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NCT ID: NCT02383264 Completed - Clinical trials for Necrotizing Enterocolitis

Splanchnic Oxygenation After the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance.

NIRS-SO
Start date: February 2013
Phase: N/A
Study type: Observational

Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm infants are at high risk of developing feeding intolerance (FI) or necrotizing enterocolitis (NEC), which is the most feared gastrointestinal complication of prematurity. The occurrence of FI often prompts clinicians to withhold, decrease or discontinue enteral feeds; thus, the establishment of an adequate early enteral nutrition is frequently hampered. Early identification of preterm infants at high risk for gastrointestinal complications could help clinical decisions on the introduction and the advancement of enteral feeding. Near-infrared spectroscopy (NIRS) provides a non-invasive monitoring of regional oxygen saturation (rSO2). A significant correlation between lower abdominal rSO2 values in the first week of life and subsequent NEC development has been reported. To date, however, splanchnic oxygenation patterns in response to the first bolus feed and possible correlations with subsequent FI development have not been yet established. This observational prospective study aims: - to assess abdominal rSO2 patterns in response to the first bolus feed; - to evaluate possible correlations with subsequent development of gastrointestinal complications.

NCT ID: NCT02381054 Completed - Cancer Clinical Trials

Translation, Cross-cultural Adaptation and Validation of PRO-CTCAE for Italian-speaking Cancer Patients

PRO-CTCAE
Start date: May 2015
Phase: N/A
Study type: Observational

The purpose of this study is to see if the Italian language version of a questionnaire about symptoms that patients may have during cancer treatment is understandable to Italian speaking patients. The questionnaire is called the PRO-CTCAE, and was originally developed at the U.S. National Cancer Institute to help get information about patients' symptoms directly from the patients themselves. The Italian version of the questionnaire will be used in future studies to gain a better understanding of patient symptoms.

NCT ID: NCT02380521 Completed - Clinical trials for Type 2 Diabetes Mellitus

Exenatide Once Weekly, Cardiovascular Risk and Type-2 Diabetes

Start date: January 2015
Phase: Phase 4
Study type: Interventional

The glucagon-like peptide 1 (GLP-1) agonist exenatide represents an effective therapy in patients with type 2 diabetes mellitus (T2DM), which also seems to have some important non-glycemic effects. Yet, these non-glycemic effects are still largely unknown. The effect of exenatide once weekly was investigated in controlled, blinded and open-label clinical studies in subjects with T2DM who were controlled on diet and exercise alone or in combination with oral antidiabetic agents, but also in multi-dose controlled studies and such studies resulted in significant reductions in glycemic parameters (mean glycated hemoglobin (HbA1c), fasting serum/plasma glucose as well as postprandial plasma glucose levels), but also in body weight, over 24 to 30 weeks. Meaningful reductions were observed as early as week 4 of treatment, and maintained through 6 years of treatment. The study investigating cardiovascular effects of exenatide once weekly is currently undergoing. The results available are not numerous (such as DURATION-2, DURATION-3, DURATION-4 studies) and cannot lead to definitive conclusions. In this study the investigators will evaluate the effect of exenatide once-weekly on multiple cardiovascular risk markers. These markers are related to subclinical atherosclerosis, endothelial dysfunction, oxidative stress and atherogenic lipoproteins. The investigators will perform an open label, single-arm, prospective, intervention study using exenatide once weekly for a period of 8 months on 60 patients with T2DM.

NCT ID: NCT02380495 Completed - Asthma Clinical Trials

"Studio NaVA" - National Study on Quality of Life in Adolescents Affected by Allergic Rhinitis With or Without Asthma

Start date: March 2015
Phase: N/A
Study type: Observational

"Studio Nava" is a National Study aiming to assess allergic rhinitis and asthma outcomes on Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. "Studio Nava" also proposes the innovative use of a web platform ("http://nava.ibim.cnr.it/") that contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI, Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents; Rhinasthma; VAS scale), that will be available for the doctors after the registration to the web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to fill them during the waiting time of the visit.

NCT ID: NCT02380170 Completed - Urosepsis Clinical Trials

Epidemiology and Outcomes of Gram Negative Urosepsis

SERPENS
Start date: September 2014
Phase:
Study type: Observational

The study aims to get an insight on the causative bacteria of sepsis derived from the urinary tract. Furthermore, it is the intention to understand the outcomes of these patients. For this purpose a non-interventional, observational study will be conducted.

NCT ID: NCT02379845 Completed - Clinical trials for Adult Soft Tissue Sarcoma

NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Randomized Patients in Two Arms With Soft Tissue Sarcoma of the Extremity and Trunk Wall

Start date: March 3, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering surgery more feasible or easier and achieve better local control of the tumor. PURPOSE: This phase II/III is a prospective randomized, multi-center, open-label and active controlled two arms study in patients with locally advanced soft tissue sarcoma (STS) of the extremity and trunk wall. Patients will be randomized to receive either NBTXR3 as intratumor injection, activated by external beam radiation therapy or external beam radiation therapy alone, as preoperative treatment. Once the radiotherapy treatment is completed, tumor surgery will be performed in all patients.

NCT ID: NCT02379598 Completed - Cow's Milk Allergy Clinical Trials

Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy

Start date: May 2012
Phase: N/A
Study type: Observational

Cow's milk allergy is an immunologically mediated adverse reaction to milk proteins. In industrialized countries there is an incidence of 2-3% in children younger than 2 years. Cow's milk allergy may present with different clinical pictures and symptoms often nonspecific. Among the most common are certainly food refusal and failure to thrive until frameworks frank malnutrition. It was also noted that the cow's milk allergy can have a negative impact on the quality of life of the patient and his family. The treatment of this condition provides the setting of a diet that is free of the allergen to the base of the adverse reaction. There are some types of formulas for the treatment of this condition. The formulas based on amino acids are currently used in all cases non-responsive to treatment with the above formulas or in all those characterized by severe allergic reactions. Being made from amino acids such formulas are by definition non-allergenic. They have also proven to ensure a rapid resolution of symptoms favoring a resumption of growth, nutritional status, as well as lead to a rapid improvement in the quality of life of the patient and his family. However, the studies currently available to us concerning the effects of nutritional formulas based on amino acids affect short observation periods (usually less than 6 months) and were directed to a comparison only with hydrolysates of whey protein or casein and not with healthy subjects. To date thus lack consistent data on the nutritional effects in the medium to long term.

NCT ID: NCT02378688 Completed - Crohn's Disease Clinical Trials

Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

Start date: March 2015
Phase: Phase 2
Study type: Interventional

The primary objectives of the study are: - To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease(CD) - To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.

NCT ID: NCT02378584 Completed - Infertility Clinical Trials

Natural Cycle Versus Endometrial Preparation for Healthy Blastocyst Transfer

Start date: February 2015
Phase: N/A
Study type: Interventional

This study evaluates the difference in pregnancy rate transferring a healthy blastocyst in natural or artificial cycle.

NCT ID: NCT02377921 Completed - GNE Myopathy Clinical Trials

Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sialic Acid in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)

GNEM
Start date: May 20, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of 6 g/day aceneuramic acid extended-release (Ace-ER) treatment of participants with GNEM on upper extremity muscle strength (upper extremity composite [UEC] score) as measured by dynamometry.