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NCT ID: NCT02447666 Completed - Clinical trials for Myelodysplastic Syndrome

Study With Azacitidine in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome (MDS) and Juvenile Myelomonocytic Leukemia (JMML)

Start date: September 15, 2015
Phase: Phase 2
Study type: Interventional

Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT). Objectives Primary Objective The primary objective is to assess the treatment effect on response rate (MDS: either complete remission [CR], partial remission [PR], or marrow CR; JMML: either clinical complete remission [cCR] or clinical partial remission [cPR]); at Cycle 3 Day 28 (each cycle is 28 days) and to compare against standard therapy using a matched-pairs analysis of historical data. Secondary Objective The secondary objective is to further evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of azacitidine in this subject population. Study Design This is a prospective, open-label, Phase 2 study consisting of 2 parallel experimental arms, one for each disease group: MDS and JMML. Each arm is designed based on Simon's Optimal 2 stage study design. The sample size has been calculated to allow evaluation of the response rate at 28 day-Cycle 3 Day 28 in each of the 2 disease groups. Each of the experimental arms will also individually be compared against a historical control arm using data retrospectively collected from the European Working Group of MDS in childhood (EWOG-MDS) registry by means of a matched-pairs analysis; matched for predefined subject baseline characteristics defined before any results from this study are known post Stage 1. If matched pair is not viable then other methodologies will be explored to evaluate and compare response rates reported in literature and also in registry database Twenty subjects with MDS and 35 JMML subjects evaluable for the primary endpoint (ie, subjects that receive at least 1 dose of investigational product [IP]) will be enrolled at approximately 45 centers in Europe. Each experimental arm has 1 interim analysis planned (at the end of Stage 1). If, during Stage 1 evaluation, less than 2 subjects are observed with a CR, PR, or marrow CR after 3 months of azacitidine in the first 9 subjects with MDS, then enrollment will be stopped. Similarly, if less than 3 subjects are observed with a cPR or cCR after 3 months of azacitidine in the first 18 subjects with JMML, then enrollment will be stopped.

NCT ID: NCT02447302 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis

Start date: October 15, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.

NCT ID: NCT02447172 Completed - Infection Clinical Trials

Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers

COACT-2
Start date: June 2015
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. After completing treatment, patients will return to the clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.

NCT ID: NCT02445248 Completed - Clinical trials for Diffuse Large B-cell Lymphoma (DLBCL)

Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients

JULIET
Start date: July 29, 2015
Phase: Phase 2
Study type: Interventional

This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.

NCT ID: NCT02443155 Completed - Diabetes Clinical Trials

A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

Start date: November 10, 2015
Phase: Phase 2
Study type: Interventional

This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.

NCT ID: NCT02441946 Completed - Breast Cancer Clinical Trials

A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

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

The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.

NCT ID: NCT02439749 Completed - Hypertension Clinical Trials

SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

Start date: June 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.

NCT ID: NCT02438488 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D and Mortality: an Individual Participant Data Meta-analysis of Standardized 25-hydroxyvitamin D

Start date: April 2015
Phase: N/A
Study type: Observational

Vitamin D deficiency is a risk factor for mortality but existing data are limited by missing standardization of laboratory methods for 25-hydroxyvitamin D (25[OH]D). In a European consortium of eight cohort studies we use protocols of the Vitamin D Standardization Program (VDSP) to obtain standardized 25(OH)D data. Individual participant data (IPD) meta-analyses using a one step procedure will be performed to study associations of original and standardized 25(OH)D with all-cause, cardiovascular, and cancer mortality.

NCT ID: NCT02437591 Completed - Clinical trials for Inflammatory Bowel Disease (IBD)

Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

PROFILE
Start date: August 13, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI). This study will also compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. difficile total viable count and spore count during treatment with FDX and if achieved; the time to microbial eradication; determine time to negative CDI toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving FDX; record the incidence and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.

NCT ID: NCT02437474 Completed - Neoplasms Clinical Trials

Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival - A Pilot Study

Start date: April 2015
Phase: N/A
Study type: Observational

The purposes of this study are - to test the hypothesis that elimination or reduction of dietary animal proteins leads to an improved prognosis in tumor patients - to estimate the effect size and thus to enable sample size calculations for further studies - to test the feasibility and tolerance of different diets, especially a vegan diet, in cancer patients and to proof that a vegan diet does not lead to a deterioration of health, tumor progression or to malnutrition - to test the online platform as a study platform - to test validity of self reported and online generated data