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NCT ID: NCT04053023 Completed - Cholestasis Clinical Trials

Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects

Start date: August 27, 2019
Phase: Phase 1
Study type: Interventional

In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC], OCA, or both) the addition of linerixibat to OCA therapy may be considered following marketing approval. It is therefore important to characterize any potential effect of linerixibat on the pharmacokinetics of OCA in humans at clinically relevant dosages. Accordingly, a drug-drug interaction (DDI) study with linerixibat (potential perpetrator) and OCA (potential victim) will be conducted to inform both future clinical trials with linerixibat and the potential concomitant administration of these drugs in a clinical setting. This is a single-center, one part (with optional second part) open-label, single sequence crossover, drug interaction study to investigate the effect of linerixibat on plasma concentrations of OCA and OCA conjugates in healthy participants. Approximately 19 participants will be enrolled in part A and further 19 participants in part B (if performed) in the study and will have a phone call follow-up till 7-14 days post-last linerixibat dose.

NCT ID: NCT04052997 Completed - Clinical trials for Refractory Hodgkin Lymphoma

Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma

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

The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).

NCT ID: NCT04052217 Completed - Peyronie Disease Clinical Trials

Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse

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

Our hypothesis is that reducing the length of the penis does not lead to loss of sexual satisfaction or emotional closeness in the female partner. This will be investigated by a single case experimental design in 12 couples.

NCT ID: NCT04051944 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Start date: August 21, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess long-term safety and tolerability of weekly doses of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

NCT ID: NCT04051281 Completed - Clinical trials for Prescribing, Off-Label

CMO Letter to Reduce Inappropriate Antibiotic Prescribing Winter 2019/2020

Start date: August 31, 2019
Phase: N/A
Study type: Interventional

This trial aims to reduce inappropriate prescription of antibiotics and broad spectrum antibiotics by general practitioners (GPs) in England. Unnecessary prescriptions are defined as those that do not improve patient health outcomes. The intervention is to send GPs a letter from the Chief Medical Officer (CMO) that gives feedback on their practice's prescribing levels. There will be three intervention samples: 1. practices whose prescribing in the past year was under the new target of 0.965 items per STAR-PU but who would exceed the target if they had a 5% increase in prescribing; trial compares prescribing of practices whose GPs receive a letter informing them that their practice's prescribing is just under the new target to that of practices that are not sent a letter 2. Practices whose prescribing in the past year was above the new target but who not in the top 20% of prescribers; trial compares prescribing of practices whose GPs receive a letter informing them that their practice's prescribing exceeds the new target to practices who get a letter that includes a graph showing their prescribing relative to the target and to practices that are not sent a letter 3. Practices that are currently in the top 20% of prescribers; trial compares effect on prescribing of a feedback letter with a social norms message (current standard practice for this group) to a letter informing GPs that their practice's prescribing exceeds the new target and to a letter with a social norms message, that includes a specific example of a case of patient harm caused by antimicrobial resistance.

NCT ID: NCT04051073 Completed - Acute Kidney Injury Clinical Trials

Can Continuous Non-invasive Monitoring Improve Stability of Intraoperative Blood Pressure - A Feasibility Study.

iSTABILISE
Start date: June 13, 2019
Phase: Phase 3
Study type: Interventional

Background During anaesthesia for repair of a broken hip, many patients experience low blood pressure. There have been many studies showing that patients who experience low blood pressure during anaesthesia are at increased risk of sustaining kidney or heart damage, strokes, having a post-operative infection, or dying. During anaesthesia, in most cases blood pressure is monitored using a cuff which inflates on the arm (the 'normal' way blood pressure is measured in a GP practice or hospital ward). This gives a reading each time the cuff goes up and down, every 3-5 minutes typically. There is a less well used way to measure blood pressure, using an additional cuff on the finger which gives a constant, continuous measure of blood pressure. We think that using this monitor, rather than the 'standard' monitor, will mean that low blood pressure is recognised more quickly, therefore treated more quickly, and will lead to patients having less exposure to dangerously low blood pressures. If this is the case, we hope that it will reduce how often patients experience kidney or heart damage, have an infection after surgery, suffer a stroke, and reduce the risk of death. Methodology To test this, we would need to run a large clinical trial comparing the continuous monitor to the standard monitor. This would be expensive and involve a great deal of work in a large number of hospitals, and so first we wish to determine whether the trial we would like to run is practical, and possible to deliver in the real world. To do this we plan to run the trial first on a small-scale feasibility (pilot) study, where we will recruit 30 patients, half of whom will have the standard monitor, and half of whom will have the continuous monitor. We will see what proportion of the patients who could enter the trial actually do so and complete it, and use it as an opportunity to iron out problems with the trial. If we find it is possible to run the trial on a small scale, we will apply for funding to run a full study. This will aim to answer the question of whether the continuous monitor improves the patient outcomes which were agreed during development with the patient public involvement group locally; rate of kidney damage, heart damage, stroke, post-operative infections, risk of death, and hospital length-of-stay. Expected outcomes and implications. We anticipate we will find the trial to be feasible with amendments to the way it is run, and if this is the case, we will apply to run the full scale trial. If this shows that using the continuous monitor improves the patient outcomes above, then it would represent new, significant evidence that may lead to the NHS adopting it's use as 'standard care' during anaesthesia for repair of a broken hip, and would like lead to similar trials in other operations where patients may benefit in a similar way.

NCT ID: NCT04049877 Completed - Clinical trials for X-linked Hypophosphatemia (XLH)

Retrospective and Prospective Disease Progression and Quality of Life in XLH

Start date: July 7, 2019
Phase:
Study type: Observational

There is limited empirical data documenting disease progression and impact on quality of life for patients with X-linked hypophosphatemia (XLH). This study seeks to investigate the impact of XLH in adults living in the UK retrospectively and prospectively over a 12 month period, using qualitative interviews, SEIQoL-DW, EQ-5D-5L, SF36 quality of life tools. XLH is a rare, genetic, chronically debilitating and deforming condition (www.nice.org.uk/guidance/HST8). XLH is characterised by renal phosphate wasting, hypophosphatemia and defective bone mineralisation. The incidence of XLH is reported to be between 1:20,000 and 1:25,000 live births. In the UK, it is estimated that there are around 250 paediatric XLH patients and around 2,500 adult XLH patients (Delmestri,et al [Unpublished report]2018). The clinical phenotype of XLH is varied amongst patients, even among affected members of the same family. This can range from no signs or symptoms, slow growth in children, short stature, bone abnormalities that can affect movement and result in pain, bowed legs and knocked knees (where lower legs are positioned at an outward angle), tooth abscesses and excessive dental caries and hearing loss (adult patients only). This study will recruit 36 adults living with XLH, who are aged 28 years or over and living in the UK. The study will be advertised by the Sponsor and funder Medialis Ltd and via the patient organisation Metabolic Support UK. All study activities will take place via tele-visits and online questionnaires. The study will last approximately 2 years, allowing for one-year recruitment and a further 12 months to conduct all study visits.

NCT ID: NCT04048096 Completed - Aging Clinical Trials

Krill Oil and Muscle in Older Adults

Start date: March 7, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effects of krill oil supplementation on muscle mass in function in older adults. Half of the participants will receive krill oil supplements and the other half a placebo.

NCT ID: NCT04048018 Completed - Clinical trials for Latent Tuberculosis Infection

Performance Evaluation of the VIDAS TB-IGRA Assay.

Start date: December 5, 2019
Phase:
Study type: Observational

This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection. This study is designed to assess (1) the sensitivity of this assay, (2) its percent agreement with other diagnostic tests, (3) its measurement precision , and (4) any potential interference of the presence of other non-tuberculosis mycobacterial bacterial infections with this assay.

NCT ID: NCT04046653 Completed - Prostate Cancer Clinical Trials

Accumulation of Dietary Bioactives and Prostate Cancer

ADaPT
Start date: July 3, 2019
Phase: N/A
Study type: Interventional

Current research suggests that diets rich in multiple food types (such as broccoli, onions and garlic) are beneficial to our health and may reduce the risk of some cancers, including prostate cancer. The purpose of this study is to investigate the relationship between ingestion of the bioactive compounds from broccoli and garlic, and prostate metabolism.