linjc16/ctgov huggingface dataset:
Adverse Event Scale in Patients With Epilepsy (aEscape) - A European Survey for Physicians With Epilepsy Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the survey is to explore through a structured interview and patient examination the rate and distribution of neurological and systemic adverse effects related to antiepileptic treatment. Adverse effects and considerations to modify the therapy will be assessed in pediatric and adult patients with controlled as well as uncontrolled epilepsy with different seizure types

Official Title
-----------------
A Multicenter, Non-interventional Surveillance Study to Evaluate the Adverse Effects of Antiepileptic Drug Treatment in Patients With Epilepsy

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients from the age of 4 years Confirmed diagnosis of epilepsy requiring AED treatment Patients already receiving daily AED treatment as a monotherapy or a polytherapy with maximum 2 AEDs within the terms of marketing authorization with the following medications: Carbamazepine, Clobazam, Clonazepam, Gabapentin, Lamotrigine, Levetiracetam, Oxcarbazepine, Phenobarbital, Phenytoin, Pregabalin, Tiagabine, Topiramate, Valproate, Zonisamide Treatment must be stable for at least 3 months prior to assessment Absence of other severe and/or uncontrolled symptomatic chronic illness

Ages Eligible for Study
-----------------
Minimum Age: 4 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
-----------------
Non-Interventional, Surveillance, Adverse Effects, AntiEpileptic Drug treatment
Accuracy of Using the CPAP Technique to Eliminate Air Leak and Prevent Excessive Endotracheal Tube Cuff Pressures

Study Overview
=================
Brief Summary
-----------------
In common clinical practice, one means of ensuring an acceptable cuff pressure in endotracheal tubes (ETT) is to hold continuous positive airway pressure (CPAP) of 20-25 cmH2O and inflate the cuff of the ETT until no gas leak is noted around the cuff. The purpose of this study is to validate this technique by checking the intracuff pressure using a manometer after the cuff is inflated using the CPAP technique.

Conditions
-----------------
Surgical Patients Intubated With Cuffed ETT

Intervention / Treatment
-----------------
* Other: Manometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having a cuffed ETT placed per treating anesthesiologist < 18 yrs of age. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- |
| Cuffed ETT<br>Patients intubated with cuffed endotracheal tubes. | Other: Manometer<br>* Measuring cuff pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cuff pressure | cm H2O measured by manometer | Baseline |
Treatment of Venous Thromboembolism in Real-Life Patients

Study Overview
=================
Brief Summary
-----------------
In a population of patients with venous thromboembolism and treated with oral anticoagulants (OAC) in routine clinical practice in Denmark this study will describe patients treated with each OAC

Official Title
-----------------
Treatment of Venous Thromboembolism in Real-Life Patients: A Nationwide, Population-Based Study

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients ≥ 18 years diagnosed with incident VTE at Danish public hospitals from 2006 through 2015 First-time (index) VTE will be defined as an in- or out-patient diagnosis of DVT or PE among patients redeeming a prescription for anticoagulant drugs within 30 days after index date Exclusion Criteria: 1. In the analyses on type and duration of anticoagulant use, Patients with cancer will be excluded as they typically receive low molecular heparin directly from the hospital and their use of anticoagulants can therefore not be captured by redeemed prescriptions at pharmacies.

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 |
| --- | --- |
| VKA patients<br>Vitamin K antagonist (VKA) patients | Other: Non-Interventional<br>* Non-Interventional<br>|
| NOAC patients<br>nonvitamin K antagonist oral anticoagulants (NOAC) patients | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization rate in VKA patients for VTE | Hospitalization rate for first-time Venous thromboembolism (VTE) in Vitamin K antagonist (VKA) patients | Approximately 180 months | 
| VTE hospitalization rate in VKA patients by sex |  | Approximately 180 months | 
| VTE hospitalization rate in VKA patients by age |  | Approximately 180 months | 
| Hospitalization rate in NOAC patients for VTE | Hospitalization rate for first-time venous thromboembolism in nonvitamin K antagonist oral anticoagulants (NOAC) patients | Approximately 180 months | 
| VTE hospitalization rate in NOAC patients by sex |  | Approximately 180 months | 
| VTE hospitalization rate in NOAC patients by age |  | Approximately 180 months | 
| Duration of Treatment in NOAC patients |  | Approximately 180 months | 
| Duration of treatment in VKA patients |  | Approximately 180 months |
A Modified Rehabilitation Intervention for Working Persons With Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the effects of a brief vocational rehabilitation intervention on individuals with arthritis who are concerned about their ability to remain employed.

Official Title
-----------------
Efficacy of a Modified Vocational Rehabilitation Intervention for Work Disability

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Behavioral: Vocational Rehabilitation Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Live or work in eastern Massachusetts Age 25-63 years Risk of work loss due to arthritis Arthritis Chronic back pain Currently employed Exclusion Criteria: Unemployed No arthritis

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 63 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Therapist/Occupational Therapist Intervention<br>This group will be assigned a physical therapist or occupational therapist to meet with followed by 2 phone consultations. | Behavioral: Vocational Rehabilitation Intervention<br>* Physical or occupational therapist will deliver a vocational rehabilitation intervention using the Work Experience Survey for Persons with Rheumatic Conditions (WES-RC) assessment tool to assess subject's health and vocational background as well as work barriers.<br>|
| No Intervention: Control<br>This is the control group. This group will not receive the vocational rehabilitation intervention from an occupational or physical therapist. They will receive written information regarding job accommodations and disability advocacy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in work status | Work limitation will be assessed using the Work Limitation Questionnaire, a tool developed to assess limitation in ability to work due to health. | Baseline, 6, 12, 24 month follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
supportive employment, vocational rehabilitation
Dexamethasone for Pain After Shoulder Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.

Official Title
-----------------
High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial

Conditions
-----------------
Shoulder Impingement Syndrome, Arthritis

Intervention / Treatment
-----------------
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Arthroscopic subacromial decompression and/or acromioclavicular resection General anaesthesia Daysurgery, Horsens Hospital Exclusion Criteria: Incompetent Pregnant Age under 18 or over 90 years Allergy toward dexamethasone Diabetes Active gastric ulcer Untreated hypertension Glaucoma Daily use of glucocorticoids or strong opioids Daily use of analgesics for unrelated illness Myasthenia gravis Mitochondrial disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 8 mg dexamethasone<br> | Drug: Dexamethasone<br>* Singe dose preoperatively in 100 ml saline intravenously<br>* Other names: Fortecortin;|
| Placebo Comparator: Placebo, saline<br> | Drug: Dexamethasone<br>* Singe dose preoperatively in 100 ml saline intravenously<br>* Other names: Fortecortin;|
| Experimental: 40 mg dexamethasone<br> | Drug: Dexamethasone<br>* Singe dose preoperatively in 100 ml saline intravenously<br>* Other names: Fortecortin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score by numeric rating scale |  | At 8 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of analgesics | Need for supplemental analgesic medication during stay in recovery on the day of operation, until discharge. | During hospital stay, about 4 hours | 
| Pain score by numeric rating scale | On the morning of the first postoperative day, the self-evaluated level of pain as assessed by numeric rating scale. | At about 8 a.m. on the first postoperative day |
CT Lucia 601 IOL Implantation in the Sulcus

Study Overview
=================
Brief Summary
-----------------
To perform a retrospective investigation of the CT Lucia 601 IOL implantation in the sulcus

Detailed Description
-----------------
The purpose of the study is to collect data that are parameters of post-IOL implantation safety: Questionnaire on subjective quality of vision Centration and anteroposterior position of the IOL (using biometry) Presence and quantification of any inflammation or pigment present in the anterior chamber (flare meter) Refractive outcome, with calculation of customized A-constant of the CT Lucia 601 IOL in-the-sulcus and quantification of higher-order aberrations (HOA) General safety-parameters: Visual acuity Intra-ocular pressure Presence of macular edema or retinal nerve fiber layer (RNFL) thinning (SD-OCT) Any adverse ophthalmic events

Official Title
-----------------
CT Lucia 601 IOL Implantation in the Sulcus

Conditions
-----------------
Posterior Capsule Tear, Cataract; Complicata, Lens Dislocation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an implantation of a CT Lucia 601 lens for different reasons: During vitrectomy to treat a complicated cataract surgery and had the implantation of a CT Lucia 601 IOL in the sulcus or patients During phaco surgery with a posterior capsule tear that necessitated the implantation of the implant lens in the sulcus Explantation of an in-the-bag lens and implantation of a CT Lucia 601 as replacement lens (e.g. to treat opacification of the implant lens or intolerance of the implant lens). Age : > 18 years Signed informed consent Preoperative myopia less than 10 diopters Implantation of the CT Lucia IOL at least six months earlier Exclusion Criteria: History of uveitis Ocular pathology or history that could influence the biometry of the effective lens position, such as ocular trauma with zonulolysis, congenital iris- or lens defects etc. Any eye condition influencing the lens position (to be specified) according to the investigator

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 |
| --- | --- | --- |
| safety of the CT Lucia 601 IOL in the sulcus | determine whether the CT Lucia 601 IOL can be used safely in the sulcus | 2019-2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CT Lucia 601 lens
Optimal Length for Nasal Mid-turbinate and Nasopharyngeal Swabs

Study Overview
=================
Brief Summary
-----------------
This study aim to explore the optimal swap insertion length for mid-turbinate and nasopharyngeal samples. Our clinical trial took place at a Covid-19 test center in Copenhagen. Participants consisted of voluntary citizens who were at the test center for a nasopharyngeal antigen quicktest. An endoscopic examination was performed simultaneous with the swap to measure the length from the vestibulum nasi to the posterior wall of the nasopharynx and the mid-turbinate.

Official Title
-----------------
Optimal Insertion Length for Nasal Mid-turbinate and Nasopharyngeal Swabs for Respiratory Virus Infection Diagnostic Testing - a Clinical Trial

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Nasopharyngeal swab for COVID-19 testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred for COVID-19 testing Exclusion Criteria: Nose patology

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Collecting of Clinical Specimens for COVID-19 Testing<br>Nasopharyngeal swab is performed on all participants to collect specimens for Rapid antigen COVID-19 Testing | Diagnostic Test: Nasopharyngeal swab for COVID-19 testing<br>* A nasopharyngeal swab was performed endoscopically video guided to measure the actual length from to the mid turbinate and the posterior nasopharyngeal wall<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length from the vestibulum nasi to the posterior wall of the nasopharynx. | Endoscopic measurement of the length from the vestibulum nasi to the posterior wall of the nasopharynx. | From inclusion at the testcenter until the COVID-19 testing was completed. | 
| Length from the vestibulum nasi to the mid-turbinate. | Endoscopic measurement of the length from the vestibulum nasi to the mid-turbinate. | From inclusion at the testcenter until the endoscopic examination was completed |
Pharmacokinetic/Pharmacodynamic Evaluation Amikacin in Critically Ill Patients Admitted at the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients with severe sepsis and septic shock.

Official Title
-----------------
Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Amikacin in Patients With Severe Sepsis or Septic Shock Admitted at the Emergency Department(ED)

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: Amikacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients admitted at the emergency department with a diagnosis of severe sepsis or septic shock in whom amikacin is indicatied Exclusion Criteria: < 18 years pregnancy burns amikacin treatment in the previous 2 weeks known allergy to aminoglycosides Do Not Reanimate Code ≥ 2 Hospitalized patients with a prolonged deep venous or arterial catheder Continuous renal replacement, intermittent hemodialysis and death within the time of start of amikacin replacement and 1 hour later

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: amikacin standard dose<br>amikacin in a single standard dose | Drug: Amikacin<br>* Amikacin administered in a single dose for critical care patients<br>|
| Active Comparator: amikacin dose for critical care patients<br>amikacin in a single dose for critical care patients | Drug: Amikacin<br>* Amikacin administered in a single dose for critical care patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with amikacin PK/PD target attainment | The primary outcome of this study was evaluation of PK/PD target attainment defined as amikacin peak concentration/Minimal Inhibitory Concentration > 8 in the 15 vs.25 mg/kg amikacin group in function of 1) actual MIC of isolated pathogens 2) breakpoints of European Committe on Antimicrobial susceptibility testing (EUCAST) of Enterobacteriaceae and Pseudomonas aeruginosa | Participants will be followed for the duration of hospital stay, an expected average of 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, aminoglycosides
The Reproducibility of Microvascular Flow Imaging in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that Macrovascular Flow imaging could contribute to 2D power Doppler and 3D power Doppler in depicting fibroid vascularity. However, data concerning the feasibility and reproducibility of Macrovascular Flow imaging is lacking. Therefore the purpose of our study was to determine 1) the reproducibility of Macrovascular Flow imaging, 2) its correlation with 2D and 3D power Doppler, and 3) penetration depth, in order to investigate the added value for daily clinical practice.

Official Title
-----------------
The Reproducibility of Microvascular Flow in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes: a Prospective Cohort Study

Conditions
-----------------
Fibroid Uterus

Intervention / Treatment
-----------------
* Diagnostic Test: microvascular flow imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: one or more uterine fibroids diameter between 1,5 and 12 cm fibroid easily recognizable on ultrasound Exclusion Criteria: younger than 18 years pregnancy uterine or cervical malignancy adenomyosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: microvascular flow imaging|microvascular flow imaging|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reproducibility by inter- and intraobserver agreement | The primary outcome was calculated by the assessment of intercorrelation coefficient (ICC) and its 95% confidence interval (CI) using a two-way mixed model. An ICC value of 0.75-1.00 indicates a good to excellent agreement(19). Bland-Altman plots showed the distribution of data. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| penetration in centimeters | The penetration was measured along the direction of the ultrasound wave, from the probe to the deepest ultrasound signal visible, both for Microvascular Flow and power Doppler. Differences in ordinal data was tested by Mann Whitney U, non-normal continuous data by Wilcoxon rank test and normally distributed continuous data by a one sample t-test. | Day 1 | 
| architecture | architecture of vessels visible in different regions yes/no. | Day 1 | 
| presence doppler signal | yes/no in different regions | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibroid, microvascular flow, power doppler