A randomized, double-blind, placebo controlled, phase 1 study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of LB-102, a selective dopamine D/5-HT inhibitor.

LB-102 is an N-methylated analogue of amisulpride under development to treat schizophrenia. LB-102 was evaluated in a Phase 1, double-blind, placebo-controlled, clinical study to evaluate safety and pharmacokinetics. This was a first-in-human study examining single and multiple doses of LB-102 administered orally in 64 healthy volunteers.

Can digital engagement improve outcomes for total joint replacements?

Background: Patient activation and engagement can improve outcomes of medical and surgical care by increasing involvement of patients in their care plan. We designed a digital engagement tool to improve surgical cancellation and post-surgical outcomes for adult patients undergoing total joint replacements by providing patient education materials via email or text, in small increments throughout the perioperative period.

Methods: We assessed the tool's impact using a quasi-experimental design comparing patients scheduled for surgery January-June 2017 (pre-intervention) versus January-June 2018 (post-intervention).

Pharmacokinetic Profile and Tolerability of Liposomal Bupivacaine Following a Repeated Dose via Local Subcutaneous Infiltration in Healthy Volunteers.

Background: Liposomal bupivacaine is indicated for administration into the surgical site to produce post-surgical analgesia.

Objectives: The objectives of this study were to characterize the pharmacokinetic and safety profiles of liposomal bupivacaine following a repeated dose in healthy volunteers.

Methods: Healthy adults were assigned to receive liposomal bupivacaine via subcutaneous infiltration in a single 266 mg dose (cohort 1) or in two 266 mg doses, with the second dose given immediately, 24, 48, or 72 h after the first dose (cohorts 2-5).

Utility of DNA postreplication repair protein Rad6B in neoadjuvant chemotherapy response.

Neoadjuvant chemotherapy is a standard therapy for patients with locally advanced breast cancer (LABC) and is increasingly used for early stage operable breast cancer. Not all patients benefit from it, and reliable markers for predicting response are needed. The cytotoxic effects of chemotherapy are mediated by induction of DNA damage in tumor cells.

A phase II study of docetaxel, doxorubicin, and infusional 5-fluorouracil in the treatment of patients with locally advanced breast cancer.

Objective: The primary aim of this study was to estimate the rate of clinical and pathologic response to preoperative docetaxel, doxorubicin, and infusional 5-fluorouracil in patients with locally advanced breast cancer. Secondary objective included the determination of toxicity profile.

Patients And Methods: Thirty-nine patients (median age 49 years) with histologically confirmed locally advanced breast cancer (stage IIIA or IIIB) were studied.

Drug-induced liver damage -- a three-year study of patients from one gastroenterological department.

Background: The aim of our study was to analyze drug-induced liver disease over a 3-year period in one gastroenterological department.

Material/methods: International consensus standard definitions and criteria for assessing causality of adverse drug reactions were applied to all patients with abnormal hepatic test results.

Results: Drugs were implicated in hepatic injury in 14 patients (8 females) in whom causal relationship between drug and liver disease was definite or highly probable.

Clinicopathologic Analysis of Fas, Fas Ligand, and Other Biomarkers in Locally Advanced Breast Carcinoma.

Fas and Fas ligand (FasL) mediate T-lymphocyte cytotoxicity and may also induce physiologic apoptosis in breast epithelium associated with menstruation and cessation of lactation. Altered expression may thus be associated with breast carcinoma progression, chemotherapy response, or outcome. We performed a clinicopathologic analysis of immunohistochemical staining for Fas and FasL, as well as bax, bcl-2, glutathione-s-transferase, HER-2 (c-erbB-2), Ki67, P-glycoprotein, p53, and hormone receptors in pretreatment breast biopsies from 34 patients with locally advanced or limited stage IV breast carcinoma who received preoperative (neoadjuvant, primary) chemotherapy followed by lumpectomy or mastectomy.

Surgical outcomes after breast cancer surgery: measuring acute lymphedema.

Background: Studies of lymphedema have used inconsistent measures and criteria. The purpose of this pilot study was to measure the onset and incidence of acute lymphedema in breast cancer survivors using strict criteria for limb evaluation.

Materials And Methods: Eligible women were those undergoing breast cancer surgery that included axillary staging and/or radiation therapy of the breast.

HER-2/neu expression in pancreatic adenocarcinoma: relation to tumor differentiation and survival.

HER-2/neu expression in pancreatic adenocarcinoma has been inconsistently reported and has not been fully evaluated with respect to histologic grade and tumor grade heterogeneity. We studied HER-2/neu expression in a series of 79 primary pancreatic carcinomas using immunohistochemical methods, with expression scored for each histologic grade represented in each tumor. We found significantly lower expression of HER-2/neu in poorly differentiated (PD) portions of tumors-those areas lacking glandular differentiation-compared to well-differentiated (WD) and moderately differentiated (MD) portions of tumors.

Antitumor efficacy of interleukin-2 alone and in combination with adriamycin and dacarbazine in murine solid tumor systems.

Recombinant interleukin-2 (IL-2)/chemotherapy combinations have recently entered clinical trial. The rationale for sequencing has primarily been empiric or based on in vitro data. To establish in vivo models for chemoimmunotherapy trials, we investigated IL-2 alone and in combination with dacarbazine (DTIC) and adriamycin.

Antitumor efficacy of PD115934 (NSC 366140) against solid tumors of mice.

PD115934 (NSC 366140) is a soluble pyrazoloacridine derivative presently undergoing preclinical toxicology evaluation with the anticipation of Phase I human investigation. The agent displayed both human and murine solid tumor selectivity in vitro in a soft agar disk diffusion assay, relative to its activity against murine L1210 leukemia. In vivo it was highly active against solid tumors colon adenocarcinoma 38 and pancreas ductal carcinoma 03, which was consistent with the cellular cytotoxicity seen in the disk diffusion assay.

Activity of datelliptium acetate (NSC 311152; SR 95156A) against solid tumors of mice.

Datelliptium acetate (NSC 311152) is a water soluble analogue of ellipticine. It is a solid tumor selective compound. In vitro, in a disk diffusion, soft agar colony formation assay (25 micrograms/disk), the compound demonstrated solid tumor selectivity (compared to leukemia L1210) against colon adenocarcinoma 38 and pancreas ductal carcinoma 03.