1. Articles in category: Clinical Trials

    1-24 of 312 1 2 3 4 ... 11 12 13 »
    1. Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia

      Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia

      Patients with Barrett's Esophagus (BE) undergoing endoscopic therapy through our Barrett's Esophagus Unit will be approached for study enrollment. Patients with no endoscopic evidence of BE will be considered for the study. Surveillance biopsies will be obtained per standard clinical protocol and reviewed to confirm absence of intestinal metaplasia. Patients who have achieved complete eradication of intestinal metaplasia (CRIM) will be enrolled in the study and will undergo the Nvision® Imaging System (VLE). Patients enrolled in the study will undergo clinical follow-up consisting of surveillance endoscopy every 3 months for 1 year. Surveillance endoscopy intervals may be prolonged ...

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    2. Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using Optical Coherence Tomography(OCT)[LINK It Two]

      Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using Optical Coherence Tomography(OCT)[LINK It Two]

      Eicosapentaenoic acid and statin therapy prevents cardiovascular events. However, the impact of these treatment in patients with in-stent neoatherosclerosis has not been clarified. So, the investigators conducted LINK IT study. This study showed that eicosapentaenoic acid(EPA) and rosuvastatin therapy improve lipid index in patients compared with rosuvastatin alone therapy. However, it was insufficient to directly evaluate the efficacy of additional effect of EPA for neoatherosclerosis. Because, statin dose of two groups was different and type of stent was variety. Therefore, the investigators designed a new prospective, randomized OCT study. The OCT operators randomly assigned 75 patients who were detected ...

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    3. Impact of Real-time Angiographic Co-registered OCT on PCI Results - the OPTICO-integration II Study

      Impact of Real-time Angiographic Co-registered OCT on PCI Results - the OPTICO-integration II Study

      Intracoronary optical coherence tomography (OCT) imaging allows for high-resolution characterization of coronary lesions. Difficulties in matching cross-sectional OCT-images with angiographic lesion localization, however, may limit its clinical utilization. The investigators sought to prospectively assess the impact of a novel system of real-time OCT-coregistration with angiography (ACR) compared to OCT alone and to the clinical standard proceeding (angiographic guided-PCI) all used for coronary lesion evaluation before percutaneous coronary interventions (PCI). The investigators hypothesize that the use of ACR will lead to less incidence of insufficient covered coronary lesions (geographical mismatch) and/or a less rate of edge dissections after PCI (combined ...

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    4. Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

      Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

      The purpose of this study is to develop a novel noninvasive bedside optical coherence tomography (OCT) imaging technique in newborn infants with HIE that improves our ability to assess the range of retinal effects from HIE and to diagnose and monitor treatments of HIE

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    5. Detecting Dementia in the Retina

      Detecting Dementia in the Retina

      This retrospective case control explores the retinal features of dementia associated with neurodegenerative diseases, particularly Alzheimer's disease. By linking a pseudonymised dataset of three-dimensional retinal scans, called optical coherence tomography , with nationally held data on dementia, corresponding characteristics will be evaluated through descriptive statistics and machine learning techniques.

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    6. Effect of a Basic Skin Care Product on the Structural Strength of the Skin

      Effect of a Basic Skin Care Product on the Structural Strength of the Skin

      The process of aging involves numerous structural and functional changes also affecting the skin. The skin fulfills a variety of protective and regulatory functions. Compared to other organs, the skin is constantly exposed to harmful environmental influences. Besides intrinsic factors these external factors may accelerate skin aging. Due to its ageing-related loss of functional capacity the skin becomes susceptible to develop adverse skin conditions and dermatological diseases (e.g. skin dryness, fungal infections). Especially old aged, care depended, and severely ill individuals are at high risk for developing severe skin injuries and wounds (e.g. decubitus, skin tears) with high ...

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    7. Optical Coherence Tomography-guided Coronary Intervention and Optimal Use of Dual Anti-Platelet Therapy In Patients With Complex Lesions (OCCUPI Trial)

      Optical Coherence Tomography-guided Coronary Intervention and Optimal Use of Dual Anti-Platelet Therapy In Patients With Complex Lesions (OCCUPI Trial)

      There is no definite conclusive work about optimal duration of DAPT after PCI of complex lesions, which have been left at each operator's discretion. It is needed to be investigated how optimal duration of dual antiplatelet therapy will be decided in complex lesions. Also, the benefit of OCT-guided PCI assuming better stent optimization should be determined in complex PCI. In the study, we will explore the clinical implication of OCT-guided PCI of complex lesions. Optimal duration of DAPT after PCI of complex lesions with or without OCT-guidance will be also investigated.

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    8. PET-MR Imaging of Coronary Atherothrombosis

      PET-MR Imaging of Coronary Atherothrombosis

      Heart attacks remain a common cause of death in the United Kingdom and throughout the world. The most common initiating event is the formation of a blood clot (thrombus) within the coronary arteries occluding blood supply to the heart. However, we know that thrombus often occurs within the coronary arteries without causing any symptoms, and may be found in patients with stable angina. We wish to investigate whether thrombus within the coronary arteries can be detected in patients who have had a heart attack and in patients with stable angina using combined positron emission tomography and magnetic resonance (PET-MR) imaging ...

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    9. A First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

      A First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

      The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System(IBS). The main purpose of this study is to evaluate the feasibility, preliminary safety and efficacy of IBS. To provide the basis for subsequent large-scale, multi-center, randomized controlled clinical trials of IBS.

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    10. Adalimumab Microneedles in Healthy Volunteers

      Adalimumab Microneedles in Healthy Volunteers

      Adalimumab (Humira, AbbVie) is a highly effective treatment for a variety of auto-immune/auto-inflammatory diseases including juvenile idiopathic arthritis (JIA). Adalimumab works by binding to tumor necrosis factor alpha (TNF), hereby preventing its interaction with the TNF receptor. In the presence of complement, adalimumab can also lyse TNF-expressing cells. Adalimumab is administered via subcutaneous injection, which has the major drawback of being perceived as unpleasant and painful, especially during long term use for both adults and children. As subcutaneous administration may therefore eventually jeopardize treatment adherence, there is a clear need for less invasive alternatives to administer highly effective biological ...

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    11. Optical Coherence Tomography Examination in Myocardial Infarction

      Optical Coherence Tomography Examination in Myocardial Infarction

      Acute myocardial infarction (AMI), which results from coronary artery occlusion due to thrombosis, remains the leading cause of death and disability worldwide. Pathological studies have demonstrated that plaque rupture accompanied by subsequent thrombus formation is the main mechanism responsible for AMI, accounting for approximately two thirds of cases; the remaining approximately one third of cases are the result of plaque erosion. Moreover, previous studies showed that the risk of cardiovascular events is significantly higher in patients with plaque rupture compared to those with plaque erosion. The EROSION study suggested that in patients with acute coronary syndrome presenting with plaque erosion ...

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    12. Semi-manual Vessel Density Analysis on Optical Coherence Tomography Angiography Images of Healthy Adults

      Semi-manual Vessel Density Analysis on Optical Coherence Tomography Angiography Images of Healthy Adults

      Optical coherence tomography angiography (OCTA) is a software upgrade on conventional spectral-domain or swept-source optical coherence tomography devices that enables non-invasive, dye-free, three dimensional analysis of the retinal vessels. Vessel density is a very important parameter almost in all retinal disorders. In the recent past, automated quantification software was built into some OCTA devices which can automatically calculate the retinal vessel density as well. In this study two semi-manual techniques are used in order to analyze the vessel density of healthy subjects' OCTA images. Vessel density is also measured with a new automated quantification program, and results of the three ...

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    13. Optical Coherence Tomography Compared With Intravascular Ultrasound to Guide High-speed Rotational Before Stent Implantation in the Treatment of Moderate-to-severe Calcified Lesion in Coronary Artery

      Optical Coherence Tomography Compared With Intravascular Ultrasound to Guide High-speed Rotational Before Stent Implantation in the Treatment of Moderate-to-severe Calcified Lesion in Coronary Artery

      This study is a prospective, multi-center, randomized controlled clinical trial, aims to assess the safety and effectiveness of Optical Coherence Tomography or Intravascular Ultrasound to guide high-speed rotational before Firehawk stent implantation , and compared with angiography guided stent implantation in the treatment of moderate-to-severe calcified lesion in coronary artery.

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    14. Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery

      Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery

      Brief Summary: The purpose of this study is to investigate how pretreatment with a topical medication for acne affects application and delivery of gold microparticles to the skin in acne patients. In addition, the investigators want to investigate the biodistribution of gold microparticles in pretreated skin and compare this with the biodistribution of untreated skin using the non-invasive imaging techniques optical coherence tomography and reflectance confocal microscopy. Reflectance Confocal Microscopy (RCM) and Optical Coherence Tomography (OCT) are non-invasive imaging technologies allowing for imaging of the upper skin layers. Gold microparticles have been shown to have a contrast effect on the ...

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    15. OCT Measures Predicting FFR

      OCT Measures Predicting FFR

      Background: the decision-making process of patients with angiographically-intermediate coronary lesions (ICL) is clinically challenging and may benefit from adjunctive invasive techniques. Fractional-flow-reserve (FFR) represents the gold standard to evaluate ICL but optical-coherence-tomography (OCT) is a novel, promising, high resolution coronary imaging technique. Objectives: Investigate the relation between OCT and FFR parameters in ICL and understand if OCT measures may predict FFR. Understand if OCT parameters may predict clinical outcome of patients with ICL not underwent revascularization on the bases of negative FFR. Study design: multicentre, international, individual patient's level data pooled analysis.

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    16. Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)

      Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)

      With regard to the characteristics of spasm segment, had been clearly described by other invasive imaging methods including intravascular ultrasound and optical coherence tomography . However, there is potential risk during these invasive procedures, such as severe myocardial ischemia or fatal arrhythmia. Presently available imaging test for coronary artery disease in multi detector-row computed tomography angiography (MDCTA) evaluation has high diagnostic accuracy to evaluate coronary artery stenosis. However, previous report assessing imaging findings or diagnostic accuracy of MDCTA in patients with vasospastic angina (VSA) is lacking.

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    17. Imaging of Coronary Plaques in Subjects Treated With Evolocumab

      Imaging of Coronary Plaques in Subjects Treated With Evolocumab

      This study seeks to identify morphologic changes, such as increase in fibrous cap thickness (FCT), in atherosclerotic plaques associated with treatment with evolocumab and maximally tolerated statin therapy with or without additional lipid-modifying medication in patients presenting with non-ST-segment elevation (NSTE)-ACS using optical coherence tomography (OCT;primary, secondary, and exploratory endpoints) and intravascular ultrasound (IVUS; exploratory endpoints only)

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    18. Study on STEMI Reperfusion Strategy Based on the Characterization of Criminal Lesions Stability

      Study on STEMI Reperfusion Strategy Based on the Characterization of Criminal Lesions Stability

      A randomized controlled study of whether stent implantation in STEMI patients with ≤70% coronary stenosis was designed. A total of 240 STEMI patients with coronary artery diameter stenosis ≤ 70% were randomly assigned to either an OCT-guided group or an angiography-guided group. OCT guidance group: Stent implantation or drug therapy is determined based on the stability of the culprit lesions by the OCT. Angiographic guide group: According to the results of coronary angiography, stent implantation or drug treatment was determined. Comparing two groups the implantation rate, the incidence of HF within one year, the incidence of MACE, and the safety end ...

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    19. Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate

      Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate

      Brief Summary: A prospective clinical, uncontrolled, open-label, explorative phase 2a trial on patients with histologically-confirmed superficial and nodular basal cell carcinoma (BCC). The study assesses tolerability and tumor clearance after laser-assisted topical delivery of topical ingenol mebutate. Detailed Description: Patients will receive ablative fractional laser (AFXl)-assisted ingenol mebutate (IM) as a treatment for their cutaneous basal cell carcinoma (BCC). Treatment areas consisting of tumors and a 5 mm margin will undergo AFXl exposure (CO2 laser) followed by IM 0.015% or 0.05% under occlusion for 2-3 days. . local skin reactions are monitored at baseline (day1), day 3/4 ...

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    20. Leveraging WeChat Social-Media and Messaging Platform to Increase Physical Activity in Chinese Glaucoma Patients

      Leveraging WeChat Social-Media and Messaging Platform to Increase Physical Activity in Chinese Glaucoma Patients

      The positive effects of exercise on ocular health are known, but modern lifestyles have made it difficult to incorporate physical activity into the daily lives of the Chinese population. Recent studies suggest that exercise plays an important role in lowering intraocular pressure (IOP) by protecting retinal ganglion cells (RGCs) in glaucoma patients as well as other potential neuroprotective benefits. Increasing the amount of physical activity within the Chinese glaucoma population may have marked effects on health outcomes and coincides with the Chinese government's efforts to make exercise an urgent public health priority. There is a need for innovative, cost-effective ...

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    21. The EXPLORE Study - The Use of Binocular OCT Imaging for the Assessment of Ocular Disease

      The EXPLORE Study - The Use of Binocular OCT Imaging for the Assessment of Ocular Disease

      Optical coherence tomography (OCT) is an imaging modality, first described in 1991, that provides cross-sectional images of the eye in a non-invasive manner. OCT is analogous to ultrasonography but measures the "echoes" of light waves rather than sound and, as a result, generates extremely high-resolution images (~5 μm axial resolution). Although OCT has already proven revolutionary in ophthalmology, current OCT systems are large, expensive, and require skilled personnel for image acquisition and interpretation. Furthermore, current OCT systems are limited to examination of specific regions of single eyes - for example, separate devices are typically required for anterior segment (e.g., cornea ...

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      Mentions: Pearse A. Keane
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