A Double-Blind, Randomized, Placebo-Controlled Clinical Study of Trofinetide in the Treatment of Fragile X Syndrome.

Background: We analyze the safety and tolerability of trofinetide and provide a preliminary evaluation of its efficacy in adolescent and adult males with fragile X syndrome.

Methods: This study was an exploratory, phase 2, multicenter, double-blind, placebo-controlled, parallel group study of the safety and tolerability of orally administered trofinetide in 72 adolescent and adult males with fragile X syndrome. Subjects were randomly assigned in a 1:1:1 ratio to 35 or 70 mg/kg twice daily trofinetide or placebo for 28 days.

Double-blind, randomized, placebo-controlled study of trofinetide in pediatric Rett syndrome.

Objective: To determine safety, tolerability, and pharmacokinetics of trofinetide and evaluate its efficacy in female children/adolescents with Rett syndrome (RTT), a debilitating neurodevelopmental condition for which no pharmacotherapies directed at core features are available.

Methods: This was a phase 2, multicenter, double-blind, placebo-controlled, parallel-group study, in which safety/tolerability, pharmacokinetics, and clinical response to trofinetide were characterized in 82 children/adolescents with RTT, aged 5 to 15 years. Sixty-two participants were randomized 1:1:1:1 to receive placebo twice a day (bid) for 14 days, followed by placebo, 50, 100, or 200 mg/kg bid of trofinetide for 42 days.

A Double-Blind, Randomized, Placebo-Controlled Clinical Study of Trofinetide in the Treatment of Rett Syndrome.

Background: This study aimed to determine the safety and tolerability of trofinetide and to evaluate efficacy measures in adolescent and adult females with Rett syndrome, a serious and debilitating neurodevelopmental condition for which no therapies are available for its core features.

Methods: This was an exploratory, phase 2, multicenter, double-blind, placebo-controlled, dose-escalation study of the safety and tolerability of trofinetide in 56 adolescent and adult females with Rett syndrome. Subjects were randomly assigned in a 2:1 ratio to 35 mg/kg twice daily of trofinetide or placebo for 14 days; 35 mg/kg twice daily or placebo for 28 days; or 70 mg/kg twice daily or placebo for 28 days.

Impact of the Minnesota Parental Notification Law on abortion and birth.

Background: The impact of the Minnesota Parental Notification Law on abortion and birth was examined.

Methods: Using linear models, outcome parameters were compared before and after enactment of the law. Time by age group interactions also were examined.

Longer hospitalization at Veterans Administration hospitals than private hospitals. Verification and additional insights.

Utilizing 1,297 male patients under the primary care of an identical group of house officers and under treatment between 1985 and 1987 for ten common medical diagnoses, length of hospitalization was compared between a private sector (n = 481) and Veterans Administration (VA) (n = 816) facility, both affiliated with the same medical school. All patients were rated by the Horn Severity of Illness Index. After researchers controlled for diagnosis, severity of illness, age, race, and physician, results in this study indicate that an additional 3.

Psychological impact of abortion: methodological and outcomes summary of empirical research between 1966 and 1988.

A systematic "roadmap" through the medical literature that empirically examines the incidence of psychological sequelae of induced abortion is presented. Because outcome incidence rates and methodological profiles vary substantially across studies, selective use of articles from this literature without an accompanying rationale for that selectivity could foster erroneous conclusions. Information compiled here can facilitate a rapid methodological critique of citations in abortion-related materials.