linjc16/ctgov huggingface dataset:
The Future of Revascularization Using a Bioprotec Graft

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is the rate assessment of rescued limbs, one year after a BIOPROTEC vascular graft.

Detailed Description
-----------------
The BIOPROTEC grafts are controverted: they are useful in some cases, but they are known as frequently broken or thrombosed. However they are always posed in a complicated situations, in a fragile patients who have ever had many of revascularizations or in an infectious state (which is supportive of the pseudoaneurysm and thrombosis) Despite the frequent use of this graft in France, the results have never been published.

Official Title
-----------------
The Future of the Revascularization Using a Bioprotec Graft

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Procedure: Revascularization using a BIOPROTEC Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ Eighteen years old. Critical ischemia (Phase 4-6 of Rutherford): no saphenous equipment for the vascular reconstruction; at least one leg axis permeable. Exclusion Criteria: Pregnant woman. Patient with an acute ischemia. Patient with an exceeded ischemia.

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

| Intervention/Treatment |
| --- |
|Procedure: Revascularization using a BIOPROTEC Graft|It is about a routine care study not changing the usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular Doctor in 1 month, 6 months, 12 months, 18 months and 2 years.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Limb rescue rate one year after a BIOPROTEC graft | Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The revascularization permeability rate | Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years | Two years | 
| The amputation rate | Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years | Two years | 
| Infection resistance rate | Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral Artery Disease, Revascularization, Graft, Vein, Artery, Limb, Amputation
Fenestrated AAA Endovascular Graft Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.

Official Title
-----------------
Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Post-Approval Study

Conditions
-----------------
Abdominal Aortic Aneurysm (AAA), Aorto-iliac Aneurysm, Juxtarenal Aneurysm

Intervention / Treatment
-----------------
* Device: Zenith® Fenestrated AAA Endovascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair Exclusion Criteria: proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal renal artery stenosis greater than 50 percent

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: Zenith® Fenestrated AAA Endovascular Graft<br> | Device: Zenith® Fenestrated AAA Endovascular Graft<br>* The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneursyms having morphology suitable for endovascular repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success : AAA Related Mortality | patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% , | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aneurysm, Aortic Aneurysm, Iliac Aneurysm, Aortic Aneurysm, Abdominal, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
Auditory Neuropathy and Cochlear Implants

Study Overview
=================
Brief Summary
-----------------
The electrical stimulation generated by the Cochlear Implant (CI) may improve the neural synchrony and hence contribute to the development of auditory skills in patients with Auditory Neuropathy / Auditory Dys-synchrony (AN/AD). Goal: The goal of the research was to evaluate the auditory performance and the characteristics of the electrically evoked compound action potential (ECAP) in a group of 18 cochlear implants recipients with AN/AD.The auditory perception was evaluated by sound field thresholds and speech perception tests. To evaluate ECAP's characteristics, the threshold and amplitude of neural response together with the amplitude growth and recovery functions were evaluated at 80Hz stimulation rate.The CI was seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients considered by the research. The auditory perception benefits as well as the possibility to measure the ECAP showed that the electrical stimulation could compensate the neural dys-synchrony caused by the AN/AD. However, a unique clinical procedure cannot be proposed at this point. Therefore, a careful and complete evaluation of each AN/AD patient before recommending the Cochlear Implant is advised

Official Title
-----------------
Cochlear Implants in Children With Auditory Neuropathy/ Auditory Dys-Synchrony

Conditions
-----------------
Cochlear Implants, Auditory Neuropathy

Intervention / Treatment
-----------------
* Device: Cochlear Implants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children with AN/AD who had received the cochlear implant during the research´s period.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Auditory Neuropathy Patients<br> | Device: Cochlear Implants<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The CI was seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients considered by the research. |  |  |
NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the recommended dose of NC-6004 according to the dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy, safety and tolerability.

Official Title
-----------------
Phase I/II Study of the Combination Therapy With NC-6004 and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer in Asian Countries

Conditions
-----------------
Locally Advanced and Metastatic Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Nanoplatin (NC-6004) and Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chemo-naive, advanced pancreatic cancer Nonresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer Exclusion Criteria: Pulmonary fibrosis or interstitial pneumonia Marked pleural effusion or ascites above Grade 2 Severe drug hypersensitivity Metastasis to the central nervous system and brain

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Nanoplatin<br>Nanoplatin (NC-6004) had to be administered once every 3 weeks, on Day 1, Day 22 and Day 43 etc. Gemcitabine had to be administered to every patient 2 times on Day 1 and Day 8 every 3 weeks after the infusion of Nanoplatin (NC-6004). | Drug: Nanoplatin (NC-6004) and Gemcitabine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of DLT and Response rate |  | DLT is evaluated for 3 weeks o the treatment, Response rate is evaluated at 7,13,19 and 25weeks of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1.5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cancer, Gemcitabine
Chronic Pain After Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain. A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased. Two techniques of inguinal hernia repair will be evaluated: open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation) open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation) Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.

Official Title
-----------------
A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh

Conditions
-----------------
Inguinal Hernia, Chronic Pain

Intervention / Treatment
-----------------
* Procedure: selfgrip mesh
* Procedure: lightweight mesh with suture fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary unilateral inguinal hernia 18 years and older Exclusion Criteria: bilateral hernia recurrent hernia incarcerated hernia malignant disease within the last 5 years not able to understand the questionaire

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: selfgrip mesh<br>* inguinal hernia repair using a selfgrip mesh<br>|
| Active Comparator: 2<br> | Procedure: lightweight mesh with suture fixation<br>* inguinal hernia repair using a lightweight mesh with suture fixation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic pain |  | 3 months, 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity |  | 3 months, 15 months | 
| recurrence rate |  | 3 months and 15 months | 
| quality of life |  | 3 months and 15 months |
Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution

Study Overview
=================
Brief Summary
-----------------
This is a research study of a novel, breast-dedicated positron emission tomography (PET) camera with 1 millimeter spatial resolution. The main goal of the study is for the personnel to understand practical and logistical issues with using the camera in the clinic

Detailed Description
-----------------
Primary Objective To obtain initial experience using the novel, breast-dedicated PET camera design in the breast imaging clinic. Secondary Objectives To understand, given the 10-fold higher sensitivity of this novel camera, how low we can go with administered tracer dose, and, given the >100-fold better volumetric spatial resolution, understand the achievable image quality.

Official Title
-----------------
Pilot Study of a Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution

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

Intervention / Treatment
-----------------
* Drug: 18F-FDG
* Device: Breast-dedicated PET camera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy-confirmed breast cancer measuring ≥ 5 mm on mammogram or ultrasound. Prior diagnostic imaging test(s) with another modality such as MRI, CT, or x-ray mammography (or other applicable imaging modalities) within 60 days prior to the study date. Documented written informed consent document. Exclusion Criteria: 1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance. Known allergies to FDG Pregnant or nursing.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18-F FDG Study using Breast-Dedicated PET Camera<br>Breast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose | Drug: 18F-FDG<br>* Participant will be injected IV (intravenously) with 10 ± 2 mCi of 18F-FDG.<br>* Other names: 18F-FDG radiotracer;Device: Breast-dedicated PET camera<br>* Breast-dedicated PET camera designed by Stanford satellite radiochemistry facility<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality with the breast-dedicated PET camera | Feasibility of the pilot breast-dedicated PET camera will be assessed on the basis of whether acceptable images are obtained. Images will be assessed and graded as 1 of 3 quality ratings: excellent, good, and poor. The outcome will be reported as the number of images that are excellent, good, and poor, a number without dispersion. | 1 day |
Effect of UHT Treated Milk on Blolipid Profile

Study Overview
=================
Brief Summary
-----------------
The studie are to investigate the effect of ultra heat treated (UHT) versus pasteurised milk on bloodlipid profile

Official Title
-----------------
Effect of UHT Treated Milk on Blolipid Profile

Conditions
-----------------
To Investigate the Effect of UHT Treated Milk Versus Pasteurised Milk on Bloodlipid Profil

Intervention / Treatment
-----------------
* Dietary Supplement: UHT treated milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men and women 22-50 years of age BMI 25-30 non smokers Exclusion Criteria: lactose intolerance milk allergy or other types of food allergy Intestinal, abdominal or endocrinnologic diseases daily use of dietary supplements incl. vitamins and minerals cronic diseases (diabetes, CVD etc.) user of medicin on perscription that can influence the resuts of the study allergic to paraamino benzoe acid Physical activity > 10 h pr week Blood donor on a diet or change of dietary habits within 3 months body weigh change > 3 kg within the last 3 month special diets concomitant participation on other studies not able to comply with protocol

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UHT treated milk<br>1,5 L of 1,5% UHT milk pr day for 3 weeks (21days) | Dietary Supplement: UHT treated milk<br> <br> |
| Placebo Comparator: Paseurised milk<br>1,5 L 1,5% pasteurised milk pr day for 3 weeks (21 days) | Dietary Supplement: UHT treated milk<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipids |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
crossover, UHT milk, Pasteurised milk, supplement
Retinal Sensitivity in BRVO After Anti-VEGF Therapy

Study Overview
=================
Brief Summary
-----------------
The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully investigated. The purpose of this study is to compare the changes in retinal sensitivity after ranibizumab therapy or combination therapy of ranibizumab and laser photocoagulation in eyes with BRVO.

Official Title
-----------------
Retinal Sensitivity in Branch Retinal Vein Occlusion After Anti-VEGF Therapy

Conditions
-----------------
Branch Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: Ranibizumab
* Drug: Ranibizumab and laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment naive patients of branch retinal vein occlusion with visual acuity of less than 1.0 and macular edema of more than 250 micrometers in foveal thickness. Exclusion Criteria: Patients with history of treatment for branch retinal vein occlusion, possibility of pregnancy, allergy for ranibizumab, intraocular infection, or severe inflammation will be excluded.

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 |
| --- | --- |
| Active Comparator: Ranibizumab<br>After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. | Drug: Ranibizumab<br> <br> |
| Active Comparator: Ranibizumab and laser<br>After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. Macular laser photocoagulation will be performed when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. | Drug: Ranibizumab and laser<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan) |  | At 12 months |
Efficacy and Safety of Moxonidine in Indian Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate efficacy and safety of Moxonidine in Indian subjects.

Official Title
-----------------
Open Label, Multi-Center, Force-Titration Study to Evaluate the Efficacy and Safety of Moxonidine in Ambulatory Subjects With Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Moxonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension Exclusion Criteria: Severe concomitant diseases, CHF, secondary hypertension, severe hypertension, significant hepatic disease, unstable angina

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure reduction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Piggy-back pharmacoeconomic evaluation; Safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Efficacy and safety of moxonidine in Indian hypertensives