46 results on '"badania kliniczne"'
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2. NOWE REGULACJE PRAWNE DOTYCZĄCE BADAŃ KLINICZNYCH – WYBRANE ZAGADNIENIA ADMINISTRACYJNOPRAWNE
- Author
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Aleksandra Trębska
- Subjects
zdrowie publiczne ,administracja publiczna ,badania kliniczne ,prawo farmaceutyczne ,Law - Abstract
Kryzys związany z pandemią COVID-19 uwidocznił nieprzygotowanie UE w dziedzinie zdrowia publicznego, w tym dostępu do nowych terapii, ale zobrazował też możliwości oraz pole do dalszych działań. Celem tego opracowania jest przedstawienie nowych inicjatyw oraz uwarunkowań prawnych w kwestii badań klinicznych nowych produktów leczniczych z punktu widzenia szans i zagrożeń dla zdrowia publicznego. W ramach analizy omówiono wybrane zagadnienia dotyczące unijnego rozporządzenia 536/2014 oraz ustawy o badaniach klinicznych. Ponadto poruszono bieżące inicjatywy UE w zakresie zdrowia publicznego oraz nowej strategii farmaceutycznej dla Europy w kontekście problematyki zdrowotnego bezpieczeństwa obywateli.
- Published
- 2024
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- View/download PDF
3. Prevalence of alcohol abuse in patients with rheumatic diseases participating in a clinical trial.
- Author
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Mojs, Ewa, Jeka, Marta, Waszczak-Jeka, Marzena, Stelcer, Bogusław, Trzeszczynska, Natalia, Sikorska, Dorota, and Samborski, Włodzimierz
- Subjects
- *
ALCOHOLISM , *RHEUMATISM , *ALCOHOL drinking - Abstract
Introduction: Phenomena such as a pandemic can cause many medical, psychological, and sociological problems, including increased alcohol use, which was noticed among healthy people and patients with long-term diseases. The aim of the study was to evaluate alcohol consumption in adult patients with rheumatic diseases, who completed participation in a phase 3 clinical trial for biologic drugs or treatment under a drug program, and consented to participate in the study. Material and methods: 128 patients between the ages of 18 and 77 years (M = 46.88, SD = 13.80) with disease duration of 1-46 years (M = 12.30, SD = 8.53) participated in the study. In the research group, more than half (57.8%) were women, most of the subjects (60.2%) were economically active, 74.2% of the subjects are not addicted to tobacco, 61.7% of the subjects were in a relationship, 52.3% of the patients were participating in a drug program at the time of the study, and 23.4% of the subjects had completed participation in clinical trials. The Baltimore questionnaire and AUDIT-4 were used in the study. Results: Regarding the norms set by the authors of the Baltimore test, it was recognised that 24 people (18.8%) had an alcohol problem, medium risk of disease applied to 6 people (4.7%), low risk of disease applied to 12 people (9.4%), and no alcohol problem applied to 86 people (67.2%). Conclusions: Alcohol drinking is a serious problem among patients treated in drug programs and clinical trials. Smoking is significantly associated with alcohol abuse and drinking patterns. It is necessary to control with alcohol drinking questionnaires during treatment with expensive drugs, to identify alcohol abuse or risky drinking patterns as a factor that may reduce compliance. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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- View/download PDF
4. PROBIOTYKI - ZALETY I OGRANICZENIA.
- Author
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JAGACKA, ANNA
- Abstract
The paper addresses the definition, benefits, and limitations of probiotics. As living organisms, probiotics provide various health benefits primarily through the regulation of gut microbiota and immune response. Furthermore, a variety of probiotic strains, such as Lactobacillus, Bifidobacterium, Saccharomyces, are discussed in view of their specific properties and clinical applications. The authors also highlight the significance of adverse effects, including systemic infections and metabolic issues, as well as potential risks, such as antibiotic resistance gene transfer. Additionally, the paper emphasizes the need for further research regarding the safety and efficacy of probiotics, and for the development of appropriate clinical guidelines. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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5. Od mutacji do leku.
- Author
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Wnuk, Jan and Wilanowski, Tomasz
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DRUG design ,BRAF genes ,MELANOMA ,VEMURAFENIB ,SKIN cancer - Abstract
Copyright of Advances in Biochemistry / Postepy Biochemii is the property of Polish Biochemical Society / Acta Biochimica Polonica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2023
- Full Text
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6. Likopen – wpływ suplementacji na proces starzenia się skóry.
- Author
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Wawrzyniak, Dariusz, Rolle, Katarzyna, and Barciszewski, Jan
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LYCOPENE ,SUNSHINE ,SKIN aging ,REACTIVE oxygen species ,FREE radicals ,HUMAN body - Abstract
Copyright of Advances in Biochemistry / Postepy Biochemii is the property of Polish Biochemical Society / Acta Biochimica Polonica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2023
- Full Text
- View/download PDF
7. The latest scientific reports in the field of invasive cardiology: Transcatheter Cardiovascular Therapeutics (TCT) Congress, Orlando, November 4–6, 2021.
- Author
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Bujak, Adrian, Figiel, Łukasz, and Kasprzak, Jarosław D.
- Abstract
Copyright of Folia Cardiologica is the property of VM Medica-VM Group (Via Medica) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2022
- Full Text
- View/download PDF
8. UMOWY O PRZEPROWADZANIE BADAŃ KLINICZNYCH PRODUKTÓW LECZNICZYCH I WYROBÓW MEDYCZNYCH
- Author
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Roksana Turchan
- Subjects
badania kliniczne ,produkty lecznicze ,wyroby medyczne ,umowy dotyczące badań klinicznych ,prawo medyczne. ,Law - Abstract
Artykuł omawia problematykę związaną z umowami o przeprowadzanie badań klinicznych produktów leczniczych i wyrobów medycznych. Autor przedstawia w nim najważniejsze aspekty dotyczące umów o przeprowadzanie badań klinicznych produktów leczniczych i wyrobów medycznych, między innymi określa akty prawne, które regulują kwestie z nimi związane, charakteryzuje ich przedmiot oraz strony, określa formę, w jakiej powinny być zawierane, wskazuje na najważniejsze elementy ich treści, a także stara się dokonać ich klasyfikacji według kryteriów przyjętych w prawie cywilnym. Ze względu na doniosłą rolę, jaką pełnią umowy o przeprowadzanie badań klinicznych produktów leczniczych i wyrobów medycznych, wobec nieprecyzyjnej regulacji prawnej autor stara się zapoznać czytelnika z ich specyfiką. Prawidłowo sporządzona umowa pozwala bowiem zwiększyć bezpieczeństwo uczestników badań klinicznych, a także osób stosujących produkty lecznicze czy wyroby medyczne po dopuszczeniu ich do obrotu.
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- 2022
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9. Stosowanie leku adukanumab przynosi klinicznie istotną korzyść związaną z obniżeniem poziomu amyloidu.
- Author
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Cummings, Jeffrey, Aisen, Paul, Lemere, Cynthia, Atri, Alireza, Sabbagh, Marwan, and Salloway, Stephen
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- 2021
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10. Nowe strategie terapeutyczne choroby Alzheimera.
- Author
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Nowak, Dominika, Słupski, Wojciech, and Rutkowska, Maria
- Abstract
Summary: Alzheimer's disease (AD) described as a chronic and irreversible neurodegenerative disease remains the most common cause of dementia. Due to the aging of the population, the incurability of AD has become a growing problem of medicine in the 21st century. Current treatment is only symptomatic, providing minimal, temporary improvement in the patient's cognitive function. This paper presents the latest trends in the search for effective pharmacotherapy capable of preventing or inhibiting AD progression. Since the exact pathogenesis of Alzheimer's disease is not known, the main therapeutic strategies are based only on the following hypotheses: amyloid cascade, tau protein, oxidative stress, neuroinflammation and those associated with dysfunction of the cholinergic system as well as glutamatergic. Most of the compounds currently tested in clinical trials are targeted at pathological amyloid β (A β), which is considered the cause of neurodegeneration, according to the most widely described cascade theory. Most of the compounds currently tested in clinical trials are targeted at pathological amyloid β (Aβ), which is the main cause of neurodegeneration according to the widely described theory of the amyloid cascade. Attempts to fight the toxic Aβ are based on the following: immunotherapy (vaccines, monoclonal antibodies), compounds that inhibit its formation: γ-secretase inhibitors/modulators and β-secretase. Immunotherapy can also be used to increase the clearance of hyperphosphorylated tau protein, the occurrence of which is another feature of Alzheimer's disease. In addition to immunotherapy, anti-inflammatory, metabolic and neuroprotective compounds have been the subject of a number of studies. A range of symptomatic compounds that improve cognitive functions by compensating cholinergic, noradrenergic and glutamatergic signaling deficits have also been investigated in clinical trials. [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
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11. Wpływ suplementacji diety selenem na przebieg autoimmunologicznego zapalenia tarczycy – przegląd badań klinicznych przeprowadzonych w populacji europejskiej.
- Author
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Kryczyk-Kozioł, Jadwiga, Zagrodzki, Paweł, and Paśko, Paweł
- Abstract
Many observations indicate the existence of a relationship between reduced selenium status in the body and various thyroid diseases, including autoimmune thyroiditis. In most studies devoted to this issue, change in concentration of anti-TPO antibodies was the main measure of the effectiveness of selenium supplementation in patients with autoimmune thyroiditis. The concentration of anti-TPO has an impact on the intensity of lymphocytic infiltration in the thyroid gland and the degree of damage to this gland; therefore, reducing their concentration as a result of increased selenium consumption may contribute to more effective treatment of autoimmune thyroiditis. In some works, the evaluation of immunoregulatory effect of selenium in the course of autoimmune thyroiditis was considered in relation to a wider range of biochemical and immunological parameters (mainly changes in the production of cytokines and chemokines). Many authors have confirmed the effect of selenium on reducing the concentration of anti-TPO, but pooled results of all the studies are ambiguous. The discrepancy may have been caused by a different degree of saturation of the thyroid with selenium and iodine in patients, a different severity of the disease, different doses of selenium administered to patients, the use or non-use of simultaneous therapy with L-thyroxine, and single nucleotide polymorphisms (SNPs) occurring in genes encoding particular selenoproteins. Based on literature, it can be concluded that the issue concerning the role of selenium in autoimmune thyroiditis is still poorly understood. There is a need to continue research evaluating the effect of selenium on the course of this disease, which should include also other parameters apart from anti-TPO. The results of such extensive research may be helpful in formulating new guidelines for supporting treatment by appropriate modification of diet, including selenium supplementation. [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
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12. MOŻLIWOŚCI WYKORZYSTANIA MIODU W TERAPII COVID-19 - POTENCJALNE MECHANIZMY DZIAŁANIA I PRZEGLĄD BADAŃ KLINICZNYCH.
- Author
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GRABEK-LEJKO, DOROTA and DŻUGAN, MAŁGORZATA
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EMERGING infectious diseases ,COVID-19 treatment ,SARS-CoV-2 ,COVID-19 ,NATURAL products ,BUCKWHEAT - Abstract
Copyright of Zywnosc is the property of Polish Society of Food Technologists - Scientific Publishing and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2021
- Full Text
- View/download PDF
13. Polifenole w leczeniu nieswoistych chorób zapalnych jelit.
- Author
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Chojnacka, Katarzyna and Laskowska, Justyna
- Abstract
Copyright of Advances in Biochemistry / Postepy Biochemii is the property of Polish Biochemical Society / Acta Biochimica Polonica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2020
- Full Text
- View/download PDF
14. The impact of research waste on the scientific validity and integrity of clinical trials.
- Author
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Wasylewski, Mateusz
- Subjects
CLINICAL trials ,RESEARCH methodology ,PUBLICATION bias - Abstract
Copyright of EDUKACJA Quarterly is the property of Educational Research Institute and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2019
- Full Text
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15. ETYCZNE PROBLEMY BADAŃ KLINICZNYCH PRODUKTU LECZNICZEGO.
- Author
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ŚLĘCZEK-CZAKON, Danuta
- Abstract
Copyright of Scientific Papers of Silesian University of Technology. Organization & Management / Zeszyty Naukowe Politechniki Slaskiej. Seria Organizacji i Zarzadzanie is the property of Silesian Technical University, Organisation & Management Faculty and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2018
- Full Text
- View/download PDF
16. Fitoterapia zaburzeń laktacji - dowody naukowe i bezpieczeństwo stosowania.
- Author
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Szałabska, Katarzyna, Wojnar, Weronika, and Kaczmarczyk-Sedlak, Ilona
- Abstract
Some women after childbirth are struggling with the problem of producing too little milk and cannot feed the child only on breast milk. Therefore, they need to introduce synthetic milk into newborn's diet or to look for a way to increase their lactation. Breast milk provides the newborn with optimal supply of nutrients, increases its immunology and has a positive effect on its further development. The lack of a synthetic drug which can increase the lactation in nursing women prompts them to turn to the phytotherapy. A large part of medicinal plants aimed at increasing lactation in breastfeeding women is used as traditional medicinal products. There is, however, very few studies involving breast-feeding mothers confirming the lactagogic action of the plant or carried out with newborns confirming that there is no trace of the drug in breast milk or, if there is, it shows an appropriate safety profile for such a small child. The purpose of this review was to check which medicinal plants, commonly considered galactogogues, have clinically proven activities and whether their safety profile has already been tested for both the nursing mother and her child. [ABSTRACT FROM AUTHOR]
- Published
- 2018
17. Clinical trials from the perspective of the sociology of medicine.
- Author
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Tobiasz-Adamczyk, Beata
- Subjects
- *
SOCIAL medicine , *PUBLIC health , *MEDICAL ethics , *CLINICAL trials , *MEDICAL sociologists ,SOCIAL aspects - Abstract
Although clinical trials are rarely of interest to medical sociologists, in the last decades there has been increased focus on the processes of medicalization as well on the social critical approach to these multidimensional phenomena by health sociologists. From the perspective of the sociology of illness, clinical trials could be perceived as a bridge between the 'society of remission' and 'risk society'. Public opinion polls did not give a clear answer regarding the social attitudes and the level of social trust presented by Poles towards clinical trials although patients or healthy volunteers are the main subject of this research. Creating an atmosphere of social trust (using the role of mass-media) towards clinical trials (through social awareness, methods of investigation and using the results in everyday medical practice) gives a chance to create a new 'quality of relations' between scientific teams responsible for clinical trials and society. [ABSTRACT FROM AUTHOR]
- Published
- 2018
- Full Text
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18. Zaburzenia przedsionkowe w cukrzycy.
- Author
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NAROŻNY, WALDEMAR
- Abstract
Diabetes is a metabolic disease characterised by hyperglicemia (increased glucose levels in blood) which occurs as a result of production or activity defect of beta cells in pancreas. Longlasting diabetes leads to serious complications which affect many organs, mainly organs of vision (microvasculature of the retina, cataract, blindness), kidneys (nephropathy), autonomic nervous system (polyneuropathy, neuropathy). Among organs less often affected by diabetic complications is inner ear (hearing loss, vestibular disorders). The author analysed the available literature on research on the impact of diabetes on the balance system carried out based on the animal model, human temporal bone and human studies. Results of clinical research devoted to this issue presented in 11 publications dated between 1990 and 2017 were part of the conducted analysis. Analyzed results of experimental and clinical research of the vestibular system indicate that both among animals and humans with diabetes there occurs a defect of peripheral and central part of the vestibular system. Within maculae of the saccule a degeneration of type I hair cells, lower density of type I hair cells, overproduction of extracellular matrix, dislodgement of otoconia fragments from maculae of the utricle and saccule surface to the posterior and lateral semicircular canals has been noted. Within the vestibular nerve a significant damage or thinning of the myelin sheath and smaller axonal fiber diameters have been noted. Clinical research confirmed presence of vestibular disorders in patients with diabetes. Their extensity and frequency was dependent on the duration of the illness, accompanying diseases and type of diabetes. [ABSTRACT FROM AUTHOR]
- Published
- 2017
19. Fingolimod w leczeniu stwardnienia rozsianego
- Author
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Marek Juszczak, Paweł Gierach, and Andrzej Głąbiński
- Subjects
fingolimod ,stwardnienie rozsiane ,leczenie doustne ,immunomodulacja ,badania kliniczne ,Medicine - Abstract
W chwili obecnej leczenie immunomodulujące stwardnienia rozsianego (łac. sclerosis multiplex, SM) polega na podawaniu leków w postaci iniekcji podskórnych, domięśniowych bądź dożylnych. Powoduje to liczne niedogodności dla pacjentów, wobec czego istnieje zapotrzebowanie na wprowadzenie leku doustnego o skuteczności przewyższającej skuteczność leków obecnie stosowanych. Pierwszym tego typu lekiem jest fingolimod (FTY720). Lek ten dobrze wchłania się z przewodu pokarmowego, a maksymalne stężenie we krwi osiąga po 12-16 godzinach od podania. Mechanizm działania fingolimodu polega na powodowaniu sekwestracji dojrzałych limfocytów w węzłach chłonnych i kępkach Peyera, co zmniejsza ich liczbę we krwi oraz w naciekach limfocytarnych. FTY720 nie upośledza funkcji limfocytów, a zwłaszcza aktywacji limfocytów T. Uważa się, że fingolimod może hamować migrację limfocytów na drodze dwóch niezależnych mechanizmów: pierwszy to zmniejszanie liczby receptorów S1P1 na limfocytach T i osłabienie sygnału do ich migracji, drugi to stałe pobudzanie tych receptorów obecnych na śródbłonku zatok w węzłach chłonnych do wzmacniania bariery ograniczającej migrację limfocytów. Zachęcające wyniki badań klinicznych II fazy umożliwiły zaprojektowanie dwóch dużych badań III fazy, które otworzyły fingolimodowi drogę do rejestracji: FREEDOMS (FTY720 Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis) i TRANSFORMS (Trial Assessing Injectable Interferon versus FTY720 Oral in Relapsing-Remitting Multiple Sclerosis). W zakresie wszystkich klinicznych i rezonansowych punktów końcowych w badaniu FREEDOMS udowodniono przewagę fingolimodu nad placebo. Badanie TRANSFORMS pozwoliło udowodnić, że fingolimod zmniejsza aktywność SM skuteczniej niż interferon β-1a. Dane te potwierdzają, że fingolimod jest obiecują- cym nowym lekiem w terapii SM.
- Published
- 2010
20. Farmakologiczne możliwości leczenia rogowacenia słonecznego.
- Author
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Zwierzyńska, Ewa, Zawistowska, Anna, and Pietrzak, Bogusława
- Abstract
Actinic keratosis (AK) is a disease characterized by hyperkeratotic lesions on skin damaged by ultraviolet. radiation. These lesions may progress to squamous cell or basal cell carcinoma. Currently pharmacotherapy and different surgical procedures are used in AK therapy. The most common treatment options are 5-fluorouracil, imiquimod, diclofenac, ingenol mebutate, and first and third generation retinoids (retinol, adapalene, tazarotene). Furthermore, research is being carried out in order to test new medications including nicotinamide, resiquimod, piroxicam, potassium dobesilate and oleogel based on a triterpene extract (betulin, betulinic acid). Recently, the preventive effect of acetylsalicylic acid and celecoxib has also been investigated. [ABSTRACT FROM AUTHOR]
- Published
- 2016
- Full Text
- View/download PDF
21. Clinical research challenges in the era of cardiovascular medical devices.
- Author
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Borowiec, Jan W.
- Subjects
- *
MEDICAL equipment , *PATIENTS , *CARDIOVASCULAR diseases , *EQUIPMENT & supplies - Abstract
New therapeutic alternatives, such as innovative medical devices, are frequently the only treatment options left for patients when other efficient medical modalities are lacking or insufficient. Development of novel devices, which are safe and effective, requires understanding of complex premarket and postmarket provisions, including characteristics of clinical trials. Speeding up patient access to new technologies may imply the need to make choices in terms of extent and robustness of clinical evaluation without losing the patient safety perspective. In such situations, some challenges can readily arise due to existing methodological solutions and aspects of current legislation in the field. In this context, some challenges, occurring at various stages of the device lifecycle, will be presented in order to observe the changes and hopefully to contribute to better knowledge and improvements in the area. [ABSTRACT FROM AUTHOR]
- Published
- 2016
- Full Text
- View/download PDF
22. Leki wpływające na układ inkretynowy i nerkowy transport glukozy: czy spełniają oczekiwania nowoczesnej terapii cukrzycy typu 2?
- Author
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Gumieniczek, Anna
- Abstract
Agents introduced into therapy of type 2 diabetes in the last few years are still the subject of numerous clinical and experimental studies. Although many studies have been completed, we still do not know all aspects of these drugs' action, especially the long-term effects of their use. Most questionable is their impact on the processes of cell proliferation, on the cardiovascular and immune systems, on lipids and uric acid metabolism. A summary of the most important observations on the use of three groups of new drugs - analogs of glucagon-like peptide 1 (GLP-1), inhibitors of dipeptidyl peptidase IV (DPPIV) and inhibitors of sodium glucose cotransporters (SGLT1 and SGLT2) - has been made, based on a review of the literature over the past five years (2010-2014). The information included in the present review concerns the structure and activity relationship, therapeutic efficacy, side effects and the observed additional therapeutic effects, which can determine new standards in therapy of diabetes and also facilitate the development of better antidiabetic drugs. [ABSTRACT FROM AUTHOR]
- Published
- 2016
- Full Text
- View/download PDF
23. Rak jajnika – od biologii do kliniki.
- Author
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Kujawa, Katarzyna Aleksandra and Lisowska, Katarzyna Marta
- Abstract
Ovarian cancer is the most frequent cause of deaths from among gynecologic malignancies. Due to its asymptomatic development the disease is frequently diagnosed at an advanced, incurable stages. Although ovarian cancers usually respond well to the first line chemotherapy based on platinum compounds and taxanes, majority of patients develop recurrence and chemo-resistance. Despite many years of studies there is still lack of reliable diagnostic markers as well as other diagnostic methods enabling early detection and suitable for screening. Thus, current studies are aimed on finding new biomarkers with diagnostic, prognostic and predictive potential as well as on the search for the new therapeutic targets. Interestingly, an understanding of ovarian cancer etiology has changed fundamentally within recent years. The classical theory, claiming that ovarian cancers originate from ovarian surface epithelial cells, was undermined. Currently, there is a lot of evidence that majority of serous ovarian cancers have its origin in malignant tubal epithelium, while endometrioid and clear cell ovarian cancers develop most likely from endometriosis. These new findings will have an impact on diagnostic approaches as well as on the prevention options for women with genetic predisposition to ovarian cancer. The new knowledge about an origin of different histological types of ovarian cancer may open new pathways in basic research and clinical studies. In this paper we report current knowledge about ovarian cancer risk factors, we also present the arguments for extraovarian origin of the majority of ovarian cancers and stress the mechanisms of action of new drugs for targeted therapies that show most promising results in the current clinical trials. [ABSTRACT FROM AUTHOR]
- Published
- 2015
24. Legal conditions for transferring rights and obligations from the clinical trial agreement
- Author
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Warsewicz, Agnieszka
- Subjects
clinical trials ,cession of the contract ,assignment of rights and obligations from the clinical trial agreement ,wierzytelność wobec samodzielnego publicznego zakładu opieki zdrowotnej ,cesja praw i obowiązków z umowy o przeprowadzenie badania klinicznego ,badania kliniczne ,cesja umowy ,claim against an independent public health care institution - Abstract
Artykuł przedstawia prawne aspekty cesji praw i obowiązków z umowy o przeprowadzenie badania klinicznego. Autorka omawia instytucję cesji umowy w polskim prawie cywilnym oraz przedstawia ogólne uwarunkowania zawierania takich czynności na gruncie badań klinicznych. W dalszej kolejności w artykule zaprezentowano wykładnię art. 54 ust. 5 ustawy o działalności leczniczej. Ponadto rozważono skutki, jakie niesie za sobą zastosowanie powyższej normy do cesji umowy o przeprowadzenie badania klinicznego. Podsumowując swoje rozważania, autorka przedstawia proponowaną przez siebie koncepcję interpretacyjną art. 54 ust. 5 oraz formułuje postulat de lege ferenda. This article presents legal aspects of the assignment of rights and obligations from a clinical trial agreement. Author discusses the institution of cession of the contract in Polish civil law and presents general circumstances for concluding such activities on the basis of clinical trials. Subsequently, the article presents the jurisprudence and doctrinal concepts of interpretation of the Article 54(5) of The Therapeutic Activity Act. The analysis of the consequences of applying the above standard to the assignment of a clinical trial contract was also provided. Summarizing deliberations, author proposes interpretation concept of art. 54(5) and formulates a de lege ferenda postulate.
- Published
- 2021
25. Retigabina – nowy lek przeciwpadaczkowy o odmiennym mechanizmie działania.
- Author
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Zwierzyńska, Ewa and Pietrzak, Bogusława
- Abstract
Retigabine belongs to a new generation of antiepileptic drugs. Its mechanism of action is different from that previously known. Retigabine opens potassium channels of subfamily Kv 7, especially Kv 7.2 and Kv 7.3. The drug enhances GABA-ergic transmission. It is well absorbed from the digestive system and undergoes metabolism via glucuronidation and acetylation. There is no interaction between retigabine and other antiepileptic drugs except lamotrigine. The drug has been registered as treatment of partial onset seizures with or without secondary generalization in adults. The efficacy of retigabine is being tested in other types of seizures and disorders characterized by neuronal hyperexcitability. Neuroprotective activity of retigabine is also being researched. [ABSTRACT FROM AUTHOR]
- Published
- 2013
26. Inhibitory deacetylaz histonów - mechanizmy działania na poziomie molekularnym i zastosowania kliniczne.
- Author
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Grabarska, Aneta, Dmoszyńska-Graniczka, Magdalena, Nowosadzka, Ewa, and Stepulak, Andrzej
- Subjects
- *
HISTONE deacetylase inhibitors , *GENE expression , *CANCER treatment , *CLINICAL trials , *CANCER cells , *CELL cycle - Abstract
Histone deacetylases (HDACs) play an important role in the epigenetic regulation of gene expression implicated in cancer pathogenesis. Inhibitors of HDACs (HDI) are under investigation as novel anti-cancer drugs, which induce histone hyperacetylation. These agents modulate chromatin structure leading to transcriptional changes of a very large number of genes, which affect signaling pathways, inhibit cell cycle progression and angiogenesis, and induce apoptosis in cancer cells. Currently, several HDI are in clinical trials used in monotherapy or in combination with other cytostatics, showing promising anticancer effects. To date, more than 15 HDIs have been found as potential drugs. This paper reviews the molecular mechanisms of HDI action on cancer cells and summarizes clinical trials of the most promising HDIs in the treatment of patients with hematologic malignancies and solid tumors [ABSTRACT FROM AUTHOR]
- Published
- 2013
27. Opinia prawna w sprawie zgodności z Konstytucją RP projektu rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE.
- Author
-
Czarny, Piotr
- Subjects
CLINICAL trial laws ,MEDICAL botany ,LEGAL opinions ,CONSTITUTIONS ,RIGHT to life (International law) ,LAW - Abstract
The main point of the legal opinion is the question of conformity with Poland's Constitution of the proposal for regulation of the European Parliament and of the Council [COM (2012) 369 inal]. In provides an in-depth analysis of matter presented (only in general terms) in the opinion dated 27 August 2012. The author claims that Article 30(1) of the proposed regulation should be declared to be partly (i.e. in relation to the scope of regulation) inconsistent with Article 39 of the Constitution. He points out that the Constitution establishes a prohibition against medical experimentation on the human subject (and this notion includes clinical trials referred to in the proposed regulation) without his personal and prior consent. No limitation of this right is allowed, except for when it collides with other "equivalent" constitutional values, especially the right to life protection (Article 38 of the Constitution) and the right to health protection (Article 68 of the Constitution). [ABSTRACT FROM AUTHOR]
- Published
- 2012
28. Opinia wsprawie projektu rozporządzenia Parlamentu Europejskiego i Rady wsprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE.
- Author
-
Bosek, Leszek and Olejniczak, Dorota
- Subjects
CLINICAL trial laws ,MEDICAL botany ,TREATY on European Union (1992). Protocols, etc., 2007 December 13 ,MEDICAL laws ,LAW - Abstract
The purpose of the opinion is to examine thoroughly the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use. Presently, the issue of clinical trials is regulated differently in particular EU member states, due to their different legal traditions and constitutional standards. By allowing for experimentation on human beings without their knowledge or consent, the proposed regulation substantially infringes the principles of subsidiarity, proportionality and conferred competences, as well as human dignity and the right to integrity of the person guaranteed by Articles 1 and 3 of the Charter of Fundamental Rights of the European Union. These circumstances sufficiently justify initiation by the Polish Sejm of the procedure specified in Article 6 of Protocol 2 on the application of the principles of subsidiarity and proportionality annexed to the Lisbon Treaty. [ABSTRACT FROM AUTHOR]
- Published
- 2012
29. Opinia prawna w sprawie zgodności z Konstytucją RP projektu rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi.
- Author
-
Banaszak, Bogusław
- Subjects
CLINICAL trial laws ,MEDICAL botany ,CONSTITUTIONS ,PREAMBLES (Law) ,LAW - Abstract
The purpose of the opinion is not to examine thoroughly the proposal for a regulation but only to assess the legal basis for its issue, and to provide an analysis of those provisions of the proposal that may raise doubts about their conformity with the Constitution of the Republic of Poland. The main conclusions of the opinion relate to the lack of grounds for delegation by the Republic of Poland to the bodies of the European Union of the competence to regulate the issue of clinical trials on medicinal products for human use under primary law of the EU. Such delegation would infringe Article 90(1) of the Constitution. The author claims that the time limits speciied in the proposal for regulation for action of the State make it impossible for Polish public authorities to implement obligations resulting from the preamble to the Constitution and their duties relating to protection of individual's rights referred to in its Article 30. [ABSTRACT FROM AUTHOR]
- Published
- 2012
30. Opinia na temat projektu rozporządzenia Parlamentu Europejskiego i Rady wsprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE.
- Author
-
Wróbel, Włodzimierz
- Subjects
CLINICAL trial laws ,CONSTITUTIONS ,MEDICAL experimentation on humans -- Law & legislation - Abstract
The main subject of the analysis is the question of conformity with Poland's Constitution of the possibility of carrying out clinical trials on minors. The author concludes that the provisions of Article 31 of the proposed regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, providing for the possibility of conducting clinical trials on minors, which are not aimed to be delivered for health beneit of those persons, are inconsistent with Article 39 of the Constitution of the Republic of Poland. [ABSTRACT FROM AUTHOR]
- Published
- 2012
31. Indywidualizacja terapii przeciwnowotworowej; molekularne uwarunkowania mechanizmów działania nowoczesnych leków onkologicznych.
- Author
-
Regulska, Katarzyna, Stanisz, Beata, and Regulski, Miłosz
- Subjects
- *
ONCOLOGY , *CELLULAR signal transduction , *DISEASE progression , *CLINICAL trials , *DRUG resistance - Abstract
Deregulation of cellular signal transduction, caused by gene mutations, has been recognized as a basic factor of cancer initiation, promotion and progression. Thus, the ability to control the activity of overstimulated signal molecules by the use of appropriate inhibitors became the idea of targeted cancer therapy, which has provided an effective tool to normalize the molecular disorders in malignant cells and to treat certain types of cancer. The molecularly targeted drugs are divided into two major pharmaceutical classes: monoclonal antibodies and small-molecule kinase inhibitors. This review presents a summary of their characteristics, analyzing their chemical structures, specified molecular targets, mechanisms of action and indications for use. Also the molecules subjected to preclinical trials or phase I, II and III clinical trials evaluating their efficiency and safety are presented. Moreover, the article discusses further perspectives for development of targeted therapies focusing on three major directions: systematic searching and discovery of new targets that are oncogenic drivers, improving the pharmacological properties of currently known drugs, and developing strategies to overcome drug resistance. Finally, the role of proper pharmacodiagnostics as a key to rational anticancer therapy has been emphasized since the verification of reliable predictive biomarkers is a basis of individualized medicine in oncology. [ABSTRACT FROM AUTHOR]
- Published
- 2012
32. Perazyna w leczeniu zaburzeń psychotycznych - przegląd badań.
- Author
-
Kiejna, Andrzej
- Subjects
ANTIPSYCHOTIC agents ,PSYCHOSES ,SCHIZOPHRENIA ,CLINICAL trials ,SEDATIVES ,LABORATORY test panels - Abstract
The author reviewed the relatively poor literature on the topic and its key clinical trial reports on perazine, a classical antipsychotic most frequently prescribed in Poland for psychoses, especially for schizophrenia. Based mainly on the Leucht and Hartung's metaanalysis as well as on other authors' trials with broader context of typical and atypical neuroleptics comparisons, it could be concluded that the perazine bearing balanced profile of psychotropic action (antipsychotic, anti-autistic and sedative) has also some atypical features which explain its broad applications in clinical practice. Not without a meaning are also a few dozen-fold lower costs of treatment, which are even more meaningful when costs of necessary laboratory tests required for monitoring atypical antipsychotics use are taken into consideration. [ABSTRACT FROM AUTHOR]
- Published
- 2010
33. Zespól objawów odstawiennych po lekach antydepresyjnych w badaniach naukowych - implikacje dla lekarzy i pacjentów.
- Author
-
Heitzman, Janusz and Solak, Maggdalena
- Subjects
SYMPTOMS ,ANTIDEPRESSANTS ,DRUG efficacy ,SEROTONIN ,NEUROTRANSMITTERS ,NORADRENALINE - Abstract
Copyright of Psychiatria Polska is the property of Editorial Committee of Polish Psychiatric Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2009
34. The placebo response in gastroenterology and beyond.
- Author
-
Klosterhalfen, Sibylle and Enck, Paul
- Subjects
- *
GASTROENTEROLOGY , *PLACEBOS , *NOCEBOS , *META-analysis , *CLINICAL trials - Abstract
The placebo literature has substantially increased in the last decade, and more and more medical and psychological subspecialties have added empirical data to our knowledge. The theoretical framework of our understanding of the placebo response needs extension to account for findings that cannot be attributed to (Pavlovian) conditioning or expectancies alone. Gender aspects have been demonstrated for the placebo and nocebo response. It has been shown that nocebo research needs a methodological and ethical framework that allows its exploration. Finally, analyses of clinical trial data, either as meta-analyses or as reanalyses of trial raw data may allow identifying factors that subsequently can be used in experimental work. This has fostered the development of novel and alternative ways to test drugs against placebo that better control for placebo mechanisms without ignoring them. [ABSTRACT FROM AUTHOR]
- Published
- 2009
35. [The role of emollients in atopic dermatitis in children]
- Author
-
Ewa, Kamińska
- Subjects
Male ,emolienty ,clinical trials ,Adolescent ,Emollients ,atopic dermatitis ,dzieci ,humectants ,Infant, Newborn ,Infant ,Varia/Varia ,Filaggrin Proteins ,Dermatitis, Atopic ,children ,Child, Preschool ,Humans ,Female ,Child ,atopowe zapalenie skóry ,humektanty ,badania kliniczne - Abstract
Streszczenie Atopowe zapalenie skóry jest przewlekłą chorobą zapalną, przebiegającą z nawrotowymi zaostrzeniami, uporczywym świądem, rumieniem, suchością skóry wskutek uszkodzenia bariery naskórkowej i zakażeniami gronkowcowymi. Czynnikami wywołującymi są mutacje w genie kodującym filagrynę, rozregulowanie układu immunologicznego, zmiany dotyczące mikrobiomu skóry i lipidów w stratum corneum, niedobór peptydów antymikrobiologicznych AMPs. Choroba dotyczy głównie dzieci, powodując znaczne pogorszenie jakości życia, a jej pierwsze objawy występują w około 90% przypadków przed ukończeniem 5. r.ż. Przez lata termin „emolienty” odnoszono do substancji natłuszczających stosowanych w celu uelastycznienia i zmiękczenia skóry w chorobach przebiegających z szorstkością, złuszczaniem i suchością skóry. Obecnie wiadomo, że emolienty mogą także działać nawilżająco poprzez zatrzymywanie wody w skórze, stąd często terminy „emolient” i „substancja nawilżająca” są używane zamiennie. Zgodnie z najnowszymi rekomendacjami towarzystw dermatologicznych podstawową terapią w atopowym zapaleniu skóry jest długotrwałe stosowanie preparatów emoliencyjnych aplikowanych regularnie na skórę oraz dodawanych do kąpieli. Emolienty mogą być stosowane w monoterapii lub –w okresach zaostrzeń –w skojarzeniu z miejscowo stosowanymi kortykosteroidami lub inhibitorami kalcyneuryny. Badania kliniczne wykazały, że systematyczne stosowanie preparatów emoliencyjnych pomaga zarówno przywrócić funkcje ochronne bariery skórnej, jak i wpływa na zmniejszenie zużycia miejscowo stosowanych kortykosteroidów u niemowląt, dzieci i dorosłych pacjentów z atopowym zapaleniem skory. Wyniki badań oraz wieloletnie doświadczenie kliniczne dowodzą skuteczności i bezpieczeństwa stosowania preparatów emoliencyjnych. W pracy przedstawiono aktualny stan wiedzy na temat emolientów, tj. przegląd składników preparatów emoliencyjnych, właściwości i mechanizmy działania emolientów, a także omówiono ich znaczenie w atopowym zapaleniu skóry oraz wyniki badań klinicznych przeprowadzonych z udziałem dzieci z atopowym zapaleniem skóry.
- Published
- 2019
36. Drugs affecting the incretin system and renal glucose transport: do they meet the expectations of modern therapy of type 2 diabetes?
- Author
-
Anna Gumieniczek
- Subjects
Microbiology (medical) ,Incretin ,lcsh:Medicine ,Type 2 diabetes ,Pharmacology ,Incretins ,Dipeptidyl peptidase ,inhibitory SGLT1 i SGLT2 ,chemistry.chemical_compound ,Sodium-Glucose Transporter 1 ,Sodium-Glucose Transporter 2 ,Glucagon-Like Peptide 1 ,Diabetes mellitus ,Humans ,Hypoglycemic Agents ,Medicine ,Sodium-Glucose Transporter 2 Inhibitors ,Dipeptidyl peptidase-4 ,Dipeptidyl-Peptidase IV Inhibitors ,business.industry ,Therapeutic effect ,lcsh:R ,Glucose transporter ,analogi GLP-1 ,rekomendacje terapeutyczne ,inhibitory DPPIV ,medicine.disease ,Glucose ,Infectious Diseases ,Diabetes Mellitus, Type 2 ,chemistry ,Uric acid ,badania doświadczalne ,business ,badania kliniczne - Abstract
Agents introduced into therapy of type 2 diabetes in the last few years are still the subject of numerous clinical and experimental studies. Although many studies have been completed, we still do not know all aspects of these drugs' action, especially the long-term effects of their use. Most questionable is their impact on the processes of cell proliferation, on the cardiovascular and immune systems, on lipids and uric acid metabolism. A summary of the most important observations on the use of three groups of new drugs - analogs of glucagon-like peptide 1 (GLP-1), inhibitors of dipeptidyl peptidase IV (DPPIV) and inhibitors of sodium glucose cotransporters (SGLT1 and SGLT2) - has been made, based on a review of the literature over the past five years (2010-2014). The information included in the present review concerns the structure and activity relationship, therapeutic efficacy, side effects and the observed additional therapeutic effects, which can determine new standards in therapy of diabetes and also facilitate the development of better antidiabetic drugs.
- Published
- 2016
37. Metody zaślepiania badań klinicznych w fizjoterapii.
- Author
-
Opara, Józef, Kucio, Cezary, Małecki, Andrzej, and Pilch, Jan
- Abstract
Copyright of Physiotherapy / Fizjoterapia is the property of Physiotherapy and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2013
- Full Text
- View/download PDF
38. Komórki macierzyste a złudzenie terapeutyczne
- Author
-
Waligora, Marcin
- Subjects
komórki macierzyste ,stem cells ,clinical tests ,badania kliniczne - Published
- 2015
- Full Text
- View/download PDF
39. Liability Insurance as a Method of Risk Management in Clinical Trials Medical Products
- Author
-
Piechota, Anna and Uniwersytet Łódzki, Katedra Ubezpieczeń
- Subjects
clinical trials ,produkt medyczny ,liability insurance ,ubezpieczenie odpowiedzialności cywilnej ,badania kliniczne ,medical products - Abstract
According to polish legislation, regulations concerning clinical trials are different for therapeutic products than for medical products, equipment of the medical device or active implantable medical devices. This article discusses the regulations concerning the registration of medicines, particularly the civil liability of the researcher’s and the sponsorʼs responsibility in case of conducting the clinical trials of the therapeutic product. Also, there are presented the risks and threats for the agents involved in the clinical trial, including the clinical trial participant, as this person takes the risk for unwanted of medical product intake. W ustawodawstwie polskim regulacja badań klinicznych jest odrębna dla produktów leczniczych oraz dla wyrobów medycznych, wyposażenia wyrobu medycznego lub aktywnego wyrobu medycznego do implantacji. W niniejszym artykule omówione zostały regulacje dotyczące rejestracji leków, w szczególności odpowiedzialności cywilnej badacza i sponsora w przypadku przeprowadzania badań klinicznych produktu leczniczego. Ponadto przybliżone zostały ryzyka i zagrożenia stron badania klinicznego, w tym uczestnika badania klinicznego jako podejmującego ryzyko związane z ewentualnym wystąpieniem zdarzeń niepożądanych badanego produktu leczniczego.
- Published
- 2013
40. How can the representation of elderly patients in clinical trials be increased? The views of Polish participants of PREDICT project
- Author
-
Szczerbińska, Katarzyna, Cwynar, Marcin, and Zalewski, Zbigniew
- Subjects
rekrutacja ,clinical trials ,kryteria wyłączenia ,exclusion criteria ,recruitment ,elderly ,badania kliniczne ,osoby starsze - Abstract
Wstęp. W wyniku systematycznego przeglądu literatury przeprowadzonego w ramach wieloośrodkowego, międzynarodowego programu badawczego „Zwiększanie udziału osób starszych w badaniach klinicznych” (PREDICT), finansowanego przez Komisję Europejską z funduszy 7. Projektu Ramowego, wykazano małe uczestnictwo osób w wieku podeszłym w badaniach klinicznych. Materiał i metody. Na podstawie tych rezultatów opracowano kwestionariusz wywiadu w celu zbadania opinii pracowników opieki zdrowotnej, etyków i przedstawicieli przemysłu farmaceutycznego na temat przyczyn małego udziału osób starszych w badaniach klinicznych oraz czynników, które mogą sprzyjać stosownemu zwiększaniu ich reprezentacji w projektach badawczych. Badanie zostało przeprowadzone w 9 krajach: Republice Czeskiej, Hiszpanii, Holandii, Izraelu, Litwie, Polsce, Rumuni, Wielkiej Brytanii i we Włoszech. W niniejszym artykule przedstawiono jednak tylko opinie polskich respondentów, akcentując zasadnicze różnice w porównaniu z poglądami w pozostałych krajach. Wyniki. W opinii polskich respondentów osoby starsze nie są wystarczająco reprezentowane w badaniach klinicznych, a starszy wiek nie powinien stanowić kryterium wykluczającego z badań. Określono listę czynników, które potencjalnie mogą wpływać na proces rekrutacji osób w starszym wieku do badań klinicznych. Najczęściej wskazywanymi przyczynami wykluczania osób starszych były: współistnienie wielu chorób w tej grupie wiekowej, częste występowanie polipragmazji, zaburzeń funkcji poznawczych i obawa przed pojawianiem się zdarzeń niepożądanych. Wnioski. Wyniki tych badań wraz z innymi realizowanymi w ramach projektu posłużyły do opracowania Karty PREDICT zawierającej rekomendacje zmierzające do zapewnienia równoprawnego udziału osób starszych w badaniach klinicznych. Introduction. A systematic review of literature conducted in frame of multicentre, international the ‘Increasing the PaRticipation of the ElDerly In Clinical Trials’ (PREDICT) project, financed by the EU within the FP7, indicated that elderly persons are underrepresented in the clinical trials. Material and methods. Basing on those results the interview questionnaire has been elaborated to examine the opinion shared by the health care professionals, ethicists, and representatives of pharmaceutical industry on the possible reasons of underrepresentation of old people in clinical trials and promoters of their higher participation in it. The study has been conducted in 9 countries: Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain, and the UK. However this paper presents only opinions of Polish respondents to underline the main differences in views in comparison to other countries. Results. According to respondents in Poland older persons are insufficiently represented in clinical trials, and older age should not be used as a criterion of exclusion. The list of potential factors that might influence the recruitment process to clinical trials has been established. The most frequently indicated reasons of older people exclusion from trials were: more often co-morbidity, polypragmasy, cognitive impairment and fear of adverse effects. Conclusions. The results of this study together with other findings coming out of the project enabled creation of PREDICT charter which contains recommendations aiming to increase the participation of elderly people in clinical trials.
- Published
- 2012
41. Off-label drugs use in children : clinical perspective
- Author
-
Kwinta, Przemko
- Subjects
off-label ,side effects ,clinical trials ,children ,leki ,licencja ,dzieci ,działania niepożądane ,unlicensed ,adverse drug reaction ,poza rejestracją ,drug ,badania kliniczne - Published
- 2011
42. The charter of older people rights to participate in clinical trials
- Author
-
Szczerbińska, Katarzyna, Zalewski, Zbigniew, and Salvà, Joaquim Oristrell
- Subjects
clinical trials ,dyskryminacja ,prawa pacjenta ,patients' rights ,elderly ,charter ,badania kliniczne ,osoby starsze ,PREDICT ,karta ,discrimination - Abstract
The results of initial literature review indicate thai elderly persons are underrepresented in the clinical trials on which clinical recommendations are based. This gave stimulus to perform the 'lncreasing the PaRticipation of the EIDerly In Clinical Trials' (PREDICD project, financed by the EU within the FP7. The goal of the PREDICT was to study reasons why older people are excluded from clinical trials based on age-related criteria and development of the charter including recommendations to prevent their exclusion. The project gathered investigators from 11 inslitutions in 9 countries: Czech Republic, lsrael, ltaly, Lithuania, the Netherlands, Poland, Romania, Spain, and the UK. Within the scope of PREDICT, first, to assess the scope of the problem the systematic review of literature was performed, !hen the opinion shared by the health care professionals, ethicists, and representatives of pharmaceutical industry on the possible reasons of underrepresentation of ald people in trials was examined, !hen finally the opinion of elderly patients and their caregivers were assessed. The analysis of gathered data enabled creation of PREDICT charter which contains recommendations aiming to increase the participation of elderly people in clinical trials.
- Published
- 2011
43. The representation of elderly patients in clinical trials – presentation of assumptions of PREDICT project
- Author
-
Szczerbińska, Katarzyna, Zalewski, Zbigniew, Gąsowski, Jerzy, Hartman, Jan, Cwynar, Marcin, Szymczakiewicz-Multanowska, Agnieszka, Edbrooke, David L., Mills, Garry H., Crome, Peter, Cherubini, Antonio, Salvà, Joaquim Oristrell, Hertogh, Cees M., Topinková, Eva, Lesauskaite, Vita, Prada, Gabriel I., Clarfield, Mark, Dieppe, Paul, Beswick, Andrew, and Sinclair-Cohen, Judith
- Subjects
charter PREDICT ,clinical trials ,dyskryminacja ,prawa pacjenta ,karta PREDICT ,elderly ,badania kliniczne ,osoby starsze ,patients rights ,discrimination - Abstract
Wstęp. Liczne doniesienia wskazują na małą i nierówną reprezentację osób starszych w badaniach klinicznych stanowiących podstawę tworzenia zaleceń dotyczących postępowania. Stało się to przesłanką do przeprowadzenia wieloośrodkowego, międzynarodowego programu badawczego „Zwiększanie udziału osób starszych w badaniach klinicznych” (PREDICT), finansowanego przez Komisję Europejską w ramach VII Projektu Ramowego. Celem projektu było rozpoznanie przyczyn i skali zjawiska oraz stworzenie zaleceń odnośnie do włączania osób w starszym wieku do badań. Materiał i metody. W projekcie uczestniczyło 11 instytucji z 9 krajów: Czech, Hiszpanii, Holandii, Izraela, Litwy, Polski, Rumunii, Wielkiej Brytanii i Włoch. Zastosowano systematyczny przegląd literatury w celu zbadania zagadnienia udziału osób starszych w badaniach klinicznych, czynników sprzyjających ich uczestnictwu i utrudniających to uczestnictwo, przyczyn niskiego uczestnictwa oraz sposobów jego zwiększania. Wyniki. Potwierdzono hipotezę małej i nierównej reprezentacji osób starszych w badaniach klinicznych, a wyniki przeglądu stały się podstawą do przeprowadzenia w 9 krajach badań opinii pracowników opieki zdrowotnej oraz opinii pacjentów w starszym wieku na temat udziału osób starszych w badaniach klinicznych. Wnioski. Ostatecznym rezultatem tych badań jest karta zawierająca rekomendacje zmierzające do zapewnienia równoprawnego udziału osób starszych w badaniach klinicznych. Background. Several research reports indicate that elderly persons are underrepresented in the clinical trials on which clinical recommendations are based. This gave stimulus to perform the ‘Increasing the PaRticipation of the ElDerly In Clinical Trials’ (PREDICT) project, financed by the EU within the FP7. The goal of the PREDICT was to establish the reasons and extent to which old people are excluded from trials based on age-related criteria. Material and methods. The project gathered investigators from 11 institutions in 9 countries: Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain, and the UK. The systematic review of literature has been applied to assess the scope of the problem in terms of participation, predisposing and obstructive factors, reasons of low participation and possible interventions to enhance it. Results. The hypothesis of low and unequal representation of older people in clinical research has been confirmed. The systematic review results became the background for conducting in 9 countries a study of opinion shared by the health care professionals and elderly patients on their participation in clinical research. Conclusions. The analysis of gathered data enabled creation of PREDICT charter which contains recommendations aiming to assure the equal rights to older people to participate in clinical trials.
- Published
- 2010
44. Antidepressant discontinuation syndrome in clinical and laboratory studies : implications for clinicians and patients
- Subjects
leki antydepresyjne ,antidepressant drugs ,zespół odstawienia ,discontinuation syndrome ,clinical sudies ,badania kliniczne - Abstract
The rate at which the antidepressant drug is terminated and the duration of treatment appear to be key factors in predicting discontinuation symptoms. The development of animal models to explain the mechanisms of this clinical problem has proved challenging, because less than half of all the patients experience any discontinuation symptoms, many of which are subjective. One explanation is that antidepressant discontinuation symptoms may arise from the rapid decrease in serotonin availability when treatment ends abruptly. It would appear that discontinuation discomfort may not be mediated exclusively through serotonin receptors, given the major regulatory role serotonin exerts on a number of specific chemical receptor systems in the brain. As a result, attempts to explain the determinants of this phenomenon rely on a certain level of speculation. The article discusses the three systems most likely to account in the symptomatology - the serotonin, the norepinephrine, and the cholinergic systems - and the possible interactions among them. Those clinical and laboratory studies were reviewed, which have influence on clinicians decisions about choosing drugs, the way of its discontinuation and patients general feeling. This article is continuation of our latest paper “Antidepressant discontinuation syndrome - a problem for the clinician and the patient”.
- Published
- 2009
45. Ochrona uczestników badań klinicznych w Polsce
- Author
-
Bański, Roman, Czabanowska, Katarzyna, Niedziałkowska, Magdalena, Błoniarczyk, Barbara, and Juszczyk, Grzegorz
- Subjects
ochrona uczestników badań ,eksperyment medyczny ,badania kliniczne - Published
- 2007
46. Antihypertensive treatment among hypertensives with diabetes type 2 in light of current clinical research
- Author
-
Rajzer, Marek, Kawecka-Jaszcz, Kalina, and Wojciechowska, Wiktoria
- Subjects
farmakoterapia ,arterial hypertension ,clinical trials ,diabetes ,cukrzyca ,antihypertensive pharmacotherapy ,nadciśnienie tętnicze ,badania kliniczne - Published
- 2003
Catalog
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