linjc16/ctgov huggingface dataset:
Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath

Study Overview
=================
Brief Summary
-----------------
Purpose: An evidence implementation of a randomized controlled trial for whether there is the difference in intermittent flushing 0.9% normal saline and heparin? Design: a single-blind randomized controlled trial Method: This study is based on the 5A (Ask, Acquire, Appraise, Apply, Audit) of evidence health care step, and design randomized controlled trial for evidence implementation. We will include inpatients over 20 years-old adults in New Taipei City TuCheng Hospital, Taiwan, who need administration medicine by port-a-catcher. The sample size is 192 according to G-power software. Random allocation software has using for block randomization, would assign to group A: flushing with 0.9% normal saline 10ml, group B: flushing with 0.9% normal saline 20ml, and group C: flushing with heparin 100 USP/ml. SPSS 20.0 software for statistical analysis, mean or standard deviation, one- way ANOVA would use.

Official Title
-----------------
Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath: Randomized Controlled Trial

Conditions
-----------------
Port-a-cath Occlusion, Normal Saline, Heparin Lock

Intervention / Treatment
-----------------
* Drug: Normal Saline Flush 20 ml
* Drug: Normal Saline Flush 10 ml
* Drug: Heparin Flush (1000 USP, 10ml)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-pediatric inpatients over 20 years of age with PAC placed for any disease and who need medication during hospitalization. Exclusion Criteria: History of PAC obstruction, continuous high volume drip via PAC, taking anticoagulant or antiplatelet agents, abnormal blood coagulation, pregnancy or contraceptive use, specified flushing solution by case

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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal saline 20 ml<br> | Drug: Normal Saline Flush 20 ml<br>* Normal Saline Flush 20 ml<br>|
| Experimental: Normal saline 10 ml<br> | Drug: Normal Saline Flush 10 ml<br>* Normal Saline Flush 10 ml<br>|
| Active Comparator: usual care (heparin)<br> | Drug: Heparin Flush (1000 USP, 10ml)<br>* Heparin Flush (1000 USP, 10ml)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| port-a-cath occlusion | failure to infusion fluid | in hospitalized (during admission), up to 12 weeks | 
| port-a-cath infection | blood culture from port-A show bacterial growth | in hospitalized (during admission), up to 12 weeks |
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this early feasibility study is to assess the predictive low glucose suspend (PLGS) feature's safety, functionality and performance.

Official Title
-----------------
An Early Feasibility Study to Evaluate the Predictive Low Glucose Suspend Functionality and Safety in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: AID System
* Drug: Insulin Lispro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months Have a body mass index of 18.5 to 37 kilogram per meter squared Have a hemoglobin A1c level ≥6.0% and ≤9.0% Exclusion Criteria: Have known allergies or history of hypersensitivity to insulin lispro Have had an episode of severe hypoglycemia within the past 6 months Have had more than 1 episode of diabetic ketoacidosis in the past 6 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AID System Containing Insulin Lispro<br>The automated insulin delivery (AID) system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a PLGS algorithm, and a continuous glucose monitor (CGM) component. | Device: AID System<br>* AID system<br>* Other names: LY8888AU;Drug: Insulin Lispro<br>* Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.<br>* Other names: LY275585;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AEs) | Number of AEs | In-Patient Period (2 Days) | 
| Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL | CGM measured percentage of time <70 milligrams per deciliter (mg/dL) | In-Patient Period (2 Days) |
Assessment of Left Ventricular Diastolic Function in Patients With Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This study is a single-center, prospective cohort study to investigate non-invasive method to assess left ventricular diastolic function using echocardiography. Patients with AF who are referred radiofrequency catheter ablation (RFA) will be included prospectively. Transthoracic echocardiography will be performed during, immediately before RFA and with no cardiovascular medication taken between the exams so that the loading conditions during catheterization and echocardiography are as similar as possible. We will validate previously proposed echocardiographic parameters and creat an algorithm to identify the relationship between echocardiographic parameters of diastolic function and invasively measured LA pressure in patients with atrial fibrillation.

Official Title
-----------------
Assessment of Left Ventricular Diastolic Function in Patients With Atrial Fibrillation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ≥ 19 year-old Patients who scheduled to perform radiofrequency catheter ablation for atrial fibrillation Patients who had paroxysmal, persistent, or chronic AF Patients provided with the written, informed consent to participate in this study Exclusion Criteria: Patients with prosthetic valve Life expectancy < 12 months Subject who the investigator deems inappropriate to participate in this study

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Association between mean left atrial pressure and echocardiographic parameters | Correlation between echocardiographic parameters or algorithm to estimate invasively measured left atrial pressure. Echocardiographic parameters: E/A ratio, E velocity, e' velocity, E/e', IVRT. LV strain, RV strain,, LA strain, Vp, E/Vp, LA volume index, TV V max, and Peak acceleration rate of mitral E velocity | up to 12 weeks after collecting all data |
Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.

Study Overview
=================
Brief Summary
-----------------
The degree of TH1-skewing by mycobacteria is controlles by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.

Detailed Description
-----------------
A randomised single blinded intervention study in high-risk newborns vaccinated at the age of 6 weeks with BCG or placebo. Inclusion: high-risk was defined as either a mother or a father and a sibling with present or past atopic disease. Exclusion: maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother), the use of antibiotics directly post-partum (newborn)

Official Title
-----------------
Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.

Conditions
-----------------
Food Allergy, Atopic Dermatitis, Asthma, Rhinitis

Intervention / Treatment
-----------------
* Biological: BCG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high-risk was defined as either a mother or a father plus a sibling with present or past atopic disease. Exclusion Criteria: maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother) or directly post partum (newborn)

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: BCG|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of atopic disease. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prospective, randomised, intervention, BCG, atopy
Accuracy of MRI-based Patients Matched Instruments vs Jig-based Instruments in Total Knee Arthroplasty (TKA)

Study Overview
=================
Brief Summary
-----------------
Total knee arthroplasty (TKA) is the common and effective procedure for treatment of end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important factors which effects on survival of prosthesis. High percentage of misalignment has been reported in conventional technique with using the jig based instruments. Several methods and devices were established to solve this problem. Customized or patient matched instruments were the novel technology that made from magnetic resonance imaging (MRI) of lower limb. With using special software to calculate the alignment axis, it was thought that accurate alignment can be achieved by using this instruments. Therefore, the study aimed to compare the accuracy of MRI based patient matched instruments and jig based instruments in TKA.

Official Title
-----------------
Accuracy of MRI-based Patients Matched Instruments and Jig-based Instruments in Total Knee Arthroplasty

Conditions
-----------------
Osteoarthritis of Knee

Intervention / Treatment
-----------------
* Device: Patient matched instruments
* Device: Jig based instruments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed primary osteoarthritis of knee and planned to undergo total knee arthroplasty Exclusion Criteria: Previous complex surgery of the affected knee Metalic implant in the affected lower limb Patients who unable or contraindicated to perform MRI Extra-articular deformities of the affected lower limb Extensive bone loss of distal femur or/and proximal tibia More than 30 degrees of knee flexion contracture Unable to perform TKA within 12 weeks after MRI

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Experimental: Group 1<br>Patient matched instruments | Device: Patient matched instruments<br>* The patients undergo TKA with using patient matched instruments<br>* Other names: The Zimmer Patient Specific Instruments System;|
| Experimental: Group 2<br>Jig based instruments | Device: Jig based instruments<br>* The patients undergo TKA with using jig based instruments<br>* Other names: Zimmer Nexgen LPS MIS system;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The alignment of mechanical axis after TKA |  | Within 1 month after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The alignment of femoral and tibial components after TKA |  | Within 1 month after operation |
Assisted Fluid Management IDE Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.

Detailed Description
-----------------
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness. Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.

Official Title
-----------------
A Validation of the Assisted Fluid Management Feature

Conditions
-----------------
Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery, Pelvic Surgery, Major Peripheral Vascular Surgery

Intervention / Treatment
-----------------
* Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be ≥ 18 years of age Abdominal, pelvic, major peripheral vascular surgery expected to last >2 hours post anesthesia induction Participate or have authorized representative participate in the Informed Consent process and sign/date the IRB approved informed consent form. Exclusion Criteria: Are < 18 years of age Emergent or cardiovascular surgical procedure Are pregnant Participation in any other drug, device, or biologic study concomitantly, or within the last 30 days (which may clinically interfere with this Clinical Study) Refusal of patient or authorized representative to sign consent

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: Assisted Fluid Management<br> | Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature<br>* Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the Assisted Fluid Management Feature: Stroke volume change meeting the clinician-selected fluid strategy | Stroke volume change meeting the clinician-selected fluid strategy | 30 Day follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Cardiac, Non-Thoracic, Fluid Management, Perioperative Goal Directed Therapy
LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)

Study Overview
=================
Brief Summary
-----------------
Two weeks study to evaluate the efficacy and safety of Levocetirizine and Desloratadine in patients suffering from Allergic Rhinitis (AR)

Official Title
-----------------
A Multicentre, Double-blind, Parallel, Randomized, Placebo-controlled Study : Evaluation of the Efficacy and Safety of Levocetirizine 5 mg and Desloratadine 5 mg Administered Orally as Capsules Once Daily, in the Morning, Over 2 Weeks in Patients Suffering From Allergic Rhinitis (AR)

Conditions
-----------------
Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Drug: Levocetirizine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 2-year history of Allergic Rhinitis that became symptomatic during the annual grass pollen season. A skin test for grass pollens positive: Have rhinitis symptoms of such severity that the mean T4SS over the baseline period must be 6. Exclusion Criteria: Have an associated asthma requiring corticosteroid treatment, Have an atopic dermatitis or an urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids,

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levocetirizine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline of T4SS (four symptoms score) over two weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy over the first and over two weeks of treatment measured by symptoms (scored and individuals); Onset of action; Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic Rhinits, Symptoms (sneezing, rhinorrhea, nasal/ocular pruritus, nasal congestion), LEADER, Xyzal, Levocetirizine
Preoperative Assessment for Synchronous Carcinoma or Polyps With Magnetic Resonance (MR) Colonography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to diagnose possible synchronous carcinomas and polyps with magnetic resonance (MR) colonography in patients booked for operation because of carcinoma in the descending or sigmoid colon, where a preoperative full colonoscopy is not possible. Two days before colonography, patients ingest a 200 ml Barium sulfate solution four times a day, which will render fecal masses invisible on the following MR colonography. The study is primarily a feasibility study with altered operative strategy as a secondary end-point. Gold standard is colonoscopy and operation.

Official Title
-----------------
Preoperative Assessment for Synchronous Carcinoma or Polyps With MR Colonography in Patients With Obstructing Cancer. A Prospective Study.

Conditions
-----------------
Obstructing Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: MR colonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obstructing colorectal cancer Exclusion Criteria: Suspicion of IBD Pacemaker Metal in the body Claustrophobia Pregnancy

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MR colonography|Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps |  | 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Altered operative strategy due to findings on MR colonography |  | 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer, polyps, Virtual colonoscopy, synchronous carcinoma, MR colonography
The Impact of Infectious Disease on QT Segment

Study Overview
=================
Brief Summary
-----------------
Sepsis related to the development of cardiac complications. However, the investigators understanding regarding this condition remains incomplete. Possible explanations raised include coronary perfusion decrease, activation of the coagulation system and release of inflammatory mediators, including endotoxins, cytokines and others. In this study the investigators wanted to examine the impact of any infectious disease, (not necessarily Pneumonia), on the QT interval in patients hospitalized for acute infectious disease.

Official Title
-----------------
The Impact of Infectious Disease on QT Segment

Conditions
-----------------
Sepsis, Pneumonia, Cardiomyopathy, Secondary

Intervention / Treatment
-----------------
* Device: ekocardiogram test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Internal ward hospitalized patient, due to illness which its etiology is bacterial, fungal or viral Exclusion Criteria: Can not technically perform reliably ECG (amputated legs, lack of cooperation, etc.) Subject with permanent pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- |
| Patients admitted to an internal medicine department due to an<br> | Device: ekocardiogram test<br>* ekocardiogram test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolongation of the QT | QT will be measured by ECG | 5 days |