linjc16/ctgov huggingface dataset:
Gaps Between Evidence and Practice in Prevention of Surgical Site Infection in Spain

Study Overview
=================
Brief Summary
-----------------
Web-based survey to members of 10 Spanish Associations of surgical nurses and surgeons of different specialities to know the application of preventative measures for surgical site infection.

Detailed Description
-----------------
A web-based survey to the members of the Colorectal Chapter of 10 Spanish Associations of surgical nurses and surgeons of different specialities. A link to the web page containing the survey will be disseminated via email, newsletter and Twitter. A board from the Surgical Infection Section did a review of evidence and previous guidelines to be used in the evaluation of the results. The most recent clinical practice guidelines have been analysed. According to the review, the preventive measures analysed in the survey have been distributed into two groups: high or low level of evidence. The survey aim to assess knowledge, beliefs, and practices of attending nurses and surgeons on preventative measures. Furthermore, the questions address the level of accordance between their beliefs and the protocols or the usual practice of their units. The agreement rate between the beliefs and usual practice of all respondents will be calculated on a scale from 0 to 100. For discussion, the responses on the implementation of major surgical site infection (SSI) prevention measures will be compared with the recommendations of the expert group. The results will be expressed in percentages on the total answers obtained. Responses will be entered into a computerized database that will be analysed using an specific program. The results will be analysed using the chi-square test with statistical significance defined as p <0.05.

Official Title
-----------------
Gaps Between Evidence and Practice in Prevention of Surgical Site Infection in Spain: A Survey of the Observatory of Infection in Surgery

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Other: Survey among perioperative nurses and surgeons


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nurses and surgeons pertaining to invited societies Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey among perioperative nurses and surgeons|Online survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Awareness of practice | Percentage of responders who use each preventive measures for surgical site infection | 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical site infection, Preventative measures
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and safety of DWP14012 compared to esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los Angeles(LA) classification grades A to D.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Active-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease.

Conditions
-----------------
Erosive Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: DWP14012
* Drug: Esomeprazole
* Drug: DWP14012 placebo
* Drug: Esomeprazole placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults between 20 and 75 years old based on the date of written agreement Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy Those who experienced symptoms of heartburn or acid reflux within the last 7 days Exclusion Criteria: Those who have undergone gastric acid suppression or gastric, esophageal surgery Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP14012 20mg<br>DWP14012 20mg, tablet, orally, once daily | Drug: DWP14012<br>* tablet<br>Drug: DWP14012 placebo<br>* tablet<br>Drug: Esomeprazole placebo<br>* tablet<br>|
| Experimental: DWP14012 40mg<br>DWP14012 40mg, tablet, orally, once daily | Drug: DWP14012<br>* tablet<br>Drug: DWP14012 placebo<br>* tablet<br>Drug: Esomeprazole placebo<br>* tablet<br>|
| Experimental: DWP14012 80mg<br>DWP14012 40mg*2, tablet, orally, once daily | Drug: DWP14012<br>* tablet<br>Drug: DWP14012 placebo<br>* tablet<br>Drug: Esomeprazole placebo<br>* tablet<br>|
| Active Comparator: Esomerpazole 40mg<br>Esomerpazole 40mg, tablet, orally, once daily | Drug: Esomeprazole<br>* tablet<br>* Other names: Nexium;Drug: DWP14012 placebo<br>* tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of subjects who were completely cured of mucosal defects by 8 weeks |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of subjects who were completely cured of mucosal defects by 4 weeks |  | 4 weeks |
Continuous Glucose Monitorization in Hospitalized Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
DM2 is a major comorbidity of COVID-19. It has been observed that subjects with DM2 require more medical interventions, have a significantly higher mortality (7.8% versus 2.7%) and injuries of multiple organs that the individuals not diabetics. In situations of glycemic variability, phenomena of oxidative stress and activation of protein kinase C can be initiated , through the release of pro-inflammatory cytosines , which could induce microvascular damage .Patients with diabetes and COVID-19 were shown to be more likely to develop serious or critical illness with more complications, and to have higher incidence rates of antibiotic therapy, non-invasive and invasive mechanical ventilation, and death (11.1% vs. 4.1%).

Official Title
-----------------
Assessment of the Effect of Continuous Glucose Monitorization on Glycemic Variability and Insulin's Prescription in Hospitalized Patients With COVID-19

Conditions
-----------------
Diabetes Mellitus, Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed COVID-19 pneumonia Diabetes mellitus Exclusion Criteria: Less than 3 days of hospital care

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose variability | Percentage of time within the ADA recommended range | For up to two weeks, during hospitalization | 
| Insulin use | Average daily UI of insulin per patient | For up two weeks, during hospitalization |
Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
To study the effect of anti-inflammatory diet on clinical and biological outcomes in patients with knee osteoarthritis

Detailed Description
-----------------
The investigators would like to evaluate how inflammation occurs in the joints of subjects with osteoarthritis, and identify molecules and bacteria that can predict whether a patients with knee osteoarthritis will have more or less pain . Blood, urine and stool will be evaluated in the laboratory and compared to their own samples after changes in diet. This is an exploratory study, which is meant to gather preliminary data about the quick effects of changes in diet and treatment on molecules in blood/urine and bacteria in stools. These studies can provide clues to the cause of disease and might ultimately lead to new therapies.

Official Title
-----------------
Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Dietary Supplement: ITIS diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed of Knee Ostoeaarthritis without changes in treatment in the last 3 months Exclusion Criteria: food allergies 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITIS diet<br>anti-inflammatory (ITIS) diet for 28 days | Dietary Supplement: ITIS diet<br>* anti-inflammatory (ITIS) diet for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of baseline pain measured by visual analogue scale (0-10) after 28 days | Change of baseline pain measured by visual analogue scale (0-10) after 28 days, being 0 no pain, and 10 the worse outcome | 28 days |
Interference With Cognitive Control by Transcranial Direct Current Stimulation

Study Overview
=================
Brief Summary
-----------------
Insufficient cognitive control over emotional distracters is characteristic for major depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is associated with this deficit. In this study the investigators assess the effect of a decrease of dlPFC activity in healthy subjects by cathodal transcranial direct current stimulation (tDCS) on cognitive control. In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators determine the effect of a single-session of cathodal tDCS to the left dlPFC on cognitive control in healthy subjects. To assess the cognitive control the investigators use a delayed response working memory task (DWM)and an arithmetic inhibition task (AIT) with pictures of varying valence.

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Device: Cathodal transcranial direct current stimulation (tDCS)
* Device: Sham transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent Exclusion Criteria: psychiatric or neurological disorders seizures cardiac pacemakers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cathodal transcranial direct current stimulation<br> | Device: Cathodal transcranial direct current stimulation (tDCS)<br>* Cathodal transcranial direct current stimulation (tDCS) 20min, 1mA, F3 (EEG 10/20), reference right M. deltoideus<br>|
| Sham Comparator: Sham transcranial direct current stimulation<br> | Device: Sham transcranial direct current stimulation<br>* Sham transcranial direct current stimulation (tDCS) 40s, 1mA, F3 (EEG 10/20), reference right M. deltoideus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correctness and reaction time of response | Correctness is defined as the percentage of correct responses in the DWM and AIT | Within 30 min starting 5 min after the initiation of stimulation |
Comparison of 2 Hemostasis Techniques After Transradial Coronary

Study Overview
=================
Brief Summary
-----------------
Randomized clinical trial to compare radial artery patency after transradial coronary catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or therapeutic coronary catheterization will be prospectively enrolled in this single-center trial and will be randomized to radial hemostasis with TerumoBand® or a standardized compressive dressing with gauze and elastic bandage.

Detailed Description
-----------------
Randomized clinical trial to compare radial artery patency after transradial coronary catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or therapeutic coronary catheterization will be prospectively enrolled in this single-center trial and will be randomized to radial hemostasis with TerumoBand® or a standardized compressive dressing with gauze and elastic bandage. Interventions: Radial hemostasis with TerumoBand® and Radial hemostasis with a standardized compressive dressing

Official Title
-----------------
Effect of Two Compression Devices on the Occurrence of Artery Occlusion After Transradial Cardiac Catheterization: Randomized Clinical Trial

Conditions
-----------------
Coronary Artery Disease With Myocardial Infarction

Intervention / Treatment
-----------------
* Device: Standardized compressive dressing
* Device: Hemostasis with TerumoBand®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients submitted to elective or urgent coronary catheterization who presented with a A, B or C curve on oximetry test before the procedure Exclusion Criteria: Inability to understand the study and sign the informed consent form

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>Standardized compressive dressing | Device: Standardized compressive dressing<br>* Standardized compressive dressing<br>|
| Experimental: Intervention group<br>Hemostasis with TerumoBand® | Device: Hemostasis with TerumoBand®<br>* Hemostasis with TerumoBand®<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial artery occlusion evaluated using Barbeau's test | test immediately after hemostasis compression device withdrawal | up to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular complications | Clinical assesment | up to 3 hours | 
| Radial access site pain | standardized scale | up to 3 hours |
Protein Synthesis in Midthigh Muscles PET/CT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a new imaging technique to help scientists study sarcopenia, the process by which muscle becomes weaker with age.

Conditions
-----------------
Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: young healthy women aged 25-35 years and older healthy women above 70 years old. Exclusion Criteria: no cardiac disease, not taking medication for high blood pressure Asthma HIV any other cardiac conditions

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Old age group of healthy women<br>Old women over 70 years old | |
| young group of healthy women<br>aged 25-35 years | |

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
-----------------
study sarcopenia, which muscle becomes weaker with age
Long Term Integrity Follow-up Evaluation

Study Overview
=================
Brief Summary
-----------------
To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads over 5 years.

Detailed Description
-----------------
There are few prospective long term follow-up studies on implanted cardiac device (pacemaker/implantable cardioverter defibrillator (ICD)) survivability. This study will evaluate the long term performance (5 years) of the transvenous defibrillation leads (ENDOTAK ENDURANCE EZ and teh ENDOTAK RELIANCE. Data will be collected at implant, 1 and 6 months, 1,3 and 5 years.

Official Title
-----------------
Long Term Integrity Follow-up Evaluation

Conditions
-----------------
Sudden Cardiac Death

Intervention / Treatment
-----------------
* Device: defibrillation lead (ENDOTAK EZ and RELIANCE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients selected for Guidant ICD system implant, available for follow-up at the defined intervals Exclusion Criteria: Patients enrolled in other studies, not available for follow-up, < 18 yrs, unable to sign consent, life expectancy < 1 year due to a medical condition

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 |
| --- | --- |
| control<br>all patients in the control group | Device: defibrillation lead (ENDOTAK EZ and RELIANCE)<br>* defibrillation lead<br>|

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
-----------------
defibrillator
Relationship Between Postoperative Pain and Overall 30-day Complications in Major Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
This study evaluates the possible correlation of early postoperative pain in a broad surgical adult population and infectious complications in de first 30 days after surgery. It is a large retrospective cohort study in a single center.

Official Title
-----------------
Relationship Between Postoperative Pain and Overall 30-day Complications in Major Abdominal Surgery: an Observational Study

Conditions
-----------------
Infectious Complications, Postoperative Pain, Acute Pain, Postoperative Complications, Surgery--Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major abdominal surgery under general anesthesia Exclusion Criteria: younger than 18 years of age procedures outside the operation room procedures solely under regional anesthesia, i.e. no general anesthesia

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients without painscores available during hospital stay<br> | |
| Patients with painscores available during hospital stay<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute postoperative pain | Early pain following abdominal surgery within 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious complications postoperative | within 30 days | 30 days | 
| Overall complications postoperative | within 30 days | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early postoperative pain, Infectious complications
Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
This study will examine the Performance of Sepraspray in Patients undergoing open abdominal surgery NOTE regarding reason for study termination: A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor. A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.

Official Title
-----------------
Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

Conditions
-----------------
Adhesion Prevention (Abdominal)

Intervention / Treatment
-----------------
* Device: Sepraspray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years old and over that require open abdominal surgery Exclusion Criteria: Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sepraspray<br>Receive Sepraspray | Device: Sepraspray<br>* Max. 10g of Sepraspray<br>|
| No Intervention: Control<br>no treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | 30 days |