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Showing "2019 Cytomegalovirus HHV5 Infections Clinical Trials Guide Companies" PubMed Articles 1–25 of 38,000+

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

Determination of anti-p52 IgM and anti-gB IgG by ELISA as a novel diagnostic tool for detection of early and late phase of primary human cytomegalovirus infections during pregnancy.

Dating of primary human cytomegalovirus (HCMV) infection in pregnancy is crucial to define whether infection occurred before or during pregnancy and at which gestational age.

Challenges and Clinical Implications of the Diagnosis of Cytomegalovirus Lung Infection in Children.

Pulmonary cytomegalovirus (CMV) infection is a potential lethal disease in children, but it remains a diagnostic challenge. The differentiation between latent CMV infections with viral shedding and active infections is difficult and may lead to false positives in bronchoalvolar lavage (BAL) PCR detection. This review summarizes current diagnostic approaches for CMV lung infection in children including progress in the identification of underlying immune defects linked to this condition.

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.

Reporting infections in clinical trials of patients with haematological alignancies - A systematic review.

Infections are common among patients treated for haematological malignancies and are associated with significant morbidity and mortality. The completeness of reporting infectious complications in randomized controlled trials (RCTs) assessing treatments for haematological malignancies is unknown.

Cytomegalovirus hepatitis after bone marrow transplantation: An autopsy study with clinical, histologic, and laboratory correlates.

Mortality from Cytomegalovirus disease after marrow transplantation can be reduced by treatment with anti-viral drugs based on detection of viremia and organ involvement. We examined autopsy liver specimens to determine the frequency, extent, and outcome of cytomegalovirus hepatitis and whether cytomegalovirus hepatitis occurred in the absence of cytomegalovirus disease elsewhere. Autopsy specimens from 50 transplant patients were evaluated for cytomegalovirus-infected cells, in five groups of 10, according...

CROI 2019: complications and coinfections in HIV infection.

The 2019 Conference on Retroviruses and Opportunistic Infections provided a considerable amount of new information on the progress in implementation of strategies to reduce morbidity and mortality from complications and coinfections that occur in people with HIV infection, and on the clinical management of these important problems. This review will address new insights into the prevention and treatment of tuberculosis, fungal infections, sexually transmitted infections, malignancies, and a range of metaboli...

Breast cancer and cytomegalovirus.

To determine whether cytomegalovirus is causally associated with breast cancer and whether cytomegalovirus should be categorised as an oncogenic virus.

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.

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?

Payments From Pharmaceutical Companies to Authors Involved in the Valsartan Scandal in Japan.

Financial relationships between pharmaceutical companies and physicians can bias the conduct, findings, and reporting of clinical trials. In Japan, the valsartan scandal was a significant event: all 5 key articles on the valsartan clinical trials were retracted after the revelation of data falsification. Consequently, the Japan Pharmaceutical Manufacturers Association issued transparency guidelines, and pharmaceutical payments have been publicly disclosed since 2013. However, the distribution of payments fr...

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 ...

Productive cytomegalovirus infection is associated with impaired endothelial function in ST-elevation myocardial infarction.

An association between productive cytomegalovirus infection and atherosclerosis was shown recently in several trials, including a previous study of ours. However, the mechanism involved in this association is still under investigation. Here, we addressed the interaction between productive cytomegalovirus infection and endothelial function in patients with ST-elevation myocardial infarction (STEMI).

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...

Primary cytomegalovirus (CMV) infection in pregnancy: Diagnostic value of CMV PCR in saliva compared to urine at birth.

Due to its ease of collection saliva was recently recommended as the preferred specimen, not only for screening, but also for diagnosis of congenital cytomegalovirus (CMV) infection.

The impact of maternal HIV and malaria infection on the prevalence of congenital cytomegalovirus infection in Western Kenya.

Data on congenital cytomegalovirus (CMV) infection in Africa are limited.

Guidance for design and endpoints of clinical trials in chronic hepatitis B - Report from the 2019 EASL-AASLD HBV Treatment Endpoints Conference.

Representatives from academia, industry, regulatory agencies, and patient groups convened in March 2019 with the primary goal of developing agreement on chronic hepatitis B virus (HBV) treatment endpoints to guide clinical trials aiming to 'cure' HBV. Agreement among the conference participants was reached on some key points. 'Functional' but not sterilizing cure is achievable and should be defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post-treatment. The primary endpoint of p...

Strategic Trials to Define the Best Available Treatment for Neonatal and Pediatric Sepsis Caused by Carbapenem-resistant Organisms.

The optimal standard of care for carbapenem-resistant bloodstream infections in children is currently unknown. This systematic review, aiming to define the best available treatments to be compared with new antibiotics in clinical trials, clearly points out the paucity of available data. The simplification and a wider harmonization of study design are a global priority to inform the best strategies to treat these life-threatening infections in children.

Carbapenems vs tigecycline for the treatment of complicated intra-abdominal infections: A Bayesian network meta-analysis of randomized clinical trials.

Complicated intra-abdominal infections (cIAIs) are common in clinical practice, caused by a mixture of aerobic and anaerobic bacteria, increase the risk of mortality. Carbapenems and tigecycline (TGC) are recommended for antimicrobial therapies for cIAIs.

Assessment and prevention of cytomegalovirus infection in allogeneic hematopoietic stem cell transplant and in solid organ transplant: a multidisciplinary consensus conference by the Italian GITMO, SITO and AMCLI societies.

Cytomegalovirus (CMV) remains a major cause of morbidity and mortality in allogeneic hematopoietic stem cell transplantation (allo-HSCT) and solid organ transplantation (SOT) recipients. In view of the uncertainties on the assessment and prevention of CMV infection in both transplant procedures, three Italian Scientific Societies for HSCT and SOT and for Clinical Microbiology appointed a panel of experts to compose a framework of recommendations. Recommendations derived from a comprehensive analysis of the ...

The Risk of Cytomegalovirus Infection after Treatment of Acute Rejection in Renal Transplant Recipients.

The risk of cytomegalovirus infection (CMV) after rejection treatment is poorly understood. To investigate this, we conducted a case/control(1:2) analysis of adult renal-transplant recipients between 1/1/2005-12/31/2015 via incidence-density sampling and survival analysis. Our objective was to evaluate the association of prior acute-rejection with subsequent CMV, including epidemiology and outcomes. There were 2481 eligible renal-transplants within the study period and 251 distinct CMV infections. Despite t...

Late versus early-onset CMV infections in kidney transplantation, still a topical issue, reply to Ono et al.

We read with great interest the recently published article entitled "Late cytomegalovirus (CMV) infections after kidney transplantation under the preemptive strategy: Risk factors and clinical aspects" by of G. Ono et al. The authors found that these late-onset CMV infections were associated with a higher rate of invasive disease and graft loss than earlier infections occurring in the first 6 months following the transplantation . In a previous article, we found that late-onset CMV diseases were associated...

Contact Lens Health Week - August 19-23, 2019.

August 19-23, 2019, marks the sixth annual Contact Lens Health Week. In collaboration with partners from clinical, public health, industry, and regulatory sectors, CDC is promoting healthy contact lens wear and care practices to reduce the risk for eye infections among the approximately 45 million persons in the United States who wear contact lenses. Studies conducted following outbreaks of rare but serious eye infections in the United States have found that these infections occur most frequently in contact...

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