A Phase IIa, Single Centre, Open Label Study to Characterize the Safety of Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1

Prospective, Open Label, Cohort Study in Traumatic Brain Injury Patients. The goal of this study is to assess the safety of NTx®-265. NTx®-265 will be administered over 9 days, and patients will be followed for an additional 6 months.

开始日期2010-11-01

申办/合作机构

University of Calgary

[+1]

NCT00715364 / Withdrawn临床2期

A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients

To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients.
To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control.

开始日期2009-08-01

申办/合作机构

Stem Cell Therapeutics

NCT00663416 / Terminated临床2期

A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS)

Primary objective: To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control.
Secondary objective: To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients.

开始日期2008-03-01

申办/合作机构

Stem Cell Therapeutics

100 项与 NTx 265 相关的临床结果

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100 项与 NTx 265 相关的转化医学

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100 项与 NTx 265 相关的专利（医药）

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项与 NTx 265 相关的文献（医药）

2025-02-01·Bioelectrochemistry

PolyPyrrole based-impedimetric aptasensor for selective determination of beta-HCG from urine sample

Article

作者: Özgür, Erdoğan ; Deniz, Alparslan ; Uzun, Lokman ; Karasu, Tunca

Herein, a conjugated conducting polymer-based impedimetric aptasensor has been developed to detect beta-human chorionic gonadotropin (bHCG), the one of the important biomarkers in gynecology, from synthetic human urine samples. In this context, gold electrodes were, firstly coated with pyrrole and pyrrole-3-carboxylic acid to obtain the poly(pyrrole-pyrrole-3-carboxylic acid) [poly(Py-PyCOOH)] conductive copolymer by cyclic voltammetry (CV). Then, bHCG-specific peptide aptamer was covalently linked onto the surface via applying a well-known carbodiimide-succinimide chemistry. The sensor developed was characterized to confirm modification steps via both electrochemical methods including CV, electrochemical impedance spectroscopy (EIS), and chronoamperometry and physico-chemically via attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR), scanning electron microscopy (SEM), energy dispersive X-ray analysis (EDX), atomic force microscope (AFM), and contact angle measurements (CA). The analytical performance of the sensor was evaluated in the concentration range from 1 μg/mL to 100 μg/mL for successful detection of bHCG even in the presence of interference agents. The results have also revealed that the sensor could be classified as a promising alternative to its benchmark commercial clinical methods due its superior properties such as cost-friendliness, easy-to-prepare, stable, robust, and selectivity / sensitivity.

2024-03-01·Ultrasound in Obstetrics & Gynecology

Updating M6 pregnancy of unknown location risk‐prediction model including evaluation of clinical factors

Article

作者: Timmerman, D ; Bobdiwala, S ; Abughazza, O ; Vathanan, V ; Ayim, F ; Kirk, E ; Gould, D ; Guha, S ; Van Calster, B ; Bourne, T ; Kyriacou, C ; Ledger, A

ABSTRACTObjectivesEctopic pregnancy (EP) is a major high‐risk outcome following a pregnancy of unknown location (PUL) classification. Biochemical markers are used to triage PUL as high vs low risk to guide appropriate follow‐up. The M6 model is currently the best risk‐prediction model. We aimed to update the M6 model and evaluate whether performance can be improved by including clinical factors.MethodsThis prospective cohort study recruited consecutive PUL between January 2015 and January 2017 at eight units (Phase 1), with two centers continuing recruitment between January 2017 and March 2021 (Phase 2). Serum samples were collected routinely and sent for β‐human chorionic gonadotropin (β‐hCG) and progesterone measurement. Clinical factors recorded were maternal age, pain score, bleeding score and history of EP. Based on transvaginal ultrasonography and/or biochemical confirmation during follow‐up, PUL were classified subsequently as failed PUL (FPUL), intrauterine pregnancy (IUP) or EP (including persistent PUL (PPUL)). The M6 models with (M6P) and without (M6NP) progesterone were refitted and extended with clinical factors. Model validation was performed using internal–external cross‐validation (IECV) (Phase 1) and temporal external validation (EV) (Phase 2). Missing values were handled using multiple imputation.ResultsOverall, 5473 PUL were recruited over both phases. A total of 709 PUL were excluded because maternal age was < 16 years or initial β‐hCG was ≤ 25 IU/L, leaving 4764 (87%) PUL for analysis (2894 in Phase 1 and 1870 in Phase 2). For the refitted M6P model, the area under the receiver‐operating‐characteristics curve (AUC) for EP/PPUL vs IUP/FPUL was 0.89 for IECV and 0.84–0.88 for EV, with respective sensitivities of 94% and 92–93%. For the refitted M6NP model, the AUCs were 0.85 for IECV and 0.82–0.86 for EV, with respective sensitivities of 92% and 93–94%. Calibration performance was good overall, but with heterogeneity between centers. Net Benefit confirmed clinical utility. The change in AUC when M6P was extended to include maternal age, bleeding score and history of EP was between −0.02 and 0.01, depending on center and phase. The corresponding change in AUC when M6NP was extended was between −0.01 and 0.03. At the 5% threshold to define high risk of EP/PPUL, extending M6P altered sensitivity by −0.02 to −0.01, specificity by 0.03 to 0.04 and Net Benefit by −0.005 to 0.006. Extending M6NP altered sensitivity by −0.03 to −0.01, specificity by 0.05 to 0.07 and Net Benefit by −0.005 to 0.006.ConclusionsThe updated M6 model offers accurate diagnostic performance, with excellent sensitivity for EP. Adding clinical factors to the model improved performance in some centers, especially when progesterone levels were not suitable or unavailable. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

2023-10-01·International Journal of Surgery Case Reports

A unilateral twin ectopic pregnancy in the fallopian tube: A rare case report

作者: Samha, Raghad ; Wardeh, Abdulkareem Muhammad ; Ibrahem, Ali Mohammad ; AlAwad, Yara ; Abo Moughdeb, Aimar Khir

INTRODUCTIONThe implantation of a fertilized ovum outside of the normal uterine cavity is referred to as ectopic pregnancy, most frequently in the fallopian tube. Unilateral tubal twins are a rare diagnosis since they occur in around 1 in 125,000 spontaneous pregnancies.PRESENTATION OF CASEWe report a case of A 39 -year- old female (Gravida 6, para 6) who presented to the emergency department with continuous abdominal pain and with vaginal bleeding, Transvaginal Ultrasound,and positive hCG levels suggested having an ectopic pregnancy that was managed by surgical laparotomy that revealed a twin ectopic pregnancy.DISCUSSIONBy using transvaginal ultrasound and urine/serum beta-human chorionic gonadotropin (bHCG) tests, early ectopic pregnancy identification has improved, reducing related morbidity and death. In our case, a gestational sac was detected during a vaginal ultrasound and the high level of bHCG (63,000) suggested an ectopic pregnancy. Surgical management was chosen because the pregnant sac was on the verge of bursting.CONCLUSIONThis case serves as a reminder of the importance of considering the potential for having twin ectopic pregnancies.

100 项与 NTx 265 相关的药物交易

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