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NCT ID: NCT02994797 Completed - sjögren Disease Clinical Trials

Ultrasound Elastography of Salivary Glands

ELSA
Start date: June 2016
Phase:
Study type: Observational

Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients with sicca syndrome and pSS.

NCT ID: NCT02994576 Completed - Clinical trials for Nonsmall Cell Lung Cancer

Atezolizumab as Induction Therapy in Non-small Cell Lung Cancer

PRINCEPS
Start date: December 12, 2016
Phase: Phase 2
Study type: Interventional

Based on the efficacy of immunotherapies in advanced disease with a reasonable safety profile/tolerability we could hypothesize that, immunotherapy should work best in the situation of minimal residual disease, Two clinical trials are ongoing to test the role of immunotherapeutic agents in the adjuvant setting: PEARLS trial, a randomized phase III trial with anti-PD1 monoclonal antibody pembrolizumab (MK-3475 or pembrolizumab) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy, and the second randomized phase III trial (NCT02273375) will evaluate the efficacy of an anti-PD-L1 (MEDI 4736) for a maximum of 12 months versus placebo as adjuvant therapy in completed resected stage IB-IIIA NSCLC and completed standard ACT. The role of immunotherapeutic approaches for NSCLC in the neoadjuvant setting is currently unknown. However, based on the survival efficacy of immunotherapeutic strategies in advanced NSCLC where the tumor has not been removed which could produce higher immunogenicity and based on the efficacy of neoadjuvant treatments in NSCLC, we propose to test the safety and efficacy of atezolizumab as neoadjuvant therapy in subjects diagnosed with stage I, II, or IIIA (non N2) NSCLC and who are deemed suitable for surgical resection. Clinical staging of NSCLC is based on computed tomography (CT) of the chest and upper abdomen, brain CT or magnetic resonance imaging and 18F-FDG PETscan to rule out metastatic disease and assess the potential for curative-intent resection. Adjuvant chemotherapy will be performed according the standard clinical guidelines.

NCT ID: NCT02994407 Completed - Clinical trials for Congenital Bleeding Disorder

Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A

alleviate 1
Start date: January 30, 2017
Phase: Phase 1
Study type: Interventional

The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.

NCT ID: NCT02994316 Completed - Clinical trials for Diabetic Ketoacidosis Children

Plasma Copeptin Levels in Children With Diabetic Ketoacidosis

COPACD
Start date: October 3, 2016
Phase: N/A
Study type: Interventional

Children with diabetic ketoacidosis risk neurological complications such as cerebral edema with high morbidity. To prevent cerebral edema, it is essential to control correction of hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic ketoacidosis don't always permit an optimal care. Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis. Therefore, monitoring of plasma copeptin levels could be of interest in children with diabetic ketoacidosis and risk of sévère neurological complications.

NCT ID: NCT02994225 Completed - Breast Cancer Clinical Trials

Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity

ARMONIC
Start date: March 10, 2017
Phase: N/A
Study type: Interventional

The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes is of paramount importance in the subsequent management of this cancer and surgery of invasive breast cancer (BC) involves axillary lymph node dissection (ALND). To preserve arm lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is uncertain. The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of draining lymphatics. The project aims to train surgeons to the technique and to identify predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary pathological parameters to better select patients who would not require removal of the ARM node in the future

NCT ID: NCT02994056 Completed - Clinical trials for Hepatitis C Virus Infection

Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis

Start date: January 23, 2017
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis.

NCT ID: NCT02994017 Completed - Cystic Fibrosis Clinical Trials

Prognostic Value of Functional Exercise Test (EFX) in Cystic Fibrosis

EFX
Start date: March 5, 2012
Phase: N/A
Study type: Interventional

The objective of study is to prospectively determine if CPET with blood gas analysis should have a prognostic value in CF. The study plans to include 300 cystic fibrosis patients. Inclusion criteria will be: age >15 years, cystic fibrosis confirmed by chloride sweat test or genetic analysis, clinical and functional stability in the 2 month before CPET. Patients will perform a maximal exercise test on a cycloergometer during the inclusion visit, with pulmonary function testing and a six-minute walk test. The study will also include a visit every 6 months with: body mass index calculation, pulmonary function testing with DLCO (diffusing lung capacity for carbon monoxide), a six minute walk test, and antibacteriological study of sputum. The results of this study could help identify earlier the patients for referral to a lung transplantation centre, by using the usual criteria and the CPET abnormalities.

NCT ID: NCT02993731 Completed - Clinical trials for Carcinoma, Pancreatic Ductal

A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

CanStem111P
Start date: December 2016
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma.

NCT ID: NCT02993276 Completed - Neuroma Clinical Trials

Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

Start date: April 17, 2017
Phase:
Study type: Observational

PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT Neuro) This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.

NCT ID: NCT02993133 Completed - Clinical trials for Autoimmune Bullous Dermatose

Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.

PEMPA
Start date: December 2016
Phase: Phase 3
Study type: Interventional

The main autoimmune bullous dermatoses are pemphigus and cicatricial pemphigoid. Pemphigus is an autoimmune dermatological disease characterized by the production of anti-desmoclesin antibodies 1 and 3, affecting the skin and mucous membranes.The cicatricial pemphigoid is an autoimmune dermatological disease, characterized by the production of anti-zone antibodies of the basal membrane and characterized by a predominant mucosal involvement. Mycophenolic acid (MPA) is an increasingly used form of corticosteroid. Despite its increasing use, pharmacokinetics in autoimmune bullous dermatosis remain little studied.