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NCT ID: NCT03920072 Recruiting - Clinical trials for X-linked Hypophosphatemia

Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH

Start date: March 7, 2019
Phase: Phase 3
Study type: Interventional

This is phase 3b open-label, international, multicenter study to continue to monitor the long-term safety and efficacy of burosumab in adult patients with XLH that participated in previous clinical trials with burosumab (UX023-CL303 / UX023-CL304).

NCT ID: NCT03911986 Recruiting - Clinical trials for Atrial Fibrillation and Flutter

Risk-Based Screening for the Evaluation of Atrial Fibrillation Trial

R-BEAT
Start date: March 21, 2018
Phase: N/A
Study type: Interventional

1. To determine whether a risk-based screening programme for occult paroxysmal atrial fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of 3 or greater, increases the detection of new atrial fibrillation/flutter. 2. To determine whether a risk-based screening programme for occult paroxysmal atrial fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of 3 or greater, is cost-effective. 3. To determine the sensitivity, specificity, positive predictive value and negative predictive values of self-monitoring of pulse in adults for detection of atrial fibrillation. 4. To determine the cost, cost effectiveness, and budget impact of a risk-based screening programme for occult paroxysmal atrial fibrillation, relative to a control of usual care in general practice.

NCT ID: NCT03901898 Not yet recruiting - Diabetes Clinical Trials

Feasibility of an Intervention to Increase Diabetic Retinopathy Screening Attendance

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

The purpose of this study is to test a way to support practices to improve attendance at retinopathy screening among people with diabetes. This new approach will be delivered to staff in general practice and involves: 1) briefing and audit training for practice staff; 2) electronic alerts on patient files to prompt GPs and nurses to remind patients, 3) face-to-face, phone and letter reminders and a brief information sheet for people with diabetes who have not attended screening, and; 4) payment to practices. The practice will carry out an audit to identify patients who have not attended screening, and re-audit at 6 months to identify any changes in attendance. The study will test this new approach over six months in eight different practices to determine whether it is feasible to deliver in a real-world setting. Four practices will be randomly assigned to receive the new approach straight away (intervention group), while the other four practices will be assigned to the group who wait, deliver care as usual, and roll out the new approach after six months (wait-list-control group). After the new approach has been tested for six months, the research team will use staff questionnaires, and carry out focus groups and interviews with patients and practice staff to learn about their experiences. The time and resources needed to deliver the approach will also be recorded to estimate the cost of delivering the new approach and how feasible it would be to carry out a larger study.

NCT ID: NCT03896737 Not yet recruiting - Multiple Myeloma Clinical Trials

Daratumumab-bortezomib-dexamethasone (Dara-VCd) vs Bortezomib-Thalidomide-Dexamethasone (VTd), Then Maintenance With Ixazomib (IXA) or IXA-Dara

Start date: April 16, 2019
Phase: Phase 2
Study type: Interventional

This protocol is a phase II multicenter, randomized, open label study designed to assess the efficacy and safety of daratumumab combined with bortezomib, cyclophosphamide and dexamethasone (Dara-VCd) versus the association of bortezomib, thalidomide and dexamethasone (VTd) as pre transplant induction and post transplant consolidation, followed by maintenance with ixazomib alone or in combination with daratumumab, in newly diagnosed multiple myeloma (MM) patients eligible for autologous stem cell transplantation. Patients enrolled in the Dara-VCd arm will receive: 4 cycles of daratumumab-bortezomib-cyclophosphamide-dexamethasone induction, followed by transplantation and 2 cycles of daratumumab-bortezomib-cyclophosphamide-dexamethasone consolidation. The choice of cyclophosphamide in combination with bortezomib and dexamethasone is suggested by the better safety profile of cyclophosphamide, in comparison with thalidomide and the efficacy of the alkylator agent, when combined with bortezomib. Once-weekly bortezomib seems to be equally effective and better tolerated than the standard twice weekly schedule. The outcomes and response rate did not appear to be affected by the bortezomib dosing schedule. Patients enrolled in the VTd arm will receive: 4 cycles of bortezomib-thalidomide-dexamethasone induction, followed by autologous transplantation and 2 cycles of bortezomib-thalidomide dexamethasone as consolidation. The VTd drug association is the current standard first line induction therapy for multiple myeloma patients who are eligible to stem cell transplantation. At the end of consolidation phase patients with at least a partial response (≥ PR) will be rerandomized (assigned by chance) to one of 2 treatment groups to receive maintenance treatment with ixazomib alone or in combination with daratumumab. Patients will receive treatment until any sign of progression or intolerance, up to 24 months.

NCT ID: NCT03894267 Recruiting - Wounds Clinical Trials

An Evaluation of the Impact of a Wound Dressing on Pressure Ulcer Incidence.

Start date: March 12, 2019
Phase: N/A
Study type: Interventional

A pressure ulcer (PU) is localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear. PUs are common, affecting up to 40% of participants receiving health care. Furthermore, PUs impact negatively on an individual's health related quality of life, with pain being the most frequently cited complaint. PUs commonly occur in those who cannot reposition themselves to relieve pressure/shear over bony prominences. The ability to reposition is often diminished in the very old, the malnourished and those with acute illness. Pressure ulcers are common devastating wounds, extending from deep in the bone and muscle layers through to the skin, occurring most often in older persons with limited mobility. They contribute to significant morbidity and mortality as they are smelly, highly painful and very prone to infection. Existing research carried out by the RCSI School of Nursing and Midwifery shows that both high and low movers are at risk of pressure ulcer development.

NCT ID: NCT03892395 Active, not recruiting - Bone Health Clinical Trials

An Intervention Study to Investigate the Effect of B-vitamin Supplementation for 2-years on Bone Health

Opti-Age
Start date: May 5, 2017
Phase: N/A
Study type: Interventional

An intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health. This is a dual centre (UCD and University of Ulster) 2-year randomised, placebo controlled, double blind intervention.

NCT ID: NCT03871998 Recruiting - Eczema Clinical Trials

Short-term Topical Application to Prevent Atopic Dermatitis

STOP AD
Start date: April 16, 2019
Phase: N/A
Study type: Interventional

This is a randomised, open-label, controlled study designed to investigate the effect of short-term neonatal skin barrier protection using a commercially available moisturiser on the prevention of atopic dermatitis and food allergy in high risk children.

NCT ID: NCT03871023 Not yet recruiting - Clinical trials for Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay

Prophylactic Negative Wound Therapy in Laparotomy Wounds.

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

Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. The impact of different types of wound therapy are not clear in the literature. The hypothesis of this study is that NPWT has the potential to reduce Surgical Site Infections, however no study has compared the most commonly used products against standard dressings.

NCT ID: NCT03869892 Not yet recruiting - Clinical trials for Metastatic Colorectal Cancer

Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.

SOLSTICE
Start date: March 20, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.

NCT ID: NCT03869762 Recruiting - Metastatic Cancer Clinical Trials

Phase II Study of Denosumab in Combination With Enzalutamide in Progressive Metastatic Castrate-resistant Prostate Cancer and Bone Metastases.

DICE
Start date: January 9, 2019
Phase: Phase 2
Study type: Interventional

Open-label phase II multi-centre single arm study of Denosumab in combination with enzalutamide in progressive metastatic castrate-resistant prostate cancer.