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NCT ID: NCT02682719 Recruiting - Clinical trials for Diastolic Dysfunction

ARNI in Asymptomatic Patients With Elevated Natriuretic Peptide and Elevated Left Atrial Volume Index eLEvation

PARABLE
Start date: December 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether LCZ696 (valsartan/sacubitril) is safe and has beneficial effects on the heart and blood vessels in patients with high blood pressure and/or diabetes or other risk factors for developing heart failure (elevated levels of natriuretic peptide and elevated left atrial volume index). Patients will be randomized to receive LCZ696 or valsartan (and matching placebo) for 18 months to assess the impact on left ventricular diastolic function.

NCT ID: NCT02682368 Completed - Biliary Disease Clinical Trials

Multicentric Point of Care UltraSound by Surgeons Trial

POCUSS
Start date: October 1, 2015
Phase:
Study type: Observational

Acute gallbladder pathology and acute diverticulitis are common conditions met in emergency departments and comprise the bulk of admissions throughout general surgical calls. Both entities need imagistic description to tailor further management, which may be not readily available at the moment of patient's presentation. These delays may lose the window of opportunity for timed, quality decision making and may induce increased length of stay and subsequent increased costs. Ultrasound scanning has become very popular over the last half century and the equipment has become more compact, of a higher quality and less expensive, which has facilitated the growth of point-of-care ultrasonography - POCUS - that is, ultrasound performed and interpreted by the clinician at the bedside. The concept of an 'ultrasound stethoscope' is rapidly moving from theory to reality. There are a number of studies and case reports that are highlighting the advantages of POCUS, but still common grounds need to be sought after. Some countries, like USA and Germany, incorporate basic ultrasound in their resident's curriculum among different specialties. In the author's knowledge and based on the literature, there are a few-second-to-none studies regarding POCUS involving strictly the surgeons. The hypothesis of this study is that, surgeon performed ultrasound can be as accurate as the radiologists' findings for basic diagnostics in the aforementioned pathology, leading to real time decision making in the benefit of the patient. The closing remark is that by learning and doing these procedures the surgeon performing POCUS doesn't undermine his/her radiologist colleague's authority and skill. The big picture is that some basic tasks are transferrable and if used in an appropriate and methodical manner the final common goal - the benefit of the patient - is readily achieved.

NCT ID: NCT02678364 Completed - Clinical trials for Vitamin D Deficiency

Effect of Vitamin D-biofortified Eggs on Wintertime Serum 25-hydroxyvitamin D in Adults: Randomized Controlled Trial

EnhanceDeggs
Start date: January 2015
Phase: N/A
Study type: Interventional

While there have been a considerable number of studies on the impact of additional vitamin D in the diets of hens on the resulting egg vitamin D content, the effect of consumption of such vitamin D-enhanced eggs on vitamin D status of healthy human subjects has not been tested in a RCT.

NCT ID: NCT02676986 Active, not recruiting - Clinical trials for Primary Breast Cancer ER+ve

Short-term Preoperative Treatment With Enzalutamide, Alone or in Combination With Exemestane in Primary Breast Cancer

ARB
Start date: August 2015
Phase: Phase 2
Study type: Interventional

Open-label, international, multicentre window of opportunity phase II trial to evaluate the effects of short-term preoperative therapy with enzalutamide (alone or in combination with exemestane) in women with newly diagnosed invasive primary breast cancer. The study has two cohorts: - ER+ve breast cancer - AR+ve, Triple-negative (i.e. ER-negative, PR-negative and HER2-negative) breast cancer Study treatment is planned for a minimum of 15 days and a maximum of 29 days unless there is evidence of unacceptable toxicity or the patient requests to be withdrawn from the trial. Thereafter, patients will either be considered for definitive surgery or primary medical treatment (e.g. neoadjuvant chemotherapy) at the discretion of the treating physician. The effects of enzalutamide (alone or in combination with exemestane) will be assessed on tumour tissue specimens taken at baseline and on the last day of study treatment.

NCT ID: NCT02676908 Recruiting - Varicose Veins Clinical Trials

Optimum Duration of Compression Stockings After Endovenous Varicose Vein Surgery

Start date: September 2016
Phase: N/A
Study type: Interventional

Compression stockings are traditionally worn for a period of time after varicose vein surgery to reduce pain and bruising. The investigators provide an ambulatory endovenous ablation service. Patients come to the Veins Unit, receive oral sedation, have their veins treated with either laser or radiofrequency ablation plus phlebectomies* under local anaesthetic, recover for an hour and then go home. *Phlebectomy describes the technique of pulling out small varicose veins through small incisions in the overlying skin. The standard practice of the Veins Unit is to advise patients to wear class two compression stockings for four weeks post-operatively. Many patients would prefer a shorter period of time in stockings. The Nice Guidelines for Varicose Veins has posed the question: 'How long should stockings be worn for after endovenous ablation?' Three trials have addressed this issue: Bakker looked at patients who wore stockings for either two or seven days after laser ablation only; the group who wore stockings for seven days fared better. Elderman looked at patients who either wore no stockings or stockings for two weeks after laser ablation only; the group who wore stockings for two weeks had less pain. Krasznai looked at patients who wore stockings for either 4 hours or 72 hours after radiofrequency ablation only; there was no significant difference in post-op pain among groups. None of these trials included patients who had phlebectomies at the same time. This study aims to answer the question 'How long is it necessary to wear compression stockings for after endovenous ablation (either laser or radiofrequency) plus concomitant phlebectomies?' The investigators plan to divide 110 patients into two groups- either 'stockings for 2 weeks' (trial group) or 'stockings for 4 weeks' (usual treatment group). Pre-operatively, all patients will fill out a pain score and two short quality of life questionnaires, one specific to varicose veins. Post-operatively at home, all patients will be asked to keep a diary of pain and analgesia use. They will also document bruising at seven days on charts and on a visual scale. At their four week clinic review, all patients will be asked to fill out a pain and bruising score, a bruising chart and the two short quality of life questionnaires again. The group with the best pain, bruising and quality of life scores post-operatively will help guide duration of compression therapy for future patients.

NCT ID: NCT02675426 Completed - Clinical trials for Rheumatoid Arthritis

A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

SELECT-NEXT
Start date: December 17, 2015
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.

NCT ID: NCT02674815 Completed - Clinical trials for Colorectal Neoplasms

Preoperative High Intensity Interval Training: The PHIIT Trial

PHIIT
Start date: February 2016
Phase: N/A
Study type: Interventional

Colorectal and thoracic surgical patients are susceptible to poor postoperative outcome including complications, mortality and increased length of stay. Preoperative physical fitness is protective against poor postoperative outcome in intra-abdominal and thoracic surgery. The current colorectal/thoracic pathway from diagnosis to surgery is about 2 weeks and therefore interventions of longer duration are not feasible. Clinicians may be presented with a difficult choice in delaying surgery to perform prehab or cancel the pre-op intervention. To create greater improvements in aerobic fitness, participants are required to exercise at high levels of VO2peak (e.g. ≥80% VO2peak). High intensity interval training (HIIT) requires participants to exercise at high levels of VO2peak (≥80% VO2peak) for short periods (e.g. 15 seconds) followed by a recovery (active or passive) and typically continue this pattern for 30 minutes or until exhaustion. HIIT programmes are safe and a recent meta-analysis noted that HIIT produced a more pronounced incremental gain in participants' mean VO2peak when compared with continuous moderate intensity exercise (+1.78mL/kg/min, 95% CI: 0.45-3.11). HITT has not been investigated as a preoperative intervention to either optimize fitness prior to surgery or reduce post-surgical complications. Preoperative HIIT is an intense intervention which will require significant participant adherence. The safety, cost and clinical application of such a programme needs to be performed. This feasibility study aims to assess the ability of HIIT to improve aerobic fitness two weeks prior to surgery and determine its feasibility.

NCT ID: NCT02674308 Completed - Clinical trials for Ulcerative Colitis and Crohn's Disease

Entyvio (Vedolizumab) Long Term Safety Study

Entyvio PASS
Start date: March 24, 2015
Phase:
Study type: Observational

The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).

NCT ID: NCT02673593 Completed - Healthy Clinical Trials

Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects

Start date: July 2015
Phase: Phase 1
Study type: Interventional

The purpose of the study is to investigate the safety, pharmacokinetics and food effect of DS102 (up to 2000mg single and multiple daily doses) and placebo in healthy participants. DS102 capsules will be orally administered for up to 4 weeks, and will be compared against placebo. The study will enrol approximately 56 adult subjects.

NCT ID: NCT02669069 Completed - Tinnitus Clinical Trials

Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

Start date: June 27, 2016
Phase: N/A
Study type: Interventional

This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.