Page last updated: 2024-12-05

dexamethasone 21-phosphate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

Dexamethasone 21-phosphate is a synthetic glucocorticoid that is a prodrug of dexamethasone. It is a potent anti-inflammatory and immunosuppressive agent. Dexamethasone 21-phosphate is used to treat a variety of conditions, including inflammatory diseases, allergic reactions, and autoimmune disorders. It is also used to prevent organ rejection after transplantation. Dexamethasone 21-phosphate is typically administered intravenously or intramuscularly. It is rapidly converted to dexamethasone in the body. Dexamethasone 21-phosphate is a valuable tool for treating a variety of inflammatory and autoimmune conditions. It is also used to prevent organ rejection after transplantation. However, it is important to note that dexamethasone 21-phosphate can have serious side effects, including Cushing's syndrome, osteoporosis, and increased risk of infection. Therefore, it is important to use this medication only as directed by a physician.'

dexamethasone 21-phosphate: has anti-inflammatory activity [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

dexamethasone phosphate : A steroid phosphate that is the 21-O-phospho derivative of dexamethasone. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID9400
CHEMBL ID1201302
CHEBI ID68637
SCHEMBL ID135283
MeSH IDM0045158

Synonyms (46)

Synonym
(11beta,16alpha)-9-fluoro-11,17-dihydroxy-16-methyl-3,20-dioxopregna-1,4-dien-21-yl dihydrogen phosphate
neodecadron
dexamethasone 21-orthophosphate
hexadrol phosphate
dexamethasone 21-(dihydrogen phosphate)
dexamethasone 21-phosphate
einecs 206-232-0
betnelan phosphate
dexamethasone-21-phosphate
oradexon phosphate
dexamethasone-21-dihydrogen-phosphate
dexamethasone phosphate
wymesone
pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-alpha-methyl-, 21-(dihydrogen phosphate)
9-fluoro-11beta,17,21-trihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen phosphate)
[2-[(8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] dihydrogen phosphate
decadron-phosphate (tn)
312-93-6
D07802
3t5 ,
(11alpha,16alpha)-9-fluoro-11,17-dihydroxy-16-methyl-3,20-dioxopregna-1,4-dien-21-yl dihydrogen phosphate
AKOS016007098
dexamethasone phosphoric acid
CHEMBL1201302
chebi:68637 ,
2bp70l44pr ,
unii-2bp70l44pr
egp-437
pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-,(11.beta.,16.alpha.)-
al38905
dexamethasone phosphate [who-dd]
dexamethasone dihydrogen phosphate
dexamethasone phosphate [mart.]
dexamethasone phosphate [usp-rs]
9-fluoro-11.beta.,17,21-trihydroxy-16.alpha.-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen phosphate)
dexamethasone phosphate [vandf]
al-38905
VQODGRNSFPNSQE-CXSFZGCWSA-N
SCHEMBL135283
DTXSID2047430
erydex
(11alpha,16beta)-9-fluoro-11,17-dihydroxy-16-methyl-3,20-dioxopregna-1,4-dien-21-yl dihydrogen phosphate
Q27137065
2-((8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl dihydrogen phosphate
312-93-6 (acid)
egp437

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Thus, toxic effects can be caused by preservatives or inadequate osmolarity of the vehicles alone."( Experimental and clinical observations of the intraocular toxicity of commercial corticosteroid preparations.
Arena, JE; Chandler, D; Hida, T; Machemer, R, 1986
)
0.27
" Corticosteroids and ibuprofen have been proven to slow down the impairment of the pulmonary function in CF patients but their use is limited by the frequency of adverse events."( A pilot trial on safety and efficacy of erythrocyte-mediated steroid treatment in CF patients.
Bella, S; Lucidi, V; Tozzi, AE; Turchetta, A, 2006
)
0.33
" Unfortunately, its adverse effects, mainly hypersensitivity skin reactions and hepatotoxicity, have hampered the use of nevirapine."( RAT CYP3A and CYP2B1/2 were not associated with nevirapine-induced hepatotoxicity.
Abraham, AM; Barr, S; Walubo, A, 2006
)
0.33
"The results of this investigation suggest that repeated transscleral iontophoresis with dexamethasone phosphate may be safe for use as a treatment for inflammatory ocular disorders that require prolonged and/or repeated corticosteroid therapy."( Evaluation of ocular and general safety following repeated dosing of dexamethasone phosphate delivered by transscleral iontophoresis in rabbits.
Burgos, M; Gee, R; Isom, WP; Patane, MA; Ruiz-Perez, B; Sanford, T; Schubert, W, 2013
)
0.39
" There was 100% technical success of drug delivery and no procedural or drug-related adverse events."( Safety and feasibility of adjunctive dexamethasone infusion into the adventitia of the femoropopliteal artery following endovascular revascularization.
Alley, HF; Conte, MS; Gasper, WJ; Grenon, SM; Owens, CD; Walker, JP, 2014
)
0.4
"Adventitial drug delivery via a microinfusion catheter is a safe and feasible alternative to intimal-based methods for adjunctive treatment in the femoropopliteal segment."( Safety and feasibility of adjunctive dexamethasone infusion into the adventitia of the femoropopliteal artery following endovascular revascularization.
Alley, HF; Conte, MS; Gasper, WJ; Grenon, SM; Owens, CD; Walker, JP, 2014
)
0.4
" Repeat applications of DSP-Visulex are safe and well tolerated for weekly administrations over 4-12 weeks."( Ocular Drug Distribution and Safety of a Noninvasive Ocular Drug Delivery System of Dexamethasone Sodium Phosphate in Rabbit.
Brar, B; Higuchi, JW; Higuchi, WI; Papangkorn, K, 2018
)
0.48

Pharmacokinetics

ExcerptReferenceRelevance
" Plasma levels of the ester and dexamethasone were measured and pharmacokinetic parameters were calculated."( Pharmacokinetics of dexamethasone and its phosphate ester.
Barth, J; Derendorf, H; Möllmann, H; Rehder, J; Rohdewald, P,
)
0.13
"Since multi-drug resistance 1 gene (MDR1) has a potential influence on Dexamethasone (Dex) bioavailability, we designed this study to investigate the correlation between MDR1 genotype and Dex pharmacokinetic after its delivery in patients with inflammatory bowel disease (IBD)."( The polymorphism of multi-drug resistance 1 gene (MDR1) does not influence the pharmacokinetics of dexamethasone loaded into autologous erythrocytes of patients with inflammatory bowel disease.
Andriulli, A; Annese, V; Bossa, F; Dallapiccola, B; Damonte, G; Latiano, A; Magnani, M; Pierigé, F; Rossi, L; Serafini, S,
)
0.13
" The concentrations of DSP and Dex were measured by HPLC, and were used to estimate in vivo distribution and pharmacokinetic parameters of Dex in the inner ear."( [In vivo distribution and pharmacokinetics of dexamethasone sodium phosphate thermosensitive in situ gel following intratympanic injection].
Chen, G; Hou, SX; Liu, J; Luan, JG; Zhang, Y, 2006
)
0.33
" However, this sensitivity was not satisfactory for corticosterone during pharmacokinetic studies involving dexamethasone due to its strong adrenosuppressive effect."( Quantification of dexamethasone and corticosterone in rat biofluids and fetal tissue using highly sensitive analytical methods: assay validation and application to a pharmacokinetic study.
Jusko, WJ; Samtani, MN, 2007
)
0.34
" The mean area under the plasma concentration-time curve and the mean elimination half-life were 133."( Pharmacokinetics of dexamethasone after intravenous and intramuscular administration in pigs.
Croubels, S; De Backer, P; De Baere, S; Meyer, E; Plessers, E; Watteyn, A; Wyns, H, 2013
)
0.39
" Thus, we used this method to assess the pharmacokinetic (PK) characteristics of MFH and DSP in rabbit ocular tissues and plasma after single doses."( Simultaneous Determination of Moxifloxacin Hydrochloride and Dexamethasone Sodium Phosphate in Rabbit Ocular Tissues and Plasma by LC-MS/MS: Application for Pharmacokinetics Studies.
Qiao, H; Shao, Q; Yuan, Y; Zhao, X, 2022
)
0.72

Bioavailability

ExcerptReferenceRelevance
" Bioavailability of the acetate was greatest; that of the sodium phosphate was the lowest."( Effect of derivatization of the bioavailability of ophthalmic steroids. Development of an in vitro method of evaluation.
Flint, GR; Morton, DJ, 1984
)
0.27
" The number of times DEX-P was administered was not a significant factor in the induction of either hepatic or intestinal CYP3A; however, administration of DEX-P multiple times markedly decreased the bioavailability of DEX-P by self-induction of CYP3A."( Time-dependent changes in hepatic and intestinal induction of cytochrome P450 3A after administration of dexamethasone to rats.
Honjo, T; Iwanaga, K; Kakemi, M; Miyazaki, M, 2013
)
0.39
"21 h and a high absolute bioavailability of 131."( Pharmacokinetics of dexamethasone after intravenous and intramuscular administration in pigs.
Croubels, S; De Backer, P; De Baere, S; Meyer, E; Plessers, E; Watteyn, A; Wyns, H, 2013
)
0.39
" The bioavailability of such ophthalmic drugs can be enhanced significantly using contact lenses incorporating drug-loaded nanoparticles (NPs)."( Synthesis and Characterization of Poly(2-hydroxyethylmethacrylate) Contact Lenses Containing Chitosan Nanoparticles as an Ocular Delivery System for Dexamethasone Sodium Phosphate.
Behl, G; Fitzhenry, L; Iqbal, J; McLoughlin, P; O'Reilly, NJ, 2016
)
0.43
"To investigate the bioavailability of nebulised DSP and determine whether it induces airway inflammation or hypothalamic-pituitary-adrenal (HPA) axis suppression in healthy adult horses."( Bioavailability and tolerability of nebulised dexamethasone sodium phosphate in adult horses.
Berghaus, LJ; Davis, JL; Giguère, S; Hart, KA; Haspel, AD, 2018
)
0.48
"Dexamethasone sodium phosphate administered via nebulisation had minimal systemic bioavailability and did not induce lower airway inflammation or HPA axis suppression in healthy horses."( Bioavailability and tolerability of nebulised dexamethasone sodium phosphate in adult horses.
Berghaus, LJ; Davis, JL; Giguère, S; Hart, KA; Haspel, AD, 2018
)
0.48
" Topical corticosteroids are the first line treatment for suppressing CNV, but poor ocular bioavailability and rapid clearance of eye drops makes frequent administration necessary."( Controlled release of dexamethasone sodium phosphate with biodegradable nanoparticles for preventing experimental corneal neovascularization.
Chen, B; Ding, Z; Eberhart, CG; Ensign, LM; Hanes, J; Kulkarni, V; Lamb, NW; Meng, T; Oh, Y; Stark, WJ; Suarez, MJ; Tang, Y; Wang, B; Xia, S; Xu, Q, 2019
)
0.51
" A recent study reported that nebulisation of injectable dexamethasone had low systemic bioavailability in healthy horses and could represent a cost-effective therapy for equine inflammatory lung diseases."( Nebulisation of dexamethasone sodium phosphate for the treatment of severe asthmatic horses.
Bessonnat, A; Lavoie, JP; Mainguy-Seers, S; Picotte, K, 2019
)
0.51
"Oral Dex-P had lower bioavailability than Beta-P, giving a lower maximum maternal and fetal concentration."( Oral antenatal corticosteroids evaluated in fetal sheep.
Bridges, JP; Clarke, M; Fee, EL; Jobe, AH; Kannan, PS; Kemp, MW; Kumagai, Y; Newnham, JP; Saito, M; Schmidt, AF; Usuda, H, 2019
)
0.51

Dosage Studied

ExcerptRelevanceReference
"05) between responses resulting from the 2 dosage rates."( Plasma endogenous ACTH concentrations and plasma cortisol responses to synthetic ACTH and dexamethasone sodium phosphate in healthy cats.
Feldman, EC; Smith, MC, 1987
)
0.27
" A dose-response study, at the range of 2-40 mg/kg, showed that a significant decrease was noted at 6 mg/kg and it was maximal (45% inhibition) at 20 and 40 mg/kg."( Inhibition of prostaglandin synthesis in brain of rat by dexamethasone: lack of effect of dexamethasone phosphate ester and various hormonal steroids.
Abu-Amer, Y; Shohami, E; Weidenfeld, J, 1988
)
0.27
" Although their initial dosage is subject to some controversy, corticosteroids (CS) provide currently the basis of therapy."( [Immediate treatment of bullous pemphigus with a corticosteroid-cyclophosphamide combination].
Klene, C; Maleville, J; Taïeb, A, 1986
)
0.27
" Ninety-eight ferrets were used in these experiments, which were undertaken to evaluate the efficacy of steroids and/or a long-acting vasoconstrictor, to develop dose-response curves for dexamethasone sodium phosphate if it proved efficacious, and to evaluate the possible synergistic effects of combination therapy."( Use of steroids and a long-acting vasoconstrictor in the treatment of postintubation croup. A ferret model.
Pillsbury, HC; Postma, DS; Prazma, J; Sidman, J; Woods, CI, 1987
)
0.27
" The results showed that in this low dosage dexamethasone did not worsen the course of the infection in a single case."( [Effect of corticosteroids in antimycotic therapy of Candida keratitis].
Behrens-Baumann, W; Küster, M, 1987
)
0.27
" In this double-masked, crossover study of 17 subjects, the same eye of each subject was dosed with both steroids, instillation of the second steroid following a one-month washout period."( Ocular pressure response to fluorometholone acetate and dexamethasone sodium phosphate.
Rosenthal, AL; Smith, JP; Stewart, RH, 1984
)
0.27
"The purpose of this study was to determine the effects of two dosage regimens of dexamethasone on the serum cortisol levels of a group of patients undergoing major maxillofacial surgical procedures."( Dosage effects of pulsed steroid therapy on serum cortisol levels in oral and maxillofacial surgery patients.
Butler, RC; Finstuen, K; Vorono, AA, 1993
)
0.29
" Mice in groups 2-5 were immunosuppressed with dexamethasone phosphate administered ad libitum in drinking water at a dosage level of 12 microg/ml."( Effects of pine bark extract administered to immunosuppressed adult mice infected with Cryptosporidium parvum.
Healey, JM; Kim, HC, 2001
)
0.31
" Despite the frequent dosing schedule, the dexamethasone concentration in the aqueous humor is far lower than after a subconjunctival injection with dexamethasone disodium phosphate."( Intraocular penetration and systemic absorption after topical application of dexamethasone disodium phosphate.
Cohen, AF; Lentjes, EG; Romijn, FP; Schoemaker, RC; van Meurs, JC; Weijtens, O, 2002
)
0.31
" A safe, effective dosage of rh-BMP-2 in the cervical spine has yet to be determined."( Adverse swelling associated with use of rh-BMP-2 in anterior cervical discectomy and fusion: a case study.
Anand, N; Cooper, M; Lauryssen, C; Perri, B,
)
0.13
" The specificity of the developed methods was investigated by analyzing laboratory prepared mixtures and the combined dosage form."( A comparative study of novel spectrophotometric methods based on isosbestic points; application on a pharmaceutical ternary mixture.
Hassan, NY; Lotfy, HM; Saleh, SS; Salem, H, 2014
)
0.4
" When comparing all three groups, a statistically significant dose-response relationship was seen for present, average and worst pain intensity after 8 h and on the following morning."( Dexamethasone for pain after outpatient shoulder surgery: a randomised, double-blind, placebo-controlled trial.
Bjørnholdt, KT; Mønsted, PN; Nikolajsen, L; Søballe, K, 2014
)
0.4
"Although our data supported a dose-response relationship, increasing the dexamethasone dose from 8 to 40 mg did not improve analgesia significantly after outpatient shoulder surgery."( Dexamethasone for pain after outpatient shoulder surgery: a randomised, double-blind, placebo-controlled trial.
Bjørnholdt, KT; Mønsted, PN; Nikolajsen, L; Søballe, K, 2014
)
0.4
" However, steroids delivered in eye drops are rapidly cleared from the surface of the eye, so the required frequency of dosing for corneal graft rejection management can be as high as once every 2h."( Corticosteroid-loaded biodegradable nanoparticles for prevention of corneal allograft rejection in rats.
Alwadani, S; Boylan, NJ; Eberhart, CG; Emmert, DG; Hanes, J; Heflin, T; Lamb, NW; Pan, Q; Stark, WJ; Tang, L; Xu, Q; Yang, JC, 2015
)
0.42
"25 mg) during a 6-month PRN (pro re nata) dosing regimen."( Intravitreal combination of dexamethasone sodium phosphate and bevacizumab in the treatment of exudative AMD.
Deligiannis, I; Echiadis, G; Giannikakis, S; Kavalarakis, E; Papaefthymiou, I; Pervena, A; Vakalis, N, 2015
)
0.42
"The aim of this study was to apply quality by design (QbD) for development of dexamethasone sodium phosphate (DSP) and tobramycin sulfate (TS)-loaded thermoresponsive ophthalmic in situ gel containing Poloxamer 407 and hydroxyl propyl methyl cellulose (HPMC) K4M for prolonging the pre-corneal residence time, ocular bioavability and decreases the frequency of administration of dosage form."( Formulation and development of ophthalmic in situ gel for the treatment ocular inflammation and infection using application of quality by design concept.
Baldaniya, L; Gandhi, T; Gohel, M; Metalia, V; Patel, N; Thakkar, V, 2016
)
0.43
" In this study, the effects of two different long-term GC dosing regimens on lipid metabolism and behavior were investigated."( Timing of glucocorticoid administration determines severity of lipid metabolism and behavioral effects in rats.
Chen, Y; Fu, Z; Jiang, J; Kong, B; Li, H; Lu, P; Wu, T; Yang, L; Zhang, W; Zhao, B; Zhao, Z; Zhu, J, 2017
)
0.46
" A comprehensive in-silico platform, which includes appropriate numerical tools for fitting, could contribute to iontophoretic drug-delivery devices design and correct dosage and drug clearance profiles as well as to perform much faster in-silico experiments to better determine parameters and performance criteria of iontophoretic drug delivery."( Computational and experimental model of transdermal iontophorethic drug delivery system.
Bijelic, G; Filipovic, N; Graells, BO; Rac, V; Saveljic, I, 2017
)
0.46
" We report the pharmacokinetics and pharmacodynamics of oral dosing of ACS using a preterm sheep model."( Oral antenatal corticosteroids evaluated in fetal sheep.
Bridges, JP; Clarke, M; Fee, EL; Jobe, AH; Kannan, PS; Kemp, MW; Kumagai, Y; Newnham, JP; Saito, M; Schmidt, AF; Usuda, H, 2019
)
0.51
"Using a sheep model, we demonstrate the use of pharmacokinetics to develop oral dosing strategies for ACS."( Oral antenatal corticosteroids evaluated in fetal sheep.
Bridges, JP; Clarke, M; Fee, EL; Jobe, AH; Kannan, PS; Kemp, MW; Kumagai, Y; Newnham, JP; Saito, M; Schmidt, AF; Usuda, H, 2019
)
0.51
" First, we performed pharmacokinetic studies in non-pregnant monkeys to compare blood levels of the steroids using oral dosing with Beta-P, Dex-P and an effective maternal intramuscular dose of the beta-acetate component of the clinical treatment."( Oral dosing for antenatal corticosteroids in the Rhesus macaque.
Bridges, JP; Clarke, MW; Jobe, AH; Kannan, PS; Kemp, MW; Milad, M; Miller, LA; Schmidt, AF, 2019
)
0.51
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (1)

RoleDescription
glucocorticoid receptor agonistAn agonist that selectively binds to and activates a glucocorticoid receptor.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (6)

ClassDescription
steroid phosphate
11beta-hydroxy steroidAny 11-hydroxy steroid in which the hydroxy group at position 11 has beta- configuration.
17-hydroxy steroidA hydroxy steroid carrying a hydroxy group at position 17.
3-oxo-Delta(4) steroidA 3-oxo steroid conjugated to a C=C double bond at the alpha,beta position.
fluorinated steroidA steroid which is substituted with one or more fluorine atoms in any position.
tertiary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a carbon bearing two organyl groups.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Research

Studies (455)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990125 (27.47)18.7374
1990's51 (11.21)18.2507
2000's98 (21.54)29.6817
2010's149 (32.75)24.3611
2020's32 (7.03)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 25.01

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index25.01 (24.57)
Research Supply Index6.35 (2.92)
Research Growth Index4.68 (4.65)
Search Engine Demand Index28.85 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (25.01)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials88 (18.11%)5.53%
Reviews7 (1.44%)6.00%
Case Studies45 (9.26%)4.05%
Observational4 (0.82%)0.25%
Other342 (70.37%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (99)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for the Treatment of Dry Eye in the Controlled Adverse Environment (CAE) Model [NCT01129856]Phase 3198 participants (Actual)Interventional2010-06-30Completed
Evaluations of Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Ataxia Teleangiectasia Patients [NCT01255358]Phase 222 participants (Actual)Interventional2011-02-28Completed
Pediatric Postoperative Analgesia With Quadratus Lumborum Block And Dexamethasone As An Adjuvant In Two Routes With Bupivacaine. Prospective Controlled Clinical Trial [NCT04963816]3 participants (Actual)Interventional2021-06-16Completed
Role Of Dexamethasone In Induction Of Labor : A Randomized Clinical Trial . [NCT03603418]Phase 480 participants (Anticipated)Interventional2018-07-13Recruiting
Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery [NCT03332316]Phase 484 participants (Actual)Interventional2017-11-02Completed
Effect of Dexamethasone on Postoperative Symptoms of Scleral Buckling Surgery Patients: a Randomized Control Trial [NCT01326585]Phase 40 participants (Actual)Interventional2011-04-30Withdrawn(stopped due to lack of funding)
[NCT00750633]Phase 3990 participants (Actual)Interventional2008-06-30Completed
A Prospective Randomized Comparative Trial of Targeted Injection Via a Transforaminal Approach With Dexamethasone Versus an Epidural Catheter Via an Interlaminar Approach With Particulate Steroid for the Treatment of Cervical Radicular Pain [NCT03382821]Phase 4120 participants (Actual)Interventional2017-09-15Completed
Impact of Perioperative Dexamethasone and Flurbiprofen Axetil on Delirium After Surgery for Non-small Cell Lung Cancer: A 2x2 Factorial Randomized Controlled Trial [NCT03200600]Phase 4126 participants (Actual)Interventional2017-08-02Terminated(stopped due to Protocol violation occurred frequently during the postoperative period.)
Impact of Perioperative Dexamethasone and Flurbiprofen Axetil on Long-term Survival After Surgery for Non-small Cell Lung Cancer: A 2x2 Factorial Randomized Controlled Trial [NCT03172988]Phase 4126 participants (Actual)Interventional2017-08-02Terminated(stopped due to Protocol violation occurred frequently during the postoperative period.)
A Randomized, Parallel Group, Double-masked, Active-controlled Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of Dexamethasone Sodium Phosphate Visulex System for the Treatment of Non-infectious Anterior Uveitis [NCT02309385]Phase 1/Phase 244 participants (Actual)Interventional2014-10-31Completed
Effect of Antenatal Corticosteroids on Neonatal Morbidity. [NCT03446937]150 participants (Actual)Interventional2017-12-01Completed
Prophylactic Mirtazapine or Dexamethasone for Post-spinal Anesthesia Shivering in Patients Undergoing Gynecological Surgeries: a Randomized Controlled Trial [NCT03675555]Phase 4300 participants (Actual)Interventional2018-03-01Completed
Prophylactic Paracetamol or Dexamethasone for Post-spinal Anesthesia Shivering in Patients Undergoing Non-obstetric Surgeries: a Randomized Controlled Trial [NCT03679065]Phase 4300 participants (Actual)Interventional2018-03-01Completed
Effect of Submucosal Cryotherapy Compared to Steroidal and Non-Steroidal Anti-Inflammatory Drugs Injection on Postoperative Endodontic Pain [NCT06090500]40 participants (Anticipated)Interventional2023-03-20Recruiting
An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates [NCT00579020]Phase 2144 participants (Actual)Interventional2007-12-31Terminated(stopped due to Management decision)
Dexamethasone Blunts the Hypotensive Effect of Spinal Anesthesia in Geriatric Patients Undergoing Lower Limb Orthopedic Surgeries: a Double Blind, Placebo-controlled Study [NCT03664037]Phase 4110 participants (Actual)Interventional2018-03-01Completed
Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model [NCT00765804]Phase 289 participants (Actual)Interventional2008-10-31Completed
Quadratus Lumborum Block (QLB) With and Without Dexamethasone: the Effect on Postoperative Pain and Recovery After Laparoscopic Nephrectomy [NCT03339284]Phase 490 participants (Anticipated)Interventional2017-12-04Recruiting
Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization [NCT03942601]Phase 260 participants (Anticipated)Interventional2019-10-01Recruiting
Phase II Study of SOM230 LAR in Combination With Bortezomib and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma [NCT01329289]Phase 20 participants (Actual)Interventional2011-12-31Withdrawn(stopped due to Clinical trial being transferred to Columbia University with the Investigator.)
Prevention of Cisplatin-Induced Hearing Loss by Intratympanic Dexamethasone Treatment. [NCT01372904]Phase 430 participants (Actual)Interventional2011-06-30Completed
PHASE 2 STUDY OF DEXAMETHASONE 21-PHOSPHATE LOADED INTO AUTOLOGOUS ERYTHROCYTES IN STEROID-DEPENDENT ULCERATIVE COLITIS PATIENTS [NCT01171807]Phase 240 participants (Anticipated)Interventional2003-04-30Recruiting
Evaluation of Corticosteroid as Modulators of Humeral and Cellular Immune Response in Open Heart Surgery in Egyptian Population [NCT03876041]Phase 460 participants (Actual)Interventional2019-09-01Completed
Comparative Evaluation of the Effect of a Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial [NCT03745105]42 participants (Anticipated)Interventional2018-12-25Not yet recruiting
The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty . A Double -Blinded Randomized Controlled Study. [NCT04084912]Phase 386 participants (Anticipated)Interventional2020-01-01Not yet recruiting
Comparison of the Effects of Different Time of Intravenous Dexamethasone on Brachial Plexus Block: a Randomized Control Study [NCT04714112]Phase 4180 participants (Actual)Interventional2021-01-10Completed
A Prospective, Multi-Center, Randomized, Double-Masked, Safety, Tolerability and Efficacy Study of Four Iontophoretic Doses of Dexamethasone Phosphate Ophthalmic Solution in Patients With Non-Infectious Anterior Segment Uveitis [NCT00694135]Phase 240 participants (Actual)Interventional2008-06-30Completed
The Effectiveness of Cervical Transforaminal Epidural Steroid Injection for the Treatment of Cervical Radicular Pain: A Prospective Cohort Study. [NCT04544683]Phase 429 participants (Actual)Interventional2018-10-23Active, not recruiting
Analgesic Duration of Interscalene Block After Outpatient Arthroscopic Shoulder Surgery With Intravenous Dexamethasone, Dexmedetomidine or Their Combination: A Randomized Controlled Trial [NCT03270033]Phase 4198 participants (Actual)Interventional2017-09-18Completed
Multi-Center, Double-Masked, Randomized, Placebo-Controlled Phase 2b Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Having Undergone Cataract Surgery With Implantation o [NCT03180255]Phase 2101 participants (Actual)Interventional2017-07-26Completed
Single Dose Dexamethasone is as Effective as Two Doses in Mild to Moderate Pediatric Asthma Exacerbations in the Emergency Department [NCT02192827]Phase 3318 participants (Actual)Interventional2015-04-30Completed
A Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition Disease [NCT00520767]Phase 235 participants (Actual)Interventional2007-09-30Completed
Comparison of Perioperative Intravenous vs Periarticular Dexamethasone vs no Steroid Supplementation in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Primary Total Knee Arthroplast [NCT04432012]Phase 4159 participants (Anticipated)Interventional2020-07-01Recruiting
A Multi-central Perspective Randomized Controlled Study Evaluating the Efficacy and Safety of Aprepitant in Autologous Hematopoietic Stem Cell Transplantation [NCT02576327]Phase 4130 participants (Anticipated)Interventional2015-10-31Active, not recruiting
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Ultrasound-guided Intermediate Cervical Plexus Block in Patients Undergoing Thyroidectomy [NCT05793060]Phase 460 participants (Anticipated)Interventional2022-04-15Recruiting
Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS) [NCT01030601]Phase 248 participants (Anticipated)Interventional2010-01-31Completed
Efficacy of Soluble Dexamethasone by Echo-guided Infiltration Through the Sacrococcygeal Hiatus in Refractory Sciatica: a Prospective Randomised Double-blind Study Versus Placebo [NCT05000658]Phase 3106 participants (Anticipated)Interventional2021-12-16Recruiting
A Prospective, Multi-Center, Single-Dose, Phase 1 Clinical Trial Designed to Evaluate the Pharmacokinetics of Dexamethasone Phosphate Ophthalmic Solution Delivered Via the EyeGate® II Drug Delivery System in Patients Undergoing Vitrectomy for Macular Hole [NCT02644694]Phase 110 participants (Actual)Interventional2016-03-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study Evaluating AVM0703 in Patients With Acute Respiratory Distress Syndrome [NCT04366115]Phase 116 participants (Anticipated)Interventional2022-12-01Not yet recruiting
The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure [NCT00953303]Phase 2/Phase 3102 participants (Actual)Interventional2009-01-31Completed
A Phase I/II Double-Blinded Randomized Prospective Study of Sterile Amniotic Fluid Filtrate Epidural Injection for the Treatment of Lumbosacral Radicular Pain Due to Spinal Stenosis: Improving Safety and Outcomes in the Treatment of Pain and Disability Re [NCT04537026]Phase 1/Phase 2112 participants (Anticipated)Interventional2021-06-16Recruiting
Effect of Laparoscopic-Guided Transversus Abdominus Plane (TAP) Block on Opioid Consumption Using Dual-Adjunct Therapy With Dexmedetomidine and Dexamethasone Versus Liposomal Bupivacaine (Exparel®) Following Minimally Invasive Colorectal Surgery: A Single [NCT05216055]Phase 20 participants (Actual)Interventional2022-04-19Withdrawn(stopped due to No Accrual. PI left Institution)
Perineural Dexamethasone Administered in Femural Nerve Block After Anterior Cruciate Ligament Reconstruction [NCT02749162]Phase 390 participants (Actual)Interventional2015-11-30Completed
Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy [NCT00564603]Phase 4300 participants (Actual)Interventional2007-08-31Completed
Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study [NCT01059955]Phase 118 participants (Actual)Interventional2012-01-31Completed
Comparison Of The Effectiveness Of Submucosal Corticosteroid Injection And Elastic Therapeutic Bandage Applications On Pain, Swelling And Trismus After Surgical Removal Of Mandibular Third Molar Teeth [NCT04200885]Phase 452 participants (Actual)Interventional2019-05-02Completed
Evaluation the Effect of Diclofenac Drops vs Dexamethasone Drops in Trabeculectomy and Cataract Surgery [NCT00825864]50 participants (Anticipated)Interventional2004-01-31Completed
Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progenitor Cell Mobilization Prior to Autologous Transplantation [NCT00293384]40 participants (Actual)Interventional2004-10-31Completed
Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization [NCT01983449]Phase 4285 participants (Actual)Interventional2013-11-30Completed
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars) [NCT04593706]40 participants (Anticipated)Interventional2020-11-01Not yet recruiting
Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma [NCT00335140]Phase 226 participants (Actual)Interventional2007-08-23Terminated(stopped due to slow accrual)
Glucocorticoid Postauricular Injection Treatment for Sudden Hearing Loss: a Multi-center, Opened, Randomized, Controlled Clinical Trial [NCT02026479]300 participants (Anticipated)Interventional2014-01-31Not yet recruiting
OPEN-LABEL, MULTI-CENTER, PHASE 1b/2a CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF IONTOPHORETIC DEXAMETHASONE PHOSPHATE OPHTHALMIC SOLUTION IN PATIENTS HAVING UNDERGONE CATARACT SURGERY WITH IMPLANTATION OF A POSTERIOR CHAMBER INTRAOCUL [NCT02571556]Phase 1/Phase 280 participants (Actual)Interventional2015-11-30Completed
A Phase I Study of Venetoclax in Combination With Cytotoxic Chemotherapy, Including Calaspargase Pegol, for Children, Adolescents and Young Adults With High-Risk Hematologic Malignancies [NCT05292664]Phase 192 participants (Anticipated)Interventional2023-03-29Recruiting
Comparison of Local and Intra Venous Dexamethasone on Post Operative Pain and Recovery After Caeseream Section [NCT02784340]Phase 4120 participants (Actual)Interventional2014-05-31Completed
A Phase I/II Multicenter, Randomized, Open Label, Dose-Escalation Study To Determine The Maximum Tolerated Dose, Safety, And Efficacy Of CC-4047 Alone Or In Combination With Low-Dose Dexamethasone In Patients Wth Relapsed And Refractory Multiple Myeloma W [NCT00833833]Phase 1/Phase 2259 participants (Actual)Interventional2008-06-30Completed
A Volunteer Study to Determine the Optimal Dose of IV Dexamethasone Required for Prolongation of Peripheral Nerve Block [NCT02864602]Phase 318 participants (Actual)Interventional2016-11-12Completed
The Effects and Dose Response of Dexamethasone on Intercostal Nerve Blocks With Bupivicaine in Post Thoracic Surgery Patients [NCT02936427]Phase 360 participants (Anticipated)Interventional2016-07-31Recruiting
A Phase 2, Open-label, Pharmacokinetic Study of a Single Intra-articular Administration of TLC599 in Subjects With Mild to Moderate Osteoarthritis of the Knee [NCT03754049]Phase 2102 participants (Anticipated)Interventional2019-01-21Recruiting
The Effectiveness of Combined U.S. Guided Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus U.S.Guided Thoracic Paravertebral Block in Controlling Perioperative Pain in Modified Radical Mastectomy, a Blinded Randomized Controlled Trial [NCT04778267]Phase 430 participants (Actual)Interventional2021-03-12Completed
Intravenous Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia and Allergy to E. Coli Asparaginase (IND 104224) [NCT00928200]Phase 11 participants (Actual)Interventional2009-04-13Terminated(stopped due to Study was terminated due to lack of accrual.)
Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery [NCT01515826]Phase 30 participants (Actual)Interventional2014-03-31Withdrawn(stopped due to Management decision)
High Dose Oral Steroids in Sudden Sensorineural Hearing Loss [NCT03255473]Phase 24 participants (Actual)Interventional2017-08-30Completed
Intraluminal Ureteric Injection of High Concentration Alkalinised Long-acting Local Anaesthetic and STeroid Post urEteroscopy: A Prospective Double Blinded Randomised Controlled Trial (LASTE Trial) [NCT03296189]150 participants (Anticipated)Interventional2018-11-01Not yet recruiting
An Open Label, Phase 1/2 Study Evaluating Immunomodulatory AVM0703 in Patients With Lymphoid Malignancies (OPAL Study) [NCT04329728]Phase 1/Phase 2144 participants (Anticipated)Interventional2020-11-06Recruiting
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2 [NCT05736549]Phase 266 participants (Anticipated)Interventional2023-02-07Recruiting
Perineural Steroids for Saphenous Peripheral Nerve Blocks: An Equivalency Dosing Study. [NCT02462148]Phase 485 participants (Actual)Interventional2015-07-31Completed
The Effects of Systemic Steroids on the Duration of a Psoas Compartment Block. [NCT02464176]Phase 4115 participants (Actual)Interventional2015-06-30Completed
A Phase I Study of Arsenic Trioxide and Ascorbic Acid (ATO/AA) in Combination With Low Dose Velcade-Thalidomide-Dexamethasone (VTD) in Relapsed/Refractory Multiple Myeloma (MM) [NCT00258245]Phase 15 participants (Actual)Interventional2005-05-31Completed
A Phase 1 Dose-Escalation and Exploratory Dose Expansion Study of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomide, and Dexamethasone in Relapsed and/or Refractory Myeloma [NCT03031730]Phase 140 participants (Anticipated)Interventional2018-06-14Recruiting
A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspen [NCT01505088]Phase 3193 participants (Actual)Interventional2011-12-31Completed
A Prospective, Multi-Center, Randomized, Double-Masked, Negative-Controlled Clinical Trial Designed to Compare the Safety and Efficacy of EGP-437 (Dexamethasone Phosphate Ophthalmic Solution) Delivered by EyeGate® II Iontophoresis to Placebo in Patients U [NCT01602068]Phase 245 participants (Actual)Interventional2012-05-31Completed
A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery [NCT01748942]76 participants (Actual)Interventional2012-12-31Completed
Tocilizumab, Dexamethasone, Olanzapine, Flow-targeted Versus Pressure-targeted Hemodynamic Management, and Low Tidal Volume Ventilation in Patients Undergoing On-pump Cardiac Surgery - a Multifactorial Design Randomized Trial [NCT05635227]1,200 participants (Anticipated)Interventional2022-11-10Recruiting
Perioperative Tonsillectomy Protocol Development for Preoperative Acetaminophen and Intraoperative High Dose Dexamethasone: a Randomized Control Trial [NCT03323047]Phase 460 participants (Anticipated)Interventional2018-03-01Recruiting
Pharmacokinetics Study to Measure Plasma Concentrations of Dexamethasone Following EryDex (Dexamethasone Sodium Phosphate Encapsulated in Autologous Erythrocytes) Infusion in Healthy Volunteers [NCT01925859]Phase 118 participants (Actual)Interventional2013-06-30Completed
A Korean Multicenter, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapies (MEC, Non-AC R [NCT01636947]Phase 4494 participants (Actual)Interventional2012-12-12Completed
Double Blind Prospective Study of IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery [NCT03855059]Early Phase 150 participants (Actual)Interventional2019-06-05Completed
A Phase II Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) Plus Dexamethasone & Choline Magnesium Trisalicylate in the Treatment of Patients With Relapsed/Refractory Acute Myelogenous Leukemia [NCT01009931]Phase 21 participants (Actual)Interventional2011-03-31Terminated(stopped due to Study was terminated early due to lack of experimental medication (supply issues))
Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture [NCT02421419]Phase 426 participants (Actual)Interventional2015-06-30Terminated(stopped due to Study closed; recruitment problems)
Effect of Continuous Paravertebral Nerve Block Combined With Dexamethasone Palpitate vs Combined With Dexamethasone Sodium Phosphate on Chronic Postoperative Pain in Patients Undergoing Minimally Invasive Cardiac Surgery [NCT05920967]902 participants (Anticipated)Interventional2023-07-11Recruiting
Effect of 24 mg Dexamethasone Preoperatively on Surgical Stress, Pain and Recovery in Robotic-assisted Laparoscopic Hysterectomy [NCT04762381]100 participants (Anticipated)Interventional2022-06-01Recruiting
A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study to Evaluate the Efficacy and Safety of TLC599 in Patients With Osteoarthritis of the Knee [NCT04123561]Phase 3506 participants (Actual)Interventional2019-11-26Completed
Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis [NCT02415335]Phase 2119 participants (Actual)Interventional2015-04-30Completed
The Effects of Dexamethasone Administration on Jaundice Following Liver Resection: a Randomized Controlled Trial [NCT02991339]Phase 2/Phase 376 participants (Actual)Interventional2016-06-30Completed
Iontophoresis With Dexamethasone in Combination With Physical Therapy for the Treatment of Pediatric Patients Diagnosed With Apophysitis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial [NCT03606980]Phase 246 participants (Actual)Interventional2018-11-05Completed
Role of Prophylactic Dexamethasone Administration Before Elective Cesarean Section at Term in Reducing the Incidence of Neonatal Respiratory Distress Syndrome (A Randomized Controlled Trial) [NCT04816097]Phase 4950 participants (Anticipated)Interventional2021-04-01Not yet recruiting
Evaluation of Lacrimal Punctal Changes by Anterior Segment Optical Coherence Tomography AS-OCT After Topical Combined Antibiotics and Steroids Treatment in Cases of Inflammatory Punctual Stenosis [NCT05028907]Phase 464 participants (Actual)Interventional2020-11-15Completed
Postoperative Steroids and Recovery After Spine Fusion [NCT04568837]Phase 4420 participants (Anticipated)Interventional2021-03-01Not yet recruiting
Comparison of the Effects of Perineural Versus Systemic Dexamethasone on Low Dose Interscalene Brachial Plexus Block: A Randomized Control Trial [NCT02322242]Phase 4182 participants (Actual)Interventional2015-01-31Completed
A Multi-Centre Randomised Study Comparing Tapering Low Dose Dexamethasone to Other Standard of Care Therapies for Taxane- Associated Pain Syndrome (TAPS) in Breast Cancer Patients (OTT 17-02 REaCT-TAPS) [NCT03348696]Phase 4124 participants (Actual)Interventional2018-02-28Completed
LIMBO-ATX: Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Atherectomy (ATX)-Based Revascularization [NCT02479620]Phase 2120 participants (Anticipated)Interventional2016-06-30Active, not recruiting
A Prospective, Multi-Center, Randomized, Double-Masked, Positive Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspe [NCT02517619]Phase 3251 participants (Actual)Interventional2016-01-16Completed
A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL [NCT01483690]Phase 1/Phase 223 participants (Actual)Interventional2011-12-31Terminated(stopped due to Toxicity)
Open-label, Multli-center, Phase 1b/2a Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients With Macular Edema [NCT02485249]Phase 1/Phase 225 participants (Actual)Interventional2015-07-31Terminated(stopped due to Slow enrollment)
LIMBO-PTA: Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Percutaneous Transluminal Angioplasty Revascularization [NCT02479555]Phase 2120 participants (Anticipated)Interventional2016-01-31Recruiting
Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study [NCT03245671]Phase 40 participants (Actual)Interventional2017-12-31Withdrawn(stopped due to Unable to address regulatory concerns.)
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study [NCT05279092]Phase 2250 participants (Anticipated)Interventional2022-09-08Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00293384 (4) [back to overview]Delayed Vomiting Controlled
NCT00293384 (4) [back to overview]Overall Nausea Controlled
NCT00293384 (4) [back to overview]Proportion of Participants With Controlled Acute Vomiting
NCT00293384 (4) [back to overview]Toxicity Grade 3, 4, or 5
NCT00335140 (1) [back to overview]Complete Response Rate - Locally Reviewed
NCT00520767 (3) [back to overview]Overall Survival
NCT00520767 (3) [back to overview]Time to Treatment Failure (TTF)
NCT00520767 (3) [back to overview]Complete Hematologic Response
NCT00833833 (10) [back to overview]Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off
NCT00833833 (10) [back to overview]Phase 2: Percentage of Participants With Progression-Free Survival (PFS) Events as of the 01 April 2011 Cut-off
NCT00833833 (10) [back to overview]Phase 2: Time to Response as of the 01 April 2011 Cut-off
NCT00833833 (10) [back to overview]Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off
NCT00833833 (10) [back to overview]Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off
NCT00833833 (10) [back to overview]Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off
NCT00833833 (10) [back to overview]Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off
NCT00833833 (10) [back to overview]Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1
NCT00833833 (10) [back to overview]Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off
NCT00833833 (10) [back to overview]Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off
NCT00928200 (1) [back to overview]Occurrence of a Dose-Limiting Toxicity
NCT01483690 (2) [back to overview]Number of Participants Who Experienced a Dose Limiting Toxicity (DLT).
NCT01483690 (2) [back to overview]Disease Response Rate After Treatment.
NCT01602068 (1) [back to overview]Percentage of Subjects With AC Cell Count of Zero on Day 7
NCT01636947 (8) [back to overview]Percentage of Participants With One or More Clinical Adverse Event
NCT01636947 (8) [back to overview]Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage
NCT01636947 (8) [back to overview]Percentage of Participants With No Impact on Daily Life - Overall Stage
NCT01636947 (8) [back to overview]Number of Emetic Events - Overall Stage
NCT01636947 (8) [back to overview]The Percentage of Participants With No Vomiting - Overall Stage
NCT01636947 (8) [back to overview]Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages
NCT01636947 (8) [back to overview]Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages
NCT01636947 (8) [back to overview]Percentage of Participants With No Vomiting - Acute and Delayed Stages
NCT01748942 (7) [back to overview]UM-QOL Eating
NCT01748942 (7) [back to overview]Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
NCT01748942 (7) [back to overview]PSS Normalcy of Diet
NCT01748942 (7) [back to overview]Opioid Use
NCT01748942 (7) [back to overview]Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)
NCT01748942 (7) [back to overview]Eating Assessment Tool (EAT)-10 Scores
NCT01748942 (7) [back to overview]Days With Feeding Tube
NCT02192827 (3) [back to overview]Number of Participants Returning to Care Following Discharge From the Emergency Department
NCT02192827 (3) [back to overview]Reported Number of Days Until Symptom Resolution
NCT02192827 (3) [back to overview]Reported Side Effects Experienced by Participants
NCT02322242 (10) [back to overview]Duration of Motor Block
NCT02322242 (10) [back to overview]Duration of Sensory Block
NCT02322242 (10) [back to overview]Infection
NCT02322242 (10) [back to overview]Number of Participants With Postoperative Nausea and/or Vomiting
NCT02322242 (10) [back to overview]Opioid Consumption
NCT02322242 (10) [back to overview]Post-operative Oxygen Saturation on Room Air
NCT02322242 (10) [back to overview]Postoperative Serum Blood Glucose
NCT02322242 (10) [back to overview]Time to First Opioid Consumption
NCT02322242 (10) [back to overview]Numeric Rating Scale for Pain (NRS 0-10)
NCT02322242 (10) [back to overview]Number of Participants With Nerve Damage From Interscalene Block
NCT02421419 (4) [back to overview]Degree of Triggering
NCT02421419 (4) [back to overview]Number of Participants With Adverse Effects
NCT02421419 (4) [back to overview]Presence of Triggering
NCT02421419 (4) [back to overview]VAS
NCT02462148 (6) [back to overview]Verbal Pain Scores
NCT02462148 (6) [back to overview]Time to First Opioid Analgesic Request
NCT02462148 (6) [back to overview]Rate of Post Operative Nausea and Vomiting
NCT02462148 (6) [back to overview]Post Operative Opioid Use and Consumption
NCT02462148 (6) [back to overview]Duration of Sensory Nerve Block
NCT02462148 (6) [back to overview]Neurologic Complications
NCT02464176 (4) [back to overview]Duration of Sensory Blockade
NCT02464176 (4) [back to overview]Total Opioid Consumption
NCT02464176 (4) [back to overview]Verbal Numeric Pain Score Comparisons
NCT02464176 (4) [back to overview]Time to First Analgesic Request
NCT03382821 (4) [back to overview]The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score
NCT03382821 (4) [back to overview]Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III
NCT03382821 (4) [back to overview]Neck Disability Index-5
NCT03382821 (4) [back to overview]"The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)"
NCT03855059 (1) [back to overview]Analgesia Duration

Delayed Vomiting Controlled

(NCT00293384)
Timeframe: at 25-120 hours

Interventionparticipants (Number)
Aprepitant, Dexamethasone, Cytoxan & Kytril22

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Overall Nausea Controlled

(NCT00293384)
Timeframe: at 0-120 hours

Interventionparticipants (Number)
Aprepitant, Dexamethasone, Cytoxan & Kytril31

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Proportion of Participants With Controlled Acute Vomiting

No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration. (NCT00293384)
Timeframe: at 0-24 hours

Interventionparticipants (Number)
Aprepitant, Dexamethasone, Cytoxan & Kytril20

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Toxicity Grade 3, 4, or 5

(NCT00293384)
Timeframe: at 0-120 hours

Interventionparticipants (Number)
Aprepitant, Dexamethasone, Cytoxan & Kytril2

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Complete Response Rate - Locally Reviewed

"Assessed by the ECOG-ACRIN data manager based upon local review of images and data sent by the local sites.~Treatment response was determined by calculating the sum of the maximal cross section in 2 separate axes using enhancing lesion(s) on CT or MRI imaging. The same imaging modality was to be used throughout assessment. Complete response was defined as the disappearance of all contrast enhancing tumor size on CT or MRI, patient was off all glucocorticoids, and resolution of all meningeal and vitreous involvement if present. Response must have lasted at least 4 weeks." (NCT00335140)
Timeframe: For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17).

Interventionpercentage of participants (Number)
Rituximab + Standard Chemotherapy64

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Overall Survival

time from day of registration until day of death. (NCT00520767)
Timeframe: time from day of registration until 72 months.

Interventionmonth (Median)
Melphalan, Dexamethasone, Bortezomib,31.1

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Time to Treatment Failure (TTF)

Time from start of treatment until date of documented disease progression, removal from protocol due to toxicity, or death from any cause. (NCT00520767)
Timeframe: start of treatment until 72 months

Interventionmonth (Median)
Melphalan, Dexamethasone, Bortezomib,18.1

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Complete Hematologic Response

(NCT00520767)
Timeframe: Up to 12 months

Interventionparticipants (Number)
Melphalan, Dexamethasone, Bortezomib,16

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Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off

"Progression free survival (PFS) is the time from randomization to the first documentation of disease progression or death from any cause during study, whichever occurs earlier. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).~For the primary PFS analysis, participants who withdrew for any reason or received another antimyeloma therapy (except adding dexamethasone to the Phase 2: Pomalidomide arm) without documented PD (as determined by the IRAC review) were censored on the date of their last adequate response assessment, prior to receiving any other anti-myeloma therapy. Subjects who were still active at the time of the data cut-off date without PD (as determined by the IRAC) were censored on the date of their last adequate response assessment.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 67 weeks

Interventionweeks (Median)
Phase 2: Pomalidomide + Dexamethasone16.6
Phase 2: Pomalidomide10.7

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Phase 2: Percentage of Participants With Progression-Free Survival (PFS) Events as of the 01 April 2011 Cut-off

"Percentage of participants with the progression-free survival events: disease progression and death. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 67 weeks

Interventionpercentage of participants (Number)
Phase 2: Pomalidomide + Dexamethasone76.1
Phase 2: Pomalidomide75.0

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Phase 2: Time to Response as of the 01 April 2011 Cut-off

"Time to myeloma response is defined as the time from randomization to the time the response criteria for complete response (CR) or partial response (PR) are first met.~Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described previously.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 70 weeks

Interventionweeks (Median)
Phase 2: Pomalidomide + Dexamethasone8.1
Phase 2: Pomalidomide8.9

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Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off

"TEAEs that occurred during Phase 1 after dexamethasone was added to pomalidomide treatment.~Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: Up to week 126

,,,
Interventionpercentage of participants (Number)
1 or more (1+) AE1+ AE related to pomalidomide1+ AE related to dexamethasone1+ severity grade 3-4 AE1+ severity grade 3-4 AE related to pomalidomide1+ severity grade 3-4 AE related to dexamethasone1+ serious AE (SAE)1+ SAE related to pomalidomide1+ SAE related to dexamethasone1+ AE leading to discontinuation of pomalidomide1+ AE -- discontinuation of dexamethasone1+AE -dose reduction/interruption of pomalidomide1+ AE-dose reduction/interruption of dexamethasone1+related AE-reduction/interruption of pomalidomid1+related AE-reduction/interruption of dexamethaso
Phase 1: 2 mg Pomalidomide100.0100.0100.00.00.00.00.00.00.00.00.00.00.00.00.0
Phase 1: 3 mg Pomalidomide100.075.075.075.075.075.075.025.050.025.025.050.075.025.075.0
Phase 1: 4 mg Pomalidomide90.080.070.070.020.020.040.020.010.020.020.040.060.020.020.0
Phase 1: 5 mg Pomalidomide100.0100.085.757.142.90.028.60.00.00.00.071.471.457.142.9

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Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off

"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: Up to week 104

,,,
Interventionpercentage of participants (Number)
1 or more (1+) AE1+ AE related to pomalidomide1+ severity grade 3-4 AE1+ severity grade 3-4 AE related to pomalidomide1+ serious AE (SAE)1+ SAE related to pomalidomide1+ AE leading to discontinuation of pomalidomide1+AE-dose reduction/interruption of pomalidomide1+related AE-reduction/interruption of pomalidomid
Phase 1: 2 mg Pomalidomide100.066.783.333.350.00.016.716.70.0
Phase 1: 3 mg Pomalidomide100.075.037.525.012.512.50.075.037.5
Phase 1: 4 mg Pomalidomide100.085.778.642.942.97.121.442.928.6
Phase 1: 5 mg Pomalidomide100.0100.080.070.030.010.00.080.070.0

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Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off

"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: Up to week 70

,,,
Interventionpercentage of participants (Number)
1 or more (1+) AE1+ AE related to pomalidomide1+ severity grade 3-4 AE1+ severity grade 3-4 AE related to pomalidomide1+ serious AE (SAE)1+ SAE related to pomalidomide1+ AE leading to discontinuation of pomalidomide1+related AE --discontinuation of pomalidomide1+AE - reduction of pomalidomide1+ AE - interruption of pomalidomide1+ related AE - interruption of pomalidomide1+related AE - reduction of pomalidomide
Phase 2: Pomalidomide (Overall)100.088.889.767.367.320.612.13.729.958.932.724.3
Phase 2: Pomalidomide (Pom + Dex Only)93.468.970.544.347.519.73.31.69.836.121.38.2
Phase 2: Pomalidomide (Pom Only)99.187.984.158.946.79.310.32.825.247.724.320.6
Phase 2: Pomalidomide + Dexamethasone100.089.388.462.561.617.98.01.820.563.427.717.9

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Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off

"Duration of myeloma response is defined as the time from when the response criteria are first met for partial response (PR) or better, until the first date the response criteria are met for progressive disease (PD) or until the participant dies from any cause, whichever occurs first. Duration of response for participants last known to be alive with no progression after a complete response (CR) or PR was censored at the date of last adequate response assessment. Participants with confirmed responses that occur after receiving any other anti-myeloma therapy (except for adding dexamethasone to the pomalidomide treatment arm), including radiation therapy initiated after baseline, was censored at the last adequate assessment prior to the initiation of such treatment.~Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described in the previous outcome." (NCT00833833)
Timeframe: up to 70 weeks

Interventionweeks (Median)
Phase 2: Pomalidomide + Dexamethasone32.1
Phase 2: PomalidomideNA

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Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1

"The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle.~DLTs were defined as:~Grade 4 neutropenia or thrombocytopenia~Febrile neutropenia~Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment~Serum transaminase > 20 * upper limit of normal (ULN)~Serum transaminase > 5 * ULN for >= 7 days~Delay of the start of cycle 2 by >7 days due to pomalidomide-related adverse event" (NCT00833833)
Timeframe: Up to Day 28 (Cycle 1)

Interventionparticipants (Number)
Phase 1: 2 mg Pomalidomide1
Phase 1: 3 mg Pomalidomide1
Phase 1: 4 mg Pomalidomide2
Phase 1: 5 mg Pomalidomide4

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Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off

"IRAC used EBMT criteria to assess myeloma response:~Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of lytic bone lesions, plus other factors)~Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others~Minimal Response (MR)- 25-49% reduction in serum monoclonal paraprotein plus others~Stable Disease (SD)- not MR or progressive disease (PD)~Progressive Disease (PD)- reappearance of monoclonal paraprotein, lytic bone lesions, other~Not Evaluable (NE).~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 70 weeks

,
Interventionpercentage of participants (Number)
Complete response (CR)Partial response (PR)Minimal response (MR)Stable disease (SD)Progressive disease (PD)Not evaluable
Phase 2: Pomalidomide0.09.315.746.315.713.0
Phase 2: Pomalidomide + Dexamethasone0.929.215.035.46.213.3

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Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off

"Overall survival was defined as the time between randomization and death. Participants who die, regardless of the cause of the death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the subject was known to be alive, or clinical cut-off date if it was earlier.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 70 weeks

Interventionweeks (Median)
Phase 2: Pomalidomide + Dexamethasone62.6
Phase 2: Pomalidomide59.3

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Occurrence of a Dose-Limiting Toxicity

The MTD in each stratum will be the highest dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy. (NCT00928200)
Timeframe: Beginning with the first dose of investigational product until 30 days following the last dose of Erwinase

InterventionParticipants (Count of Participants)
Single Arm0

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Number of Participants Who Experienced a Dose Limiting Toxicity (DLT).

To evaluate the side effects of giving decitabine and vorinostat before and during chemotherapy using the standard drugs vincristine, dexamethasone, PEG-asparaginase and mitoxantrone. (NCT01483690)
Timeframe: 6 weeks

,
InterventionParticipants (Count of Participants)
# of patients with DLT# of patients without DLT# of patients not evaluable
Initial Dose Level221
Modified Dose Level1125

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Disease Response Rate After Treatment.

Bone marrow evaluation was performed on Day 35 of study to evaluate treatment response. CR defined as attaining M1 marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease in addition to recovery of peripheral blood counts (ANC >750/uL and platelet count >75,000/uL). CRp was defined as attaining an M1 marrow with no evidence of circulating blasts or extramedullary disease in addition to recovery of ANC but insufficient recovery of platelets. CRi was attaining M1 marrow with no evidence of circulating blasts or extramedullary disease but insufficient recovery of ANC with or without sufficient recovery of platelets. PR was defined as no evidence of circulating blasts and achievement of M2 marrow (5-25% blasts) without new sites of disease and with recovery of ANC. SD is for patients who did not meet the criteria for PR, CR, CRp, or CRi. PD is an increase of at least 25% in the absolute number of leukemia cells or development of new sites. (NCT01483690)
Timeframe: 6 weeks

,
InterventionParticipants (Count of Participants)
complete response (CR)complete response without platelet recovery (CRp)complete remission with incomplete recovery (CRi)stable disease (SD)patient not evaluable for response
Initial Dose Level01112
Modified Dose Level13347

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Percentage of Subjects With AC Cell Count of Zero on Day 7

Percentage of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups (NCT01602068)
Timeframe: At Day 7 (plus or minus two days) following the study treatment

InterventionParticipants (Count of Participants)
Dexamethasone Phosphate Ophthalmic3
100 mM Sodium Citrate Buffer2

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Percentage of Participants With One or More Clinical Adverse Event

An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition, which is temporally associated with the use of the study drug, is also an adverse event. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event. (NCT01636947)
Timeframe: Day 1 through Day 29 (Up to 28 days after first dose of study drug)

InterventionPercentage of Participants (Number)
Aprepitant Regimen56.2
Control Regimen53.2

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Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage

"Nausea was to be assessed using a 100-mm horizontal visual analogue scale (VAS) located in the participant diary labeled: How much nausea have you had over the last 24 hours? The left end of the scale (0 mm) was labeled no nausea, and the right end of the scale (100 mm) is labeled nausea as bad as it could be. In this study, No Significant Nausea was defined as a VAS nausea rating <25 mm." (NCT01636947)
Timeframe: Days 1 to Day 5

InterventionPercentage of Participants (Number)
Aprepitant Regimen76.4
Control Regimen72.4

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Percentage of Participants With No Impact on Daily Life - Overall Stage

"The Functional Living Index-Emesis questionnaire (FLIE) is a validated, participant-reported instrument to measure the impact of chemotherapy-induced nausea and vomiting on daily life. There are 9 nausea-related items and 9 vomiting-related items, each on a 7-point scale. For the purposes of this study, No Impact on daily life was defined as an average item score of >6 on the 7-point scale; a total score >108 indicates no impact on daily life. Overall Stage=0 to 120 hours after initiation of MEC." (NCT01636947)
Timeframe: Day 6

InterventionPercentage of Participants (Number)
Aprepitant Regimen76.8
Control Regimen73.8

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Number of Emetic Events - Overall Stage

The number of emetic events that occurred during the Overall Stage (0 to 120 hours after initiation of MEC) are presented. (NCT01636947)
Timeframe: Hour 0 on Day 1 to Day 5 (approximately 120 hours)

InterventionNumber of Emetic Events (Number)
Aprepitant Regimen54
Control Regimen68

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The Percentage of Participants With No Vomiting - Overall Stage

A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC). (NCT01636947)
Timeframe: Hour 0 on Day 1 to Day 5 (approximately 120 hours)

InterventionPercentage of Participants (Number)
Aprepitant Regimen77.2
Control Regimen72.0

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Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages

The percentage of participants who used no rescue therapy after initiation of MEC is presented for the Overall, Acute and Delayed Stages. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. (NCT01636947)
Timeframe: Day 1 to Day 5

,
InterventionPercentage of Participants (Number)
Overall StageAcute StageDelayed Stage
Aprepitant Regimen84.898.784.8
Control Regimen87.799.288.5

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Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages

A Complete Response was defined as no vomiting or dry heaves and no use of a rescue therapy. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. (NCT01636947)
Timeframe: Hour 0 on Day 1 to Day 5 (approximately 120 hours)

,
InterventionPercentage of Participants (Number)
Overall StageAcute StageDelayed Stage
Aprepitant Regimen73.495.874.3
Control Regimen70.497.971.2

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Percentage of Participants With No Vomiting - Acute and Delayed Stages

A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. (NCT01636947)
Timeframe: Day 1, Day 2 to Day 5

,
InterventionPercentage of Participants (Number)
Acute StageDelayed Stage
Aprepitant Regimen95.878.5
Control Regimen98.872.4

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UM-QOL Eating

"The University of Michigan Head and Neck Quality of Life Questionnaire (UM-QOL) is 20 item, 1-5 scale, questionnaire that measures how much the patient has been bothered during various activities as a result of head and neck condition or treatment in the past four weeks with 1= Not at all and 5=Extremely. The scores are calculated using a Likert Scale, which transforms the 1-5 choices into a 0-100 scale with 100 being normal and 0 being poor quality of life. This test contains separate domains (eating, etc.) that can be scored independently. Scores were analyzed between cohorts pre and post operatively." (NCT01748942)
Timeframe: 21 days

Interventionunits on a scale (Mean)
Arm I (Treatment)59.3
Arm II (Control)60.1

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Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale

"Visual Analog Scale (VAS) is a 0-10 scale for patients to indicate intensity level of pain with 0 indicating No pain and 10 indicating Worst possible, unbearable, excruciating pain. A descriptive time plot of VAS scores will be produced for all enrolled subjects, with loess curve fitted separately for the experimental and control groups. A linear mixed effects model will be used to compare the pain VAS scores between the experimental and control groups." (NCT01748942)
Timeframe: 21 days

,
Interventionunits on a scale (Mean)
Postoperative day #1Postoperative day #2Postoperative day #3Postoperative day #7-21
Arm I (Treatment)7.46.05.33.0
Arm II (Control)6.86.46.72.5

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PSS Normalcy of Diet

"Performance Status Score (PSS) - Normalcy of Diet score is a 0-100 scale that measures diet restrictions with 0= Non-oral feeding (tube fed) and 100 = Full diet (no restrictions)" (NCT01748942)
Timeframe: 30 days

Interventionunits on a scale (Mean)
Arm I (Treatment)51.7
Arm II (Control)36.7

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Opioid Use

(NCT01748942)
Timeframe: 3 days

Interventionmg of oxycodone equivalent (Mean)
Arm I (Treatment)137.1
Arm II (Control)147.3

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Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)

Kaplan-Meier functions will be fitted to compare the length of hospital stay between the experimental and control groups. (NCT01748942)
Timeframe: Up to 21 days

Interventiondays (Median)
Arm I (Treatment)5
Arm II (Control)4

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Eating Assessment Tool (EAT)-10 Scores

"Statistical Analysis between placebo and steroid cohorts to assess differences. The Eating Assessment Tool (EAT-10) is a 10 item questionnaire that evaluates swallowing and the extent of how problematic with certain eating activities. Questions are answered using a five point (0-4) plus Not Applicable scale with 0 = No problem and 4= Severe problem. A descriptive time plot will be produced for EAT-10 scores using baseline and postoperative measurements on days 3 and day 7-21. Descriptive statistical analyses will be conducted for a summary of EAT-10 scores at baseline, days 3 and day 7-21 after surgery. A linear mixed effects model will be used to compare the EAT-10 scores between the two groups." (NCT01748942)
Timeframe: Up to 12 months

Interventionunits on a scale (Mean)
Arm I (Treatment)20.0
Arm II (Control)20.2

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Days With Feeding Tube

(NCT01748942)
Timeframe: 12 months

Interventiondays (Median)
Arm I (Treatment)4
Arm II (Control)11

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Number of Participants Returning to Care Following Discharge From the Emergency Department

The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician. (NCT02192827)
Timeframe: 5 days

InterventionParticipants (Count of Participants)
Single Dose Dexamethasone14
Two Dose Dexamethasone12

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Reported Number of Days Until Symptom Resolution

Will determine number of days to symptom resolution, including missed school days. (NCT02192827)
Timeframe: 5 days

InterventionDays (Mean)
Single Dose Dexamethasone2.4
Two Dose Dexamethasone2.5

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Reported Side Effects Experienced by Participants

The investigators will determine during phone follow up if patient experienced any side effects related to the Dexamethasone, including vomiting, mood swings, behavior changes, appetite changes, sweating or headache. (NCT02192827)
Timeframe: 5 days

,
InterventionParticipants (Count of Participants)
No side effectsDecreased AppetiteDifficulty SleepingMood swings/AgitationHeadacheOtherMultiple
Single Dose Dexamethasone714973517
Two Dose Dexamethasone837031418

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Duration of Motor Block

Defined as time from completion of block procedure to return to baseline motor function (in hours) (NCT02322242)
Timeframe: 1 day postoperative

Interventionhours (Mean)
Perineural Dexamethasone18.5
Systemic Dexamethasone20.3

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Duration of Sensory Block

Defined as time from completion of block procedure to NRS for pain > 0 (in hours) (NCT02322242)
Timeframe: 1 day postoperative

Interventionminutes (Mean)
Perineural Dexamethasone521
Systemic Dexamethasone566

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Infection

Number of participants with localized infection at nerve block site (NCT02322242)
Timeframe: 7 Days postoperative

InterventionParticipants (Count of Participants)
Perineural Dexamethasone0
Systemic Dexamethasone0

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Number of Participants With Postoperative Nausea and/or Vomiting

Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively (NCT02322242)
Timeframe: 7 days postoperative

InterventionParticipants (Count of Participants)
Perineural Dexamethasone32
Systemic Dexamethasone32

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Opioid Consumption

Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours, and 7 days (NCT02322242)
Timeframe: 7 days postoperative

Interventionmg (oral morphine equivalent) (Mean)
Perineural Dexamethasone148.8
Systemic Dexamethasone167.2

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Post-operative Oxygen Saturation on Room Air

Pulse oximetry (in %) measured 1 hour after arrival in post-operative recovery room, scale 0-100, higher number is better (NCT02322242)
Timeframe: 1 hour postoperative

InterventionRoom air oxygen saturation percent (Mean)
Perineural Dexamethasone96.6
Systemic Dexamethasone97.0

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Postoperative Serum Blood Glucose

Measured 1 hour after arrival to the post-operative recovery room (NCT02322242)
Timeframe: 1 hour postoperative

Interventionmmol/L (Mean)
Perineural Dexamethasone6.8
Systemic Dexamethasone6.6

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Time to First Opioid Consumption

Defined as time from completion of block procedure to first consumption of opioid analgesic (in hours) (NCT02322242)
Timeframe: 1 day postoperative

Interventionhours (Mean)
Perineural Dexamethasone9.1
Systemic Dexamethasone9.6

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Numeric Rating Scale for Pain (NRS 0-10)

Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better. (NCT02322242)
Timeframe: 7 days postoperative

,
Interventionunits on a scale (Mean)
7 days24hours12hours
Perineural Dexamethasone3.14.93.3
Systemic Dexamethasone3.44.73.3

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Number of Participants With Nerve Damage From Interscalene Block

Defined as persistent paresthesia, and sensory/motor block at 7 days (NCT02322242)
Timeframe: 7 Days postoperative

InterventionParticipants (Count of Participants)
Perineural Dexamethasone0
Systemic Dexamethasone0

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Degree of Triggering

A Green classification number (0-4) is given to each subject pre-injection and at 6 weeks post-injection based on their degree of triggering. 0 = No triggering, no pain; 1 = Pre-triggering; pain, history of catching, but not demonstrable on physical examination; tenderness over the A1 pulley; 2 = Active; demonstrable catching, but the patient can actively extend the digit; 3= Passive; demonstrable catching requiring passive extension or inability to actively flex; and 4 = Contracture; demonstrable catching with a fixed flexion contracture of the PIP joint. (NCT02421419)
Timeframe: Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey

,,
InterventionParticipants (Count of Participants)
Green classification 0 (pre-injection)Green classification 1 (pre-injection)Green classification 2 (pre-injection)Green classification 3 (pre-injection)Green Classification 4 (pre-injection)Green classification 0 (6-weeks post-injection)Green classification 1 (6-weeks post-injection)Green classification 2 (6-weeks post-injection)Green classification 3 (6-weeks post-injection)Green classification 4 (6-weeks post-injection)
Corticosteroid Alone (CS) Group0240020220
Corticosteroid/Lidocaine (CSL) Group01100010271
Corticosteroid/Saline (CSS) Group0160110421

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Number of Participants With Adverse Effects

Incidence of adverse effects (NCT02421419)
Timeframe: Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.

,,
InterventionParticipants (Count of Participants)
Adverse effects 1 minute post-injectionAdverse effects 10 minutes post-injectionAdverse effects 6 weeks post-injection
Corticosteroid Alone (CS) Group000
Corticosteroid/Lidocaine (CSL) Group000
Corticosteroid/Saline (CSS) Group000

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Presence of Triggering

Patients are asked how often their finger triggers - not at all, rarely, occasionally, or frequently at time intervals indicated in the outcome measure time frame. Count of participants for each of these answers was collected. (NCT02421419)
Timeframe: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection

,,
InterventionParticipants (Count of Participants)
Triggering frequently pre-injectionTriggering not at all pre-injectionTriggering occasionally pre-injectionTriggering rarely pre-injectionTriggering not at all 1 minute post-injectionTriggering rarely 1 minute post-injectionTriggering occasionally 1 minute post-injectionTriggering frequently 1 minute post-injectionTriggering same as before 1 minute post-injectionTriggering not at all 10 minutes post-injectionTriggering rarely 10 minutes post-injectionTriggering occasionally 10 minutes post-injectionTriggering frequently 10 minutes post-injectionTriggering same as before 10 min. post-injectionTriggering not at all 6 wks post-injectionTriggering rarely 6 wks post-injectionTriggering occasionally 6 weeks post-injectionTriggering frequently 6 wks post-injectiontriggering same as before 6 wks post-injection
Corticosteroid Alone (CS) Group2040301024010130012
Corticosteroid/Lidocaine (CSL) Group7040101082011611018
Corticosteroid/Saline (CSS) Group5210300054000410025

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VAS

Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst). (NCT02421419)
Timeframe: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection

,,
Interventionunits on a scale (Mean)
VAS pre-injectionVAS 1 minute post-injectionVAS 10 minutes post-injectionVAS 6 weeks post-injectionVAS Recollection
Corticosteroid Alone (CS) Group2.22.32.11.55.2
Corticosteroid/Lidocaine (CSL) Group3.02.21.23.36.6
Corticosteroid/Saline (CSS) Group3.94.93.34.05.9

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Verbal Pain Scores

Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours. (NCT02462148)
Timeframe: 0 to 30 hours

,,
Interventionunits on a scale (Mean)
0h6h12h18h24h30h
1 mg Perineural Dexamethasone2.31.32.11.81.83.1
4mg Perineural Dexamethasone2.10.81.71.61.52.4
Placebo2.11.13.03.33.14.3

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Time to First Opioid Analgesic Request

Time it took for the first opioid analgesic request was recorded. (NCT02462148)
Timeframe: 0 to 36 hours

Interventionminutes (Mean)
4 mg Perineural Dexamethasone Group686.18
1 mg Perineural Dexamethasone Group654.97
Placebo Group658.17

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Rate of Post Operative Nausea and Vomiting

Number of participants that experienced nausea and vomiting was recorded. (NCT02462148)
Timeframe: 0 to 30 hours

InterventionParticipants (Count of Participants)
4 mg Perineural Dexamethasone Group5
1 mg Perineural Dexamethasone Group14
Placebo Group4

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Post Operative Opioid Use and Consumption

Amount of opioid use and consumption was recorded. (NCT02462148)
Timeframe: 0-30 hours

Interventionmg oxycodone equivalents (Mean)
4 mg Perineural Dexamethasone Group27.16
1 mg Perineural Dexamethasone Group26.04
Placebo Group42.33

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Duration of Sensory Nerve Block

The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours. (NCT02462148)
Timeframe: 12 to 48 hours

Interventionhours (Mean)
4 mg Perineural Dexamethasone Group37.00
1 mg Perineural Dexamethasone Group31.75
Placebo Group29.67

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Neurologic Complications

Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur. (NCT02462148)
Timeframe: throughout study completion, up to 48 hours

Interventionneurological complications (Mean)
4 mg Perineural Dexamethasone Group0
1 mg Perineural Dexamethasone Group0
Placebo Group0

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Duration of Sensory Blockade

The primary outcome will be duration of sensory blockade in the distribution of the lumbar plexus as determined by pin-prick sensation as tested every two hours with pin-prick sensation. (NCT02464176)
Timeframe: 30 hours

Interventionhours (Mean)
4 mg Dexamethasone Group18.5
8 mg Dexamethasone Group18.1
Control Group19.6

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Total Opioid Consumption

(NCT02464176)
Timeframe: 30 hours

Interventionoxycodone mg equivalents (Median)
4 mg Dexamethasone Group36.6
8 mg Dexamethasone Group30
Control Group39.2

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Verbal Numeric Pain Score Comparisons

This secondary outcome includes pain scores utilizing the verbal numeric pain score scale (0 to 11). Higher values indicate worse outcomes (higher pain scores). Lower values are better. (NCT02464176)
Timeframe: 24 hour

Interventionscores on a scale (Median)
4 mg Dexamethasone Group3
8 mg Dexamethasone Group2
Control Group3

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Time to First Analgesic Request

Time (in minutes) will be recorded to first analgesic request following the block placement (NCT02464176)
Timeframe: 30 hours

Interventionminutes (Median)
4 mg Dexamethasone Group474
8 mg Dexamethasone Group533
Control Group432

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The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score

The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score (NCT03382821)
Timeframe: 1 month follow up

Interventionpercentage of participants (Number)
Transforaminal ESI With Dexamethasone49.1
Interlaminar Catheter-targeted ESI With Triamcinolone68.5

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Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III

The Medication Quantification Scale (MQS) is an instrument used for clinical and research applications for quantifying medication regimen use in chronic pain populations. A 6.8 point reduction is considered equivalent to 10 morphine eqivalents. (NCT03382821)
Timeframe: 1 month, 3 month, 6 month, and 1 year follow up

,
Interventionpercentage of participants (Number)
One monthThree monthSix monthOne year
Transforaminal Catheter-targeted ESI With Triamcinolone1917198
Transforaminal ESI With Dexamethasone1620157

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Neck Disability Index-5

Percentage of patients with >30% improvement in Neck Disability Index-5 score. (NCT03382821)
Timeframe: 1 month, 3 month, 6 month, and 1 year follow up

,
Interventionpercentage of participants (Number)
One monthThree monthSix monthOne year
Transforaminal Catheter-targeted ESI With Triamcinolone62585660
Transforaminal ESI With Dexamethasone48565547

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"The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)"

"Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating much improved and very much improved)" (NCT03382821)
Timeframe: 1 month, 3 month, 6 month, and 1 year follow up

,
Interventionpercentage of participants (Number)
One monthThree monthsSix monthsOne year
Transforaminal Catheter-targeted ESI With Triamcinolone59575361
Transforaminal ESI With Dexamethasone41425557

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Analgesia Duration

The investigator would like to investigate if the dexamethasone given IV or with the nerve block in young patients undergoing lower limb surgery produces the same duration of analgesia. (NCT03855059)
Timeframe: 24 - 48 hours

InterventionHours (Mean)
Intervenous Steroid22.1
Perineural Steroid25.7

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