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Filter by:It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Elizaria® (eculizumab, GENERIUM JSC, Russia) versus Soliris® (Alexion Pharma GmbH, Switzerland) in patients with paroxysmal nocturnal hemoglobinuria.
This is a single ascending dose trial in healthy volunteers. The study will be conducted in up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the current cohort versus dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 7 cohorts based on safety and/or PK and/or PD data.
The purpose of current study is to provide a comprehensive comparison of the reliability of corneal topographic measurements between Optovue AS- OCT and a combined Scheimpflug imaging using Wavelight Oculyzer Pentacam HR in normal and keratoconus eyes.
After appendectomy was first described by Mcburney in 1889, it has been the most practiced emergency surgery in the world with the lifetime incidence of acute appendicitis being 5%-25%. Most cases are uncomplicated cases without any complications and perforation (20%-30%). Although appendectomy is still a curative therapy, medical treatment has come to the fore in uncomplicated cases after improvements in imaging methods for diagnosing acute appendicitis and especially the developments in antibiotherapy. Medical treatment for acute appendicitis is, in fact, not a new condition. Practicing the option of elective surgery following intravenous antibiotherapy for plastron appendicitis that is among the complicated acute appendicitis has lead to further consideration of medical treatment. A number of studies conducted for this purpose suggest that conservative treatment in uncomplicated acute appendicitis may be a first-line treatment. Medical treatment of the uncomplicated acute appendicitis prevents negative appendectomies, which indicates that surgical removal of non-inflamed appendix ranging from 6% to 20%. In addition to preventing unnecessary organ loss, it ensures eliminating postoperative complications such as intestinal obstruction and wound site complications due to surgery. Immature granulocytes (IG) are monitored in peripheral blood as immature polymorphonuclear cells because of the activation of bone marrow. Although their counts can be determined through direct inspection, they can be provided with automated systems within complete blood count parameters as well as technological developments. The increase in their number specifically suggests the activation of the bone marrow and can provide information about the infectious process before leukocytosis is observed. This study aimed to determine the importance of IG count and percentage to evaluate the role of medical treatment and control its success in cases of uncomplicated acute appendicitis.
This study was conducted to assess the postoperative painscores in patients undergoing open inguinal hernia repair between two groups receiving either U/S guided ilioinguinal/iliohypogastric nerves block with Ropivacaine or wound infiltration with Ropivacaine.The safety of two analgesic interventions(ilioinguinal/iliohypogastric nerves blocks and wound infiltration) was measured alongwith comparison of opioid use between the two groups over 24 hours postoperatively was made. Patient satisfaction between the two groups was also assessed by the Likert scale.
The EXAMINATION trial was a superiority trial that compared everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population. The patient-oriented endpoint was not superior at 1-year, but it was at 5-year. However, very-long term follow-up is unknown. The study had an independent Clinical event Committee (CEC). All events were adjudicated by an independent clinical committee, according to the Academic Research Consortium 1.
The present study aims to evaluate the effectiveness of acupuncture in the treatment of chemotherapy drug paclitaxel induced peripheral neuropathy in patients with early stage breast cancer
Examination of pirfenidone (Esbriet®) therapy in coal workers' pneumoconiosis (black lung) with pulmonary fibrosis (scarring of the lung).
This study is 'A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' The primary objectives are as follows: - To assess the safety and tolerability of AHCQ administered as a single dose by oral inhalation in healthy individuals at escalating doses until either the maximum tolerated dose (MTD) is identified or 1 mL of a 50 mg/mL solution is administered. - To determine the recommended Phase 2a dose (RP2D). Secondary objectives: • To characterize pharmacokinetics (PK) of single dose AHCQ in healthy individuals.
To address the health disparities in SLE outcomes for minorities, targeted intervention will be used to address the common barriers to care among patients; a comprehensive patient navigator approach will be utilized based on evidence from prior studies is the purpose of this research. The navigator services most commonly provided include facilitation and coordination of care, practical support, including scheduling transportation and referrals to financial assistance programs, appointment scheduling and reminders, education and psycho-social support. The most effective patient navigators address both health system and patient barriers.