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NCT ID: NCT05550792 Completed - Heart Failure Clinical Trials

Cardiac Contractility Modulation in Patients With Chronic Heart Failure and the Various Forms of Atrial Fibrillation

Start date: August 31, 2018
Phase: N/A
Study type: Interventional

Chronic heart failure (CHF) is a global pandemic which affects around 26 million people worldwide and develops in 10% of people over 70 years . According to the results of the EPOCHA-CHF study, CHF is detected in 7-10% of cases in the Russian Federation . Atrial fibrillation (AF) is the most common arrhythmia in patients with both preserved (HFpEF) and reduced ejection fraction (HFrEF) heart failure. The prognostic impact of AF on CHF is negative, including the significant increase in mortality and hospitalization. One of the common causes of decompensation of CHF is AF. The debut of AF in CHF is one of the markers of disease progression. Rapid development in interventional cardiology due to the invention of cardiac catheter technologies during the last decades provided a new option for non-pharmacological treatment of CHF. Nowadays the use of electrophysiological methods of treatment can significantly improve the prognosis of CHF. Pacemakers, cardiac resynchronization devices, and cardioverter defibrillators are the most commonly implanted devices in patients with CHF. In 2014, the European Society of Cardiology presented a report of the European Heart Rhythm Association on the use of new devices for CHF, including the Optimizer device for delivery of cardiac contractility modulation therapy (CCM) . It is worth noting that CCM is a new step in the CHF treatment. This device is of proven benefit to patients with symptomatic heart failure on optimal medical therapy who do not qualify for cardiac resynchronization therapy. Multiple studies of CCM show clinical improvement with this therapy, including metrics such as peak VO2, 6MW, and NYHA functional class. However, the vast majority of patients enrolled in these studies were patients in sinus rhythm. As the technology progressed and the need for the trial sensing led wanted, further experiences incorporated patients with AF. A new generation of devices (Optimizer Smart®), which does not require the implantation of an atrial electrode made it possible to implant CCM in patients with AF. The present trial demonstrates the results of a pilot study conducted in National Medical Research Center of Cardiology Ministry of Health of the Russian Federation which compares the efficacy of CCM in patients with AF and ischemic and non-ischemic CHF compared to patients who received only optimal drug therapy CHF

NCT ID: NCT05550220 Completed - Clinical trials for Mechanical Ventilation Complication

A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.

NCT ID: NCT05550181 Completed - Surgery Clinical Trials

Intraoperative Hypocapnia in PROVHILO and PROBESE

iHypoPRO
Start date: November 29, 2022
Phase:
Study type: Observational

To gain a better understanding of the epidemiology of intraoperative hypocapnia, in particular the associations of intraoperative hypocapnia with patient demographics, ventilator characteristics, and perioperative complications we will perform an individual patient-level meta-analysis of two recent randomized clinical trials of intraoperative ventilation, the 'PROtective Ventilation using High versus LOw PEEP trial' (PROVHILO), and the 'Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients trial' (PROBESE).

NCT ID: NCT05549947 Completed - Clinical trials for Moderate to Severe Atopic Dermatitis

Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis

Start date: October 8, 2022
Phase: Phase 2
Study type: Interventional

This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis

NCT ID: NCT05549089 Completed - Clinical trials for Orthodontic Appliance Complication

The Validity of Customized Orthodontic Bracket Set up

Start date: June 3, 2022
Phase: N/A
Study type: Interventional

CAD/CAM systems have assisted orthodontists in planning and positioning brackets to minimize errors and improve the excellence of treatment. This study aimed to validate measurements obtained from manual and digital systems, as well as evaluate the effectiveness, and periodontal changes that occurred after the treatment. Materials and Methods: This study is a prospective randomized controlled trial, in which clinical evaluation of virtual setup (digital and manual) techniques versus CAD/CAM brackets (Ormco© Insignia™ .022" twin brackets) in terms of expression of bracket prescription and treatment outcome. The sample consisted of 30 young adults with Angle Class I malocclusion. Cone beam computer tomography (CBCT) were obtained before and after the treatment to assess the parallelism between the dental roots and periodontal conditions. Digital impression by three dimensional (3D) intraoral scans (IOS) will be obtained for all participants. The 3D models are converted to stereolithography (STL) for all groups. The sample will be dividing randomly into three groups; the first one treated with CAD/CAM brackets (Ormco© Insignia™ .022" twin brackets), while the other two groups were treated by customization of bracket base of the conventional pre-adjusted twin bracket with orthodontic adhesive material, this will be done through planning and creating the virtual setup by using Maestro® 3D Ortho Studio software. The Indirect bonding devices for the second group will manufacturing from 3D printed models while third group from the manual double-layer vacuum-formed thermoplastic trays. All patients will treat with fixed orthodontic twin brackets appliances. The 3D models of the Virtual setup are comparing with the treated occlusion. The linear and angular measurements are performing by the Geomagic® software and using the 3Shape's Ortho-Analyzer TM software in all groups to assess the American Board of Orthodontics grading system scores. Random errors are assessing by Intra-class Correlation Coefficient (ICC) and method errors. Descriptive statistical analysis, Shapiro-Wilk test to detect the normality of variable distribution and the Chi-square test evaluated whether the ABO scores measurements are within the limits of agreement of each criterion. ABO scores between both groups are analyze by using Wilcoxon test. The Bland-Altman analysis evaluated if differences are within the limits of agreement.

NCT ID: NCT05547386 Completed - Clinical trials for Metastatic Prostate Carcinoma

68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer

Start date: May 9, 2022
Phase: Phase 3
Study type: Interventional

This phase III study provides access to 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) imaging for patients with castrate-resistant prostate cancer that has spread to other places in the body (metastatic) being considered for177Lu-PSMA-617 therapy. T PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of this tracer. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Combining a PET scan with a CT scan can help make the images easier to interpret. The 68Ga-PSMA-11 PET/CT scan is done with a very small amount of radioactive tracer call 68- gallium PSMA-11. In patients that have been diagnosed with prostate cancer, a protein called prostate-specific membrane antigen (PSMA) appears in large amounts on the surface of the cancerous cells. The radioactive imaging agent (68Ga-PSMA-11) has been designed to circulate through the body and attach itself to the PSMA protein on prostate cancer cells. A PET/CT scan is then used to detect the location of prostate cancer lesions. By gaining access to 68Ga-PSMA-11 PET/CT scans, patients may be safely screened for 177Lu-PSMA-617 therapy in the treatment of metastatic castrate resistant prostate cancer.

NCT ID: NCT05547087 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Dose Finding Study of VN-0200

Start date: October 13, 2022
Phase: Phase 2
Study type: Interventional

This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.

NCT ID: NCT05546983 Completed - Clinical trials for Congenital Heart Disease in Children

How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?

Pedia-Card
Start date: September 1, 2022
Phase:
Study type: Observational

Congenital heart disease is a common abnormality in newborns. The marked improvement in the surgical management of congenital heart disease has led to a reduction in postoperative mortality, historically a quality criterion for surgical and resuscitation management. With the improvement of medical knowledge and surgical techniques, mortality is no longer a single quality criterion for a center and the search for other quality criteria is essential.

NCT ID: NCT05546125 Completed - Clinical trials for Pulmonary Arterial Hypertension (PAH)

a Non-interventional Study of Sildenafil in the Treatment of Pulmonary Arterial Hypertension (PAH) in Adults From China

Start date: December 23, 2021
Phase:
Study type: Observational [Patient Registry]

This observational study will involve analysis of data collected by the National Rare Disease Registry or medical records .The study will describe outcomes only in PAH(Pulmonary arterial hypertension) patients treated with sildenafil; there will be no comparison with another treatment group. Approximately 100 adults with PAH will be recruited in China hospitals This NIS(non-interventional study) data will be recorded by a physician in the medical records, during the patients' clinical visits, and in the electronic Case Report Forms (CRF).

NCT ID: NCT05545137 Completed - Clinical trials for Uncomplicated Urinary Tract Infection

Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary Tract Infection

Start date: September 29, 2022
Phase: Phase 3
Study type: Interventional

the purpose of this study is to evaluate the efficacy and safety of pivmecillinam hydrochloride tablets in the treatment of uncomplicated urinary tract infection in China