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NCT ID: NCT06270576 Not yet recruiting - Asthma Clinical Trials

Nasal Inflammation Following Endotoxin Challenge in Patients With Asthma

Nasal-LPS
Start date: April 2024
Phase: Phase 1
Study type: Interventional

A phase I clinical research study aimed at determining mechanisms that regulate airway mucosal inflammation in asthma endotypes using intranasal administration of endotoxin (lipopolysaccharide from E. coli) in healthy controls and subjects diagnosed with asthma.

NCT ID: NCT06271330 Not yet recruiting - AMD Clinical Trials

Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD.

FAR-WEST
Start date: April 2024
Phase:
Study type: Observational

Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab [1] and aflibercept [2] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound [3] is that it extends the injection interval in the Treat and Extend (T&E) protocol, which is more extensive than with previous anti-VEGF agents. The patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections. As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication.

NCT ID: NCT06271590 Not yet recruiting - Clinical trials for Coronary Artery Disease

MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels

MAGICAL-SV
Start date: April 2024
Phase: N/A
Study type: Interventional

This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm). A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of ~50% of enrollees.

NCT ID: NCT06271668 Not yet recruiting - Harm Reduction Clinical Trials

Clinical Decision Support to Improve System Naloxone Co-prescribing

Start date: April 2024
Phase:
Study type: Observational

The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions. Prescribing naloxone with opioids is a best practice described in the 2022 US Center for Disease Control and Prevention (CDC) guidelines on opioid prescribing. The CDS can improve quality of care delivered by improving compliance with the guideline defined best practices. The project will compare CDS alert facilitated co-prescribing of naloxone with high-risk opioid prescriptions vs usual care to evaluate the effectiveness of the CDS alert for improving naloxone prescribing. The patients are not assigned to an intervention and will be receiving any changes in care as part of their routine medical care, rather than a specific intervention that is distinct from their usual medical care. The researchers hypothesize that the CDS alert will be acceptable to providers while increasing naloxone co-prescribing which will reduce the number of opioid overdoses in subsequent 6 months.

NCT ID: NCT06272045 Not yet recruiting - Clinical trials for Cardiovascular Health

Early Intervention to Promote Cardiovascular Health of Mothers and Children

ENRICH
Start date: April 2024
Phase: N/A
Study type: Interventional

Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung & Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors.

NCT ID: NCT06273254 Not yet recruiting - Clinical trials for Bioequivalence Study

A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions

Start date: April 2024
Phase: Phase 1
Study type: Interventional

Primary objective is to is to evaluate the bioequivalence of two formulations

NCT ID: NCT06274437 Not yet recruiting - Cancer Clinical Trials

A Study of BND-35 in Participants With Advanced Solid Tumors

Start date: April 2024
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization (Part 2). Part 1 is comprised of three sub-parts: BND-35 administered alone (Sub-Part 1A), BND-35 administered in combination with nivolumab (Sub-Part 1B), and BND-35 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of BND-35 per indication are administered in combination with nivolumab or with cetuximab.

NCT ID: NCT06274593 Not yet recruiting - Glaucoma Clinical Trials

Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma

OGA
Start date: April 2024
Phase:
Study type: Observational

Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness. To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma. The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl).

NCT ID: NCT06276127 Not yet recruiting - Clinical trials for Atrial Flutter With Rapid Ventricular Response

Oral Bisoprolol Vs IV Diltiazem in Atrial Fibrillation or Flutter With Rapid Ventricular Rate.

BisoAF
Start date: April 2024
Phase: Phase 3
Study type: Interventional

INTRODUCTION: The study focuses on comparing the effectiveness of oral Bisoprolol, a beta-1 adrenergic receptor blocker, against intravenous Diltiazem, a calcium channel blocker, in treating rapid atrial fibrillation or flutter with rapid ventricular response in an emergency setting. This research aims to fill the gap in empirical evidence regarding the use of oral Bisoprolol for these conditions, potentially offering a convenient, evidence-based alternative for patient management in emergency departments where established protocols are lacking. METHOD: This study is a randomized controlled trial targeting patients who present to the emergency room with symptomatic atrial fibrillation or flutter and rapid ventricular response requiring intervention. Participants will be split into two groups and undergo continuous monitoring of vital signs and regular electrocardiograms to ensure safety and document any adverse effects. The primary focus is on patient safety while evaluating the efficacy of the treatments. AIM: Evaluate the efficacy and safety of oral bisoprolol in treating atrial fibrillation or atrial flutter with rapid ventricular response in an emergency department setting. PRIMARY OJECTIVES: The primary efficacy outcome will be evaluated by achieving a HR<110 beats per minute or a decrease ≥20% of baseline HR at 60 minutes. The primary safety outcome measures are HR < 60 bpm and SBP < 95 mm Hg. SECONDARY OBJECTIVES: The use of Rescue medication, proportion of patients who required hospitalization, worsening of heart failure or pulmonary oedema, side effect of medication ( dizziness, headaches, gastrointestinal symptoms) PATEINT POPULATION: Adults (18 and older) presenting to the emergency department at Sultan Qaboos University Hospital with symptomatic atrial fibrillation or atrial flutter with rapid ventricular response requiring treatment. INTERVENTION: A single oral dose of 5 mg Bisoprolol (maximum dose of 5 mg) or a single intravenous dose of Diltiazem at 0.25 mg/kg (to a maximum dose of 30 mg). CLINICAL MEASURMENT: Heart rate recorded every 15 minutes up to the 90-minute mark, with a 12-lead ECG performed every 30 minutes. OUTCOME: For therapy to be considered effective, patients must achieve a ventricular rate ≤110/min or experience a drop-in ventricular rate of at least 20% at 60 minutes.

NCT ID: NCT06276140 Not yet recruiting - Colorectal Cancer Clinical Trials

Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery

ID-COLO
Start date: April 2024
Phase:
Study type: Observational

The aim of this prospective, observational cohort study is to assess the impact of iron deficiency anaemia on the incidence of perioperative complications and the quality of recovery after surgery in patients undergoing colorectal cancer surgery. The main questions the study aims to answer are: - whether the presence of preoperative iron deficiency anaemia leads to a poorer quality of postoperative recovery in patients undergoing colorectal cancer surgery - whether different combinations of complete blood count parameters (red blood cell indices) could be suitable diagnostic tools for the detection of iron deficiency in the latent stage (without laboratory-confirmed anaemia) in colorectal cancer patients. Blood samples for laboratory analyses will be collected from each study patient admitted to the surgical ward one day prior to elective surgery and on the first postoperative day during the stay in the intensive care unit. The pre-operative laboratory analyses include a complete blood count and serum iron status parameters (iron concentration, ferritin concentration, TIBC, UIBC and TSAT). Laboratory parameters analysed on the first postoperative day include complete blood count, serum concentration of electrolytes (Na, K, Ca, Cl, Mg), serum concentration of urea and creatinine, parameters of haemostasis (aPTT, PT, INR), serum concentration of C-reactive protein and procalcitonin. Data about overall morbidity, intraoperative complications, quality of postoperative recovery, red blood cell transfusion rate, all-cause infection rate, antibiotic usage, as well as length of hospital stay will be collected. The researchers will compare the group of patients with iron deficiency anaemia, the group of patients with iron deficiency in the latent stage and the control group to determine whether patients with iron deficiency have a higher incidence of perioperative complications and impaired recovery after surgery. The researchers will investigate whether iron deficiency can be detected at an early stage, when anaemia is not yet present, by calculating various red blood cell indices.