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Phase II Study

Open-label Phase II study of everolimus plus endocrine therapy in postmenopausal women with ER-positive and HER2-negative metastatic breast cancer (Chloe trial)

Open-label Phase II study of everolimus plus endocrine therapy in postmenopausal women with ER-positive and HER2-negative metastatic breast cancer (Chloe trial)

... ongoing Phase II study (BOLERO-4 trial, NCT 01698918) is being conducted overseas to evaluate the efficacy and safety of combined use of everolimus with letro- zole as the initial therapy for ...

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Diagnostic accuracy of the Eurotest for dementia: a naturalistic, multicenter phase II study

Diagnostic accuracy of the Eurotest for dementia: a naturalistic, multicenter phase II study

... this study for any clinical neurological reason, not limited to cognitive impairment; and 3) had an estab- lished clinical and cognitive diagnosis before being assessed using the ...a phase II ...

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Phase II study of reintroduction of oxaliplatin for advanced colorectal cancer in patients previously treated with oxaliplatin and irinotecan: RE-OPEN study

Phase II study of reintroduction of oxaliplatin for advanced colorectal cancer in patients previously treated with oxaliplatin and irinotecan: RE-OPEN study

... Background: The effectiveness of reintroducing oxaliplatin in patients with metastatic colorectal cancer refractory to standard chemotherapy has not been verified. We performed a single-arm, open-label, Phase ...

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Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma.

Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma.

... a phase II study of idelalisib (all-grade, 43%; grade ≥3, 13%) [15, 16, ...one study, 86% of patients (12/14) treated with idelalisib for ≥3 months with idelalisib-induced diarrhea had colitis ...

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Pirfenidone gel in patients with localized scleroderma: a phase II study

Pirfenidone gel in patients with localized scleroderma: a phase II study

... our study include the small number of patients, the lack of a control group and the short duration of ...follow-up phase must be prolonged to allow for the definition of the optimal treatment period and ...

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Phase II study of whole brain radiotherapy with or without erlotinib in patients with multiple brain metastases from lung adenocarcinoma

Phase II study of whole brain radiotherapy with or without erlotinib in patients with multiple brain metastases from lung adenocarcinoma

... All enrolled patients were required to sign a study-specific informed consent, and Tianjin Medical University Cancer Institute and Hospital ethical requirements were met. Pretreatment evaluations included a ...

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Pilot Phase II study of mazindol in children with attention deficit/hyperactivity disorder

Pilot Phase II study of mazindol in children with attention deficit/hyperactivity disorder

... This study was supported by a grant from Assistance Publique – Hôpitaux de Paris ...this study and provided the tablets of ...the study design and methodology, and MededGlobal Solutions ...this ...

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Phase Ib/II randomized, open-label study of doxorubicin and cyclophosphamide with or without low-dose, short-course sunitinib in the pre-operative treatment of breast cancer

Phase Ib/II randomized, open-label study of doxorubicin and cyclophosphamide with or without low-dose, short-course sunitinib in the pre-operative treatment of breast cancer

... recommended phase II dose based on immunohistochemical evidence of vascular normalization in our dose-finding phase Ib ...randomized phase II study, we observed definite ...

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LUME-Meso: Design and Rationale of the Phase III Part of a Placebo-Controlled Study of Nintedanib and Pemetrexed/Cisplatin Followed by Maintenance Nintedanib in Patients With Unresectable Malignant Pleural Mesothelioma.

LUME-Meso: Design and Rationale of the Phase III Part of a Placebo-Controlled Study of Nintedanib and Pemetrexed/Cisplatin Followed by Maintenance Nintedanib in Patients With Unresectable Malignant Pleural Mesothelioma.

... randomised, phase II study, sample size was selected for proof- of-clinical-concept and all planned analyses were intended to be ...the study be expanded to include a confirmatory phase ...

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Targeted therapy in melanoma

Targeted therapy in melanoma

... A phase II study evaluated the efficacy and tolerability of DTIC in combination with thalidomide in metastatic melanoma patients. Fifteen patients were enrolled in the study. Of the 13 ...

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Lenvatinib and other tyrosine kinase inhibitors for the treatment of radioiodine refractory, advanced, and progressive thyroid cancer

Lenvatinib and other tyrosine kinase inhibitors for the treatment of radioiodine refractory, advanced, and progressive thyroid cancer

... in Phase I studies, is 25 mg ...in Phase I study and confirmed in the subsequent Phase II and III studies, are hypertension, proteinuria, and gastrointestinal symptoms such as nausea, ...

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Impact of etanercept tapering on work productivity in patients with early rheumatoid arthritis: results from the PRIZE study

Impact of etanercept tapering on work productivity in patients with early rheumatoid arthritis: results from the PRIZE study

... entered phase II, 125 reported that they were still employed at week 52, and 68 were ...for phase II: 39 patients in the ETN25+MTX treatment group, 49 in the MTX group and 32 in the placebo ...

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How shall we treat early triple-negative breast cancer (TNBC): from the current standard to upcoming immuno-molecular strategies

How shall we treat early triple-negative breast cancer (TNBC): from the current standard to upcoming immuno-molecular strategies

... a phase III trial of carboplatin monotherapy is about to begin for patients with residual TNBC after conventional neoad- juvant chemotherapy (NCT01752686), and trials adding cisplatin or carboplatin to taxanes ...

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Multicenter Evaluation of Bactec MGIT 960 System for Second Line Drug Susceptibility Testing of Mycobacterium tuberculosis Complex

Multicenter Evaluation of Bactec MGIT 960 System for Second Line Drug Susceptibility Testing of Mycobacterium tuberculosis Complex

... tested susceptible by AP but resistant by MGIT 960. Both strains in group A demonstrated pinpoint colonies on the ETH-containing quadrant on Middlebrook 7H10 plates by AP. It indicated some degree of inhibition by the ...

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A phase II dose-ranging study of mirabegron in patients with overactive bladder

A phase II dose-ranging study of mirabegron in patients with overactive bladder

... Results Mirabegron 25, 50, 100, and 200 mg resulted in dose- dependent reductions (improvements) from baseline to end-of- treatment in micturition frequency of 1.9, 2.1, 2.1, and 2.2 micturitions/24 h respectively, ...

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Piper betle induces phase I & II genes through Nrf2/ARE signaling pathway in mouse embryonic fibroblasts derived from wild type and Nrf2 knockout cells

Piper betle induces phase I & II genes through Nrf2/ARE signaling pathway in mouse embryonic fibroblasts derived from wild type and Nrf2 knockout cells

... of phase 2 genes by electrophiles and antioxi- dants ...with phase 2 inducers including sulforaphane ...of phase 2 genes ...in phase 2 genes such as GCLC, GST and NQO1 through Keap1-Nrf2-ARE ...

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Bortezomib in the management of multiple myeloma

Bortezomib in the management of multiple myeloma

... the rate of MR or better in this study is 86%, with 24% of study participants achieving a CR/near CR (nCR) and 67% achieving a PR or better. Among patients who respond to therapy, the median duration of ...

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Metastatic bone disease: Pathogenesis and therapeutic options: Up-date on bone metastasis management.

Metastatic bone disease: Pathogenesis and therapeutic options: Up-date on bone metastasis management.

... type II serine/ threonine kinase receptor (ActRIIA), whose recombinant analogues have been investigated in pre-clinical and clinical ...A phase II clinical trial showed improved BMD and bone pain in ...

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Randomized phase II designs.

Randomized phase II designs.

... on phase II studies, they identify the important prognostic variables and their contributions to one-year OS and six-month PFS rates, as well as to the survival distributions for either time-to-event ...

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Value of transfusion independence in severe aplastic anemia from patients’ perspectives – a discrete choice experiment

Value of transfusion independence in severe aplastic anemia from patients’ perspectives – a discrete choice experiment

... survey study among pa- tients with MDS found consistently significantly higher utility scores for transfusion independence compared to reduced transfusions (P < ...

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