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NCT ID: NCT03804996 Not yet recruiting - B-Cell Lymphoma Clinical Trials

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

Start date: February 2019
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT03804554 Active, not recruiting - 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 Recruiting - 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 (CBD) 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. Only participants from the ZYN2-CL-016 study 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 Not yet recruiting - Clinical trials for Fibrotic Interstitial Lung Disease

High Intensity Interval Training in Fibrotic Interstitial Lung Disease

HIIT in fILD
Start date: April 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 Recruiting - 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 Phase Ib, open-label, multicenter study evaluating the safety and efficacy of ipatasertib in combination with atezolizumab and paclitaxel or nab-paclitaxel for patients with locally advanced or metastatic triple-negative breast cancer (mTNBC) who have not previously received chemotherapy in the advanced setting. Two triplets; ipatasertib in combination with atezolizumab and paclitaxel (Paclitaxel arm) and ipatasertib in combination with atezolizumab and nab-paclitaxel (Nab-Paclitaxel arm) are being evaluated for first-line chemotherapy treatment for advanced TNBC. Cohort 1 will evaluate first-line chemotherapy treatment in advanced TNBC patients and Cohort 2 will contain biopsy assessments of TNBC patients who have progressed after at least one line of chemotherapy in the advanced setting.

NCT ID: NCT03798574 Recruiting - Clinical trials for Meningococcal Infections

The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults

AMEND
Start date: March 1, 2016
Phase:
Study type: Observational

Aim of Study: To assess the clinical, physical, neurocognitive, economic and societal impact on families from invasive meningococcal disease (IMD) in Australian adolescents and young adults. Hypothesis: 1. IMD in adolescence and early adulthood has a significant impact on survivors and their families compared to controls for outcomes such as poorer physical and mental health, quality of life and educational achievement. 2. IMD imposes a significant financial burden upon individuals, families and society. 3. Serogroup B disease is associated with an increased risk of sequelae. Study design: This is a cohort study with survivors of IMD and non-IMD healthy controls invited to be enrolled in the study. Retrospective IMD cases admitted in the previous 10 years will be identified through each of the participating hospitals (paediatric and adult hospitals). During the course of the study prospective recruitment of IMD cases will also occur at participating hospitals. To be eligible for the study IMD is required to be confirmed by either PCR or culture from blood or cerebrospinal fluid (CSF). Meningococcal foundations/groups will also be approached and asked to advertise and conduct a mail out to their members to inform them about the study. Controls will be selected by "snowballing technique" whereby healthy friends or acquaintances of the enrolled IMD case will be approached by the enrolled participant and information about the study provided to them. Control participants may also be identified from databases at each participating site, through advertising, or meningococcal foundations/group mail out. An assessment of enrolled cases including neurocognitive, psychological, physical examination, and qualitative interview will be conducted at 2 - 10 years post IMD admission. Control cases 17 - 34 years of age will also undergo neurocognitive, psychological, and physical examination.

NCT ID: NCT03797664 Not yet recruiting - Healthy Clinical Trials

A Study of the Safety and Tolerability of CDX-6114 in Healthy Volunteers

Start date: January 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of an oral solution of CDX-6114 when administered as a single dose in healthy volunteers

NCT ID: NCT03793257 Not yet recruiting - Cardiac Arrest Clinical Trials

The EXCEL Study: A Comprehensive Bi- National Registry on the Treatment and Outcomes of Patients Requiring ECMO

Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

ICU patients with severe heart or lung failure may require an external device called extra-corporeal membrane oxygenation (ECMO) to oxygenate their blood. The use of ECMO is rapidly increasing. It has the capability to completely replace a non-functioning heart or lungs for days to weeks, but ECMO patients only have a 42% hospital survival rate. ECMO use is associated with significant costs and risks, and it needs experienced staff. To better manage this complex intervention, the investigators need to have quality data on patients who require ECMO. The aim of EXCEL is to create a bi-national network of integrated care that will identify best practice and cost effectiveness for patients suffering from acute cardiac failure, lung failure, or cardiac arrest and require ECMO. The investigators will collect information on 525 ECMO patients while in the ICU and the investigators aim to utilise telephone follow-up of survivors to assess disability free survival, quality of life and other long term outcomes at 6 and 12 months. Information collected will be stored in the EXCEL database and will be periodically reviewed to address safety concerns, clinical questions and process of care issues. Data will be collected over a 3 year period.

NCT ID: NCT03793244 Completed - Critical Illness Clinical Trials

TARGET-Metabolic Effects

TARGET-ME
Start date: July 1, 2017
Phase:
Study type: Observational

The estimation of calorie needs during routine practice in critically ill patients is highly variable and the thermogenic effect of continuous delivery of enteral nutrition (EN) on overall calorie utilisation in critically ill adults is unknown. The TARGET-ME study is a substudy of the TARGET trial (NCT02306746). The TARGET trial provides the perfect opportunity to measure calorie utilisation via indirect calorimetry (IC) and ventilator-derived carbon dioxide production (VCO2) to compare measured calorie utilisation to estimation methods, determine the potential thermic effect of EN solutions with different energy concentrations and investigate any associations with outcome.