linjc16/ctgov huggingface dataset:
One-Stage Exchange for Chronically Infected Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The primary goal of the study is to evaluate the success rate of routine one-stage exchange for treatment of chronically infected total hip arthroplasty performed at the investigators institution, and to compare it to the current literature reporting success rate of selected one-stage exchange procedure or two-stage procedure. The secondary goal is to detect the potential prognostic factors and potential selection criteria which may influence the success rate. The tested hypothesis is following: the success rate of routine one-stage exchange is lower than that of selected one-stage or two-stage procedure

Official Title
-----------------
Evaluation of Routine One-Stage Exchange Procedure for Chronically Infected Total Hip Arthroplasty

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronically infected total hip Arthroplasty One-stage exchange procedure operated on at the investigators institution between January 1, 2007 and November 30, 2010 Exclusion Criteria: Patient refused to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| infection of the prosthesis | Rate of diagnosis infection of the prosthesis | For the duration of hospital stay, up to 1 year] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip, Arthroplasty
Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography

Study Overview
=================
Brief Summary
-----------------
This study is aimed at creation and validation of a vitreous haze scoring system using ultrasonography B-scan of the eye. Images will be obtained from patients with uveitis and quantification of inflammation will be done to create the scoring scale.

Detailed Description
-----------------
Patients with uveitis may present with Vitreous Haze (VH) resulting in obscuration of fundus details. VH is composed of cells and protein exudation and results in decrease visual acuity.The degree of VH is an important indicator of disease activity, severity and response to therapy in patients with uveitis. Color fundus images are commonly used to objectively document VH.

Official Title
-----------------
Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Device: Ultrasonography B-scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Ability to provide written informed consent and comply with study assessments for the full duration of the study Age 18 -90 years Diagnosis of uveitis Exclusion Criteria: • Patients with posterior segment complications including retinal detachment, choroidal detachment or hemorrhage Patients with any intraocular foreign body or displaced intraocular lens Patients with silicon oil filled eye or with gas tamponade. Patients with vitreous hemorrhage Patients with media opacity including visually significant cataract that precludes grading of VH based on fundus photography

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasonography B-scan<br>Patients of uveitis who are included in the study will be imaged using ultrasound B-scan | Device: Ultrasonography B-scan<br>* The patient's eye will be anesthetized. The ultrasound probe will then be used to obtain images by keeping the probe in light contact with the eye.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-observer correlation for vitreous haze grading | Inter-observer correlation for vitreous haze (VH) grading will be assessed using number of eyes as the unit of measure as well as standardized grading scheme for VH | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitreous Haze, Ocular ultrasound, B scan, Uveitis
Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the prevalence of nontuberculous mycobacteria in sputum cultures from patients with cystic fibrosis. II. Compare the clinical course of patients with negative versus positive cultures.

Detailed Description
-----------------
PROTOCOL OUTLINE: Participants are screened for nontuberculous mycobacteria (NTM) with 3 sputum acid-fast bacilli smears and mycobacterial cultures, with speciation of positive cultures, collected over 1 year. Demographic data, diagnostic criteria, clinical measurements, and other respiratory pathogen data are collected using the Cystic Fibrosis Foundation Patient Registry Questionnaire. NTM-positive patients (cases) matched with NTM-negative controls identified in screening are followed every 3 months for 15 months. Cases are evaluated for NTM burden during the first 3 months. Appropriate therapy is offered to consistently NTM-positive cases. Lung transplant recipients are removed from study.

Conditions
-----------------
Cystic Fibrosis, Atypical Mycobacterium Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Patients over age 10 with cystic fibrosis documented as follows: Pilocarpine sweat chloride test at least 60 mEq/L OR Genotyping or transepithelial potential difference AND Clinical symptoms of suppurative respiratory disease or pancreatic insufficiency Able to produce at least 3 sputum samples Bronchoscopy specimens acceptable Throat/nasal specimens not acceptable No Pseudomonas cepacia colonization

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atypical mycobacterium infection, bacterial infection, cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, immunologic disorders and infectious disorders, mycobacterium infection, rare disease
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric congenital heart disease.

Official Title
-----------------
A Randomised, Double-blind, Parallel Group, Placebo-controlled Comparison of Recombi-nant Factor VIIa (rFVIIa/ NovoSeven®) With Standard Haemostatic Replacement Therapy, and Standard Haemostatic Replacement Ther-apy Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease

Conditions
-----------------
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent obtained from parent or legal guardian before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject Children with complex congenital heart disease requiring corrective surgery with cardiopulmonary bypass (CPB) Exclusion Criteria: Congenital heart disease that does not require CPB surgery

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

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: Activated recombinant human factor VII<br> | Drug: activated recombinant human factor VII<br>* Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from reversal of heparin with protamine sulphate to chest closure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of units/volume of fresh frozen plasma (FFP) and/or platelets and/or red-cell concentrates transfused during surgery and in the post-surgery period |  |  | 
| Blood loss |  |  | 
| Adverse events |  |  |
A Study of Two Different Formulations of LY3209590 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to look at the amount of the study drug, LY3209590, that gets into the blood stream and how long it takes the body to get rid of LY3209590 when given as different formulations. The tolerability of LY3209590 will also be evaluated and information about any side effects experienced will be collected. The study will last up to 142 days.

Official Title
-----------------
Comparative Pharmacokinetics of LY3209590 After Administration of a Lyophilized Formulation and a Solution Formulation in Healthy Participants

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

Intervention / Treatment
-----------------
* Drug: LY3209590


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are overtly healthy males or non-pregnant females. Additionally, women of childbearing potential must test negative for pregnancy Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m²), inclusive at screening Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study Have veins suitable for blood sampling Have given written informed consent approved by Lilly and the ethical review board governing the site Exclusion Criteria: Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study Are women who are pregnant or lactating Have a history of multiple and/or severe allergic reactions Show clinical evidence of HIV, hepatitis C, or hepatitis B, and/or test positive Regularly use known drugs of abuse or with positive drug results

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3209590 Lyophilized Formulation<br>LY3209590 as lyophilized formulation administered subcutaneously (SC) in one of the two study periods. | Drug: LY3209590<br>* Administered SC.<br>|
| Experimental: LY3209590 Solution Formulation<br>LY3209590 as solution formulation administered SC in one of the two study periods. | Drug: LY3209590<br>* Administered SC.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3209590 | PK: Cmax of LY3209590 | Predose on Day 1 through Day 65 | 
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3209590 | PK: AUC(0-inf) of LY3209590 | Predose on Day 1 through Day 65 |
Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. The investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal tissue.

Official Title
-----------------
Multimodality Functional Imaging (MRS and Tumor Perfusion) Predicts Tumor Migration, Invasiveness, and Patterns of Failure of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide

Conditions
-----------------
Glioblastoma, Glioma

Intervention / Treatment
-----------------
* Procedure: Functional MRI imaging and tomotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed glioblastoma multiforme Ages 18-65 Karnofsky Performance Scale (KPS) equal to or less than 70 Minimal neurological deficit Eligible for concurrent temozolomide chemotherapy Exclusion Criteria: Prior radiation therapy to hand or neck area, chemotherapy, or radiosensitizer

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Functional MRI imaging and tomotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine tumor response and pattern of failure using functional MRI imaging |  | Study completion | 
| time to disease progression |  | Study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distinguish residual tumor from treatment-related necrosis |  | study completion | 
| survival |  |  | 
| acute late toxicity of tomotherapy and hypofractionation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
magnetic resonance imaging, functional, radiation therapy, temozolomide, functional imaging, concurrent chemoradiation
Wireless US-guided CVC Placement in Infants

Study Overview
=================
Brief Summary
-----------------
Background: Neonates and small infants with congenital cardiac disease undergoing cardiac surgery represent major challenges facing pediatric anesthesia and perioperative medicine. Aims: We here aimed to investigate the success rates in performing ultrasound guided central venous catheter insertion (CVC) in neonates and small infants undergoing cardiac surgery, and to evaluate the practicability and feasibility of thereby using a novel wireless ultrasound transducer (WUST). Methods: Thirty neonates and small infants with a maximum body weight of 10 kg and need for CVC before cardiac surgery were included in this observational trial and were subdivided into two groups according to their weight: < 5 kg and ≥5 kg. Cannulation success, failure rate, essential procedure related time periods, and complications were recorded and the clinical utility of the WUST was assessed by a 5-point Likert scale.

Official Title
-----------------
Performing Central Venous Catheters in Neonates and Small Infants Undergoing Cardiac Surgery Using a Wireless Transducer for Ultrasound Guidance: a Prospective, Observational Pilot Study

Conditions
-----------------
Wireless Ultrasound, Central Venous Catheter, Congenital Heart Disease in Children

Intervention / Treatment
-----------------
* Device: use of a wiresless US transducer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonates and small infants with a maximum body weight of 10 kg and need for insertion of a CVC before cardiac surgery at our institution Exclusion Criteria: missing consent for study participation >10 kg body weight emergency surgery central venous catheter in situ

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: use of a wiresless US transducer|to (evaluate the practicability of applying a wireless US transducer for central venous catheter-placement in these patients.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of success using a wireless US for pediatric CVC | Clinical applicability of a wireless US transducer for CVC insertion for pediatric cardiac surgery | during cardiac surgery |
Bi-Axial Rotating Magnetic Field Therapy in Refractory Neuropathic Foot Pain Secondary to Diabetic Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
The researchers will study the application of a commercial pulsed magnetic stimulating device to the feet of patients with moderate-severe foot pain secondary to diabetic peripheral neuropathy (DPN).

Official Title
-----------------
Bi-Axial Rotating Magnetic Field Therapy in Refractory Neuropathic Foot Pain Secondary to Diabetic Peripheral Neuropathy. Multi-Center, Randomized Placebo Controlled Trial

Conditions
-----------------
Diabetic Neuropathies

Intervention / Treatment
-----------------
* Device: foot energizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DPN stage 2 and 3; symptomatic > 6 months Exclusion Criteria: Pacemaker in patient or mate

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: foot energizer|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of neuropathic foot pain |  |  | 
| improve quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serial changes in EDX, QST, autonomic functions, biopsy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulsed magnetic field therapy, diabetic peripheral neuropathy, neuromodulation, diabetic peripheral neuropathic pain, sleep benefit, diabetic peripheral neuropathic functioning
Screening for NAFLD in Flanders

Study Overview
=================
Brief Summary
-----------------
In the Belgian adult population more than half, and numbers are still increasing, of the population is overweight or obese. These people are at risk to develop NAFLD. However, we lack epidemiological data in Belgium. Therefore, it is important to do epidemiological studies to investigate NAFLD prevalence and disease severity based on a non-invasive approach and evaluate how patients are to be referred.

Official Title
-----------------
Screening for Non-Alcoholic Fatty Liver Disease (NAFLD) in a General Practitioner Population, in Flanders, Belgium.

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Other: screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older, able to understand Dutch, able to understand the informed consent Exclusion Criteria: secondary causes of steatosis excessive alcohol abuse

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: participants<br> | Other: screening<br>* The determination of the prevalence of NAFLD in a general population in Flanders, Belgium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CLDQ-NAFLD | The determination of the prevalence of NAFLD in a general population in Flanders, Belgium by using A disease-specific quality of life instrument for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis | baseline | 
| 36-Item Short Form Survey (SF-36) | SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. | baseline |