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NCT ID: NCT04299412 Completed - Diagnoses Disease Clinical Trials

Diagnostic Accuracy of the DPP II Assay

Start date: October 28, 2019
Phase:
Study type: Observational

Burkholderia pseudomallei is responsible for melioidosis, a disease that can present a range of signs and symptoms and can be treated by a specific drug regimen. Diagnosis of melioidosis is made by isolation of the bacteria from body fluids or tissues such as blood, skin or sputum. Although this is considered the gold standard, bacterial isolation has low diagnostic sensitivity, requires specific infrastructures (biosafety level 3 laboratories) and skilled staff that are not always available in LMICs. This may lead to inappropriate patient management and care. Chembio, in partnership with FIND, has developed a multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect antigens from common causes of febrile illnesses, included Burkholderia. FIND will conduct a laboratory study in Menzies Health School of Research to estimate the diagnostic accuracy of the DPP II Assay using retrospective samples that are positive for B. pseudomallei. Results will help in estimating the diagnostic accuracy of the assay for this pathogen.

NCT ID: NCT04296890 Completed - Clinical trials for Fallopian Tube Cancer

A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

SORAYA
Start date: July 23, 2020
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in patients with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. All patients will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight administered on Day 1 of every 3-week cycle.

NCT ID: NCT04296799 Completed - Healthy Volunteers Clinical Trials

A Phase 1 Study of SMP-100 in Normal Healthy Volunteers

Start date: June 25, 2020
Phase: Phase 1
Study type: Interventional

This will be the first clinical study of oral administration SMP-100 in healthy subjects. The proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single and multiple ascending dose study in approximately 72 healthy male and female subjects.

NCT ID: NCT04295070 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Safety and Immunogenicity of a Live-attenuated Vaccine Against Respiratory Syncytial Virus in Elderly Volunteers

Start date: July 10, 2020
Phase: Phase 1
Study type: Interventional

This Phase I trial will enroll 36 healthy adult volunteers. The study will enroll a sentinel group of 6 younger adults aged 18 to 49 years followed by approximately 30 healthy older adults aged 50 to 75 years. All participants will receive two doses, 28 days apart. The vaccine will be administered as nose drops to both the low and high dose cohorts.

NCT ID: NCT04293094 Completed - Clinical trials for Advanced Solid Tumors

Study of AMG 650 in Adult Participants With Advanced Solid Tumors

Start date: March 11, 2020
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

NCT ID: NCT04292912 Completed - Macular Edema Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema

Start date: September 7, 2020
Phase: Phase 1
Study type: Interventional

The study will be composed of 3 periods for all participants: Screening, 28-day Treatment period, and Follow-up visit (approximately 28 days after the final dose).

NCT ID: NCT04292197 Completed - Addiction Clinical Trials

A Study to Assess 18-Methoxycoronaridine (18-MC HCl) in Healthy Volunteers

Start date: April 14, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the safety and tolerability of a single day dosing and a separate multiple day dosing of 18-MC HCl administered orally, each part of the study having a different set of healthy male and female volunteers.

NCT ID: NCT04290533 Completed - Impulsive Behavior Clinical Trials

HD-tDCS Over the dACC in High Trait Impulsivity

Start date: March 4, 2019
Phase: N/A
Study type: Interventional

Psychological disorders characterized by impulsivity often show alterations in dorsal anterior cingulate cortex (dACC) activity. Recent research has therefore focused on non-invasive neurostimulation therapies for the modulation of functional activity in the dACC. To date there has only been one proof-of-concept study providing evidence for modulating dACC activity with non-invasive electrical neurostimulation (e.g. transcranial electrical stimulation). Since transcranial Direct Current Stimulation (tDCS) is relatively safe, tolerable, and mobile as compared to other neurostimulation techniques, it is worthwhile looking further into the effects of tDCS on functional dACC activity. The aim of the present research is to explore whether HD-tDCS can induce changes in the dACC in individuals with high trait impulsivity (N=20) in a double-blind cross-over study. Functional changes in dACC activity will be measured by the error related negativity (ERN), which is an event related potential generated by the dACC. The ERN is less pronounced in people that score high on impulsivity. It is therefore expect enhanced ERN amplitudes after HD-tDCS over the dACC. In addition, performance on the multisource interference task will be used as measure of dACC activity. It is hypothesize that increased dACC activity will be related to decreased impulsivity in high impulsive individuals as shown by improved inhibitory control on the Go/NoGo task. The results of the study may have implications for patient populations that are characterized by impulsivity.

NCT ID: NCT04287985 Completed - Clinical trials for Immunoglobulin A Nephropathy

Safety and Efficacy Study of VIS649 for IgA Nephropathy

Start date: July 20, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)

NCT ID: NCT04285723 Completed - Clinical trials for PIK3CA-Related Overgrowth Spectrum (PROS)

Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib

EPIK-P1
Start date: June 9, 2020
Phase:
Study type: Observational

The study was a site-based retrospective non-interventional medical chart review of pediatric and adult male and female patients with PIK3CA-Related Overgrowth Spectrum (PROS) who initiated alpelisib at least 24 weeks before the cut-off date at a MAP site. The study cut-off date was 09-Mar-2020. Patient-level data were abstracted from medical charts of all eligible patients at all participating sites. Study completion date refers to the last date data was extracted. Information from patients treated with alpelisib was used to describe the efficacy and safety of alpelisib in PROS patients.