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NCT ID: NCT03507764 Completed - Clinical trials for Work-Related Condition

Evaluation of a Treadmill Workstation in an Emergency Dispatch Center

Marche_15
Start date: February 15, 2018
Phase: N/A
Study type: Interventional

The principal objective of this study is to determine if the provision of a treadmill workstation in an emergency medical services (EMS) dispatch center increases the number of steps that participants make daily within 6 months compared to the usual working conditions. The investigators hypothesized that the provision of a treadmill workstation with a slow walking could increase the number of daily steps and decrease days of leave, musculoskeletal disorders without decreasing the dispatch quality.

NCT ID: NCT03507686 Completed - Choroideremia Clinical Trials

A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111

GEMINI
Start date: November 29, 2017
Phase: Phase 2
Study type: Interventional

The objective of the study is to evaluate the safety of bilateral, sequential sub-retinal administration of a single dose of BIIB111 in adult male participants with Choroideremia (CHM).

NCT ID: NCT03507140 Completed - Clinical trials for Hepatocellular Carcinoma

Microbiota Study in Liver Transplanted Patients

BIM-LT
Start date: April 16, 2019
Phase:
Study type: Observational

Many studies describe the relationship between microbiota alteration and the occurrence of metabolic, alcoholic or inflammatory liver diseases. Nevertheless, the modifications of microbiota during liver transplantation (LT) as well as its implication are poorly studied. Similarly, only the intestinal microbiota is studied in this context, and no data are available on the biliary microbiota, even if it is known that bile microbiota can interfere with hepatobiliary diseases. This study proposes a clinical and biological in-depth follow-up with multiple sampling of liver transplanted patients to study biliary and intestinal microbiota alterations along LT, as well as bile acids metabolism in corresponding fluids. Indeed, in recipient samples as saliva, blood, urine, and feces can be taken before LT, and surgeons can easily perform bile sampling during LT. In donors all samples can be taken during liver removal. This offers the opportunity to have a microbiotic landscape of individuals without liver disease (donor), and patients suffering from a chronic liver disease or a liver cancer before and after transplantation. Also, in Grenoble University hospital, in case of biliary anastomotic incongruence, a biliary stent is placed during LT in 60% of recipients. This stent is removed by endoscopic retrograde cholangiopancreatography (ERCP) within 6 months after LT, offering a second opportunity to obtain bile samples in transplanted patients, after the early post-LT period. Patients who do not require a biliary stent will also be included for the study of secondary objectives, as intestinal microbiota is very poorly characterized in liver transplanted patients too. A portion of the patients without biliary stent, may also develop an anastomotic biliary stricture requiring an ERCP. If this ERCP is realized within the follow-up period of the study, the patient will also be included in the primary objective of the study. These multiple and sequential samples will allow a complete analysis of microbiota changes in LT patients and aim to answer to 3 questions: 1. What are the modifications of intestinal and biliary microbiomes during LT? 2. What is the influence of bile acids' composition on intestinal and biliary microbiota? 3. What are the relationships between microbiome alterations and the emergence of LT complications?

NCT ID: NCT03506529 Completed - Anal Cancer Clinical Trials

Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT

HYPHYCA
Start date: September 17, 2018
Phase:
Study type: Observational

Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal

NCT ID: NCT03506022 Completed - Clinical trials for Diabetes Mellitus, Type 1

Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes

APT1
Start date: January 12, 2018
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) and Type 2 diabetes are two frequent diseases that occur in adult population. The prevalence of OSA is higher in people with Type 2 diabetes compared with the general population7 ; in addition, the OSA syndrome is almost assessed in obese type 2 diabetes. The relationship between OSA and Type 2 diabetes has been well characterized: the OSA can contribute to increased insulin resistance or glucose intolerance; and, diabetes may worsen sleep-disordered breathing because of autonomic neuropathy8,9. The main link between OSA and Type 2 diabetes is central obesity, which triggers glucose intolerance/insulin resistance and is also an independent risk factor for OSA. Type 1 diabetes is generally not related to obesity; however, sleep-disordered breathing in these patients was described in few reports early as 1985 by pioneers such as Guilleminault5 and the prevalence of OSA is estimated at range 10 to 40% in type 1 diabetes patients. Few studies had evaluated the prevalence of sleep disorders in particular the sleep apnea syndrome in patients with type 1 diabetes and even less their influence on the glycemic control. This study will take place at the CHU of Amiens-Picardie during a one-night hospitalization. The investigators will study in 44 type 1 diabetes mellitus (IAH apnea hypopnea index ≥15) who underwent polysomnography and continuous glucose monitoring of blood glucose

NCT ID: NCT03505723 Completed - Venous Thrombosis Clinical Trials

PeriOperative ISchemic Evaluation-3 Trial

POISE-3
Start date: June 27, 2018
Phase: Phase 3
Study type: Interventional

This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.

NCT ID: NCT03505710 Completed - Clinical trials for Non-Small Cell Lung Cancer

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

DESTINY-Lung01
Start date: May 21, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.

NCT ID: NCT03505125 Completed - Clinical trials for Phenylketonuria (PKU)

A Non-Interventional Interview Study of Phenylketonuria (PKU) Adults

165-901
Start date: March 31, 2018
Phase:
Study type: Observational

The 165-901 study is designed to identify the appropriate tools for use in future interventional studies on the neurocognitive effects of pegvaliase on adults with PKU.

NCT ID: NCT03505021 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS

REFALS
Start date: June 21, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2 mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important efficacy measures include time to respiratory events, clinical global impression (CGI), assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index and Epworth sleepiness scale). Patient safety is monitored using conventional methods including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is performed 14-25 days after the last study treatment administration. The study will be monitored by an independent data and safety monitoring board. A long-term extension study will be available for patients completing the study.

NCT ID: NCT03504696 Completed - Melanoma Clinical Trials

Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced Melanoma

Start date: December 20, 2016
Phase:
Study type: Observational

This study will be conducted with the aim of estimating the effectiveness, safety, patterns of use of nivolumab, and characteristics of patients with unresectable or metastatic melanoma, treated with nivolumab monotherapy in the ATU setting.