50 colorectal cancer patients receiving FOLFOX 6: (Oxaliplatin 85mg/m2 IV over 2 hrs + leucovorin 400mg/m2 IV over 2 hrs, followed by 5-FU 400mg/m2 IV bolus, followed by 5-FU 1,200mg/m2 /day IV x 2 days (total 2,400mg/m2 ) as a 46-48 hr continuous infusion. Repeat every 2 weeks) in addittion to atorvastatin (20 mg once daily) or FOLFIRI 6:( Irinotecan 180mg/m2 IV + leucovorin 400mg/m2 IV, followed by 5-FU 400mg/m2 IV bolus, followed by 5-FU 1,200mg/m2 /day IV x 2 days (total 2,400mg/m2 ) as a 46-48 hr continuous infusion. Repeat every 2 weeks) in addittion to atorvastatin (20 mg once daily) in addittion to atorvastatin (20 mg once daily)

50 colorectal cancer patients receiving FOLFOX 6: (Oxaliplatin 85mg/m2 IV over 2 hrs + leucovorin 400mg/m2 IV over 2 hrs, followed by 5-FU 400mg/m2 IV bolus, followed by 5-FU 1,200mg/m2 /day IV x 2 days (total 2,400mg/m2 ) as a 46-48 hr continuous infusion. Repeat every 2 weeks) or FOLFIRI 6:( Irinotecan 180mg/m2 IV + leucovorin 400mg/m2 IV, followed by 5-FU 400mg/m2 IV bolus, followed by 5-FU 1,200mg/m2 /day IV x 2 days (total 2,400mg/m2 ) as a 46-48 hr continuous infusion. Repeat every 2 weeks)

Colorectal Cancer

Atorvastatin 20mg

Faculty of Pharmacy

Effect of Atorvastatin on 5-Fluorouracil Induced Mucositis

The Effect of Atorvastatin on The Prevention of 5-fluorouracil-induced Mucositis in Colorectal Cancer Patients

screening the patients seeking mucositis & grading mucositis using Common Terminology Criteria for Adverse Events, CTCAE version 5 ( ranging from grade 1 of better outcome to 5 of worst outcome ) and evaluating the effect of atorvastatin on mucositis

the grade of mucositis will be assessed using common terminology criteria of adverse effects version 5

the pain due to mucositis will be assessed using visual analogue scale

The Oral Health Impact Proﬁle-14 (OHIP-14) will be used to assess the effect of mucositis on the patients' liferanging from 0 of better outcome to 56 of worst outcome

serum ALT and AST will be assessed before each cycle

serum tumor necrosis factor α (TNF-α) will be assessed at baseline and after 6 months

Radwa Salah Lotfy Abdel-Rahman

Clinical Pharmacist at nasser institute

Ain Shams University

Nasser Institute For Research and Treatment

Prospective, Randomized, controlled, open-label pilot study will be conducted on 100 colon cancer patients receiving 5-FU adjuvant FOLFOX -6 & FOLFIRI-6 therapy.

High Altitude Cerebral Edema

Dexamethasone 3.3 mg/mL solution for injection

Dexamethasone

Sodium Chloride 0.9% w/v solution for injection

Placebo

University Hospitals Coventry and Warwickshire NHS Trust

Spectroscopic and Diffusion Weighted Analysis of the Effects of Dexamethasone on High Altitude Cerebral Oedema (HACE)

Differences in oedematous changes in the brain and spinal cord as measured by changes in brain and spinal cord MRI imaging

To assess the role of primary blood brain barrier breakdown in hypoxic cytotoxic oedema as measured by variation in serum markers

Change in glial specific (GFAP) and non-glial specific (purines) serum biomarkers from baseline and at 8, 11, 22 and 26 hours post hypoxic insult

To develop a hypoxic spinal cord model for use in future research looking into complex vascular surgery.

Individual participant data will not be shared with other researchers

Double-blind, randomised controlled trial

The participant, Investigator supervising the visit and the Outcome Assessor will be blinded to the treatment allocation

Patients with mitochondrial disease, investigated by blood samples and exercise test.

Patients with metabolic myopathy, investigated by blood samples and exercise test.

Patients with muscular dystrophy, investigated by blood samples and exercise test.

Healthy controls, investigated by blood samples and exercise test.

Mitochondrial Disease

Metabolic Myopathy

Muscular Dystrophy

Rigshospitalet

GDF-15 as a Biomarker for Mitochondrial Disease

The blood sample will be analysed with a Luminex analyser to determine the concentration of GDF-15.

The subjects perform an incremental exercise test until exhaustion on a cycle ergometer. The concentration of GDF-15 is measured afterwards with a Luminex analyser.

Lactate is a muscle marker, that is measured in this study.

Pyruvate is a muscle marker, that is measured in this study.

Creatin kinase is a muscle marker, that is measured in this study.

FGF-21 (Fibroblast Growth Factor 21) is a muscle marker that is measured in this study.

During the exercise test, the subjects will breath through a mask, that is connected to a machine. The machine is able to calculate the VO2max.

The Wmax will be calculated during the exercise test.

Nanna Scharff Nielsen

Student researcher

Rigshospitalet, Denmark

To Evaluate the Effect of Therapy With IT MTX on the Disease Course of Patients With Progressive MS

12.5 mg of methotrexate diluted to a concentration of up to 4 mg/mL in 0.9 percent sodium chloride with 4 mg Dexamethasone via lumbar puncture needle.

Intrathecal methotrexate

Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm Study

Disability will be measured every visit by the Multiple Sclerosis Functional Composite (MSFC)

adverse events will be followed until resolution. Serious adverse events will be reported to the IRB within 24 hours of noticed.

(Composite measure) We will measure new gd+ enhancing lesions, number of lesions, brain and upper spinal cord atrophy and cortical thickness and compare these measure between the time before and after treatment along. Overall each participant will undergo 5 scans , the first before treatment installation and then before each treatment . one scan will be done 3 month after the last treatment

(Composite measure) Cerebrospinal fluid (CSF) sample will be obtained and analyze for parameters including cell count and differential, protein and glucose concentration, oligoclonal bands, IgG concentration, cellular analysis by flow cytometry for CD3+, CD20+, CD14+ cell subsets, and measurement of several soluble mediators such as: CXCL13, CD23, light chains, TNFa, IFNg, IL-17, IL-2, IL-10, BDNF and Neurofilaments will be studied by ELISA

purine/fatigue

Effect of Atorvastatin on 5-Fluorouracil Induced Mucositis

Spectroscopic and Diffusion Weighted Analysis of the Effects of Dexamethasone on High Altitude Cerebral Oedema (HACE)

GDF-15 as a Biomarker for Mitochondrial Disease

Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm Study

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