linjc16/ctgov huggingface dataset:
Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery

Study Overview
=================
Brief Summary
-----------------
Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery especially in gastric bypass surgery patients.

Detailed Description
-----------------
The investigators' department performs 150 gastric bypass surgeries annually. Surgeons use both harmonic scalpel and ligasure sealing device in cases. Aim is to compare both of these devices over coming each other. Benefits ease of these devices are compared.

Official Title
-----------------
Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Device: Harmonic scapel
* Device: Ligasure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obesity BMI over 40 kg/m^2 Exclusion Criteria: Normal BMI cases

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

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: harmonic scapel<br>Obesity surgery cases where hamonic scalpel is used for the comparison of different surgical devices | Device: Harmonic scapel<br>* different surgical devices used in the obesity surgery<br>* Other names: ultrasonic dissector;Device: Ligasure<br>* Bipolar vessel sealing system used in obesity surgery<br>* Other names: Bipolar Vessel sealing device;|
| Placebo Comparator: Ligasure sealing device<br>Ligasure used in obesity surgery for the comparison of different surgical devices Randomly chosen cases where ligasure is used instead of hamonic scalpel in surgical procedures comparison of multiple dissectors | Device: Harmonic scapel<br>* different surgical devices used in the obesity surgery<br>* Other names: ultrasonic dissector;Device: Ligasure<br>* Bipolar vessel sealing system used in obesity surgery<br>* Other names: Bipolar Vessel sealing device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of sealing | Aim to compare the fogging and the time spend performing the gastric resection to form the gastric pouch. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Amount of blood loss in the operation | During the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopy, obesity, harmonic scalpel, ligasure
Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers

Official Title
-----------------
Biomarker Study to Evaluate Participants With Previously Treated Lyme Disease in Comparison to Healthy Volunteers

Conditions
-----------------
Lyme Disease

Intervention / Treatment
-----------------
* Other: Stool and blood collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females ≥18 years of age. Able to read, understand, and provide signed informed consent. Willing to provide blood and stool samples. Able to communicate adequately and to comply with the requirements for the entire study. Must be willing to discontinue antibiotics 2 weeks prior to sample collection. If participating in the previously treated Lyme Disease arm, the participants must meet the following criteria: 1) Diagnosis of prior Lyme Disease supported by either an erythema migrans rash (either classic bull's eye or irregular) OR a CDC-positive Western blot, 2) previously treated with antibiotics for Lyme Disease, 3) remains ill six months or more after receiving preliminary treatment with antibiotics for Lyme disease (e.g., fatigue, musculoskeletal pain, or neurocognitive symptoms). If participating in the healthy volunteer arm, the participants must meet the following criteria: 1) must not have had a Lyme Disease diagnosis, 2) in generally good health Exclusion Criteria: 1. Unwilling or unable to comply with the protocol (e.g., scheduled visits, laboratory tests, other study procedures, and study restrictions).

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 |
| --- | --- |
| Previously Treated for Lyme Disease<br> | Other: Stool and blood collection<br>* One-time stool and blood collection<br>|
| Healthy Volunteers<br> | Other: Stool and blood collection<br>* One-time stool and blood collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease |  | 30 days | 
| • To evaluate and compare the transcriptome of normal participants and participants with previously treated Lyme Disease |  | 30 days | 
| • To evaluate and compare the metabolome of normal participants and participants with previously treated Lyme Disease |  | 30 days | 
| • Evaluation of symptoms and prior medications/treatments of normal participants and participants with previously treated Lyme Disease |  | 30 days |
Rate of Pelvic Inflammatory Disease at St. Michael's Hospital

Study Overview
=================
Brief Summary
-----------------
A retrospective review of women who came through the ER at SMH with a pelvic inflammatory disease (PID) or tubo-ovarian abscess (TOA) between 1995-2005. They were looking at people with this diagnosis to determine how they were treated, whether as inpatient or outpatient and whether they were treated with drugs and how were these given and also did they develop an abscess.

Official Title
-----------------
Rate of Pelvic Inflammatory Disease and Tubo-ovarian Abscess at SMH

Conditions
-----------------
Pelvic Inflammatory Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women admitted to Emergency with pelvic-inflammatory disease or tubo-ovarian abscess from the year range: 1995-2000 Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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
-----------------
tubo-ovarian abscess, pelvic-inflammatory disease
Obstetric & Pediatric Evolution Following Parental Refusal for Early Termination of Pregnancy Despite Fetal Risk

Study Overview
=================
Brief Summary
-----------------
More and more parents decide to maintain pregnancy which could have been interrupted because of serious fetal pathologies. In this observational study, the investigators examine obstetrical and pediatric evolution of these pregnancies, from 2006 to 2016 in Montpellier University Hospital.

Official Title
-----------------
Evolution of Maternal & Infantile Health Following Parental Refusal of Termination of Pregnancy Despite Such Option Being Allowable by the Centre Pluridisciplinary de Diagnostic Prenatal (Interdisciplinary Center for Prenatal Diagnostics)

Conditions
-----------------
Termination of Pregnancy

Intervention / Treatment
-----------------
* Other: not accurate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - refusal of termination of pregnancy despite serious fetal pathology Exclusion criteria: termination of pregnancy termination of pregnancy not accepted by the Interdisciplinary Center for Prenatal Diagnostics
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: not accurate|not accurate|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apgar score at 5 minutes | Apgar score at 5 minutes | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health status of children | health status of children at 1 year old : alive or dead. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fetal pathology, Obstetrical outcome, Pediatric outcome
A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis

Study Overview
=================
Brief Summary
-----------------
A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of plaque psoriasis Exclusion Criteria: Skin disorder other than plaque psoriasis in the areas to be treated. Disease on only elbows, knees, and scalp

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Double


Arms and Interventions

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

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
-----------------
Treatment Outcome, Tacrolimus, Safety, Psoriasis
Postoperative Intensive Care Surveillance

Study Overview
=================
Brief Summary
-----------------
Several score systems were created to stratify perioperative risk and predict mortality. The study rises from the needing of a rapid and simple system to identify the patient worthy of Postoperative Intensive Surveillance. In the first phase Authors retrospectively investigated on patients underwent to elective surgery searching for determining factors (DFs) for postoperative ICU admission. Later, Researchers prospectively studied how DFs could predict the admission in ICU of consecutive patients scheduled for elective surgery during a three-months period and created an index, named PoIS (Post-operative Intensive Surveillance), based on the results of this analysis. Authors used surgical invasiveness (SI), Diabetes Mellitus (DM), Myocardiopathy (MCP), Cerebrovascular Disease (CVD), Body Mass Index (BMI), age, serum creatinine level (sCr), Tiffenau Index (TI) and male sex for the development of the original model. Authors classified SI from G1 (lowest) to G5 (highest). The results show that the power of prediction of postoperative morbidity of PoIS and POSSUM resulted coincident and better than the American Society of Anesthesiology scoring system.

Official Title
-----------------
POSTOPERATIVE INTENSIVE CARE SURVEILLANCE. A Tool to Optimize ICU-beds Management?

Conditions
-----------------
Post-operative Adhesion(s)

Intervention / Treatment
-----------------
* Other: ICU admission


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery Exclusion Criteria: multiple surgery age less than 18

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 |
| --- | --- |
| ICU<br>patients postoperatively admitted to ICU | Other: ICU admission<br> <br> |
| no ICU<br>patients who didn't required ICU admission postoperatively | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative intensive care surveillance scoring system |  | 1 hour after the end of surgery |
Improved Analysis Methods for Infusion Tests

Study Overview
=================
Brief Summary
-----------------
Objective: Patients with Idiopathic Normal Pressure Hydrocephalus are improved with shunt surgery. To increase the accuracy of the diagnosis, supplementary tests that characterize the cerebrospinal fluid (CSF) dynamics are used. The infusion test is one of these, used for shunt surgery selection and postoperative evaluation of shunt function. Forty-eight patients that had a preoperative investigation because of communicating hydrocephalus at the university hospitals in Umeå and Uppsala, Sweden, participated in the study. The purpose of this study was to evaluate a new method, with a new infusion protocol and new analysis methods, and compare it to the current method.

Official Title
-----------------
Novel Infusion Method for Describing CSF Dynamics

Conditions
-----------------
Idiopathic Normal Pressure Hydrocephalus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preoperative investigation because of communicating hydrocephalus ventriculomegaly (Evans ratio > 0.3) no obstruction to CSF flow at visual inspection Exclusion Criteria: postoperative infusion test investigations patients that were unable to understand instructions
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
-----------------
new infusion test method, reference method, cerebrospinal fluid dynamics
Characterization of Potential Biomarkers of Eye Disease and Vision

Study Overview
=================
Brief Summary
-----------------
Characterize potential biomarkers of sight-threatening eye diseases based on the information acquired in clinical practice at CEC, AIBILI

Detailed Description
-----------------
This is a registry study. Only patients followed under the clinical practice at AIBILI Clinical Trial Centre, and with a signed informed consent form will be included. Based on the clinical information collected under the clinical practice, and based on patients' characteristics, scientific questions will be raised and data will be collected and analysed accordingly. Any procedure performed under clinical practice that may allow for the characterization of the disease and/or for the identification of potential biomarkers will be collected and analysed.

Official Title
-----------------
Characterization of Potential Biomarkers of Eye Disease and Vision Loss.

Conditions
-----------------
Eye Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient followed under the normal clinical practice at AIBILI Clinical Trial Centre, and with a AIBILI signed informed consent form for data collection, Imp. 11-7-2 Consentimento Informado para tratamento de dados. Exclusion criteria: None

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize potential biomarkers of sight-threatening eye diseases based on the information acquired in clinical practice at CEC, AIBILI. |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eye, Imaging
Heparin-Binding Protein and Heparins

Study Overview
=================
Brief Summary
-----------------
Heparin-Binding protein is a protein from primary and secretory granluae of white blood cells. It is released when white blood cells become activated and has been advocated as a biomarker for sepsis. The aim of this study is to find out if Heparins in clinical doses can change the level of Heparin-binding protein in plasma.

Detailed Description
-----------------
Blood samples are taken from patients before and after Heparins in clinical doses. The effects of heparins on Heparin-binding protein concentration in plasma is measured. This is a small observational study.

Official Title
-----------------
Heparin-binding Protein and Heparins

Conditions
-----------------
Vascular Disease, Peripheral, Thromboprophylaxis, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Blood samples for Heparin-binding protein measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned endovascular treatment of aortic aneurysm or peripheral vascular surgery where unfractionated heparin in >3000 units are given perioperatively Planned subcutaneous low molecular weight heparin as a thromboprophylactic treatment after major surgery or on Intensive Care treated patients. Planned open heart surgery with cardiopulmonary bypass. Exclusion Criteria: Under 18 years Unable to get informed consent from patient or relative

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 |
| --- | --- |
| Vascular surgery group<br>Patients which are given unfractionated heparin during their vascular surgery. | Diagnostic Test: Blood samples for Heparin-binding protein measurement<br>* Blood samples before and after given heparin<br>|
| Thromboprophylaxis group<br>Patients which are given low molecular heparins as a thrombosprofylax after major surgery | Diagnostic Test: Blood samples for Heparin-binding protein measurement<br>* Blood samples before and after given heparin<br>|
| Cardiothoracic surgery<br>Patients which are given high dose unfractionated heparin during their open heart surgey | Diagnostic Test: Blood samples for Heparin-binding protein measurement<br>* Blood samples before and after given heparin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the level of Heparin-binding protein | Blood samples are taken before and after given heparin | Repeated blood sampling during minimum of 1 hour and maximum of 5 hours after given heparin | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heparin-binding protein, Heparin, Biomarker
Tracheal Anatomy After Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
The investigators aimed at investigating the effects of thyroidectomy on tracheal anatomy and airflow in patients with benign nodular goiter, employing a prospective observational study. Magnetic resonance images of the neck and respiratory flow-volume curves were performed prior to and six months following surgery. Tracheal and thyroid volumes, smallest cross-sectional area of the trachea (SCAT), tracheal narrowing, tracheal deviation and tracheal encirclement by the thyroid were evaluated. Through flow-volume curves respiratory function, including both in- and expiration, was evaluated.

Official Title
-----------------
Thyroidectomy Improves Tracheal Anatomy and Airflow in Patients With Nodular Goiter: A Prospective Cohort Study

Conditions
-----------------
Goiter, Nodular

Intervention / Treatment
-----------------
* Procedure: Thyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reads and write Danish Exclusion Criteria: Suspected or present malignancy Neuromuscular disease Prior surgery to the neck

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- |
|Procedure: Thyroidectomy|Remove the nodular goiter on the neck by thyroidectomy (standard procedure)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tracheal anatomy | Change in tracheal narrowing (cross sectional area of the trachea at the goiter level compared to cross-sectional area of the trachea at the carina) | 6 months follow-up |
Effect of Adaptive Servoventilation on Cardiac Function in Chronic Heart Failure and Cheyne-Stokes Respiration

Study Overview
=================
Brief Summary
-----------------
Sleep disordered breathing is common in patients with chronic heart failure. Adaptive servoventilation is a novel method of treatment central sleep apnoea, especially associated with Cheyne-Stokes-respiration. The aim of the study is to investigate effect of adaptive servoventilation on cardiac function, exercise tolerance and quality of life in patients with chronic heart failure.

Official Title
-----------------
Effect of Adaptive Servoventilation on Cardiac Function, Exercise Tolerance and Quality of Life in Patients With Chronic Heart Failure and Cheyne-Stokes Respiration

Conditions
-----------------
Chronic Heart Failure, Central Sleep Apnea, Cheyne-Stokes Respiration

Intervention / Treatment
-----------------
* Device: Adaptive servoventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic heart failure with ejection fraction ≤45% optimal medical treatment for at least 1 month clinical diagnosis of Cheyne-Stokes respiration Exclusion Criteria: unstable heart failure stroke transient ischemic attack in last 6 months pacemaker, cardioverter-defibrillator or resynchronization device implanted less than 6 months before study entrance severe chronic obstructive pulmonary disease

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASV<br> | Device: Adaptive servoventilation<br>* Background expiratory positive airway pressure with some inspiratory pressure support when needed<br>|

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

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