Vascular doses of drugs will be used, including in group ASA and Rivaroxaban: 1 x/day ASA 75-100 mg + 2 x/day 2.5 mg Rivaroxaban (Xarelto).

Vascular doses of drugs will be used, including in group ASA: 1 x/day ASA 75-100 mg

Blood -EDTA samples, Serum samples, DNA samples

Peripheral Arterial Disease

Rivaroxaban

Influence of Rivaroxaban for Intermittent Claudication and Exercise Tolerance in Patients With Symptomatic PAD

Influence of Rivaroxaban 2.5 mg Two Times a Day for Intermittent Claudication and Exercise Tolerance in Patients With Symptomatic Peripheral Arterial Disease (PAD) - a Randomised Controlled Trial

Number of participants diagnozed with ischemic or hemorrhagic stroke

Number of participants diagnozed with Myocardial infarction

Number of participants who died because of Cardiovascular causes

Death for any reason not related to accidents.

Number of participants diagnozed with Acute limb ischaemia definied as limb threatening ischaemia with evidence of acute arterial obstruction by radiological criteria or a new pulse deficit leading to an intervention (ie, surgery, thrombolysis, peripheral angioplasty, or amputation.

Number of participants diagnozed with Major limb amputation was defined as amputations due to a vascular event above the forefoot, or defined as minor amputation if involving the forefoot and digits.

Change in the distance of intermittent claudication in the test according to Gardner's protocol

Change in the maximal distance of intermittent claudication in the test according to Gardner's protocol

Bleeding that directly results in death within 7 d.

Non-fatal symptomatic intracranial haemorrhage.

Non-fatal, non-intracranial haemorrhage symptomatic bleeding into a critical organ

Other major bleeding (surgical site bleeding requiring). reoperation or bleeding leading to hospitalization)

Fatal or symptomatic bleeding into a critical organ

Major bleeding according to modified the International Society on Thrombosis and Haemostasis (ISTH) criteria for major bleeding, defined as the composite of bleeding that was fatal, symptomatic bleeding into a critical organ, surgical site requiring reoperation, or requiring hospitalization (including presentation to an acute care facility without an overnight stay).(ISTH)/Scientific and Standardization Committee (SSC) definitions

Minor bleeding: A clinically relevant minor bleed: an acute or subacute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following:
A hospital admission for bleeding, or
A physician guided medical or surgical treatment for bleeding, or
A change in antithrombotic therapy (including interruption or discontinuation of study drug).

Sites of bleeding - other than: gastrointestinal, intracranial, genitourinary, ocular, skin, respiratory.

These data will be made available on reasonable request

Poznan University of Medical Sciences

Poznan University of Physical Education

Institute of Human Genetics, Polish Academy of Sciences

The treatment group will receive vortioxetine 10 mg per day, which will be increased to 20 mg or decreased to 5 mg, if deemed clinically necessary, at week 4 or 8.

Major Depression

The study drug, vortioxetine received approval from the U.S. Food and Drug Administration (FDA) to treat adults with major depressive disorder. This study is being done to determine its effectiveness in a specialized population, i.e. those who have developed major depression after a traumatic brain injury. As patients who have sustained a TBI are medically fragile and sensitive to side-effects of medications, it is important to test the effectiveness and safety of vortioxetine in this population.

Vortioxetine

A placebo comparator will be used in one subset of patients.

Placebo

Vortioxetine for the Treatment of Major Depression and Co-morbidities After Traumatic Brain Injury (TBI)

Vortioxetine for the Treatment of Major Depression and Neuropsychiatric Co-morbidities After Traumatic Brain Injury (TBI)

Prior to the initiation of the study, a method will be developed for data collection. Each participant will have a study folder with a unique identifying number to contain the results of study tests and evaluations. Another folder will also be kept that will hold all consent forms and identifying demographic information. The folders will be reviewed monthly for inconsistencies. The data will be entered into a database maintained in the Neuropsychiatry Division of Johns Hopkins Bayview Medical Center, which is password protected and only the PI and her Research team will have access to the study folders and database.
The data monitoring committee will include Dr. Rao (PI), and members of the Data & Safety monitoring board: Drs. Christopher Marano, Paul Rosenberg and Jin Joo. All members of the Diagnostic and Statistical Manual of Mental Disorders (DSM) board are psychiatrists and faculty Johns Hopkins University. The 3 DSM members are not connected with the study.

5 hydroxytryptamine/accident vascular cerebral

Influence of Rivaroxaban for Intermittent Claudication and Exercise Tolerance in Patients With Symptomatic PAD

Vortioxetine for the Treatment of Major Depression and Co-morbidities After Traumatic Brain Injury (TBI)

Cea mai completă bază de date cu plante medicinale susținută de știință