End points for sickle cell disease clinical trials: patient-reported outcomes, pain, and the brain

To address the global burden of sickle cell disease (SCD) and the need for novel therapies, the American Society of Hematology partnered with the US Food and Drug Administration to engage the work of 7 panels of clinicians, investigators, and patients to develop consensus recommendations for clinical trial end points. The panels conducted their work through literature reviews, assessment of available evidence, and expert judgment focusing on end points related to: patient-reported outcomes (PROs), pain (non-PROs), the brain, end-organ considerations, biomarkers, measurement of cure, and low-resource settings. This article presents the findings and recommendations of the PROs, pain, and brain panels, as well as relevant findings and recommendations from the biomarkers panel. The panels identify end points, where there were supporting data, to use in clinical trials of SCD. In addition, the panels discuss where further research is needed to support the development and validation of additional clinical trial end points

Stereotypical Behaviors in Chimpanzees Rescued from the African Bushmeat and Pet Trade

Many orphaned chimpanzees whose mothers are illegally killed for their meat (bushmeat) in Africa are sold as pets or kept caged at hotels and businesses to attract tourists. As a result of being separated from their mothers and other chimpanzees at an early age, and spending years in impoverished captive conditions, some of these individuals engage in abnormal behaviors, including stereotypically scratching at their flesh and repetitively rocking back and forth. This paper presents case studies of Poco and Safari, two chimpanzees who were rescued by sanctuaries after living alone on display for humans at businesses for the first 7 to 8 years of their lives. Decades after their rescue, they still engage in stereotypical behaviors as a result of the psychological and physical trauma they endured early on. This paper combines data from in depth interviews with caregivers and direct observations of abnormal behaviors to assess psychological distress in captive-living chimpanzees. Our results highlight some lesser known harms of the bushmeat trade and the detrimental life-long consequences that keeping chimpanzees as “pets” can have on their mental health

Transport Properties of Concentrated Aqueous Sodium Dodecyl Sulfate Solutions in Polymer Membranes Derived from Cellulose Esters

Polymer membranes with differing degrees of hydrophilicity were prepared from mixtures of cellulose acetate butyrate and cellulose acetate hydrogen phthalate. The degree of hydrophilicity was determined from measurements of water uptake and the apparent water diffusion coefficient. The transport properties of sodium dodecyl sulfate through these membranes were studied by measuring permeability using the time-lag technique. The mutual differential diffusion coefficients of the surfactant are 1−2 orders of magnitude lower than in aqueous solution. The permeability and partition coefficients between the aqueous subphase and membranes were found to depend on the hydrophilicity of the polymer blend, but to be virtually independent of temperature. Possible applications of these systems in surfactant purification are suggested

End points for sickle cell disease clinical trials:Patient-reported outcomes, pain, and the brain

To address the global burden of sickle cell disease (SCD) and the need for novel therapies, the American Society of Hematology partnered with the US Food and Drug Administration to engage the work of 7 panels of clinicians, investigators, and patients to develop consensus recommendations for clinical trial end points. The panels conducted their work through literature reviews, assessment of available evidence, and expert judgment focusing on end points related to: patient-reported outcomes (PROs), pain (non-PROs), the brain, end-organ considerations, biomarkers, measurement of cure, and low-resource settings. This article presents the findings and recommendations of the PROs, pain, and brain panels, as well as relevant findings and recommendations from the biomarkers panel. The panels identify end points, where there were supporting data, to use in clinical trials of SCD. In addition, the panels discuss where further research is needed to support the development and validation of additional clinical trial end points.</p