA-21 in Vaseline should improve psoriasis in two weeks.

Official Title
-----------------
Intrapatient Comparison Study of Efficacy of STA-21 Ointment on Psoriatic Skin Lesions

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Topical application of STA-21 ointment for treatment of psoriasis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A history of plaque psoriasis for a minimum of 2 years. In good general health, as evidenced by blood, renal function, and liver function tests conducted before commencing the study. Patients of childbearing age who agreed to continue using birth control for the duration of the study. Men or women between 20 and 80 years old. Exclusion Criteria: Chronic plaque psoriasis involving >40% of the body surface. Pustular or generalized erythrodermic psoriasis. Use of medications that might affect the psoriasis during the study Systemic therapy for psoriasis within 60 d of baseline. UV therapy within 21 d of baseline. Topical therapy within 14 d of baseline. Positive for HIV, hepatitis B, or hepatitis C. Clinically significant laboratory abnormality in blood, renal function, or liver function. Lactating, pregnant, or planning to become pregnant. Participation in another clinical trial in the last 30 d. Unwillingness to comply with the study protocol. Any other condition that in the opinion of the investigators could compromise the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psoriasis therapy<br> | Drug: Topical application of STA-21 ointment for treatment of psoriasis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe) |  | 2 weeks |
Safety and Efficacy of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis

Study Overview
=================
Brief Summary
-----------------
Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. The study aims to investigate the safety and efficacy of the medication when given over a period of 6 months.

Detailed Description
-----------------
For severe, chronic hand dermatitis, refractory to topical treatment and the avoidance of aggravating factors such as allergens and irritants, no registered systemic treatment is available. Current systemic treatment options consist in the off-label use of systemic immune suppressants, such as cyclosporine, methotrexate. Severe chronic hand dermatitis is a debilitating disease, with massive impact on social life and working ability. A huge proportion of the population suffers for more than a decade, and job losses are a frequent consequence. This open-label trial investigates the safety and efficacy of oral alitretinoin 30mg as a single daily dose for up to 6 months. The trial is complementary to the pivotal efficacy study BAP00089.

Official Title
-----------------
Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis

Conditions
-----------------
Hand Dermatoses

Intervention / Treatment
-----------------
* Drug: alitretinoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hand dermatitis, rated as severe by physicians global assessment, present for at least 6 months, that has not responded to the avoidance of allergens and irritants and the use of topical steroids Exclusion Criteria: female of childbearing potential, unless participating in a pregnancy prevention program psoriasis active major psychiatric condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: alitretinoin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: |  |  | 
| Adverse Events |  |  | 
| Safety Laboratory |  |  | 
| Radiological investigations (bone density, x-ray) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physicians Global Assessment |  |  | 
| modified Total Lesion Symptom Score |  |  | 
| Patients Global Assessment |  |  | 
| Patient Defined Outcomes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hand Dermatoses,, hand dermatitis, hand eczema, chronic hand dermatitis, retinoid
A Study of OPC-262 in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to evaluate the safety and efficacy of OPC-262 5 mg in patients with type 2 diabetes by repeated administration orally for 52 weeks.

Official Title
-----------------
A Long-term Study of OPC-262 in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: OPC-262


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes patients with HbA1C above 6.5% and below 10% at both of the time of the 1st and the 2nd screening examinations and who have been undergoing diet and exercise therapies only for at least 8 weeks prior to the 1st screening examination Patients who are capable of giving informed consent Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period) Exclusion Criteria: Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus Patients with a medical history of diabetic coma Patients with poorly-controlled hypertension Patients with heart failure Patients with a complication of active hepatitis or hepatic cirrhosis Patients undergoing treatment of glomerular diseases other than diabetic nephropathy Patients with a history or complication of malignant tumor

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC-262 5 mg<br>OPC-262 5 mg will be orally administered once daily fro 52 weeks. | Drug: OPC-262<br>* OPC-262 5 mg will be orally administered once daily fro 52 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF) |  | each visit (OC) and Week 52 (LOCF) | 
| Clinical laboratory tests |  | every 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fasting blood glucose (FBG) from baseline to each visit (OC) and Week 52 (LOCF) |  | each visit (OC) and Week 52 (LOCF) |
Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants designed to provide access to autologous muscle derived cells (AMDCs). Treating physicians may submit requests for expanded access to Cook MyoSite's investigational product by email to MYO-ExpandedAccess@CookMyoSite.com.

Detailed Description
-----------------
Cook MyoSite, Inc. (Cook MyoSite) is committed to conducting rigorous, controlled clinical trials with variable inclusion and exclusion criteria based upon the indicated use under investigation. Participation in our clinical trials is the first and most preferable route to access our investigational product. We understand that there may be patients with a serious, life-threatening disease or condition that have explored all other treatment options and are unable or ineligible to participate in our clinical trials. Expanded access, otherwise known as compassionate use or pre-approval access, is a potential pathway to access an investigational product that a patient may otherwise be unable to receive. Cook MyoSite will consider providing an investigational product to a qualified requesting physician currently licensed within the United States via the United States Food and Drug Administration's (FDA's) expanded access pathway outside of an active clinical trial when eligibility criteria are met.

Official Title
-----------------
Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)

Intervention / Treatment
-----------------
* Biological: Autologous Muscle Derived Cells (AMDCs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility Criteria: The patient has a serious or life-threatening disease or condition with no satisfactory alternative. Positive assessment that the anticipated benefits outweigh the risks to the patient. Positive assessment that Cook MyoSite has an adequate supply of resources for producing the investigational product. A determination that expanded access will not interfere with Cook MyoSite's ability to complete clinical trials in a timely fashion or which might otherwise delay marketing approval and ultimately availability to all patients. The patient can undergo a muscle biopsy procedure(s). The patient can undergo Cook MyoSite's required donor screening and testing.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Autologous Muscle Derived Cells (AMDCs)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pro-adrenomedullin as a Prognostic Marker in Neonatal Sepsis

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to clarify the prognostic value of serum pro-Adrenomedullin level in neonatal sepsis. Eighty term and preterm neonates with sepsis were enrolled in this study. Eighty healthy matched neonates served as a control group.

Official Title
-----------------
Zekai Tahir Burak Maternity Teaching Hospital Neonatal Intensive Care Unit

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical sepsis and/or proven sepsis. Exclusion Criteria: Acute kidney injury Intracranial hemorrhage (Grade III and IV)

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks
Maximum Age: 42 Weeks

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 |
| --- | --- |
| Clinical sepsis<br> | |
| Proven sepsis<br> | |
| Control group<br>healthy neonates | |

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
-----------------
Pro-adrenomedullin, Neonatal sepsis, Prognosis, Sepsis marker, Clinical sepsis, Proven sepsis
Microarray Analysis of microRNA Expression Profiles in Cutaneous Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
MicroRNAs (miRNAs) are a novel class of short RNAs which have shown to be dysregulated in a variety of cancers. Data of miRNA expression in cutaneous squamous cell carcinoma (cSCC) is very limited and microarray based genome wide miRNA expression profiles of cSCC have not been investigated so far.

Detailed Description
-----------------
Patients with cutaneous SCC were enrolled in the present study. Tumor biopsies were taken from the center of the tumor. Adjacent healthy skin was biopsied as a control (intraindividual control). miRNA expression profiles of specimen were detected by microarray miRNA expression profiling. Microarray results were confirmed by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).

Official Title
-----------------
Microarray Analysis of microRNA Expression Profiles in Cutaneous Squamous Cell Carcinoma

Conditions
-----------------
Cutaneous Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cutaneous squamous cell carcinoma Exclusion Criteria: other skin cancer than cutaneous squamous cell carcinoma

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| squamous cell carcinoma<br> | |
| non-lesional skin<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |