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NCT ID: NCT04015518 Completed - Clinical trials for Palmoplantar Pustulosis (PPP)

A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis

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

The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety. Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.

NCT ID: NCT04014920 Completed - Obesity Clinical Trials

Non-invasive Ventilation Following Extubation (Prophylactic) to Prevent Extubation Failure in Critically Obese Patients

EXTUB-OBESE
Start date: October 2, 2019
Phase: N/A
Study type: Interventional

Mechanical ventilation is the first artificial support used in intensive care. After a period of invasive mechanical ventilation, patients should be separated from the ventilator (weaning period of mechanical ventilation). If weaning and extubation (removal of the tracheal tube) are successful in approximately 80 to 90% of resuscitation patients, 10 to 20% will develop acute respiratory failure (ARF) in the days following extubation. Obesity concerns 20 to 30% of resuscitation admissions in France. The pathophysiological changes in the obese patient explain the over-risk of desaturation and ARF in the post-extubation period. In order to decrease the incidence of extubation failure (need for reintubation within 48-72h post-extubation) of the most fragile patients, it is recommended in intensive care unit to prophylactically use various ventilatory support strategies and / or oxygenation, among which noninvasive ventilation (NIV) and oxygen therapy, which can be administered in two ways: High-Flow Humidified Nasal Oxygen Therapy (HFNO) or standard oxygen therapy. These strategies have never been compared in the obese post-extubation critically ill patient. Our hypothesis is that NIV is superior to oxygen to prevent the development of ARF in obese extubated patients in intensive care unit.

NCT ID: NCT04014868 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

During-exercise Physiological Effects of Nasal High-flow in Patients With Chronic Obstructive Pulmonary Disease

AIRVO-PHYSIO
Start date: November 22, 2019
Phase: N/A
Study type: Interventional

Chronic obstructive pulmonary disease is a major cause of disability and mortality worldwide. This disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation teaches chronic obstructive pulmonary disease patients to cope effectively with the systemic effects of the disease and improves exercise capacity, dyspnea and quality of life in patients with chronic obstructive pulmonary disease. However, the best training modality remains unknown. Physiological studies highlight the benefit of high intensity endurance training. However, many patients do not tolerate such a training due to ventilatory limitation and dyspnea. Therefore, a strategy to reduce dyspnea would allow a greater physiological muscle solicitation and improvement. Thus, many studies focus on means to increase exercise tolerance in patients with chronic obstructive pulmonary disease. Nasal high flow delivers heated and humidified high flow air (up to 60 L/min) through nasal cannula providing physiological benefits such as positive airway pressure and carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure. More recently, nasal-high flow has been shown to improve endurance exercise capacity in patients with chronic obstructive pulmonary disease. However, the underlying physiological mechanisms have not been yet elucidated but may help to optimise the utilization of the device. Therefore, the primary objective of this study is to assess the respiratory physiological effects nasal high-flow during-exercise in stable patients with chronic obstructive pulmonary disease. Secondary objectives are to assess the effects nasal high-flow during-exercise on endurance capacity, respiratory drive, dynamic hyperinflation, cardiorespiratory pattern and muscular metabolism.

NCT ID: NCT04014426 Completed - Healthy Volunteers Clinical Trials

Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy

PIPAC-Secure
Start date: January 2, 2018
Phase: N/A
Study type: Interventional

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new treatment that applies chemotherapeutic drugs into the peritoneal cavity as an aerosol. It is used to treat patient with Peritoneal Carcinomatosis (PC). During this procedure, healthcare workers may be under risks of exposure to cytotoxic treatments. The purpose of this study is to evaluate the safety of the heathcare workers and the risk of operation room Oxaliplatin's contamination during a PIPAC.

NCT ID: NCT04013867 Completed - Depression Clinical Trials

Identification of the Best Self-questionnaire to Diagnose Depression in Patients With Psoriasis (DePsoVal)

DePsoVal
Start date: July 22, 2019
Phase:
Study type: Observational

Prevalence of depression shows great heterogeneity in patients with psoriasis. This could be explained by the psychometric properties of the questionnaires assessing depressive symptoms: these tests have not been developed in a context of dermatosis. The complaints and symptoms associated with psoriasis can be misidentified by questionnaires as a manifestation of depressive symptomatology and may overestimate depressive symptoms. In other diseases such as asthma and rheumatoid arthritis, tools have been validated specifically to take into account these symptoms. The purpose of this study is to validate and compare assessment tools for depression in patients with psoriasis.

NCT ID: NCT04013061 Completed - Clinical trials for Surgical Procedures, Operative

Impact of a Pharmacist-anesthesiologist Collaboration During Anesthesia Consultation on Prevention of Perioperative Medication Errors of Patients in Programmed Surgery

PREVEMCA
Start date: February 25, 2020
Phase:
Study type: Observational

The investigators will evaluate the efficiency of a pharmacist-anesthesiologist collaboration in the anesthetic consultation in the prevention of medical errors perioperatively in patients undergoing scheduled surgery

NCT ID: NCT04012359 Completed - Pulmonary Emphysema Clinical Trials

Description of Bullous Emphysema Using Lung Ultrasound and Comparison to the Characteristics of Pneumothorax

BulleEcho
Start date: June 26, 2019
Phase:
Study type: Observational

Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease affecting a growing number of adults in the world which is responsible for a large public health burden through heavy morbidity and mortality. Emphysema is one of a wide spectrum of pulmonary complications linked to COPD, defined as the abnormal permanent enlargement of the airspaces distal to the terminal bronchioles accompanied by destruction of the alveolar wall. Disease progression is correlated to worsening and enlargement of emphysema lesions, sometimes conflating in sizeable bullae, deleterious to normal mechanical pulmonary function. Bullous emphysema (BE) is sometimes eligible to invasive curative treatment through surgery or interventional bronchoscopy. Diagnosis of BE relies on computerized tomodensitometry (CT), the gold-standard for evaluating pulmonary parenchyma. However, CT is not always available, and bullous emphysema can present as pneumothorax on chest radiography. The practice of lung ultrasound is currently growing in respiratory medicine and emergency departments owing to an increasing amount of evidence showcasing its reliability as a diagnostic tool, most notably for pneumothorax and other pleural diseases. Despite BE having been reported to present similarly to pneumothorax in ultrasound, its characteristics have not yet been precisely described. The primary aim of this study is to describe BE using lung ultrasound. Participants with known BE on CT will undergo a simple ultrasound examination. The secondary aim is to compare the characteristics of BE to those of pneumothorax using lung ultrasound. To achieve this, a second group of participants with currently treated pneumothorax will also undergo lung ultrasound.

NCT ID: NCT04012320 Completed - Children Clinical Trials

Efficacy and Safety on the Use of Bisphosphonates in Paediatrics

Bisphosphonate
Start date: October 31, 2018
Phase:
Study type: Observational

The investigators suppose that the impact of bisphosphonate therapy is beneficial on the bone during the growth period with few adverse events.

NCT ID: NCT04012229 Completed - Breast Cancer Clinical Trials

IMpact of Breast cAncer Gene Status on Survival in Adjuvant Breast Cancer (IMBASSA)

IMBASSA
Start date: July 28, 2017
Phase:
Study type: Observational

Relationship between the presence of the BRCA mutation (BReast Cancer) and outcomes is unclear in high-risk early breast cancers (BC). This study is a multi-center retrospective cohort of patients treated in region Franche-Comté for an early BC by neoadjuvant and/or adjuvant chemotherapy. The primary aim was to describe clinical and pathological characteristics considering BRCA mutated (BRCAm) patients versus BRCA wild type (BRCAwt) patients or untested patients. The second objective was to assess the prognostic impact of germinal BRCAm in this high-risk population.

NCT ID: NCT04011046 Completed - Stent Thrombosis Clinical Trials

Register of Patients Benefiting From a Coronary Bifurcation Angioplasty at the University Hospital of Nîmes and Montpellier in 2017

Register
Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

Cardiovascular diseases are the second leading cause of death in France and the world's leading cause.Coronary bifurcations are conducive to the development of atheromatous lesions due to flow turbulence generating a pro-atherogenic effect. They represent about 15% of coronary lesions and 30% of lesions in pluri truncular patients.Coronary bifurcation angioplasty is a complex angioplasty with a high risk of complications.Numerous studies have compared different angioplasty techniques with 2 stents in bifurcation lesions. However, two studies of The Nordic-Baltic Bifurcation Study did not show at 6 months or 5 years of age any significant difference in major cardiovascular events (death, heart attack, stent thrombosis, emergency revascularization of the target vessel) in patients with a one-stent strategy compared to the systematic use of two stents. There are also several post-expansion techniques and the one that appears to be the most commonly used today (known as the "KISSING-BALLOON") consists of inflating two balloons at the same time, one in the main branch and the other in the daughter branch in order to open the meshes of the stent towards the daughter branch. Studies on a test bench to evaluate the deformation of a stent in different coronary anatomies according to the material and technique used have nevertheless revealed several limitations to this technique, in particular an elliptical deformation of the stent linked to the inflation of 2 simultaneous balloons. From this work, a new technique known as "POT SIDE POT" was born, consisting in post dilating the proximal part of the stent of the main branch in order to place it as closely as possible against the wall, then open the stent meshes towards the lateral branch by balloon dilation followed by a new post dilation of the proximal part of the mother branch stent to avoid the use of 2 simultaneous balloons and thus reduce stent deformation by maintaining a circular geometry while allowing proper stent attachment. However, to date, there are no clinical studies comparing the POT SIDE POT technique with that of KISSING-BALLOON in coronary bifurcation angioplasty. This is why we would like to compare these two post-dilation techniques by a retrospective study on the occurrence of major cardiovascular events and stent thrombosis in patients who received a coronary bifurcation angioplasty in 2017 at the University Hospital of Nîmes.