linjc16/ctgov huggingface dataset:
Epidemiological Study on the Surgical Removal of Third Molars

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to get a clear view on current practice of surgical third molar removal in Belgium and the association with morbidity and complications. For this prospective cohort study, patients who visit the outpatient department of Oral and Maxillofacial Surgery of the University Hospitals Leuven or hospitals affiliated with the Flemish Hospital Network will be participating. All included patients are referred from primary dental providers for the surgical removal of one or more third molars. Before participating, written informed consent will be recorded from all eligible subjects. Patients consult one of the oral and maxillofacial surgeons or residents working on the department of the University Hospitals Leuven for the removal of third molars. In the standard procedure, patients are not routinely clinically monitored after one week at the department. Pre-operative, operative and postoperative data will be collected through a questionnaire, extracted data from the patient's medical file and panoramic radiography. The surgeon's individual operation technique will be registered through a one-off questionnaire. The questionnaires are taken at the same time of consultation and includes a maximum of 8 questions per time and are considered as non-invasive and a minimal burden for the patient. Postoperatively, patients record their recovery status and ability to resume daily- and work activities at day 3 and 10 by using a dairy system and, if necessary, revisit the outpatient department of oral and maxillofacial surgery.

Official Title
-----------------
Epidemiological Study on the Surgical Removal of Third Molars

Conditions
-----------------
Impacted Third Molar Tooth

Intervention / Treatment
-----------------
* Procedure: Third molar removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: referred for the removal of one or more third molars Exclusion Criteria: other concomitant oral procedures in the same surgical session

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Third molar removal|The surgical removal of third molars|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Assessing pain, trismus, swelling and neurosensory disturbances | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resuming daily activities | Household, work, studies | 10 days |
Low Flow Anaesthesia

Study Overview
=================
Brief Summary
-----------------
To study the Flow-I breathing circle during low flow general anaesthesia, whether this non-below system has advantages reduced time to reach Et 1MAC (minimal alveolar concentration) and lower consumption of inhaled agent

Detailed Description
-----------------
Assessing whether there are clinical differences in anaesthetic performance between standard anaesthesia workstation including a below and the new Flow-I device without a below

Official Title
-----------------
Low Flow Anaesthesia; Cost-effectiveness of the Flow-I Anaesthesia Machine, a Comparison to Established Anaesthesia Delivery Unit

Conditions
-----------------
General Anaesthesia

Intervention / Treatment
-----------------
* Device: Flow-I
* Device: Asys


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1-2 patient 18 - 65 years scheduled for elective surgery Exclusion Criteria: ASA > 2 heart failure COPD

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We studied the time to reach a MAC value for two fifferent anaesthetic machines, Flow-i versus Aisys looking at the time to reach 1 MAC desflurane
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flow-I<br>Wash in of desflurane in an anaesthesia machine without below | Device: Flow-I<br>* Desflurane Dialed setting 18 %<br>|
| Active Comparator: Asys<br>Wash in of desflurane in conventional anaesthesia machine Asys | Device: Asys<br>* Desflurane dialed 18%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach 1.5 MAC (minimal alveolar concentration) Et | The time needed, seconds, to increase the end tidal desflurane concentration during wash-in from a 1 MAC to a 1.5 MAC with a constant fresh gas flow of 1 L/min and the vaporiser set a 3 MAC ( minimal alveolar concentration) (18%) will be compared between the two study groups | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of inhaled agent consumed ml/min | The vaporiser will be weighed before and after each case and the amount of vapor, desflurane, consumed during the anaesthesia will be calculated Gr/min. | 5 hours | 
| Postoperative Quality of Recovery | Quality of recovery will be followed during the first 72 hours after anaesthesia | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fresh gas flow, quality of anaesthesia, minimal alveolar concentration
Rivastigmine Capsules in Patients With Probable Vascular Dementia

Study Overview
=================
Brief Summary
-----------------
The goal of this research study is to evaluate, in the open-label extension phase, the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.

Official Title
-----------------
An Open-label Extension to Evaluate the Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

Conditions
-----------------
Vascular Dementia

Intervention / Treatment
-----------------
* Drug: Rivastigmine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who complete the double-blind treatment phase or those who have dropped out early in the study, but have returned for all the remaining scheduled efficacy assessments (retrieved drop-out patients) without significant protocol violations are eligible to participate. Exclusion Criteria: Retrieved drop-out patients, who have been treated with other cholinergic drugs during the past 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 52 week's treatment with rivastigmine on cognition, activities of daily living, behavior and clinical staging in patients with VaD and probable VaD |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Vascular, Rivastigmine, Stroke, Memory loss
Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Requiring Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and mortality. Clot formation and clot stability are important factors in coagulation and hemostasis. As such platelet dysfunction and impaired thrombin generation play a central role in bleeding after cardiac surgery. The primary objective of this study is to evaluate the relationship between point-of-care determined platelet function and thrombin generation and postoperative bleeding in infants and young children undergoing cardiac surgery with cardiopulmonary bypass adjusting for clinically important confounding factors.

Official Title
-----------------
Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Conditions
-----------------
Platelet Function Tests, Thrombin Generation Tests, Perioperative Coagulopathy

Intervention / Treatment
-----------------
* Device: Thrombin generation and Platelet Function Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤5 years Undergoing cardiac surgery with cardiopulmonary bypass Exclusion Criteria: Non-english speaking parents/care-givers Refusal to consent Extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery Therapeutic heparin use (unfractionated or low molecular weight) in the immediate preoperative period (<12 hr) Weight <3 kg

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Thrombin generation and Platelet Function Testing|Point-of-care testing of thrombin generation, platelet function, and rotational thromboelastometry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative chest tube blood loss |  | 24hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative chest tube blood loss |  | 6hr | 
| Postoperative chest tube blood loss |  | 12hr | 
| Transfusion of blood products |  | 24hr | 
| All-cause mortality |  | within 30 days | 
| Length of hospital stay |  | through study completion, an average of less than one month | 
| Length of ICU stay |  | within 30 days | 
| Duration of mechanical ventilation |  | within 30 days | 
| Inotropes | Duration of inotropic support | within 30 days | 
| Kidney injury | Acute kidney injury | within 30 days |
A Epidemiological Survey of Preoperative Pain Perception and Postoperative Pain in Chinese Population

Study Overview
=================
Brief Summary
-----------------
Object: Every person's pain perception and possible postoperative pain is different. As the investigators know, they are affected by many factors. However, the investigators don't know whether the smoking factors, alcohol factors, surgery type, education background, etc. will affect individual pain perception and possible postoperative pain in Chinese population. This study was conducted to investigate the power of these possible affect factors. Method: Patients receiving elective surgery under general anesthesia were recruited into this study. The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO)and also investigated the patient's personal information of smoking factors, alcohol factors, surgery type, education background, etc. In addition, we retrospectively investigated the visual analog scale (VAS) during patient-controlled analgesia (PCA) treatment 0 to 48 h after operation as well as the PCA press frequency and drug consumption of those patients who received PCA administration.

Detailed Description
-----------------
Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or pregnancy or at the lactation period.

Official Title
-----------------
A Epidemiological Survey of Preoperative Pain Perception and Postoperative Pain in Chinese Population

Conditions
-----------------
Pain, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 to 70 The right hand is handedness Agreed to participate the research Not with known chronic disease Not taking analgesics within 3 months Exclusion Criteria: History of chronic pain diseases Diabetes mellitus Severe cardiovascular diseases Kidney or liver diseases Alcohol or drug abuse Pregnancy or at lactation period Disagree to participate to the research

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 |
| --- | --- | --- |
| Pressure pain threshold |  | 1 year | 
| Pressure pain tolerance |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on visual analog scale after operation |  | 1 year | 
| Opioid consumption dose after operation |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain perception, postoperative pain, demography, smoking, alcohol
Fingolimod in Endovascular Treatment of Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
Proof-of concept clinical trials have indicated that the sphingosine-1-phosphate receptor modulator fingolimod may be efficacious in attenuating brain inflammation and improving clinical outcomes in patients with acute ischemic stroke as a single therapy beyond 4.5 hours of disease onset, or in combination with alteplase within 4.5 hours of disease onset. This study aim to determine whether fingolimod enhance the action of endovascular treatment for acute ischemic stroke

Official Title
-----------------
Combinating Fingolimod With Endovascular Treatment in Acute Ischemic Stroke

Conditions
-----------------
Stroke Inflammation

Intervention / Treatment
-----------------
* Drug: Fingolimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with anterior circulation acute ischaemic stroke who are eligible for mechanical thrombectomy commenced within 6-24 hours of stroke onset. Patient, family member or legally responsible person depending on local ethics requirements has given informed consent. Patient's age is 18-80 years. Arterial occlusion on internal carotid artery proximal or middle cerebral artery Imaging inclusion criteria: infarct core volume between 15-70 mL Exclusion Criteria: Pre-existing neurologic disability (a score greater than 2 on the mRS). Swallowing difficulties that would prevent administration of oral fingolimod. Patients with any history of bradyarrhythmia, atrioventricular block or current use of beta-blockers or verapamil. Patients with serious acute or chronic infection, or hepatic injury Concomitant use of antineoplastic, immunosuppressive or immune modulating therapies. Macular edema.

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endovascular treatment with fingolimod<br> | Drug: Fingolimod<br>* Patients randomized to fingolimod will also receive oral fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days, with the first dose being given at the time in which patients are enrolled which is more than 3 hour prior to mechanical thrombectomy.<br>|
| No Intervention: endovascular treatment without fingolimod<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the grade of collateral circulation | Multiphasic contrast-enhanced CT collateral grades with six-point pial arterial filling ordinary score as established at the University of Calgary | Baseline (before endovascular treatment) |
Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia

Study Overview
=================
Brief Summary
-----------------
Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

Official Title
-----------------
A 5-Day, Double-Blind, Placebo-Controlled Multicenter Study of Oral YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

Conditions
-----------------
Hyponatremia

Intervention / Treatment
-----------------
* Drug: YM087 oral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum Sodium 115 to <130mEq/L Plasma Osmolarity <290 mOsmol/kg H2O Exclusion Criteria: Significant renal insufficiency Serum sodium increase of ≥8 mEq/L over the baseline day ( Hours 0 to 12)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: YM087 oral|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum sodium from Baseline Safety of each dosing regimen |  | Beginning through end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyponatremia, hypervolemic, euvolemic, conivaptan
Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus

Study Overview
=================
Brief Summary
-----------------
To establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal Staphylococcus aureus colonization against clinical microbiology laboratory culture methods.

Official Title
-----------------
Multi-Center Clinical Performance Evaluation of a Rapid In Vitro Diagnostic Device for Direct Detection of Staphylococcus Aureus Nasal Colonization: Comparative Analysis to Culture Screening Methods

Conditions
-----------------
Staphylococcus Aureus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18 years of age or older, male or female and from any race or culture. Subjects who are ambulatory (able to walk unaided or with a cane, walker, wheelchair) on the day of their pre-operative visit for non-emergent surgery. Exclusion Criteria: Subjects who are on the nasal topical antibiotic Mupirocin (Bactroban® Nasal Ointment) within the last 4 weeks. Subjects who are present at the preoperative visit with prescribed nasal medical devices (e.g. CPAP = Continuous Positive Airway Pressure or Nasal Cannula), nasal prosthetics, the wearing of nasal jewelry or trauma to the nose or anything that may inhibit sampling of the anterior nares.

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

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Staphylococcus aureus, Nasal colonization, pre-surgical patients, Sensitivity, Specificity, Nasal Staphylococcus aureus in pre-surgical patients
A Woman Suffered From Leukocytopenia and Widespread Migration After Polyacrylamide Hydrogel (PAAG) Injection in Epicranial Aponeurosis

Study Overview
=================
Brief Summary
-----------------
Polyacrylamide hydrogel (PAAG) has been used as an injectable filler for soft tissue augmentation in different parts of the body , such as face, breast , or even penis for more than a decade . However, there are never reports about the application of a large amount of PAAG in epicranial aponeurosis to change the contour of the upper cranium accompanied with leukocytopenia. This fancy application turned out to be a disaster for the women who suffered from leukocytopenia , widespread migration of PAAG, recurrent swelling of the affected tissues and temporal pain changing with the temperature and the facial expression .

Conditions
-----------------
Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PAAG injected into bilateral temporal epicranial aponeurosis Exclusion Criteria: PAAG injected into other parts of the body

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

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
-----------------
Polyacrylamide hydrogel, leukocytopenia, migration, complication, epicranial aponeurosis, PAAG injection