linjc16/ctgov huggingface dataset:
Characterizing Upper Extremity Function in Individuals With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Upper extremity (UE) function is critical to maintaining independence. Better understanding of UE involvement in MS will provide necessary information to prioritize the design and selection of future interventions. The goal of the proposed project is to characterize UE involvement in a population of community-based persons with MS across the International Classification of Functioning, Disability & Health (ICF) domains and constructs.

Official Title
-----------------
Characterizing Upper Extremity Function in Individuals With Multiple Sclerosis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed clinical Clinical diagnosis of MS Receive MS care at the Mandell MS Center Cognitively able to understand directions and complete protocol Signed consent form approved by the Saint Francis Institutional Review Board 18 years of age or older Exclusion Criteria: Unwilling or unable to complete assessments

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 |
| --- | --- |
| PwMS receiving care at the Mandell Center<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalance of Impairment in the Upper Extremity |  | 3hours |
Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases

Study Overview
=================
Brief Summary
-----------------
The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities. The management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensation, the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution. The objective of this pilot study was designed to evaluate the cerebral plasticity of patients who undergo bilateral hand allograph

Official Title
-----------------
Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases

Conditions
-----------------
Amputation

Intervention / Treatment
-----------------
* Procedure: hand allograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: double amputated patients minimum of 3 months and maximum of 3 years interval between amputation and graft adult aged 20 to 40 years psychological maturity written informed consent Exclusion Criteria: mono amputated patients previous history of malignant tumor in remission for less than 5 years, malignant tumor previous psychiatric history American Society of Anesthesiology (ASA) score >2 New York Heart Association (NYHA) >1 nenal insufficiency severe hypertension

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: hand allograft<br> | Procedure: hand allograft<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI for evaluation of brain plasticity after transplant | Evaluation of brain plasticity after transplant | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rejection |  | Every 6 months following graft up to 5 years | 
| Adverse events |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allograft, hands, immunosuppression, fMRI
Visual Performance With a Trifocal Intraocular Lens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the visual performance of a trifocal intraocular lens at distance, near and intermediate viewing, by way of visual acuity measurement, contrast sensitivity. Patient satisfaction and quality of vision will also be assessed by way of a questionnaire.

Detailed Description
-----------------
Monocular and Binocular Unaided (UCVA) and Best Corrected Visual Acuity (BCVA) will be measured at 6m in LogMAR units under photopic conditions (85cd/m2). Subjective Refraction will be performed to establish any residual refractive error will for distance, intermediate and near. Defocus Profiles (visual acuity over imposed defocus) are measured for each patient. The patient observes the 6m LogMAR chart through best distance correction, then defocusing is achieved by the addition of pairs of lenses from +2.00D to -4.00D in 0.50D steps.. The LogMAR acuity will be recorded and the data plotted. Contrast Sensitivity will be evaluated monocularly under photopic (85cd/m2) conditions and mesopic (4cd/m2) using the Pelli-Robson Contrast Sensitivity Chart. Near and intermediate performance will be evaluated using the Radner Reading Charts to assess acuity (LogRAD units) and reading speed in photopic conditions 85cd/m2

Official Title
-----------------
Visual Performance Adn Quality of Vision Evaluation After Implantation of a Trifocal Intraocular Lens

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40-70yrs Bilateral implantation of a trifocal intraocular lens Exclusion Criteria: existing ocular pathology surgical complications corneal astigmatism > 1.50DC

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- | --- |
Amputee Gait Training Using Virtual Reality and Real-Time Feedback

Study Overview
=================
Brief Summary
-----------------
The purpose of this repeated measures design gait training study is to develop and quantitatively assess the effectiveness of a virtual reality training environment using real-time feedback for modification of pelvic motion during gait.

Official Title
-----------------
Amputee Gait Training Using Virtual Reality and Real-Time Feedback

Conditions
-----------------
Abnormal Gait Kinematics

Intervention / Treatment
-----------------
* Other: Gait Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral traumatic trans-tibial or transfemoral amputation Independent ambulation without an assistive device for a minimum of three months Ability to ambulate continuously for a minimum of 15 minutes Trans-femoral participants must use an ischial containment socket VAS Pain scores on the involved side of less than 4/10 Sagittal plane ankle, knee and hip strength of 4 or greater on the uninvolved side as determined by manual muscle test. Exclusion Criteria: Blindness TBI-Glascow Coma Scale score of 12 or lower at the time of injury Cardiac or pulmonary problems limiting physical activity PTSD or other psychological condition with symptoms that would be exacerbated by participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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: Gait Training<br> | Other: Gait Training<br>* 12 sessions, 30 minutes of walking on treadmill with real time therapist directed feedback on gait kinematics.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Biomechanics |  | 3 weeks | 
| Gait Biomechanics |  | immediately prior to start of 3 week training | 
| Gait Biomechanics |  | Immediately post training | 
| Gait Biomechanics |  | 3 weeks from initial post training |
Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection

Study Overview
=================
Brief Summary
-----------------
This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.

Detailed Description
-----------------
Surgical site infection after cardiac surgery is a major cause for increased morbidity and mortality. Vacuum assisted closure (VAC) has been used in the management of open and infected wounds. However, its effectiveness as a prophylactic measure for prevention of surgical site infection after routine cardiac surgery is unknown.

Official Title
-----------------
Negative Pressure Wound Therapy for Prevention of Wound Infection After Heart Surgery

Conditions
-----------------
Surgical Wound Infection

Intervention / Treatment
-----------------
* Device: Prevena Incision Management System
* Other: Conventional sterile dry wound dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Transplant patients BMI >30 Type I (insulin-dependent) diabetics Severe chronic obstructive pulmonary disease (COPD) Steroid-dependent patients Previous Tracheostomy Exclusion criteria: BMI<30 Thoracotomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective group<br>Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively. | Device: Prevena Incision Management System<br>* negative pressure therapy that will be applied instead of the regular dressing immediately postoperatively in high risk patients and kept for 6-7 days<br>* Other names: Prevena;|
| Active Comparator: Retrospective arm<br>Conventional sterile dry wound dressing applied immediately postoperatively. | Other: Conventional sterile dry wound dressing<br>* regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy<br>* Other names: standard dressing after sternotomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Infection After Open Heart Surgery | The total number of participants with surgical site infections after cardiac surgery. | 30 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation for Wound Infection | The total number of reoperations required due to infection. | 30 days post surgery |
Weight Loss in Diabetic, Older Obese Adults

Study Overview
=================
Brief Summary
-----------------
This study examines the effects of weight loss and aerobic exercise training on sugar metabolism and other risk factors for heart disease in obese older individuals.

Official Title
-----------------
5449 Genetics, Weight Loss and Glucose Metabolism in Older Obese Men

Conditions
-----------------
Metabolic Syndrome X

Intervention / Treatment
-----------------
* Behavioral: Weight Loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 50 years, Body mass index (BMI) > 27kg/m(2), No prior history of diabetes or coronary disease, Sedentary

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Weight Loss|nan|

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
-----------------
aging, exercise, metabolic syndrome, insulin resistance
Molecular Mechanisms of Fibrillin/LTBP Superfamily in Renal Fibrosis and Cardiorenal Syndrome

Study Overview
=================
Brief Summary
-----------------
This project is to understand the LTBP4 expression in human renal fibrotic tissues. The investigators will exam major location of LTBP4 expression and check any similar or discrepancy in renal fibrosis with different etiologies.

Detailed Description
-----------------
The investigators will obtain the residual renal tissues with different etiologies and check the expression of LTBP4. The location and quantitation of LTBP4 in renal tissues will be checked. It will be great to understand the association between the severity of fibrosis and the expression of LTBP4 and other matrix proteins.

Official Title
-----------------
Molecular Mechanisms of Fibrillin/LTBP Superfamily in Renal Fibrosis and Cardiorenal

Conditions
-----------------
Renal Fibrosis, CKD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Abnormal kidney function, proteinuria, hematuria Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Expression of LTBP4 in human renal fibrotic tissue |  | 5 years | 
| Expression of biomarkers in human renal fibrotic tissue | Potential markers: eg. ROS-related proteins (8-oxodG, 4-HNE) | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LTBP4
Acute Salt Handling in Orthostatic Intolerance

Study Overview
=================
Brief Summary
-----------------
The investigators will test the hypothesis that patients with chronic orthostatic intolerance or postural orthostatic tachycardia syndrome (OI or POTS) will be unable to conserve urinary sodium as compared to healthy control subjects.

Detailed Description
-----------------
Patients with chronic OI appear to be hypovolemic with abnormalities in hormones that regulate salt & water handling. Increases in dietary salt have salutary effects on orthostatic tolerance in a physiological laboratory. The infusion of intravenous saline acutely decreased heart rate in this patient population. Preliminary data from Vanderbilt suggests abnormal salt handling in patients with chronic OI in a few patients. These data need to be confirmed and a better understanding of sodium handling in response to acute salt loads is required in these patients.

Official Title
-----------------
Acute Renal Salt Handling in Orthostatic Intolerance

Conditions
-----------------
Postural Tachycardia Syndrome, Orthostatic Tachycardia, Orthostatic Intolerance

Intervention / Treatment
-----------------
* Other: normal saline (0.9%)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with orthostatic intolerance by Vanderbilt Autonomic Dysfunction Center (or healthy control subject) Exclusion Criteria: Overt or acute cause for orthostatic tachycardia Hypertension (BP>145/95 or need for anti-hypertensive medications) QRS duration > 120 msec on EKG Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>saline infusion for sodium loading | Other: normal saline (0.9%)<br>* liter normal saline over 30 minutes x 1 dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Na excretion |  | 24h and then hourly post saline load | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catecholamine levels |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
saline, sodium, kidney, tachycardia
A Retrospective Study on the Effect of HBA or HBB Genetic Defects on Early Embryonic Development

Study Overview
=================
Brief Summary
-----------------
Thalassemia is an anemia or pathological state caused by compounding absently or inadequately of one or more globin chains of hemoglobin due to the defects of the globin gene,and the carrying rate is high in southern China. Although there are many studies of Thalassemia, the relationship between the globin gene defects and the early embryo development has not been reported. This study intends to carry out a retrospective analysis on the embryonic development of the patients with thalassemia assisted by PGD from January 1, 2011 to now in our hospital, to explore whether the HBA or HBB gene defects have a certain influence on the early embryo development, so as to accumulate certain data for reproductive health research.

Official Title
-----------------
A Retrospective Study on the Effect of HBA or HBB Genetic Defects on Early Embryonic Development

Conditions
-----------------
Thalassemia,Embryonic Development,Reproductive Sterility and Infertility

Intervention / Treatment
-----------------
* Procedure: Preimplantation genetic diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertility couples with thalassemia(one or both ) infertility couples treat by PGD Exclusion Criteria: abortion of amplification for blastula biopsy PGD without diagnostic results or with unclear diagnostic results embryos with both HBA and HBB genetic defect
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HBA<br>alpha-Thalassemia | Procedure: Preimplantation genetic diagnosis<br> <br> |
| HBB<br>beta-Thalassemia | Procedure: Preimplantation genetic diagnosis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gardner grading of blastocysts | development status of blastocysts | embryo cultured in-vitro for 5-7 days |
Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)

Study Overview
=================
Brief Summary
-----------------
Post-marketing surveillance to investigate the clinical safety and effectiveness in patients of all implantation of Gliadel with malignant glioma in the actual medical setting.

Official Title
-----------------
Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)

Conditions
-----------------
Malignant Glioma

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All-patient of Gliadel implantation Exclusion criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events/Serious Adverse Events |  | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Survival rate of subjects measured up to 1 year after implantation of Gliadel | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malignant Glioma, Glioblastoma Multiforme