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Filter by:The study plan outlined here represents an investigation of instruments on the patients treated in the acute ward of child and adolescent psychiatry at the University Medical Center Hamburg Eppendorf (UKE). The psychosocial burden of the affected children and adolescents is evident due to the severity of the disorders leading to specific admission. The psychosocial burden can be defined as "psychological, social, or school-occupational functional impairment [...] that has arisen as a consequence of a mental disorder, a specific developmental disorder, or an intellectual impairment". The current research project aims to survey the severity of psychosocial distress, personality functioning impairment, and social withdrawal. A better knowledge of these factors may contribute to a more suitable, specialized treatment offer on the acute ward in the medium term.
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.
Objective: To evaluate the safety and efficacy of Human Insulin rDNA (Insuget) in patients with Type II Diabetes Mellitus. Study Design: Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study. Sample size: The estimated target sample size is n=230. Study duration: 12 months (data lock point will be completion of 6 months' follow-up from the time of last patient's enrollment date) After recruitment, patient is supposed to have three visits for follow-ups. Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy. - Primary (SAFETY Outcomes): - Frequency of adverse events during the course of study follow-up. - Frequency of serious adverse events. - SECONDARY OUTCOME MEASURES (EFFICACY ENDPOINTS) - Change from baseline in HbA1c% to the last-observation. - Change from baseline in fasting plasma glucose to the last- observation on treatment Ethical consideration: The ethical approval of study is taken from an independent ethics committee. The study will be conducted in compliance with the protocol, good clinical practices (GCP), the ethical principles that have their origin in the Declaration of Helsinki and the applicable regulatory requirements.
Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial effects in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF). In this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on whole body and skeletal metabolism in patients with HFpEF and T2D.
This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors. The purpose of this study is to define the dosing schedule, and maximally tolerated dose to be used in subsequent development of PRT2527.
A cross-sectional study will be conducted recruiting children of age group 8-15 years. Pilot study has been conducted for the determination of the sample size. The calculated sample size has come out to be, n=378 which can be taken for males and females separately. Stratified random sampling will be done according to age. Child will be asked to perform all tests one by one and the time taken (in seconds) will be noted required to perform the tests. The mean of three readings will be obtained using a mobile-based stop watch.
Low and middle-income countries (LMICs) urgently need cost-effective adaptive technologies to provide CPAP. The lead investigator has designed a device that has already been approved by the Directorate General of Drug Administration (DGDA), Government of the People's Republic of Bangladesh. The design of the nasal seal was comfortable and well tolerated by all the participants. Patients were told about some mild discomfort at higher delivered pressures (14 or 15 cm PEEP), consistent with pressurised nasal delivery by similar devices. The safety phase has been initiated since 1st November 2020 and ended in April 2021. One patient withdrew from the study but none of them developed any adverse events. The feasibility phase started at the end of September 2021. Objectives: 1. To evaluate the barriers and operational challenges related to the introduction of adult bubble CPAP oxygen therapy 2. To evaluate the acceptability of introducing adult bubble CPAP in tertiary level hospitals of Bangladesh
Regional block of ilioinguinal and iliohypogastric (IIIH) nerves has been applied to provide postoperative analgesia after inguinal hernia repair. Magnesium sulfate (MgSo4) blocks N-methyl-d-aspartate receptors, and that is why, it was used as an adjuvant to the local anesthetic (LA) in different anesthetic approaches. Although the prolongation in postoperative duration resulting from the addition of MgSO4 to LA was significant in some literature studies, it was insignificant in others. This study was designed to investigate the adjunctive effect of MgSo4 when added to bupivacaine for IIIH blockade on the postoperative analgesic duration as a primary outcome and on the verbal rating scale (VRS) scores, analgesic consumption, and hemodynamics as secondary outcomes.
Propofol is one of the most commonly used anesthetics in the world. However, the dose-response of propofol was remarkable variety. Herein, this study aims to investigate the possible association of gene polymorphism and propofol susceptibility, and to research more precise infusion model of this drug.
This is a cross-sectional, prospective study of iron deficiency anaemia among pregnant patients presenting for antenatal care at a secondary level institution in the Western Cape, Mowbray Maternity Hospital, over a one-week period.