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NCT ID: NCT04277754 Completed - Development, Child Clinical Trials

Motor and Visual Development in 2 Year Olds

Start date: January 2, 2020
Phase:
Study type: Observational

It is a study where investigators are going to measure variables related to motor development and vision through objective tests in children with typical development of two years of age.

NCT ID: NCT04272671 Completed - Clinical trials for Opioid-Related Disorders

De-prescribing Program to Evaluate Falls in Older Adults

Start date: February 26, 2020
Phase: N/A
Study type: Interventional

Purpose: The proposed study will implement and evaluate the effect of an opioid and benzodiazepine (BZD) de-prescribing intervention on falls risk in older adults. Participants: Outpatient clinics with older adult patients, healthcare providers, older adult patients Procedures (methods): In this proposed study, there will be 10 primary care clinics randomly assigned to the intervention arm and 10 primary care clinics randomly assigned to the control arm. In the first phase of this study, patient and provider focus groups will be used to inform the development of the intervention which will be tested during the active trial phase. The intervention has the following components: 1) alerts given to providers to identify patients taking opioids or benzodiazepines (BZD) and therefore at risk for falls; 2) educational materials to inform providers on best practices for de-prescribing opioids and BZDs in patients at risk; and 3) recommendations on de-prescribing provided by a consultant pharmacist. Impact of the intervention will be evaluated using pre-post surveys evaluating changes in providers' knowledge, confidence, and skills as well as information from the electronic health record (EHR) to evaluate impact of the intervention on de-prescribing opioids and BZDs.

NCT ID: NCT04272554 Completed - Hemophilia B Clinical Trials

AAV Gene Therapy Screening/Observational Protocol (ECLIPSE)

ECLIPSE
Start date: February 14, 2020
Phase:
Study type: Observational [Patient Registry]

Freeline is developing adeno-associated virus (AAV) vector based gene therapies for a number of diseases and is actively advancing a programme in Haemophilia B (HB). This study aims to collect prospective data to characterise bleeding events and Factor IX (FIX) concentrate consumption in HB patients that can be used as baseline for participants who elect to participate in a subsequent Freeline gene therapy study. The study will also screen participants for antibodies to a novel AAV vector to assess their suitability for inclusion in a Freeline gene therapy treatment study.

NCT ID: NCT04272476 Completed - Clinical trials for Depressive Disorder, Major

The Activation on Prefrontal Cortex With Acupuncture and Moxibustion for Major Depressive Disorder: A Study of Functional Near Infrared Spectroscopy

ACUfNIRS
Start date: January 2014
Phase: Phase 2
Study type: Interventional

This study evaluates the activation on prefrontal cortex with acupuncture and moxibustion for major depressive disorder.Half of participants will receive the treatment of acupuncture and moxibustion, while the other participants will receive the fluoxetine.

NCT ID: NCT04272398 Completed - Cerebral Palsy Clinical Trials

Effects of Using Dynamic Elastomeric Fabric Orthoses

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Purpose: The aim of this study was to investigate the effects of dynamic elastomeric fabric orthoses (DEFOs) used for lower trunk and pelvis on balance, gait parameters, and pelvis symmetry in children with cerebral palsy. Materials and Methods: Twenty-two children (7 girls, 15 boys) in an age range of 4-10 years, with spastic type cerebral palsy, and at gross motor function classification system levels 1 or 2 were included in the study. Children who met the inclusion criteria were randomly divided into two groups. Ten children were included in the control group (Group I) and 12 children were included in the orthosis group (Group II). Both groups received a physiotherapy and rehabilitation program twice a week for 8 weeks in accordance with neurodevelopmental treatment approaches. Children in Group II were treated with DEFOs in lower body and pelvis in addition to physiotherapy and rehabilitation sessions. The use frequency of the orthosis was extended over the course of the week during which they were active for 8 hours a day. After the demographic data of the children were recorded, the Pediatric Balance Scale and the Timed Up and Go Test were used for balance assessment. Gait parameters and kinematic values of the pelvis were evaluated using the BTS G-Walk®, a wireless mini digital gait analysis system.

NCT ID: NCT04265131 Completed - Anorexia Nervosa Clinical Trials

Emotion Regulation in Eating Disorders: How Can Art Therapy Contribute to Treatment Outcome?

Start date: October 25, 2019
Phase: N/A
Study type: Interventional

Eating disorders are difficult to treat. Some forms of treatment have already been found to be effective, nevertheless chronicity is a major problem. For example, both cognitive behavioral therapy and family therapy (FBT; family-based treatment) appear to be effective treatment methods, in which FBT distinguishes itself primarily in its long-term effect. However, eating disorders persist in 20 to 25 percent of cases, only 46 percent of patients with Anorexia Nervosa fully recover and one third only partially improve. Since the mortality rate of this mental disorder is particularly high, it is necessary to keep looking to improve treatment. Because emotion regulation problems play an important role in the cause and maintenance of an eating disorder, more emotion-focused therapies may improve treatment outcome. Dialectical Behavioral Therapy is a treatment that has a strong focus on emotions regulation, but so far only limited evidence has been found for the effectiveness of this type of therapy in eating disorders. Some studies show that art therapy (AT; art therapy) can contribute to a more adaptive regulation of emotions. However, this type of therapy has not been studied in the context of eating disorders yet. AT is an experiential form of therapy in which art techniques and supplies (including drawing, painting, clay, etc.) are used methodically with a therapeutic purpose. The idea that creative expression can perpetuate or improve mental well-being has been accepted worldwide for many years. Despite the long history of practical applications, to date little evidence exist on the effectiveness of this form of treatment. There's growing worldwide interest in scientific research and the emphasis on evidence-based practice (EBP) for this form of treatment. In a recent study, Lock and colleagues compare AT with cognitive remediation therapy (CRT) and the added value of both in a sample of adolescents with anorexia nervosa combines with obsessive-compulsive problems. Both CRT and AT are offered in this study in combination with family based therapy (FBT). The group in which the combination of FBT and AT was offered yielded better results than those in which FBT is combined with CRT. Study hypothesis: the investigators expect that complementing treatment as usual (TAU) with art therapy (AT) will lead to a decrease in emotion regulation problems in patients with an eating disorder in comparison with TAU only, without AT.

NCT ID: NCT04259554 Completed - Depression Clinical Trials

OFC rTMS in Emotionally Unstable and Depressed Patients

ORIENT
Start date: February 14, 2020
Phase: N/A
Study type: Interventional

Treatment of depression with conventional transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. Recently, it could be demonstrated that treatment of the right orbitofrontal cortex may be effective in patients who did not respond to conventional DLPFC rTMS. Orbitofrontal cortex (OFC) seem to be involved in the etiopathology of emotionally instable personality disorders. Thus, the present one-arm trial is a pilot study investigating if OFC rTMS is feasable, tolerable and effective.

NCT ID: NCT04257955 Completed - Pancreatic Cancer Clinical Trials

COMMUNIcation and Patient Engagement at Diagnosis of PAncreatic CAncer

COMMUNICARE
Start date: September 15, 2020
Phase:
Study type: Observational

BACKGROUND: The diagnosis of pancreatic adenocarcinoma (PDAC) in many cases is completely unforeseen by the patient, who often faces a disease that is already at an advanced stage, with poor prognosis. The clinical visit during which the diagnosis is communicated together with the first information regarding the planned treatments is of paramount importance. It is hypothesized that the clarity of such information is able to influence patients's engagement and thus the compliance. AIMS: The aim of this study is to collect quantitative data on the level of PDAC patient engagement and the rate of understanding of the information received from the doctor, and investigate the possible association between these two variables and with the patient's level of compliance. METHODS: This is a single-center, observational, cross-sectional cohort study focused on patients diagnosed with PDAC, approved by the Ethics Committee of the San Raffaele Hospital. As no preliminary data are available on the association between PDAC patient's understanding rate and their level of engagement and of compliance no power calculation is possible. This is a pilot study, aimed at enrolling at least 45 PDAC patients during a 3 months frame. CONCLUSION: COMMUNI.CARE will be the first study specifically investigating whether there is a relation between PDAC patients' rate of understanding, their engagement and compliance at time of diagnosis.

NCT ID: NCT04256811 Completed - Children, Only Clinical Trials

DC/TMD Axis I for Children

Start date: May 19, 2015
Phase:
Study type: Observational

The aim of the present investigation was to perform the content and construct validation of the diagnostic criteria for TMD (DC/TMD) Axis I, for children 7 to 11 years old. A Delphi process was used to perfom the content validity of the DC/TMD Axis I. 189 7-11 years old children were assessed with the adapted instrument. Confirmatory factor analysis (CFA) was used to investigate construct validity of the DC/TMD for children. A baseline one-factor model was compared against a two-factor (Model 2) and a seven-factor (Model 3) models based on the original DC/TMD. Root-mean-squared error of approximation (RMSEA), comparative fit index (CFI), chi-square, change in chi-square and Cronbach's Alpha were used to analyze the data. All analysis were performed in STATA© version 13.0.

NCT ID: NCT04256252 Completed - Clinical trials for Neuromyelitis Optica Spectrum Disorder

Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)

Start date: April 2014
Phase: Phase 4
Study type: Interventional

In this research, a prospective, multicenter(Tangdu Hospital of Fourth Military Medical University, Xi'an Gaoxin Hospital of Xi'an Medical College, Xianyang Central Hospital, Baoji Central Hospital, Xi'an Central Hospital, The First Hospital of Xi'an, The Fourth Hospital of Xi'an) open-label, follow-up clinical trial will carry out to evaluate the efficacy and safety of low-dose rituximab in treating NMOSD in Northwest China.