TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02077933
Drug: alpelisib
Normalized name: ALPELISIB
DrugBank: Alpelisib (DB12015)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: alpelisib is administered orally once a day on a continuous dosing schedule and dosed on a flat-fixed dose and not adjusted by body weight or body surface area, starting on Day 8 of Cycle 1 in the dose escalation and Day 1 of Cycle 1 in the dose expansion.~In the doublet dose escalation, the alpelisib starting dose is 300 mg. The alpelisib dose may be escalated or de-escalated, as needed.~In the triplet dose escalation part, the alpelisib starting dose is one dose level lower of the MTD as determined during the doublet escalation. The alpelisib dose may be escalated or de-escalated, as needed.~In the doublet dose expansion and triplet dose expansion (patients assigned to alpelisib, everolimus and exemestane), alpelisib is administered at the recommended dose determined in the dose escalation.~In the triplet dose expansion (patients assigned to alpelisib and exemestane), alpelisib is administered at a dose of 250 mg daily.
Study: NCT02077933
Drug: everolimus
Normalized name: Everolimus
DrugBank: Everolimus (DB01590)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: everolimus is administered orally once a day on a continuous dosing schedule and dosed on a flat-fixed dose and not adjusted by body weight or body surface area, starting on Day 1 of cycle 1 in both the dose escalation and dose expansion parts.~In the dose escalation part, the everolimus starting dose is 2,5 mg. In the dose expansion part, everolimus is administered at the recommended dose determined in the dose escalation.
Study: NCT02077933
Drug: exemestane
Normalized name: Exemestane
DrugBank: Exemestane (DB00990)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: exemestane is administered orally once a day on a continuous dose of 25 mg starting on Day 1 of Cycle 1 in both the dose escalation and dose expansion.
Study: NCT01243112
Drug: 0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000)
DrugBank: Lidocaine (DB00281)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 0.2ml Intradermal injection once.
Study: NCT00652041
Drug: Bortezomib
Normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4 and Prednisone, 60 mg/m2 oral, days 1 to 4
Study: NCT00652041
Drug: Thalidomide
Normalized name: Thalidomide
DrugBank: Thalidomide (DB01041)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Thalidomide, day 1 cycle 1, 100 mg/24 h. oral, in combination with cyclophosphamide and dexamethasone. If toxicity is \<Grade 2, dose should be increased to 200 mg/24 h. in day 15
Study: NCT02634580
Drug: Ezetimibe
Normalized name: Ezetimibe
DrugBank: Ezetimibe (DB00973)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Tablet for oral administration
Study: NCT02634580
Drug: Placebo to Evolocumab
DrugBank: Evolocumab (DB09303)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Administered by subcutaneous injection
Study: NCT00652041
Drug: Bortezomib
Normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4, Prednisone, 60 mg/m2 oral, days 1 to 4 and Adriamicine, 40 mg/m2 IV day 1 or Caelyx 30 mg/m2 IV day 1.
Study: NCT00517621
Drug: Paclitaxel
Normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT00517621
Drug: EPO
Normalized name: Epo B
DrugBank: Patupilone (DB03010)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02947529
Drug: Tranexamic Acid
Normalized name: Tranexamic Acid
DrugBank: Tranexamic acid (DB00302)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: intravenous dose
Study: NCT02634580
Drug: Placebo Ezetimibe
DrugBank: Ezetimibe (DB00973)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Tablet for oral administration
Study: NCT01193400
Drug: Clofarabine
Normalized name: Clofarabine
DrugBank: Clofarabine (DB00631)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT01193400
Drug: Cytarabine
Normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT04028596
Drug: Paracetamol
Normalized name: Paracetamol
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: once, 1000mg, 2 h before ECT session
Study: NCT04028596
Drug: Nimotop
Normalized name: Nimotop
DrugBank: Nimodipine (DB00393)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: once, 60mg, 2 h before ECT session
Study: NCT00375830
Drug: 18F-Fludeoxyglucose (18F-FDG)
Normalized name: Fluorine (18F) fludeoxyglucose
DrugBank: Fludeoxyglucose (18F) (DB09502)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Radiolabel for positron emission tomography scan procedures
Study: NCT00375830
Drug: 18F-Sodium Fluoride (18F-NaF)
Normalized name: (18F)-Fluoride
DrugBank: Sodium citrate (DB09154)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Study: NCT00375830
Drug: Gadopentetate dimeglumine
Normalized name: Gadopentetate Dimeglumine
DrugBank: Gadopentetic acid (DB00789)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A gadolinium-based contrast agent for MRI
Study: NCT00375830
Drug: Gadofosveset
Normalized name: Gadofosveset
DrugBank: Gadofosveset trisodium (DB06705)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A gadolinium-based contrast agent for MRI
Study: NCT00375830
Drug: Gadobutrol
Normalized name: Gadobutrol
DrugBank: Gadobutrol (DB06703)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A gadolinium-based contrast agent for MRI
Study: NCT01495247
Drug: Paclitaxel
Normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: The paclitaxel infusion will be given in the morning and directly thereafter the BEZ235 dose will be given.~BEZ235 doses will be escalated in cohorts of 3 to 6 patients guided by an adaptive Bayesian logistic regression model with overdose control until MTD/RP2D has been established. The initial dose level for the first cohort will be 200mg (BID), and then based on the Bayesian model the dose may be escalated to 300mg, 400mg, 500mg or 600mg for the next cohorts.
Study: NCT03200496
Drug: DA-5206(Fasting)
Normalized name: DAS-181
DrugBank: DAS-181 (DB15313)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Test drug l : DA-5206(Fasting)
Study: NCT03200496
Drug: DA-5206(Fed)
Normalized name: DAS-181
DrugBank: DAS-181 (DB15313)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Test drug ll : DA-5206(Fed)
Study: NCT03029013
Drug: Apatinib
Normalized name: Apatinib
DrugBank: Rivoceranib (DB14765)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Apatinib， 250 mg qd，po，after 7 days , paclitaxel (135-175 mg/m2) and platinum two drug standard chemotherapy, 21 days as a treatment cycle，during the chemotherapy of 7-21 days continue to offer the Apatinib. without disease progress, after 4 chemotherapy cycles, patients continue to accept the Apatinib maintenance treatment.
Study: NCT01234922
Drug: lisinopril
Normalized name: Lisinopril
DrugBank: Lisinopril (DB00722)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given orally
Study: NCT01234922
Drug: losartan potassium
Normalized name: Losartan Potassium
DrugBank: Losartan (DB00678)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given orally
Study: NCT01234922
Drug: benazepril hydrochloride
Normalized name: Benazepril Hydrochloride
DrugBank: Benazepril (DB00542)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given orally
Study: NCT01234922
Drug: ramipril
Normalized name: Ramipril
DrugBank: Ramipril (DB00178)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given orally
Study: NCT01507363
Drug: Gabapentin
Normalized name: Gabapentin
DrugBank: Gabapentin (DB00996)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Tables with Gabapentin (1300 mg/ day) for 7 days, starting on the day of surgery
Study: NCT01507363
Drug: Gabapentin
Normalized name: Gabapentin
DrugBank: Gabapentin (DB00996)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Tables with Gabapentin (900 mg/day) for 7 days, starting on the day of surgery
Study: NCT04122066
Drug: sofosbuvir \daclatsvir
DrugBank: Sofosbuvir (DB08934)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: study the effect of the new oral antihepatitis C drugs on the respiratory system
Study: NCT04066595
Drug: Cabozantinib
Normalized name: Cabozantinib
DrugBank: Cabozantinib (DB08875)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 60 mg cabozantinib oral daily. When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.
Study: NCT03590912
Drug: Mometasone 50 Mcg/Inh Nasal Spray
DrugBank: Mometasone (DB00764)
Approvals — FDA: no, EMA: no, PMDA: no
Description: One spray in each nostril once daily for one month
Study: NCT02697383
Drug: Ixazomib (MLN9708)
DrugBank: Ixazomib (DB09570)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT02697383
Drug: Dexamethasone
Normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00720928
Drug: flucinolone acetonide
Normalized name: Fluocinolone Acetonide
DrugBank: Fluocinolone acetonide (DB00591)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Intra-vitreal implantation of RETISERT on the study eye. The implant is a sustained-release delivery system containing 0.59 mg of flucinolone acetonide designed to deliver the drug for approximately 3 years.
Study: NCT01627587
Drug: Ketoconazole
Normalized name: Ketoconazole
DrugBank: Ketoconazole (DB01026)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Treatment B: 400 mg of Ketoconazole single dose
Study: NCT03590912
Drug: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)
DrugBank: Histamine (DB05381)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Children in this group will be treated with antiboitics (syp cefpodoxime) at 10 mg/kg/day in two divided dose for a week, plus antihistamine and nasal decongestants. Oral levocetirizine (Syrup levocet 2.5 mg/5ml) 1.25 mg once daily for age up to six years, 2.5 mg once daily for elder children for a month, plus oxymetazoline (Nasivion) 0.025%, 4 drops twice daily for two weeks
Study: NCT01627587
Drug: GSK221149 750 mg Fasted
Normalized name: Fast Freeze
DrugBank: Camphor (DB01744)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Treatment D: 750 mg of GSK221149 administered fasted
Study: NCT03412409
Drug: Cytarabine
Normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: RIC preconditioning regimen consisted of cytarabine (2 g/m2/day, days -10 to -9), busulfan (3.2 mg/kg/day on days -8 to -6), cyclophosphamide (1.0 g/m2/day, days -5 to -4), fludarabine (30 mg/m-2/day, days -6 to -2), semustine (250 mg/m-2, day -3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France).
Study: NCT03967327
Drug: Buprenorphine transdermal patches
Normalized name: buprenorphine Transdermal System
DrugBank: Buprenorphine (DB00921)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: It should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest. The skin should be relatively hairless. If none are available, the hair at the site should be clipped, not shaven.
Study: NCT03967327
Drug: Morphine Sulfate Sustained-Release Tablet
Normalized name: Morphine Sulfate
DrugBank: Morphine (DB00295)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: It will be administered orally twice (q12h) daily.
Study: NCT03256045
Drug: Carfilzomib
Normalized name: Carfilzomib
DrugBank: Carfilzomib (DB08889)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT03256045
Drug: Dexamethasone
Normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given PO
Study: NCT03256045
Drug: Panobinostat
Normalized name: Panobinostat
DrugBank: Panobinostat (DB06603)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Given PO
Study: NCT00684190
Drug: Esomeprazole
Normalized name: Esomeprazole
DrugBank: Esomeprazole (DB00736)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 40 mg od, oral, 7 days
Study: NCT01622569
Drug: Fluticasone Propionate
Normalized name: Fluticasone Propionate
DrugBank: Fluticasone propionate (DB00588)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Delivered via Optinose Exhalation Delivery System
Study: NCT03666650
Drug: Edoxaban 60 MG
Normalized name: edoxaban 60 MG
DrugBank: Edoxaban (DB09075)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Viscoelastic analysis and standard laboratory tests after edoxaban ingestion
Study: NCT02410694
Drug: Ixazomib
Normalized name: Ixazomib
DrugBank: Ixazomib (DB09570)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT02410694
Drug: Thalidomide
Normalized name: Thalidomide
DrugBank: Thalidomide (DB01041)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02410694
Drug: Dexamethasone
Normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02085291
Drug: Crystalloid
Normalized name: Crystal ammonia
DrugBank: Ammonium carbonate (DB15926)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients received 500 ml crystalloid for fluid challenge within 20 minutes, then a PLR test was performed to predict fluid responsiveness. If the patient was fluid responsive, more 500 ml crystalloids were given until fluid nonresponsive. If the MAP still not achieved the target value, NE was increased to achieve the target one.
Study: NCT03430596
Drug: Pramipexole
Normalized name: Pramipexole
DrugBank: Pramipexole (DB00413)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The dose of pramipexole range from 0.375mg/d to 0.75mg/d , The accurate dose of pramipexole can be adjusted by the patient's condition and tolerance .
Study: NCT03512548
Drug: Relacorilant 350mg
Normalized name: Relacorilant
DrugBank: Relacorilant (DB14976)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Relacorilant 350mg
Study: NCT03512548
Drug: Itraconazole
Normalized name: Itraconazole
DrugBank: Itraconazole (DB01167)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Itraconazole 200 mg
Study: NCT03512548
Drug: Relacorilant 300mg
Normalized name: Relacorilant
DrugBank: Relacorilant (DB14976)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Relacorilant 300mg
Study: NCT00002825
Drug: docetaxel
Normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01081834
Drug: Canagliflozin
Normalized name: Canagliflozin
DrugBank: Canagliflozin (DB08907)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks (Main Study) or 26 weeks (High Glycemic Substudy)
Study: NCT01081834
Drug: Sitagliptin
Normalized name: Sitagliptin
DrugBank: Sitagliptin (DB01261)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)
Study: NCT03634800
Drug: Nivolumab 240mg
Normalized name: nivolumab
DrugBank: Nivolumab (DB09035)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Patients with multiple myeloma will receive Nivolumab intravenously at 240 mg every two weeks. Infusions will be given over 60 minutes (not bolus or IV push). Patients will continue to receive infusions every two weeks until disease progression or dose limiting toxicity is reached.
Study: NCT02336724
Drug: Famitinib
Normalized name: Famitinib
DrugBank: Famitinib (DB11741)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02679235
Drug: POST Triheptanoin
DrugBank: Triheptanoin (DB11677)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.
Study: NCT02631538
Drug: Belimumab
Normalized name: Belimumab
DrugBank: Belimumab (DB08879)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Belimumab will be provided as a 200 mg sterile, liquid product in a prefilled syringe. Each syringe contains 1.0 mL of 200 mg/mL belimumab. Each syringe will be a single use.
Study: NCT02631538
Drug: Rituximab
Normalized name: Rituximab
DrugBank: Rituximab (DB00073)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Rituximab will be provided as a 100 mg concentrated solution for infusion. It is a clear, colorless liquid.
Study: NCT02631538
Drug: Placebo belimumab
Normalized name: Belimumab
DrugBank: Belimumab (DB08879)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: The placebo control will be provided as a sterile liquid product in a prefilled syringe. Each syringe will be of a single use.
Study: NCT02631538
Drug: Placebo rituximab
DrugBank: Rituximab (DB00073)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Placebo rituximab will be provided as solution for infusion. It is a clear, colorless liquid.
Study: NCT03844217
Drug: Macimorelin 0.5mg/kg body weight
DrugBank: Macimorelin (DB13074)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin
Study: NCT03844217
Drug: Macimorelin 0.75mg/kg body weight
DrugBank: Macimorelin (DB13074)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight Macimorelin
Study: NCT00471432
Drug: custirsen sodium
Normalized name: Custirsen
DrugBank: Custirsen (DB05487)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00471432
Drug: docetaxel
Normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01491256
Drug: Pre-procedural High dose atorvastatin loading
DrugBank: Atorvastatin (DB01076)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention
Study: NCT01491256
Drug: No pre-procedural high-dose atorvastatin loading
DrugBank: Atorvastatin (DB01076)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention
Study: NCT04028505
Drug: Terlipressin Injectable Product
Normalized name: terlipressin Injectable Product
DrugBank: Terlipressin (DB02638)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous terlipressin will be obtained from Clinical Trials Unit, AKUH pharmacy in standard IV infusion form.~Participants who are randomized to the intervention arm will be administered a continuous infusion of Terlipressin at a rate of 0.5mg/hour for the first 24 hours. Participants randomized into the control group will be administered a bolus form of Terlipressin at a rate of 2mg every six hourly for the first 24 hours respectively. In case of weekends/public holidays intravenous terlipressin will be obtained from the main pharmacy of AKUH.
Study: NCT03430596
Drug: Trihexyphenidyl hydrochloride
Normalized name: Trihexyphenidyl Hydrochloride
DrugBank: Trihexyphenidyl (DB00376)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: he dose of Antan range from 2 mg/d to 4 mg/d , The accurate dose of pramipexole can be adjusted by the patient's condition and tolerance .
Study: NCT01988103
Drug: Apremilast
Normalized name: Apremilast
DrugBank: Apremilast (DB05676)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 20 mg tablet BID for 68 weeks
Study: NCT01851408
Drug: sorafenib tosylate
Normalized name: Sorafenib Tosylate
DrugBank: Sorafenib (DB00398)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given orally
Study: NCT01851408
Drug: temsirolimus
Normalized name: Temsirolimus
DrugBank: Temsirolimus (DB06287)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Given IV
Study: NCT02743247
Drug: Tacrolimus
Normalized name: Tacrolimus
DrugBank: Tacrolimus (DB00864)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02743247
Drug: Mycophenolate mofetil
Normalized name: Mycophenolate Mofetil
DrugBank: Mycophenolate mofetil (DB00688)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00670410
Drug: Busulfan
Normalized name: Busulfan
DrugBank: Busulfan (DB01008)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Busulfan (Busulfex) \[4mg/kg/dose for patients \< 4 years; 3.2 mg/kg/dose for patients \> 4 years\] will be given IV in 0.9% sodium chloride or D5W to a final concentration \> 0.5 mg/mL solution for infusion equal to 10 times the volume of diluent to Busulfex, through a central venous access device over 3 hours once daily.
Study: NCT00670410
Drug: Thymoglobulin
Normalized name: Thymoglobulin
DrugBank: Antithymocyte immunoglobulin (rabbit) (DB00098)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients with an umbilical cord blood donor will also receive Thymoglobulin (ATG-rabbit) during the preparative regimen.
Study: NCT00670410
Drug: Fludarabine
Normalized name: Fludarabine
DrugBank: Fludarabine (DB01073)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fludarabine 30 mg/m2 x 5 days, total dose = 150 mg/m2. Patients \< 12 kg will receive Fludarabine 1 mg/kg x 5 days, total dose = 5 mg/kg. Fludarabine will be given IV in 100 ml (or to a concentration of 1 mg/mL) of D5W or 0.9% sodium chloride, and infused over 30 min on Days -6 to 2.
Study: NCT03728946
Drug: Liposomal Bupivacaine
Normalized name: bupivacaine liposome
DrugBank: Bupivacaine (DB00297)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Addition of 15mL of liposomal bupivacaine to 15mL of standard nerve block anesthetic solution containing 0.5% bupivacaine and 4mg of decadron
Study: NCT01114529
Drug: Everolimus
Normalized name: Everolimus
DrugBank: Everolimus (DB01590)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Early CNI to everolimus conversion
Study: NCT00592475
Drug: conivaptan
Normalized name: Conivaptan
DrugBank: Conivaptan (DB00872)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: IV
Study: NCT00356031
Drug: Bevacizumab
Normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Study: NCT00440726
Drug: Bortezomib
Normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Intravenous on days 1, 4, 8 and 11. Dose assigned at study entry.
Study: NCT00440726
Drug: Dexamethasone
Normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 10 mg/m2/day divided BID, oral administration for 14 days.
Study: NCT00440726
Drug: PEG-asparaginase
Normalized name: Peg-asparaginase
DrugBank: Pegaspargase (DB00059)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 2500 IU/m2/day, intramuscular injection on Days 2, 8, 15 and 22
Study: NCT00440726
Drug: Cytarabine
Normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given intrathecally on Day 1 of course 1 at the dose defined by age below.~* 30 mg for patients age 1-1.99~* 50 mg for patients age 2-2.99~* 70 mg for patients \>3 years of age
Study: NCT00440726
Drug: Vincristine
Normalized name: Vincristine
DrugBank: Vincristine (DB00541)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22.
Study: NCT00440726
Drug: Triple IT Therapy
Normalized name: IT-139
DrugBank: IT-139 (DB17145)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Triple IT therapy will be given intrathecally on Day 8, 15, and 22 for patients who are CNS 2 and CNS 3 at study entry. Regimen/dosing as follows:~Methotrexate-~* \<2 years: 8 mg~* 2 - \<3 y: 10 mg~* 3 - \<9 y: 12 mg~* \>=9 y: 15 mg~Cytarabine:~* \<2 years: 16 mg~* 2 - \<3 y: 20 mg~* 3 - \<9 y: 24 mg~* \>=9 y: 30 mg~Hydrocortisone:~* \<2 years: 8 mg~* 2 - \<3 y: 10 mg~* 3 - \<9 y: 12 mg~* \>=9 y: 15 mg