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NCT ID: NCT01623635 Recruiting - Postoperative Pain Clinical Trials

Intraperitoneal Atomization of Ropivacaine During Gynecologic Laparoscopic Surgery

Start date: February 2012
Phase: Phase 3
Study type: Interventional

Pain following laparoscopic surgery continues to be a clinically important problem with 80% or more patients requiring opioid analgesia post-operatively to control their pain. By reducing this surgical complication patients can experience less discomfort and be discharged from the recovery room more rapidly leading to reduced resource utilization and expense. HYPOTHESIS: Post-operative pain after laparoscopic procedures could be treated by topical anesthetics sprayed directly into the abdomen (inside the abdominal cavity, on the nerve endings of the visceral peritoneal lining and diaphragm surface) via the surgical incision METHODS: Randomized controlled trial on use of topical anesthetic (namely 0.25% ropivacaine) delivered directly onto the target sites both at the beginning and the end of surgery in patients undergoing laparoscopic gynecologic procedure for uterine or adnexal benign pathology. The drug will be delivered using a CE approved delivery system that will direct a fine mist of drug directly to the areas of the peritoneal cavity that are theoretically the cause of post-op pain (diaphragms, peritoneal abdominal surface, surgical dissection site). GOAL: to assess the efficacy of intraperitoneal topical anesthesia in reducing postoperative pain, opioid requirements in patients undergoing laparoscopic gynecologic procedure for uterine or adnexal benign pathology

NCT ID: NCT01613066 Recruiting - Clinical trials for Advanced Haematological Malignancies

Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Start date: November 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Cord blood (CB) from an unrelated donor is increasingly used an alternative source of hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched donor. However, the utilization of single-unit CB for transplantation of adult patients has been impeded by the low number of nucleated cells available from individual CB units. Direct intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult patients with advanced or high-risk hematological malignancies

NCT ID: NCT01609855 Recruiting - Colonic Adenomas Clinical Trials

Does the Hyoscine N-Butylbromide Administered During Colonoscopy Increase the Adenoma Detection Rate?

Start date: January 2012
Phase: Phase 4
Study type: Interventional

The primary aim of the study was to test if the administration of Hyoscine Butyl Bromide, at time of caecal intubation, increases the adenoma detection rate.

NCT ID: NCT01607814 Recruiting - Cirrhosis Clinical Trials

Oxidative Stress and Haemostasis Abnormalities in Cirrhosis

Start date: November 2011
Phase: N/A
Study type: Observational

Patients with cirrhosis can have abnormalities in laboratory tests reflecting changes in primary and secondary haemostasis. Such changes have been considered particularly relevant in the bleeding complications that occur in cirrhosis. However, several studies have shown that routine diagnostic tests are not clinically useful to stratify bleeding risk in patients with cirrhosis. Moreover, treatments used to increase platelet count or to modulate platelet function could potentially do harm. Consequently the optimal management of bleeding complications is still a matter of discussion. Moreover, in the last two decades there has been an increased recognition that not only bleeding but also thrombosis complicates the clinical course of cirrhosis. Over the last years, emerge that in vivo platelet function and coagulation cascade might be modulated by an alteration of pro-oxidant and antioxidant balance. Thus It has previously been demonstrated that chronic liver diseases are characterized by increased oxidative stress state. Aim of the study is to analyse the relationship between oxidative stress, haemostatic balance and clinical complications in cirrhosis.

NCT ID: NCT01604720 Recruiting - Clinical trials for Definition of Sample Size in Randomized Clinical Trial Assessing Liver Disease

Sample Size Definition in Cochrane Hepato-Biliary Trials

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

Sample size definition provides important information, allowing the groundwork for transparent reporting. The sample predefinition allows the trial to be large enough to be able to address the question that is being asked. The aim of the present study is to assess, in all the randomized controlled trials (RCT) included in the Cochrane Hepato-Biliary Group (CHBG) systematic reviews, the quality of reporting sample size the accuracy of the calculations, the accuracy of the a priori assumptions and the effect on the agreement with pooled results in meta-analyses.

NCT ID: NCT01603745 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Effects of Drospirenone-ethinylestradiol and/or NOMAC-valerate Estradiol on Cardiovascular Risk in Women With Polycystic Ovary Syndrome

Start date: April 2012
Phase: Phase 1
Study type: Interventional

Polycystic ovary syndrome (PCOS) is often associated with pathological conditions, such as insulin resistance (IR), type 2 diabetes (DM2), obesity and it has potentially increased risk for cardiovascular disease (CVD). Of note, risk factors for CVD including dyslipidaemia, hypertension, oxidative stress and inflammation are associated with PCOS. The investigators want to evaluate the effects of two different types of E/P therapy on cardiovascular risk in PCOS.

NCT ID: NCT01602354 Recruiting - Clinical trials for Gram Negative Septic Shock

Endotoxin in Gram-negative Septic Shock

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

The purpose of this observational study is to determine whether endotoxin levels and/or their trends can be considered predictive of morbility or mortality in septic shock caused by gram-negative bacteria, searching also for a possible correlation with Simplified Acute Physiology Score (SAPS II), Sequential Organ Failure Assessment (SOFA), White Blood Cells (WBC) and Platelets (PLT).

NCT ID: NCT01598870 Recruiting - Clinical trials for Spontaneous Bacterial Peritonitis

Diagnosis of Spontaneous Bacterial Peritonitis

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

The study is aimed to revise the current criteria for the diagnosis of spontaneous bacterial peritonitis and the decisional thresholds to start treatment. The accuracy of current diagnostic tests will be compared with that of new tests, which could potentially become more accurate reference standards. This could lead to the definition of a more accurate and effective diagnostic algorithm.

NCT ID: NCT01593865 Recruiting - Clinical trials for Multivessel Coronary Artery Disease

The Catholic University BIMA Grafting Study

CATHEXIS
Start date: April 2012
Phase: N/A
Study type: Observational

The present study hypothesizes that the systematic use of bilateral internal mammary artery (BIMA) grafting is feasible in the practice of a University Cardiac Surgery Institution for the treatment of multivessel coronary artery disease (primary hypothesis). The secondary study hypothesis is that the BIMA grafting meets the safety endpoint compared with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets. The tertiary study hypothesis is that the BIMA grafting yields better follow-up results in terms of recurrence of symptoms related to coronary disease, of repeat revascularization and of cardiac mortality compared with patients treated with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets.

NCT ID: NCT01589874 Recruiting - Clinical trials for Anemia of Acute Inflammation

Anemia of Inflammation: Investigation on Impaired Iron Regulation in Acutely Ill Patients and Their Clinical Outcome

Start date: January 2008
Phase: N/A
Study type: Observational

Anemia of inflammation (AI), a normochromic, normocytic anemia, associated with abnormal iron utilization, erythropoietin hyporesponsiveness, and decreased red blood cells (RBC) survival is a very common problem in hospitalized patients for acute inflammatory diseases and develops within few days from the onset of illness. Deleterious effects of anemia include increased risk of cardiac related morbidity and mortality in critically ill and older patients. Anemia is mediated by hepcidin, the 25-amino acid polypeptide hormone that is central to iron trafficking. Several studies have been performed on pathophysiology of AI in patients affected by chronic diseases but few explore iron metabolism in humans with acute inflammation. The aim is to develop effective new strategies to detect and manage AI in the setting of acutely ill patients, based on the understanding of iron balance underlying this disorder.