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Hypersensitivity clinical trials

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NCT ID: NCT04531813 Completed - Hypersensitivity Clinical Trials

Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)

Start date: June 10, 2013
Phase: Phase 3
Study type: Interventional

In this study researchers want to study the potential skin reaction after repeated application of an antifungal cream containing trolamine. The study plans to enroll about 32 healthy female or male participants with the age 18 - 79 years. Researchers will apply on the skin of the upper back between the shoulder blades of the study participants three different patches to cover a small amount of the antifungal cream or 0.3% solution of sodium lauryl sulfate, which is known to cause skin irritation (so called positive control). A third patch will cover a skin area without any product (so called negative control). Participants will return daily to the study center to have new patches containing the test products applied on the same skin area of the back, excluding weekends, for 21 days of continuous skin contact. At each visit the skin will be investigated by the researchers for redness, dryness and other reactions to learn about the skin reaction after repeated application.

NCT ID: NCT04531540 Completed - Hypersensitivity Clinical Trials

Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)

Start date: September 9, 2013
Phase: Phase 3
Study type: Interventional

In this study researcher want to learn more about possible skin reactions such after repeated application of an antifungal cream containing Trolamine. They are especially interested in skin irritations or allergic skin reactions. The study plans to enroll about 225 female or male participants with the age 18 - 79 years. The antifungal test cream will be applied on the back between the shoulder blades of the participants and covered by a special dressing patch. This will be repeated 3 times a week for the first 3 weeks of this study applying the cream on the same area of the back. At each visit the skin will be investigated for redness, dryness and other reactions. After a rest period of two weeks the test cream will be applied on the same skin area as before and on a second new skin area nearby. After 2 and 4 days the two skin areas will again be investigated for redness, dryness and other reactions.

NCT ID: NCT04529473 Completed - Metabolic Syndrome Clinical Trials

Efficacy and Safety of 12-weeks Supplementation of Eubacterium Hallii on Insulin Sensitivity and Glycaemic Control

Start date: February 3, 2021
Phase: N/A
Study type: Interventional

This 12 week placebo-controlled study evaluates the efficacy and safety of E. hallii supplementation.

NCT ID: NCT04528693 Active, not recruiting - Insulin Resistance Clinical Trials

The Effect of 12-week Circuit Training on Insulin Sensitivity and Endothelial Function in Women With Insulin Resistance

Start date: August 17, 2020
Phase: N/A
Study type: Interventional

During the last 10 years many studies concerning the impact of physical training on whole-body insulin sensitivity have been published, but there is a lack of an extended investigation on the potential clinical benefits of novel circuit training-based on strength and endurance exercises-relating to the optimization of insulin sensitivity and vascular endothelial function. It is of interest to precisely determine the physiological and biochemical effects of circuit training. An important aspect of the planned research will be the analysis of the effects of physical training on the released during muscle contraction myokines capable of modulating various metabolic processes. We hypothesized that in studied participants 12 weeks of the novel form of training would result in improving insulin sensitivity and vascular endothelial function mainly via myokines released by contracting skeletal muscles. The following questions will be asked: (1) whether the 12-week circuit training (combined strength and endurance exercises) performed by women with insulin resistance, improves insulin sensitivity, carbohydrate and lipid metabolism and promotes the efficiency of endothelial defense mechanisms? (2) whether the 12-week circuit training (combined of strength and endurance exercises) changes the concentrations of transcription factors regulating lipid and carbohydrate metabolism or the synthesis and/or secretion of myokines and adipokines in women with insulin resistance? (3) whether the 12-week strength training, interspersed with bouts of endurance exercise has a positive effect on cytokine profile? (4) whether there is a relationship between changes in body composition, HOMA-IR, and the level of myokines caused by physical training? (5) whether the 12-week circuit training reduces low back pain symptoms, plantar stifness and improve functioning of the patient in everyday life? A group of 80 women, aged 25 to 45 years, with diagnosed insulin resistance will participate in the planned study. Participants will be enrolled in the research program based on medical qualification. Before the intervention all women will have venous blood collected to determine fasting glucose, hemoglobin glycosylated (HbA1C) and insulin levels and insulin resistance by the homeostasis model assessment of insulin resistance (HOMA-IR) will be calculated. The inclusion criteria will be as follows: (1) women, age: 25-45 years, menstruating, (2) BMI 18,5-29,9 kg/m2, (3) insulin resistance based on HOMA-IR (cut-off point 2.5), (4) HbA1C ≤ 6.5%, (5) not contraindicated to physical activity. Participants meeting the inclusion criteria will be randomly divided into two groups. The first group of women will undergo circuit training, consisting of exercises performed on 7 machines arranged in a circuit. Thanks to the use of adequate software the machines will automatically adjust their parameters, such as seat height or resistance to the exercising person, and the training progress will be individually monitored. The planned training will last for 3 months, during which the patients will exercise 3 times a week for 30 minutes (2 circuits will be done during each session). The planned duration of the training session will be controlled (one minute for strength exercises, four minutes for endurance exercises and a 30-second break between each exercise). In the training group, one-repetition maximum exercise test (1RM) will be performed to determine the appropriate training load and later after the program to verify the increase in muscle strength. The range of maximum heart rate (HRmax) will also be determined in all exercising women. The second group of women, who will be asked to maintain their current level of physical activity and their diet for a period of 3 months will serve as a control group. Before and after the training program in all participants of the study pulse wave velocity, anthropometric parameters and body composition will be assessed. Concurrently venous blood will be taken to determine biochemical indicators related to carbohydrate and lipid metabolism, insulin resistance, vascular endothelium function, inflammation and adipocytokines and myokines. In both groups of women, the questioners concerning dietary intake and the level of daily physical activity will be administered. Results will be subjected to analysis involving descriptive, and advanced statistic method among them analysis of correlations, regression, variance and cluster analysis. All calculations and statistics will be performed using TIBCO Statistica 13.3 software (TIBCO).

NCT ID: NCT04527159 Completed - Clinical trials for Dentin Hypersensitivity

Comparison of Desensitizing Materials

Start date: January 6, 2019
Phase: N/A
Study type: Interventional

To compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.

NCT ID: NCT04520503 Completed - Clinical trials for Propofol Overdose of Undetermined Intent

Relationship Between Pre-induction Electroencephalogram Pattern of Adult Patients and Their Sensitivity to Propofol

Start date: September 9, 2020
Phase:
Study type: Observational

The induction dose of propofol is generally determined based on patients' characteristics, underlying disease, general condition, and also by clinician's experiences. However, It is difficult to anticipate and objectively calculate an adequate dose of propofol for every patient considering the variability of an individual's response to propofol. If there is a specific pattern in EEG prior to induction of anesthesia that can provide information about the patient's susceptibility to propofol, every induction may be performed far more smoothly with a precisely optimized dose of propofol for each patient. The study is to find a relationship between the pre-induction EEG pattern of adult patients and their sensitivity to propofol.

NCT ID: NCT04519827 Completed - Allergy;Food Clinical Trials

A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula

CHARM
Start date: May 21, 2020
Phase: N/A
Study type: Interventional

Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by around 3-5 years. Breast feeding is the most optimal form of feeding for all infants, regardless of their condition, and in those with CMA maternal dairy exclusion is recommended as first line treatment. In non-breast fed or mixed feeding, a hypoallergenic milk substitute is recommended for young infants. The AAP and other societies such as EAACI and ESPGHAN considers a formula to be 'hypoallergenic' if at least 90% of children with documented CMA tolerate it, with a 95% CI, under double-blind, placebo-controlled conditions.This equates to at least 29 children who should tolerate the product following blind and open challenge.

NCT ID: NCT04519151 Recruiting - Ovarian Neoplasms Clinical Trials

Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer

Start date: April 12, 2021
Phase: Phase 2
Study type: Interventional

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) for the treatment of platinum sensitive recurrent ovarian cancer. Participants will receive pembrolizumab and lenvatinib.

NCT ID: NCT04513938 Completed - Allergy Penicillin Clinical Trials

Interest of the Second Phase of the Oral Challenge Test in Patients With Suspected Long-standing Penicillin Allergy

PENI
Start date: July 20, 2020
Phase:
Study type: Observational

The most common drug allergy reported is penicillin allergy, approximately 10% of the world's population. According to the latest studies, only 1-2% of them have a proven hypersensitivity to penicillins. Being wrongly labeled "allergic" leads to a loss of chance for patients to be treated with a molecule of less efficacy than penicillins, an increase in bacterial resistance by broadening the spectrum of action of the molecules prescribed as an alternative and ultimately a additional financial cost. There are several forms of hypersensitivity: the two most classic: immediate hypersensitivity (type I according to Gell and Combs) with a reaction within an hour of taking and non-immediate hypersensitivity with a reaction occurring several days later (type IV according to Gell and Combs). A large majority of patients report a history of allergy in childhood that is poorly described and most often absent from health records. In most cases, this may be a viral rash concomitant with a febrile episode mistakenly mistaken for an allergic skin reaction. Patients are then tested for several decades, in adulthood, after their initial reaction. This latency of time involves a risk of negativation of the allergic tests and it is not excluded that the skin tests or drug reintroductions re cause sensitization to the antibiotic tested and that ultimately the patient reacts when taking the future drug. In fact, it is recommended to optimally explore patients approximately 6 months after an allergic reaction (except for severe drug eruptions). The exploration of drug hypersensitivity to penicillins therefore involves a strict questioning of the circumstances of the so-called allergic reaction allowing the reaction to be classified as immediate or delayed, then skin tests (prick test, IDR and Patch test according to the immediate profile or delayed) and finally the hospital provocation test. While provocation tests are carried out conventionally most often within one day, it has been shown that some patients react several days after taking penicillin repeatedly: 6.1% have a reaction in their protocol of taking for 5 days at home in the context of a delayed allergy. In the allergology service at hôpital Paris Saint-Joseph, the protocol corresponds to 2 successive reintroductions. This study is to evaluate the protocol for reintroducing Amoxicillin or Augmentin carried out over two stages: a first with 100 mg (i.e. 1 / 10th of a dose) then a second with a dose of 1200 mg 1 month later. It would be a question of seeing if with the second reintroduction, one could not catch up with allergic people who would have presented a false negative during the first reintroduction because of explorations too far away from their initial reaction.

NCT ID: NCT04512924 Completed - Caregiver Burnout Clinical Trials

The Psychosocial Outcomes in Caregivers of Children With Food Allergy

FASST
Start date: December 8, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate use of a mobile application (also commonly referred to as an app) designed to support caregivers of children with newly diagnosed food allergy. This study has 2 phases. In Phase 1, the researchers obtained feedback regarding use of mobile apps from caregivers who have been managing their child's food allergy for one year or more. The researchers then used this feedback to build a mobile app for caregivers of children with newly diagnosed food allergy. In Phase 2, the researchers will evaluate the mobile app during a 4-week evaluation period with a group of caregivers of children newly diagnosed with food allergy. The data obtained from this study will hopefully benefit caregivers of children with newly diagnosed food allergy.