Application to a Phase I Trial with Continuous Toxicity
Preferential amplification of CD8 effector-T cells after transcutaneous application of an inactivated influenza vaccine: a randomized phase I trial
... In Phase I/II studies of a live- attenuated measles vaccine in humans, Etchard et ...MHC-Class I restricted peptides) allowed the induction of peptide-specific CD8 ...vaccine application; ...
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A phase I trial of low-dose inhaled carbon monoxide in sepsis-induced ARDS
... novel application of the CFK equa- tion, and demonstrates that iCO therapy can be effectively delivered with real-time monitoring of mea- sured and predicted COHb levels to ensure consistent systemic uptake in ...
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Phase I–II trial design for biologic agents using conditional auto‐regressive models for toxicity and efficacy
... chemotherapy phase I–II trial designs is that dose increases lead to both more toxicity as well as more ...of toxicity and efficacy has come into question as potential cancer treatments ...
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Continuous anti-angiogenic therapy after tumor progression in patients with recurrent high-grade epithelial ovarian cancer: phase I trial experience
... In the current study, we sought to determine whether prior exposure to bevacizumab-based therapy potentially affected the antitumor activity of further treatment with bevacizumab-based chemotherapeutic regimens in ...
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Phase I Trial of Concurrent Administration of Topotecan and Docetaxel for Cancer Treatment
... hematologic toxicity with grade 4 neutropenia; 2 of them also experi- enced neutropenic ...detailed toxicity data for this group is summarized in Table ...
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Continuous hyperfractionated accelerated radiotherapy - Escalated dose (CHART-ED): A phase i study
... Discussion Despite considerable effort over the last few decades, there has been little improvement in survival for NSCLC when compared to other sites such as breast and colorectal cancers. Many reasons are documented ...
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A two-phase substrate model for enzymatic hydrolysis of lignocellulose: application to batch and continuous reactors
... direct application in process design or CFD ...cellulose-only application of this model has previously been implemented in the con- text of CFD simulation of a stirred reactor, quantifying the impacts of an ...
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Topical cutaneous application of carbon dioxide via a hydrogel for improved fracture repair: results of phase I clinical safety trial
... cutaneous application of carbon dioxide (CO 2 ) via a CO 2 absorption-enhancing hydrogel accelerates fracture repair in rats by increasing blood flow and angiogenesis and promoting endochondral ...
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Safety Evaluation of Topical Application of Nano-Liposomal Form of Amphotericin B (SinaAmpholeish) on Healthy Volunteers: Phase I Clinical Trial
... Although CL is a self-limiting lesion, healing process is slow. It might take up to years, and leaving scars. Various treatment modalities have been used in the treatment of CL, but still, the standard treatment of CL is ...
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A phase I trial investigating the Aurora B kinase inhibitor BI in combination with
... After the 5 mg dose cohorts, the protocol was amended to escalate the BI 811283 doses to approximately half the highest dose that was considered safe in a concurrent BI 811283 monotherapy trial conducted in solid ...
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A phase I trial of the HIV protease inhibitor nelfinavir in adults with solid tumors
... limiting toxicity of nelfinavir is neutropenia, and a blood smear from a patient that experienced this DLT showed the presence of cytoplasmic vacuoles in their neutrophils and monocytes, as well as ...this ...
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Phase I clinical trial of combination imatinib and ipilimumab in patients with advanced malignancies
... Of importance, although the side-effect profile of the combination included toxicities observed with each agent in monotherapy, these did not seem exacerbated by the combination, even at higher doses. A critical con- ...
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Dosimetry and Gastrointestinal Toxicity Relationships in a Phase II Trial of Pelvic Lymph Node Radiotherapy in Advanced Localised Prostate Cancer.
... bowel toxicity in patients undergoing prostate and pelvic radiotherapy for high-risk PCa showed bV40-bV50 to be predictive with CFRT, whereas higher (bV55) and lower (bV15) dose-points were less ...late ...
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5-Fluorouracil as protracted continuous intravenous infusion can be added to full-dose docetaxel (Taxotere®)-cisplatin in advanced gastric carcinoma: a phase I-II trial
... this trial presented 10 episodes of non-fatal FN, while we observed nine such episodes in our previous TC trial enrolling 48 ...non-hematological toxicity were observed in the occurrence of grade 1/2 ...
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A Bayesian approach for dose escalation in a phase I clinical trial incorporating pharmacodynamic endpoints
... Introduction Phase I dose-escalation studies are generally conducted in small samples of healthy male volunteers in order to determine safe doses for later ...one continuous and one binary component, ...
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A phase-I trial of pre-operative, margin intensive, stereotactic body radiation therapy for pancreatic cancer: the 'SPARC' trial protocol.
... radiotherapy achieves sufficient accuracy and precision to enable pre-operative margin-intensive dose escalation with the goal of increasing rates of clear resection margins and local disease control. Methods/Design: ...
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PRE-APPLICATION PACKAGE (PHASE I)
... .Once your realtor submits the offer and all of the required documents, LHC will review it along with any other offers that may have been submitted. ***Incomplete offers will NOT be reviewed*** If your offer is selected, ...
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APPLICATION FORM VILLA (PHASE - I)
... the application and refund all amounts received until then after deducting therefrom specified and described herein along with booking amount plus interest, brokerage charges plus applicable taxes, paid or ...
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Session 6 Clinical Trial Assessment Phase I Clinical Trial
... • Pregnant women - Prior to the inclusion of pregnant women in clinical trials, all the reproduction toxicity studies and the standard battery of genotoxicity tests should be conducte[r] ...
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Joint Modelling of Efficacy and Toxicity in the Dose Escalation Phase I Studies
... 3. Simulation Study Set-Up 3.1. Dose-Finding Procedure For dose escalation decisions, each new cohort will consist of 3 to 6 patients who will be treated at the specific dose level, but additional patients could be ...
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