linjc16/ctgov huggingface dataset:
Prospective Cohort Study in Patients With NAFLD

Study Overview
=================
Brief Summary
-----------------
To assess the importance of intracellular signalling pathways and its deregulation in adiposity and diabetes-related insulin resistance, liver tissue samples of patients suffering from non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)will be analyzed prospectively from a liver tissue bank.

Detailed Description
-----------------
Patients with suspected fatty liver disease will be screened (and excluded in the presence) of alternative clinical condition associated with NAFLD (see exclusion criteria). Of all patients fulfilling inclusion criteria, relevant baseline characteristics (incl. epidemiological, physiological and biochemical data) will be obtained. In addition, radiological examination will be performed using sonography and fibroscan to assess non-invasively the individual extent of hepatic fat deposition, liver stiffness (fibrosis) and amount of visceral fat mass. In case of high clinical, laboratory and radiological suspicion for NAFLD, a diagnostic liver biopsy will be performed. A part of the liver tissue is used for histological confirmation of NAFLD and subsequent grading and staging according established criteria. Parts of the remaining liver tissue will be stored for later molecular and histological analysis. In addition, several serum samples are collected of patients and stored for future analysis. All patients will be followed up annually (incl. physical examination, metabolic characterisation, clinical chemistry and liver sonography) and additional serum samples will be collected for future analysis. Liver biopsy is not repeated after defined time period, but in case of clinical evidence for disease progression.

Official Title
-----------------
Multicentric, Prospective, Non-interventional, Long-term Cohort Study in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)

Conditions
-----------------
Non-alcoholic Fatty Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with histologically confirmed fatty liver disease Exclusion criteria: History of significant alcohol consumption Viral hepatitis Autoimmune hepatitis Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency) Hepatotoxic medication (e.g. amiodarone).

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Disease regression/progression |  | 20 years |
A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate efficacy and safety of NPC-02 in patients with Zinc Deficiency.

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency

Conditions
-----------------
Zinc Deficiency

Intervention / Treatment
-----------------
* Drug: NPC-02
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The serum zinc concentrations are under the normal level before registration Exclusion Criteria: Heavy hepatitis Malignant tumor Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc. The serum albumin under 2.8 g/dL Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement) Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration Pregnant, suspected pregnant, lactating, patients who wish to have a child Patient who participated in other clinical trials within 12 weeks before registration Unsuitable as a target of this clinical trial judged by doctor

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPC-02<br>Oral dose | Drug: NPC-02<br> <br> |
| Placebo Comparator: Placebo<br>Oral dose | Drug: Placebos<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change amount of serum zinc concentration between starting and 8 weeks after dosing |  | 8 weeks |
Randomized Trial of Fluticasone in Bronchial Premalignancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers

Detailed Description
-----------------
Bronchial epithelium exposed to cigarette smoke undergoes a series of histological changes that may ultimately lead to invasive cancer. In rats exposed to cigarette smoke inhaled corticosteroids reduce the number of lung tumors. The purpose of this study is to assess the efficacy of fluticasone on premalignant lesions in volunteers with a smoking history of >10 pack-years and patients cured of head and neck cancer or lung cancer. Participants are screened for premalignant lesions by bronchoscopy and if these are present randomised to receive a powder inhalation device containing either fluticasone 500 μg or a placebo. After 6 months, biopsies are taken from the same locations. Efficacy of treatment is assessed by reversal of metaplasia/dysplasia; secondary end-points are reversal of increased p53 immunoreactivity and hTERT expression.

Official Title
-----------------
The Influence of Fluticasone Inhalation on Intermediate Markers of Carcinogenesis in the Bronchial Epithelium of a High Risk Population : A Double Blind Placebo-Controlled Randomised Phase II Study

Conditions
-----------------
Bronchogenic Carcinoma

Intervention / Treatment
-----------------
* Drug: Fluticasone propionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent age over 18 metaplasia index > 15% over 25 pack years smoking history or history of lung- or head&neck cancer male/female of non-childbearing potential or using approved contraception Exclusion Criteria: use of inhaled/systemic corticosteroid drugs in the preceding 12 months contraindications for bronchoscopy/use of fluticasone major illness Baseline FEV1<1000ml Previous participation in clinical study nodules > 1cm on CT

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluticasone propionate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversal of histological abnormality bronchial biopsies at 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversal of suprabasal p53 staining at 6 months |  |  | 
| Reversal of elevated hTERT mRNA levels at 6 months |  |  | 
| Reversal of increased KI-67 at 6 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchial squamous metaplasia, bronchial squamous dysplasia
Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome

Study Overview
=================
Brief Summary
-----------------
This study evaluates the safety of defibrotide in subjects with sickle cell disease (SCD)-associated acute chest syndrome (ACS).

Official Title
-----------------
A Phase II Study to Determine the Safety of Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome

Conditions
-----------------
Sickle Cell Disease, Acute Chest Syndrome

Intervention / Treatment
-----------------
* Drug: Defibrotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SCD-associated ACS with the presence of any two or more of the following signs not explained by other etiologies: Fever, Chest pain, Cough, Dyspnea, Tachypnea for age, Pulmonary infiltrate on CXR and/or Chest CT scan, Decreased O2 saturation with or without oxygen supplement; Age 2 to 40 years of age; Homozygous Hemoglobin S Disease, Hemoglobin SC Disease or Hemoglobin S 0/+ thalassemia; Informed consent/assent; Consent of patient/parent within ≤72 hours after inpatient admission for SCD-associated ACS. Females of childbearing age will have a negative pregnancy test. Exclusion Criteria: Current Grade III or IV hemorrhage; Previous hypersensitivity reaction to defibrotide; Current systemic anti-coagulant therapy and/or fibrinolytic therapy; Consent of patient/parent greater than 72 hours of inpatient admission for SCD-associated ACS; No signed informed consent

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 40 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Defibrotide 6.25 mg/kg IV q6h | Drug: Defibrotide<br>* Defibrotide 6.25 mg/kg IV q6h up to 7 days<br>* Other names: Defitelio®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with grade III/IV allergic reaction to defibrotide | All patients will be monitored for allergic reaction probably or definitely related to defibrotide administration. | 30 days | 
| Number of patients with grade III/IV hemorrhage | All patients will be monitored for hemorrhage probably or definitely related to defibrotide. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with improvement in clinical signs of Acute Chest Syndrome | Patients will have pre and post treatment assessments with imaging and blood tests to monitor clinical signs of ACS | 30 days |
Large Sample PD Patients and Healthy Controls

Study Overview
=================
Brief Summary
-----------------
Resting-state functional magnetic resonance imaging (RS-fMRI) has frequently been used to investigate local spontaneous brain activity in Parkinson's disease (PD) in a whole-brain, voxel-wise manner. To quantitatively integrate these studies, we conducted a coordinate-based meta-analysis on 15 studies that used amplitude of low frequency fluctuation (ALFF) and 11 studies that used regional homogeneity (ReHo). All these ALFF and ReHo studies have compared PD patients with healthy controls. We also performed a validation RS-fMRI study of ALFF and ReHo in a frequency-dependent manner for a novel dataset consisting of PD and healthy controls.

Detailed Description
-----------------
Seed-based d Mapping (formerly Signed Differential Mapping, SDM) software (version 5.141 for Windows) (www.sdmproject.com) was used for meta-analysis. For the validation, fMRI data were acquired on a 3 Tesla Magnetic Resonance scanner (Trio system; Siemens Magnetom scanner, Erlangen, Germany) with gradient-echo echo-plannar imaging sequences. Whole brain fMRI scanning was carried out. All participants were instructed to keep their eyes closed, relax, remain motionless, not think of anything in particular, and not fall asleep. Foam pads were used to minimize head motion.

Official Title
-----------------
Large Sample Collection for Observation of PD Patients and Healthy Controls

Conditions
-----------------
Neuro-Degenerative Disease

Intervention / Treatment
-----------------
* Device: MRI scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The PD diagnoses were based on the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria. Patients were assessed using the UPDRS III and Hoehn and Yahr disability scale. Exclusion Criteria: 1. history of head trauma, 2. substance abuse, 3. psychiatric disorder. For healthy controls, additional exclusion criteria included any history of neuropsychiatric disorders.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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 |
| --- | --- |
| PD patients<br>the entire group underwent MRI scan | Device: MRI scan<br>* All participants underwent the MRI scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreased spontaneous brain activity in PD patients | We found a decreased spontaneous brain activity in left putamen in PD patients | 06/2015-01/2016 |
Experience From the Italian S-ICD Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to collect data on implant parameters, early, mid and long-term clinical effectiveness of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) therapies in order to better understand how to improve the clinical care of patients and effectiveness of S-ICD therapies.

Detailed Description
-----------------
ISIR is an observational, multicentric registry designed to collect implant and follow-up data of consecutive patients implanted with Subcutaneous Implantable Cardioverter Defibrillator (S-ICD). A number of about 10 enrolling centers is estimated with an overall number of 400 patients. A minimal follow-up of 6 months is required before analyzing clinical outcomes. The data analysis will focus on implant outcomes and early, mid and long-term effectiveness of S-ICD therapies and safety.

Official Title
-----------------
Experience From the Long-term Italian Subcutaneous Implantable Cardioverter Defibrillator Registry (ELISIR)

Conditions
-----------------
Cardiac Arrest, Sudden Cardiac Death, Ventricular Arrythmia, Implantable Cardiac Defibrillator

Intervention / Treatment
-----------------
* Device: Subcutaneous Implantable Cardioverter Defibrillator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >/= 18 years Patients successfully implanted with S-ICD Patients able to provide written informed consent or have informed consent as provided by a legal representative

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

| Intervention/Treatment |
| --- |
|Device: Subcutaneous Implantable Cardioverter Defibrillator|Patients implanted with a totally subcutaneous defibrillator system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Overall or arrhythmic mortality | 2 years | 
| Appropriate shocks | Appropriate therapies delivered by the devices | 2 years | 
| Inappropriate shocks | Inappropriate therapies delivered by the devices | 2 years |
The Predictors for Asthma Control by Stepwise Treatment During 6 Months in Korean Elderly

Study Overview
=================
Brief Summary
-----------------
The Predictors for asthma control by stepwise treatment during 6 months in Korean elderly

Official Title
-----------------
The Predictors for Asthma Control by Stepwise Treatment During 6 Months in Korean Elderly

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 60 years or more, articulate in Korean Patients diagnosed with asthma, at least 1 year in duration. Exclusion Criteria: Patients being followed-up for asthma treatment less than 1 year before baseline Patients taking immune therapy Patients previously enrolled/randomized in the present clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 60 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>Total 300 subjects who was diagnosed with asthma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline characteristics related to asthma control in the elderly |  | 6 months | 
| Asthma exacerbation rate of the elderly during guideline-based stepwise treatments |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Proportion of controlled, partially controlled, and controlled patients among the elderly patients with asthma in Korea |  | 6 months | 
| 2. Baseline characteristics related to asthma specific QOL in the elderly patients with asthma |  | 6 months | 
| Mean frequency of PFT, sputum assessments, refill adherence(%), prescription persistence in elderly asthma for the last 1 year before study enrollment |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Predictors for asthma control, Asthma Exacerbation rate, Mean frequency of PFT, sputum assessments, refill adherence(%), prescription persistence
Pneumothorax Post CT Lung Biopsy

Study Overview
=================
Brief Summary
-----------------
A CT scan is performed after a lung biopsy in order to detect a Pneumothorax. We postulate that CT is more useful than chest radiography

Official Title
-----------------
Pneumothorax Following CT-Guided Lung Biopsy: Is There a Role for the Post Biopsy CT in Patient Management

Conditions
-----------------
Lung Nodules

Intervention / Treatment
-----------------
* Procedure: CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients having a lung biopsy Exclusion Criteria: none

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: CT scan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of pneumothorax |  |  |
Comparing Point of Care Clotting Tests in the OR Versus Standard Laboratory Clotting Tests

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is determine the agreement of point of care (POC) clotting tests (INR and aPTT) by the POC device by Hemochron Jr versus standard laboratory clotting tests (INR and aPTT) in patients undergoing elective cardiac surgery.

Detailed Description
-----------------
The study is a correlation between POC Hemochron Jr INR and aPTT with the standard.

Official Title
-----------------
Comparison Between Point of Care INR and aPTT Hemochron Jr Whole Blood Measurement With Standard Laboratory in Patients Having Elective First Time on Pump Coronary Artery Bypass Grafting (CABG)

Conditions
-----------------
Coronary Artery Bypass Grafting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: did not receive anticoagulants or clopidogrel within 5 days preoperatively Exclusion Criteria: history of coagulopathy heparin resistance receiving heparin or warfarin hepatic or renal dysfunction pregnancy urgent or emergency cases

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 |
| --- | --- |
| POC INR and APTT Hemochron<br>Adult patients undergoing elective on pump coronary artery bypass grafting surgery who have not received anticoagulants or clopidogrel within 5 days preoperatively. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between pre cardiopulmonary bypass (CPB) and post CPB POC INR and PTT with standard laboratory INR and PTT |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coagulation, INR, aPTT, point of care, laboratory, CABG, surgery
The Effect of Facial Exercise on the Appearance of Aging

Study Overview
=================
Brief Summary
-----------------
This study seeks to evaluate the effects of facial exercises on aging of the face.

Official Title
-----------------
A Pilot Study of the Efficacy of a Facial Exercise Program

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Behavioral: Facial Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 40-65 years No significant medical illness No chronic smokers Subject with mild to moderate facial atrophy Subjects who provide and interest and who understand the importance of consistently executing the program daily. Subjects with the willingness and ability to understand and provide informed consent. Exclusion Criteria: Under 40 years of age, Over 65 years of age Pregnant or lactating Subjects who have ever had any invasive cosmetic procedure, including facelifts, neck lifts, laser resurfacing, dermabrasion, or liposuction Subjects who have non-invasive or minimally invasive cosmetic procedures, such a non-ablative lasers, medium-depth or deeper chemical peels, injectable neurotoxins or fillers, within the past year. Subjects who have used topical or oral retinoids within the past year.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facial Exercise<br> | Behavioral: Facial Exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of face and neck after facial exercise compared to baseline |  | up to 20 weeks |