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Clinical Trials About "Statistical considerations optimal study design human plasma proteomics" RSS

16:56 EDT 23rd October 2017 | BioPortfolio

We list hundreds of Clinical Trials about "Statistical considerations optimal study design human plasma proteomics" on BioPortfolio. We draw our references from global clinical trials data listed on ClinicalTrials.gov and refresh our database daily.

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Showing "Statistical considerations optimal study design human plasma proteomics" Clinical Trials 1–25 of 14,000+

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Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

The purpose of this study is to determine the optimal dose of sodium nitrate administered during resuscitation to achieve a plasma level of 10 μM by hospital arrival. Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV dose of sodium nitrite will achieve the optimal (based on preclinical studies) neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100 patients, we will determine whether 25 mg IV admin...


Pilot Study of Protein Profiling of the Human Epidermal Cells After Ultraviolet Irradiation

The main focus of this pilot study is to construct a fairly complete protein profile of the epidermis. This will allow us to study how the epidermis responds to external stressors such as ultra-violet. We hypothesize that by using the cutting edge technology, proteomics, we will be able to construct a fairly complete profile of different epidermal cells (keratinocytes, epidermal nerve fibers (ENFs), melanocytes, Langerhans cell,...etc) of normal and ultraviolet (UV) irradiate...

Proteomics in Morbid Obesity After Bariatric Surgery

Glycemic control is rapidly restored in patients with insulin resistance after bariatric surgery, in particular after the mal-absorptive one (i.e. Bilio-pancreatic diversion, BPD). To evaluate the mechanisms allowing restoration of insulin sensitivity after BPD the investigators aimed at identifying by using a proteomic approach plasma proteins or peptides that may be involved in the remarkably fast and explicit restoration of insulin sensitivity. In addition to the unbiased ...


Quality of Life Improvements With Cord Blood Plasma

This study aims to look at whether human umbilical cord blood plasma (HUCBP) is safe for intravascular (iv) administration; and whether it provides any reversal of frailty or other age-related biological measures.

A Study of Exosome Proteomics and Hemodynamics in Sepsis

This research will be the first study for exosomes purified in blood and urine from septic patients who had multiple organ failures. Proteomics studies in exosomes from blood or urine specimens. Analyze autophage, and apoptosis related biomarkers of exosomes by bioinformatics. To find the correlations between exosomes biomarkers and hemodynamic parameters.

A Study of Plasma-Derived Human Butyrylcholinesterase Administered Intramuscularly

The purpose of this placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of a single dosage of human butyrylcholinesterase (HuBChE) in healthy adults. HuBChE, which occurs naturally in human plasma, is being evaluated for prophylaxis and treatment in the event of exposure to chemical nerve agents (as employed during chemical warfare or as an act of terrorism). Volunteers will receive a single intramuscular infusion of either HuBChE or normal sal...

Trial of Plasma Exchange for Acute Renal Failure at the Onset of Myeloma

Background:Plasma exchange has been suggested to be of theoretical benefit in the treatment of acute renal failure at the onset of multiple myeloma. Two small-randomized trials provide conflicting evidence. Objective: To assess the effect of 5 to 7 plasma exchanges in the treatment of acute renal failure at the onset of multiple myeloma. Design: Randomized controlled trial with 4 strata (chemotherapy and dialysis dependence) from 1998 to 2004. Setting: Hospit...

Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion

This purpose of this study is to perform a pilot investigation to determine if opioid peptides such as casomorphin can be detected in human plasma after cheese ingestion.

Pharmacokinetic (PK) and Safety Study of Plasma-Derived Human Butyrylcholinesterase Administered Intravenously

The purpose of this placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of a single dose regimen of human butyrylcholinesterase (HuBChE) in healthy adults at 3 ascending dosage levels administered IV. HuBChE, which occurs naturally in human plasma, is being evaluated for prophylaxis and treatment in the event of exposure to chemical nerve agents (as employed during chemical warfare or as an act of terrorism). Volunteers in each dosage cohort wi...

L-arginine in Treatment as Usual in Schizophrenia

STUDY OBJECTIVES: To determine whether the addition of L-arginine to treatment as usual (TAU) in schizophrenia further improves and enhances therapeutic efficacy (positive, negative and depressive symptoms) and effectiveness of antipsychotic treatment STUDY POPULATION: Patients diagnosed (DSM-IV criteria) with schizophrenia or schizoaffective disorder Total expected number of patients: 14 INVESTIGATIONAL COMPOUND: L-arginine capsules, 3 grams of L-arginine given twice...

Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus

This is a multicenter, randomized, partial-blinded, five-arm, placebo-controlled study of human plasma-derived alpha1-proteinase inhibitor (alpha1-PI) in children (ages 6-11 years old) and teens/adults (ages 12-35 years old) with new onset Type 1 Diabetes Mellitus (T1DM). Currently enrolling ages 12-35 only. Once 25 patients are randomized and data is reviewed enrollment will be opened to the child cohort. The purpose of this study is to evaluate the safety and efficacy of f...

Safety and Efficacy Study To Compare Uniplas With Cryosupernatant Plasma In Thrombotic Thrombocytopenic Purpura (TTP)

Prior to the use of plasma products, thrombotic thrombocytopenic purpura (TTP) was usually a fatal condition. During plasma exchange therapy, patients need transfusion plasma that is blood group specific. Transfusing a patient with an incorrect blood group may have fatal consequences. Uniplas is a universally applicable human plasma, which can be administered irrespective of the patient's blood group. This study will test the safety and efficacy of Uniplas in comparison to cry...

Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

In recent years it has been observed that the gut microbiome can produce metabolites into systemic circulation and thus have important health effects even outside the gastrointestinal system. These metabolites may play a role in the pathogenesis of common public health problems such as diabetes, obesity and cardiovascular disorders. Modern techniques of mass spectrometry-based metabolomics from peripheral blood and gut metagenome sequencing now enable detailed examination of th...

Acute Hemodynamic Effects of Cocoa Polyphenols in Subjects With Hypertension and Optimal Blood Pressure

Intake of cocoa-containing foods has been found to lower blood pressure (BP) in several clinical trials. It is supposed that the cocoa polyphenols represent the active principle, lowering BP by increasing the formation of vasodilative nitric oxide. However, direct evidence for this assumption from controlled clinical studies is lacking. Moreover, in hypertensive subjects vascular dilation appears to be impaired due to endothelial dysfunction and vascular smooth muscle remodelin...

Proteomics Investigation of Subpopulation of Exosomes Released From Sepsis-damaged Organs-double-markers Identification of Specific Organ Failure Using Fluorescent Nanoparticle Tracking Analysis

Systematic establishment of exosome proteomics in co-culture medium and clinical sepsis specimens will be done. Ubiquitination-autophagy-apoptosis biomarkers in exosomes will be detected and correlated to specific organ failure in sepsis. The inflammatory process also will be validated by cytokines analysis. NTA double markers identification will be a smart method to understand the exosome subpopulations.

A Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease

The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R (optional) in the living human brain. No formal statistical analysis will be conducted

Quantitating the Impact of Plerixafor

The primary objective of this study is to conduct a proof of concept pilot study that will provide a preliminary evaluation of the safety of plerixafor alone or in combination with bortezomib on plasma cell mobilization, Human Leukocyte Antigen (HLA) antibody levels and toxicity profile in sensitized patients awaiting kidney transplantation. The secondary objective of this study is to conduct additional analyses of the study regimen on HLA antibody levels using multiple differ...

Danish ICD Study in Patients With Dilated Cardiomyopathy

Primary objective: The primary objective of this study is to determine the efficacy of ICD therapy compared with control on the endpoint of death from any cause. Secondary objective: The secondary objectives of the study are to determine if ICD therapy reduces sudden death. Study design: Randomized, unblinded, controlled, parallel two group trial. Primary endpoint: Time to death from any cause. Sample size: In total, 1000 patients with 500 receiving ICD and 500 patien...

Measuring the Impact of Dietary Supplementation With a New Baking Product on Gut Microbiota and Cholesterol Metabolism

Study hypothesis: Diet integrated with food prepared with olive, buckwheat, peas and chestnut flour as in PreBIOil product combination can modify the gut microbiota and the cholesterol metabolism. Primary objectives of the study are to assess whether the test product to be able to change: 1. fecal microbiota profile; 2. Plasma cholesterol LDL, total, total LDL and HDL ratio; 3. plasma triglycerides; 4. Apolipoprotein ApoA-I, ApoB, and Lp. Seconda...

A Pilot Study to Determine Optimal Procedure Steps to Obtain and Maintain Uterine Artery Occlusion With the D-UAO Device

This pilot study has a sequential design involving three groups to ensure appropriate development and evaluation of the optimal procedural steps of the D-UAO device and to confirm that those steps are reproducible in the hands of multiple surgeons.

Dance for People With Parkinson's Disease

The randomized clinical trial will aim to analyze the influence of binary and quaternary rhythm through a protocol on motor symptoms, sleep, fatigue and quality of life in individuals with Parkinson's disease. The study design with a randomized clinical trial, including individuals diagnosed with Parkinson's Disease, will be divided into two groups: 1) Control group 2) Experimental group. Cognition, balance, gait freezing, functional mobility, quality of life, sleep, daytime sl...

Proteomics for Identification of Hyperoxia-induced Changes in Protein Expression

Aim of the present study is to investigate the influence of hyperoxia on the protein expression using the differential analysis of protein expression in tissues (proteomics). In the study, blood and urine samples will be collected from participants who undergo a short term hyperoxia using 100% oxgen for 3 hours. Here, gel electrophoresis, protein separation and mass spectroscopy allow to identify affected proteins. Based on these results, different induction factors of protein...

Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples

The primary objective of the study is to establish the correlation between NT-proBNP measurements in fresh human whole blood samples and those in plasma samples from the same study subjects, where said samples are collected in EDTA and Li-Hep anticoagulant tubes and measured by the StatusFirst™ CHF NT-proBNP device in conjunction with the DXpressTM Reader in a laboratory setting.

The Relationship Between Saliva β-endorphins Levels, Cold Pressor Test and Perception of Pain in Oral Surgery Procedures

The purpose of this study is to evaluate the correlation between β-endorphin levels in blood plasma and saliva in healthy participants with different pain sensitivity and in those with acute pain in oral and maxillofacial region. Expected results - Relation between blood plasma and saliva β-endorphins levels - Differences of blood plasma β-endorphins levels in healthy participants with different pain sensitivity and in those with acute pain - Di...

Statistical Basis for Hemochromatosis Screening

To determine optimal values for transferrin saturation for use in population screening for hereditary hemochromatosis.


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