View clinical trials related to Hypersensitivity.
Filter by:Background Digital vasospasm as part of frostbite sequelae is comparable to the vasospastic disorders found in Raynaud's phenomenon which has been successfully treated with Botulinum toxin type A injections in the palm of the hands. Aim of this pilot study To investigate the effect of Botulinum toxin type A for frostbite sequelae in the fingers. Hypothesis The null hypothesis which is that all study-subjects will have equal distribution of symptoms and measurements after treatment, regardless of injection with Botulinum toxin type A or placebo. Methodology A randomized, double-blind, placebo-controlled study design, The study population consists of four patients with frostbite sequelae. The patients are randomized to either treatment with Botulinum toxin type A or placebo Two patients in the primary treatment group will receive Botulinum toxin type A at their first injection at inclusion, while the two patients in the secondary treatment group will receive normal saline (placebo) as their first injection at inclusion. At 6 weeks follow up, the primary treatment group will receive their second injection of Botulinum toxin type A and the secondary treatment group now will receive their second injection, but this will be their first injection of Botulinum toxin type A. By using the described study-design, all participating soldiers will get treatment. However, the secondary treatment group will have a delayed onset of treatment with Botulinum toxin type A and serves as a control for the primary treatment group during the initial 6 weeks observation. Botulinum toxin A and placed will be injected near the neurovascular bundle at the A1 pulley in the palm of the hand using a total dosage 100 U per hand (concentration 50 U per ml), 8-12 U/ injection site. The effect of Botulinum toxin type A on subjective symptoms will be measured by Patients Subjective Symptom Score (PSSS) The effect of Botulinum toxin type A on peripheral microcirculation will be evaluated with dynamic infrared thermography (DIRT) of the dorsal side of the hands. Quantitative sensory testing will be used to evaluate the effect of Botulinum toxin type A on peripheral nerve function. Both DIRT and QST will be performed prior to the treatment with Botulinum toxin type A and placebo at the start of the pilot study, at 6 weeks as well as 6 weeks after the last injections. Statistical methods and data analysis will be performed according to the EMA guidelines for biostatistics. Statistical analysis will be performed according to the null hypothesis.
Multicenter, prospective, open-labeled, 2-arm, randomized non-comparative (2:1) phase II trial assessing the efficacy of lurbinectedin in association with durvalumab
Children are often reported to have antibiotics allergies, with approximately 10% of the US population labeled as allergic to an antibiotic, however, recent studies have demonstrated that the majority of symptoms reported as an allergy by parents are often non-IgE-mediated adverse reactions or symptoms of a viral illness (e.g. rash, vomiting, diarrhea). Additionally, over 90% of patients with reported penicillin allergy have negative skin testing results. Several studies in children have found that an allergy questionnaire can accurately identify those who are at low risk for severe antibiotic allergy and the allergy label can be safely removed. Appropriately delabeling antibiotic allergies has been shown to improve patient care through changing prescribing behavior and lowering health care costs. In this study, the investigators will perform a randomized trial comparing a provider-targeted clinical decision support tool to a pharmacist-led approach. The physician-targeted CDS tool will inform providers of their patient's allergy risk stratification result, protocol, electronic health record order and documentation support. The pharmacist-led approach consists of electronic health record dashboard that includes identical information to the provider arm. The primary outcome will be the frequency of penicillin allergy encounters with an allergy label removed at the time of discharge. Secondary outcomes will include the percentage of encounter with a penicillin allergy label in the electronic medical record 3 months after discharge, hospital length of stay and antibiotic utilization.
The main objective of this trial is to evaluate the activity of pamiparib plus low dose TMZ as maintenance treatment in improving progression free survival (PFS) in patients with advanced BTC who have received first line platinum-based chemotherapy. The primary objective is to test with a one-sided type I error of 10% whether pamiparib plus low dose TMZ as maintenance treatment increases PFS according to RECIST (version 1.1) in the entire study population as compared to standard treatment with Cisplatin-Gemcitabine chemotherapy regimen (or Gemcitabine-Oxaliplatin if cisplatin is contra-indicated). This is an open label randomized controlled multi-center phase II trial. Patients must meet all the criteria to be eligible. Eligible patients will be centrally randomized between the two arms in a 1:1 ratio. Randomization will be stratified by the following factors: - Tumour response CR/PR vs SD vs non-measurable/non-PD after previous platinum-based chemotherapy as confirmed by central review - Tumour location (intrahepatic bile ducts vs. gallbladder vs. perihilar bile ducts and distal bile duct and /ampulla of Vater tumours). Patients will receive treatment until progression or for a maximum period of 2 years.
Multicenter randomized (1:1) trial of strict avoidance versus sub-threshold dietary introduction of peanut in peanut allergic infants 4-14 months of age who react at a minimum cumulative dose of at least 430 mg of peanut protein at initial oral food challenge (OFC) for 12 months, followed by cross-over to sub-threshold dietary introduction of peanut in those randomized initially to avoidance.
This research is a study to test the reliability of Hyperpolarized Xenon MRI (HXe MRI) as a biomarker in interstitial lung disease. The study is a non-randomized study to evaluate the test-retest performance of HXe MRI in Idiopathic Pulmonary Fibrosis (IPF) and chronic Hypersensitivity Pneumonitis (cHP) as a non-invasive biomarker of disease severity and prognosis. The study will include approximately 15 subjects with IPF, 15 subjects with cHP and 10 sex and age-matched normal controls performed across 3 sites.
This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.The cumulative incidence of FRNS and adverse events for one year were evaluated in the 3-month and 6-month groups.
This is a multicenter, prospective, observational study designed to determine the clinical sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on Abionic's abioSCOPE device using K3-EDTA anticoagulated plasma samples from atopic and non-atopic pediatric and adult patients. Patients' sensitization determined with the abioSCOPE will be compared to the clinical assessment of allergy.
This is a multicenter, prospective, observational study to evaluate the analytical performance of the Abionic IgE Multi-Allergen Test Panel on the abioSCOPE® device in a U.S. point-of-care environment within a clinical laboratory operating under a CLIA certificate for tests of moderate complexity. The study will assess point-of-care ('external') precision, sample type comparison and correlation with a reference method (Phadia Laboratory System, ThermoFisher Scientific).
Postoperative surgical site infection (SSI) is associated with unnecessary use of heath care resources including prolonged hospitalization and increased hospital readmission. Perioperative antibiotic prophylaxis is one of the most important strategies for prevention of SSI. If there is a beta-lactam allergy, second tier antibiotics (vancomycin and clindamycin) are recommended alternatives to first- and second-generation cephalosporins because of fears of possible allergy. This prospective, randomized, and single-blinded clinical trial is designed to examine causality between second tier antibiotics use and surgical site infections in the subjects with a documented unverified penicillin allergy. Unverified beta-lactam allergy could be associated with antimicrobial treatment failure with second tires antibiotics during postoperative period.