linjc16/ctgov huggingface dataset:
Extension Study of Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
This multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study CSMS995 0802. During this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe NPDR and low risk PDR.

Official Title
-----------------
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Octreotide acetate in microspheres


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent provided prior to participation in the extension study successful completion of study CSMS995 0802 willingness to comply with all study requirements Exclusion Criteria: more than 8 weeks interval since the completion of study CSMS995 0802 premature discontinuation from study CSMS995 0802 Other protocol-defined inclusion/exclusion criteria may apply.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Octreotide acetate in microspheres|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monitor long-term efficacy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic retinopathy, octreotide acetate in microspheres
Retrobulbar Injection of Anesthesia Versus Healon 5 in the Management of Intraoperative Floppy Iris Syndrome

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators plan to compare the incidence and complications of intraoperative floppy iris syndrome (IFIS) during cataract surgery in patients taking tamsulosin (Flomax) and treated with retrobulbar injection of anesthesia, versus injection of Healon 5 viscoelastic into the anterior chamber.

Official Title
-----------------
Retrobulbar Injection of Anesthesia Versus Injection of Healon 5 Viscoelastic Into the Anterior Chamber in the Management of Intraoperative Floppy Iris Syndrome

Conditions
-----------------
Intraoperative Floppy Iris Syndrome

Intervention / Treatment
-----------------
* Procedure: Healon 5 injection
* Procedure: Retrobulbar anesthetic injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cataract patients taking tamsulosin Exclusion Criteria: Patients with any history of iridocyclitis Presence of iris neovascularization History of prior iris surgery Presence of traumatic cataracts Presence of zonular dialysis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Healon 5 | Procedure: Healon 5 injection<br>* Healon 5 (2.3% Sodium hyaluronate) ophthalmic viscoelastic device will be injected into the anterior chamber as needed for pupillary dilation and adequate cataract extraction with intraocular lens placement.<br>|
| Experimental: 2<br>Retrobulbar Anesthetic Injection | Procedure: Retrobulbar anesthetic injection<br>* 3-4cc of anesthetic (1% lidocaine/0.75% bupivicaine) will be injected with a 25 gauge needle into the extraocular muscle cone prior to patient and microscope positioning. Cataract extraction with intraocular lens placement will then proceed in standard fashion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupil diameter after hydrodissection |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupil diameter after nuclear removal |  | 2 years | 
| Pupil diameter after cortex removal |  | 2 years | 
| Pupil diameter at conclusion of surgery |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Floppy Iris Syndrome
Laboratory Diagnosis of of Rickettsial and Rickettsia-like Diseases

Study Overview
=================
Brief Summary
-----------------
The low confirmed rickettsioses cases rate may indicate the presence of rickettsiosis other than scrub typhus, murine typhus, and Q fever. The clinical presentation of rickettsiosis is variable and atypical that laboratory confirmation is necessary. This project is aimed to set up the laboratory to diagnose rickettsial and rickettsial like disease, which could help in develop rapid diagnostic kits, epidemiologic surveillance and prognostic factor.

Official Title
-----------------
Laboratory Diagnosis of of Rickettsial and Rickettsia-like Diseases

Conditions
-----------------
Rickettsioses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rickettsioses reported cases
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
-----------------
Rickettsioses, Scrub Typhus, Q fever, Typhus fever, Spotted fever, Rickettsioses reported cases
Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether treatment to the axilla (area under the arm) can be safely minimized by omitting axillary surgery and full axillary radiation therapy and replacing it with radiation therapy to the breast and lower axilla.

Detailed Description
-----------------
Patients will have undergone conservative breast surgery without axillary dissection prior to enrollment in this study. Patients will receive radiation therapy to the breast, including the lowest axillary lymph nodes, over a period of 6 1/2 weeks. No radiation will be specifically directed toward the upper axilla or supraclavicular lymph nodes. Patients will also receive 5 years of tamoxifen or another type of hormone therapy determined by the medical oncologist. Follow-up visits will occur every 6 months and mammograms every 12 months.

Official Title
-----------------
Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer

Conditions
-----------------
Early-Stage Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Tangential radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have clinical stage I or II breast cancer, clinically uninvolved axillary nodes. Patients must be 55 years or older. Patients must undergo total excision of the primary invasive tumor Final pathologic margin status must be negative Only estrogen receptor (ER) or progesterone receptor (PR) positive tumors will be permitted Exclusion Criteria: Prior history of malignancy, except for non-melanoma skin cancers and carcinoma in situ fo the cervix

Ages Eligible for Study
-----------------
Minimum Age: 55 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

| Intervention/Treatment |
| --- |
|Procedure: Tangential radiation|Radiation given over 6 1/2 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of this treatment. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Axillary Dissection, Tangential Radiation
Evaluation at 5 and 10 Years of Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
5 and 10 years follow-up of the oxyop study.

Detailed Description
-----------------
Oxyop (NCT02652520 PHRC) was a safety study evaluating the use of an oxygen carrier HEMO2life® as an additive in organ preservation solution in 60 transplanted kidneys. This was a national multicenter (6 centers) open-labeled safety study on HEMO2life® that included 58 recipients. The first patient was included on March 24th, 2016 and the study was completed on February 23th, 2018 (1 year of recruitment and 1 year of follow-up). Some efficacy secondary end points using a paired analysis was also analyzed (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop 5 and 10 years aims to analyse 5 and 10 years results.

Official Title
-----------------
Evaluation at 5 and 10 Years of Renal Transplant Patients Who Received a Graft Preserved in a Solution HEMO2life®

Conditions
-----------------
Transplant; Complication, Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed patients participating to the oxyop study Patient having completed the OXYOP M12 follow-up visit Patient agreeing to participate in the observational study Exclusion Criteria: Opposition to the use his medical data patient deceased or with graft lost before M48

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 |
| --- | --- |
| interventional group<br>kidney graft preserved with M101 | |
| control group<br>kidney graft preserved in standard condition (without M101) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR | estimated GFR (CKDEPI) | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient survival | patient survival at last follow-up | 5 and 10 years | 
| graft survival | graft survival at last follow-up | 5 and 10 years | 
| rejection rate | biopsy proven rejection | 5 and 10 years | 
| infection rate | all infection episodes | 5 and 10 years | 
| hospitalization | number of hospitalization, hospital stay | 5 and 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal transplantation, organ preservation, oxygen carrier
High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

Study Overview
=================
Brief Summary
-----------------
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU). This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.

Official Title
-----------------
High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma: a Feasibility Study. A Multicentric, Open, Uncontrolled Study

Conditions
-----------------
Breast Fibroadenoma

Intervention / Treatment
-----------------
* Device: Ultrasonic ablation device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of breast fibroadenoma based on:Clinical examination, Ultrasound image and mammogram for women older than 35 years, and histology Fibroadenoma size superior at 1 cm at its largest dimension (measured by Ultrasound) Exclusion Criteria: Patient pregnant or lactating Microcalcifications within the lesion at the mammogram. History of breast cancer or history of laser or radiation therapy to the target breast Breast implant in the target breast. Fibroadenoma not clearly visible on the ultrasound images (in B mode) Patient participating in other trials using drugs or devices

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Focused Ultrasound (HIFU)<br> | Device: Ultrasonic ablation device<br>* High Intensity focused ultrasound treatment<br>* Other names: TH-One;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma |  | 6 months after HIFU treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume reduction of the fibroadenoma | reduction in volume at 2, 4, 6 and 12 months after HIFU session or total regression of the fibroadenoma evaluated with ultrasound just before surgery | 12 months after HIFU treatment | 
| - Pain score during the HIFU treatment evaluated by the Visual Analog Scale. |  | at treatment | 
| Percentage of patients with Adverse events |  | at 12 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Fibroadenoma, High Intensity Focused Ultrasound
Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this compassionate use study is to provide clinical and technical support of the Bion® microstimulator system to the subjects who have decided to keep the system for relief of headache symptoms that have not responded to medical treatment. These study subjects were enrolled and implanted with the Bion® system during a previous clinical investigation of the Bion® for occipital nerve stimulation (ONS) in the United States.

Official Title
-----------------
Compassionate Use Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches

Conditions
-----------------
Chronic, Medically Refractory Headache

Intervention / Treatment
-----------------
* Device: bion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject participated in a prior clinical feasibility study of the Bion for occipital nerve stimulation in the treatment of chronic headaches (IDE G030225) and remained implanted with the Bion system. Subject elects to enroll in this compassionate use study and provides written informed consent. Subject understands the type and duration of clinical, technical or product support provided in the study. Subject is willing to comply with protocol-required activities. Exclusion Criteria: Subject is currently participating or intends to participate in another investigational drug or device clinical trial for chronic headaches during the study period.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: bion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provision of one year of clinical and technical support | This is a compassionate use study. There are no primary outcome measures. |  |
Monitoring of Patients With Chronic Respiratory Failure Treated With Non-invasive Home Ventilation: Contribution of New Monitoring Tools

Study Overview
=================
Brief Summary
-----------------
Single-center retrospective study conducted on a population of patients with chronic hypercapnic respiratory failure treated by non-invasive ventilation at home, followed at the CHRU of Nancy. The objective is to assess the contribution of reading the NIV card with a standardized grid in their follow-up. The main objective is to assess the inter-observer agreement of a standardized NIV card reading grid, the secondary objective is to compare the results of NIV card reading between the usual NIV card reading method in the service and this same method completed by the addition of the standardized reading grid. The hypothesis is that the use of a standardized NIV card reading grid improves patient follow-up by standardizing their care.

Official Title
-----------------
Monitoring of Patients With Chronic Respiratory Failure Traeted With Non-invasive Home Ventilation: Contribution of New Monitoring Tools

Conditions
-----------------
Chronic Hypercapnic Respiratory Failure

Intervention / Treatment
-----------------
* Device: NIV cards
* Other: Medical file


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patients Patients with chronic hypercapnic respiratory failure with a validated indication of long-term NIV Follow-up at the CHRU of Nancy at Unité de Médecine Ambulatoire (UMA) department between 11/01/2020 and 05/30/2021 Exclusion Criteria: Data not usable / missing Tracheal ventilation Patients' opposition to the use of their data for the purposes of this research

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 |
| --- | --- |
| Chronic hypercapnic respiratory failure treated by home non-invasive ventilation (NIV)<br> | Device: NIV cards<br>* Reading the data available on the NIV cards<br>Other: Medical file<br>* Using the data available in the medical file including clinical data, blood gas results, nocturnal oximetry results<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of responses to a standardized NIV reading grid between 2 observers |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the results between two observers between the method of reading NIV card usually performed in the department and this same method supplemented with a standardized NIV reading grid |  | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic hypercapnic respiratory failure, non-invasive ventilation, standardized NIV reading grid
Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
To evaluate long-term intraocular lens (IOL) decentration and tilt in eyes with pseudoexfoliation syndrome (PES) following cataract surgery using Visante anterior segment OCT and iTrace Visual Function Analyzer.

Detailed Description
-----------------
64 eyes following cataract surgery from 2009 to 2012 were included, 34 eyes had PES, 30 eyes did not show PES. A standard phacoemulsification procedure followed by IOL implantation was performed and patients were followed 4-6 years after surgery (mean=69 months). Best corrected visual acuity (BCVA), intraocular pressure (IOP) and capsulorhexis size were measured. IOL tilt and IOL decentration were evaluated using Visante Omni anterior segment OCT (Carl Zeiss Jena GmBH, Germany). The iTrace VFA (Visual Function Analyzer, Topcon Medical Systems, Inc.) was used to measure internal, corneal and total optical aberrations.

Official Title
-----------------
Assessment of Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery

Conditions
-----------------
Cataract, Pseudoexfoliation Syndrome, Pseudophakia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients 4-6 years after standard cataract surgery pseudoexfoliation Syndrome (PES) Exclusion Criteria: Diabetic retinopathy Age related macula Degeneration retinal bloodvessel disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 125 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PEX<br>Patients after Cataract surgery with PES | Other: no intervention<br>* no intervention<br>|
| Control<br>Patients after Cataract surgery without PES | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOL decentration | decentration of IOL is measured using Hoya iTrace | 4-6 years after cataract surgery | 
| IOL tilt | tilt of implanted IOL is measured using Hoya iTace | 4-6 years after cataract surgery | 
| IOL decentration | decentration of IOL is measured using Zeiss OCT | 4-6 years after cataract surgery | 
| IOL tilt | tilt of implanted IOL is measured using Zeiss OCT | 4-6 years after cataract surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pseudoexfoliation Syndrome, Cataract, Aberration, IOL decentration, IOL tilt