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NCT ID: NCT03686982 Completed - Clinical trials for Exercise Performance

The Impact of Supplementation With Novel Prototype Nutrition Bar on Nitric Oxide Bioavailability and Measures of Athlete Performance

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Dietary nitrate, L-citrulline, epicatechin, vitamin C and glutathione have the potential to improve nitric oxide (NO) bioavailability, in humans, by influencing both the nitrate-nitrite-NO and NO synthase-dependent pathways, and the storage of NO. The study is designed to assess the efficacy of a newly developed product containing a mixture of these compounds. Specifically, the study will assess if the product is capable of increasing NO bioavailability and if this results in positive effects on exercise economy and intermittent exercise performance. These outcome measures have been chosen because they have previously been positively impacted by an increase in NO bioavailability.

NCT ID: NCT03684811 Completed - Clinical trials for Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas)

A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation

Start date: November 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas. The study is divided into two parts: single agent FT-2102 followed by combination therapy. Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or altered dose schedules may be explored. Part 2: An open-label study of FT-2102 in combination with other anti-cancer agents. Patients will be enrolled across 4 different disease cohorts, examining the effect of FT-2102 + azacitidine (glioma and chondrosarcoma), FT-2102 + nivolumab (hepatobiliary tumors), and FT-2102 + gemcitabine/cisplatin (intrahepatic cholangiocarcinoma). There will be a safety lead-in followed by a Phase 2 evaluation in up to four cohorts of patients.

NCT ID: NCT03684746 Completed - Staff Attitude Clinical Trials

Innovation Adoption in Medical Robotic Surgery: Case of Royal Bournemouth Hospital

Start date: July 11, 2018
Phase:
Study type: Observational

This research sets to address two key areas. The first is identified by the researcher in academic literature that there is a lack of a comprehensive innovation adoption model in UK National Health System (NHS), specifically for Medical Robotic Surgery. Existing frameworks are mainly developed in the US or in other fields. The second problem was identified by surgeons involved in Robotic Surgery in Royal Bournemouth Hospital (RBH). The project started by offering RBH a deeper understanding of the innovation adoption process, issues and development of an adapted innovation model, however after our initial meeting with the Surgical Director and his team, it was clear that one the main areas RBH was keen for us to investigate, was the communication pathway of all stakeholders involved in robotic surgery adoption. They were concerned that key staff dealing with patients undergoing medical robotic surgery were uninformed about the technology and process which can impact patients' experience and staff communication. The research will develop a comprehensive innovation adoption model for robotic surgery (and similar medical innovation) in NHS. Currently there are no models adapted to NHS UK structure and requirements. This model will assist the NHS to understand and evaluate any innovation adoption process within the NHS and to avoid future innovation adoption failure. The case example will Identify the communication pathway and key stakeholders in RBH for the process of Gastrointestinal Robotic Surgery, evaluation of stakeholders' knowledge and needs and further proposing ways to improve adoption and increase knowledge. NHS can use the proposed communication pathway to identify stakeholders that need to be informed, trained and communicated to, in any innovation adoption process within NHS.

NCT ID: NCT03684733 Completed - MRI Clinical Trials

Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer

MR-BTC
Start date: March 13, 2017
Phase:
Study type: Observational

This is a combination retrospective/prospective observational study with two arms:

NCT ID: NCT03684200 Completed - Clinical trials for Eccentric Hip Adduction Strength

The Copenhagen Adductor Exercise Trial

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the efficacy of a 6-week intervention, using the Copenhagen adductor exercise, on adductor muscle strength in sub-elite male footballers. Secondly, it will also examine the effect of a 3-week detraining period, after stopping the Copenhagen adductor exercise, on adductor muscle strength. The primary outcome measure is eccentric hip adduction strength measured using a handheld dynamometer. Additionally, peak isometric adductor squeeze strength will also be measured using a handheld dynamometer. The hypothesis is that strength training of the adductor muscles elicited by the Copenhagen adductor exercise will result in enhanced eccentric hip adduction strength.

NCT ID: NCT03683576 Completed - Asthma Clinical Trials

GB001 in Adult Subjects With Moderate to Severe Asthma

Start date: October 22, 2018
Phase: Phase 2
Study type: Interventional

A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.

NCT ID: NCT03682978 Completed - Clinical trials for Autism Spectrum Disorder

Arbaclofen in Children and Adolescents With ASD

AIMS2-CT1
Start date: September 19, 2019
Phase: Phase 2
Study type: Interventional

AIMS-2-CT-01 is a randomized, double-blind, placebo controlled, study to explore the efficacy, safety and tolerability of Arbaclofen administered to children and adolescents (ages 5-17) for the treatment of social adaptive function in participants with ASD. The effects of Arbaclofen on social function in children and adolescents with ASD will be evaluated in a randomized, placebo controlled, parallel-group study of 16 weeks duration. Subjects who meet protocol criteria will be randomly allocated to receive either Arbaclofen or placebo in a 1:1 ratio in the Treatment Period. There will be 7 recruiting sites and randomization will be stratified by site. A sample of 130 patients will be recruited. Blinding will be maintained by utilizing identical tablets containing either Arbaclofen or placebo.

NCT ID: NCT03682705 Completed - Clinical trials for Rheumatoid Arthritis (RA)

A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis

Start date: October 8, 2018
Phase: Phase 2
Study type: Interventional

This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and ABBV-599 (ELS plus upadacitinib [UPA]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.

NCT ID: NCT03682419 Completed - Atrial Fibrillation Clinical Trials

Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device (OPTIMAL)

OPTIMAL
Start date: September 17, 2018
Phase: N/A
Study type: Interventional

Comparison of capillary whole blood INR determined by LumiraDx Instrument to venous plasma INR determined by laboratory reference method (IL ACL ELITE PRO) for method comparison and assessment of accuracy and bias by regression analysis and other analytical methods.

NCT ID: NCT03681860 Completed - Safety Clinical Trials

EMaBS TB Vaccine Study

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

The study will commence with a dose-escalation and age de-escalation study in healthy adults and adolescents from the previous Entebbe Mother and Baby Study (EMaBS) in Entebbe, Uganda, focusing on ChAdOx1 85A, to provide safety data for ChAdOx1 85A in this population. These measures are not required for MVA85A since this vaccine has been more widely used, including among adolescents in Uganda, and the dose has been standardised. ChAdOx1 85A dose escalation and age de-escalation will be followed by a Phase IIa randomised trial comparing the immunogenicity of ChAdOx1 85A and MVA85A with the immunogenicity of BCG revaccination. ChAdOx1 85A and MVA85A will be administered via the intramuscular route. The target dose for the Phase IIa trial is 2.5x10^10 viral particles (vp) because the lower dose is expected to have lower immunogenicity, based on the Oxford study, TB034. Data from the Oxford study suggest that this dose will be well tolerated. However, if this dose is not tolerated then the lower dose will be used. The dose of MVA85A will be 1 x 10^8 plaque-forming units (pfu) in the groups in which it is given. There will be 6 study groups with 3 to 30 volunteers in each group. Dose escalation for ChAdOx1 85A in adults Group 1: The first three adults will receive ChAdOx1 85A at 5 x10^9 vp. Group 2: The next three adults will be enrolled after safety data has been reviewed by the trial management team to one week after ChAdOx1 85A vaccination in group 1. These adults will receive ChAdOx1 85A at 2.5 x10^10 vp. Age de-escalation and dose escalation for ChAdOx1 85A in adolescents Group 3: The first three adolescents will be enrolled after safety data has been reviewed to one week after ChAdOx1 85A vaccination in group 2. These three adolescents will receive ChAdOx1 85A at 5 x10^9 vp Group 4. The next three adolescents will be enrolled after safety data has been reviewed to one week after ChAdOx1 85A vaccination in group 2. These three adolescents will receive ChAdOx1 85A at 2.5 x10^10 vp. Randomised comparison of ChAdOx1 85A-MVA85A versus BCG revaccination: Once safety data has been reviewed for groups 1 to 4 to one week post ChAdOx1 85A vaccination, recruitment to the randomised trial will commence. Sixty adolescents will be randomised, 30 (group 5) to receive ChAdOx1 85A at 2.5 x10^10 vp followed by MVA85A boost and 30 (group 6) to receive BCG revaccination. BCG will be obtained from the Serum Institute of India, an approved provider for Uganda, and used at the standard dose of 0.1mL. BCG will be given intradermally.