In recent years there has been growing interest in the potential benefits of CBD-rich cannabis treatment for children with ASD. Several open label studies and one double-blind placebo-controlled study have reported that CBD-rich cannabis is safe and potentially effective in reducing disruptive behaviors and improving social communication. However, previous studies have mostly based their conclusions on parental reports without the use of standardized clinical assessments. Here, we conducted an open label study to examine the efficacy of 6 months of CBD-rich cannabis treatment in children and adolescents with ASD. Longitudinal changes in social communication abilities and restricted and repetitive behaviors (RRB) were quantified using parent report with the Social Responsiveness Scale and clinical assessment with the Autism Diagnostic Observation Schedule (ADOS). We also quantified changes in adaptive behaviors using the Vineland, and cognitive abilities using an age-appropriate Wechsler test. Eighty-two of the 110 recruited participants completed the 6-month treatment protocol. While some participants did not exhibit any improvement in symptoms, there were overall significant improvements in social communication abilities as quantified by the ADOS, SRS, and Vineland with larger improvements in participants who had more severe initial symptoms. Significant improvements in RRB were noted only with parent-reported SRS scores and there were no significant changes in cognitive scores. These findings suggest that treatment with CBD-rich cannabis can yield improvements, particularly in social communication abilities, which were visible even when using standardized clinical assessments. Additional double-blind placebo-controlled studies utilizing standardized assessments are highly warranted for substantiating these findings.
There is growing evidence that intraoperative radiation therapy (IORT) may be a viable option in selected patients with early breast cancer. This study reports our 4-year experience with IORT. The perioperative outcome and imaging data of all patients who underwent IORT for early breast cancer at a tertiary medical center in 2014-2018 were retrospectively retrieved. The cohort included 158 patients aged 52-84 years (mean 68) with stage I (n = 137) or II (n = 21) breast cancer. Mean applicator size was 4.13 cm; IORT added a mean of 29 minutes to the operative time.Minor wound infections (n = 18, 11.4%) requiring antibiotics and drainage were the only postoperative complication. In 25 patients (15%), postoperative mammography demonstrated a seroma (n = 22) or fat necrosis (n = 3). The risk of wound infection or a new postoperative imaging finding was unrelated to patient age, operative time, tumor size, or comorbid diabetes or obesity. After a mean of 30 months' follow-up, none of the patients who met the institutional criteria for IORT had local recurrence, regardless of age, histology, tumor grade, KI67 proliferation index, pathologic stage, Recurrence Score, or additional whole-breast irradiation or adjuvant treatment.Patients for whom a Recurrence Score was determined (n = 55, 35%) had a significantly higher tumor grade, pathologic stage, and whole-breast irradiation/adjuvant chemotherapy rate than the remaining patients. IORT may be a safe alternative to traditional external beam radiation in well-selected patients with early breast cancer, with few minor complications and good 30-month outcome. K E Y W O R D Searly breast cancer, electronic brachytherapy, intraoperative radiation, radiation, Recurrence Score, targeted radiotherapy | 947 MELNIK Et aL.
In recent years there has been growing interest in the potential benefits of CBD-rich cannabis treatment for children with ASD. Several open label studies and one double blind placebo-controlled study have reported that CBD-rich cannabis is safe and potentially effective in reducing disruptive behaviors and improving social communication. However, previous studies have mostly based their conclusions on parental reports without the use of standardized clinical assessments. Here, we conducted an open label study to examine the efficacy of 6 months of CBD-rich cannabis treatment in children and adolescents with ASD. Longitudinal changes in social communication abilities and restricted and repetitive behaviors (RRB) were quantified using parent report with the Social Responsiveness Scale and clinical assessment with the Autism Diagnostic Observation Schedule (ADOS). We also quantified changes in adaptive behaviors using the Vineland, and cognitive abilities using an age-appropriate Wechsler test. Eighty-two of the 110 recruited participants completed the 6-month treatment protocol. While some participants did not exhibit any improvement in symptoms, there were overall significant improvements in social communication abilities as quantified by the ADOS, SRS, and Vineland with larger improvements in participants who had more severe initial symptoms. Significant improvements in RRB were noted only with parent reported SRS scores and there were no significant changes in cognitive scores. These findings suggest that treatment with CBD-rich cannabis can yield improvements, particularly in social communication abilities, which were visible even when using standardized clinical assessments. Additional double-blind placebo-controlled studies utilizing standardized assessments are highly warranted for substantiating these findings. Lay summary: Previous studies have reported that treatment with CBD-rich cannabis may reduce aberrant behaviors and improve social communication when measured with parent reported measures. Here we performed standardized clinical assessments before and after 6 months of treatment with CBD-rich cannabis. Both parent and clinician measures demonstrated that participants improved significantly in social skills, a core symptom of ASD. These encouraging results suggest that CBD-rich cannabis may be an effective treatment for at least some individuals with ASD.
Background: With approximately 1.6 million annual procedures in the United States and 3 million world-wide, needle biopsy is considered the Gold Standard for breast cancer diagnosis and treatment planning. Overdiagnosis can result in unnecessary treatment, cost, and anxiety, while underdiagnosis can delay treatment and diminish outcomes. A 2015 study published in JAMA1 found nearly 25% discordance between pathology diagnosis and expert review, most pronounced in cases of DCIS, Atypia and in patients with dense breasts. It has been well established that physiologic differences between benign and malignant tissues are reflected in their electrical properties.2,3,4 Access to real-time tissue properties during the biopsy procedure has the potential for increasing accuracy by enabling the most suspicious tissue to be sampled, and by providing the tissue characterization to pathology for comparison with histologic findings. Through research made possible by the European Union’s Horizon 2020 research award, this feasibility study sought to determine if five 0.8mm miniaturized, flexible RF sensors (Dune Medical Devices, Alpharetta, GA) mounted within the sample cavity of a 14-gauge biopsy needle can accurately measure and map the electrical properties of multiple breast tissue types. Methods: Between March, 2018 and March, 2019, 44 patients undergoing mastectomy or lumpectomy at three medical centers in Israel were enrolled in the study. The biopsy needle was applied to freshly excised specimens, with continuous readings by the sensors. An average of 8.1 cores (ranging from 2-10) were obtained from each specimen. Cores were oriented and analyzed by standard histopathology. Based on histology, the dielectric properties of the various tissue types were derived, and the ability of the device to differentiate between malignant and non-malignant tissue was assessed. Results: A total of 357 cores from 44 specimens were analyzed. Ease of use and quality of tissue samples were equivalent to that of a standard biopsy needle. The dielectric properties of three tissue groups: Fat, Healthy non-Fat, and Malignant, in the low radiofrequency range were measured, showing distinct differences between the various types. Feature sizes larger than 0.8 mm were analyzed. The differentiation ability between tissue types was characterized using sensitivity and specificity of 85% and 99% respectively. Conclusions: Miniature, flexible RF sensors can be incorporated onto a biopsy needle. Although this study utilized a 14-gauge core needle, the 0.8mm sensor size allows for configuration within both vacuum-assisted and core biopsy needles of various gauges. The dielectric properties of breast tissue can be assessed in real-time during the biopsy procedure. These results show promise in differentiating between breast tissue types, specifically cancerous and benign, enabling more accurate tissue sampling and subsequent diagnosis. Improving the accuracy of breast biopsies should provide immediate clinical impact by reducing overstaging and subsequent unneeded treatment, procedures and cost, as well as reducing understaging of breast cancer which results in delayed diagnosis and missed cancer. Forward-looking, real-time tissue characterization during biopsy could prove especially beneficial should newer protocols currently under trial, such as active surveillance for low risk DCIS5 and omission of surgery for exceptional responders of neoadjuvant chemotherapy,6 become treatment options. The ability to mount the sensors to minimally invasive treatment devices will lay the foundation for expanding the technology to other cancer types, with the potential for precision delivery of new targeted drugs, radiation and ablation therapies at the site of the cancer. Citation Format: Noemi Weisenberg, Avihai Lachman, Lisa Cadena, Inbal Shimens, Olga Shmain, Ahuva Grubstein, Yael Rapson, Hana Cernik, Debora Kidron, Tania Zehavi, Evgeny Edelstein, Vladimir Kravtsov, Tatiana Kogan, Meirav Wolff Bar, Judith Diment, Ilana Haas, Patricia Malinger, Eran Sharon, Yehudit Birnbaum, Ada Magen, Yael Sobol, Osnat Givon Madhala, Sonya Wadhawker, Tanir M Allweis. Feasibility of incorporating miniaturized, flexible radiofrequency (RF) sensors in a breast biopsy needle for accurate real-time characterization of benign and malignant tissue [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT3-04-01.
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