linjc16/ctgov huggingface dataset:
Optimization of Spectroscopic Imaging Parameters and Procedures for Prostate at 3 Tesla Using an External Probe

Study Overview
=================
Brief Summary
-----------------
This study performed a retrospective analysis of patient images to develop software in determining dose delivered for each fraction treatment.

Official Title
-----------------
Optimization of Spectroscopic Imaging Parameters and Procedures for Prostate at 3 Tesla Using an External Probe

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject 18 years of age and over

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

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

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 |
| --- | --- | --- |
PrOgnosis Following Esophageal fisTula formaTion in Pts Undergoing cathetER Ablation for AF Study

Study Overview
=================
Brief Summary
-----------------
Pulmonary vein isolation emerged as an effective and safe strategy to treat atrial fibrillation patients. Atrio-oesophageal fistula (AOF) represents a rare but devastating complication of AF ablation procedure. This complication (0.016-0.07%) requires an international effort to allow for better understanding of the factors contributing to its occurrence and the best management strategies. A worldwide, retrospective, multicenter registry focusing on the incidence, diagnosis and management of this complication.

Detailed Description
-----------------
Data about the incidence, optimal management and outcome of AOF is sparse. The largest national and international surveys report on less than 50 AOF. The latest worldwide survey was conducted in 2015 and managed to include 31 patients who developed AOF after atrial fibrillation ablation procedure. In the meanwhile, the total number of AF ablation procedures increased significantly. Additionally, AF ablation technology changes significantly with e.g. increasing numbers of cryoballoon ablation and contact force guided radiofrequency ablation. The study is designed as a worldwide, multi-centre, anonymised registry study to evaluate the incidence, optimal management and outcome of this AOF. More than 50 patients with AOF following percutaneous catheter ablation will be included in the register.

Official Title
-----------------
World-wide Survey on the Incidence, Diagnosis and Prognosis of Atrio-oesophageal Fistula Following Percutaneous Catheter Ablation

Conditions
-----------------
Atrial Fibrillation, Atrio-Oesophageal Fistula, PVI, Catheter Ablation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrio-oesophageal fistula after Ablation Indication for AF ablation as per current guidelines Performing the ablation at an ablation centre Exclusion Criteria: No Atrio-oesophageal fistula after Ablation
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 |
| --- | --- | --- |
| Incidence of AOF following percutaneous catheter ablation | 1. Evaluating the Incidence of atrio-oesophageal fistula after percutaneous catheter ablation in patients with atrial fibrillation, as well as the more detailed analysis of the incidence of AOF after PVI with Cryo Balloon or RF Contact Force | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis and management of AOF | Evaluating the diagnosis and management of the AOF | 5 year | 
| Mortality rate | Analysis of the mortality rate | 5 year |
Evaluation of Novel Lung Function Parameters and Quantitative Computed Tomography (qCT) in Patients With Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Current diagnostic tools used in pulmonary disease often do not meet the challenges set by the respective pathophysiology. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of patients with various pulmonary diseases.

Official Title
-----------------
Evaluation of Novel Lung Function Parameters and Quantitative Computed Tomography (qCT) in Patients With Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Bronchial Asthma, Interstitial Lung Disease

Intervention / Treatment
-----------------
* Device: multiple breath washout test (MBW)
* Device: impulse oscillometry (IOS)
* Device: body plethysmography (BP)
* Device: quantitative computed tomography (qCT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: known or suspected pulmonary lung disease indication for computed tomography Exclusion Criteria: pregnancy inability to participate

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 |
| --- | --- |
| pulmonary disease<br>patients with known or suspected pulmonary disease | Device: multiple breath washout test (MBW)<br> <br> Device: impulse oscillometry (IOS)<br> <br> Device: body plethysmography (BP)<br> <br> Device: quantitative computed tomography (qCT)<br>* ultra-low-dose qCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of lung clearance index (LCI) as determined by multiple breath washout with emphysema quantification as determined by qCT |  | 2 weeks | 
| correlation of airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry with emphysema quantification as determined by qCT |  | 2 weeks | 
| correlation of residual volume and airway resistance as determined by body plethysmography with and emphysema quantification as determined by qCT |  | 2 weeks |
Improvement Project To Optimizing Nutrition With Higher Protein and Calorie Pediatric Tube Feeding

Study Overview
=================
Brief Summary
-----------------
This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients.

Detailed Description
-----------------
This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients. The primary aim of this quality improvement project is to better meet protein needs of ICU critically ill children

Official Title
-----------------
An Improvement Project Towards Optimizing Nutrition Intervention With a Higher Protein and Calorie Pediatric Tube Feeding Formula

Conditions
-----------------
Critically Ill Children

Intervention / Treatment
-----------------
* Other: Peptide-based enteral formula
* Other: Retrospective review of enteral tube feeding formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 1-18 years old with enteral feeding access and anticipated to be fed for 5 days Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 13 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 |
| --- | --- |
| RFG<br>Retrospective review of enteral feeding in pediatric ICU patients for up to 5 days | Other: Retrospective review of enteral tube feeding formula<br>* Enteral formula tube feeding will be retrospectively reviewed<br>|
| PFG<br>Pediatric ICU population to be fed a peptide-based enteral formula with higher protein and higher calories for up to 5 days | Other: Peptide-based enteral formula<br>* Peptide-based, higher protein and higher calorie enteral formula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enteral formula volume | Daily total formula volume (mL) delivered | 5 days |
Comparative Evaluation of Post-endodontic Pain Using Two Rotary Instrumentation Systems

Study Overview
=================
Brief Summary
-----------------
In this study the investigators aim to compare the post-operative pain using two single-file endodontic rotary systems : Reciproc and One shape.

Detailed Description
-----------------
Comparison of the post operative pain with two rotary systems including Reciproc and One shape. Confounding factors were neutralized and the rotary systems were compared.

Official Title
-----------------
Comparison of Post-endodontic Pain Using Reciproc and Oneshape Rotary Instrumentation Systems: A Randomized Clinical Trial

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: Control
* Procedure: Reciproc
* Procedure: One shape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systematically healthy patients First or second molars with irreversible pulpitis without periapical pathosis. Single visit endodontic treatment Exclusion Criteria: Root canal retreatment Pregnancy The presence of a difficult root canal anatomy Internal or external resorption Teeth with open apices Any accident of complication occurred during treatment Presence of periapical lesion, abscess or sinus tract

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>K-file hand instrumentation | Procedure: Control<br>* K-file hand instrumentation<br>|
| Experimental: Reciproc<br>rotary reciprocating protocol | Procedure: Reciproc<br>* reciprocating rotary instrument<br>|
| Experimental: One shape<br>one shape continuous rotation protocol | Procedure: One shape<br>* full rotation protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval | The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10). | 6 hours | 
| Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals |  | 72 hours | 
| Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Root canal treatment, pain, endodontic instruments
Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods (Lungbarometry)

Study Overview
=================
Brief Summary
-----------------
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (PEEP) is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. The measurements are performed in sedated and mechanically ventilated patients in the intensive care unit.

Detailed Description
-----------------
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations in esophageal pressure divided by the tidal volume (Method 1). This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described in Method 1 above are compared to values obtained with a new method (Method 2) in which a PEEP-step is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. Measurements using Method 1 and 2 are performed in sedated and mechanically ventilated patients in the intensive care unit.

Official Title
-----------------
Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods (Lungbarometry)

Conditions
-----------------
Acute Lung Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanically ventilated patients in the intensive care unit Exclusion Criteria: Patients with chronic obstrucive lung disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Measurement of lung elastance and transpulmonary pressure | Comparison of a new versus the classical method for measurement of transpulmonary pressure | Within one hour |
Genetic an Functional Studies of Patient With Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to study the response of macrophages, isolated from patients with ulcerative colitis (Crohn's disease) or Crohn's disease (CD), to 6 candidate enterogenous and their derivatives, depending on the genotype for associated polymorphisms. to the development of IBD

Official Title
-----------------
Genetic an Functional Studies of Patient With Inflammatory Bowel Disease

Conditions
-----------------
Inflammatory Bowel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with definite crohn's disease or ulcerative colitis Exclusion Criteria: patient receiving anti-TNF therapy during 14 days before inclusion.

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- | --- |
| Isolated macrophage response measured by PCR | identification of macrophage activation markers specific analysis of gene expression (by PCR in real time) and / or the production (ELISA) of proinflammatory molecules (IL-6, TNF-1 and IL-8), anti-inflammatory (IL-10) and immunomodulatory (IL4,PPAR -2, MOR) | Baseline: one session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn disease, Ulcerative colitis, genetic makers, cytokines
Comparison Performance Vigileo vs. Continuous CCO (Vigilance) in Patients With Induced Therapeutic Hypothermia

Study Overview
=================
Brief Summary
-----------------
Patients resuscitated from a cardiac arrest undergo therapeutic hypothermia as a treatment option. Measuring the cardiac output in these patients is sometimes important, but difficult, as these patients require an invasive device for measurement. Recently, a non-invasive device based on pulse-contour analysis of the arterial pulse was developed (the Vigileo). Hypothermia changes the pulse contour, so the performance of the Vigileo in patients with induced therapeutic hypothermia is not known. Therefore we conduct this observational study in which the cardiac output of the patients is measured with the traditional method and the Vigileo simultaneously.

Official Title
-----------------
Comparison of the Performance of a New Pulse-contour Analysis Cardiac Output Measurement (Vigileo) With the Traditional Method in Patients With Induced Therapeutic Hypothermia After Cardiac Arrest

Conditions
-----------------
Cardiac Arrest, Hypothermia, Induced

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who survived a cardiac arrest and are treated with therapeutic hypothermia pulmonary arterial catheter placed by treating physician Exclusion Criteria: arterial catheter placement is contraindicated Aortic valve insufficiency (moderate to severe) placement of intra-aortic balloon pump (IABP) or a LVAD (left ventricular assist device)

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

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Validation of Cardiac Output measurement in hypothermic patients
Quality of Life in Patients With Refractory Angina

Study Overview
=================
Brief Summary
-----------------
The health and well being of patients with refractory angina will be assessed using validated questionnaires (SF-36 and Seattle Angina Questionnaire [SAQ]) at baseline and one year.

Official Title
-----------------
Health Status of Patients Enrolled in the OPTions In Myocardial Ischemic Syndrome Therapy (OPTIMIST) Program

Conditions
-----------------
Refractory Ischemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In the OPTIMIST clinic with documented refractory angina Have consented to participate in the OPTIMIST Long-term Follow-up Database Exclusion Criteria: Decline to participate or are unwilling to give written 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health and anginal status of refractory angina patients |  | baseline and one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Related Quality of Life (HRQL) |  | one year | 
| Association between MACE and changes in Health Related Quality of Life (HRQL) |  | one year | 
| Health Related Quality of Life (HRQL) and change in HRQL by subgroup |  | baseline and one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
angina, health related quality of life
Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children

Study Overview
=================
Brief Summary
-----------------
Study of Nitazoxanide (NTZ) based therapeutic regimens for Helicobacter pylori in children

Detailed Description
-----------------
Study of Novel triple Nitazoxanide (NTZ) based new therapeutic regimens for Helicobacter pylori in children

Official Title
-----------------
Study of Novel Triple Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori in Children

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Drug: Nitazoxanide
* Drug: Clarithromycin
* Drug: Metronidazole
* Drug: Proton pump inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Positive helicobacter infection. Exclusion Criteria: Previous treatment for H. Pylori.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitazoxanide group<br>Clarithromycin, Nitazoxanide and Proton pump inhibitor | Drug: Nitazoxanide<br>* Nitazoxanide twice daily<br>* Other names: nanazoxid;Drug: Clarithromycin<br>* Klacid twice daily<br>* Other names: Klacid;Drug: Proton pump inhibitor<br>* Omeprazoe twice daily<br>|
| Active Comparator: Traditional group<br>Clarithromycin, Metronidazole and Proton pump inhibitor | Drug: Clarithromycin<br>* Klacid twice daily<br>* Other names: Klacid;Drug: Metronidazole<br>* Metronidazole twice daily<br>* Other names: Flagyl;Drug: Proton pump inhibitor<br>* Omeprazoe twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with cured helicobacter infection | Total number of patients with eradicated helicobacter infection | 6 months |