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Showing "2019 Strongyloidiasis Clinical Trials Guide Companies Drugs Phases" PubMed Articles 1–25 of 40,000+

From research to practice: clinical phases for drug development.

Clinical trials become very relevant in the development of new drugs when their pharmacokinetics, pharmacodynamics, efficiency, safety and possible adverse effects are being assessed. So new drugs are available for their daily use in patients, a model has been proposed for more than four decades; This model consists in the realization of sequential research studies, which were called clinical phases I, II, III and IV, which begin once the drugs' effects have been verified in cellular and animal models (prec...

New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights.

The enactment of the New Drugs and Clinical Trials Rules, 2019 (hereafter New Rules), on March 19 by the Ministry of Health and Family Welfare (MoHFW), Government of India (1), is the use of power delegated to the political executive by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940. Has this power been used wisely? Whose interests do these rules represent?

Key indicators of phase transition for clinical trials through machine learning.

A significant number of drugs fail during the clinical testing stage. To understand the attrition of drugs through the regulatory process, here we review and advance machine-learning (ML) and natural language-processing algorithms to investigate the importance of factors in clinical trials that are linked with failure in Phases II and III. We find that clinical trial phase transitions can be predicted with an average accuracy of 80%. Identifying these trials provides information to sponsors facing difficult...

Meeting abstracts from the 5th International Clinical Trials Methodology Conference (ICTMC 2019) : Brighton, UK. 06-09 October 2019.

Tyrosine kinase inhibitors for the treatment of rheumatoid arthritis: phase I to Ⅱ clinical trials.

: Rheumatoid arthritis (RA) is a chronic, refractory disorder caused by autoimmunity in the synovial joints. Disease-modifying anti-rheumatic drugs (DMARDs) and biologicals offer remission in only two-thirds of RA patients within 3 months, hence new therapeutic approaches are necessary. Tyrosine kinase inhibitors (TKIs) are newly developed small molecule drugs which have demonstrated encouraging results in this disease.: The key findings from phase I and II clinical trials that have investigated the use of ...

Phase 1, 2 and 3 trials in inflammatory bowel diseases: a practical guide for the non-specialist.

In the last decades several new molecules have been developed in the field of inflammatory bowel diseases. However, the process that leads to the approval and use of a new drug is very long, expensive, and complex, consisting of various phases. There is a pre-clinical phase that is performed on animals and a clinical phase that is instead directed to humans. Each research phase aims to evaluate different aspects of the drug and involves a specific target group of subjects. In addition, many aspects must be ...

Huntington's Disease Clinical Trials Corner: June 2019.

In this edition of the Huntington's Disease Clinical Trials Corner we expand on the HD-DBS and on the TRIHEP3 trials, and we list all currently registered and ongoing clinical trials in Huntington's disease.

US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis.

The size of estimated treatment effects on the basis of which the US Food and Drug Administration (FDA) has approved drugs and devices with data from nonrandomized clinical trials (non-RCTs) remains unknown.

Glucose-lowering drugs and heart failure: Implications of recent cardiovascular outcome trials in type 2 diabetes.

Heart failure (HF) is common in Type-2 diabetes mellitus (T2DM), and viceversa, leading to a mutual impact on prognosis. Knowledge about this complex interplay has dramatically changed recently, due to development of new glucose-lowering drugs, and to specific FDA and EMA Guidance mandating to perform cardiovascular outcome trials (CVOTs), aimed at establishing cardiovascular safety, for new anti-diabetic treatments before they enter the market. Such CVOTs have demonstrated that the effects of the new antid...

Drugs for preventing post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: Network meta-analysis of randomized clinical trials and trial sequential analysis.

Different categories of drugs are used to reduce the incidence of post-operative nausea and vomiting (PONV) following laparoscopic cholecystectomy (LC). This study is a network meta-analysis of randomized clinical trials with such drugs.

Cooper et al. Established search filters may miss studies when identifying randomized controlled trials. J Clin Epidemiol. 2019 Apr 13;112:12-19. doi: 10.1016/j.jclinepi.2019.04.002.

Pharmacotherapy in obesity: a systematic review and meta-analysis of randomized controlled trials of anti-obesity drugs.

Obesity poses a significant increase in morbidity and mortality and thus five anti-obesity drugs have been approved currently by US FDA. Several phase 3 trials have shown a significant improvement in cardio-metabolic profile including significant weight reduction with these agents compared to placebo.Areas covered:We systematically searched the database of PubMed, Embase, The Cochrane Library and The up to September 30, 2019 and retrieved all the randomized controlled trials (RCTs) that w...

The impact of evidence from clinical trials on counselling for over-the-counter drugs: A national survey of pharmaceutical staff in German pharmacies.

Evidence from clinical trials should form the foundation of healthcare advice. Comparatively little has been investigated about the implementation of evidence in over-the-counter (OTC) counselling in community pharmacies. The objective of this study was to explore the current impact of clinical trials on OTC counselling from the perspective of pharmaceutical staff.

Emerging drugs for the treatment of noninfectious uveitis.

: Uveitis is a leading cause of visual impairment and a significant burden of blindness. Although corticosteroids and conventional immunosuppressive agents have been successfully used, these are non-specific, and their long-term use may induce significant adverse effects. : This article discusses existing local and systemic applied treatments for ocular inflammation including corticosteroids, non-biologic, and biologic disease-modifying anti-rheumatic drugs (DMARD). Potential drugs being studied in clinical...

Financial Ties between Authors of the Clinical Practice Guidelines and Pharmaceutical Companies: an example from Japan.

The future of clinical trials in urological oncology.

Well-designed clinical trials in urological oncology help to guide treatment decisions and aid in counselling patients, ultimately serving to improve outcomes. Since the term evidence-based medicine was first used by Gordon Guyatt in 1991, a renewed emphasis on methodology, transparent trial design and study reporting has helped to improve clinical research and in turn, the landscape of medical literature. Novel clinical trial designs (including multi-arm, multistage trials, basket and umbrella studies and ...

Comparative efficacy and acceptability of first-line drugs for the acute treatment of generalized anxiety disorder in adults: A network meta-analysis.

The guide recommends SSRI and SNRI drugs as first-line treatments for generalized anxiety disorder (GAD). Therefore, we aimed to update the evidence using network meta-analysis by comparing the efficacy and acceptability of first-line drugs. The relevant electronic databases were searched for placebo-controlled and head-to-head trials of 11 drugs used for the acute treatment of adults with GAD from 1980 up to January 1, 2019. Data on demographics, clinical, and treatment information were extracted from each...

Development of immunochromatographic device as a point-of-care tool for serodiagnosis of human strongyloidiasis cases.

Human strongyloidiasis is an important gastrointestinal disease with an estimated 30 to 100 million people infected. Prevalence is generally underestimated since many infections are asymptomatic, and traditional diagnostic tests based on parasitological examination of stool samples are not adequately sensitive. Serological tests are useful and supportive but are still only available in a reference research setting. We made an immunochromatographic test (ICT) kit for rapid serodiagnosis of human strongyloidi...

Diarylamides in anticancer drug discovery: A review of pre-clinical and clinical investigations.

Several diarylamide compounds have been highlighted as potential anticancer agents. Among them, imatinib, dasatinib, and nilotinib have been marketed for treatment of chronic myeloid leukemia (CML). CML is a cancer type that originates in specific cells in bone marrow and is considered as life-threating disease. Imatinib is the first generation of tyrosine kinase inhibitor (TKI) to be approved for treatment of CML. Second generation drugs, dasatinib and nilotinib, were introduced for patients that are resis...

Clinical drug development for dementia with Lewy bodies: past and present.

: Dementia with Lewy bodies (DLB) is an under-researched area despite being the second most common type of degenerative dementia after Alzheimer's disease. It is an area of unmet need with no approved symptomatic or disease-modifying therapies. The pharmacological management of DLB is complex and challenging because early trials of drugs for DLB have resulted in no demonstrable efficacy. Randomized controlled trials (RCTs) in the DLB population have only recently been initiated. Understanding results from p...

Description of vaccine clinical trials in Africa: a narrative review.

Clinical research is important in establishing the effects of health care interventions. Vaccine clinical trials are to examine the effectiveness and safety of vaccines for the prevention of diseases. Africa has a high burden of infectious diseases such as malaria, tuberculosis, HIV/AIDS, and Ebola virus disease. Here we report a database surveillance study of vaccine-related clinical trials conducted in Africa. An objective is to address and profile vaccine clinical trials conducted in Africa. Data were ex...

Framework for rational donor selection in fecal microbiota transplant clinical trials.

Early clinical successes are driving enthusiasm for fecal microbiota transplantation (FMT), the transfer of healthy gut bacteria through whole stool, as emerging research is linking the microbiome to many different diseases. However, preliminary trials have yielded mixed results and suggest that heterogeneity in donor stool may play a role in patient response. Thus, clinical trials may fail because an ineffective donor was chosen rather than because FMT is not appropriate for the indication. Here, we descri...

Emerging antibiotics for Community-Acquired Pneumonia.

: Community-acquired pneumonia is the most common infection leading to hospitalization and death in all age groups, especially in elderly populations. Increasing antibiotic resistance among the common bacterial pathogens associated with community-acquired pneumonia, especially Streptococcus pneumoniae and staphylococci, has made its empirical treatment increasingly problematic, highlighting the need for effective antibiotic therapy. : We searched PubMed and for English-language reports of...

Developing Effective Alzheimer's Disease Therapies: Clinical Experience and Future Directions.

Alzheimer's disease (AD) clinical trials, focused on disease modifying drugs and conducted in patients with mild to moderate AD, as well as prodromal (early) AD, have failed to reach efficacy endpoints in improving cognitive function in most cases to date or have been terminated due to adverse events. Drugs that have reached clinical stage were reviewed using web resources (such as,, company press releases, and peer reviewed literature) to identify late stage (Phase II and Ph...

Strongyloidiasis screening in migrants living in Spain: systematic review and meta-analysis.

To provide information regarding the prevalence of strongyloidiasis among migrants coming from Strongyloides stercoralis-endemic areas who reside in Spain.

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