Active clinical trials for "Hyperthermia"

BHSAI is developing a computational system that provides early alerts of a rise and fall in core body temperature to help reduce the risk of thermal injury in the field and during training. The goal of the body temperature alerting system is to use it during rest, exercise in the heat and cold. Therefore, the primary purpose of this investigation is to validate a body temperature alerting system using physiological responses that occur during rest, exercise in the heat and cold. Multiple cold ambient temperatures will be validated.

Electrosurgery allows for dissection with simultaneous haemostasis. One of its disadvantages is that the heat production can cause injury to the surrounding tissue which may result in wound healing problems and an increased rate of seromas. The PEAK PlasmaBlade™ (PPB) is a new electrosurgery device which may overcome this by having the ability to operate on a lower temperature, therefore reducing collateral thermal damage. Different experimental studies in both animal and human models comparing the PEAK PlasmaBlade™ and other surgical dissection devices for incisions have shown a reduction in width of zone of thermal injury, reduction in wound inflammation, increased wound strength and reduced scaring in favour of the PEAK PlasmaBlade™ and comparable to scalpel incisions. A prospective clinical study published by Dogan et al. in 2013, including 46 consecutive breast cancer patients receiving a modified radical mastectomy either with the conventional diathermy (n=22) or the PEAK PlasmaBlade™ (n=24), showed a statistically significant reduction in wound fluid production (p=0.025), leading to earlier drain removal (p=0.020) in the PEAK PlasmaBlade™ group. Comparable to oncological breast surgery, prolonged drain requirements for high wound fluid production and seromas are often experienced in the abdominal donor side after deep inferior epigastric perforator/ muscle sparing transverse rectus abdominis muscle flap (DIEP/MS-TRAM) breast reconstruction. To evaluate the effects of the PEAK PlasmaBlade™ for abdominal dissection in autologous breast reconstruction on wound fluid production and complications such a seroma, this double blinded randomised controlled clinical trial was conducted. It was hypothesised the use of the PEAK PlasmaBlade™ for the harvest of the DIEP/ MS-TRAM flap would result in 1) a shorter abdominal drains requirement (days); 2) a lower total drainage volume (mL) from the abdominal drains; 3) lower levels of inflammatory cytokines in the drain fluid and 4) less and smaller seromas would be identified using ultrasound in the follow-up period.

Abstract: Introduction: Pile excision is frequently associated with post-operative pain and prolong hospital stay. A modern technique performed with LigaSure appears to be mainly effective in large pile tissue removal is required. The study compares LigaSure pile excision with diathermy for the treatment of III-IV degree pile. Patients and Methods: 208 patients with pile III or IV degree randomized into 2 groups. Group one LigaSure and group two diathermy. The study evaluates the mean post-operative time, post-operative pain, discharge date, time return to usual works early and late complication. All patient followed-up for range (12-24) months. Results: 108patient treated by diathermy, 100 by LigaSure. The mean operative time significantly shorter in LigaSure, post-operative pain disappears earlier in LigaSure than diathermy. The time return to work less in LigaSure, while no difference in hospital stay and post-operative complications. Conclusions: LigaSure is effective procedure when large degree III or VI pile excised. The procedure enhances to use LigaSure as treatments of choice for class III-IV pile, even it is more expensive than diathermy operation.

The goal of this study is to assess the feasibility of the approach, conduct a dose-finding investigation, and obtain pilot data on hyperthermia via sauna to apply in follow-up trials in the assessment of human chemical body burden reduction, for general wellness, detoxification, and pain reduction. The investigators wish to determine if a hyperthermia-based detoxification protocol is feasible to conduct: including assessment of recruitment, enrollment, retention, protocol adherence, adverse events, and changes in serum polychlorinated biphenyls (PCBs).

Since the 1st pandemic of the 21st century caused by SARS coronavirus, the world has experienced outbreaks of swine origin H1N1 influenza, Ebola and Zika viruses, which have all resulted in global health crises. Rapid mass vaccination with an effective vaccine such as a live attenuated vaccine, of vulnerable immune-naïve populations to establish herd immunity is an approach to control outbreaks. Such live attenuated vaccine had been used with great success in sporadic yellow fever outbreaks and recently successfully employed in Ebola field trial, both of these diseases have the potential for pandemic spread. Indeed, live attenuated vaccines have proven especially effective in controlling childhood diseases and have even succeeded in eradicating polio and measles from most parts of the world. However, deployment of such vaccines for pandemic control cannot be limited to children but must include adults in order to rapidly elevate herd immunity rates to halt transmission. Vaccinating adults may produce efficacy rates significantly different to those observed in children due to the prevalence of chronic diseases and their associated metabolic complications. Presently, there are 1 billion people who are overweight, many suffer from concurrent metabolic disorders. As activation of the adaptive immunity is reliant on a robust innate immune response to vaccines, metabolic disorders and long-term anti-inflammatory therapy with interventions such as statins may reduce vaccine immunogenicity resulting in suboptimal efficacy in this subpopulation. This study would therefore test the hypothesis that statins reduce live attenuated vaccine immunogenicity. We will combine a clinical trial with systems vaccinology approaches to define the impact statins has on the innate immune, B and T-cell responses to live attenuated vaccination. Our study will thus extend upon another recently completed trial by us and will provide new insights into the determinants of vaccine efficacy in a rapidly growing and aging population globally

Recent data suggests that increased temperature improves inotropic function during systole and may improve diastolic function in healthy humans at rest, despite a reduction in left ventricular volume at end diastole. The effect of heat stress has not been reported in patients receiving general anesthesia and the impact of general anesthesia on these findings is not known. Trans-esophageal echocardiography will be used to measure parameters important to both systolic and diastolic function at temperature intervals of 1°C in patients undergoing "Heated Intraoperative Peritoneal Chemotherapy" (HIPEC.) That general anesthesia will not alter the cardiovascular effects of increased temperature that has been reported in healthy, un-anesthetized humans is the hypothesis.

The goal of this clinical trial is to test the performance of the Masimo noninvasive temperature device in patients with fever. The main question it aims to answer is whether the Masimo temperature device is comparable to standard methods of taking temperature such as inserting a probe under the tongue or using a forehead thermometer. Participants will be asked to sit still while rounds of measurements are taken using the Masimo temperature device and the reference temperature device. Researchers will compare the measurements taken with the Masimo device with the measurements taken with the reference device.

In a multi-center open-label cluster-randomized controlled parallel-group multiple crossover non-inferiority trial in children and adolescents up to 20 years diagnosed with cancer requiring chemotherapy, primarily the safety, and secondarily the efficacy and other endpoints, of a high (39.0°C) versus low (38.5°C) temperature limit defining fever (TLDF) for the diagnosis of fever in chemotherapy-induced neutropenia (FN) is studied. Safety is assessed by the rate of safety relevant events per chemotherapy exposure time, a composite endpoint including serious medical complications and bacteremia during FN. Patients are repeatedly randomized (cluster: study site) to the high or the low TLDF every month, resulting in possible multiple crossovers in one patient. The high TLDF is declared not to be inferior regarding safety compared to the low TLDF if non-inferiority of the rate ratio of safety relevant events is proven, with a single-sided non-inferiority margin of 1.33, applying mixed Poisson regression.

Clinical trial intended to reduce the antibiotic therapy duration in "in-hospital" patients with haematological diseases who develop fever and low white blood cell count (neutropenia).

The use of e-health in improving the quality of health services is a rapidly expanding research area, in particular its usefulness in patient management of the home-hospital care pathway. Febrile neutropenia is a serious and frequent complication of cytotoxic chemotherapy and better identification of low-risk patients who can be treated at home could be made possible by these technologies. The objective of this study is to evaluate a shared health information system (NEUTROSIS) for home-hospital management of febrile neutropenia after anti-tumor chemotherapy. The study aims to compare the average length of hospital stay for febrile neutropenia among patients receiving NEUTROSIS and those receiving standard care Materials and methods A shared information system (NEUTROSIS) has been developed to connect a smartphone web application for the patient to the existing shared medical record of the Paris Sud hospital group (AP-HP, France - 4D software). The study consists of conducting a randomized controlled trial to compare a cohort of patients receiving cytotoxic chemotherapy for solid cancer or heamatological malignancies using the NEUTROSIS shared information system (n=100) and a cohort of patients followed by the hospital's standard care over a treatment period of six months (n=100). During the 15 days following each chemotherapy cycle, the 2 groups of patients must take their temperature daily. Both groups are trained like any patient under chemotherapy to contact the team in case of fever. The NEUTROSIS group captures daily its temperature and the occurrence of other symptoms on the smartphone application. This information is then transmitted instantly to the hospital care team who will be alerted in case of fever and will contact the patient. The control group will indicate these same data in a paper diary and will have to contact the health team in case of fever as done in the usual care. The two groups of patients will be followed 6 months through a questionnaire asked to the patient at each hospital visit for chemotherapy cycle. The questionnaire collects information on the occurrence of symptoms and healthcare use between two chemotherapy cycles. A last follow-up questionnaire is asked by phone at the endpoint follow-up (6 months). The study will take place in two hospital sites of the Paris University hospital (A Béclère and Kremlin-Bicètre).