title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Background | allergic rhinoconjunctivitis | ALLERGIC RHINOCONJUNCTIVITIS | Edited by: Jamie Marie Orengo, Regeneron Pharmaceuticals, Inc., United StatesReviewed by: Sang Min Lee, Gachon University Gil Medical Center, Republic of Korea; Hideyuki Kawauchi, Shimane University, Japan†These authors have contributed equally to this workPediatric allergic rhinoconjunctivitis has become a public conc... | PMC10428014 |
Objective | By comparing with SCIT, this study aimed to evaluate the long-term efficacy and safety of intra-cervical lymphatic immunotherapy (ICLIT). | PMC10428014 | ||
Methods | dust mite allergen, dust mite allergy, pain, allergic rhinoconjunctivitis | ADVERSE REACTIONS, SECONDARY, TSS, ALLERGIC RHINOCONJUNCTIVITIS | This is a prospective randomized controlled study. A total of 50 allergic rhinoconjunctivitis children with dust mite allergy was randomly divided into ICLIT group and SCIT group, receiving three cervical intralymphatic injections of dust mite allergen or three years of subcutaneous injection, separately. Primary outco... | PMC10428014 |
Results | allergic symptoms, systemic adverse reactions, pain | ADVERSE REACTIONS, TSS | Both groups had significantly decreased TNSS, TOSS, TSS, TMS, and total quality of life score after 36 months of treatment (p<0.0001). Compared with SCIT, ICLIT could rapidly improve allergic symptoms (p<0.0001). The short-term efficacy was consistent between the two groups (p=0.07), while the long-term efficacy was be... | PMC10428014 |
Conclusion | allergic symptoms, pain | ICLIT could ameliorate significantly the allergic symptoms in pediatric patients with an advantage in effectiveness and safety, besides an improved life quality including shortened period of treatment, frequency of drug use and pain perception. | PMC10428014 | |
Clinical trial registration | PMC10428014 | |||
Introduction | respiratory tract allergy, allergic rhinoconjunctivitis, Allergic rhinoconjunctivitis, dust mite allergy, Dust mite-induced allergy, allergic reactions | ALLERGIC REACTION, ALLERGIC RHINOCONJUNCTIVITIS | Allergic rhinoconjunctivitis refers to immunoglobulin E (IgE)-mediated transmitter release triggered locally by inhaled allergens in the nasal mucosa, and type I allergic reactions involving multiple cells and immunoactive factors (Dust mite-induced allergy accounts for 85% of all patients with respiratory tract allerg... | PMC10428014 |
Materials and methods | PMC10428014 | |||
Study population | itching, Allergic Rhinitis, dust mite-induced allergic rhinoconjunctivitis, nasal itching, nasal congestion | ASTHMA, ALLERGIC RHINITIS | A total of 50 pediatric patients at outpatient department of otorhinolaryngology were recruited in our hospital from June 2018 to September 2018, and were then randomly divided into ICLIT group and SCIT group with a ratio of 1:1.The inclusion criteria were as follows: (1) aged 6 to 17 years; (2) confirmed history of du... | PMC10428014 |
Randomization | Eligible patients were randomly allocated in a 1:1 ratio to ICLIT or SCIT group. With random-number tables, we selected 50 random numbers in sequence starting from any random number and put them in numerical order. Numbers 1-25 and 26-50 were divided into ICLIT group and SCIT group, respectively. The randomization was ... | PMC10428014 | ||
Study design | allergic symptoms, allergy, dust mite allergen extract, ’ pain | ADVERSE REACTIONS, ALLERGY | This is a prospective randomized controlled study with 25 patients receiving ICLIT (Study design. The trial included 1 pre-treatment screening visit, 3 treatment visits, 5 follow-up visits within 36 months after treatment. ICLIT, intra-cervical lymphatic immunotherapy; SCIT, subcutaneous immunotherapy Eav, eosinophils ... | PMC10428014 |
Treatment process | PMC10428014 | |||
ICLIT group | Injections were performed under color Doppler ultrasound guidance using a 7-gauge needle, three times on the same side. Under strict aseptic procedures, 0.1ml (50TU) of 500TU/mL (concentration grade 2) of alum-adsorbed allergen extracts was injected into the superficial II or III area cervical lymph nodes (approximatel... | PMC10428014 | ||
SCIT group | The injection site was either lateral to the distal third of the upper arm or dorsal to the middle third of the forearm, and treatment consisted of two phases which were dose accumulation and dose maintenance.Allergen injection with a starting dose of 50 TU/mL was injected once a week for up to 15 weeks. In the first 1... | PMC10428014 | ||
Observation indicators | PMC10428014 | |||
Primary indicators | allergic symptoms | Primary outcomes were assessed before treatment (baseline), at 3 month, 6 month, 12 month, 24 month and 36 month, including (1) change in allergic symptoms associated with dust mite was assessed by a four-scale system where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=most severe symptoms ( | PMC10428014 | |
Secondary indicators | pain | ADVERSE REACTIONS | Secondary outcomes included (1) pain perception during treatment was assessed by patients themselves (or assisted by their families) after each treatment using visual analogue scale (VAS). Scores were marked on the ruler with cartoon icon of facial expressions, ranging from 0 to 10 where 0=painless and 10=most painful.... | PMC10428014 |
Other secondary indicators | allergy, Peripheral venous blood | SECONDARY, ALLERGY | Other secondary outcomes were changes in circulating immunoglobulin level (serum dust mite-specific IgE) at baseline, 24 month and 36 month. Peripheral venous blood was taken and was separated by centrifugation at room temperature for 7 minutes at 3500 r/min, and then was stored at -80°C pending analysis. Serum Derp an... | PMC10428014 |
Ethics and permissions | The institutional review board of the First People’s Hospital of Foshan approved this randomized controlled study (approval number [2018]-10) and all participants or their families signed informed consent. This study was registered in Chinese Clinical Trial Registry (clinical trial registration number: ChiCTR1800017130... | PMC10428014 | ||
Statistical analysis | Normal distribution was decided by D’Agostino-Pearson omnibus normality test.Continuous variables were expressed as mean (standard deviation) and categorical variables were presented as n (%).Intragroup comparation was evaluated by paired t test or Wilcoxon Signed Rank test for normally distributed and non-normally dis... | PMC10428014 | ||
Results | PMC10428014 | |||
General information | A total of 50 eligible patients were randomly divided into ICLIT group (n=25) and SCIT group (n=25) (Research flow chart. ICLIT, intra-cervical lymphatic immunotherapy; SCIT, subcutaneous immunotherapy.As shown in Baseline characteristics by treatment group.SPT, skin prick test; SI, skin index; ++, 0.5≤SI<1;+++, 1≤SI<2... | PMC10428014 | ||
Primary outcomes | PMC10428014 | |||
ICLIT had a significant long-term effect | TOSS | TSS | At baseline in ICLIT group, TNSS was 10.3 (1.7), TOSS was 2.4 (0.8), TSS was 12.3 (1.9), TMS was 3.5 (1.3), and total quality of life score was 92.8 (4.9). At baseline in SCIT group,TNSS was 10.4 (1.3), TOSS was 2.6 (1.2), TSS was 12.8 (2.1), TMS was 3.1 (1.0), and total quality of life score was 92.3 (7.5). No signifi... | PMC10428014 |
ICLIT improved the overall efficacy more quickly | TSS | At 3 month of treatment, TSS in ICLIT group and SCIT group was 9.4 (1.7) and 12.5 (2.0), separately. Change of TSS in ICLIT group was 2.9 (1.2) with a decreased rate of 22.7% and change of TSS in SCIT group was 0.3 (0.5) with a decreased rate of 2.2%. ICLIT group showed significant degree of symptom improvement compare... | PMC10428014 | |
ICLIT was not as effective as SCIT in a long term | allergic symptoms | TSS | Short-term efficacy and long-term efficacy were observed for allergic symptoms at the first and third year after treatment in both groups. At baseline, there was no significant difference in TSS between ICLIT group (12.3 (1.9)) and SCIT group (12.8 (2.1)). At 1 year after treatment, TSS in ICLIT and SCIT group was 7.9 ... | PMC10428014 |
ICLIT significantly improved the symptoms of most allergic rhinoconjunctivitis children | allergic symptoms | Short-term efficacy and long-term efficacy were observed for allergic symptoms at the first and third year after treatment only in ICLIT group. After undergoing ICLIT, 23 patients had significant symptom improvement (p < 0.0001) in both short-term (1 year after treatment) and long-term (3 year after treatment) (Symptom... | PMC10428014 | |
Secondary outcomes | PMC10428014 | |||
ICLIT had less pain | Pain, pain |
Pain perception were compared between patients in ICLIT and SCIT groups. The total pain score of patients injected into cervical lymph nodes and veins was recorded. ICLIT, intra-cervical lymphatic immunotherapy; SCIT, subcutaneous immunotherapy. | PMC10428014 | |
ICLIT had higher safety | redness, itching, wheezing, rash, urticaria, rhinitis, asthma, anaphylactic shock, hypotension, Systemic adverse reactions, muscular vascular edema | ADVERSE REACTIONS, ADVERSE EVENT, URTICARIA, INDURATION, RHINITIS, ASTHMA ATTACK, ASTHMA, ANAPHYLACTIC SHOCK |
Adverse events associated with intra-cervical lymphatic and subcutaneous injections.Local adverse reactions mainly include redness, itching, induration, rash, etc. at the injection site. Mild local adverse reactions refer to a diameter of ≤ 4 cm, moderate local adverse reactions refer to a diameter of>4 cm and>15 minu... | PMC10428014 |
Other secondary outcomes | PMC10428014 | |||
ICLIT significantly decreased serum dust mite-specific IgE levels | sIgE was an important pathogenic antibody of AR, there were no significant differences in serum Derp and Derf sIgE between the two groups at baseline. After 3 years of treatment, serum Derp and Derf sIgE levels significantly decreased in both groups, but no significant difference in the changes was found between the tw... | PMC10428014 | ||
Discussion | redness, dyspnea, itching, hoarseness, allergic rhinoconjunctivitis, ’, local adverse reactions, dysphonia, Allergic Rhinitis, allergic symptoms, obstruction of the airway, systemic adverse reactions, allergic diseases | ADVERSE REACTIONS, LARYNGEAL EDEMA, ALLERGY, ADVERSE EVENTS, AIRWAY OBSTRUCTION, MINOR, ALLERGIC RHINITIS, ALLERGIC RHINOCONJUNCTIVITIS, ADVERSE EFFECTS, ASTHMA, IMMUNE TOLERANCE | In recent years, pediatric allergic rhinoconjunctivitis has become a global health issue and one of the most concerned allergic diseases. As the first-line treatment recommended by Allergic Rhinitis and its Impact on Asthma (ARIA) guideline and European Academy of Allergy and Clinical Immunology (EAACI) guideline (In 2... | PMC10428014 |
Conclusion | allergic symptoms, allergic rhinoconjunctivitis, pain | ALLERGIC RHINOCONJUNCTIVITIS | This study first demonstrated that ICLIT could significantly relieve the allergic symptoms, improve the safety and compliance, and reduce the pain response among children with allergic rhinoconjunctivitis. In summary, ICLIT was a novel immunotherapy that could improve the clinical symptoms, save time and economic costs... | PMC10428014 |
Data availability statement | The original contributions presented in the study are included in the article/supplementary material. Further inquiries can be directed to the corresponding authors. | PMC10428014 | ||
Ethics statement | The studies involving human participants were reviewed and approved by the institutional review board of the First People’s Hospital of Foshan. Written informed consent to participate in this study was provided by the participants’ legal guardian/next of kin. | PMC10428014 | ||
Author contributions | QW wrote this manuscript and data analysis, KW independently completed the research design and concept, YQ collected data and followed up patients, YX and YG processed statistical data on the manuscript, WH, YL, and QY revised and proofread the manuscript, RZ reviewed and provided important guidance on the manuscript, ... | PMC10428014 | ||
Acknowledgments | We would like to express our gratitude to Dr. Meihua Liu from the Otolaryngology Immunotherapy Center of Foshan First People's Hospital for his hard work in Intra-cervical lymphatic immunotherapy. We would also like to express our gratitude to Dr. Yue Xiong, an ultrasound doctor, for patiently administering Intra-cervi... | PMC10428014 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10428014 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10428014 | ||
References | PMC10428014 | |||
Objective | T2DM | TYPE 2 DIABETES MELLITUS, CARDIOVASCULAR DISEASES | Type 2 diabetes mellitus (T2DM) is associated with an increased risk of cardiovascular diseases. This study aimed to assess the effects of soymilk plus probiotics co-administration on cardiovascular risk factors in T2DM patients. | PMC9912676 |
Methods | T2DM | One hundred patients with T2DM (aged 40–75 years old) were randomly assigned into 4 groups (soymilk + probiotics supplement, soymilk + placebo, conventional milk + placebo, and probiotics supplement) for 6 weeks. Standard protocols were followed for the collection of fasting blood samples, dietary intakes, and anthropo... | PMC9912676 | |
Results | It was shown that soymilk + probiotics consumption significantly decreased diastolic blood pressure (DBP) ( | PMC9912676 | ||
Conclusion | T2DM | Soymilk and probiotics consumption might improve some cardiovascular risk factors in patients with T2DM. However, possible synergic effects while consumption of soymilk plus probiotics supplement didn’t show in this study which warranted further research. | PMC9912676 | |
Keywords | PMC9912676 | |||
Introduction | cancer, T2DM, bone loss | CARDIOVASCULAR DISEASE, BONE LOSS, KIDNEY DISEASE, CANCER, TYPE 2 DIABETES MELLITUS | Globally, the number of people with type 2 diabetes mellitus (T2DM) is increasing rapidly [Soy and soy products have been shown to have protective effects against a variety of outcomes, including cardiovascular disease, kidney disease, bone loss, cancer, and menopausal symptoms [ | PMC9912676 |
Methods | PMC9912676 | |||
Design and participants | diabetic, T2DM, allergic | BREAST CANCER | This study included patients with T2DM aged 40–75 years old who were referred to Motahari hospital in Shiraz city, Iran. The patients were considered diabetic if they had an FBS level of 126 mg/dL or higher or were taking glucose-lowering agents or insulin injections. They were not allowed to participate if they were p... | PMC9912676 |
Study procedure | T2DM | DISEASE | This double-blind randomized clinical trial was conducted on T2DM patients who were referred to Motahari hospital in Shiraz city, Iran. In the beginning, a participant's disease was diagnosed with the help of an endocrinologist. Then, the study procedure was explained to the participants and informed written consent wa... | PMC9912676 |
Interventions preparation and compliance to study protocol | Soymilk and cow milk were respectively produced by Soya Sun Company and Mihan-Dairy Company in Iran. The amount of soymilk that should be consumed was determined based on a study conducted in Iran [ | PMC9912676 | ||
Measurements | Anthropometric measurements, including height and body weight, were assessed in all patients at baseline and at the end of the study period. Standing and shoeless heights and body weight were measured while participants were minimally clothed with no shoes using digital scales. Body mass index (BMI) was calculated as b... | PMC9912676 | ||
Statistical analysis | Statistical tests were conducted using SPSS 22 and | PMC9912676 | ||
Discussion | T2DM, TG, tumor necrosis | TUMOR NECROSIS | This randomized double-blind clinical trial aimed to examine the effects of soymilk and probiotics supplement co-administration on cardiovascular risk factors in patients with T2DM. The results showed soymilk plus probiotics supplement consumption significantly improved DBP, TC, TG, HDL-C, and insulin levels after 6 we... | PMC9912676 |
Acknowledgements | We are grateful to the Isfahan soymilk company that provided soymilk products for the present study. We would like to express our special thanks to all patients that participate in our study. | PMC9912676 | ||
Authors’ contributions | A.H. contributed to data collection and wrote the primary draft of the manuscript; SM.M and M.SH. designed the study and revised the manuscript; S.B. managed the study and supervised the final manuscript. The authors read and approved the final manuscript. | PMC9912676 | ||
Funding | shiraz | This study was financially supported by shiraz university of medical sciences (grant number: 93–06-115–5566). | PMC9912676 | |
Availability of data and materials | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC9912676 | ||
Declarations | PMC9912676 | |||
Ethics approval and consent to participate | All procedures were under Helsinki declaration and approved by the Research Council and Ethics Committee of Shiraz University of Medical Sciences (IR.SUMS.REC.1394.62). Written informed consent was obtained from all participants. | PMC9912676 | ||
Consent for publication | Not applicable. | PMC9912676 | ||
Competing interests | The authors declare no competing interests. | PMC9912676 | ||
References | PMC9912676 | |||
Objective | knee dislocation | The purpose of this study was to evaluate the clinical outcomes of two-stage reconstruction (peripheral reconstruction in phase I and central anterior cruciate ligament (ACL) / posterior cruciate ligament (PCL) reconstruction in phase II) with remnant preservation for patients with knee dislocation. | PMC10704695 | |
Methods | knee dislocation | A total of 70 patients (10 IIIM, 17 IIIL, and 43 IV) with knee dislocation were randomly divided into the remnant-preserved group and the simple reconstruction group. Patients underwent two-stage reconstruction, including the reconstruction of collateral ligament in phase I and the reconstruction of ACL/PCL in phase II... | PMC10704695 | |
Results | After the surgery, the lateral stability recovered in all patients, and X-ray revealed a good position of bone tunnel. Follow-up was performed at 12 months postoperatively and ranged from 24 to 91 months. At the final follow-up, knee flexion angle, IKDC, Lysholm, and Tegner scores were all higher in both groups compare... | PMC10704695 | ||
Conclusion | The knee function was well recovered after two-stage ligament reconstruction with remnant preservation. | PMC10704695 | ||
Keywords | PMC10704695 | |||
Introduction | Remnant, automobile accidents, dislocation, knee dislocation | Knee dislocation is an uncommon and severe injury that frequently induced by high-energy impact injuries, ranging from automobile accidents to contact sports [Until now, the treatment principle for cruciate ligament injuries following knee dislocation is still controversial. Some scholars recommend that ligament recons... | PMC10704695 | |
Materials and methods | PMC10704695 | |||
Subjects | traffic accidents, right knee injuries, knee dislocation, left knee injuries, injuries, sports-related | MAY | A total of 70 patients (10 IIIM, 17 IIIL and 43 IV) with knee dislocation were screened at our hospital from May 2010 to August 2020. All patients were randomly divided into two groups: the remnant-preserved group and the simple reconstruction group (Phase I reconstruction + Phase II reconstruction without remnant pres... | PMC10704695 |
Phase I reconstruction | avulsion injury of the MCL, fracture, knee joints, avulsion injuries | In phase I, the collateral ligament was repaired first following detumescence (within 2 weeks of injury). For the avulsion injury of the MCL, the broken end was sutured and fixed at the femoral end or the tibial side using anchor nails, and the substantial fracture was directly sutured. For avulsion injuries of the LCL... | PMC10704695 | |
Phase II arthroscopic reconstruction of ACL and PCL | After phase I reconstruction for at least 12 weeks, phase II arthroscopic reconstruction of anterior and posterior cruciate ligaments was performed. | PMC10704695 | ||
Graft acquisition | Semitendinosus and gracilis tendons of both lower limbs were separated from patients as grafts. Both ends of tendons were folded into four strands for backup after measuring the diameter. | PMC10704695 | ||
Bone tunnel establishment | ACL | ADHESION, BENDING | Femoral tunnel- Arthroscopy was performed routinely and concomitant injuries were treated. The adhesion between the anterior and posterior cruciate ligaments was removed to prevent damage to the ligament remnants. The internal opening of the femoral tunnel of the ACL is located at the end point of the anteromedial fasc... | PMC10704695 |
Graft fixation | CAVITY | Under arthroscopy, the PCL/ACL-Retrobutton compound was pulled into the joint cavity through the tibial tunnel, and then into the femoral tunnel with a traction line. The Retrobutton was fixed after the femoral end was turned over. When the Drawer and Lachman tests were negative, the knee was bent for 70 | PMC10704695 | |
Postoperative rehabilitation exercise | tenesmus | A mild rehabilitation plan was applied according to the rehabilitation of PCL. To protect the reconstructed PCL during rehabilitation exercises, shinbone tenesmus should be avoided. From the second week post-surgery, knee flexion training was performed twice a day and gradually increased to 90°. The knee flexion reache... | PMC10704695 | |
Postoperative evaluations | After the surgery for 12 months, the symptoms, range and stability of joint flexion and extension, Lysholm score, Tegner score, and IKDC score were evaluated. X-ray and MRI were performed to reveal the changes of bone tunnel and ligament healing. Lachman, Drawer, Valgus/Varus stress, and axial displacement tests were p... | PMC10704695 | ||
Results | PMC10704695 | |||
Collateral ligament reconstruction in patients | Within 2 weeks after the injury of collateral ligament of knee joint, repair surgery was performed in patients in different ways, including the posterolateral structure of knee joint (N = 12), lateral termination of the fibula (N = 8), ipsilateral partial biceps femoris tendon reentry (N = 15), MCL (suture of broken en... | PMC10704695 | ||
Postoperative outcomes | postoperative knee flexion angle was 132.4 ± 5.1 | POSTOPERATIVE COMPLICATIONS | No intraoperative and postoperative complications were observed in all patients. After the surgery, the lateral stability recovered in all patients. In the remnant-preserved group, the remnants of both the ACL and PCL were retained. The postoperative knee flexion angle was 132.4 ± 5.1 | PMC10704695 |
Postoperative imaging | After the surgery, X-ray revealed a good position of the bone tunnel, and the position of the internal orifice of ACL tunnel (AT) and PCL tunnel (PT) is consistent with the normal attachment position (Fig.
X-ray images revealed that the internal orifice of anterior cruciate ligament tunnel (AT) and posterior cruciate ... | PMC10704695 | ||
Follow-up evaluation | POSTOPERATIVE COMPLICATIONS | All enrolled 70 cases were followed up for 24–91 months (average 60.3 ± 17.9 months). Follow-up results showed that all patients had no intraoperative and postoperative complications. Compared with the preoperative period, the knee flexion angle, IKDC score, Lysholm score, and Tegner score were significantly improved i... | PMC10704695 | |
Acknowledgements | Not applicable. | PMC10704695 | ||
Author Contributions | Wenpu Ma and Yiqun Yang: conception, design and analysis of data, performed the data analyses and wrote the manuscript; Xin Ha: contributed to the conception of the study; wrote the manuscript; All authors have read and approved the manuscript. | PMC10704695 | ||
Funding | Not applicable. | PMC10704695 | ||
Data Availability | This study did not use public datasets. All data in the manuscript is available through the responsible corresponding author. | PMC10704695 | ||
Declarations | PMC10704695 | |||
Ethical approval and consent to participate | This retrospective study was approved by the institutional ethical review board of Liaocheng People’s Hospital. All the study participants have signed written informed consent. | PMC10704695 | ||
Consent for publication | Not applicable. | PMC10704695 | ||
Competing interests | The authors declare no competing interests. | PMC10704695 | ||
References | PMC10704695 | |||
Supplementary Information | AML, tumor | ACUTE MYELOID LEUKEMIA, AML, TUMOR | Long-term survival in patients with acute myeloid leukemia (AML) remains low, and current treatment modalities are inadequate. Milademetan (DS-3032, RAIN-32), a small-molecule specific murine double minute 2 inhibitor, has shown a p53 status-dependent antitumor effect in vitro studies. This is the first phase I study r... | PMC9813109 |
Keywords | PMC9813109 | |||
Introduction | AML, tumors, tumor | TUMOR, ACUTE MYELOID LEUKEMIA, AML, REMISSION, TUMORS, HEMATOLOGICAL MALIGNANCY | Acute myeloid leukemia (AML) is a hematological malignancy characterized by an autonomous growth of myeloid blast cells that cannot differentiate or further develop into mature white blood cells. Moreover, it has a diverse clinical presentation [While AML is now treatable and curable, the long-term survival rate after ... | PMC9813109 |
Materials and methods | PMC9813109 | |||
Study design and treatment | toxicity, lymphomas, AML, hematologic malignancies | MYELODYSPLASTIC SYNDROME, SOLID TUMORS, AML, HEMATOLOGIC MALIGNANCIES, LYMPHOMAS | This phase I, open-label, and dose-escalation study conducted at eight centers in Japan recruited patients with R/R AML. Four fixed-dose milademetan schedules were planned (Supplementary Fig. 1A). Increases in the milademetan dose were guided by the modified continual reassessment method (mCRM), with a planned maximum ... | PMC9813109 |
Study population | toxicity, chronic myeloid leukemia, AML | DISEASE PROGRESSION, ADVERSE EVENTS, MYELODYSPLASTIC SYNDROME, BLAST CRISIS, GRAFT-VERSUS-HOST DISEASE, AML, CENTRAL NERVOUS SYSTEM LEUKEMIA, ACUTE PROMYELOCYTIC LEUKEMIA, CHRONIC MYELOID LEUKEMIA, REMISSION, ONCOLOGY | This study included patients ≥ 20 years old with R/R AML and those with a history of myelodysplastic syndrome. Also eligible were patients who failed to achieve remission with at least one cycle of prior induction therapy, who relapsed after achieving remission with prior therapy, could not achieve persistent remission... | PMC9813109 |
Objectives | AML, tumor | SECONDARY, AML, TUMOR | This study primarily aimed to evaluate the safety, tolerability, and MTD of milademetan monotherapy in Japanese patients with R/R AML. The secondary objective was to determine the PK profile and tumor response. Additionally, the recommended dose of the further study was determined. Furthermore, the | PMC9813109 |
Safety evaluation | DLTs, toxicities, failure, primary disease, disability or incapacity | ADVERSE EVENTS, EVENTS, COMPLICATIONS | Relative dose intensity (in percentage) was calculated as a proportion of dose intensity/planned dose intensity (proportion of dose administered/total treatment duration). Safety assessments were completed by documenting the AEs, ECOG PS, laboratory data, body weight, vital signs, and the results of 12 lead ECGs. Serio... | PMC9813109 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.