Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk for long-term complications and creating an immense management burden for caregivers. We ...conducted the first evaluation of the Omnipod 5 Automated Insulin Delivery System in this population.
A total of 80 children aged 2.0-5.9 years used the investigational system in a single-arm study for 13 weeks following 14 days of baseline data collection with their usual therapy.
There were no episodes of severe hypoglycemia or diabetic ketoacidosis. By study end, HbA1c decreased by 0.55% (6.0 mmol/mol) (P < 0.0001). Time with sensor glucose levels in target range 70-180 mg/dL increased by 10.9%, or 2.6 h/day (P < 0.0001), while time with levels <70 mg/dL declined by median 0.27% (P = 0.0204).
Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline.
Objective
To assess the safety and efficacy of short‐term meal replacement therapy followed by topiramate for body mass index (BMI) reduction in adolescents with severe obesity.
Methods
Adolescents ...(ages 12–18 years) with severe obesity (BMI ≥1.2 times the 95th percentile or BMI ≥35 kg/m2) were recruited for this double‐blind, randomized, placebo‐controlled trial. Participants completed 4 weeks of meal replacement therapy followed by randomization (1:1) to either 24 weeks of topiramate 75 mg/day or placebo. Mean changes were compared between groups.
Results
Thirty adolescents (mean age 15.2 ± 1.7 years, mean BMI 40.3 ± 4.6 kg/m2) completed the meal replacement phase and were randomized; 21 completed the study. The difference in mean percent change in BMI between the topiramate and placebo groups was not significant (−1.9%; 95% CI: −5.2% to +1.5%; P = 0.291). Significant improvements in visceral fat and very‐low‐density lipoprotein cholesterol were observed in the topiramate compared with the placebo group. There were no concerning changes in neurocognitive function or bone health.
Conclusions
In this pilot study, 4 weeks of meal replacement therapy followed by 24 weeks of low‐dose topiramate compared with meal replacement therapy alone did not result in significant BMI reduction for adolescents with severe obesity.
The objective of this pilot study was to evaluate the effects of exenatide on BMI (primary endpoint) and cardiometabolic risk factors in nondiabetic youth with extreme obesity. Twelve children and ...adolescents (age 9–16 years old) with extreme obesity (BMI ≥1.2 times the 95th percentile or BMI ≥35 kg/m2) were enrolled in a 6‐month, randomized, open‐label, crossover, clinical trial consisting of two, 3‐month phases: (i) a control phase of lifestyle modification and (ii) a drug phase of lifestyle modification plus exenatide. Participants were equally randomized to phase‐order (i.e., starting with control or drug therapy) then crossed‐over to the other treatment. BMI, body fat percentage, blood pressure, lipids, oral glucose tolerance tests (OGTT), adipokines, plasma biomarkers of endothelial activation, and endothelial function were assessed at baseline, 3‐, and 6‐months. The mean change over each 3‐month phase was compared between treatments. Compared to control, exenatide significantly reduced BMI (−1.7 kg/m2, 95% confidence interval (CI) (−3.0, −0.4), P = 0.01), body weight (−3.9 kg, 95% CI (−7.11, −0.69), P = 0.02), and fasting insulin (−7.5 mU/l, 95% CI (−13.71, −1.37), P = 0.02). Significant improvements were observed for OGTT‐derived insulin sensitivity (P = 0.02) and β‐cell function (P = 0.03). Compliance with the injection regimen was excellent (≥94%) and exenatide was generally well‐tolerated (the most common adverse event was mild nausea in 36%). These preliminary data suggest that exenatide should be evaluated in larger, well‐controlled trials for its ability to reduce BMI and improve cardiometabolic risk factors in youth with extreme obesity.
The standard treatment of hypoparathyroidism is to control hypocalcemia using calcitriol and calcium supplementation. However, in severe cases this approach is insufficient, and the risks of ...intravenous (i.v.) calcium administration and prolonged hospitalization must be considered. While the use of recombinant human parathyroid hormone 1-34 rhPTH(1-34) for long-term control of hypocalcemia has been established, the benefits of short-term rhPTH(1-34) treatment in children have not been explored. We report two patients with hypoparathyroidism treated with rhPTH(1-34). Patient 1 is a 10-year-old female with polyglandular autoimmune syndrome type 1. Patient 2 is a 12-year-old female with hypoparathyroidism after total thyroidectomy. Both patients showed poor response to i.v. and oral calcium and calcitriol, and patient 1 did not respond to phosphate binders. Patient 1 had rapid increase in serum calcium with a decrease in serum phosphate after a 3-day course of subcutaneous rhPTH(1-34). Patient 2 had normalization of calcium and phosphate levels after a 7-day course of rhPTH(1-34). These cases support a role for rhPTH(1-34) in the acute management of hypoparathyroidism in hospitalized patients to more rapidly correct hypocalcemia and hyperphosphatemia, shorten hospitalization, and reduce the need for frequent i.v. calcium boluses.
To determine glove use and handwashing practices, the factors associated with infection control practices, and the frequency of potential microbial transmission in a long-term-care facility (LTCF).
...Observational study of 230 staff-resident interactions in an LTCF. We recorded resident characteristics, type of activity, staff credentials, and movements of the staff member's hands, then used the LTCF's guidelines to judge appropriateness of glove use and handwashing.
255-bed, university-based LTCF in Baltimore, Maryland.
A systematic sample of staff-resident interactions.
Gloves were worn in 139 (82%) of 170 interactions when indicated, but changed appropriately in only 1 (16%) of 132. Hands were washed when needed before an interaction in 27%, during an interaction in 0%, and after an interaction in 63%. Gloves were less likely to be used when caring for residents with gastrostomy tubes compared with other residents (relative risk, 0.85; 95% confidence interval, 0.73-0.98). Guidelines were followed more frequently during wound care than during other activities. Microbial transmission potentially could have occurred in 158 (82%) of 193 evaluable interactions.
We documented marked deficiencies in glove and handwashing, demonstrated the possible impact of these deficiencies, and identified factors associated with inadequate handwashing and glove use. This information can be used in future educational and research efforts to improve infection control practices.
To prevent the global health burdens of human immunodeficiency virus HIV and unintended/mistimed pregnancies, we developed an intravaginal ring IVR that delivers tenofovir TFV at ~10mg/day alone or ...with levonorgestrel LNG at ~20μg/day for 90 days. We present safety, pharmacokinetics, pharmacodynamics, acceptability and drug release data in healthy women. CONRAD A13-128 was a randomized, placebo controlled phase I study. We screened 86 women; 51 were randomized to TFV, TFV/LNG or placebo IVR 2:2:1 and 50 completed all visits, using the IVR for approximately 15 days. We assessed safety by adverse events, colposcopy, vaginal microbiota, epithelial integrity, mucosal histology and immune cell numbers and phenotype, cervicovaginal CV cytokines and antimicrobial proteins and changes in systemic laboratory measurements, and LNG and TFV pharmacokinetics in multiple compartments. TFV pharmacodynamic activity was measured by evaluating CV fluid CVF and tissue for antiviral activity using in vitro models. LNG pharmacodynamic assessments were timed based on peak urinary luteinizing hormone levels. All IVRs were safe with no significant colposcopic, mucosal, immune and microbiota changes and were acceptable. Among TFV containing IVR users, median and mean CV aspirate TFV concentrations remained above 100,000 ng/mL 4 hours post IVR insertion and mean TFV-diphosphate DP concentrations in vaginal tissue remained above 1,000 fmol/mg even 3 days post IVR removal. CVF of women using TFV-containing IVRs completely inhibited 94-100% HIV infection in vitro. TFV/LNG IVR users had mean serum LNG concentrations exceeding 300 pg/mL within 1 hour, remaining high throughout IVR use. All LNG IVR users had a cervical mucus Insler score <10 and the majority 95% were anovulatory or had abnormal cervical mucus sperm penetration. Estimated in vivo TFV and LNG release rates were within expected ranges. All IVRs were safe with the active ones delivering sustained high concentrations of TFV locally. LNG caused changes in cervical mucus, sperm penetration, and ovulation compatible with contraceptive efficacy. The TFV and TFV/LNG rings are ready for expanded 90 day clinical testing. Trial registration ClinicalTrials.gov #NCT02235662.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
In 2002, the Policy Center on the First Year of College (supported by The Pew Charitable Trusts, The Atlantic Philanthropies, and Lumina Foundation for Education) sponsored a project to recognize ...colleges and universities as "Institutions of Excellence" in their design and execution of the first year. Thirteen colleges and universities--representing a broad spectrum of campus types--were selected as exceptional institutions that place a high priority on the first-year experience. "Achieving and Sustaining Excellence in the First Year of College" includes case studies of each of the thirteen exemplary institutions. These studies illustrate and analyze the colleges' best practices in teaching, assessing, and retaining first-year college students. The individual case studies offer lessons learned and have broad potential application beyond the particular type of institution represented. After a foreword, preface, and two initial chapters, this book is divided into 7 parts: (1) Case Studies of Two-Year Institutions; (2) Case Studies of Four-Year Institutions with Fewer Than 2,000 Students; (3) Case Studies of Four-Year Institutions with 2,000 to 5,000 Students; (4) Case Studies of Four-Year Institutions with 5,000 to 10,000 Students; (5) Case Studies of Four-Year Institutions with 10,000 to 20,000 Students; (6) Case Studies of Four-Year Institutions with More Than 20,000 Students; and (7) Conclusion. The following are appended: (1) All Participants in the Institutions of Excellence Study (N = 130); (2) Initial Letter of Invitation to Participate in the Institutions of Excellence Project; (3) Semifinalists; (4) Letter to Semifinalists; (5) Announcement Letter to Thirteen Institutions of Excellence; and (6) Research Subject Information and Consent Form. An epilogue, list of references, and index are also included.
Multipurpose prevention technologies (MPTs), which prevent sexually transmitted infection(s) and unintended pregnancy, are highly desirable to women. In this randomized, placebo-controlled, phase I ...study, women used a placebo or tenofovir (TFV) and levonorgestrel (LNG) intravaginal ring (IVR), either continuously or cyclically (three, 28-day cycles with a 3 day interruption in between each cycle), for 90 days. Sixty-eight women were screened; 47 were randomized to 4 arms: TFV/LNG or placebo IVRs used continuously or cyclically (4:4:1:1). Safety was assessed by adverse events and changes from baseline in mucosal histology and immune mediators. TFV concentrations were evaluated in multiple compartments. LNG concentration was determined in serum. Modeled TFV pharmacodynamic antiviral activity was evaluated in vaginal and rectal fluids and cervicovaginal tissue ex vivo. LNG pharmacodynamics was assessed with cervical mucus quality and anovulation. All IVRs were safe with no serious adverse events nor significant changes in genital tract histology, immune cell density or secreted soluble proteins from baseline. Median vaginal fluid TFV concentrations were >500 ng/mg throughout 90d. TFV-diphosphate tissue concentrations exceeded 1,000 fmol/mg within 72hrs of IVR insertion. Mean serum LNG concentrations exceeded 200 pg/mL within 2h of TFV/LNG use, decreasing quickly after IVR removal. Vaginal fluid of women using TFV-containing IVRs had significantly greater inhibitory activity (87-98% versus 10% at baseline; p<0.01) against HIV replication in vitro. There was a >10-fold reduction in HIV p24 antigen production from ectocervical tissues after TFV/LNG exposure. TFV/LNG IVR users had significantly higher rates of anovulation, lower Insler scores and poorer/abnormal cervical mucus sperm penetration. Most TFV/LNG IVR users reported no change in menstrual cycles or fewer days of and/or lighter bleeding. All IVRs were safe. Active rings delivered high TFV concentrations locally. LNG caused changes in cervical mucus, sperm penetration, and ovulation compatible with contraceptive efficacy. Trial registration: ClinicalTrials.gov #NCT03279120.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background
Although exercise has been shown to improve cancer survivorship in other communities, cancer exercise studies among Native American communities are rare. We sought to adapt a ...Navajo-tailored cancer exercise pilot program to serve a broader Native American cancer community.
Methods
Tribal experts representing 10 different Tribal Nations were engaged in small focus groups (n = 2–4) to assess program materials for cultural appropriateness and adaptation to expand tribal inclusiveness. Facilitated by a trained Native American interviewer, focus groups were provided a primer survey and then reviewed intervention materials (protocols, incentives, logo, flyers, etc.). Consensus was reached by the research team on all program adaptations.
Results
The program name, Restoring Balance, layout, graphics, and symbols were considered culturally appropriate overall. Program exercises and biomarker measurements were viewed as valuable to health improvements in the community. Important color, linguistic, and logistic program modifications were recommended to improve cultural alignment. The order of incentive items was revised to highlight restoration and the logo rotated to align with the four corners of the earth, an important cultural element. Linguistic modifications primarily related to prior traumatic research experiences in Native American communities where data had been taken without adequate community benefit or permission. Program emphasis should be on nurturing, added value and giving.
Conclusion and Relevance
The methodology used for cultural expert review was successful in eliciting adaptations to expand the tribal inclusiveness of Restoring Balance. Culture, as well as historically traumatic research experiences, among Native American populations must be considered when adapting health promotion programming.
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