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Hyperthermia clinical trials

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NCT ID: NCT03689478 Completed - Bladder Cancer Clinical Trials

Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT

I-HIVEC
Start date: October 22, 2018
Phase: N/A
Study type: Interventional

This is a prospective single-arm pilot study investigating the safety and feasibility of giving hyperthermic intravesical chemotherapy immediately following transurethral resection of bladder tumour.

NCT ID: NCT03551626 Completed - Malignant Melanoma Clinical Trials

Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

COMBI-APlus
Start date: August 29, 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.

NCT ID: NCT03429387 Completed - Clinical trials for Acute Myeloid Leukemia

PET/CT and Bacterial/Fungal PCR in High Risk Febrile Neutropenia

PIPPIN
Start date: January 8, 2018
Phase: N/A
Study type: Interventional

Patients with acute leukaemia requiring induction or consolidation chemotherapy and those requiring a haematopoietic stem cell transplant are at high risk of fever and infection when they have low white cell counts (neutropenic fever). The causes of neutropenic fever are frequently unknown and patients are treated with broad antibiotics, without a clear target to what is being treated. This study will prospectively enroll patients who are receiving chemotherapy for acute leukaemia or for a stem cell transplant and compare the diagnostic utility of bacterial and fungal PCR performed directly off blood drawn, to the standard blood culture. Patients who have persistent fever after 72 hours of antibiotics will then be randomized to have either the interventional scan (PET/CT) or the conventional scan (standard CT) to look for a source of infection. Diagnostic yield, change in management and outcomes will be compared between arms.

NCT ID: NCT03399318 Completed - Malaria Clinical Trials

Aggressive Antipyretics for Fever Reduction in CNS Malaria

Start date: January 7, 2019
Phase: Phase 2
Study type: Interventional

The study will examine whether prophylactic and scheduled treatment with acetaminophen and ibuprofen can decrease the maximum temperature experienced during the acute illness in children with CNS malaria.

NCT ID: NCT03359811 Completed - 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: NCT03330028 Completed - 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.

NCT ID: NCT03104595 Completed - Febrile Neutropenia Clinical Trials

Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer

Start date: October 30, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

To assess the safety and establish the dose to assess the pharmacokinetic activity following administration of EC-18 in patients with advanced breast cancer receiving low febrile neutropenia risk chemotherapy who are the candidates for second-line or higher combination therapy with doxorubicin and cyclophosphamide.

NCT ID: NCT03087227 Completed - Solid Tumor Clinical Trials

Shared Health Information System for Febrile Neutropenia

NEUTROSIS
Start date: February 22, 2017
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT02993757 Completed - Dengue Fever Clinical Trials

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil®

Start date: December 1, 2016
Phase: Phase 3
Study type: Interventional

The aim of the study was to assess the safety and immunogenicity of the CYD dengue vaccine and Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant) when administered concomitantly or sequentially. Primary objectives: - To demonstrate that the humoral immune response (in terms of geometric mean titers [GMTs]) to Gardasil after concomitant administration was non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil. - To demonstrate that the humoral immune response to the CYD dengue vaccine after concomitant administration was non-inferior to sequential administration with Gardasil measured 28 days after the last dose of the CYD dengue vaccine. Secondary Objectives: - To demonstrate that the humoral immune response (in terms of seroconversion) to Gardasil vaccine after concomitant administration was non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil. - To describe the humoral immune response to Gardasil at baseline and after each dose of Gardasil in each and any group. - To describe the humoral immune response to the CYD dengue vaccine at baseline and after each dose of the CYD dengue vaccine in each and any group. - To describe the safety of Gardasil and the CYD dengue vaccine after each and any dose in each group.

NCT ID: NCT02979535 Completed - Dengue Fever Clinical Trials

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Cervarix®

Start date: November 16, 2016
Phase: Phase 3
Study type: Interventional

The aim of this study was to investigate the immunogenicity and safety of CYD dengue vaccine and Cervarix when administered concomitantly or sequentially in healthy female participants aged 9-14 years of age. Primary objectives: - To demonstrate that the humoral immune response (in terms of geometric mean titers [GMTs]) to Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of GMTs) after sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix. - To demonstrate that the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after concomitant administration with Cervarix is non-inferior to the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after sequential administration with Cervarix measured 28 days after the last dose of the CYD dengue vaccine. Secondary Objectives: - To demonstrate that the humoral immune response (in terms of seroconversion) to Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of seroconversion) to Cervarix sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix. - To describe the humoral immune response to Cervarix at baseline and after each dose of Cervarix in each and any group. - To describe the humoral immune response to the CYD dengue vaccine at baseline and after each dose of the CYD dengue vaccine, in each and any group. - To describe the safety of Cervarix and CYD dengue vaccine after each and any dose in each group.