linjc16/ctgov huggingface dataset:
A Measurement of Knee Osteoarthritis Usual Care

Study Overview
=================
Brief Summary
-----------------
Osteoarthritis is the most common affection of joints worldwide. Multiple international guidelines on the approach and treatment of knee osteoarthritis are available. Nevertheless there seems to be a gap between usual care and the preferred one. A vigorous set of evidence-based quality indicators on osteoarthritis diagnosis and therapy was developed by a multidisciplinary expert team. This project aims to map usual care and to explore the gaps between usual care and international guidelines in a second stage. This will enable us to develop a tightly targeted quality improvement intervention later on.

Conditions
-----------------
Osteoarthritis, Knee, Guideline Adherence, Quality Indicators, Health Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of knee osteoarthritis Exclusion Criteria: Knee replacement surgery Acute trauma (recruitment by orthopedic surgeons)
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 |
| --- | --- | --- |
| Guideline adherence measured by a number of quality indicators and presented as the percentage of patients in whom a quality indicator was reached | Guideline adherence by physicians and physiotherapists will be measured by quality indicators. A questionnaire about the care patients received from diagnosis of knee osteoarthritis till now will be used. | one measurement at the point of recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers and facilitators for guideline adherence | Barriers and facilitators for guideline adherence will be explored by focusgroup research with focusgroups of general practitioners, orthopedic surgeons and patients | 10 years |
Lung Volume Recruitment for Lung Function and Cough Impairment in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Multiple sclerosis is a neurological disease that can affect lung function and cough efficacy. This pilot study will examine whether the lung volume recruitment technique can slow down the decline in lung function and cough.

Official Title
-----------------
Lung Volume Recruitment for Lung Function and Cough Impairment in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Procedure: Lung volume recruitment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of multiple sclerosis, diagnosed by a neurologist in accordance with the 2010 McDonald criteria Exclusion Criteria: Concomitant parenchymal pulmonary disease or pleural disease Symptomatic cardiomyopathy Unable to perform pulmonary function testing or lung volume recruitment, due to comprehension or cooperation issues, physical inability such as bulbar or cerebellar dysfunction Contra-indication to pulmonary function testing or lung volume recruitment such as myocardial infarction, bleeding aortic aneurysm, intracranial hemorrhage within the previous month Known susceptibility to pneumothorax or pneumomediastinum Not competent to provide informed consent

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung volume recruitment<br>Lung volume recruitment twice daily for 9 months | Procedure: Lung volume recruitment<br>* Inflation of the lungs to their maximal insufflation capacity by the consecutive delivery, by a manual resuscitator in this study, of volumes of air that are held with a closed glottis<br>* Other names: Glossophayngeal breathing;|
| No Intervention: Standard care<br>Standard care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of decline of FVC (forced vital capacity) |  | up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of decline of peak cough flow |  | baseline, 2, 4, 6 and 9 months | 
| Change from baseline in FVC at 2, 4, 6 and 9 months |  | baseline vs 2, 4, 6 and 9 months | 
| Change from baseline in peak cough flow at 2, 4, 6 and 9 months |  | baseline vs 2, 4, 6 and 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple sclerosis, Lung volume recruitment, Pulmonary function impairment, Cough impairment
Sonographic Venous Doppler Imaging in Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
The first presentations of patients with acute kidney injury (AKI) are usually to the emergency departments. While the mortality rate is 5-10% in uncomplicated AKI, it is between 40-90% in patients hospitalized in the intensive care unit. Therefore early diagnosis and treatment of AKI in the emergency department is important in terms of morbidity and mortality. Sonographic evaluation of the venous system (hepatic, portal and renal vein) may be useful for diagnosis. Studies conducted so far have generally been based on predicting cardiorenal AKI and renal poor outcomes and have been designed in general ICU conditions. In this study, the investigators aimed to determine the diagnostic value of sonographic venous Doppler imaging in terms of distinguishing subgroups of AKI in patients presented to the emergency department with AKI.

Official Title
-----------------
Diagnostic Accuracy of Sonographic Venous Doppler Imaging in Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Diagnostic Test: Sonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AKI diagnosis Exclusion Criteria: Patients with end-stage renal failure (stage 4), who received 500 mL IV fluid or 40 mg diuretics, who are pregnant, with renal transplantation, with cirrhosis and liver malignancy, with postrenal AKI, who were referred from another center after starting treatment, who do not give consent for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Sonography|Sonographic Venous Doppler Imaging|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic accuracy of sonographic venous Doppler imaging in the patients with AKI |  | 1 year |
Continuous Glucose Monitoring System (CGMS) in Type 2 Diabetic Patients Inadequately Controlled by Metformine Monotherapy; Analyze of Glycemic Profile Before and After Association of Glimepiride

Study Overview
=================
Brief Summary
-----------------
Analyse the glucose profile, based on continuous glucose monitoring by CGMS, in type 2 diabetics inadequately controlled by metformin, before and after the addition of Glimepiride.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: GLIMEPIRIDE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women aged 35 to 70 years Having given their consent Type 2 diabetics (HBA1c greater than 6.5% Fasting glycaemia greater than 1.40 g/l) not controlled by Metformin for at least 6 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in interstitial glucose levels between the observation and maintenance phases. |  | The mean of 24 variations in average hourly glucose readings recorded by CGMS. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c and fasting blood glucose levels. |  | Measured in the observation and maintenance phases, and change between the two phases. |
Effectiveness and Safety of Respiratory Training in the Prevention and Severity of COVID-19

Study Overview
=================
Brief Summary
-----------------
A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.

Official Title
-----------------
Effectiveness and Safety of Respiratory Training Devices in the Prevention and Severity of COVID-19: A Randomized Controlled Clinical Trial

Conditions
-----------------
Disease, Infectious, Respiratory Disease, Safety Issues, Effectiveness

Intervention / Treatment
-----------------
* Device: Inspiratory training device
* Device: Expiratory training device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: Drugs Surgery Neurology diseases Rheumatic diseases Systemic diseases Smokers

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory training<br> | Device: Inspiratory training device<br>* Inspiratory training by a Power-breath device<br>|
| Experimental: Expiratory training<br> | Device: Expiratory training device<br>* Expiratory training a Winner-flow device<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 disease diagnosis | Dichotomous categorical variable measured by yes or no responses | Change from Baseline COVID-19 disease diagnosis at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 disease symptoms severity | Dichotomous categorical variable measured by slight or severe responses | Change from Baseline COVID-19 disease symptoms severity at 8 weeks | 
| Adverse effects | Polytomous categorical variable measured by adverse effects responses | Change from Baseline adverse effects at 8 weeks |
Indoleamine 2,3-dioxygenase (IDO) Activity in Patients With Chronic Lymphocytic Leukemia (CLL)

Study Overview
=================
Brief Summary
-----------------
The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia (CLL) is studied.

Detailed Description
-----------------
The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia (CLL)is studied in patients and healthly controls.

Official Title
-----------------
The Activity of Indoleamine 2,3-dioxygenase in Patients With Chronic Lymphocytic Leukemia (CLL)

Conditions
-----------------
CLL

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CLL and lymphocyte count > 10 x 109/l Exclusion Criteria: Acute infection

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 85 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 |
| --- | --- |
| CLL-patients<br> | |
| Controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IDO activity and expression measured by kynurenine/tryptophan ratio in serum and by PCR in peripheral blood mononuclear cells. | Indoleamine 2,3 -dioxygenase (IDO) activity in patients with CLL was measured by the serum kynurenine/tryptophan (kyn/trp) ratio and - the expression of INDO (encoding IDO enzyme) and INDOL1 (encoding IDO2 enzyme) genes in peripheral blood mononuclear cells via TaqMan real-time PCR. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL, IDO
Kidney Damage in Patients With Moderate Fall in eGFR

Study Overview
=================
Brief Summary
-----------------
To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR

Detailed Description
-----------------
This is a pilot study having a randomized, double-blind parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have eGFR greater than or equal to 30 mL/min and less than or equal to 59 mL/min. Statistical summaries will be presented to analyze the various lab tests results for the two groups.

Official Title
-----------------
Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin as New Biomarker in Patients With Moderate Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320

Conditions
-----------------
Coronary Artery Stenosis

Intervention / Treatment
-----------------
* Drug: Iopamidol
* Drug: Iodixanol-320


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age and provides informed consent Scheduled to undergo percutaneous coronary intervention Documented pre-dose Estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73 m squared and less than or equal to 59 mL/min/1.73 m squared Exclusion Criteria: Pregnant or lactating females Severe congestive heart failure History of hyperthyroidism; Unstable renal function Emergency PCI History of hypersensitivity to iodinated contrast agents Receiving diuretics to prevent acute renal injury

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iopamidol<br>Non-ionic low-osmolar iodinated contrast media | Drug: Iopamidol<br>* Iopamidol 370, one time administration for percutaneous coronary intervention<br>* Other names: Isovue-370;|
| Active Comparator: Iodixanol<br>Non-ionic iso-osmolar iodinated contrast media comparator | Drug: Iodixanol-320<br>* Iodixanol-320 single administration for percutaneous coronary intervention procedure<br>* Other names: Visipaque 320;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media. | Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose |
Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion

Study Overview
=================
Brief Summary
-----------------
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).

Official Title
-----------------
A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Device: Acclarent Tympanostomy Tube Delivery System (TTDS).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion Exclusion Criteria: History of sensitivity or reaction to anesthesia chosen for the procedure Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane Otitis externa Active acute otitis media Otitis media pathology requiring T-tubes Stenosed ear canal Anatomy that precludes sufficient visualization of and access to the tympanic membrane Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tympanostomy tube<br>Performance and safety of tympanostomy tube delivery system | Device: Acclarent Tympanostomy Tube Delivery System (TTDS).<br>* tympanostomy tube delivery system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ear Outcome Success | Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects). | Day 0 (at procedure visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Success | Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects). | Day 0 (at procedure visit) | 
| Tube Retention | Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects). | 1 week |
Sternomental Displacement Test for Predicting Difficult Airway in Obese Patients

Study Overview
=================
Brief Summary
-----------------
Difficulties airway significantly contribute to the morbidity and mortality associated with anesthesia. Identifying situations and patients at risk for airway management problems is the key to optimal care and has been the focus of numerous publications. Although controversial, Body Mass Index (BMI) is considered as associated with difficult intubation in both and operating theaters. A modified measurement of SMD is obtained with the head in neutral position (SMD neutral), then the difference between SMD extension and SMD neutral was calculated and it was referred to as sternomental displacement (SMDD). SMDD was proved to be a good objective predictor for difficult laryngoscopy in adult patients, and its predictive ability was increased when combined with other tests as neck circumference (NC). To the best of our knowledge, the validity of the SMDD test was not previously assessed in obese patients.

Official Title
-----------------
Sternomental Displacement and Neck Circumference as Predictors of Difficult Airway in Obese Patients During General Anesthesia: a Prospective Observational Cohort Study

Conditions
-----------------
Difficult Airway Intubation

Intervention / Treatment
-----------------
* Diagnostic Test: Sterno-mental displacement test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of either sex, aged between 18-60 years old, ASA physical status II & III with BMI > 30 Kg/m2 undergoing elective surgical procedures under general anesthesia using endotracheal intubation by conventional laryngoscopy. Exclusion Criteria: neuromuscular disorders, craniofacial abnormalities, abnormal dentition, lesions or scares in head and neck limiting the neck mobility, uncooperative, who needed awake intubation and patients who underwent emergency operations

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Sterno-mental displacement test|While the patient is in sitting position, (SMD neutral) will be is measured using tape as the distance between upper borders of the manubrium sterni to the mentum with the head in a neutral position. The (SMD extension) will be then measured in the same way with the head extended on the neck. The difference between SMD extension and SMD neutral will be then calculated as sternomental displacement (SMDD).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A a cut-off value, sensitivity (Sn), specificity (Sp), positive predictive values (PPV), negative predictive values (NPV) of sternomental displacement in predicting difficult laryngoscopy in obese patient undergoing GA. |  | before induction of general anesthesia |