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NCT01019694
The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.
NCT02270424
The aim of this study is to compare the effectiveness of two treatments for severe / very severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments and conventional medicine, which have been evaluated and have certain effect.
NCT02269800
The purpose of study is to evaluate the efficacy and safety of Benzalkonium Chloride Solution clearing the oral colonized bacterium in hospitalized patients with COPD.
NCT02000271
Vaginal packing is used routinely following vaginal reconstructive surgery. Despite little data to support the practice, purported benefits include reduced pelvic fluid accumulation or blood loss. Patients often complain of discomfort associated with the packing or its removal. This randomized controlled trial seeks to document differences in subjective impressions of pain in women undergoing vaginal repairs treated with and without packing. The investigators also aim to assess differences in postoperative fluid collection in those with and without packing.
NCT01644162
The aim of this study is to determine whether respiratory disease exacerbations (a sudden worsening of symptoms) can be predicted by variables that are monitored by non-invasive ventilators (small machines that assist breathing) in patients requiring long term home ventilation. The investigators hypothesise that acute exacerbations of patients with respiratory disease and ventilatory failure will be predicted by changes in the respiratory variables monitored and stored by ventilators during chronic home ventilator use.
NCT02266316
The World Health Organisation defines chronic obstructive pulmonary disease (COPD) as 'not one single disease but an umbrella term used to describe chronic lung diseases that cause limitations in lung airflow' covering emphysema and chronic bronchitis; and estimates (2004) that worldwide there are currently 64 million sufferers with 3 to 4 million in the UK. COPD results from damaged airways in the lungs, causing them to become narrower and making it harder for air to get in and out of the lungs. It is diagnosed by measuring the amount of air that can be expelled in the first second of breathing out (FEV1) in litres per second. COPD is a progressive disease and the condition can have a serious impact on the quality of life of sufferers. Going out in very cold weather can cause an immediate drop in FEV1, and increased breathlessness. This is a randomised crossover controlled trial of participants with COPD. It compares the effectiveness of an air-warming face mask which covers the mouth compared with no face covering, in increasing participants exercise capacity and quality of life in cold weather. The mask warms air at the mouth by drawing on air warmed beneath the participants clothing, through a 20cm long hollow plastic tube and a one-way inspiratory valve into the mask. Air is expired through the nose. 24 participants with moderate or severe COPD, will undertake 3 exercise tests on 3 separate days. Two tests will be in an environmentally controlled chamber performed at 5°C with participants wearing either the mask or no face covering. The third test will be performed at ambient temperature outside the chamber. The order will be determined by random allocation. Participants will undergo the Treadmill 6 Minute Walk Test; various measurements will be taken, all of which will be non-invasive.
NCT01020344
A randomised controlled trial will be performed to evaluate the effects of lung volume reduction surgery (LVRS) in patients with COPD on systemic inflammation, oxidative stress, endothelial function, arterial stiffness and blood pressure. We hypothesize that LVRS will lead to a reduction of systemic inflammation, oxidative stress, arterial stiffness and blood pressure and to improved endothelial function. For this purpose 30 patients with severe/very severe COPD (GOLD III-IV) and pulmonary emphysema who are to undergo LVRS will be randomised to one of two groups: group 1 receiving immediate LVRS and group 2 receiving LVRS after a delay of 3 months. Measures of systemic inflammation, oxidative stress, endothelial function, arterial stiffness and blood pressure will be measured at baseline and 3 months after surgery and no surgery, respectively (group 2 receiving surgery only after a delay of 3 months will serve as control group) to investigate the effects of LVRS on the described outcomes.
NCT02050763
Intimate partner violence (IPV) is a precursor to and consequence of HIV infection. Few interventions combining HIV and IPV prevention have been evaluated and none has significantly decreased both outcomes. A cluster-randomized trial was conducted in Rakai, Uganda. Four intervention arm clusters (N=5,339) received an IPV prevention intervention (the Safe Homes and Respect for Everyone (SHARE) Project), enhanced HIV testing and treatment and routine HIV services provided by Rakai Health Sciences Program (RHSP). Seven control arm clusters (N=6,112) received standard of care HIV services alone. Baseline and two follow-up visits were conducted via the Rakai Community Cohort Study between 2005 and 2009. Primary outcomes were past year emotional, physical and sexual IPV and HIV incidence. Secondary outcomes included past year intimate partner rape/forced sex, number of total and extra-marital sex partners, alcohol use surrounding sex, condom use, discussion about condom use, partner's disclosure of HIV status and respondent's disclosure of HIV status. Analysis was by intention-to-treat. Modified Poisson regression was used to estimate prevalence risk ratios (PRR) to detect the impact of the intervention on IPV and secondary outcomes. Poisson regression was used to estimate incidence rate ratios (IRR) of HIV acquisition per 100 person years (py). Our study had three research aims and related hypotheses. Aim 1 was to assess the impact of SHARE + RHSP community services on report of victimization from and perpetration of physical and/or sexual IPV in the past 12 months, compared to the impact of RHSP community services alone. Hypothesis 1(a): SHARE intervention will reduce women's reports of IPV victimization in intervention vs. control arms. Hypothesis 1(b): SHARE intervention will reduce men's reports of IPV perpetration in intervention vs. control arms. Aim 2 was to assess the impact of SHARE + RHSP services on report of sexual risk behaviors among men and women compared to the impact of RHSP community services alone. Hypothesis 2(a): SHARE intervention will reduce selected sexual risk behaviors in the intervention vs. control arms. Aim 3 was to assess the impact of SHARE + RHSP services on HIV incidence compared to the impact of RHSP community services alone. Hypothesis 3(a): Incidence of HIV will be lower in the intervention vs. control arms.
NCT01533870
Study in healthy volunteers to investigate the effects of Rifampin on the Pharmacokinetics of NKTR-118.
NCT01594619
Study in healthy volunteers to investigate the effects of Diltiazem on the Pharmacokinetics of naloxegol.
NCT00690339
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
NCT01658020
The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple dose of Zabofloxacin Tablet 400 mg.
NCT02124343
Exercise is a cornerstone of pulmonary rehabilitation in the treatment of Chronic Obstructive Pulmonary Disease (COPD). Although researchers have shown numerous benefits with exercise in COPD patients, most studies have only looked at exercise tolerance and psychological outcomes following training. COPD is characterised by persistent inflammation that can cause progressive decline in lung function and multisystemic complications. This inflammation can be amplified in patients when they suffer acute exacerbations. There is a wellknown relationship between exercise, immune function and risk of infection. Exercise has also been shown to have an antiinflammatory effect when performed regularly. There is a lack of research looking into the inflammatory or immune response to exercise in patients with COPD. The exercise within this study will be individually tailored to patients with COPD based on their validated 6 minute walk test (6MWT) but the protocol will involve interval exercise that has been used previously. This type of exercise is considered most appropriate for research into mechanisms of benefit because it maintains the exercise training effects of other modalities (e.g. continuous low intensity aerobic exercise) while avoiding the occurrence of limitations to exercise in people with lung problems (e.g. dynamic hyperinflation). It also closely mirrors daily activity of someone with COPD. The investigators want to explore the effects of exercise specifically on immune function in 15 people COPD and compare any changes to 15 Controls. By better understanding the mechanisms of how exercise affects inflammation, the investigators could eventually design better Pulmonary Rehabilitation interventions, especially for those most at risk.
NCT02078765
A new study have shown that high night time blood pressure (BP) and/or non-dipping (lack of fall in BP during night time) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Three factors seem to affect the night time BP: chronic kidney disease, obstructive sleep apnea (OSA) and the way ambulatory blood pressure is monitored. Hypothesis: Central 24-h blood pressure monitoring is a better way of monitoring blood pressure than conventional peripheral monitoring. In hypertension, chronic kidney disease and obstructive sleep apnea (OSA) the night time blood pressure is elevated, and is OSA the elevation is correlated to the severity of OSA. In OSA the kidneys handling of salt and water is disturbed. In OSA there is disturbances in hormonal balance.
NCT01645358
Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory failure, it is largely employed as a "rotating" strategy when the facial mask is poorly tolerated. In a multicenter randomized controlled trial, the investigators will compare the clinical efficacy of a new helmet designed to specifically improve the performance in chronic obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.
NCT02255396
Estradiol and Testosterone are two important hormones for the regulation of an effective spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in seminal plasma of men with non-obstructive azoospermia may be a predictive test before surgical testicular biopsy to determine the chance of a positive sperm extraction to use for ICSI.
NCT00507767
This phase II trial studies how well dasatinib works in treating patients with head and neck cancer that has come back or spread to other areas of the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT01896180
This is a pilot, proof of concept study to evaluate the safety and efficacy of ALZ-1101 dosed once daily for 28 days compared to latanoprost 0.005% ophthalmic solution in patients with elevated intraocular pressure not adequately controlled with latanoprost.
NCT02249338
Study to investigate the effect of 14-day treatment with BIIL 284 BS on sputum neutrophils and specific inflammatory markers in patients with clinically well-defined moderate chronic obstructive pulmonary disease (COPD)
NCT02247817
Cardiac resynchronization therapy has become one of the cornerstones of the treatment of heart failure. However, a large proportion of patients still fails to this type of therapy. This may be due to a suboptimal position of the left ventricular pacing lead, which may be caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video assisted thoracic surgery is more flexible and evades the venous system altogether, resulting in a much more favorable position of the pacing lead, with better treatment results as e consequence.