hnio phase iii apbi trial

... giving their written informed consent [20] There are no patients in the phase II study who were enrolled in this phase III trial Table defines the study population Admission criteria also included ... patients with oral CCII or MTX in a randomized, doubleblind, multicenter, and controlled phase III clinical trial Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by pain, ... in rodents have provided the basis for human clinical trials In a randomized, double-blind, multicenter, and controlled phase II clinical trial involving 236 patients with severe active RA, a...

Ngày tải lên: 12/08/2014, 11:22

... studies for breast cancer patients including phase II and III trials comparing different agents in the treatment of radiation dermatitis In one Phase III trial, 194 female patients receiving breast ... cream Statistical considerations The study was designed as a prospective and randomized Phase III clinical trial with a planned accrual of 45 eligible patients The APP cream and aloe vera gel were ... randomized prospective trial Oncol Rep 2001, 8:305-309 Fisher J, Scott C, Stevens R, Marconi B, Champion L, Freedman GM, Asrari F, Pilepich MV, Gagnon JD, Wong G: Randomized phase III study comparing...

Ngày tải lên: 09/08/2014, 10:21

... await the results of phase III trials with progesterone in traumatic brain injury In the meantime, the scientific community needs to continue to pursue similar, early phase trials with other candidate ... are necessary The challenge moving forward will be the design of an appropriate multicenter phase III trial with several questions remaining to be resolved For example, what is the most appropriate ... mechanism, the results of this clinical trial are promising and provide compelling evidence to support the use of progesterone in head injured patients While this trial provides further safety data...

Ngày tải lên: 13/08/2014, 11:22

... enrolled in this trial are listed in Table Grade III non-hematological adverse events were observed in P1 (CNS hemorrhage at the brain metastasis) and P4 (hypoxia), and grade III hematological ... peptides derived from gp100 to treat HLA-A*2402-positive melanoma patients We have conducted a phase I clinical trial to treat the HLA-A*2402-positive patients with stage IV melanoma by vaccination with ... recognize the gp100-derived epitopes in an HLA class I-restricted manner (Fig 5) Discussion A phase I clinical trial was performed using an HLAA*2402-restricted epitope-peptide derived from gp100 to...

Ngày tải lên: 18/06/2014, 16:20

... of Adalimumab Every Other Week Dosing in Moderate to Severe Psoriasis TriAL (REVEAL) study, a 52-week, Phase III clinical trial in adult patients with moderate to severe chronic plaque psoriasis ... for patients with moderate to severe psoriasis [16-19] In a 16-week, Phase III, randomized, double-blind, placebo-controlled trial, adalimumab improved HRQOL outcomes in patients with psoriasis, ... Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trial Br J Dermatol 2005, 153(6):1192-1199 Revicki D, Willian MK, Saurat JH, Papp KA, Ortonne...

Ngày tải lên: 18/06/2014, 19:20

... Testing of Body Armor Materials: Phase III Testing of Body Armor Materials Phase III Committee on Testing of Body Armor Materials for Use by the U.S Army— Phase III Board on Army Science and Technology ... Materials: Phase III Copyright © National Academy of Sciences All rights reserved Testing of Body Armor Materials: Phase III COMMITTEE ON THE TESTING OF BODY ARMOR FOR THE U.S ARMY – PHASE III LARRY ... the three -phase study Phases I and II resulted in two NRC letter reports: one in 2009 and one in 2010.1 This is the Phase III report Findings and recommendations from the Phase I and Phase II...

Ngày tải lên: 29/06/2014, 09:21

... an update of radiation therapy oncology group trial (RTOG) 90-01 J Clin Oncol 2004, 22(5):872-80 Pearcey R, Brundage M, Drouin P, et al: Phase III trial comparing radical radiotherapy with and ... hematologic toxicities were significantly lower in the Page of cisplatin-alone arm [53] A phase III randomized trial testing this combination for definitive CTRT in stages IIB to IVA disease, has ... were treated with high-dose rate Iridium brachytherapy Patients who had parametrial involvement also received a parametrial boost to the affected side Median total dose to point A was 74 Gy (range:...

Ngày tải lên: 09/08/2014, 09:20

... most published data from phase I/II trial not have sufficient follow-up to draw conclusions Table Acute urinary and rectal toxicity after prostate EBRT RTOG GRADE I II III IV GENITOURINARY On-treatment ... hypofractionated regimens, early biochemical control is encouraging [11-13] A recent phase III randomized trial [14] comparing hypofractionated (62 Gy/20 fractions/5 weeks) and conventional fractionation ... physics 2007, 69:1084-1089 14 Arcangeli G, Saracino B, Gomellini S, et al: A Prospective Phase III Randomized Trial of Hypofractionation Versus Conventional Fractionation in Patients With High-Risk...

Ngày tải lên: 09/08/2014, 09:21

... comparability of results Methods A randomized phase III trial of Radiosurgery Or Surgery for operable Early stage (stage 1A) non-small cell Lung cancer (ROSEL, ClinicalTrials.gov ID = NCT00687986) has been ... end-expiration phase bins using axial, sagittal and coronal views In addition to the MIP contouring, the GTV should also be contoured in a single phase (preferably the end-expiration phase, because ... RTOG trial 0236 defined a set of parameters to quantify the conformity of the dose and PTV coverage The same parameters were used in RTOG trial 0618 and are used here However, the ROSEL trial...

Ngày tải lên: 09/08/2014, 09:22

... in elective cardiopulmonary bypass patients: a randomized double-blind, dose-dependent, phase IV clinical trial Journal of Cardiothoracic Surgery 2011 6:138 ... 6:138 http://www.cardiothoracicsurgery.org/content/6/1/138 Page of 10 Figure Randomized control trial flow diagram groups in cerebrovascular events, renal pathology, myocardial infarction, mechanical ... mean and 95% confidence interval; frequencies and percentages; median and percentiles b Inter-atrial communication D-dimer [3,20,21] This amplified IR is especially relevant in CPB In a previous...

Ngày tải lên: 10/08/2014, 09:22

... incorporation of phase II sites in phase III lead to contamination? Seven of the 12 sites participated in phase II, which will end at least six months prior to the onset of phase III We believe ... Implementation study Why we need to conduct this proposed phase III implementation study, especially after the large and successful phase I derivation and phase II validation studies? First, physician behaviour ... Canadian C-Spine Rule with detailed followup of patients in phase II In order to significantly reduce the resources required for phase III, we propose not to specifically follow all patients who...

Ngày tải lên: 11/08/2014, 05:22

... in the present study had HIV or viral hepatitis Conduct of the trial has been approved by the internal review board and has ClinicalTrials.gov Identifier: NCT01222338 Randomization, clinical endpoints ... revaccination trial in the area of high TB endemicity with increased probability of occult disease has produced worrisome outcome, which might be interpreted as a fatal Koch-like TB reactivation The trial ... ND, Yurchenko LV, Sokolenko NI, Frolov VM, Tarakanovskaya MG, Jirathitikal V, Bourinbaiar AS: Phase trial of V-5 Immunitor (V5) in patients with chronic hepatitis C co-infected with HIV and Mycobacterium...

Ngày tải lên: 11/08/2014, 08:21

... region Study design A dose of × 108 pfu (1 ml) MVA-5T4 was established as safe in a Phase I trial [11] In this trial, the first dose was given by intramuscular injection alone and booster vaccination ... metastatic RCC In order to take advantage of IL-2 during the contraction phase of the immune response, we designed an exploratory trial in which an initial vaccination was administered alone and subsequent ... immunizations were supported by the addition of high-dose bolus IL-2 Methods Patients This phase II trial was an open label study of MVA-5T4 vaccine in patients with metastatic clear cell or...

Ngày tải lên: 18/06/2014, 15:20

... clinically important difference Control Clin Trials 1989, 10:407-415 doi:10.1186/1479-5876-8-20 Cite this article as: DiPaola et al.: A randomized phase II trial of mitoxantrone, estramustine and ... S, Rao KV, Kane M, Dave N, Capanna T, Doyle-Lindrud S, Engle E, Jin L, Todd M, DiPaola RS: A phase II trial of docetaxel and vinorelbine in patients with hormone-refractory prostate cancer Cancer ... Pharmacol 2005, 56:199-204 Hussain A, Dipaola RS, Baron AD, Higano CS, Tchekmedyian NS, Johri AR: Phase II trial of weekly patupilone in patients with castration-resistant prostate cancer Ann Oncol...

Ngày tải lên: 18/06/2014, 16:20

... Human Use (ICH)-Good Clinical Practice (GCP)-registered phase I/II clinical trial of rh-HGF As this application is the first clinical trial to administer rh-HGF to humans, we performed additional ... to evaluate renal involvement, including serum creatinine and histological findings A phase I/II clinical trial for patients with acute liver failure Overview This single-arm, open-labeled, and ... significant (Table 3) Discussion This clinical trial covered patients with FH, an extremely severe and fatal liver disease: subjects enrolled in this trial are predicted to die without liver transplantation...

Ngày tải lên: 18/06/2014, 19:20

... toxicity profile These trials provide a clear rationale for replacing infusional 5-FU with oral capecitabine as part of chemoradiation [11,12] Patients and methods This phase II trial included 43 ... adjuvant and first line treatment for colorectal cancer The results from two large, randomized phase III trials including over 1200 patients showed that oral capecitabine was more active than bolus ... respectively The incidence of acute toxicity in the present study is obviously lower than other phase II trials using capcitabine, where 4–16% grade leucopenia [21-23], 2% grade anemia and neutropenia...

Ngày tải lên: 09/08/2014, 04:21

... single-injection (subcutaneous), dose-escalation phase I trial, which was conducted at Duke University Medical Center and sponsored by Savient Pharmaceuticals This trial was approved by the Duke University ... second phase I trial of intravenous PEG-uricase Although confirming the induction of anti-PEG antibodies, no infusion reactions or allergic phenomena were observed in the 24 subjects in that trial ... activity was observed, indicating that antibody against PEG- Efficacy of PEG-uricase In this first phase I trial, single subcutaneous injections of to 24 mg of PEGylated mammalian uricase were administered...

Ngày tải lên: 09/08/2014, 07:20

... radiotherapy for locally advanced rectal cancer (phase I trial) J Med Assoc Thai 2006, 89:1874-1884 39 Wong SJ, Sadasiwan C, Erickson B: A phase I trial of preoperative capecitabine and concurrent ... GERCOR phase II study Oncology 2007, 73:169-176 30 Freedman GM, Meropol NJ, Sigurdson ER, Hoffman J, Callahan E, Price R, Cheng J, Cohen S, Lewis N, Watkins-Bruner D, Rogatko A, Konski A: Phase I trial ... 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomized, phase III trials Br J Cancer 2004, 90:1190-1197 Velenik et al Radiation Oncology 2010, 5:88 http://www.ro-journal.com/content/5/1/88...

Ngày tải lên: 09/08/2014, 09:20

... patients These data support further studies of belimumab in autoimmune disorders Trial Registration NCT00657007 [clinicaltrials.gov] Introduction ers in mice [19] In cynomolgus monkeys treated with ... standard deviation; t1/2,α, elimination half-life for the distribution phase; t1/2,β, elimination half-life for the terminal phase; V1, volume of distribution for the central compartment; Vss, volume ... (Fc-peptide fusion protein [peptibody] with binding affinity for BLyS) has been evaluated in phase I SLE trials Gradual reductions in CD20 B cells and immunoglobulin isotypes, particularly IgM, were...

Ngày tải lên: 09/08/2014, 13:21