linjc16/ctgov huggingface dataset:
Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe:

Study Overview
=================
Brief Summary
-----------------
A planned analysis of outcomes among consecutive patients after MIPD from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

Detailed Description
-----------------
The European registry for Minimally Invasive Pancreatic Surgery (E-MIPS) is an E-AHPBA endorsed registry with the aim to monitor and safeguard the introduction of MIPD in Europe. International multicenter audit-based studies focusing on outcomes of minimally invasive pancreatoduodenectomy (MIPD) are lacking. A planned analysis of outcomes among consecutive patients after MIPD from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

Official Title
-----------------
Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe: A Critical Appraisal of the First 3 Years of the E-MIPS Registry

Conditions
-----------------
Pancreas Disease

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Data from all patients who underwent R-MIPD and L-MIPD between January 1st 2019 and December 31st 2021 were included Exclusion Criteria: Other pancreatic procedures Hybrid approaches (reconstruction phase open) Procedures with insufficient baseline data / missing primary outcome data.

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 |
| --- |
|Other: No intervention|all patients undergoing minimally invasive pancreatic surgery, no intervention, no randomization|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major morbidity |  | 30 days | 
| 30-day/in-hospital mortality. |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
registry, minimally invasive surgery, robot-assisted, laparoscopy, pancreatoduodenectomy, pancreatic surgery
Robotic Versus Laparoscopic Roux En-y Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
This study retrospectively identified 33 consecutive obese patients who underwent either laparoscopic or robotic gastric bypass procedures over a 2-year period.

Official Title
-----------------
Can Robotic Gastric Bypass be Considered a Valid Alternative to Laparoscopy: Our Early Experience

Conditions
-----------------
Roux-en-y Anastomosis Site, Obesity, Morbid, Bypass Complication, Anastomosis; Complications, Surgery-Complications

Intervention / Treatment
-----------------
* Procedure: Roux en-Y gastric bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity BMI≥40kg/m2, age ≥ 18 years. Exclusion Criteria: Re-do surgery procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese patients underwent laparoscopic gastric bypass<br> | Procedure: Roux en-Y gastric bypass<br>* gastric bypass with jejuna-jenual anastomosis and gusto-jejunal anastomosis<br>|
| obese patients underwent robotic gastric bypass<br> | Procedure: Roux en-Y gastric bypass<br>* gastric bypass with jejuna-jenual anastomosis and gusto-jejunal anastomosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences between the robotic and laparoscopic gastric bypass | incidence of mortality and morbidity (percentage) | two years period | 
| differences between the robotic and laparoscopic gastric bypass | BMI ( kg/m2) | two years period | 
| differences between the robotic and laparoscopic gastric bypass | age (years) | two years period | 
| differences between the robotic and laparoscopic gastric bypass | weight (kg) | two years period |
18F-FDG Tomography and Labeled Leukocyte Scintigraphy

Study Overview
=================
Brief Summary
-----------------
The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte scintigraphy in patients with a malignant otitis externa.

Detailed Description
-----------------
The management of malignant otitis externa (MEO) is a major issue in patients who are often polypathological and fragile. Appropriate antibiotic therapy must be started quickly after the diagnosis is made and followed for a period of at least 6 weeks. Imaging plays a major role in assessing the extent of the infection and especially healing, after 6 weeks of antibiotic therapy. The persistence of an infection at the end of the treatment, observed in imaging, will allow a change of antibiotic line. This study consists in studying in a population affected by an OEM, the performance of PET/CT with 18F-FDG compared to scintigraphy with labeled leukocytes. The usefulness of the latter in the follow-up of the pathology after antibiotic therapy has already been proven in the literature. The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte scintigraphy.

Official Title
-----------------
Comparison of the Performance of 18F-FDG PET/CT With That of Labeled Leukocyte Scintigraphy in the Follow-up of Malignant Otitis Externa.

Conditions
-----------------
Malignant Otitis Externa

Intervention / Treatment
-----------------
* Other: 18F-FDG PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with malignant otitis externa who received a 18F-FDG positron emission tomography and a labelled leukocyte scintigraphy Exclusion Criteria: patients who refuse to have their imaging data used

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 18F-FDG PET/CT|Patients who underwent an 18F-FDG PET/CT examination and a labeled leukocyte scintigraphy before and after antibiotic therapy in the case of management of an EO.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18F-FDG positron emission tomography | measurement of standard uptake value | one day | 
| Labeled leukocyte scintigraphy | measurement of standard uptake value | one day |
Semantic Recognition Task (SRT) in Alzheimer Disease

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to observe the outcomes of a semantic recognition task in Alzheimer Disease and discuss what this might add to clinical practice.

Detailed Description
-----------------
In classical memory testing procedures, the outcomes of recognition task is related to hippocampal memory deficits knowing that the recognition task is not purely temporal lobe activity. The aim of this study is to propose a recognition task more specific to temporal lobe activity.

Official Title
-----------------
A Sensitive Measurement Proposal in Alzheimer's Disease: Semantic Recognition Task

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Behavioral: Semantic Recognition Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to have biomarker analysis for Alzheimer disease (positive or negative). Exclusion Criteria: illiteracy
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Semantic recognition task outcomes are observed in people diagnosed with Alzheimer's disease with Non-Alzheimer population.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semantic information in Alzheimer Disease<br>To observe the semantic information processing in early stages of Alzheimer Disease is the main aim of the study. A paper-pencil neuropsychological assessment battery will be used. For memory testing FCSRT (free and cued selective reminding test) will be used. The patients are going to be assessed while in clinical diagnosis routine. | Behavioral: Semantic Recognition Procedure<br>* A semantic recognition task is going to be added to administrated FCSRT procedure after immediate and delayed recall phases.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semantic Recognition Task | The number of correct answers will be observed just after the short-term learning procedure and just after the delayed recall procedure among people with positive biomarker compared to those with negative biomarker to Alzheimer Disease. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer Disease, Recognition, Semantic, Memory, Free and Cued Selective Reminding Test
Information Flow of Waiting List for Scheduled Surgical Admissions

Study Overview
=================
Brief Summary
-----------------
Definition and experimentation of the aforementioned information flow within the Regions participating in the three-year project, a Technical Subgroup was identified on a voluntary basis in charge of defining the design and following the experimental operational phases

Official Title
-----------------
Information Flow of Waiting List for Scheduled Surgical Admissions

Conditions
-----------------
Chirurgical Intervention

Intervention / Treatment
-----------------
* Other: Waiting list


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adult patients Exclusion Criteria: Minor patients

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 |
| --- | --- |
| Sperimental<br>Patient on the waiting list for scheduled surgical admissions | Other: Waiting list<br>* patient on the waiting list for scheduled surgical admissions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verification of the completeness of the data entered within the flow to guarantee ex Ante monitoring of the waiting list for scheduled surgical hospitalization |  | At baseline (Day 0) |
Evolution of EIFL Following PPV

Study Overview
=================
Brief Summary
-----------------
Various classification systems have been described for epiretinal membrane (ERM). One of them is a new OCT-based staging scheme based on displacement and reorganization of inner retinal layers called ectopic inner retinal layers (EIFL). We evaluated pre-and perioperative factors related to time for evolution of EIFL.

Official Title
-----------------
Long-term Follow-up Results of Ectopic Inner Foveal Retinal Layers Evolution Following Pars Plana Vitrectomy

Conditions
-----------------
Epiretinal Membrane

Intervention / Treatment
-----------------
* Other: optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing idiopathic epiretinal membrane surgery Exclusion Criteria: Patients undergoing seconder epiretinal membrane 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 |
| --- | --- |
| Stage 2 ERM<br> | Other: optical coherence tomography<br>* We observed the postoperative improvement in EIFL severity with optical coherence tomography<br>|
| Stage 3 ERM<br> | Other: optical coherence tomography<br>* We observed the postoperative improvement in EIFL severity with optical coherence tomography<br>|
| Stage 4 ERM<br> | Other: optical coherence tomography<br>* We observed the postoperative improvement in EIFL severity with optical coherence tomography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | Best corrected visual acuity | 1-month |
iCare ST500 Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Clinical validation of iCare ST500 tonometer per ANSI Z80.10:2014 standard

Official Title
-----------------
Clinical Validation of a Slit Lamp Mounted Rebound Tonometer

Conditions
-----------------
Intraocular Pressure

Intervention / Treatment
-----------------
* Device: iCare ST500
* Device: GAT
* Device: iCare IC200


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 18 years old Exclusion Criteria: Subjects with only one functional eye Subjects having poor or eccentric fixation in the study eye(s) High corneal astigmatism >3D in the study eye(s) Central corneal scarring History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s) Microphthalmos Buphthalmos Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally Dry eyes (clinically significant) Lid squeezers - blepharospasm Nystagmus Keratoconus Any other corneal or conjunctival pathology or infection relevant to this study Central corneal thickness greater than 600 μm or less than 500 μm in the study eye(s) Cataract Extraction within last 2 months in the study eye(s)

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCare ST500 vs GAT and iCare IC200<br>Measurement of intraocular pressure (IOP) with iCare ST500 compared to GAT and iCare IC200. Measurements will be performed in three categories: Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (≥23 mmHg). | Device: iCare ST500<br>* Measurement of Intraocular Pressure (IOP)<br>Device: GAT<br>* Measurement of Intraocular Pressure (IOP)<br>Device: iCare IC200<br>* Measurement of Intraocular Pressure (IOP)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers | Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups. | Through study completion, an average of 4 months |
A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.

Official Title
-----------------
Post-Marketing Surveillance (PMS) Study on Zeposia® (Ozanimod) Use Among Moderate to Severe Active Ulcerative Colitis Patients in Korea

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Ozanimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult participants 19 years of age or older Participants who will receive ozanimod according to the approved label after enrollment Participants who sign the informed consent form voluntarily Exclusion Criteria: Participants who are prescribed ozanimod for therapeutic indications not approved in Korea Participants for whom ozanimod is contraindicated as clarified in Korean prescribing information approved by Ministry of Food and Drug Safety

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with moderate to severe active ulcerative colitis treated with ozanimod<br> | Drug: Ozanimod<br>* According to local product label<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs for ozanimod | Up to 52 weeks |
Standardization of Anti-Seizure Medications Withdrawals After Seizure Remission in Young Patients With Epilepsy

Study Overview
=================
Brief Summary
-----------------
The proper period of anti-seizure medication (ASM) treamtment is important for decreasing side effect of ASM and recurrence of seizure. We evaluate reliable risk factor analysis for safe withdrawal of ASM in children with epilepsy. Futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of ASM.

Detailed Description
-----------------
The proper period of anti-seizure medication (ASM) treamtment is important for decreasing side effect of ASM and recurrence of seizure. We evaluate reliable risk factor analysis for safe withdrawal of ASM in children with epilepsy. Futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of ASM. The enroll criteria as follow: patients with epilepsy or acute provoked seizure accroding to the ILAE definition patients who have been 2 years of seizure free with or without ASM The patients with seizure recurrence during follow-up or end of follow-up period of 24 months will end this stutdy.

Official Title
-----------------
Anti-Seizure Medications Withdrawals After 2 Years of Seizure Remission

Conditions
-----------------
Epilepsy, Epilepsy in Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Epilepsy or acute provoked seizure according to the ILAE guideline Patients with 2 years of seizure free periods Exclusion Criteria: Uncertain diagnosis of epilepsy or acute provoked seizure Patients who do not want to participate in the study

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Patients umber of seizure recurrence | Patients umber of seizure recurrence | Up to 2 years |
Role of Laparoscopy in Penetrating Anterior Abdominal Wall Injuries

Study Overview
=================
Brief Summary
-----------------
The current study is aiming to evaluate the diagnostic and therapeutic role of laparoscopy in patients with penetrating anterior abdominal wall trauma as regard the accuracy of diagnosis and efficacy in management and avoidance of unnecessary laparotomy

Official Title
-----------------
Role of Laparoscopy in Penetrating Anterior Abdominal Wall Injuries

Conditions
-----------------
Evaluate Laparoscopic Management in Patients With Penetrating Anterior Abdominal Wall Trauma

Intervention / Treatment
-----------------
* Procedure: diagnostic laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with penetrating anterior abdominal wall injuries Age will be between 5 - 65 years old Exclusion Criteria: Vitally unstable patients Patients with associated injuries

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with penetrating anterior abdominal wall injuries<br> | Procedure: diagnostic laparoscopy<br>* diagnosis and management of patients with penetrating anterior abdominal wall injuries<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 month |