linjc16/ctgov huggingface dataset:
Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of FID 112903 given as an immediate treatment replacement in dry eye subjects that discontinue at least 6 months use of RESTASIS.

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be at least 18 years of age Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye, and must use Restasis BID for at least 6 months. Lastly, patients must have a sodium fluorescein (NaFl) corneal staining sum score of greater than or equal to 3 in the worse eye. Exclusion Criteria: Patients cannot wear contact lenses during the study and cannot have a history of hypersensitivity to any component of FID 112903. Patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have punctal plugs of any type. Patients cannot use any prescription topical medication for other ocular conditions (such as glaucoma, uveitis, etc). Patients cannot use systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit 1. Patients cannot have ocular conditions that, in the opinion of the investigator, preclude the safe administration of the test article. Patients cannot have a history and/or current evidence of the following: epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; active ocular rosacea; acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal diseases of the eye.

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: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)<br>SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily | Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)<br>* Patients will dose 4 times daily for 4 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in Total Corneal Staining. |  | 4 months |
Development of Serologic Assays for Human Herpes Virus-8

Study Overview
=================
Brief Summary
-----------------
Dr. Burbelo and colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of pathogens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV-8 (KSHV, the etiologic agents of Kaposi's sarcoma, an AIDS-defining condition). We initially plan to examine samples from patients with Kaposi's sarcoma, since all those patients are almost certainly infected with HHV-8. We are thus using samples from patients with previously diagnosed Kaposi's sarcoma. The samples in question are stored at the NCI FCRF repository operated by SAIC Frederick or in Rockville, MD.

Detailed Description
-----------------
Our colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of antigens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV- 8 (KSHV, the etiologic agent of Kaposi s sarcoma, an AIDS-defining condition). In addition we would like to potentially measure antibody responses to HIV, other infectious agents, and human antigens, to see if antibodies (or high antibody titers) to these antigens are associated with Kaposi s sarcoma or HIV infection. We initially plan to examine samples from patients with Kaposi s sarcoma, since all those patients are almost certainly infected with HHV-8. We would subsequently plan to examine samples from HIV positive and HIV negative patients without known Kaposi s sarcoma. We are thus requesting permission to use samples from patients with and without previously diagnosed Kaposi's Sarcoma. In addition to antibody testing, we would also like to examine these samples for evidence of infection with other infectious agents, such as newly identified or unknown viruses, using techniques such as PCR or deep sequencing.

Official Title
-----------------
Development of Serologic Assays for Human Herpes Virus-8

Conditions
-----------------
Kaposi Sarcoma, HIV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Data analysis only

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| HIV negative<br>HIV negative without Kaposi sarcoma | |
| HIV positive<br>HIV positive without Kaposi sarcoma | |
| HIV positive KS<br>HIV positive with Kaposi sarcoma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HHV8 serology | Direction of antibodies to HHV8 proteins | At sample collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Antibody, Kaposi's Sarcoma, Kaposi Sarcoma
Status of Surgical Resection and Histologic Subtype as Predictors of Local Recurrence in Retroperitoneal Liposarcoma

Study Overview
=================
Brief Summary
-----------------
Soft tissue sarcomas are rare malignant tumors. Liposarcoma constitute the most frequent histological subtype of retroperitoneal sarcoma. The prognosis of soft tissue sarcomas depend on clinical and histologic characteristics. Objective: Evaluate variables that may be related to overall survival and local recurrence free survival in patients with retroperitoneal liposarcoma. Methods: retrospective analysis of medical records of 60 patients attended from 1997 to 2017, who underwent surgical resection of retroperitoneal liposarcoma.

Official Title
-----------------
Status of Surgical Resection and Histologic Subtype as Predictors of Local Recurrence in Retroperitoneal Liposarcoma - Case Series

Conditions
-----------------
Liposarcoma of Soft Tissue, Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Procedure: Retroperitoneal Liposarcoma resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who underwent surgical resection of retroperitoneal liposarcoma Exclusion Criteria: Unresectable disease (upper mesenteric artery or vein involvement) or metastatic disease (sarcomatosis or distant disease)

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 76 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Retroperitoneal Liposarcoma resection|Retroperitoneal Liposarcoma resection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate |  | 60 months | 
| Local recurrence-free survival rate |  | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retroperitoneal liposarcoma, overall survival, local recurrence free survival
Epidemiologic, Laboratory, and Clinical Characterization of Individuals With Ocular Diseases

Study Overview
=================
Brief Summary
-----------------
Environmental and genetic factors may play a role in the progression of ocular diseases (cataract, retinopathy, age-related macular degeneration, glaucoma, retinal detachment, ocular tumor, etc.). The goal of this project is to establish a series of case-control studies to evaluate risk factors of ocular diseases in China.

Detailed Description
-----------------
This study is designed to investigate the epidemiologic, genetic, laboratory and clinical characterization of individuals with ocular diseases (cataract, retinopathy, age-related macular degeneration, glaucoma, retinal detachment, ocular tumor, etc.). We will accrue approximately 800 patients as experimental group. The control group consists of age/sex frequency-matched subjects who will be confirmed without ocular diseases. We will explore the environmental (including family history, life style, diet, physical activity, neuropsychological functioning，plasma levels of oxidative stress and angiogenic factors, etc.) and genetic (including oxidative stress and angiogenic factors, etc.) risk factors. We will study the association between various environmental risk factors with the clinical characterization and correlation between the genetic polymorphisms and the presence of various ocular diseases.

Conditions
-----------------
Ocular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This is a study only of Chinese. Subjects will be allowed to participate if they self-identify as Chinese. Individuals with ocular diseases (cataract, retinopathy, age-related macular degeneration, glaucoma, retinal detachment, ocular tumor, etc.) will be allowed to participate. To participate in the study as the control, subjects should be confirmed without ocular diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ocular diseases, risk factors, genetic factors
The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The pharmacokinetics of sodium thiosulfate in humans with different degrees of renal failure and in healthy volunteers will be after two single shot applications.

Detailed Description
-----------------
Two single shot applications of i.v. sodium thiosulfate will be given to dialysis patients. One application will be given immediately before a dialysis session and the second dose will be given after the consecutive dialysis session. In healthy volunteers sodium thiosulfate will be given only once. In both groups, dialysis patients and healthy volunteers, blood and urinary/dialysate samples will be collected at defined time points.

Official Title
-----------------
The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy

Conditions
-----------------
Renal Failure

Intervention / Treatment
-----------------
* Drug: Sodium thiosulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteer or patient with renal failure Exclusion Criteria: pregnancy withdrawal of consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dialysis<br>Two doses of sodium thiosulfate | Drug: Sodium thiosulfate<br>* 6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min<br>* Other names: Na2S2O3;|
| Experimental: healthy volunteer<br>One dose of sodium thiosulfate | Drug: Sodium thiosulfate<br>* 6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min<br>* Other names: Na2S2O3;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination half life in dependence of the degree of renal failure |  | 0, 15, 30, 60, 180 minutes and 24 hours after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in acid-base parameter after application of sodium thiosulfate |  | 0, 15, 30, 60, 180 minutes and 24 hours after application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal failure, sodium Thiosulfate, pharmakokinetic
Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this Study is to determine whether non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex.

Detailed Description
-----------------
Visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (VRT), but when combined with transcranial direct current stimulation (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic stage. Because it is possible that such therapy may be more effective during the early recovery phase after the stroke and can reach patients during the rehabilitation phase, investigators wished to explore the applicability, efficacy and safety of early intervention with a combined tDCS/VRT treatment. Seven post-acute stroke homonymous hemianopia patients were assigned to 10 sessions of combined tDCS (2mA, 10 daily sessions of 15-20 min) and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds in percent. The results were compared to 7 age and stroke lesion matched controls of our patient data pool who received standard rehabilitation.

Official Title
-----------------
Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study

Conditions
-----------------
Hemianopia, Stroke

Intervention / Treatment
-----------------
* Device: tDCS
* Behavioral: Standard rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Posterior Cerebral Artery Stroke Visual Field Defect Lesion age 4 weeks up to 6 month max Exclusion Criteria: Electrical Implants Metal artefacts in head Epilepsy Visual Neglect

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tDCS<br>group receiving complete treatment of transcranial direct current stimulation | Device: tDCS<br>* Device: verum tDCS real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes Behavioral: VRT Vision restoration training, 10 sessions, 20 minutes<br>|
| Active Comparator: Standard rehabilitation<br>Standard rehabilitation procedures | Behavioral: Standard rehabilitation<br>* Standard rehabilitation procedures involving PC-based training of saccades and visual exploration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention |  | 14-20 days post treatment, |
Scleroligation for Eradication of Gastroesophageal Varices.

Study Overview
=================
Brief Summary
-----------------
Gastric varices occur in 5-33% of patients with portal hypertension. Concomitant gastro esophageal varices are the most common type. Both endoscopic sclerotherapy and band ligation are very effective in controlling acute esophageal varices bleeding and preventing rebleeding.

Detailed Description
-----------------
Evaluation of a new scleroligation technique for management of bleeding gastro-esophageal varices regarding efficacy, complications, variceal recurrence, and survival.

Official Title
-----------------
Scleroligation is a Safe and Effective New Technique for Eradication of Gastroesophageal Varices.

Conditions
-----------------
Gastroesophageal Varices

Intervention / Treatment
-----------------
* Procedure: Sclerotherapy
* Procedure: Band ligation
* Procedure: Scleroligation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cirrhotic patients presenting with an acute or recent episode of gastro-esophageal variceal bleeding. Exclusion Criteria: Patients were excluded if they had malignancy of any origin. Any terminal illness, such as heart failure, uremia, or chronic pulmonary diseases. Other potential causes of GIT bleeding. Patients with previous endoscopic or surgical intervention for varices were also excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sclerotherapy group<br>thirty patients treated by sclerotherapy for OV using ethanolamine oleate 5%. | Procedure: Sclerotherapy<br>* Injection of varices<br>|
| Active Comparator: Endoscopic band ligation group<br>thirty patients treated by endoscopic banding using the Euro-Ligator system. | Procedure: Band ligation<br>* endoscopic banding of varices<br>|
| Experimental: Sclero-ligation (SL) group<br>thirty patients treated by intra variceal endoscopic sclerotherapy combined with band ligation. | Procedure: Scleroligation<br>* intra variceal endoscopic sclerotherapy combined with band ligation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sessions to complete variceal obliteration |  | 1 year |
Accuracy of Holladay 2 Formula in the Absence of Lens Thickness

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Holladay 2 formula is still accurate even used without lens thickness data.

Official Title
-----------------
Accuracy of Holladay 2 Formula Using IOLMaster Parameters in the Absence of Lens Thickness

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Device: optical biometric measurement (IOLMaster)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with cataract Exclusion Criteria: previous ocular diseases previous ocular surgery

Ages Eligible for Study
-----------------
Minimum Age: 44 Years
Maximum Age: 89 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: Mean absolute errors, median absolute errors<br> | Device: optical biometric measurement (IOLMaster)<br>* IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean absolute error of Holladay2 formula | IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique. | 6 months |
Simons Variation in Individuals Project, Functional Common Acquisition Protocol

Study Overview
=================
Brief Summary
-----------------
The University of California, San Francisco (UCSF) Simons Variation in Individuals Project (Simons VIP) is currently recruiting healthy controls for a study aimed at better understanding autism spectrum disorder. The UCSF site of the Simons VIP is conducting functional and structural imaging, neuropsychological evaluation, genetic testing, and neurologic exams in healthy individuals to compare with findings in autism spectrum disorder.

Detailed Description
-----------------
To better understand autism spectrum disorders, the UCSF Simons VIP team is recruiting healthy controls to participate in a study involving brain imaging and psychological assessments and questionnaires. The study will involve phone interviews, cognitive testing and questionnaires, genetic testing, physical exam, photographs, non-invasive brain imaging sessions (MRI and MEG). The study can take up to 17 hours to complete, and there may be up to 5 study visits to UCSF and UC Berkeley.

Official Title
-----------------
Functional Common Acquisition Protocol Phase of the Simons VIP

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy persons age 7 and older Must use English as primary language Must be able to lie still in MRI scanner for two hours Must be willing to travel to UCSF and UC Berkeley for up to 5 study visits. Exclusion Criteria: Any metal implanted in the body Extensive dental work History of psychiatric of neurological illness History of drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 60 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy children, Healthy adults, individuals ages 7-60