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NCT ID: NCT02967796 Completed - Clinical trials for Postpartum Perineal Pain

Strategy of Micronutrient Management in Parturient and Layered Women With a Dietary Supplement Rich in Porphyra HSP®

Start date: September 4, 2015
Phase:
Study type: Observational

The aim of the study is to evaluate in primiparous patients the benefit of supplementation with Proteochoc® to reduce perineal pain in the postpartum especially, in sitting posture. The patient is followed from the delivery to 6 to 8 weeks after.

NCT ID: NCT02967679 Completed - Clinical trials for Peripheral Neuropathy

SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study

Start date: December 5, 2016
Phase: Phase 2
Study type: Interventional

The single-center, open-label Phase II study has the objective of assess the effect of MD1003 on motor and sensory conduction in patients suffering from demyelinating polyneuropathies in 15 subjects.

NCT ID: NCT02967237 Completed - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment

Transition II
Start date: January 4, 2016
Phase: Phase 4
Study type: Interventional

Primary Objective: The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement. Secondary Objectives: - Evolution of fasting plasma glucose - Evolution of insulin dose and body weight - Hypoglycemia incidence - Safety - Patients satisfaction when they change their insulin for HOE901-U300

NCT ID: NCT02967224 Completed - Clinical trials for Diabetes Mellitus, Type 2

A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Naïve Patients Initiating Insulin

Reach-Control
Start date: November 5, 2015
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change Secondary Objectives: - To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority is met, measured as HbA1c change. - To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification. - Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on Hypoglycemia). - Change in fasting plasma glucose (FPG). - Change in body weight. - Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs and DTSQc). - Change in hypoglycemic control subscale (HCS) - Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

NCT ID: NCT02967211 Completed - Clinical trials for Diabetes Mellitus, Type 2

A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin

REGAIN CONTROL
Start date: December 21, 2015
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change Secondary Objectives: - To demonstrate superiority of Toujeo versus "standard of care" basal insulin if non-inferiority criterion is met, measured by HbA1c change. - To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification. - Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or severe (according to ADA Working Group). - Change in fasting plasma glucose (FPG). - Change in body weight. - Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc). - Change in hypoglycemic control subscale (HCS). - Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

NCT ID: NCT02966925 Completed - Vulvar Atrophy Clinical Trials

Autologous Platelet Concentrate Combined to Hyaluronic Acid Obtained With Cellular Matrix® BCT-HA Kit and Vulvovaginal Dryness

Start date: March 2016
Phase: N/A
Study type: Interventional

Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms of vaginal atrophy include dryness, itching, burning and dyspareunia. This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who cannot benefit from reference treatments (hormonal therapies).To achieve this, 20 patients suffering from vulvovaginal dryness will be treated with one session of injections in the vulva, the posterior vaginal wall and the perineum, and followed-up for 6 months. Improvement of vaginal dryness will be primarily appreciated through Friedmann score and pH value, and secondarily through the Female Sexual Function Index (FSFI), as measured at baseline and 1, 3 and 6 months after the treatment.

NCT ID: NCT02966847 Completed - Thoracoscopy Clinical Trials

Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery

CAVIT
Start date: May 11, 2017
Phase: N/A
Study type: Interventional

In the coming years, an increase in lung nodule resection is expected, particularly in Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a tool whose use is constantly spreading.

NCT ID: NCT02966834 Completed - Cholestasis Clinical Trials

Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis

Start date: January 11, 2017
Phase: Phase 2
Study type: Interventional

This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). Participants will receive either placebo or one of the 4 dose regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily). Participants on GSK2330672 will also receive placebo tablets to maintain blinding. The study has a prospectively defined adaptive design that will utilize interim data to further inform and potentially optimize the doses under investigation. Hence, additional dose regimen may be added during study. The total duration of a participant in the study will be up to 45 days of screening and 24 weeks of study including follow-up.

NCT ID: NCT02966795 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

ENDURANCE-5 6
Start date: January 25, 2017
Phase: Phase 3
Study type: Interventional

A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.

NCT ID: NCT02966691 Completed - Bladder Cancer Clinical Trials

Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors

VISIOCYT 1
Start date: January 24, 2017
Phase: N/A
Study type: Interventional

This clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol VisioCyt.