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NCT ID: NCT03921905 Completed - Clinical trials for Peripheral Artery Disease

Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.

PAD&CAD
Start date: September 25, 2019
Phase:
Study type: Observational

Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with which is associated in most cases with a more severe prognosis. Because of higher risk conferred by concomitant PAD an early diagnosis is recommended in subjects with CAD. PAD can be diagnosed relatively easily and noninvasively with the ankle-brachial index (ABI) measure. An ABI ≤0.9 is an indicator of the presence of lower extremity PAD, indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. However, ABI is not routinely applied in the clinical practice. Data on prevalence of PAD are scanty and in patients with stable CAD are lacking. The under-diagnosis of PAD may be a barrier to the use of treatments to improve prognosis. The primary aim of this study is to assess the coexistence of PAD in subjects with stable CAD and to evaluate the management and the prognosis of these patients in primary care at 12-month after the inclusion in the study.

NCT ID: NCT03921697 Recruiting - Parkinson Disease Clinical Trials

Improving Walking Ability in Parkinson Disease

PASTA
Start date: April 23, 2019
Phase:
Study type: Observational

Gait impairments of patients with Parkinson's disease (PD) limit the independence in the daily activities and sensibly increase the risk of falls. New gait analysis methods, based on wearable inertial sensors, have been proposed to track the gait features during treatment and in real-life conditions. Gait training based on auditory cues as Rhythmical Auditory Stimulation (RAS) have preliminarily shown positive effects improving gait velocity, stride length, step cadence of walking in PD. In the current project, the research group will aim to develop a smartphone application (Parkinson App Smartphone Aimed: P.A.St.A.) integrated with sensors and RAS. In a second time, investigators will analyze the spatio-temporal gait parameters obtained by the wearable sensors and the sociodemographic and clinical data, thus generating a big data set, to improve the knowledge about current pharmacological therapies and rehabilitation.

NCT ID: NCT03921671 Active, not recruiting - Thymoma Clinical Trials

Ramucirumab and Carbo-Paclitaxel for Untreated Thymic Carcinoma / B3 Thymoma With Carcinoma (RELEVENT)

RELEVENT
Start date: November 1, 2018
Phase: Phase 2
Study type: Interventional

This is a multicentric study. All patients with TET (thymic epithelial tumors) of any histological type will participate in the study. This is an open-label phase 2 study that will follow a Green-Dahlberg 2-stage design whose objective is to evaluate the activity and safety of the combination of ramucirumab (10 mg / kg) + carboplatin (AUC 5) and paclitaxel (200 mg / m2) in patients with relapsed and / or metastatic thymic carcinoma/ thymoma B3, in the first line (RELEVENT trial).

NCT ID: NCT03921541 Completed - Hyperargininemia Clinical Trials

Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency

Start date: April 10, 2019
Phase: Phase 3
Study type: Interventional

CAEB1102-300A is a multi-center randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of pegzilarginase in patients with ARG1-D. This study will consist of a screening period; a randomized, double-blind treatment period; a long-term extension; and a follow up visit for final safety assessments.

NCT ID: NCT03921528 Completed - Clinical trials for Neuromuscular Diseases

An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular Atrophy

TOPAZ
Start date: April 22, 2019
Phase: Phase 2
Study type: Interventional

The TOPAZ study will assess the safety and efficacy of SRK-015 in later-onset Spinal Muscular Atrophy (SMA Type 2 and Type 3) in pediatric and adult patients.

NCT ID: NCT03920787 Recruiting - Insulin Resistance Clinical Trials

Evaluating the Effect of Inositol Supplementation in Overweight Children on Basal Insulin and Body Weight

Start date: March 10, 2018
Phase: N/A
Study type: Interventional

Inositol in involved in the insulin pathway. In literature it has been demonstrated to improve insulin sensitivity and ovarian function in women affected by PCOS. In a preliminary study conducted on obese children between 7 and 15 years, the investigators have demonstrated that Inositol administration (Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg) before a Glucose Oral Tolerance Test reduces the increase of insulin levels, particularly in subjects with basal insulin ≥ 15 uU/ml. So the aim of this study is to evaluate the potential therapeutic effect of inositol, as non-pharmacologic agent, in preventing tipe II diabetes in children.

NCT ID: NCT03920657 Terminated - Clinical trials for Myelodysplastic Syndromes

Early and Low Dose Deferasirox (3.5 mg/kg FCT) to Suppress NTBI and LPI as Early Intervention to Prevent Tissue Iron Overload in Lower Risk MDS

Start date: October 4, 2019
Phase: Phase 2
Study type: Interventional

The scientific rationale for this study is the evolving understanding that iron-induced tissue damage is not only a process of progressive bulking of organs through high-volumes iron deposition, but also a reactive iron species related "toxic" damage. Iron mediated damage can occur prior reaching high iron storage thresholds derived from thalassemia major setting, free toxic iron species being already present when transferrin saturation >60-70% (25); therefore a timely early adoption of iron chelation may be of benefit before overt iron overload is seen. Our hypothesis is that early and low dose DFX-FCT is better tolerated and is able to prevent iron accumulation and consequently tissue iron related damage, by consistently suppressing iron reactive oxygen species (NTBI and LPI). If this hypothesis is confirmed this approach could contribute to an improvement of clinical practice of patients managements. Additionally this approach might also be a contribute in preventing future iron overloaded related complication, in this already frail and co-treated patient population.

NCT ID: NCT03920488 Recruiting - Clinical trials for Triple Negative Breast Cancer

Next-Generation Sequencing-based Germline and Somatic Genetic Testing in Triple-negative Breast Cancer

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

For patients with triple negative breast cancer, implementation of genetic testing in decision making might impact both risk management for the patient and her family, but also, importantly, therapeutic management. Identifying genetically predisposed subjects dictates risk-reducing strategies that may imply bilateral salpingo-oophorectomy and mastectomy or long term medical approaches. In the advanced setting, genetic testing can influence decision for medical therapy (e.g. use of platinum derivatives, poly-ADP ribose polymerase inhibitors (PARP inhibitors) in breast cancer patients with breast cancer susceptibility gene (BRCA) mutation. The selection of patients for testing has long relied on the presence of a strong family history of breast and ovarian cancer. It is now clear that this criterion will result in substantial numbers of those with a BRCA mutation being missed. Systematic large-scale genetic testing, simultaneously on germline and somatic tissues, is likely to improve decisional algorithms in patients with ovarian cancer. Feasibility of such approach in the clinical setting, in terms of a turnaround time compatible with clinical needs and sensitivity comparable if not superior to single-gene testing needs to be demonstrated before such diagnostic platforms can be routinely implemented in the diagnostic workflow. This is the scope of the present study.

NCT ID: NCT03920293 Completed - Clinical trials for Generalized Myasthenia Gravis

Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

Start date: March 12, 2019
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).

NCT ID: NCT03920254 Terminated - Clinical trials for Ulcerative Colitis (UC)

TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study

Start date: July 23, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157