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NCT ID: NCT03720834 Completed - Clinical trials for Surgery--Complications

Verbal Probability Expressions in Peri-operative Risk

Start date: November 1, 2018
Phase:
Study type: Observational

Before having an operation doctors use expressions such as high risk, or low risk to describe the chance of complications occurring. Complications include things such as strokes and heart attacks and even death. It is thought that using words like this, instead of percentages makes it easier for patients to understand their level of risk. It is also often hard for a doctor to give a patient an exact percentage. It is important that patients have a good understanding about their level of risk associated with an operation so they can make informed decisions about whether to go ahead with it. This is an important part of taking consent before an operation. The aim of this study is to assess whether using expressions such as high risk and low risk to communicate the chance of a complication occurring during an operation is useful. Different patients may assign different meanings to these expressions. If it is found that patients interpret these expressions differently from how the doctor intended it would suggest that the way doctors communicate risk to patients should be reviewed. Patients will be asked if they are willing to participate in the study and after giving consent they will complete a questionnaire. The questionnaire will list various expressions used by doctors to describe the chance of a complication occurring during an operation, such as high risk and low risk. Each participant will be asked to give a percentage for each of the expressions. The questionnaire will be completed by patients who are waiting to have an operation at the Royal Hallamshire Hospital.

NCT ID: NCT03720587 Completed - Clinical trials for Greater Trochanteric Pain Syndrome

The Experiences of Patients With Greater Trochanteric Pain Syndrome.

Start date: December 1, 2018
Phase:
Study type: Observational

Greater Trochanteric Pain syndrome (GTPS) is a debilitating condition causing pain on the outside of the hip. This study aims to explore the experiences, beliefs and expectations of patients with GTPS, using semi-structured interviews.

NCT ID: NCT03720470 Completed - Dermatitis, Atopic Clinical Trials

Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

JADE Compare
Start date: October 29, 2018
Phase: Phase 3
Study type: Interventional

B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily will be evaluated relative to placebo over 12 weeks. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.

NCT ID: NCT03719846 Completed - Pregnancy Clinical Trials

Continuous Sample Collection Study

CSC
Start date: November 5, 2018
Phase:
Study type: Observational

This study will provide urine cycles from both pregnant and not pregnant volunteers to maintain the SPD sample bank. Study volunteers, seeking to conceive will be provided with Clearblue Ovulation product to help them pinpoint their most fertile time and aid conception. All volunteers will provide daily early morning urine samples throughout the study period and keep a study diary of menses and pregnancy test results for 1 menstrual cycle. Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts at stored at -80˚C until required. The study will also gather optional information from volunteers regarding a woman's general health and stress levels when trying to conceive. This will be used to study the relationship between general health, stress and conception.

NCT ID: NCT03719807 Completed - Clinical trials for Scoliosis Idiopathic

Protocol of Accelerated Rehabilitation Following Surgical Correction of Adolescent Idiopathic Scoliosis

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

This study aims to identify whether an accelerated physiotherapy led rehabilitation programme for adolescents undergoing idiopathic scoliosis correction surgery can be delivered safely and effectively post-operatively, and whether it might improve activity levels and quality of life outcomes for the study group. This research is being conducted as previous research indicates that up to 41% of patients who have surgical correction of their scoliosis either return to athletic activity at a lower level than before, or they do not return to athletic activity at all. This is despite significant advancement in the instrumentation being used in recent years which makes the corrections more stable and robust. Some studies have shown that surgically treated AIS patients have significantly reduced physical function and quality of life scores, and that this could be improved with exercise. So far no trials have investigated whether post-operative rehabilitation can improve quality of life for these patients. The initial study will be a pilot study, comprising of 20 participants in a small, pragmatic randomised controlled trial (RCT). It will be conducted at The Royal Orthopaedic Hospital, a specialist National Health Service (NHS) orthopaedic centre. Adolescents (between 11-18 years of age) who have a diagnosis of adolescent idiopathic scoliosis (AIS) and are on the waiting list for surgical correction of this scoliosis will be included. The study will compare a post-operative accelerated rehabilitation programme (commenced at 6 weeks post surgery) with usual care and investigate if the accelerated intervention can be delivered safely and effectively after this procedure. Following surgery, both groups will have the same inpatient rehabilitation up until the point of discharge home. The intervention group will then complete 12 sessions of physiotherapy as an outpatient, which starts at 6 week post-op. The usual care group will not have any further physiotherapy, in line with current standard practice at this centre. Both groups will be assessed using patient reported outcome measures pre-operatively, and at 6 months and 12 months post-operatively, to assess function and quality of life.

NCT ID: NCT03719716 Completed - Cancer of Pancreas Clinical Trials

Early Support in Primary Care for People Starting Treatment for Cancer

GI-ACP
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

This is a feasibility, randomised controlled trial (RCT) of a person-centred care planning intervention involving patients recently diagnosed with a poor prognosis cancer who are starting a palliative oncology treatment in a Scottish regional cancer centre.

NCT ID: NCT03719690 Completed - HNSCC Clinical Trials

Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy

AIM-HN/SEQ-HN
Start date: March 15, 2019
Phase: Phase 2
Study type: Interventional

An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.

NCT ID: NCT03719313 Completed - Clinical trials for Hepatitis Delta Virus

Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a

D-LIVR
Start date: December 1, 2018
Phase: Phase 3
Study type: Interventional

Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase (ALT) normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks) virologic response and ALT normalization will be used. Virologic response will be defined as a 2 log10 IU/mL reduction from baseline.

NCT ID: NCT03718481 Completed - Education, Medical Clinical Trials

Perceptions of the Annual Review of Competence Progression (ARCP) in Surgical Training in the UK and Ireland

Start date: October 1, 2017
Phase:
Study type: Observational

A Prospective Cross Sectional Questionnaire Study was conducted to evaluate surgical trainees' experiences of the ARCP process in order to identify areas for improvement.

NCT ID: NCT03718208 Completed - Cerebral Palsy Clinical Trials

Acceptability and Tolerance Study of a Low Calorie Peptide Based Paediatric Tube Feed Formula.

Start date: August 8, 2018
Phase: N/A
Study type: Interventional

This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of a low calorie paediatric peptide based tube feed formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).