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NCT ID: NCT03906175 Completed - Clinical trials for Depression, Unipolar

Whole-body Hyperthermia for Mild to Moderate Depressive Disorder

HYPE1
Start date: June 11, 2019
Phase: N/A
Study type: Interventional

The primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in comparison to wait list on depressive symptom severity in patients with mild to moderate depressive disorder currently not under psychotherapeutic or antidepressant drug treatment. Secondary aims included further quality of life outcomes, immunological parameters, and tolerability/safety of the hyperthermia.

NCT ID: NCT03906149 Completed - Clinical trials for Depression, Unipolar

Whole-body Hyperthermia for Moderate to Severe Depressive Disorder

HYPE2
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

The primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in addition to standard medical care in comparison to standard medical care alone on depressive symptom severity in patients with moderate to severe depressive disorder. Secondary aims included further quality of life outcomes, immunological parameters, and tolerability/safety of the hyperthermia.

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: NCT03875560 Withdrawn - Dengue Fever Clinical Trials

IC14 in Adult Patients With Dengue Fever

Start date: May 2019
Phase: Phase 2
Study type: Interventional

Randomized, double-blind, placebo-controlled, safety, PK/PD and preliminary efficacy study of intravenous IC14 in adult patients in a dengue-endemic region presenting with fever > 38°C for < 48 hours with a positive NS1 strip assay or reverse-transcriptase polymerase chain reaction assay for dengue virus.

NCT ID: NCT03842982 Recruiting - Ovarian Cancer Clinical Trials

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI)

CHIPPI
Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

This is a phase III, multicenter, interventional and randomized study which evaluates the use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian cancer. This study aims to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC combined with standard care (PDS or IDS) or standard care alone.

NCT ID: NCT03793205 Recruiting - Gynecologic Cancer Clinical Trials

G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients

Start date: January 3, 2019
Phase: Phase 4
Study type: Interventional

This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF.

NCT ID: NCT03787290 Suspended - Clinical trials for Major Depressive Disorder

Mild-Intensity Whole Body Hyperthermia (WBH) for Major Depressive Disorder

Start date: December 1, 2025
Phase: Phase 2
Study type: Interventional

Overall, the objective of this pilot study is to utilize the IL-6 receptor antagonist tocilizumab to prospectively evaluate the role of IL-6 in the antidepressant and immunological effects of whole body hyperthermia (WBH). The study seeks to replicate findings thus far that WBH has an antidepressant effect by administering the intervention at a site not involved in studies to date. Moreover, the current proposal may help the investigators better understand the role of IL-6 in the pathogenesis and treatment of depression which might point to novel immune-based interventions for Major Depressive Disorder (MDD). Finally, the current proposal holds promise for better understanding of a novel treatment for MDD, which is among the leading causes of health-related disability in the world.

NCT ID: NCT03776786 Completed - Clinical trials for Treatment of Acute Yellow Fever Virus Infection

Safety and Tolerability of an Antibody Against Yellow Fever Virus (TY014) in Humans

Start date: December 6, 2018
Phase: Phase 1
Study type: Interventional

Yellow Fever is an acute viral hemorrhagic disease caused by the Yellow Fever Virus (YFV), a re-emerging arbovirus transmitted by the same mosquito vector (Aedes aegypti) that transmits Dengue virus (DENV) and Zika virus (ZIKV). YFV is endemic in tropical and subtropical areas of South America and Africa, causing an estimated 200,000 infections and 30,000 deaths annually. It has now become a growing public health problem, rapidly spreading throughout the two (2) continents in a cyclical pattern. With climate change, global travel and urbanisation, which increase the chance for mosquito-borne diseases to spread rapidly, the risk of YFV establishing its foothold in the Asia-Pacific region with periodic epidemic bursts remains a real public health concern. Although there is currently a safe and effective vaccine available on the market, global shortages of supplies have severely hampered any efforts in the prevention and control of YFV outbreaks. To date, no YFV therapy (biologic or small molecule) has advanced to clinical trials. TY014 will be the first therapeutic in the world, specifically targeting YFV, to enter clinical trials. It is anticipated that a monoclonal antibody therapeutic could be administered to infected cases to reduce disease severity within the patient and their contacts. This is a Phase 1, first-in-human TY014, YFV monoclonal antibody (mAb), study to be conducted in two (2) arms: - Safety Arm (1A): Healthy adult volunteers - Efficacy Arm (1B): Healthy adult volunteers challenged with YF-17D Vaccine Strain 24 hours prior to TY014 dosing TY014 will be administered once through single IV infusion over 30 minutes. Total duration of study participation is estimated at approximately 114 days from the date of screening. The main objectives of this study are to: (a) evaluate the safety of TY014 in healthy adult volunteers, and (b) evaluate the safety of TY014 in YF-17D Vaccine Strain-challenged healthy adult volunteers. Percentage aviremia of YF-17D Vaccine Strain-challenged subjects within 48 hours after IV infusion of TY014 will also be assessed.

NCT ID: NCT03768869 Withdrawn - Fever Clinical Trials

Fever and Neutropenia in Pediatric Oncology Patients

Start date: February 2006
Phase: Phase 3
Study type: Interventional

It is possible to distinguish between pediatric oncology patients who are at high or low risk for serious infection during periods of fever and treatment related neutropenia based on clinical parameters. Patients with low risk can be safely treated as outpatients primarily using oral antibiotics. It is possible to improve methods of risk stratification through the addition of genomic and proteomic factors.