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NCT ID: NCT03242252 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

SOTA-CKD3
Start date: August 16, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment. Secondary Objectives: - To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight. - To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.

NCT ID: NCT03242018 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

SOTA-CKD4
Start date: August 16, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: - To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c - To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo - To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo

NCT ID: NCT03241368 Completed - Crohn Disease Clinical Trials

Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease.

BLINK
Start date: December 21, 2017
Phase: N/A
Study type: Interventional

This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease. The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease. There will be assessment of mucosal disease activity at baseline. Patient satisfaction questionnaire will be completed at baseline.

NCT ID: NCT03240302 Not yet recruiting - Infertility Clinical Trials

A Comparative Study of Sibling Oocytes: ICSI vs. the PICSI Sperm Selection Method

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

The aim of this research is to compare sibling oocytes using two sperm selection methods for choosing the best quality spermatozoa before they are injected into oocytes and the influence of each of these methods on embryo quality and IVF outcome.

NCT ID: NCT03240276 Not yet recruiting - Infertility Clinical Trials

A Comparative Study of Sibling Oocytes: ICSI vs. the IMSI Sperm Selection Method

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

The aim of this research is to compare sibling oocytes using two sperm selection methods for choosing the best quality spermatozoa before they are injected into oocytes and the influence of each of these methods on embryo quality and IVF outcome.

NCT ID: NCT03240133 Completed - Clinical trials for Hereditary Angioedema (HAE)

Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema

Start date: July 31, 2017
Phase: Phase 2
Study type: Interventional

This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor, BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks) or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject diary entries completed at pre-defined times post-dose.

NCT ID: NCT03237455 Recruiting - Diabetes Mellitus Clinical Trials

Magnetic Resonance Imaging in High Risk Patients for the Development of Diffuse Idiopathic Skeletal Hyperostosis (DISH)

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

Diffuse idiopathic skeletal hyperostosis (DISH) is a poorly understood, systemic condition characterized by progressive calcification and ossification of ligaments and entheses. The current classification criteria allow diagnosing the disease in its late course, when significant bony overgrowth already involves the vertebral column and the appendicular skeleton. The research of the pathogenic mechanisms in DISH, is significantly hampered by the late diagnosis resulting from this definition.Based on recent MRI studies in both axial spondyloarthritis (axSpA) and in DISH, it seems that changes similar to the classical early inflammatory changes described in axSpA, can be detected in patients with DISH. We therefore hypothesize, that patients with metabolic syndrome without radiographic evidence for spinal DISH, might exhibit early MRI changes. If this hypothesis proves to be correct, early diagnosis and research of the possible pathogenetic mechanisms at this early stage might be very rewarding in investigations of the early aberrations of the entheses homeostasis and eventually early, more targeted therapeutic interventions. The study will examine MRI changes in patients, in their 5th decade of life, with high risk for the development of DISH (ie diabetes mellitus, metabolic syndrome) compared with patients who don't have this risk.

NCT ID: NCT03235544 Active, not recruiting - Lymphoma Clinical Trials

A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

(CITADEL-205)
Start date: November 20, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

NCT ID: NCT03234712 Completed - Clinical trials for Advanced Solid Tumors Cancer

A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)

Start date: October 10, 2017
Phase: Phase 1
Study type: Interventional

This is an open-label, Phase 1, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-321 for participants with advanced solid tumors likely to overexpress the epidermal growth factor receptor (EGFR). The study will consist of 2 phases: Dose Escalation Phase and Expansion Phase.

NCT ID: NCT03234647 Completed - Acute Heart Failure Clinical Trials

First In Human Study of the Doraya Catheter for the Treatment of AHF Patients

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

Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.