linjc16/ctgov huggingface dataset:
STN-Stimulation Versus Best Medical Treatment in Advanced PD

Study Overview
=================
Brief Summary
-----------------
Assessment of the therapeutic effect of deep brain stimulation of the subthalamic nucleus compared with drug treatment alone in patients with advanced Parkinson's disease.

Detailed Description
-----------------
Patients are randomized either to medical treatment or subthalamic stimulation. The observation period was 6 months. The primary outcome criterium: PDQ-39 and UPDRS III.

Official Title
-----------------
Randomized, Multicenter, Prospective, Parallel-Group Study of the Effect of Deep Brain Stimulation (Subthalamic Nucleus) on Quality of Life and Motor Complications in Patients With Advanced Parkinson's Disease Compared With Best Medical Treatment

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Procedure: Implantation of stimulation electrodes in the STN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: advanced Parkinson's disease with UPDRS III score >29/104 or Dyskinesia score > 2 or tremor >2 Exclusion Criteria: age>75 years depression psychosis surgical contraindications

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Implantation of stimulation electrodes in the STN|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 
| Motor Score in the OFF (UPDRS III) |  |  |
Identification of Prognostic Urinary Biomarker for Acute Kidney Injury in Preterm Infants by Proteomics

Study Overview
=================
Brief Summary
-----------------
Clinical definitions of acute kidney injury (AKI) have been based on an increase in serum creatinine and a decrease in urine output. However, applying this definition to neonates remains challenging because of the normal renal physiologic features that serum creatinine levels are expected to increase in the first days after birth, and impaired sodium reabsorption and concentrating ability. Because of several limitations of early detection of AKI, investigators are focused on identifying biomarkers that predict AKI before an increase serum creatinine level. Investigators will collect urine from preterm infants before and after administrating ibuprofen for closing patent ductus arteriosus. To identify novel biomarkers, investigators will analyze urine by proteomics. To verify those biomarkers, investigators will use initial urine on the first day of life from preterm infants who diagnosed AKI within 7 days after birth without any risk factors for AKI and enrolled institutional bio-repository.

Official Title
-----------------
Identification of Prognostic Urinary Biomarker for Acute Kidney Injury in Preterm Infants by Proteomics

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants less than 32 weeks gestational age or birth weight less than 1,500 g admitted to the neonatal intensive care unit at Seoul National University Children's hospital Exclusion Criteria: Congenital heart disease Known major congenital anomalies of the kidney and urinary tract Other genetic syndromes or medical conditions that preclude enrollment per judgement of the attending neonatologist

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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 |
| --- | --- | --- |
| change the level of novel urinary biomarkers after ibuprofen administration |  | change from 1 day before ibuprofen administration to 1 day after ibuprofen administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of novel urinary biomarkers in initial urine |  | within 24 hours after birth |
Functional Respiratory Imaging of Airways in ARDS

Study Overview
=================
Brief Summary
-----------------
This is a prospective single-center cohort trial to compare regional bronchial recruitment, bronchial distention and alveolar recruitment in 6 patients with acute respiratory distress syndrome (ARDS). The investigators used CT scan images as the imaging modality, and the subjects were scanned on end-expiratory lung volume with different positive end-expiratory pressures. Those images were post-processed to evaluate the airways.

Official Title
-----------------
Functional Imaging With Computational Fluid Dynamics to Evaluate the Airways in Patients With Acute Lung Injury

Conditions
-----------------
ARDS, Human

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mechanically ventilated moderate or severe ARDS, as defined by the Berlin criteria Exclusion Criteria: pregnancy hemodynamic instability obesity (BMI >30)

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: Diagnostic
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>Repeated CT scan | Procedure: Repeated CT scan<br>* CT scan of chest on different PEEP levels, 4 in total<br>Device: CT scan<br>* CT scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional bronchial recruitment | The difference in bronchial tree volume increase from one PEEP level to the other | Through study completion, within 24 hours after inclusion | 
| Regional bronchial dilation | The difference in bronchial diameter from one PEEP level to the other | Through study completion, within 24 hours after inclusion | 
| Regional alveolar recruitment | The difference in alveolar volume from one PEEP level to the other | Through study completion, within 24 hours after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between parenchymal recruitment and bronchial recruitment | Correlation between parenchymal recruitment (in milliliter) and bronchial (in milliliter) recruitment for each type of ARDS (focal versus diffuse) | Through study completion, within 24 hours after inclusion |
An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study

Study Overview
=================
Brief Summary
-----------------
This is an observational study aiming to identify and validate biomarkers (including imaging and clinical descriptors) for chronic obstructive pulmonary disease (COPD), cardiovascular disease (CVD) and lung cancer.

Official Title
-----------------
BIG3 - An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Cardiovascular Diseases, Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 45-75 years

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- |
| exposed<br>current daily smokers 100 cigarettes or more during lifetime | |
| unexposed<br>current non-smokers | |

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
-----------------
Prospective Cohort Study, Respiratory Function Tests, Computed Tomography, Electrocardiography, Peripheral Arterial Disease
Etiological Diagnosis of Traveler's Diarrhoea

Study Overview
=================
Brief Summary
-----------------
Traveler's diarrhoea or turista is the most common disease in travelers. It has been reported based on studies in 20 to 60% of travelers, depending among other conditions and travel destinations. Currently, less than 30% of the etiology of diarrhoea is identified by bacteriological v,irological and parasitology traditional techniques. This ignorance of the diarrhoea etiology causes difficulties in the establishment of a specific and rapid management in this extremely common condition and having a significant cost to society. Technological advances in laboratory diagnosis, such as quantitative real-time Polymerase Chain Reaction (PCR), can allow us now to improve the etiological diagnosis of traveler's diarrhoea using simple rectal swabs. So, the principal objective of this study is to assess the efficacy of a new diagnosis strategy in order to establissh the etiological diagnosis of traveler's diarrhoea. The hypothesis consists in improving the number of patients with a confirmed etiological diagnosis of traveler's diarrhoea by 5%.

Conditions
-----------------
Traveler's Diarrhoea

Intervention / Treatment
-----------------
* Other: Rectal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient leaving for a trip outside France for a period (not exceeding 3 months) Patient who get seen by Travel information Service at hospital before departure. Adult patients (> 18 years). Patient who freely signed the written informed consent Patient affiliated to a social security regime. Exclusion criteria Minor patient (<18 years) Pregnant or nursing woman. Adult patient under guardianship. Patient deprivated with liberty under court order. Patient refusing to sign the wrtten consent form

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient suffering from traveler's diarrhoea<br>Patient suffering form traveler's diarrhoea during a stay (up to 3 months) outside metropolitan France | Other: Rectal swab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a confirmed etiological diagnosis of traveler's diarrhoea |  | Up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Turista
Barriers to Peritoneal Dialysis Selection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand what prevents chronic kidney disease patients from making a timely decision about dialysis modality options. This understanding will allow us to develop and implement interventions to assist patients in this turning point so that they can make the right decision for them in a timely enough manner so that each patient can start dialysis in the safest and best way for them. 200 later stage chronic kidney disease patients (20% or less of kidney function remaining) will be asked to participate in the study with the goal of having 150 patients participate in the study. Hypotheses: 50 % of patients will have made a modality decision when interviewed and patients in the action stage of behavior will be more likely to make a modality selection than patients in earlier stages of behavior change. Barriers to modality selection will act at several levels including patient, provider and health system level and will vary by behavioral stage of change 10-15% of patients might choose home dialysis. Knowledge, self efficacy in terms of CKD, education, and income will likely be barriers to home dialysis choice.

Official Title
-----------------
Barriers to Selection and Initiation of Peritoneal Dialysis in the United States

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients of age greater than or equal to 18 years at MHMC who are late stage CKD Exclusion Criteria: Patients who have acute renal failure and then recover renal function to levels of eGFR (estimated glomerular filtration rate) 20 mL/min/1.73m2 and in whom the nephrologist feels will not progress to ESRD in 2 years Patients who are not candidates for peritoneal dialysis Pregnant women

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 |
| --- | --- |
| Chronic kidney disease<br>Patients with chronic kidney disease (20% or less kidney function remaining. Patients with end stage renal disease who are currently receiving dialysis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers to making a dialysis modality decision | Determine the proportion of patients that made a dialysis modality decision and determine the barriers to being able to make a decision. Determine the proportion of patients choosing home dialysis and barriers associated with choice of home dialysis therapy. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
modality choice, peritoneal dialysis, kidney disease
DORAYA-HF Early Feasibility Study

Study Overview
=================
Brief Summary
-----------------
The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.

Official Title
-----------------
DORAYA-HF: Assessment of the Doraya Catheter for the Treatment of Volume Overload in Acute Heart Failure Patients With Insufficient Response to Diuretics

Conditions
-----------------
Acute Decompensated Heart Failure

Intervention / Treatment
-----------------
* Device: Doraya catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is hospitalized with primary diagnosis of ADHF. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m or BNP≥250 pg/mL. Evidence of fluid overload. Subject insufficiently responds to IV diuretic therapy Exclusion Criteria: Systolic blood pressure < 90 mmHg at the time of screening. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology). Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \severe regurgitation) or Severe mitral disease with planned intervention. Evidence of active systemic infection documented by either one of the following: fever >38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite > 48 hours of antibiotic treatment). Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADHF patients<br>ADHF patients with insufficient response to diuretics treated with the Doraya catheter | Device: Doraya catheter<br>* Temporary deployment of the Doraya catheter in ADHF patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | Device or procedure related SAEs rate (including MACE) based on CEC adjudication. | 30 days | 
| Urine Output | Change in rate of urine output | baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHF
Gastric Cancer Screening and Alarm Symptoms in Early Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Most of the early gastric cancer are asymptomatic. Symptoms of advanced gastric cancer are weight loss, abdominal pain, nausea, vomiting, anorexia dysphagia, gastrointestinal bleeding. Gastric cancer found according to warning symptoms such as gastrointestinal bleeding, weight loss usually can not be cured. Therefore, early gastric cancer can not be detected and impossible to treatment if endoscopy is performed according to the warning signs. National gastric cancer screening is conducted in men and women of more than 40 years old. The purpose of screening for gastric cancer is discovering a case of possible cure, so increasing the survival rate. The purpose of this study is review of the feasibility of screening for gastric cancer.

Official Title
-----------------
Gastric Cancer Screening and Alarm Symptoms in Early Gastric Cancer

Conditions
-----------------
Early Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gastric cancer patients in St.mary's hospital Exclusion Criteria: gastric lymphoma, gastric GIST patients in St.mary's hospital

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 90 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 |
| --- | --- | --- |
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single subcutaneous dose of UB-621 in healthy volunteers.

Detailed Description
-----------------
This is a phase I, open-label, single dose, dose escalation study in healthy volunteers. Eligible volunteers will be sequentially enrolled into four escalating-dose cohorts at a study site. After administration of a single subcutaneous dose of UB-621, subjects will be followed for 70 or 112 days and monitored for safety, tolerability, and pharmacokinetics parameters.

Official Title
-----------------
A Phase I, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Subcutaneous Dose of UB-621 in Healthy Volunteers

Conditions
-----------------
Herpes Simplex Virus Infection

Intervention / Treatment
-----------------
* Drug: UB-621


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With age between 20 and 55 years. With no clinically relevant abnormalities in vital signs, and clinical laboratory tests at screening visit judged by investigator. Body weight: <85 kg. Subject has signed the written informed consent form. Exclusion Criteria: With significant active infection (acute or chronic) within 28 days prior to the screening visit. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases, or clinical findings within 3 months prior to the screening visit. Positive serology for HIV antibody, HCV antibody or HBV surface antigen. Female subjects who are breastfeeding, pregnant, and planning to become pregnant during the study period. The clinical investigator considers that the subject is not in the condition to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UB-621<br>Intervention drug: UB-621 | Drug: UB-621<br>* 100 mg/ml, subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Up to 70 or 112 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak concentration of UB-621 |  | Up to 70 or 112 days |