• Title/Summary/Keyword: Prospective registry

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A 10-year Study of Esophageal Cancer in Guilan Province, Iran: The Guilan Cancer Registry Study (GCRS)

  • Mansour-Ghanaei, Fariborz;Heidarzadeh, Abtin;Naghipour, Mohammad Reza;Joukar, Farahnaz;Valeshabad, Ali Kord;Fallah, Mohammad-Sadegh;Rezvani, Seyed Mahmoud;Sedigh-Rahimabadi, Massih;Rokhshad, Hasan;Dadashi, Arsalan
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.12
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    • pp.6277-6283
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    • 2012
  • Background: Northern Iran counts as one of the highest prevalence regions for esophageal cancer (EC) worldwide. This study was designed to assess the epidemiologic aspects of EC in north central and northwest Iran over a 10 year period. Materials and Methods: The Guilan cancer registry study (GCRS) is a population-based cancer registry study featuring retrospective (1996-2003) and prospective (2004-2005) phases. A detailed questionnaire based on WHO standards for cancer registratration was applied to gather the required information. Two trained physicians coded information using ICD-O-3 in close coordination with an expert pathologist. Results: A total of 19,936 cases of malignancy (mean age $55.4{\pm}18.0$ years, range: 1-98 years) were registered, including 1,147 cases (670 males, 447 female; mean age: $64.0{\pm}11.5$ years) of EC. In 1996 the male/female ratio among patients with EC was 1.25 which increased to 1.53 in 2005. The lower third of the esophagus still remained the most common site of tumors. The average age-standardized rate (ASR) was 6.9 and 4.1 per $10^5$ men and women, respectively. In 1996, the ASRs were 7.2 and 5.2 per $10^5$ men and women which decreased to 6.9 and 4.1 per $10^5$ in 2004-2005. Squamous cell carcinoma (SCC) was the most prevalent histological subtype of EC accounting over 80% of cases. Conclusions: However the prevalence of adenocarcinoma (ADC) showed an increase to 18.4%. Guilan province may be considered a relatively low incidence region for EC.

Effects of Acupuncture Stimulation on the Radial artery's Pressure Pulse Wave in Healthy Young Participants: Protocol for a prospective, single-Arm, Exploratory, Clinical Study

  • Shin, Jae-Young;Ku, Boncho;Kim, Tae-Hun;Bae, Jang Han;Jun, Min-Ho;Lee, Jun-Hwan;Kim, Jaeuk U.
    • Journal of Pharmacopuncture
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    • v.19 no.3
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    • pp.197-206
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    • 2016
  • Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery's pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz ($SE_{10-30Hz}$) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University's Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number: This trial was registered with the Clinical Research Information Service (CRIS) at the Korea National Institute of Health (NIH), Republic of Korea (KCT0001663), which is a registry in the World Health Organization's (WHO's) Registry Network.

Prostate Cancer Incidence in Turkey: An Epidemiological Study

  • Zorlu, Ferruh;Divrik, Rauf Taner;Eser, Sultan;Yorukoglu, Kutsal
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.21
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    • pp.9125-9130
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    • 2014
  • Background: This study aimed to determine the incidence of prostate cancer in Turkey in a population-based sample, and to determine clinical and pathological characteristics of the cases. Materials and Methods: All newly diagnosed prostate cancer patients were included in this national, multi-centered, prospective and non-interventional epidemiological registry study conducted in 12 cities representing the 12 regions of Turkey from July 2008 to June 2009. The population-based sample comprised 4,150 patients with a recent prostate cancer diagnosis. Results: Age-adjusted prostate cancer incidence rate was 35 cases per 100,000 in Turkey. At the time of diagnosis, median age was 68, median PSA level was 10.0 ng/mL. Digital rectal examination was abnormal in 36.2% of 3,218 tested cases. Most patients had urologic complaints. The main diagnostic method was transrectal ultrasound guided biopsy (87.8%). Gleason score was ${\leq}6$ in 49.1%, 7 in 27.8% and >7 in 20.6% of the cases. There was a statistically significant positive correlation between serum PSA level and Gleason score (p=0.000). The majority of patients (54.4%) had clinical stage T1c. Conclusions: This is the first population-based national data of incidence with the histopathological characteristics of prostate cancer in Turkey. Prostate cancer remains an important public health concern in Turkey with continual increase in the incidence and significant burden on healthcare resources.

Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocol

  • Kim, Jihye;Kim, Hyunho;Kim, Keun Ho
    • Integrative Medicine Research
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    • v.6 no.3
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    • pp.317-324
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    • 2017
  • Background: Bu-Zhong-Yi-Qi-Tang (BZYQT) has long been used for the treatment of severe weakness caused by general fatigue, loss of appetite, or indigestion. The aim of this feasibility study is to assess the effectiveness and safety of BZYQT for the treatment of functional dyspepsia (FD) with spleen qi deficiency. Methods: This study will be conducted at a single center as a prospective, nonrandomized, nonblinded, single-arm feasibility study. A total of 30 participants diagnosed with FD in accordance with the Rome III criteria will be enrolled. All patients will receive BZYQT for 4 weeks. The primary outcome is the change in the Nepean Dyspepsia Index-Korean version (NDI-K) scores between the baseline and 4-week images. The secondary outcomes include the tongue coating thickness, blood parameters, and BZYQT Questionnaire score. The NDI-K score will be acquired four times, at Weeks 0 (baseline), 2 (during treatment), 4 (after treatment), and 8 (after follow-up). Written informed consent will be obtained from all study participants prior to enrollment. This study has been approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital. This study protocol is registered with the national clinical trial registry of the World Health Organization International Clinical Trials Registry Platform. Results will be published in a journal and will be disseminated both electronically and in print. Discussion: The results of this study may serve as a guide for researchers seeking to effectively evaluate the effects of BZYQT.

Non-Randomized Confirmatory Trial of Laparoscopy-Assisted Total Gastrectomy and Proximal Gastrectomy with Nodal Dissection for Clinical Stage I Gastric Cancer: Japan Clinical Oncology Group Study JCOG1401

  • Kataoka, Kozo;Katai, Hitoshi;Mizusawa, Junki;Katayama, Hiroshi;Nakamura, Kenichi;Morita, Shinji;Yoshikawa, Takaki;Ito, Seiji;Kinoshita, Takahiro;Fukagawa, Takeo;Sasako, Mitsuru
    • Journal of Gastric Cancer
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    • v.16 no.2
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    • pp.93-97
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    • 2016
  • Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospective study evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japanese institutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints are overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. The UMIN Clinical Trials Registry number is UMIN000017155.

Tobacco Related Habits among First Degree Relatives of Patients Undergoing Surgery for Advanced Head and Neck Malignancies in India

  • Balagopal, P.G.;George, N.A.;Venugopal, A.;Mathew, A.;Ahamed, M. Iqbal;Sebastian, P.
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.1
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    • pp.217-220
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    • 2012
  • This prospective study records the tobacco related habits among the relatives of patients with advanced head and neck cancers who underwent both surgery and chemotherapy as part of their treatment from September 2009 to March 2010. A total of 200 relatives were interviewed (148 males and 52 females). 198 (99%) were aware of the fact that tobacco use can lead to cancer and 168 (84%) had any one of the habits. Smoking alone was reported in 36 (18%) individuals, pan chewing alone in 66 (33%) and multiple habits in 64 (32%). Alcohol and tobacco chewing alone was reported in one case each. There were change in habits following diagnosis of head and neck cancers among the relatives, 33 (16.5%) stopped their habits and smoking was reduced by 25% in 72 (36%)and by 50% in 63 (31.2%) individuals. However, 135 continued the habit even after the diagnosis of cancer in their relatives. Of note, 15 out of the 33 who quit the habit did it because of health advice given to them during the hospital visit.

Epidemiologic Study of Geriatric Cerebrovascular Accident Inpatients (노인 뇌졸중 입원환자의 역학적 연구)

  • Kim, Su-Il;Lee, Mi-Young
    • Physical Therapy Korea
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    • v.12 no.2
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    • pp.98-104
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    • 2005
  • This study was done to research the general information, causes of stroke, risk factors, complications during admission of geriatric CVA inpatients. We retrospectively studied 208 above 65 years old geriatric CVA inpatients treated in Ajou university hospital from 1994 to 2003 by medical record. These were divided into two groups by following years. We were gathered information about sex, onset age, cause of stroke, number of stroke, complications, housing, family, insurance, smoking, alcohol. Most of incidence of the stroke was noted in the group of young old age (65~74 years old) and old age (75~84 years old). The occurrence rate of male stroke (38.5%) was less than of female stroke (61.5%) and the ratio of male to female was 1:1.6. The occurrence rate of ischemic stroke (72.6%) was higher than of hemorrhagic stroke. The occurrence rate of ischemic stroke increased more and more at the late stage. The most common risk factors for stroke was hypertension and complications during hospitalization were neurogenic bowl and bladder. These results of epidemiologic study may help above 65 years old geriatric CVA early treatment and prevention, rehabilitation and use basic data for multiple prospective study using stroke registry.

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Reproductive Risk Factors for Thyroid Cancer: A Prospective Cohort Study in Khon Kaen, Thailand

  • Sungwalee, Wararat;Vatanasapt, Patravoot;Kamsa-ard, Siriporn;Suwanrungruang, Krittika;Promthet, Supannee
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.9
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    • pp.5153-5155
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    • 2013
  • Background: Because of the gender disparity in the incidence of thyroid cancer, this study aimed to determine the association between reproductive factors and thyroid cancer. Methods: A total of 10,767 eligible women from the Khon Kaen Cohort, recruited and interviewed between 1990 and 2001, were followed up until 2011. The data were linked to the Khon Kaen Population-Based Cancer Registry to detect thyroid cancer cases. Results: There was 17 thyroid cancer cases detected, an incidence of 11.2 per 100,000 person-years, of which 70.6 % were papillary tumors. The incidence was apparently greater among those with an early age of menarche, nulligravida women, and oral contraceptive users. Conlusions: There was a trend for thyroid cancer to develop in relation to longer estrogen exposure. This evidence is inconclusive but warrants further investigation.

Hypogonadal men with moderate-to-severe lower urinary tract symptoms have a more severe cardiometabolic risk profile and benefit more from testosterone therapy than men with mild lower urinary tract symptoms

  • Saad, Farid;Doros, Gheorghe;Haider, Karim Sultan;Haider, Ahmad
    • Investigative and Clinical Urology
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    • v.59 no.6
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    • pp.399-409
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    • 2018
  • Purpose: To analyze data from an observational, prospective, cumulative registry study in 805 hypogonadal men stratified by mild or moderate-to-severe lower urinary tract symptoms (LUTS) according to International Prostate Symptom Score. Materials and Methods: A total of 412 men underwent testosterone therapy (TTh) with injectable testosterone undecanoate, 393 men served as untreated controls. Measures of urinary function, anthropometric and metabolic parameters were performed at least twice per year. Results: Data from 615 men with mild LUTS (253 treated, 362 untreated) and 190 with moderate-to-severe LUTS (159 treated, 31 untreated) were available. During a follow-up period of 8 years a significant improvement of LUTS was noted for all TTh-patients whereas the control-groups showed deterioration or fluctuation around initial values. Despite advancing age, TTh fully prevented worsening of symptoms. In parallel, a considerable improvement of anthropometric parameters, lipids and glycemic control, blood pressure, C-reactive protein, and quality of life was found. Moderate-to-severe LUTS was associated with worse cardiometabolic risk profile at baseline as well as worse cardiovascular outcomes during follow-up in comparison to mild LUTS. Effect size of TTh was more pronounced in men with moderate-to-severe than with mild LUTS. Conclusions: Correcting hypogonadism by TTh is highly effective and safe for improving LUTS in hypogonadal men. TTh may also improve cardiometabolic risk and major adverse cardiovascular events.

Protocol of a Nationwide Observational Study among Patients with Nontuberculous Mycobacterium Pulmonary Disease in South Korea (NTM-KOREA)

  • Kwak, Nakwon;Choi, Hongjo;Jeon, Doosoo;Jhun, Byung Woo;Jo, Kyung-Wook;Kang, Young Ae;Kwon, Yong-Soo;Lee, Myungsun;Mok, Jeongha;Shim, Tae-Sun;Shin, Hong-Joon;Whang, Jake;Yim, Jae-Joon
    • Tuberculosis and Respiratory Diseases
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    • v.83 no.2
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    • pp.141-146
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    • 2020
  • Background: The burden of nontuberculous mycobacterial (NTM) pulmonary disease (PD) is increasing globally. To understand the treatment outcomes and prognosis of NTM-PD, a unified registry is needed. In this project, we aim to construct a multicenter prospective observational cohort with NTM-PD in South Korea (NTM-KOREA). Methods: The primary objective of this study is to analyze treatment outcomes according to the species. In addition, recurrence rate, adverse events, the impact of each drug on treatment outcomes as well as the impact of characteristics of mycobacteriology will be analyzed. The inclusion criteria for the study are as follows: fulfilling the criteria for NTM-PD having one of the following etiologic organisms: Mycobacterium avium complex, M. abscessus subspecies abscessus, M. abscessus subspecies massiliense, or M. kansasii; receiving the first treatment for NTM-PD after enrollment; age >20 years; and consenting to participate in the study. Seven institutions will participate in patient enrollment and about 500 patients are expected to be enrolled. Participants will be recruited from 1 March 2020 until 19 March 2024 and will be observed through 19 March 2029. During the follow-up period, participants' clinical course will be tracked and their clinical data as well as NTM isolates will be collected. Conclusion: NTM-KOREA will be the first nationwide observational cohort for NTM-PD in South Korea. It will provide the information to optimize treatment modalities and will contribute to deeper understanding of the treatment outcomes and long-term prognosis of patients with NTM-PD in South Korea.