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NCT ID: NCT04829214 Completed - Subjective Tinnitus Clinical Trials

OTO-313 in Subjects With Unilateral Subjective Tinnitus

Start date: March 22, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus.

NCT ID: NCT04828590 Completed - Clinical trials for Coronary Artery Disease

The ADAPT Study: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease

ADAPT
Start date: August 10, 2020
Phase:
Study type: Observational

DEEPVESSEL FFR is a medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography-derived fraction flow reserve (FFR) values from coronary CT angiogram images. The primary objective of this multi-center clinical validation study is to validate the clinical performance of DEEPVESSEL FFR in identifying patients with myocardial ischemia due to significant obstructive coronary artery diseases.

NCT ID: NCT04825405 Completed - Stroke, Ischemic Clinical Trials

The Use of the Tip Stim Glove Device to Achieve Coordinated Movement of the Human Hand

Start date: July 10, 2019
Phase: N/A
Study type: Interventional

The study was to evaluate the use of the Tip Stim device to achieve coordinated movement and grip force in stroke patients under conditions of active and passive stabilization of the trunk.

NCT ID: NCT04822857 Completed - Hypertension Clinical Trials

The Impact of Menopause on the Development of Heart Failure and Organ Damage of Hypertension

Start date: January 22, 2019
Phase:
Study type: Observational

Introduction: The average age of menopause in the Polish population is around 50 years. After the occurrence of the last menstruation in the woman's body there are series of hormonal changes that may result in the emergence of new diseases, i.e. osteoporosis or ischemic heart disease. Hypertension is the most important cardiovascular risk factor affecting morbidity and mortality due to cardiovascular disease. It is estimated that there are as many as 34% of adult Poles. The incidence of hypertension increases with age in both women and men, and significantly greater increases are observed in perimenopausal women. An equally important and growing health and economic problem in Poland is heart failure. It is estimated that up to 700,000 patients in our country are struggling with this disease, and the proportion of women in this group is constantly growing. This is the third reason for the death of women in Poland, causing more deaths than cancer. The influence of menopause on the occurrence of heart failure in a group of women with controlled hypertension remains unclear and is the subject of ongoing research. Similarly, there is still no convincing data on the increased risk of organ complications of arterial hypertension in the group of postmenopausal women. The aim of the study is to assess the effect of menopause on myocardial function indexes, haemodynamic parameters and body mass composition in women aged> 40 years. Material: about 100 women hospitalized in the Department of Cardiology and Congenital Heart Diseases of Adults > 40 years of age will be enrolled in the study. with controlled hypertension. The population will be divided into two groups: I: 50 women before the onset of menopause and II group: 50 women ≥ 1 year after the onset of menopause. Methods: Basic laboratory tests and concentrations of ADMA, NT-proBNP, neprilysin, estradiol and FSH will be performed in patients. The other planned examinations are: full clinical examination with BMI assessment, resting ECG test, full echocardiography using tissue doppler, volume and function of the left atrium and vascular stiffness index assessed using the sphygmocor device. In addition, it is planned to analyze the composition of body mass using electrical bioimpedance, intima-media complex measurement and spiroergometric study. One year after the inclusion in the study, a telephone interview will be carried out with the patients, with particular attention to the diagnosed diseases / onset of intervention: heart failure, diabetes, atrial fibrillation, the need for coronary angiography or rehospitalisation. The collected data will be statistically processed. New values: Studies carried out as part of this work will supplement the current knowledge on the impact of menopause in the population of women with hypertension on the risk of heart failure and complications of organ hypertension. Thanks to the observed relationships, it will be possible to early start the appropriate diagnostic procedure, the selection of personalized treatment and the development of a model of cardiac care for women in the perimenopausal period, and thus improve quality and extend their life.

NCT ID: NCT04821518 Completed - Stroke Clinical Trials

The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke

Start date: November 15, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of the present study was to quantitatively assess the risk factors that may affect the re-occurrence of a CVD event and the use of a commercially available mobile application Samsung Health for the assessment of parameters of exercise tolerance and the ECG M-Trace Base II application for the assessment of cardiological parameters.

NCT ID: NCT04819776 Completed - Bipolar I Disorder Clinical Trials

Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

Start date: March 22, 2021
Phase: Phase 3
Study type: Interventional

The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder.

NCT ID: NCT04819113 Completed - Clinical trials for Meningococcal Vaccine

Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age

Start date: April 9, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants <6 months of age, followed by the booster at 12 months

NCT ID: NCT04817280 Completed - Covid19 Clinical Trials

COVID-19 in Polish Ice Swimmers.

ICE
Start date: December 1, 2020
Phase:
Study type: Observational

Ice swimming is an increasingly common phenomenon in Poland. It has been confirmed that it has a beneficial effect on health by increasing the natural non-specific immunity to infections. In the face of the current Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic causing Coronavirus Disease 2019 (COVID-19), researchers decided to use a survey to check the incidence of COVID-19 among Polish ice swimmers, as well as recent ailments. Then, the researchers will compare the obtained results with epidemiological data for Poland.Researchers will also investigate the relationship between susceptibility to SARS-CoV-2 infection and the blood group and Rh factor among ice swimmers.

NCT ID: NCT04816643 Completed - Clinical trials for SARS-CoV-2 Infection, COVID-19

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

Start date: March 24, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants <6 months of age may subsequently be evaluated.

NCT ID: NCT04813614 Completed - Esthetics Clinical Trials

Effectiveness and Safety of STYLAGE® M Lidocaïne for Lips' Volume Augmentation and/or Redefinition of the Outline of the Lips (SMILE)

SMILE
Start date: May 31, 2021
Phase: N/A
Study type: Interventional

STYLAGE® M Lidocaine is a hyaluronic acid injectable gel CE (conformité européenne)-marketed since 2009 . It is indicated for the outline of the lips and/or for lips augmentation in lips mucosa. It is also indicated to fill skin depressions on the face. Lidocaine is intended to reduce the pain associated with the injection. The aim of SMILE study is to demonstrate that STYLAGE® M Lidocaine is non-inferior to an active comparator that has shown its effectiveness in lips' volume augmentation and restoration in improving the aesthetic appearance of the lips evaluated by subjects. In this study, 92 healthy volunteers between 18 and 65 years old, who expressed the wish for augmentation or restoration of the volume of the lips and/or lips' outline redefinition, confirmed by investigators at inclusion, who have given his/her informed consent and who met all the eligibility criteria, will be enrolled. Subjects will randomly receive STYLAGE® M Lidocaïne or the active comparator (ratio 1:1) injection in the lips at first visit on Day 0. At second visit, one month after Day 0, an optional touch-up injection could be performed according to subject's and investigator's opinions and if the subject is still eligible. Subjects will have a total of 6 visits over a 12 months follow-up period and a screening visit prior to first injection. Proportion of subjects having a global aesthetic improvement of their lips (blinded self-evaluation), 3 months after treatment initiation will be assessed and compared between the two groups. This will also be done during the other visits (1, 6, 9 and 12 months after treatment initiation). Global aesthetic improvement according to blinded independent evaluator, subjects' satisfaction, pain during injection and safety parameters will also be assessed during the study period.