Tissue-resident memory CD8 T cells (TRM) principally reside in peripheral nonlymphoid tissues, such as lung and skin, and confer protection against a variety of illnesses ranging from infections to cancers. The functions of different memory CD8 T cell subsets have been linked with distinct metabolic pathways and differ from other CD8 T cell subsets. For example, skin-derived memory T cells undergo fatty acid oxidation and oxidative phosphorylation to a greater degree than circulating memory and naive cells.
View Article and Find Full Text PDFObjective: In the LIBERTY 1 and LIBERTY 2 placebo-controlled trials, once-daily relugolix combination therapy reduced menstrual blood loss volume and pain in women with heavy menstrual bleeding associated with uterine leiomyomas and was well tolerated, with preservation of bone mineral density (BMD) through 24 weeks. Here we report the long-term efficacy and safety of relugolix combination therapy treatment for up to 52 weeks.
Methods: Women with uterine leiomyoma-associated heavy menstrual bleeding who completed any treatment arm in either the LIBERTY 1 or LIBERTY 2 trial were eligible to enroll in a 28-week long-term extension study.
J Pediatr Gastroenterol Nutr
February 2022
Infants born with congenital gastroschisis are at risk for intrauterine growth restriction, small for gestational size at birth, and growth failure during the newborn period despite advanced care. Body composition provides a more complete picture of proportional growth than weight and length alone. Fat-free mass (FFM) represents organ growth, and in preterm infants without gastroschisis, improved FFM deposition is associated with improved neurodevelopmental outcomes.
View Article and Find Full Text PDFObjective: To understand the nutritional intake and growth outcomes of very low birth weight infants with surgical necrotizing enterocolitis (NEC).
Study Design: In a retrospective cohort study, linear mixed models were used to compare growth outcomes from birth to 24 months corrected age for very low birth weight (VLBW) infants with surgical NEC to those with spontaneous intestinal perforation (SIP). Kaplan-Meier curves were developed to demonstrate the duration of parenteral nutrition (PN) use.
Objective: To assess the contraceptive efficacy, safety, and tolerability of a contraceptive transdermal delivery system, (TDS; TWIRLA) containing levonorgestrel (LNG) and ethinyl estradiol (EE).
Study Design: This single-arm, open-label, multicenter, 1-year (13 cycle), phase 3 study enrolled sexually active women ≥18 years old at risk for pregnancy irrespective of body mass index (BMI). Women used patches in 28-day cycles (3 consecutive administrations of 7-day patches followed by 7 days off-treatment/patch-free week).
Objective: The aim of this study was to determine whether a regional quality improvement (QI) initiative decreased incidence and severity of surgical necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants.
Study Design: A retrospective review of all VLBW infants who received care at one of the three hospitals involved in a NEC QI initiative from 2011 to 2016. Primary outcome was the number of surgical NEC cases per year.
Background: Uterine fibroids are hormone-responsive neoplasms that are associated with heavy menstrual bleeding. Elagolix, an oral gonadotropin-releasing hormone antagonist resulting in rapid, reversible suppression of ovarian sex hormones, may reduce fibroid-associated bleeding.
Methods: We conducted two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids 1 and 2 [UF-1 and UF-2]) to evaluate the efficacy and safety of elagolix at a dose of 300 mg twice daily with hormonal "add-back" therapy (to replace reduced levels of endogenous hormones; in this case, estradiol, 1 mg, and norethindrone acetate, 0.
Objective: To estimate contraceptive efficacy, safety, acceptability, and fit of a single-size diaphragm used with contraceptive gel.
Methods: We conducted a multicenter trial in which 450 couples used the single-size diaphragm, 300 randomized to acid-buffering gel and 150 to nonoxynol-9, for at least 190 days and six menstrual cycles. Visits were at enrollment and after menstrual cycles 1, 3, and 6.
Background: The present study was designed to determine the effect of short-term moderate-intensity exercise training on arterial stiffness in patients with chronic kidney disease (CKD) stage 3.
Study Design: Randomized controlled trial with a parallel-group design.
Setting & Participants: Testing and training sessions were performed at Springfield College.
Background: Tenofovir (TFV) gel is being evaluated as a microbicide with pericoital and daily regimens. To inhibit viral replication locally, an adequate concentration in the genital tract is critical.
Methods And Findings: Forty-nine participants entered a two-phase study: single-dose (SD) and multi-dose (MD), were randomized to collection of genital tract samples (endocervical cells [ECC], cervicovaginal aspirate and vaginal biopsies) at one of seven time points [0.
This study was conducted to determine the safety of tenofovir (TFV) gel, a potential microbicide, following seven consecutive daily penile applications. Eighteen circumcised and 18 uncircumcised healthy men were randomly assigned to TFV gel versus K-Y Jelly in a 2:1 ratio within circumcision group. TFV gel or K-Y Jelly was applied onto the penis at bedtime and washed off 6-10 hours later.
View Article and Find Full Text PDFBackground: Only one female condom [FC1 Female Condom (FC1)] is currently marketed, but it is poorly utilized, perhaps due to difficulty with insertion, discomfort and suboptimal functional performance during intercourse. The Program for Appropriate Technology in Health (PATH) Woman's Condom (WC) was developed in an effort to overcome these obstacles.
Study Design: This was a randomized crossover study to evaluate the functional performance, safety and acceptability of the FC1 and WC.
Background: The study was conducted to evaluate the efficacy and safety for the prevention of pregnancy of a 28-day oral contraceptive (OC) containing 150 mcg desogestrel (DSG)/20 mcg ethinyl estradiol (EE) for 21 days followed by 7 days of 10 mcg EE (Cette-28).
Study Design: A 6-month, prospective, multicenter, single-arm study was conducted in 1302 women aged 18-45 years.
Results: Over six cycles of treatment, the cumulative risk of pregnancy among all treated subjects (n=1262) was 0.
Background: Higher rates of unwanted pregnancies and lower rates of contraceptive use have been reported among Hispanic women than among non-Hispanic whites. Despite these differences, it is unclear how these groups differ with respect to various psychosocial factors that are associated with contraceptive decision making, including contraceptive knowledge, attitudes, self-efficacy and social support.
Methods: A total of 443 sexually active, nonpregnant, low-income women (137 non-Hispanic whites, 74 US-born Hispanics and 231 non-US-born Hispanics) were surveyed at two publicly funded clinics.
Objective: To examine physicians' views and practices concerning estrogen+progestogen therapy (EPT).
Design: Questionnaires were mailed to a random sample of physicians in the United States (US) in 2003. A total of 1614 (53.
Perspect Sex Reprod Health
December 2005
Context: Hormonal contraceptive users may be at increased risk for HIV and other STDs. An understanding of their decisions and abilities to use condoms is needed to focus intervention programs aimed at improving their protective behaviors.
Methods: Between 1999 and 2001, 426 new users of depot medroxyprogesterone acetate (DMPA) and oral contraceptives were recruited from public clinics providing family planning services to low-income women and surveyed when they began their method and again three months later.
Hematopoietic stem cells (HSCs) maintain tissue homeostasis by rapidly responding to environmental changes. Although this function is well understood, the molecular mechanisms governing this characteristic are largely unknown. We used a sequenced-based strategy to explore the role of both transcriptional and post-transcriptional regulation in HSC biology.
View Article and Find Full Text PDFObjective: To investigate quantitative aberrations involving p53 copy numbers in eutopic endometrial and endometriotic tissue from two populations.
Design: Comparative analysis of normal and diseased tissue.
Setting: Tissue specimens collected in Iceland and USA.
Objectives: The purpose of this study was to examine the independent role of paternal influences on the onset of prenatal care among Hispanic women.
Methods: A total of 300 pregnant Hispanic women seeking prenatal care on or before their 35th week of gestation were surveyed about their and their partner's pregnancy intention. Women in this study were recruited from clinics providing services to low income and medically indigent women.
Background: ACIDFORM gel is being studied as a vaginal contraceptive and microbicide. This study was conducted to make certain that males will not be subjected to an unacceptable risk of penile irritation as a result of exposure to the product in future studies.
Methods: This was a randomized, double-masked, single-center Phase I study in circumcised and uncircumcised men to assess penile irritation, safety and acceptability of seven consecutive doses of ACIDFORM gel compared with K-Y Jelly Personal Lubricant.
Objective: To examine the acceptability of five nonoxynol-9 (N-9) spermicides.
Methods: We analyzed data from a randomized trial of five products, including three gels containing different amounts of N-9 per dose, a film and a suppository. In the trial, 1536 participants were asked to use the assigned spermicide for 7 months and to complete questionnaires 4 weeks after admission and at discontinuation.
Objectives: The safety and efficacy of a single-rod implantable contraceptive containing etonogestrel (Implanontrade mark) were investigated in a multicenter clinical trial.
Study Design: Sexually active American women (N=330) with apparently normal menstrual cycles used the implant for up to 2 years. All subjects recorded bleeding and/or spotting daily in a diary.