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NCT ID: NCT03905642 Completed - Cystic Fibrosis Clinical Trials

Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase

Start date: January 8, 2009
Phase: Phase 2
Study type: Interventional

A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of patients with CF in the U.S. are infected. Liposomal amikacin for inhalation (LAI; Arikayce™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and delivery to the lungs of infected patients when delivered via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit drug close to the bacterial colonies (Meers, et al., 2008) (Clancy, et al., 2013), thus improving the bioavailability of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI formulation can effectively increase the half-life of the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several advantages over current therapies in treating patients with CF with chronic infection caused by P. aeruginosa.

NCT ID: NCT03888066 Completed - Hyperkalemia Clinical Trials

Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)

DIAMOND
Start date: April 24, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.

NCT ID: NCT03862898 Completed - Clinical trials for Chronic Low Back Pain

Efficacy of the Lumbar Stabilization and Thoracic Mobilization Exercises in Chronic Low Back Pain Patients

Start date: June 29, 2017
Phase: N/A
Study type: Interventional

Chronic low-back pain (CLBP) is a heterogeneous group of disorders, which according to the new classification of the International Association for Pain Research (IASP), is recognized as an independent entity and belongs to a mixed type of pain caused by central sensitization , which is present for more than 12 weeks. Studies have found that lumbar segmental instability (LSI) is one of the most significant cause of lumbar pain through the movement of each spinal segment where degenerative changes were observed in the discs. The aim of this study was to compare the program of lumbar stabilization exercises in the open and closed kinetic chain, in relation to the program of lumbar stabilization exercises and thoracic mobilization in a closed kinetic chain, to evaluate the clinical efficacy of both exercise programs and determine whether initial pain intensity values and disability levels affect the outcome of patients with chronic low back pain. The study was conducted as randomized, single-blind, controlled trial in 80 chronic low-back pain (CLBP) patients of both sexes (35 male, 45 female), average age (48.45 +/- 10.22 years, treated at the Rehabilitation Clinic "Dr. Miroslav Zotović" in Belgrade between June 2017 and March 2018. Respondents were divided into two groups of 40 patients by simple randomization. Participants were given laser therapy, transcutaneous electrical nerve stimulation (TENS) and an eight-week kinesiotherapy that included exercises to strengthen the deep lumbar spine stabilizers. Retesting was done after 4 and 8 weeks. Patients who performed lumbar stabilization and thoracic mobilization exercises program in a closed kinetic chain had better functional recovery and a significant reduction in pain intensity compared to respondents who performed a lumbar stabilization program in opened and closed kinetic chain.

NCT ID: NCT03856047 Completed - Obesity Clinical Trials

Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.

Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study. As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either take NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 8 months. Participants will have 12 clinic visits with the study doctor.

NCT ID: NCT03851705 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

ORION-5
Start date: February 6, 2019
Phase: Phase 3
Study type: Interventional

This study was a Phase III,A two-part (double-blind placebo-controlled/open-label) multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH).

NCT ID: NCT03847896 Completed - Asthma Clinical Trials

A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma

DENALI
Start date: March 20, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study to compare 2 dose levels of budesonide/albuterol BDA MDI (PT027) to its components budesonide BD MDI (PT008) and albuterol AS MDI (PT007) on improvement in lung function and asthma symptoms after 12 weeks of treatment in adult, adolescent, and child subjects with symptomatic asthma currently being treated with a short/rapid-acting β2-adrenoreceptor agonist (SABA) as needed alone or with low-dose inhaled corticosteroid (ICS) maintenance therapy plus SABA as needed.

NCT ID: NCT03846141 Completed - Clinical trials for Exercise Performance

Hydrogen Inhalation for Health and Exercise Performance

HIHEP
Start date: January 15, 2018
Phase: N/A
Study type: Interventional

In this randomized double-blind, placebo-controlled, crossover pilot trial, we evaluated the effects of 7-day H2 inhalation on exercise performance outcomes and serum hormonal and inflammation profiles in a cohort of young men and women.

NCT ID: NCT03845517 Completed - Clinical trials for Systemic Lupus Erythematosus

A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Start date: April 18, 2019
Phase: Phase 2
Study type: Interventional

Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.

NCT ID: NCT03840148 Completed - Clinical trials for Urinary Tract Infections

Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections

CERTAIN-1
Start date: August 7, 2019
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.

NCT ID: NCT03832660 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Sacubitril/Valsartan vs Lifestyle in Hypertrophic Cardiomyopathy

SILICOFCM
Start date: May 3, 2019
Phase: Phase 2
Study type: Interventional

The overall aim of this project is to establish potential benefits of a novel lifestyle (physical activity and dietary nitrate) and pharmacological (angiotensin receptor neprilysin inhibitor) interventions in patients with hypertrophic cardiomyopathy (HCM). HCM is the most common genetic cardiovascular disease with a broad spectrum of disease severity. Angiotensin receptor neprilysin inhibitor reduces death, hospitalisation, and may improve cardiac function and exercise tolerance in heart failure. Exercise training is associated with a significant increase in exercise tolerance, but appear to have limited effect on measures of cardiac morphology or function in patients with HCM. Dietary supplementation with inorganic nitrate (i.e. concentrated nitrate-rich beetroot juice) improves exercise capacity, vasodilatation and cardiac output reserves while reduces arterial wave reflections, which are linked to left ventricular diastolic dysfunction and remodelling. Using a five-centre, open label, three-arm, pilot design, the present study will evaluate the effect of lifestyle (physical activity and dietary supplementation with inorganic nitrate) and pharmacological (angiotensin receptor neprilysin inhibitor sacubitril / valsartan) interventions in patients with HCM. The Aim is to examine whether these interventions improve functional capacity, clinical phenotypic characteristics, and quality of life in patients with HCM.