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NCT ID: NCT03705403 Active, not recruiting - NSCLC Stage IV Clinical Trials

IMMUNOtherapy and Stereotactic ABlative Radiotherapy (IMMUNOSABR) a Phase II Study

IMMUNOSABR2
Start date: April 4, 2019
Phase: Phase 2
Study type: Interventional

This will be a phase II trial testing if the combination of stereotactic ablative body radiotherapy (SABR) and L19-IL2 improve the progression-free survival in patients with limited metastatic non-small cell lung cancer (NSCLC). The trial consists of one cohort with two arms; C-arm and an E-arm. Patients with oligometastatic disease will receive SABR to minimal 1 and max all metastatic sites (max 5 sites irradiated) and patients with diffuse metastatic lesions (6 to max 10) will receive radiotherapy to max 5 sites. In the experimental arm, immunotherapy will be given after irradiation.

NCT ID: NCT03704129 Completed - Clinical trials for Educational Problems

Educational Programme in Diaphragm Ultrasonographic Assessment

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

Diaphragm ultrasound non-invasively explores the diaphragm function and it can be useful in several clinical situations. Diaphragm ultrasound is able to evaluate the cranio-caudal displacement of the diaphragm and its thickening fraction at the end of inspiration, in relation to the end-expiratory value. While several studies have been conducted in the evaluation of educational programmes for echocardiography, to date data lack regarding this aspect in diaphragm ultrasonographic assessment. Based on the experience gained in some specialization schools in Anaesthesia and Intensive Care, the investigators hypothesize that the participation in a two-hour course, including a theoretical part and a practical training, allows to acquire the appropriate theoretical and practical skills necessary to correctly perform the measurement of the diaphragm excursion and thickening fraction, compared to the theoretical lesson only, followed by a brief explanation by an expert tutor, on the practical use of the ultrasound. The investigators hypothesized that the association of the theoretical part and of the practical training is able to obtain: 1. Passing the theoretical test with at least 70% of the correct answers; 2. The correct identification of the areas where the probe is affixed; 3. The appropriate measure of Diaphragmatic thickening and displacement.

NCT ID: NCT03704077 Withdrawn - Gastric Cancer Clinical Trials

An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Start date: October 31, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.

NCT ID: NCT03703999 Completed - Clinical trials for Diabetes Mellitus, Type 1

Freestyle Libre Use in Real Life: Efficacy and Acceptance

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

Aim of the study is to evaluate efficacy of freestyle Libre system (flash glucose monitoring) in real life in term of Glycated Haemoglobin reduction and acceptance of the system evaluated through validated questionnaires after 3 and 6 months of device's use.

NCT ID: NCT03703310 Completed - Clinical trials for Basal Cell Nevus Syndrome

Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome)

Start date: February 19, 2019
Phase: Phase 3
Study type: Interventional

This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome. Participants will be required to apply the investigational product for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new BCCs that develop over the 12 month period.

NCT ID: NCT03703297 Active, not recruiting - Clinical trials for Small Cell Lung Cancer

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

ADRIATIC
Start date: September 27, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy

NCT ID: NCT03702920 Recruiting - Clinical trials for Acute-On-Chronic Liver Failure

Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%

APACHE
Start date: February 21, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects. The study will involve approximately 40 study centers in the United States, Canada, and Europe with expertise in the management of subjects with ACLF. Subjects with ACLF at a high risk of hospital mortality will be enrolled. The study will consist of a Screening Period during which subjects will be randomized (1:1) to receive either standard medical treatment (SMT) + PE-A 5% (treatment group) or SMT only (control group), followed by a Treatment Period, and a Follow-up Period. The Treatment Period for subjects in the SMT+ PE-A 5% treatment group will be between 7 and 17 days, depending on ACLF evolution. The Treatment Period for subjects in the SMT control group will be a minimum of 7 days for all subjects and up to 17 days depending on the ACLF evolution. Subjects in this group will receive SMT according to the institution's standards. The Follow-up Period for subjects in both groups will be 90 days.

NCT ID: NCT03702504 Recruiting - Clinical trials for Intensive Care Medicine

Margherita-PROSAFE:Promoting Patient Safety and Quality Improvement in Critical Care

Start date: November 2008
Phase:
Study type: Observational [Patient Registry]

The general objective is to promote patient safety and quality improvement in critical care towards a significant reduction of observed mortality rates and economic costs through the improvement of outcomes and reduction of medical errors.

NCT ID: NCT03701763 Terminated - Psoriasis Clinical Trials

Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Start date: December 19, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis. At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.

NCT ID: NCT03701334 Active, not recruiting - Early Breast Cancer Clinical Trials

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

NATALEE
Start date: December 7, 2018
Phase: Phase 3
Study type: Interventional

A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer (EBC)