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NCT ID: NCT03316885 Completed - Cataract Clinical Trials

Post-Market Clinical Investigation of the Clareon® IOL

Start date: March 14, 2018
Phase: N/A
Study type: Interventional

The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.

NCT ID: NCT03316300 Completed - Clinical trials for Macular Telangiectasia Type 2

A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A

Start date: November 24, 2017
Phase: Phase 3
Study type: Interventional

This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the NT-501 implants in participants with macular telangiectasia type 2.

NCT ID: NCT03315143 Terminated - Heart Failure Clinical Trials

Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

SCORED
Start date: December 19, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.

NCT ID: NCT03314298 Completed - Clinical trials for Mammographic Density

A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole

Start date: August 14, 2017
Phase: Phase 1
Study type: Interventional

A single dose trial to evaluate the pharmacokinetics of testosterone and anastrozole from subcutaneous testosterone and anastrozole (T+Ai) in premenopausal women

NCT ID: NCT03314181 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma

Start date: April 2, 2018
Phase: Phase 2
Study type: Interventional

This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 3 distinct parts: Part 1 includes participants with t(11;14) positive relapsed/refractory (R/R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R/R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd); Part 3 includes participants with t(11;14) positive R/R multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd). Part 1 and Part 2 are non-randomized and will be initiated with a dose-escalation phase in which increasing doses of venetoclax will be given with fixed doses of daratumumab and dexamethasone (Part 1a) or with fixed doses of daratumumab, bortezomib, and dexamethasone (Part 2a). Each dose escalation phase will be followed by a single-arm, open-label expansion phase. Part 3 will include a randomized, open-label expansion phase with participants receiving venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).

NCT ID: NCT03314012 Active, not recruiting - Clinical trials for Hypertension,Essential

First-In-Human Study Evaluating a Novel Catheter Device in Subjects With Treatment-Resistant Hypertension

Start date: December 11, 2015
Phase: N/A
Study type: Interventional

The carotid body is located at the bifurcation of the internal and external carotid arteries. It is a chemoreceptor that plays a role in the sympathetic nervous system and in the development and maintenance of hypertension. Hypertension is a major cardiovascular risk factor and is associated with coronary artery disease, stroke, chronic kidney disease, and heart failure. The objective of this study is to assess the effectiveness and safety of a catheter-based system to ablate the carotid body and reduce blood pressure (BP) in patients with resistant hypertension and to confirm sustainability of the treatment benefits long-term as seen following surgical CB removal.

NCT ID: NCT03313778 Recruiting - Solid Tumors Clinical Trials

Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors

KEYNOTE-603
Start date: August 14, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone and in combination in participants with solid tumors.

NCT ID: NCT03313180 Completed - Clinical trials for Lung Diseases, Interstitial

A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis

Start date: November 27, 2017
Phase: Phase 3
Study type: Interventional

The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).

NCT ID: NCT03312634 Completed - Clinical trials for Fibrodysplasia Ossificans Progressiva

An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.

MOVE
Start date: November 30, 2017
Phase: Phase 3
Study type: Interventional

Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO) often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to ankyloses of major joints with cumulative and irreversible loss of movement and disability.

NCT ID: NCT03311204 Completed - Clinical trials for Contact Lens Discomfort

The Effect of Eyelid Margin Debridement on Contact Lens Discomfort

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

In this study, clinical variables related to eyelids that potentially have an effect on contact lens discomfort will be investigated such as eyelid signs and secretions, eyelid sensitivity, eyelid microbiome, Demodex infestation and tear film properties. The main aim of this study is to understand the duration of efficacy of debridement of the eyelid margin and its impact on various eyelid signs (such as lid wiper epitheliopathy, lid-parallel conjunctival folds, eyelid sensitivity, meibomian gland morphology and meibum secretions, palpebral conjunctival reaction, eyelid microbiome and Demodex infestation, tear properties (both biophysical properties such as tear volume, tear meniscus height, tear evaporation, tear osmolarity and tear breakup time; and biochemical properties that are tear lipid analysis). To observe these variables, this study employs a cross-sectional design to study the effect of treatment at three instances, that is at baseline and two follow-up visits.