Articles with "label single" as a keyword



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Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1, Open-Label, Single-Dose, Parallel-Group Study.

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Published in 2023 at "Clinical pharmacology in drug development"

DOI: 10.1002/cpdd.1244

Abstract: Rimegepant is a small-molecule calcitonin gene-related peptide receptor antagonist (gepant) with demonstrated efficacy and safety in the acute and preventive treatment of migraine. Here, we report the pharmacokinetics and safety of a single 75-mg oral… read more here.

Keywords: label single; rimegepant subjects; hepatic impairment; impairment ... See more keywords
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An open‐label, single‐site study to evaluate the tolerability, safety, and efficacy of using a novel facial moisturizer for preparation and accelerated healing pre and post a single full‐face radiofrequency microneedling treatment

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Published in 2019 at "Journal of Cosmetic Dermatology"

DOI: 10.1111/jocd.12817

Abstract: Skincare cosmeceutical products have been shown to address intrinsic and extrinsic skin aging. Radiofrequency (RF) with microneedling is effective and safe in improving skin laxity and texture. Pairing skincare cosmeceutical products pre‐ and post‐procedure is… read more here.

Keywords: radiofrequency microneedling; open label; label single; pre post ... See more keywords
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An open-label, single arm, phase IIa study of bortezomib, lenalidomide, dexamethasone, and elotuzumab in newly diagnosed multiple myeloma.

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Published in 2017 at "Journal of Clinical Oncology"

DOI: 10.1200/jco.2017.35.15_suppl.8002

Abstract: 8002Background: Elotuzumab (elo) is approved for use in combination with lenalidomide (len) and dexamethasone (dex) for relapsed and refractory multiple myeloma (MM). This phase 2a study evaluated ... read more here.

Keywords: phase; myeloma; study; multiple myeloma ... See more keywords
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An open-label, single-arm, multi-institutional phase II trial of avelumab for recurrent, metastatic nasopharyngeal carcinoma.

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Published in 2017 at "Journal of Clinical Oncology"

DOI: 10.1200/jco.2017.35.15_suppl.tps6092

Abstract: TPS6092Background: The majority of patients with nasopharyngeal carcinoma (NPC) present with locally advanced disease, with a predilection for early systemic dissemination. For patients who develop... read more here.

Keywords: multi institutional; label single; single arm; open label ... See more keywords
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An open-label, single-group, multicenter phase II study of lanreotide autogel (LAN) in Japanese patients (pts) with neuroendocrine tumors (NET).

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Published in 2017 at "Journal of Clinical Oncology"

DOI: 10.1200/jco.2017.35.4_suppl.471

Abstract: 471Background: LAN is a long-acting somatostatin analog indicated in EU for the treatment of carcinoid syndrome and in the US and EU as antiproliferative treatment in pts with gastroenteropancreatic (GEP) -NET. The antitumor efficacy of… read more here.

Keywords: phase; study; label single; open label ... See more keywords
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QUADRA: A phase 2, open-label, single-arm study to evaluate niraparib in patients (pts) with relapsed ovarian cancer (ROC) who have received ≥3 prior chemotherapy regimens.

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Published in 2018 at "Journal of Clinical Oncology"

DOI: 10.1200/jco.2018.36.15_suppl.5514

Abstract: 5514Background: PARP inhibitors (PARPi) are approved as active treatment only for pts with BRCA mutations. The PARPi niraparib demonstrated increased PFS vs placebo in the maintenance setting of pl... read more here.

Keywords: arm study; quadra phase; phase open; label single ... See more keywords