phase-I trial
Human neural stem cell transplantation in ALS: initial results from a phase I trial
... An additional, significant finding from this study is the lack of acute or delayed toxicity that might have ensued from the transplantation of our hNSCs lines. The latter are routinely generated anew and banked as tissue ...
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A phase I trial of low-dose inhaled carbon monoxide in sepsis-induced ARDS
... Randomization and masking. Participants were randomized to receive iCO or placebo air at a ratio of 2:1 using a permuted block method (block size of 3) (58). We used SAS version 9.4 to generate the sequence to assign ...
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A Phase I trial using local regional treatment, nonlethal irradiation, intratumoral and systemic polyinosinic-polycytidylic acid polylysine carboxymethylcellulose to treat liver cancer: in search of the abscopal effect
... the trial, deemed due to overembolization, as the main right hepatic artery was entirely embolized and the patient experienced dramatic hepatic dysfunction immediately following the ...
11
Phase I Trial of a CD8+ T-Cell Peptide Epitope-Based Vaccine for Infectious Mononucleosis
... this trial was to establish that CD8 ⫹ T-cell epitope-based vaccination of EBV seronegative individ- uals was safe in the context of a primary EBV ...This trial illustrates that single- epitope vaccination ...
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Epidermal growth factor receptor T790M mutation-positive metastatic non-small-cell lung cancer: focus on osimertinib (AZD9291)
... In Phase I trial of osimertinib in advanced lung cancer after progression on EGFR TKIs, the response rate and disease control rate were 61% and 95%, ...subsequent Phase II (AURA2) trial ...
10
Phase I clinical trial of sipuleucel-T combined with escalating doses of ipilimumab in progressive metastatic castrate-resistant prostate cancer
... Cytotoxic T-lymphocyte antigen-4 (CTlA-4) is a negative regulator of T-cell activation; ipilimumab (IPI) specifically blocks CTlA-4, thus enhancing T-cell activation. Based on this mechanism of action, we and others have ...
6
Combination therapy with histone deacetylase inhibitors (HDACi) for the treatment of cancer: Achieving the full therapeutic potential of HDACi
... pharmacodynamic phase I/II study of valproic acid in combination with epirubicin/FEC, 64% of breast cancer patients had an objective response in the dose expansion ...a phase I combination ...
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Phase I safety trial of intravenous ascorbic acid in patients with severe sepsis
... Vital signs were monitored every 5 minutes during infusion and every 5 minutes for 45 minutes afterwards by bedside Medical Respiratory Intensive Care Unit (MRICU) Nursing and the investigative team. Patient safety in ...
10
Phase I clinical trial results of aceneuramic acid for GNE myopathy in Japan
... The phase I trial of aceneuramic acid consisted of two tri- als, both of which were conducted at Department of Neurology, Tohoku University Graduate School of Medi- cine in accordance with the Good ...
15
Phase I dose-escalation trial of intravaginal curcumin in women for cervical dysplasia
... dose-escalation Phase I trial in a group of women aged 18–45 ...the trial, all events were grade I based on the National Cancer Institute Common Terminology Criteria for Adverse Events ...
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Profile of inotuzumab ozogamicin and its potential in the treatment of acute lymphoblastic leukemia
... Results of two major studies are awaited: a larger Phase I trial to evaluate pharmacokinetics, levels of MRD, and response is ongoing (B1931010 trial), and a Phase III pivotal trial o[r] ...
8
Phase I clinical trial of multiple peptide vaccination for patients with advanced biliary tract cancer
... This study was conducted as a phase I trial. Patients who received standard chemotherapy under a diagnosis of inoperable BTC between June 2009 and May 2010 were invited to participate after providing ...
11
Fifteen years of irinotecan therapy for pediatric sarcoma: where to next?
... a phase I trial of orally administered iri- notecan in which the daily use of the oral cephalosporin cefixime reduced the incidence of grade 3–4 diarrhea such that the maximum tolerated dose was 50 % ...
7
A phase I/II trial of AT9283, a selective inhibitor of aurora kinase in children with relapsed or refractory acute leukemia: challenges to run early phase clinical trials for children with leukemia.
... A phase I trial of AT9283 (a selective inhibitor of aurora kinases) in children and adolescents with solid tumors: a cancer research UK study ...
31
A Bayesian approach for dose escalation in a phase I clinical trial incorporating pharmacodynamic endpoints
... experience of Cohort I subjects dosed using the stricter criterion should provide sufficient assurance to allow this. Figure 6 shows the results from a simulated run using these criteria, and with the DLE ...
22
Emerging treatments in Castleman disease – a critical appraisal of siltuximab
... randomized Phase II trial showed increased benefit of siltux- imab for patients younger than 65, race other than white, male sex, and lack of corticosteroid use at randomization, which may serve as a proxy ...
7
EBOLA VIRUS A PROTOTYPE PATHOGEN CAUSING HAEMORRHAGIC FEVER, AN EPIDEMIC HEALTH THREAT IN PUBLIC WORLD’S NEXT AIDS STATUS OF IT'S VACCINE AND RESEARCH DEVELOPMENT
... Although progress has been made in understanding virus biology, no licensed vaccines or treatments currently exist, as there is a desperate need for a vaccine that not only prevents it’s transmission but also to control ...
13
Review of pemetrexed in combination with cisplatin for the treatment of malignant pleural mesothelioma
... Abstract: Malignant pleural mesothelioma is a resistant form of lung cancer, and its incidence continues to rise in Europe and Australia. Until recently, chemotherapy had not been shown to be effective in the treatment ...
8
A phase I followed by a randomized phase II trial of two cycles carboplatin olaparib followed by olaparib monotherapy versus capecitabine in BRCA1 or BRCA2 mutated HER2 negative advanced breast cancer as first line treatment (REVIVAL): study protocol for a randomized controlled trial
... NCT00516724 trial suggest that the proposed dose escalation scheme will not lead to subtherapeutic dosing despite incorporating carboplatin only in the first two ...
9
<p>Evaluating the Safety and Efficacy of Nivolumab in Patients with Advanced Hepatocellular Carcinoma: Evidence to Date</p>
... (SHARP trial), 8 there was a sad saga of almost a decade where no systemic therapeutic agent showed over- all survival bene fi ...a Phase III ...recent Phase I/II clinical trials involving ...
8