Use of osteogenic bone matrix in patients with traumatic long bone defects: An open label, single center study.

Background: Osteogenic Bone Matrix (Altis™ OBM) is a tissue-engineered, porcine-derived demineralized bone matrix prepared using a humanization processing technology that confers biocompatibility and improved osteoinductivity. The objective of this study was to determine the safety and efficacy of OBM in patients with traumatic long bone defects in an open-label, non-randomized single-center study.

Methods: Diagnosis and main criteria for inclusion were open long bone fractures graded as Gustilo-Anderson Grade II, IIIA or IIIB.

Safety, Tolerability, Pharmacokinetics, and Metabolism of Telacebec (Q203) for the Treatment of Tuberculosis: a Randomized, Placebo-Controlled, Multiple Ascending Dose Phase 1B Trial.

A phase 1b, randomized, placebo-controlled, double-blind, multiple ascending dose study (NCT02858973) was conducted to assess the safety, tolerability, and pharmacokinetics of the new antituberculosis agent telacebec (Q203). A total of 47 healthy adult subjects entered the study; 36 received telacebec, and 11 received placebo. Telacebec at doses of 20, 50, 100, 160, 250, and 320 mg was orally administered once daily with a standard meal for 14 days.

Safety, Tolerability, and Pharmacokinetics of Telacebec (Q203), a New Antituberculosis Agent, in Healthy Subjects.

Telacebec (Q203) is a potent drug candidate under clinical development for the treatment of drug-naïve and drug-resistant tuberculosis. The first-in-human randomized, placebo-controlled, double-blind, dose-escalation Phase 1A trial (Q203-TB-PI-US001) was conducted to evaluate the safety, tolerability, and pharmacokinetics of telacebec. A total of 56 normal, healthy, male and female subjects (42 active and 14 placebo) were enrolled in the study.

Bactericidal activity of pyrazinamide and clofazimine alone and in combinations with pretomanid and bedaquiline.

Rationale: New regimens to shorten tuberculosis treatment and manage patients with drug-resistant tuberculosis who are infected with HIV are urgently needed. Experimental and clinical evidence suggests that the new drugs bedaquiline (B) and pretomanid (Pa), combined with an existing drug, pyrazinamide (Z), and a repurposed drug, clofazimine (C), may assist treatment shortening of drug-susceptible and drug-resistant tuberculosis.

Objectives: To evaluate the 14-day bactericidal activity of C and Z in monotherapy and in combinations with Pa and B.

Home-based administration of Sayana® Press: review and assessment of needs in low-resource settings.

A new presentation of the subcutaneous (SC) injectable contraceptive depot medroxyprogesterone acetate (DMPA) increases the possibilities for home and self-administration of this popular contraceptive method. Sayana® Press is DMPA-SC in the prefilled Uniject™ injection system and consists of one dose that provides 3 months of contraceptive protection. Studies indicate that lay caregiver and self-injection of various medications, including other injectable presentations of DMPA-SC, are acceptable and effective.

Making evidence work for communities: the role of nongovernmental organizations in translating science to programs.

Evidence-informed public health refers to the process of applying proven interventions within the context of community preferences in order to achieve positive health impacts. A key role for nongovernmental organizations (NGOs) in evidence-informed public health is to use and expand on research to help shape appropriate interventions for diverse communities. This article suggests that NGOs are particularly well positioned for this role for a number of reasons, including their geographic reach, their engagement with diverse stakeholders, and their extragovernmental position, which enables them to develop and advocate for innovative, scientifically sound solutions to long-standing health challenges.