Study protocol of a phase 1 clinical trial establishing the safety of intrapleural administration of liposomal curcumin: curcumin as a palliative treatment for malignant pleural effusion (IPAL-MPE)respiratory medicine (see thoracic medicine)adult thoracic medicine...
thestudyofwhethersuchtoxicityisreversible3)toidentifysafetyparametersforclinicalmonitoring7CoreToxicityEvaluation(1)•Forsingle-dosephaseIandrepeat-dosephaseIstudiesofupto14daysduration:–ADME/toxicokineticsinrodentandnon-rodentanimalspecies–Safetypharmacology(cardiovascular,CNS,respiratory–ICHS7A)–Non-clinical...
All clinical data have been provided in the paper in the form of figures, in the text or in Supplementary Information (including the clinical trial protocol, STROBE checklist and the statistical analysis plan). Additional requests for clinical data should be addressed to the corresponding author ...
To manage these conflicts, UMN and WUSM investigators led this trial, were sponsors of the IND, managed all the data in the study, and had final responsibility for the manuscript. The study protocol was an investigator-initiated clinical trial. UMN and WUSM investigators performed the clinical ...
A Phase I clinical study of cisplatin-incorporated polymeric micelles (NC-6004) in patients with solid tumoursdoi:10.1038/bjc.2011.6cisplatin... - 《British Journal of Cancer》 被引量: 0发表: 2011年 Cisplatin-incorporating polymeric micelles (NC-6004) can reduce nephrotoxicity and neurotoxicity of...
Details of the study can be found in the attached clinical study protocol NT-001 and patient demographics can be found in Table 1. Nine clinical sites enrolled patients including Dana Farber Cancer Institute, City of Hope National Medical Center, Icahn School of Medicine at Mount Sinai, Massachus...
Open-label phase I clinical study to assess the safety of intravenous eptifibatide in patients undergoing internal carotid artery angioplasty and stent pla... Open-label phase I clinical study to assess the safety of intravenous eptifibatide in patients undergoing internal carotid artery angioplasty and...
Objective: To evaluate the safety and clinical efficacy of cilostazol and aspirin therapy following internal carotid artery stent placement up to 1 month postprocedure. Methods: A phase I open-label, nonrandomized two-center prospective study was conducted. All subjects received aspirin (325 mg/day...
Standard protocol approvals – Registration – Patient consent This Phase I single-arm, prospective, open-label study evaluating the use of intrathecal autologous AD-MSC therapy for patients with SCI, was reviewed and allowed to proceed by the United States Food and Drug Administration (ClinicalTrial...
Study design Twelve patients were recruited between December 2021 and June 2022 at Xinqiao Hospital of Army Medical University (the clinical trial protocol is provided as separate supplementary information). After 3 days of lymphodepletion preconditioning [fludarabine (30 mg/m2) and Cytoxan (300–500 ...