Phase II Clinical Trial
Open-label phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L
... Both of the aforementioned clinical endpoints, ie, OS and decrease in AFP levels, were in favor of V5 interven- tion. Abdominal CT scans, when available, indicated that AFP-lowering effect of V5 coincided with ...
11
The effects of heterogeneity on Simon Phase II clinical trial design operating characteristics
... To further identify the effect of heterogeneity, Tables 3 and 4 display the probability distributions for the oversizing or underpowering of the trial. Under HRH and GRH, as the heterogeneity imbalance increases, ...
8
Phase II clinical trial of pembrolizumab efficacy and safety in advanced adrenocortical carcinoma
... multiple clinical challenges related to other co- morbidities, such as hypertension, hyperglycemia, hypokal- emia, bone loss, hypercoagulability, and the potential for immune suppression ...multiple ...
9
The high pCR rate of sandwich neoadjuvant treatment in locally advanced rectal cancer may translate into a better long-term survival benefit: 5-year outcome of a Phase II clinical trial
... Our Phase II trial indicated that the sandwich NACRT conferred an improved short-term curative effect compared with previous ...the trial was ...
7
Nimotuzumab combined with radiotherapy for esophageal cancer: preliminary study of a Phase II clinical trial
... The date of the last follow-up was January 30, 2013. The median follow-up time was 37 months (range 31–41 months). At 1 month after the treatment, none of the patients had attained complete response (CR); 22 (52.4%) ...
8
<p>Pharmacokinetics and pharmacodynamics of the novel Nrf2 activator omaveloxolone in primates</p>
... ongoing Phase II clinical trial with omaveloxolone in Friedreich’s ataxia patients (NCT02255435) are described and compared with the output from the monkey PK/PD model to estimate the dose ...
12
Changes in CD4+ T-cells and HIV RNA resulting from combination of anti-TB therapy with Dzherelo in TB/HIV dually infected patients
... open-label, phase II clinical trial of antituberculosis therapy (ATT) with or without oral immunomodulator Dzherelo (Immunoxel) was conducted in TB/HIV coinfected, antiretroviral therapy naïve ...
8
Potential role of ixekizumab in the treatment of moderate-to-severe plaque psoriasis
... a Phase I clinical trial, treatment with ixekizumab resulted in both clinical and histopathologic improvement of psoriasis, which suggests that IL-17 may be a key driver in the pathogenesis of ...
6
Addressing the elephant in the room, therapeutic resistance in non-small cell lung cancer, with epigenetic therapies
... randomized Phase II trial with regorafenib 7/10 colorectal cancer (CRC) patients have been resensitized to previously failed irinotecan for 4 months or longer post-RRx-001 progression, which suggests ...
11
Clinical trials update: endocrine and biological therapy combinations in the treatment of breast cancer
... A phase II clinical trial of letrozole and trastuzumab in patients with ER+/HER2+ metastatic breast cancer revealed that the combination was well tolerated and had a clinical benefit ...
10
The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study
... A Phase II clinical trial of two dosages of adalimumab and placebo in the treatment of moderate to severe psoriasis provided an opportunity to further explore the psycho- metric ...
12
Clinical trials for treating recurrent head and neck cancer with boron neutron capture therapy using the Tsing-Hua Open Pool Reactor
... another clinical trial entitled “A phase I/II trial of boron neutron capture therapy combined with image‑guided intensity‑modulated radiotherapy (IG‑IMRT) for locally recurrent HN ...
7
Phase II trial of weekly nab-paclitaxel and carboplatin treatment with or without trastuzumab as nonanthracycline neoadjuvant chemotherapy for locally advanced breast cancer
... confirmatory Phase III data, nab-paclitaxel monotherapy is being increas- ingly adopted to treat metastatic breast cancer after failure of anthracycline-based ...
7
Neoadjuvant treatment strategies for locally advanced rectal cancer
... randomised phase II trials or retrospective cohorts ...9203 trial [32], including T downstaging to ypT0 and tumour regression grade ...for phase III trials ...
22
Characterization of Methicillin Resistant Staphylococcus aureus Strains Recovered from a Phase IV Clinical Trial for Linezolid versus Vancomycin for Treatment of Nosocomial Pneumonia
... Among those MRSA strains originating from the APAC region, the CC5-MRSA-II and CC239-MRSA-III clones represented 83.5% of all strains included. Previous investigations have dem- onstrated the predominance of these ...
9
Neuroprotection in acute brain injury: an up to date review
... of clinical trial failures, especially for pharmacologic pro- tection after ...before clinical trials are commenced (Box ...early phase II trials, before proceeding to more definitive ...
11
Pathways in pulmonary arterial hypertension: the future is here
... Fibrosis Clinical (MUSIC) study (a phase II trial of macitentan in idiopathic pulmonary fibrosis), the incidence of liver enzyme elevations with macitentan was similar to placebo ...and ...
7
Combination therapy with histone deacetylase inhibitors (HDACi) for the treatment of cancer: Achieving the full therapeutic potential of HDACi
... subsequent phase I/II clinical trial with valp- roic acid and decitabine included 54 patients with ...Two phase I clinical trials were carried out to assess the phar- ...
15
Emerging therapeutic potential of nanoparticles in pancreatic cancer: a systematic review of clinical trials
... restrictions. Clinical trials involving the use of nanoparticles as a therapeutic or prognostic option in patients with pancreatic cancer were ...10 clinical trials including one randomised control ...
20
Validating intramyocardial bone marrow stem cell therapy in combination with coronary artery bypass grafting, the PERFECT Phase III randomized multicenter trial: study protocol for a randomized controlled trial
... PERFECT trial, representing the first Phase III trial for evaluation of intramyocardial bone marrow stem cell therapy during CABG surgery, was initiated in ...and clinical results from ...
5