Active clinical trials for "Hyperthermia"

The aim of this trial is to investigate the primary efficacy of SBRT combined with PD-1 inhibitor and thoracic hyperthermia in patients with EGFR, ALK, and ROS1 negative stage IV NSCLC patients who progressed after first-line treatment. At least one lesion (primary or metastatic) was selected for SBRT treatment, and the radiotherapy dose of each lesion was 32Gy/4Fx. SBRT was combined with thoracic hyperthermia from the first fraction, and hyperthermia was performed 6 times, twice a week. PD-1 inhibitor was used on the second day after the completion of SBRT. The PD-1 inhibitor was administered at a dose of 200mg every time, every 3 weeks for 2 years (35 times total), or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression. During the period, the overall response rate and toxicities were regularly evaluated.

Cesarean section is the common surgery in world wide. But the complication like febrile morbidity such as surgical site infection, fever, urinary tract infection and endometritis can be occurred even giving the standard antibiotics. Therefore if wider bacterial spectrum coverage antibiotic like azithromycin is added to the standard antimicrobial prophylaxis(1st generation cephalosporin), the incidence of febrile morbidity could be reduced. We will compare the regimen of cefazolin plus azithromycin and standard regimen of cefazolin alone in prevention of febrile morbidity after emergency cesarean section.

A randomized, multidisciplinary study, Phase II-III clinical trial.The study is opened to the incorporation of other centers that would increase the power of the obtained results . Our hypothesis considers that using Hyperthermic Intra-abdominal Chemotherapy,HIPEC, with gemcitabine after cytoreductive surgery ,will decrease tumor progression of pancreatic cancer by reducing the neoplastic volume and subpopulation of pancreatic cancer stem cells, improving the survival of patients with pancreatic cancer, and decreasing the recurrence of the disease

This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.

Primary objective of this trial is to identify the maximum tolerated dose (MTD) of paclitaxel combined with a fixed dose of cisplatin (75 mg/m2) delivered as hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian cancer. In this single-center Phase I trial, Bayesian Optimal Interval Design (TITE-BOIN) was used. The starting dose for paclitaxel was 175 mg/m2, with escalation in 25 mg/m2 increments until the MTD was determined or the maximum dose level of 225 mg/m2 was reached. The target dose-limiting toxicity (DLT) rate was 25%, and the total sample size was 30 patients.

An investigator-initiated, open-label, multi-center, randomized, non-inferiority trial of children aged 3 months to 13 years with acute uncomplicated febrile urinary tract infection. The primary objective is to determine whether individualized antibiotic therapy based on an algorithm (experimental arm) versus standard antibiotic therapy of 10 days (control arm) can reduce the number of days with antibiotic therapy within 28 days after treatment initiation without increasing the risk of recurrent urinary tract infection regardless of the pathogen or death of any cause within 28 days after end of treatment. Children will be randomized 1:1. The medical treatments received are identical in both groups.

This study aims to assess whether transmusculr quadratus lomborum block (QL block) can reduce postoperative pain after cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC). Patients will be randomly assigned to either QL block group or control group. Ultrasound-guided bilateral transmuscular quadratus lomborum block will be performed in QL block group using 0.375% ropivacaine. Multimodal analgesic regimen including acetaminophen, nonsteroidal antiinflammatory drugs (NSAIDs), and rescue opioids will be used in every patient. Primary outcome is opioid consumption for 24 hours after surgery. Secondary outcomes included pain scores, time to first rescue analgesics, quality of recovery score, length of hospital stay.

Febrile aplasia is a common occurrence in children/adults treated with chemotherapy for malignant blood diseases or solid cancers. This acquired deficiency of immunity mainly causes susceptibility to bacterial and fungal infections, pathogens normally recognized by specific receptors of innate immunity (Pattern Recognition Receptor, PRR). Thus, the febrile episodes in the context of post-chemotherapy neutropenia can be bacterial or fungal etiology, but can also frequently be related to viral infections, toxic phenomena or other etiologies. In the absence of a discriminating marker, treatment for all these children is based on early, broad-spectrum antibiotic therapy in hospital. Septic shock or even death by refractory septic shock remain, even if they are rare, real complications in pediatric oncology, requiring discriminatory markers for effective management, While trying to reduce the number and duration of hospitalizations for children at low risk for severe febrile aplasia. It is therefore necessary to identify other markers allowing the earliest possible classification of episodes of febrile aplasia. A previous study, conducted by our team, PTX3 and febrile aplasia, studied pentraxin 3 (PTX3), a soluble PRR of the pentraxin family that plays a key role in immune surveillance against pathogens. Preliminary results obtained from samples from a cohort of patients treated in adult hematology and pediatric onco-hematology support a prognostic character of PTX3 in the severity of aplasia, with higher elevations of serum protein during episodes of severe sepsis or septic shock (ongoing analyses and interpretations for the adult population). The available data to date on the pediatric cohort are insufficient to conclude on the value of using PTX3. The investigators therefore wish to create a new paediatric cohort, in order to evaluate the PTX3 levels for the paediatric population and also to perform the assay of a new marker, clusterin. Clusterin (CLU) is an extracellular chaperone protein of constitutive expression. The Innate Immunity team of the National Institute of Health and Medical Research (INSERM) "1307-Scientific Research National Center (CNRS) 6075" unit has shown that Clu binds to extracellular histones and inhibits their inflammatory, thrombotic and cytotoxic properties. The investigators also observed (i) that in adults without severe sepsis neutropenics, low serum levels of Clu at intake and lack of normalization of rates are associated with higher mortality and (ii) Clu levels are inversely correlated with circulating histone levels. All these data suggest that Clu would have a protective role for histone-induced lesions during sepsis independently of antibiotic treatment, opening an innovative therapeutic pathway in the management of severe sepsis. CluPPFeN is based on the hypothesis that, in a pediatric population with episodes of febrile aplasia, serum Clu and serum PTX3 levels would discriminate between febrile episodes caused by bacterial infection and other etiologies and, As a result, would reduce the consumption of antibiotics, which provide resistance, and the length of hospitalization.

In Sub-Saharan Africa (SSA), fever remains a major public health problem in children. The introduction of malaria rapid diagnostic tests (RDTs) in routine healthcare has greatly improved the management of malaria. However, despite the good attitude of healthcare workers to adhere to malaria RDT test results, persisting hrp2antigen and low sensitivity of pLDH RDT negatively affect antimalarials and antibiotics prescriptions practices. This is one of the main causes of antimicrobial resistance (AMR) and inappropriate management of febrile diseases. To improve the diagnosis of febrile diseases and subsequent prescription of antimicrobials, it is hypothesized that the implementation of an algorithm including a two-step malaria RDT PfHRP2/pLDH supported by point-of-care tests (POCTs) for C-reactive protein, oximetry, and bacterial infection such as Group A Streptococcus, and Salmonella/Shigella, will significantly improve the management of febrile diseases and thereby tackling AMR. To assess the value of the proposed algorithm, an open-label randomized controlled trial with three arms, enrolling febrile children under 5 years is proposed. In the control arm, febrile children will benefit from a complete clinical examination. Treatment will be done according to the national guideline. In RDTs decisional algorithm (RDT-DA) arm (intervention), the complete clinical examination will be supported by two-step malaria RDT and bacterial infections RDTs. Prescription will be left to the discretion of the healthcare workers. In e-algorithm arm (intervention), the complete clinical examination and the outcomes of RDTs (malaria and bacterial infections) will be digitalized. Diagnostic and prescription will be done by the algorithm. A final follow-up visit (day7) will be scheduled for all participants. Patients will be asked to return to the health facilities in case of no improvement. Primary study outcomes will be the proportion of curative case and antimicrobial(s) prescribed in each arm. Secondary outcomes include: (i) adherence of healthcare workers to the algorithm; (ii) adherence of parents/guardian to treatment; (iii) accuracy of the algorithm for the diagnostic of malaria. This project will serve as a path of policy change in the management of febrile diseases and AMR. By relying on existing RDTs available, the implementation of this algorithm will tackle AMR and provide better care. If successful, the project will equip the lead applicant to establish himself as an independent researcher with ability to further build his own research team. The project will also offer training opportunities to young scientists, and further strengthen already existing capacities of the home institute.

In Health Posts of rural areas operated by the Government of Nepal, there are limitations of tests to differentiate between bacterial and viral infections. Due to this, health workers are obliged to prescribe antimicrobials (antibacterials) just on the basis of clinical features. This can lead to irrational use of antimicrobials, consequently contributing to antimicrobial resistance. C-reactive protein is the marker of inflammation which rises during bacterial infection but rarely rises during viral infection. The investigators wish to compare the effect on antimicrobial usage of using CRP(C-Reactive Protein) test, a rapid diagnostic test used to differentiate bacterial and viral infection, with usual standard of care, by carrying out a cluster-randomized controlled trial. The investigators plan to carry out this study in eight Health Posts of Resunga, Dhurkot and Gulmi-Durbar Municipalities of Gulmi District. The investigators will randomly allocate four Health Posts (clusters) to the intervention arm- CRP TESTS in addition to Usual Standard of Care, and four Health Posts (clusters) to the control arm- Usual Standard of Care Alone. The investigators plan to study all patients above one year of age presenting with fever or a history of reported fever with a duration of up to 7 days in Health Posts. Primarily, the investigators will assess the rates of antimicrobial use per patient who presents with febrile illness. Secondarily, the investigators will also assess the outcome of illness of the patient such as need for subsequent hospital admission or severe or complicated illness. This testing method will supplement the existing methods to differentiate bacterial and viral infections based on history and clinical examination by health professionals as a part of usual standard of care in the Health Posts included in this study.