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Filter by:Lorlatinib is a third-generation, oral, reversible, ATP-competitive, macrocyclic TKI of ALK and ROS1. Lorlatinib was specifically designed to penetrate the CNS and to overcome known secondary resistance mutations in the ALK tyrosine kinase domain. This is a Phase 4, open-label, multicenter, non-randomized, prospective, single arm study to evaluate the safety and tolerability of lorlatinib in adult participants with unresectable advanced and/or recurrent ALK-positive NSCLC with resistance or intolerance to at least 1 prior ALK inhibitor treatment. This study is being conducted as a post approval study to fulfill Central Drugs Standard Control Organization (CDSCO) request relating to additional information on use of Lorlatinib in Indian patients.
Despite the fact that the topic of air pollution has been in focus of researchers for many years, there are no big studies that take up the matter of its influence on acute coronary, cerebral syndromes and CVD mortality in Europe. Taking into consideration the scarce number of surveys from Europe the investigators decided to analyze the impact of air pollution on cardiovascular diseases and CVD mortality in Poland.
This phase II trial investigates how well sodium thiosulfate works in preventing ototoxicity (hearing loss/damage) in patients with squamous cell cancer of the head and neck that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing a chemoradiation. Sodium thiosulfate is a type of medication used to treat cyanide poisoning and to help lessen the side effects from cisplatin. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. The purpose of this trial is to find out whether it is feasible to give sodium thiosulfate 4 hours after each cisplatin infusion along with standard of care radiation therapy in patients with head and neck cancer. Giving sodium thiosulfate after cisplatin may help decrease the risk of hearing loss.
Topical steroid therapy is considered the first line of treatment for Oral Inflammatory Ulcerative Diseases with current treatment regimens requiring multiple application or rinses daily. Using Mucolox™ as a vehicle to deliver topical dexamethasone to the oral mucosa has the potential to effectively prolong contact time between the medication. The primary objective of this study is to determine the clinical efficacy and tolerability of compound dexamethasone at 0.5 mg/5 mL in Mucolox™ for the treatment of Oral Inflammatory Ulcerative Diseases as measured by a reduction in oral symptoms between patients treated with compounded dexamethasone 0.5mg/5ml solution in Mucolox™ (group A) and patients treated with topical commercial dexamethasone 0.5mg/5ml solution only (group B). and mucosa, leading to improved clinical outcomes due to the need for less frequent application.
Objective: Reducing inappropriate medications for primary care COPD patients with comorbidities ('medication-comorbidity clashes'), by evaluation of the Desktop Helper (number 10) in a pragmatic cluster randomized controlled trial. Study design: A four-arm pragmatic cluster randomized controlled trial (cluster RCT), which will be conducted in GP practices in the Netherlands. In the cluster RCT, the control condition (arm 1: care as usual) will be compared with three intervention arms (i.e. arm 2: the 'Desktop Helper (number 10)' , arm 3: an e-learning module, and arm 4: the 'Desktop Helper (number 10)' accompanied by the e-learning module). At baseline and at 26 weeks of follow-up, a data-extraction of comorbidities and prescribed medications will be obtained from the EMR of participating GP practices. Study population: Primary care patients with COPD who have 1 or more comorbidities and who are prescribed one or more medications. Intervention (if applicable): Clinical rules to remediate 'medication-comorbidity clashes' as outlined in the 'Desktop Helper (number 10)'. These clinical rules will be implemented in the EMR to enable the identification of patients with 'medication-comorbidity clashes'. In addition, e-learning about these 'medication-comorbidity clashes' will be offered depending on the treatment arm of the trial. Main study parameters/endpoints: The number of 'medication-comorbidity clashes'.
The study aims at determining whether replacing the classical chemical absorber Dräegersorb 800+ on Dräeger Perseus A500 machines (Dräeger, Lübeck, Germany) by the new membrane technology-based product (Memsorb™, DMF Medical Inc., Halifax, NS, Canada) with the help of high-quality monitoring (BIS and NOL) and high-end ventilators (Dräeger Perseus A500 machines; Dräeger, Lübeck, Germany) that allow minimal fresh gas flow, will significantly decrease the use of sevoflurane and its related atmospheric pollution.
the present study was designed to compare the efficacy and safety of two different doses of dexmedetomidine as an adjuvant to bupivacaine in unilateral TAP block in pediatric patients undergoing lower abdominal surgery.
Background: Multimodal analgesia; a combination of opioid and non-opioid analgesics, for management of acute post-operative pain significantly reduces the incidence of adverse effects associated with liberal post-operative opioid use including sedation, respiratory depression, constipation, ileus, urinary retention, delayed recovery, addiction etc. However, opioid addiction remains a worsening public health problem and have followed administration of opioid analgesics for post-operative pain and subsequent chronic use in many addicts; especially the opioid naive. Caesarean section is a commonly performed surgery and is a common source of first exposure to opioids in women. Trend in post-operative analgesia is moving towards opioid-free (multimodal) analgesia; a combination of non-opioid and adjuvant analgesics. Magnesium sulphate is an adjuvant analgesic. When administered peri-operatively, it has been reported to prolong the duration of spinal anaesthesia, decrease post-operative pain and opioid use without adverse effect. Aim: To determine the effectiveness and safety of a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac as opioid-free, multimodal analgesia for management of acute post-operative pain after a caesarean section. Null Hypothesis: Combination of intravenous magnesium sulphate, intravenous paracetamol, and rectal diclofenac as analgesia regimen for acute post-operative pain after a caesarean section is not as effective and safe as a routine opioid-based multimodal analgesia regimen used in the study setting. Alternate Hypothesis: Combination of intravenous magnesium sulphate, intravenous paracetamol, and rectal diclofenac as analgesia regimen for acute post-operative pain after a caesarean section is as effective and safe as a routine opioid-based multimodal analgesia regimen used in the study setting. Materials and Methods: A randomized clinical trial, comparing a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac with an opioid-based multimodal regimen as control. Eligible patients will be consecutively selected from among women booked for caesarean section at the Federal Medical Centre, Yenagoa. Control group will receive a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac. Pain intensity will be determined in both groups and compared. Need for rescue opioid analgesic will be determined in both groups and compared. Incidence of any adverse event in both groups will be determined.
The pathophysiology of HF is highly variable, with overlapping pathogenic mechanisms that complicates any attempt to create a simple and unified conceptual model. Left ventricular (LV) ejection fraction (EF), assessed as the fraction of the end-diastolic volume that is ejected upon contraction, has been the cornerstone metric for characterization of LV systolic function in patients with HF. LVEF demonstrates a strong inverse relationship with clinical outcomes in HF in patients with reduced EF (HFrEF). Current management options for the treatment of HFrEF include medical management, mechanical circulatory support, and cardiac transplantation. In the setting of refractory end stage HFrEF, the standard of care is heart transplantation. Since limited organ procurement is a significant constraint to the treatment of patients with advanced disease, durable mechanical circulatory support (MCS) with left ventricular assist devices (LVAD) were developed as a safe and efficacious treatment strategy for patients with advanced HF that is refractory to medical therapy. The advances in LVAD engineering and design, tailored towards defined physiological goals, have resulted in the creation of much smaller continuous-flow (CF) pumps that possess technical superiority, pump durability, and ease of implantation compared to the older and larger pulsatile-flow pumps. The addition of speed modulation algorithms to the next generation centrifugal CF LVADs, has decreased the incidence of device related adverse events. Our interest lies in the impact of continuous flow hemodynamics on endothelial function and the cardiac and end-organ responses to this novel therapy. Current knowledge of the impact of these specific advances in LVAD therapy is however limited by the relative youth of the field. Thus, the goal of this research project is to study human LVAD patients and to determine the impact of speed modulation algorithms in CF physiology on microvascular and endothelial function and its association with cardiac and peripheral organ function. The investigators hypothesize that restoration of cardiac output using an LVAD with modern speed modulation algorithm improves vascular endothelial function. In addition, these changes would have a positive correlation with functional outcomes.
Postoperative nausea and vomiting (PONV) is an unwanted and distressing complication for patients. PONV affects one-third of untreated patients after general anesthesia. PONV is a hard state for patients, surgeons, and anesthesiologists and increases the anxiety of patient. There are many pharmacologic agents efficient in treatment and prophylaxis of PONV, however, these drugs have many side effects. At the same time, there are many non-pharmacological strategies for antiemetic therapies. Therefore there is an interest to nonpharmacologic agents. Such as acupuncture, ginger, peppermint …etc. Mint is a popular vegetable used as an antispasmodic, analgesic, antimicrobial and anti-vomiting treatment. The use of mint is safe and no certain side-effects and interactions. Chewing affects on postoperative bowel functions. Our hypothesis was mint chewing gum is effective on treatment of PONV. Laparoscopic cholecystectomy surgery has a high risk for PONV in adults. In this study, our aim is to investigate the effect of mint gum chewing in the treatment of PONV in laparoscopic cholecystectomy surgery.