linjc16/ctgov huggingface dataset:
A Clinical Trial to Evaluate the Blood Pressure Lowering Effect of a Candemore Plus Tab Versus Cantabell Tab in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

Study Overview
=================
Brief Summary
-----------------
Phase 4 clinical trial to Evaluate the blood pressure lowering effect of a Candesartan/Hydrochlorothiazide(Candemore Plus Tab) versus Candesartan/Amlodipine(Cantabell Tab) in Hypertensive Patients

Official Title
-----------------
A Randomized, Double-blind, Non-inferiority, Multi-center, Phase 4 Trial to Evaluate the Blood Pressure Lowering Effect of a Candesartan/Hydrochlorothiazide(Candemore Plus® Tab) Versus Candesartan/Amlodipine(Cantabell® Tab) in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Cantabell Tab
* Drug: Candemore Plus Tab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 19 years old Agreement with written informed consent Hypertensive Patients Exclusion Criteria: Patients with secondary hypertension Participated in other trial within 30 days In investigator's judgement

Ages Eligible for Study
-----------------
Minimum Age: 19 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: A<br> | Drug: Cantabell Tab<br>* Patients assigned to experimental group are treated with Cantabell Tab<br>|
| Active Comparator: B<br> | Drug: Candemore Plus Tab<br>* Patients assigned to experimental group are treated with Candemore Plus Tab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cSBP(central Systolic Blood Pressure) | Average cSBP change after 8 weeks compared to baseline | change after 8 weeks compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cDBP(central Diastolic Blood Pressure) | Average cDBP change after 8 weeks compared to baseline | change after 8 weeks compared to baseline | 
| sitSBP(sitting Systolic Blood Pressure) | Average sitSBP change after 8 weeks compared to baseline | change after 8 weeks compared to baseline | 
| sitDBP(sitting Diastolic Blood Pressure) | Average sitDBP change after 8 weeks compared to baseline | change after 8 weeks compared to baseline |
Cystic Fibrosis (CF) Flow Rates Study

Study Overview
=================
Brief Summary
-----------------
We wish to measure the inspiratory flow and volumes generated by the subjects inhaling from a spirometer with a high resistance dry powder inhaler in series in subjects with cystic fibrosis.

Official Title
-----------------
An Open, Observational, Non-Interventional Study of Inspiratory Flow Rates and Volumes in Subjects With Cystic Fibrosis Inhaling Via a Spirometer With the High Resistance RS01 Dry Powder Inhaler Device in Series

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CF FEV1 ≥ 30% and < 90% predicted Exclusion Criteria: Be considered terminally ill or listed for lung transplantation Have had a lung transplant Have had a significant episode of haemoptysis (>60 ml) in the three months prior to enrolment Have had a myocardial infarction in the three months prior to enrolment Have had a cerebral vascular accident in the three months prior to enrolment Have had major ocular surgery in the three months prior to enrolment Have had major abdominal, chest or brain surgery in the three months prior to enrolment Have a known cerebral, aortic or abdominal aneurysm Be breast feeding or pregnant Be using beta blockers Have unstable asthma

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 50 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 |
| --- | --- |
| cystic fibrosis<br>adults and children with cystic fibrosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inspiratory flow rates |  | single visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inspiratory volumes |  | single visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
device characteristics
Study of the Follow-up of Stroke Treated With Anticoagulants

Study Overview
=================
Brief Summary
-----------------
Stroke is a major public health problem as it is very frequent (140,000 cases/year in France), and very serious (leading cause of death, 2nd leading cause of dementia, 3rd leading cause of handicap). Ischemic cardio-embolic stroke accounts for around 25% of ischemic strokes, and ischemic cardio-embolic stroke in a context of cardiac arrhythmia due to atrial fibrillation (CAAF) is the leading non-atheromatous cause. The aim of this study is to optimise the secondary prevention of CAAF-related stroke identified at the University Hospital of Dijon Burgundy in the framework of the recommendations of the '2010-2014 stroke plan' and the Compulsory Consultation at the 6th month (Directive DGOS//2015/262 of the 3rd August 2015)

Official Title
-----------------
Prevention of Cardio-embolic Stroke Using Anti-vitamin K and Direct Oral Anticoagulants. A Model of Action in Burgundy.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Drug: Anticoagulants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients managed for stroke at the stroke unit of Dijon University Hospital for CAAF-related cardio-embolic stroke Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stroke related to CAAF<br> | Drug: Anticoagulants<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of stroke recurrences |  | 12 months after inclusion |
Predictors of Postoperative Complications and Readmissions in Laparoscopic Pancreas Resection

Study Overview
=================
Brief Summary
-----------------
Laparoscopic resection of the pancreas has become widely accepted in the treatment of lesions which are benign or of low-grade malignancy. The objective of this study is to analyze the factors that predict postoperative complications and hospital readmission in a series of laparoscopic pancreatectomies.

Detailed Description
-----------------
The investigators conducted a retrospective study using a prospective database of laparoscopic resections performed between 2000 and 2020. Data were collected on age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, type of surgery, histologic type, operative time, hospital stay, postoperative complications, degree of severity and hospital readmission

Official Title
-----------------
Predictors of Postoperative Complications and Readmissions in Laparoscopic Pancreas Resection: Results of 105 Consecutive Cases

Conditions
-----------------
Laparoscopic Surgery, Pancreas

Intervention / Treatment
-----------------
* Procedure: Laparoscopic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A retrospective study was carried out using data from a prospective database of all consecutive patients undergoing laparoscopic resection of the pancreas between 2000 and 2020 in the Clínica Universidad de Navarra Exclusion Criteria: n/a

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 |
| --- |
|Procedure: Laparoscopic|Laparoscopic resection of the pancreas has become widely accepted in the treatment of lesions which are benign or of low-grade malignancy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Gender, Age, body mass index with the outcomes | The investigators evaluate multiple variables in relation in the designed outcomes: Gender, Age, body mass index (weight and height will be combined to report BMI in kg/m^2) | 20 years | 
| Readmission | Readmission defined as an admission to any hospital for 24 hours or more for any reason within 60 days of surgery | 60 days |
The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment

Study Overview
=================
Brief Summary
-----------------
The utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment in the adult onset atopic dermatitis

Detailed Description
-----------------
The study consists of 9 visits. Duplimab will used in the treatment of adult onset atopic dermatitis. Qualified subjects will receive 5 dupilumab open-label injections. Skin biopsies/ skin strips will be obtained at the beginning and the end of treatment. TARC and IgE levels will be obtained at the beginning and end of treatment. Subjects will complete daily diaries assessing atopic dermatitis symptoms. Patient reported out comes will be completed at each visit

Official Title
-----------------
The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment

Conditions
-----------------
Atopic Dermatitis, Eczema

Intervention / Treatment
-----------------
* Biological: Dupilumab Prefilled Syringe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of adult onset atopic dermatitis Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 19 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: open-label<br>open-label | Biological: Dupilumab Prefilled Syringe<br>* open-label<br>* Other names: dupixent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to correlate cutaneous transcriptomes with before and after Dupilumab treatment outcomes in patients who meet the clinical diagnostic criteria for adult onset AD. | Data will be analyzed from skin punch biopsies from active skin lesions and uninvolved skin samples before and after treatment | after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate possible influence of Dupilumab on serologic protein biomarkers in patients with adult onset AD | Total IgE, TARC and eotaxin will be compared pre and post treatment | after 6 months |
An Evaluation of the FreeStyle Libre Flash Glucose Monitoring System

Study Overview
=================
Brief Summary
-----------------
Medium-term (6-12 months) evaluation of the use, the identified problems, the usability and the effect on the metabolic control of the FreeStyle Flash Libre glucose monitoring system in 90 children by questionnaires and routine measurement of HbA1c values.

Official Title
-----------------
A Medium-term Evaluation of the Use, the Identified Problems, the Usability and the Effect on the Metabolic Control of the FreeStyle Flash Libre Glucose Monitoring System

Conditions
-----------------
Flash Glucose Monitoring, Metabolic Control

Intervention / Treatment
-----------------
* Device: FreeStyle Flash Libre glucose monitoring system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitis Being followed in the Pediatric Diabetes Unit of the Jessa Hospital Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 4 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cases<br>children (4-18 years) with type 1 diabetes mellitis using the FreeStyle Flash Libre glucose monitoring system (standard care) | Device: FreeStyle Flash Libre glucose monitoring system<br>* glucose monitoring system with sensors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the FreeStyle Flash Libre glucose monitoring system | Usability of the FreeStyle Flash Libre glucose monitoring system by a questionnaire | 6-12 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Problems associated with the FreeStyle Flash Libre glucose monitoring system | Problems associated with the FreeStyle Flash Libre glucose monitoring system by a questionnaire | 6-12 months follow up | 
| The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients | The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients by measurement of the HbA1c values | 6-12 months follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flash Glucose Monitoring, Usability, Metabolic control
Evaluation of Patient Characteristics and Treatment Approaches to Patients With Bipolar Disorder in Turkey

Study Overview
=================
Brief Summary
-----------------
A registry study to identify the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in Turkey.

Official Title
-----------------
Evaluation of Patient Characteristics and Treatment Approaches to Patients With Bipolar Disorder in Turkey

Conditions
-----------------
Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients previously or currently diagnosed with bipolar disorder Patients (or any of their relatives) who give a written informed consent. Exclusion Criteria: Patients who were previously included in this 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with bipolar disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in Turkey. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the time period that elapsed since the diagnosis of bipolar disorder |  |  | 
| Evaluation of co-morbid psychiatric diseases |  |  | 
| Identification of treatment modalities selected according to the disease phase |  |  | 
| Identification of the number of first degree relatives diagnosed with bipolar disorder |  |  | 
| Evaluation of the relationship between patient and disease characteristics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar disorder, patient characteristics, treatment characteristics
Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Late vitreous hemorrhage in postvitrectomized diabetic eyes may be due to fibrovascular tuft formation in sclerotomy sites. Cryotherapy of sclerotomy sites may prevent bleeding by regressing the fibrovascular tuft. This study will detect the safety and efficacy of cryotherapy of sclerotomy sites for prevention of late vitreous hemorrhage in vitrectomized diabetic eyes.

Conditions
-----------------
Late Postvitrectomy Diabetic Hemorrhage.

Intervention / Treatment
-----------------
* Procedure: Cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic retinopathy cases undergoing vitrectomy Exclusion Criteria: History of deep vitrectomy or cataract surgery Renal failure Silicone oil injection during surgery Early rebleeding History of antithrombotic drugs usage
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cryotherapy | Procedure: Cryotherapy<br>* Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.<br>|
| Placebo Comparator: 2<br> | Procedure: Cryotherapy<br>* Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of late vitreous hemorrhage in the cryo group. |  | 6 months | 
| Incidence of late vitreous hemorrhage in the control group. |  | 6 months | 
| Comparing incidence of late vitreous hemorrhage in both groups. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rebleeding, Diabetic vitreous hemorrhage, Cryotherapy
Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to develop and evaluate fluorine-18 (F-18) fluorocholine (FCH) positron emission tomography (PET) as an imaging technique that can be used to delineate malignant tumors in the prostate gland. The proposed technique works by measuring the tissue metabolism of FCH, a substrate that is preferentially metabolized by cancer cells due to malignant over-expression of the choline transporter and choline kinase enzyme. The project scope covers a clinical study to recruit men with prostate cancer who have elected treatment by radical prostatectomy surgery. These men will undergo pre-operative PET scanning to measure F-18 FCH uptake in anatomical sextants of the prostate gland. Imaging results will be compared to histopathologic analyses of the prostatectomy specimen to determine the accuracy of F-18 FCH PET for detecting cancerous prostate sextants.

Official Title
-----------------
Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: Fluourine-18 Fluoromethylcholine PET/CT Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy Exclusion Criteria: Weight > 300 lb

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Investigational Imaging Device | Device: Fluourine-18 Fluoromethylcholine PET/CT Imaging<br>* Single-dose Study<br>* Other names: Fluorocholine PET/CT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis |  | Immediate - no longitudinal data collected |