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NCT ID: NCT03671681 Not yet recruiting - Chronic Migraine Clinical Trials

Mindfulness Therapy for Chronic Migraine

Mind-CM
Start date: November 2018
Phase: N/A
Study type: Interventional

The aim is to assess the efficacy of adding on a Mindfulness-based therapy to pharmacological prophylaxis (experimental group: pharmacological prophylaxis + Mindfulness) against pharmacological prophylaxis only (control group) on the reduction of monthly headaches frequency (primary endpoint), symptomatic medications intake, inflammatory pattern, depression, anxiety, cutaneous allodynia, improving disability and quality of life (secondary endpoints). Moreover, other aims are to assess whether adding on Mindfulness-based therapy is also associated to a superior improvement of neuroimaging pattern among patients prescribed neuromodulators or antidepressants and to assess the cost-efficacy of adding on a Mindfulness-based therapy to pharmacological prophylaxis. Mindfulness will be provided in small groups (5-7 patients each) by specifically trained therapists. The treatment consists in six 45 minutes weekly sessions in which one will work on meditation, acceptance and awareness. The program of control group will consist in education of patients, followed by pharmacological prophylaxis. Prophylaxis is prescribed based on patients' profile, such as previous failures, contraindications and so on by a neurologist with expertise in headache treatments. We expect that adding-on Mindfulness will determine a wider reduction of headaches frequency and improvement of secondary endpoints, and that disease cost reduction will support the cost-efficacy of Mindfulness. The study will be a Phase III; randomized, Open-Label; Monocentric study. Patients will be enrolled to detect a 20% difference between the two groups on the primary outcome (50% or more of headache reduction by 12 months). For each medication type and research arm 20 patients will be selected: thus 80 patients will be enrolled for neuroradiological investigation.

NCT ID: NCT03670992 Completed - Clinical trials for Renal Cell Carcinoma

Surgical Treatment of Pancreatic RCC Metastases

Start date: January 10, 2016
Phase:
Study type: Observational

Data from 26 patients undergoing resection of Pancreatic Metastases and extra-Pancreatic Metastases from RCC were retrospectively analysed. Clinical data were collected from a digital database and QoL was assessed through patient's interview and Karnofsky performance scale.

NCT ID: NCT03669874 Recruiting - Clinical trials for Gastro-esophageal Reflux

Endoscopic Fundoplication With MUSE System

Start date: September 16, 2015
Phase:
Study type: Observational

This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives: - Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of: - effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores - effect on the use and dosage of proton pump inhibitors (PPI) - feasibility and safety of the endoluminal fundoplication procedure - Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure. The study design includes the following phases: *Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI - 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI - 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI - Yearly clinical follow-up (up to 6 years): PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

NCT ID: NCT03669315 Recruiting - Gambling Disorder Clinical Trials

Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation

TMS-GD
Start date: May 20, 2018
Phase: Phase 3
Study type: Interventional

In this project the investigators propose a randomized double-blind placebo-controlled design in which 40 patients with GD will receive active or sham cTBS to the pre-SMA for 2 weeks. The investigators will combine TMS, multimodal structural and functional MRI and behavioral measures in order to identify circuit-level mechanisms of action and therapeutic targets (connectivity changes that explain clinical improvement) and assess the efficacy of TMS in modulating inhibitory control and symptom severity in this population.

NCT ID: NCT03668938 Not yet recruiting - Rehabilitation Clinical Trials

Occupational Therapy Intervention in Patients With Complex Needs to Improve Social Reintegration

Start date: September 24, 2018
Phase: N/A
Study type: Interventional

A previous study that involved the intervention of the occupational therapist (OT) on complex patients both in hospital and at home showed the effectiveness of OT during hospitalization. The effectiveness was not demonstrated in the post-discharge phase. Now, the investigators presented a RCT to compare the levels of social reintegration between the intervention group and control group. The hypothesis is that the intervention group obtains a higher and clinically relevant level of social reintegration compared to the group treated with the usual care.

NCT ID: NCT03668782 Not yet recruiting - Clinical trials for Placental Transfusion

Cord Milking in Elective Cesarean Section

Start date: October 1, 2018
Phase:
Study type: Observational

The objective of the study was to investigate the efficacy and safety of umbilical cord milking as compared with immediate cord clamping on placental transfusion, estimated by Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age, in elective cesarean delivered neonates.

NCT ID: NCT03668418 Recruiting - Pancreatic Cancer Clinical Trials

Xenotransplantation of Primary Cancer Samples in Zebrafish Embryos

xenoZ
Start date: June 1, 2018
Phase:
Study type: Observational

The study consists in a co-clinical trial by using zebrafish embryos. Specifically, an observational prospective clinical trial on patients operated of epato-biliar-pancreatic cancers and gastro-intestinal cancers undergoing a chemotherapy treatment will be run concurrently to an animal trial on zebrafish embryos xenotransplanted with patient cancer cells in order to demonstrate that zebrafish model is able to predict the therapeutic regimen with the best efficacy for each patient.

NCT ID: NCT03668236 Not yet recruiting - Septic Shock Clinical Trials

The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial

CLASSIC
Start date: November 2018
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to assess patient important benefits and harms of IV fluid restriction vs. standard care fluid therapy in patients with septic shock.

NCT ID: NCT03668080 Completed - Burnout Syndrome Clinical Trials

Burnout Syndrome Among Medical Residents

Start date: October 16, 2017
Phase:
Study type: Observational

Whether and to what extent burnout risk is actually higher in surgical specialties than in non-surgical specialties is still unknown. Little is also known about what factors are associated with burnout between surgical residents and non-surgical residents. In this context, the present study has a three-fold aim: 1) to measure the prevalence of burnout among a sample of Italian medical residents; 2) to contrast the prevalence of burnout and psychological distress in surgical residents and non-surgical residents, and 3) to identify the work-related factors associated with burnout between surgical residents and non-surgical residents.

NCT ID: NCT03666936 Recruiting - Neoplasms Clinical Trials

Facilitate the Return to Work of Cancer Survivors

Start date: April 4, 2018
Phase: N/A
Study type: Interventional

Cancer patients could experience physical limitations, cognitive symptoms, fatigue and pain, that could be perceived at diagnosis but may also occur during treatment, limiting the person from carrying out their activities of daily living, including work tasks. Return to work is a major goal, as it facilitates the patient's ability to deal with the disease and improve general health. At present, there is no path aimed at supporting cancer patients in the return to work process. Because of this, the investigators want to assess the feasibility of a multidisciplinary social-health care pathway aimed at manage the difficulties that cancer patients might perceive in the return to work process.