Current Issue : October - December Volume : 2017 Issue Number : 4 Articles : 5 Articles
Background: Migraine is included in the top-ten disabling diseases and conditions among the Western\npopulations. Non-invasive neurostimulation, including the Cefaly�® device, for the treatment of various types of pain\nis a relatively new field of interest. The aim of the present study was to explore the clinical experience with Cefaly�®\nin a cohort of migraine patients previously refractory or intolerant to topiramate prophylaxis.\nMethods: A prospective, multi-center clinical study was performed in patients diagnosed with episodic or chronic\nmigraine with a previous failure to topiramate treatment requiring prevention with Cefaly�® according to the\ntreating physicianâ��s suggestion. A 1-month period of baseline observation was followed by a 3-month period of\nobservation during the use of transcutaneous supraorbital nerve stimulation (t-SNS) with Cefaly�® as the only\npreventive treatment.\nResults: A small but statistically significant decline was shown over time in the number of days with headache (HA),\nthe number of days with HA with intensity â�¥5/10, and the number of days with use of acute medication after\n3 months (p < 0.001 for all of the three changes). Twenty-three patients (65.7%) expressed their satisfaction and intent\nto continue treatment with Cefaly�®. Compliance was higher among satisfied subjects compared to non-satisfied\nsubjects. None of the explored factors were significantly associated with the reason for the failure of topiramate.\nConclusion: Three-months of preventive treatment for episodic or chronic migraine with t-SNS proved to be an\neffective, safe and well tolerated option for the treatment of patients with migraine who were intolerant or did not\nrespond to topiramate....
Background: Neoadjuvant chemoradiation is not recommended as an approach for treatment of esophageal squamous\ncell carcinoma due to its significant postoperative mortality. However, it is assumed the combination of neoadjuvant\nchemoradiation with minimally invasive esophagectomy (MIE) may reduce postoperative mortality, which can revive\npreoperative chemoradiation. No randomized controlled studies comparing neoadjuvant chemoradiation plus MIE with\nneoadjuvant chemotherapy plus MIE have been performed so far. The present trial is initiated to obtain valid information\nwhether neoadjuvant chemoradiation plus MIE yields better survival without worse postoperative morbidity and mortality\nin the treatment of locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).\nMethods/design: CMISG1701 is a multicenter, prospective, randomized, phase III clinical trial, investigating the safety and\nefficacy of neoadjuvant chemoradiation plus MIE compared with neoadjuvant chemotherapy plus MIE. Patients with\nlocally advanced resectable esophageal squamous cell carcinoma (cT3-4aN0-1M0) are eligible for the study. A total of 264\npatients are randomly assigned to neoadjuvant chemoradiation (arm A) or neoadjuvant chemotherapy (arm B) with a 1:1\nallocation ratio. The primary outcome is overall survival assessed with a minimum follow-up of 36 months. Secondary\noutcomes are progression-free survival, recurrence-free survival, postoperative pathologic stage, treatment-related\ncomplications, postoperative mortality as well as quality of life.\nDiscussion: The objective of this trial is to identify the superior protocol with regard to patient survival, treatment\nmorbidity/mortality and quality of life between neoadjuvant chemoradiation plus MIE and neoadjuvant chemotherapy\nplus MIE....
Background: Allogeneic hematopoietic stem cell transplantation (HSCT), the most widely used potentially curable\ncellular immunotherapeutic approach in the treatment of hematological malignancies, is limited by life-threatening\ncomplications: graft versus host disease (GVHD) and infections especially viral infections refractory to antiviral drugs.\nAdoptive transfer of virus-specific T cells is becoming an alternative treatment for infections following HSCT. We\nreport here the results of a phase I/II multicenter study which includes a series of adenovirus-specific T cell\n(ADV-VST) infusion either from the HSCT donor or from a third party haploidentical donor for patients transplanted\nwith umbilical cord blood (UCB).\nMethods: Fourteen patients were eligible and 11 patients received infusions of ADV-VST generated by interferon\n(IFN)-Ã?³-based immunomagnetic isolation from a leukapheresis from their original donor (42.9%) or a third party\nhaploidentical donor (57.1%). One patient resolved ADV infection before infusion, and ADV-VST could not reach\nrelease or infusion criteria for two patients. Two patients received cellular immunotherapy alone without antiviral\ndrugs as a pre-emptive treatment.\nResults: One patient with adenovirus infection and ten with adenovirus disease were infused with ADV-VST\n(mean 5.83 Ã?± 8.23 Ã?â?? 103 CD3+IFN-Ã?³+ cells/kg) up to 9 months after transplantation. The 11 patients showed in\nvivo expansion of specific T cells up to 60 days post-infusion, associated with adenovirus load clearance in ten of\nthe patients (91%). Neither de novo GVHD nor side effects were observed during the first month post-infusion,\nbut GVHD reactivations occurred in three patients, irrespective of the type of leukapheresis donor. For two of\nthese patients, GVHD reactivation was controlled by immunosuppressive treatment. Four patients died during\nfollow-up, one due to refractory ADV disease.\nConclusions: Adoptive transfer of rapidly isolated ADV-VST is an effective therapeutic option for achieving in\nvivo expansion of specific T cells and clearance of viral load, even as a pre-emptive treatment. Our study\nhighlights that third party haploidentical donors are of great interest for ADV-VST generation in the context of\nUCB transplantation. (NÃ?° Clinical trial.gov: NCT02851576, retrospectively registered)....
Background: Current influenza vaccines, based on antibodies against surface antigens, are unable to provide\nprotection against newly emerging virus strains which differ from the vaccine strains. Therefore the population has to be\nre-vaccinated annually. It is thus important to develop vaccines which induce protective immunity to a broad spectrum\nof influenza viruses. This trial is designed to evaluate the immunogenicity and safety of FLU-v, a vaccine composed of\nfour synthetic peptides with conserved epitopes from influenza A and B strains expected to elicit both cell mediated\nimmunity (CMI) and humoral immunity providing protection against a broad spectrum of influenza viruses.\nMethods: In a single-center, randomized, double-blind and placebo-controlled phase IIb trial, 222 healthy volunteers\naged 18ââ?¬â??60 years will be randomized (2:2:1:1) to receive two injections of a suspension of 500 Ã?¼g FLU-v in saline (arm 1),\none dose of emulsified 500 Ã?¼g FLU-v in Montanide ISA-51 and water for injection (WFI) followed by one saline dose\n(arm 2), two saline doses (arm 3), or one dose of Montanide ISA-51 and WFI emulsion followed by one saline\ndose (arm 4). All injections will be given subcutaneously. Primary endpoints are safety and FLU-v induced CMI,\nevaluated by cytokine production by antigen specific T cell populations (flow-cytometry and ELISA). Secondary\noutcomes are measurements of antibody responses (ELISA and multiplex), whereas exploratory outcomes include\nclinical efficacy and additional CMI assays (ELISpot) to show cross-reactivity.\nDiscussion: Broadly protective influenza vaccines able to provide protection against multiple strains of influenza are\nurgently needed. FLU-v is a promising vaccine which has shown to trigger the cell-mediated immune response. The\ndosages and formulations tested in this current trial are also estimated to induce antibody response. Therefore, both\ncellular and humoral immune responses will be evaluated....
Background: In diabetic patients a predisposed coronary microcirculation along with a higher risk of distal particulate\nembolization during primary percutaneous intervention (PCI) increases the risk of peri-procedural microcirculatory\ndamage. However, new antiplatelet agents, in particular Ticagrelor, may protect the microcirculation through its\nadenosine-mediated vasodilatory effects.\nMethods: PREDICT is an original, prospective, randomized, multicenter controlled study designed to investigate\nthe protective effect of Ticagrelor on the microcirculation during PCI in patient with diabetes mellitus type 2 or prediabetic\nstatus. The primary endpoints of this study aim to test (i) the decrease in microcirculatory resistance with\nantiplatelet therapy (Ticagrelor > Clopidogrel; mechanistic effect) and (ii) the relative microcirculatory protection of\nTicagrelor compared to Clopidogrel during PCI (Ticagrelor < Clopidogrel; protective effect).\nConclusions: PREDICT will be the first multicentre clinical trial to test the adenosine-mediated vasodilatory effect of\nTicagrelor on the microcirculation during PCI in diabetic patients. The results will provide important insights into the\nprospective beneficial effect of this drug in preventing microvascular impairment related to PCI (http://www.clinicaltrials.\ngov No. NCT02698618)....
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