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Hypersensitivity clinical trials

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NCT ID: NCT06460194 Withdrawn - Sensory Disorders Clinical Trials

Treatment of Frostbite Sequelae With Botulinum Toxin A

Start date: November 2022
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT06458283 Active, not recruiting - Breastfeeding Clinical Trials

Effıcıency Of Hybrıd Based Sımulatıon Method In Breastfeedıng Educatıon

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

It was planned to determine the effect of hybrid simulation-based breastfeeding training on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences

NCT ID: NCT06456541 Not yet recruiting - Cow's Milk Allergy Clinical Trials

Infant Formula in Infants and Children With Cow's Milk Allergy

Start date: July 2024
Phase: N/A
Study type: Interventional

This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.

NCT ID: NCT06452212 Not yet recruiting - Clinical trials for Metastatic Hormone-Sensitive Prostate Cancer

Non-Interventional Study to Establish Consensus on Management of Metastatic Hormone-Sensitive Prostate Cancer Patients

Start date: July 31, 2024
Phase:
Study type: Observational

The purpose of this study is to establish an expert consensus recommendations on managing patients with mHSPC in South Korea, and to provide clinicians with a comprehensive guide to support their clinical decision making. There are no secondary objectives for this study.

NCT ID: NCT06448169 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

Observational Study on the Sensitivity of Neoadjuvant Immunotherapy in Early Triple-Negative Breast Cancer

Start date: May 30, 2024
Phase:
Study type: Observational

Studies have reported that tumors with the same immunogenic mutations may induce T cell receptor (TCR) domains with similar antigen recognition functions. By assembling the complementarity-determining region 3 (CDR3) of TCRs from RNA-seq data and correlating them with 9142 samples from TCGA data, an in-depth analysis of the TCR pool in the tumor microenvironment found a strong correlation between the CDR3 sequences of tumor-infiltrating T cells and tumor mutation burden. Fairfax et al. found that in patients responding to tumor immunotherapy, the TCR immune pool of CD8+ T cells produces many clones with extremely high abundance (exceeding 0.5%) . Cader et al. also found significant changes in the TCR immune pool of patients with Hodgkin's lymphoma responding to PD-1 tumor immunotherapy. Based on these theoretical foundations, evaluating the dynamic changes of the TCR immune pool is expected to be used to analyze the immune characteristics and changes in diseases such as malignant tumors.

NCT ID: NCT06446206 Not yet recruiting - Clinical trials for Platinum-sensitive Relapsed Ovarian Cancer

Adebrelimab Plus Chemotherapy, Bevacizumab and Fluzoparib in Platinum-Sensitive Relapsed Ovarian Cancer

Start date: June 2024
Phase: Phase 2
Study type: Interventional

The investigators explore the efficacy and safety of adebrelimab (PD-L1 inhibitor) plus chemotherapy and bevacizumab induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib (PARP inhibitor)and bevacizumab in platinum-sensitive relapsed ovarian cancer.

NCT ID: NCT06445374 Recruiting - Hypersensitivity Clinical Trials

Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges

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

The purpose of this exploratory study is to evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity who experience a systemic allergic reaction (SAR) while undergoing allergy testing, immunotherapy or oral challenges.

NCT ID: NCT06437171 Recruiting - Food Allergy Clinical Trials

FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA

Start date: May 2024
Phase: Phase 4
Study type: Interventional

This is a Phase IV, open-label, single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA.

NCT ID: NCT06429813 Not yet recruiting - Clinical trials for Metastatic Prostate Cancer

Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)

Start date: July 2024
Phase: N/A
Study type: Interventional

This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B). The study will enroll 24 patients who are starting ADT (Androgen Deprivation Therapy)/ARSI (Androgen-Receptor Signaling Inhibitors) therapy for newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC). All participants will be asked to complete 1-2 training sessions at UVA prior to starting the exercise. All participants will be asked to complete aerobic and strength testing before and after the exercise program. Participants will be asked to answer questionnaires throughout the program. The at-home exercise will last for 12 weeks.

NCT ID: NCT06428162 Active, not recruiting - Drug Abuse Clinical Trials

An Evaluation of Healthcare Providers' Adherence to Pharmacovigilance Practices in an African Community

Start date: February 18, 2024
Phase:
Study type: Observational

Egypt's several regions-rural, mixed, and urban-were given pre-designed surveys pertaining to drug adverse events and the role of pharmacovigilance in detection and reporting. The three sections of the survey were dedicated to studying health care professionals' knowledge concerning pharmacovigilance concepts and practices, as well as demographics and people reported or not reported. The survey also asked more questions regarding adverse occurrences that were reported.