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NCT ID: NCT03268954 Active, not recruiting - Clinical trials for Myelodysplastic Syndrome

Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)

PANTHER
Start date: November 28, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).

NCT ID: NCT03266783 Recruiting - Clinical trials for Venous Thromboembolism

Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism

COBRRA
Start date: December 13, 2017
Phase: Phase 4
Study type: Interventional

Apixaban and rivaroxaban have been compared to standard therapy for treatment of acute symptomatic venous thromboembolism (VTE) in randomized controlled trials (RCTs), and are both approved by Health Canada. No safety or efficacy data is available from direct head-to-head comparison of these two anticoagulants. Lawsuits in the United States over bleeding events, patient perceptions, and concerns with medication adherence are additional factors highlighting the importance of a comparison trial. This multi-center, pragmatic, prospective, randomized, open-label, blinded end-point (PROBE) trial aims to compare the safety of apixaban and rivaroxaban for the treatment of VTE.

NCT ID: NCT03266679 Completed - Clinical trials for Metacognitive Capacities

Psychological Factors In The Treatment Of Bipolar Mood Disorders

Start date: July 26, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to trial an intervention targeting potential deficits in an individual's ability to form, and reflect upon, ideas about themselves and others (known as metacognitive capacities), specifically in relation to individuals diagnosed with a bipolar mood disorder (BMD). The proposed research will adopt a mixed qualitative and quantitative design. Participants will be recruited through hospital outpatient groups (i.e., Metro South Addiction & Mental Health Services Woolloongabba Community Health Centre & Beenleigh Community Health Centre in Brisbane, Queensland), and, as necessary, local non government organisations (NGOs), psychiatrists, general practitioners, online support networks (SANE Australia, Black Dog Institute), community mental health services(such as MINDNET), and/or social media groups (Facebook, Twitter) supporting people who meet criteria for a BMD. The research will then use clinical interviews and quantitative (survey) methods to: (1) confirm diagnosis of participants; and (2) confirm deficits in metacognitive capacities of participants. Following this, the research will then involve the implementation of an adapted intervention across a course of 12 months, aimed at improving the metacognitive capacities of participants with a diagnosis of a BMD. The research will provide an enriched understanding of a dimension of people with BMDs that has not been previously explored. The research will help with gaining an understanding of the metacognitive processes of people with BMDs, and inform more targeted psychological interventions.

NCT ID: NCT03265288 Completed - Cystic Fibrosis Clinical Trials

Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults

APPLAUD
Start date: October 10, 2018
Phase: Phase 2
Study type: Interventional

An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF.

NCT ID: NCT03264651 Completed - Clinical trials for Mammographic Density

Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density

Start date: February 1, 2017
Phase: Phase 1
Study type: Interventional

To evaluate the impact of a selective androgen receptor modulator combined with an aromatase inhibitor in reducing high mammographic breast density.

NCT ID: NCT03263936 Completed - Clinical trials for Acute Myelogenous Leukemia

Epigenetic Reprogramming in Relapse/Refractory AML

Start date: July 11, 2017
Phase: Phase 1
Study type: Interventional

This is a pilot study using decitabine and vorinostat before and during chemotherapy with fludarabine, cytarabine and G-CSF (FLAG).

NCT ID: NCT03263091 Terminated - Clinical trials for Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts)

Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden

Start date: September 7, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.

NCT ID: NCT03261739 Completed - NAFLD Clinical Trials

Safety Tolerability, and PK of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)

Start date: August 28, 2017
Phase: Phase 1
Study type: Interventional

BRB-018-001 is a multicenter, adaptive design, randomized, parallel group study to evaluate the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD.

NCT ID: NCT03261401 Completed - Healthy Clinical Trials

First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants

Start date: September 15, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants following infection with Plasmodium falciparum.

NCT ID: NCT03261011 Recruiting - Advanced Cancer Clinical Trials

Study of the Safety, Pharmacokinetics, and Antitumor Activity of AK104 in Subjects With Advanced Solid Tumors

Start date: October 3, 2017
Phase: Phase 1
Study type: Interventional

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK104 as a single agent in adult subjects with advanced solid tumor malignancies. The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK104 as a single agent, and a dose expansion phase (Phase 1b) which will characterize treatment of AK104 as a single agent at the MTD or RP2D.