Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2...
Moderate to Severe Persistent AsthmaThis study will evaluate the efficacy, safety of two dose levels of CBP-201 in patients with moderate to severe persistent asthma with Type 2 inflammation.
Antidepressant Trial With P2X7 Antagonist JNJ-54175446
Depressive DisorderMajor1 moreDepression is one of the most important causes of disability in the world today, with major personal, social and economic costs. Although some moderately effective drug treatments are already available, about a third of patients with major depressive disorder (MDD) remain depressed despite current treatment. There is growing evidence that inflammation - the response of the body's immune system to physical and social stresses - can cause depressive symptoms in some patients. It is therefore predicted that anti-inflammatory drugs could have anti-depressant effects and the research team aims to test this using a new drug, JNJ-54175446, which blocks the activity of a receptor called P2X7. P2X7 is present on many immune cells and plays a key role in the release of inflammatory molecules during stress, which may be linked to stress-related depression. The research team will recruit approximately up to 142 participants with MDD to this clinical trial. Patients will have moderate-severe depressive symptoms despite ongoing treatment with a conventional anti-depressant drug, and they will have blood test results at screening that indicate they are likely to have active P2X7 signalling in the brain. Eligible participants will be randomly allocated to receive either 50mg/day JNJ-54175446 or placebo for 8 weeks. Participants will be assessed at weeks 2, 5 and 8 using a standard clinical depression scale and the scores compared between those treated with placebo and those treated with JNJ-54175446. To understand more about the effects of JNJ-54175446 on the immune system and the brain, patients will also complete additional blood tests, questionnaires and magnetic resonance imaging (MRI) brain scans at different visits throughout the trial. The trial will be carried out across 5 centres in the UK.
A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With...
Chronic Kidney Disease and Systemic InflammationThis study is conducted to see how the ziltivekimab works in the body of Chinese people with chronic kidney disease and systemic inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body. Participants' chance of getting ziltivekimab or placebo is the same. Participants will get their study medicine in a pre-filled syringe. The study doctor or staff will do 3 injections of study medicine during clinical visits. The study is expected to last for about 6 months. Participants will have blood and urine samples taken at all of the clinic visits. Participants will have their heart examined using electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)...
SinusitisChronic3 moreThis randomized study compares operative techniques in chronic rhinosinusitis with polyposis (CRSwNP) surgery. It aims to evaluate outcomes in asthma and CRSwNP, safety and costs. The investigators want to see if patients with certain clinical and/or genetic predispositions will benefit from extended surgery. They also aim to find biomarkers for detection and management models for of severe airway inflammation and to further develop markers for progressive disease forms.
Potential Harms of Untargeted Iron Supplementation in Cambodia Where Iron Deficiency is Not the...
AnemiaIron Deficiency4 moreIn 2016, the World Health Organization (WHO) set a global policy recommending daily oral iron supplementation (60 mg iron) for 12 weeks for all women living in countries where anemia prevalence is >40%, such as in Cambodia. However, recent studies have shown the prevalence of iron deficiency to be low in Cambodian women and that supplementation would likely only benefit ~10% of women. Iron supplementation may be harmful in women with genetic blood disorders (e.g. thalassemia), which are common in Cambodia, as these individuals are already at an increased risk of iron overload. The risks are made greater by the fact that iron absorption from most common form of supplementation, ferrous sulfate, is low. Typically less than 20% is absorbed in the gut; the remaining 80% passes unabsorbed into the colon where it can increase the risk of pathogen growth and gut inflammation. Alternatively, ferrous bisglycinate is a newer supplemental form of iron. This amino acid chelate has 2-4x higher bioavailability than ferrous sulfate and is associated with fewer GI side-effects. In view of WHO policy and risks of supplementation, there is a need to determine the potential for harm, and if novel forms of iron supplements are safer.
A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors...
PsoriasisInflammation2 moreThe primary purpose of this proof-of-activity, phase 2 trial is to evaluate the safety and activity of orticumab in subjects with moderate to severe psoriasis and cardiometabolic risk factors.
Dextenza in the Post-op Management of Vitreoretinal Surgeries
Vitreoretinal SurgeryOcular Inflammation2 moreThis study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group. Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.
Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug...
Dry EyeKeratoconjunctivitis Sicca1 moreThe purpose of this interventional study is to assess safety, patient tolerability, plug retention rate, and preliminary efficacy in improving the symptoms of Dry Eye Disease (DED) of EXP-TC tacrolimus releasing punctal plug. The main questions it aims to answer are: The safety of using EXP-TC plug following all study adverse events The number of patients with Adverse Events related to the us of EXP-LP plug The number of patients discontinuing the study due to plug discomfort The total patients with plugs remained during the 3-months study duration from plug insertion Exploratory: change from baseline in the study eye to follow-up visits in various Dryness clinical measurements. The change of measurements from baseline will also be compared between the study and fellow control eye (receiving artificial tears only, 0.15% sodium hyaluronate).
Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive...
ALK-Positive Large B-Cell LymphomaDiffuse Large B-Cell Lymphoma Activated B-Cell Type43 moreThis phase II trial studies how well nivolumab with or without varlilumab works in treating patients with aggressive B-cell lymphomas that have come back (recurrent) or do not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as varlilumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
The Novel Electrolyzed Water Spray Treatment the Genital Itching
Genital InflammationItchingThe purpose of this study is to test whether spraying the genitalia of patients by use of the novel electrolyzed water spray will produce improvement in the condition of genitalia itching.