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NCT ID: NCT04710901 Active, not recruiting - HIV Infections Clinical Trials

uTECH: Machine Learning for HIV Prevention Among Substance Using GBMSM

uTECH
Start date: November 24, 2020
Phase: N/A
Study type: Interventional

This project seeks to develop and test the acceptability, appropriateness and feasibility of uTECH, a novel social media "big data" machine learning intervention for HIV-negative substance-using sexual and gender minority people who have sex with men that aims to reduce HIV transmission risk by integrating biomedical and behavioral risk reduction strategies, including pre-exposure prophylaxis (PrEP) for HIV prevention and medication assisted treatment (MAT) for substance use harm reduction

NCT ID: NCT04710641 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Radomised Phase II Study of MTL-CEBPA Plus Sorafenib or Sorafenib Alone

OUTREACH2
Start date: January 1, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase II study in patients with advanced liver cancer (hepatocellular carcinoma) as a result of hepatitis B and/or C infection. Participants will be dosed with either MTL-CEBPA (an experimental treatment) and sorafenib or sorafenib alone. The MTL-CEBPA is administered once every 3 weeks via intravenous infusion. Sorafenib is taken orally from Day 8 for the combination group or Day 1 for the sorafenib alone group at a dose of 400 mg twice a day. Participants will receive 3 week cycles of treatment until disease progression, unacceptable toxicity, withdrawal of consent or death occurs. The combination of MTL-CEBA and sorafenib combination of treatment was tested in a previous Phase I study (OUTREACH) which showed anti-tumour activity along with a good safety and toxicity profile.

NCT ID: NCT04710576 Active, not recruiting - Clinical trials for Chronic Graft-versus-host-disease

A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

AGAVE-201
Start date: March 4, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy.

NCT ID: NCT04710550 Active, not recruiting - Alzheimer Disease Clinical Trials

Exploring the Utility of [18F]3F4AP for Demyelination Imaging in Controls, Neurodegeneration and Traumatic Brian Injury

Start date: January 25, 2021
Phase: Phase 1
Study type: Interventional

The overall objective is to obtain an initial assessment of the value of using [18F]3F4AP for imaging demyelinating diseases such as traumatic brain injury (TBI), neurodegenerative diseases such as mild cognitive impairment (MCI) and Alzheimer's Disease (AD): - Aim 1) Assess the safety of [18F]3F4AP in healthy volunteers and subjects with traumatic brain injury (TBI) and neurocognitive impaired subjects (AD/MCI). Hypothesis 1: Administration of [18F]3F4AP will result in no changes in vitals or other adverse events. - Aim 2) Assess the radiation doses to the main organs in healthy volunteers. Hypothesis 2: the radiation doses to each organ will be comparable in all subjects and within the acceptable limits. - Aim 3) Assess the pharmacokinetics of a bolus infusion of [18F]3F4AP in humans including healthy volunteers and patients. Hypothesis 3: the pharmacokinetics of [18F]3F4AP at the whole brain level will be similar in controls, TBI and AD/MCI subjects. The kinetics in demyelinated lesions will be slower than in healthy areas. - Aim 4) Correlate MR images with [18F]3F4AP PET images. Hypothesis 4A: all the lesions seen on the MRI will show increased signal (VT or SUV) on the PET images. Hypothesis 4B: some of the lesions on the MRI will show increased signal (VT or SUV) on the PET but not all. - Aim 5) Correlate [18F]3F4AP PET signal with neuropsychological testing in people with TBI and AD/MCI. Hypothesis 5A: increased PET signal (VT or SUV) will correlate with impaired Mini Mental State Examination (MMSE).

NCT ID: NCT04710498 Active, not recruiting - Clinical trials for Cutaneous Squamous Cell Carcinoma

Neoadjuvant Atezolizumab in Surgically Resectable Advanced Cutaneous Squamous Cell Carcinoma

Start date: June 22, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this research is to evaluate whether the administration of atezolizumab before surgical resection of your tumor is feasible and to evaluate the treatment response, safety, and tolerability of atezolizumab.

NCT ID: NCT04710030 Active, not recruiting - Clinical trials for Mild Cognitive Impairment

Valacyclovir for Mild Cognitive Impairment

VALMCI
Start date: February 1, 2021
Phase: Phase 2
Study type: Interventional

Anti-viral treatment in Mild Cognitive Impairment (MCI) is a Phase II, placebo-controlled, 52-week trial using oral valacyclovir 4 g/day in 50 HSV seropositive, AD biomarker-positive, amnestic mild cognitive impairment (MCI) patients (eMCI and lMCI). The trial will directly address the long-standing viral etiology hypothesis of Alzheimer's disease (AD) which posits that viruses, particularly the very common herpes simplex virus-1 (HSV1) and herpes simplex virus-2 (HSV2), may be etiologic or contribute to the pathology of AD. This trial will intervene at an earlier stage (MCI). We will compare the repurposed drug valacyclovir to placebo in patients with amnestic MCI (eMCI and lMCI) in a randomized, double-blind, two-arm parallel group 52-week pilot trial. Our Phase II trial will be the first antiviral drug trial conducted in MCI.

NCT ID: NCT04709562 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Clinical Stabilization of Hypercapnia: NIPPV v HVNI

HYPERACT
Start date: November 11, 2020
Phase: N/A
Study type: Interventional

This study will evaluate the ability of High Velocity Nasal Insufflation [HVNI] to effect ventilation and related physiologic responses in hypercapnic patients when compared to noninvasive positive pressure ventilation [NIPPV].

NCT ID: NCT04708886 Active, not recruiting - Osteoporosis Clinical Trials

Romosozumab in Women With Chronic SCI

Start date: March 1, 2021
Phase: Phase 2
Study type: Interventional

This two-year open-label pilot clinical trial will evaluate the efficacy and safety of romosozumab to treat bone loss in females with chronic spinal cord injury (SCI) and osteoporosis (OP). Participants will receive monthly injections of romosozumab during the first 12 months of the study. During the second year, participants will take oral alendronate tablets on a weekly basis.

NCT ID: NCT04708860 Active, not recruiting - Breast Cancer Clinical Trials

Feasibility of Fasting & Exercise in Pts With HR+ MBC

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

This research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.

NCT ID: NCT04708340 Active, not recruiting - COVID-19 Clinical Trials

Tolerability and Efficacy of RJX in Patients With COVID-19

RJX
Start date: March 25, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed as a 2-part, 2-cohort, double-blind, randomized, placebo controlled, multicenter Phase 1/2 study to evaluate the safety, tolerability and efficacy of RJX in patients with COVID-19.