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NCT03391765
The purpose of this study was to assess the long-term safety and efficacy of ABBV-8E12 (tilavonemab) in participants with progressive supranuclear palsy (PSP).
NCT03773861
Basic Life Support (BLS) is important for outcome in cardiac arrest.Therefore, it is crucial to improve the quality of education in resuscitation training. Better training will eventually lead to more effective CPR skills in course participants. BLS courses in both international resuscitation associations (European Resuscitation Council and American Heart Association are typically taught in small groups of 6 participants. In reality group sizes of up to 10 participants are used, because these courses are highly demanded and cost intensive. There is no evidence for the effective group size to be clinical and cost effective. Therefore the investigators perform this prospective study to determine the maximum number of participants an instructor can oversee without missing more than 20% of errors made during an instructional BLS session.
NCT04736264
With the improvement of health system, the life span of Asians has increased tremendously especially in Malaysia. As an early preparation to be an 'aging country' in 2023, Malaysia needs to prepare infrastructure and policy to improve quality of life (QoL) in older adults. Glaucoma is an aging related chronic disease that cause progressive optic neuropathy and visual field defect1. The main aim of glaucoma treatment is to slow down disease progression and preserve patient's QoL2. Modification of intraocular (IOP) is believed to be the mainstay of treatment but may not prevent progression of the disease. Modification of lifestyle has been found to change the prognosis of many chronic diseases such as diabetes mellitus. However, there is minimal evidence on the effect of lifestyle modification on glaucoma. Although constricted visual field almost asymptomatic especially in primary open angle glaucoma but many domestic injuries such as fall has been reported. Glaucoma patients reported greatest restriction with mobility especially driving compared to the other domains3,4. Reduction of walking and moderate-to-vigorous physical activity was also found in those with bilateral visual field loss5. Progressive constriction of visual field has been found to increase dependency, reduce mobility, pleasure of reading and QoL of glaucoma patients6. This will lead to psychological and emotional disturbance, in certain cases even resulted in depression. On the other hand, being physically active is found to have some protective effect against development and severity of glaucoma8,9. Thus, identifying problems related to physical activities in constricted visual field is important for improvement of rehabilitation and exercise regime for glaucoma patients. An exercise regime must be effective without causing major changes to IOP, safe in patients with constricted visual field and sensitive to social culture of Malaysians. Addressing these issues will lessen dependency and promotes healthy living among older adults. Improvement in navigation perhaps may increase the physical activities in glaucoma. Reading is another important pleasure in life. Visual field defect in glaucoma patients has been reported to associate with slower reading speed, saccade rate and visual span10,11. Identification of factors associated with difficulty in reading among glaucoma patients and development of rehabilitation regime in reading may improve the happiness index in literate patients. Nevertheless, there is no specific rehabilitation program to improve reading abilities among glaucoma patients. A combination of visual rehabilitation of low vision therapy and occupational therapy is ideal. Although, there is improvement in reading ability and mobility post low visual aid rehabilitation but there is no evidence on glaucoma patients specifically12. Improvement in daily living and dependency may improve their QoL. Happiness perhaps may improve the balance between oxidative stress damage and antioxidant level. Many previous studies discovered that various biomarkers of oxidative stress are elevated in people with depression, and anxiety disorders13. Similarly, oxidative stress has been implicated in pathogenesis of glaucoma and accelerates retinal ganglion cell damage in glaucoma14. Indirectly, improvement of QoL will help in halting the progression of visual field defect. Based on the previous research project on Malays in Malaysia, navigation and mobility has been identified to be mostly affect in primary glaucoma patients based on QoL questionnaires. Physical activities have potential protective effect against progression and severity of glaucoma9. Improvement in navigation, physical activities and reading ability, perhaps may improve their QoL. The main problem is how do we improve their navigation, physical activities and reading ability despite their constricted visual field. The most important step is to understand the problem and issues pertaining to the navigation, physical activities and reading faced by patients with glaucoma.
NCT02708966
Prediabetes (PD) was defined as an state in which glucose levels are above normal but not enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with IGT, it is expected that by 2035 this number will increase to 417 million people affected. Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including: increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose utilization in various ways and inhibition of glucose uptake in the intestine.
NCT00751049
Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure
NCT02925299
The main study objective is to determine whether 24/7 automated closed-loop glucose control combined with low glucose feature will improve glucose control as measured by HbA1c. This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a 6 month period of home study during which day and night glucose levels will be controlled either by a closed-loop system combined with low glucose feature (intervention group) or by insulin pump therapy alone (control group). It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with type 1 diabetes will be recruited through paediatric outpatient diabetes clinics of the investigation centres. Participants will all be on subcutaneous insulin pump therapy. Subjects in the intervention group will have proven competencies both in the use of the study insulin pump and the study continuous glucose monitoring (CGM) device, and will receive appropriate training in the safe use of closed-loop insulin delivery system and low glucose feature. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is between group differences in HbA1c levels at 6 months post study arm initiation. Secondary outcomes are the time spent in the glucose target (3.9 to 10.0mmol/l; 70 to 180mg/dl), time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes and diabetic ketoacidosis (DKA).
NCT02682693
Pharmacologic inhibition of RANKL attenuates the development of mammary carcinoma and inhibits metastatic progression in multiple mouse models. In a retrospective analysis it could be demonstrated that elevated expression of RANK was found in 14.5% of patients overall, with a significant predominance in patients with hormone-receptor-negative disease. Expression of RANK was associated with a higher pathological complete response rate but with a shorter disease-free and overall survival. The ABCSG-18 study showed that adjuvant denosumab reduces clinical fractures, improves bone health, and can be administered without added toxicity. It appears therefore reasonable to test denosumab, a clinically available antibody against RANKL in patients with hormone-receptor-negative primary breast cancer as an adjunct to neoadjuvant chemotherapy for its ability to increase pCR rate and improve outcome in relation to the expression of RANK.
NCT00847483
Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost
NCT00334750
This descriptive, non-interventional study will collect information on the presence of risk factors in newly diagnosed ocular hypertension and open-angle glaucoma patients in Canada.
NCT00751062
PhXA41 is not inferior to timolol in reducing intra-ocular pressure
NCT03908372
The purpose of this study is to optimize treatment strategies for patients with stage II and III nasopharyngeal carcinoma, reduce the side effects related to treatment and improve the quality of life.
NCT03827239
Individuals with pre-diabetes or diabetes would benefit from low impact methods that would improve their insulin sensitivity and aid in maintaining glucose homeostasis. Physical activity helps the body decrease its insulin resistance and burn excess sugar. Many diabetics also suffer from obesity and specific forms or durations of physical exercise may not be viable options for these individuals. Determining whether short bursts of moderate exercise improve blood glucose levels in healthy humans may identify a further method for diabetics to improve their glucose homeostasis. The aim of this study is to determine the most effective moderate exercise that can be completed in 3 minutes and its effectiveness on improving glucose handling, in response to a single day of standardized high-fat and high-carbohydrate feeding in comparison to periods of prolonged sitting.
NCT02254317
The objective is to identify the lowest effective dose of Grape Seed Extract (GSE) on glucose control in people with impaired glucose tolerance (IGT).
NCT01796041
According to the World Health Organization, breast cancer is the most common cancer in women, and is responsible for 686,000 new cases every year. The WHO also posit that nearly 420,000 women perished from the disease in 2002. Surgery remains the best option for patients presenting with operable Stage I, II or III cancers. Breast conservation surgery has been shown to be as efficacious as mastectomy. About 60-70% of these women with operable breast cancer are breast conservation candidates. However, the need to achieve negative tumor margins often requires a second operation (re-excision) in up to 70% of the women having lumpectomy surgery. Currently, tumor margins assessment in the operating room is often assessed grossly by palpation. The ability to evaluate tumor margin using our proposed intraoperative imaging technique may provide the surgeon with an alternative, and hopefully, more sensitive method to assess tumor margins which may decrease re-excision and the morbidity associated with additional surgery, and, perhaps, lower the risk of local regional recurrence.
NCT03797768
Chronic Obstructive Pulmonary Disease (COPD) is the fourth most important cause of death worldwide and is one of the commonest non-communicable diseases (NCDs) in Nepal. The presence of risk factors like indoor and outdoor air pollution, the high prevalence of smoking and lack of general awareness of COPD makes it a serious public health concern. However, no attempt has been made in Nepal to estimate its burden and address the disease at the community level. This community-based cluster randomized controlled study aims to fulfil that gap through mobilization of Female Community Health Workers (FCHVs) who will be trained to perform a certain set of health promotion activities aimed at prevention of the disease and its progression. Baseline and follow-up surveys will be conducted to compare the intervention and control groups. This study has the potential to generate evidence in helping address NCDs in Nepal and also other similar resource-limited countries.
NCT04726384
The aim of the project was to assess the acceptability of the device as well as adherence to the study. The objective of study was to assess physical activity in patients with COPD during in-hospital pulmonary rehabilitation program. The number of steps, average energy expenditure expressed in MET and kcal, and physical activity time during the consecutive 5 days of the rehabilitation stay were analyzed. Physical activity level was continuously monitored to assess intensity during in-hospital procedures as well as during leisure time.
NCT04727346
CBCT is considered an innovative imaging modality that can view the upper respiratory airway anatomy in a 3D manner. Recent studies tried to evaluate the accuracy of CBCT in analyzing the upper respiratory airway and its related structures. Although, most of these studies aimed to evaluate the 3D imaging of upper respiratory airway in OSA patients and their healthy counterparts, the determination of its level of collapse with the aid of CBCT wasn't clearly evaluated. DISE is considered a dynamic approach to determine the level of upper respiratory airway collapse accurately, but CBCT can offer better evaluation of anatomical upper respiratory airway characteristics and morphology which in turn affects treatment planning and patients' satisfaction after surgery. The hypothesis is agreed with other studies who found that retroglossal collapse appears more frequently during the end of expiration imaged by dynamic MRI. Our hypothesis is the validity of CBCT in determining the level of collapse through assessing different orthogonal planes at end of inspiration and expiration especially in those patients having a tongue/palate interaction or lengthy palate where this anatomical variation wasn't been probably evaluated with DISE.
NCT03680716
A lot of patient have posterior knee pain after ACL reconstruction despite saphenous nerve block. Recently a new block has been described, know as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee). The objective of this randomized controlled double-blinded trial is to assess whether a combined saphenous nerve block with IPACK block is more effective for the postoperative pain than a local infiltration analgesia.
NCT03457805
This is a pilot study assessing efficacy and safety in patients with advanced prostate cancer.
NCT04057053
Primary aim of the study is to determine whether a rho kinase inhibitor, Netarsudil, can speed corneal clearance after DWEK. Secondary aim of the study is to investigate whether patient factors, such as baseline age, pachymetry, or endothelial cell count influence response to Netarsudil.