Background Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. Methods We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0•9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0•9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124.
Background This study assessed the maximum tolerated dose (MTD) of the PI3K inhibitor buparlisib given concurrently with cetuximab in recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Methods Twelve patients with R/M HNSCC were enrolled. Patients were given oral buparlisib starting day 7 and daily thereafter. The dose of buparlisib was escalated in a 3 + 3 design followed by a dose expansion cohort of 6 patients. The MTD of buparlisib per protocol was 100 mg daily with cetuximab given intravenously every 14 days starting day 0. Results Ten patients had ≥2 previous treatment regimens (11 with prior cetuximab). There were no dose limiting toxicities observed during dose escalation. One patient achieved a partial response and 4 achieved stable disease. Conclusion Based on this pilot study, buparlisib at 100 mg daily plus cetuximab proved to be well‐tolerated. Patients previously treated with cetuximab monotherapy showed benefit from this combination.
Background Vitamin D is not only an essential part of a healthy diet but it is also known as the sunshine hormone. It helps to absorb calcium and phosphate within the body and is essential for the development of teeth and bones in growing children. Deficiency in vitamin D causes weak bones, osteoporosis in older individuals, and osteomalacia in children. It also causes loss of alveolar bone around the teeth, increased dental cavities, and other problems associated with gum disease. It can cause depression, fatigue, and appetite loss. This study aims to observe vitamin D deficiency, insufficiency, and sufficiency among children, adults, adolescents, and elders in the Pakistani population. Methods A cross-sectional survey was conducted with 27,880 individuals referred from the general out-patient-department (OPD) to Dow Diagnostic Research and Reference Laboratory (DDRRL) units at Dow University of Health Sciences (DUHS) Karachi, Pakistan, for a period of three months from January to March 2017. They were examined for laboratory findings of serum 25 hydroxyvitamin D levels to determine vitamin D deficiency, insufficiency, and sufficiency among all age groups of both male and female genders. Results A total of 26,750 individuals with a mean age of 38 ± 18 years were statistically examined for laboratory findings of serum vitamin D levels. Vitamin D deficiency was observed in 56% of individuals with a mean log of 1.01 ± 0.18 ng/ml serum vitamin D levels, vitamin D insufficiency in 20% of individuals with a mean log of 1.38 ± 0.05 ng/ml serum vitamin D levels and vitamin D sufficiency in 24% individuals with a mean log of 1.63 ± 0.12 ng/ml serum vitamin D levels. The highest percentage of individuals deficient in vitamin D were children and adolescents of age ranging between 6 to 18 years. Conclusion The findings of vitamin D deficiency in children and adolescents direct higher authorities in the public health sector to take immediate steps to screen, intervene and educate high-risk populations incorporating vitamin D supplements to establish preventive and therapeutic measures.
Background Dentin hypersensitivity (DH) is a sharp toothache that influences a patients' oral health-related quality of life. Oral dentifrices have been marketed for pain relief within a minute for DH. The permanent management of DH is being investigated with the remineralisation potential of bioactive agents in dentinal tubules. This study investigated the relief from pain in DH in one minute after applying over the counter (OTC) dentifrices with Pro-Argin™ and strontium acetate and directly compared them with fluoro-calcium phospho-silicate (FCPS)-based dentifrices for immediate and sustained inhibition of painful stimulus provoking DH. Methods A randomised, controlled, triple-blinded clinical trial was conducted with 140 participants clinically diagnosed with DH and equally randomized into four groups with parallel treatment assignment of FCPS, Pro-Argin™, 8% strontium acetate, and sodium fluoride-based OTC dentifrices, and tested for DH with air blast, mechanical, and water jet stimuli on SCHIFF cold air sensitivity scale (SCASS) and visual analogue scale (VAS) at interim efficacy intervals of one minute, three days, two, four, and six weeks, subsequently. Results A total of 128 participants completed the trial. All the treatment groups showed statistically significant improvement in DH with p < 0.001 relative to baseline at all time points. Pro-Argin™ showed a greater reduction in DH with mean scores of (1.34 ± 0.68) (4.20 ± 1.70) (3.05 ± 2.17) followed by strontium acetate (1.57 ± 0.81) (4.65 ± 1.87) (3.75 ± 1.97) on SCASS and VAS for mechanical and water jet stimuli, one minute after application. There was no statistically significant treatment difference between the two (p = 0.499). FCPS showed the highest reduction in DH on SCASS and VAS for waterjet stimuli with mean scores of (0.97 ± 0.68) (1.80 ± 1.73) and Pro-Argin™ on VAS for mechanical stimuli with mean scores of (2.15 ± 1.92) in six weeks. Conclusion OTC dentifrices with Pro-argin™ and strontium acetate are effective for immediate pain relief from DH, and FCPS could be the best possible treatment option for long term management of DH. Trial registration ID: NCT04249336 (https://clinicaltrials.gov/ct2/show/NCT04249336), Date of Registration: January 30, 2020 (Retrospectively registered).
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