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NCT ID: NCT02460978 Completed - Clinical trials for Type 1 Diabetes Mellitus

Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

DEPICT 2
Start date: July 8, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

NCT ID: NCT02452931 Completed - Clinical trials for Precocious Puberty, Central

Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

Start date: August 31, 2015
Phase: Phase 3
Study type: Interventional

This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

NCT ID: NCT02452762 Completed - Hypovitaminosis D Clinical Trials

Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial

VITdAL-PICU
Start date: January 2016
Phase: Phase 2
Study type: Interventional

Documented roles for vitamin D in calcium homeostasis, cardiovascular and respiratory health, inflammation, innate immunity, and neuromuscular function have led to the hypothesis that deficiency might represent a modifiable risk factor for outcomes in critical illness. In recent years, dozens of adult studies have reported both high deficiency rates, and associations between lower vitamin D levels and organ dysfunction, health resource utilization, and mortality in the intensive care unit (ICU). More recently, similar observations have been made in critically ill pediatric populations. The cumulative body of basic science and clinical literature demonstrates that deficiency is common in critical illness and rapid normalization of vitamin D status could improve clinical outcomes and/or reduce health care costs. However, before conducting a phase III trial to determine whether restoration of vitamin D status improves outcomes in the PICU, the appropriate dosing regimen must be identified. Consequently, the investigators propose a phase II, double blind randomized controlled trial to determine a loading therapy dosing regimen that can safely and rapidly normalize vitamin D status in critically ill children.

NCT ID: NCT02451514 Completed - Clinical trials for Infections, Meningococcal

A Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)

Start date: June 30, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate persistence of bactericidal antibodies for N. meningitidis serogroups A, C, W, and Y and serogroup B test strains approximately 4 years after primary vaccination in subjects who previously received a 2-dose series of MenABCWY+Outer membrane Vesicles (OMV) or a single dose of MenACWY, to evaluate immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a dose of MenABCWY+OMV in previously vaccinated subjects, and 30 days after a 2-dose series in vaccine-naive subjects of similar age, to evaluate kinetics of immune response at 3, 7, and 30 days after a booster dose of MenABCWY+OMV in previously vaccinated subjects and to explore differences in the kinetics of immune response 3, 7 and 30 days after an accelerated 2 dose series of MenABCWY+OMV separated by 30 days given to vaccine-naive subjects, and to assess immunogenicity of 2 doses of MenABCWY+OMV at Day 61 in vaccine-naive subjects and subjects who previously received one dose of MenACWY

NCT ID: NCT02450214 Completed - Pain, Postoperative Clinical Trials

Intraoperative Ketamine and Magnesium Therapy for Control of Postoperative Pain After a Liposuction and Lipoabdominoplasty

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

Lipoabdominoplasty and liposuction are one of the most common plastic surgeries. The management of postoperative pain is complex. Non Steroidal Anti Inflammatory Drugs (NSAIDs) are insufficient, while opioids are avoided by their adverse effects and regional techniques are hampered by a premature discharge. In this context, the investigators seek an intraoperative multimodal analgesic technique blocking NMDA receptors with ketamine plus magnesium to significantly decrease postoperative pain.

NCT ID: NCT02447081 Completed - Stroke Clinical Trials

Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)

Amulet™PMS
Start date: June 1, 2015
Phase:
Study type: Observational [Patient Registry]

This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."

NCT ID: NCT02446912 Completed - Clinical trials for Active Systemic Lupus Erythematosus

Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Start date: June 9, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

NCT ID: NCT02446743 Completed - Clinical trials for Infections, Meningococcal

Combined Study - Phase 3b MenB Long Term Persistence in Adolescents

Start date: November 17, 2015
Phase: Phase 3
Study type: Interventional

The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in adolescents [who previously participated in parent studies V72_41 (NCT0142384) and V72P10 (NCT00661713)] and 2) the kinetics of immune response following booster vaccination with rMenB+OMV NZ

NCT ID: NCT02442089 Completed - Attendance Clinical Trials

Impact of Automated Calls on Pediatric Patient Attendance in Chile

Health Call
Start date: December 2013
Phase: N/A
Study type: Interventional

Missed health care appointments present a serious challenge to patient care. Especially in government funded health systems like that of Chile, missed appointments can lead to delayed care, wasted resources, and escalating costs. This private-public-research collaboration seeks to provide a rigorous, practical evaluation of a new patient reminder system, evaluate how health beliefs impact patient attendance, and capture the potential for scaling up this or other health technology systems. Using a mixed-methods approach this study will provide contextualized, triangulated analysis of pediatric patient attendance in Chile.

NCT ID: NCT02441179 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training for Incomplete Spinal Cord Injury Patients

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

Spinal cord injury (SCI) interrupts descending synaptic pathways from brainstem premotor neurons to spinal motor neurons, thereby paralyzing muscles below the neurological level. In recent years, considerable evidence has demonstrated that acute intermittent hypoxia (AIH) elicits plasticity in the spinal cord and strengthens spare synaptic pathways which is expressed as respiratory and somatic functional recovery in animals and humans suffering from incomplete SCI. The fundamental hypothesis guiding this project is that AIH-induced motor plasticity can be "harnessed" to improve walking capacity in incomplete SCI patients, classified as C and D categories according to International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The inclusion criteria include patients > 18 years-old, with traumatic or non-traumatic, non-progressive incomplete SCI, onset > 6 months, neurological level C5-T12, with walking ability with or without assistive devices, without joint contractures, orthopedic injuries, osteoporosis, cutaneous lesions, cardiopulmonary complications and a body weight below 150 Kg. A randomized, triple-blind, placebo-controlled parallel design study will be done including 100% of patients fulfilling the criteria. Participants will receive repetitive acute intermittent hypoxia (rAIH: 15 episodes of 90 second 9% inspired oxygen interspersed with 90-second normoxia) or repetitive continued normoxia (rSham: 21% inspired oxygen) combined with 45 minutes body weight-supported treadmill training on 5 consecutive days and then three times per week for 3 weeks. Primary outcome measurement will be the 10-meter walking test. Secondary outcome measurements include the 6-minute walking test, timed up and go test, body/weight load, modified ashworth scale and visual analog scale. All outcomes will be measured before beginning the protocol (baseline), after five days of AIH/Sham (D5), weekly up to the end of the study (W2-W4), and a post-study follow-up for 2 weeks (F1-F2). Aditionally, cognitive assesment before and after the study will be performed using the "Figura compleja de Rey-Osterrieth" and the "Test de aprendizaje verbal España Complutense (TAVEC)". Repetitive AIH and body weight-supported treadmill training may represent a novel, safe, and noninvasive potential therapy to partially restore walking function in incomplete sub-acute and chronic SCI patients, a population with limited, if any, potential for improved function.