View clinical trials related to Aggression.
Filter by:Background: - Desmoid tumors (also known as aggressive fibromatosis), are rare, locally invasive, slow-growing soft-tissue tumors. The disease can be either asymptomatic or be associated with severe loss of organ function and significant morbidity. - Treatment with the selective small-molecule Gamma-secretase inhibitor PF-03084014 caused significant tumor shrinkage in patients with unresectable desmoid tumors in an early phase clinical trial. - The Notch pathway is a key regulator of cell differentiation, proliferation and apoptosis; aberrant signaling via the Notch pathway is associated with carcinogenesis. Objectives: - Primary: Determine the response rate (Complete Response (CR)+Partial Response (PR)) of PF-03084014 in patients with desmoid tumors/aggressive fibromatosis - Secondary: Assess symptom measures at baseline and on study; perform genotyping for germline and somatic mutations in adenomatous polyposis coli gene (APC) and catenin-beta 1 (CTNNB1) genes; correlate clinical response to therapy with genotyping data; and assess modulation of the Notch pathway by evaluating notch response genes in tumor biopsies at baseline and after drug administration Eligibility: - Age greater than or equal to18; histologically confirmed desmoid tumor not amenable to curative resection or definitive radiation therapy that has progressed after receiving at least one line of standard treatment; adequate organ function - Willingness to provide blood samples and 10 unstained slides or a tumor block for genetic research studies Study Design: - This is an open-label Phase II trial of PF-03084014; study drug will be administered orally at 150 mg twice a day in 21-day cycles - Optional tumor biopsies for research purposes will be performed at baseline prior to study treatment and at the beginning of cycle 7 (+/- one cycle) - Restaging scans (magnetic resonance imaging (MRI) with diffusion weighting) will be performed at baseline, at the end of cycles 1 and 6, and then every 6 cycles - Health-related quality of life (HRQOL)/symptom questionnaires will be administered at baseline and at each Clinical Center visit
This is a randomized controlled study of cognitive-behavioral therapy (CBT) for disruptive behavior such as irritability, anger and aggression in children and adolescents. CBT will be compared to Supportive Psychotherapy (SPT) and participants of this study will be randomly assigned (like the flip of a coin) to receive CBT or SPT. Participants will be also asked to complete functional magnetic resonance imaging (fMRI) and electrophysiological (EEG) tasks (recordings/images of brain activity) before and after treatment.
This is a European multinational, multicenter, non-interventional (observational) and prospective study. It is carried on to confirm in real life conditions the benefit/risk of vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC.
Clinical and pharmacokinetic data suggest that the effect of rituximab could be improved by prolonged exposure to the drug. To test for this hypothesis we performed a prospective randomized trial of rituximab maintenance therapy versus observation in patients (pts) with aggressive CD20+ B-cell lymphoma and mantle cell lymphoma.
Recent studies estimate that the prevalence of pituitary adenomas is approximately 1/1500 persons. Pituitary tumours are usually considered as benign. However, local invasion is reported in 35-40% of pituitary adenomas; resistance to medical treatment or recurrence leading to multimodal therapy is reported in about 15% of cases. These tumours are considered as aggressive pituitary tumours and present a distinct biological and clinical entity with continued growth despite multimodal therapy, including surgery and radiotherapy (McCormack et al., 2011). Whilst these tumours have malignant potential, the term of pituitary carcinoma is strictly reserved for those rare tumours (0.2%) with demonstrated craniospinal or systemic metastases (Heaney, 2011). Pituitary aggressive and malignant tumours are very difficult to control and ultimately prove to be lethal. It was suggested that early aggressive treatments (chemotherapy, radiotherapy) may control progression and occurrence of metastases. However, these therapeutic options are associated with important side effects limiting their use and the prediction of pituitary tumor behaviour remains a challenge. At the diagnosis, clinical signs are not specific and the results concerning proliferative factors (Ki-67 and P53), putative oncogenes (PTTG) conflict from one series to another. In a case-control retrospective study of a cohort of 410 patients (HYPOPRONOS), we validated a prognostic pathological classification based on histological and radiological data (J. Trouillas 2012 in preparation). Tumours were classified into 3 grades: grade 1= non-invasive tumour, grade 2= invasive tumour and grade 3 = aggressive-invasive tumor with the combination of radiological signs of invasion and 2 of 3 signs of increased proliferation (Ki-67 index>3%, number of mitoses>2 per 10 fields at 400X, P53 nuclear detection). It is now widely accepted that cancer is a clonal disease, which arises from a single normal cell and progresses thanks to the accumulation of DNA alterations (Sanson et al., 2011). To identify the role of these DNA alterations, we conducted array CGH analysis limited to 13 prolactin pituitary tumours, from frozen fragments, and identified allelic loss of chromosome 11 associated with aggressiveness and malignancy (Wierinckx et al., 2011). To confirm these encouraging results we propose to conduct a study on a large series of tumours, fixed and embed, and to be correlated the results to clinical data.
Agitation/aggression is one of the most common and serious behavioral complications of dementia. If the behavior is refractory to standard care (behavior approaches and off label use of psychotropic medications), other evidence based treatment options are not currently available. Retrospective reviews and preliminary studies have indicated Electroconvulsive Therapy (ECT) may be a safe, effective intervention in this patient population. This study will measure the impact of open-label ECT on symptoms of agitation, aggression, cognition, mood and psychosis for patients referred for ECT who accept this intervention vs. those patients referred for ECT but decline this intervention (i.e. standard care controls). It will also assess adverse events, activities of daily living and caregiver burden during study participation. The hypothesis is that subjects with dementia related aggression/agitation who receive ECT will show significantly greater reductions in these behaviors than subjects who do not consent for ECT and continue with standard care. Pine Rest is partnering with McLean Hospital (Massachusetts) to answer this question. To our knowledge, this is the first prospective study to examine whether patients receiving ECT or standard care differ in reduction of aggression and agitation symptom severity and changes in cognition pre- and post- treatment.
The purpose of this study is to improve behavior control displayed by persons with traumatic brain injury by assessing effectiveness of treatments for post-TBI irritability and aggression.
The purpose of this study is to establish a reliable method for detection of rectal cancer patients with aggressive tumor at risk of metastatic disease and death by functional MRI.
Family centered mental health treatment with children values and supports the role of parents in their child's recovery. However, medications are often the primary focus in community treatment, even in preschool age youth, with increasing use of antipsychotic medication for serious mood and behavior problems. Although medication may be necessary to address safety issues (such as severe aggression) it can cause serious side effects, such as obesity, and medication only does not follow recommended care for these types of problems. Psychosocial treatments are highly recommended (e.g. Programs that coach empower parents to manage their child's difficult behaviors) as part of comprehensive child treatment. Parent involvement in psychosocial treatment has clear benefits for their child's mental health, and unlike medication, the effects can last long after treatment is completed. However, problems related to access (e.g. long waiting lists) and use (e.g. parent mistrust mental health services) of services are common. Maryland, like other states, has developed a system to improve medication safety by reviewing health information about the child to determine if the treatment is appropriate. This reduces unnecessary medication treatment and ensures children have adequate health screening before starting any treatment. Those approved for medication have moderate-severe mental health problems, which supports their need for comprehensive (medication and psychosocial) treatment, instead of medication only. In this study, investigators partner with parents/family advocates, child-serving agencies, and health providers to develop a Family Navigator (FN) Service to link with this medication program. A FN is an individual who has cared for their own child with mental illness. The FN supports parents, provide information on psychosocial treatment options, and address barriers to using services. The goals of this program are to improve use of psychosocial services, and to improve parent empowerment, support, and satisfaction with their child's mental health treatment. The investigators also expect that the FN Service will improve the child's overall mental health and reduce the likelihood of a medication dose increase or another medication added during the initial treatment period. The FN Service is provided for parents of public insured children ages 3-15 years newly approved for antipsychotic medication treatment. The FN Services will be provided by phone, which supports families in both rural and urban settings. The investigators' long term goal is to develop a FN program that strongly supports Family-centered treatment of children and can be used to help families in other underserved areas beyond Maryland.
This study is a large-scale, randomized longitudinal evaluation of Second Step: Student Success Through Prevention (Second Step - SSTP), a middle school intervention (Committee for Children, 2008), which targets the shared underlying risk and protective factors for bullying, sexual harassment, and dating aggression. This program is unique in its emphasis on the role of peer group norms, attitudes, and behavior in the initiation and maintenance of bullying and other forms of violence. Because of this, this investigation will involve a direct test via social network analysis the extent to which peer norms or shifts in peer attitudes are impacted by the intervention. Bullying is conceptualized as including verbal, physical, relational, and cyber-aggression. Sexual violence is conceptualized as including sexual harassment, sexual coercion in dating relationships, and homophobic teasing. Thirty-six schools were drawn from four school districts in Illinois and one large district in Wichita, Kansas and randomly assigned to Second Step - SSTP or a control condition. Second Step -SSTP program draws from the risk/protective factors model and social-cognitive theories of aggression. Lessons focus on the outcomes of bullying, relational aggression, sexual harassment, dating relationships, and substance use. Risk factors targeted include inappropriate classroom behavior, favorable attitudes toward aggression and substance abuse, deviant peer affiliation, peer rejection, and impulsiveness are targeted as risk factors. Targeted protective factors include empathy, problem-solving skills, school connectedness, assertiveness and adoption of conventional norms. The P3R: Stories of Us - Bullying program, composed of a series of film-based education will be used in the control schools. All 6th graders at each school will be recruited and followed for the three year study period. Students and teachers will complete self-report and nomination tasks. Growth curve analysis via hierarchical linear modeling (HLM; Bryk & Raudenbush, 1992) will be utilized to assess change in the major dependent variables (bullying, sexual harassment perpetration, dating aggression), structural equation modeling will test for mediators across the study period, and social network analysis will be instrumental in identifying peer norms and attitudes.