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Filter by:This is a randomized, multiple-dose, open-label, parallel-group study. Subjects will undergo screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 280 eligible subjects will be randomized in a 1:1 ratio into 1 of 2 treatment groups. Subjects will be admitted to the clinical facilities the day before dosing (Day 0), and will be randomized and receive the first dosing on Day 1. Subjects will stay at site till Day 2 after PK collection. All subjects will return to the clinical sites at designated study days for dosing, PK sample collections and assigned clinical activities. All subjects randomized to LY03010 treatment group will receive the first dose of 351 mg LY03010 by IM injection on Day 1 in the deltoid muscle, followed by five (5) monthly dosing of 156 mg LY03010 in the gluteal muscle with the last dose on Day 141. All subjects randomized to SUSTENNA treatment group will receive the first dose of 234 mg SUSTENNA by IM injection on Day 1 in the deltoid muscle, and a second IM dose of 156 mg SUSTENNA on Day 8 in the deltoid muscle, followed by five (5) monthly IM dosing of 156 mg of SUSTENNA in the gluteal muscle with the last dose on Day 148. End of Study (EOS) visit for LY03010 treatment group will be on Day 169, 28 days after last dosing day; End of Study for SUSTENNA treatment group will be on Day 176, 28 days after last dosing. At EOS visit, subjects will complete the study after a series of assigned clinical assessments. A 30-day follow up call will be conducted by the clinical research staff to ensure participant's well-being.
The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years.
The aim of this study is to evaluate the clinical effectiveness of internet-based cognitive therapy for severe health anxiety within regular psychiatric care. A longitudinal cohort study will be conducted investigating 400 patients who have received ICBT for severe health anxiety between 2018-2020 in an outpatient psychiatric clinic providing Internet-based treatment. The primary outcome measure will be the Short Health Anxiety Inventory, SHAI, and a within-group design with repeated measures will be used for primary analysis. It is hypothesized that ICBT will be associated with a significant reduction in health anxiety as measured with SHAI, both after treatment and at six-month follow-up.
Deep brain stimulation is an established treatment for movement disorders. New indications for deep brain stimulation are under investigation, among them severe and treatment-resistant obsessive-compulsive disorder. Here, the investigators investigate clinical outcomes, safety and mechanism of action of DBS in the BNST in a series of 11 participants with severe therapy-refractory OCD.
Lack of sleep and poor sleep quality in pregnant women are associated with maternal depression and cognitive-sensual irregularities. These irregularities were reported worsening women's life quality and even increasing suicide ideation. It is also associated with obstetrical complications such as fetal growth deficiency, preterm birth, prolonged labor, preeclampsia and increased abdominal delivery frequency.Vitamin D also may affect the sleep indirectly through the cases with nonspecific pains. It was reported that vitamin D levels are correlated with sleep disorders such as obstructive sleep apnea and restless legs syndrome. The primary purpose of this study is to examine sleep disorders and vitamin D levels in pregnant women, and also, secondarily, vitamin D - anxiety and sleep disorders - anxiety relations were assessed.
Nursing home staff face multiple stresses during the Covid-19 pandemic including personal risk of infection, risk of transmission of the virus to residents and relatives, and risk of witnessing end-of-life scenarios under difficult contexts (absence of families). The hypothesis of this study is that the Covid-19 period is associated with an incidence of more than 30% of post-traumatic stress in nursing home staff.
The overarching goal of this study is to demonstrate the efficacy, feasibility, and acceptability of Mindful Attention Training (MAT), a novel mindfulness-based intervention that is specifically developed for firefighters. This project is designed to improve the health of firefighters, an integral, essential component of our national and international communities. Moreover, the study aims to promote health service psychologists by enhancing our contributions to the mental healthcare of firefighters, an understudied and underserved segment of the population by virtue of their service to our communities. This study therefore has significant potential to identify, develop, and promote an effective model of quality, evidence-based mental health promotion and illness prevention by integrating health service psychology into the fire service.
Studies on Antisocial Personality Disorder (ASPD), in which criminal behaviors, aggression and anger behaviors are frequently seen, are very rare. Developed by Nosrat Peseschkian, positive psychotherapy is an eclectic therapy approach born from the psychodynamic approach, existential-humanist approach, behavioral approach and intercultural therapy approach. Psychodynamic psychotherapy is a humanistic, psychodynamic, resource-focused, conflict-solving, integrative and intercultural approach that has its own unique intervention methods as well as the features of other therapy theories. In this study, it was aimed to determine the primary and secondary abilities of individuals with criminal and non-criminal antisocial personality disorder within the scope of positive psychotherapy, to compare these abilities with respect to healthy individuals, and to examine the effects on crime, aggression behavior and anger levels.
The current study aimed to explore the associations between neck pain and temporomandibular disorders in office workers
Aim 1: To test the efficacy of contingency management for patients with hoarding disorder (HD). Hypothesis 1. Participants completing CM will show significant pre- to post-treatment decreases in severity of hoarding symptoms and clinician-rated impairment, and significant increases in quality of life. Exploratory analyses will examine whether effect sizes compare with those of prior trials of cognitive-behavioral therapy (CBT) for HD conducted within our clinic, whether problem severity at follow-up is predicted by hoarding severity measured immediately after treatment completion, and whether readiness for change improves with treatment.