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NCT ID: NCT05119413 Completed - Melanosis Clinical Trials

Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma

Kligman
Start date: November 30, 2021
Phase: Phase 2
Study type: Interventional

Kligman's trio remains the gold standard treatment for melasma. It contain hydroquinone which is an effective anti-melanogenic compound but that has poor tolerance and numerous side-effects. Thiamidol has been proven to be at least as effective as hydroquinone and has a very good safety profile. The objective of this study is to compare the Kligman's trio to the same preparation in which hydroquinone is replaced by thiamidol.

NCT ID: NCT05119361 Completed - Acute Kidney Injury Clinical Trials

Early Dry Cohort : Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit.

Early Dry
Start date: July 1, 2021
Phase:
Study type: Observational

Fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. If fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). In patients with continuous renal therapy, often presenting an inadequate diuresis, it includes the net ultrafiltration setting. A potential side effect of deresuscitation strategy is to induce iatrogenic hypovolemia. We have implemented a perfusion-based protocol to induce systematic early fluid removal on patients after haemodynamic stabilization. We would like to observe the impact on the fluid balance of such a protocol and to explore the recruitment capacity of our centre and exploratory outcomes to lead a future randomized control study.

NCT ID: NCT05119244 Recruiting - Cannabis Use Clinical Trials

Environment and Lung Cancer

PPE
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Cannabis is the most consumed drug in the world and the French are the main consumers in Europe. The most recognized effects of cannabis on human health are of a neuro-psychic nature. The medical literature on the effects of cannabis on the lung in general, and on lung carcinogenesis in particular, is most often reassuring (Tashkin, Chest 2018; Zhang, Int J Cancer 2015; Ghasemiesfe JAMA Netw. Open. 2019), despite the fact that the concentration of carcinogens in cannabis smoke is higher than that contained in tobacco smoke (Moir, Chem. Res. Toxicol. 2008), and that cannabis smoking has been implicated in the occurrence of ENT cancers. Rather, research focuses on the therapeutic effects of cannabis, especially analgesics, and even on its possible anti-tumor virtues (Abrams, Jama Oncol. 2020). These reassuring data should, however, be viewed with a great deal of caution. On the one hand, the illegal nature of cannabis in most countries and its frequent association with tobacco consumption make studies on the subject difficult and often biased. On the other hand, the daily practice of oncologists, who observe numerous cases of advanced and rapidly progressive lung cancer occurring in young patients who are heavy users of cannabis, raises suspicion of an unrecognized role of cannabis in lung carcinogenesis. In a preliminary multicenter study on French patients under 50 years of age operated for primary lung cancer (Betser, ERJ 2021), we demonstrated that cannabis consumption was extremely frequent, concerning 43% of patients, but mentioned in patients' medical records only in 4 out of 10 cases, while the smoking status was always noted. In addition, by comparing people who smoke cannabis (always here associated with tobacco) to patients who only smoke tobacco or to non-smokers, we identified a different profile of lung cancers, with more poorly differentiated tumors, presenting at a more advanced stage (more T3-T4 versus T1-T2) requiring more complex surgery, and mostly located in the upper lobes of the lung. Similar research work is currently underway at Gustave Roussy (Dr Pradere-Dr Planchard, Villejuif, France) on patients with metastatic lung cancer, with a focus on overall survival and molecular profile.

NCT ID: NCT05119010 Recruiting - Clinical trials for Metastatic Renal Cell Carcinoma

A Pilot Study Evaluating a Ketogenic Diet Concomitant to Nivolumab and Ipilimumab in Patients With Metastatic Renal Cell Carcinoma

KETOREIN
Start date: March 24, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to assess objective response rate (partial and complete response) of Nivolumab and Ipilimumab concomitant to a special diet (ketogenic diet, continuous or discontinuous) or standard diet with or without BHB according to RECIST v1.1 at 8 weeks.

NCT ID: NCT05118906 Recruiting - Clinical trials for Binge-Eating Disorder

Pilot Study on BP1.4979 Effect on Binge Eating Disorders

Start date: March 7, 2022
Phase: Phase 2
Study type: Interventional

This pilot study is to assess the efficacy and safety of BP1.4979 15 mg BID in female patients with moderate to severe binge eating disorder (BED), as defined according to DSM-5 guidelines.

NCT ID: NCT05118789 Recruiting - Clinical trials for Metastatic Solid Tumor

A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Start date: January 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-520 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors.

NCT ID: NCT05118152 Completed - Clinical trials for Congenital Heart Disease

Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle

VU3D
Start date: June 1, 2021
Phase:
Study type: Observational

Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Among CHD, univentricular heart disease or "single ventricle" is rare and complex. As a result of the improved patient care over the last decades, the number of children and adults with single ventricle is increasing significantly. Today, the main challenge is to ensure an optimal follow-up of these new patients in order to improve their life expenctancy as well as their quality of life (QoL). Currently, echocardiography and cardiopulmonary exercice test (CPET) are central in management of patients with single ventricle as part of good clinical practice guidelines. Single ventricle volumes and function are very difficult to asses with conventional echocardiography because of their complex geometry. Indeed, single ventricle size and morphology vary depending on the patient characteristics and on the initial CHD (before surgical repair). That's why conventional 2D echocardiographic parameters are not reliable for single ventricle assessment. Magnetic resonance imaging (MRI) is more effective in assessing single ventricle volumes and function. Nevertheless, MRI is not universally available, is not practical in many situations, is expensive, and is a relative contraindication in patients with pacemakers. Over the past decade, the use of the 3D echocardiography has increased. This is an available tool that can assess ventricular function and volumes in few seconds. Recent studies shown a good correlation between 3D echocardiography and MRI for assessment of ventricular volumes and function in patient with CHD and especially in those with single ventricle. Moreover, according to some authors, CPET parameters are strongly correlated with risk of hospitalization, risk of death, physical activity and quality of life, especially in patients with single ventricle. To date, there is no study performed about the relationship between 3D echocardiography and CPET parameters in patients with single ventricle.

NCT ID: NCT05118113 Recruiting - Healthy Volunteers Clinical Trials

Development of a Cell Culture Process for the Production of Human T-lymphocyte Precursors

SMART101-HV1
Start date: April 26, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to finalise the development of a process for the production of T-cell progenitor cells.

NCT ID: NCT05117996 Completed - Crohn Disease Clinical Trials

Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease

CROHN-PREP
Start date: July 5, 2022
Phase: N/A
Study type: Interventional

The European guidelines currently recommend to use 2 L of polyethylene glycol and free residue diet before any capsule endoscopy. However, up to now, no studies have been conducted to specifically evaluate bowel preparation modalities before small bowel capsule endoscopy in patients with Crohn's disease. In patients with Crohn's disease and small bowel ulcers, polyethylene glycol may remove some fibrin from these ulcers and alter bowel preparation. Moreover, it is important to select the most acceptable bowel preparation because patients with Crohn's disease will have to repeat capsule endoscopy several times after initiating treatment, for monitoring under treatment, or for detection of post-operative recurrence. In a preliminary retrospective study, it has been suggested that a simplified bowel preparation with liquid diet the evening before and water on the morning of the capsule endoscopy induced a better bowel preparation than the standard method with polyethylene glycol. Thus, the aim of the study is to demonstrate the superiority of this simplified bowel preparation compared to the standard preparation modality in terms of quality of bowel preparation, patient's acceptability and diagnostic yield.

NCT ID: NCT05117840 Recruiting - Lung Cancer Clinical Trials

Screening for High Frequency Malignant Disease

SHIELD
Start date: January 13, 2022
Phase:
Study type: Observational

The SHIELD (Screening for High Frequency Malignant Disease) study is a prospective, observational, multi-site basket design trial without randomization. The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations.