We reviewed procedures for and data about patient notification of the suspension of the treatment protocol for four clinical trials. We also examined how data collected after the suspensions were used. All four trials were designed to evaluate treatments for cytomegalovirus retinitis in patients with AIDS and were conducted by the Studies of Ocular Complications of AIDS Research Group. Documentation that patients were notified of the results varied from 62--100% with three of the four studies documenting the process for > or =92% of patients. The median time between the recommendation for protocol suspension and patient notification varied from 7--49 days with three of the four trials at 12 days or fewer. Most of the analyses of data collected after the suspension of the treatment protocol did not focus on comparisons among treatment groups. Although they provided useful information about the long-term outcomes and the nature of the disease, they did not alter the conclusions about safety and efficacy from the randomized portion of the trial. Control Clin Trials 2001;22:62-68
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1016/s0197-2456(00)00112-4 | DOI Listing |
Mol Psychiatry
January 2025
Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University, Shanghai, China.
To understand the neural mechanism of autism spectrum disorder (ASD) and developmental delay/intellectual disability (DD/ID) that can be associated with ASD, it is important to investigate individuals at an early stage with brain, behavioural and also genetic measures, but such research is still lacking. Here, using the cross-sectional sMRI data of 1030 children under 8 years old, we employed developmental normative models to investigate the atypical development of gray matter volume (GMV) asymmetry in individuals with ASD without DD/ID, ASD with DD/ID and individuals with only DD/ID, and their associations with behavioral and clinical measures and transcription profiles. By extracting the individual deviations of patients from the typical controls with normative models, we found a commonly abnormal pattern of GMV asymmetry across all ASD children: more rightward laterality in the inferior parietal lobe and precentral gyrus, and higher individual variability in the temporal pole.
View Article and Find Full Text PDFMed J Malaysia
January 2025
Universiti Teknologi MARA, Faculty of Medicine, Department of Public Health Medicine, Sungai Buloh, Selangor, Malaysia.
Introduction: Tuberculosis (TB) is one of the major global health challenges and concerns. Despite the availability of effective treatment in Malaysia, it remained a consistently high notification rate of TB cases. The objective of this study was to determine the proportion of successful TB treatment outcomes and its determinants among TB with comorbidities patients in Negeri Sembilan, Malaysia.
View Article and Find Full Text PDFSurg Endosc
January 2025
Department of Surgery 1, General (Endoscopic) Surgery, Hamamatsu University School of Medicine, 1-20-1 Handayama Chuouku, Hamamatsu, Shizuoka, 431-3192, Japan.
Background: The impact of completely reducing or transecting a hernia sac on seroma formation in laparoscopic surgery for lateral inguinal hernias remains debated. To date, no studies have compared the incidence of seroma in hernia sacs left untouched versus other surgical approaches. Abandoning the hernia sac involves avoiding manipulation of the inguinal canal, unlike the manipulation required for transection or reduction of the hernia sac.
View Article and Find Full Text PDFJ Paediatr Child Health
January 2025
School of Clinical Medicine, The University of New South Wales, Sydney, New South Wales, Australia.
Aim: The introduction and increasing popularity of indoor trampoline facilities has seen increases in the incidence of trampoline park injuries (TPIs), particularly amongst the paediatric population. A challenge to the development of effective injury prevention interventions is the limited study pool of detailed activity and outcome data to provide better understanding of the characteristics of injurious events.
Methods: A cross-sectional study of individuals under 16 years of age hospitalised after TPI from November 2018 to December 2021 was conducted.
BMC Public Health
January 2025
National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Via Portuense, Rome, 292-00149, Italy.
Background: The coronavirus disease 2019 (COVID-19) emergency has represented a profound upheaval in the dynamics of infectious diseases transmission worldwide. This phenomenon has been at least in part driven by the introduction of non-pharmaceutical interventions (NPIs), implemented to counteract viral transmission. Our study aimed to assess the magnitude and the features of the impact of the COVID-19 pandemic on the incidence of notifiable infectious diseases (NIDs) in the Lazio region, Italy.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!