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NCT ID: NCT03439046 Completed - Breast Cancer Clinical Trials

Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant

BioItaLEE
Start date: February 2, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and, in patients with a PIK3CA mutation, on second-line treatment with alpelisib plus fulvestrant

NCT ID: NCT03438396 Completed - Cervical Cancer Clinical Trials

A Trial of Tisotumab Vedotin in Cervical Cancer

Start date: June 12, 2018
Phase: Phase 2
Study type: Interventional

A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.

NCT ID: NCT03438175 Recruiting - Critical Illness Clinical Trials

Intensiva 2.0: Improve the Communication Towards Families of Critically Ill Patients

Intensiva2
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The admission of a loved one in an ICU is a hard experience for family members. They frequently feel fear and grief, develop anxiety and depression symptoms, or even show some behaviors as this event was a real traumatic one, like hyper-arousal, avoidance and intrusion in the daily life.To improve the communication between them and the ICU staff members, and to meet their needs in terms of medical comprehension and emotional legitimization, a specific website was built, and a brochure was printed to make them welcomed in the ICU; moreover, a series of poster was prepared for the family waiting room outside the ICU. These instruments appeared able to improve the correctness of prognosis comprehension and to decrease the post-traumatic stress symptoms in a multicenter study involving Italian ICUs. The proposal of the present study is to verify on a larger scale if these instruments can really ameliorate the empathic communication among staff members, without increase in workload, and to make less traumatic, for the family members, their experience during and after the ICU stay.

NCT ID: NCT03437733 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.

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

This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.

NCT ID: NCT03437642 Recruiting - Breast Cancer Clinical Trials

Psyhosomatic Medicine in Oncologic and Cardiac Disease Study

PSYCHONIC
Start date: March 27, 2018
Phase:
Study type: Observational [Patient Registry]

Psychological processes play a complex role in the pathophysiology of many diseases. However, the body and emotional perception of patients and the relationship between dreams and disease still need to be investigated. The investigators planned an observational and controlled research aimed at assessing some previously unaddressed baseline psychological characteristics and their changes at 1 and 5 years after a short-term psychotherapy in carefully characterised patients with heart or oncologic diseases . The patients that will be enrolled are: - 50 patients ≤ 75 year old with acute myocardial infarction; - 30 patients ≤ 75 year old with Tako-Tsubo syndrome; - 50 women ≤ 75 year old, recently operated on breast cancer: - 90 control subjects of the same age and gender of the enrolled patients, without relevant pathologies during the last 10 years. Relevant pathologies are defined as those that required a hospitalisation or a long-lasting medical therapy. At the enrolment all the subjects will undergo a complete medical evaluation, and the following psychometric tests: Self-evaluation test, Social Support Questionnaire, Beck Depression Inventory II (BDI II), MacNew Heart Disease Health-Related Quality of Life Questionnaire, State-Trait Anxiety Inventory (STAI), State-Trait Anger Expression Inventory (STAXI 2). In two distinct following meetings, an open questionnaire exploring the body and emotional perception, and another exploring past and recent dreams, will be administered. The same evaluation will be done for the healthy subjects. After the initial evaluation, all the patients will be given the choice to start a short-term psychotherapy lasting 6 months on top of medical therapy or to continue classic medical therapy only. Healthy subjects will be not offered the possibility to follow psychotherapy. At first year of follow-up, the battery of psychometric test, and the two questionnaires exploring the body and emotional perception, and changes and characteristics of dreams during the psychotherapy, will be re-administered. The following data will be evaluated: Psychological characteristics at follow-up. Incidence of new relevant medical events Quality of life Relationship between psychological characteristics and health status, and quality of life At 5 year follow-up psychometric tests and the clinical data will be evaluated in all the groups.

NCT ID: NCT03436940 Completed - Patient Discharge Clinical Trials

Comparison Between Two Strategies of Discharge Planning for the Reduction of Short Term Hospital Readmissions

PROMENADE
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to improve discharge planning effectiveness by comparing two strategies [on-Demand Discharge Planning (DDP) vs. Routine Discharge Planning (RDP)], in terms of reduction of hospital readmissions for inpatients classified at intermediate risk of complex discharge using the simplified Blaylock Risk Assessment Screening Score (BRASS).

NCT ID: NCT03436602 Active, not recruiting - Follicular Lymphoma Clinical Trials

Personalized Risk Stratification Model of Follicular Lymphoma Patients

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

The study aims at developping and validating an integrated clinico-molecular model for an accurate identification of FL patients who are progression free and progressed, respectively, at 24 months after treatment.

NCT ID: NCT03436524 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Prognostic Tool for Early Stage CLL

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

The study aims at developing a model for the prediction of time to first treatment in chronic lymphocytic leukemia patients presenting with asymptomatic early stage disease

NCT ID: NCT03435796 Recruiting - Neoplasms Clinical Trials

Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

Start date: June 19, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

NCT ID: NCT03434704 Completed - Clinical trials for Myelodysplastic Syndromes

Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole

SIR-POSA
Start date: June 18, 2018
Phase: Phase 2
Study type: Interventional

SIR-POSA is a phase II trial of peripheral blood stem cell (PBSC) transplantation from a partially compatible family (Haplo) donor in patients with a blood tumor (myelodysplastic syndrome (MDS) and acute leukemia) treated for the prevention of primary fungal infections with posaconazole. The aim is evaluate the composite end-point graft-versus-host disease-free, relapse-free survival (GRFS) in these patients and evaluate the feasibility and efficacy of posaconazole oral tablets as primary antifungal prophylaxis.