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NCT ID: NCT03587181 Recruiting - Atrial Fibrillation Clinical Trials

Investigation of Substrates Associated With the Recurrence of Atrial Fibrillation After PV Cryoablation

SubstrateAF
Start date: April 3, 2017
Phase:
Study type: Observational

The two main mechanisms for atrial fibrillation (AF) recurrence after cryoablation include Pulmonary vein (PV) reconnection and the presence of non-PV associated arrhythmic focuses. The aim of this study is to investigate the prevalence of each mechanism and if biomarkers may be used to predict of these events. Eighty patients with paroxysmal or persistent AF will undergo PV isolation with cryoablation followed by loop recorder implantation. Patients in whom atrial tachyarrhythmias recur during 12 months follow-up (outside of the 3-month post procedure blanking window) will be offered a second electrophysiology study (EP) study to assess PV isolation and non-PV focuses and further ablation performed as required. At baseline blood samples will be taken to investigate the correlation between specific biomarkers and both the incidence and type of recurrence. The correlation between recurrence of atrial tachyarrhythmias due to non-PV associated arrhythmic focuses and elevated baseline levels of NT-ProBNP, CRP, TNF, MMP1 will be pre-specified. 40 consecutive patients will have a biopsy taken from the intraventricular and interatrial septum to investigate the correlation between myocardial inflammation, the presence of fibrosis and recurrence of atrial tachyarrhythmias. Correlation between biomarkers of inflammation and biopsy-proven myocardial inflammation or fibrosis will be assessed.

NCT ID: NCT03586401 Recruiting - Physical Activity Clinical Trials

Creating a Decision Support System for the Corporate Management of Physical Therapy

Start date: November 1, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to create a software product on the basis of the support technologies for making decisions for the collaboration of the different specialists, the family and the patient himself in the process of physical therapy of children treated for cancer. The basic model of the technology is a qualification model of the state of health and physical limitations, based on data from a survey of 1,000 children treated for cancer. The software product is supposed to be created on the basis of the Splunk system, the key link is a personal office with a two-way login system: for specialists and for patients. The patient introduces the results of self-examination, monitoring and additional surveys in real time, specialists - additional recommendations. To assess the effectiveness of the collaboration based on the software product, a long-term follow-up (at least 3 years) is planned for the participants of the study with repeated examinations at the Medical-Rehabilitation Scientific Center "Russe pole" at least twice a year. Condition or disease Hemoblastosis Solid brain tumors The condition after hematopoietic stem cell transplantation

NCT ID: NCT03586063 Completed - Clinical trials for Internal Endometriosis

Study of Diphereline 3.75 mg Treatment In Women Suffering From Internal Genital Endometriosis

Start date: November 3, 2011
Phase:
Study type: Observational

To describe Gonadotropin-Releasing Hormone agonists (GnRH-a) treatment effectiveness on reduction of internal genital endometriosis symptom - menorrhagia - in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3,75 mg - assessment performed six months after the last injection.

NCT ID: NCT03585686 Recruiting - Clinical trials for Langerhans Cell Histiocytosis

A Combination of Vemurafenib, Cytarabine and 2-chlorodeoxyadenosine in Children With LCH and BRAF V600E Mutation

Start date: June 26, 2018
Phase: Phase 2
Study type: Interventional

Langerhans cell histiocytosis (LCH) is a disease caused by clonal expansion, proliferation, and dissemination of cells that are phenotypically close to Langerhans cells in different tissues and organs. The clinical presentation of LCH varies greatly from one solid bone tumor to multisystem lesion that involves liver, spleen and bone marrow. The basis of LCH is the clonal proliferation of the pathological cells. These cells express CD1a and CD207 markers on their surface and originate from myeloid progenitors. The main event in life circle of these cells is the MEK-ERK cascade mutation. The most common mutation is the substitution of valine for glutamic acid in position 600 of BRAF gene. The influence of this mutation was confirmed by G.Badalyan-Very et al. in 2010. About 64% of all LCH are caused by clonal proliferation due to BRAF V600E mutation. Despite generally good results of therapy of monosystemic LCH, the treatment of LCH with risk organs lesion is still a challenge: 5-years survival is as low as 40-50%. Combination of cytarabine and 2-chlorodeoxyadenosine was supposed to improve the results, but the cost was a very high toxicity, that limits the application of the regimen in patients with severe infections. Currently, there is a lot of information on BRAF V600E inhibitors in patients with LCH and other histiocytic disorders. Most of them report the dramatic efficacy of BRAF V600E inhibitors but after quick effect patients usually burden minimal disease activity ("plateau" effect). However, discontinuation of the therapy results in quick disease reactivation. Considering this a trial that combines targeted therapy (vemurafenib) and low-dose chemotherapy (cytarabine and 2-chlorodeoxyadenosine) in order to achieve complete response with manageable toxicity is proposed.

NCT ID: NCT03579004 Recruiting - Clinical trials for Squamous Cell Carcinoma

Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer

Start date: July 10, 2017
Phase: Phase 2
Study type: Interventional

This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma

NCT ID: NCT03578809 Recruiting - Clinical trials for ST Elevation Myocardial Infarction

A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

REAL-TIMI 63B
Start date: June 5, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult subjects presenting with acute STEMI (ST segment elevation myocardial infarction). The study will enrol subjects presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all subjects, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of subjects will also undergo an index and an end of study CTA.

NCT ID: NCT03577977 Completed - Multiple Sclerosis Clinical Trials

Betaferon Use in Children and Adolescents With Multiple Sclerosis

Start date: June 1, 2008
Phase:
Study type: Observational

The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents

NCT ID: NCT03577535 Active, not recruiting - Mucositis Oral Clinical Trials

Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients.

Start date: November 1, 2017
Phase: Phase 2
Study type: Interventional

Oral mucositis is one of the most spread side effects of anticancer therapy. It is associated with both chemo- and radiotherapy, decreases QoL, relative dose intensity and leads to nutritive deficiency. Oral mucositis causes secondary infections, increased hospital stay, whereas pain syndrome results in an emotional distress, anorexia and disables natural feeding.

NCT ID: NCT03575702 Completed - Overactive Bladder Clinical Trials

Efficacy and Safety Evaluating Study to Compare Uritos® (Imidafenacin) and Urotol® (Tolterodine) for Treatment of Overactive Bladder.

Start date: July 18, 2016
Phase: Phase 3
Study type: Interventional

Objective of this study was confirmation on non-inferiority and validation of similar safety profile of new anti-muscarinic medicinal product Uritos® (Imidafenacin) in comparison with other product from m-cholinergic antagonists group Urotol® (Tolterodine).

NCT ID: NCT03572023 Recruiting - Clinical trials for Acute Coronary Syndrome

Investigation of the Heart and the Clinical Course of Acute Coronary Syndrome in Patients With Non-obstructive Lesion of the Coronary Arteries

MINOCA
Start date: May 28, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to improve the differential diagnosis and clinical outcomes of acute coronary syndrome with non-obstructive coronary arteries, to investigate the relationship between the structural and functional state of the heart and the clinical course of the disease.