Clinical Trials Logo

Filter by:
NCT ID: NCT04022759 Not yet recruiting - Depression Clinical Trials

Priming Attachment Security Within an IAPT Setting

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

There is growing evidence that priming attachment security is associated with improved attitudes towards therapy, increased engagement and decreased levels of depression and anxiety. Within the Improving Access to Psychological Therapies (IAPT) programme a consistent problem has been identified of high dropout rates at step 2 services (i.e. where mild to moderate anxious and depressed patients receive guided self-help interventions). The current study incorporates a feasibility and pilot design. The feasibility element will explore issues related to study design to determine suitability for conducting a future randomised control trial (RCT). The pilot study will look at the processes outlined in the protocol to determine whether the study components all work together. Moreover, it will preliminarily aim to explore the effectiveness of the attachment security priming intervention on symptoms of depression and anxiety, as well as impaired functioning. Both elements of the study will determine whether any changes are needed to the study design or protocol, and whether a future RCT is suitable and necessary.

NCT ID: NCT04018547 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Investigating a Wrist-sensor Oximeter to Screen for Sleep Apnoea.

Start date: September 17, 2019
Phase:
Study type: Observational

The primary study objective is to investigate sensitivity and specificity of a wrist sensor pulse oximeter (the Oxitone Medical Oxitone 1000M device) to screen for obstructive sleep apnoea. This study will involve thirty participants attending a sleep centre suspected of suffering from obstructive sleep apnoea (case finding screening). The secondary objective is to assess patient convenience with the screening procedure.

NCT ID: NCT03998072 Not yet recruiting - Treatment as Usual Clinical Trials

Does Five Session CAT Consultancy Lead to Improved Outcomes?

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Five session CAT (Cognitive Analytic Therapy) consultancy was developed for patients whom services 'struggle to help', such as those with diagnoses of personality disorder. Five session CAT consultancy works with both patients and care coordinators, utilising key elements of CAT including reciprocal roles and reformulation to inform care planning and case management. The proposed study expands on the existing evidence base by utilising a comparator; a treatment as usual condition. The proposed mixed methods feasibility study will compare outcomes for both patients and care coordinators to assess the effectiveness of the intervention compared to controls in a community mental health team.

NCT ID: NCT03996356 Not yet recruiting - Weight Gain Clinical Trials

Clozapine Induced Weight Gain

Start date: March 2020
Phase:
Study type: Observational

Clozapine is prescribed to patients with psychosis in whom other treatments have not worked. Research has shown, however, that clozapine may be associated with weight gain and abnormal blood sugar levels in some patients. There is strong evidence to suggest that genetic variation between individuals plays an important role in the development of these side effects in response to the medication. Our research aims to evaluate the effects of two genes and the blood level of clozapine on side-effects such as weight changes and blood sugar levels in patients receiving clozapine treatment. From out-patient clinics in Cwm Taf UHB, the investigators aim to recruit 160 patients who are taking clozapine; collect information/ measurements from recruits relating to size/ weight/ BMI, risk of diabetes and blood samples to measure markers of blood sugar, fat/lipids, clozapine and its breakdown products, blood cells and variants of two specific genes. From this information the investigators will be particularly interested to understand if there is any association between the variation in these two genes with weight gain or changes in blood sugar, in patients taking clozapine.

NCT ID: NCT03982056 Not yet recruiting - Lung Function Clinical Trials

Float First: An Index of Floating: Factors Affecting Floating in Different Populations

Start date: July 1, 2019
Phase:
Study type: Observational

The study involves measurements of body composition using a DEXA scanner, lung function, buoyancy and floating technique. An understanding of the effects of physiological and anthropometric measures on an individual's ability to float may lead to the creation of a 'Floatability Score' to aid current public information. With this floatability score a set of actions that people of certain body types should adopt in water will be created, to tailor the current public safety messaging in an attempt to ensure more people are aware of how they can float in water

NCT ID: NCT03946696 Not yet recruiting - Dementia Clinical Trials

Animal-Assisted Therapy for People With Dementia

AATPD
Start date: July 15, 2021
Phase:
Study type: Observational

This study is a qualitative anthropological research that explores the effects of Animal-Assisted Therapy (AAT) for people with moderate and severe dementia living in a care facility. In particular, the study explores the effects that AAT can have on people with moderate and later stages of dementia, living in a care facility, on: Behavioural and Psychological Symptoms of Dementia (BPSD); mood (depression); quality of life; activity (physical). The AAT effects on people with moderate and later stages of dementia will be compared with effects that other activities provided in the care facility where participants live, may have on the same participants. This study does not test hypotheses.

NCT ID: NCT03944226 Not yet recruiting - Clinical trials for Malignant Breast Tissue Neoplasm

Is Dietary Nitrate Effective in Reducing Aerobic Glycolysis in Breast Cancer?

BEET
Start date: May 13, 2019
Phase: N/A
Study type: Interventional

Breast cancer is the most prevalent cancer affecting women, with 1 in 8 women in the UK developing breast cancer in their life time. Chemotherapy drugs, currently used for locally advanced breast cancers, are associated with side effects while dietary supplements have complex effects with a relatively small effect size. Breast tumours have different metabolism compared to healthy tissue, including elevated lactate production by aerobic glycolysis (AG), an underpinning feature of metabolism in breast cancer cells. Dietary nitrate, contained in leafy green vegetables and beetroot, has been shown to improve energy efficiency in exercising skeletal muscle, positioning itself as a disruptor of AG. The purpose of this study is to examine if dietary nitrate can disrupt AG and as a result to halt or even reverse tumour progression and survival. This study will look at scans of breast tumours using magnetic resonance imaging (MRI). Changes to tumour related biochemical substances will be measured by advanced magnetic resonance spectroscopy and changes to tissue structure will be measured by advanced diffusion MRI techniques. In this study, 16 patients undergoing surgery will be recruited for two MRI scans following a 5 day intervention programme.

NCT ID: NCT03938090 Not yet recruiting - Heart Failure Clinical Trials

Optimised MultiSite Pacing Vector Study

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

The objective of this clinical investigation is to evaluate the clinical benefits of an MultiSite pacing (MSP) with patient specific left ventricular vector optimization in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy. This clinical investigation is a single-center, prospective, two-arm, randomized 1:1, crossover study designed to evaluate the effectiveness of Optimized MSP CRT compared to conventional bi-ventricular pacing. Data will be collected at enrolment, CRT implant procedure, hospital pre-discharge, one, three and six months post implant. Enrolment data collection will include demographics, cardiovascular history, medication, echocardiography measurements, heart failure quality of life questionnaire and six minute walk test distance. CRT implant procedure data collection will include implanted system information, lead location and conduction times. The electrical conduction recording procedure will include surface ECG and device electrogram (EGM) recordings during various MSP vector pacing configurations at the time of CRT device implant. Patients will also undergo simultaneous invasive pressure measurements using a left ventricular pressure wire to allow haemodynamic measurements (dP/dtmax) during various MSP vector pacing configurations. Optimal MSP programming settings will be determined by the narrowest QRS duration recorded by 12 lead ECG and the greatest change in dP/dtmax by pressure wires study. In a subgroup of patients (approximately 25 patients), non-invasive electrical activation data will be collected with electrocardiographic imaging (ECGi) within 45 days of the implant procedure. Patients will then be randomized 1:1 to receive either standard biventricular pacing or Optimized MSP at their one-month follow-up (± 15 days) visit. At the 3 months (± 15 days) post randomization follow up visit, data collection will include surface ECG, EGMs, echocardiographic parameters and quality of life questionnaire. The patients will then undergo cross-over to the alternate randomization group with programming adjusted accordingly. At the final, 6 months (± 15 days) post randomization follow-up visit, data collection will include surface ECG, EGMs, echocardiographic parameters and quality of life questionnaire. This will mark the completion of the study for each patient. The expected duration of enrolment is 18 months. The total duration of the clinical investigation is expected to be 25 months.

NCT ID: NCT03936842 Not yet recruiting - Breast Pain Clinical Trials

Evaluation of an Educational Intervention for Women With Breast Pain

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

Evaluation of an educational intervention for women with breast pain Target Problem -Symptomatic breast pain Study Objectives- The primary objective is to obtain knowledge of women's perceptions of an educational video about breast pain, breast awareness and self-examination and its impact on their confidence in self-management of breast pain. The secondary objectives -proportion of women who report that the video 1. Was informative 2. Might have reassured them enough not to have needed to seek an appointment in secondary care. Study Design- Prospective single-centre mixed methods study through semi-structured interviews for Masters in Public Health thesis Trial Population -Women, aged 18-40, referred to "one-stop" / rapid diagnostic breast clinic at The Royal Marsden Hospital (RMH) with breast pain alone. Recruitment target Until saturation, expected sample 10-15 Trial Design- Mixed methods study using semi-structured interviews Primary endpoint -This is a qualitative study, with no statistical primary end point. Secondary endpoints-Descriptive summaries of two questions will be reported as a secondary end point. Inclusion Criteria - Women aged between 18 years and 40 years on the day of clinic attendance - Breast pain as the only symptom - Normal clinical examination - No further investigation (imaging, biopsy etc) Exclusion Criteria - Presence of suspicious features during clinical examination requiring further investigation - Strong family history of breast cancer - Previous breast imaging within last 12 months - Previous history of breast cancer - Current or previous treatment with Tamoxifen - Concurrent cancer - Medical or psychiatric illness which might impact their participation in the study

NCT ID: NCT03935672 Not yet recruiting - Clinical trials for Oropharyngeal Cancer

PEARL PET-based Adaptive Radiotherapy Clinical Trial

PEARL
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

The PEARL study will recruit approximately 50 patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC) who are about to undergo primary treatment with concurrent chemo-radiation from South Wales (Velindre Cancer Centre and Singleton Hospital, Swansea) and Bristol. The main aim is to see whether it is feasible to preform a positron emission tomography-computed tomography (PET-CT) scan after 2 weeks of radiotherapy and re-plan the radiotherapy based on this PET-CT scan, to re-distribute the dose of radiotherapy being delivered, so that a smaller area of normal tissues in the mouth and throat are treated to a high dose of radiotherapy.