linjc16/ctgov huggingface dataset:
Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI 2)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of implanting 2 novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

Detailed Description
-----------------
20 patients will be included in this 6 months interventional study. All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of 2 interposition supraciliary permanent devices. Several patient data like IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up. Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Official Title
-----------------
Non Randomised Mono-centered Study to Evaluate Safety and Efficacy of a Novel Interposition Supraciliary Implant in Glaucoma Patients Refractory to Topical Therapy

Conditions
-----------------
Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Device: Interposition supraciliary implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of POAG Schafer 3 or 4 Medicated IOP ≥ 21 Exclusion Criteria: - Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Interposition supraciliary implant<br>Any patients corresponding to inclusion / exclusion criteria | Device: Interposition supraciliary implant<br>* Surgical placement of 2 interposition supraciliary implant in the supraciliary space<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess post-op IOP reduction | Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% | 6 months | 
| Assess post-op IOP clinical success | Proportion of Eyes With Intraocular Pressure (IOP) < 21 mmHg | 6 months |
Expression Levels of RISC and Microprocessor Complex Components in Epithelial Skin Cancer

Study Overview
=================
Brief Summary
-----------------
MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. In the present study, the investigators examines the expression profiles of the microprocessor complex subunit DGCR8 and the RISC components TARBP1, TARBP2, argonaute-1, argonaute-2 and PACT in epithelial skin cancer and its premalignant stage.

Detailed Description
-----------------
Patients with premalignant actinic keratoses, basal cell carcinomas and squamous cell carcinomas were included in the study. Punch biopsies were harvested from the center of the tumors, from sites of healthy skin and a healthy control group. DGCR8, TARBP1, TARBP2, argonaute-1, argonaute-2 and PACT mRNA expression levels were detected by quantitative real-time reverse transcriptase polymerase chain reaction.

Official Title
-----------------
Expression Levels of RNA-induced Silencing Complex (RISC) Components TARBP1, TARBP2, Argonaute-1, Argonaute-2, PACT and Microprocessor Complex Component DGCR8 in Epithelial Skin Cancer

Conditions
-----------------
Skin Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: epithelial skin cancer Exclusion Criteria: other known previous malignancies

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basal Cell Carcinoma<br> | |
| Squamous Cell Carcinoma<br> | |
| Actinic Keratosis<br> | |
| healthy non-lesional skin<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
-----------------
Basal Cell Carcinoma, Squamous Cell Carcinoma, Actinic Keratosis, microRNA, Dicer, Drosha, RISC, microprocessor complex, Argonaute, DGCR8, TARBP
Multi-catheter High Dose Rate (HDR) Breast Brachytherapy

Study Overview
=================
Brief Summary
-----------------
Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.

Official Title
-----------------
A UW Phase II Trial of Multi-catheter HDR Brachytherapy Following Lumpectomy for Early Stage Breast Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: brachytherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is < 3 cm, N0 or N1 if 1-3 + nodes with no extracapsular extension

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>breast brachytherapy to a dose of 34 Gy | Radiation: brachytherapy<br>* breast brachytherapy to 34 Gy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years |  | 3 years |
Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation

Study Overview
=================
Brief Summary
-----------------
The occipital nerve stimulation (ONS) is used to treat patients with refractory primary chronic headache but its mechanism of action (MoA) remains unknown. Different hypothesis have been suggested in particular a specific action on cerebral generators involved in different types of primary headaches or a non specific action on pain modulatory network. The aim of this study, using the chronic cluster headache as a model, is to determine the changes in cerebral metabolism induced by ONS to precise its MoA in the treatment of primary chronic headache.

Official Title
-----------------
Study of the Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation

Conditions
-----------------
Refractory Chronic Cluster Headache

Intervention / Treatment
-----------------
* Radiation: 18F-FDG PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years chronic cluster headache (according to the IHS) refractory in who a treatment by ONS have been indicated patient affiliated at social security, informed consent signed Exclusion Criteria: contraindication to MRI contraindication to 18F-FDG PET women without contraception/pregnant/breast-feeding patient non-compliant patient on legal guardianship

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subjects with refractory chronic cluster headache<br>Adult subjects with refractory chronic cluster headache and ONS indication | Radiation: 18F-FDG PET<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of cerebral metabolism | Changes of cerebral metabolism associated with ONS efficacy | Baseline (before ONS), 1 week after ONS , 3 month after ONS |
Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with conventional 20, 23, and 25-gauge vitrectomy were compared.

Detailed Description
-----------------
The 424 eyes of 347 patients of PDR who underwent vitreous surgery for persistent vitreous hemorrhage or progressive proliferative membrane were evaluated.

Official Title
-----------------
Comparison of Small-gauge and Conventional Vitrectomy for Proliferative Diabetic Retinopathy

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

Intervention / Treatment
-----------------
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients of proliferative diabetic retinopathy who underwent vitreous surgery and followed at least 6 months Exclusion Criteria: The patients of proliferative diabetic retinopathy who underwent vitreous surgery but did not follow more than 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 10 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proliferative diabetic retinopathy<br> | Procedure: Vitrectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of retinal breaks |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of neovascular glaucoma |  | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proliferative diabetic retinopathy, Vitrectomy
MACE and PE in Elective Primary TKA & THA

Study Overview
=================
Brief Summary
-----------------
This study ought to identify the occurence of the major adverse cardiovascular events (MACE) and the pumonary emoblism (PE) in patients undergoing elective primary THA & TKA

Detailed Description
-----------------
The study included 220 consecutive patients undergoing elective primary THA & TKA from January 2018 to December 2018. The occcurence of major adverse cardiovascular events (MACE) and the pumonary emoblism (PE) were recorder. Under the term MACE the following were included; non fatal cardiac arrest acute myocardial infraction congestive cardiac failure cardiac arrhythmia agnina stroke cardiovascular death cerebrovascular death

Official Title
-----------------
Registration of the Major Adverse Cardiovascular Events and Pulmonary Embolism in Primary Total Joint Arthroplasty

Conditions
-----------------
Cardiovascular Complication, Pulmonary Embolism, Stroke, Transient Ischemic Attack, Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients age 18 years or older, with a diagnosis of primary osteoarthritis of the hip or knee, who underwent elective, primary, unilateral TKA or THA. Exclusion Criteria: previous TKA or THA within 3 months Revision surgery Surgical procedures related to a previous complication ASA PS IV recent history (6 months) of unstable acute coronary syndrome or decompensated heart failure
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TJA<br>patients with primary osteoarthritis of the knee and hip who underwent elective primary total hip and total knee arthroplasty. MACE and pulmonary embolism were recorded | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | MACE (non-fatal-cardiac arrest, acute myocardial infraction, congestive cardiac failure, cardiac arrhythmia, angina, stroke, cardiovascular death, cerebrovascular, death) | 1month postoperatively | 
| Pulmonary Embolism | PE | 1month postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total joint arthroplasty, total hip arthroplasty, total knee arthroplasty, major adverse cardiovascular events, pulmonary embolism
Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus

Official Title
-----------------
Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Jardiance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male and female Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment Exclusion criteria: None

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 |
| --- | --- |
| Jardiance<br>Patients with T2DM to receive Jardiance tablets 10 mg, 25 mg | Drug: Jardiance<br>* Empagliflozin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Adverse Drug Reactions (ADRs) | Number of patients with adverse drug reactions. | From first drug administration until 7 days after last drug administration, up to 247 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period | Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period. | At start of treatment and at last observation on treatment, up to 246 weeks. | 
| Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period | Change from baseline in fasting plasma glucose (FPG) at the last- observation during observation period. | At start of treatment and at last observation on treatment, up to 246 weeks. |