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NCT ID: NCT03364907 Not yet recruiting - Clinical trials for Peritoneal Carcinomatosis

Clinical Pharmacology of Platinum-based Hyperthermic Intraperitoneal Chemotherapy

GUTOX
Start date: January 1, 2018
Phase: N/A
Study type: Observational

Currently, there is a lack of knowledge on the effect of additional flushing after HIPEC on tumour platinum exposure, systemic platinum exposure and platinum concentration in drain exudate and thereby personal exposure. Therefore the investigators want to perform a study to investigate the effect of flushing after HIPEC on tumour exposure, systemic exposure and on wound exudate concentration.

NCT ID: NCT03364257 Not yet recruiting - Infection Clinical Trials

iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients

IDENTIFY
Start date: January 15, 2018
Phase: N/A
Study type: Observational

Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia

NCT ID: NCT03360656 Not yet recruiting - Fever Clinical Trials

Transnasal Induction of Normothermia in Febrile Stroke Patients

Start date: December 2017
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.

NCT ID: NCT03359811 Recruiting - Peritoneal Cancer Clinical Trials

Four Quadrants Transverse Abdominus Plane (4Q-TAP) Block With Plain and Liposomal Bupivacaine vs. Thoracic Epidermal Analgesia (TEA) in Patients Undergoing Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) on an Enhanced Recovery Pathway

Start date: November 27, 2017
Phase: Phase 3
Study type: Interventional

The goal of this clinical research study is to compare the effects of 4 quadrant TAP block (4Q-TAP block) with the standard-of-care thoracic epidural analgesia (TEA) in patients recovering from cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). A 4Q-TAP block is also known as an abdominal wall block and TEA is also known as a thoracic epidural. Both are types of anesthetics but are given in different ways. A 4Q-TAP block is when anesthetic injections are given in 4 different parts of the abdomen. A TEA is when an anesthetic injection is given in the space surrounding the spinal cord through your back. This is an investigational study. The surgery and the levels of anesthetic participant is receiving are standard-of-care. It is investigational to compare 4Q-TAP block with TEA. Up to 140 participants will be enrolled in this study. All will take part at MD Anderson.

NCT ID: NCT03352414 Not yet recruiting - Ileus Clinical Trials

Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

ILEUS
Start date: December 1, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the ability of alvimopan to reduce the time to return of bowel function in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Half of the participants will receive alvimopan or and half will receive placebo immediately before and for up to seven days after surgery.

NCT ID: NCT03342365 Not yet recruiting - 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: November 2017
Phase: N/A
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: NCT03338231 Completed - Clinical trials for Yellow Fever Vaccine

Clinical Study of Immunity Duration of Yellow Fever Vaccine in Military

Start date: March 27, 2017
Phase: N/A
Study type: Observational

Yellow fever is an acute viral disease transmitted by mosquitoes in South America, Central America and Africa. It is more prevalente in males gender and the age above 15 years due to the greater exposure in the wild endemic area of yellow fever. According to the World Health Organization (WHO), a single dose of the yellow fever vaccine is sufficient to maintain protective immunity against yellow fever for a lifetime, therefore a booster dose is not required. This issue is difficult to evaluate because there is no serological correlate of protection against yellow fever and seropositivity is defined with several cut-off points. Although studies indicate that the duration of protection after vaccination is long, many studies have demonstrated a reduction of the antibody titrer over the years. Consequently, there is more concern about people who live in endemic areas. For this reason, Brazil recommends revaccinating once at least until additional studies are performed. It is important to know the duration of immunity induced by lower doses of YF vaccine. In our knowledge, there is a lack of clinical studies evaluating the immunity duration of the yellow fever vaccine with lower doses. This information is relevant to subsidize the routine recommendation of YF vaccine fractional dose for adults.

NCT ID: NCT03334019 Not yet recruiting - Q Fever Clinical Trials

Prevalence and Risk Factors for Coxiella Burnetii Seropositivity (Q Fever) Among Adults in Western France

MEDVETFQ
Start date: November 2017
Phase: N/A
Study type: Observational

Diseases naturally transmitted between animals and humans (zoonoses) are one of the leading causes of emergence or re-emergence of human infectious diseases. Non-foodborne zoonoses are commonly transmitted to human directly by contact with infected animals or contaminated environment. People working with animals such as farmers and veterinarians are particularly at risk of infection. Some zoonoses can also be transmitted indirectly thought the air and therefore can affect the general population. Example is Q fever, a disease caused by Coxiella burnetii, a bacterium highly resistant in the environment. In Western France, Q fever is endemic in cattle herds. To improve human zoonotic disease surveillance, the investigators will conduct a population based study in this area. The aims of the study are: 1. To assess seroprevalence of Coxiella burnetii infection among general population, farmers and veterinarians in Western France 2. To identify risk factors for Coxiella burnetii seropositivity in these populations

NCT ID: NCT03332069 Recruiting - Cervical Cancer Clinical Trials

Modulated Electro-Hyperthermia Plus Chemo-radiation for Locally Advanced Cervical Cancer Patients in South Africa

mEHT
Start date: January 9, 2014
Phase: Phase 3
Study type: Interventional

This is a phase III randomised clinical trial. The aim is to investigate the clinical effects of the addition of modulated electro-hyperthermia (mEHT) to standard treatment protocols (chemoradiotherapy, CRT) for Human Immunodeficiency Virus (HIV) positive and negative locally advanced cervical cancer patients (LACC). SAMPLE: The investigators aim to enrol 236 HIV negative and HIV positive women with LACC, FIGO (Fédération Internationale de Gynécologie et d'Obstétrique) Stages IIB (distil) to stage III. Participants will be randomly assigned to a control group (N=118) and a study group (N=118). METHODOLOGY: Randomisation is based on age, stage and HIV. Participants from both groups will receive the standard treatment for cervical cancer at the hospital at the Charlotte Maxeke Johannesburg Academic Hospital in South Africa: Up to three doses of 80mg/m2 cisplatin, administered three weeks apart; 50Gy external beam radiation (EBR) in fractions of 2Gy; Three doses of 8Gy High Dose Rate (HDR) brachytherapy. The study group will have two 55 minute mEHT treatments per week, at 130W, directly before the EBR using the EHY 2000 Device. OUTCOMES: 1) Determine the local disease control after treatment at 6 months using a Positron Emission Tomography (PET) and computerised tomography (CT) scans. 2) Determine the progression-free survival (PFS) at 6, 12, 18 and 24 months after the last treatment date. PFS will be assessed in all registered participants, regardless of completion (Intent to Treat-ITT) as well as only in the subset of participants who complete the prescribed CRT. 3) Overall survival at two years will be assessed. 4) To evaluate the adverse events associated with mEHT. 5) The effect of mEHT on chemotherapy and radiotherapy tolerability and toxicity will be evaluated. 6) The quality of life of enrolled participants will be assessed before, at 6 weeks, and at 3, 6, 9, 12, 18 and 24 months after completion of therapy using the EORTC (European Organisation for Research and Treatment of Cancer) and EuroQoL forms. 7) To evaluate the economic viability of the addition of mEHT to standard treatment protocols for LACC. 8) The effect, if any, of mEHT treatments on the HIV disease status of HIV positive patients will be assessed by the presence of Autoimmune Deficiency Syndrome (AIDS) defining illnesses before and after treatment. 9) The cancer recurrence patterns will be described and compared in all the participants.

NCT ID: NCT03330028 Recruiting - Clinical trials for Diseases of Oesophagus Stomach and Duodenum

Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

Start date: October 27, 2017
Phase: Phase 1
Study type: Interventional

The goal of this clinical research study is to find the highest tolerable dose of paclitaxel that can be given as hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with gastric or gastroesophageal cancer. HIPEC is a system in which heated chemotherapy is delivered directly inside the abdomen during surgery. In this study, paclitaxel is being combined with mitomycin and cisplatin to see if this study drug combination can help to control the disease. This is an investigational study. Mitomycin, cisplatin, and paclitaxel are FDA-approved and commercially available for the treatment of gastric and gastroesophageal cancer. It is investigational to give these drugs by HIPEC. The study doctor can describe how the study drugs and HIPEC are designed to work. Up to 48 participants will be enrolled in this study. All will take part at MD Anderson.