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.

Bronchiectasis

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Bronchiectasis

Bronchiectasis refers to the infection of bronchiectases, which are permanent dilations resulting from damage to the muscular elements that form the walls of the bronchi. The widening of the bronchi can be caused by congenital anomalies, bacterial infections, and other factors. Common causes of the condition include stress, social tension or isolation, unfortunate events such as the loss of a relative, long-term illnesses, and hormonal imbalances.

The disease is characterized by symptoms such as chronic cough, accompanied by abundant sputum, often mixed with blood or pus. The illness may present with alternating periods of exacerbation and remission.

Hypertriglyceridemia

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Hypertriglyceridemia

Hypertriglyceridemia is diagnosed when plasma triglyceride levels are elevated above 2.0 mmol/L. Triglycerides can be exogenous—obtained through food—or endogenous, synthesized in the liver and transported in the blood as VLDL.

When triglyceride levels are high, there is a risk of atherosclerosis and cardiovascular diseases. Critically high levels increase the risk of acute pancreatitis. Elevated triglycerides can lead to clinical manifestations such as pain in the back, chest, or abdomen, nausea, shortness of breath, and dermatological symptoms like xanthomas.

The causes of hypertriglyceridemia are varied: hereditary conditions, obesity, hypothyroidism, pregnancy, diabetes mellitus, certain medications, and more.

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.

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

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.

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.

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.

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.

Contact us

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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Need further information?

If you need any further information with regards to future clinical trials or for any current ones that you cannot find the information needed, please do not hesitate to contact us straight away. contact with us today