Clinical Trials Logo

Filter by:
NCT ID: NCT02967510 Completed - Vaginal Atrophy Clinical Trials

Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy

Start date: October 2016
Phase: Phase 2
Study type: Interventional

A Phase 2, Dose-ranging, 12-week Randomized, Double-blind, Placebo controlled, Parallel-group Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005% Estriol Vaginal Gel, 0.002% Estriol Vaginal Gel, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women with Vulvovaginal Atrophy. Vulvovaginal atrophy is a natural consequence of the progressive estrogen deficiency that occurs in menopause. Epidemiological data have indicated that about 50% of otherwise healthy women over 60 years of age experience symptoms related to urogenital atrophy such as vaginal dryness, dyspareunia, burning, itching, as well as urinary complaints or infections of the lower urinary tract. As these alterations frequently affect the quality of life of postmenopausal women, it is important for doctors to detect their presence and offer treatment options. Estrogen therapy is the most effective treatment of moderate to severe symptoms of vulvar and vaginal atrophy. One advantage of local treatment with estrogen is avoidance of first-pass liver metabolism, making it possible to use lower doses of estrogen compared with oral therapy; the local route also minimize systemic adverse effects. The search for therapeutic alternatives which may present improvements in relation to the current products has been encouraged.

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: 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: NCT02966769 Completed - Surgery Clinical Trials

N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation

Start date: June 2016
Phase: N/A
Study type: Observational

The objective of this multicenter retrospective study is to compare overall survival in patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus definitive chemoradiation. Secondary objectives are to analyze disease-free survival, median survival, locoregional and distant relapses as well as mortality and toxicity related to treatment.

NCT ID: NCT02966600 Completed - Parkinson Disease Clinical Trials

Strength Training and Different Subtypes of Parkinson´s Disease

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

The aim of this randomized controlled trial was to assess the impact of progressive resistance exercise (PRE) in PD patients with akinesia and rigidity (AR-subtype). The investigators hypothesized the intervention would have a beneficial effect on the study outcomes.

NCT ID: NCT02966353 Completed - Clinical trials for Primary Myelofibrosis

Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.

REALISE
Start date: March 31, 2017
Phase: Phase 2
Study type: Interventional

This was a study of treatment with ruxolitinib in patients who presented with transfusion dependent or independent anemia. Starting dose was 10 mg BID. This dose was maintained for the first 12 weeks of the study and up-titrated thereafter unless the subject met criteria for dose hold or dose reduction

NCT ID: NCT02966028 Completed - Clinical trials for Cardiovascular Diseases

Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)

Start date: November 2016
Phase: Phase 2
Study type: Interventional

The primary objective is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg) compared to placebo on the progression of coronary artery calcium volume score over a 12-month (52 weeks) period in ESRD patients on HD

NCT ID: NCT02965989 Completed - Infection Control Clinical Trials

Effectiveness of a Online Training Program With a Clinical Procedure Standardized in Units of Nursing (CPSUN)

CPSUN
Start date: May 2015
Phase: N/A
Study type: Interventional

This study evaluates if the implementation of an online platform with procedures and protocols, improve the knowledge of professionals and can have a health impact related to decreased contamination of blood cultures.

NCT ID: NCT02965573 Completed - Myasthenia Gravis Clinical Trials

A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

Start date: December 30, 2016
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of autoimmune Myasthenia Gravis (MG) with generalized muscle weakness.