• The most common adverse events associated with degarelix treatment include injection-site reactions (eg, pain, erythema, swelling, induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). (formularywatch.com)
  • The most common adverse reactions (≥10%) during FIRMAGON therapy included injection site reactions (eg, pain, erythema, swelling, or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase. (firmagon.com)
  • Dose-dependent induction of Nrf2 transcriptional target proteins, ferritin and gamma-glutamyl transferase (GGT), was observed at doses as low as 20 mg and reached statistical significance from baseline at doses of 80 mg and higher. (globenewswire.com)
  • One advantage of the Healthy-Iron proprietary panel called FeGGT LifePro™ is that it includes Gamma Glutamyl transferase (GGT), a liver enzyme that can provide information about your body's antioxidant defenses. (irondisorders.org)
  • exceptions include lab results for Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma glutamyl transferase (GGT) and Alkaline phosphatase (ALP), which would be exclusionary at Screening and Day -1 if greater than 1.5x +/- upper limit of normal (ULN) of reference ranges regardless of clinical significance. (who.int)
  • 3 † Includes elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and gamma-glutamyl transferase (GGT). (firdapsehcp.com)
  • Sometimes a young boy may come to medical attention because of elevated liver function enzymes (AST, ALT), and, in such cases, serum creatine kinase and gamma-glutamyl transferase (GGT) levels should be checked prior to considering liver biopsies. (medscape.com)
  • Intralipid is indicated as a source of calories and essential fatty acids for adult and pediatric patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD). (drugs.com)
  • Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase, and cholestasis. (drugs.com)
  • CD19-positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and pediatric patients. (gurufocus.com)
  • relapsed or refractory CD19-positive B-cell precursor ALL in adults and pediatric patients. (gurufocus.com)
  • pediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation. (gurufocus.com)
  • 9) and in pediatric patients with any degree of hepatic impairment. (wikidoc.org)
  • Safety of FIRDAPSE was evaluated in pediatric patients in an expanded access program in which 21 pediatric patients received FIRDAPSE for at least 1 year. (firdapsehcp.com)
  • Adverse reactions reported in pediatric patients were similar to those seen in adult patients, with the exception of clinically significant weight loss in two pediatric patients at doses of 60 mg per day and higher. (firdapsehcp.com)
  • FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. (firdapsehcp.com)
  • Grade 3-4 treatment-related adverse events occurred in 15 patients (19%), including elevated liver function tests (LFTs), anemia, and visual changes. (bvsalud.org)
  • Resmetirom (Madrigal Pharmaceuticals) is a selective thyroid hormone receptor-beta agonist that is reputed to offer optimal beneficial effects on the liver, while minimizing adverse cardiovascular and bone metabolic events that are mediated through a different pathway by the thyroid hormone receptor-alpha. (medscape.com)
  • Serious adverse reactions were reported in 65 percent of patients. (southcarolinablues.com)
  • In the key North American clinical trials (n=830 patients), 90% of the adverse events reported were mild to moderate in severity and transient in nature. (druglib.com)
  • Additional adverse systemic clinical events reported in 1.0% or less of the patients in the initial North American trials are listed below within each body system. (druglib.com)
  • In this trial, treatment-emergent adverse events were reported by 402 patients, 204 (91.9%) in the piperacillin/tazobactam group and 198 (92.1%) in the imipenem/cilastatin group. (druglib.com)
  • 0.05) discontinued treatment due to an adverse event. (druglib.com)
  • Pts were randomized in a 2:1 ratio to receive S or P, 300 mg, orally, once daily, until disease progression or intolerable adverse events. (hutch-med.com)
  • Patients with a known history of serious hypersensitivity reactions to FIRMAGON should not be re-challenged with FIRMAGON. (firmagon.com)
  • Herein we aimed to present novel evidence on the association of two VDBP polymorphisms (rs4588) and (rs7041) with CAD in patients after acute myocardial infarction and study possible correlations of these polymorphisms with 25-hydroxyvitamin D [25(OH)D] serum levels. (amegroups.org)
  • Related tests include serum alkaline phosphatase and gamma-glutamyltransferase (GGT). (medscape.com)
  • An elevated arterial or free venous serum ammonia level is the classic laboratory abnormality reported in patients with hepatic encephalopathy. (medscape.com)
  • Patients who remain persistently neutropenic may warrant a longer course of therapy pending resolution of the neutropenia. (wikidoc.org)
  • This efficacy, together with extended exposure in the largest safety database in NASH, supports a positive benefit:risk for OCA in patients with fibrosis due to NASH," said Dr. Arun Sanyal, Chair, Division of Gastroenterology/Hepatology/Nutrition & Director, Stravitz-Sanyal Liver Institute, VCU Health, Department of Internal Medicine. (biospace.com)
  • Regulators indicated that an additional trial would be needed to assess the efficacy of reproxalap to treat patients with dry eye. (formularywatch.com)
  • The long-term efficacy seen with the dual immunotherapy regimen in CheckMate -227 reinforce the importance of nivolumab plus ipilimumab to transform outcomes for appropriate patients with metastatic non-small cell lung cancer. (advfn.com)
  • The trial design allows the first placebo-controlled data collection on the efficacy and safety of secukinumab in patients with GCA. (biomedcentral.com)
  • This application is supported by data from the Phase 3 MARIPOSA-2 ( NCT04988295 ) study evaluating the efficacy and safety of RYBREVANT ® and chemotherapy in patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC who had disease progression on or after treatment with osimertinib. (fox5sandiego.com)
  • MARIPOSA-2 ( NCT04988295 ), which enrolled 657 patients, is a randomized, open-label Phase 3 study evaluating the efficacy and safety of two combination regimens of RYBREVANT ® (with and without lazertinib) and chemotherapy. (fox5sandiego.com)
  • A total of 90 patients were enrolled on the study from August 24, 201,7 to March 29, 2019, 78 of whom underwent their assigned treatment and were included in the safety and efficacy analysis. (cancernetwork.com)
  • The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. (firmagon.com)
  • The efficacy of doses higher than 50 mg daily in the other adult patients for whom caspofungin is indicated is not known. (wikidoc.org)
  • Surufatinib, a kinase inhibitor targeting vascular endothelial growth factor receptors, fibroblast growth factor receptor 1 and colony stimulating factor-1 receptor, has demonstrated superior efficacy in extra-pancreatic neuroendocrine tumors (NETs) in a prior phase III study (ESMO 2019 Abs. (hutch-med.com)
  • Ex vivo drug screening refers to the out-of-body assessment of drug efficacy in patient derived vital tumor cells. (biomedcentral.com)
  • The purpose of these methods is to enable functional testing of patient specific efficacy of a. (biomedcentral.com)
  • Toviaz is not recommended for use in patients with severe hepatic impairment (Child-Pugh C). Dosage adjustment may not be necessary for elderly patients (≥ 65 years of age). (pfizermedicalinformation.ca)
  • Nevirapine should not be used in patients with severe hepatic impairment (Child-Pugh C, see section 4.3). (who.int)
  • No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see sections 4.4 and 5.2). (who.int)
  • Adult patients with mild hepatic impairment (Child-Pugh score 5 to 6) do not need a dosage adjustment. (wikidoc.org)
  • For adult patients with moderate hepatic impairment (Child-Pugh score 7 to 9), caspofungin 35 mg once daily is recommended based upon pharmacokinetic data. (wikidoc.org)
  • Twelve adult patients with acromegaly or a functional, well-differentiated NET with carcinoid symptoms, previously treated and stabilized with Sandostatin® LAR®, were included in the trial. (camurus.com)
  • for the treatment of patients with symptoms associated with functional gastro-entero-pancreatic neuroendocrine tumors: carcinoid tumors with features of the carcinoid syndrome, VIPomas,glucagonomas, gastrinomas/Zollinger-Ellison syndrome, insulinomas, GRFomas.Treatment of patients with advanced neuroendocrine tumors of the midgut or unknown primary tumor location. (camurus.com)
  • Rare instances of sudden escape from symptomatic control in patients with GEP neuroendocrine tumors may occur in patients being treated with Sandostatin Injection with rapid recurrence of severe symptoms. (camurus.com)
  • The patient displayed typical myasthenic symptoms, including bilateral ptosis, Cogan's lid twitch signs, bilateral weakness of ocular movements, and dysarthria. (cdc.gov)
  • Symptoms worsened with prolonged talking, including dysphagia and myasthenic weakness of all limbs, such that the patient was dependent on a wheelchair and unable to raise his arms. (cdc.gov)
  • The treatment of patients with overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence or any combination of these symptoms. (pfizermedicalinformation.ca)
  • and follow patients for signs and symptoms of respiratory depression and sedation. (nih.gov)
  • Physicians should advise patients to administer preservative-free artificial tears at least 4 times a day beginning on the first day of infusion and continuing until completion of treatment as this may reduce corneal symptoms (see section 4.4). (medicines.org.uk)
  • For patients with dry eye symptoms, additional therapies may be considered as recommended by their eye care professional. (medicines.org.uk)
  • Mirum will acquire Travere's rights to Cholbam®, indicated for the treatment of bile acid synthesis disorders due to single enzyme deficiencies and adjunctive treatment of peroxisomal disorders in patients who show signs or symptoms of liver disease, and Chenodal®, indicated for the treatment of radiolucent stones in the gallbladder, which is also under Phase 3 clinical evaluation for cerebrotendinous xanthomatosis (CTX). (kanerepublican.com)
  • Long-term disease history, clinical symptoms, health status, and healthcare utilization in patients suffering from Lambert Eaton myasthenic syndrome: results of a patient interview survey in Germany. (firdapsehcp.com)
  • In July 2000, Cephalon Inc. reported that, compared to placebo, modafinil therapy did not reduce the symptoms of attention-deficit hyperactivity disorder (ADHD) in adults, as measured by the DSM-IV ADHD Rating Scale in a phase III trial. (empowerpharmacy.com)
  • The symptoms of hepatic encephalopathy may range from mild to severe and may be observed in as many as 70% of patients with cirrhosis. (medscape.com)
  • The primary endpoint is the proportion of patients in sustained remission until week 28 in the secukinumab group compared to the proportion of patients in the placebo group. (biomedcentral.com)
  • The application is based on positive results from an interim analysis of the Phase III JAVELIN Bladder 100 trial, which met its primary endpoint of overall survival (OS). (emdserono.com)
  • The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. (adctherapeutics.com)
  • The FDA approval was based on data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment of adult patients with r/r DLBCL following two or more prior lines of systemic therapy. (adctherapeutics.com)
  • BLENREP is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. (medicines.org.uk)
  • RYBREVANT ® (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity, received accelerated approval by the U.S. Food and Drug Administration (FDA) in May 2021 for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. (fox5sandiego.com)
  • median: 14 days) have been studied in 100 adult patients with candidemia and other Candida infections. (wikidoc.org)
  • Adult patients on rifampin should receive 70 mg of caspofungin once daily. (wikidoc.org)
  • Adult patients on nevirapine , efavirenz , carbamazepine , dexamethasone , or phenytoin may require an increase in dose to 70 mg of caspofungin once daily. (wikidoc.org)
  • During LMS 002 (Study 1), the majority of adult patients (62%) with no prior exposure to amifampridine experienced transient paresthesia while taking FIRDAPSE. (firdapsehcp.com)
  • MORRISTOWN, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced additional supportive data from its pivotal Phase 3 REGENERATE study of obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH). (biospace.com)
  • The trial enrolled patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplants and CAR-T therapy prior to their treatment with ZYNLONTA. (adctherapeutics.com)
  • The FDA approval of Blincyto was based on results of Amgen's '211 trial, a phase 2, multicenter, single-arm open-label study involving 185 adults with Philadelphia chromosome-negative relapsed or refractory precursor B-cell ALL (Amgen, 2014). (southcarolinablues.com)
  • Eligible patients were greater than 18 years of age with Ph- relapsed or refractory B-cell precursor ALL. (southcarolinablues.com)
  • Patients with PD-1/PD-L1-refractory metastatic non-small cell lung cancer did not achieve additional benefit when radiotherapy was added to durvalumab and tremelimumab. (cancernetwork.com)
  • Although the addition of radiotherapy did not increase responses vs durvalumab (Imfinzi) and tremelimumab alone for patients with PD-1/PD-L1-refractory metastatic non-small cell lung cancer (NSCLC), select patients may benefit from the PD-L1/CTLA-4 combination, according to findings from a phase 2 study (NCT02888743). (cancernetwork.com)
  • Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies (e.g., amphotericin B, lipid formulations of amphotericin B, itraconazole). (wikidoc.org)
  • Patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC who had disease progression on or after treatment with osimertinib were randomized to treatment with RYBREVANT ® plus chemotherapy, RYBREVANT ® plus chemotherapy with lazertinib, or chemotherapy alone. (fox5sandiego.com)
  • The study enrolled 657 patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC who had disease progression on or after treatment with osimertinib. (fox5sandiego.com)
  • Submission of a supplemental Biologics License Application (sBLA) for BAVENCIO® (avelumab)* for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). (emdserono.com)
  • ROCKLAND, Mass. and NEW YORK, April 9, 2020 / PRNewswire / -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced completion of the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for BAVENCIO ® (avelumab)* for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). (emdserono.com)
  • In this study, BAVENCIO plus best supportive care (BSC) as first-line maintenance therapy significantly extended the survival of patients with previously untreated locally advanced or metastatic UC whose disease did not progress on induction chemotherapy, compared with BSC only. (emdserono.com)
  • BAVENCIO is the first immunotherapy to demonstrate a statistically significant improvement in overall survival in a Phase III clinical trial in the first-line setting for patients with locally advanced or metastatic urothelial carcinoma,' said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. (emdserono.com)
  • EXPERIMENTAL DESIGN: Patients ≥18 years of age with selected advanced solid tumors [namely, adenoid cystic carcinoma (ACC)] and hematologic malignancies were eligible. (bvsalud.org)
  • Lund - 12 July 2016 - Camurus announces the completion of a multi-center Phase 2 study of long-acting octreotide FluidCrystal® formulation (CAM2029), supporting its potential in treating patients with acromegaly or neuroendocrine tumors (NETs). (camurus.com)
  • The results from this Phase 2 study of CAM2029 are encouraging, with long-acting octreotide release and sustained disease control seen in patients with acromegaly as well as neuroendocrine tumors," said lead investigator Professor Marianne Pavel, MD, Senior Physician and Leader of the Section for Neuroendocrine Tumors in the Department of Hepatology and Gastroenterology at the Charité-Universitätsmedizin, Berlin, Germany. (camurus.com)
  • The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. (adctherapeutics.com)
  • Ogsiveo will be available within five to 10 business days to treat patients with desmoid tumors. (formularywatch.com)
  • New treatment options are urgently needed in the post-osimertinib setting, where patients continue to face unacceptable survival rates," said Kiran Patel , M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. (fox5sandiego.com)
  • A statistically significant improvement was demonstrated in both co-primary populations: all randomized patients and patients with PD-L1-positive tumors. (emdserono.com)
  • recommended phase II dose was declared as 500 mg twice daily (5 days on, 2 days off weekly). (bvsalud.org)
  • Blood glucose levels should be monitored when treatment is initiated or when the dose is altered especially in patients with Type 1 diabetes. (camurus.com)
  • Part 1 of MOXIe was a double-blind, randomized, placebo-controlled, dose-ranging, multi-center, international trial that enrolled a total of 69 FA patients to receive placebo (n = 17) or omaveloxolone (n = 52) at doses of 5 mg to 300 mg given orally, once-daily for 12 weeks. (globenewswire.com)
  • Part 1 randomized eight to 16 patients in a 3:1 ratio of omaveloxolone to placebo across seven dose levels and was not powered to demonstrate statistical separation from placebo at any single dose level. (globenewswire.com)
  • Instruct patients to swallow Hydrocodone Bitartrate Extended-Release Capsules whole to avoid exposure to a potentially fatal dose of hydrocodone. (nih.gov)
  • Daily doses of Hydrocodone Bitartrate Extended-Release Capsules, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. (nih.gov)
  • Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. (nih.gov)
  • Patients (N=620) were randomized to receive subcutaneous (SC) degarelix at a starting dose of 240 mg (40 mg/mL) followed by monthly doses of 160 mg (40 mg/mL), SC degarelix at a starting dose of 240 mg (40 mg/mL) followed by monthly doses of 80 mg (20 mg/mL), or intramuscular (IM) leuprolide 7.5 mg monthly for 1 year. (formularywatch.com)
  • Among patients treated with degarelix, 98.3% (95% CI, 94.8%-99.4%) of patients in the 240/160-mg dose group and 97.2% (95% CI, 93.5%-98.8%) of patients in the 240/80-mg dose group achieved this end point compared with 96.4% (95% CI, 92.5%-98.2%) of patients treated with leuprolide. (formularywatch.com)
  • Patients who do not achieve remission by week 12 experience a flare after remission or cannot adhere to the prednisolone tapering will enter the escape arm and receive prednisolone at a dose determined by the investigator's clinical judgment. (biomedcentral.com)
  • We conducted a [randomized], phase 2 study testing the hypothesis that either repeated low-dose fractionated radiotherapy or hypofractionated radiation would increase the systemic overall response rate to durvalumab-tremelimumab in patients with NSCLC who had previously progressed on PD(L)-1-directed therapy. (cancernetwork.com)
  • Patients were randomized 1:1:1 to receive either the durvalumab/tremelimumab combination alone or in combination with low-dose radiotherapy or hypofractionated radiotherapy. (cancernetwork.com)
  • If a dose is missed and it is within 8 hours of when it was due, the patient should take the missed dose as soon as possible. (who.int)
  • If a dose is missed and it is more than 8 hours of when it was due, the patient should only take the next dose at the usual time. (who.int)
  • No dose adjustment is required for patients with creatinine clearance 20 ml/minute (see section 5.2). (who.int)
  • For patients on renal dialysis, an additional dose of [HA570 trade name] is recommended after each dialysis. (who.int)
  • Consider discontinuation or dose-reduction of FIRDAPSE in patients who have a seizure while on treatment. (firdapsehcp.com)
  • After an average of 8 months of treatment with pralsetinib, 72% of previously untreated patients and 59% of patients who had previously received chemotherapy had considerable shrinkage of their tumours. (bvsalud.org)
  • Amgen continues to advance a robust development program for BLINCYTO, including studies aimed at treating patients with MRD-negative B-ALL, trials designed to minimize chemotherapy, and the clinical investigation of a subcutaneous formulation, all intended to help address remaining unmet needs for patients. (gurufocus.com)
  • Bristol Myers Squibb (NYSE: BMY) today announced six-year results from Part 1 of the Phase 3 CheckMate -227 trial, which continues to demonstrate long-term, durable survival benefits of Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to chemotherapy in the first-line treatment of patients with metastatic non-small cell lung cancer (mNSCLC), regardless of PD-L1 expression levels. (advfn.com)
  • We are ecstatic to see Opdivo plus Yervoy continue to demonstrate almost double the overall survival rates as chemotherapy after six years of follow-up - the longest-ever for a Phase 3 trial with immunotherapy in metastatic non-small cell lung cancer. (advfn.com)
  • WASHINGTON - In patients with cirrhosis associated with non-alcoholic steatohepatitis (NASH), 1 year of treatment with the investigational oral thyromimetic agent resmetirom (MGL-3196) was safe and effective at lowering markers of both cardiovascular risk and NASH fibrosis, new research has found. (medscape.com)
  • The expanding list of nontraditional biomarkers is outweighed by the standard risk factors for predicting future cardiovascular events and adds only moderately to standard risk factors. (medscape.com)
  • The most informative biomarkers for predicting major cardiovascular events were BNP and the urinary albumin-to-creatinine ratio. (medscape.com)
  • Importantly, in these new analyses, we found that this antifibrotic effect is even more pronounced in patients with advanced fibrosis without cirrhosis at baseline, which underscores the urgency in treating patients before they progress to liver cirrhosis. (biospace.com)
  • Antifibrotic effect was more pronounced in individuals with advanced fibrosis without cirrhosis (F3) at baseline (n=520), with 25.4% of patients in the OCA 25 mg group demonstrating an improvement in fibrosis by at least 1 stage without worsening of NASH as compared to 9.5% in placebo (p=0.0001). (biospace.com)
  • Two cohorts comprising a total of 180 patients with well-compensated NASH cirrhosis enrolled in an open-label arm of the phase 3 MAESTRO-NAFLD-1 trial . (medscape.com)
  • In addition, the investigators presented data on a cohort of 105 patients with well-compensated NASH cirrhosis who were treated in an open-label study, as previously reported by Medscape Medical News . (medscape.com)
  • At The Liver Meeting, Harrison presented data on the same cohort combined with data on an additional cohort of 75 patients with well-compensated NASH cirrhosis and no prior history of decompensation. (medscape.com)
  • A 6-year-old female (height: 115 cm, weight: 22 kg) patient with pediatric living donor LT for biliary atresia (cirrhosis with portal hypertension) with a pulmonary AVF, HPS, was admitted to an intensive care unit (ICU) transplantation. (transpopmed.org)
  • Some patients with cirrhosis are completely asymptomatic and have a reasonably normal life expectancy. (medscape.com)
  • Electroencephalography may be helpful in the initial workup of a patient with cirrhosis and altered mental status, when ruling out seizure activity may be necessary. (medscape.com)
  • This is a summary of a research study called ARROW, which tested a medicine called pralsetinib in patients with non-small cell lung cancer (NSCLC), thyroid cancer, and other advanced solid tumours caused by a change in a gene called RET. (bvsalud.org)
  • In total, 281 patients with RET fusion+ NSCLC had taken part in this study across the USA, Europe, and Asia. (bvsalud.org)
  • Overall, the ARROW study showed that pralsetinib was effective in shrinking tumours in patients with RET fusion+ NSCLC regardless of previous treatment history. (bvsalud.org)
  • The positive pharmacokinetic profile and promising disease control data seen in this Phase 2 study when switching patients from Sandostatin®LAR®to CAM2029, together with the option for self-administration by patients, underscores the potential for CAM2029 to fill an unmet medical need," said Fredrik Tiberg, PhD, President & CEO of Camurus. (camurus.com)
  • In that study, patients who received resmetirom had significantly greater reductions in relative hepatic fat content compared with patients who received placebo at both 12 weeks and 36 weeks of follow-up. (medscape.com)
  • The isolate obtained from the patient in this study with severe myasthenic manifestation of leptospirosis. (cdc.gov)
  • We find these results to be very exciting, and they are the ideal outcome for an early Phase 2 study. (globenewswire.com)
  • Twice-daily danuglipron was being studied in a phase 2 study in adults with obesity. (formularywatch.com)
  • This is a randomized, parallel-group, double-blind, placebo-controlled, multi-center, phase II study in which patients, treating physicians, and the associated clinical staff as well as the sponsor clinical team are blinded. (biomedcentral.com)
  • As brain metastases can lead to significant burden and poor outcomes for patients, this aspect of the study design provides critical information in an area of high unmet need. (fox5sandiego.com)
  • Investigators recruited patients from outpatient oncology clinics who had histologically or cytologically confirmed disease for the open-label, multicenter, randomized study. (cancernetwork.com)
  • To be eligible for the study, patients needed to be 18 years of age or older with an ECOG performance status of 0 or 1, a life expectancy of 6 months or more, and evidence of disease progression on systemic PD-1/PD-L1 therapy. (cancernetwork.com)
  • In a completed study of nosocomial lower respiratory tract infections, 222 patients were treated with ZOSYN in a dosing regimen of 4.5 g every 6 hours in combination with an aminoglycoside and 215 patients were treated with imipenem/cilastatin (500 mg/500 mg q6h) in combination with an aminoglycoside. (druglib.com)
  • In an extension study, 135 patients crossed over from leuprolide to FIRMAGON. (firmagon.com)
  • 12. Participant must be willing to stay within the clinical research unit for the duration of the in-patient study period and return for all additional study visits as specified by the protocol. (who.int)
  • Patients should be carefully monitored for tumor expansion. (camurus.com)
  • Intravenous Opdivo has helped transform the treatment of several solid tumor types over the past decade, but there remains a need for additional administration options to address treatment burden on patients and improve efficiencies in healthcare systems," said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. (businesswire.com)
  • CTCs can be isolated from blood in a non-invasive approach, and can be used to follow patients over time since these cells can provide significant information for a better understanding of tumor biology and tumor cell dissemination. (shengsci.com)
  • Patients and caregivers may prepare and administer Intralipid for home use after appropriate training by a trained healthcare provider. (drugs.com)
  • Test results will be delivered securely and directly to only the patient/customer, generally in PDF (portable document format), which can easily be shared with healthcare providers, caregivers, and iron educators. (irondisorders.org)
  • This Orphan Drug Designation recognizes the significant unmet need in patients with diffuse large B-cell lymphoma in the European Union (EU)," said Joseph Camardo, MD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. (adctherapeutics.com)
  • We are incredibly proud to deliver on our goal of bringing treatments like BESREMi to the polycythemia vera community where there is clear unmet need for more effective, tolerable and durable treatments to preserve patients' health and well-being," said Ko-Chung Lin, Ph.D., Co-Founder and Chief Executive Officer for PharmaEssentia and inventor of ropeginterferon alfa-2b-njft. (cliniexpert.com)
  • The CAM2029 product has been studied in four Phase 1/2 clinical trials, which have evaluated the safety and tolerability as well as pharmacokinetic and pharmacodynamic properties of the product in a total of about 250 individuals. (camurus.com)
  • Approximately 50% of patients receiving blinatumomab in clinical trials experienced neurological toxicities (Amgen, 2014). (southcarolinablues.com)
  • Pseudomembranous colitis was reported in one patient during the clinical trials. (druglib.com)
  • Surveys of patient satisfaction in clinical trials for narcolepsy noted that modafinil produces a decreased sense of fatigue and an increase in mental alertness. (empowerpharmacy.com)
  • For the purposes of this summary, only patients with NSCLC with a change in RET called fusion (RET fusion+) are highlighted. (bvsalud.org)
  • As we strive to transform the standard of care in patients with EGFR-mutated NSCLC, we are committed to working closely with the FDA during review of this submission for RYBREVANT in this expanded patient population. (fox5sandiego.com)
  • In previously untreated patients, the most common severe side effects that were considered related to pralsetinib treatment were decreased white blood cells (neutrophils and lymphocytes), increased blood pressure, and an increase in a blood protein called creatine phosphokinase. (bvsalud.org)
  • Anesthesiologists should know the comprehensive preoperative assessment and underlying pathophysiologic condition, determine an anesthesia plan for patients with HPS, meticulously account for HPS-related hypoxia and PVR conditions, and follow up closely perioperatively for successful outcomes. (transpopmed.org)
  • As this research continues to develop and evolve, the enhanced use of precision oncology in cancer treatment ultimately aims to improve prognosis and outcomes for patients. (biomedcentral.com)
  • In previously treated patients, the severe side effects were decreased white blood cells (neutrophils, lymphocytes, and leukocytes), increased blood pressure, and low levels of red blood cells. (bvsalud.org)
  • In both untreated and previously treated patients, the most common severe side effects that required hospital attention were lung inflammation/swelling causing shortness of breath (pneumonitis) and lung infection (pneumonia). (bvsalud.org)
  • Severe clinical presentations include acute decompensation and acute-on-chronic liver failure in a patient with chronic liver disease, leading to high mortality. (xiahepublishing.com)
  • Muscle wasting in patients with sepsis, severe injury, and cancer is associated with increased transcription of several genes regulating different proteolytic pathways. (shengsci.com)
  • Increased risk in patients with renal impairment, including preterm neonates. (drugs.com)
  • Blincyto was approved under the FDA's accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients (FDA, 2014). (southcarolinablues.com)
  • In 2019, Harrison and colleagues reported results of a phase 2, double-blind, placebo-controlled trial of resmetirom in adults with biopsy-confirmed NASH (fibrosis stages 1-3) and hepatic fat content greater than 10% as assessed by MRI-PDFF. (medscape.com)
  • In an attempt to mimic real-world conditions, patients in the trial did not receive a baseline biopsy but were determined to have NASH or presumed NASH with either results of a previous liver biopsy or noninvasive techniques, including FibroScan and MRI-PDFF. (medscape.com)
  • Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -67T clinical trial. (businesswire.com)
  • CheckMate -67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme's proprietary recombinant human hyaluronidase, rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous (IV) Opdivo , in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. (businesswire.com)
  • This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo to patients. (businesswire.com)
  • IRVING, Texas, June 01, 2017 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq:RETA) ("Reata" or "the Company"), a clinical-stage biopharmaceutical company, today announced positive data from Part 1 of the Company's Phase 2 trial (MOXIe) of omaveloxolone for the treatment of Friedreich's ataxia (FA). (globenewswire.com)
  • The trial demonstrated that in FA patients, omaveloxolone induced Nrf2, which is suppressed in FA patients, and this was associated with improvements in mitochondrial and neurological function. (globenewswire.com)
  • The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with very difficult to treat disease, including patients with high-grade B-cell lymphoma. (adctherapeutics.com)
  • Results from the trial demonstrated an overall response rate (ORR) of 48.3% (70/145 patients), which included a complete response (CR) rate of 24.1% (35/145 patients) and a partial response (PR) rate of 24.1% (35/145 patients). (adctherapeutics.com)
  • At the most recent data cut-off for patients enrolled in the trial, the median duration of response (mDoR) was 13.4 months. (adctherapeutics.com)
  • Amifampridine phosphate (FIRDAPSE ® ) is effective and safe in a phase 3 clinical trial in LEMS. (firdapsehcp.com)
  • Nevertheless, the Five-Shot questionnaire is shorter and easier to use in a general practice setting and has nearly the same diagnostic properties in male and female general practice patient populations. (blogspot.com)
  • LT was contraindicated in previous years in ESLD patients with HPS due to potential preoperative and postoperative complications. (transpopmed.org)
  • However, in recent years, LT has been accepted as the only effective treatment in these patients with HPS. (transpopmed.org)
  • Nevirapine has not been specifically investigated in patients over the age of 65 years. (who.int)
  • A random sample of patients who were over 18 years of age (n = 1992) attending 69 general practices situated in the same region in Belgium. (blogspot.com)
  • When dystrophinopathy primarily affects cardiac muscle, the disease is referred to as X-linked dilated cardiomyopathy and patients present at age 20-40 years with congestive heart failure and dilated cardiomyopathy. (medscape.com)
  • Preparations are currently ongoing for Phase 3 trials of CAM2029 expected to start in 2017. (camurus.com)
  • However, the recent ACCORD and ADVANCE trials in patients with longstanding T2DM have shown that aggressive glucose control in such patients has no clear benefits, or may even increase CVD events (3). (ddw-online.com)
  • During the initial clinical investigations, 2621 patients worldwide were treated with ZOSYN in phase 3 trials. (druglib.com)
  • Following the original analysis of the ITT population in 2019, an additional 676 patients became eligible for Month 18 biopsies prior to a protocol change in REGENERATE that eliminated this biopsy requirement. (biospace.com)
  • Evolving data suggests that, contrary to intuition, liver transplant recipients and patients with autoimmune liver disease on immunosuppression do not have increased mortality. (xiahepublishing.com)
  • We look forward to building on the meaningful work initiated by the talented Travere team and delivering on our commitment to advancing research and bringing treatments to rare liver disease patients in need. (kanerepublican.com)
  • We look forward to working with Mirum to ensure a seamless transition and continuing the commitment to delivering these important medicines to patients in the rare liver disease community. (kanerepublican.com)
  • We believe this new option, given as a single injection administered in less than five minutes, could transform the treatment experience for both patients and physicians. (businesswire.com)
  • Physicians should consider whether the benefits of ADT outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA or Class III antiarrhythmic medications. (firmagon.com)
  • Many times, patients pressure their physicians to order various test procedures as well as treatment. (basicmedicalkey.com)
  • Immunotherapy has transformed the treatment of advanced lung cancer, and thankfully, a diagnosis no longer means the same thing as it used to for many patients. (advfn.com)
  • The FDA's decision to grant a full approval for blinatumomab further validates the use of this therapy to treat adults and children with B-cell precursor ALL with MRD present following a remission, which is a strong predictor of relapse in this patient population. (gurufocus.com)
  • Looking at imaging biomarkers in the combined cohorts of patients with responses, they saw that of patients with at least a 25% change over baseline in FibroScan VCTE, 48% of patients with baseline PDFF of 5% or less, and 42% of those with baseline PDFF greater than 5% had significant improvement at 1 year. (medscape.com)
  • Testosterone suppression to castration levels occurred more rapidly among degarelix patients, with 96% of degarelix-treated patients achieving this end point by Day 3 compared with 0 leuprolide-treated patients. (formularywatch.com)
  • 1% of patients (n=7) in the pooled FIRMAGON group, compared to 2% of patients (n=4) in the leuprolide group, had a QTcF ≥500 msec. (firmagon.com)
  • The labeling recommends that blinatumomab be interrupted or discontinued in patients experiencing these side effects. (southcarolinablues.com)
  • Life-threatening or fatal cytokine release syndrome (CRS) occurred in patients receiving blinatumomab (Amgen, 2014). (southcarolinablues.com)
  • Modafinil-induced wakefulness does not influence nocturnal sleep patterns or the incidence of cataplexy in narcoleptic patients. (empowerpharmacy.com)
  • Over 100 free commonly used clinical formulas and calculator tools to help diagnose, treat, prevent, and determine prognosis of patients at point of care. (guidelinecentral.com)
  • Molecular heterogeneity is one of the most important concerns in colorectal cancer (CRC), which results in a wide range of therapy responses and patient prognosis. (biomedcentral.com)
  • An additional analysis of the subset of patients in the ITT population who had evaluable biopsies at baseline and Month 18 (n=747) was conducted within each treatment arm to show improvement, worsening or no change in fibrosis stage. (biospace.com)
  • Fifty patients are randomly assigned in a 1:1 ratio to receive either 300 mg secukinumab or placebo subcutaneously at baseline, weeks 1, 2 and 3, and every 4 weeks from week 4. (biomedcentral.com)
  • Patients should have an ophthalmic examination (including visual acuity and slit lamp examination) performed by an eye care professional at baseline, before the subsequent 3 treatment cycles, and as clinically indicated whilst on treatment (see section 4.4). (medicines.org.uk)
  • Today's full approval underscores the clinical benefit of BLINCYTO for people living with B-ALL, and we look forward to exploring how we can continue to make a significant impact for these patients. (gurufocus.com)
  • Sandostatin LAR is also indicated for the treatment of patients with acromegaly in whom surgery or radiotherapy is inappropriate of ineffective or in the interim period until radiotherapy becomes fully effective. (camurus.com)
  • This agent was approved on December 24, 2008, for the treatment of patients with advanced prostate cancer. (formularywatch.com)
  • Patients in both treatment arms receive a 26-week prednisolone taper regimen. (biomedcentral.com)
  • The investigational long acting CAM2029 octreotide subcutaneous product for treatment of acromegaly and NET is being developed as a ready-to-use injection in a prefilled syringe equipped with a needle stick safety device that supports CAM2029 administration by patients themselves. (camurus.com)
  • Intralipid 20% (20% I.V. Fat Emulsion) is made of 20% soybean oil used to provide calories to patients who are getting their nutrition through an injection into the vein. (rxlist.com)