linjc16/ctgov huggingface dataset:
The Efficacy and Safety of CARTO 3D Mapping System Versus Conventional Method in AF and VT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of electroanatomic imaging compared to conventional method in patients with VT.

Detailed Description
-----------------
To evaluate the efficacy and safety of electroanatomic imaging (CARTO) compared to conventional fluoroscopically guided activation mapping (Conventional) method in patients with Atrial Fibrillation and Substrate-dependent Ventricular Tachycardia To evaluate cost-effectiveness of CARTO 3D image system compared to conventional method in the same study subjects

Official Title
-----------------
Phase Ⅳ Study of CARTO 3D Mapping System vs Conventional Method in AF & VT

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: CARTO 3D
* Device: Angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with AF or substrate-dependent VT Exclusion Criteria: administering with anticoagulants

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Angiography<br>Conventional fluoroscopically guided activation mapping | Device: Angiography<br>* Conventional fluoroscopically guided activation mapping<br>* Other names: Celsius;|
| Experimental: CARTO 3D<br>CARTO (3D Electroanatomic imaging) | Device: CARTO 3D<br>* CARTO (3D Electroanatomic imaging)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoroscopic time | Total duration of procedure using fluoroscopy on , in minute | 24weeks | 
| Procedural duration | Time from after puncture to catheter remover | 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablation time | Time from to Ablation | 24weeks | 
| Procedural Success | Achievement of the procedure endpoint for each arrhythmia | 24weeks | 
| Clinical Success | 3 months freedom from recurrence of target arrhythmia > 6 months freedom from recurrence of target arrhythmia | 24weeks | 
| Radiation dose | Calculated dose (in Gray) to the patient as recorded in the laboratory log | 24weeks | 
| Morphology of ablation | Number of Gap and the distance from the ostia of the pulmonary veins (In conventional group) | 24weeks | 
| Complications | procedure and device related adverse event requiring any intervention to prevent permanent medical intervention Important complications are reported individually | 24weeks | 
| Cost Effectiveness |  | 24weeks | 
| Survival Rate |  | 24weeks |
Bile Leak After Liver Surgery

Study Overview
=================
Brief Summary
-----------------
The definition of biliary fistula is heterogeneous and the more accepted is that proposed by the ISGLS. We devised a precise definition of post-resectional biliary fistula and a well-established policy both for its disclosure and management.Aim was the validation of our definition, and management of biliary fistula after hepatic resection in a large prospective cohort of patients and its comparison with that of the International Study Group of Liver Surgery (ISGLS).

Detailed Description
-----------------
Data on abdominal drains and on clinical, pathological and short-term outcome were reviewed in a prospective cohort of patients who underwent hepatic resection between 2004 and 2012. Drains were maintained at least 7 days, and the bilirubin levels were measured in POD3, 5, and 7. Drains were removed if the bilirubin level in POD7 was inferior than in POD5, and less than 10 mg/dl. Statistical analysis on prognostic factors for biliary fistula was performed.

Official Title
-----------------
Validation of Our Policy of Long-term Drains Maintenance After Hepatic Resection: Results of a Prospective Cohort Analysis

Conditions
-----------------
Bile Leak, Hepatic Resection, Liver Resection, Hepatectomy, Biliary Fistula

Intervention / Treatment
-----------------
* Procedure: Hepatic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient submitted to hepatic resection at our Unit between the established frame time Exclusion Criteria: any patient with incomplete data or follow-up

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bile leak after hepatic resection<br> | Procedure: Hepatic resection<br> <br> * Other names: Hepatectomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bile leak | The first study endpoint was the ability of our criteria to detect and manage bile leak after liver surgery. For this purpose we considered the rate of bile leaks detected and managed using the surgical drains, and the rate of abdominal collections that required any surgical or radiological intervention after drains removal. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ISGLS definition | The second endpoint was the exploration of the ISGLS definition of bile leak in the herein presented cohort of patients in regards of the rate of bile leaks and abdominal collections. | 7 days | 
| ISGLS definition | Exploration of reliability and efficacy of the International Study Group on Liver Surgery (ISGLS) definition of bile leak after hepatectomy | 90 days |
A Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal residual disease after autologous haematopoietic stem cell transplantation (bone marrow or peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2 intravenously once every week. The anticipated time on study treatment is 4 weeks.

Official Title
-----------------
Multicentre, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab in Patients Suffering From Follicular Non-Hodgkin's Lymphoma (FNHL) With Residual Minimal Disease After Autologous Transplantation of hematopoïetic Stem Cell (Bone Marrow or Peripheral Blood)

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: rituximab [MabThera/Rituxan]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, 18-75 years of age Diagnosis of follicular non-Hodgkin's lymphoma (FNHL) Previously treated with chemotherapy with autologous haemotopoietic stem cell transplantation (bone marrow or peripheral blood cells) Exclusion Criteria: Active viral hepatitis Eastern Cooperative Oncology Group (ECOG) performance status >2 Patients not willing to sign informed consent form

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Drug: rituximab [MabThera/Rituxan]<br>* 375 mg/m2 intravenously once a week for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response rate according to World Health Organization criteria (Group A) |  | Day 50 | 
| Normalization of B-cell lymphoma 2 levels |  | Day 50 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 3 years | 
| Progression-free survival |  | 3 years | 
| Duration of treatment response |  | 3 years |
Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy

Study Overview
=================
Brief Summary
-----------------
Recently, treatment with tafamidis in patients with cardiac ATTR lead to a significant reduction in mortality. The Perugini score is commonly used on planar bone scans to differentiate cardiac ATTR from other amyloidosis or normal patients but fails to evaluate amyloid burden and patient prognosis. Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.

Detailed Description
-----------------
Cardiac amyloidosis is a cause of restrictive cardiomyopathy with preserved ejection fraction associated with amyloid fibrils deposits in the myocardium. Two types of amyloid commonly infiltrate the heart: immunoglobulin light-chain amyloid (AL), and transthyretin-related amyloid amyloidosis (ATTR). Cardiac imaging is currently used for the diagnosis of ATTR, including planar scintigraphy with bone seeking radiopharmaceuticals, cardiac magnetic resonance and echocardiography with global longitudinal strain assessment.Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.

Official Title
-----------------
Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy for the Follow-up of Patients With Transthyretin Amyloidosis Treated With Tafamidis

Conditions
-----------------
Cardiac Amyloidosis

Intervention / Treatment
-----------------
* Diagnostic Test: bone scintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient, male or female, over 18 years of age Patient diagnosed with transthyretin cardiac amyloidosis confirmed by scintigraphy Patient with signed consent Exclusion Criteria: Patients with systemic AL amyloidosis Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision Pregnant or breastfeeding woman

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 |
| --- | --- |
| Other: Patients with transthyretin related cardiac amyloidosis<br>Bone scintigraphy | Diagnostic Test: bone scintigraphy<br>* Bone scintigraphy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy |  | 6 months |
A Study Evaluating Splinting and Casting for Distal Radius Fractures in the Elderly

Study Overview
=================
Brief Summary
-----------------
Distal radial fractures are the most common fracture of the upper extremity in adults, with a higher incidence in those 65 years of age or older. In 2009, Karl et al demonstrated that there are 25.42 distal radial fractures in this age group per 10,000 person-years in the US. Despite the frequency of distal radius fractures, there is still debate over the best method of treatment. In contrast to younger patients, patients who are 65 years or older appear to have acceptable functional outcomes and treatment satisfaction regardless of the presence of malalignment on radiographic imaging.Therefore, nonsurgical management has been shown to be a viable treatment option. The purpose of this study is to compare non-operative treatment with a removable splint versus a short arm cast for distal radial fractures in patients who are 65 years of age or older who are indicated for non-operative fracture treatment.

Official Title
-----------------
A Prospective Randomized Evaluation of Splinting and Casting for Distal Radius Fractures in the Elderly

Conditions
-----------------
Distal Radius Fracture

Intervention / Treatment
-----------------
* Other: Wrist Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients greater than 65 years old with isolated distal radius fracture amenable to non-operative treatment Exclusion Criteria: Patients younger than 65 years old Open fractures (Gustilo Grade 2 or 3) Pathologic fractures Multiple fractures in the upper or lower extremities Fracture indicated for surgical repair of the distal radius for any reason Lack of health insurance Inability to provide consent to the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cast Group<br>participant with distal radius fracture will be treated with short arm fiberglass cast | Other: Wrist Rehabilitation<br>* participants will undergo immobilization for the first 6 weeks of treatment<br>|
| Other: Splint Group<br>participant with distal radius fracture will be treated with short arm velcro wrist splint | Other: Wrist Rehabilitation<br>* participants will undergo immobilization for the first 6 weeks of treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture treatment outcome | The rate of successful outcomes of participants who are treated for a distal radius fracture nonsurgically by splinting compared to participants who are treated by casting | 6 weeks |
Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the clinical characteristic of recurrent acute rhinosinusitis in children.

Official Title
-----------------
Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children

Conditions
-----------------
Acute Recurrent Sinusitis

Intervention / Treatment
-----------------
* Other: Recurrent Acute Rhinosinusitis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children the age less than 15 years with recurrent acute rhinosinusitis who are attending the pediatric allergy clinic during Jan 2010 - Dec 2012. Exclusion Criteria: Children who had lost medical record.

Ages Eligible for Study
-----------------
Maximum Age: 15 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 |
| --- | --- |
| Recurrent Acute Rhinosinusitis<br>Recurrent Acute Rhinosinusitis is defined as acute rhinosinusitis more than 3 times/6 months or more than 4 times/year | Other: Recurrent Acute Rhinosinusitis<br>* Clinical Characteristic of Recurrent Acute Rhinosinusitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presenting symptoms of recurrent acute rhinosinusitis |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age of onset |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Characteristic, Recurrent Acute Rhinosinusitis, Children
Long-term Study of CS-3150 as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
To examine antihypertensive effect, pharmacodynamics, and safety of long-term administration of CS-3150 as monotherapy and in combination with calcium channel blocker or renin-angiotensin system inhibitor in patients with essential hypertension.

Official Title
-----------------
Open-label, Multicenter, Interventional, Dose Titration Study to Assess the Long-term Study of CS-3150 2.5mg and 5mg Alone as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: CS-3150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged 20 years or older at informed consent Subjects with essential hypertension, who do not receive any antihypertensive drugs or receive calcium channel blocker, angiotensin converting enzyme ACE inhibitor, or angiotensin-II receptor blockade ARB during run-in period (Sitting systolic blood pressure SBP ≥ 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure DBP ≥ 90 mmHg and < 110 mmHg, and mean 24hr SBP ≥ 130 and DBP ≥ 80 mmHg) Exclusion Criteria: Secondary hypertension or malignant hypertension Diabetes mellitus with albuminuria Serum potassium level < 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive ACE inhibitor, or ARB) Reversed day-night life cycle including overnight workers estimated glomerular filtration rate eGFR < 60 mL/min/1.73 m^2.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: CS-3150<br>CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks | Drug: CS-3150<br>* CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in sitting systolic and diastolic blood pressure |  | week 0 (baseline) to end of weeks 12, 28, and 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 24-hr ambulatory blood pressure monitoring (ABPM) |  | week 0 (baseline) to end of weeks 12, 28, and 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Essential hypertension, Long-term treatment, Mineralocorticoid receptor antagonist
The PerX360º System™ Registry

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, non-randomized post marketing surveillance registry including up to 125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should be per standard of care.

Detailed Description
-----------------
For all patients participating in the registry, the following outcomes will be analyzed: Change in pain score on the Visual Analog Scale(VAS) from baseline for leg pain Change in pain score on the Visual Analog Scale(VAS) from baseline for back pain Change in Oswestry Disability Index (ODI) score from baseline Proportion of patients with a device related complication Proportion of patients with lack of revision, removal, or reoperation Proportion of patients with radiographic fusion

Official Title
-----------------
An Observational, Multi Center, Non-Randomized (Single Arm) Registration of the PerX360º System™

Conditions
-----------------
DDD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient understands the nature of the procedure and provides written informed consent Patient is willing to return to the treating physician for his/her routine follow-up visits up to 12 months post treatment Age > 18 years Patient is treated with the Optiport™ and Opticage™ products 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PerX360º System™<br>Patients treated with PerX360º System™ | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion | Image Assessment | 1 year |