Clinical reasearches

Doctors and scientists are always trying to find better treatment for their patients. In order for doctors to make a scientific breakthrough they have to conduct clinical research with volunteers and patients called Clinical Trials. Clinical trials are highly regulated and controlled by the Health authorities. Taking part in them is always voluntary and patients’ rights, dignity, health and safety and welfare are protected and always above all other interest.

Active clinical trials

Medical Center Hera in Sofia takes part in clinical research in many different areas of medicine. Our trained specialists are ready to provide detailed information with regards to the steps which complete the process of given clinical trial.

Lupus

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Lupus

Systemic lupus erythematosus (SLE) is a chronic, inflammatory, autoimmune disease. This means that the body’s immune system is “imbalanced” leading to the production of autoantibodies directed against healthy tissues in the body in addition to producing antibodies for protection against infections.

 

Over time, the disease can potentially affect many different organs and tissues in the body. Lupus significantly affects women more often than men, in a ratio of 9:1. It mainly manifests in women between the ages of 15 and 44 but in recent years it has also been observed in children and older adults.

 

The clinical manifestations of the disease vary greatly among different patients and over the course of the disease. Some of the most common symptoms of lupus include painful and swollen joints (arthritis), excessive fatigue, skin rashes, anaemia, and kidney problems.

 

The treatment of lupus is complex and often requires the efforts of a multidisciplinary team of specialists – rheumatologists, clinical immunologists, nephrologists, cardiologists, haematologists, dermatologists, neurologists, endocrinologists, and others.

Heart failure

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Heart failure

Heart failure is a clinical syndrome resulting from structural and functional disorders of the myocardium of the heart. It can also result from diseases of the valves, endocardium, pericardium, rhythm, conduction disorders. It increases with age, with the frequency in individuals over 70 years old being over 10%. The lifetime risk by the age of 55 for the onset of heart failure is 33% in men and 28% in women.

 

One of the first symptoms is shortness of breath during exertion, meaning when patients cover some distance, they start to breathe heavily and need to stop or slow down. The same is true when climbing stairs. In people with heart failure, physical capacity decreases, they feel tired with certain physical efforts. Another symptom is orthopnea – people wake up at night feeling short of breath, and to breathe well, some of them use two to three pillows. Those suffering from heart failure also have swelling in the lower extremities.

Respiratory Syncytial Virus (RSV)

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Respiratory Syncytial Virus (RSV)

Respiratory Syncytial Virus (RSV) is a common respiratory virus that causes mild symptoms similar to the common cold. Typically, individuals infected with RSV recover in about a week without requiring medical treatment. However, RSV can cause severe illness and death in infants under six months of age, individuals over 65 years of age, and people with compromised immune systems.

 

Each year in the EU, Norway, and the United Kingdom, RSV is responsible for hospitalizing approximately 213,000 children under the age of five and about 158,000 adults with some requiring intensive care. Every year, one in twenty elderly individuals in Europe becomes infected with RSV.

 

RSV affects different age groups differently but the most common symptoms of the disease include:

  • Coughing
  • Sneezing
  • Fever
  • Wheezing
  • Hoarseness
  • Sore throat
  • Headache
  • Nasal congestion
  • Fatigue

Purulent Hidradenitis

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Purulent Hidradenitis

Suppurative or purulent hidradenitis is a rare condition that affects the sweat glands in the areas of the armpits and groin, the anal opening, and under the breasts in women. It is characterized by red swellings, often painful or itchy, or with an unpleasant odour. Women and people aged 20-30 are more affected.

 

The development of the condition involves the blocking of hair follicles, but the exact causes are not specified. Experts believe it may be due to genetic predisposition, hormonal imbalance, smoking, or overweight.

Multiple Sclerosis

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Multiple Sclerosis

Multiple sclerosis (MS) is a condition in which the myelin, the substance that insulates and protects the nerve cells of the brain and spinal cord, is damaged.
 

The damage disrupts communication between the nervous system and the rest of the body. In addition to myelin loss, there may sometimes be damage to the nerve fibres themselves, leading to increased disability that may occur over time.

 

The disease usually begins between the ages of 20 and 40 and is twice as common in women as in men. Symptoms of MS are highly varied and vary significantly among different patients, as well as at different stages of the disease in the same individual. Some MS patients may not develop symptoms for a varying period of time. Others experience 2-3 attacks per year. Symptoms can be categorized into several groups:

 

  • Numbness and tingling;
  • Pain and spasms;
  • Fatigue and weakness;
  • Balance and dizziness issues;
  • Bladder and bowel dysfunction;
  • Sexual dysfunction;
  • Cognitive problems;
  • Changes in emotional health.

Endometriosis

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Endometriosis

Endometriosis is a condition in which tissue similar to the lining of the uterus called the endometrium and spreads outside the uterus. These tissues are called endometrial lesions. They are usually found in the pelvis or abdominal cavity and can appear on organs such as the fallopian tubes or ovaries.

 

Similar to the endometrium, this tissue is influenced by and reacts to the menstrual cycle. Over time, the tissue that has been shed has nowhere to go and remains trapped. This can lead to inflammation, adhesions and ovarian cysts. Endometriosis is classified based on its stage and type as well as its location, depth, size, and amount of tissue. The type of endometriosis plays a role in the symptoms and treatment.

 

The main symptom of the condition is pelvic pain usually during menstruation. Pain during sexual intercourse, digestive issues, or pain during bowel movements may also be felt. Other symptoms may include heavy periods, chronic fatigue, diarrhoea, constipation, bloating, and nausea.

Spondyloarthritis

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Spondyloarthritis

Spondyloarthritis is a condition characterized by inflammation of the intervertebral joints of the spinal column. What sets it apart from other types of arthritic inflammation is that spondyloarthritis affects the areas where bones and ligaments connect.

 

In spondyloarthritis the facet joints rub painfully against each other between the individual vertebrae of the spinal column. Wear and tear in advanced age or overuse lead to the loss of the cartilaginous layer between the facet joints. Spondyloarthritis is also known as facet joint osteoarthritis or spinal osteoarthritis.

 

Those affected suffer from chronic back pain, especially after standing up or moving, i.e. whenever they load the spinal column.

 

The typical symptoms of spondyloarthritis depend on the strain on the back. About 15-20% of all patients with back pain have issues with facet joints. The first pain typically occurs in the morning immediately after getting up. This is because after a night’s rest, the spinal column sinks slightly under the weight of the body which needs to be moved and the painful and worn cartilaginous surfaces of the facet joints slide against each other. The lumbar spine area is most commonly affected. If spondyloarthritis is in the neck area the patient suffers from neck pain which may radiate to the shoulders, the back of the head, or even the upper back.

Bronchiectasis

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Bronchiectasis

Bronchiectasis disease refers to the infection of bronchiectasis. In turn, bronchiectasis represents permanent enlargements acquired after damage to the muscular elements forming their walls.

 

The enlargement of the bronchi can be caused by congenital anomalies, bacterial infections and others. Common causes of the condition often include stress, social tension or isolation, unfortunate events such as loss of a relative, chronic illnesses, hormonal imbalance.

 

The disease is characterized by chronic cough accompanied by copious sputum often mixed with blood or pus. The condition can progress with alternating periods of exacerbation and remission.

Psoriatic arthritis (PsA)

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Psoriatic arthritis (PsA)

Psoriatic arthritis (PsA) is a condition where the patient suffers from both psoriasis and arthritis. Like other forms of arthritis, PsA causes joint pain, stiffness, and inflammation, which can lead to irreversible joint damage.

 

Depending on the onset of skin psoriasis and arthritis, three courses of PsA are possible:

 

  • Skin lesions appear first, with a varying period before the development of PsA – up to 20 years or more (usually around 10 years). During this period, only symptoms of psoriasis vulgaris are present.
  • Arthritis appears before the skin changes.
  • Rarely they occur simultaneously.

 

PsA is most common among the white race, with a gender distribution of 1:1 except for some subgroups of patients. The disease can debut at any time but most commonly between the ages of 20 and 50, with skin involvement usually preceding joint involvement.

Flu Vaccine

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Flu Vaccine

The primary means of preventing influenza and its associated complications and premature death is seasonal influenza vaccination.

 

Bulgaria is one of the countries in the European Union with a very low immunization coverage – 4 to 5 doses of influenza vaccine per 100 individuals.

 

A direct task of the public health system in Bulgaria is to create an effective organization for conducting routine annual pre-season influenza vaccination primarily targeting high-risk groups of the population. Increased use of influenza vaccines in accordance with the recommendations of the World Health Assembly since 2003 will lead to a reduction in the burden and losses from influenza epidemics – results that not only have significant health importance but also have proven economic effectiveness. Modern influenza vaccines are trivalent and contain one antigenic representative of subtypes A/H3N2/ and A/H1N1/ of influenza viruses of type A and one of the influenza virus type B.

 

Influenza vaccines are recommended for annual immunization of:

  • Individuals who, due to their age or the presence of predisposing conditions, are at increased risk of complications from influenza.
  • Individuals who are at increased risk of influenza infection.
  • Everyone who is in contact with individuals at increased risk of complications from influenza.
  • Individuals of all age groups who wish to protect themselves from the disease.

Hypertension

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Hypertension

Hypertension, also known as high blood pressure, affects many people, and the initial symptoms are often considered to be a result of another problem. These include intense headaches, ringing in the ears, difficulty falling asleep, and restlessness.

 

In hypertensive individuals, the pumping of blood is stronger, creating tension in the arteries and the risk of damaging vital organs. Arterial hypertension occurs when regular measurements reveal a persistent increase in both the lower and upper limits of blood pressure – above 90 mmHg for diastolic and above 140 mmHg for systolic.

 

The causes of hypertension can be other diseases or conditions, but in most cases, they are associated with improper diet, lack of physical activity, stress, and age.

Schizophrenia

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Schizophrenia

The main symptoms of schizophrenia are in the realm of experiences, thoughts, and sensations. Among the early signs that indicate consultation with a specialist are significant changes in behaviour that cannot be explained by specific reasons—such as separation, death of a loved one, or bullying. This should always be a cause for concern. One of the most characteristic experiences is the feeling of loss of free will and a sense of submission to an external force or foreign will. An aspect of this experience is perceiving even one’s own thoughts as something external, dictated by another. Disturbances in perception in the form of auditory and sensory hallucinations are commonly encountered in this condition.

 

Paranoid fears are another important sign of schizophrenia. It is believed that it is not the disease itself that is inherited, but the predisposition to it. Therefore, schizophrenia is not a classical hereditary condition. If one parent suffers from the condition, the likelihood of the child becoming ill is around 15%, but if both parents have this problem, the probability increases to 30%. There are other factors that have not yet been sufficiently identified, and if they are investigated, it will improve prevention in the family or school environment. Specialists define family relationships as a very important factor.

Urticaria

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Urticaria

Also known as nettle fever, urticaria is a skin rash characterized by raised, itchy welts. In more severe cases, angioedema may also occur.

 

There are two forms of urticaria: acute and chronic, which are more common in women. The most common form is acute, which typically resolves within 6 weeks in 95% of patients. Symptoms of chronic urticaria persist for a longer duration.

 

Triggers for urticaria can vary widely and include: foods, medications, infections, underlying medical conditions, low air temperature, hot water, sun exposure, and others.

Depression

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Depression

Depression is a common disorder characterized by a wide range of emotional, cognitive and physical symptoms. These symptoms affect everyday life. People with depression have little control over their mood and emotions and feel consistently down. As a result, they may struggle to maintain their job, continue their education, and/or sustain their family and social relationships.

 

Depression can affect anyone but various social and biological factors can increase a person’s risk of developing the disorder. Additionally, stressful experiences such as illness, unemployment, or significant loss can trigger the onset of the condition in some individuals.

 

Depression may occur once in a lifetime but it is typically an episodic disorder. During these episodes symptoms occur for most of the day, nearly every day and may include:

 

  • Feelings of sadness, crying spells;
  • Outbursts of anger, irritability or a generally bad mood most of the time;
  • Difficulty falling asleep or excessive sleeping;
  • Significant change in appetite, often with weight gain or loss;
  • Fatigue and lack of energy;
  • Feelings of worthlessness, self-blame and guilt;
  • Difficulty concentrating on everyday activities;
  • Slowed or restless movements;
  • Unexplained physical problems such as back pain or headaches;
  • Withdrawal from usual activities and social interactions;
  • Feelings of hopelessness or emptiness;
  • Frequent or recurring thoughts of death, suicidal thoughts, suicide attempts;
  • Loss of pleasure in activities that usually bring happiness – sports, hobbies, including sexual activity.

Allergic Rhinitis

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Allergic Rhinitis

Allergic rhinitis is a condition in which the nasal mucosa becomes inflamed as a result of exposure to an allergen such as pollen from specific plants, animal dander, etc. It can manifest seasonally or year-round, depending on the cause and occurs in both adults and children. It usually develops around the age of 10-20 years, and as a person gets older the allergy tends to weaken but it does not completely disappear.

 

The condition is characterized by the following symptoms: swelling of the nasal mucosa; itching, tickling, burning in the nose; prolonged sneezing; abundant nasal discharge; loss of smell; nosebleeds.

Without timely and thorough treatment, the condition leads to the development of severe complications affecting internal organs. Impaired normal nasal breathing leads to the development of bronchial asthma and heart disorders. Additionally, nasal polyps may form further narrowing their lumens. The risk of chronic sinusitis and otitis media also significantly increases.

COPD

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COPD

Chronic Obstructive Pulmonary Disease (COPD) is among the lung diseases characterized by partial or complete restriction of airflow. It results from inflammation of the lung tissue due to inhaling gases and particles from the air.

 

It can manifest as chronic bronchitis or as pulmonary emphysema. A primary risk factor for the disease is smoking. Those affected are mainly men around the age of 50 who are smokers.

 

Symptoms typical of COPD include coughing, breathlessness, chest tightness, and phlegm production, among others. Periods of exacerbation may alternate with symptom-free periods.

Alzheimer's disease with psychosis

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Alzheimer's disease with psychosis

Alzheimer’s disease with psychosis is a condition characterized by memory loss and cognitive impairment. As the frequency of Alzheimer’s disease continues to rise, efforts in medical science to discover the cause of the disorder are increasing as well.

 

The disease is known as a complex “multifactorial” disorder. This means that while scientists are not sure exactly how Alzheimer’s disease begins, they believe it is caused by environmental circumstances combined with genetic factors.

 

Everyone experiences episodes of forgetfulness from time to time. But people with Alzheimer’s disease display certain persistent behaviours and symptoms that worsen over time. These may include: memory loss affecting daily activities, such as keeping appointments; problems with familiar tasks, such as using a microwave; difficulty solving problems; speech or writing problems; disorientation in time or place; decreased judgment; decreased personal hygiene; mood and personality changes; withdrawal from friends, family, and community. Symptoms vary depending on the stage of the disease.

Atrial Fibrillation

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Atrial Fibrillation

In atrial fibrillation the passage of electrical signals through the heart is disrupted and is leading to a rapid and chaotic heart rhythm in the upper part of the heart (atria). As a result, the atria cannot contract effectively and pump blood well to the lower part of the heart (ventricles) so blood is not fully pumped out and is retained in the heart. This often leads to the formation of clots which can enter the bloodstream, reach the brain and cause a stroke.

 

The condition usually progresses without symptoms which is why it often goes undetected or is only discovered in the emergency department after a stroke when it is already too late.

 

A significant risk factor for atrial fibrillation is high blood pressure (hypertension). About 70% of all patients with Afib also suffer from hypertension which only underscores the benefit of screening for atrial fibrillation when measuring blood pressure. Other risk factors for atrial fibrillation include diabetes, coronary artery disease, and obesity.

Anxiety

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Anxiety

Anxiety is a normal reaction that occurs in response to stress. Sometimes, however, people experience reactions of fear and anxiety that are triggered without any threats or they may perceive the threat as more dangerous than it actually is. For people struggling with anxiety, their fear and worry interfere with their ability to function and compromise their ability to enjoy life. Fortunately, there is plenty of support and numerous treatment options available for managing anxiety.

 

Anxiety can manifest in various forms, such as generalized anxiety, panic attacks, obsessive-compulsive disorder, phobias and others.

Ulcerative colitis

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Ulcerative colitis

Ulcerative colitis can affect different segments of the gastrointestinal tract. Because symptoms and complications in patients with this condition can vary depending on the type and severity of the disease manifestation, it is important for these patients to know the type of ulcerative colitis they have been diagnosed with and how it will affect them.

 

The disease usually begins with abdominal pain and swelling, followed by spasms and bleeding. Diarrhoea is particularly characteristic, occurring up to 40 times a day in its acute phase and often accompanied by bloody and mucous discharge. The affected person experiences constant urge for defecation.

 

In addition to being very distressing, this causes the body to lose fluids, vitamins and minerals. This results in deficiencies of nutrients, especially proteins, calcium, iron, folic acid, vitamin D, and B12.
Deficiencies provoke additional symptoms: weight loss, anaemia, susceptibility to infections, exhaustion. Less commonly eye irritation, joint pain and rashes on the body may occur. In severe cases, paralysis of the colon may occur.

Asthma

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Asthma

Asthma is a long-term condition that causes inflammation of the airways. The inflammation and swelling of the airway wall lead to narrowing of their lumen.

 

Because of this inflammation, the muscles around the airways become more sensitive to various irritants. This can cause their contraction and also lead to narrowing of the bronchial tubes’ lumen, making breathing difficult. The smaller the diameter of the airways, the harder it is to breathe. More mucus may also be produced, which further obstructs breathing by accumulating in the bronchial tubes’ lumen.

 

The condition is characterized by recurrent episodes of wheezing, shortness of breath, chest tightness, and coughing, triggered by nonspecific irritants (toxic gases such as sulphur dioxide, nitrogen dioxide, ozone, dust, cold air and odours).

 

The severity of asthma attacks varies from mild to life-threatening. The characteristic feature of asthma is that the attacks are periodic.

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How to take part?

Taking the decision to take part in given clinical trial is fully personal decision. There is no need or pressure to participate. Given the voluntary nature of this process it is not needed for the individual decision to be enrolled in clinical trial to be shared with third party including your GP. Despite this, everyone who is willing to take part can make his decision and discuss with their family at his own time. The team at Medical Center Hera will provide extensive and detailed information regarding all rights and responsibilities of the parties which are involved in any given clinical trial. All of that information is vital in making the final decision by the participant. In any event, if you’re willing to take part in future clinical trials, our team will be in a position to offer the most suitable research based on your profile as a candidate. For any additional questions with regards to clinical trials which are conducted at our center and if you’re willing to take part in any of them you can always contact us today.

Свържете се с нас

Learn more about your rights and responsibilities as a participant in clinical research, clickHERE

Partnerships

Since 2023, MC Hera is part of the first Bulgarian Prime Site of IQVIA – leading global company which provides advanced analytical methods, technological solutions and clinical investigator services in the sector of medical and biological sciences. IQVIA employs more 87,000 people worldwide and is operating in more than 100 countries. The Bulgarian Prime Site is the 19th Prime Site in Europe.

FAQs

Clinical trials are extremely complicated processes needed for developing of drugs and therapies all patients take for granted. Careful research and testing of each medicine is a difficult, time-consuming, and very expensive process. Years of hard work are needed, alongside collaboration between health authorities, regulatory entities, laboratories, clinics, and patients willing to participate.

There are several phases of the clinical trials. Every new medicine or a process needs to pass all of them. After the early steps of the process, the important phases focus on monitoring and analysis of the investigated medicine for a specific condition.
As a result of the painstaking process, only about 0,1% of all drugs are tested on people. Merely 10% reach the market eventually. The incredibly high costs are mainly generated by the clinical trials. The investment required is often too high to be covered by expected profit from selling the drug. The lack of financial perspective and the potential loss for the investors combined with the complexity of clinical trials are the reason for low productivity. This results in the absence of much needed and often vital new medicines and therapies. We must act now to change that.

Clinical trials are needed because the results generated from these processes help for a more effective and timely treatment for all of us.
This is a summary of the goals of every clinical trial: Diagnostics and monitoring of an illness’ development; Prevention and reduction of the number of patients diagnosed with a certain condition; Increase of the number of recovered patients; Increase of the quality of life of patients suffering from chronic diseases and reduction of the symptoms and side effects of their conditions; Determining the most appropriate medicines for the treatment of any given condition.

Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.
Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations. Doctors, other health care providers, and other individuals can also sponsor clinical research.

Each trial needs participants who meet certain requirements, like having a certain disease or medical condition. These requirements are called inclusion criteria. Other inclusion criteria include age, sex, body type, and current treatment plan.
Some trials might have rules that prevent a person from being in a trial. These rules are in place to protect people whose conditions might get worse if they were in the trial. These rules are called exclusion criteria.
Inclusion and exclusion criteria are in place to make sure the researchers get the most accurate results. They also help make trials as safe as possible.
Not all clinical trials test a new treatment or vaccine. “Observational” studies collect information about people’s health during their normal care. This helps researchers learn more about specific health issues.

All clinical trials have guidelines spelling out who can participate. These are called eligibility criteria. The factors that allow you to participate in a clinical trial can include age, gender, the type and stage of your disease, previous treatment history, and other medical conditions.
Following eligibility criteria helps us keep you safe and ensures that researchers learn the information they need.

All participants in a clinical trial are not obliged to inform anyone about their participation. Their decision cannot be involuntary. The participants have the right to receive all the details related to changes in the process, the risks, the benefits, and the range of the trial.
All clinical trials are conducted in compliance with the EU 2016/679 Regulation (GDPR). The personal data collected is confidential and in case a participant doubts the process, they should contact the relevant authority immediately.

Yes. Being in a trial is optional. You can stop being in a trial at any time and for any reason. The trial staff will help you do this safely.

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