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Correlative Science Measures: Study specific research blood and tissue test s will be conducted:. Additionally, PBMC from each of the time points will be analyzed for the presence of circulating populations of regulatory T cells, myeloid-derived suppressor cells MDSC , as well as activated and exhausted T cells.

Additionally, TIL will be analyzed for the presence of infiltrating populations of regulatory T cells, myeloid-derived suppressor cells MDSC , as well as activated and exhausted T cells.

Number of subjects experiencing any of the criteria listed below:. Within each category of RECIST response [partial response PR , stable disease SD , progressive disease PD ], the number of subjects experiencing a pathologic complete response, pathologic partial response, and no pathologic response.

Pathologic response will be evaluated in the resected tumor as follows:. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

For general information, Learn About Clinical Studies. Patients are eligible to be in the study if they meet all of the following criteria:.

Patients will be excluded from the study if they meet any of the following criteria:. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms x. COVID is an emerging, rapidly evolving situation. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.

Federal Government. Read our disclaimer for details. Results First Posted : May 22, Last Update Posted : August 28, Study Description.

Show detailed description. Hide detailed description. Detailed Description:. Study Interventions: The investigational agent, ipilimumab, will be added to neoadjuvant chemotherapy for cycles 2 and 3.

Drug Information available for: Paclitaxel Carboplatin Ipilimumab. FDA Resources. Arms and Interventions. Outcome Measures. Disease-free survival DFS is defined as the time from surgical resection to disease recurrence first disease recurrence or death, whichever comes first after surgery.

Patients alive who had not recurred as of the last follow-up had DFS censored at the last follow-up date. Number of patients experiencing a metastasis between baseline and cycle 3.

Eligibility Criteria. Both sexually active males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and their health care team, during the study and for 3 months following the last dose of study drug.

Kamilla Blecharz-Klin 1. Dagmara Mirowska-Guzel 1. Kamilla Blecharz-Klin. Nowadays, dihydroergotamine DHE is sporadically used as a vasoconstrictor in the treatment of acute migraine.

The importance of this drug in medicine has significantly decreased in the recent years. Limitations on the use of dihydroergotamine are due to the high toxicity and increased the risk of severe adverse events after prolonged theraphy.

The Committee for Medicinal Products for Human Use of the European Medicines Agency recommends limiting the use of drugs that contain ergotamine derivatives due to the potential risk of ischemic vascular events, fibrosis and ergotism.

However, ergot alcaloids preparations are not recommended for use in the prophylaxis of migraine pain, although it is still a good alternative for people with status migrainosus, migraine recurrence or chronic daily headache that do not respond to the classical theraphy.

In clinical practice, DHE can be used as a rescue medication to treat migraine attacks involving aura or without aura, as well as for the acute treatment of cluster headache episodes.

The effectiveness of DHE in alleviating migraine headache was assessed in multiple clinical studies. This review describes the pharmacodynamic and pharmacokinetic properties of DHE in an expanded view and its role in modern therapy based on available clinical trials.

Most clinical data confirm that the drug is still an important element of contemporary migraine therapy, especially in cases when conventional medicine fails.

Where is dihydroergotamine mesylate in the changing landscape of migraine therapy? Expert Opin Pharmacother. Becker WJ. Cluster headache: conventional pharmacological management.

The acute treatment of migraine in adults: the american headache society evidence assessment of migraine pharmacotherapies. Müller-Schweinitzer E.

Alpha-adrenoceptors, 5-hydroxytryptamine receptors and the action of dihydroergotamine in human venous preparations obtained during saphenectomy procedures for varicose veins.

Naunyn Schmiedebergs Arch Pharmacol. Agonistic properties of alniditan, sumatriptan and dihydroergotamine on human 5-HT1B and 5-HT1D receptors expressed in various mammalian cell lines.

Br J Pharmacol. Agonist actions of dihydroergotamine at 5-HT2B and 5-HT2C receptors and their possible relevance to antimigraine efficacy.

Dihydroergotamine, ergotamine, methysergide and sumatriptan — basic science in relation to migraine treatment. Ergotamine and dihydroergotamine: history, pharmacology, and efficacy.

Rescue therapy for acute migraine, part 1: triptans, dihydroergotamine, and magnesium. Dihydroergotamine: a review of formulation approaches for the acute treatment of migraine.

CNS Drugs. Bioavailability of dihydroergotamine in man. Br J Clin Pharmacol. Barthel W. Z Gesamte Inn Med. Bioavailability of intranasal formulations of dihydroergotamine.

Eur J Clin Pharmacol. Saper JR, Silberstein S. Pharmacology of dihydroergotamine and evidence for efficacy and safety in migraine.

Randomized, double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of MAP orally-inhaled DHE in adult asthmatics.

Curr Med Res Opin. Silberstein S. MAP dihydroergotamine mesylate inhalation aerosol for acute treatment of migraine. Pharmacokinetic investigation of oral and i.

Aellig WH. Buck M. Pediatric Pharmacotherapy. Oral dihydroergotamine for therapy-resistant migraine attacks in children.

Pediatr Neurol. Continuous intravenous dihydroergotamine in the treatment of intractable headache. Magnoux E, Zlotnik G.

Outpatient intravenous dihydroergotamine for refractory cluster headache. Inpatient treatment of status migraine with dihydroergotamine in children and adolescents.

Charles JA, von Dohln P. Outpatient home-based continuous intravenous dihydroergotamine therapy for intractable migraine. Tepper SJ. Orally inhaled dihydroergotamine: a review.

A retrospective analysis of triptan and dhe use for basilar and hemiplegic migraine. Pharmacologic treatment of pediatric headaches: a meta-analysis.

JAMA Pediatr. Acute treatment of paediatric migraine: a meta-analysis of efficacy. J Paediatr Child Health.

Dihydroergotamine and its use in migraine with posterior fossa symptoms. Tfelt-Hansen PC. Relatively slow and long-lasting antimigraine effect of dihydroergotamine is most likely due to basic pharmacological attributes of the drug: a review.

Mayans L, Walling A. Acute Migraine Headache: Treatment Strategies. Am Fam Physician. Parenteral dihydroergotamine for acute migraine headache: a systematic review of the literature.

Ann Emerg Med. Dihydroergotamine DHE use during gestation and the risk of adverse pregnancy outcomes. Involvement of signaling pathways in bovine sperm motility, and effect of ergot alkaloids.

Eur J Neurol. Transient global amnesia, migraine, thalamic infarct, dihydroergotamine, and sumatriptan. Reversible vasospasm in association with the use of heparin and dihydroergotamine.

Clin Orthop Relat Res.

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