Clinical Trials Logo

Filter by:
NCT ID: NCT03365453 Active, not recruiting - Clinical trials for Aortic Valve Disease

Frailty in Elderly Patients Receiving Surgical or Percutaneous Procedures for Valvular Disorders

FRASER-VD
Start date: December 1, 2017
Phase: N/A
Study type: Interventional

In Italy, life expectancy at birth has reached 80 years in men and 85 in women; in about 50 years, life expectancy at the age of 80 has increased by an extraordinary 61% and 55%, respectively, due to more effective therapies and lower mortality of many diseases. Yet, chronic diseases are nowadays more important, and often coexist as comorbidity or multimorbidity, depending on whether an index condition has been considered. These conditions increase the risk of death and reduce functional autonomy in the elderly and, therefore, should be carefully considered within comprehensive geriatric assessment. The epidemiology of valvular disease shows a clear trend in age-dependent, as the number of events and their incidence increases with age, and about half are concentrates over 75 years. In addition, some observational studies in elderly patients have suggested an association between frailty and cardiovascular disease: fragility and cardiovascular disease share a common biological pathway, and cardiovascular diseases may accelerate the onset of frailty. The frailty syndrome was identified in 25% to 50% of patients with cardiovascular disease, according to the rating scale used and the population studied. Frail patients with cardiovascular disease, in particular those undergoing invasive procedures or suffering from coronary artery disease and aortic valve disease, have a much higher adverse events and complications, suggesting the need for a more accurate functional stratification and a more careful evaluation of the risk/benefit ratio of some invasive procedures. Among the numerous tests proposed in the literature for the functional evaluation and objective measures of physical capability in elderly patient, the Short Physical Performance Battery (SPPB) and the evaluation of hand grip strength (grip strength) are those characterized by an improved prognostic ability and an easy administration. The present study is performed to assess if SPPB and handgrip are helpful to better stratify the prognosis (all-causes death and hospital admission for all causes) in elderly patients admitted to hospital for cardiac causes.

NCT ID: NCT03364153 Active, not recruiting - Clinical trials for Stargardt's Macular Dystrophy

Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)

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

The purpose of this study is to evaluate the safety and efficacy of avacincaptad pegol intravitreal injection compared to Sham in participants with autosomal recessive Stargardt disease 1 (STGD1).

NCT ID: NCT03362177 Active, not recruiting - Clinical trials for Chemotherapy-induced Thrombocytopenia

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer

RECITE
Start date: September 30, 2019
Phase: Phase 3
Study type: Interventional

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer

NCT ID: NCT03358472 Active, not recruiting - Clinical trials for Head and Neck Cancer

Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

Start date: December 1, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

NCT ID: NCT03355209 Active, not recruiting - Clinical trials for Lennox Gastaut Syndrome

A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

Start date: November 27, 2017
Phase: Phase 3
Study type: Interventional

This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

NCT ID: NCT03351088 Active, not recruiting - Prostate Cancer Clinical Trials

Outcomes From a RCT Comparing Preventive Versus Delayed Ligation of DVC During Robot-assisted Radical Prostatectomy

Start date: August 2016
Phase: N/A
Study type: Interventional

Since its introduction, robot-assisted radical prostatectomy (RARP) have become the standard surgical approach for the treatment of prostate cancer in the United States and then in Europe. Continuous refinements of surgical technique has been described in order to maximise outcomes while minimizing morbidities. The management of DVC is a crucial steps during RARP. It could be done prior or after its transection thanks to haemostatic effects of the pneumoperitoneum. This topic has been already investigated by some authors. However, no high quality evidence is available to opt in favour of either of the two approaches. Findings about estimated blood loss, positive surgical margins and urinary recovery differ among these studies and only one is a randomized controlled trial in a laparoscopic setting with a limited number of patients. Therefore, our objective was to evaluate in a prospective randomised setting whether a delayed ligation of the dorsal vascular complex impacted on perioperative, functional and oncological outcomes as compared to preventive ligation during robot-assisted radical prostatectomy.

NCT ID: NCT03349801 Active, not recruiting - Clinical trials for Age Related Macular Degeneration (AMD)

Development of Novel Clinical Endpoints in Intermediate AMD

MACUSTAR
Start date: March 26, 2018
Phase:
Study type: Observational

Development of novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (AMD) - MACUSTAR

NCT ID: NCT03345823 Active, not recruiting - Crohn's Disease Clinical Trials

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

U-ENDURE
Start date: March 21, 2018
Phase: Phase 3
Study type: Interventional

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

NCT ID: NCT03343171 Active, not recruiting - Osteoarthritis Clinical Trials

Continuum Ceramic on Ceramic Bearing Post Market Clinical Follow-Up Study

Start date: September 15, 2010
Phase:
Study type: Observational

The primary objective of this study is to obtain implant survivorship and clinical outcome data for the commercially available Zimmer® Continuumâ„¢ Ceramic-on-Ceramic Bearing System when used in primary hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and efficacy of the Continuum Ceramic-on-Ceramic Bearing System.

NCT ID: NCT03340272 Active, not recruiting - Clinical trials for Intermediate Risk Prostate Cancer

PROspective Multicenter Observational Study on Elective Pelvic Nodes Irradiation.

PRO-EPI
Start date: February 21, 2017
Phase:
Study type: Observational [Patient Registry]

The general aim of the study is to describe the use of elective pelvic node irradiation (ENI) in Italy, in patients with intermediate/high/very high-risk prostate cancer patients submitted to adjuvant or radical Radiation Therapy (RT) with or without concomitant Androgen Deprivation hormone Therapy (ADT). The study aims at the definition of survival, toxicity and QoL data in a representative sample of intermediate, high and very high risk prostate cancer patients consecutively recruited in Italian Radiation Oncology Center over two years.