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NCT ID: NCT03845764 Completed - Lung Cancer Clinical Trials

Can a Pulmonologist Reliably Assess the Tumor Burden on ROSE Slides Obtained From Pulmonary Nodules and Lymphadenopathy

Start date: February 18, 2019
Phase:
Study type: Observational

The study is aimed at verifying if a pulmonologist can reliably assess the tumor burden for the extractive molecular analysis in ROSE samples obtained with endoscopic sampling procedures from intrathoracic lymphadenopathy and pulmonary nodules.

NCT ID: NCT03845543 Completed - Clinical trials for Peripheral Arterial Disease

Belgian-Italian Trial to Evaluate the Efficacy and Safety of Below The Knee (BTK) Treatment With the Luminor 14 Paclitaxel Coated Percutaneous Transluminal Angioplasty Balloon Catheter of iVascular

BIBLIOS
Start date: November 28, 2018
Phase: N/A
Study type: Interventional

The BIBLIOS trial investigates the efficacy and safety of BTK treatment of patients suffering from critical limb ischemia (Rutherford 5) with the Luminor-14 Paclitaxel coated Percutaneous Transluminal Angioplasty Balloon catheter of iVascular. An expected total of 150 patients will be treated. Infrapopliteal lesions will be treated during this trial. The Paclitaxel eluting balloon Luminor-14 is designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation. The balloon is coated with Paclitaxel intended to avoid cellular proliferation. The drug is released by means of rapid inflation as to release a high dose in a short amount of time. Patients will be invited for a follow-up visit at 1, 6 and 12 months post-procedure. The primary efficacy endpoint is defined as freedom from major adverse limb events, defined as above the ankle target limb amputations or major reintervention to the target lesions at 6 months. The primary safety endpoint is freedom from major adverse limb event at 30 days. The secondary endpoints consist of functional flow in target vessel, freedom from clinically driven target lesion revascularisation, above the ankle amputation free survival and limb salvage at 6 and 12 months, and also procedural success, wound healing status and wound healing time.

NCT ID: NCT03845517 Completed - Clinical trials for Systemic Lupus Erythematosus

A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Start date: April 18, 2019
Phase: Phase 2
Study type: Interventional

Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.

NCT ID: NCT03845491 Completed - Ischemic Stroke Clinical Trials

ASSIST Registry Studying Various Operator Techniques

Start date: January 23, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO).

NCT ID: NCT03845335 Active, not recruiting - Edentulism Clinical Trials

Clinical Performance Evaluation of Two Different Dental Implants

HAHy-vs-C
Start date: February 25, 2019
Phase: N/A
Study type: Interventional

In brief, the aim of this randomized controlled trial is to evaluate the patient satisfaction and the clinical performance of two types of implants: 1) HA-coated hybrid dental implant and 2) non-coated moderately rough dental implant. The comparison will be studied during a routine implant placement of experienced dental implantologists.

NCT ID: NCT03845166 Active, not recruiting - Colorectal Cancer Clinical Trials

A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

STELLAR-001
Start date: March 20, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.

NCT ID: NCT03844932 Terminated - Colitis, Ulcerative Clinical Trials

A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

Start date: January 24, 2019
Phase: Phase 2
Study type: Interventional

Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and endoscopy sub-scores; score range 0-9).

NCT ID: NCT03844867 Completed - Healthy Subjects Clinical Trials

Healthy Properties of Two Almond Varieties. CEA vs. CARMEL

ALMOND1
Start date: February 9, 2017
Phase: N/A
Study type: Interventional

The cultivation of almond (Amygdalus communis L.) has always been a hallmark of the Mediterranean, representing a resource both food and economic. Almonds are high in fat (55.3%, mainly (39.4%) they consist of MUFA), are an excellent source of vitamin E, manganese, magnesium, copper, phosphorus, fiber, riboflavin and protein, phenolic and polyphenolic. Numerous studies correlate moderate and regular consumption of nuts with an important role in health. In particular, habitual almond consumption does not lead to weight gain, and their inclusion in low-calorie diets appears to promote more weight loss than a comparable carbohydrate-based low-calorie diet. Also, almonds have a low glycemic index and do not adversely impact insulin sensitivity. So they reduce certain risk factors linked to diabetes and cardiovascular disease. Almonds are an excellent source of bioavailable α-tocopherol, and increasing their intake enhances the resistance of LDL against oxidation. In addition, the polyphenolic constituents of almonds have been characterized recently and found to possess antioxidant actions. Some studies show as consumption of almonds has been shown to be associated with lower levels of serum cholesterol and triglycerides thanks of their poly-unsaturated fatty acids. Despite Mediterranean countries have dominated world trade for a long time, from the '80 years, Italy underwent a strong production crisis, mainly due to the lack of new plants conducted according to the most modern techniques of cultivation and competition from other crops considered more profitable (e.g. wine, horticultural and citrus). The United States, in particular California, currently control more than a third of the world production of almond, using different cultivars and agronomic practices, based on more modern systems. In Apulia, various native cultivars have been developed such as "Filippo Cea", which have resisted the invasion of the most productive varieties of California. The aim of the project is to assess the quality and the beneficial effects of almonds, comparing a local cultivar (Filippo Cea) with an imported (Carmel) one. The study will be characterized by different phases: - Organoleptic analysis of the two different cultivars of almonds - evaluation of gastrointestinal motility after taking the two types of almonds.

NCT ID: NCT03844763 Recruiting - Clinical trials for Head and Neck Cancer

Targeting the Tumor Microenvironment in R/M SCCHN

CONFRONT
Start date: January 7, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I - II trial of the combination of cyclophosphamide, RT, and Avelumab in relapsed/metastatic HNSCC (R/M-HNC). Patients pretreated with at least one line therapy containing platinum, fluorouracil, and Cetuximab. Treatment consists of metronomic cyclophosphamide 50 mg daily without drug free break, avelumab 10 mg/kg d1 and 15 q 29, and radiotherapy in one or three daily fractions up to 8 Gy maximum dose, starting at day 8. The aim of the study is to reverse tumor immune-escape by: 1. Provide a self-vaccination with radiotherapy 2. Inhibit the immunosuppressive CD4+ CD25+ FoxP3+ Treg cells with metronomic cyclophosphamide 3. Reactivate the effector T cell by the inhibition of PD-1 - PD-L1 axis with avelumab. Due to the supposed biological effects of the present trial, an ancillary translational study is needed and will be extended to all the patients' population enrolled.

NCT ID: NCT03844737 Completed - Ocular Discomfort Clinical Trials

Evaluation of the VisuXL® Performance on Ocular Surface Discomfort

Start date: October 8, 2018
Phase: N/A
Study type: Interventional

VisuXL® is a medical device that is effective in various ocular surface disorders (ocular dryness, changes in the continuity of the corneal and conjunctival surface, environmental stress, exposure to UV and ionizing radiation, prolonged use of videoterminals, etc.). Therefore, the aim of this study is to demonstrate that the clinical benefits and quality of life of the swimmers, exposed for a long time to water added with chlorine, are strongly linked to the unique composition of the long-term VisuXL® medical device.