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NCT ID: NCT03284723 Completed - Breast Neoplasms Clinical Trials

PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors

Start date: November 1, 2017
Phase: Phase 1
Study type: Interventional

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer.

NCT ID: NCT03284008 Completed - Clinical trials for Axillary Web Syndrome

Assessing Efficacy of Axillary Web Syndrome Treatment

Start date: July 16, 2013
Phase: N/A
Study type: Interventional

The aim of this study is verify the effectiveness of manual maneuver associated with stretching exercises in the treatment of Axillary Web Syndrome.

NCT ID: NCT03283813 Recruiting - Insulin Resistance Clinical Trials

ZIMBA: Clinical Trial in Paediatric Obesity

ZIMBA
Start date: February 5, 2018
Phase: Phase 4
Study type: Interventional

Myoinositol (MI) and D-chiro inositol (DCI) are isomeric forms of inositol that were found to have insulin-like properties, acting as second messengers in the insulin intracellular pathway; both of these molecules are involved in the increasing insulin sensitivity of different tissues to improve metabolic and ovulatory functions. Myoinositol is the predominant form that can be found in nature and food. Inositol has been mainly used as a supplement in treating several pathologies such as polycystic ovary syndrome (PCOS), metabolic syndrome, type 2 diabetes mellitus (T2DM) and gestational diabetes (GDM). In the case of GDM, a condition defined as a glucose impairment first detected in pregnancy, a preventive role of inositol for GDM onset was recognized. In addition, inositol has been studied as a therapeutic option for the treatment of GDM and T2DM. The main effect of inositol is decreasing the level of insulin resistance. Consequently, a potential role of inositol as a treatment option could be hypothesized for other conditions typically characterized by insulin resistance like metabolic syndrome and obesity. Zinc also plays an important role in insulin action and carbohydrate metabolism. It may also have a protective role in the prevention of atherogenesis. Several human studies have demonstrated that Zinc supplementation reduces total cholesterol, LDL cholesterol and triglycerides, in addition to increasing the HDL cholesterol levels. Studies have shown that diabetes is accompanied by hypozincemia and high levels of Zinc in urine. In addition Zinc is also an integral part of key anti-oxidant enzymes and Zinc deficiency impairs their synthesis, resulting in increased oxidative stress. A supplementation with Myo-Inositol and Zinc could represent a valid strategy in paediatric obesity in addiction to a standard approach. The purpose of our study is to evaluate the supplementation of Myo-inositol and Zinc in the treatment of paediatric obesity.

NCT ID: NCT03283696 Completed - Soft Tissue Sarcoma Clinical Trials

A Study of Olaratumab (LY3012207), Doxorubicin, and Ifosfamide in Participants With Advanced or Metastatic Soft Tissue Sarcoma

Start date: October 18, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of ifosfamide when added to the combination regimen of olaratumab and doxorubicin in participants with advanced or metastatic soft tissue sarcoma (STS).

NCT ID: NCT03283501 Recruiting - TAVI Clinical Trials

Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL)

REVIVAL
Start date: April 20, 2017
Phase: N/A
Study type: Observational

Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.

NCT ID: NCT03283085 Completed - Ulcerative Colitis Clinical Trials

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

Start date: February 27, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)

NCT ID: NCT03282955 Completed - Clinical trials for Patients Requiring Home Parenteral Nutrition

The HOME Study (HPN With OMEGA-3)

HOME
Start date: January 8, 2018
Phase: Phase 4
Study type: Interventional

The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.

NCT ID: NCT03282760 Completed - Clinical trials for Secondary-progressive Multiple Sclerosis

Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients

NSC-SPMS
Start date: September 9, 2017
Phase: Phase 1
Study type: Interventional

This will be a phase I, open, multicenter, international study performed by 3 participating centres across two countries (Italy and Switzerland). Fifteen to 24 patients affected by SPMS will be enrolled, according to a "standard" phase I design over 18 months. All patients will enter a 3 months run in phase. Thereafter they will receive one of four different doses of allogenic hNSCs (dose A=5 millions hNSCs; dose B=10 millions hNSCs; dose C=16 millions hNSCs; dose D=24 millions hNSCs). Following hNSCs injection, all SPMS patients will receive immunosuppression with tacrolimus for 6 months. Patients will be clinically followed monthly for 1 year and then every 6 months for the 5 years following the study completion (possibly all life long). MRI assessments will be performed monthly for the first 6 months and then every 3 months for 5 years following the study completion.

NCT ID: NCT03282747 Completed - Clinical trials for Venous Thromboembolism

Distribution of Risk Factors for Venous Thromboembolism in Blood Donors

ANEMONE
Start date: July 15, 2017
Phase:
Study type: Observational

Venous thromboembolism occurs with an incidence of about 1 per 1000 per year in adults . The main consequences are death, recurrence, post-thrombotic syndrome and major bleeding due to anticoagulation. Mortality rates are lower among patients with idiopathic venous thrombosis and higher among those in whom thrombosis occurs in the presence of cancer. The risk increases with the age for unclear reasons. There are also differences in the incidence according to ethnicity; however, data in subjects of European ancestry are scarce. Several studies have documented an association between thrombosis and ABO group. Specifically, non-O blood groups have a higher risk of myocardial infarction, angina, peripheral vascular disease, cerebral ischemia and venous thromboembolism than O. While there are numerous studies carried out in patients who have already shown thromboembolic events, data on the incidence of risk factors in the healthy population are completely inadequate. Understanding the risk factors for venous thrombosis is necessary to maximize the prevention of this disease in individuals and groups of high-risk patients . For this purpose a self-administered questionnaire will be used. Data obtained by blood donors on exposure to risk factors will be used to set up a clinical score to validate in future studies to carry out in patients with VTE.

NCT ID: NCT03282292 Withdrawn - Clinical trials for Congenital Heart Disease

Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery

PRECiSE
Start date: September 12, 2017
Phase: N/A
Study type: Interventional

Randomized controlled trial comparing femoral vs internal jugular insertion site of central venous catheters (CVC) in newborns and infants undergoing cardiac surgery. The experimental hypothesis is that the jugular insertion site is superior to the femoral in terms of catheter colonization.