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NCT ID: NCT02732951 Completed - Macular Edema Clinical Trials

Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema

Start date: April 14, 2016
Phase: Phase 2
Study type: Interventional

This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12 weeks in patients with mild vision impairment due to center-involved DME

NCT ID: NCT02731287 Completed - Hemangioma Clinical Trials

Topical Timolol for Infantile Hemangioma in Early Proliferative Phase

Start date: March 2014
Phase: Phase 2
Study type: Interventional

Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a non-selective beta-blocker, is an emerging treatment which has been reported to be effective and safe for the treatment of IH, especially for superficial hemangiomas. Investigators hypothesize that treatment with topical timolol in the first two months of life, before the proliferative phase or in early proliferative phase, may prevent from further growing and the need to treat with oral propranolol.

NCT ID: NCT02731222 Completed - Onychodystrophy Clinical Trials

Prevalence of Onychodystrophy in Patients With Chronic Venous Disease of the Lower Limbs

Start date: November 9, 2015
Phase: N/A
Study type: Observational [Patient Registry]

The objective of this study is to determine the degree of correlation between the clinical severity of chronic venous disease and the prevalence of onychodystrophy. The completion of the study will require a previous synthetic explanation of the aforementioned two diseases, emphasizing the factors which have an impact on the proposed analysis.

NCT ID: NCT02730975 Completed - Prostate Cancer Clinical Trials

Pharmacokinetic Food-effect Study of Abiraterone Acetate (AA) in Castration Resistant Prostate Cancer

ABIFOOD01
Start date: May 12, 2014
Phase: Phase 1
Study type: Interventional

ABIFOOD study is a randomized open-labelled, phase I study to evaluate food effect in the pharmacokinetic parameters of abiraterone acetate (AA) at reduced doses, versus AA in fasting conditions at conventional doses, in castration resistant prostate cancer (mCRPC) patients who have progressed to docetaxel.

NCT ID: NCT02730455 Completed - Clinical trials for Acute Ischemic Stroke

Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke

ACTION2
Start date: July 18, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess the clinical effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of functional independence and activities of daily living. The secondary objective of the study is to explore dose and exposure response and the clinical treatment effects of natalizumab versus placebo in acute ischemic stroke on the following: measures of independence, activities of daily living, neurologic function, quality of life, cognition, and safety and tolerability

NCT ID: NCT02730169 Completed - Clinical trials for Hypogonadotropic Hypogonadism

Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism

Start date: May 12, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268 subjects.

NCT ID: NCT02729051 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Comparative Study of Fluticasone Furoate(FF)/Umeclidinium Bromide (UMEC)/ Vilanterol (VI) Closed Therapy Versus FF/VI Plus UMEC Open Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: June 29, 2016
Phase: Phase 3
Study type: Interventional

This multicenter study will be conducted to compare the effect of FF/UMEC/VI with FF/VI plus UMEC on lung function after 24 weeks of treatment. This is a phase IIIB, 24-week, randomized, double-blind, parallel group multicenter study. This study will test the hypothesis that the difference in trough forced expiratory volume in one second (FEV1) between treatment groups is less than or equal to a pre-specified non-inferiority margin. Alternatively, this study will also test the hypothesis that the difference between treatment groups is greater than the margin. The triple therapy of FF/UMEC/VI in a single inhaler is being developed with the aim of providing a new treatment option for the management of advanced Global Initiative for Chronic Obstructive Lung Disease (GOLD) Group D COPD which will reduce the exacerbation frequency, allow for a reduced burden of polypharmacy, convenience, and improve lung function, health related quality of life (HRQoL) and symptom control over established dual/monotherapies. This study has a 2 week run in period where subjects will continue to have their existing COPD medications. At randomization, subjects will discontinue all existing COPD medications and will be assigned to treatment of FF/UMEC/VI, 100 microgram (mcg)/62.5 mcg/25 mcg and placebo or FF/VI, 100 mcg/25 mcg and UMEC, 62.5 mcg in a 1:1 ratio for 24 weeks. Subjects will have clinical visits at Pre-Screening (Visit 0), Screening (Visit 1), Randomization (Week 0, Visit 2), Week 4 (Visit 3), Week 12 (Visit 4) and Week 24 (Visit 5). A follow-up visit will be conducted at 1 week after the end of treatment period or after early withdrawal visit. Approximately, 1020 subjects will be enrolled in this study. There will be two pharmacokinetic (PK) groups (subset A and subset B). Approximately 120 subjects will be assigned to subset A and approximately 60 subjects will be assigned to subset B. The total duration of subject participation will be approximately 27 weeks, consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up period.

NCT ID: NCT02727660 Completed - Clinical trials for Chronic Obstructive Pulmonary Disorder

A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

Start date: April 29, 2016
Phase: Phase 3
Study type: Interventional

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.

NCT ID: NCT02727530 Completed - Infant Colic Clinical Trials

The Effectiveness of the Manual Therapy on Infant Colic (MT-IF)

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

The main goal of this study is to get to know if applying manual therapy will reduce the infant colic symptoms for to improve quality of life of babies and parents.

NCT ID: NCT02727400 Completed - Clinical trials for Female Infertility Due to Advanced Maternal Age

Mitochondrial Energy Production in ART (Assisted Reproductive Technology )

Mitenergy
Start date: April 1, 2017
Phase:
Study type: Observational

Oocyte maturation requires a lot of energy, which is provided by the mitochondria via the synthesis of ATP. The majority of patients with advanced maternal age (AMA) have poor egg quality. One of the reasons depends on oxidative phosphorylation of Pyruvate to undergo maturation; on the contrary, the cells of the cumulus (CC) show great activity glycolytic so that these cells are able to provide ATP(adenosine triphosphate and energy substrates to the oocyte. The goal of this work is to analyze the mitochondrial function and energy production in oocyte donors compared with a group of women of advanced maternal age subject to a same ovarian stimulation Protocol