The Safety and Pharmacokinetics Study of TAKC-02 Inhalation Solution in Healthy Adult Males.
Healthy VolunteerMEX3B is an RNA-binding protein that is conserved in many animal species and has wide range of biological function. The MEX3B protein is deeply involved in the expression of various cytokines associated with the onset and exacerbation of several diseases such as inflammatory diseases, metabolic diseases, and malignant tumors. TAKC-02 is a nucleic acid medicine, antisense oligonucleotide, inhibits the MEX3B synthesis expected to have potential as new medication. This plans to evaluate the safety profile of the inhalation solution in order to develop TAKC-02 for severe asthma. The study is a double-blind, randomized, placebo-controlled Phase I study. The primary objective of the study is to assess the safety and tolerability of single and multiple inhaled doses of TAKC-02 in healthy male subjects. The study is a Single Ascending Dose (Step 1) followed by a Multiple Comparative Dose (Step 2).
Effects of Inspiratory Muscle Training in Pulmonary Hypertensive Patient
Inspiratory Muscle TrainingAlthough the progressive nature of pulmonary hypertension (PH), including the impairment of respiratory muscle function, studies have demonstrated beneficial effects of physical exercise on the functional limitations caused by the disease in this population, being an important collaborator to the conventional drug therapy.Respiratory muscle training (RMT) improves functional capacity and quality of life (QoL) in patients.A randomized controlled trial was conducted to evaluate the effectiveness of this protocol on respiratory muscle strength and endurance, functional capacity. 18 subjects were allocated in 2 groups, group A was control group and group B was experimental group. Group A or Control group received deep breathing exercises. Group B received 30 minutes of IMT 6days weekly for 2 weeks by using a pressure threshold device. The purpose of this study was to investigate the effects of inspiratory muscle training (IMT) in PAH. To evaluate effectiveness of IMT mouth pressure device ,functional capacity using 6 minute walking test (6MWT)health assessment via SF 36 questionnaire were used before and after training protocol.
Effects of Inspiratory Muscle Training (IMT) on Balance Ability and Quality of Life of Diabetes...
Diabetes MellitusThe disease burden of Diabetes Mellitus (DM) is growing rapidly, and multiple complications have been reported including cardiopulmonary and high fall risk which declines the overall quality of life. IMT can be useful technique to improve the physical and functional performance, reduce the severity of complications and enable the individuals to become active members of community. The current study is intended to evaluate the dual effects of IMT on postural stability and pulmonary function of diabetic patients.
Inhaled Nitric Oxide Treatment for Aneurysmal SAH Patients With Intractable Cerebral Vasospasm
SAHInhaled Nitric Oxide2 moreAneurysmal subarachnoid haemorrhage (aSAH) is a rare but severe subtype of stroke with high mortality and morbidity. Besides rebleeding, delayed cerebral ischaemia and cerebral vasospasm (CVS) are thought to be major reasons for the poor outcome in survivors of aSAH. Despite advances in the detection and treatment of CVS 20-40% of CVS patients experience cerebral Ischaemia. Experimental animal studies for ischaemic stroke, traumatic brain injury, and SAH showed that inhaled nitric oxide (iNO) selectively dilates cerebral arteries and arterioles in hypoperfused brain tissue. The investigators therefore performed this prospective pilot study to evaluate the effects of iNO on cerebral perfusion in patients with refractory vasospasm after aSAH.
The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in...
SmokingThis short-term study aims to prove the potential cardio-protective physiological effect of inhaled aclidinium bromide/formoterol fumarate on inspiratory pleural pressures. Smoking is associated with gas-trapping (hyperinflation), even in the absence of chronic obstructive pulmonary disease. Breathing in the presence of gas-trapping requires large negative inspiratory pleural pressures, which are transmitted to the surface of the heart and increase cardiac wall stress. Inhaled aclidinium bromide and formoterol fumarate has been shown to reduce gas-trapping, but the impact on inspiratory pleural pressures and biomarkers of cardiac stress in smokers is unknown.
Sleep Disordered Breathing, Adenotonsillectomy, Cognition and Pre-school Age Children
Sleep Disordered BreathingSleep disorder breathing (SDB) is a condition affecting 10% of children aged 2-6 years. It is a combination of snoring most nights during sleep, patchy sleep, short periods of stopping breathing (apnoea) and usually big tonsils. Most of these children get better with no treatment by 8 years old. It has been suggested that having SDB mean that some children concentrate and behave less well during the day and may learn more slowly than children who don't snore. It has become common for many Ear, Nose and Throat (ENT) surgeons to take out tonsils and adenoids (adenotonsillectomy) for this condition. Removing the tonsils and adenoids (which are normally big at this age) means that most children quickly stop snoring and seem to be cured. Unfortunately it is not clear if this operation makes any difference to learning compared to just watching the child and letting them "grow out" of the condition (watchful waiting). There is no set treatment in the UK today. Children may be offered adenotonsillectomy or watchful waiting; it is not know which, long term, is the right thing to do. Therefore the investigators wish to do a study looking at these two different treatments to see if there is a difference in children's learning over time between the two different treatments. The investigators will look at children with SDB, measure their learning (and behaviour) and then randomly select which children get one treatment or the other. They will then re-measure learning (and behaviour) 7 months later to see if there is any difference between the two groups. The investigators will also scientifically measure their sleep. This is possibly quite a difficult study to do, the investigators are unsure whether families will agree to take part and how easy it will be to measure learning with such young children (aged 2:6 - 5).
Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia
Fear of FlyingThe study investigated the effect of diaphragmatic breathing as an additional coping strategy during Virtual Reality Exposure Therapy in patients with aviophobia. The authors assumed that diaphragmatic breathing (DB) would lead to less fear and physiological arousal during the VRET and to an enhanced treatment outcome
Peak(R) vs. Electrocautery in Children Undergoing Tonsillectomy With Adenoidectomy
Sleep Disordered BreathingGiven the large numbers of children who undergo tonsillectomy (by the time a child is 15 years old, 13% of his/her peers will have had a tonsillectomy), the significant morbidity, and direct and indirect costs associated with absences for child from school or parent from work or other responsibilities, it is vitally important to identify surgical techniques which will minimize pain and serious negative outcomes. This study aims to compare a new surgical technique, PEAK® Surgery System, with electrocautery, one of the most commonly used methods for tonsillectomy with or without adenoidectomy in children 3 to 6 years old with a diagnosis of sleep-disordered breathing. In this project, the investigator will evaluate intra-operative outcomes including, surgery time and bleeding rates, and post-operative pain scores, bleeding rates, time to resumption of normal diet and activity, analgesic type and use, and frequency of emergent visits over 14 days following surgery. The hypothesis is that there is no difference in outcomes between the traditional extracapsular electrocautery dissection method of tonsillectomy versus the newly introduced Peak® Surgery System. The long-term goal is to minimize pain and risk of bleeding and shorten the time to resumption of normal eating and activities in children undergoing tonsillectomy.
Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)...
HealthyThis study evaluates the effect of pre-treatment with either cromolyn sodium or albuterol sulfate on the safety and tolerability or PUL-042 Inhalation Solution in healthy subjects.
Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional...
Cystic FibrosisIt is extensively reported in the literature that patients with chronic obstructive lung disease may have impairments in balance and postural control which further increase the disease burden. Mechanisms related to these impairments include, but are not limited to increased work of breathing, diaphragm weakness, peripheral muscle weakness and systemic inflammation. Since the similar symptoms are reported for the children with cystic fibrosis, it is hypothesized that balance and postural control may also be compromised in these patients. Inspiratory muscle training (IMT) is shown to improve diaphragm strength and pulmonary function. Considering the relation between diaphragm which is one of the core muscles, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength, pulmonary function and functional capacity in these patients. Thus, the aim of this study was to investigate the effects of inspiratory muscle training and conventional chest physiotherapy on postural stability, balance, pulmonary function and functional capacity in children with cystic fibrosis.