There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study was undertaken to evaluate bone response in metastatic prostate cancer patients treated with Enzalutamide with or without Zoledronic Acid in combination with luteinizing hormone-releasing hormone (LHRH) analogue with the use of Whole Boby (WB) DW-MRI.
Background: An imbalance between prefrontal cortex (PFC) and the mesolimbic reward system has been suggested to contribute to GD. GD patients showed increased functional connectivity between regions of the PFC and mesolimbic reward system, as well as reduced connectivity in the area of the PFC. The altered interaction between prefrontal structures and the mesolimbic reward system in GD shares similarity with functional organization reported in Substances Use Disorders (SUDs), suggesting a more general pathophysiology for addictive disorders Objectives: To test if rTMS can reduce craving and playing in Gambling Disorder, and also affect several mood, behavioral and cognitive alterations associated with prolonged Gambling Disorder. Eligibility: Healthy, right-handed adults ages 18-65 who do have Gambling Disorder. Design: This is a non-randomized, open label study. The study includes three phases: 1) a rTMS continued treatment phase; 2) a rTMS follow-up; and 3) a no rTMS follow-up. Prior to participating, participants will be screened with: - Questionnaires - Cognitive tests - Medical history - Physical exam After being enrolled, baseline behavioral and imaging data will be collected. In particular, participants will undergo: - Questionnaires - Cognitive tests During the continued rTMS phase, participants with Gambling Disorder will receive real rTMS. Repetitive TMS will be delivered during 10 outpatient treatment days, over 2 weeks (5 days/week). Following this phase, subjects will have 12 follow-up visits (once/weekly), during which they will receive rTMS, and behavioral assessments will be performed. At the end of the rTMS follow up period, participants will further receive 3 follow up visits (once a month), during which rTMS will not be performed, but behavioral data will be collected. Treatment includes: - rTMS: A coil is placed on the head. Brief electrical current passes through the coil. At each visit, participants will receive two rTMS sessions, with a 1hr interval between sessions. At the beginning of each rTMS session, they view gambling-related images for few minutes. - Repeat of screening tests and questionnaires
Background: Cocaine use disorders (CUD) is a complex brain disorder, involving several brain areas and neurocircuits. Effective treatments for CUD are still needed. Repetitive transcranial magnetic stimulation (rTMS) stimulates non-invasively parts of the brain. Preliminary data suggest that rTMS may help reducing cocaine craving and consumption. Researchers want to learn how the brain and the drug-seeking behavior may change with this treatment. Objectives: To test if rTMS can reduce cocaine craving and use, and also affect several mood, behavioral and cognitive alterations associated with prolonged cocaine use. Eligibility: Healthy, right-handed adults ages 18-65 who do have cocaine use disorder (moderate to severe). Design: This is a randomized, double-blind, sham-controlled study. The study includes three phases: 1) a rTMS continued treatment phase; a rTMS follow-up; and a no rTMS follow-up. Prior to participating, participants will be screened with: - Questionnaires - Medical history - Physical exam - Urine tests - MRI (structural) After being enrolled, baseline behavioral and imaging data will be collected. In particular, participants will undergo: - Questionnaires - Functional MRI During the continued rTMS phase, participants with cocaine use disorder will be randomized to receive real or fake rTMS. Repetitive TMS will be delivered during 10 outpatient treatment days, over 2 weeks (5 days/week). Following this phase, subjects will have 12 follow-up visits (once/weekly), during which they will receive rTMS, and behavioral and imaging assessments will be performed. At the end of the rTMS follow up period, participants will further receive 3 follow up visits (once a month), during which rTMS will not be performed, but behavioral data will be collected. Treatment includes: - rTMS: A coil is placed on the head. A brief electrical current passes through the coil. At each visit, participants will receive two rTMS sessions, with a 1hr interval between sessions. At the beginning of each rTMS session, they view cocaine-related images for few minutes. - MRIs at baseline and at follow-up visit #12: Participants lie on a table that slides into a cylinder that takes pictures of the brain. They respond to images while in the scanner. - Repeat of screening tests and questionnaires - Urine toxicological screen
Breast cancer related lymphedema (BCRL) is a debilitating and distressing condition affecting approximately one out of five breast cancer survivors. BCRL is a chronic swelling of the upper arm following axillary lymph nodes dissection, and it is associated to a significant functional, psychological and social morbidity, with an heavy impact on life quality. Several studies reported BCRL incidence between 6.7% and 62.5% for different population cohorts. Randomized clinical trials (RCTs) reported that sentinel lymph node biopsy (SLNB) when compared with axillary lymph node dissection (ALND) leads to a significant reduction in postoperative complications. However, the advent of SLNB does not solve the problem of BCRL with a concrete chance to develop a lymphedema after single SLNB around 7%. Health care cost of BCRL rehabilitative treatment is not available in literature yet. Few studies considered incidence, risk factors and treatment costs of BCRL among working-age women after breast cancer treatment, reporting that BCRL population had significantly higher rehabilitative medical costs ($14,877 to $23,167) with twice as much risk to develop BCRL complications, such as lymphangitis or cellulitis when compared to "BCRL free" population (OR = 2.02, P = .009). Axillary reverse mapping (ARM) procedure claims to map and preserve arm lymphatic drainage during ALND and/or during SLNB, reducing BCRL development. ARM is developed as result of assumption that arm's lymphatic pathway is not involved by metastatic tumor cells of the primary breast cancer. However, when the arm lymph node correspond to the SLN it should be removed for correct tumor staging, thus a lymphatic drainage disruption onset will be expected with BCRL risk increase. During the ARM procedure, a fluorescence imaging technique (photodynamic procedure) is useful for detecting lymphatic drainage of the upper limb and it allows in differentiating the fluorescent ARM node from the SLN identified by the radioguided technique (99mTC-Nanocoll).
BACKGROUND Psoriatic arthritis (PsA) is a systemic inflammatory disease with articular and extra-articular features. Establishing the prognosis of a patient with PsA is hence important to define the treatment strategy. Currently, observational and prospective cohort studies have identified prognostic factors correlating with the achievement of therapeutic response. Nevertheless, despite the importance of identifying prognostic factors in a disease with a functional disability comparable to rheumatoid arthritis, the studies are still limited. PRIMARY OBJECTIVE In PsA with clinically active joint disease starting a new course of therapy, to evaluate the additional value of UltraSound(US)-score over clinical examination in detecting patients achieving MDA at 6 months. STUDY DESIGN The study follows a multi-centre observational prospective cohort study design. PATIENTS AND METHODS INCLUSION CRITERIA - Adult > 18 years of age with PsA (PsA according to the ClASsification criteria for Psoriatic Arthritis (CASPAR) - with joint involvement) - At least one joint clinically involved (both swelling and tenderness); - prescription of new course of d NSAIDs (monotherapy), steroid intra-articular injections (monotherapy), conventional Disease-Modifying AntiRheumatic Drugs (DMARDs), biologic DMARDs, including switches or dose augmentations indicated by the treating rheumatologist according to usual clinical practice before US acquisition; - Stable treatment before treatment modification (6 weeks); - Signed informed consent form. CLINICAL ASSESSMENT Patient's clinical assessment will be performed according to the core set of domains for PsA proposed by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT). ULTRASOUND ASSESSMENT Sonographic evaluations will be performed by expert ultrasonographers in 44 joints, 36 tendons, 12 entheses and 2 bursae according to the score developed for psoriatic arthritis by the study group ultrasound of the Italian Society of Rheumatology (US-score PsA-SIR) EXPECTED RESULTS AND SIGNIFICANCE The aim of this study is to identify clinical and US predictors of achieving MDA in PsA patients with active peripheral arthritis starting a new course of therapy.
This is a multi-center, open-label trial to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib (CA-4948) in adult patients with relapsed or refractory (R/R) hematologic malignancies. Part A will evaluate the safety and tolerability of escalating doses of emavusertib as monotherapy (Part A1), and in combination with ibrutinib. In Protocol Version (v) 1.0 through v6.0, patients with Waldenström macroglobulinemia/ lymphoplasmacytic lymphoma (WM/LPL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) were also enrolled at ibrutinib doses of 420 mg (Part A2). Enrollment into Parts A1 and A2 has been closed. Part B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in patients with primary central nervous system lymphoma (PCNSL).
The prospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world regional setting. The protocol includes two different networks. The first network includes all cath-labs in the Emilia-Romagna region (SHERPA). The second includes the centers partecipating into the MAGIC retrospective study. Both networks joined into the prospective SHERPA-MAGIC project. Investigators from both networks agreed in indications and strategy implanatation described by the protocol. In each center, after IRB approval, the patients will be enrolled according to established criteria.
Anastomotic leakage (AL) is considered the commonest major complication after surgery for rectal cancer. Transanal tube drainage role in the prevention of AL is still debatable.
- Previous in vitro and in vivo studies detected the Hemopatch Sealing Hemostat® to be a new versatile, self-adhering hemostatic sealing pad consisting of a polyethylene glycol-coated collagen. - Initial study assessed that Hemopatch Sealing Hemostat® can be applied to seal almost any bleeding surface encountered during a range of procedures. The Authors shown that the device is eminently capable in both via laparotomy and laparoscopic approaches, and in patients with impaired coagulation or highly variable anatomies. They support the ease-of-use, application, and immediate hemostatic effect of the patch across a broad range of surgical settings and clinical applications, including solid organ, gastrointestinal, biliopancreatic, endocrine, cardiovascular, and urologic surgeries. - In a recent published case report the authors reported the feasibility in using Hemopatch Sealing Hemostat® for the management of a myocardial wound, performing the procedure on cardiopulmonary bypass, which meant the patient had to be heparinized. Despite these major risk factors for bleeding Hemopatch Sealing Hemostat® managed to contain bleeding and seal the wound without needing any suture. These initial results lead up to future randomized clinical trials with more extensive follow-up to assess which is the real contribution of Hemopatch Sealing Hemostat to reduce postoperative bleeding complications in cases where mechanical or energy-driven hemostasis is not possible or insufficient.
The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.