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Filter by:UNLOCKED: A Phase 2 Trial to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care
Subjects completing participation in study PQ-110-001 (EudraCT 2017-000813-22 / NCT03140969) will be given the opportunity to enroll into the extension study for continued dosing if available data support current and/or future benefits for the subject. Study PQ-110-002 will provide long-term safety, tolerability, pharmacokinetic (PK), and efficacy data of QR-110.
The aim of the study is to evaluate the impact of the outpatient ambulatory child psychiatric care system on the functioning of anxio-depressive adolescents in school retreat by describing the modalities of individual psychic functioning.
Assisted animal therapy (AAT) is getting more and more used worldwide, in such areas as gerontology, psychiatry, or oncology. It is a complementary therapy, and benefits for patients are various, including decrease of anxiety. In ICU, some case reports exist, but no study has ever been made in order to prove its benefits, not even its feasibility. In ReAnimal, the investigator aims to compare a group of patients receiving assisted animal therapy, versus a group of patients not receiving it. Primary objective will be the evolution of anxiety scores between the 2 groups of patients. Secondary objectives will be the comparison of mood scores, post traumatic stress syndrome scores, pain scores, and physiologic parameters such as blood pressure, cardiac frequency. The investigating team will also compare multi drug resistant bacteria incidence between the 2 groups. In the assisted animal therapy group, patients will also be asked to answer a satisfaction questionnaire.
Suvorexant (trade name Belsomra) is an orexin receptor antagonist that has TGA approval for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. It may also have a role in addictions as the orexins play a critical role in drug addiction and reward-related behaviours. Orexins appear to be involved in both alcohol withdrawal and in alcohol seeking triggered by external cues (eg contexts or stressors) through both OX1 and OX2 receptor signalling. Chief investigator, Professor Lawrence was the first to demonstrate a role for endogenous orexin signaling in alcohol-seeking. Alcohol is known to effect the sleep of healthy and alcohol dependent individuals with effects on daytime sleepiness, physiological functions during sleep, and the development of sleep disorders. There are various estimates of the co-occurrence of insomnia and alcohol use disorder ranging from 36-72%. In alcohol dependent individuals sleep is disturbed both while drinking and for months of abstinence and abstinent sleep disturbance is predictive of relapse. This proposal aims to evaluate the use of suvorexant as a safe and effective pharmacotherapy to treat sleep disorders in alcohol dependent patients undergoing acute alcohol withdrawal and thereafter for six months. The study will also examine the effectiveness of suvorexant in reducing craving for alcohol and promoting duration of abstinence. This will be the first double blind controlled trial of suvorexant in the management of the alcohol withdrawal syndrome and maintenance of abstinence post withdrawal.
Anxiety disorders are the most common childhood psychiatric disorders, with prevalence rates as high as 15% to 20%. Success rates of the first choice treatment strategy (i.e. Cognitive Behavioural Therapy; CBT) are around 50%. Non-response increases the risk for other psychiatric disorders, school dropout, social isolation, alcoholism, and suicide attempts. These negative consequences endorse the urgent need to develop more effective and accessible treatments that enhance effectiveness of current treatment options. A promising new treatment for childhood anxiety disorders is Attention Bias Modification Treatment (ABMT). ABMT is based on evidence that anxiety-disordered individuals selectively allocate their attention toward threatening information (i.e. attention bias). This bias in early and automatic attention processes starts a cascade of subsequent biases in information processing and memory, resulting in heightened anxiety. Attention bias is an underlying mechanism of anxiety. Thus ABMT, which implicitly trains individuals to attend away from threatening information should alleviate anxiety. In contrast to ABMT, CBT explicitly targets later stages of information processing that are under volitional control. Meta-analyses of studies in adults have shown that ABMT indeed results in increased recovery rates and clinically significant changes in anxiety, compared to so-called "sham" attention training (control condition). Imaging studies have shown that ABMT modifies lateral prefrontal cortex activity to emotional stimuli. Despite its promising results, fewer studies have examined ABMT in anxiety-disordered children. The aim of this trial is to enhance treatment effectiveness by combining web-based ABMT with CBT in a large sample of anxiety-disordered children. The primary aim is to compare ABMT-augmented CBT with CBT as monotherapy on recovery rates for anxiety disorders and changes in anxiety. The secondary aim is to compare ABMT with sham attention training on anxiety disorder recovery rates and changes in anxiety. We hypothesize that (1) ABMT-augmented CBT will result in a significantly better treatment success than CBT alone, and (2) ABMT will result in a significantly better treatment success than sham attention training. The design will be a randomized, double-blind, sham-controlled clinical trial.
This study is conducted at the Henry Ford Health System with Lifegraph's behavioral monitoring technology, to examine the relation between migraine attacks and behavioral and environmental changes as detected from the smartphone sensors. The investigators hypothesize that Lifegraph's technology can predict the occurrence of migraine attacks with high precision.
Functional Neurological Disorder (FND/ Conversion Disorder) is a highly prevalent and disabling neuropsychiatric condition. Motor FND symptoms include Functional Movement Disorders (FMD) and Functional Weakness and Psychogenic Nonepileptic Seizures (PNES).Though patients with FND present with a wide variety of symptoms, FMD, PNES, and functional weakness may be viewed as overlapping conditions lying along a phenotypic spectrum for a single disorder. Patients with FND frequently present with psychiatric symptoms, including depression, anxiety, Borderline Personality Disorder, and Post-Traumatic Stress Disorder, alongside their physical symptoms. To treat these symptoms, patients with FND are frequently enrolled in physical therapy and cognitive behavioral therapy, which are considered usual care for FND at our center. Developing a further understanding of treatment outcome, including biomarkers of clinical improvement and psychometric factors associated with treatment response, could inform future interventions and better tailor treatments to patients with specific FND symptom profiles. We hypothesize that treatment response will be associated with structural and functional alterations in salience network regions and that more adaptive neuropsychiatric profiles at baseline will predict a positive treatment outcome.
This study will evaluate the use of topical 5 or 10% sinecatechins, a botanical drug derived from green tea for the alleviation of sexual pain in the area around the vaginal opening (the vulvar vestibule), that is a main source of pain during sexual contact or dyspareunia, in postmenopausal women, with vulvovaginal atrophy. Women may or may not be using estrogens. Half of the women will receive the study drug, 5 or 10% sinecatechins and half will receive placebo. In addition to the reduction or elimination of pain upon penetration, women may also experience increase in lubrication, arousal and intensity of orgasm
Dietary difficulties and eating disorders of the child are a common reason for consulting infants and young children. There is currently little data on the psychomotor development of these children and their association with parent-child attachment. The objective of this study is to evaluate, at the same time, the three physiological, psychomotor and attachment dimensions of children with eating disorders.