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NCT ID: NCT04185948 Completed - Body Weight Changes Clinical Trials

Pilot Study on the Impact of the Mediterranean Diet and Intermittent Fasting

Start date: January 19, 2019
Phase: N/A
Study type: Interventional

This clinical trial attempts to evaluate the feasibility and acceptability of an intervention combining intermittent fasting and the Mediterranean diet guidelines vs an comparative intervention combining intermittent fasting but using the UK dietary guidelines. Participants will be randomised to these intervention using a parallel design. Weight change and blood lipids will be assessed.

NCT ID: NCT04185415 Completed - Clinical trials for Progressive Supranuclear Palsy

A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)

Start date: December 3, 2019
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the safety and tolerability of UCB0107 in study participants with Progressive Supranuclear Palsy (PSP).

NCT ID: NCT04184726 Completed - Photophobia Clinical Trials

Mindfulness Based Cognitive Therapy Modified for Visual Symptoms (MBCT-vision)

MBCT-vision
Start date: January 9, 2020
Phase: N/A
Study type: Interventional

This is a research study on Mindfulness-Based Cognitive Therapy for visual symptoms (MBCT-vision), to treat patients with debilitating symptoms of visual snow (VS) and is associated visual symptoms, severe light sensitivity (i.e. photophobia) and migrainous visual aura. Participants will receive an intervention of an 8-week MBCT course modified for visual symptoms, which will involve 8 weeks of once weekly group sessions and home practice between sessions.

NCT ID: NCT04183790 Completed - Cystic Fibrosis Clinical Trials

Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older

Start date: February 17, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF).

NCT ID: NCT04182958 Completed - Healthy Adult Male Clinical Trials

A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects

Start date: November 25, 2019
Phase: Phase 1
Study type: Interventional

- To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815. - To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815 - To assess the PK of total radioactivity in plasma and whole blood following a single IV infusion of (14C)-OPC-61815 - To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV infusion of (14C)-OPC-61815

NCT ID: NCT04182230 Completed - Clinical trials for Antimicrobial Resistance

UROGEN WELL D-ONE : Evaluation of a Novel Diagnostic for Sexually Transmitted Bacterial Infections

Start date: September 5, 2018
Phase:
Study type: Observational

UROGEN WELL D-ONE Principal research question: Can the UROGEN WELL D-ONE assay detect urinary tract infections and urethritis in clinical samples from patients attending Genitourinary Medicine outpatient clinics as accurately as standard laboratory microscopy and culture methodologies, while simultaneously identifying antimicrobial resistance? The primary aim of this study is to evaluate the rapid diagnostic assay UROGEN WELL D-ONE and determine if it can accurately detect infectious organisms causing UTI's and urethritis. Secondary research question: Is the antimicrobial resistance identified by the UROGEN WELL D-ONE assay accurate as compared to determination by the Clinical and Laboratory Standards Institute international guidelines? The secondary research objective will be to assess the accuracy of the breakpoint antimicrobial susceptibility measurement by the assay. This is particularly important with the global increase in antibiotic resistance, when the acquisition of mobile resistance genes to the remaining effective therapeutics is rising internationally.

NCT ID: NCT04182074 Completed - Acute Leukemia Clinical Trials

Monitoring the Diagnosis and Management of Acute Leukaemia In Pregnancy Study.

LIPS
Start date: November 22, 2019
Phase:
Study type: Observational [Patient Registry]

Acute leukaemia (AL) is an aggressive but potentially curable cancer that can affect women of childbearing age. When a pregnancy is complicated by a diagnosis of AL, clinicians face a complex dilemma: to balance risking the mother's survival through delaying treatment, against the potential harm to the foetus through exposure to cancer drugs. Reports suggest that, providing the first trimester is avoided, successful treatment of AL during pregnancy is possible, and considered safe. However, there is currently no standard approach to treatment of these women. This observational study aims to monitor and record the current treatment and outcomes of patients diagnosed with acute leukaemia during or prior to pregnancy. Patients will receive the treatment recommended by their doctor, the study will not alter the treatment pathway of participants. This study will establish a new research database of Leukaemia in Pregnancy, initially collecting data from cases since August 2009, and any new cases that are diagnosed during the current funding period. The initial planned analyses from this dataset will enable more robust, evidence-based recommendations to be made on how to monitor and manage these patients, and will add value to and improve the existing British Committee for Standards in Haematology (BCSH) guidelines, which were largely derived from expert opinion. This should enable healthcare professionals to have greater confidence in managing these patients, leading to a more standardised approach to providing high quality care. The study will benefit National Health Service (NHS) Trusts and patients across the United Kingdom (UK) through more informed clinical decision making with regards to the care they receive. It will also provide an important data resource which researchers can apply to use in further analyses, with plans to continue data collection if further funding is obtained.

NCT ID: NCT04181619 Completed - Soccer Performance Clinical Trials

Influence of Coffeeberry Ingestion on Soccer Skill Performance

Start date: November 6, 2019
Phase: N/A
Study type: Interventional

The study of soccer skill performance has 3 objectives. Objective 1 is to compare effects of coffeeberry (300mg) and placebo ingestion on dribbling speed and precision and passing and shooting speed and accuracy compared to placebo. 30 subjects will be assessed before dosing, after a 1 hr resting absorption period, and after simulated soccer match play. Of these 30, 20 subjects will proceed to Objective 2 (45 minutes of intense simulated soccer match play) and Objective 3 (repeated sprint activity continued until volitional fatigue).

NCT ID: NCT04180709 Completed - Sleep Clinical Trials

CBT to Reduce Insomnia and Improve Social Recovery in Early Psychosis

CRISP
Start date: October 30, 2020
Phase: N/A
Study type: Interventional

Sleep disturbances and cognitive dysfunction are consistently reported as extremely troublesome aspects of psychotic illnesses. While sleep disturbances are not included in definitions of psychosis they are associated with poor levels of daily function and impaired social recovery. Despite sleep problems being documented as co-occurring with psychosis, sleep remains unexamined as a potential therapeutic target pathway for social recovery. Specific areas of cognition are known to be associated with psychosis, sleep deficits and daily function, yet these have not been tested as possible mediators of the association between improved sleep and better daily function and social recovery. This study will examine the relationship between sleep quality, daily function and ultimately social recovery in early psychosis. A secondary aim will examine whether specified areas of cognition (i.e. attention, memory, executive function, social and emotional recognition) mediate the proposed association between sleep and social recovery. Participants will have experienced a first episode psychosis and be currently engaged with CAMEO early intervention, in Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) or Early Intervention in Psychosis Services (EIS), in Norfolk and Suffolk NHS Foundation Trust (NSFT). Cameo CPFT and Early Intervention in Psychosis Services NSFT are services for people aged 14-65 years old who are experiencing symptoms of psychosis for the first time (http://www.cameo.nhs.uk and https://www.nsft.nhs.uk/adults/service/early-intervention-in-psychosis-services-norfolk-and-w aveney-103/). A publicly available, online intervention based on cognitive behavioural therapy (CBT) for insomnia (Sleepio) will be utilised to improve sleep. Participants will be randomised to receive the intervention + treatment as usual (TAU) through their early intervention team or TAU alone over an eight-week period. The entire study will last for seventeen weeks including an eight-week follow-up period.

NCT ID: NCT04180384 Completed - Solid Tumor Clinical Trials

A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients

Start date: September 23, 2015
Phase: Phase 2
Study type: Interventional

Oraxol is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain paclitaxel. HM30181 is a drug that helps the body absorb paclitaxel, a drug used to treat cancer. Initially this study is intended as an extension study of KX-ORAX-002 pharmacokinetic study for patients who wish to continue Oraxol treatment and who are eligible to participate. The purpose of this study is to check the safety and tolerability of Oraxol when it is administered on a weekly basis and to confirm the sustained oral bioavailability of paclitaxel following multiple dosing; also compare the relative bioavailability of paclitaxel tablets vs paclitaxel capsules (Group B only).