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NCT ID: NCT03408847 Recruiting - Clinical trials for Ulcerative Colitis Chronic Mild

Monocultivar Coratina Extra Virgin Olive Oil in UC Patients

EVORCU
Start date: November 20, 2017
Phase: N/A
Study type: Interventional

Epidemiological studies suggest that daily intake of fruits and vegetables high in polyphenols or the addition of olive oil containing many polyphenols is associated with a reduced risk of chronic diseases including cardiovascular, metabolic, neurodegenerative, and inflammatory bowel conditions. In vivo experiments demonstrated that the administration of a diet associated with daily intake of extra virgin olive oil (EVOO) reduces histological lesions and symptomatology in rats with a dextran sulfate sodium (DDS) induced colitis. A diet supplemented with hydroxytyrosol (a component of olive oil) showed a reduction of the inflammatory process at the inflamed colon of the rats.

NCT ID: NCT03408600 Completed - Abdominal Sepsis Clinical Trials

Physiologic Indicators for Prognosis in Abdominal Sepsis Study

PIPAS
Start date: February 1, 2018
Phase:
Study type: Observational

Early detection and timely therapeutic intervention can improve the prognosis of patients with sepsis. However, early diagnosis of sepsis can be difficult; because determining which patients presenting with signs of infection during an initial evaluation, do currently have, or will later develop a more serious illness is not easy. Physiological deterioration often precedes clinical deterioration as patients develop critical illness. In this study, the investigators aim to evaluate vital signs in a global cohort of patients with acute secondary peritonitis, determining which parameters are statistically significant to predict in-hospital mortality and ICU admission.

NCT ID: NCT03408067 Recruiting - Malnutrition Clinical Trials

Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients

Start date: September 2016
Phase: N/A
Study type: Observational

In several hospital clinical trials, the nutritional intervention has been proven to be effective in preventing and/or reducing malnutrition. Therefore, a procedure to identify the risk of malnutrition or malnourishment in hospitalized patients is necessary to guarantee an adequate and timely nutritional treatment. Aims: to compare two validated nutritional screening tools: NRS 2002 and SGA. These are used to identify the risk of malnutrition or malnourishment in hospitalized patients. Patients and Methods: The study is currently carried out at the Federico II University Hospital of Naples, Italy. The in patients admitted in the Clinical Wards since September 2016 are being evaluated. The two screening test results and the assessment of the patients' parameters are collected within 72 hours following admission. Age, sex, height, weight, Body Mass Index (BMI), calf circumference and dominant hand of the participants are being noted. Venous blood samples are collected for routine biochemistry and inflammatory parameters ; all measurements are determined by routine laboratory methods at the Department of Laboratory Medicine of the University Hospital Federico II, Naples.

NCT ID: NCT03408002 Completed - Surgery Clinical Trials

PREPARE - PREoPerative Anxiety REduction

PREPARE
Start date: June 14, 2017
Phase: N/A
Study type: Interventional

The study aims to verify if a short individual psychological intervention might increase perceived self-efficacy in managing preoperative anxiety in patients who will undergo pancreatic surgery. It is a randomized clinical trial where half of participants will attend a psychological intervention based on "the four elements protocol" by Elan Shapiro the day before surgery, while the other half will follow usual care.

NCT ID: NCT03407911 Completed - Clinical trials for Periodontal Diseases

Microbiota Around Periodontal Teeth and Implants Affected by Peri-implant Disease.

Start date: February 1, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of the study was to evaluate, from a microbiological point of view, microbiota around teeth and implants in the same patient affected by periodontal disease and peri-implant disease, all compared with a healthy tooth. From the identification of particular bacterial species in the examined sites, it is intended to be traced back to the identification of a clear etiopathogenic process, which may shed light on the similarities and differences between the two diseases. In recognition of these mechanisms, the investigators think to develop new therapeutic strategies for the future.

NCT ID: NCT03407560 Completed - Spinal Fusion Clinical Trials

Use of the Bone Substitute SintLife® in Vertebral Arthrodesis Procedures. A Pilot Study.

Start date: March 31, 2017
Phase: N/A
Study type: Interventional

This pilot study is to evaluate the potential effectiveness of bone substitute SintLife within the spinal surgery in spinal stabilization applications for degenerative diseases. In particular, the investigators propose to evaluate: - the ability of bone regeneration/ fusion, defined as the presence of trabecular bone continuous bridge and absence of radiolucent lines, verified by diagnostic imaging in accordance with the Brantigan scale; - the patient's state of health, evaluated through the comparison of the functional-symptom pattern between the pre- and post-operative phases, verified by Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and EuroQol (EQ-5D); - the safety of the medical device, evaluated through the impact of any adverse events, complications, unexpected reactions, accidents. STUDY DESIGN This collection of clinical data is set up as pilot study post-marketing. In the study will be included all consecutive patients who require spinal fusion surgery, in accordance with the inclusion and exclusion criteria after signing the informed consent. Patients will be treated and followed postoperatively according to the normal clinical, surgical and therapeutic practice, in place at the Rizzoli Orthopaedic Institute of Bologna. The total duration of data collection is 36 months: - the stage of patient enrollment is 18 months from the date of approval of the study by the Ethics Committee of the center; - the phase of post-operative monitoring is 18 months, with planned at 6, 12 and 18 months follow-up (± 15 days before scheduled date).

NCT ID: NCT03407144 Active, not recruiting - Hodgkin Lymphoma Clinical Trials

Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)

Start date: April 9, 2018
Phase: Phase 2
Study type: Interventional

This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.

NCT ID: NCT03406988 Recruiting - Systemic Sclerosis Clinical Trials

Autologous Adipose Tissue in the Treatment of Systemic Sclerosis Digital Ulcers

ADUL-SSc
Start date: July 18, 2017
Phase: N/A
Study type: Interventional

A randomized controlled trial will be performed to confirm preliminary uncontrolled data indicating that regional adipose tissue grafting is effective in inducing digital ulcer healing in patients with systemic sclerosis. Systemic Sclerosis patients with digital ulcers will be randomized to be blindly treated with adipose tissue implantation or a sham procedure. Adipose tissue grafting will consist of injection at the base of the finger with digital ulcer of 0.5-1 ml of adipose tissue after centrifugation of fat aspirate. Sharm procedure will consist of false liposuction and local injection of saline solution. The primary end-point will be to compare the cumulative prevalence of healed digital ulcers in the two groups within the following 8 weeks.

NCT ID: NCT03406104 Completed - Clinical trials for Leber Hereditary Optic Neuropathy

RESCUE and REVERSE Long-term Follow-up

RESTORE
Start date: January 9, 2018
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess the long-term safety and efficacy of GS010, a gene therapy, and assess the quality of life in subjects with LHON due to the G11778A ND4 mitochondrial mutation and who were treated in the Rescue or Reverse studies.

NCT ID: NCT03406091 Completed - Multiple Myeloma Clinical Trials

Detection of Poor Mobilizer (PM) in Multiple Myeloma (MM) Patients

Start date: November 26, 2015
Phase:
Study type: Observational

The study is an italian multicentric and will be conducted in 20 centers. The aim of this study is to evaluate poor mobilizer (PM) rate in newly diagnosed MM patients who are mobilized with cyclophosphamide and G-CSF and plerixafor on demand. Plerixafor is a specific reversible inhibitor of the chemokine receptor CXCR4 and prevents the binding of its ligand stromal cell derived factor SDF-1α also known as CXCL12, thereby releasing hematopoietic stem cells into the circulation.