linjc16/ctgov huggingface dataset:
AqueSys Microfistula Implant in Refractory Glaucoma

Study Overview
=================
Brief Summary
-----------------
To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.

Detailed Description
-----------------
A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys Microfistula Implant in refractory glaucoma patients who have previously failed a glaucoma procedure and who are not well-controlled on IOP lowering medications.

Official Title
-----------------
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma

Conditions
-----------------
Glaucoma, Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Device: AqueSys Microfistula Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Refractory Glaucoma Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg Visual field mean deviation score of -3 dB or worse Shaffer Angle Grade ≥ 3 Area of free, healthy and mobile conjunctiva in the targeted quadrant Exclusion Criteria: Active Neovascular Glaucoma Previous glaucoma shunt/valve in the targeted quadrant History of corneal surgery, opacities or disease/pathology Anticipated need for ocular surgery Non-study eye with BCVA of 20/200 or worse

Ages Eligible for Study
-----------------
Minimum Age: 45 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: AqueSys Microfistula Implant<br> | Device: AqueSys Microfistula Implant<br>* Placement of the AqueSys Microfistula Implant in the study eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in IOP from baseline |  | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma Implant, Trabeculectomy, POAG
Intravitreal Bevacizumab for Low Vision in Neovascular Age-related Macular Degeneration (AMD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.

Detailed Description
-----------------
There is no clear indication regarding the treatment of patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200. Treatment of eyes with low visual acuity could lead to a waste of resources, without any functional and social improvements. Aim of the present study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in

Official Title
-----------------
Intravitreal Bevacizumab for the Treatment of Patients With Low Vision Due to Neovascular Age-related Macular Degeneration

Conditions
-----------------
Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age-related macular degeneration naïve subfoveal choroidal neovascularization best-corrected visual acuity less then 20/200 Exclusion Criteria: previous treatments any other condition able to limit the visual improvement

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 90 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: bevacizumab<br>three-monthly intravitreal bevacizumab, followed by PRN monthly injection on the basis of the detection of any fluid on the optical coherence tomography | Drug: Bevacizumab<br>* 1.25 mg intravitreal bevacizumab<br>* Other names: avastin;|
| No Intervention: control<br>monthly follow-up | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in best-corrected visual acuity | change in best-corrected visual acuity at the end of the follow-up | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in central macular thickness | change in central macular thickness on OCT | 6 months | 
| NEI VFQ-25 scores | change in NEI VFQ-25 scores questionnaire | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
age-related macular degeneration, bevacizumab
Postoperative Atrial Fibrillation and Long-term Survival

Study Overview
=================
Brief Summary
-----------------
The aim of the investigators trial was to evaluate association between new onset postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.

Detailed Description
-----------------
The material of this retrospective study consist patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously . A total of 519 consecutive patients underwent coronary artery bypass surgery, aortic valve replacement or combined aortic valve with coronary bypass surgery in Kuopio University Hospital from 2004 to 2008. Patients with previous episodes of atrial fibrillation (AF) or flutter and also patients with mitral valve surgery were excluded. All patients had continuous postoperative ECG monitoring for at least 48 hours. AF episodes lasting longer than 5 minutes were registered. Thereafter 12 lead ECG was recorded daily and in case of symptoms of rhythm disturbances. Medical records were reviewed during 2012 using standardized data collection protocol. Statistics Finland database was used for mortality data.

Official Title
-----------------
Postoperative Atrial Fibrillation After Cardiac Surgery is Not an Independent Risk Factor for Long-term Cardiovascular Morbidity and Mortality in Anticoagulated Patients

Conditions
-----------------
Death, Stroke, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previously cardiac operation, CABG or AVR Exclusion Criteria: Previous Atrial fibrillation
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 |
| --- | --- | --- |
| cardiovascular and all-cause death |  | 1-105 month | 
| stroke |  | 1-105 month | 
| late atrial fibrillation |  | 1-105 month | 
| myocardial infarction |  | 1-105 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, CABG, Stroke
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Have to be Vaccinated MenBVac®

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before the first vaccination (T0), after the second MenBvac vaccination (6 weeks after the second vaccination), before the third MenBvac vaccination and after the third MenBvac vaccination (6 weeks after the second vaccination) and one year after the third menBvac vaccination.

Official Title
-----------------
Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child.

Conditions
-----------------
Vaccination

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray, vaccinated five times by MenBVac parental authority(ies)assent Exclusion Criteria: no parental authority(ies)assent no blood sample during the third vaccination impossibility of third vaccination children with guardianship children yet vaccinated or non eligible for vaccination

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 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 |
| --- | --- |
| 1<br>children born between 06/04/2004 and 17/04/2008 and called to menBvac vaccination and living around Neufchatel en Bray. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of natural Immunity with measure of percent of children who have hSBA title >= 4 at TO. assessment of antibodies blood persistence during measurement of percent of children who have hSBA title >= 4 |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neisseria meningitidis B:14, P1-7, 16, Serum bactericidal activity, Menbvac
Procalcitonin Role in Influenza Patients With Regard to Morbidity, Mortality and Antibiotic Use

Study Overview
=================
Brief Summary
-----------------
The investigators intend to observe the inflammatory marker procalcitonin (PCT) in comparison with patient variables on morbidity, mortality and antibiotic treatment. The overall aim is to observe if a low PCT value can have potential in reducing unessesary antibiotic use in seasonal influenza patients.

Detailed Description
-----------------
This is an observational study of the clinical utility of early PCT measurements in seasonal influenza, with particular attention to PCT's predictive value for prognosis and bacterial respiratory superinfection. The aim is to evaluate PCT as a supplementary aid in the standard clinical evaluation of influenza patients. Patients may be included if a positive influenza test is reported within 48 hours after an initial clinical suspicion of influenza, and the hospital stay is lasting more than one day. The investigators have included 74 patients from the second half of the 2018-19 influenza season and will continue to include patients from the complete 2019-20 season. Primary endpoints: Mortality (in-hospital and within 30 days post-discharge), bacterial respiratory tract superinfection. Secondary endpoints: Intensive care unit stay, the proportion of patients on antibiotic use and total antibiotic use in doses and LOT (length-of-treatment).

Official Title
-----------------
Procalcitonin Role in Influenza Patients With Regard to Morbidity, Mortality and Antibiotic Use

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Behavioral: antibiotic stewardship efforts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient admitted to the hospital with positive influenza test Exclusion Criteria: none

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 |
| --- |
|Behavioral: antibiotic stewardship efforts|The local antibiotic team plan to implement procalcitonin use among the hospital physicians. the interventions are not ready yet.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | From the national registry the investigators will register wheather or not the patient has died within day 14 and day 30, and in case of dead the date will be registered | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibiotic use | From a elecronical medical chart (Metavision) the investigators will search and register the type of antibiotic used, the days of treatment and the total dose given in grams | up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
procalcitonin
Determining Patterns In Trial Experiences of Diabetic Neuropathy Patients

Study Overview
=================
Brief Summary
-----------------
Historically, participation in clinical studies is highly skewed towards particular demographic groups of people. This study will invite several participants to gather a wide range of information on clinical trial experiences for diabetic neuropathy patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of diabetic neuropathy. The data collected from this study will help improve future outcomes for all diabetic neuropathy patients as well as those in under-represented demographic groups.

Official Title
-----------------
An In Depth Study Examining Patterns in the Clinical Trial Experiences of Diabetic Neuropathy Patients

Conditions
-----------------
Diabetic Neuropathies, Diabetic Neuropathy Peripheral

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient plans to participate in an interventional clinical trial for the condition of diabetic neuropathy Patient has been diagnosed with a type of diabetic neuropathy Patient is a minimum of 18 years of age Patient has access to a home internet connection in order to provide regular updates through the course of the study Exclusion Criteria: Patient is not able to provide consistent digital updates as per study requirements Patient does not complete or agree to terms outlined in the Informed Consent Form Patient has an ECOG score of 4 or higher

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 |
| --- | --- | --- |
| Number of patients who decide to enroll in an diabetic neuropathy clinical trial |  | 3 months | 
| Rate of patients who remain in diabetic neuropathy clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic neuropathy, neuropathy
Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open-label, parallel design Phase I clinical trial to evaluate the safety/tolerability and pharmacokinetic of DWJ211 in healthy volunteers

Official Title
-----------------
A Randomized, Open-label, Parallel Design Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic of DWJ211 in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: DWJ211


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult aged between 19 and 65 at screening Those whose BMI is less than 40kg/m2 Subject who will agree with the no treatment(liposuction or surgery, obesity treatment) Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc Exclusion Criteria: Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history History of any intervention to treat Submental fat or abdominal fat History or current symptoms of dysphagia History of trauma associated with the chin or neck or abdominal areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GroupA<br>Inject the Drug into submental fat and abdominal fat via subcutaneous | Drug: DWJ211<br>* Inject the Drug into submental fat and abdominal fat via subcutaneous<br>|
| Experimental: GroupB<br>Inject the Drug into submental fat and abdominal fat via subcutaneous | Drug: DWJ211<br>* Inject the Drug into submental fat and abdominal fat via subcutaneous<br>|
| Experimental: GroupC<br>Inject the Drug into submental fat and abdominal fat via subcutaneous | Drug: DWJ211<br>* Inject the Drug into submental fat and abdominal fat via subcutaneous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum concentration of DWJ211 | 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h | 
| Tmax | Time of maximum concentration | 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h | 
| AUCt | Area under the drug concentration-time curve | 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h |
18F-FAPI PET in the Diagnosis of Liver Fibrosis

Study Overview
=================
Brief Summary
-----------------
It is an open label observation clinical trial, all participants are chronic liver disease. The investigators deem to make a novel evaluate criteria to hepatic fibrosis. The point of the clinical trial is to evaluate the novel biomaker 18F-FAPI-04 by PET-CT scan in the evaluation of the hepatic fibrosis.

Detailed Description
-----------------
Participants are with clinically confirmed chronic liver disease,including chronic viral hepatitis, autoimmune hepatitis, liver disease after liver transplantation, nonalcoholic fatty liver disease, alcoholic hepatitis, primary biliary cholangitis, primary sclerosing cholangitis and congestive hepatopathy etc. Participants are without liver tumor and other liver disease besides liver fibrosis Participants has no history of malignant tumors Participants agree to performe FAPI PET and liver biopsy

Official Title
-----------------
A Prospective Study for Effectiveness of 18F-FAPI PET in the Diagnosis of Liver Fibrosis: Comparison With Liver Biopsy

Conditions
-----------------
FAP, Liver Fibrosis, Positron Emission Tomography

Intervention / Treatment
-----------------
* Diagnostic Test: 18F-FAPI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically confirmed chronic liver disease,including chronic viral hepatitis, autoimmune hepatitis, liver disease after liver transplantation, nonalcoholic fatty liver disease, alcoholic hepatitis, primary biliary cholangitis, primary sclerosing cholangitis and congestive hepatopathy etc. Without liver tumor and other liver disease besides liver fibrosis No history of malignant tumors Agree to performe FAPI PET and liver biopsy Exclusion Criteria: Pregnancy With anti-hepatic fibrosis treatment in 6 months With contraindications to percutaneous liver biopsy,for such as uncooperative patient, severe coagulopathy, extrahepatic biliary obstruction,etc.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 18F-FAPI|Patients with chronic liver disease underwent 18F-FAPI-04 PET/CT and percutaneous liver biopsy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18F-FAPI PET in the Diagnosis of Liver Fibrosis | 18F-FAPI as a PET-CT biomarker to Liver Fibrosis | 12.01.2021 to12.01.2022 |
ACTH Stability on Whole Blood

Study Overview
=================
Brief Summary
-----------------
ACTH is a peptide secreted by pituitary gland and plays an important role in regulating cortisol secretion. ACTH is determined in plasma by immunoassays using specific antibodies. Its determination is difficult because of instability in whole blood. Several factors which influence ACTH stability in blood before analysis have been identified: temperature, hemolysis, time to centrifugation and presence of protease inhibitors. Published results on ACTH whole blood stability seem contradictory. The objective of this study is to evaluate the effect of aprotinin in 10 healthy volunteers. ACTH measurements will be performed on cobas e602 (Roche Diagnostics, Mannheim, Germany).

Official Title
-----------------
Adrenocorticotropic Hormone Stability on Whole Blood

Conditions
-----------------
ACTH

Intervention / Treatment
-----------------
* Biological: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient aged 18 to 60, Exclusion Criteria: Adult with insufficient venous capital for blood collection

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br>blood sampling is done on healthy volunteers | Biological: Blood sampling<br>* blood sampling is done on healthy volunteers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACTH concentration in plasma |  | 8 hours |