• 제목/요약/키워드: e-Clinical Trials

검색결과 152건 처리시간 0.027초

Targeting the Epithelium-Derived Innate Cytokines: From Bench to Bedside

  • Jongho Ham;Jae Woo Shin;Byeong Cheol Ko;Hye Young Kim
    • IMMUNE NETWORK
    • /
    • 제22권1호
    • /
    • pp.11.1-11.26
    • /
    • 2022
  • When epithelial cells are exposed to potentially threatening external stimuli such as allergens, bacteria, viruses, and helminths, they instantly produce "alarmin" cytokines, namely, IL-33, IL-25, and TSLP. These alarmins alert the immune system about these threats, thereby mobilizing host immune defense mechanisms. Specifically, the alarmins strongly stimulate type-2 immune cells, including eosinophils, mast cells, dendritic cells, type-2 helper T cells, and type-2 innate lymphoid cells. Given that the alarm-raising role of IL-33, IL-25, and TSLP was first detected in allergic and infectious diseases, most studies on alarmins focus on their role in these diseases. However, recent studies suggest that alarmins also have a broad range of effector functions in other pathological conditions, including psoriasis, multiple sclerosis, and cancer. Therefore, this review provides an update on the epithelium-derived cytokines in both allergic and non-allergic diseases. We also review the progress of clinical trials on biological agents that target the alarmins and discuss the therapeutic potential of these agents in non-allergic diseases.

Current Status and Future Direction of Immunotherapy in Hepatocellular Carcinoma: What Do the Data Suggest?

  • Hye Won Lee;Kyung Joo Cho;Jun Yong Park
    • IMMUNE NETWORK
    • /
    • 제20권1호
    • /
    • pp.11.1-11.14
    • /
    • 2020
  • Most patients with hepatocellular carcinoma (HCC) are diagnosed at an advanced stage of disease. Until recently, systemic treatment options that showed survival benefits in HCC have been limited to tyrosine kinase inhibitors, antibodies targeting oncogenic signaling pathways or VEGF receptors. The HCC tumor microenvironment is characterized by a dysfunction of the immune system through multiple mechanisms, including accumulation of various immunosuppressive factors, recruitment of regulatory T cells and myeloid-derived suppressor cells, and induction of T cell exhaustion accompanied with the interaction between immune checkpoint ligands and receptors. Immune checkpoint inhibitors (ICIs) have been interfered this interaction and have altered therapeutic landscape of multiple cancer types including HCC. In this review, we discuss the use of anti-PD-1, anti-PD-L1, and anti-CTLA-4 antibodies in the treatment of advanced HCC. However, ICIs as a single agent do not benefit a significant portion of patients. Therefore, various clinical trials are exploring possible synergistic effects of combinations of different ICIs (anti-PD-1/PD-L1 and anti-CTLA-4 antibodies) or ICIs and target agents. Combinations of ICIs with locoregional therapies may also improve therapeutic responses.

야제 (夜啼)의 한의학 치료에 대한 최신 중의학 임상 연구 동향 -2000년대 이후 발표된 임상 연구 논문을 중심으로- (Review of Clinical Research Literatures on Effect of Traditional Chinese Medicine for Pediatric Night Crying)

  • 김상민;이진용;이선행;도태윤
    • 대한한방소아과학회지
    • /
    • 제32권3호
    • /
    • pp.100-118
    • /
    • 2018
  • Objectives The purpose of this study is to analyze some of the TCM (traditional Chinese medicine) clinical research literatures about pediatric night crying in order to learn clinical application of Korean medicine treatment for pediatric night crying. Methods We searched clinical trial literatures about TCM treatment of pediatric night crying from the CNKI (China National Knowledge Infrastructure) (January 2000 to June 2018). We analyzed the literature in regards to the treatment methods and the results. Results Among the 459 searched studies, 13 randomized controlled trials and 41 case studies were selected and analyzed. In most of the studies, the effectiveness of TCM in treating patients was significantly high, so we confirmed the effectiveness of TCM on pediatric night crying. The most commonly used pattern differentiations (辨證) were Spirit damage due to fright and fear (驚恐傷神), Spleen deficiency and cold (脾虛寒) and Heart fire heat (心火熱). Methods of treatment include herbal medicines (internal medicine and external application), massage therapy (Tuina methods), acupuncture and other treatments (bloodletting). The most commonly used herb medicines were Cicadidae Periostracum (蟬?), Poria Cocos (茯?), Glycyrrhizae Radix (甘草), Uncariae Ramulus et Uncus (釣鉤藤), Junci Medulla (燈心草), Fossilia Ossis Mastodi (龍骨), Atractylodis Rhizoma Alba (白朮), Cinnabaris (朱砂), and Coptidis Rhizoma (黃連). The most commonly used massage methods were Clearing Liver Channel (淸肝經), Clearing Heart Channel (淸心經), Kneading $Xi{\check{a}}oti{\bar{a}}nx{\bar{i}}n$ (?小天心), Supplementing Spleen Channel (補脾經), Clearing $Ti{\bar{a}}nh{\acute{e}}shu{\check{i}}$ (淸天河水), and Rubbing Abdomen (摩腹). Conclusions Based on the results of clinical studies from China, the use of Korean medicine for the treatment of pediatric night crying has been shown to be effective in relieving symptoms. Based on the results of this study, it is possible to widen the scope of Korean medicine by additionally reviewing clinical and experimental studies on pediatric night crying.

아킬레스건 파열 수술 후 걷기 및 달리기 운동역학적 분석 (Biomechanical Analysis of Walking and Running after a Surgically Repaired Achilles Tendon Rupture)

  • Heo, Jeong;Park, Sang-Kyoon
    • 한국운동역학회지
    • /
    • 제31권4호
    • /
    • pp.241-248
    • /
    • 2021
  • Objective: The purpose of this study was to investigate the difference in muscle strength, kinematics, and kinetics between injured and non-injured sides of the leg after Achilles Tendon Rupture surgery during walking and running. Method: The subjects (n=11; age = 30.63 ± 5.69 yrs; height = 172.00 ± 4.47 cm; mass = 77.00 ± 11.34 kg; time lapse from surgery = 29.81 ± 10.27 months) who experienced Achilles Tendon Rupture (ATR) surgery participated in this study. The walking and running trials were collected using infrared cameras (Oqus 300, Qualisys, Sweden, 100 Hz) on instrumented treadmill (Bertec, U.S.A., 1,000 Hz) and analyzed by using QTM (Qualisys Track Manager Ver. 2.15; Qualisys, U.S.A). The measured data were processed using Visual 3D (C-motion Inc., U.S.A.). The cutoff frequencies were set as 6 Hz and 12 Hz for walking and running kinematics respectively, while 100 Hz was used for force plate data. Results: In ATR group, muscle strength there were no difference between affected and unaffected sides (p> .05). In kinematic analysis, subjects showed greater ROM of knee joint flexion-extension in affected side compared to that of unaffected side during walking while smaller ROM of ankle dorsi-plantar and peak knee flexion were observed during running (p< .05). In kinetic analysis, subjects showed lower knee extension moment (running at 2.2 m/s) and positive ankle plantar-flexion power (running at 2.2 m/s, 3.3 m/s) in affected side compared to that of unaffected side (p< .05). This lower positive ankle joint power during a propulsive phase of running is related to slower ankle joint velocity in affected side of the subjects (p< .05). Conclusion: This study aimed to investigate the functional evaluation of the individuals after Achilles tendon rupture surgery through biomechanical analysis during walking and running trials. Based on the findings, greater reduction in dynamic joint function (i.e. lower positive ankle joint power) was found in the affected side of the leg compared to the unaffected side during running while there were no meaningful differences in ankle muscle strength and walking biomechanics. Therefore, before returning to daily life and sports activities, biomechanical analysis using more dynamic movements such as running and jumping trials followed by current clinical evaluations would be helpful in preventing Achilles tendon re-rupture or secondary injury.

Alveolar ridge preservation with a collagen material: a randomized controlled trial

  • Schnutenhaus, Sigmar;Doering, Isabel;Dreyhaupt, Jens;Rudolph, Heike;Luthardt, Ralph G.
    • Journal of Periodontal and Implant Science
    • /
    • 제48권4호
    • /
    • pp.236-250
    • /
    • 2018
  • Purpose: Resorption of the alveolar bone is an unavoidable consequence of tooth extraction when appropriate alveolar ridge preservation (ARP) measures are not taken. The objective of this trial was to test the hypothesis that dimensional changes in the alveolar bone after tooth extraction would be reduced by inserting an equine collagen membrane and a collagen cone to fill and seal the alveolus (as ARP), in comparison to extraction with untreated alveoli. Methods: In this randomized clinical trial, 31 patients were directly treated with the collagen material after extraction of a tooth from the maxilla (the ARP group). Twenty-nine patients served as the control group. After extraction, no further treatment (i.e., no socket preservation measures) was performed in the control group. Changes in the alveolar process immediately after extraction and after an 8 (${\pm}1$)-week healing period were evaluated 3-dimensionally. Blinded analyses were performed after superimposing the data from the digitalized impressions and surfaces generated by cone-beam computed tomography. Results: Both the ARP and control groups showed a reduction of bone in the alveolar area after tooth extraction. However, significantly less bone resorption was detected in the clinically relevant buccal region in the ARP group. The median bone reduction was 1.18 mm in the ARP group and 5.06 mm in the control group (P=0.03). Conclusions: The proposed hypothesis that inserting a combination material comprising a collagen cone and membrane would lead to a difference in alveolar bone preservation can be accepted for the clinically relevant buccal distance. In this area, implantation of the collagen material led to significantly less alveolar bone resorption. German Clinical Trials Register at www.drks.de, DRKS00004769.

Clinical Application of Serum Tumor Abnormal Protein from Patients with Gastric Cancer

  • Liu, Jin;Huang, Xin-En
    • Asian Pacific Journal of Cancer Prevention
    • /
    • 제16권9호
    • /
    • pp.4041-4044
    • /
    • 2015
  • Background: To verify whether serum tumor abnormal protein (TAP) would correlate with the responsiveness of palliative chemotherapy in patients with advanced gastric cancer, and the variation of conventional serum tumor markers e.g., carcinoembryonic antigen (CEA), antigen 125 (CA125),carbohydrate antigen19-9 (CA19-9) of adjuvant chemotherapy in patients with early gastric cancer. Materials and Methods: Patients with histologically confirmed gastric cancer and treated with chemotherapy were enrolled into this study. TAP values of these patients were determined by detecting abnormal sugar chain glycoprotein in serum, combined with the area of agglomerated particles. For patients with advanced gastric cancer, responsiveness of palliative chemotherapy was compared with variation of TAP and the relation between variation of TAP and tumor markers in patients with early gastric cancer was analyzed. Results: Totally 82 gastric cancer patients were enrolled into this study. The value of TAP is more closely related to responsiveness of palliative chemotherapy for patients with advanced gastric cancer. The correlation between TAP and responsiveness to palliative chemotherapy is stronger than the correlation between several conventional serum tumor markers (CEA, CA125 and CA199). The variation of TAP was also positively correlated with the trend of CA125 in adjuvant chemotherapy. Conclusions: TAP is sensitive in monitoring the responsiveness to palliative chemotherapy in patients with advanced gastric cancer. But this result should be confirmed by randomized clinical trials for patients with gastric cancer.

우울증 변증도구 개발을 위한 기초연구 (Preliminary Study to Develop the Instrument on Pattern Identifications for Depression)

  • 이은희;최우창;정인철
    • 동의신경정신과학회지
    • /
    • 제24권4호
    • /
    • pp.435-450
    • /
    • 2013
  • Objectives: The purpose of this study is to develop a standard tool for pattern identifications in Korean Medicine for depression. Methods: The advisor committee for this study was organized by 15 Korean Medicine neuropsychiatry professors from 11 Colleges of Korean Medicine. The items and structure of the tools were based on reviews of published literature. In order to develop the tool, we took the consultation from discussions with the advisor committee twice and also incorporated additional advices from e-mail correspondences. Results: 1) We divided the symptoms and signs of depression into 11 pattern identifications. 2) We obtained the mean weights which reflected the standard deviations from each symptoms of the 11 pattern identifications which were scored on a 100-point scale by 15 experts. 3) We designed the Korean medicine pattern identification tool for depression. It was composed of 66 questions in the question- and-answer format. Conclusions: There are some points which should be considered in this study. First, we couldn't reach a complete agreement on the concept of 11 patterns. Second, each pattern identification has a different number of symptoms and signs. In addition, the items of symptoms and signs of each pattern identification are unequal. Third, as we did not set any clinical trials when using this tool, it was not possible to test its validity and reliability. Although there are some limits in this study, the development of pattern identification tools for depression through discussions with the advisor committee is meaningful. If the validity and reliability of the Korean Medicine pattern identification tools for depression are confirmed through clinical trial,s this tool is expected to be applied to the subsequent researches in the future.

Type of tooth movement during en masse retraction of the maxillary anterior teeth using labial versus lingual biocreative therapy in adults: A randomized clinical trial

  • Sadek, Mais M.;Sabet, Noha E.;Hassan, Islam T.
    • 대한치과교정학회지
    • /
    • 제49권6호
    • /
    • pp.381-392
    • /
    • 2019
  • Objective: The objective of this two-arm parallel trial was to compare the type of tooth movement during en masse retraction of the maxillary anterior teeth using labial versus lingual biocreative therapy. Methods: Twenty-eight subjects were randomized in a 1 : 1 ratio to either the labial or lingual group. En masse anterior retraction was performed using labial biocreative therapy in group A and lingual biocreative therapy in group B. Cone beam computed tomography scans were taken before and after retraction and the primary outcome was the type of tooth movement during anterior retraction. Data were analyzed using paired t-tests for comparisons within each group and independent-sample t-test for comparison of the mean treatment changes between the two groups. Results: Significant differences were found between the two groups in relation to the type of tooth movement (labiolingual inclination of the central incisor; mean difference, $5.85{\pm}1.85^{\circ}$). The canine showed significant distal tipping in the lingual group (mean difference, $6.98{\pm}1.25^{\circ}$). The canine was significantly more intruded in the lingual group (mean difference, $1.67{\pm}0.49mm$). Good anchorage control and significant soft tissue changes occurred in both groups. No serious adverse effects were detected. Conclusions: With a 10-mm retraction hook, the labial biocreative technique with the reverse curve overlay provided anterior retraction with good torque control, while in the lingual group, anterior retraction occurred with controlled tipping movement with significant distal tipping and intrusion of the canine (trial registration: The trial was registered at ClinicalTrials.gov [NCT03239275]).

Albendazole and Mebendazole as Anti-Parasitic and Anti-Cancer Agents: an Update

  • Chai, Jong-Yil;Jung, Bong-Kwang;Hong, Sung-Jong
    • Parasites, Hosts and Diseases
    • /
    • 제59권3호
    • /
    • pp.189-225
    • /
    • 2021
  • The use of albendazole and mebendazole, i.e., benzimidazole broad-spectrum anthelmintics, in treatment of parasitic infections, as well as cancers, is briefly reviewed. These drugs are known to block the microtubule systems of parasites and mammalian cells leading to inhibition of glucose uptake and transport and finally cell death. Eventually they exhibit ovicidal, larvicidal, and vermicidal effects on parasites, and tumoricidal effects on hosts. Albendazole and mebendazole are most frequently prescribed for treatment of intestinal nematode infections (ascariasis, hookworm infections, trichuriasis, strongyloidiasis, and enterobiasis) and can also be used for intestinal tapeworm infections (taeniases and hymenolepiasis). However, these drugs also exhibit considerable therapeutic effects against tissue nematode/cestode infections (visceral, ocular, neural, and cutaneous larva migrans, anisakiasis, trichinosis, hepatic and intestinal capillariasis, angiostrongyliasis, gnathostomiasis, gongylonemiasis, thelaziasis, dracunculiasis, cerebral and subcutaneous cysticercosis, and echinococcosis). Albendazole is also used for treatment of filarial infections (lymphatic filariasis, onchocerciasis, loiasis, mansonellosis, and dirofilariasis) alone or in combination with other drugs, such as ivermectin or diethylcarbamazine. Albendazole was tried even for treatment of trematode (fascioliasis, clonorchiasis, opisthorchiasis, and intestinal fluke infections) and protozoan infections (giardiasis, vaginal trichomoniasis, cryptosporidiosis, and microsporidiosis). These drugs are generally safe with few side effects; however, when they are used for prolonged time (>14-28 days) or even only 1 time, liver toxicity and other side reactions may occur. In hookworms, Trichuris trichiura, possibly Ascaris lumbricoides, Wuchereria bancrofti, and Giardia sp., there are emerging issues of drug resistance. It is of particular note that albendazole and mebendazole have been repositioned as promising anti-cancer drugs. These drugs have been shown to be active in vitro and in vivo (animals) against liver, lung, ovary, prostate, colorectal, breast, head and neck cancers, and melanoma. Two clinical reports for albendazole and 2 case reports for mebendazole have revealed promising effects of these drugs in human patients having variable types of cancers. However, because of the toxicity of albendazole, for example, neutropenia due to myelosuppression, if high doses are used for a prolonged time, mebendazole is currently more popularly used than albendazole in anti-cancer clinical trials.

Intraperitoneal Paclitaxel Combined with S-1 Plus Oxaliplatin for Advanced Gastric Cancer with Peritoneal Metastasis: a Phase I Study

  • Kim, Dong-Wook;Seo, Won Jun;Youn, Sang Il;Jee, Ye Seob;Jang, You-Jin;Kim, Jong-Han
    • Journal of Gastric Cancer
    • /
    • 제21권4호
    • /
    • pp.418-425
    • /
    • 2021
  • Purpose: We designed a new regimen by combining intraperitoneal (IP) paclitaxel (PTX) with systemic S-1 plus oxaliplatin (SOX) for the treatment of advanced gastric cancer with peritoneal metastasis. This dose-escalation study aimed to determine the maximum tolerated dose (MTD) and recommended dose (RD) of IP PTX administered weekly to patients. Materials and Methods: Eight cycles of IP PTX plus SOX regimen were administered to the patients. S-1 was administered orally twice daily at a dose of 80 mg/m2/day for 14 consecutive days, followed by 7 days of rest. Intravenous oxaliplatin was administered at a fixed dose of 100 mg/m2 on day 1, while IP PTX was administered on days 1 and 8. The initial dose of IP PTX was 40 mg/m2, and the dose escalation was set in units of 20 mg/m2 up to 80 mg/m2. Dose-limiting toxicities (DLTs) were defined as grade 3 non-hematologic toxicities, grade 4 leukopenia, grade 3 febrile neutropenia, and grade 3 thrombocytopenia. Results: Nine patients were included in the study. No DLTs were observed in any of the enrolled patients. Therefore, the MTD was not reached, and the RD of IP PTX was determined to be 80 mg/m2. Four patients (44%) showed a decreased peritoneal cancer index score on second-look laparoscopic examination. Conclusions: The present study determined the dose for further clinical trials of IP PTX to be 80 mg/m2, when combined with a systemic SOX regimen.