3 capsules per day (1 before each meal) of cellulose

3 capsules per day (1 before each meal) of seaweed extract

Metabolic Syndrome

Insulin Sensitivity

Seaweed extract

Placebo

Roehampton University

Seaweed Extract Supplementation and Metabolic Biomarkers

Pilot Exploratory Investigation Into the Effects of Brown Seaweed Extract Supplementation on Metabolic Biomarkers

Changes in plasma glucose in healthy volunteers with BMI>25 after 3 weeks of treatment

Changes in plasma insulin in healthy volunteers with BMI>25 after 3 weeks of treatment

Changes in insulin sensitivity based on Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) test

Changes in total cholesterol, HDL-C and triglycerides following 3 weeks supplementation

Changes in Tumor Necrosis Factor-alpha, Interleukin-6, Interleukin-1b, Interleukin-10, Interferon-gamma and C-Reactive Protein following 3 weeks of supplementation

Dr. George Tzortzis

Principle Investigator Human Health

BioAtlantis Ltd.

University of Roehampton

The product is prepared from cord blood serum (CBS) analyzed in advance with regard to the content of specific neurotrophic growth factors.

Glaucoma

Neuro-Degenerative Disease

The product is dispensed as sterile frozen vials containing 0.8 ml of product for the daily administration. The product is thawed and administered at a dose of 1 drop / 8 times each eye during the waking period.

CBS eyedrop

AOU Bologna, Ophthalmology Unit

Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma

Change of IOP at baseline, after treatment , and after two months from the end of treatment

The change in best corrected visual acuity (BCVA) through baseline, 2 and 4 months from end of treatment

Evaluation of change in visual field 24-2 and 10-2, through baseline, 2 and 4 months as assessed by any one of the following two indices:
Pattern Standard Deviation (PSD);
Mean Deviation (MD).

Ophthalmoscopy of the following structures - Optic nerve - Choroid - Retina / Macula - Vitreous - Cup / Disco ratio performed by fundus oftlamoscopy

The change in retinal nerve fiber layer thickness as measured by spectral domain optical coherence tomography (sdOCT).

PERG: obtained with low temporal frequencies (maximum 4 hz equivalent to 8 inversions per second). Reversal rate: 2 hz (4 inversions / sec). Contrast: ceiling for white and black squares. Luminance: photopic. Wave width P50-N95 and wave latency P50.
Flash ERG: ERG 3.0 - maximal response in the eye adapted to the dark. Full-field stimulation with Ganzfeld's dome. Amplitude A1-B1 (the amplitude of the wave b is measured from the peak of the wave until to the peak of the wave b) - the latency of the wave b is measured by the flash lighting at the peak of the wave b

data will be published in a scientific manuscript, in anonymous

Emilio C Campos

Full Professor of Ophthalmology - University of Bologna

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

University of Bologna

Weekly subcutaneous immunoglobulin therapy (0.1g/Kg) Cuvitru 20% Injectable Solution for 1 Year

Standard Care arm without immunoglobulin replacement therapy

Bronchiectasis

Immunoglobulin Subclass Deficiency

Cuvitru 20 % Injectable Solution

Royal Infirmary of Edinburgh

Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis

Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis- A Proof of Concept Study

With IgG replacement therapy, does the sputum bacterial load change in treated versus untreated group

With IgG replacement therapy, does the frequency with >=10(6) colony forming units/ml change in treated versus untreated group?

Does sputum colour change in treated versus untreated group?

Does 24 hour sputum volume change in treated versus untreated group

Does Sputum microbiome change in treated versus untreated group

Does forced expired volume in 1 second change in treated versus untreated group

Does forced expired volume in 1 second change % predicted in treated versus untreated group

Does forced vital capacity in treated versus untreated group

Does forced vital capacity % predicted in treated versus untreated group

Does the incremental shuttle walk test change in treated versus untreated group

Does cough related quality of life change in treated versus untreated group using the Leicester Cough Questionnaire mean score (range 3-21)

Does cough related quality of life change in treated versus untreated group using the Leicester Cough Questionnaire proportion that have 1.3 or more Unit improvement (minimum clinically important difference)

Does quality of life change in treated versus untreated group using the St George's Respiratory Questionnaire proportion that have 4 Unit or more improvement (minimum clinically important difference)

Does quality of life change in treated versus untreated group using the St George's Respiratory Questionnaire mean score (range 0-100)

Does sputum myeloperoxidase change in treated versus untreated group

Does sputum elastase change in treated versus untreated group

Does sputum interleukin 8 change in treated versus untreated group

Do serum IgG and subclasses change in treated versus untreated group

Do serum white cell count change in treated versus untreated group

Do serum C reactive protein change in treated versus untreated group

Do serum erythrocyte sedimentation rate change in treated versus untreated group

Do serum intercellular adhesion molecule 1 change in treated versus untreated group

Does peripheral blood neutrophil phagocytosis and killing of Pseudomonas aeruginosa change in treated versus untreated group

Does peripheral blood neutrophil phagocytosis and killing of Staphylococcus aureus change in treated versus untreated group

Is there antibody deficiency with pneumococcal vaccination

Is the time to first exacerbation requiring antibiotic therapy change in treated versus untreated group

Does the number of exacerbations change in treated versus untreated group

Does the mean exacerbations change in treated versus untreated group

What are the number of participants with side effects of IgG therapy

What are the compliance rates of IgG therapy

What are the completion rates of IgG therapy

No plan to share IPD- will present overall data

University of Edinburgh

NHS Lothian

1 Group receiving active immunoglobulin replacement therapy

polysaccharide/atrofia

Seaweed Extract Supplementation and Metabolic Biomarkers

Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma

Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis

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