linjc16/ctgov huggingface dataset:
Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds

Study Overview
=================
Brief Summary
-----------------
Comparing the incidence of SSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery

Detailed Description
-----------------
Comparing the incidence of surgical site infection (SSI) in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery. Also, comparing the post hospital stay.

Official Title
-----------------
Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds; Multi-center, Double Blind, Randomized Study

Conditions
-----------------
Surgical Site Infection, Surgical Wound, Surgical Wound Infection

Intervention / Treatment
-----------------
* Drug: coated vicryl plus
* Drug: Vicryl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 18-75 clean-contaminated wound surgery Exclusion Criteria: Patient has immunodeficiency disorder. Patient receiving anti-cancer / immunosuppressive therapy. Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized-controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coated Polyglactin 910 with Triclosan<br>Coated vicryl plus | Drug: coated vicryl plus<br>* Coated Polyglactin 910 with Triclosan (coated vicryl plus)<br>* Other names: Coated Polyglactin 910 with Triclosan;|
| Active Comparator: Coated Polyglactin 910 without Triclosan<br>Coated vicryl | Drug: Vicryl<br>* Coated Polyglactin 910 without Triclosan (vicryl)<br>* Other names: Coated Polyglactin 910 without Triclosan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical site infection | Incidence of surgical site infection within 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | duration of hospital stay | 30 days |
OCT in Fuchs' Dystrophy

Study Overview
=================
Brief Summary
-----------------
This is an observational study using optical coherence tomography (OCT) technology to quantify corneal edema in Fuchs' endothelial dystrophy and predict refractive shift from resolving corneal edema after surgical treatments.

Official Title
-----------------
Evaluating Corneal Edema in Fuchs' Endothelial Dystrophy Using Optical Coherence Tomography

Conditions
-----------------
Fuchs Dystrophy, Pseudophakic Bullous Keratopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Damaged or diseased corneal endothelium from Fuchs' or PBK Willingness to commit to required study visits Exclusion Criteria: Prior Endothelial Keratoplasty (EK) or any other surgery except uncomplicated cataract surgery Presence of a condition that increases the probability for treatment failure (e.g., heavily vascularized cornea, uncontrolled uveitis) Other primary endothelial dysfunction conditions (e.g., posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy, iridocorneal endothelial syndrome) Central sub-epithelial or stromal scarring that could impact post-operative clarity assessment Peripheral anterior synechiae in the angle greater than 3 clock hours Hypotony Uncontrolled glaucoma Visually significant optic nerve or macular pathology

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 |
| --- | --- |
| Group A: No Surgery Group<br>This group consists of adults ages 18 or older who have been diagnosed with Fuchs' dystrophy or pseudophakic bullous keratopathy but do not require surgery per standard-of-care guidelines. | |
| Group B: Surgery Group<br>This group consists of adults ages 18 or older who have been diagnosed with Fuchs' dystrophy or pseudophakic bullous keratopathy, who require Descemet's Stripping Endothelial Keratoplasty (DSAEK), Descemet's Membrane Endothelial Keratoplasty (DMEK), or Descemet's Stripping Only (DSO) surgery. All treatment decisions will be made by the attending physician based on standard-of-care guidelines. (The study does not designate a treatment modality or pay for the treatment.) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Epithelial Edema/Haze | OCT will be used to measure corneal epithelial edema/haze (in microns) in participants with Fuchs' or PBK | up to 2 years | 
| Corneal Stromal Edema/Haze | OCT will be used to measure corneal stromal edema/haze (in microns) in participants with Fuchs' or PBK | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PBK, Fuchs, Pseudophakic Bullous Keratopathy, Optical Coherence Tomography (OCT)
Tricuspid Isthmus Imaged by CARTOsound, Patients With Typical Atrial Flutter

Study Overview
=================
Brief Summary
-----------------
The investigators propose a third hypothesis based on the anatomic observations made in pathological studies. The investigators hypothesize that the anatomic architecture determines the functional properties of the TV-IVC isthmus. As a result, • Muscular bundles are preferential routes of conduction through the TV-IVC isthmus. The isthmus acts like a series of discreet conduction routes rather than as a sheet of tissue. The muscular bundles form selective targets for ablation and therefore the entire anatomic line need not be ablated. This has direct implications for ablation of the isthmus.

Detailed Description
-----------------
Patients undergoing atrial flutter ablation will have cartosound imaging done during procedure to determine if this will shorten ablation times.

Official Title
-----------------
Tricuspid Isthmus Architecture as Imaged by CARTOsound, Determines Ablation Times in Patients With Typical Atrial Flutter

Conditions
-----------------
Atrial Flutter

Intervention / Treatment
-----------------
* Device: tricuspid isthmus imaging with Cartosound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be over 18 years of age provided written informed consent documented atrial flutter by ECG , holter monitor or TTM Exclusion Criteria: previous atrial flutter ablation non isthmus dependent atrial flutter prior right atrial surgery

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 |
| --- | --- |
| imaging<br>imaging with usual catheter/fluoroscopy, no cartosound | Device: tricuspid isthmus imaging with Cartosound<br>* tricuspid isthmus imaging with Cartosound<br>* Other names: Cartosound;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| observational including ablation lesion number, ablation time in minutes, fluoroscopic |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial flutter, tricuspid isthmus, ablation
Clinical Trial of Bile Etiology ,Proteomics and Metabonomics of Malignant Biliary Obstruction

Study Overview
=================
Brief Summary
-----------------
To investigate bile culture and susceptibility test in patients with malignant biliary obstruction (MBO) or relation between bile, portal vein or vein culture and biliary infection. Also to get the information of bile metabonomics to find potential tumor marker .Culture of the organism is recognized as the gold standard for diagnosis of infection. Our research may be one of the first research on culture and susceptibility test in patients with MBO. The results of the trial research will be benefit to experiential therapy of MBO with biliary infection and diagnosis of MBO.

Detailed Description
-----------------
We will obtain bile sample for culture and susceptibility ,proteomics metabonomics test after PTBD. Also get the blood and urine samples.

Official Title
-----------------
Clinical Trial of Bile Etiology,Proteomics and Metabonomics of Malignant Biliary Obstruction

Conditions
-----------------
Malignant Biliary Obstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those with MBO who can receive Percutaneous Transhepatic Biliary Drainage(PTBD) Exclusion Criteria: Those with MBO who cannot receive Percutaneous Transhepatic Biliary Drainage(PTBD)

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?
-----------------
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
-----------------
Malignant biliary obstruction (MBO)
Improvement of the Accuracy of Spatial Representation of Invasive Exploratory Electrodes in Focal Epilepsy

Study Overview
=================
Brief Summary
-----------------
Reconstruction software allows visualization of cortical structure in 3 dimensions, showing on a single picture the position of all the electrodes. The EEG signal of each recording plot of the electrode is analyzed and compared with the underlying brain structure reconstructed by the software. It is therefore possible to visualize 1) ictogenic and epileptogenic areas using neurophysiological stereoelectroencephalography (SEEG) data and 2) adjacent functional cortical areas with functional imaging and SEEG. Software makes it possible to determine the links between these areas. This study aims to show that using these software is an asset in surgical decision and in the choice of surgical strategy. Each patient has presurgical evaluation (usual care), including morphologic and (if necessary) functional MRI, EEG and SEEG. In this study, software will be used to analyze the processed data (FSL software, FMRIB laboratory, Oxford University and BrainVisa/Anatomist. The surgical decision will be taken according to the usual staff procedures, based on the usual examination results. After the decision making process, the staff will be asked to reconsider the surgical decision, according to the analysis provided by the software. The discrepancies between the decisions will be recorded.

Conditions
-----------------
Focal Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged 18 months to 17 years old drug resistant focal epilepsy scheduled for deep brain electrodes exploration to assess surgical indication Exclusion Criteria: contraindication to anesthesia or surgery refusal (of parents or child) to participate in the study no health insurance coverage

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 17 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 |
| --- | --- | --- |
| number of patients for whom surgical strategy would change if using the software | change in medical strategy includes surgery indication, resection volume, topography of resection area | 1 day |
ADHERE-S (NIS Brilique)

Study Overview
=================
Brief Summary
-----------------
noninterventional study investigating persistence and adherence on ticagrelor in ACS patients in Serbia

Official Title
-----------------
Non-interventional Prospective Data Collection on Persistence and Adherence on Ticagrelor in ACS Adult Patients in Serbia

Conditions
-----------------
ACS (Acute Coronary Syndrome)

Intervention / Treatment
-----------------
* Drug: ticagrelor 90 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age diagnosed with ACS - STEMI or NSTEMI or unstable angina, invasively or non-invasively treated Patients already on treatment with ticagrelor at least for 1 month and no longer than 3 months prior to study initiation. Enrolment in this study must not be trigger for ticagrelor initiation. read and signed the Informed Consent Form Exclusion Criteria: Any contraindications as per approved SmPC of Brilique • Patients with life-threatening conditions which could disable patients to comply with scheduled visits and/or not able to fill in the patient questionnaires.

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

| Intervention/Treatment |
| --- |
|Drug: ticagrelor 90 mg|persistence and adherence on ticagrelor in ACS patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration (number of days) on ticagrelor therapy in patients with acute coronary syndrome |  | 1 year (12 months) |
Safe Use of New Oral Anticoagulants in Ablation for Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Use of new oral anticoagulants (NOAC) in patients before and after catheter based pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients are followed for 3 month after ablation. All complications possible being related to the use of NOAC are registered.

Detailed Description
-----------------
Use of new oral anticoagulants (NOAC) in patients before and after radiofrequency ablation with pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients paused their NOAC treatment for 24 hours before ablation. Patients were routinely followed up after 3 months with a standard formular focused on possible adverse events (major bleeding complications or thromboembolic events) to NOAC treatment. Adverse events related to the use of NOAC were registered during treatment or during 3 months of follow-up.

Official Title
-----------------
Safe Use of New Oral Anticoagulants in Patients Treated by Catheter Ablation for Atrial Fibrillation

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

Intervention / Treatment
-----------------
* Procedure: Pulmonary venous ostia isolation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic atrial fibrillation despite pharmacological treatment. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pulmonary venous ostia isolation|Percutaneous, catheterbased, radiofrequency ablation with left atrial access via atrial septal puncture. Helped by 3D-imaging system (Carto(tm)) and electrical signal guidance the PV ostia together with neighbouring atrial tissue is electrically isolated from the rest of the left atrium.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with bleeding or thromboembolism during PVI and/or three months of follow up | Any bleeding or thromboembolism observed during the PVI procedure and/or during 3 months of follow-up are registered. Also, if any procedure related complication was worsened by treatment with NOAC was registered. | Up to three months after PVI |
Internet-based Cognitive Behaviour Therapy (CBT) for Persons Diagnosed With Bipolar II

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to test the feasibility and acceptability of internet-based Cognitive Behaviour Therapy (CBT) for persons diagnosed with bipolar disorder, type II. The idea is to treat residual depressive symptoms as well as using psychoeducation to improve their prognosis. Each participant will have a personal therapist that will provide guidance and support throughout the treatment.

Official Title
-----------------
Internet-based Cognitive Behaviour Therapy for Persons Diagnosed With Bipolar II - a Pilot Study

Conditions
-----------------
Bipolar Disorder, Type II

Intervention / Treatment
-----------------
* Behavioral: Guided internet-based cognitive behavior therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of bipolar disorder type II Mild to moderate depressive symptoms 18 years of age Stable medication with a mood stabiliser Access to the internet Exclusion Criteria: Diagnosis of psychosis Having received psychiatric in-patient care during the past year Ongoing psychotherapy Previous manic episode Previous suicide attempt Previous parasuicidal behavior documented in patient record (e.g. self-injury)

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: Guided internet-based cognitive behavior therapy (CBT)<br> | Behavioral: Guided internet-based cognitive behavior therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on the Montgomery-Åsberg Depression Rating Scale - Self rated (MADRS-S) between baseline and post treatment | A nine item questionnaire of depressive symptoms | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the score on the Affective Self Rating Scale (AS-18-M) between baseline and post treatment | A nine item subscale of the AS-18 measuring symptoms of mania/hypomania. | 9 weeks |
Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution used four times daily in a population of adult and geriatric subjects

Official Title
-----------------
A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects

Conditions
-----------------
Ocular Redness

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Brimonidine tartrate 0.025%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 40 years of age Must have normal ocular health Must have history of redness relief drop use or desire to use Exclusion Criteria: Must not have any ocular/systemic health problems Must agree to avoid disallowed medications

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 drop in each eye daily for up to 35 days<br>|
| Experimental: Brimonidine Tartrate 0.025%<br> | Drug: Brimonidine tartrate 0.025%<br>* 1 drop in each eye for up to 35 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular redness | redness evaluated by investigator prior to study medication instillation and redness evaluated by the subject as captured in dosing diary | at specified timepoints for up to 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Redness | evaluated prior to study medication instillation and at 5 minutes post instillation | up to 5 minutes post study medication instillation |
Transient Osteoporosis of Pregnancy: A Possible Peptide Mediator

Study Overview
=================
Brief Summary
-----------------
Transient osteoporosis of pregnancy (TOoP) is uncommonly encountered in orthopedic and obstetric practice, with most reports consisting of single cases. This rare condition consists of significant osteoporosis affecting the hips and spine, causing significant morbidity, and putting young female patients at risk for vertebral and femoral neck fractures. The pathogenesis of transient osteoporosis of pregnancy is unknown, with various theories as to its etiology. Recently, a number of reports have described elevated levels of PTHrP in patients with transient osteoporosis in pregnancy and of the postpartum period Our goal in this study is to assess the role of PTHrP in transient osteoporosis of pregnancy

Conditions
-----------------
Transient Osteperosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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