linjc16/ctgov huggingface dataset:
Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma

Study Overview
=================
Brief Summary
-----------------
Prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of the Glaukos® Trabecular Micro-Bypass System Model iS3 (three stents per study eye) in subjects with refractory glaucoma.

Detailed Description
-----------------
This is a prospective, multi-center, single arm, open-label clinical trial of the iS3 system. Up to 65 qualified subjects will be implanted with three G2-W stents in one eye and will be followed for 12 months postoperatively.

Official Title
-----------------
A Prospective, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Model iS3 three-stent trabecular micro-bypass system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of refractory open-angle glaucoma (including pigmentary and pseudoexfoliative glaucoma) that is uncontrolled despite medical therapy and/or prior conventional incisional intraocular glaucoma surgeries. Phakic or pseudophakic. Males or females, 45 years of age or older. Exclusion Criteria: Traumatic, uveitic, neovascular, or angle-closure; or glaucoma associated with vascular disorders. Active corneal inflammation or edema. Retinal disorders not associated with glaucoma.

Ages Eligible for Study
-----------------
Minimum Age: 45 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
Interventional Model Description: The iStent infinite Trabecular Micro-Bypass System Model iS3 is a sterile, single-use injector system that is pre-loaded with three G2-W stents, and is designed to deliver the stents into Schlemm's canal. The three G2-W stents are heparin-coated and manufactured from implant grade titanium.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implant Group<br>Qualified eyes with refractory glaucoma will be implanted unilaterally with the Glaukos® Trabecular Micro-Bypass System Model iS3 (three G2-W stents per study eye), and will be followed through 12 months postoperative. | Device: Model iS3 three-stent trabecular micro-bypass system<br>* Provided in Arm/Group descriptions.<br>* Other names: Implant Group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary effectiveness endpoint | The change in mean diurnal IOP from baseline at 12 months | Month 12 postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
refractory
Enteric Nervous System in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The core of the neuronal lesions in Parkinson's disease (PD) is the progressive degeneration of dopamine neurons in the substantia nigra. A significant loss of dopamine neurons and the presence of Lewy bodies (a pathological hallmark in PD) in enteric neurons have also been reported in that disease. These lesions may explain the frequent gastro-intestinal dysfunction observed in PD patients. Alterations of other neuronal populations within the enteric nervous system (ENS) as well as the mechanisms responsible for these lesions (type of cell death, alteration of neuromediators gene expression) remain to be identified. The aim of the study is to demonstrate that alterations of the human ENS in PD can be evidenced by bowel biopsies and to determine whether they are correlated to the severity of motor disability and to gastrointestinal dysfunction.

Official Title
-----------------
Analysis of Dopamine Neuronal Cell Loss Within the Enteric Nervous System in Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Procedure: Biopsies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease patients at 3 different stages: Early PD (before L-DOPA-induced complication); Patients with L-DOPA-induced complication; Patients with balance impairment or cognitive decline. Controls: patient at risk of colic cancer for whom a coloscopy is required.

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

Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Procedure: Biopsies<br> <br> |
| Experimental: Parkinson stade 1<br> | Procedure: Biopsies<br> <br> |
| Experimental: Parkinson stade2<br> | Procedure: Biopsies<br> <br> |
| Experimental: Parkinson stade 3<br> | Procedure: Biopsies<br> <br> |

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
-----------------
Parkinson's disease, enteric nervous system
Cochlear Implantation After Gamma Knife Radiosurgery With eABR and Correlation to Postoperative Hearing Results - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Patients undergoing cochlear implantation after radio surgery for vestibular schwannoma will be included in the study. Patients will undergo preoperative and intraoperative eABR measurement. Correlations to postoperative hearing results will be drawn.

Detailed Description
-----------------
Patients treated with radio surgery for vestibular schwannoma often suffer from hearing loss. Especially when the contralateral side has progressive hearing loss assessment if cochlear implantation is feasible, should be carried out. Patients undergo extensive audiometric testing. Additionally, patients will undergo preoperative eABR. Intraoperatively eABR is carried out and cochlear implantation is performed. The eABR results will be correlated with postoperative hearing. EABR measurements are not part of the study. The results of eBAR will be categorized in three groups (good response, weak response and no response). The eABR results will then be correlated to speech understanding with cochlear implants measured with Freiburger monosyllables test.

Official Title
-----------------
Cochlear Implantation After Gamma Knife Radiosurgery With eABR and Correlation to Postoperative Hearing Results - a Pilot Study

Conditions
-----------------
Vestibular Schwannoma, Hearing Loss

Intervention / Treatment
-----------------
* Other: eABR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone radio surgery for vestibular schwannoma Patients wanting cochlear implantation for hearing rehabilitation Exclusion Criteria: Patients not wanting to participate in the study

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 |
| --- |
|Other: eABR|eABR|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eABR correlation | eABR is correlated with postoperative hearing results eABR will be divided in three categories - good response, weak response, no response Hearing results will be measured with speech understanding in Freiburg monosyllables word test which is measured in % of monosyllables understanding at 65 and 80dB | 2 years |
rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport

Study Overview
=================
Brief Summary
-----------------
When there is a bone defect, bone transport is used to bridge the defect. Frequently, the bone in the docking site (where the transported bone comes together) doesn't heal. The objective is to study the effectivity of rhBmp-2 (inductos) to stimulate bone healing, in order to find new techniques to treat non-union of long bones. The method of the study is a randomized controlled trial, to compare rhBMP-2 and autologous bone grafting in stimulating bone healing in the docking site.

Official Title
-----------------
rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport

Conditions
-----------------
Pseudarthrosis

Intervention / Treatment
-----------------
* Device: rhBMP-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with bone transport (Ilizarov technique) and have non-union of the docking site, which is characterized by absence of bridging callus after two months of compression in the docking site. Exclusion Criteria: Allergy for inductos active growth, malignancy infection PAD pathological fracture

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Autologous bone grafting<br>autologous bone of the iliac crest | Device: rhBMP-2<br> <br> |
| Experimental: rhBMP-2<br>Inductos, recombinant human bone morphogenetic protein | Device: rhBMP-2<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone healing in the docking site |  | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection |  | up to one year | 
| Edema |  | up to one year | 
| cancer |  | up to one year |
Tight Glycemic Control in Acute Exacerbations of COPD

Study Overview
=================
Brief Summary
-----------------
Glucose control has been shown as an important and independent prognostic factor in several acute conditions in hospitalized patients, including Acute MI, stroke, cardiac surgery and in critical care units. Patients with acute exacerbation of COPD (AECOPD)and diabetes treated with insulin had a longer in-patient stay and more frequent isolation of Gram negative bacteria from sputum than those without diabetes.Hyperglycemia (>11 mmol/l) on admission predicted failure of non-invasive ventilation and infectious pulmonary complications in patients admitted to the ICU with acute respiratory failure caused by severe AECOPD. The primary goal of this study is to test the hypothesis that in AECOPD, tight glycemic control during hospital stay will improve outcome of hospitalization. The secondary goal of this study is to test new ways in controlling patients in the internal medicine ward.

Official Title
-----------------
Tight Glycemic Control in Acute Exacerbations of COPD

Conditions
-----------------
COPD, Hyperglycemia

Intervention / Treatment
-----------------
* Drug: tight insulin treatment in patients hospitalized with COPD exacerbation
* Procedure: tight glycemic control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current or past smokers (at least 20 py) patient with COPD be ATS criteria hospitalized with acute exacerbation, 2/3 criteria:1- worsening of SOB 2-change in sputum volume 3- change in sputum color signed informed concent Exclusion Criteria: respiratory failure (pH<7.35 ו Pco2>60 ) pneumonia pneumothorax bronchiectasis lung collapse congestive heart failure lung cancer suspected pulmonary emboli immune deficiency (acquired 0r congenital) cystic fibrosis post lung implantation asthma/ non smokers

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 90 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

| Intervention/Treatment |
| --- |
|Drug: tight insulin treatment in patients hospitalized with COPD exacerbation|treatment with basal plus bolus insulin|
|Procedure: tight glycemic control|treatment with basal and bolus insulin|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospialization |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inpatients with COPD, glucose control
A Study of the Effect of INCB013739 on Cortisone Reducing Enzyme Activity in Obese People Predisposed to Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the investigational drug INCB013739 has an effect on systemic and adipose tissue 11-HSD1 activity in obese, insulin resistant subjects.

Detailed Description
-----------------
Proprietary Information: Exploratory (Non-Confirmatory) Trial.

Official Title
-----------------
A Double-blind, Placebo Controlled Pharmacodynamic Study of the Effect of INCB013739 on Systemic and Adipose Tissue 11βHSD1 Activity in Obese, Insulin Resistant Subjects.

Conditions
-----------------
Obesity, Insulin Resistance

Intervention / Treatment
-----------------
* Drug: INCB13739


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects between 18 years and 65 years of age. BMI between 30 and 42 kg/m2, inclusive. FPG <126 mg/dL Exclusion Criteria: Meet criteria for diagnosis of diabetes mellitus at the screening evaluation, female subjects with a history of gestational diabetes are permitted. Are receiving oral antidiabetic agents within the 3 months prior to screening.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: INCB13739|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pharmacokinetics of INCB013739 through analysis of blood samples. |  | Serial collections at each visit | 
| Evaluation of change in cortisol laboratory values |  | Serial collections at each visit | 
| Assessment of ECGs, laboratory results and physical exams for adverse events |  | Measured from baseline through study completion |
Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
The aim of this research project is to better understand the origin and clinical significance of two lupus-specific genetic signatures (IFN signature and plasma cell signature) in patient subgroups with well-defined clinical characteristics. Our aim is to correlate these genetic signatures with cell activation profiles and the production of specific cytokines in different populations from whole blood and in short-term cultures of these circulating cells.

Detailed Description
-----------------
The aim of the experiment is, on the one hand, to identify and study the different cell populations from whole blood by flow cytometry and, on the other hand, to assay different cytokines in blood and urine samples from diseased (SLE) and control subjects (with non-inflammatory rheumatic diseases) in order to highlight and correlate the presence of biomarkers to disease activity or to a clinical manifestation of the disease. In vitro studies will also be carried out on short-term cultures of PBMCs (Peripheral Blood Mononuclear Cells).

Official Title
-----------------
Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus. Recherche de Biomarqueurs de l'activité de la Maladie Chez Des Patients Atteints de Lupus érythémateux disséminé.

Conditions
-----------------
Lupus Nephritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfilment of the EULAR/ACR classification criteria of SLE. 18 years of age or above. Incident or Flare biopsy-proven proliferative or membranous LN Exclusion Criteria: Antiphospholipid syndrome nephropathy (APSN). Pregnancy at baseline (pregnancy during follow-up will not lead to exclusion). Anticipated non-adherence to therapy. Medical conditions interfering with outcome evaluations. Inability to read and/or sign the informed consent form.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Systemic Lupus Erythematosus - Lupus Nephritis Cohort<br>Systemic Lupus Erythematosus - Lupus Nephritis Cohort | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker analysis of lupus nephritis activity - whole blood cell populations | whole blood cell populations - flow cytometry assay | baseline | 
| Biomarker analysis of lupus nephritis activity - blood cytokines | blood cytokines - flow cytometry assay | baseline | 
| Biomarker analysis of lupus nephritis activity - urine cytokines | urine cytokines - flow cytometry assay | baseline |
A Study of SI-6603 in Patients With Lumbar Disc Herniation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in patients with lumbar disc herniation.

Conditions
-----------------
Intervertebral Disc Disease, Lumbar Disc Disease

Intervention / Treatment
-----------------
* Drug: Condoliase
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root. Patients assessed as positive in the SLR test. Patients with sciatica in either leg. Patients with no improvement from conservative treatment Exclusion Criteria: Patients who have 2 or more lumbar disc herniations as assessed by MRI. Patients in whom a rupture into the posterior longitudinal ligament is identified by MRI. Patients who have received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent. Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SI-6603<br>SI-6603 is administrated into the nucleus pulposus of the intervertebral disc | Drug: Condoliase<br>* 1.25U, intradiscal injection, one time<br>|
| Sham Comparator: Control<br>Sham injection | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg pain | Assessed by Visual Analog Scale (VAS) | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate evaluation | Assessed by leg pain (VAS), Oswestry Disability Index disability questionnaire, neurologic status (motor, sensory, reflexes), and no treatment failure | 13 weeks |