The magic formulas of MD Ana Aslan to prevent aging

Gerovital H3, a romanian brand was marketed after the succes of clinical studies on olderly population.

In 1951, MD Ana Aslan had formulated a procaine product she called Gerovital H3 (GH3) after first studying it as a local anestethic in the National Institute of Gerontology and Geriatrics in Romania.  She initiated a clinical study on a group of 25 patients that received procaine 2%. She was the first gerontologist to study the effects of procaine as an anti-aging tool.

Procaine is an ester composed of PABA (para-amino benzoic acid) and DEAE (diethyl amino ethanol). Both of these are water soluble B vitamins. PABA stimulates the production of folic acid and vitamins K and B1. It has its greatest beneficial effects in the hair, glands and intestines. DEAE is a precursor to choline and acetylcholine. These factors are well known for their importance in nerve function.

Another product containing procaine, Aslavital was formulated later,  in 1970. Aslavital contains additional antioxidants as well as the GH3 ingredients. It is considered to be more potent than GH3 and to be used in addition to GH3 for chronic situations. It is acceptable to take a combination of GH3 and Aslavital.

The beneficial effects of Gerovital have been scientifically recognized. However, some studies have failed to replicate the anti-aging effects. In 1957 GH3 was approved by the romanian Ministry of Health, followind clinical investigations involving 7600 patients but is currently banned in the U.S. by the FDA as an “unapproved new drug”.

Please read the full material here: www.longevity-formulas.com

 

 

Administration of Aspirin in Preeclampsia

Administration of Aspirin in Preeclampsia

 

Decreased incidence of preterm preeclampsia was asscociated with admistration of low doses of aspirin.

Preeclampsia represents one of the most frequent causes of maternal and perinatal morbidity and mortality and the interventions to reduce the prevalence of this desease represent a major challenge in modern obstetrics.

The efficacy of low-dose aspirin administration during pregnancy in prevention of preeclampsia was shown by the researchers from King’s College Hospital, London, England after a double blind clinical trial.

The clinical trial was performed on 1620 pregnant women with high risk of preterm preeclampsia who received a dose 150 mg aspirin per day or placebo from 11 to 14 weeks of pregnancy until 36 weeks of pregnancy. Preterm preeclampsia appeared at 1.6% of participants treated with aspirin, as compared with participants treated with placebo (4.3 %).

For more information, please access the full text article.

 

New Medical Device Regulations!

Challenges for Medical Device manufacturers as the European Medical Device Regulations (MDR 2017/745) will enter into force

Substantial changes were included in the new “REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON MEDICAL DEVICES, AMENDING DIRECTIVE 2001/83/EC, REGULATION (EC) No 178/2002 AND REGULATION (EC) No 1223/2009 AND REPEALING COUNCIL DIRECTIVES 90/385/EEC AND 93/42/EEC” published in May 2017 (MDR 2017/745)

The Regulations will enter into force in 26 May 2020 bringing key changes related to the aspects of market surveillance, device identification and traceability, Conformity Assessment, Clinical Evaluation, and Safety.

Medical device manufacturers will be challenged to prove the clinical safety or performance for their medical devices placed on market in a more rigorous way. Requirements for clinical data and clinical investigation will be replacing the equivalence.

Mandatory Unique Device Identification (UDI) will be introduced with the intention to facilitate the traceability of devices.

Also, manufacturers will be required to report a serious incident (or Field Safety Corrective Action (FSCA)) to the relevant using EUDAMED within 15 days, in case of death or unanticipated serious health deterioration the maximum is 10 days. In case of a serious public health threat this timeframe is limited to two days.

New Treatment for Chronic Hepatitis C

Maviret and Vosevi, two new drugs for the treatment of chronic hepatitis C virus (HCV) infection in adults, have been approved by the European Medicines Agency.

HCV infection represents the most common single cause of liver transplantation in the EU and it affects between 0.4% and 3.5% of the population. In Europe, approximately 15 million people are chronically infected with HCV.

Maviret and Vosevi are effective against all genotypes of the virus. They have the role to block the action of proteins essential for HCV replication reaching a high degree of recovery without the need for interferon administration which are known for their serious side effects and poor tolerability.

Maviret is composed of two antiviral agents: glecaprevir (inhibitor of HCV NS3/4A protease) and pibrentasvir (inhibitor of HCV NS5A) and its effect were studied on 2,376 patients. Twelve weeks after the end of treatment, the HCV could not be detected in over 90% of patients.

The second drug, Vosevi, contains three active ingredients: sofosbuvir (nucleotide analogue non-structural protein NS5B polymerase inhibitor), velpatasvir (inhibitor of HCV NS5A) and voxilaprevir (HCV NS3/4A protease inhibitor). Its effects were studied on over 1,700 patients and twelve weeks after the treatment, over 90% of patients have no HCV.

For more information please access the European Medicine Agency .

 

A clinically proven benefit of extra-virgin olive oil against Alzheimer’s Disease

 

A variety of health benefits are associated with the Mediterranean diet, especially the lower incidence of dementia.

The researchers from the Lewis Katz School of Medicine at Temple University Philadelphia, USA have studied the effects of extra-virgin olive oil consumption. They have shown that the extra-virgin olive oil has the role to reduce the formation of classic markers of Alzheimer’s disease, like neurofibrillary tangles and amyloid-beta plaques and to protect learning ability and memory.

For this study there was used a well-established Alzheimer’s mouse model. The mice were divided in two groups, one group fed with diet enriched with extra-virgin olive oil and the other group fed with diet without olive oil. A significant increase in steady state levels of synaptophysin, a marker of synaptic integrity and some remission of behavioral deficits have been shown at the mice that received the extra-virgin olive oil diet.

More information can be found on Alzheimer’s News Today website.

Clinical Trials Day!

Respect for Persons. Beneficience. Justice.

Major innovations improve quality of lives or even save lives.

Claude Bernard (1813 – 1878) called “one of the greatest of all men of science” was one of the first to suggest the use of  blind experiments to ensure the objectivity of scientific observations.

He also bought into attention the need of respecting ethical principles in conducting clinical studies on human saying that one should not injure one person regardless of the benefits that might come to others.

Nowadays, researchers are spread around the world targetting the improvement of medical care, searching better ways to prevent or to treat diseases.

The medical community is supporting and contributing to medical research with respect for the rights, safety and well-being of the patient.

More details can be found on the official event website.

We strongly recommend Immunization!

What is Immunization?

Immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. The vaccines contain a small amount of weakened or killed virrus or bacteria or bits of lab-made protein that imitate the virus. There are two types of immunization, active immunization that can occur naturally when a person comes in contact with a microbe and passive immunization, where pre-synthesized elements of the immune system are transferred to a person so that the body does not need to produce these elements itself.

History of Vaccines

Until the 1880s vaccination referred only to smallpox, but Louis Pasteur developed immunization methods for chicken cholera and anthrax in animals and for human rabies. In 1923, Alexander Glenny perfected a method to inactivate tetanus toxin with formaldehyde. The same method was used to develop a vaccine against diphtheria in 1926.

Importance of Immunization

The professional health organizations recommend  immunization due to the fact that the vaccines protect us and the people around us and they represent the best way to  prevent infectious disease.

World Health Organization estimated that vaccination prevents 2 to 3 million deaths each year. Certain disease have already been eradicated by rigorous vaccination campaigns, while other are hoped to be eliminated soon. The diseases that have been wiped out by vaccines are: polyomielitis, Haemophilus influenzae type b, whooping cough, measles, tuberculosis, smallpox, rabies and tetanus-diphtheria.

According to World Health Organization there are 25 diseases for which vaccines are available: anthrax, measles, rubella, cholera, meningococcal disease, influenza, diphtheria, mumps, tetanus, hepatitis A, pertussis, tuberculosis, hepatitis B, pneumoccocal disease, typhoid fever, hepatitis E, poliomyelitis, tick-borne encephalitis, Haemophilus influenzae type b, rabies, varicella and herpes zoster (shingles), human papilloma-virus, rotavirus gastroenteritis, yellow fever, japanese encephalitis, malaria, dengue fever.

 

Keep yourself safe and strong!

 

A clinical trial in two months!

CeasLiving in times in which we are surrounded by technology, there is no novelty that all things unfold with breakneck speed, so our team, keeping up with all the clients needs,  has conducted a clinical trial in just 2 months, without compromising any aspect of the study at the expense of speed, managing to satisfy the client needs,  reaching his main goal to present the results of this clinical trial at the VitaFoods Europe 2016.

Therefore we planned with the client the  following study timetable:

 

20 January 2016 Final Budget Proposal
29 January 2016 Study Synopsis and Abstract
09 February 2016 End of Protocol and study documents
09 February 2016 Local Ethical Committee Approval (Timisoara, Romania)
29 February 2016 First Patient Enrolled
10 March 2016 50% Patients Enrolled (29 patients)
19 March 2016 Last Patient Enrolled (49 patients)
28 March 2016 Last Patient Last Visit
31 March 2016 Statistical Analysis
01 April 2016 Poster with final results for VitaFood 2016

As you can notice, in 2 months the protocol was written and approved by the Ethical Committee, 50 patients were enrolled and treated, the statistical analysis and the report finished. And on April 1st we  presented the poster with final results at VitaFoods Europe 2016.

 

Clinical Trials in Central and Eastern Europe

 

Opera Consortium will attend the conference Clinical Trials in Central and Eastern Europe from 25 – 26 April 2017, at Novotel Budapest Centrum.

Last year’s Clinical Trials in CEE Forum hosted more than 130 delegates from following countries:

Belgium • Poland • Slovakia • Slovenia • Croatia • Czech Republic • Germany
Italy • Romania • Ukraine • United Kingdom • Armenia • Bulgaria • Finland
Hungary • Latvia • Lithuania • Netherlands • Russian Federation • Spain
Switzerland • United States

This conference will provide up-to-date information about Clinical Trials in the region, the industry best practice and will create platform for information to be exchanged between Government official, CROs, Investigations & Biotechnological companies and Clinical trials professionals. As well as a carefully researched and in-depth programme, the conferences will bring you the opportunity to network with a diverse mix of participants, through our structured and less-formal networking sessions.

Some of the Speakers 2017:

  • Csilla Pozsgay- Director General National Institute of Pharmacy and Nutrition (Hungary)
  • Francis Crawley- Executive Director Good Clinical Practice Alliance, Europe & EAP, Belgium
  • Divya Chadha- Head of Business Development, CRN
  • Alexander Fetkovsky- Managing Partner, Slovak Republic
  • Marco Salami- Sr Clinical Outsourcing Manager, Chiesi Farmaceutici SpA (Italy)
  • Vladimir Misik- Founder & Managing Partner, LongTaal
  • Rahul Chaudhary- Director Business Development- Histopathology, Synevo Division
  • Jaroslav Rejnek- Clinical Research Director, PENTA Hospitals
  • Michaela Vancova- Clinical Operations Director, Co-Founder, Slovak Research Center
  • Tomasz Miszalski Jamka- MD, PhD, Medical Director, Clinical Trial Center of Innovation
  • Gjon Mirdita- Vice President, Site Management Regional Head, Key Markets R&D Solutions NEMEA & CESE, QuintilesIMS

The Forum’s key questions and takeaways

  • What is the regulatory outlook across the region?
  • What would facilitate and empower an Investigator?
  • How to maximise the Sponsor/CRO/Investigator relationship and cooperation?
  • How to stimulate patient recruitment and ensure patient retention? What are the patient-centric approaches in CT?
  • What are the innovative approaches to trial design?