Consecutive early stage breast cancer patients who are treated according to the national guidelines. Observation over 11 years.

Breast Cancer

Breast Cancer is 100 x more frequent in female than in male

Breast Concervative or Meastectomy

Helse Stavanger HF

Helse Bergen HF

Prospective Breast Cancer Biobanking

Prospective Breast Cancer Biobanking Project

Time from surgery to relapse of breast cancer

Time from surgery until death of any cause

VAS=visual analogue scale; range 0 to 100 mm; higher score is worse fatigue)

percent of patients on disability pension i.e not participation in work

The precent of patients still on tamoxifen after 5 years and 10 years follow-up

The precent of patients still on taromatase inhibitor after 2 years and 5 years follow-up

Percent infiltration of inflammation cells (higer score means more inflammation)

Haavard Soiland

Consultant Breast Cancer Surgery / Professor dr. med.

Helse-Bergen HF

Ivermectin 200 mcg/kg once orally on empty stomach plus Nitazoxanide 500 mg twice daily orally with meal for 6 days

COVID-19

Ivermectin plus Nitazoxanide

Standard Care

Ivermectin and Nitazoxanide Combination Therapy for COVID-19

Clinical Trial Evaluating Safety and Efficacy of Ivermectin and Nitazoxanide Combination as Adjuvant Therapy in COVID-19 Newly Diagnosed Egyptian Patients: A Tanta University Hope

improved breaths per minute for the patients

Serum iron in microgram/dL of the patients

Serum ferritinin microgram/L of the patients

International normalized ratio "INR" for prothrombin time of 2

CBC for lymphocyte count in cells/microliter

Mortality rate [number of dead patients/total number of treated patients]

Prof. Dr. Kamal Mohammed Okasha

Vice-President of Postgraduate Studies and Research Affairs

Tanta University

This study will be a double blind randomized controlled parallel study

Crohns disease patients in remission(Harvey Bradshaw index <4 and CRP<5mg/dl and faecal calprotectin <50ug/g) suffering from fatigue (General fatigue and physical fatigue score on the Multiple Fatigue Inventory-20 >14, and a score of >4 in the Fatigue questionnaire.)

Crohns disease patients in remission(Harvey Bradshaw index <4 and CRP<5mg/dl and faecal calprotectin <50ug/g) without fatigue (General fatigue and physical fatigue score on the Multiple Fatigue Inventory-20 <14, and a score of <4 in the Fatigue questionnaire.)

Age,gender,muscle mass, and physical activity-matched healthy controls.

Crohn Disease

Measurement of maximum voluntary isometric contraction of the quadricep muscle on a cybex isokinetic dynomometer. This will be followed by a fatigue assessment where the torque decrement over 20 isokinetic knee extensions at a fixed angular velocity will be quantified to assess muscle fatigue

Muscle strength and fatigue assessment

Body composition will be assessed via DEXA scan (Lunar Prodigy, GE Medical Systems, Bucks, UK)

Dual-energy X-ray absorptiometry (DEXA scan)

VO2 peak will be quantified during completion of a continuous, incremental exercise test performed in the supine position on an MR adapted stepper machine (Ergospect, Innsbruck Austria)

Supine cardiorespiratory fitness assessment

Measurement of cardiac output and, cerebral and regional perfusion using Blood-Oxygen-level-dependent (BOLD) measures and arterial spin-labelling (ASL)-MRI as well as fractional oxygen extraction using TRUST-MRI during supine exercise of the quadriceps with the MR compatible cardiostepper (Ergospect, Innsbruck, Austria) at 50% of relative VO2 peak as measured during the supine cardiorespiratory fitness assessment.

fMRI Exercise assessment

Limb blood flow will be occluded with a cuff, whilst participants perform repeated plantar flexion exercise in a MRI scanner. This will drive PCr, (the available reserve of ATP) to zero. Once the cuff is removed, they will undergo non-invasive and well-established in vivo 31P magnetic resonance (31P MRS) measurements on the gastrocnemius to determine PCr re-synthesis rate during resting recovery.

Muscle deconditioning assessment

Nottingham Biomedical Research Centre

Non-invasive Approaches to Identify the Cause of Fatigue in Inflammatory Bowel Disease Patients.

Non-invasive Approaches to Identify the Cause of Fatigue in Inflammatory Bowel Disease Patients

Cerebral perfusion will be used as a surrogate measure of central fatigue: Arterial spin labelling (ASL) data will be motion corrected and modelled to quantify brain perfusion in ml/100g/min. Both global and regional perfusion will be measured pre , during and post exercise.

T2 relaxation under spin tagging (TRUST) data will be used to compute fractional oxygen extraction. Data will be expressed as a percentage of cerebral blood flow and quantified pre, during and post exercise.

Phase contrast MRI (PC-MRI) will be used to quantify realtime cardiac output. This will be quantified in the pre, during and post exercise period via quantification of heart rate and stroke volume using Phillips intellispace software. Data will be presented in L/min.

Quantification of phosphocreatine (PCr) re-synthesis rate following depletion via repeated plantar flexion exercise under blood flow occluded conditions. Since the rate of phosphocreatine re-synthesis is directly proportional to mitochondrial mass and oxygen delivery is not limiting during exercise recovery, this will allow measurement of muscle metabolic deconditioning in vivo. The rate of muscle PCr resynthesis will be expressed in (mmol.kg) and plotted as a function of time. The speed of PCr recovery rate will be compared across groups and provide a gold standard measurement of muscle deconditioning and reveal any peripheral contributions to premature fatigue development.

VO2 peak obtained during an incremental supine exercise test performed on an MR compatible stepper. VO2 peak will be expressed in ml/min/kg, with a higher value reflecting an individuals ability to utilise a higher volume of oxygen during exercise.

Maximum voluntary contraction performed on an isokinetic dynomometer. Torque values will be recorded in Newton-meters (NM).

Rate of torque decrement (Newton-meters) during 20 knee extension repetitions performed on an isokinetic dynamometer at a constant angular velocity of 90 degrees per second.

The Multiple Fatigue Inventory- 20 consists of 20 questions quantifying 20 sub-sections of fatigue. Questions 1,5,12 and 16 assess general fatigue. A higher score reflects a higher degree of fatigue. Patients scoring >14 on the general fatigue questions will be grouped into the "fatigued group" whilst patients scoring <14 will be grouped into the "non-fatigued" group. We will actively exclude any healthy volunteer participants (controls) who score >14 on the generl fatigue section of the MFI-20.

Regional fat quantified in grams (g) via DEXA scan.

Lean masses quantified in grams (g) via DEXA scan.

The Multiple Fatigue Inventory- 20 consists of 20 questions quantifying 20 sub-sections of fatigue. Questions 2,8,14 and 20 assess physical fatigue. A higher score reflects a higher degree of fatigue. Patients scoring >14 on the physical fatigue questions will be grouped into the "fatigued group" whilst patients scoring <14 will be grouped into the "non-fatigued" group. We will actively exclude any healthy volunteer participants (controls) who score >14 on the physical fatigue section of the MFI-20.

Scores obtained from completion of the Hospital Anxiety and Depression questionnaire. This compromises separate sections of questions related to the assessment of depression and anxiety, yielding a final score for each. A higher anxiety score reflects a higher level of anxiety, whilst a lower depression score reflects more severe depression. Regarding both Anxiety & Depression scales: A score of 8-10 indicates Mild, 11-14 Moderate and 15-21 severe. We will actively exclude participants scoring >8 on either anxiety, depression, or both.

Scores obtained from completion of the CUCQ-32 questionnaire can range from 0-272, where a higher score reflects a worse quality of life. There are no pre-existing, published cut off scores for this questionnaire. Mean scores will be compared across the three experimental groups to identify any differences in self-reported quality of life.

Obtained from pedometer worn for 7 day period during the study.

Obtained from Cognitive Assessment: Montreal Cognitive Assessment (MoCA) performed at screening. The maximum score is 30 marks, with >26 considered as normal.

Concentrations of IL-1, IL-6, and TNFα obtained from blood sampling during screening.

Obtained from blood sampling during screening

University of Nottingham

3 groups of hemophilia patients - Those with > 20 bleeds into a joint, those with < 2 bleeds into a joint and those with no bleeds into a joint will be enrolled into the study

3 groups of hemophilia patients Group I - Those with > 20 bleeds into a joint, Group II - those with < 2 bleeds into a joint and Group III - those with no bleeds into a joint will be enrolled into the study

plasma samples for angiogenic and cartilage degradation markers

Hemophilia A

Hemophilia B

Hemarthroses

ultrasound will be performed in hemophilia boys with a history of 20 joint bleeds- Group I, less than 2 joint bleeds into a joint -Group II and no joint bleeds- Group III

ultrasound

Feinstein Institute of Medical Research Northwell Health

Ultrasonography in Hemophilic Joint Disease and Serum Markers

Ultrasonography in Hemophilic Joint Disease

Synovial changes on USG- PDS:
Scoring system for synovitis which has 2 components - joint effusion and synovial thickening: Joint effusion will be defined as a compressible anechoic intracapsular area and the amount of fluid will be semiquantitatively scored usinga previosuly described scoring system by Martinoli et al. Quantitative assessment of the power Doppler signal: Power Doppler signal will be assessed subjectively for degree of vascularity -Table 2, Table 2
Degree of Vascularity PDS Signal Score Normal or minimal No signal or local dark red 1 Mild hyperemia Dark red to red 2 Moderate hyperemia Red to orange 3 Marked hyperemia Orange to yellow 4

Blood will be collected on the smae day of the study to measure synovial angiogenesis markers- VEGF, MMP-9, SDF-1, HIF-1 , endothelial progenitor cells and hematopoietic progenitor cells

arthralgia/hypoxia

Prospective Breast Cancer Biobanking

Ivermectin and Nitazoxanide Combination Therapy for COVID-19

Non-invasive Approaches to Identify the Cause of Fatigue in Inflammatory Bowel Disease Patients.

Ultrasonography in Hemophilic Joint Disease and Serum Markers

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