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NCT ID: NCT03884790 Terminated - Bone Substitutes Clinical Trials

Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)

Start date: January 22, 2019
Phase: N/A
Study type: Interventional

Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects up to 6 cm using GreenBone Implant. After the surgery, the Patients will be monitored at pre-scheduled visits up to 12 months. Adverse events, pain, quality of life and functional parameters, as well as X-ray and CT scan, will be evaluated at scheduled follow-up visits. An independent Data Safety Monitoring Board (DSMB) will review the safety reports at regular intervals and Serious Adverse Events (SAE) as soon as reported, to protect Patients participating in the study. The initial phase of the study contemplates the treatment of bone defects up to 3 cm. An adaptive interim analysis will be performed when the first 7 Patients will have completed the 6-month follow-up visit. The DSMB will review the results of the interim analysis with respect to the primary endpoint (safety), and provide one of the following recommendations to the Sponsor: a) to stop the study for unacceptable frequency and severity of adverse events or b) to continue the study up to 25 Patients recruited and to include at least 5 Patients with a longer bone defect (> 3 cm up to 6 cm).

NCT ID: NCT03874234 Terminated - Leishmaniasis Clinical Trials

Safety, Tolerability and Pharmacokinetics (PKs) Investigation of GSK3186899 in Healthy Subjects

Start date: April 30, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and PK profile of single and repeat ascending doses of GSK3186899 in healthy subjects. This is a Phase 1 first time in human study, to investigate the effect of food on PK of GSK3186899. This study will consists of two parts. Part A (dose escalation phase) will be a single ascending, sequential cross-over design in cohorts 1, 2 and 3 of subjects. Cohort 1 and 2 will be 4-way cross-over which includes 4 dosing regimens of GSK3186899 and placebo (3:1 ratio) under fasted conditions. Cohort 3 will be 2-way cross-over which includes 2 treatment periods, 2 dosing regimens in fasted and fed conditions. In Part B (repeat dose escalation phase) subjects will be randomized to receive repeat doses of either GSK3186899 or placebo (3:1 ratio) in either fed or fasted conditions. Part B will be conducted based on the review of all safety, tolerability and PK data from Part A. The study duration includes screening, treatment periods and follow-up.

NCT ID: NCT03871309 Terminated - Ischemic Stroke Clinical Trials

Tigertriever Distal Vessels Registry

Start date: February 7, 2020
Phase:
Study type: Observational [Patient Registry]

A registry study to collect data on the Tigertriever device at restoring blood flow by removing clots in M2 or distal vessels in patients experiencing acute ischemic stroke, during commercial use.

NCT ID: NCT03870841 Terminated - Cystic Fibrosis Clinical Trials

The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis

Start date: April 3, 2019
Phase: Phase 2
Study type: Interventional

This study tests the effects of an experimental drug PC945 in people with cystic fibrosis whose lungs are infected by the fungus Aspergillus fumigatus. PC945 may be useful in treating patients infected with Aspergillus fumigatus as, unlike the usual treatments, it is inhaled into the lung and has been designed to stay there and treat the infection. Participants will continue to be treated with their usual cystic fibrosis treatment and will also receive PC945. The amount of fungus in the patients' phlegm will be measured over the course of the study. The study will take place at multiple sites in UK and will include approximately 18 participants. The maximum study duration will be about 16 weeks.

NCT ID: NCT03870152 Terminated - Clinical trials for Lung Cancer Squamous Cell

Electrocautery Ablation for the Prevention of Lung Cancer

EARL
Start date: October 29, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This study evaluates whether EC treatment is effective in delaying the progression of high-grade lung lesion(s) to invasive lung cancer. Participants will be randomised to receive either electrocautery (EC) treatment with bronchoscopy surveillance (=intervention), or bronchoscopy surveillance alone (=control) in a 2:1 ratio.

NCT ID: NCT03869086 Terminated - Healthy Clinical Trials

Metabolism of Anthocyanins and Heart Health

AMP
Start date: June 4, 2019
Phase: N/A
Study type: Interventional

This study aims to find out if consuming a single dose of blueberries, rich in anthocyanins, within an energy dense meal, improves blood vessel function and biomarkers of heart health. The study specifically aims to confirm if differences in how individuals process the bioactive compounds in blueberries, called anthocyanins, has an influence on heart health. The investigators will assess the effects of eating one portion of blueberries on vascular health over a 48hour period, and will track the breakdown compounds within blood and urine, to see if health effects are related to metabolism.

NCT ID: NCT03864328 Terminated - Chronic Cough Clinical Trials

A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF

SCENIC
Start date: March 29, 2019
Phase: Phase 2
Study type: Interventional

Idiopathic pulmonary fibrosis (IPF) is a rare, progressive life-threatening disease that is characterized by exertional dyspnea and persistent dry cough. Cough in IPF is both a presenting and a complicating clinical feature, which affects approximately three quarters of IPF cases. It is often a debilitating symptom that adversely affects quality of life (QoL) and is usually refractory to medical therapy. Inhaled RVT-1601 (formerly, PA101B), a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer, is being evaluated in this Phase 2b study for the treatment of persistent cough in patients with IPF.

NCT ID: NCT03862846 Terminated - Clinical trials for Primary Mitochondrial Myopathy

A Study of the Safety of REN001 in Patients With Primary Mitochondrial Myopathy

Start date: May 10, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess REN001 safety in subjects with primary mitochondrial myopathy

NCT ID: NCT03859661 Terminated - Colorectal Surgery Clinical Trials

A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc)

Fitabisc
Start date: December 2015
Phase: N/A
Study type: Interventional

A study to evaluate the palatability of a nutritional support biscuit (Fitabisc) in patients about to undergo colorectal surgery.

NCT ID: NCT03851250 Terminated - Asthma Clinical Trials

A Study of MRx-4DP0004 in Asthma

Start date: July 4, 2019
Phase: Phase 1
Study type: Interventional

This is a multicentre, phase I/II, double-blind, placebo-controlled study of MRx-4DP0004 in participants taking long-term medication for asthma. Participants will take two capsules of MRx-4DP0004 twice daily in addition to their existing asthma medication for 12 weeks. Safety and tolerability and immune modulatory effects of MRx-4DP0004 will be assessed throughout the study.