linjc16/ctgov huggingface dataset:
The Results of Pars Plana Vitrectomy in Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
This study will be a retrospective analysis of vitrectomy results in patients suffering from diabetic macular edema.

Official Title
-----------------
The Results of Pars Plana Vitrectomy in Diabetic Macular Edema

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Procedure: vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic macular edema patients after vitrectomy Exclusion Criteria: All others

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|Pars plana vitrectomy and ILM (internal limiting membrane) peeling|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Visual acuity will be measured using the Snellen Chart before and after vitrectomy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular thickness | Macular thickness will be measured using Optical Coherence Tomography before and after vitrectomy | 6 months |
A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and feasibility of BXT-51072 as a cardioprotective agent in diabetics undergoing elective angioplasty / percutaneous intervention (PCI), a procedure to open coronary arteries. BXT-51072 belongs to a class of drugs called glutathione peroxidase mimics. BXT-51072 works by imitating a substance produced in various tissues in the body, which prevents damage of the heart and blood vessels.

Detailed Description
-----------------
Following screening, baseline measurements and informed consent, patients will receive BXT-51072 40 mg or placebo in a 2:1 ratio, 30 minutes before their scheduled PCI and then three times per day for 2 days. There will be 5 treatment visits and 3 follow-up visits. Blood samples will be obtained for CK-MB, troponin and routine chemistry. A 24-hour continuous electrocardiogram will be obtained following the PCI and regular electrocardiograms will be obtained during the study and follow-up period.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Effects of BXT-51072 on CK-MB in High-Risk Type 2 Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention

Conditions
-----------------
Acute Coronary Syndrome, Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: BXT-51072


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Scheduled for elective angioplasty with acute coronary syndrome within 72- hours or MI within 7 days Exclusion Criteria: CK-MB above normal Elevated troponin not showing a decreasing value Congestive heart failure Atrial fibrillation or left bundle branch block Uncontrolled diabetes

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BXT-51072|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CK-MB |  |  | 
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in troponin |  |  | 
| Myocardial ischemia by 24-hour continuous 12-lead ECG |  |  |
A Pharmacokinetic Study of CVX-096 (PF-04856883) in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to further evaluate the PK characteristics of PF-04856883.

Official Title
-----------------
A Phase 1, Randomized, Open-label, Parallel-group Study To Evaluate The Pharmacokinetics Of Pf-04856883 (Cvx-096) Following Subcutaneous Administration In Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: PF-04856883
* Biological: PF-04856883
* Biological: PF-04856883
* Biological: PF-04856883


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04856883 Treatment Arm 1<br> | Biological: PF-04856883<br>* Dose A<br>|
| Experimental: PF-04856883 Treatment Arm 2<br> | Biological: PF-04856883<br>* Dose B<br>|
| Experimental: PF-04856883 Treatment Arm 3<br> | Biological: PF-04856883<br>* Dose C<br>|
| Experimental: PF-04856883 Treatment Arm 4<br> | Biological: PF-04856883<br>* Dose D<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PF-04856883 Pharmacokinetics including Cmax, Tmax, AUCo-infinity, AUClast, Cl/F, Vz/F and t1/2 |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with AEs reported |  | 4 weeks | 
| Number of subjects with abnormal physical examination findings |  | 4 weeks | 
| Number of subjects with abnormal clinical laboratory results |  | 4 weeks | 
| Number of subjects with abnormal ECGs |  | 4 weeks | 
| Number of subjects with abnormal vital signs |  | 4 weeks |
Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
Biventricular Pacing has been shown an improvement of symptoms in patients with heart failure. A temporary pacing is necessary in patients after cardiac procedures. In patients with hypertrophic cardiomyopathy, a single right ventricular pacing can decrease the cardiac output and blood pressure. The investigators propose that biventricular pacing in these patients and conditions results in an improvement of symptoms instead of single right pacing.

Official Title
-----------------
Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

Conditions
-----------------
Hypertrophic Cardiomyopathy

Intervention / Treatment
-----------------
* Procedure: additional temporary pacewire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years Hypertrophic Cardiomyopathy Aortic valve replacement Exclusion Criteria: Atrial fibrillation Pericarditis postoperative low output Preoperative permanent pacemaker placement

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biventricular pacing<br> | Procedure: additional temporary pacewire<br>* Placement of an additional pacing wire on the left side of the heart after aortic valve replacement in patients with hypertrophic cardiomyopathy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output |  | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertrophic Cardiomyopathy Diastolic Ventricular Interaction, Biventricular Pacemaker cardiac surgery aortic valve replacement
Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level

Study Overview
=================
Brief Summary
-----------------
Early statin therapy in SLE patients that have high cholesterol level and other atherosclerosis risk should reduce atherosclerosis and coronary artery events in later course of disease. By the way, statin is used in restricted groups of rheumatologists due to awareness of side effects; myositis and hepatitis, that are frequently found in SLE patients more so than other groups of atherosclerosis patients and reporting data of autoimmune diseases that occur after statin use.

Official Title
-----------------
Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in SLE Patients With Corticosteroid Therapy and High LDL Cholesterol Level

Conditions
-----------------
Systemic Lupus Erythematosus, High LDL Cholesterol Level

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SLE patients that on prednisolone more than 30 mg/day Normal liver faction: AST and ALT < 80 mg/dl Normal muscle enzyme : CPK < 100 U/L LDL cholesterol level > 100 mg/dl Exclusion Criteria: Patients that was treated with pulse methylprednisolone or corticosteroid equivalent to prednisolone > 1mg/kg/day at screening. Statin allergy On statin treatment before screening On cyclosporine, antifugal (azole group), antibiotics (macrolide group), rifampicin, warfarin, phenytoin Pregnancy Abnormal liver function: AST or ALT > 80 mg/dl Abnormal muscle enzyme : CPK > 300 U/L

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|10 mg per day for 12 weeks|
|Drug: Simvastatin|20 mg per day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction of LDL Cholesterol level |  | 6 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that have transminitis, myositis or active SLE |  | 6,12, 18 and 24 weeks |
Nexplanon Removal: Subcutaneous vs. Topical Lidocaine

Study Overview
=================
Brief Summary
-----------------
A randomized trial of using EMLA cream for anesthesia to remove Nexplanon versus the standard route of subcutaneous lidocaine for anesthesia. Primary endpoints are pain during procedure and time to removal.

Official Title
-----------------
Nexplanon Removal: Subcutaneous vs. Topical Lidocaine

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Eutectic Lidocaine Prilocaine
* Drug: Subcutaneous Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females with Nexplanon implant in place, desiring removal No allergy to lidocaine or any component of EMLA cream Age greater than or equal to 18years English as primary language Not pregnant Exclusion Criteria: pregnant non-emglish speaking age less than 18 yo Allergy to lidocaine or EMLA

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMLA<br>Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed. | Drug: Eutectic Lidocaine Prilocaine<br>* Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed.<br>* Other names: EMLA;|
| Active Comparator: Subcutaneous Lidocaine<br>Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected at the removal site and then undergo Nexplanon removal. | Drug: Subcutaneous Lidocaine<br>* Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected by the provider at the removal site in an amount decided on by the provider.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain of procedure | Using the pain scale the participant is asked to circle the numerical value of pain they had during removal. | during procedure | 
| time to perform procedure | the medical assistant times the procedure from incision to removal of the device. | procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How likely to recommend their anesthetic? |  | procedure | 
| Provider's sense of ease of removal? |  | procedure |
BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.

Study Overview
=================
Brief Summary
-----------------
Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.

Detailed Description
-----------------
This is a randomized, double-blind, placebo controlled study of low dose nesiritide to prevent renal insufficiency after cardiopulmonary bypass surgery. Patients included are those with greater than mild renal insufficiency preoperatively as defined by having a creatinine clearance of less than 50 mL/minute determined by the Cockroft-Gault formula. The infusion of nesiritide (BNP) 0.005 mcg/Kg/minute or placebo begins 1 hour before surgery and runs for 24 hours started after the induction of anesthesia prior to cardiopulmonary bypass.

Official Title
-----------------
Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery.

Conditions
-----------------
Acute Kidney Failure

Intervention / Treatment
-----------------
* Drug: Neseritide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years old, undergoing cardiac surgery requiring cardiopulmonary bypass with baseline creatinine clearance < 50 ml/min and who are not dialysis dependent. Exclusion criteria: Cardiogenic shock or hypotension with systolic BP < 90 mmHg. Patients with acute or chronic aortic dissection. Patients who are enrolled in other studies that have an effect the renal function.

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: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Neseritide|Dose of Nesiritide infusion will be 0.005 ug/Kg/min|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula |  | 72 hours post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients requiring dialysis during the hospitalization |  | before hospital discharge | 
| Plasma aldosterone levels at 12 hours and 24 hours |  | 12 hours and 24 hours postoperatively | 
| Total time on ventilator, ICU length of stay, total length of stay in hospital |  | total length of hospital stay | 
| pre and postoperative diuretic dose used |  | pre operative and postoperate | 
| Need or absence of need for inotropic support in the 72 hour perioperative period |  | 72 hours perioperative |
Bone UltraSonic Scanner (BUSS) Clinical Optimization Study

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical study using Bone UltraSonic Scanner (BUSS) is to obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.

Detailed Description
-----------------
The specific aims of this clinical study are: To optimize the data collection technique and establish an examination procedure; To collect data necessary for assessing the performance of BUSS sensors; To evaluate the probe ergonomic design and participant tolerance to probe application; To assess the clinical suitability of the software interface in data collection; To adjust the BUSS diagnostic algorithms using dual-energy X-ray absorptiometry (DEXA) data as a gold standard in osteoporosis detection and characterization; To evaluate BUSS performance including ease of use and consistency.

Official Title
-----------------
Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any race or ethnical group DEXA examination scheduled within next two weeks or DEXA examination was completed within the last six months adn DEXA results are available Exclusion Criteria: Open wounds or rashes on the tibial testing area Active skin infection Recent tibia surgery Abnormal tibia Anatomy Current or previous tibial fracture Body Mass Index >34.9 Hyperparathyroidism or hypoparathyroidism within 5 years Osteitis deformans Renal osteodystrophy Osteomalacia Stroke with total or partial paralysis with residual disability lasting more than 3 months Current or recent (within past 6 months) use of bone-active drugs Drugs under research protocols Chronic use of over the counter antacids -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| To obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis, bone fracture risk, bone ultrasonometry
Action-effect Anticipation in Patients With Parkinson's Disease : A Study of the Sensory Attenuation Marker.

Study Overview
=================
Brief Summary
-----------------
The ideomotor theory of action control is considered to be central to the understanding of human voluntary action. According to the ideomotor theory, an action is represented in terms of its desired sensory effects and actions are selected by internally activating these effect representations. Recent imagery and behavioral studies showed that this anticipated representation of action-effects triggered a sensory attenuation, meaning a decrease of perceptive performances or a decrease of sensory event-related potentials (ERP) for an expected event. Thus, the sensory attenuation constitutes a relevant behavioral tool to investigate sensory anticipation impairment in patients with Parkinson's disease. In a behavioral paradigm, patients and matched control participants have to perform a perceptive task on predicted visual action-effects mixed with mispredicted visual action effects. Performances should be better in mispredicted visual action effects for control participants only.

Official Title
-----------------
The Process of Sensory Anticipation in Patients With PARKINSON's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Behavioral: behavioral observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease Normal or corrected vision Exclusion Criteria: Other pathology or neurological or psychiatric history Known pregnancy or breastfeeding Absence of affiliation to the French Social Security Person under legal protection Patient's opposition to participate

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 with Parkinson's disease<br> | Behavioral: behavioral observation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median score | scores measured with the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, Action-effect prediction, Sensory attenuation, Voluntary action