Drugs, Investigational

Publication Title: 
European Journal of Pharmaceutical Sciences: Official Journal of the European Federation for Pharmaceutical Sciences

Piplartine (piperlongumine, 5,6-dihydro-1-[(2E)-1-oxo-3-(3,4,5-trimethoxyphenyl)-2-propenyl]-2(1H)-pyridinone) is a biologically active alkaloid/amide from peppers, as from long pepper (Piper longum L. - Piperaceae). Long pepper is one of the most widely used in Ayurvedic medicine, which is used to treat many diseases, including tumors.

Author(s): 
Bezerra, Daniel P.
Pessoa, Claudia
de Moraes, Manoel O.
Saker-Neto, Nicolau
Silveira, Edilberto R.
Costa-Lotufo, Leticia V.
Publication Title: 
The American journal of bioethics: AJOB

The Catholic Church proscribes methods of birth control other than sexual abstinence. Although the U.S. Food and Drug Administration (FDA) recognizes abstinence as an acceptable method of birth control in research studies, some pharmaceutical companies mandate the use of artificial contraceptive techniques to avoid pregnancy as a condition for participation in their studies. These requirements are unacceptable at Catholic health care institutions, leading to conflicts among institutional review boards, clinical investigators, and sponsors.

Author(s): 
Casey, Murray Joseph
O'Brien, Richard
Rendell, Marc
Salzman, Todd
Publication Title: 
Contemporary Clinical Trials

One of the most influential factors in science and medicine has been the development of placebo-controlled clinical trials. However, recruitment of patients for clinical trials is sometimes a major problem in clinical research. Successful patient recruitment may be enhanced with a clear understanding of the motivating factors that determine a patient's decision to enter a study.

Author(s): 
Rojavin, Mikhail A.
Downs, Pamela
Shetzline, Michael A.
Chilingerian, Raffy
Cohard-Radice, Marielle
Publication Title: 
Bulletin of the World Health Organization

Despite the urgent need of a new antimalarial drugs, particularly those against multiresistant falciparum malaria, only a limited number of drugs are now at an advanced stage of preclinical or clinical development. They include artemisinin derivatives, pyronaridine and benflumetol (all originally developed in China), as well as new antifolate combinations, the hydroxynaphoquinone atovaquone which has a novel mode of action, and a new 8-aminoquinoline which appears more active and less toxic than primaquine. Some of these drugs may become available in the next few years.

Author(s): 
Olliaro, P. L.
Trigg, P. I.
Publication Title: 
Hawaii Medical Journal

INTRODUCTION: There are hundreds of millions of cases of malaria each year worldwide resulting in a million deaths. These deaths are mostly due to Plasmodium falciparum. The only Federal Drug Administration approved treatment for severe malaria is intravenous quinidine gluconate. Intravenous quinidine is increasingly unavailable in the United States. In 2007, the Center for Disease Control and Prevention implemented an investigational new drug protocol to allow the use of intravenous artesunate for cases of severe malaria in the United States.

Author(s): 
Callender, David M.
Hsue, Gunther
Publication Title: 
Expert Opinion on Emerging Drugs

IMPORTANCE OF THE FIELD: The present review is aimed at going over the pharmacological profile (and the clinical impact) of the emerging drugs involved in the management of patients with ST-elevation myocardial infarction (STEMI) in order to provide the cardiologists who deal with these patients in the early phase with the most recent evidence on this topic. AREAS COVERED IN THIS REVIEW: Anticoagulant and antiplatelet drugs are the main cornerstones of therapy in the treatment of STEMI patients undergoing primary percutaneous coronary intervention (PCI).

Author(s): 
Lazzeri, Chiara
Tarquini, Roberto
Valente, Serafina
Abbate, Rosanna
Gensini, G. F.
Publication Title: 
Expert Opinion on Emerging Drugs

IMPORTANCE OF THE FIELD: The present review is aimed at going over the pharmacological profile (and the clinical impact) of the emerging drugs involved in the management of patients with ST-elevation myocardial infarction (STEMI) in order to provide the cardiologists who deal with these patients in the early phase with the most recent evidence on this topic. AREAS COVERED IN THIS REVIEW: Anticoagulant and antiplatelet drugs are the main cornerstones of therapy in the treatment of STEMI patients undergoing primary percutaneous coronary intervention (PCI).

Author(s): 
Lazzeri, Chiara
Tarquini, Roberto
Valente, Serafina
Abbate, Rosanna
Gensini, G. F.
Publication Title: 
Asian Pacific journal of cancer prevention: APJCP

Homeopathy is considered as one modality for cancer therapy. However, there are only very few clinical reports on the activity of the drugs, as well as in experimental animals. Presently we have evaluated the inhibitory effects of potentized homeopathic preparations against N'-nitrosodiethylamine (NDEA) induced hepatocellular carcinoma in rats as well as 3-methylcholanthrene-induced sarcomas in mice. We have used Ruta, Hydrastis, Lycopodium and Thuja, which are commonly employed in homeopathy for treating cancer.

Author(s): 
Kumar, K. B. Hari
Sunila, E. S.
Kuttan, Girija
Preethi, K. C.
Venugopal, C. Nimita
Kuttan, Ramadasan
Publication Title: 
Gut Microbes

Researchers from a diverse array of scientific disciplines have focused and continue to focus on opportunities and areas for responsible clinical research involving the possible beneficial health effects of "probiotics." Investigators and researchers should be aware that not all clinical research involving probiotics reasonably falls within the requirements of the "investigational new drug" (IND) rubric administered and enforced by the US Food and Drug Administration.

Author(s): 
Degnan, Fred H.
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