Corrigendum: Safety, feasibility, tolerability, and clinical effects of repeated psilocybin dosing combined with non-directive support in the treatment of obsessive-compulsive disorder: protocol for a randomized, waitlist-controlled trial with blinded ratings.

[This corrects the article DOI: 10.3389/fpsyt.2023.1278823.].

Safety, tolerability, and clinical and neural effects of single-dose psilocybin in obsessive-compulsive disorder: protocol for a randomized, double-blind, placebo-controlled, non-crossover trial.

Background: Psilocybin may help treat obsessive-compulsive disorder (OCD). To date, only one open-label study of psilocybin for OCD exists, necessitating further investigation with a randomized controlled design. The neural correlates of psilocybin's effects on OCD have also not been studied. Objectives: This first-of-its-kind trial aims to evaluate the feasibility, safety, and tolerability of psilocybin in the treatment of OCD, provide preliminary evidence on the effects of psilocybin on OCD symptoms, and elucidate neural mechanisms that may mediate psilocybin's effects on OCD. Design: We use a randomized (1:1), double-blind, placebo-controlled, non-crossover design to examine the clinical and neural effects of either a single dose of oral psilocybin (0.25 mg/kg) or active placebo-control agent (250 mg of niacin) on OCD symptoms. Methods and analysis: We are enrolling 30 adult participants at a single site in Connecticut, USA who have failed at least one trial of standard care treatment (medication/psychotherapy) for OCD. All participants will also receive unstructured, non-directive psychological support during visits. Aside from safety, primary outcomes include OCD symptoms over the past 24 h, assessed by the Acute Yale-Brown Obsessive-Compulsive Scale and Visual Analog Scale ratings. These are collected by blinded, independent raters at baseline and the primary endpoint of 48 h post-dosing. Total follow-up is 12 weeks post-dosing. Resting state neuroimaging data will be collected at baseline and primary endpoint. Participants randomized to placebo will be offered the chance to return for an open-label dose of 0.25 mg/kg. Ethics statement: All participants will be required to provide written informed consent. The trial (protocol v. 5.2) was approved by the institutional review board (HIC #2000020355) and registered with ClinicalTrials.gov (NCT03356483). Discussion: This study may represent an advance in our ability to treat refractory OCD, and pave the way for future studies of neurobiological mechanisms of OCD that may respond to psilocybin.

Safety, feasibility, tolerability, and clinical effects of repeated psilocybin dosing combined with non-directive support in the treatment of obsessive-compulsive disorder: protocol for a randomized, waitlist-controlled trial with blinded ratings.

Background: To date, few randomized controlled trials of psilocybin with non-directive support exist for obsessive-compulsive disorder (OCD). Results and participant feedback from an interim analysis of an ongoing single-dose trial (NCT03356483) converged on the possibility of administering a higher fixed dose and/or more doses of psilocybin in future trials for presumably greater benefits. Objectives: This trial aims to evaluate the safety, feasibility, tolerability, and clinical effects of two doses of psilocybin paired with non-directive support in the treatment of OCD. This trial also seeks to examine whether two doses of psilocybin lead to greater OCD symptom reduction than a single dose, and to elucidate psychological mechanisms underlying the effects of psilocybin on OCD. Design: A randomized (1:1), waitlist-controlled design with blinded ratings will be used to examine the effects of two doses of oral psilocybin paired with non-directive support vs. waitlist control on OCD symptoms. An adaptive dose selection strategy will be implemented (i.e., first dose: 25 mg; second dose: 25 or 30 mg). Methods and analysis: This single-site trial will enroll 30 adult participants with treatment-refractory OCD. Aside from safety, feasibility, and tolerability metrics, primary outcomes include OCD symptoms assessed on the Yale-Brown Obsessive-Compulsive Scale - Second Edition (Y-BOCS-II). A blinded independent rater will assess primary outcomes at baseline and the primary endpoint at the end of the second dosing week. Participants will be followed up to 12 months post-second dosing. Participants randomized to waitlist will be rescreened after 7 weeks post-randomization, and begin their delayed treatment phase thereafter if still eligible. Ethics: Written informed consent will be obtained from participants. The institutional review board has approved this trial (protocol v. 1.7; HIC #2000032623). Discussion: This study seeks to advance our ability to treat refractory OCD, and catalyze future research seeking to optimize the process of psilocybin treatment for OCD through understanding relevant psychological mechanisms.Clinical trial registration: ClinicalTrials.gov, identifier NCT05370911.

Intracardiac atypical leiomyoma involving all four cardiac chambers and the aorta.

Intravenous leiomyomatosis is a rare gynecologic disease that can be complicated with intracardiac involvement. All reported cases with cardiac extension involved the right cardiac chambers. Intracardiac leiomyoma may present with dyspnea, chest pain, palpitations, lower extremity swelling, or syncope. This is a unique case of a 40-year-old asymptomatic woman with incidental finding of a cardiac murmur. Echocardiography showed an echodensity in all cardiac chambers. Urgent cardiac surgery revealed an intracardiac leiomyoma, extending from the inferior vena cava and involving all four cardiac chambers and the aortic root.

Calcaneonavicular coalition: treatment by excision and fat graft.

BACKGROUND: Symptomatic calcaneonavicular coalitions treated with resection and interposition of the extensor digitorum brevis (EDB) muscle often have unpredictable improvement of symptoms. Concerns with regard to skin cosmesis from a bony prominence on the lateral aspect of the foot and inadequate filling of the resection gap potentially causing reossification have motivated us to use fat graft interposition instead. The purpose of this study was to describe our surgical technique and report our clinical and radiographic outcomes for fat graft interposition after resection of a calcaneonavicular coalition. METHODS: A retrospective review of all pediatric patients surgically treated with a calcaneonavicular coalition resection from January 1999 to December 2006, was performed. Presenting symptoms and examination findings were recorded. Postoperative examinations and imaging studies were evaluated to grade reossification, and functional outcomes were assessed for all patients with minimum 1-year postoperative follow-up. In addition, a cadaveric study was performed to compare the efficacy of EDB and fat graft interposition in terms of filling the postresection gap. RESULTS: Foot pain was the most common presenting complaint, though limitation of activities, stiffness, preoperative hindfoot malalignment, and associated injuries were also frequently observed. One year after resection, 87% of the patients returned to sport or their past activities, whereas 5% had symptomatic regrowth requiring repeat resection. Seventy-four percent had improvement of subtalar motion and 82% had improvement of plantarflexion; which was identified as an additional clinical sign of a calcaneonavicular bar. Preoperative pain averaged 7 of 10, whereas postoperative pain averaged less than 1 of 10 at rest, while walking, and with activities. The cadaveric study showed that the EDB was able to fill on average only 64% of the resected gap, leaving approximately 10 mm of the plantar gap unfilled. CONCLUSIONS: Reossification and reoperation rates with fat graft interposition in our series were lower than in most published reports of EDB interposition. Ankle and subtalar motion improved in a vast majority of the patients, and most patients returned to sport without requiring further surgery. Resection of a calcaneonavicular coalition with interposition of fat graft, when meticulously performed, is an effective way to relieve symptoms, restore subtalar motion, and return patients to activities, while preventing reossification.

Spontaneous lumbar curve correction in selective thoracic fusions of idiopathic scoliosis: a comparison of anterior and posterior approaches.

STUDY DESIGN: A retrospective evaluation of adolescent idiopathic scoliosis (AIS) patients treated with selective thoracic instrumentation and fusion. OBJECTIVE: To evaluate the predictors and the effect of surgical approach (anterior versus posterior) on spontaneous lumbar curve correction (SLCC) after selective thoracic fusion in patients with structural thoracic and compensatory lumbar curves. SUMMARY OF BACKGROUND DATA: Spontaneous coronal correction of the unfused lumbar curve has been described previously; however controversy continues regarding the effect of surgical approach on SLCC. METHODS: One hundred thirty-two anterior and 44 posterior selective thoracic fusions instrumented distally to T11, T12, or L1 were identified from a multicenter AIS database. A 2-way ANOVA was used to compare SLCC with regards to surgical approach and the lowest instrumented vertebra (LIV). A Pearson's correlation analysis was utilized to identify radiographic variables associated with SLCC. A secondary analysis of surgical approach was then performed on 28 pairs of patients matching the factors that correlated positively with SLCC. RESULTS: The average SLCC for the anterior approach (44% +/- 19%) was less than that for the posterior approach (49% +/- 19%; P = 0.07), and was found to increase significantly with a more distal LIV (P = 0.03). Pearson's correlation analysis revealed the strongest correlations between SLCC and preoperative lumbar curve flexibility (r = 0.20) and 2-year postoperative thoracic curve percent correction (r = 0.47). A secondary analysis of SLCC in paired curves matched by LIV, lumbar curve flexibility and thoracic percent correction revealed no difference between anterior (48%) and posterior (49%) approaches (P = 0.75). CONCLUSION: Anterior and posterior instrumented fusions performed selectively on the appropriate curves result in equal SLCC when matched by LIV, flexibility of the lumbar curve, and percent thoracic curve correction achieved. This suggests that the observed phenomenon of SLCC after selective thoracic fusion in AIS is independent of surgical approach and can be reliably achieved with either technique.

Pediatric supracondylar humerus fractures: treatment by type of orthopedic surgeon.

PURPOSE: Outcomes in children with supracondylar humerus fractures were stratified by type of treating orthopedic surgeon: pediatric orthopedic surgeon and nonpediatric orthopedic surgeon. METHODS: The outcome factors in 444 children examined included: open reduction rate, complications, postoperative nerve injury, repinning rate, need for physical therapy, and residual nerve palsy at final follow-up. RESULTS: For the severe fractures, significantly more fractures were treated by open reduction in the pediatric orthopedic surgeon group than in the nonpediatric orthopedic surgeon group. There were no other significant differences in outcomes between the fractures treated by the pediatric orthopedic surgeons and nonpediatric orthopedic surgeons. CONCLUSIONS: This study supports the assertion that both pediatric and nonpediatric orthopedic surgeons in an academic setting have sufficient training, skill, and experience to treat these common injuries.

Inhibition of iNOS with 1400W improves contractile function and alters nos gene and protein expression in reperfused skeletal muscle.

This study examined the effects of 1400W, an inhibitor of inducible nitric oxide (iNOS), on contractile function and iNOS expression in reperfused skeletal muscle. The right extensor digitorum longus (EDL) muscle of 104 rats underwent a sham operation or 3-h ischemia followed by 3-h or 24-h reperfusion (I/R). Rats received 3 mg/kg 1400W, 10 mg/kg 1400W, or water subcutaneously. Results showed that EDL contractile function in both 1400W-treated groups significantly outperformed the controls at 24-h but not at 3-h reperfusion. Although iNOS expression increased in all three I/R groups during reperfusion, a significantly smaller increase was found in 1400W-treated muscles after 3-h reperfusion, and more dramatically so after 24-h reperfusion. Our results indicate that inhibition of iNOS preserved the contractile function in reperfused skeletal muscle, perhaps via downregulating iNOS expression. Protection by 1400W at 24-h reperfusion suggests that the role of iNOS in exaggerating reperfusion injury is more prominent in the later stages of injury.