linjc16/ctgov huggingface dataset:
Comparison of Higher Order Aberrations and Contrast Sensitivity Between Acrysof SN60AT, SN60WF and Restore Intraocular Lenses

Study Overview
=================
Brief Summary
-----------------
This project involves evaluation of post operative contrast sensitivity and wavefront aberration results among patients implanted with standard monofocal lenses (Acrysof SN60AT/SN60WF) and the new presbyopic correcting multifocal lens (Acrysof ReSTOR). Higher Order aberrations are visual phenomena such as glare and haloes. They are more prevalent after cataract surgery and can affect night driving.

Detailed Description
-----------------
The Project involves evaluation of contrast sensitivity and higher order aberrations in patients implanted with SN60AT, SN60WF and ReSTOR intraocular lenses. Patients in the department of Ophthalmology will be asked to participate in the study on a routine postoperative visit at least 3 months after cataract surgery. Patients will be asked to sign a consent form prior to participation. Wavefront analysis involves the patient resting their chin in a device similar to a slit lamp; they focus on a distant light and the machine performs the measurements in mesopic and scotopic conditions (light and dark). Contrast sensitivity is a measure of how faded or washed out an image can be before it becomes indistinguishable from a uniform field; it involves the patient identifying patterns on a chart. Wavefront analysis and contrast sensitivity are noninvasive tests that do not employ sedation or anesthesia and does not expose the patient to x-rays or microwaves. The proposed research will not alter usual standard postoperative care and can be done on a routine office visit.

Official Title
-----------------
Comparison of Higher Order Aberrations and Contrast Sensitivity Between Acrysof SN60AT, SN60WF and Restore Intraocular Lenses

Conditions
-----------------
Refractive Errors

Intervention / Treatment
-----------------
* Device: Wavefront and Contrast Sensitivity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subject implanted with either SN60AT, SN60WF or ReSTOR intraocular lenses after cataract removal. Subjects include those 18 yrs and over, male and female, all races. Patients will sign an informed consent Exclusion Criteria: Patients younger than 18 yrs. Patients with other concurrent visually significant ophthalmic disease.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Wavefront and Contrast Sensitivity|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative wavefront aberration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative contrast sensitivity |  |  |
10 Years Evaluation of Composite Restoration

Study Overview
=================
Brief Summary
-----------------
This randomised, split-mouth clinical study evaluated the marginal quality of direct Class I and Class II restorations made of microhybrid composite and applied using two polymerisation protocols,

Official Title
-----------------
Marginal Quality of Posterior Microhybrid Resin Composite Restorations Applied Using Two Polymerisation Protocols

Conditions
-----------------
Dental Restoration, Permanent

Intervention / Treatment
-----------------
* Device: Astralis 10 HPM
* Device: Astralis 10 RM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects at least 18 years old, require restorations due to primary caries in contralateral quadrants with opposing and adjacent tooth contact, having no restoration in the antagonist, Exclusion Criteria allergic to resin-based materials, pregnant or nursing, periodontal disease

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Astralis 10 HPM<br>Polymerization High-power mode: 1300 mW/cm2 for 10 s | Device: Astralis 10 RM<br>* The cavity to be filled is in quadrant II or IV<br>|
| Experimental: Astralis 10 RM<br>Polymerisation regular mode: 650 mW/cm2 for 20 | Device: Astralis 10 HPM<br>* The cavity to be filled is in quadrant I or III<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cavity filled with problem in marginal adaptation and in marginal discoloration | Marginal quality of posterior microhybrid resin composite restorations applied using two polymerisation protocols: 5-year randomised split mouth trial. The evaluation was done using both SQUACE and USPHS criteria | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
composite, restoration, polymerization
Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
The primary hypothesis that orthopaedic surgery induces a neuroinflammatory response within 48 hours after elective hip or knee surgery and that there is an association between exaggerated CNS inflammatory response or impaired inflammatory resolution and postoperative cognitive dysfunction within one week and at three months postoperatively.

Detailed Description
-----------------
Patients at 50-85 years of age undergoing orthopedic surgery will be investigated in the perioperative period to detect signs of neuroinflammation using serial CSF and blood sampling for 48 hours in combination with cognitive testing preoperatively, at 3-7 days and after 3 months.

Official Title
-----------------
Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

Conditions
-----------------
Surgery, Acute Phase Reaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA Physical Health Class 1-4 Age 50-85 years Fluent in Swedish language Scheduled for primary hip replacement surgery due to arthrosis MMSE (minimental state test score >= 25. Exclusion Criteria: Patient refusal to participate in the trial Current autoimmune disease, including arthritis Ongoing smoking, snuff or other nicotine compound treatment Significant neurologic or psychiatric disorder (such as Alzheimer's disease, Parkinson's disease, Multiple sclerosis, schizophrenia, depression, diagnosis of dementia or cognitive impairment as defined by a preoperative MMSE score ≤ 24 History of stroke with neurological sequelae. Current severe cardiac (NYHA>IV) or renal (plasma creatinine> 0.250 mmol/l) Coagulopathy making spinal anesthesia and intrathecal catheter placement impossible Terminal phase of a chronic disease. Patient on chronic steroidal therapy Poorly controlled diabetes mellitus. Presumed uncooperativeness or legal incapacity.

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Neuroinflammation measured as IL-6 in CSF | IL-6 in CSF | Up to 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | A cognitive test battery will be applied | Before surgery, within 7 days after surgery and 3 month after surgery | 
| Peripheral inflammatory response | Cytokines i peripheral blood | Up to 48 hours | 
| Neuroinflammation | CNS specific markers in blood | Up to 48 hours | 
| Neuroinflammation | CNS specific markers in CSF | Up to 48 hours postoperatively | 
| Neuroinflammation | INflammatory Inflammatory markers in CSF | Up to 48 hours postoperatively |
Three Dimensional Evaluation of Nasolabial Changes Following Classic vs Without Alar Base Suture After Le Fort I Osteotomy

Study Overview
=================
Brief Summary
-----------------
Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after Le Fort I osteotomy A randomized controlled clinical trial

Official Title
-----------------
Three Dimensional Evaluation of Nasolabial Changes Following Classic vs Without Alar Base Suture After Le Fort I Osteotomy

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Other: 3d evaluation of nasolabial change


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with skeletal maxillomandibular deformity indicated for surgical correction by Le Fort I osteotomy. Absence of growth. Patients must be willing for the surgical procedure and follow-up, with his informed consent. Exclusion Criteria: 4. History of facial trauma with fractures of facial bones. 5. History of surgical operation in nasal region. 6. Facial asymmetry. 7. Patients with accompanying craniofacial syndromes. 8. Patients with any diseases that compromise bone or soft tissue healing. 9. Anterior open bite cases. 10. Clefts ( lip and palate). 11. Medically compromised patients not fit for general anaesthesia. 12. missing preoperative or postop-erative 3D photographs or CBCT scans 13. multi-segment Le Fort I osteotomy 14. rhinoplasty surgery during or within 1 year after the Le Fort I osteotomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after Le Fort I osteotomy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 3d evaluation of naso labial changes using alar cinch suture<br> | Other: 3d evaluation of nasolabial change<br>* Evaluation of With vs without ala cinch suture after lefort 1 osteotomy<br>|
| Other: 3d evaluation of nasolabial change without Alar cinch<br> | Other: 3d evaluation of nasolabial change<br>* Evaluation of With vs without ala cinch suture after lefort 1 osteotomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Widening of alar base | Widening of alar base | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal volume | Nasal volume | 6 months |
Assessment of the Effect of Restriction on Alimentary AGE in Progression of Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Normal-protein and low-AGE through raw or rare proteins diet versus normal-protein and high-AGE diet in stage IIIa-b renal failure patients

Official Title
-----------------
Assessment of the Effect of Restriction on Alimentary AGE (Advanced Glycation Products) in Progression of Chronic Kidney Disease (CKD)

Conditions
-----------------
Kidney Failure, Chronic, Chronic Kidney Disease stage3, Chronic Kidney Disease Stage 3B, Chronic Kidney Disease Stage 3A (Disorder), Chronic Kidney Disease, Stage 3 (Moderate), Diet Habit

Intervention / Treatment
-----------------
* Behavioral: Low-AGE diet
* Behavioral: High-AGE diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a grade IIIA-B CKD (GFR with CKD-EPI ≥ 30 mL/min and < 60mL/min) Informed consent signed Aged 18 to 89 years Exclusion Criteria: Protected adult Acute renal failure Patient already on a low-AGE diet (< 1kU AGE/day) following a dietetic consultation Current participation in another interventional research

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal-protein and low-AGE through raw or rare proteins diet<br>Normal-protein (0,8g/kg/day) and low-AGE through raw or rare proteins diet during 24 months | Behavioral: Low-AGE diet<br>* Low-AGE diet during 24 months<br>|
| Active Comparator: Normal-protein and AGE-rich diet<br>Normal-protein (0,8g/kg/day) and high-AGE through overcooked proteins diet during 24 months | Behavioral: High-AGE diet<br>* High-AGE diet during 24 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular Filtration Rate | Glomerular Filtration Rate estimated by the CKD-EPI formula with a blood sample | At 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteinuria | Proteinuria (g/24h) found in the 24-hour urine | At 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney failure, advanced glycation products, chronic kidney disease
Triceps Surae Ultrasonographic Characteristics in Hemiparetic Stroke Survivors

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate, in hemiparetic patients, changes in muscle ultrasound structure about the focal treatment of spasticity with botulinum toxin type A. For this purpose, the analysis of the mean echo intensity will be carried out on ultrasound acquisitions, identifying the possible correlations between the muscle echogenicity, the variations in the pennation angle, and the length of the fascicles. For image processing operations, ImageJ software was applied.

Official Title
-----------------
Triceps Surae Muscle Characteristics in Hemiparetic Stroke Survivors: Clinical Implications From Ultrasonographic Evaluation

Conditions
-----------------
Spastic Foot, Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral ischaemic or haemorrhagic stroke (documented with clinical examination and neuroradiological findings) presence of spasticity at lower limb muscles, at least grade 1+ in the modified Ashworth Scale 3. age ≥ 18 years Exclusion Criteria: inability to walk before stroke presence of severe cognitive impairment presence of other musculoskeletal, neurological or cardiopulmonary impairment which can interfere with clinical findings presence of skin lesions that can contraindicate BoNT-A treatment previous surgical myotendinous elongation

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle structure variations | The primary outcome consists in detecting muscle structure variations during the procedure. This measure will be related to the time frame between the first inoculation and the moment of image acquisition, and to the number of therapeutic cycles performed. The aim is to determine the potential correlation between BoNT-A injection and muscle structure evolution. The time point of assessment is not pre-defined but the time since stroke onset and, if applicable, from the first BoNT-A injection will be recorded. Each participant will be assessed once during the overall duration of the study. | single measure through study completion (1 year) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-stroke spasticity, muscle, ultrasound
The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to evaluate changes in sugar, metabolism, heart function and changes in body composition as patients lose weight following bariatric surgery. The investigators will compare improvements of the above changes as a function of the four different types of bariatric surgery. The investigators believe the most beneficial and safest procedure will be the Roux-en-Y.

Detailed Description
-----------------
The study will also examine the response of the pancreas (the insulin-producing organ) to a sugar load, as well as to a hormone called Glucagon Like Peptide 1 (GLP-1), which is released from your gut to maximally stimulate your pancreas. The release of this hormone increases when you eat food and it causes the pancreas to release more insulin than does sugar alone. Volunteers will have 22 visits over a two year period. Only people having Roux-en-Y gastric bypass surgery, gastric sleeve surgery, duodenal switch gastric surgery or lap-band/gastric banding surgery may join. Seventy volunteers will be recruited to take part in this study.

Official Title
-----------------
The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition

Conditions
-----------------
Bariatric Surgery

Intervention / Treatment
-----------------
* Drug: GLP-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female volunteers 21-65 years. BMI > 40. Preoperative hematocrit level of at least 34% for women and 38% for men. Postoperative hematocrit level of at least 34% for women and 36% for men. Exclusion Criteria: Volunteers whose hematocrit level does not meet the above criteria. Pregnant and or lactating females.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-1<br>5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period. | Drug: GLP-1<br>* 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.<br>* Other names: Glucagon-like Peptide-1;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Secretion |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric Surgery, Glucose Regulation, Cardiac Function, Body Composition
COVID-19 Soliris Expanded Access Protocol

Study Overview
=================
Brief Summary
-----------------
This protocol provides participants with COVID-19 access to Soliris.

Detailed Description
-----------------
This is an open-label, multicenter, expanded access protocol that will provide access to Soliris for participants diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection with a clinical presentation consistent with COVID-19 associated organ injury, such as acute respiratory distress syndrome, stroke, or acute renal failure. Participants who qualify for emergency treatment (whether in an inpatient or outpatient setting) will be offered the opportunity to receive up to 7 infusions of Soliris over approximately 4 weeks.

Official Title
-----------------
SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID-19) - An Expanded Access Protocol

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

Intervention / Treatment
-----------------
* Biological: Eculizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females ≥ 18 years of age and body weight ≥ 40 kg. Confirmed diagnosis of SARS-COV-2 infection by any method used by the institution (eg, via reverse transcriptase polymerase chain reaction and/or antibody test). Willing to receive vaccination against Neisseria meningitidis and prophylactic antibiotics against meningococcal infections if the participant has not been vaccinated within 5 years prior to Day 1. In the opinion of the Investigator, the participant is suitable to be enrolled in the expanded access protocol (EAP), based on the participant's overall clinical condition and the known Soliris benefit/risk profile. Exclusion Criteria: Unresolved Neisseria meningitidis infection. Known hypersensitivity to murine proteins or to an excipient of Soliris.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Eculizumab|Eculizumab 900-1200 mg will be administered intravenously.|

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
-----------------
SARS-COV-2, acute lung injury, severe pneumonia, acute respiratory distress syndrome, severe acute respiratory syndrome coronavirus 2, severe acute respiratory syndrome, multi-organ injury, hospitalization, antibodies, monoclonal, humanized, emergency treatment, viral, expanded access, Soliris, eculizumab, C5 inhibitor, COVID-19