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NCT ID: NCT04040010 Completed - Osteoporosis Clinical Trials

The Effects of Bovine Colostrum in Bone Metabolism in Humans

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Osteoporosis constitutes a major public health concern. For instance, in European Union 1 in 3 women and at least 1 in 6 men will suffer an osteoporotic fracture during their lifespan. The burden of osteoporosis is estimated to raise 25% by 2025. Worldwide, by 2050, the incidence of osteoporotic fractures is expected to increase 240% in women and 310% in men compared to 1990. The aforementioned estimates might indicate the existence of some gaps related to current products on the market for prevention and treatment of osteoporosis. Actually, the use of the approved pharmacological agents for osteoporosis have been decreasing in European Union and worldwide. Patients are becoming increasingly reluctant to take medicines; even those with severe osteoporosis are refusing treatment. Recent published reports on the matter revealed that patients fear the side effects of current pharmacological agents. Actually, therapy with bisphosphonates, the most prescribed medication for the treatment of postmenopausal, glucocorticoid-induced and male osteoporosis has been associated with severe side effects as osteonecrosis of the jaw and atypical femoral fractures. Colostrum, a milky substance produced by mammals, known to be responsible for the development of the immune and skeleton systems of the offspring, has on its constituent's lactoferrin (LF). This multi-functional protein has been shown to affect both bone resorbing and bone formation pathways. The safety and tolerance on the use of bovine colostrum in humans (children and adults) have been well documented; it has a 'Generally Recognized As Safe' status from the United States Food and Drug Administration. Allergies and lactose intolerance, which are main shortcomings of milk consumption, have not been reported in relation to colostrum. Actually, human colostrum and bovine colostrum share the same bioactive components, but bovine sources are more potent than that of human. In accordance, bovine colostrum supplementation has been used in several therapeutic applications as gastrointestinal disorders, allergies and autoimmune diseases, viral and bacterial illnesses, and HIV-associated immunomodulation HIV. However, the effectiveness of bovine colostrum (as a whole and not only LF) to reduce bone losses has not been considered yet. Therefore, this study aims at analyzing the effects of bovine colostrum in diminishing bone mass losses in humans.

NCT ID: NCT04039685 Completed - Obesity Clinical Trials

The Effects of Chronic Exercise on UCP1 Gene in Human White Adipose Tissue

Start date: June 1, 2013
Phase: N/A
Study type: Interventional

Obesity is characterized by excessive white adipose tissue (WAT) that increases risk for disease. About 700 million adults are obese worldwide, designating the need of reducing excessive WAT in humans and subsequently the risk for disease. For this reason, previous research focused on the thermogenic capacity of white adipocytes in response to chronic exercise. It is suggested that the latter occurs due to increased demand of oxidation during exercise to maintain non-esterified fatty acids flux in the circulation, thus to maintain energy supply White adipocytes express the uncoupling protein one (UCP1), which dissipates chemical energy in the mitochondria to produce heat in response to cold exposure. UCP1 was thought that exclusively appears in brown adipose tissue (BAT), which during the mitochondrial electron transport chain process, bypasses the adenosine triphosphate (ATP) synthase to produce heat, as a thermoregulatory mechanism of maintaining body temperature. Its presence in white adipocytes, indicates a thermogenic capacity of WAT, which could lead to similar health benefits as those reported for increased BAT activity; mainly reduced body mass index (BMI) and fat mass, which designate body weight loss and reduced obesity phenotype. The investigators aimed to identify whether UCP1 in human WAT is altered by chronic exercise.

NCT ID: NCT04037410 Completed - Cancer Patients Clinical Trials

Environmental Temperature and White Adipose Tissue in Cancer Patients

Start date: May 10, 2019
Phase:
Study type: Observational

The investigators aimed to retrospectively identify the association between the thermogenic capacity of white adipocytes and the environmental temperature, in cancer patients.

NCT ID: NCT04037371 Completed - Obesity Clinical Trials

Environmental Temperature and Human White Adipose Tissue

Start date: April 2, 2017
Phase:
Study type: Observational

Obesity is characterized by excessive white adipose tissue (WAT) that increases risk for disease. About 700 million adults are obese worldwide, designating the need of reducing excessive WAT in humans and subsequently the risk for disease. For this reason, previous research focused on the thermogenic capacity of white adipocytes in response to cold exposure. The investigators aimed to identify whether human WAT thermogenic activation could alter energy homeostasis and subsequently total body weight. The human WAT thermogenic capacity was assessed via Positron Emission Tomography/Computed Tomography (PET/CT) examination.

NCT ID: NCT04031846 Completed - Clinical trials for Pneumococcal Infections

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)

PNEU-PED-EU-1
Start date: September 4, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and tolerability and immunogenicity of V114 when administered to 2-month old infants. The primary hypotheses are: 1) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on response rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.

NCT ID: NCT04024371 Completed - Depression Clinical Trials

Validating Reward-related Biomarkers (RTOC)

RTOC
Start date: September 16, 2019
Phase:
Study type: Observational

Deficits or abnormalities in reward processing are present in a number of psychiatric disorders. The overarching objective of the study is to conduct initial validation work towards optimising three experimental tasks - which have previously been shown to be sensitive to reward processing deficits - for future use in clinical trials. This initial validation work has the primary objective to uncover group differences in task outcome measures between healthy control participants, participants with Major Depressive Disorder (MDD) and participants with schizophrenia (SZ) using statistical analyses. This may provide some indications for the use of these tasks as clinically-relevant biomarkers. Primary aims include: (i) comparing the investigator's endpoint means and distributions to those in previously published data; (ii) replication of previously-reported differences between MDD/SZ vs. healthy control participants, and, (iii) exploring the relationship between task endpoints and subjective participant- and clinician-rated report of reward-related constructs (e.g. anhedonia, negative symptoms).

NCT ID: NCT04020341 Completed - Clinical trials for Urinary Tract Infections

A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)

Start date: October 17, 2019
Phase: Phase 3
Study type: Interventional

The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.

NCT ID: NCT04014764 Completed - Multiple Myeloma Clinical Trials

Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy

(ANSWer)
Start date: December 15, 2019
Phase:
Study type: Observational [Patient Registry]

This is a prospective, multicenter observational study to collect clinically annotated biospecimens in order to assess the correlation between ex vivo data generated by the Notable assay platform and clinical outcome.

NCT ID: NCT04004208 Completed - Clinical trials for Retinopathy of Prematurity (ROP)

Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy

FIREFLEYE
Start date: September 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.

NCT ID: NCT04001881 Completed - Clinical trials for Spinal Anesthetic Toxicity

Echocardiography and Spinal Induced Hypotension.

Start date: August 1, 2019
Phase:
Study type: Observational

Modern guidelines have combined both the maximum diameter of IVC at expiration (dIVC max) and the IVCCI to appreciate right atrial pressure (RAP) measurements and consequently to assess intravascular volume status. In fact, IVC diameter <2.1 cm with IVCCI >20% (quite inspiration) suggests normal RAP of 3mmHg (range, 0-5mmHg), whereas IVC diameter >2.1 cm with IVCCI<20% suggests high RAP of 15mmHg (range, 10-20mmHg). In occasions where the IVC diameter and collapse is not fit the above categories, an intermediate value of 8 mmHg (range, 5-10 mmHg) is applied. From a clinical standpoint, it is conceivable that both measurements must be measured in isolation to enable RAP assessment. To circumvent this limitation the two indices have been consolidated to dIVCmax-to-IVCCI ratio. Although this ratio has been shown high accuracy to predict spinal-induced hypotension in elderly patients with preserved ejection fraction (EF) of the left ventricle (LV), its value in patients with cardiac dysfunction and reduced LV-EF has not been investigated. From the aforementioned, this study sets out to address the role of dIVCmax-to-IVCCI ratio in the prediction as well as in the management of hypotension after spinal anesthesia in elderly orthopaedic patients with reduced LV-EF.