linjc16/ctgov huggingface dataset:
Detect Fluid Early From Intra-thoracic Impedance Monitoring

Study Overview
=================
Brief Summary
-----------------
To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.

Official Title
-----------------
Detect Fluid Early From Intra-thoracic Impedance Monitoring

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Impedance Monitoring Feature


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months Exclusion Criteria: History of kidney disease requiring hemodialysis Refractory end stage heart failure

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Implantable Cardioverter Defibrillator (ICD)<br>Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD). | Device: Impedance Monitoring Feature<br>* Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads<br>|
| Other: Cardiac Resynchronization Therapy (CRT-D)<br>Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device. | Device: Impedance Monitoring Feature<br>* Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False Positive Rate | False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5. | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity is defined as the ability of the algorithm to detect heart failure events. Sensitivity is calculated as the number of heart failure events detected by the algorithm (true positives) divided by the total number of heart failure events (true positives + false positives). | 6-months |
Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age

Study Overview
=================
Brief Summary
-----------------
This study will assess the pharmacokinetics (PK), safety, and tolerability of a single intravenous (IV) dose of rezafungin in paediatric subjects from birth to <18 years who are receiving concomitant systemic antifungals as clinically indicated.

Detailed Description
-----------------
To date, there are no clinical studies evaluating rezafungin in paediatric subjects. This study will assess the pharmacokinetics (PK), safety and tolerability of rezafungin in subjects from birth to <18 years of age who are receiving concomitant systemic antifungal treatment as standard of care.

Official Title
-----------------
A Phase 1, Multicentre, Open-Label Study to Evaluate the PK, Safety, and Tolerability of a Single IV Dose of Rezafungin in Paediatric Subjects, Receiving Systemic Antifungals as Prophylaxis for IFI or to Treat a Suspected or Confirmed FI

Conditions
-----------------
Invasive Fungal Infections

Intervention / Treatment
-----------------
* Drug: Rezafungin Acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female paediatric subjects from birth to <18 years of age who are receiving concomitant systemic antifungals (oral or IV) as prophylaxis for invasive fungal infection (IFI) or to treat a suspected or confirmed fungal infection. Exclusion Criteria: History of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals and/or excipients of this formulation Previous or current medical conditions of severe ataxia, persistent tremors, intracranial hemorrhage or neuropathy, or a diagnosis of epilepsy, multiple sclerosis, or a movement disorder Subjects with impaired renal or hepatic functions Subjects with intestinal hypoxia, ischemia, necrosis, or necrotizing enterocolitis Subject status is unstable Subject is unlikely to complete required study procedures Participation in another interventional treatment trial with an investigational agent or presence of an investigational device at the time of informed consent or within 28 days preceding the informed consent.

Ages Eligible for Study
-----------------
Maximum 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rezafungin<br>It is IMP. | Drug: Rezafungin Acetate<br>* This is a Phase 1, multicentre, open-label, single-dose study. The study will be conducted at 10 sites across at least 3 countries in Europe.<br>* Other names: Rezafungin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK | Cmax | up to 30 days per patient | 
| PK | Tmax | up to 30 days per patient |
Real-Time MV/kV Image Guided Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
In current radiation therapy, imaging (typically, cone beam CT imaging or two orthogonal X-ray projection imaging) is done for patient setup before radiation dose delivery. Dose delivery typically takes 2 to 5 minutes depending on the delivery technique used for treatment. A tumor target may change its position during the dose delivery process. The goal of this project is develop a real-time imaging strategy to monitor the tumor position during dose delivery and evaluate its potential clinical impact.

Official Title
-----------------
Real-Time MV/kV Image Guided Radiation Therapy

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

Intervention / Treatment
-----------------
* Device: Real-time kV/MV Prostate Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study population will be drawn from available patient population that will be treated using IMRT/VMAT. The Stanford population of IMRT/VMAT will be taken as roughly representative of prospective IMRT patients and will not be subdivided by any additional characteristics. Exclusion Criteria: The study population will be drawn from available patient population that will be treated using IMRT/VMAT. The Stanford population of IMRT/VMAT will be taken as roughly representative of prospective IMRT patients and will not be subdivided by any additional characteristics.

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Real-time kV/MV Prostate Imaging<br> | Device: Real-time kV/MV Prostate Imaging<br>* The kV images will be acquired using onboard kV X-Ray imaging system existing in the clinical linear accelerator (LINAC).<br>* Other names: External beam radiotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To verify improved tumor targeting accuracy using IMRT (intensity modulated radiation therapy) and VMAT (volumetric modulated radiation therapy) |  | 2 years |
Longitudinal MRI Assessment in Patients With Diffuse Low-grade Gliomas

Study Overview
=================
Brief Summary
-----------------
Retrospective longitudinal follow-up in patients with diffuse low-grade glioma with multimodal MRI assessment

Official Title
-----------------
Retrospective Longitudinal Follow-up in Patients With Diffuse Low-grade Glioma With Multimodal MRI Assessment

Conditions
-----------------
Low-grade Glioma

Intervention / Treatment
-----------------
* Other: Repeated Measurements of the relative regional cerebral blood volume


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Initial WHO grade II At least 3 exploitable MRI each including a morphologic FLAIR sequence and perfusion imaging Exclusion criteria: -Major protected person ( trusteeship, curatorship, justice safeguard)

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 |
| --- | --- |
| Gliomes de grade II initial<br>Gliomes de grade II initial | Other: Repeated Measurements of the relative regional cerebral blood volume<br>* Repeated Measurements of the relative regional cerebral blood volume variation through an every 6 monts Magnetic Resonance Imaging use.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal variation of the relative regional cerebral blood volume | Longitudinal variation of the relative regional cerebral blood volume from first pass perfusion imaging data for each MRI performed | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of histological | Collection of histological | 1 day | 
| Collection of radiological | Collection of radiological | 1 day | 
| Collection of clinical varaibles | Collection of clinical varaibles | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glioma, Magnetic Resonance Imaging, Magnetic Resonance Angiography, Disease Progression, Supratentorial Neoplasms, Blood Volume, Contrast Media, Gadolinium DTPA, Image Processing, Computer-Assisted, Neovascularization, Pathologic, Diffuse low grade glioma, Relative regional cerebral blood volume ( rRCBV), Early prognosis of anaplasic transformation, Diffuse low grade glioma anaplasic transformation
Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.

Official Title
-----------------
A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: Lamivudine
* Drug: Telbivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented clinical history compatible with chronic hepatitis B Patient has compensated liver disease Patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with hepatitis C, hepatitis D or HIV Patient previously received antiviral treatment for hepatitis B other than lamivudine in the preceding 12 months Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- |
|Drug: Lamivudine|nan|
|Drug: Telbivudine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effects of Barberry Juice Consumption in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the effect of barberry juice (BJ) as a natural antioxidant, on cardiovascular risk factors in patients with type 2 diabetes (T2DM). In a randomized clinical trial study, 46 T2DM patients, 30-70 years old recruited from Diabetes Association of Iran-Babul . Patients were randomly allocated to either the BJ group (n=23) who consumed 200 ml of BJ daily for eight weeks, or the control group (n=23) with no intervention. At the baseline and the end of 8-week intervention, blood pressure and biochemical markers were conducted.

Official Title
-----------------
The Effects of Barberry Juice Consumption on Glycaemic Control, Lipid Profile, Blood Pressure and Oxidative Stress in Patients With Type 2 Diabetes: A Randomized Clinical Trial

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: barberry juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting blood glucose>100 mg/dL (5.6 mmol /L) Systolic blood pressure>130 mmHg or diastolic blood pressure>85mmHg Triglycerides> 150 mg/dL (1.7 mmol/L) Exclusion Criteria: taking insulin smoking using antioxidant supplements

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>patients in this group were received 200 ml/d barberry juice for tow month | Other: barberry juice<br> <br> |
| No Intervention: control group<br>patients in this group received no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting blood glucose |  | 8 weeks | 
| total cholesterol |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL- cholesterol |  | 8 weeks | 
| HDL- cholesterol |  | 8 weeks | 
| Triglyceride |  | 8 weeks | 
| HbA1c |  | 8 weeks | 
| Systolic BP |  | 8 weeks | 
| Diastolic BP |  | 8 weeks |
Evaluation of Next-Generation Sequencing-based Metabarcoding Versus Culturing for Microbiological Assessment in Infectious Keratitis

Study Overview
=================
Brief Summary
-----------------
Infectious keratitis is a potential sight threatening condition. In conventional clinical practice culturing is performed in order to identify the causative microbial organism; however in recent years Next Generation Sequencing for the presence of ribosomal DNA from bacteria, fungi, or amoeba has become available. The present study aims to compare conventional culturing with Next Generation Sequencing for identifying microorganism causing keratitis.

Detailed Description
-----------------
Patients admitted with microbial keratitis to the department of ophthalmology at Aarhus University Hospital is evaluated with both conventional culturing at agar plates, broth culture, and Next Generation Sequencing for ribosomal DNA. Only patients with a corneal infiltrate of a minimum of 2 mm or of 1 mm within the central 6 mm of the cornea will be included in the study. Sampling includes two samples from the contralateral healthy eye to control for the patient's normal microbiome, evaluated with culturing in broth and with NGS. From the infiltrate, samples include culturing on Sabouraud agar, chocolate agar, and blood agar, culturing in broth medium, and samples for NGS. A total of 100 patients will be included.

Official Title
-----------------
Evaluation of Next-Generation Sequencing-based Metabarcoding Versus Culturing in Infectious Keratitis

Conditions
-----------------
Keratitis

Intervention / Treatment
-----------------
* Diagnostic Test: Next generation sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with a corneal infiltrate of minimum 2 mm in diameter or of 1 mm diameter within the central 6 mm of the cornea Exclusion Criteria: - Patients below 18 years of age

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 |
| --- |
|Diagnostic Test: Next generation sequencing|Evaluation of microbiological culturing versus next generation sequencing for ribosomal DNA|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of clinically relevant microorganisms identified using culture or next generation sequencing |  | 1 year | 
| Comparison of clinically relevant identified microorganisms on a genus level |  | 1 year |
Vanderbilt-Zambia Innovations in Global Health Technologies

Study Overview
=================
Brief Summary
-----------------
Investigators will evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to process capillary blood in order to improve the sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria infection. Results will be compared to those obtained using unenhanced capillary blood specimens directly applied to approved malaria RDTs. Participants seeking care for possible malaria in Zambia will be recruited to enroll in the study.

Official Title
-----------------
Vanderbilt-Zambia Innovations in Global Health Technologies

Conditions
-----------------
Malaria Diagnosis

Intervention / Treatment
-----------------
* Other: mBEADS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals giving written informed consent for themselves Children under the age of 18 for whom a parent or guardian can give consent Individuals seeking care or treatment of suspected or possible malaria Individuals being screened as a contact of someone with recent malaria Other individuals willing to have their blood tested for malaria Exclusion Criteria: Anyone over 18 unwilling or unable to provide informed consent Anyone under 18 who does not have a parent or guardian to give consent Anyone between the age of 12 and 18 who does not give assent

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: mBEADS|Evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to improve the sensitivity of already approved malaria RDTs.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enhancement of malaria RDT to detect low levels of P falciparum parasites | The expected outcome of this research project is to enhance the ability of standard malaria RDTs to detect low levels of Plasmodium falciparum malaria in human capillary blood. | 5 years |
Assessing the Quality of Life in Adults With Spinal Deformity

Study Overview
=================
Brief Summary
-----------------
Spinal deformities, such as scoliosis, can have a significant impact on the physical and psychological health of patients. Over time, specific tools for this condition have been developed to investigate the extent of this impact, such as the SRS-22 questionnaire and ISYQOL questionnaire. The latter was initially used for underage patients, but given that some of them continue their therapy and the monitoring beyond the age of 18, we have continued its use in these subjects as well. Given the clinical usefulness and given the lack of questionnaires developed in the Rasch environment for adults, we have extended the application of the ISYQOL questionnaire to the adult population. However, a comparison between the ISYQOL and SRS-22 in adults has not yet been made. The objective of this study is to verify the validity of ISYQOL and to compare the properties of ISYQOL with those of the SRS-22 questionnaire in adults with spinal deformity.

Official Title
-----------------
Assessing the Quality of Life in Adults With Spinal Deformity: a Retrospective Comparison Between Two Questionnaires

Conditions
-----------------
Scoliosis, Quality of Life

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Diagnosis of idiopathic or degenerative scoliosis with ≥30 ° Cobb curve Exclusion Criteria: Previous spinal surgery Previous and relevant illnesses, surgery or trauma

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 |
| --- | --- |
| Quality of life<br>Adult patients treated conservatively for idiopathic scoliosis or undergoing clinical monitoring who have completed both questionnaires at least once and simultaneously and who meet the following inclusion criteria: Age ≥ 18 years Diagnosis of idiopathic or degenerative scoliosis with curve ≥30 ° Cobb | Other: Questionnaire<br>* Adults with spinal deformities were asked to complete two questionnaires assessing quality of life<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical properties of SRS-22 and ISYQOL questionnaire | The Spearman correlation coefficient will be used to evaluate the concurrent validity of ISYQOL questionnaire. Cronbach's alpha will be used to evaluate the internal validity of ISYQOL questionnaire. Rasch analysis will be applied to explore the characteristics of the two tools. In addition, the reproducibility of the measurement. Usually, the goal is to obtain a reliability> 0.8. | through study completion, an average of 1 year |