Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.
Medical Reference Publication
Such a reduction is possible. for example, with regimens containing the highly potent
bactericidal drug rifampicin. hiany rifampicin-containing short-course regimens, with
different drug combinations, dosage schedules. durations of the initial intensive and continuation
phases of chemotherapy, and different intervals between doses, have been evaluated
in controlled clinical trials. Their therapeutic efficacy has been established, as well
as the types and frequency of pos...
A basic feature of the organization of most con-
trolled clinical trials is the collection of specified
data at fixed intervals. For trials with diseases such
as tuberculosis, involving a long period of observation,
well-organized clerlcal procedures are essential
to ensure that all the requisite data are collected
at the appropriate intervals. Although these clerical
procedures are relatively simple to initiate, it is
usually difficult to maintain precise standards o\,...
Executive summarv and
Four vaccine manufacturers are undertaking clinical trials with new pneumococcal
conjugate vaccines (PCVs) that include up to 11 serotypes. A phase III trial of the
vaccines is well advanced in South Africa, and trials have begun in the Gambia,
Israel and the Philippines. Phase III trials are at the preparatory stage in Argentina,
Australia, Chile, Costa Rica, the Czech Republic, and Singapore. In Lombok,
Indonesia, a Haemophilus influen...
To initiate, as a pilot study, the OMSLEP system of
information relevant to the Clinico-epidemiology of leprosy
in the province.
Clinical studies on the various methods of oral rehydration therapy
(Om)ha ve been going on for over three decades since ~ a r r v ' sre port
+ in 1949 on a solution containing Na , K+, C1-, H C 9 - and glucose for
infants w i t h diarrhoeas.
Whlle these studies a m in trickles in the f i r s t 2 decades, there
was virtually a deluge of these clinical studies on OKT in this l a s t
decade, particularly Ln the l a s t 5 years. This coincided with the
Government Accountability Integrity Reliability Office Collection
Excerpt: The 1991 NIH-BMS CRADA was one of the first CRADAs to result in a major breakthrough drug. NIH?s partnership with BMS provided the company with the research results that enabled Taxol to be commercialized quickly and made available as a treatment for cancer patients. Prior to the CRADA and during the first 2 years of the agreement, NIH conducted most of the clinical trials associated with the drug. The results of these trials were critical for BMS to secure FDA?...
This report summarizes the findings of a pilot study to assess the usefulness of the Centers for Disease Control and Prevention’s (CDC) short version of the International Classification of External Causes of Injury (ICECI) in capturing external-cause-of-injury data from hospital emergency department (ED) records. CDC’s short ICECI was designed to capture major mechanisms of injury (e.g., fall, motor vehicle traffic crash, struck by/against, cut/pierce, fire/burn, poisoni...
Description: Institute of Photogrammetry and Remote Sensing, Technische Universität Dresden, 01062 Dresden, Germany. The growing number of glacial margin lakes that have developed due to glacier retreat, have caused an increase of dangerous Glacial Lake Outburst Floods (GLOFs) in several regions over the last decade. A GLOF can occur when the water from the lake finds a path underneath the bottom of the glacier and the lake is draining rapidly. This causes normally a flo...
Description: In November 1997, investigators from Johns Hopkins University and Makerere University in Uganda began the HIVNET 012 clinical trial to evaluate the efficacy and safety of single-dose nevirapine (NVP) and shortcourse zidovudine (ZDV) regimens for preventing mother-to-child transmission of HIV infection. The trial was initially designed as a randomized, double-blind, placebo-controlled trial, but the placebo arms were dropped after results from a study in Thai...
Description : Imatinib mesylate induces complete cytogenetic responses in patients with chronic myeloid leukemia (CML), yet many patients have detectable BCR-ABL transcripts in peripheral blood even after prolonged therapy. Bone marrow studies have shown that this residual disease resides within the stem cell compartment. Quiescence of leukemic stem cells has been suggested as a mechanism conferring insensitivity to imatinib, and exposure to the Granulocyte-Colony Stimul...
Description : Our aim was to identify genes that influence the inverse association of coffee with the risk of developing Parkinson’s disease (PD).
We used genome-wide genotype data and lifetime caffeinated-coffee-consumption data on 1,458 persons with PD and 931
without PD from the NeuroGenetics Research Consortium (NGRC), and we performed a genome-wide association and interaction
study (GWAIS), testing each SNP’s main-effect plus its interaction with coffee, adjusting f...
Description : Purpose : The efficacy of partial ventilatory support modes that allow spontaneous breathing in patients with acute lung
injury (ALI) and acute respiratory distress syndrome (ARDS) is unclear. The objective of this scoping review was to assess the
effects of partial ventilatory support on mortality, duration of mechanical ventilation, and both hospital and intensive care
unit (ICU) lengths of stay (LOS) for patients with ALI and ARDS: the secondary objectiv...
Description : Dendritic cells have been investigated in clinical trials, predominantly with the aim of stimulating immune responses against
tumours or infectious diseases. Thus far, however, no clinical studies have taken advantage of their specific
immunosuppressive potential. Tolerogenic DCs may represent a new therapeutic strategy for human immune-based
diseases, such as Crohn’s disease, where the perturbations of the finely tuned balance between the immune system and...
Description : Anatabine, a naturally occurring alkaloid, is becoming a commonly used human food supplement, taken for its claimed antiinflammatory
properties although this has not yet been reported in human clinical trials. We have previously shown that
anatabine does display certain anti-inflammatory properties and readily crosses the blood-brain barrier suggesting it could
represent an important compound for mitigating neuro-inflammatory conditions. The present study w...
Description : Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without
understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and
rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing
and reading about the study and the consent form at the subject’s own pace with testing and immediat...
Description : This contribution identifies spatial characteristics of tree diameter in a temperate forest in north-eastern China, based on a
fully censused observational study area covering 5006600 m. Mark correlation analysis with three null hypothesis models
was used to determine departure from expectations at different neighborhood distances. Tree positions are clumped at all
investigated scales in all 37 studied species, while the diameters of most species are spatia...
Description : Polyanionic candidate microbicides, including cellulose sulfate, carrageenan, PRO 2000, were proven ineffective in
preventing HIV-1 transmission and even cellulose sulfate showed increased risk of HIV acquisition in the Phase III efficacy
trials. Semen plays critical roles in HIV-1 sexual transmission. Specifically, amyloid fibrils formed by fragments of prostatic
acidic phosphatase (PAP) in semen termed semen-derived enhancer of virus infection (SEVI) coul...
Description : Intravenous Immunoglobulin (IVIG) has been proposed as a potential therapeutic for Alzheimer’s disease (AD) and its
efficacy is currently being tested in mild-to-moderate AD. Earlier studies reported the presence of anti-amyloid beta (Ab)
antibodies in IVIG. These observations led to clinical studies investigating the potential role of IVIG as a therapeutic agent in
AD. Also, IVIG is known to mediate beneficial effects in chronic inflammatory and autoimmune...
Description : CFTR is an integral transmembrane glycoprotein and a cAMP-activated Cl2 channel. Mutations in the CFTR gene lead to
Cystic Fibrosis (CF)–an autosomal recessive disease with majority of the morbidity and mortality resulting from airway
infection, inflammation, and fibrosis. The most common disease-associated mutation in the CFTR gene–deletion of Phe508
(DF508) leads to a biosynthetic processing defect of CFTR. Correction of the defect and delivery of DF508-C...
Description : The level of neutralizing antibodies (NtAb) induced by vaccine inoculation is an important endpoint to evaluate the efficacy
of EV71 vaccine. In order to evaluate the efficacy of EV71 vaccine, here, we reported the development of a novel
pseudovirus system expression firefly luciferase (PVLA) for the quantitative measurement of NtAb. We first evaluated and
validated the sensitivity and specificity of the PVLA method. A total of 326 serum samples from an epi...