linjc16/ctgov huggingface dataset:
Intra-Articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-Blind Randomized Study

Study Overview
=================
Brief Summary
-----------------
Intra-articular injection of etanercept in patient suffering from rheumatoid arthritis: a double-blind randomized study for evaluation of efficacy and safety of etanercept versus intra-articular steroid injection in acute synovitis (knee,wrist,ankle,elbow)

Official Title
-----------------
Intra-Articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-Blind Randomized Study for Evaluation of Efficacy and Safety of Etanercept Versus Intra-Articular Steroid Injection in Acute Synovitis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Procedure: intra-articular injection of etanercept
* Procedure: intra-articular injection of steroid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be able to understand the information about the study diagnosis of rheumatoid arthritis for 6 month at least suffering for 2 weeks at least with evaluation of pain over 4/10 with stable DMARDs treatment for three month at least Exclusion Criteria: infection or surgery on the target joint treated with infliximab,adalimumab or anakinra

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patient receiving etanercept intra-articular injection | Procedure: intra-articular injection of etanercept<br> <br> |
| Active Comparator: 2<br>patient receiving steroid intra-articular injection | Procedure: intra-articular injection of steroid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | every month during six month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intra-articular injection, acute synovitis, etanercept
Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency?

Study Overview
=================
Brief Summary
-----------------
To assess the association between stromal demarcation line after collagen crosslinking (CXL) for progressive keratoconus and mid-term (6 month) refractive, topographic and clinical outcomes of CXL

Detailed Description
-----------------
All consecutive patients treated with CXL between March 2014 and March 2015 were included. They all underwent the same procedure: accelerated-CXL protocol (10 minutes UVA irradiation with 9 mW/cm2 intensity), irradiation device (IROC UV-X™ 2000, Medeuronet). One month after the procedure, AS-OCT examination was performed in all patients (RS-3000, NIDEK). The visibility of the stromal demarcation line was scored (0: not visible line; 1: visible line, but measurement not clearly defined; 2: clearly visible line) and its depth was measured centrally at anytime it was possible. Changes in best corrected visual acuity (BCVA), spherical equivalent (SE), Kmax and thinnest pachymetry, were studied preoperatively and at 6 months

Conditions
-----------------
Progressive Keratoconus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients treated with CXL Exclusion Criteria: -

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 |
| --- | --- |
| patients treated with CXL<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visibility of the stromal demarcation line |  | month 1 |
International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to evaluate the effectiveness of vitrectomy for the treatment of diabetic macular edema. Diabetes is known to cause retinal blood vessels to leak, leading to swelling of the central retina (macula), and decreased vision. Removing the vitreous gel with vitrectomy surgery is known to decrease the swelling caused by diabetes. Diabetic retinopathy is often treated with laser or injections of medicine in to the eye.

Official Title
-----------------
International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients - the ICV-DME Study

Conditions
-----------------
Diabetes With Diabetic Retinopathy With Macular Edema

Intervention / Treatment
-----------------
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, > 18 years of age with type 1 or 2 diabetes mellitus diagnosed and treated by an endocrinologist, internist or family medicine physician Background diabetic retinopathy DME with central subfield thickness (CST) > 325 µm by Spectral Domain Optical Coherence Tomography (SD-OCT) HbA1c level of < 10.0 mg/dl Previous cataract surgery with implantation of a stable posterior chamber intraocular lens or a phakic eye with 1+ (out of 4+ scale) or less lens opacification Predominantly intact (80%) external limiting membrane (ELM) and photoreceptor inner/outer segment (IS/OS) lines within 500 µm of the fovea on horizontal and vertical SD-OCT scans Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive. Exclusion Criteria: Intraocular anti-vascular endothelial growth factor (VEGF) injection within the previous 3 months Systemic anti-VEGF or receptor tyrosine kinase inhibitor therapy within the previous 3 months Intraocular corticosteroid injection within the previous 6 months Peri-ocular corticosteroid injection within the previous 3 months Vitreomacular traction on SD-OCT scan (epiretinal membrane is allowed) Previous anterior or pars plana vitrectomy Glaucoma (IOP of > 21 mmHg or regular use of more than 2 IOP lowering drugs) Previous trabeculectomy Likelihood of needing intraocular surgery within 6 months Hard exudates involving the fovea Proliferative diabetic retinopathy with any evidence of retinal traction Cataract of grade 2+ or greater.

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 |
| --- |
|Procedure: Vitrectomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity |  | 6 months |
Video-Assisted Laryngoscopy Education

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the impact of a video recording review on the acquisition of a new technical skill (laryngoscopy and tracheal intubation).

Official Title
-----------------
Does Video-Assisted Self Review Help Students Learn a New Skill Faster?

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Other: Videolaryngoscopy review.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical students on elective rotation in anesthesiology. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Videolaryngoscopy review.<br>Video review. | Other: Videolaryngoscopy review.<br>* Review of video recordings.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of videolaryngoscopy on skill acquisition. | Recorded intubations reviewed with volunteers learning a new skill. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laryngoscopy, Tracheal Intubation, Video Laryngoscopy
Non-invasive Measurements of Elastance and Resistance

Study Overview
=================
Brief Summary
-----------------
The study aims to assess the agreement between respiratory mechanics parameters measured noninvasively by means of brief airways occlusions at the beginning of inspiration and the reference parameters obtained with standard techniques of esophageal and gastric pressure under static and dynamic conditions in a mixed population of ICU patients mechanically ventilated in pressure support ventilation mode.

Official Title
-----------------
Non-invasive Respiratory Mechanics Assessment During Spontaneous / Assisted Breathing: The ERNI (Elastance, Resistance, Non Invasive Measurements) Study

Conditions
-----------------
Respiratory Insufficiency

Intervention / Treatment
-----------------
* Other: Invasive method
* Other: Non invasive method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intact respiratory drive; PaO2/FiO2 ratio > 150 with a positive end-expiratory pressure (PEEP) ≤ 8 cmH2O; pH between 7.35 and 7.45; patient alert, conscious, and cooperative with a Glasgow Coma Scale ≥ 10. Exclusion Criteria: infection, sepsis or septic shock; (with fever no) hemodynamic instability; respiratory centres depression; esophageal deformity, or gastric/esophageal illnesses; previous recent gastric/esophageal surgery.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: measurement of respiratory mechanics<br>Invasive method: two catheters will be inserted to measure reference respiratory mechanics Non_invasive method: airway pressure measured during a 150-200 ms occlusion at the beginning of inspiration. | Other: Invasive method<br>* Esophageal and gastric catheters to measure respiratory mechanics (static and dynamic)<br>Other: Non invasive method<br>* Non_invasive method: airway pressure measured during a 150-200 ms at the beginning of inspiration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive respiratory mechanics measurement | use of 150-200 ms airway occlusions at the beginning of inspiration to measure non-invasive respiratory mechanics | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Insufficiency [C08.618.846]
Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

Study Overview
=================
Brief Summary
-----------------
A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

Official Title
-----------------
A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Other: observational disease study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Diagnosis of mCRC Having had two disease progressions since diagnosis of first metastasis that led to first systemic treatment. Exclusion Criteria: Currently participating in an investigational clinical trial (thus it does not apply to observational cohort studies) Currently being treated for other cancer(s) Not having mental capacity and/or ability to participate in the study

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: observational disease study|observation of routine clinical practices in mCRC|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | metastatic Colorectal Cancer (mCRC) overall survival in real world setting | From date of randomization until the date of death from any cause, assessed up to 24 months months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control measured by overall response | Overall response to treatment defined by complete and partial response, stable disease, progression of the disease | within 18 months from enrollment | 
| Quality of life using Patients Reported Outcomes | Patients Reported Outcomes defined by a modified version of the questionnaire ACCEPTance by the Patients of their Treatment (ACCEPT) | within 18 months from enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Real Worl Evidence
Multicomponent Therapy for Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
Therapy for fibromyalgia is a well discussed topic in literature, yet not thoroughly evidence-based. Several unicomponent therapies seem to be benificial. Whereas multicomponent and multidisciplinary therapy gains importance and revealing promising results, the investigators aim to combine two well-known therapies in a program for patients with fibromyalgia. From clinical experience, a high drop-out rate has been stated. All data will be explored to analyse explanatory factors.

Official Title
-----------------
The Effect of a 12-week Multicomponent Therapy in Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Behavioral: cognitive behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: woman with fibromyalgia between the age of 20 and 50 agreement with therapy protocol Exclusion Criteria: high indication of depression measured with the Beck Depression Index

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: cognitive behavioral therapy|exercise therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire | impact of fibromyalgia on daily life with a questionnaire | 6weeks | 
| Tampa scale for kinesiophobia | rating the kinesiophobia with a questionnaire | 6weeks | 
| Beck Depression Index | degree of depression with a questionnaire | 6 weeks | 
| Pain Coping Inventory | inventory of the use of pain coping strategies with a questionnaiire | 6 weeks | 
| Pain at tenderpoints | measuring tolerable pain at specified tenderpoints with an algometer | 6 weeks | 
| Grip strength | measuring grip strength of both hands with a dynamometer | 6 weeks | 
| Walking | 6 minute walking test on a treadmill | 6 weeks | 
| cycling | 10 minutes cycling test on a hometrainer | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multicomponent therapy
Comparison of Three Electroconvulsive Therapy (ECT) Techniques for the Treatment of Major Depression

Study Overview
=================
Brief Summary
-----------------
This study will compare the antidepressant benefits and cognitive side effects of three different types of electroconvulsive therapy (ECT) in people with unipolar or bipolar depression.

Detailed Description
-----------------
ECT is an important treatment for severely depressed people who do not respond adequately to, or are intolerant of, antidepressant medication. Traditionally, ECT has been administered with one of two standard techniques: bilateral and right unilateral electrode placement. However, these techniques are limited by either low efficacy or high cognitive impairment. Recently, an additional technique for ECT administration has shown promise in preliminary studies: bifrontal ECT. This study will compare this technique to the two traditional ECT techniques in treating people with depressive symptoms. Participants in this study will be randomly assigned to receive standard bilateral ECT, high-dose right unilateral ECT, or bifrontal ECT in their index course. Depression symptoms, neuropsychological status, and quality of life will be measured throughout the course of the ECT treatment, one week after, and at a 2-month follow-up visit. This study will run for 4 years.

Official Title
-----------------
Comparing Three Electrode Placements to Optimize ECT

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Procedure: Electroconvulsive Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of unipolar or bipolar depression

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RUL<br>Right unilateral electroconvulsive therapy | Procedure: Electroconvulsive Therapy<br>* Electroconvulsive therapy<br>|
| Active Comparator: BL<br>Bilateral electroconvulsive therapy | Procedure: Electroconvulsive Therapy<br>* Electroconvulsive therapy<br>|
| Active Comparator: BF<br>Bifrontal electroconvulsive therapy | Procedure: Electroconvulsive Therapy<br>* Electroconvulsive therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale, 24 item | Depression symptom rating | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological assessment | neuropsychological test battery | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder
Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep

Study Overview
=================
Brief Summary
-----------------
The investigators are doing this research study to find out how and where dexmedetomidine, a sedative anesthetic, acts in the brain. The investigators will do this by using a machine that records the brains electrical activity, called an electroencephalogram (EEG), and brain imaging scans to look at the brain.

Official Title
-----------------
Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep

Conditions
-----------------
Dexmedetomidine Induced Sedation

Intervention / Treatment
-----------------
* Drug: dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I 18 to 35 years of age Exclusion Criteria: MRI and/or PET screening criteria not met Abnormal sleep habits/known or suspected sleep disorder(s) Taking medication that alters sleep, cognitive function, or both -History of a known neurological or psychiatric problem -Younger than 18 or older than 35 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active study arm<br>Subjects recruited into this study will be required to undergo two magnetic resonance imaging- positron emission tomography (MRI-PET) scans of the brain in addition to high density electroencephalogram (EEG) acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused. | Drug: dexmedetomidine<br>* The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli.<br>* Other names: precedex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Changes in the Brains Default Mode Network. | Number of participants with changes in the Default Mode network during loss and recovery of consciousness under dexmedetomidine induced sedation versus baseline as assessed by changes in blood oxygen level depended (BOLD) signals during the awake, unconscious, and recovery states. | 1.5hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine, Sleep, MRI-PET, EEG