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NCT ID: NCT03808922 Recruiting - COVID-19 Clinical Trials

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

Start date: May 23, 2019
Phase: Phase 3
Study type: Interventional

This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.

NCT ID: NCT03806764 Enrolling by invitation - Clinical trials for Cytomegalovirus Infections

Cytomegalovirus (CMV) Reactivation in Allogeneic HSCT Recipient

CReSCT
Start date: April 17, 2018
Phase: N/A
Study type: Interventional

This study consists of two parts: 1) Part 1, a retrospective part on 250 consecutive patients following allogeneic haematopoietic stem cell transplant (allo-HSCT) at the Royal Melbourne Hospital from 2012 to 2017, inclusive, and 2) Part 2, a prospective part on 120 allo-HSCT patients from 4 sites in Australia: the Royal Melbourne Hospital, Peter MacCallum Cancer Centre, Austin Hospital, and Westmead Hospital. In Part 1, medical records of allo-HSCT recipients will be evaluated to determine the incidence and clinical outcomes of CMV viremia post HSCT, including both the direct (CMV disease) and indirect (such as invasive fungal infection, other viral infections, bacterial infection) effects on clinical outcomes. In Part 2, allo-HSCT participants at risk of CMV disease will be assessed to determine the association of host CMV-specific immunity with clinical management and outcomes over one year post allo-HSCT. The overall aims of the study are to establish if CMV infection in allo-HSCT patients are associated with poor clinical outcomes; and whether measurement of immunological functions could provide an early indicator to identify patients at risk and appropriate timing for initiation of CMV treatment.

NCT ID: NCT03805789 Recruiting - Clinical trials for Acute-graft-versus-host Disease

The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-Versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant

MODULAATE
Start date: March 27, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a Phase 2/3 prospective, double-blind, randomized, multi-center, placebo-controlled study for prevention of acute GVHD (aGVHD) in subjects undergoing an allogeneic hematopoietic cell transplant (HCT).

NCT ID: NCT03804996 Completed - B-Cell Lymphoma Clinical Trials

Study of TG-1801 in Subjects With B-Cell Lymphoma

Start date: March 5, 2019
Phase: Phase 1
Study type: Interventional

Phase 1 first in human Study to Assess the Bispecific Antibody TG-1801 in Subjects with B-Cell Lymphoma

NCT ID: NCT03804554 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Study of Participants in Australia Who Have Non-small Cell Lung Cancer Being Treated With Nivolumab

Start date: October 3, 2018
Phase:
Study type: Observational

This study is to capture and describe the patient and disease characteristics and the outcomes of adult patients with previously-treated advanced NSCLC who have been treated with Nivolumab

NCT ID: NCT03803969 Recruiting - Syncope Clinical Trials

ConfirmRxTM: Posture and Activity

Start date: October 30, 2018
Phase: N/A
Study type: Interventional

Insertable Cardiac Monitor's (ICM's) such as Confirm Rx™ are leadless devices implanted for long-term heart rhythm monitoring in the diagnosis and management of clinical conditions such as recurrent unexplained syncope, cryptogenic stroke, ventricular arrhythmias and monitoring atrial fibrillations (AF) post ablation. There is limited data on variations seen in signal sensing with changes in physical activity and posture. This single arm, non-randomized, open-label, multi-center, clinical investigation of 100 subjects is designed to characterise the safety and performance of Confirm RxTM by assessing quality of signal attained from the device with changes in posture and physical activity at implant and 30days post procedure. The study is also intended to assess gross migrations of the device at 30days post implant.

NCT ID: NCT03802799 Enrolling by invitation - Fragile X Syndrome Clinical Trials

Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS

Start date: November 9, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

ZYN002 is a pharmaceutically manufactured Cannabidiol that is developed as a clear gel that can be applied to the skin (called transdermal delivery). The gel will be applied to clean, dry, intact skin of the shoulders and/or upper arms. Participants from the ZYN2-CL-016 and ZYN2-CL-033 studies who meet the inclusion criteria and none of the exclusion criteria for study ZYN2-CL-017 are eligible. Parents/caregivers will apply the study gel twice daily for the 52-week treatment period.

NCT ID: NCT03800914 Recruiting - Clinical trials for Fibrotic Interstitial Lung Disease

High Intensity Interval Training in Fibrotic Interstitial Lung Disease

HIIT in fILD
Start date: July 17, 2019
Phase: N/A
Study type: Interventional

The fibrotic interstitial lung diseases (fILD) is a group of debilitating chronic lung conditions that are characterised by scarring of lung tissue, dyspnoea on exertion and significant physical impairment. Exercise training is recommended for people with fILD in improving breathlessness and exercise tolerance. However, despite the best efforts of patients and clinicians, many of those who participate are not attaining its benefits. The current exercise training strategies of moderate intensity continuous training may not be well suited to fILD. High intensity interval training (HIIT), short bouts of high-intensity exercise regularly interspersed with periods of rest or light exercise may be an alternate exercise training option for people with fILD. The study will determine to whether HIIT is better than the current method of continuous exercise training at moderate intensity in improving exercise tolerance, breathlessness and quality of life in people with fILD. A randomised controlled, assessor blinded trial will be conducted. A total 130 people with fILD will be randomly assigned to moderate intensity continuous training or HIIT. If this trial demonstrates that HIIT is effective, it will provide an exercise training strategy that can readily be implemented in practice that will maximise the outcomes of exercise training for people with fILD.

NCT ID: NCT03800836 Completed - Breast Cancer Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Start date: February 13, 2018
Phase: Phase 1
Study type: Interventional

This is a study consisting of four cohorts in this setting. In Cohort 1, the safety and efficacy of ipatasertib (ipat) in combination with atezolizumab (atezo) and paclitaxel (pac) or nab-paclitaxel will be evaluated for participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not previously received chemotherapy. In Cohort 2, ipatasertib and atezolizumab (with no chemotherapy), will be administered to participants with locally advanced or metastatic TNBC. In Cohort 3, the safety and efficacy of neoadjuvant ipatasertib, atezolizumab, doxorubicin and cyclophosphamide (AC) (Ipat + Atezo + AC) followed by Ipat + Atezo + Pac will be evaluated in participants with locally advanced Type 2-4 (T2-4) TNBC. In Cohort 4, the safety and efficacy of Ipat + Atezo + Pac will be evaluated in participants with PD-L1 (Programmed Death-Ligand-1) positive locally advanced or metastatic TNBC that is not amenable to resection and who have not previously received chemotherapy in the advanced setting.

NCT ID: NCT03798912 Completed - Healthy Volunteers Clinical Trials

A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform

RaniPill
Start date: July 9, 2019
Phase: Phase 1
Study type: Interventional

The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers