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NCT ID: NCT03503682 Recruiting - Palliative Care Clinical Trials

Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

Start date: November 8, 2017
Phase: N/A
Study type: Interventional

Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases

NCT ID: NCT03503500 Completed - Breastfeeding Clinical Trials

Laid-back Breastfeeding in Hospital Setting

Start date: March 28, 2018
Phase: N/A
Study type: Interventional

The so-called biological nurturing (BN) - or laid-back breastfeeding (LB BF), a new neurobehavioral approach to breastfeeding (BF), has the potential to enhance BF initiation and to reduce breast problems (pain, fissures, etc.), while easing the newborn attachment to the breast. BN focuses on facilitating the mother to breastfeed in a relaxed, laid-back position, with her baby laying prone on her, so that the baby's body is in the largest possible contact with mother's curves. This position opens up the mother's body and promotes baby's movements through the activation of 20 primary neonatal reflexes stimulating BF. Neurophysiological studies show that, through this approach, infants instinctively know how to feed, thanks to the presence of neonatal reflexes, at the same time mothers being able to instinctively activate the same reflexes. The main objective of this study is to assess the effectiveness of LB BF compared to standard hospital practices on the frequency of breast problems (i.e., pain, fissures, etc.) at discharge.

NCT ID: NCT03503487 Completed - Communication Clinical Trials

Surgical Planning and Informed Consent

SPLICE
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

New devices for anatomic studies and 3-D visualization have proven to be useful for pre-operative surgical planning and intra-operative procedures; the hypothesis of our study is that, in this specific case scenario, Surgical Theater and Vesalius (two devices available at the Besta NeuroSim Center, Foundation I.R.C.C.S. Neurological Institute Carlo Besta) can improve doctor-patient communication during the process of obtaining informed consent: through tridimensional representation of anatomic structures of the brain, these devices are able to help patients understand better their own anatomy and the surgical approach to their disease. The aim of our study is therefore to understand whether this high-technology 3D planning, used as a tool to optimize patient-doctor communication, can effectively improve patients' understanding of the disease and the surgical procedure they will be going through (for which they are supposed to sign the consent), as well as the benefits, the risks and all the possible complications that can derive form surgery. Surgical Theater and Vesalius may be of great help: thanks to the case-specific 3D reconstruction of the patient's anatomy, the explanation of the surgical procedure could be customized for each different person, considering that anyone has certain unique individual features that a regular standardized system could not possibly take into account.

NCT ID: NCT03503409 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome

Start date: May 14, 2019
Phase: Phase 2
Study type: Interventional

patients with MDS (Myelodysplastic Syndrome) and mutated IDH1 patients will be treated with AG120 (IDH1 inhibitor)

NCT ID: NCT03503214 Completed - Acid-Base Imbalance Clinical Trials

Non Carbonic Buffer Power of Critical Ill Patients With Sepsis

Start date: March 7, 2018
Phase:
Study type: Observational

Alterations of acid-base equilibrium are very common in critically ill patients and understanding their pathophysiology can be important to improve clinical treatment. The human organism is protected against acid-base disorders by several compensatory mechanisms that minimize pH variations in case of blood variations in carbon dioxide content. The aim of the present study is to quantify the buffer power, i.e. the capacity to limit pH variations in response to carbon dioxide changes, in critically ill septic patients and compare these results with data collected from healthy volunteers.

NCT ID: NCT03502811 Completed - Clinical trials for Mitral Regurgitation

The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices

Start date: April 26, 2018
Phase:
Study type: Observational

The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.

NCT ID: NCT03502668 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS

Start date: July 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Multicenter, open-label study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with International Prognostic Scoring System (IPSS) risk category of low-risk or Intermediate-1 MDS. This study will be conducted in two phases. In phase 1 subjects will be randomized into 3 cohorts in a 28-day cycles. Phase 2, 80 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules.

NCT ID: NCT03501095 Completed - Clinical trials for Intubation Complication

Evaluation of Laryngeal Morbidity After Orotracheal Intubation by Vocal Analysis and Laryngostroboscopy

Start date: April 17, 2018
Phase:
Study type: Observational

The delicate structures of the larynx can be compromised by innumerable causes, one of these is represented by endotracheal intubation. More frequently, these damages are represented by hematomas, edema and granulomas of the vocal cords. The pathophysiology of laryngeal damage can be explained by an ischemic attack of the chordal mucosa. Numerous risk factors can cause the onset of damage, some depending on the practice itself, such as size and type of endotracheal tube, cuff pressure, use of mandrels and / or inserting devices, use of oral or nasogastric tubes, use of neuromuscular inhibitors or sleep-inducing drugs and the duration of the intervention; others from patient-related factors, such as gender, weight, history of exposure of smoking habit, or a history of gastroesophageal reflux (GERD). The incidence of such symptoms varies from 0% to 18% among the general population, with an average of 6% with resolution of most of the symptoms within 72 hours unless substantial damage has occurred to the vocal cords or to the arytenoids. In general, the incidence of such laryngeal complications has been described by several studies, but there is no standardized protocol for measuring and evaluating their entity. The purpose of this study is to determine how the voice and the chordal clinical aspect vary after oro-tracheal intubation, evaluated through voice analysis and laryngostroboscopy.

NCT ID: NCT03501030 Recruiting - Preterm Birth Clinical Trials

Activity Restriction for Women With Arrested Preterm Labor

Start date: November 25, 2019
Phase: N/A
Study type: Interventional

to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.

NCT ID: NCT03500575 Not yet recruiting - Clinical trials for Lung Transplant Rejection

Extracorporeal Photopheresis in Lung Transplant Rejection for Cystic Fibrosis (CF) Patients

PHORLUCY
Start date: May 20, 2018
Phase: N/A
Study type: Interventional

Background/Rationale Acute rejection (AR) is common in the first year after lung transplantation. AR has usually been reversible with treatment, but it can trigger chronic rejection that is the leading causes of late morbidity and mortality. Extracorporeal photopheresis (ECP) has emerged as a promising treatment for chronic rejection. The investigators postulate that the immunoregulatory property of ECP could promote graft tolerance immediately after lung transplantation. Objectives The aim of this trial is to evaluate the safety and efficacy of ECP as induction therapy for prevention of AR in recipients affected with cystic fibrosis in the first year after lung transplantation. The extracellular vesicles in the cell-to-cell communication and immunomodulation will be also investigated. Preliminary results (personal) A preliminary study, conducted in Vienna, demonstrated that 9 patients treated with ECP as induction therapy had 0% of chronic rejection versus 50% in the control group. The Institution hosting the current project is among largest lung transplantation centers in Italy with high rate of cystic fibrosis recipients. The Institution has experience in ECP and a dedicated instrument was specifically bought for the project. Internal collaborators have strong expertise in biological aspects including the extracellular vesicle compartment.