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Filter by:The purpose of this study is to evaluate the safety and tolerability of ONL1204 in participants with Macula-off, Rhegmatogenous Retinal Detachment (RRD). RRD is an acute and serious vision threatening condition in which a tear in the retina, typically resulting from a vitreous detachment, allows liquid to accumulate under the retina, detaching the photoreceptor (PR) layer of the retina from the retinal pigment epithelium (RPE). As the RPE is the principal source of nutritional support for the PR layer, the photoreceptors begin a cascade of inflammation and cell death. Photoreceptor cell death is the primary mechanism of vision loss after retinal detachment. ONL1204 is a first-in-class inhibitor of Fragment Apoptosis Stimulator receptor (Fas)-mediated cell death. ONL1204 has demonstrated protection of multiple retinal cell types in numerous preclinical models of acute ocular injury. This will be a first-in-human (FIH) study to evaluate safety and tolerability of a single-dose of ONL1204 in participants with macula-off RRD. The standard of care for surgical repair of macula-off RRD is reattachment surgery within 7 days of the macula detaching. Participants in this study will receive a single intravitreal injection upon diagnosis and enrollment in the study, followed by standard of care surgery. The surgery includes vitrectomy, a procedure that removes the bulk of drug remaining in the vitreous.
Positional cranial deformities (PCD), plagiocephaly and brachycephaly are a common reason for pediatric consultation, which has increased significantly since the recommendation to lay babies on their backs to prevent unexpected infant death (ILD). CPD is a source of concern for parents about their impact on psychomotor development and the aesthetic risk of deformity. The High Authority for Health (HAS) will soon put in place recommendations with a fact sheet for health professionals and the public. The aim of this research is to study whether early treatment of rotation disorders and hypertonia in newborns by manual osteopathic techniques would prevent the occurrence of positional deformities of the skull. The main objective is to evaluate the effectiveness of an early osteopathic treatment on the rate of CPP (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk. the secondary objective is: to evaluate the effectiveness of an early osteopathic treatment on the quality of life of the child at 4 months. Methodology: Controlled, randomized monocentric two-arm parallel study between (1) osteopathic follow-up and (2) osteopathy-free follow-up. The inclusion period will be 18 months and the follow-up period is 4 months. Procedure: The two groups will be evaluated at 3 days and 4 months. The experimental group will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of 3 to 4 sessions. Both groups will benefit from sleeping, carrying, positioning and stimulation advice. The perspectives are: - the decrease in the prevalence of CPP after early osteopathic treatment. - Defining a decision algorithm for early osteopathic treatment. - Subject to recommendations on the indication of early osteopathic treatment in neonates at risk.
While external DCR is the gold standard procedure for primary NLDO as well as complicated cases, SI with MMC could achieve comparable success rates in primary acquired NLDO, hence should be considered as an alternative as a safe and minimally invasive procedure.
The aim of the study is to evaluate the influence of physical training and respiratory rehabilitation performed by patients at home on quality of life, symptoms, physical endurance, force of respiratory and skeletal muscles and body mass composition in patients with pulmonary arterial hypertension (PAH) or left ventricular heart failure with reduced ejection fraction - HFREF), or ischemic heart disease and evaluation the number of stem cells, natural lymphoid cells and distribution of subpopulations of monocytes (including proangiogenic monocytes) in examined persons and evaluation of theirs eventual influence of the course of disease.
Problems with sexual function are common and distressing. The most frequent sexual difficulty in women is a lack of sexual desire with a prevalence of 20-30%. When low sexual desire is experienced over several months and causes significant personal distress, a sexual dysfunction can be diagnosed (ICD-10: Hypoactive Sexual Desire Disorder: HSDD). A distressing lack of desire is reported by 6% of sexually active women. Psychological interventions are the treatment of choice for women with HSDD. Promising treatment approaches include cognitive-behavioral and mindfulness-based interventions. A recent meta-analysis also showed that Internet-delivered programs are a valid alternative to face-to-face treatments. Aim of this project to assess the effectivity of two eight-week online-programs consisting of cognitive-behavioral (COPE) and mindfulness-based (MIND) interventions for women with HSDD. Both treatments will be compared to a waitlist-control group. For this project, two well-established group-treatment manuals will be translated into German and adapted to a multimedia online-environment. All participants will be guided through the programs by well-qualified eCoaches.
This study was designed to assess the effect of adding dopamine infusion in addition to restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate levels as an indicator for tissue hypo perfusion and renal function in comparison to restrictive hydration combined with noradrenaline infusion only and standard hydration during open abdominal surgeries.
This study will be conducted to assess the safety and tolerability of BOS172738 when administered to patients with advanced solid tumors with rearranged during transfection (RET) gene alterations and also to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BOS172738.
The method "Collaborative and Proactive Solutions" (CPS) was developed by Dr. Ross Greene, Harvard University, to understand and help kids with social, emotional, and behavioral challenges. The underlying theory is that challenging behavior is caused by lagging cognitive skills, commonly in the domains of flexibility/adaptability, frustration tolerance, and problem‐solving. Thus, challenging behavior can be seen as a form of developmental delay, and the most effective way for adults to help the children and to facilitate interaction with them is to understand the lagging skills behind the behavior and to change their own mindset accordingly. ADHD and autism belong in a group of overlapping neurodevelopmental conditions now often referred to under the umbrella term of ESSENCE (Early Symptomatic Syndromes Eliciting Neurodevelopmental Clinical Examinations). A common impairing problem in both autism and ADHD - and in several of the other disorders in the group of ESSENCE (including Tourette syndrome and other tic disorders) - is the marked inability to control temper, coupled with oppositional-defiant behaviors. The CPS-method has been evaluated by Ross Greene et al. in United States studies for families, in schools, and in institutions for young people with serious behavior problems. Our research group published the first Swedish study with the method in 2012, a small open pilot study. Based on experiences in clinical work after that study our group reached the conclusion that, in order for the intervention to be useful for families with severely impairing ESSENCE, the CPS model needed to be modified. After a number of research meetings and seminars, we therefore designed a new model, based on our CPS-experience, that we now refer to as PR-ESSENCE (Problem Resolution in ESSENCE). The present study is a randomized controlled trial for approximately 130 children and adolescents aged 5-18 years, with neuropsychiatric disorders (for instance Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Autism Spectrum Disorder (ASD), Tourette syndrome, learning difficulties), children who have been assessed at our Child Neuropsychiatry Clinic (CNC), and from the Habilitation Services, Child Psychiatry Units or schools in the Göteborg region.
The study intends to provide important data on whether the noval method using quantitative flow ratio could predict microvascular dysfunction.
The study was based on the clinical trial BCA-01 (NCT01368640) "Generation of prediction equations to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" and implicates an extension of the study collective. Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand.