This is a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients with locally advanced or metastatic solid tumors. The study is divided into …
The main goal of the study is to verify the efficacy of the GRAIL system in respect to the walking pattern improvement in a population of hemiparetic subjects. In particular, the specific goals will be: increase in walking symmetry and a better distribution among the time of stance and swing. …
This study evaluates the long-term safety and efficacy of CORETOX in the treatment of moderate to severe glabellar lines.
This study is to explore the markers in early prediction of the efficacy of pre-operative pertuzumab plus trastuzumab (PH) combined with chemotherapy for early stage or locally advanced human epidermal growth factor receptor-2 (HER-2) positive primary breast cancer.
Using a public health facility Komfo Anokye Teaching Hospital in Ghana the overall goal of the research is to examine: 1) the feasibility of implementing respectful care modules (RMC-M) in Kumasi, Ghana; 2) whether exposure to RMC-M increases participants perception of respectful maternity care in a public hospital setting in …
JCOG1801 is a randomized phase III trial which was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for local relapse-free survival over standard treatment, i.e. surgery plus adjuvant chemotherapy, for previously non-irradiated locally recurrent rectal cancer.
The study's purpose is to validate STAGE images and, when applicable, their equivalence to conventional MRI through an assessment by a trained certified neuroradiologist in a clinical setting. For STAGE images without conventional equivalent, the neuroradiologist will determine if their contrasts, intensities, and quality are sufficient and meet expectations for …
Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this …
The main objective of this study is to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 …
Primary Objectives: Phase 1: To characterize the safety and tolerability of isatuximab in kidney transplant candidates. Phase 2: To evaluate the efficacy of isatuximab in desensitization of patients awaiting kidney transplantation. Secondary Objectives: Phase 2: To characterize the safety profile of isatuximab in kidney transplant candidates. To characterize the pharmacokinetic …
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