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NCT ID: NCT03368014 Not yet recruiting - Clinical trials for Mental Health Wellness 1

"Fun.Feel.Share" Lyrics-writing and Singing Show

Start date: December 11, 2017
Phase: N/A
Study type: Interventional

"Fun.Feel.Share" Lyrics-writing and Singing Show - A Pilot Project is part of the Community-based Mental Wellness Project for Adolescents and Adults, which aims at promoting sharing, mind and enjoyment and enhancing mental well-being. The Mental Wellness Project is financially supported by the Health Care and Promotion Fund from Food and Health Bureau and led by the School of Public Health, University of Hong Kong (HKU). The major subjects of "Fun.Feel.Share" Lyrics-writing and Singing Show - A Pilot Project RCT Study are 720-900 students. 3 to 4 secondary schools in Hong Kong will be included in the evaluation. Schools will either be assigned into lyrics-writing and singing show intervention group or wait-list control group (the intervention won't be provided during the evaluation period and will be provided after the evaluation period.). There will then be 4 assessments (pre-intervention, immediate post intervention, one month and three months after) to evaluate the effects of the intervention programme. In the assessments, students will be asked to complete a questionnaire to measure the changes in parent-child interaction and SME (Sharing, Mind, Enjoyment) of families, knowledge and attitude towards the mental health problems. HKU team will conduct the evaluation during the programme implementation stage. The effectiveness of the intervention, as well as the level of participation and ratings for the intervention will be evaluated.

NCT ID: NCT03361956 Not yet recruiting - Hepatitis B Clinical Trials

An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection

Start date: February 5, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.

NCT ID: NCT03361475 Recruiting - Clinical trials for Mental Health Wellness 1

SME (Sharing, Mind & Enjoyment) App

Start date: January 11, 2018
Phase: N/A
Study type: Interventional

SME (Sharing, Mind, Enjoyment) App, A Pilot Project is part of the Community-based Mental Wellness Project for Adolescents and Adults, which aims at promoting sharing, mind and enjoyment and enhancing mental wellbeing. The Mental Wellness Project is financially supported by the Health Care and Promotion Fund from Food and Health Bureau and led by the School of Public Health, University of Hong Kong (HKU). The major subjects of SME (Sharing, Mind, Enjoyment) App Pilot Project RCT Study are 300-500 students. 2 schools will be included in the evaluation. Schools will either be assigned to app intervention group or waitlist control group. There will then be 4 assessments (pre-intervention, immediate post-intervention, one month and three months after) to evaluate the effects of the intervention programme. In the assessments, students will be asked to complete a questionnaire to measure the changes in parent-child interaction and SME (sharing, mind and enjoyment) of families, knowledge and attitude towards the mental health problems. HKU team will conduct evaluation during the programme implementation stage. The effectiveness of the intervention, as well as the level of participation and ratings for the intervention, will be evaluated.

NCT ID: NCT03361462 Recruiting - Clinical trials for Mental Health Wellness 1

Joyful Adventure Day

Start date: December 11, 2017
Phase: N/A
Study type: Interventional

Joyful Adventure Day - A Pilot Project is part of the Community-based Mental Wellness Project for Adolescents and Adults, which aims at promoting sharing, mind and enjoyment and enhancing mental wellbeing. The Mental Wellness Project is financially supported by the Health Care and Promotion Fund from Food and Health Bureau and led by the School of Public Health, University of Hong Kong (HKU). The Project will organize two joyful adventure days in secondary schools in the form of physical activities and competitions with the following activities: - Fitness assessment (enjoyment) and in-door games, which will be designed, supervised and supported by experienced social workers; - Short interactive talk on SME, positive thinking and understanding of adolescent mental health problem (in particular the anxiety disorders) and mental well-being; - Issue achievement / improvement stickers to students, and attractive prizes to the 10 fittest students by chairperson / members of Parent-Teacher Association (sharing); - Provide physical activity diary after 1st session of adventure day, and invite family members / peers to join the competition at the 2nd session. The major subjects of Joyful Adventure Day Pilot Project RCT study are 200-300 students. 4 schools will be included in the evaluation. Schools will either be assigned into intervention group or waitlist control group (the intervention won't be provided during evaluation period and will be provided after the evaluation period.). There will then be 4 assessments (pre-intervention, immediate post intervention, one month and three months after) to evaluate the effects of the intervention programme. In the assessments, students will be asked to complete a questionnaire to measure the changes in fitness enjoyment, physical activity frequency and knowledge and attitude towards the SME (Sharing, Mind, Enjoyment) and the adventure day. HKU team will conduct evaluation during the programme implementation stage. The effectiveness of the intervention, as well as the level of participation and ratings for the intervention will be evaluated.

NCT ID: NCT03356834 Recruiting - Chronic Hepatitis B Clinical Trials

Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF

SWITAF
Start date: November 2017
Phase: Phase 4
Study type: Interventional

In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF). However, some of patients on long term TDF experienced impairment of renal function and bone mineral density. After Tenofovir alafenamide(TAF) was in clinical practice, these group of patients got an clinical option to switch from TDF to TAF. The investigators designed a prospective cohort study to evaluate the real life effectiveness and safety in participants with chronic HBV infection switch from TDF to TAF vs. maintaining on TDF.

NCT ID: NCT03354429 Not yet recruiting - Clinical trials for Acute Ischaemic Stroke

THALES - Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death

THALES
Start date: January 31, 2018
Phase: Phase 3
Study type: Interventional

Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo (inactive tablet) and ASA in preventing new stroke events.

NCT ID: NCT03353207 Recruiting - Clinical trials for Neurodegenerative Diseases

Striatal Dopamine Transmission in Individuals With Isolated Rapid Eye Movement Sleep With Atonia: a Search for Precursor Biomarker for Neurodegeneration

Start date: October 30, 2017
Phase: N/A
Study type: Observational [Patient Registry]

Background: Previous studies have confirmed that most patients with idiopathic REM sleep behaviour disorder (iRBD) eventually develop neurodegenerative diseases. In addition, REM sleep without atonia (RSWA), a hallmark of RBD feature, is a significant predictor of development of neurodegenerative diseases in patients with iRBD. Some preliminary studies have implied that isolated RSWA in the absence of RBD symptoms may also indicate neurodegeneration. However, this speculation needs to be confirmed by more refined study with sophisticated measures in both RSWA and markers of neurodegeneration Objectives: 1) to determine the differences in striatal dopamine transmission and other markers of neurodegeneration among individuals with isolated RSWA and healthy controls; 2) to examine the correlation of severity of RSWA with striatal dopamine transmission. Design: Case-control study Setting: Community-based sample Participants: 1) iRBD first degree relatives with isolated RSWA (n=18) 2) iRBD first degree relatives without isolated RSWA (n=18) 3) Community-based health controls without isolated RSWA (n=18) Main outcome measures: 1. The dopamine transmission as measured by triple-tracer PET/ CT imaging protocol including 18F-DOPA, 11C-Raclopride and 18F-FDG images; 2. Brain glucose metabolism and neurocognitive measures; 3. Severity of EMG activity during REM sleep

NCT ID: NCT03352778 Recruiting - NPC Clinical Trials

IMRT vs 2DRT for NPC Patients

Start date: November 29, 2017
Phase: N/A
Study type: Observational

Irradiation of the parotid gland with subsequent long-term xerostomia is a well-recognized complication after radiotherapy for head and neck (HAN) cancers. A number of studies have shown that IMRT could minimize the radiation dose to the parotid glands and hence the risk of developing xerostomia. The benefit of IMRT has also been demonstrated in prior dosimetric and non-randomized studies in NPC patients. In 2007, the investigators have published the prospective randomized study of IMRT versus 2DRT in early stage NPC patients. In the study, IMRT had lower incidence of observer-rated severe xerostomia, higher parotid and whole saliva flow rate, than patients in 2DRT arm at 1 year after treatment. However, there was no significant difference in patient-reported outcome, i.e. subjective xerostomia scoring, between the 2 arms. The underlying reason for the incoherent findings in terms of objective and subjective xerostomia outcome remains uncertain. One of the possible explanations for this observation could be the better parotidsparing with IMRT alone may not entirely sufficient to maintain oral cavity lubrication while the other mucin-secretory salivary gland protection is also essential. Another possible explanation for the insignificant improvement in patient-reported outcome with IMRT is the short follow-up time. Gradual recovery or improvement in various quality of life parameters was not uncommonly seen several years after definitive radiotherapy for HAN cancer patients. There is much interest in studying the long term clinical outcome, especially the treatment-related complications, for the patients who had randomized and treated in the prior presented prospective study. In this study, the long term results, in particular the xerostomia rating will be assessed and compared in NPC patients who had participated in the prior reported prospective randomized study of IMRT vs 2DRT.

NCT ID: NCT03352310 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia

Start date: December 1, 2017
Phase: Phase 1
Study type: Interventional

The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and anemia. Umbilical cord blood (UCB) is collected following labor and is transfused intravenously within 48 hours after the birth. Following the autologous UCB transfusion, HIE subjects will be followed for 2 years for survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to assess the survival and change of hematocrit and hemoglobin levels.

NCT ID: NCT03348761 Recruiting - Depression Clinical Trials

rTMS Response Trajectories in Depression

Start date: August 4, 2015
Phase: N/A
Study type: Interventional

Background: Previous studies on network mechanism of repetitive transcranial magnetic stimulation (rTMS) suggest that pre-treatment resting-state fMRI (rs-fMRI) connectivity between left dorsolateral prefrontal cortex (lDLPFC) and subgenual anterior cingulate cortex (sgACC) might serve as predictive biomarker for antidepressant treatment response, although direct evidence is still lacking. Furthermore, the time course of symptomatic change to explain inter-individual differences in treatment prediction models has been largely ignored. Therefore, the aim of this study is to directly investigate the predictive role of lDLPFC-sgACC rs-fMRI connectivity on rTMS treatment response trajectories (time-dependent changes in depressive symptom scores) in treatment-refractory depression. Methods: Rs-fMRI data are collected from treatment-refractory depressed patients before undergoing 20 sessions of 10 Hz lDLPFC neuronavigation rTMS over 4 weeks. Primary outcome measure is time-dependent change (trajectory) in depressive symptom scores measured with Montgomery-asberg Depression Rating Scale at baseline, week 2, 4, 6, 8, and 12. Multiple regression with backward elimination is used to investigate predictors of treatment response at week 12. Symptom score trajectories are analyzed using growth curve analysis.