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Hypersensitivity clinical trials

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NCT ID: NCT05561777 Withdrawn - Antibiotic Allergy Clinical Trials

Penicillin Allergy Risk-Stratification and Delabeling of Low-Risk Patients

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04796454 Withdrawn - Clinical trials for Platinum-Sensitive Biliary Tract Cancer

Pamiparib and Low Dose Temozolomide In Patients With Platinum Sensitive Biliary Tract Cancer

PAMICC
Start date: May 2022
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04761835 Withdrawn - Food Allergy Clinical Trials

STEP-IT-UP - Peanut Allergy Study for Infants

Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04677426 Withdrawn - Clinical trials for Idiopathic Pulmonary Fibrosis

129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study

Start date: May 1, 2022
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04536181 Withdrawn - Clinical trials for Steroid-Sensitive Nephrotic Syndrome

Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

Start date: January 1, 2021
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT04442932 Withdrawn - Allergy Clinical Trials

abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies

Start date: November 15, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT04401631 Withdrawn - Allergy Clinical Trials

Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation

Start date: November 2020
Phase:
Study type: Observational

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).

NCT ID: NCT04401553 Withdrawn - Clinical trials for Surgical Site Infection

Prophylactic Antibiotics for Surgical Site Infections and Beta-Lactam Allergy

Start date: August 16, 2024
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04259190 Withdrawn - Anxiety Sensitivity Clinical Trials

A Comparison of Treatment Rationales on Willingness to Tolerate Distress in Interoceptive Exposure

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

The purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention for the reduction of anxiety sensitivity. A standard treatment rationale without values emphasis will serve as a control.

NCT ID: NCT04200989 Withdrawn - Food Allergy Peanut Clinical Trials

Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy

Start date: March 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Use of three intralymphatic injections of peanut allergen one month apart to induce tolerance to peanut in peanut allergic people.