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NCT ID: NCT03334422 Completed - Atopic Dermatitis Clinical Trials

Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis

BREEZE-AD2
Start date: November 27, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.

NCT ID: NCT03334396 Completed - Atopic Dermatitis Clinical Trials

A Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis

BREEZE-AD1
Start date: November 23, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.

NCT ID: NCT03332784 Completed - Clinical trials for Healthy Participants and Patients With Narcolepsy

Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Participants With Narcolepsy

Start date: November 4, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate safety, tolerability, and pharmacokinetics of TAK-925 when a single dose of TAK-925 is administered to healthy adult participants, healthy elderly participants and patients with type 1 narcolepsy.

NCT ID: NCT03332459 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection

Start date: January 5, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the clinical diagnosis of asthma and the frequency of wheezing in infants and children with respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo) and have completed their last planned study-related visit in a feeding Phase 2 study (64041575RSV2004).

NCT ID: NCT03330444 Completed - Clinical trials for Infertility of Uterine Origin

Development of a Microbiome Non-invasive Diagnosis Tool

ERA-niMIC
Start date: August 4, 2017
Phase:
Study type: Observational

Although the endometrium tissue has been traditionally considered free of bacteria, recent studies have documented the presence of an endometrial microbiome. In a pilot study conducted by our research team, the microorganisms present in the endometrium were analysed in samples of endometrial fluid (EF) using next generation sequencing (NGS).Consistent with previously published studies, in normal conditions the endometrium is mainly composed of different species of the genus Lactobacillus. It was further noted that the presence of other pathogenic bacteria such as Streptococcus, and/or Gardnerella may alter the endometrial microbiome and can disrupt the uterine environment, affecting implantation rates and pregnancy success. This project aims to validate the microbiome found in the endometrium of women of reproductive age and try to corroborate the relationship between the endometrial microbiome and the reproductive outcomes in patients undergoing assisted reproduction treatment (ART). The use of Endometrial Receptivity Analysis (ERA) tool, together with the analysis of the endometrial flora before the embryo transfer will allow to evaluate the impact of the presence of endometrial pathogens on implantation in receptive patients. Therefore, the focus of this project is the development and clinical validation of a non-invasive diagnosis tool to analyse the microbiota, adding the microbiome study to the ERA analysis.

NCT ID: NCT03329846 Completed - Melanoma Clinical Trials

An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma

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

The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated

NCT ID: NCT03329690 Completed - Clinical trials for Neoplasm, Gastrointestinal

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]

Start date: November 2, 2017
Phase: Phase 2
Study type: Interventional

The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens including fluoropyrimidine agent, platinum agent, and trastuzumab.

NCT ID: NCT03329196 Completed - Clinical trials for Anemia; Non-dialysis Dependent Chronic Kidney Disease

Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

Start date: October 30, 2017
Phase: Phase 3
Study type: Interventional

For Non-dialysis subjects with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548. For subjects not currently receiving ESAs, evaluate Hb correction and maintenance effect of MT-6548 and for subjects currently receiving ESAs, evaluate Hb conversion and maintenance effect of MT-6548

NCT ID: NCT03324113 Completed - Neoplasm Malignant Clinical Trials

Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors

Start date: October 17, 2017
Phase: Phase 1
Study type: Interventional

Primary Objective: - To evaluate tolerability and safety of SAR408701 when administered as a single agent according to the investigational medicinal product (IMP) related dose limiting toxicities (DLTs) to determine the recommended dose (RD) of SAR408701 in Japanese patients with advanced malignant solid tumors. Secondary Objectives: - To characterize the overall safety profile of SAR408701 monotherapy. - To characterize the pharmacokinetic (PK) profile of SAR408701 and its metabolites. - To evaluate the pharmacodynamic (PDy) effect of SAR408701 on levels of circulating carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) for main dose escalation part. - To assess preliminary efficacy according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and other indicators of antitumor activity. - To assess the potential immunogenicity of SAR408701.

NCT ID: NCT03322631 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes

Start date: November 15, 2017
Phase: Phase 1
Study type: Interventional

The purposes of this study are to determine: - The safety of tirzepatide and any side effects that might be associated with it. - How much tirzepatide gets into the bloodstream and how long it takes the body to remove it. - How tirzepatide affects the levels of blood sugar. This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC) injections just under the skin. The study will last about 16 weeks (total), including screening and follow-up. This study is for research purposes only and is not intended to treat any medical conditions.