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NCT ID: NCT02333370 Completed - Clinical trials for Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Start date: February 4, 2015
Phase: Phase 1
Study type: Interventional

The purpose of the Phase Ib is to: 1. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in Asian non-Japanese patients 2. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and activity data in Japanese patients 3. evaluate the safety and anti-tumor activity of LEE011 at the RP2D established in the dose escalation part in combination with a standard dose of letrozole, fulvestrant or tamoxifen plus goserelin in Japanese patients.

NCT ID: NCT02330107 Completed - Clinical trials for Lower Urinary Tract Symptoms

Auriculotherapy on Lower Urinary Tract Symptoms in Elderly Men

Start date: September 2014
Phase: N/A
Study type: Interventional

Lower urinary tract symptoms (LUTS) represent a widespread health problem that negatively affects the quality of life (QoL) of majority of the male aging population. Although LUTS are not life threatening, these symptoms include urinary retention, voiding difficulty, frequent feeling of urinary urgency, and nocturia, all of which negatively affect the daily functions, sleep quality, and sexual activities of patients. Despite the proven effectiveness of conventional pharmacological therapies, most men are reluctant to try these treatments because of perceived side effects and potential complications. Other non-invasive complementary treatments for LUTS should be explored because of the limitations of pharmacological therapy. Auriculotherapy (AT), one of the approaches in traditional Chinese medicine, is a therapeutic method in which specific points in the auricle are stimulated to treat various physical disorders. AT is a specialized form of acupuncture in which the ear is viewed as a microsystem of the body. A minimally invasive measure of AT, instead of using needles, is adopted in this study to avoid pain induction. This randomized controlled trial (RCT) aims to determine the effectiveness of AT in improving the conditions of the elderly with LUTS in terms of symptom relief, enhancing QoL, and improving sleep conditions. Male subjects, who are 60 years old or above and with moderate to severe LUTS, will be recruited. Subjects in 'Treatment arm 1' will receive MAT and placebo LA on specific auricular points on one side of the ear during each treatment session. Subjects in 'Treatment arm 2' will receive LA and placebo MAT using low-energy laser applied to selected acupoints of the ear, and a plaster centred with a portion of Junci Medulla that mimics MAT treatment will also be given. Subjects in 'Treatment arm 3' will receive a combined approach (both MAT and LA). Subjects in the 'placebo arm' will serve as placebo controls. Six auricular acupoints that are considered to affect LUTS will be selected. Only one ear at a time will receive treatment. Thus, the ears will be treated alternately. The total treatment period will be four weeks. The experimental objects will be replaced every other day. Therefore, treatment will be performed thrice a week. Subjects will be assessed at baseline up to 3 months after the therapy. This study can advance our knowledge of complementary approaches to improve the LUTS conditions of the elderly population and the feasibility of AT among clients with LUTS in a future large-scale study.

NCT ID: NCT02329457 Completed - Clinical trials for Varicella Zoster Infection

VZV Vaccine for Hematopoietic Stem Cell Transplantation

VZIDST
Start date: December 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Hematopoietic stem cell transplantation (HSCT) is well-established therapy for patients with malignant hematological diseases. Varicella zoster virus (VZV) reactivation, clinically manifested as herpes zoster (HZ), is a major complication that affects up to 50% of patients. Most patients will require hospitalization. Despite treatment with high dose acyclovir, patients may develop severe complications including the disabling postherpetic neuralgia, corneal ulceration, viral dissemination and secondary bacterial infection. The median onset of infection is the fifth month following transplantation, with 91% of cases occurring within the first year. Direct vaccination of transplants recipients with subcutaneous live-attenuated VZVv before transplantation and up to one year after transplantation is contraindicated. A small prospective non-randomized study has demonstrated that subcutaneous vaccination for donors before HSCT may offer some protection against VZV reactivation in the recipients. Recently, dose-sparing influenza vaccine delivered via a novel intradermal microneedle has been shown to elicit a good immunogenic response in both healthy and elderly subjects. We sought to assess the efficacy and safety of the novel intradermal live-attenuated VZVv in sibling donors undergoing HSCT.

NCT ID: NCT02325739 Completed - Clinical trials for Hepatocellular Carcinoma (HCC)

FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression

Start date: December 29, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401 as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and as single agent in patients with other solid malignancies based on RECIST 1.1.

NCT ID: NCT02323061 Completed - Stroke Clinical Trials

Brain Computer Interface(BCI) System for Stroke Rehabilitation

Start date: May 1, 2015
Phase: N/A
Study type: Interventional

A BCI system for stroke subjects will be designed in an attempt to train the motor-related areas in their brains responsible for hand open/close function. A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the motor cortex. A randomized controlled trial study design will be adopted. All subjects will be assessed by clinical assessments including FMA and neuroimaging assessments using multimodal MR techniques before and after the training to evaluate training effectiveness.

NCT ID: NCT02314507 Completed - Back Pain Clinical Trials

Gua Sha for Chronic Low Back Pain in Elderly

Start date: July 2014
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate whether Gua sha is an effective modality for relieving chronic low back pain specifically in the aged population by comparing the baseline measures of pain intensity, self-perceived disability, back range of motion, back local muscle stiffness, depression, sleeping quality, quality of life, biomarkers measurement, and analgesic intake on days 1 and 7 after a single session of Gua sha treatment. In addition, the investigators are going to compare between Gua sha and hot pack treatments for the above parameters.

NCT ID: NCT02312960 Completed - Clinical trials for Neoplasm Metastasis / Bone and Bones

Radium-223 Dichloride Long-term Follow-up Program

Start date: December 18, 2014
Phase: Phase 4
Study type: Interventional

Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .

NCT ID: NCT02310672 Completed - Clinical trials for Pulmonary Arterial Hypertension

REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension

REPAIR
Start date: June 1, 2015
Phase: Phase 4
Study type: Interventional

The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.

NCT ID: NCT02307929 Completed - Chronic Disease Clinical Trials

Evaluation of Quality of Care - Nurse Allied Health Clinic Programme, HA

QoC NAHC
Start date: September 2010
Phase: N/A
Study type: Observational

In the past two decades, as a result of population aging and shifts in patient needs, we have seen an increased demand for chronic disease management (CDM) delivered in the community. The Hong Kong Government introduced six nurse allied health clinics (NAHC) programme to assist the delivery of care to facilitate the increased demand on chronic disease management (CDM) in the community, which are currently being piloted within the government funded general outpatient clinics (GOPC) of the Hospital Authority (HA). These programmes are designed to enhance CDM in primary care through patient empowerment and use of multi-disciplinary nurse and allied health led teams, and aim for secondary prevention and treat-to-target for specific health conditions. This model of care has already been established in a number of countries, namely United Kingdom, Australia, Canada and United States, where multi-disciplinary allied-health clinics, nurse practitioners and nurse-led clinics have already been integrated into routine practice in primary care (Thomas, Cullum et al. 2000; Laurant, Reeves et al. 2005). The six NAHC programmes which have been developed to date address falls prevention (FP), continence care (CC), mental wellness (MW), wound care (WC), respiratory disease management (respiratory clinic) and medication management and compliance (MMCC). The evaluation on the QOC is an essential part of the programme in order to inform future policy. he Department of Family Medicine and Primary Care (FMPC) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the QOC of the programme. The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the NAHC programme is achieved. Each NAHC participating clinic will be invited to complete a structured evaluation questionnaire. Anonymized data of all patients who have enrolled into the NAHC programme for more than 6 months will be included in the evaluation on the process and outcomes of care. Data on the process of care will be retrieved from the HA medical records. In-depth study of NAHC CC programme: In order to compare the outcomes over time between subjects who have and who have not participated in the NAHC Continence Care Programme, three hundred and sixty control patients who have not been enrolled into the NAHC CC programme will be selected for the comparison in the outcomes of care. Subjects will be followed up by telephone to evaluate the effect of the programme in quality of life (QOL), patient enablement, and global rating of change in health condition at baseline , 12-month and 24-month after enrollment. Main Outcome Measures: The primary outcomes are the proportion of participants who have received the planned process of care and have improvement in clinical outcomes. Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be calculated. The changes in clinical, service and patient reported outcomes between baseline and discharge will assessed by paired sample t-test. The audit cycle will be repeated 4 times over a period of 5 years. In-depth study of NAHC CC programme: the clinical outcomes between NAHC CC subjects and control group will be compared by independent sample t-test or Chi-square test. Results: The QOC of the NAHC programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified. Conclusion: The results of this study will provide empirical evidence on whether the HA's NAHC programmes enhance the QOC of their participating patients. This information will be used to guide service planning and policy decision making.

NCT ID: NCT02307903 Completed - Clinical trials for End-stage Renal Failure (ESRF)

Evaluation of Quality of Care - Haemodialysis Public-Private-Partnership, Hospital Authority

QoC HDPPP
Start date: September 2010
Phase: N/A
Study type: Observational

Patients with end-stage renal failure (ESRF) have lost the function to excrete urea and maintain electrolyte balance, which is lethal unless they are given renal replacement therapy (Gibney, Hoste et al. 2008). As one of the initiatives of service improvement, the HA has introduced the haemodialysis public-private partnership (HD PPP) programme to shorten the waiting time for patients with ESRF needing HD treatment. HD PPP programme is a new service provision model that purchases healthcare services from non-Government healthcare organizations. The evaluation on the quality of care (QOC) is an essential part of the programme in order to inform future policy. The Department of Family Medicine and Primary Care of the University of Hong Kong has been appointed by the HA to carry out the evaluation of the QOC of the programme. The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the HD PPP programme is achieved. Each HD PPP participating hospitals and centers will be invited to complete a structure evaluation questionnaire. Sixty patients who have agreed to join HD PPP and 60 control patients who have refused to take part in HD PPP will be included. The participants will be followed up by telephone to evaluate the effect of the programme on quality of life (QOL), patient enablement, and global rating of change in health condition. Data on the process of care and clinical outcomes of care will be retrieved from the HA medical records. Main Outcome Measures: The primary outcomes are the proportion of participants who have received the planned process of care and adequate haemodialysis (HD) measured by the Kt/V Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be calculated. The outcomes of HD PPP subjects will be compared at 6, 12, 24, 36 and 48 months by paired sample t-test. The outcomes between HD PPP subjects and control group will be compared by independent sample t-test or Chi-square test. Results: The QOC of the HD PPP programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified. Conclusion: The results of this study will provide empirical evidence on whether the HD PPP can achieve equivalent QOC as the usual HA care in order to guide service planning and policy decision making for patients with ESRF.