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NCT ID: NCT04727801 Terminated - Febrile Clinical Trials

A Clinical Data Collection Study of Verily Patch

Start date: March 11, 2021
Phase:
Study type: Observational

This is a single center, prospective, non-randomized prospective observational data collection study of the Verily Patch. The Verily Patch is an investigational wearable, continuous temperature sensor which will be evaluated against reference oral and axillary temperature measurements to support development activities for the Verily Patch.

NCT ID: NCT04182945 Terminated - Fever Clinical Trials

Fever Algorithm Development of a Non-invasive Wearable Core Body Temperature Sensor System in Intensive Care Unit Patients

Start date: December 11, 2019
Phase: N/A
Study type: Interventional

Background and Rationale: The gold standard to assess fever, is to conduct invasive intravascular, esophageal or bladder thermistor core body temperature (CBT) measurements. Since these methods are time consuming for the medical staff and more importantly displeasing to the patients, alternative CBT/fever assessments is needed. greenTEG is developing a CBT algorithm that will be able to reliably calculate CBT continuously form skin temperature (ST) and the corresponding heat flux (HF). This can be achieved from subjects developing fever in intensive care unit, since the prevalence of fever is high and optimally assessed. Objective(s): The aim of this study is to develop and validation of an algorithm that allows the detection of fever in patients through a non-invasive wearable prototype sensor, which calculates CBT from ST, HF and heart rate (HR) data streams, allowing a more effective patient management Endpoint(s): ST, HF, HR and CBT data are collected for at least 24hrs until 3 day, depending on the ICU length of stay of the patient. ST, HF, HR and CBT values from different measurement positions (subclavicular, lateral ribcage, upper arm and wrist) of the non-invasive wearable research prototypes will be compared with each other and compared to clinical invasive method particularly CBT measured by blood temperature from a pulmonary catheter if present or vesical temperature Study Design: Interventional-Single Group Assignment, monocentric, open label. Statistical Considerations: The measure of quality will be the mean absolute difference (MAD) between the CBT prediction and the reference signal where the mean is taken over the whole measurement of a single candidate. An aggregate performance measure over a group of candidates is defined by averaging the MAD values of each candidate in the group. When a group of candidates for algorithm validation is defined, the total improvement will be defined by comparing aggregate performances of old and new algorithm for the validation group. Balancing the probability of occurrence of the factors in the population and the overall size of the study, a final size of 50 candidates is reasonable. Inclusion- / Exclusion Criteria: Inclusion criteria: - Age ≥18 years old. - Patients which are treated at the cardiosurgical and vascular intensive care unit of the University Hospital Zurich. - Expected length of stay in the intensive care unit at least 24 hours - Clinical standard monitoring including an invasive CBT measurement (e.g. blood temperature from a pulmonary catheter if present or from a vesical catheter routinely placed) - Informed consent signed by the patient Exclusion criteria: - Acute medical contraindications against the measurement of the non-invasive wearable device (e.g. skin diseases) and band-aid allergies. - Implanted pacemakers or other implanted life sustaining devices - Comatose state of the patient - Pregnant Women Number of Participants with Rationale: Number of participants in the study :50 candidates. The study will be divided in two parts. In the first part data are collected from 38 patients. In the second part, data form 12 patients will be collected. The reason for the first part is to collect data in order to develop the algorithm. The reason to collect additional data from 12 candidates in the second part is to validate and adjust the algorithm that is develop in the first part of the study. Study Intervention: 50% of the research prototypes (4 pieces) will be mounted to the patient on left side of the body (sub clavicula, lateral ribcage, upper arm and wrist), after being admitted to the ICU and having signed the informed consent. As soon as a patient gets fever, the other 50% of the research prototypes (4 pieces) will be applied on the right side of the body (sub clavicula, lateral ribcage, upper arm and wrist). Control Intervention: Not applicable Study procedures: Patients will be recruited and screened 1-3 days before the measurements starts. 50% of the research prototypes (4 pieces) will be applied to the patient on the left side of the body (sub clavicula, lateral ribcage, upper arm and wrist), after being admitted to the ICU and having signed the informed consent. After the development of the fever, the other 50% of the research prototypes (4 pieces) will be applied on the right side of the body (sub clavicula, lateral ribcage, upper arm and wrist). At the end of intervention all prototypes will be removed from the patient. A greenTEG employee will collect all the prototypes.

NCT ID: NCT04104334 Terminated - Clinical trials for Colorectal Neoplasms

Impact of an Optimised Monitored Anesthesia on the Patients' Recovery After Cytoreduction Surgery Plus HIPEC

CHIPNOL
Start date: May 8, 2019
Phase: N/A
Study type: Interventional

The objective of our PILOT study is to evaluate the impact of a controlled (monitored) randomized anesthesia during cytoreductive surgery with HIPEC to oxaliplatin in order to treat adenocarcinomas of colorectal origin. The combination of NOL monitoring, BIS monitoring and continuous hemodynamic monitoring (FloTrac EV1000 system) can improve patient safety by reducing the length of hospital stay by decreasing total hypnotic doses and intraoperative opioids and side effects following anesthesia.

NCT ID: NCT04076345 Terminated - Fever Clinical Trials

Interest of the Presepsin Assay as a Biomarker of Bacterial Infection, in the Management of Newborns and Infants Under 3 Months of Age Admitted for Fever in Pediatric Emergency Service (Presepsin)

presepsin
Start date: July 29, 2019
Phase:
Study type: Observational

The purpose of this study is to validate presepsin as a biological marker for identifying bacterial fever among febrile syndromes of infants under three months of age. Clearly, our goal is to determine if this marker can help us distinguish a viral infection from a bacterial infection. Indeed, presepsin would be specific for bacterial infection, and rise earlier in the blood during infection than biological markers currently used. Such validation could improve the precocity of the therapeutic management by a better targeted antibiotic therapy, and the limitation of invasive complementary examinations (lumbar puncture), in infants for whom the fear of a bacterial infection leads to examinations and systematic treatments.

NCT ID: NCT03891420 Terminated - COVID-19 Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effects of Galidesivir in Yellow Fever or COVID-19

Start date: April 9, 2020
Phase: Phase 1
Study type: Interventional

This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics, safety and antiviral activity of galidesivir in subjects with yellow fever (YF) or COVID-19.

NCT ID: NCT03889106 Terminated - Lassa Fever Clinical Trials

Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever

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

Lassa fever carries a treated mortality in hospitalized patients of up to 50%. Lassa fever is often described as being characterized by vascular leak and shock in the terminal phase, but, whilst animal data supports this, there are limited data in humans. Therefore, an aim of this study therefore is to characterize cardiovascular function in patients with Lassa fever, with the ultimate goal of informing future trials of supportive or therapeutic strategies. Ribavirin is the current standard of care. However, the efficacy of ribavirin has not been established in a randomised controlled trial (RCT). There is very limited pharmacokinetic (PK) data on ribavirin in patients with Lassa fever and the optimal dose of ribavirin for an RCT is unknown. Furthermore, there are various hypothesized mechanisms of action of ribavirin, none of which have been investigated in humans with Lassa fever. Further aims of this study therefore are to characterize the PK of ribavirin in Lassa fever, and identify any associations between ribavirin PK parameters, viral load and markers of immune/inflammatory status.

NCT ID: NCT03618992 Terminated - Coccidioidomycosis Clinical Trials

Improving the Appearance of Skin and Hair in Patients Undergoing Valley Fever Treatment

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

This will be a multi-visit study that will take approximately 3 hours in total. Up to 200 subjects from the BUMC Valley Fever and BUMC Dermatology clinics will be enrolled in this study and assigned to one of three cohorts according to timeline of oral anti-fungal therapy. Subjects in Cohort 1 will be randomized to apply topical cholesterol-containing moisturizers to the skin, hair and lips on either the right or left side of the body daily. Measurements of skin barrier function, appearance of skin and hair, and hair samples will be obtained at baseline and at 4 week follow-up visits. Cohorts 2 and 3 will be observational groups at differing points in oral antifungal treatment regimen. Subjects will be randomized to have measurements of skin barrier function and hair and skin characteristics obtained from either the right or left side of the body at baseline and at monthly follow-up visits.

NCT ID: NCT03342365 Terminated - Febrile Neutropenia Clinical Trials

Evaluation of Intestinal Bacterial and Fungal Translocation and Intestinal Microbiota in Febrile Neutropenic Patients in Pediatric Onco-hematology

TRANSNEUTROFEB
Start date: April 13, 2018
Phase:
Study type: Observational

This pilot study aims to study intestinal bacterial and fungal translocation and the evolution of the intestinal microbiota in patients over the course of their medical surveillance to search for a link between dysbiosis and bacterial/fungal translocation, but also to better understand the elements involved in febrile episodes in these patients (lack of detection of blood microorganisms, translocation of constituent elements of these microorganisms, etc.). We hypothesize that the composition of the intestinal microbiota as well as the phenomenon of intestinal microbial translocation will have an influence on the occurrence of fever and/or bacteremia in neutropenic patients hospitalized in pediatric onco-hematology.

NCT ID: NCT03182465 Terminated - Clinical trials for Febrile Neutropenia, Drug-Induced

Predictive Value of ProCalcitonin for the Detection of Bacteraemia in Patients Presenting to the Emergency Department for Low Risk Chemo-induced Febrile Neutropenia

CALIF
Start date: October 4, 2017
Phase: N/A
Study type: Interventional

CALIF study is a monocentric observational study which aim is to analyse the value of adding procalcitonin (PCT, a pre-hormon increased in bacterial infection and septicaemia) in the management of chemo-induced febrile neutropenia occurring in patient with solid tumour. Febrile neutropenia will be managed according to international guidelines. PCT will be dosed at initial presentation. Primary objective is to determine the optimal value of PCT for the detection of septicaemia in low risk (according to MASCC score). The investigators plan also to compare two risk stratification scores: the validated MASCC score and a recently developed score which includes PCT and other more objective items.

NCT ID: NCT03003273 Terminated - Pediatric Cancer Clinical Trials

Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: -DALFEN Study

DALFEN
Start date: January 2017
Phase: Phase 3
Study type: Interventional

Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low risk features (culture awaited), will be started on intravenous antibiotics (Inj Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or reappearance of fever within follow-up of ≤ 10 days.