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NCT ID: NCT05688930 Completed - Clinical trials for Prevention and Control

Effects of a Neuromuscular Training Ankle Preventive Program in Soccer Player

PENT
Start date: July 7, 2021
Phase: N/A
Study type: Interventional

Objetive:To determine the effects of a functional ankle instability prevention neuromuscular training (PENMT) program compared to the conventional FIFA 11+ program on the occurrence of ankle sprains, flexibility, balance and muscle activation in 17-year-old male youth soccer players to 20 years. Subjects and Methods: An experimental investigation, controlled, randomized and single-blind clinical trial was carried out in 40 subjects randomized to start the control or experimental group (soccer Players). The trial compared the effects of a differential intervention with a protocol focused on an ankle neuromuscular training program vs the usual FIFA 11+ program, in order to strengthen functional ankle stability in youth soccer in male players. In each subject, 2 measurements were taken: Pre-intervention and Post-intervention. For each measurement, a hypothesis test was performed. Results: The FIFA11+ is expressed as an injury risk factor when buying it with the PENMT after their participation. Conclusion:The neuromuscular training program for the ankle or PENMT applied in the experimental group did not generate a negative effect with respect to the FIFA 11+ program, in addition to the time of departure in the post test, the PENMT program is expressed as a protection factor of player injuries when contrasted with the FIFA 11+ program, that is, it presents effectiveness against the risk factor of functional ankle instability.

NCT ID: NCT05686733 Recruiting - Aneurysm Clinical Trials

Pre SEAL™ IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial

Pre SEAL™ IT
Start date: January 26, 2022
Phase: Phase 1
Study type: Interventional

To establish the preliminary safety and effectiveness of the SEAL™ Endovascular Aneurysm Lattice System for the treatment of saccular intracranial aneurysms. The data from this study will be used to support: 1. EU CE Mark labelling 2. US FDA Investigational Device Exemption (IDE) approval support of PMA approval.

NCT ID: NCT05686070 Not yet recruiting - Clinical trials for Acute Non-cardioembolic Ischemic Stroke

A Study to Learn More About Asundexian (Also Called BAY2433334) for Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older Who Already Had Such a Stroke Due to a Blood Clot That Formed Outside the Heart and Travelled to the Brain, or Temporary Stroke-like Symptoms

OCEANIC-STROKE
Start date: February 16, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: - a stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or - temporary stroke-like symptoms with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Ischemic strokes or transient ischemic attacks result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together. Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting). The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. The way it works, it aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or temporary stroke-like symptoms when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health. Dependent on the treatment group, the participants will either take asundexian or placebo as tablets once a day for at least 3 months up to 31 months. Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned. During the study, the study team will: - Check vital signs such as blood pressure and heart rate - Examine the participants' heart health using an electrocardiogram (ECG) - Take blood samples - Ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.

NCT ID: NCT05677009 Completed - Oxygen Deficiency Clinical Trials

Sustainable Preservation of Essential Oxygen Resources: A Phase 4 Crossover Study of the BUFEO System: SAVE O2

SAVEO2
Start date: November 4, 2022
Phase: N/A
Study type: Interventional

The current methods of oxygen supply administer medicinal oxygen to the patient at a constant flow. Oxygen is being delivered when the patient needs it (at inhalation) and when the patient does not need it (at exhalation and at rest) if the volume of oxygen needs to be adjusted, the clinician typically increases the rate of flow in an effort to increase the oxygen concentration in the air inhaled by the patient. This traditional way of administering oxygen is clinically effective but it also wastes significant amounts of oxygen that the patient never uses. The BUFEO system addresses this problem by altering the supply of oxygen to an on-demand delivery model, the patient receives oxygen only when needed (during inhalation) and no oxygen is wasted at rest or during exhalation. The aim of this study is to evaluate, the efficacy, tolerability, and non-inferiority in SpO2 of the BUFEO device in saving oxygen and reaching a target SpO2 rate, in comparison to the standard of care by measuring the volume of oxygen used and the SpO2 reached when administering medical oxygen with the traditional supply method and through BUFEO system to hospitalized, oxygen-dependent subjects with pulmonary pathology.

NCT ID: NCT05669755 Not yet recruiting - Obesity Clinical Trials

REDEFINE 3: A Research Study to See the Effects of CagriSema on Heart Disease in People Living With Obesity and Diseases in the Heart and Blood Vessels

REDEFINE 3
Start date: March 1, 2023
Phase: Phase 3
Study type: Interventional

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with obesity and cardiovascular disease. Participants will either get CagriSema or a dummy medicine which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 3 years. Participants will have 22 clinic visits with the study doctor or study staff. Women cannot take part if pregnant, breastfeeding or plan to get pregnant during the study period. Women who are able to become pregnant must use highly effective birth control and will be counselled on the use of birth control.

NCT ID: NCT05666570 Recruiting - Diabetic Foot Ulcer Clinical Trials

The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

SPACE
Start date: May 18, 2022
Phase:
Study type: Observational

This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers. The primary objective of the study is to demonstrate the performance and safety of Avelle Negative Pressure Wound Therapy on wound and wound fluid management when used in accordance with the instructions for use. Participation in the study is anticipated to be two weeks. The Avelle™ NPWT System will be used for two weeks and participants will be seen for study visits during this time. Study participants will need to visit the doctor's office up to five times and, at a minimum, will be required to see the health care provider three times, dependent on the condition of the wound. Each visit is anticipated to last for approximately 45 to 60 minutes.

NCT ID: NCT05655000 Recruiting - Safety Issues Clinical Trials

Neonatal Thymus Transplantation in Humans

SUPERTHYM
Start date: November 15, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to demonstrate the safety of the neonatal thymus transplant in an adult patient. The main questions it aims to answer are: - Is the neonatal thymus transplant a safe procedure? - What is the adverse event profile of the neonatal thymus transplant? This is a single-subject study; thus, there will not be comparison groups. The participant will receive multidisciplinary supportive care before, during, and after the procedure.

NCT ID: NCT05643573 Recruiting - Atrial Fibrillation Clinical Trials

A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke

OCEANIC-AF
Start date: December 5, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people with atrial fibrillation and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel). Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them. Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding. The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. The way it works, it aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke. To see how well the study treatment asundexian works researchers compare: - how long asundexian works well and - how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening: - stroke and/or - systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study. To see how safe asundexian is, the researchers will compare how often major bleedings occur after taking the study treatments asundexian and apixaban, respectively. Major bleedings are bleedings that have a serious or even life-threatening impact on a person's health. The study participants will be randomly (by chance) assigned to 1 of 2 treatment groups, A and B. Dependent on the treatment group, the participants will either take the study treatment asundexian by mouth once a day or apixaban by mouth twice a day for approximately 9 - 33 months. Each participant will be in the study for approximately 9 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. Those participants who do not want or are unable to have visits to the study site may join the study remotely in selected countries. All visits for these participants will be done using electronic devices. During the study, the study team will: - take blood samples - do physical examinations - examine heart health using an electrocardiogram (ECG) - check vital signs such as blood pressure and heart rate - do pregnancy tests - ask the participants questions about their quality of life - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05636176 Not yet recruiting - Heart Failure Clinical Trials

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

HERMES
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

NCT ID: NCT05634109 Recruiting - Trauma Clinical Trials

Whole Blood in Trauma Patients With Hemorrhagic Shock

WEBSTER
Start date: January 14, 2023
Phase: Phase 3
Study type: Interventional

This study aims to evaluate among trauma patients with hemorrhagic shock the clinical impact of hemostatic resuscitation between whole blood vs. blood components therapy in the following outcomes in a hierarchical analysis: mortality at 28 days and evolution of organ dysfunction.