
Kefir and Metabolic Syndrome
Metabolic SyndromeCardiovascular Diseases1 moreMetabolic Syndrome (MS) contributes to the development of cardiovascular diseases (CVD). According to the World Health Organization (WHO), CVDs are the leading causes of death in the world. According to epidemiological data from the Ministry of Health, these diseases account for 29.4% of all deaths recorded in Brazil annually. Kefir is obtained by fermenting milk with kefir grains and has been recommended as a therapeutic form for the treatment of various clinical conditions. The hypothesis of the present study is that the daily intake of fermented beverages with kefir grains may reduce the risk factors associated with MS, thus reducing the incidence of CVD. A clinical trial was conducted with 48 volunteers, who presented at least three criteria for the diagnosis of MS. The subjects were divided into two groups that received for eleven weeks fermented dairy drink with kefir (KG) grains or homemade curd (CG). Weight and height measurements were taken to calculate BMI. The body composition evaluation was performed by determining the percentage of body fat and waist circumference (WC). The measurements of systolic blood pressure (SBP) and diastolic blood pressure (DBP) were taken. Blood samples were analyzed for fasting glycemia, glycated hemoglobin (HA1c), total cholesterol (TC), HDL cholesterol, triglycerides (Tg), C-reactive protein (CRP), aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Creatinophosphokinase (CPK), γ-Glutamyl Transferase (γ-GT), Urea Nitrogen, Urea and Creatinine. The level of non-HDL cholesterol (n-HDL) was determined by calculation. The Framingham score was used to assess the risk of developing cardiovascular events over the next ten years. Eleven weeks into the experiment, all measurements of body evaluation, SBP and DBP and biochemical analysis of blood were reevaluated.

An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed...
Short Bowel SyndromeThe purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the TED-C14-004 (NCT02340819) study.

Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients...
Tumor Lysis SyndromeThe purpose of this study is to compare the exposure of febuxostat in pediatric patients (≥6<18 years of age) and in adults suffering from hematological malignancies at intermediate to high risk of TLS and to compare the effect in terms of serum uric acid levels.

Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary...
Polycystic Ovary SyndromeA prospective, interventional, open-label, single-arm, proof-of-concept study: 18 women with Polycystic Ovary Syndrome (PCOS) will be treated with 100 mg of Anakinra/Kineret® for 4 weeks. 1 week after last injection patients will have a follow-up and a dexamethasone visit after a dexamethasone suppression test. Goal of this study is to investigate the effect of the Interleukin 1( IL-1) receptor antagonist Anakinra/Kineret® on laboratory and clinical features in women with PCOS.

Quality of Life and Sjögren Syndrome
XerostomiaHyposalivation2 moreThe aims of this study are: To compare salivary pH changes and stimulation efficacy of two different Gustatory Stimulants of Salivation (GSSS) in patients with Primary Sjögren Syndrome (PSS); To evaluate Primary Sjögren syndrome (PSS) impact and gustatory stimulants of salivary secretion (GSSS) on oral health related quality of life measured by a Portuguese version of Oral Health Impact Profile-14 (OHIP-14) and specific Xerostomia assessment questionnaires. The Products to be used are the Xeros® Dentaid system and a citric based mouthwash.

Efficiency of Mirror Therapy After Carpal Tunnel Surgery
Carpal Tunnel SyndromePhysiotherapy1 moreIn the randomized controlled study with patients who appropriate the inclusion criteria are divided into two groups by simple drawing method. In the control group, the classical physiotherapy program is being applied when the post-operative immobilization period ended, MT is applied to the mirror group in addition to this treatment for 20 minutes and a total of 10 sessions in the immobilization period. Patients who are scheduled for operation due to CTS evaluated that pain (VAS), sense (monofilament test), function (BCTQ, 9-hole peg test) before surgery, 3 weeks and 6 weeks after surgery.

Cellular Immuno-Therapy for COVID-19 Acute Respiratory Distress Syndrome
Acute Respiratory Distress SyndromeCovid19The clinical picture of the novel corona virus 2 (SARS-CoV-2) disease (COVID-19) is rapidly evolving. Although infections may be mild, up to 25% of all patients admitted to hospital require admission to the intensive care unit, and as many as 40% will progress to develop severe problems breathing due to the acute respiratory distress syndrome (ARDS). ARDS often requires mechanical ventilation, with a 50% risk of mortality. Researchers at the Ottawa Hospital Research Institute (OHRI) have been studying the potential therapeutic role of mesenchymal stromal/stem cells, or MSCs, for the treatment of ARDS for over a decade. This has led to the world's first clinical trial using MSC therapy for patients with severe infections (sepsis) which is often associated with ARDS (NCT02421484). This trial demonstrated tolerability, and potential signs of efficacy. In addition, the investigators have established expertise in producing clinical-grade MSCs and have received approval from Health Canada for the use of MSCs in three different clinical studies. This protocol consists of 2 sequential trials using the same trial infrastructure, noted as the Phase 1 trial 'CIRCA-1901' and the Phase 2a trial 'CIRCA-1902'. CIRCA-1901 is an open-label, dose-escalating and safety trial using a 3+3+3 design to determine the safety, and maximum feasible tolerated dose of repeated delivery of Umbilical Cord Mesenchymal Stromal Cells (UC-MSC) intravenously. The investigators will enroll up to 9 patients; each receiving repeated unit doses of UC-MSCs delivered by IV infusion on each of 3 consecutive days (24±4 hours apart) according to the following dose-escalation schedule (3 patients per dose panel): (i) Panel 1: 25 million cells/unit dose (cumulative dose: 75 million MSCs), (ii) Panel 2: 50 million cells/unit dose (cumulative dose: 150 million MSCs), (iii) Panel 3: up to 90 million cells/unit dose (cumulative dose: up to 270 million MSCs). If no safety issues are identified, we will continue to the Phase 2a trial. CIRCA-1902 is a single-arm, open-label extension of the CIRCA-1901 trial to assess early signs of efficacy (major morbidity and mortality). The Phase 2a trial (CIRCA-1902) will enroll 12 patients to assess early signals of benefit on mortality and major morbidity in a high risk, high mortality population.

Clinical Evaluation of the Effects of Mirror Therapy in Patients With Complex Regional Pain Syndrome...
Complex Regional Pain Syndrome Type ICRPS Type 1 can occur after traumas, surgical applications or central nervous system disorders. The triggering factor in CRPS type 1 is fracture in about half of the cases. Mirror therapy is an innovative treatment approach that is cheap, easy to administer and non-invasive. It is thought that this treatment may be complementary to other rehabilitation methods.Neurophysiologic effects of mirror therapy are noted in the brain, especially in the parietal region, cerebellum, basal ganglia and premotor cortex. Mirror therapy is also effective through the mirror neuron system. Mirror therapy triggers neuroplasticity by increasing the connection between neurons in the brain and thereby enhances communication between the motor and the sensory cortex. Recent studies have shown the positive effects of mirror therapy in patients with CRPS Type 1 disease. There are two randomized controlled trials showing the efficacy of mirror therapy in patients with CRPS Type 1 after stroke. Only one pilot study was performed in patients with CRPS Type 1 who were traumatic origin. There are no randomized controlled trials investigating the efficacy of mirror therapy in CRPS Type 1 patients who developed secondary to trauma in the literature. The purpose of this study is to investigate the clinical effects of mirror therapy applied in addition to routine rehabilitation program in patients with traumatic CRPS Type 1. The investigators hypothesized that adjunctive mirror therapy to classical rehabilitation program would result in better outcomes compared with the classical program only.

Fecal Transplantation in Patients With IBS
IBS - Irritable Bowel SyndromeThe study will characterize the biology of FMT in the context of IBS prior to wider clinical application of the method. Given the ethical concerns of unknown and long-term adverse effects of FMT therapy, the study will include patients only with moderate to severe symptoms. IBS is a heterogenous disorder and it is important to characterize the patients, and study as homogeneous patient populations as possible. Therefore the study will only include post-infectious IBS patients after the Giardia outbreak.

DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients...
Acute Myeloid LeukemiaBlasts 30 Percent or Less of Bone Marrow Nucleated Cells4 moreThis phase I trial studies the side effects of DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, decitabine, and nivolumab in treating patients with myelodysplastic syndrome or acute myeloid leukemia. DEC-205/NY-ESO-1 fusion protein CDX-1401 is a vaccine that may help the immune system specifically target and kill cancer cells. Poly ICLC may help stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, decitabine, and nivolumab may work better in treating patients with myelodysplastic syndrome or acute myeloid leukemia.