linjc16/ctgov huggingface dataset:
Radiofrequency Ablation of Atrial Fibrillation Under Totally Thoracoscope

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation (AF) is a common supraventricular arrhythmia, the incidence of which increases with age. The aim of treatment of atrial fibrillation is to restore sinus rhythm and return the heart to atrioventricular synchrony, avoiding the risk of thromboembolism. The fact that pharmacological therapy of AF is at best 50% effective has led to a search for surgical approaches over the last 20 years. Maze procedure was a classic method to treat AF. However, it is such a complex procedure that very few surgeons have adopted it. A few minimally invasive procedures to create transmural lesions which mimic MAZE procedure have been introduced. One of the mostly favored methods is catheter-based radiofrequency ablation, another one is video assisted epicardial radiofrequency ablation through small thoracic incisions in operating room. Recently, we invented an epicardial radiofrequency ablation method under totally thoracoscope, which further minimized the surgery trauma and increased the cosmetic effect.

Official Title
-----------------
Clinical Study of Radiofrequency Ablation of Atrial Fibrillation Under Totally Thoracoscope

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

Intervention / Treatment
-----------------
* Procedure: epicardial radiofrequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patients with atrial fibrillation Exclusion Criteria: Patients with hemostasis defects patients can not endure general anesthesia

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ablation<br>patients with atrial fibrillation underwent radiofrequency ablation with totally thoracoscope. | Procedure: epicardial radiofrequency ablation<br>* epicardial radiofrequency ablation to treat atrial fibrillation under totally thoracoscope<br>* Other names: radiofrequency ablation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiography |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, radiofrequency, totally thoracoscope, epicardial
Image Guidance for Improved Vessel Cannulation in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios.

Detailed Description
-----------------
Phase I Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios. n=5 patients will be enrolled, and success would be 4 children (80%) successfully cannulated with a single pass using the P-SCENERGY.

Official Title
-----------------
Image Guidance for Improved Vessel Cannulation in Pediatric Patients

Conditions
-----------------
Central Vein Cannulation

Intervention / Treatment
-----------------
* Device: central vein cannulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients of weight between 5 and 25 kg requiring a central vein cannulation Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: central vein cannulation|central vein cannulation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Central Vein Cannulation | device enabled successful cannulation on the first pass showing feasibility to aid in cvcs | 1 day |
An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).

Study Overview
=================
Brief Summary
-----------------
The DEScover Registry is designed to observe the results of using Drug Eluting Stents (DES) in patients in a real-world setting. The stents being observed are not investigational, that is, they have been approved for use in the general population.

Detailed Description
-----------------
The D.E.S.cover Registry is a prospective, multi-center, observational study. Consecutive patients undergoing PCI procedures will be asked to consent to participate in this study. For these patients, baseline, clinical and angiographic characteristics, as well as certain procedural and clinical events will be recorded using standardized case report forms. Outcomes will be assessed during hospitalization and at one, six and twelve months after discharge. Depending on results from the first year of follow-up, the study may be extended with an additional one or two years of follow-up. The strategy for achieving the scientific objectives of the Registry is to document actual, real-world PCI practice and outcomes. Accordingly, the D.E.S.cover Registry does not specify treatment protocols, require any particular assignment of patients to treatment protocols, or in any other way require participating physicians to alter their practice patterns. Participating physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the D.E.S.cover Registry database.

Official Title
-----------------
An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).

Conditions
-----------------
Cardiovascular Diseases, Vascular Disease, Arterial Occlusive Disease, Arteriosclerosis, Atherosclerosis

Intervention / Treatment
-----------------
* Device: Cypher Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients undergoing percutaneous coronary intervention at an enrolling center by study investigators Exclusion Criteria: Patient refusal or inability to provide written informed consent and/or HIPAA authorization
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cypher Stent|nan|

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
-----------------
Coronary disease, Arteries, Atherosclerosis, Arteriosclerosis
Treatment of Stress Urinary Incontinence by Injection of Autologous Muscle Fibers Into the Urethral Sphincter.

Study Overview
=================
Brief Summary
-----------------
This pilot study examines safety and efficacy of a simple procedure for treatment of stress urinary incontinence. A muscle biopsy is taken from the thigh, minced and injected into the urethral sphincter.

Official Title
-----------------
Autologous Muscle Fiber Transplantation for Repair of the Urethral Sphincter in Patients With Stress Urinary Incontinence

Conditions
-----------------
Urinary Incontinence, Stress

Intervention / Treatment
-----------------
* Procedure: Periurethral injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stress urinary incontinence refractory to conservative treatment. Exclusion Criteria: urge urinary incontinence Pregnancy Pelvic organ prolapse > grade 1

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

Sexes Eligible for Study
-----------------
Female

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: periurethral injection<br>Periurethral injection of autologous muscle fibers | Procedure: Periurethral injection<br>* Periurethral injection of autologous muscle fibers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of incontinence episodes | Reduction in the number of leakages in three days | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Consultation on Incontinence (ICIQ)short form incontinence score |  | 12 months | 
| Intraurethral pressure measured by reflectometry |  | 12 months | 
| Uroflow |  | 12 months | 
| Adverse events peri- or postoperatively |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary incontinence, stress, autologous
Preoperative i.v. Iron Substitution in Patients With Colon Cancer

Study Overview
=================
Brief Summary
-----------------
About 70% of colon cancer patients are anemic. Preoperative anemia in patients with colorectal cancer is associated with both impaired disease-free survival and overall survival. The purpose of this study is to compare the effects of preoperative iv iron substitution on postoperative recovery in preoperatively anemic (male Hb <130, female Hb <120) and iron deficient colon cancer patients in a prospective setup. As a primary outcome, the effect of iv-iron substitution on postoperative complications is investigated.

Detailed Description
-----------------
Randomized preoperative iron substitution for patient with iron deficient anemia

Official Title
-----------------
Preoperative i.v. Iron Substitution in Patients With Colon Carcinoma and Iron-deficiency Anemia

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Drug: Ferric carboxymaltose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years Dg: Colon ca The planned measure: the colon resection Men: Hb <130, women: Hb <120 and iron deficiency (elevated TfR, low TrFesat or low ferritin) Exclusion Criteria: hyperreactivity for Ferinject haemochromatosis refusal for participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron arm<br>Half of patients get i.v. iron preoperatively | Drug: Ferric carboxymaltose<br>* Iron-arm treated with Ferric carboxymaltose, non-iron arm without<br>* Other names: Ferinject (intravenous iron );|
| No Intervention: non-iron arm<br>Half of patients are treated without i.v. iron substitution | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | At study, difference between arms will be evaluated: Complications are analysed using Clavien-Dindo classification https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360123/bin/3TT1.jpg | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for red blood cell transfusion | Number of Participants in need for red blood cells transfusion per arm | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative complications
Genetic Architecture of Avoidant/Restrictive Food Intake Disorder

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to rapidly accelerate knowledge about the biology of avoidant and restrictive food intake disorder or ARFID in children ages 7-17 and in adults. The investigators will be evaluating the genetic and environmental origins of ARFID. Participants will be asked to answer questionnaires online and to submit a saliva sample for DNA using a kit that will be mailed to their home.

Official Title
-----------------
Genetic Architecture of Avoidant/Restrictive Food Intake Disorder

Conditions
-----------------
ARFID, Eating Disorders, Eating Disorders in Children, Eating, Picky

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet study criteria for ARFID Be willing to submit a saliva sample Have a US mailing address English-speaking Exclusion Criteria: Potential other eating disorders

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 99 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 |
| --- | --- |
| Cases<br>Participants will self-select into the study. All enrolled will meet study specific criteria and be considered cases. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Case definitions | Number of enrolled individuals who meet the case definition | Baseline |
Urine NT-proBNP Levels and Echocardiographic Findings in Very Low Birth Weight (VLBW) Infants

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate urine NT-proBNP levels and new Echocardiographic Findings in VLBW infants. The investigators hypothesize that high urine NT-proBNP concentrations are associated with a hemodynamically significant ductus arteriosus. The investigators also hypothesized that new echocardiographic parameters such as isovolumic relaxation time (IVRT)is useful for the prediction of ductus intervention.

Detailed Description
-----------------
Urine samples were collected within 24 to 48 hours of age, on day 7, on day 14 and on day 28 of life. The samples were spun and the platelet-free urine was stored at -80°C until NT-proBNP analysis. The NT-proBNP assay was performed with an automated immunoassay (Roche Diagnostics). Color Doppler and tissue Doppler echocardiography was determined at the same time as the urine collection. New echo parameters such as IVRT, tissue velocity, strain and strain rate were measured and compared with the standard parameters for significant ductus arteriosus. Furthermore we compared the tissue Doppler measurements with clinical findings.

Conditions
-----------------
Infant, Premature, Ductus Arteriosus, Patent, Ventricular Function, Left

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written parental informed consent VLBW infants Admitted to our NICU within 48 hours after birth Exclusion Criteria: No written parental informed consent Congenital heart disease Death

Ages Eligible for Study
-----------------
Minimum Age: 24 Hours
Maximum Age: 48 Hours

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
-----------------
NT-proBNP
A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in patients with advanced solid tumors.

Official Title
-----------------
A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors, Recurrent or Refractory Medulloblastoma, Locally Advanced or Metastatic Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: LEQ506


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma or locally advanced or metastatic basal cell carcinoma) Protocol defined laboratory parameters Performance status ≤ 2 Patients must have fully recovered from the prior effects of major surgery and from any acute toxicities of prior chemotherapy/radiotherapy Exclusion Criteria: History of central nervous system tumors of symptomatic brain metastases (excludes medulloblastoma patients) Impairment of gastrointestinal function or unresolved nausea, vomiting or diarrhea Impairment of cardiac function or significant cardiac disease Pregnant or lactating women Other protocol-defined inclusion/exclusion criteria may apply

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEQ506<br> | Drug: LEQ506<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506 |  | 21 day cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the safety and tolerability of LEQ506 treatment |  | 21 day cycles | 
| To characterize the pharmacokinetics of LEQ506 |  | 21 day cycles | 
| To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples |  | 21 day cycles | 
| Tumor response |  | every 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced solid tumors, recurrent or refractory medulloblastoma, locally advanced or metastatic basal cell carcinoma, hedgehog pathway inhibitor
Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.

Official Title
-----------------
Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart
* Drug: insulin glargine
* Drug: metformin
* Drug: glimepiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 6 months Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed Previous treatment with oral antidiabetic drugs for at least 4 months Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen BMI below 40 kg/m2 HbA1c between 7-12% Able and willing to perform self-plasma glucose monitoring Exclusion Criteria: The receipt of any other investigational drug within 4 weeks before screening A history of drug or alcohol abuse within the last 12 months Severe, uncontrolled hypertension Known or suspected allergy to trial products or related products

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|
|Drug: insulin glargine|nan|
|Drug: metformin|nan|
|Drug: glimepiride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 16 weeks of treatment | 
| Plasma glucose profiles |  |  | 
| Change in body mass index |  |  | 
| Incidence of hypoglycaemic episodes |  |  | 
| Safety profile |  |  |