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NCT ID: NCT03157531 Completed - PAD Clinical Trials

Safety and Effectiveness of B-Laser™ in Subjects Affected With Infrainguinal PAD

Start date: September 6, 2017
Phase: N/A
Study type: Interventional

This is a prospective, single-arm, multi-center, international, open-label, clinical study.

NCT ID: NCT03157375 Completed - Intraocular Lens Clinical Trials

Rotation of an Intraocular Lens - HOYA Vivinex iSert P261

Rot P261
Start date: October 6, 2014
Phase: N/A
Study type: Interventional

Age-related cataract is the main cause of impaired vision in the elderly population worldwide. In the UK, more than half of people who are over 65 years old have some cataract development in one or both eyes. The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted. It is estimated that around 10 million cataract operations are performed around the world each year. Cataract operations are generally very successful, with a low risk of serious complications. During the past two decades, cataract surgery underwent tremendous change and modernisation resulting in today's small incision phacoemulsification surgery and a safe technique with a short rehabilitation time for the patient. Traditional spherical monofocal intraocular lenses (IOLs) restore best-corrected vision and may lessen the need for spectacles. These IOLs correct only the spherical portion of the total refractive error and do not correct corneal astigmatism. Astigmatism is a visually disabling refractive error affecting the general population, especially those with cataract. At least 15% to 20% of cataract patients have 1.5 diopters (D) or more of corneal or refractive astigmatism. With increased patient expectations, the trend is not only to remove the cataract but also to address the problem of pre-existing astigmatism at the time of surgery. Surgical-induced astigmatism can be reduced by smaller incisions, i.e. microincision cataract surgery (MICS), which by definition is surgery performed through incisions smaller than 2.0 mm, reducing the need for suturing. This results in better corneal optical quality, thus improving visual outcomes. There are also other surgical options to correct preexisting astigmatism during cataract surgery like: selectively positioning of the phacoemulsification incision; astigmatic keratotomy with corneal or limbal relaxing incisions; excimer laser refractive procedures such as photorefractive keratectomy, laser in situ keratomileusis, and laser-assisted subepithelial keratectomy; or implanting pseudophakic toric posterior chamber intraocular lenses (IOLs). Toric IOLs have been shown to result in good visual and refractive outcomes. Combined with MICS, these IOLs can allow effective correction of cylindrical errors intraoperatively, improving visual quality and thus leading to spectacle independence. Plate haptic and loop haptic toric IOLs have been considered for about a decade but have been associated with postoperative rotational instability. Rotation of a toric lens from its intended orientation degrades its corrective power, with approximately 3.3% loss of cylindrical power for every degree off axis. A misorientation of approximately 30° negates the effectiveness of astigmatic correction, and a misorientation of more than 30° may induce additional astigmatism. Although some patients are asymptomatic despite induced astigmatism, others experience symptoms such as blurred or distorted vision, headache, fatigue, eyestrain, squinting, or eye discomfort. Thus, IOL orientation stability is an essential goal in toric IOL design. RATIONALE The purpose of this study is to assess the axial IOL rotation and optical quality (refraction, visual acuity, contrast sensitivity, decentration and tilt) and capsular bag reaction after micro-incision surgery with an IOL implantation in cataract patients - HOYA Vivinex iSert® model P261.

NCT ID: NCT03157297 Completed - Clinical trials for Atrioventricular Conduction Block

Micra Atrial Tracking Using a Ventricular Accelerometer Study

MARVEL
Start date: July 10, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize performance of the MARVEL algorithm downloaded into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV block. A sub-study will be conducted within the Marvel study, the purpose of this study is to characterize the MARVEL algorithm in patients who were enrolled in the MARVEL study, and to collect and compare the accelerometer signals and AV synchrony at a second point in time.

NCT ID: NCT03157037 Completed - Clinical trials for Anti-Glomerular Basement Membrane Antibody Disease

Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease

GOOD-IDES-01
Start date: June 16, 2017
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and tolerability of IdeS in patients with severe anti-glomerular basement membrane (anti-GBM) disease receiving standard of care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with plasma exchange (PLEX).

NCT ID: NCT03156621 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

ODYSSEY HoFH
Start date: October 3, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment. The secondary objectives of the study are: - To evaluate the effect of alirocumab Q2W on other lipid parameters (ie, apolipoprotein [Apo] A-1 and B, non-high-density lipoprotein cholesterol [non-HDL-C], total-cholesterol [TC], proportion of participants with 15%, 30%, and 50% LDL-C reductions, Lp(a), HDL-C, triglycerides [TG]) in participants with HoFH - To evaluate the safety and tolerability of alirocumab SC Q2W in participants with HoFH - To assess the pharmacokinetics of alirocumab SC Q2W in participants with HoFH - To assess the potential development of anti-drug (alirocumab) antibodies

NCT ID: NCT03155243 Completed - Uveitis Clinical Trials

Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice

HOPE
Start date: June 20, 2017
Phase:
Study type: Observational

This study aims at evaluating real life effectiveness of originator adalimumab (Humira®) participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU) despite high-dose corticosteroid therapy; including effect on ocular inflammation, health-related quality of life, health resource utilization, work ability and medication burden, as well as describe the characteristics of NIIPPU participants treated with Humira® in the real-life setting.

NCT ID: NCT03153111 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

SERENADE
Start date: July 11, 2017
Phase: Phase 2
Study type: Interventional

This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease. The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.

NCT ID: NCT03152734 Completed - Mortality Clinical Trials

Periinterventional Outcome Study in the Elderly

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

The POSE study will predict critical stages and outcome in a large sample of all surgical and non-surgical interventional patients ≥80 years of age in Europe.

NCT ID: NCT03151551 Completed - Psoriatic Arthritis Clinical Trials

A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

SPIRIT-H2H
Start date: August 24, 2017
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.

NCT ID: NCT03148795 Completed - Prostate Cancer Clinical Trials

A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer

Start date: July 4, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone).