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NCT ID: NCT04071847 Recruiting - Parkinson Disease Clinical Trials

Abbott DBS Post-Market Study of Outcomes for Indications Over Time

ADROIT
Start date: November 26, 2019
Phase:
Study type: Observational

The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

NCT ID: NCT04071613 Completed - Clinical trials for Stroke, Acute, Stroke Ischemic

Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance

TASTEa
Start date: June 20, 2019
Phase: Phase 2
Study type: Interventional

Ischemic stroke is a major health burden globally and in Australia. Treatment for ischemic stroke is time critical and is significantly more effective if administered within the first 90 minutes of symptom onset. This clinical trial will identify if early administration of oral thrombolytic agent, tenecteplase prior to hospital can improve outcomes from stroke, and reduce costs compared to standard care of IV alteplase in hospital

NCT ID: NCT04071314 Recruiting - Healthy Clinical Trials

Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.

EARTH
Start date: April 18, 2018
Phase:
Study type: Observational

The investigators have established the "Evaluating the Alimentary and Respiratory Tracts in Health and disease" (EARTH) research program. It provides a structured approach to analysing gastrointestinal and respiratory microbiomes, along with diet and symptomatology, in children with a gastrointestinal and/or respiratory condition with recognised long-term morbidity (e.g. cystic fibrosis, obstructive sleep apnoea, or Hirschsprung's disease). The EARTH program consists of a series of prospective, longitudinal, controlled, observational studies, with each individual study comparing children with a chronic gastrointestinal and/or respiratory condition to healthy controls (HC). It will be conducted in an Australian tertiary paediatric hospital (although the methodology is applicable to other settings). Children with a chronic gastrointestinal and/or respiratory condition will be compared to age and gender matched HC across a 12-month period. The following will be collected at baseline, 6 and 12 months: (i) a stool sample, (ii) an oropharyngeal swab or sputum sample, (iii) a semi-quantitative food frequency questionnaire, (iv) details of disease symptomatology, (v) health-related quality of life, and (vi) psychosocial factors. Data on the intestinal and respiratory microbiomes and diet will be compared between children with a condition and HC. Correlations between dietary intake (energy, macro- and micro-nutrients), intestinal and respiratory microbiomes within each group will be explored. Data on disease symptomatology, quality of life and psychosocial factors will also be compared between children with a condition and HC. The investigators hypothesise that: (i) Children with chronic gastrointestinal and/or respiratory conditions will have altered intestinal and respiratory microbiomes compared to healthy children, and (ii) Diet plays a key role in influencing the intestinal and respiratory microbiomes and this may impact on clinical outcomes, biomarkers of disease, and health-related quality of life.

NCT ID: NCT04070586 Completed - Cancer, Lung Clinical Trials

Adaptive CT Acquisition for Personalised Thoracic Imaging

ADAPT
Start date: August 21, 2019
Phase:
Study type: Observational

In this trial, Respiratory Motion Guided (RMG) 4DCBCT will be implemented for the first time on lung cancer patients. RMG-4DCBCT adapts the image acquisition as the patient's breathing changes (i.e. if the patient breathes faster, imaging data is acquired faster). By adapting the acquisition to the dynamic patient, personalised images of a patients lungs are able to be acquired for radiotherapy treatments.

NCT ID: NCT04069156 Completed - Heart Failure Clinical Trials

The ARIES HeartMate 3 Pump IDE Study

Start date: July 14, 2020
Phase: N/A
Study type: Interventional

Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo

NCT ID: NCT04068610 Terminated - Clinical trials for Metastatic Microsatellite-stable Colorectal Cancer

COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC

Start date: September 13, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

COLUMBIA-1 is a Phase 1b/2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX plus bevacizumab) alone and in combination with novel oncology therapies in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC).

NCT ID: NCT04068181 Completed - Melanoma Clinical Trials

Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).

Start date: January 22, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (anti-PD-1) therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.

NCT ID: NCT04067947 Completed - Pain Clinical Trials

Phase 1 Pharmacokinetics, Safety, and Tolerability Study

Start date: July 8, 2019
Phase: Phase 1
Study type: Interventional

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers.

NCT ID: NCT04066491 Terminated - Cholangiocarcinoma Clinical Trials

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC

Start date: September 20, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin.

NCT ID: NCT04066244 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Study of Safety and of the Mechanism of BLZ945 in ALS Patients

Start date: December 30, 2019
Phase: Phase 2
Study type: Interventional

It is an open label study to evaluate safety, tolerability and brain microglia response in participants with ALS following multiple doses of BLZ945.