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Hypersensitivity clinical trials

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NCT ID: NCT06011629 Recruiting - Clinical trials for Contact Allergic Dermatitis

Aquacel Hypersensitivity Dressing in TJAs

Start date: August 18, 2023
Phase: Phase 4
Study type: Interventional

The aim of this multi-surgeon, single institution study is to prospectively evaluate the incidence of allergic contact dermatitis (ACD) following application of AQUACEL Ag, a silver-containing hydrofiber dressing, in total hip and knee arthroplasty patients. Arthroplasty-naïve patients will be compared to prior total joint arthroplasty patients who received a Aquacel dressing postoperatively.

NCT ID: NCT06011603 Recruiting - Wound Complication Clinical Trials

Prineo Sensitivity Dressing Study

Start date: August 17, 2023
Phase: Phase 4
Study type: Interventional

Wound complications can be devastating following total joint arthroplasty, resulting in an increased practice burden in the form of more frequent follow ups, increased clinic visits potential for wound dehiscence, superficial infection and deep infection with possible return to the operating room and revision surgery. Several dressing options are currently on the market designed to minimize wound complications in addition to traditional dressings, including negative pressure dressing, antimicrobial dressing, occlusive dressings, and/or skin adhesives. Prineo dressing (2-octyl cyanoacrylate adhesive (Dermabond) and n-butyl-2-cyanoacrylate adhesive) has increased in popularity as a dressing option used by joint arthroplasty surgeons. There is a well-documented adverse allergic response with these dressings resulting in peri-incisional erythema, urticaria, and/or an eczematous skin reaction. Recently, Mayman et al reported a rate of 1-1.5%, suggesting a possible rising incidence of ACD attributable to increased utilization of the specific dressing and sensitization. To our knowledge, no prospective trial has compared the rates of adverse allergic reactions in Prineo naive patients to patients who have undergone previous total joint arthroplasty (TJA) and received Prineo dressings in the past. The study team will utilize a prospective controlled study design to assess the rate of adverse allergic reactions in patients naive to Prineo versus those with previous exposure. The study team will assess rates of allergic reactions at one week post-op and at their first post-op clinic visit, 2 to 3 weeks post-op, tracking rates of allergic reactions as well as severity, the use of post-operative antibiotics, work up for prosthetic joint infection, return to the operating room, surgical site infection, confirmed prosthetic joint infection and stiffness requiring manipulation under anesthesia.

NCT ID: NCT06010914 Recruiting - Clinical trials for Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer

DADOX
Start date: October 9, 2023
Phase:
Study type: Observational

This is an observational study in which only data are collected from participants receiving their usual treatment. In this study, data will be collected and studied from men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Metastatic means that the cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with hormone-therapy such as androgen deprivation therapy (ADT). ADT lowers the level of testosterone, a male hormone, and slows down the growth of cancer cells. Men with mHSPC and who have been decided by their own doctors to be treated with darolutamide in combination with ADT and docetaxel can join this study. Darolutamide works by blocking the testosterone signals to slow the growth of the cancer cells. Docetaxel is a medicine used to treat different types of cancer. It works by stopping the growth and spread of cancer cells. Darolutamide in combination with docetaxel and ADT is an approved treatment for men with mHSPC. It was approved based on a study called ARASENS. More information is needed on how safe darolutamide is when given with ADT and docetaxel in Japanese men with mHSPC. The main purpose of this study is to collect information about the safety of this combination treatment in Japanese participants with mHSPC under real-world conditions. The main information that researchers will collect: Number and severity of heart-related medical problems participants have during the treatment Other information that researchers will collect: Number and severity of all medical problems participants have during the study Age and other information about the participants such as their illness, medical history, and other medicines taken at the same time Treatment pattern of darolutamide such as the amount of medicine given, the duration for which it is given, and any changes made to the treatment Data will be collected from August 2023 to July 2026. Researchers will observe participants from the start of darolutamide treatment until 30 days after they receive their last dose of docetaxel, which is expected to be approximately 6 months for each participant. In this study, data from regular health visits will be collected. No visits or tests are required as part of this study.

NCT ID: NCT06007157 Recruiting - Blood Pressure Clinical Trials

Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes

SALT
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The goal of this interventional study is to test whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce the effects of high dietary sodium intake in patients with type 2 diabetes. Participants will undergo a dietary intervention consisting of a week of high-sodium diet, followed by a week of low-sodium diet. At the end of each week the patients will undergo: - 24-h ambulatory blood pressure measurement; - 24-h urine collection; - bioimpedance analysis for body composition determination; - blood and urine tests. The study will compare patients treated with SGLT2i and patients not treated with SGLT2i to test whether the treatment reduces the effects of high sodium intake on blood pressure, body composition and biochemical variables.

NCT ID: NCT06004115 Recruiting - Depression Clinical Trials

Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression

Start date: November 8, 2023
Phase: Phase 4
Study type: Interventional

This mechanistic study uses an anti anxiety drug and brain imaging to study the threat processing system and associated brain circuits in people with depression, anxiety disorders and comorbid depression and anxiety disorders. In a double blind, placebo controlled crossover design, up to 65 individuals will be recruited who will have a diagnosis of major depressive disorder (MDD) and at least one anxiety disorder (AD) (AD-MDD group), up to 65 participants will have a diagnosis of MDD and no diagnosis of an AD and up to 65 participants will have no diagnosis of MDD and a diagnosis of at least one AD will be enrolled to participate in an two session study to obtain 150 completers (50 per group). All participants will receive a single dose of Lorazepam and placebo (order randomized) taken orally. After the ~2.5 hr screening session, participants will complete two identical ~5 hr experimental sessions, each of which include a 30 min eyeblink startle session and a 1 hr functional magnetic resonance imaging (MRI) brain scan session. The total time involved in the study is approximately 10.5 hours. The main questions the study seeks to answer are: - are people with comorbid depression and anxiety different than those with depression alone in terms of their eyeblink startle response to threat? - are people with comorbid depression and anxiety different than those with depression alone in terms of their brain activation in response to threat? - are people with comorbid depression and anxiety different than those with depression alone in terms of their responses to anxiety drugs?

NCT ID: NCT05983783 Recruiting - Chemotherapy Effect Clinical Trials

Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC

Start date: August 1, 2023
Phase: Phase 3
Study type: Interventional

Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.

NCT ID: NCT05956639 Recruiting - Clinical trials for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC

Start date: June 20, 2023
Phase: Phase 3
Study type: Interventional

Primary Objective: To explore whether a 6-month course of Rezvilutamide in the triple therapy regimen is non-inferior to long-term Rezvilutamide treatment in improving radiographic progression-free survival (rPFS) in patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC). Secondary Objectives: To evaluate and compare the time to prostate-specific antigen (PSA) progression, time to next bone-related event, time to initiation of subsequent anti-prostate cancer treatment, and objective response rate (ORR) between the 6-month and long-term course of Rezvilutamide with androgen deprivation therapy (ADT) plus docetaxel in patients with high tumor burden mHSPC. To assess and compare the incidence of adverse events between the 6-month and long-term course of Rezvilutamide with ADT plus docetaxel in patients with high tumor burden mHSPC. Exploratory Objectives: To observe the circulating tumor cell status at 6 months, 12 months, 18 months, and 24 months in patients with high tumor burden mHSPC receiving the triple therapy regimen.

NCT ID: NCT05955885 Recruiting - Cough Clinical Trials

Effect of Over-the-counter NSAIDS on Cough Reflex Sensitivity in Patients With Upper Respiratory Tract Infections

Start date: July 1, 2023
Phase: Early Phase 1
Study type: Interventional

The goal of this mechanism of disease study is to investigate the effect of flurbiprofen, a non-steroidal anti-inflammatory drug (NSAID), on the cough hypersensitivity associated with upper respiratory tract infections (URTI). The main questions it aims to answer are: - Q1: Does a single treatment with an approved therapeutic dose of flurbiprofen, an NSAID that prevents the production of prostaglandins, acutely reduce objective measures of cough hypersensitivity in participants with URTI? - Q2: Is the effect of flurbiprofen on cough hypersensitivity in URTI related to participant subjective ratings of acute cough severity? - Q3: Is the effect of flurbiprofen on cough hypersensitivity in URTI related to the levels of prostaglandins or other inflammatory markers measurable in upper airway secretions? Participants will be asked to undergo cough challenge testing, complete quality of life questionnaires, and have their nasal fluid, saliva and pharyngeal secretions sampled before and after a single treatment with flurbiprofen in the form of a lozenge or spray. Participants in the comparator arms of the study will instead receive a placebo lozenge or low dose flurbiprofen spray.

NCT ID: NCT05945381 Recruiting - Clinical trials for Molar Incisor Hypomineralization

Effect of Glass-Ionomer Sealing Technique on Hypersensitive Teeth With Molar Incisor Hypomineralisation

MIH_GIC
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

This single armed cohort study is aimed to assess the acceptance, durability and efficiency of glass-Ionomer sealing technique on hypersensitive MIH molars (TNI-3 & 4a/b/c) clinically shortly (15 minutes) after the application and after a time period of 3 months.

NCT ID: NCT05943704 Recruiting - Cow Milk Allergy Clinical Trials

The Frequency of Beef Allergy in Children With Cow Milk Allergy

Start date: September 2023
Phase: N/A
Study type: Interventional

This study aims to determine the frequency of allergy to beef meat in children with allergy to cow's milk by serum measurement. Also, the study aims to assess the sensitivity and specificity of beef IgE in relation to gold standardized of elimination challenge test and to assess effect of eating of cooked meat on symptoms of allergy in those proven to have either CMA alone +/- beef allergy (by serology).