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Pilot Clinical Trial (pilot + clinical_trial)
Selected AbstractsRemote Monitoring of Implantable Cardioverter Defibrillators versus Quarterly Device Interrogations in Clinic: Results from a Randomized Pilot Clinical TrialJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 5 2010M.H.S., SANA M. AL-KHATIB M.D. ICD: Remote Monitoring Versus Clinic Interrogations.,Introduction: Remote monitoring is increasingly becoming the new standard of care for implantable cardioverter defibrillator (ICD) follow-up. We sought to determine whether remote monitoring of ICDs improves patient outcomes compared with quarterly device interrogations in clinic. Methods and Results: In this single-center pilot clinical trial, adult patients with an ICD were randomly assigned to remote monitoring versus quarterly device interrogations in clinic. The primary endpoint was a composite of cardiovascular hospitalization, emergency room visit for a cardiac cause, and unscheduled visit to the electrophysiology clinic for a device-related issue at 1 year. We also examined health-related quality of life, costs, and patient satisfaction with their ICD care. Of 151 patients enrolled in this trial, 76 were randomized to remote monitoring and 75 to quarterly device interrogations in clinic. There was no significant difference in the primary endpoint (32% in the remote monitoring arm vs 34% in the control arm; P = 0.8), mortality, or cost between the 2 arms. Quality of life and patient satisfaction were significantly better in the control arm than in the remote monitoring arm at 6 months (83 [25th, 75th percentiles 70, 90] vs 75 [50, 85]; P = 0.002 and 88 [75, 100] vs 75 [75, 88]; P = 0.03, respectively), but not at 12 months. Conclusion: We showed no significant reduction in cardiac-related resource utilization with remote monitoring of ICDs. However, given the small number of patients in our study, the real clinical and health economics impact of remote monitoring needs to be verified by a large, multicenter, randomized clinical trial. (J Cardiovasc Electrophysiol, Vol. 21, pp. 545-550, May 2010) [source] Anti-gingivitis effect of a dentifrice containing bioactive glass (NovaMin®) particulateJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 2 2006Bao Jun Tai Abstract Background: The objective of this pilot clinical trial was to evaluate the anti-gingivitis and anti-plaque effects of a dentifrice containing bioactive glass (NovaMin®) compared with a placebo control dentifrice in a 6 weeks clinical study. Methods: The study design was a randomized, double-blinded, controlled clinical trial. One hundred volunteers took part in the study and were matched for plaque index (PLI), gingival bleeding index (GBI), age and gender. The protocol was reviewed and approved by the Ethical Committee of the University. The subjects received a supragingival prophylaxis to remove all plaque, calculus and extrinsic stain. Following the baseline examination, subjects were instructed to brush with their assigned dentifrice and toothbrush. The PLI and GBI were determined for the baseline and 6 weeks. The data were analysed using a repeated-measures anova conducted on the two dependent measures to compare the effect between the test and control group. Results: Ninety-five subjects finished the study. The results showed that the PLI (baseline=1.54, 6 weeks=1.29) and GBI (baseline=1.14, 6 weeks=0.47) were significantly reduced, respectively, over the 6 weeks period in the test group (p<0.001 for each measure). There was a 58.8% reduction in gingival bleeding and a 16.4% reduction in plaque growth. There was no difference of the PLI (baseline=1.60, 6 weeks=1.57) and GBI (baseline=1.18, 6-week=1.02) over the 6 week period in the control group. Conclusion: This study demonstrated that a dentifrice containing NovaMin® significantly improves oral health as measured by a reduction in gingival bleeding and reduction in supragingival plaque compared with a negative dentifrice over the 6 weeks study period. [source] Treatment of Helicobacter pylori infection with intra-gastric violet light phototherapy: A pilot clinical trial,LASERS IN SURGERY AND MEDICINE, Issue 5 2009Anthony J. Lembo MD Abstract Background and Objective Helicobacter pylori infects the mucus layer of the human stomach and causes peptic ulcers and adenocarcinoma. We have previously shown that H. pylori accumulates photoactive porphyrins making the organism susceptible to inactivation by light, and that small spot endoscopic illumination with violet light reduced bacterial load in human stomachs. This study assessed the feasibility and safety of whole-stomach intra-gastric violet phototherapy for the treatment of H. pylori infection. Study Design/Materials and Methods A controlled, prospective pilot trial was conducted using a novel light source consisting of laser diodes and diffusing fibers to deliver 408-nm illumination at escalating total fluences to the whole stomach. Eighteen adults (10 female) with H. pylori infection were treated at three U.S. academic endoscopy centers. Quantitative bacterial counts were obtained from biopsies taken from the antrum, body, and fundus, and serial urea breath tests. Results The largest reduction in bacterial load was in the antrum (>97%), followed by body (>95%) and fundus (>86%). There was a correlation between log reduction and initial bacterial load in the antrum. There was no dose,response seen with increasing illumination times. The urea breath test results indicated that the bacteria repopulated in days following illumination. Conclusion Intra-gastric violet light phototherapy is feasible and safe and may represent a novel approach to eradication of H. pylori, particularly in patients who have failed standard antibiotic treatment. This was a pilot study involving a small number of patients. Further research is needed to determine if phototherapy can be effective for eradicating H. pylori. Lasers Surg. Med. 41:337,344, 2009. © 2009 Wiley-Liss, Inc. [source] Clinical outcomes and graft characteristics in pediatric matched sibling donor transplants using granulocyte colony-stimulating factor-primed bone marrow and steady-state bone marrowPEDIATRIC TRANSPLANTATION, Issue 3 2007Kuang-Yueh Chiang Abstract:, Matched sibling donor (MSD) transplant is a life-saving procedure for children with various hematological malignancies and non-malignancies. Traditionally, steady-state bone marrow (S-BM) has been used as the source of stem cells. More recently, peripheral blood stem cell (PBSC) after granulocyte-colony stimulating factor (G-CSF) mobilization has gained popularity. Adult studies of G-CSF-primed BM (G-BM) have shown that it produces rapid white blood cell engraftment like PBSC, but with less chronic graft-vs.-host disease. No such study has been published in pediatric patients. We conducted a pilot clinical trial of G-BM for pediatric patients. Ten patients were enrolled and were compared to a contemporaneous group of 12 patients who received S-BM. Patients in the G-BM group received a higher dose of total nucleated cells/kg (7.01 vs. 3.76 × 108, p = 0.0009), higher granulocyte,macrophage colony-forming units (CFU-GM)/kg (7.19 vs. 3.53 × 105, p = 0.01) and had shorter inpatient length of stay (28 vs. 40 days, p = 0.04). The engraftment, transfusion requirement and disease-free survival between the two groups were similar. We concluded that G-BM should be considered as an alternative graft source to S-BM, with the benefits of larger graft cell dose, higher CFU-GM dose and shorter length of stay. [source] A phase I clinical trial of interferon-beta gene therapy for high-grade glioma: novel findings from gene expression profiling and autopsyTHE JOURNAL OF GENE MEDICINE, Issue 4 2008Toshihiko Wakabayashi Background High-grade gliomas are highly lethal neoplasms representing approximately 20% of all intracranial tumors. Cationic liposome-mediated interferon-beta (IFN- ,) gene transfer has been found to induce regression of experimental glioma. We have previously performed a pilot clinical trial to evaluate the safety and effectiveness of this IFN- , gene therapy in five patients with high-grade glioma. Two patients showed more than 50% reduction while others had stable disease 10 weeks after treatment initiation. Methods To identify alterations in gene expression in brain tumors 2 weeks after the gene therapy trial, we used a microarray technology and Gene Ontology analysis. The results were validated by patients' clinical course and findings of histology and autopsy. Results and conclusions Using hierarchical clustering and principal component analysis, five series of gene therapy trials were classified according to the response to IFN- , gene therapy. Significant changes in gene expression related to immunoresponse and apoptosis were observed. Moreover, novel patterns of altered gene expression, such as inhibition of neovascularization, were identified, suggesting the involvement of pathways reported previously as not involved. Autopsy and histological examinations revealed dramatic changes in the tumor tissues after therapy in all patients. Many tumor cells showed necrotic changes, and immunohistochemistry identified numerous CD8-positive lymphocytes and macrophages infiltrating the tumor and surrounding tissues; these were probably the effects of therapy. Simultaneously, CD34-immunoreactive vessels were notably decreased in the vector-injected brain. This study facilitates the understanding of the antitumor mechanism and helps identify candidate target molecules for new approaches. However, additional clinical trials are warranted. Copyright © 2008 John Wiley & Sons, Ltd. [source] Genetic engineering of cytolytic T lymphocytes for adoptive T-cell therapy of neuroblastomaTHE JOURNAL OF GENE MEDICINE, Issue 6 2004Sergio Gonzalez Abstract Background Disease relapse is the leading cause of mortality for children diagnosed with disseminated neuroblastoma. The adoptive transfer of tumor-specific T cells is an attractive approach to target minimal residual disease following conventional therapies. We describe here the genetic engineering of human cytotoxic T lymphocytes (CTL) to express a chimeric immunoreceptor for re-directed HLA-independent recognition of neuroblastoma. Methods The CE7R chimeric immunoreceptor was constructed by PCR splice overlap extension and is composed of a single-chain antibody extracellular domain (scFv) derived from the L1-CAM-specific murine CE7 hybridoma fused to human IgG1 hinge-Fc, the transmembrane portion of human CD4, and the cytoplasmic tail of huCD3-, chain (scFvFc:,). Primary human T cells were genetically modified by naked DNA electrotransfer of plasmid expression vector CE7R-pMG then analyzed by Western blotting, flow cytometry for CE7R expression and cell surface trafficking, 4-h chromium release assay for re-directed neuroblastoma lysis, and ELISA for tumor-specific activation of cytokine production. Results CE7R is expressed as an intact chimeric protein that trafficks to the cell surface as a type I transmembrane protein. Primary human CE7R-expressing CD8+ CTL clones specifically recognize human neuroblastoma tumor cells and are activated for tumor cell lysis and Tc1 cytokine production. Conclusions These data demonstrate the utility of CE7R for re-directing the effector function of CTL to neuroblastoma and have provided the rationale to initiate a FDA-authorized (BB-IND#9149) pilot clinical trial to establish the feasibility and safety of adoptive transfer of autologous CE7R+CD8+ CTL clones to children with recurrent/refractory neuroblastoma. Copyright © 2004 John Wiley & Sons, Ltd. [source] lnterferon-, gene therapy for cancer: Basic research to clinical applicationCANCER SCIENCE, Issue 11 2004Jun Yoshida Interferon-, gene therapy for cancer is the first such protocol developed in Japan. Here we describe the development process of our interferon-, gene therapy from basic research to clinical application. Interestingly, the biological and biochemical characteristics of interferon-, gene therapy through transfer of the interferon-(gene into tumor cells by means of cationic liposomes differed from those of conventional interferon-, protein therapy. Interferon-, gene transfer could induce apoptosis in interferon-, protein-resistant tumor cells, such as glioma, melanoma, and renal cell carcinoma. Induction of apoptosis was related to the level of intracellular mRNA of interferon-,, prolongation of the phos-phorylation time of molecules in the interferon-p signal transduc-tion pathway, such as JAK1, Trk2, and STAT1, and activation of DNase ,. In our preclinical study we developed lyophilized cat-ionic liposomes containing interferon-, gene (gene drug) for clinical use and confirmed their safety. Thereafter, we performed a pilot clinical trial in patients with malignant glioma and confirmed the safety and effectiveness of this interferon-, gene therapy. In this review we also comment on the status of gene therapy regulation in Japan. Interferon-, gene therapy is expected to become widely available for clinical use in cancer patients, and this new strategy might be extended to molecular targeting therapy, or used in combination with cell therapy or other therapies. [source] | ||||||||||