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Cryotherapy Effect clinical trials

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NCT ID: NCT04339218 Recruiting - Lung Adenocarcinoma Clinical Trials

Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma

CRYOMUNE
Start date: August 28, 2020
Phase: Phase 3
Study type: Interventional

This study aims to compare the one-year survival benefit of the association of cryoablation-pembrolizumab-pemetrexed-carboplatin versus pembrolizumab-pemetrexed-carboplatin in metastatic lung adenocarcinoma patients. This is a multicenter, prospective, open-labeled, 2-arm comparative randomized (1:1) phase III trial. Patients will be randomized with a 1:1 ratio into: - Arm A (experimental arm): cryoablation of one visceral lesion or bone metastasis excluding liver and sclerotic bone metastases combined with pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization. - Arm B (standard arm): pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization. Pembrolizumab and pemetrexed-carboplatin will be prescribed and administered at the dose recommended by market authorization. Cryoablation treatment should be performed within 6 weeks after the first administration of pembrolizumab. No treatment switching permitted.

NCT ID: NCT04164511 Recruiting - Postoperative Pain Clinical Trials

Does Ice Cream Help With Post-tonsillectomy Pain

Start date: November 1, 2019
Phase:
Study type: Observational

Tonsillectomy is one of the most performed procedures in childhood, which carries with it certain postoperative problems, such as the pain of the operated area. Sickness greatly impairs the quality of life in the postoperative period and further reduces food and fluid intake in children, which in turn causes prolonged recovery after surgery. The impact of cooling oropharynx in the form of ice cream consumption as a form of cryotherapy could help reduce the pain, reduce the use of oral analgesic therapy and help in faster recovery after surgery. Research goal: The aim of the study is to determine whether the consumption of ice cream, as a form of cryotherapy, influences the rate of postoperative recovery after tonsillectomy and the consumption of oral analgesics in children. The study was designed as a prospective, randomized, parallel-group, unmasked, and longitudinal study enroling 100 children undergoing tonsillectomy in a tertiary referral center. Of those children, 60 will consume the same ice cream (a combination of vanilla and chocolate as universally acceptable flavors) twice daily, morning and evening, for two weeks after surgery. 40 children will not consume ice cream during the stated period. Parents will be given a questionnaire with a validated VAS Wong-Baker FACES scale (Visual - Analogue - Scale) used by the Zagreb Pediatric Disease Clinic to be completed at home based on communication with the child and containing information on a visual-analogue subjective pain experience in children every morning after eating ice cream and the amount of analgesics the children received during the first two weeks after surgery. There will also be a record of the days when children began to consume food and drink in the same range and quality as before surgery.

NCT ID: NCT03776734 Recruiting - Cryotherapy Effect Clinical Trials

Effects of Cold Application on Exercise Performance

Start date: July 30, 2018
Phase: N/A
Study type: Interventional

It is of utmost importance to determine the individual upper limits in the recommended exercises for increasing the level of physical activity and for developing the cardiovascular system. Cardiovascular exercise tests are used in determining the exercise capacity and performance. Cardiovascular exercise tests allow maximal and submaximal loadings to determine the person's body temperature, oxygen consumption, fatigue, interpretation of cardiac responses, and exercise capacity. Thermal equilibrium is achieved by the activation or inhibition of autonomic and behavioral thermocouples in order to generate, dissipate or protect heat. These thermocouples act together and allow precise control of body temperature, which is arranged in a narrow range. Under certain conditions, such as body temperature, systemic inflammation, extreme environmental conditions, and exercise performance, it falls outside this narrow range. Metabolic heat production is 15 to 20 times greater than resting during exercise. In exercise performed under hot ambient conditions, the rate of heat production will exceed the rate of heat loss and cause it to rise rapidly before reaching a plateau. The increase due to the exhalation of body heat initiates two autonomous thermodynamics for heat dissipation: sweating and cutaneous vasodilatation. Although both mechanisms help prevent exaggerated increase in body temperature, they cause stress for the cardiovascular system. Exercise performance and level of physical activity are influenced by individual characteristics such as personality adjustment and mediocre adjustment. Adaptation is defined as adaptation under natural conditions. Robinson showed that the individual salt losses are higher in individuals who exercise in a hot environment and cannot adapt to the temperature, a decrease in both urine and sweat salt contents with temperature compliance. One research has shown that exercise performance is influenced by heat-induced muscle cramps and cardiovascular function disorders due to this significant increase in salt loss. An increase in body temperature caused by exercise can have a negative impact on exercise performance and may lead to the development of conditions associated with increased body temperature. Although many studies in literature have shown positive effects of performance of pre-exercise cold exercise on performance, there is no consensus on the use of cold applications.