linjc16/ctgov huggingface dataset:
Cytokine Regulation of Natural Killer Receptors in Inhibiting Activated T Cell Function

Study Overview
=================
Brief Summary
-----------------
In this study proposal, the investigators will extend their previous studies and examine the kinetic cytotoxic activity with concordant expression of inhibitory natural killer (NK) receptors (iNKR) on activated T cells. The inhibitory role of cytokines will be defined by utilizing the investigators' previously established models of mixed lymphocytes and tumor cells coculture to analyze the expression and activity of cytokines involved in the regulation of iNKRs on cancer-encountered T cells.

Detailed Description
-----------------
In our extended studies, we have directly examined the expressions of various inhibitory natural killer cell Receptors (iNKRs) on Tumor-infiltrating lymphocytes (TILs) derived from human Cervical cancer (CC) by triple-color flow cytometry with combination of different surface markers. We found up-regulated expression of certain iNKRs (CD94/NKG2A) in TILs and in mixed lymphocyte-cancer cell cocultures. In our previous studies, we demonstrated that certain cytokines, including IL-10, TGF-beta (Sheu et al, Journal of Immunology, 2001, 167:2972-2978), and IL-15 (Sheu et al, Cancer Research, 2005, 65:2921-2929) can be expressed by CC cells. We further demonstrated that activated T cells bear iNKRs which inhibit cytotoxic activity. iNKRs are proposed to restrain the T cell receptor (TCR)-mediated cytolysis. We found that CC cells had altered HLA-A, -B, and -C molecules in a cancer microenvironment. The acquisition of both NK-like activity and expression of iNKRs by these T cells is parallel to prevent damage to normal host cells. However, there is also limited knowledge about the regulatory role of iNKR expression in T cell cytotoxicity.

Conditions
-----------------
Cervical Cancer, Breast Cancer, Endometrial Cancer, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer patients Healthy volunteers Exclusion Criteria: Immunosuppression HIV carrier

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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
-----------------
Cervical cancer, Breast cancer, T lymphocyte, NK receptor
Safety and Efficacy Study of JV-GL1 in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The aim of this research study is to assess the safety and feasibility of lowering intraocular pressure (IOP) using an experimental study drug, JV-GL1.

Detailed Description
-----------------
This is an open-label, dose escalation and dose expansion, study in adult participants with open-angle glaucoma or ocular hypertension. The study is divided into 2 parts: Part 1 of the study is a dose escalation, sequentially testing escalating doses of JV-GL1. Part 2 of the study will be randomized 2:2:1 (Experimental Dose A: Experimental Dose B: Active Control), treating additional subjects at the selected JV-GL1 doses or Latanoprost for 28 days.

Official Title
-----------------
A Phase 1/2 Safety and Efficacy Study of JV-GL1 Applied to the Periorbital Skin in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Ocular Hypertension, Open Angle Glaucoma

Intervention / Treatment
-----------------
* Drug: JV-GL1
* Drug: Latanoprost 0.005% Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bilateral open-angle glaucoma or ocular hypertension Exclusion Criteria: -

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized Part 2, Arm 1<br>Dose 1 selected in Part I | Drug: JV-GL1<br>* Experimental Treatment<br>|
| Experimental: Randomized Part 2, Arm 2<br>Dose 2 selected in Part I | Drug: JV-GL1<br>* Experimental Treatment<br>|
| Active Comparator: Randomized Part 2, Arm 3<br> | Drug: Latanoprost 0.005% Ophthalmic Solution<br>* Active Control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | Change from baseline in Intraocular Pressure (IOP) | From Baseline to Day 28 of Treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open angle glaucoma, Ocular Hypertension
Early Retinal Nerve Fiber Layer Change of Ethambutol Optic Neuropathy by Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
Ethambutol is widely used as first-line drug, but has serious side effect of optic neuropathy. As previously reported, incidence of ethambutol optic neuropathy is about 1 2%, there was considerable screening efforts and medical cost is increasing. However, there is no effective treatment of ethambutol optic neuropathy or no definite preventable measure. Moreover, multi-drug resistance tuberculosis or extensively drug resistance tuberculosis is emerging, more toxic secondary drug is used in the long-term. It is known that retinal nerve fiber layer is increased early stage in ethambutol optic neuropathy. So we decide to evaluate the retinal nerve fiber layer thickness measured by optical coherence tomography in longitudinal manner.

Conditions
-----------------
Primary Lung Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary lung tuberculosis who has not previously treated Age more than 19 years and less than 70 years old Exclusion Criteria: spherical equivalent more than +6.00 diopter or less than -6.00 diopter by autorefraction Closed angel or intraocular pressure more than 21 mmHg Best corrected visual acuity less than 0.5 with severe cataract Retinal disorder include branch retinal vein occlusion, diabetic macular edema, wet-type age-related macular degeneration Age less than 20 years or older than 70 years old Any intraocular surgery less than 3 months Intellectual problems or illiterate whom could not obtained informed consent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| ethambutol optic neuropathy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Retinal Nerve Fiber Layer thickness measured by optical coherence tomography | Retinal Nerve Fiber Layer is axon of the retinal ganglion cell. It can be measured by optical coherence tomography. It is non-invasive and good reproducibility method to measure retinal nerve fiber layer in vivo. | Early Retinal Nerve Fiber Layer change of initial before anti-tuberculosis treatment, 4 months after anti-tuberculosis treatment, 6 months after anti-tuberculosis treatmen | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinal Nerve Fiber Layer Thickness, Optical Coherence Tomography, Ethambutol optic neuropathy
Prospective Acute Myocardial Infarction Data Bank

Study Overview
=================
Brief Summary
-----------------
In order to accelerate border crossing between basic research and clinical research in acute myocardial infarction, it is necessary to easily use clinical and biological data. That is the reason why it is very important to create a clinical, biological and pathologic database of acute myocardial infarction, mainly prospective. All data are from patients treated in 5 centers in Shanghai，including Zhongshan Hospital of Fudan University, Shanghai Renji Hospital，Shanghai Tenth People's Hospital，Shanghai First People's Hospital, and Shanghai Tongji Hospital.

Official Title
-----------------
Creation of a Prospective Acute Myocardial Infarction Data Bank

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute myocardial infarction was diagnosed based on the Fourth Universal Definition of Acute myocardial infarction criteria. The term acute myocardial infarction should be used when there is acute myocardial injury with clinical evidence of acute myocardial ischaemia and with detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL and at least one of the following: Symptoms of myocardial ischaemia; New ischaemic ECG changes; Development of pathological Q waves; Imaging evidence of new loss of viable myocardium or new regional wallmotion abnormality in a pattern consistent with an ischaemic aetiology; Identification of a coronary thrombus by angiography or autopsy. Exclusion Criteria: life expectancy of less than 12 months malignant tumor pregnancy or plans of pregnancy in the one year any anticoagulation therapy such as heparin within 24 hours of baseline blood sampling

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 |
| --- |
|Procedure: PCI|Primary percutaneous coronary intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Database of patients with acute myocardial infarction |  | 5 years |
InFlux System for Nasal Breathing Improvement

Study Overview
=================
Brief Summary
-----------------
Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing

Detailed Description
-----------------
This is a non-significant risk, prospective, non-randomized pilot study to evaluate the incidence of serious adverse events directly attributable to the Aerin Medical Wand, when used to deliver radiofrequency (RF) energy to tissues of the nasal airway for the treatment of nasal obstruction.

Official Title
-----------------
Pilot Study of Aerin Medical's InFlux System for Improvement in Nasal Breathing

Conditions
-----------------
Nasal Airway Obstruction

Intervention / Treatment
-----------------
* Device: Procedure: thermal coagulation of tissue in the nasal airway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with history of Chronic nasal obstruction and Poor nasal breathing Exclusion Criteria: Patients with prior nasal history, nasal pathology, or injury, and/or other conditions that may interfere with participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InFlux System<br>Intervention: Procedure: thermal coagulation of tissue in the nasal airway | Device: Procedure: thermal coagulation of tissue in the nasal airway<br>* The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage.<br>* Other names: Aerin Medical Wand;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Unanticipated Serious Adverse Device Effects | The study will be considered to have met its primary safety endpoint if no subject experiences an unanticipated serious adverse device effect (USADE defined as any serious adverse effect caused by, or associated with, the investigational device, that was not previously identified in nature, severity, or degree of incidence in the protocol) | 90 Days | 
| Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue | Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature. | Procedure, up to 1 hour (average, 16 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasal obstruction
Axonics SacRal NeuromodulaTIon System RegisTRY Study

Study Overview
=================
Brief Summary
-----------------
To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).

Official Title
-----------------
Axonics SacRal NeuromodulaTIon System RegisTRY Study : ARTISTRY

Conditions
-----------------
Urinary Retention, Urinary Urge Incontinence, Urgency-Frequency, Fecal Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to be trialed with the Axonics External Trial System (ETS), or patients scheduled to receive an Axonics Implantable neurostimulator (INS) or Axonics FS implant Willing and capable of providing informed consent Capable of participating in all testing associated with this clinical investigation Exclusion Criteria: For all indications: Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints Any psychiatric or personality disorder at the discretion of the study physician History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone A female who is breastfeeding A female with a positive urine pregnancy test For OAB & UR: Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) Current symptomatic urinary tract infection (UTI) For FI only: Rectomucosal prolapse or congenital anorectal malformation

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

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 |
| --- | --- | --- |
| Therapy Responder Rate | Participants with the External Trial Stimulator and received the Axonics System | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive Bladder, bladder control, bowel control
OCT Pilot in Esophagus

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium.

Official Title
-----------------
Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study

Conditions
-----------------
Barrett Esophagus

Intervention / Treatment
-----------------
* Device: optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting to University of North Carolina (UNC) for routine care upper endoscopy Meet one of the following criteria: Presenting to UNC for upper endoscopy of GI conditions without esophageal symptomology for with no history of gastroesophageal reflux disease (GERD) or other esophageal condition affecting the epithelium (asymptomatic controls), OR, History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+ Aged 18 to 80 Able to read, comprehend, and understand the informed consent document. Exclusion Criteria: Prior esophageal surgery (uncomplicated nissen fundoplication OK) Pregnant women Unable to provide written informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT of esophagus<br>optical coherence tomography of esophagus | Device: optical coherence tomography<br>* OCT measurements of 5 locations in the esophagus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa | Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy. | at baseline | 
| Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa | Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy. | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image | Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images. | at baseline |
Effect of Spinal Surgery on the Posture and the Balance of the Patients Reached of Spinal Pathologies

Study Overview
=================
Brief Summary
-----------------
Many studies are in favour of the importance of the rachis on the postural balance of the body.It is possible to study the upright posture by determining the center of pressure using a platform of strength.The spinal surgery have two objectives ,mechanic and neurologic .By deformation correction and stabilizing vertebral stages via arthrodesis, it seems to hypothesize that surgery can modify postural balance. This study aim to evaluate spinal surgery effect on posture using that plaftorm .

Detailed Description
-----------------
At the inclusion, Day 1 and day 2 after surgery, the patient will stand on the stabilometric platform, with arms extended along the body, barefoot at 30 ° with a 2 cm gap at the heels. He will fix a target located 1 meter away from him, in silence and will be instructed to stand as still as possible, with his arms along his body, look in the direction of the visual target, do not think about anything. . Then there will be a collection of data in 3 shots of 90 seconds, with a rest period between each shot, using the Winposture® software. The patient will answer health related quality of life questionnaires. 6 months after inclusion, patients will answer health related quality of life questionnaires.

Official Title
-----------------
Effect of Spinal Surgery on Stable Force Platform Parameters Estimating the Posture and the Balance of the Patients Reached of Spinal Pathologies

Conditions
-----------------
Spinal Surgery

Intervention / Treatment
-----------------
* Diagnostic Test: Use of stable force platform


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years old Patient programmed for spinal surgery Patient accepting participation Exclusion Criteria: Refusal of participation All patient with vestibular disease All patient with neurologic disease Patient with pathologies not allowing to maintain the prolonged standing.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Use of stable force platform<br>Ennrollment of every patient programmed for spinal surgery in orthopaedic service | Diagnostic Test: Use of stable force platform<br>* Use of stable force platform to appreciate the posture before and after spinal surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center of foot pressure (COP) positions | COP measurements by using stable force platform | Day 1- Day 2 |
Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if pre-operative vitamin D supplementation lowers the incidence of post-operative transient or permanent hypoparathyroidism in patients undergoing total thyroidectomy.

Official Title
-----------------
Pre-operative Vitamin D Supplementation to Reduce Post-operative Hypocalcemia in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Trial

Conditions
-----------------
Hypocalcemia

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing total thyroidecomty +/- CND Adult (age > or = 18) Exclusion Criteria: Known chronic kidney disease Known primary hyper or hypoparathyroidism Known hypoalbuminemia Concurrent use medications affecting calcium metabolism Completion hemithyroidectomy

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Experimental: Treatment<br>Pre-operative Vitamin D 800 units x 4 weeks | Drug: Vitamin D<br>* Vitamin D 800 units for 4 weeks preoperatively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypocalcemia | Clinical signs and symptoms(paraesthesias, etc.) OR Laboratory evidence (ICa < 0.9) Need for IV calcium supplementation | Transient (<72 hrs post-operatively) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypocalcemia | ICa at 6 weeks and need for continued supplementation beyond 6 weeks post-op (i.e. 3 months follow-up post-operatively) | Permanent (>4 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Permanent, temporary, hypocalcemia