Current Issue : October - December Volume : 2016 Issue Number : 4 Articles : 6 Articles
Background: Hypertensive intracerebral hemorrhage (HICH) is one of the most\ndevastating forms of stroke. Currently, no specific therapies for HICH except general\nmedical care. However, in China, medicine of promoting blood circulation (PBC) and\nremoving blood stasis (RBS) are widely and efficiently used to treat HICH and become\na potentially effective treatment for the secondary effects of HICH to alleviate brain\ninjury, accelerate neuronal recovery, and improve the prognosis. In order to evaluate\nthe safety and effect of PBC and RBS herbal drugs, we design a prospective, randomized,\nopen, double-blind controlled clinical trial on the hematoma enlargement in\nHICH patients treating with PBC and RBS herbal medicine within 6 h time window from\nthe symptom onset.\nMethods/design: A multicenter, three-group, prospective, randomized, doubleblinded\nand placebo-controlled clinical trial. Patients aged 18 or older with HICH\nconfirmed by CT scan within 6 h from the onset are included. 360 patients will be\nrandomized to 3 groups (PBC & RBS & Placebo) within 6 h of ictus. Stratified block\nrandomization is undertaken using a sequentially numbered and opaque envelope.\nAll subjects must take medicine within 6 h of ictus and have another CT scan at about\n24 h to confirm hematoma expansion. A postal questionnaire to the patients to evaluate\ntheir recorvery at 3 months. Primary outcome is the percent change in the volume\nof hematoma at 24 h. Secondary outcomes include: mortality, disability, serious adverse\nevents, etc.\nConclusions: The CRRICH Trial is expected to confirm the safety and effect of acute\nintracerebral hemorrhage treated within 6 h of ictus with ââ?¬Å?RBSââ?¬Â therapy and to determine\nwhether the traditional therapy can cause hematoma growth after intracerebral\nhemorrhage.\nDiscussions: This is the first prospective, multicenter, randomized, placebo-controlled\nclinical trial to investigate herbal medicine whether can induce the incidence of hematoma\nenlargement of AICH patient within the 6 h time window from onset. We need\nthe data to keep the herbal clinical usage safety....
Coding is an instrument which helps in bringing uniformity to the complete practice. Medical coding is compulsory mandate in many parts of the world, mainly USA and Canada. Medical coding is in itself a very professional aspect of medical practice. It helps in bringing harmonization to the practice and helps to remove the fault reporting in medical profession. Clinical trials are an important part of drug research which is often amalgamated with the medical practice. Regions other than America are becoming hot spots with respect to clinical research and clinical trial perspective. Though certain areas under clinical trials and clinical research, coding is compulsory but it is somehow restricted to clinical data management especially in the region of “Data Review and Discrepancy Management”. The present letter especially focuses on bringing coding to complete clinical research and clinical trial perspective, hence bringing in clearer harmonization in clinical trials and clinical research thus restricting the fraud claims by the investigators and sponsors to bring false products in the market through false FDA approvals....
Background: Duchenne muscular dystrophy (DMD) is the most commonly inherited neuromuscular disease.\nTherapeutic agents for the treatment of rare disease, namely ââ?¬Å?orphan drugsââ?¬Â, have recently drawn the attention of\nresearchers and pharmaceutical companies. To ensure the successful conduction of clinical trials to evaluate novel\ntreatments for patients with rare diseases, an appropriate infrastructure is needed. One of the effective solutions for\nthe lack of infrastructure is to establish a network of rare diseases.\nMethods: To accomplish the conduction of clinical trials in Japan, the Muscular dystrophy clinical trial network\n(MDCTN) was established by the clinical research group for muscular dystrophy, including the National Center of\nNeurology and Psychiatry, as well as national and university hospitals, all which have a long-standing history of\nresearch cooperation.\nResults: Thirty-one medical institutions (17 national hospital organizations, 10 university hospitals, 1 national center,\n2 public hospitals, and 1 private hospital) belong to this network and collaborate to facilitate clinical trials. The Care\nand Treatment Site Registry (CTSR) calculates and reports the proportion of patients with neuromuscular diseases in\nthe cooperating sites. In total, there are 5,589 patients with neuromuscular diseases in Japan and the proportion of\npatients with each disease is as follows: DMD, 29 %; myotonic dystrophy type 1, 23 %; limb girdle muscular\ndystrophy, 11 %; Becker muscular dystrophy, 10 %. We work jointly to share updated health care information and\nstandardized evaluations of clinical outcomes as well. The collaboration with the patient registry (CTSR), allows the\nMDCTN to recruit DMD participants with specific mutations and conditions, in a remarkably short period of time.\nConclusion: Counting with a network that operates at a national level is important to address the corresponding\nnational issues. Thus, our network will be able to contribute with international research activity, which can lead to\nan improvement of neuromuscular disease treatment in Japan....
Background: It has been observed that the efficacy of dipeptidyl peptidase-4 (DPP-4) inhibitors as compared to\nthe placebo groups in some clinical trials conducted in China is weaker than that in trials conducted outside China,\nleading to the suspicion that this may be caused by differential Glycosylated Hemoglobin (HbA1c) response in the\nplacebo arm of DPP-4 inhibitor clinical trials conducted in China compared to other countries.\nMethods: We searched published articles and other documents related to phase III placebo-control trials of DPP-4\ninhibitors in Type 2 diabetes mellitus (T2DM). We included studies from different countries and compared those\nconducted in China to those conducted in other countries. Meta-regression analysis was used to analyze the HbA1c\nresponse in the placebo arms.\nResults: A total of 66 studies met the inclusion criteria and 10 were conducted within China. There were a total of 8303\nparticipants (mean age 56, male 57 %) in placebo groups. The pooled change in HbA1c for the placebo groups of 10\ntrials conducted in patients with T2DM in China was 0.26 % (95 % CI [-0.36 %, -0.16 %], p-value < 0.001), compared to\n0.015 % (95 % CI [-0.05 %, 0.08 %], p-value is 0.637) for 56 trials conducted outside of China. The difference of placebo\neffect between trials conducted in and outside China is -0.273 % (95 % CI [-0.42 %, -0.13 %], p-value is less than 0.001)\nwhile after excluding trials conducted in Japan, the difference is -0.203 % (95 % CI [-0.35 %, -0.06 %], p-value is 0.005).\nThey are both statistically significant.\nConclusions: The meta-analysis in the article demonstrates that there is statistically significant difference in the HbA1c\nresponse in the placebo arm of DPP-4 inhibitor clinical trials conducted in China compared to other countries. This\ndifferential HbA1c response in the placebo arm should be taken into consideration by both experimenters and medical\ndecision makers when future DPP-4 studies are conducted in China....
Background: Studies have been reported that cyclin-dependent kinase5 (CDK5) was associated with the development\nof several cancers. However, the relationship between CDK5 level and clinicopathological factors is still poorly\nunderstood in cervical diseases. The aim of the current study was to investigate the expression of CDK5 and its clinical\nsignificance in variant cervical lesions.\nMethods: Immunohistochemistry (IHC) was used to detect CDK5 expression in 54 cases of chronic cervicitis, 42\ncases of condyloma acuminate (CA), 38 cases of carcinoma in situ, and 360 cases of cervical cancers [adenocarcinoma,\nn = 63; squamous cell carcinoma (SCC), n = 263; adenosquamous carcinoma, n = 34]. The clinicopathological characteristics\nin relation to CDK5 were examined by Pearson�s Chi-square test.\nResults: The positive rates of CDK5 were 27.8, 31.0, 50, 54.0, 58.8, and 62.7 % in chronic cervicitis, CA, carcinoma\nin situ, adenocarcinoma, adenosquamous carcinoma and SCC, respectively. Statistically analysis showed that CDK5\nexpression in cervical cancer tissues was higher than non-cervical cancer tissues (inflammation and CA) (P < 0.001).\nThe overexpression of CDK5 was significantly correlated with lymph node metastasis (r = 0.317; P < 0.001), histological\ntype (r = 0.198; P < 0.001), FIGO stage (r = 0.358; P < 0.001), TNM stage (r = 0.329; P < 0.001) and pathological\ngrade (r = 0.259; P < 0.001) in cervical lesions evaluated by Pearson�s Chi-square test. Furthermore, the positive\nrelationships were found between CDK5 and lymph node metastasis (P < 0.001), FIGO stage (P < 0.001), TNM stage\n(P < 0.001) and pathological grade (P < 0.001) in SCC. CDK5 was positively interrelated to TNM stage (P = 0.017) in\nadenosquamous carcinoma.\nConclusions: CDK5 may play a vital role in the development of cervical cancer, which may be a marker for the diagnosis,\ntherapy and prognosis of cervical cancer....
Poly(ADP-ribose) polymerase (PARP) inhibitors have proven to be successful agents in inducing synthetic lethality in several\nmalignancies. Several PARP inhibitors have reached clinical trial testing for treatment in different cancers, and, recently, Olaparib\n(AZD2281) has gained both United States Food and Drug Administration (USFDA) and the European Commission (EC) approval\nfor use in BRCA-mutated advanced ovarian cancer treatment. The need to identify biomarkers, their interactions in DNA damage\nrepair pathways, and their potential utility in identifying patients who are candidates for PARP inhibitor treatment is well\nrecognized. In this review, we detail many of the biomarkers that have been investigated for their ability to predict both PARP\ninhibitor sensitivity and resistance in preclinical studies as well as the results of several clinical trials that have tested the safety and\nefficacy of different PARP inhibitor agents in BRCA and non-BRCA-mutated cancers....
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