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At least 163 records · Page 9Linked to original sources
PubMedDate not supplied

Thallium-201: what do we gain from new clinical protocols and acquisition procedures? The Italian Study on Thallium Reinjection/SIRT).

Nine medical centers, equipped with the same gamma camera and computer software, participated in this multicenter study on thallium-201 reinjection imaging. Preliminary findings for the first 143 patients with ischemic heart disease and perfusion defects at stress imaging are reported. Eighty-eight patients were reinjected at rest after conventional stress-redistribution imaging. Another 55 patients were reinjected at rest on a separate day. After segmental comparison of conventional redistribution versus stress imaging, differences > 1 in the segmental scores on a reduced 3 point scale identified 58 patients with irreversible or mainly irreversible defects (dominant scar pattern) and 85 patients with reversible or mainly reversible defects (dominant ischemic pattern). When reinjection was compared to stress images, 24 patients out of 58 with a dominant scar pattern at the conventional analysis were then assigned to the group with a dominant ischemic pattern. No clinical variables or exercise stress data were found to be significantly different in this patient subgroup. Only 4 out of 85 patients with a dominant ischemic pattern were reassigned to a dominant scar pattern after reinjection scoring. These preliminary results of the SIRT study confirm the consistent problem of scar overestimation by conventional stress-redistribution imaging and the clinical value of the thallium-201 reinjection procedure for differentiating viable from necrotic myocardium.

Cell Survival↗
PubMedDate not supplied

Clinical protocol: Phase I trial to evaluate the safety of H5.020CMV.PDGF-B for the treatment of a diabetic insensate foot ulcer.

Most patients with chronic wounds fail to heal in a reasonable period of time. Despite considerable advances in elucidating the molecular basis of wound repair, attempts at developing new therapies have been disappointing. In fact, in the few studies where cytokine growth factors have been efficacious, their effect has been dramatically less than would have been predicted from animal studies. We hypothesize that platelet-derived growth factor-BB, a growth factor associated with wound healing, when produced in large quantities within the wound bed due to adenovirus mediated gene overexpression by the cells of the wound bed will dramatically enhance wound healing. Simply stated, we plan to insure the delivery of the growth factor by using gene therapy techniques so that cells locally involved in the wound healing process will temporarily increase their production of platelet-derived growth factor-BB. We present the first step in the series of human investigations to test this hypothesis which is a phase I clinical trial. Our proposed study is designed to assess local and systemic toxicity, and the feasibility of using the maximum tolerated dose of H5.020CMV.PDGF-b associated with in vivo platelet-derived growth factor-BB gene transduction via an intraulcer injection of H5.020CMV.PDGF-b in patients with a diabetic insensate foot ulcer.

Animals↗
PubMed1991

99Tcm-exametazime-labelled leucocytes: effect of volume and concentration of exametazime on labelling efficiency, and clinical protocol for high efficiency multi-dose radiolabelling.

We have investigated the effect of volume and concentration of exametazime on the labelling efficiency of 99Tcm-exametazime-labelled leucocytes. The first study examined the effect of varying the volume of exametazine solution whilst the concentration remained constant. A vial of Ceretec (Amersham Ltd plc) was reconstituted with sodium chloride injection BP. Aliquots of 0.25-2.0 ml were removed, added to sodium pertechnetate injection BP and incubated with 2 x 10(7)-5 x 10(7) leucocytes from 25 ml blood. The labelling efficiency decreased from 65 +/- 10% S.D. (0.25 ml) to 45 +/- 8% (2.0 ml) (n = 4). In a second study different concentrations of exametazime solution were used whilst the volume remained constant. A vial of Ceretec was reconstituted with sodium chloride injection BP. Aliquots of 25-200 micrograms were removed, made up to a fixed volume of 0.6 ml, added to pertechnetate and incubated with the plug of leucocytes as before. The labelling efficiency decreased as the concentration of ligand decreased. Thus for 200 micrograms/0.6 ml the labelling efficiency was 64 +/- 5% and for 25 micrograms/0.6 ml the labelling efficiency was 43 +/- 18% (n = 4). Clinical studies were performed using 50 ml blood from patients with a wide range of inflammatory disorders including inflammatory bowel disease, abdominal abscess and vasculitis. The concentration of ligand used was 83 micrograms/0.25 ml. The labelling efficiency was found to be 82 +/- 7% (n = 36).

Butanones↗
PubMed2006

Clinical protocol for angiogenesis by intramyocardial injection of autologous bone marrow mononuclear cells in patients with severe coronary artery disease: TACT-NAGOYA-HEART.

BACKGROUND: Despite recent improvements in the treatments of coronary artery disease (CAD), there are a considerable number of patients who can not receive complete revascularization because of severe or total arterial occlusion. Intramyocardial injection of autologous bone marrow mononuclear cells (ABMMCs) has been shown to induce neovascularization of ischemic myocardium. METHODS AND RESULTS: The study will investigate the safety and feasibility of intramyocardial injections of ABMMCs and test the hypothesis that this treatment would promote neovascularization and improve left ventricular (LV) global and/or regional function in patients with severe CAD who have no other option. ABMMCs (approximately 10(6) cells) will be injected into the area of ischemic myocardium where the coronary artery is not graftable, in combination with bypass surgery to the other coronary branches. Myocardial perfusion and LV global and regional function will be evaluated, based on the micromanometer-tipped catheter method, single-photon emission tomography, and myocardial enhanced and color tissue Doppler echocardiography at baseline and during 12 month follow-up. CONCLUSIONS: This project will demonstrate that intramyocardial injection of ABMMCs with or without coronary artery bypass surgery could be a safe and effective method for therapeutic neovascularization, resulting in an improvement of cardiac function in patients with severe CAD.

Bone Marrow Cells↗
PubMed2001

Clinical protocol. An open-label, phase I, single administration, dose-escalation study of ADGVPEDF.11D (ADPEDF) in neovascular age-related macular degeneration (AMD).

Age-Related Macular Degeneration (AMD) is, together with Diabetic Retinopathy, the most common cause of vision loss among adults in the U.S. and other developed countries. In the U.S., at least 1.7 million people have impaired vision due to AMD. Every year, more than 165,000 people contract AMD and 16,000 go blind from it, predominantly from a rapidly progressing form of the disease called "wet" AMD. Wet AMD is characterized by serious or hemorrhagic detachment of the retinal pigment epithelium and choroidal neovascularization. The macula has the highest concentration of photoreceptors facilitating central vision and permitting high-resolution visual acuity. The damage caused by the leakage and fibrovascular scarring in wet AMD leads to profound loss of central vision and severe loss of visual acuity (usually 20/200 or worse). People with wet AMD have several limitations, including inability to read, inability to recognize faces or drive, and the disease often leads to blindness. The onset of severe visual changes in wet AMD can occur suddenly. More than 400,000 Americans are currently affected by this form of the disease, and the incidence is rising rapidly with the aging of the population. Therefore, the serious consequences of this disease along with the limited treatment options and their effectiveness make this a very good candidate for a gene transfer treatment approach. The investigational agent, Ad(GV)PEDF.11D, is an E1-, partial E3-, E4- deleted replication-deficient, adenovirus serotype 5, gene transfer vector. The transgene in this vector is the cDNA for human pigment epithelium-derived factor (PEDF). PEDF is one of the most potent known antiangiogenic proteins found in humans. While Ad(GV)PEDF.11D is able to transduce many somatic cell types, the natural barrier to other tissues created by the retina limits the ability of Ad(GV)PEDF.11D to affect tissues other than in the eye. Intravitreal administration of Ad(GV)PEDF.11D provides a convenient means of delivering PEDF to the relevant cells within the eye likely to result in a more prolonged duration of effect versus administration of the PEDF protein alone. In three murine disease models (the laser-induced choroidal neovascularization model, the VEGF transgenic model, and the retinopathy of prematurity model) significant inhibition of neovascularization (up to 85%) was demonstrated with doses of Ad(GV)PEDF vectors ranging from 1 x 10(8) to 1 x 10(9) pu. In toxicology studies performed in Cynomolgus monkeys, a dose-related inflammatory response was observed. A dose of 1 x 10(8) pu caused no adverse effects, while the inflammatory response observed at 1 x 10(9) pu was minimal and fully reversible. The observed inflammatory response at doses of 1 x 10(10) and 5 x 10(10) pu were increasingly severe. The proposed clinical trial is an open-label, dose-escalation, phase I study to investigate the safety, tolerability and potential activity of intravitreal injection of Ad(GV)PEDF.11D in patients with wet AMD. Ad(GV)PEDF.11D will be injected once via intravitreal injection into the eye with the most advanced AMD based on visual acuity. Subjects will be age 50 or over and have severe wet AMD in at least one eye defined by a best-corrected vision of 20/200 or worse. The primary objectives of this investigation are: (1) to assess the safety, tolerability and feasibility of intravitreal injection of Ad(GV)PEDF.11D in patients with severe, neovascular AMD, (2) to identify the maximum tolerated dose (MTD) of Ad(GV)PEDF.11D, and (3) to get some indication of potential activity of Ad(GV)PEDF.11D.

Adenoviridae↗
PubMed1996

Antitumor electrochemotherapy: new advances in the clinical protocol.

BACKGROUND: Electrochemotherapy (ECT) is a new antitumor approach that combines systemic bleomycin (BLM) with electric pulses (EP) delivered locally at the tumor site. These EP permeabilize the cells in the tissue, allow BLM delivery inside the cells, and increase BLM cytotoxicity. As an extension of our initial Phase I trial on patients with head and neck squamous cell carcinoma (HNSCC) permeation nodules, we tested variations of ECT protocol to determine how to improve it. METHODS: Seven patients with multiple and/or large permeation nodules of HNSCC or of salivary or breast adenocarcinoma were treated in 10 sessions. They received BLM followed by runs of four or eight short (100 microseconds) and intense (1000 or 1300 V/cm-1) EP delivered at adjacent positions on the nodules to cover all of the tumor surface. RESULTS: We determined the therapeutic window for EP delivery to be between 8 and 28 minutes after BLM intravenous injection. We showed patient tolerance to a high number of EP, along with ECT feasibility after BLM intraarterial injection or on adenocarcinoma nodules. Clear antitumor effects were obtained, especially in the small nodules. In the largest nodules we observed extended tumor necrosis. CONCLUSIONS: Relatively efficient ECT can be performed for large and think nodules, and ECT remains safe even when a large number of EP are delivered. However, in this study, ECT's effectiveness on large nodules was lower than on the previously treated small nodules, probably due to external electrodes inadequacy. The data reported stimulated us to design a new device for EP delivery.

Adult↗
PubMed2001

Clinical protocol. A phase IIb, randomized, multicenter, double-blind study of the efficacy and safety of Trinam (EG004) in stenosis prevention at the graft-vein anastomosis site in dialysis patients.

Hemodialysis access complications remain a major cause of morbidity for patients with end-stage renal disease who are undergoing chronic hemodialysis. Vascular access complications occur in approximately 40% of patients with polytetrafluorethylene (PTFE) grafts within the first 6 months, primarily due to stenosis and thrombosis. Thrombosis at the site of vascular access increases the risk of infection and the need for hospitalization, and may lead to loss of potential new sites for vascular access. To a large extent, the failure of hemodialysis access is due to the rapid development of an intimal hyperplastic lesion in the region of anastomosis between the PTFE graft and the vein. The hospital costs related to hemodialysis access procedures are estimated to be around $1.3 billion per year and the total cost of hemodialysis complications to the US healthcare system is thought to be in excess of $2 billion per year. Ark Therapeutics Ltd. are developing a vascular endothelial growth factor D (VEGF-D) gene in an adenoviral vector which is delivered locally to the adventitial surface of a graft-vein anastomosis by means of a collagen collar device. The proposed indication for this product (Trinam) is the prevention of intimal hyperplasia at the graft-vein anastomosis site in patients who require vascular access to facilitate hemodialysis for end-stage renal disease. The rationale for Trinam to prevent intimal hyperplasia at the graft-vein anastomosis follows the discovery that VEGF has a 'vasculoprotective' action, resulting in inhibition of smooth muscle cell migration and proliferation. The fundamental mechanism for this vasculoprotective effect of VEGF, as distinct from its more widely appreciated 'angiogenic' role, is that VEGF acts on surface receptors on endothelial cells resulting in increased production of nitric oxide and prostacyclin. These entities diffuse into the media of the blood vessel wall and counter the tendency for intimal hyperplasia to develop. In an in vivo rabbit model of intimal thickening in carotid arteries, adventitial delivery of VEGF using a silastic collar as a gene delivery reservoir prevented smooth muscle cell proliferation without evidence of new blood vessel formation, indicating that the mechanism by which VEGF inhibited intimal hyperplasia did not involve angiogenesis. The objective of the proposed study is to assess the efficacy and safety of local delivery of Trinam when applied to the graft-vein anastomosis site in patients with end-stage renal disease who require vascular access for hemodialysis. At the time of surgical placement of a PTFE arm graft, patients will be randomized to either a single administration of Trinam or to 'no treatment' (i.e., control group). It is hypothesised that Trinam administration will result in less stenosis at the graft-vein anastomosis site (as measured by fistulography) compared with controls and therefore will reduce the need for interventions in dialysis patients. Approximately 210 patients will be enrolled from 10-15 centers and patients will be evaluated for efficacy and safety over 6 months. The total dose of Trinam will be 1 x 10(11) viral particles (replication-deficient adenoviral vector). This dose of Trinam was not associated with any significant toxicology findings in a preclinical study of pigs in which a PTFE loop-graft was anastomosed from the carotid artery to the internal jugular vein to mimic hemodialysis vascular access surgery.

Adenoviridae↗
PubMedDate not supplied

Preventing abuse during pregnancy: a clinical protocol.

Routine screening for abuse with appropriate intervention during pregnancy is essential to interrupt the cycle of violence and prevent future trauma. Over a decade ago, the Surgeon General called for routine abuse assessment of pregnant women (10). If women are not assessed for abuse, violence will remain undetected and untreated, placing women at risk for escalating abuse and further trauma. Additionally, if follow-up interventions are not implemented once abuse has been confirmed, the cycle of violence will continue. Routine assessment and expanded intervention strategies that includes case management and multi-agency collaboration must become standard care for all pregnant women.

Confidentiality↗
PubMedDate not supplied

Use of 35 words for evaluation of hearing loss in signal-to-babble ratio: A clinic protocol.

Data from earlier studies that presented 70 words at 24 to 0 dB signal-to-babble (S/B) ratios indicated that most young listeners with normal hearing required 0 to 6 dB S/B ratios to attain 50% correct word recognition. Older listeners with hearing loss often required a >12 dB S/B ratio to attain 50% correct word recognition. In our study, we converted the Words in Noise test from one 70-word list into two 35-word lists for quicker administration by clinicians. Using baseline data from previous studies, we used two strategies to randomize the 35-word lists: based on recognition performance at each S/B ratio and based on recognition performance only. With the first randomization strategy, the 50% correct word-recognition points on the two lists differed by 0.5 dB for 72 listeners with hearing loss. With the second randomization strategy, 48 listeners with hearing loss performed identically on the two lists.

Adult↗