Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Heart and Blood Diseases

Wounds and Injuries

Recurrence

Liver Neoplasms

Ischemia

Reperfusion Injury

Disease Attributes

Vascular Diseases

Postoperative Complications

Hematinics

All Drugs and Chemicals

Liver Extracts

patients subjected to major hepatectomy with vascular control of blood inflow and outflow of the whole liver

patients subjected to major hepatectomy by selectively clamping the portal and hepatic vessels only of the lobe harboring the tumor

major hepatectomy with vascular control of blood inflow and outflow of the whole liver

selective hepatic vascular exclusion

major liver resection by selectively clamping the portal and hepatic vessels only of the lobe harboring the tumor

semielective hepatic vascular exclusion

Kassiani Theodoraki, PhD

Severe ischemic changes of the liver remnant after hepatectomy could expedite tumor recurrence on the residual liver. Our study aimed at assessing the effect of warm ischemic/reperfusion (I/R) injuries on surgery-to-local recurrence interval and patient overall survival, during major hepatectomies under inflow and outflow vascular control.

One hundred and eighteen patients were subjected to liver resection under total inflow and outflow vascular clamping and were assigned as study group. These individuals were retrospectively matched to 112 counterparts, who underwent liver surgery applying inflow and outflow vascular clamping only of the segment harboring the tumor, sparing the liver remnant from any I/R injury (control group). The two cohorts were compared regarding recurrence-free survival and overall survival.

Recurrence of Liver Malignancy After Ischemia/Reperfusion Injury

Does Vascular Occlusion in Liver Resections Predispose to Recurrence of Malignancy in the Liver Remnant Due to Ischemia/Reperfusion Injury?

Aretaieion University Hospital

Associate Professor of Anesthesiology

Rare Diseases

Acute Graft Versus Host Disease

Magnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5

Magnesium Isoglycyrrhizinate Injection

Hua haiqing, MD

Zhou Jinhua

Wang Lijie

Ma Junxun

Lin Zhenhe

Chen Xi

Zheng Dengyun

Ouyang Ming

Chen Wensheng

Li Yongqiang

Lan Dong

An Yonghui

Xie Shaojian

Ma Wang

Yao Yi

Zhong Meizuo

Qian Keqin

Hua Haiqing, MD

Qin Shukui, MD

Wang Rui

Zhu Lingjun

Chen Jinfei

Wang Keming

Hua Dong

Liu Chaoying

Xu Haiyang

Xiong Jianping

Qiu Wensheng

Zhang Hua

This purpose of this study is to evaluate the evaluate the efficacy of Magnesium Isoglycyrrhizinate Injection in the prevention of antineoplastic chemotherapy related acute liver injury.

Total subjects: 2040, experimental group of 1360 patients, control group of 680 patients. According to the study subjects receiving antineoplastic chemotherapy, subjects are stratified randomize.

Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury

A Randomized, Controlled, Multi-center Collaborative Study to Evaluate the Efficacy of Magnesium Isoglycyrrhizinate Injection in the Prevention of Antineoplastic Chemotherapy Related Acute Liver Injury

anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT\>ULN

Cttq

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Syndrome

Sclerosis

Fibrosis

Lennox Gastaut Syndrome

Tuberous Sclerosis

Epilepsy

Epilepsies, Myoclonic

Hamartoma

Neoplasms, Multiple Primary

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Epilepsy, Generalized

Brain Diseases

Central Nervous System Diseases

Epileptic Syndromes

Chronic Graft Versus Host Disease

Dravet Syndrome

CDKL5 Deficiency Disorder

Lennox-Gastaut Syndrome

Tuberous Sclerosis Complex

Pharmaceutical Solutions

Anticonvulsants

Cannabidiol

Cannabidiol solution 100 milligrams per milliliter (mg/mL) will be administered orally at a dose level of 5 mg/kg/day for 1 week, then increase to 10 mg/kg/day by the participant or their caregiver twice each day (morning and evening).

This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.

Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

A Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

Jazz Pharmaceuticals

Substance Related Disorders

Chemical and Drug Induced Liver Injury

Liver Diseases

Gastrointestinal Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Poisoning

A total of 120 malignant tumor patients who need to receive chemotherapy are involved for miR-122 detection. They are from 3 centers, 40 for each center. For the first cycle of chemotherapy, the investigators will collect 0.5-1ml blood from the remained blood sample after routine blood test during chemotherapy for each patient.Each patient will have a routine blood test before(±3 days) each cycle of chemotherapy and 7(±3)days after chemotherapy. A routine blood test will include the test of ALT,AST,ALP and TBIL. Sample collection will stop after 4 cycles of chemotherapy. All blood samples collected by investigators are the remained sample after routine tests. Patients in routine care will also have blood tests before each cycle and on day 7(+/- 3) of each cycle of chemotherapy. These patients will also have blood test at these time points even if they are not in this trial.

Twenty healthy women or men who come to hospitals for annual physical examinations are enrolled in this study for miR-122 detection. Investigators will collect 0.5-1 ml blood from the remained blood samples after routine blood tests during their annual physical examinations.

Fourty patients are enrolled in this group for miR-122 detection. The investigators will collect 0.5-1ml blood from the remained blood samples of their routine blood tests or when they need blood tests.

Binghe Xu, MD,PHD

Qiao Li, MD

Qiao LI, MD

Binghe XU, MD, PHD

This is an open , multicenter, interventional clinical trial to conform the role of of miR-122 a real-time detection biomarker of drug-induced liver injury by chemotherapy.

The endorsed standard serum biomarkers, like ALT, AST, total bilirubin, are not tissue-specific, and cannot detect drug-induced liver injury (DILI) at a very early stage, thus unable to properly guide risk assessment and patient management. miR-122 is a liver-enriched miRNA. Many studies have demonstrated that miR-122 is a sensitive and specific biomarker when DILI occurred. However, there is a lack of a standard quantification method for miR-122 and confirmatory studies using a comprehensive list of drugs and patients. The investigators have developed the miRNA-derived Fragment Length Polymorphism (miRFLP) assay for the simultaneous quantification of multiple miRNAs.The methodology improves detection reliability by eliminating intra-assay variables. In this study, the investigators will investigate the role of miR-122 as a real-time detection biomarker of drug-induced liver injury utilizing the miRFLP assay. In addition, the investigators will try to identify the normal physiological range of miR-122 in healthy population and the relationship of miR-122 and hepatic failure in patients of intensive care unit.

Serum miR-122 and serum ALT, AST,ALP and total bilirubin level

Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy

Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy. - an Open , Multicenter, Non-interventional Clinical Trial

Serum miR-122 level (copies/uL) and liver function (such as ALT, AST, ALP, and bilirubin levels) will be tested before and after each cycle of chemotherapy, and the relationship of serum miR-122 level fluctuation and liver injury will be investigated.

To determine a primary normal physiological range of serum miR-122 level (copies/uL) in a group of 20 healthy women and/or men.

Chinese Academy of Medical Sciences

Neoplasm Metastasis

Hepatic Veno-Occlusive Disease

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Hepatic Veno-occlusive Disease

Antineoplastic Agents

Oxaliplatin

Standard of care oxaliplatin-based chemotherapy

(400 mg tablet): 2 tablets taken orally AM and 1 tablet PM daily (total 1,200 mg daily) prior to surgical resection

S-adenosylmethionine (SAMe) supplement

Surgery

Clinical Trial Navigator

Clinical Trial Recruitment Navigator

Alexandra Gangi, MD

Jun Gong, MD

Andrew Hendifar, MD

Arsen Osipov, MD

Maha Guindi, MD

Jeremy Lorber, MD

Kevin S. Scher, MD

This is an open-label, phase II study that may provide evidence that taking S-adenosylmethionine (SAMe) supplementation prevents oxaliplatin, a type of chemotherapy drug, associated liver toxicity in patients with resectable colorectal liver metastases. Resectable means that it is able to removed with surgery. Patients will take two SAMe tablets in the morning and one tablet in the evening for 3-6 months (about 6-8 cycles of chemotherapy) in addition to oxaliplatin based chemotherapy followed by surgical removal of the colorectal liver metastases.

SAMe in Prevention of Oxaliplatin-associated Liver Injury

A Phase II, Open-Label Trial of S-Adenosylmethionine (SAMe) in Prevention of Oxaliplatin Associated Liver Injury

To identify the effect of SAMe in preventing oxaliplatin associated liver injury as determined by lack of injury on histopathologic analysis in patients with liver only stage IV colorectal cancer. Improvement in liver injury will be measured by the degree/histopathologic grade of liver injury utilizing the Combined Vascular Injury (CVI) Score in non-cancerous liver tissue post therapy compared to historical controls. CVI score will evaluate and grade sinusoidal dilation, small vessel loss/obliteration, focal hepatocyte plate disruption, parenchymal extinction lesions, nodular regenerative hyperplasia, peliosis, and veno-occlusive like changes. Rate of sinusoidal obstruction syndrome (SOS), as measured by CVI Score, ranging from 0-13. A CVI score of 3 or more indicates SOS. Compared to historical controls.

To evaluate the efficacy of SAMe during oxaliplatin based therapy in stage IV liver-only colorectal cancer, Objective Response Rate (ORR) will be measured by the proportion of patients with confirmed complete response (CR) or partial response (PR) per RECIST 1.1. ORR will be assessed from screening until EOT.

Calculate surgical EBL in all patients undergoing resection

Length of hospital stay (LOS) to historical controls, the following will be conducted:

ii. Calculate hospital LOS in all patients undergoing resection iii. Account for 30-day readmission

Incidence of oxaliplatin treatment delays will be evaluated by recording the following: If treatment delay occurred and time point/duration of treatment delay

Incidence of oxaliplatin dose reduction will be evaluated by recording the following: If dose reduction occurred and time point of occurrence

Safety and tolerability of the combination will be evaluated by determining the proportion of patients with treatment-related adverse events of all grades as graded per CTCAE v.5, from first dose of study drug until 30 days post last dose of study drug.

Jarrow Formulas Inc

Cedars-Sinai Medical Center

Sponsor-Investigator

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Reproductive Control Agents

Progesterone

Ulipristal acetate

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

Women who had completed a full 12-week treatment course of Ulipristal Acetate for symptomatic uterine fibroids since September 2018

Assess the variations of liver blood test parameters during UPA treatment for symptomatic uterine fibroids

Ulipristal Acetate

Josep Estadella

Uterine fibroids are are the most common gynecological tumor. Among the pharmacological treatment options, ulipristal acetate (UPA) has proven to be effective in control of bleeding and reduction of size of fibroids.

Due to the appearance of some cases of subacute severe hepatic insufficiency in patients undergoing UPA treatment and the possible idiosyncratic effect of the drug, the European Medicine Agency (EMA) recommended performing liver function tests before, during and after each UPA treatment course as a minimization risk strategy to prevent drug induced liver injury (DILI).

The aim of the present study is to evaluate whether changes in transaminase levels or other DILI markers occur in patients receiving UPA in our center.

INTRODUCTION Fibroids are benign monoclonal tumors originated from genetically predisposed uterine smooth muscular cells in a proper hormonal environment. Fibroid growth is dependent on the ovarian steroids estrogen and progesterone. In vivo models have shown that progesterone and the presence of its receptor are the main key points for fibroid growth, being PR stimulation the primary action of estrogens.

Multiple treatment options are currently available, including surgery (hysterectomy or myomectomy), uterine artery embolization, cryomyolysis, radiofrequency myolysis, high-intensity focused ultrasound, and pharmacological treatment. Proper counseling about all therapeutic approaches should be discussed with the patient, explaining pros and cons of every treatment and taking into consideration several clinical factors such as number, location and fibroid size, age and desire for future pregnancies. Final decision of the best treatment should be taken according to the patient's desire.

Uterine fibroids still represent the most frequent indication for hysterectomy, which associates a low but significant risk of vascular, intestinal and urinary complications. Non-surgical treatments represent a good option for those young patients in order to avoid surgical scars on uterine surface and the risk of hysterectomy. Due to the Es and Prog dependent status, fibroid-related symptoms often cease once menopause status is achieved, so selected perimenopausal patients could also benefit from those therapies and avoid a surgery.

Among the pharmacological treatment options, gonadotropin-releasing hormone agonists (GnRHa) are effective in reducing bleeding and uterine volume, but with considerable side-effects due to the estrogen-suppression status. Ulipristal acetate (UPA) have been shown to be effective in bleeding control, induction of amenorrhea and fibroid reduction when compared to GnRHa, with fewer side effects as it maintains estradiol at mid-follicular phase levels. Pre-surgical UPA treatment allows recovery of Hb levels and reduction in fibroid size, allowing better minimally invasive surgery procedures. On selected patients, long-term intermittent treatment with UPA offers an alternative to surgery allowing patients to reach menopause status without surgery.

In February 2018, the European Medicines Agency (EMA) announced temporary restrictive measures to UPA treatment as 8 cases of severe liver injury were potentially linked to UPA administration. After the Pharmacovigilance Risk Assessment Committee (PRAC) evaluation concluded, the association between UPA and drug induced liver injury (DILI) was neither confirmed nor excluded. As a conclusion, the EMA stated that the benefits of UPA for the treatment of symptomatic uterine fibroids clearly outweigh the risks, but risk-minimization measures were needed in order to avoid the rare but serious possible liver injury.

In this work, the investigators evaluated evaluate whether changes in transaminase levels or other DILI markers occur in patients receiving UPA in the study center.

MATERIAL AND METHODS Retrospective observational study to assess the variations of liver blood test parameters during UPA treatment for symptomatic uterine fibroids. The study is approved by the ethics committee of the study site and will be conducted in accordance with the principles of the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines Investigators will include all women who had completed a full 12-week treatment course of UPA for symptomatic uterine fibroids since September 2018. All patients will provide written informed consent. As stated by EMA recommendations, all patients will perform a blood test including liver parameters (AST, ALT, AF, GGT, bilirubin) before initiating the treatment, monthly during the 12-week treatment course, and an additional test 2-4 weeks after ending treatment. All data will be collected in an anonymized database with restricted access to investigators

Liver Safety Assessment During Ulipristal Acetate Treatment for Uterine Fibroids (LISA)

Liver Safety Assessment During Ulipristal Acetate Treatment for Uterine Fibroids

Variations on AST or ALT blood levels during UPA treatment course.

Variations on GGT blood levels during UPA treatment course.

Variations on bilirubin blood levels during UPA treatment course.

Variations on AF blood levels during UPA treatment course.

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Recurrence of Liver Malignancy After Ischemia/Reperfusion Injury	NCT04257240	Ischemic Reperf... Liver Injury Cancer Recurren... Malignancy Liver Cancer	selective hepat... semielective he...	18 Years - 90 Years	Aretaieion University Hospital
Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury	NCT01802996	Neoplasms Liver Injury	Magnesium Isogl...	18 Years - 75 Years	Cttq
Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution	NCT05044819	Lennox Gastaut ... Dravet Syndrome Tuberous Sclero...	Cannabidiol	1 Year -	Jazz Pharmaceuticals
Recurrence of Liver Malignancy After Ischemia/Reperfusion Injury	NCT04257240	Ischemic Reperf... Liver Injury Cancer Recurren... Malignancy Liver Cancer	selective hepat... semielective he...	18 Years - 90 Years	Aretaieion University Hospital
Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy	NCT03039062	Chemotherapeuti... Malignant Tumor Liver Injury		18 Years - 70 Years	ChineseAMS
SAMe in Prevention of Oxaliplatin-associated Liver Injury	NCT06258525	Colorectal Canc... Liver Metastase... Liver Metastasi... Liver Injury Sinusoidal Obst... 5-Fluorouracil ... Liver Toxicity,...	Standard of car... S-adenosylmethi... Surgery	18 Years -	Cedars-Sinai Medical Center
Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury	NCT01802996	Neoplasms Liver Injury	Magnesium Isogl...	18 Years - 75 Years	Cttq
Liver Safety Assessment During Ulipristal Acetate Treatment for Uterine Fibroids (LISA)	NCT04004884	Leiomyoma, Uter... Liver Injury Treatment Side ...	Ulipristal Acet...	18 Years - 55 Years	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
SAMe in Prevention of Oxaliplatin-associated Liver Injury	NCT06258525	Colorectal Canc... Liver Metastase... Liver Metastasi... Liver Injury Sinusoidal Obst... 5-Fluorouracil ... Liver Toxicity,...	Standard of car... S-adenosylmethi... Surgery	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for liver injury

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We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.