Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After...
Malignant MelanomaThis is an open-label Phase IIIb study of dabrafenib in combination with trametinib in the adjuvant treatment of melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm, as well as safety, efficacy and health-related outcomes. Approximately 600 subjects will be enrolled to receive dabrafenib (150 mg BID) and trametinib (2 mg once daily) combination therapy for 12 months. At enrollment, subjects will be instructed on the pyrexia management algorithm. This study consists of two Periods for Enrolled subjects: Treatment Period - subjects will receive up to 12 months of treatment. Follow-up Period - subjects will be followed through 24 months from their first dose date for relapse, and through end of study for overall survival. Follow-up will start once treatment is complete or is prematurely discontinued and continue through the end of the study, regardless of disease recurrence.
Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for the Treatment...
Lassa FeverThis exploratory, prospective, controlled, multisite, open label, randomized clinical trial with two treatment arms aims to compare favipiravir, a new treatment candidate for Lassa fever (LF), with the current standard of care, ribavirin. The primary endpoints of this research are (1) the description of classical pharmacokinetic parameters of favipiravir in comparison with ribavirin standard treatment in patients suffering from LF and (2) the safety and tolerability of both study drugs in the investigated regimens.
Whole Body Hyperthermia and Major Depression (MDD)
Depressive DisorderMajorMajor depressive disorder (MDD) is predicted to be the second leading cause of disability worldwide by the year 2020. The economic burden of depression in the United States is significant: $83.1 billion in 2000 and increasing. Much of this burden comes from the high rate of sub-optimal treatment outcomes associated with the disorder. Indeed, only 50% of MDD patients recover in less than 12 weeks with adequate treatment, and up to 20% of patients will fail to adequately respond to all currently available interventions. Moreover, current treatments come at the cost of significant central nervous system (CNS) side effects, further highlighting the need for more effective treatments with fewer side effects. This study will compare temperature ranges from the investigators preliminary studies involving thermoafferent pathways resulting in antidepressant actions with lower temperature ranges not expected to activate these pathways as a control condition, with the goal to evaluate whether previous observations were related to the temperature range in question or can be achieved with other levels.
Celgosivir as a Treatment Against Dengue
Dengue FeverThis is a Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study to Evaluate the Activity, Pharmacokinetics, Safety and Tolerability of Celgosivir in Adults with Confirmed Dengue Fever.
Bupivacaine Digital Blocks: How Long is the Pain Relief and Temperature Elevation?
PainNo one knows how long bupivacaine finger blocks last. Many use bupivacaine with and without epinephrine, but no one knows how the epinephrine affects the duration of the block. We also don't know how long the pain part of the block lasts, which is what counts. The goal of the study is to determine the duration of action of bupivacaine digital nerve blocks (with and without epinephrine) on finger temperature and the sensory modalities of pain, touch, and pressure. 2 ml of bupivacaine 0.5% with and without epinephrine will be injected at the base of each ring finger on the palm surface. At the end of 1 hr, 6 hrs, 12 hrs, 14 hrs and each additional hour, patients will use an insulin lancet to measure pain, the Semmes Weinstein monofilament test to measure light touch and pressure and a body surface thermometer to measure finger temperature. The time for the finger to return to normal sensation and temperature will be measured.
Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic...
Febrile NeutropeniaHematological DiseasesThis study of chemotherapy occurred during the neutropenic fever in patients with antibiotic refractory fever. The investigators evaluate efficacy and safety of micafungin sodium (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a control and this study is prospective, randomized, non-inferiority trials. Therefore, this study was planned for review of the safety and efficacy in korean patients.
Procalcitonin in Fever of Unknown Etiology
FeverThe purpose of this study is to determine whether new blood test (procalcitonin) can help to reduce unnecessary use of antibiotics in patients with unexplained fever. Although fever is most commonly caused by bacterial infection there are multiple other conditions that can cause fever. It can be caused by viral infection. It can also be caused by other non infectious disease. Patients with malignancy, inflammation (such as gout or arthritis), or clots in veins can present with fever. Occasionally medications themselves can cause fever. If fever is not caused by infection antibiotics will not help. Instead they may cause side effects such as diarrhea and allergic reactions. We want to determine whether simple blood test (procalcitonin) can help us to make a difference between fever caused by infection and fever caused by others (above mentioned) non-infectious problems. We also want to determine whether such test would help us to reduce unnecessary antibiotic use and help us to find faster the real cause of the fever. A total of 90 patients with the unexplained fever will be participating in this study. This study will involve single, additional blood test, performed only if patient continue to have fever despite a few days of investigations and therapy with antibiotics. Patients will be assigned by drawing to one of two groups. In the first group blood test (procalcitonin) will help a doctor to decide whether to stop or continue antibiotics. If procalcitonin level is high antibiotics will be continued and the doctor will most probably order additional tests to determine the source of infection. If procalcitonin level is low serious bacterial infection is unlikely. The antibiotics will be stopped and a doctor will try to look for other cause of fever. In the second group blood for the tests will be collected but not reported to a doctor. You will be treated in traditional manner by a doctor. By following this procedure we will be able to determine whether therapy guided by procalcitonin level is as safe and possibly more effective than traditional approach. This study does not involve any other tests or study medications. We will attempt to contact all patients one month later by phone to determine whether you remain well after discharge.
Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic...
InfectionFebrile NeutropeniaThe aim of the study is to evaluate the efficacy and safety of Teicoplanin versus Vancomycin as part of the initial antibiotic regimen in the therapy of patients with fever and neutropenia .
Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric...
PainFeverWe are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults. Understanding how long the drug stays in the body and how the drug is changed or metabolized by the body (called pharmacokinetics) is an important step in learning what the best dose of acetaminophen for children should be. We are also interested in learning about the safety of this medication when given to children.
Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean...
Familial Mediterranean FeverEstablish the safety and efficacy of 3 months treatment with canakinumab in patients with colchicine resistant Familial Mediterranean Fever.