There are about 10560 clinical studies being (or have been) conducted in Taiwan. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Portfolios are the records of learning process, providing evidences of experiential learning. It can be a valuable tool not only for understanding the learning process but also for evaluating the accomplishment. Portfolios promote learners to reflecting, thinking, improving in learning as well as achieving learning goals. It has been widely applied in medical education. The goals of resident training outcomes in Wan-Fang Hospital are the ACGME six core competences. The Wan-Fang hospital, one of Taipei Medical University affiliated hospitals and the first implementing portfolio assessment teaching hospitals in Taiwan, will conduct portfolio assessment to assess residents competences. Facilitating residents bring reflective learning into practice, personal and professional growth and demonstrating the outcomes of training program. This study describes initiating and implementing portfolio assessment procedures. Qualitative and quantitative research methods are applied for evaluating the portfolio assessment process and the data of validity and reliability. Qualitative data collection methods of interview, focus groups and meetings will be used understanding the experiences and viewpoints of residents, mentors and assessors. Then quantitative data collection method of questionnaire will be subsequently used. The results of this study will provide experiences and suggestions for the implementation of portfolio assessment system in medical education.
Currently, most knee meniscal tears are treated by partial or complete meniscectomy, or by suture repair when it is possible. Recently, the investigators have successfully developed and implanted a novel biomaterial, platelet-rich fibrin (PRF), to treat articular cartilage defect in pigs. The PRF is autogenesis as a natural fibrin-based biomaterial favorable to the development of microvascularization and enables local and progressive delivery of growth factors providing unique properties for tissue remodeling and wound healing. The advantages of using PRF implantation include no transplant rejection and no need to perform second operation. Knee meniscal repair using PRF has not been reported before. The aim of this study is to investigate whether PRF implantation can facilitate regeneration process of meniscectomized knee and T2-map MRI can monitor the process in those patients with meniscal tears. A total of 18 adult patients with torn menisci (outer 1/3, posterior horn, medial meniscus) will be recruited and randomly divided into three groups: A (n=6), implantation of PRF after partial menisectomy; B (n=6), implantation of PRF after partial menisectomy and suture; C (n=6), partial menisectomy only. All studied knee will be scanned on a 1.5-T MRI with surface coil at baseline before surgery, 3 months and 6 months and 12 months after surgery. The investigators believe that PRF enables to facilitate regeneration of meniscectomized knee, and T2-map MRI enables monitoring healing process of meniscal tears.
This project aims to analyze and compare the prevalence of breastfeeding at one hour after delivery, discharge from hospital, one month, two months, four months, and six months after delivery and to examine factors associated with breastfeeding between baby-friendly hospitals and non baby-friendly ones. Employing a prospective cohort design, the study population is mothers who gave lived births in Taiwan area from August, 2009 to March, 2010. At least 11 hospitals both in non baby-friendly and baby-friendly hospitals from northern, middle, southern and east areas will be asked for permission to join this study (totally 22 hospitals). The research assistants will contact each eligible participant in the hospitals and explained the purposes and procedure of the study. Once permission was obtained, mothers will be asked to write a questionnaire and their telephone numbers as well as address for future contacts. After the individual case returned home, the collection of data was mainly via telephone interviews. However, if the individual case could not be contacted more than two times via telephone, she would be surveyed by questionnaire. The collection of data showed the state of mother milk feeding one month, two months, four months, or six months after delivery. 1, 000 effective questionnaires were expected to be returned (500 ones from baby friendly hospitals; 500 ones, from non baby-friendly hospitals.) The survey include questions on breastfeeding experiences (one hour after delivery, discharge from hospital, one month, two months, four months, and six months), planned duration of breastfeeding, socio-demographic information, perceived baby-friendly practices at hospital, social support regarding breastfeeding, prior infant feeding method, maternal and infant health conditions, mother's working plan, receipt of formula samples and commercial message during perinatal period. The researcher hopes that based on the research results we can have a better understanding of the influencing factors of promoting mother milk feeding in non baby-friendly hospitals, and that we know how to raise the breastfeeding rate in Taiwan area, which can serve as references for the governmental policies.
Schizophrenia (SCH) is a devastating brain disorder with grave personal, family and social cost. SCH is a complex and heterogeneous (both genetic and clinical) disorder with oligogenetic endowed vulnerability risk of disease, which manifested as a clinical syndrome comprised of positive, negative and cognitive symptoms in late adolescent or young adulthood under the interaction with environmental stress. The fact that most positive psychotic symptoms can be well controlled by dopamine-blocking antipsychotics substantiates that dopamine hyperactivity is the pathophysiological model of SCH positive symptoms. This is the dopamine model of SCH. The presence of negative and cognitive symptoms has not being fully explained by the dopamine model. The hypo-glutaminergic function was hypothesized to replace or to supplement the dopamine pathological model. The hypo-glutaminergic state was due to a neurodevelopmental disturbance in early-stage of life, and was coined as a pathophysiological mechanism of SCH. The neurodevelopmental disturbance supports the hypo-glutamine model based on the cytoarchitecture abnormality in glutamate-pyramidal cells and reduced gray matter volume. We have found potential vulnerability genes of DISC1 and NRG1 in our Taiwanese SCH family samples. These two genes have functions on neurodevelopmental process. Besides, we, the investigators, also found two vulnerability genes of DRD2 receptor gene and COMT genes in our Taiwanese SCH families. The dopamine neurotransmission disturbance could be another pathophysiological mechanism of SCH. With the awareness of confounding variables of antipsychotic treatment response revealed in pharmacogenetic studies, such as drug metabolism related genes and plasma HVA level, we intend to test the etiological genetic hypotheses in antipsychotic treatment response: (1) The group of neurodevelopmental etiology with risk variations in DISC1 and NRG1 genes is of poor treatment response group; (2) The group of pure hyperdopamine etiology with risk variation in DRD2 receptor and COMT genes is of good treatment group. The potential treatment response related biomarkers, which are directly or indirectly induced by the etiological risk genetic variations, will be examined. These potential biomarkers include homovanillic acid (HVA), glutamate, serotonin, cytokines, and signaling proteins, the neurocognitive function, event-related evoked potential, Niacin skin test, and the AKT1 level in the peripheral lymphocytes. After obtained the informed consult, we'll recruit 30 drug-naïve early schizophrenia (first episode or prodromal stage) patients for pre-treatment and post-treatment assessment on treatment response using positive and negative syndrome scale (PANSS), changes in biomarkers (including biochemical, electro-physiological and neuro-cognitive variables), and brain imaging (studies of component Project No.2 of this Integrated Program) of PET, fMRI, MRI, DSI and MRS (please refer to Project No.2) in addition to genotyping on DISC1, NRG1, DRD2 and COMT genes. The treatment agent is the dopamine stabilizing agent (aripiprazole, 15mg/day for 4 weeks) taking the advantage of dopamine activity balancing effect. Besides, we'll recruit 30 normal controls matched with age, gender, and education, who will receive genotyping and evaluations in all biomarker variables, and brain imaging studies. In order to have adequate statistical power in the genetic analysis of 17 SNP variations in 4 vulnerability genes of DISC1, NRG1, DRD2, COMT, we'll recruit 200 more cases of schizophrenia with duration of illness less than 5 years, who have received regular clinical follow up and had good compliance on medication. The treatment response will be evaluated using PANSS. These cases will also receive all biomarker examinations and genotyping studies. For comparison, we'll also recruit 100 normal controls for study. We'll delineate the heterogeneity issue of schizophrenia using genetic variation, neurobiological biomarkers. This study result will be beneficial for understanding pathogenesis of SCH, and for developing better treatment and prevention methods.
Type 2 diabetes is associated with a markedly increased risk for atherosclerotic coronary arteries and cerebrovascular diseases. The major cause of death in diabetic patients is cardiovascular disease in the world including Taiwan. Atherosclerosis is a progressive disease characterized by the response of the vessel wall to chronic, multifactorial injury, which leads ultimately to the formation of atheromatous or fibrous plaques. Endothelial dysfunction is thought to be the initial stage of atherosclerosis. Endothelial dysfunction leads to impaired control of vascular tone, a decreased in the release of anti-inflammatory factors and reduced availability of nitric oxide. Endothelial dysfunction portends diabetic vasculopathy. The loss of intact endothelial integrity and function sets in motion a cascade of serial events that lead to atherosclerosis and cardiovascular complications. The standard extracts of G. biloba leaves [G. biloba extract (GBE)] are now demonstrated the cardiovascular, cerebrovascular and neuroprotective effects. The mixture of biologically active ingredients in GBE accounts for the pleiotropic effects, including antioxidant effects, inhibition of platelet aggregation and thromboxane B2 production, vasodilation and modulation of cholesterol metabolism. Clinically, GBE was widely used in management of vertigo、dementia and improving peripheral circulation. In our previous study, ginkgo biloba extract inhibits tumor necrosis factor-alpha-induced reactive oxygen species generation, transcription factor activation, and cell adhesion molecule expression in human aortic endothelial cells. In addition, the similar benefit of prevention atherosclerosis was also found in animal study. Heme oxygenase-1 (HO-1) is a factor associated with higher risk of developing some vascular disease and also a rate-limiting enzyme in heme degradation, leading to the generation of free iron, biliverdin, and carbon monoxide (CO). CO exerts potent antiproliferative and anti-inflammatory effects in the vascular walls, thereby influencing neointimal formation after vascular injury. In addition, biliverdin is subsequently metabolized to bilirubin by the enzyme biliverdin reductase. Therefore, induction of HO-1 elicits potent anti-inflammatory, antiproliferative, antithrombotic, and antioxidant effects in the circulation via the generation of CO and bilirubin. Interestingly, recent study found that a long guanidine thymidine dinucleotide repeat [(GT) n≧ 30] in the HO-1 promotor, which is linked to impaired inducibility, is associated with a higher frequency of vascular access failure. In the present study, we will investigate the effect of GBE on recovering endothelial dysfunction and inflammation in diabetic patients with stable coronary artery disease. In particularly, we intend to determine whether the GBE modulates the HO-1 expression and investigate whose genotyping including some candidate gene about atherosclerosis and hypertension will have most therapeutic effect of GBE.
Under environmental intervention programs, to explore the associations between Environmental Tobacco Smoke (ETS) and changes of pulmonary function, cytokines and new-onset asthma between different groups.
The aim of this research project is to establish a students' perspective to most medical schools in Taiwan. We expect that these surveys will provide helpful information to candidates for selection of medical school before admission, and will also be a useful reference guide to improve quality of medical education to our governmental policy makers.
This phase III study is designed to examine if low-risk, as defined by clinical and radiological parameters, stage IB-IIB cervical cancer patients treated by cisplatin-based chemoradiation, which is a recommended method by today's standard, have greater toxicities but similar survival rate as those treated by radiotherapy (RT) alone. Patients will be primarily treated with radiotherapy with same protocol, but without concurrent chemotherapy in the control arm, and with weekly cisplatin (40 mg/M2) for 6 courses in the study arm. This study will be conducted at all branches of Chang Gung Memorial Hospital except Chia-I. Patients will be randomized to either arm after stratification of risk factors. Each arm will recruit 104 patients who have no LN and systemic metastasis as defined by CT/MRI and FDG-PET. The primary end point is grade 3-5 late toxicities, and secondary end points are 1) recurrence free survival; 2) acute toxicity of treatments; 3) sites of recurrence; 4) quality of life; 5) total treatment time. It is expected to take 5 years to recruit enough case number.
The investigators propose that clinical pharmacist interventions would reduce the rate of adverse drug events in elderly patients taking potentially inappropriate medication.
Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, in patients with advanced cervical cancer, half of them treated with contemporary radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation. The major aim of this project is to conduct a prospective, randomized phase III clinical trial to examine if cervical cancer patients treated by radiotherapy with cisplatin and gemcitabine have better survival rates than those treated by radiotherapy with cisplatin alone. Gemcitabine has been demonstrated to be a good radiosensitizer. In keeping with this, few clinical trials in early phases showed promising results when using concurrent radiotherapy with cisplatin and gemcitabine. According to these positive results, the investigators expect this trial has the potential to improve the survival in patients with advanced cervical cancer, reduce the medical costs due to tumor relapse, and then benefit the whole society.