A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation,...
HealthyThis will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at the discretion of the sponsor. Three treatments are: Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours post dose in each period. Tolerability and safety will be assessed by reported adverse events during each study period.
Production of Fortified Biscuit With Chickpea and Crushed Peanut for Improving Cognitive Performance...
Cognitive PerformanceIt is well known that globally, school-based fortification and school feeding approaches have been applied to remedy nutritional deficiencies that impact health in the primary school age group. Aim of the study: to produce a fortified biscuit with chickpea and crushed peanut. To evaluate the effectiveness of the fortified biscuits intake for 4 months in terms of its acceptability and impact on cognitive performance for a sample of children aged 8-12 years attending rural primary schools in an Egyptian village. The fortified biscuits' effect on auditory attention, visual and working memory, and learning ability was evaluated. Methodology: This study was an interventional study conducted in two stages: stage one was the production of nutritious biscuits that is based on chickpea flour and peanut in addition to whole wheat (extract 72 %), wheat germ, cinnamon, milk, and egg. All these constituents help in enhancing immunity, fighting viruses, maintaining regular and healthy bowel movement, regulating blood sugar and cholesterol levels, and more importantly improving the cognitive abilities of school-aged children. During stage two, eighty Children were randomly allocated in either chickpea and peanuts biscuits dependent group (40 children) or non-dependent group (40 children) to evaluate the impact of the fortified biscuits. All enrolled children and their mothers received 5 cognitive stimulation sessions over four months. The cognitive performance of primary school-aged children was assessed before and after the interventions by a battery of four verbal & non-verbal intelligence psychological tests. These tests covered short-term and working memory, visual memory, and the ability for categorization, learning for speed of information processing, and auditory attention ability with rising levels of difficulty. These tests were: Digit Span, the figural memory tests, Coding and Auditory vigilance tests A and B respectively. Five items were used to evaluate the physical characteristics of the biscuits: color, odor, taste, consistency, and general acceptance.
Bioequivalence Study of CRushed TriUMeq With or Without Drip Feed Compared to the Whole Tablet
HIVDolutegravir is an HIV-1 integrase inhibitor which is marketed as a single tablet (Tivicay®) and in a fixed dose combination tablet with abacavir and lamivudine (Triumeq®, referred to as TRI). For patients with swallowing difficulties, administration of whole tablets can be problematic and tablets are cut or crushed to ease administration. Currently there is no information about crushing TRI tablets. Therefore this study will be conducted to investigate whether crushed and suspended TRI and crushed and suspended TRI with drip feed are bioequivalent to taking TRI as a whole.
Bioequivalence of Crushed Stribild With a Normal Breakfast or With Drip Feed Compared to the Whole...
HIVElvitegravir is an HIV-1 integrase inhibitor which is marketed in a fixed dose combination tablet with cobicistat, tenofovir and emtricitabine (Stribild®, referred to as STB). For patients with swallowing difficulties, administration of whole tablets can be problematic and tablets are cut or crushed to ease administration. In addition if HIV patients develop opportunistic infections, patients can become severely ill and may end up on the intensive care. Patients at the intensive care might not be able to swallow medication. Therefore it is useful to know if it is possible to administer STB through a different route, like a feeding tube. If STB can be crushed or dissolved and given through a catheter it is also useful to know if it can be given with drip feed. Currently there is no information about crushing STB tablets. "Crushing STB tablets into a liquid medium has not been studied and is not recommended" according to the SPC text. Depending on the biopharmaceutical characteristics of a drug formulation, crushing tablets can lead to altered pharmacokinetics of drugs. It is important to know whether pharmacokinetics are influenced by crushing of tablets as low concentrations are associated with virologic failure. Therefore higher doses might be needed. In addition, higher Cmax and/or exposure can lead to toxicity. As a result therapeutic drug monitoring is advised, or crushing the drug is a contra-indication based on the available data. It has been shown that simultaneous oral ingestion of antacids and elvitegravir gives a decrease in Cmax and AUC of elvitegravir. This interaction is not shown for co-ingestion with omeprazole. Which makes it unlikely that this interaction is caused by a pH-lowering effect influencing the absorption of elvitegravir. It is probably a local gastrointestinal complexation phenomenon, similar to what has been observed with other HIV integrase inhibitors. A possible pharmacokinetic interaction between elvitegravir and complexation formers may be expected. Especially considering the active binding sites of elvitegravir which bind magnesium metal ion cofactors. Although there is data that STB can be ingested with a protein rich drink, it is unclear if foods or liquids containing high amounts of magnesium or other cations can cause this same interaction. Therefore this study will be conducted to investigate whether crushed and suspended STB and crushed and suspended STB with drip feed are bioe-quivalent to taking STB as a whole.
Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce
HealthyThe purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1 tablespoon) relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. A secondary objective is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the study period.
The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention...
Pressure UlcerPressure Injury3 morePressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.
The Effect of Pressure Wound Care Package on the Development of Operating Room Pressure Wound in...
Pressure InjuryOrthopedic SurgerySUMMARY In a non-randomised (quasi-experimental) clinical study, it was aimed to determine the effect of the care package applied in the early postoperative period on operating theatre pressure sores, pain, fear of falling and comfort in patients undergoing orthopaedic surgery. In the study, the care bundle for pressure injuries was prepared in accordance with the clinical guidelines and was applied to the patients in the study group. This study was conducted in the orthopaedics and traumatology clinic of a public hospital in the Southeastern Anatolia Region of Turkey.
Phase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered...
Healthy SubjectsThe purpose of this study is to assess the bioavailability of Apixaban oral solution administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban administered as crushed tablet through a nasogastric tube relative to Apixaban solution administered orally in healthy subjects.
Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons...
Pressure UlcerObservational comparison on Incidence of Pressure Injury between the Freedom Bed Automated Continuous lateral Rotation Therapy System and Manual Caregiver Re-positioning every 2 hours on a standard Hospital Bed.
The Ornge Comparison of Tracheal Occlusion Pressures to Ensure Safety Trial
Injury of TracheaFriction and Pressure Injuries2 morePatients who are intubated (breathing tube in windpipe) are often transported by air ambulance. Changes in atmospheric pressure during flight may cause pressure increases in the air-filled cuff holding the tube in the windpipe. Studies show that more than half the patients had potentially harmful pressures in the cuff during flight. High pressures lead to complications, such as injury to the windpipe. To avoid injury, cuff pressures must be kept at a safe level. There are many ways to avoid unsafe cuff pressures. One is to inflate the cuff with sterile fluid instead of air. Fluids are not subject to changes in atmospheric pressure. Using fluid, instead of air, in the cuff causes less pressure increases and less windpipe injury. The use and safety profile of this during transport by air ambulance has not been studied. This study compares tracheal tube cuff pressures, filled with air or fluid, at routine flying altitudes during patient transports by air ambulance.