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NCT ID: NCT02175303 Recruiting - Inflammation Clinical Trials

A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting

Start date: December 2013
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and inflammation, with special focus on allogeneic hematopoietic cell transplantation patients. The hypothesis to be tested is that the cells are safe to infuse and that they have an anti-inflammatory and healing effect.

NCT ID: NCT02174861 Completed - Clinical trials for Treatment for Prevention of Chronic Migraine

A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.

Start date: June 30, 2014
Phase: Phase 2
Study type: Interventional

To assess the long-term safety and efficacy of erenumab.

NCT ID: NCT02174731 Completed - Anemia Clinical Trials

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.

Start date: July 1, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.

NCT ID: NCT02174536 Recruiting - Clinical trials for Stem Cell Transplantation

A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis

Start date: March 2014
Phase: Phase 2
Study type: Interventional

A prospective double blind randomized study comparing placenta derived decidual stromal cells with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy will be superior to placebo.

NCT ID: NCT02172963 Completed - Clinical trials for Hemorrhagic Cystitis

A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis

Start date: November 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy using placenta derived decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse and that they have a positive clinical effect.

NCT ID: NCT02172937 Recruiting - Clinical trials for Graft vs Host Disease

Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease, a Phase 1-2 Study

Start date: January 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.

NCT ID: NCT02172924 Not yet recruiting - Clinical trials for Graft vs Host Disease

A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease

Start date: January 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.

NCT ID: NCT02172092 Completed - Diabetes Clinical Trials

Fluid Kinetics in Patients With Diabetic Ketoacidosis

FDKA
Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose with the study is to follow the fluid shifts that occur during fluid resuscitation of patients with diabetic ketoacidosis. In the study measurements of changes in blood and urine concentrations of Sodium and Chloride as well as blood hemoglobin are used to mathematically calculate changes in distribution volumes of these different endogenous markers.

NCT ID: NCT02171065 Completed - Clinical trials for Acute Coronary Syndrome (ACS)

PROSPECT II & PROSPECT ABSORB - an Integrated Natural History Study and Randomized Trial.

P2
Start date: June 2014
Phase: N/A
Study type: Interventional

The present study has two components, an overall prospective observational study using multimodality imaging (PROSPECT II) that will examine the natural history of patients with unstable atherosclerotic coronary artery disease with the specific goal to establish the utility of low-risk intracoronary imaging modalities, IVUS and NIRS, to identify plaques prone to future rupture and clinical events. The randomized PROSPECT ABSORB substudy will examine whether treatment of vulnerable plaques with the Absorb Bioresorbable vascular scaffold (BVS) plus GDMT safely increases the minimum lumen area (MLA) at 24 months compared with GDMT alone. The cutoff for inclusion in PROSPECT ABSORB will be a site-determined PB ≥65% (rather than the 70% cutoff identified in the original PROSPECT analysis (Stone et al., New England Journal of Medicine, 2011(5)) to account for an observed tendency for sites to underestimate plaque burden during acute treatment of ACS patients. Nonetheless, in PROSPECT, a core laboratory determined PB ≥65% was also associated with a high (7.0%) rate of major adverse cardiac event (MACE) during 3-year follow-up, a rate which may be reduced with a bioresorbable scaffold.

NCT ID: NCT02169128 Recruiting - Clinical trials for Necrotizing Fasciitis

Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

Start date: January 2014
Phase:
Study type: Observational

Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles. Approximately 40% of all patients with infections caused by S. Pyogenes develop a streptococcal toxic-shock syndrome. In these cases the mortality rates exceed 40% in spite of adequate treatment with antimicrobials. Due to the rapid progress, the extensive damage on soft tissues and high risk of death, the microbes are called "flesh-eating bacteria". The present study is a spin-off of the larger EU funded INFECT study, looking at the experiences of patient and family to understand the impact on every day life. The present prospective mixed methods study has the potential to provide important knowledge regarding the occurrence of early signs and symptoms of NSTI, quality of life 6 and 24 months after diagnosis, and how the care and treatment can be optimized and organized in a person/patient and family centered way. The study also aims at validate the SF 36 questionnaire for this group of patients.