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NCT ID: NCT04669782 Recruiting - Osteoporosis Clinical Trials

Effect of Vitamin K Supplementation on Circulating Levels of Osteocalcin on the Bone Metabolism and Aging

OstMARK
Start date: November 24, 2020
Phase: N/A
Study type: Interventional

This is an interventional study on nutraceuticals. It is a randomized controlled, open-label, prospective, single-center study that involves the enrollment of 82 patients with osteoporosis and 41 subjects without osteoporosis. The hypothesis the decarboxylated form of Osteocalcin (OC), called GluOC, represents a clinically useful marker for monitoring the effects of supplementation with vitamin K in association with anabolic treatment with teriparatide will be analyzed not only on bone but also on skeletal muscle and energy metabolism in patients with severe osteoporosis.

NCT ID: NCT04669171 Recruiting - Follicular Lymphoma Clinical Trials

A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma

SIDNEY
Start date: July 5, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to define the recommended Phase 2 Dose, safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 during monotherapy and in combination with lenalidomide and/or rituximab in patients with indolent NHL

NCT ID: NCT04669119 Recruiting - Pain, Postoperative Clinical Trials

Effects of Bromelain and Boswellia Serrata Casperome With Centella Asiatica and Vitamins on Edema, Paresthesia and Postoperative Pain After Quadrantectomy With or Without Sentinel Lymph Node Biopsy.

Start date: December 31, 2020
Phase: Phase 4
Study type: Interventional

Aim: to investigate the effects of dietary supplements on postoperative edema and pain in patients undergoing quadrantectomy for breast cancer. Methods: 120 patients will be randomized into 3 groups: A, treated with Bromelain/Boswellia Serrata Casperome and Centella Asiatica with Vitamins for 30 days; B, treated with Bromelain/Bosswellia Serrata and placebo for 30 days; C, treated with 2 placebos. Inclusion criteria: adult (>18 years) patients with breast cancer undergoing quadrantectomy with or without sentinel lymph node biopsy. Exclusion criteria: diabetic neuropathy, previous breast/chest surgeries, allergies to studied drugs, severe kidney failure, alcohol and toxics addiction, axillary lymphadenectomy. Patients will be studied through ultrasound examination for edema and collections, VAS and DN4 for pain, during 30 postoperative days. Patients will also be studied through psychological and physiatric evaluations. Wilcoxon, T student, Chi-Squared tests will be used to evaluate the outcomes. STATA 14 (StataCorp LP, College Station, Tex, USA) will be used for the analysis. P<0.05 will be statistically significant.

NCT ID: NCT04669067 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

TL-895 and KRT-232 Study in Acute Myeloid Leukemia

Start date: March 31, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates TL-895, a potent, orally available and highly selective irreversible tyrosine kinase inhibitor combined with navtemadlin (KRT-232), a novel oral small molecule inhibitor of MDM2 for the treatment of adults with FLT3 mutated Acute Myeloid Leukemia. Participants must be relapsed/refractory (e.g., having failed prior therapy) to be eligible for this study.

NCT ID: NCT04668716 Recruiting - Clinical trials for Duchenne Muscular Dystrophy

Brain Involvement in Dystrophinopathies Part 2

Start date: October 11, 2021
Phase:
Study type: Observational

The objective of this study is to understand the relationship between DMD and BMD brain comorbidities, and the location of the gene mutation which causes the disease.

NCT ID: NCT04668378 Completed - Healthy Clinical Trials

Effects of a Time Restricted Eating Protocol on Resistance Training Men

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

The study sought to investigate the effects of 16/8 time restricted eating (TRE) with windows of 16 hours of fasting and 8 hours of eating on on body composition, muscle strength, and metabolic factors during resistance training in healthy resistance trained males

NCT ID: NCT04667286 Recruiting - Covid-19 Infection Clinical Trials

Awake Pronation for Covid-19 Treatment

Start date: January 16, 2021
Phase: N/A
Study type: Interventional

Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection. None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion

NCT ID: NCT04666987 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study Looking at Long-term Blood Sugar Control in People With Type 2 Diabetes Being Treated With Xultophy® in a Real-world Setting in Italy

Start date: October 21, 2020
Phase:
Study type: Observational

The purpose of the study is to collect information on how Xultophy® works in patients like them with type 2 diabetes. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 18 months. Participants will be asked questions about their health and diabetes treatment as part of the normal study doctor's appointment.

NCT ID: NCT04666883 Not yet recruiting - Colon Cancer Clinical Trials

Splenic Hilar Nodes in Splenic Flexure Cancer

Start date: January 1, 2021
Phase:
Study type: Observational

Report the incidence of metastases to the splenic hilar lymphnodes from splenic flexure primaries. This mode of spread has not been previously characterized for these tumours.

NCT ID: NCT04666818 Completed - Clinical trials for Diabetes Mellitus in Pregnancy

Efficacy of FGM in Pregestational Diabetes

FlashMom
Start date: November 26, 2020
Phase:
Study type: Observational

Diabetes is the most common metabolic disease complicating pregnancy, and the number of women in childbearing age facing this problem is rising worldwide. The clinical and social significance of pre-gestational diabetes has become an important issue in the area of public health because this disease can cause maternal complications and influence the development of the offspring during the pregnancy and later in life. Pregnancy in women with pregestational diabetes is indeed associated with adverse perinatal outcomes including large-for gestational- age infants (ranging from 48.8 to 62.5%), preterm delivery, and other perinatal complications. Large-for-gestational-age infants to mothers with diabetes are at increased risk for birth trauma, transient tachypnea, and neonatal hypoglycemia. For all these reasons, the medical costs and social burdens caused by this disease are problematic. The mainstay of managing diabetes during pregnancy is glucose monitoring. Conventionally, glucose monitoring is by self-monitoring of blood glucose (SMBG) involving multiple pricks to the patients. The limitations of these pricks include pain and a point-in-time assessment without evaluation of the complete glycemic profile before making therapeutic adjustments. Introduction of continuous glucose monitoring (CGM) by measuring interstitial fluid glucose has overcome the deficits in SMBG by providing an overview of the glycemic profiles in patients. In most recent years another promising tool became available: the Flash Glucose Monitoring (FGM) system. Unlike traditional sensor systems, its wired enzyme sensor is calibrated in the factory and therefore requires no user calibrations (fingerstick blood glucose measurements) during the 14 days of wear. Recent studies demonstrated that FGM is effective in reducing glucose fluctuations and preventing hypoglycemic events in Type 1 and Type 2 diabetic patients. No evidence is to date available on the efficacy of FGM on the reduction of the perinatal adverse outcomes during pregnancy in women with pre-gestational diabetes. The investigators propose to randomize a group of women with poorly controlled pregestational diabetes to receive SMBG (standard antenatal care) or FGM plus SMBG during pregnancy.