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NCT ID: NCT04156295 Completed - Clinical trials for Mitral Regurgitation

Percutaneous Mitral Valve Intervention: Predicting Improvements in Left Ventricular Performance

PMVI-PiP
Start date: March 20, 2019
Phase:
Study type: Observational

The purpose of this study is to assess the role of cardiac imaging combined with demographic, clinical, and biochemical parameters in predicting outcomes following percutaneous mitral valve intervention in order to facilitate more careful risk stratification, interventional planning and avoidance of high risk futile procedures.The principle objective of this study is to determine if transthoracic echocardiography (TTE) can predict changes in left ventricular (LV) size and function following percutaneous mitral valve intervention (PMVI).

NCT ID: NCT04155970 Completed - Clinical trials for Low Back Pain, Mechanical

The Biomechanical Effects of Manual Therapy - A Feasibility Study

Start date: February 6, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to determine the feasibility of conducting a full-scale trial to explore if there is a change in intervertebral movement following a course of manual therapy in patients with acute non-specific low back pain (NSLBP). Research Questions: 1. In patients with acute NSLBP, does lumbar intervertebral movement change following a course of manual therapy? 2. In patients with acute NSLBP, do those who respond to manual therapy (established by patient reported outcomes measures) have different intervertebral movement to those who do not?

NCT ID: NCT04155294 Completed - HIV Infections Clinical Trials

Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV

REACH-UP
Start date: October 28, 2019
Phase:
Study type: Observational

Current British HIV Association (BHIVA) guidelines recommend annual cervical screening (with a cervical smear) for women living with HIV (WLWH). NHS guidelines for women in England will, however, change soon. Women will initially be tested for human papilloma virus (HPV), a virus which causes virtually all cervical cancer. Only those who are infected with HPV will then undergo the smear testing. The BHIVA guidelines, however, taking the view that HIV infection (and its ability to weaken the immune system) increases the risk of persistent HPV infection and of cancer in those who are infected, consider safer for all WLWH to go straight to annual smear testing. Most WLWH in the UK are now receiving treatment which protects their immune system - this suggests that less WLWH could be HPV infected. The identification of a group of WLWH who could benefit from less frequent screening could improve quality of life, and allow the NHS to reduce unnecessary tests and costs. A large study is needed to collect robust evidence that would support changes to standard practice. Before investing huge resources, the investigators need to know if a study would be feasible, conducting a pilot study on 70 WLWH aged 25-64, regularly attending clinics for HIV care. Participants will be asked to complete an entry survey and they will undergo routine cervical smears (baseline and after 1 year). At baseline, after six months, and one year women will take their own vaginal swabs for the detection of HR-HPV. An exit questionnaire will be undertaken at the last visit.

NCT ID: NCT04155151 Completed - Surgery Clinical Trials

Can the 6MWT Can be Used to Identify Reduced Patient Fitness at Surgical Clinic

Start date: February 8, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to assess the feasibility of using the 6 minute walk test (6MWT) as a cardiorespiratory fitness (CRF) screening tool. The screening would take place when the patient attends the hospital for their initial surgical outpatient appointment. By screening all potential major intra-abdominal surgery patients for a period of 6 months and recording the distance walked in the 6 minutes (6MWD) the aim is to produce a threshold distance for the patients of Sheffield that would identify those with sufficient CRF what would allow them to proceed to surgery without further investigations or fitness interventions. Having identified the fit it would allow the perioperative team to focus resources on the less fit with the aim of improving CRF and other elements that would lead to reduced postoperative morbidity and mortality. Other primary aims include noting the time to surgery. This data will inform on wither instigation of the early screening test would facilitate enrolment and completion of an exercise programme before surgery. The secondary aim is to assess the relationship between the 6MWD and routine CPET to confirm if those that walk the furthest are in fact the fittest.

NCT ID: NCT04154852 Completed - Oligoarthritis Clinical Trials

ADalimumab in Persistent Early Oligoarthrits Study (ADEOS)

ADEOS
Start date: June 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate adalimumab, a drug that is currently licensed for treatment of patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and inflammatory bowel disease (Crohn's disease). It is a protein (human monoclonal antibody) that is designed to block the effects of an inflammatory cytokine, tumour necrosis factor alpha (TNF alpha) which is a causative factor in joint inflammation. It is given as a subcutaneous injection. Management of established rheumatoid arthritis has been transformed with the use of TNFantagonists, the first in the class of biological agents. The benefits in early RA are also continuing to emerge. Oligoarthritis represents a subgroup of early inflammatory arthritis that warrants more effective treatment strategy including the potential to modulate the disease course and halt further progression. The TNFantagonists offer the potential of achieving this, justifying this initial investigation. Hence, this study is designed to establish the benefit of adalimumab in preventing progression of oligoarthritis. The primary aim of the study is to assess how many patients achieve remission i.e. no further evidence of joint inflammation or damage. The investigators will do this by including patients who present with inflammation of four or less joints who do not fulfil criteria for a definite arthritis condition such as rheumatoid arthritis. The investigators will perform clinical, laboratory (blood tests) and imaging assessments at regular intervals on these patients to check on safety of the study drug adalimumab and evaluate any changes in disease activity that may have resulted from use of adalimumab. All patients will receive treatment with a standard therapy (methotrexate) with randomisation of half of the patients to receive the active study drug, adalimumab as additional treatment for six months.

NCT ID: NCT04154189 Completed - Osteosarcoma Clinical Trials

A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma

Start date: March 23, 2020
Phase: Phase 2
Study type: Interventional

This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents, and Young Adults with Relapsed or Refractory Osteosarcoma.

NCT ID: NCT04154163 Completed - Ovarian Cancer Clinical Trials

Appropriate Dosing to Optimise Personalised Cancer Treatments

ADOPT
Start date: January 10, 2020
Phase:
Study type: Observational

This is a pilot study to assess feasibility of dried blood spot (DBS) samples for pharmacokinetic measurements of targeted anti-cancer drugs in oncology patients such as patients with BRAF-mutant melanoma receiving targeted treatment with BRAF and MEK inhibitors.

NCT ID: NCT04153929 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.

Start date: April 30, 2020
Phase: Phase 2
Study type: Interventional

This study is open to adults with type 2 diabetes who take metformin but still have too high blood sugar. The purpose of the study is to find the best dose of BI 456906 that reduces blood sugar. The study also looks at whether BI 456906 helps the participants lose weight. Participants are in the study for about 23 weeks. During this time, most participants visit the study site about 13 times. Some participants visit the study site about 20 times. At the start of the study, the participants are put into 7 groups. The participants in groups 1 to 6 get injections under the skin once or twice every week. Some participants get different doses of BI 456906 and other participants get placebo. Placebo injections look like the BI 456906 injections, but contain no medicine. Participants in group 7 get semaglutide injections every week. Semaglutide is another medicine for adults with type 2 diabetes. During the study, the doctors regularly take blood samples from the participants and measure their body weight. The changes in blood sugar levels and body weight are compared between the groups. The doctors also check the general health of the participants.

NCT ID: NCT04153266 Completed - Quality of Life Clinical Trials

Oral Epithelial Dysplasia Informational Needs Questionnaire

ODIN-Q
Start date: October 31, 2018
Phase:
Study type: Observational

Background: Oral epithelial dysplasia (OED) is a condition with an increased risk of oral cancer. Due to the current changes in the factors associated with these diseases (because of human papillomavirus), it is expected that those who have no history of smoking or alcohol, young (<50 years old), and white male would be commonly affected. Those individuals require a higher need for information, preferred a more active role in decision-making, and have a longer lifespan than older individuals. There remain no detailed studies of whether the informational needs delivered to patients with OED met their needs or indeed what information such patient may wish. A few tools are available to evaluate the IN of patients with head and neck disorders. However, the items of these instruments were dedicated to a particular disease (e.g. cancer) and hence are not applicable to be used for OED. Project aims: To evaluate the psychometric properties of the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q), developed and revised in the preliminary work for the proposed study, in a cohort of patients with OED. Timescale: 19 months. Clinical significance: This questionnaire can be useful in clinical practice. It could help to meet the patient's information needs and plan educational interventions for those showing unmet needs.

NCT ID: NCT04153240 Completed - Clinical trials for Sleep Apnea, Obstructive

The POSA Trial - Positional Therapy for Positional OSA

POSA
Start date: October 30, 2019
Phase: N/A
Study type: Interventional

Vibro-tactile feedback may be beneficial for some patients, who have positional obstructive sleep apnoea (OSA). Aim: to determine whether Positional Therapy, applied by a discrete neck-worn vibro-tactile feedback device, is an effective treatment for positional OSA, in reducing the disease severity and associated symptoms, compared to Sham-Positional Therapy. The interaction between treatment and age will also be assessed, since pathophysiology, symptoms and treatment tolerance varies with age. Methods: A prospective randomised, parallel, double-blinded trial comparing Positional Therapy (Night Shift™; Advanced Brain Monitoring, USA) with Sham-Positional Therapy, performed in older (>65 years) and younger patients with positional OSA (apnoea/hypopnea index (AHI)>5 events/hour, 2:1 when supine). The primary endpoint, AHI at 3 months, will be measured by a repeat study with the device in situ, and compared between Positional Therapy and Sham-Positional Therapy. Patients' subjective symptoms, wellbeing and quality of life, will be assessed by questionnaires at baseline and 3 months. Adherence to therapy will be measured.