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NCT ID: NCT03451968 Active, not recruiting - Clinical trials for Metabolism and Nutrition Disorder

Amino Acid Metabolism in Fed Surgical Critically Ill Patients

Start date: December 2, 2018
Phase: N/A
Study type: Interventional

Introduction Sarcopenia is defined as progressive generalized loss of skeletal muscle mass, strength and function. Sarcopenia due to lack of physical activity is a known phenomenon and is usually observed as a normal part of aging or in certain diseases and pathogenic processes. Major associated factors causing development of sarcopenia may be summarized as interactions of environmental and hormonal factors, underlying diseases, activation of inflammatory pathways, mitochondrial dysfunction, reduced satellite cell numbers, and loss of neuromuscular junctions. Intensive care acquired weakness (ICU-AW) known formerly as critical illness polyneuropathy, is a diagnosis that becomes more common as survival rates from long ICU hospitalization are more prevalent. It is characterized by a primary axonal degeneration, without demyelination, that typically affects motor nerves more than sensory nerves. ICU-AW affects the limbs (particularly the lower extremities) in a symmetric pattern. Weakness is most notable in proximal neuromuscular areas (e.g., the shoulders and hip girdle). In addition, involvement of the respiratory muscles can occur and can impede weaning from mechanical ventilation. The pathophysiological mechanisms of ICU-acquired weakness are believed to be multifactorial. Some suspected factors include dysfunctional microcirculation and hyperglycemia. It has been shown that tight glucose control in ICU patients reduces the risk for ICU-AW (although it has been associated with other adverse events). Sodium channels channelopathy is also a researched cause for ICU-AW. Muscle loss in the ICU are usually related to bedridden condition and lack of mobility, increase in ubiquitination and inadequate protein administration associated with large negative nitrogen balance. In addition mechanical ventilation contributes greatly to this problem. This has been particularly relevant in post trauma/surgical long stayer patients. In the past years great progress was made in the investigation of protein balance, breakdown and synthesis using stable isotope tracers in various medical conditions. In a research performed in PICU (1-5) and ICU (6, 7) regarding the measurement of plasma amino acid during critical illness, stable phenylalanine, tyrosine leucine, arginine and citrulline isotope were used intravenously without any safety issue problem. Another study was performed on adults suffering from COPD with matched healthy adults, using stable isotopes of phenylalanine, tyrosine leucine, isoleucine and valine (8). During the study the isotopes were given parenterally as well as enterally. The study showed significant change in splanchnic extraction of various amino acids and higher turnover of BCAA in COPD patients. Using the theory that supplemental milk can compensate for the elevated turnover of BCAA in COPD patients, using the isotope analysis demonstrated that this theory was proven wrong and the conclusion was that alterations are present in BCAA metabolism despite normal plasma levels in normal weight COPD. Further research is needed to find a way to compensate for it. These studies and other recent studies (9-19) show us the safety regarding the use of stable isotope tracers whether IV or PO, while giving us the opportunity to assess the metabolism of amino acid in all sorts of pathological states. Hypothesis & Aim of the study We think that based on current literature, there are important differences between critically ill patients and healthy population in the amino acid profile and distribution in the body as well as synthesis and breakdown. The aim of the study is to measure these differences in long ICU stayers (above 7 days) admitted in the ICU after surgical/trauma injury, and to try and help aiming future treatment and research in this field.

NCT ID: NCT03451916 Completed - Hip Fracture Clinical Trials

Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)

Start date: July 26, 2018
Phase: Phase 3
Study type: Interventional

The objectives of this study are to assess the efficacy, safety, and tolerability of PLX-PAD intramuscular administration for the treatment of muscle injury following arthroplasty for HF.

NCT ID: NCT03449381 Recruiting - Neoplasms Clinical Trials

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)

Start date: May 21, 2018
Phase: Phase 1
Study type: Interventional

This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink. In this study, brigimadlin is given to humans for the first time. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Brigimadlin is taken as a tablet. Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every 4 weeks. The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants' general health during the study.

NCT ID: NCT03449147 Completed - Chronic Cough Clinical Trials

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

Start date: March 15, 2018
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.

NCT ID: NCT03449134 Completed - Chronic Cough Clinical Trials

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)

Start date: March 14, 2018
Phase: Phase 3
Study type: Interventional

The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.

NCT ID: NCT03447769 Terminated - Clinical trials for Non-Small Cell Lung Cancer

Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

Canopy-A
Start date: March 16, 2018
Phase: Phase 3
Study type: Interventional

The primary purpose of the study was to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages II -IIIA according to the 8th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) and the subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).

NCT ID: NCT03447262 Terminated - Cystic Fibrosis Clinical Trials

A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy

Start date: July 13, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation.

NCT ID: NCT03447249 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Start date: March 7, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

NCT ID: NCT03447236 Completed - Clinical trials for Mild Cognitive Impairment

Functional MRI Changes Resulting From the Feuerstein Program in Older People With Mild Cognitive Impairment (MCI)

Start date: July 4, 2017
Phase: N/A
Study type: Interventional

Background: The Feuerstein Instrumental Enrichment Program was designed to prevent mental deterioration and preserve cognitive abilities among people aged 60 and above. The program is an applied practicable program based on the theories of Structural Cognitive Modifiability as well as on a Mediated Learning Experience. The program takes into consideration the unique characteristics and requirements of the older population. The program is composed of a variety of cognitive tasks that offer systematic activities intended to stimulate mental and cognitive development. Objective: To examine the influence of the Feuerstein Program on brain functional connectivity as measured by MRI assessments and cognitive function of participants suffering from Mild Cognitive Impairment (MCI). Hypothesis: The Feuerstein Program will improve cognitive abilities and affect brain functional connectivity. Methods: Residents of retirement homes will be offered to participate in the study. Participants will undergo cognitive and MRI assessments prior to and following a period of cognitive intervention using the Feuerstein Instrumental Enrichment Program.

NCT ID: NCT03443882 Active, not recruiting - Healthy Volunteers Clinical Trials

Bioavailability of Astaxanthin Formulations

Start date: March 25, 2018
Phase: Early Phase 1
Study type: Interventional

Bioavailability of dietary supplement formulations in healthy volunteers after a single oral dose.