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NCT ID: NCT02587143 Completed - Pain Clinical Trials

Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures

Start date: February 2016
Phase: N/A
Study type: Interventional

Ethyl chloride vapocoolant sprays provide transient skin anesthesia within seconds of application. The current investigation aim is to compare the effect of ethyl chloride based vapocoolant spray to placebo in reducing pain associated with arterial puncture for gasometry determinations. The investigators will conduce a double-blind randomized placebo-controlled trial at Emergency Department. We will enroll patients who come to Emergency Department who need an arterial gasometry determination. Patients will be randomized to intervention-group (ethyl chloride vapocoolant sprays will be usad before arterial puncture) or to placebo-group (alcohol spray as placebo will be used before arterial puncture.) and after the puncture they will rate their pain using a 10 points visual analogue scale.

NCT ID: NCT02586298 Completed - Infertility Clinical Trials

Autologous Mitochondrial Transfer in ICSI to Improve Oocyte and Embryo Quality in IVF Patients. Pilot Study

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

The principle objective is to improve embryo quality through autologous micro-injection of mitochondria isolated from Ovarian stem cells into the oocytes themselves, as a complementary ICSI technique in patients with low embryo quality in previous IVF cycles and in those who did not bear children. This improvement in embryo quality will be determined through on-going pregnancy rate after treatment and/or improvement in embryo quality according to morphological (ASEBIR-"Association for the study of Biology in Reproductive Science), morphokinetic criteria and in Preimplantation Genetic Screening. Using an adaptive design, retrieved oocytes of approximately 60 patients will be randomized in the first part of the study to two treatment groups; standard ICSI procedure without mitochondrial supplementation and ICSI with autologous mitochondrial supplementation. Following an interim analysis of outcomes, an additional 130 patients may be added, for a total of 190 patients.

NCT ID: NCT02586233 Completed - Clinical trials for Acute Ischemic Stroke

Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke

ASSENT
Start date: September 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2, double-blind (study participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with Acute Ischemic Stroke (AIS).

NCT ID: NCT02585986 Completed - Dermatitis, Atopic Clinical Trials

Intervention Study to Evaluate a Probiotic in Mild Atopic Dermatitis Young Patients

Start date: January 2016
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the beneficial effect of a probiotic preparation with an antiinflammatory and modulating activity on immunological processes, with positive results on different inflammatory and atopic conditions.

NCT ID: NCT02585960 Completed - Hemophilia A Clinical Trials

BAX 855 PK-guided Dosing

PROPEL
Start date: November 23, 2015
Phase: Phase 3
Study type: Interventional

1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%) 2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855

NCT ID: NCT02585934 Completed - Alzheimer's Disease Clinical Trials

Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study

Start date: October 2015
Phase: Phase 3
Study type: Interventional

This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.

NCT ID: NCT02585895 Completed - Clinical trials for Hypercholesterolemia

Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment

Start date: December 21, 2015
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.

NCT ID: NCT02585778 Completed - Clinical trials for Hypercholesterolaemia

Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)

Start date: October 23, 2015
Phase: Phase 3
Study type: Interventional

Primary Objectives: - To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. - To evaluate the safety and tolerability of alirocumab in participants with diabetes treated with insulin. Secondary Objective: To demonstrate that alirocumab was superior in comparison to placebo in its effects on other lipid parameters (i.e., measured LDL-C, non-high-density lipoprotein cholesterol [non-HDL-C], apolipoprotein B [Apo B], total cholesterol [TC], lipoprotein a [Lp(a)], high density lipoprotein cholesterol [HDL-C], triglyceride [TG] levels, triglyceride rich lipoproteins [TGRL], apolipoprotein A-1 [Apo A-1], apolipoprotein C-III [Apo C-III], and LDL particle number and size).

NCT ID: NCT02585492 Completed - Neonatal Disorder Clinical Trials

Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels.

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

The purpose of this study is to determine if the position of the mother in the first two hours after delivery, while she is in skin to skin contact with your child, influences the oxygen saturation and/or heart rate of the newborn. In this way it could provide some useful information for the prevention of seemingly lethal episodes or sudden death of the child when, following current recommendations is skin to skin contact in the first hours of life. These episodes are communicating in all developed countries and have caused great concern and interest in the scientific community. So far we only have information from case series.

NCT ID: NCT02584959 Completed - Clinical trials for Hereditary Angioedema (HAE)

Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

Start date: November 1, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of subcutaneous administration of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in adolescent and adult subjects with hereditary angioedema.