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NCT ID: NCT04222387 Completed - Clinical trials for MEK Inhibitor-Associated Serous Retinopathy

Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD Type Aromatic Amines

CAPITOX
Start date: December 19, 2019
Phase: N/A
Study type: Interventional

Hair dye products could induce minimal forms of MEKAR retinopathies (Mitogen-activated Extracellular signal-regulated Kinase - inhibitors associated retinopathies). These minimal forms of MEKAR are likely to be underdiagnosed, since the associated visual loss is usually mild and so this condition should be considered when patients report blurred vision. The aim of the study is to analyze whether in the current population that dyes the hair, minimal forms that go unnoticed by MEKAR retinopathies can be induced.

NCT ID: NCT04222374 Completed - Kidney Cancer Clinical Trials

Uro-DNA Collection for Expanded Genome-Wide Association Study (GWAS) of Renal Cell Carcinoma (RCC)

Uro-DNA - GWAS
Start date: December 10, 2019
Phase:
Study type: Observational

In the last decade, investigators from the Department of Cancer Epidemiology and Genetics (National Cancer Institute, USA) have conducted genome-wide association (GWAS) studies of renal cell carcinoma. Dr. Mark PURDUE and Dr. Stephen CAHNOCK (Department of Epidemiology of Cancer and Genetics, NCI) propose to expand their genome-wide association study (Expanded GWAS) by genotyping approximately 10,000 additional cases of kidney cancer patients, in collaboration with US institutions, South-American and European. This study describes the participation of the French Kidney Cancer Research Network (UroCCR) in the Expanded GWAS research, under the coordination of Professor BERNHARD (Bordeaux University Hospital).

NCT ID: NCT04222010 Completed - Pain, Postoperative Clinical Trials

Serratus Plain Block Versus Paravertebral Block Versus Serratus Plain Block and Paravertebral Block for Postoperative Pain Following Thoracoscopic Surgery

thoracoscopic
Start date: January 2, 2020
Phase: N/A
Study type: Interventional

Acute and chronic postoperative pain remains a major concern following thoracoscopic surgery. Firstly because pain constitutes a serious concern for patients after surgery, and secondarily because an ineffective control of pain may lead to postoperative morbidity, especially in lung cancer surgery. To date, several procedures have been described but the best modality of locoregional analgesia for thoracoscopic surgery has not been assessed yet. The main objective of this study is to evaluate efficiency of several validated approaches for preoperative locoregional analgesia, comparing serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery. To this end, the investigators will conduct an interventional prospective monocentric, double blind, compared and randomized study. Previously to thoracoscopic surgery, patients will be randomized in one of the three following arms: serratus plain block, paravertebral block or serratus plain block and paravertebral block combined.

NCT ID: NCT04221191 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP

TEC-ADHERE
Start date: August 19, 2019
Phase:
Study type: Observational

The primary objective is to compare oral dimethyl fumarate (DMF) persistence at six months in relapsing-remitting multiple sclerosis (RR-MS) participants initiating DMF with and without OroSEP patient support program (PSP), respectively. The secondary objectives are: to compare oral DMF persistence at one month and three months in RR-MS participants initiating DMF with and without OroSEP PSP, respectively; To compare oral DMF adherence at six months in RR-MS participants initiating DMF with and without OroSEP PSP; To compare at three months and six months the reason of oral DMF discontinuation, in the two groups; To describe the percentage of participants with treatment-related adverse events globally and by class of adverse events, in the two groups of participants; To assess the evolution of participants' anxiety globally and to compare it at inclusion and at six months in participants with and without OroSEP PSP, respectively; To describe participants' satisfaction regarding oral DMF initiation and follow-up globally at six months and to compare it in patients with and without OroSEP PSP, respectively; For OroSEP PSP group: To assess participants' satisfaction regarding their participation in OroSEP PSP at six months; To assess neurologists' satisfaction regarding their participation in OroSEP PSP, after the last participant last visit of center.

NCT ID: NCT04221048 Completed - Pregnancy Clinical Trials

Accuracy of Risk Prediction Scores in Pregnant Women

PREG-GUCH
Start date: December 30, 2018
Phase:
Study type: Observational

Management of pregnancy and risk stratification in congenital heart disease (CHD) population might be challenging especially due to physiological haemodynamic modifications that inevitably occur during pregnancy. We aim to compare the accuracy of the main published scores including CARPREG II score in prediction of maternal complications during pregnancy in CHD patients.

NCT ID: NCT04220996 Completed - Anxiety Disorders Clinical Trials

Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD)

RECONNECT
Start date: December 27, 2019
Phase: Phase 4
Study type: Interventional

This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder.

NCT ID: NCT04220866 Completed - Clinical trials for Head and Neck Squamous Cell Carcinoma (HNSCC)

Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002)

Start date: March 4, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag PLUS pembrolizumab (MK-3475) compared to pembrolizumab alone as a first line treatment of adults with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). The primary study hypotheses are that IT ulevostinag in combination with pembrolizumab results in a superior Objective Response Rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), compared to pembrolizumab alone: 1. In participants with a tumor that has a programmed cell death-ligand 1 (PD-L1) Combined Positive Scoring (CPS) ≥ 1, and 2. In participants with a tumor that has a PD-L1 CPS ≥ 20.

NCT ID: NCT04219852 Completed - Clinical trials for Bariatric Surgery Candidate

Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims

Start date: September 10, 2019
Phase:
Study type: Observational

Obesity is a public health phenomenon affecting more than 17% of women in France, and more than 20% of men and women in Champagne-Ardenne. Obese women are more likely to have an unplanned pregnancy, whereas these pregnancies are more at risk than women of normal weight and should be planned or considered after weight loss. These women are also often less well followed in terms of gynecology and especially on contraception. More and more patients are opting for bariatric surgery. However, bariatric surgery is not trivial. Indeed, the important loss of weight expected is at risk of nutritional deficiencies. In addition, a large number of patients are still obese during the months following surgery. This is why pregnancy is theoretically contraindicated within 12 or 18 months postoperatively. Women with bariatric surgery must have been properly informed of these risks so that they can choose a contraceptive method, and that can be adapted to both their risk factors and the surgical technique performed.

NCT ID: NCT04219722 Completed - Clinical trials for Vulvovaginal Atrophy

Efficacy and Safety of Hyaluronic Acid Injection on Symptoms of Vulvovaginal Atrophy in Postmenopausal Women

SYLIVA
Start date: January 21, 2020
Phase: N/A
Study type: Interventional

DESIRIAL® is a CE-marketed hyaluronic acid gel intented to rehydrate vaginal and vestibular mucous membranes by mucosal injections. In this study, 121 postmenopausal women of minimum age 45 with symptoms associated with vulvovaginal atrophy, refusing estrogen therapies for treatment of symptoms or with contraindications for such therapies, with at least one moderate to severe vulvovaginal symptom among dryness sensation, dyspareunia, itching / irritation and pain, who have given her informed consent and met all the eligibility criteria, will be enrolled. Patients will randomly receive 1 injection of DESIRIAL® or placebo (ratio 2:1) in the vaginal mucosa at Day 0. If still eligible 12 weeks after, patients receiving placebo at Day 0 will be treated with DESIRIAL®. Patients will come to a total of 6 to 8 visits depending on the product injected at Day 0 over a period of 11 up to 12 months. Phone interview will be performed between 3 and 5 days after injection. Variation of vulvovaginal symptomatology, sexual function, vaginal pH and safety will be assessed.

NCT ID: NCT04218942 Completed - Urinary Retention Clinical Trials

Rocamed Urethral Device (RUD) and Urinary Retention in Males

RUD
Start date: June 12, 2020
Phase: N/A
Study type: Interventional

Prospective non randomized study of the feasibility of the insertion of Rocamed urethral device by hand manipulation, i.e., without use of cystoscopy, sonography or fluoroscopy. Patients with an acute urinary retention treated by Foley catheterization in the Emergency department have a few days later a trial of Foley removal in the ambulatory unit of the Urology department. In case of failure of the Foley removal trial, i.e., recurrence of urinary retention, patients will be proposed either the insertion of a new Foley or insertion of the urethral device. After signature of an informed consent, insertion of the urethral device will be performed after instillation in the urethra of a local anesthetic gel. Device insertion success rate and complications will be studied. The device will be left in place for one month. Tolerance and complications during the month with the device in place will be studied. At one month the device will be removed: the ease of retrieval of the device and complications will be studied. Patient and doctor satisfaction with the urethral device will be compared to patient and doctor satisfaction with the Foley.