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NCT ID: NCT02323633 Not yet recruiting - Clinical trials for Attention Deficit Disorder With Hyperactivity

Phase IIa Exploratory Clinical Trial, to Examine the Safety and Efficacy of tPCS on Paediatric ADHD Participants

Start date: January 2015
Phase: Phase 2
Study type: Interventional

Children with ADHD display a certain brainwave profile which might be different to that of a child who does not have ADHD. Treatment with tPCS (transcranial pulsed current stimulation) has shown that this brainwave profile could possibly be altered to more closely resemble a brainwave profile of a child who does not have ADHD. Researchers believe that by changing this brainwave profile it might lessen symptoms of ADHD. tPCS is a name used to describe the type of current this device produces. It involves randomly (in no specific pattern) produced pulses of current at different times that the brain picks up. These pulses of low current stimulate the brain in a certain way and affect the brainwave activity. Treatment is given by applying a low frequency current using small electrodes clipped to the earlobes. The current comes from an external battery source. The pulses of current generated by this device stimulate certain parts of the brain which result in a possible increased control of attention and behaviour. This treatment has already been proven to be safe and will not hurt your child. Due to these specific parts of the brain being stimulated, and the positive results of previous research, it seems possible to control certain functions in children suffering from inattention and hyperactivity. The idea of using tPCS stimulation as a possible way for helping children with confirmed ADHD opens a new window to future research. The final goal of this device and research is to offer a safe, non-invasive (conservative treatment that does not require piercing into the body or the removal of tissue) treatment that can be used on a long-term basis and shows a clear improvement of ADHD symptoms for children and even adults with ADHD.

NCT ID: NCT02317497 Not yet recruiting - Clinical trials for Sedation of Cerebrovascular Ventilated Critical Care Patients

Sedation Depth in Neurocritical Care

MODERNISE
Start date: September 2016
Phase: Phase 2
Study type: Interventional

Background: Sedation of the intensive care unit (ICU) patient is necessary to relieve the patient from pain, anxiety and agitation and to enable mechanical ventilation, diagnostic investigations and invasive procedures. While sedation policy has shifted from deep sedation to moderate, minimal, or even no sedation in the general ICU, optimal sedation of the cerebrovascular ICU patient is unclear and controversial. Method: MOderate vs DEep Regime in NeuroIntensive care SEdation (MODERNISE) is a prospective, randomized, open, two-center trial. Patients with acute ischemic stroke, intracerebral hemorrhage or subarachnoid hemorrhage who need to be ventilated are eligible for enrollment. It is intended to enroll 50 patients per group (n=100). Patients are randomized within 72h from admission to either moderate sedation as defined by Richmond Agitation Sedation Scale (RASS) >= -3 or to deep sedation as defined by RASS < -3 for the next 72h, after which weaning from sedation is aimed for in a stepwise fashion in both groups. If reduction of sedation is not feasible, patients remain at their respective sedation level for another 12 hours, and sedation reduction is then tried again. Patients are multimodally monitored for systemic and cerebral parameters (the latter including bispectral index (BIS) monitoring). The primary endpoint is ICU length of stay (ICU-LOS); secondary endpoints are several pre-defined variables of the ICU course, feasibility of sedation levels without violation of pre-defined safety criteria, pre-defined complications, and short- and long-term functional outcome and mortality. Conclusion: The feasibility, safety and benefits of moderate as opposed to deep sedation even in the acute phase of severe cerebrovascular disease needs to be clarified in a prospective randomized study. Results from this study might change sedation regimes and help prevent unwanted effects of deep sedation in the brain-injured patient.

NCT ID: NCT02315651 Not yet recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Efficacy of Combined Treatment With CoQ10 and Methylphenidate in Children With Attention Deficit Hyperactivity Disorder

Start date: January 2015
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effects of nutritional supplement co-enzyme Q10 (CoQ10) on methylphenidate-treated ADHD children in a randomized, double-blinded, placebo-controlled prospective study. All eligible patients will undergo randomization and divided into 2 groups: a CoQ10-enriched snack and a placebo snack group. According to power calculation, total of 60 subjects are expected to participate in the study. After the screening of eligibility (up to 14 days), the study is divided into three phases: pre-treatment (first assessment) phase (up to 14 days), treatment phase 8 weeks of treatment, and post-treatment phase. Screening: each participant will undergo screening for protocol eligibility within 14 days (two weeks) of recruitment. Subjects who meet all the inclusion criteria and signed an approved informed consent (both parents and the child) will be enrolled.

NCT ID: NCT02313025 Not yet recruiting - Clinical trials for Other Developmental Disorders of Speech and Language

A Speech Sound and Phonemic Awareness Intervention in Flemish Early Childhood Education

Start date: January 2015
Phase: N/A
Study type: Interventional

The language intervention 'Kaatje Klank' is designed for stimulating the speech production and speech perception skills of 4-year-olds in an early childhood educational setting, in order to stimulate early literacy skills. These skills are crucial skills for technical reading in later ages. Good reading skills are an important condition for academic success. To measure the effect of the language intervention 'Kaatje Klank', the intervention will be applied in six Dutch preschool classes (n = 100 children, 50% native speakers of Dutch, 50% non-native speakers) during 12 weeks (daily). Teachers will be trained and observed using a coaching trajectory.To measure the effect on speech production and perception skills, a pre- and posttest and a comparison with a matched control group (n = 100 children, 50% native speakers of Dutch, 50% non-native speakers) will be used. The control group will receive a different language intervention which focuses on vocabulary development (World-project).

NCT ID: NCT02311647 Not yet recruiting - Clinical trials for Endometrial Receptivity Post Tamoxifen Exposure

Uterine Cavity Assessment and Endometrial Gene Expression in Tamoxifen Treated Breast Cancer Patients

Start date: January 2015
Phase: N/A
Study type: Observational

The aim of this multi-center study is to assess the effects of Tamoxifen on the uterine cavity and endometrial abnormalities in young premenopausal women diagnosed with breast cancer. The research contains two parts: a clinical study and a laboratory study. - Clinical part: to evaluate the association between tamoxifen treatment and uterine abnormalities. - Laboratory part: to investigate the effect of Tamoxifen treatment on endometrial tissue, by exploring the molecular aspect of endometrial receptivity.

NCT ID: NCT02301728 Not yet recruiting - Clinical trials for Short Chain Fatty Acids Concentration in Breast Milk

Study on Short Chain Fatty Acids Concentration in Breast Milk and Its Correlation With the Maternal Diet

Start date: December 2014
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether the acetate, butyrate and propionate concentration in breast milk and to evaluate the possible correlation of these concentrations with maternal diet.

NCT ID: NCT02296073 Not yet recruiting - Clinical trials for Failed Conscious Sedation During Procedure

The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.

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

To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.

NCT ID: NCT02294799 Not yet recruiting - Clinical trials for Temporomandibular Joint Dysfunction

Magnetic Ressonance Imaging of Temporomandibular Joint

MRITMJ
Start date: March 2023
Phase: N/A
Study type: Interventional

Background: Among the instrumental devices that have been proposed over the years to integrate the clinical evaluation of temporomandibular joint disorders (TMD), imaging techniques are the most studied, showing that magnetic resonance imaging (MRI) is the technique most need to describe the anatomy of the TMJ and to evaluate the correlation of imaging findings with the clinical diagnosis . Despite the amount available studies on the use of MRI for evaluation of TMJ disorders and treatments, there is a lack of studies that evaluate the imaging findings after physical therapy. Purpose: To evaluate the influence of nonspecific mandibular mobilization about the positioning of the articular disc by MRI in individuals with TMD diagnosis of anterior disc displacement with and without reduction according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Analyze the behavior of pain through the numerical scale of pain assessment (END) at baseline and after each treatment session, the quality of life of individuals with TMD at baseline, immediately, three and six months after the treatment sessions by the World Health Organization Quality of Life Assessment (WHOQOL - BREF), and The Patient's Specific Functional Scale (PSFS) at baseline and after treatment. The treatment will be performed three times a week during four weeks. Metodology: This is a randomized, placebo controlled, blind study designed to assess the effects of techniques nonspecific mandibular mobilization x placebo. Individuals will be randomized and divided into two groups: Group A (intervention) and Group B (placebo). Statistic analysis: The positioning of the articular disc, extracted through the use of MRI, will be considered the primary outcome and, as a secondary outcome will be assessed the quality of life, pain and function after treatment. The adherence of the data to a Gaussian curve will be verified by the Shapiro-Wilk and the data are expressed as mean values and standard deviation. Two-way repeated measures analysis of variance with Bonferroni post hoc test will be used for inter-and intra-group comparisons. The significance level is adjusted p ≤ 0.05.

NCT ID: NCT02284503 Not yet recruiting - Clinical trials for Non-ST-elevation Acute Coronary Syndromes

Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With Non ST-segment Elevated Acute Coronary Syndrome(NSTE-ACS)

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

This is a 30-day, randomized, open-label, 3-arm, parallel-group, multicenter study exploring efficacy of intensive rosuvastatin treatment peri-PCI in Chinese patients with NSTE-ACS.

NCT ID: NCT02281266 Not yet recruiting - Clinical trials for Curable Hepatitis B Virus-Related Hepatocellular Carcinoma

Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection

Start date: January 2015
Phase: Phase 4
Study type: Interventional

Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection.