TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01615874
Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI
Approvals — FDA: no, EMA: no, PMDA: no
Description: albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed
Study: NCT03519750
Drug: Melatonin 25 mg
Normalized name: melatonin 0.25 MG/ML
DrugBank: Melatonin (DB01065)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 24-48 hour monitoring of plasma melatonin as well as adverse events.
Study: NCT01089608
Drug: Azithromycin
Normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
Study: NCT01553318
Drug: Placebo (Sugar Pill)
Normalized name: placebo Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: After meeting the full eligibility requirement, participants will be randomized. From week 1 to 2, subjects will receive either ketotifen 1 mg BID or the equivalent placebo. Thereafter, subjects will take ketotifen to 2 mg BID or the equivalent placebo.
Study: NCT01492374
Drug: Placebo matching BMS-241027
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous (IV), 0.0 mg/kg, Once Weekly, 9 weeks
Study: NCT03496545
Drug: Acetaminophen 650 MG
Normalized name: acetaminophen 650 MG
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Acetaminophen 650 mg every 4 hours PO/NG/FT for 48 hours
Study: NCT00832572
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo to match ranolazine administered twice a day for 6 weeks
Study: NCT00445172
Drug: E0302 (mecobalamin)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intramuscular injection, mecobalamin twice a week.
Study: NCT04219124
Drug: Placebo oral tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo tablets
Study: NCT02919319
Drug: Placebo (Formulation B)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Soft capsules matching ACT-541468 Formulation B
Study: NCT02919319
Drug: Placebo tracer
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sterile NaCl 0.9% was used as placebo matching the tracer for oral and i.v. administration.
Study: NCT01746043
Drug: Minocycline
Normalized name: Minocycline
DrugBank: Minocycline (DB01017)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 100 mg by mouth 2 times a day for 6 weeks.
Study: NCT00379522
Drug: Saline placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo for arginine vasopressin
Study: NCT02037191
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Non responder patients in arm A will be re-randomized to receive from month 6 to the end of the study (month 12):~methotrexate alone or methotrexate associated with prednisone 0.3 mg/Kg/day
Study: NCT02037191
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Non responder patients in arm B will be re-randomized to receive from month 6 to the end of the study (month 12):~methotrexate alone or methotrexate associated with prednisone 0.3 mg/Kg/day
Study: NCT02059499
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given intra-anally
Study: NCT02420730
Drug: AGN-232411
Normalized name: VITEX AGNUS-CASTUS WHOLE
Approvals — FDA: no, EMA: no, PMDA: no
Description: AGN-232411 topical ophthalmic solution
Study: NCT01014364
Drug: hydrocortisone
Normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: 50mg intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week
Study: NCT01014364
Drug: isotonic saline
Approvals — FDA: no, EMA: no, PMDA: no
Description: intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week
Study: NCT00184548
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo
Study: NCT04644705
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo to the interventional drug
Study: NCT02502812
Drug: Clop F1
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state.
Study: NCT02502812
Drug: Clop F2
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state.
Study: NCT02502812
Drug: Innovator
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state.
Study: NCT02171234
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02171234
Drug: BIA 2-093
Normalized name: Oatmeal 10 mg in 1 mL TOPICAL CREAM [BIA Eczema Relief]
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01809301
Drug: TRIA-662
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00464646
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Both Cohorts: Cyclophosphamide 600 mg/m2 IV every 21 days x 4 cycles
Study: NCT02953210
Drug: Fentanyl Hydrochloride
Normalized name: fentanyl hydrochloride
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: intravenous
Study: NCT01261702
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Normal saline IV
Study: NCT01090570
Drug: PLX3397
Approvals — FDA: no, EMA: no, PMDA: no
Description: Once-daily oral capsules
Study: NCT01346319
Drug: ABT-SLV361
Normalized name: ABT-925
Approvals — FDA: no, EMA: no, PMDA: no
Description: For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days.
Study: NCT01346319
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days.
Study: NCT02953210
Drug: Ketorolac Injectable Solution
Normalized name: ketorolac Injectable Solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: at the of the procedure
Study: NCT03121001
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 14.5 mg/kg IV on days -6 and -5 and 50 mg/kg/d on days +3 and +4
Study: NCT01624948
Drug: Mycophenolic acid dose reduction
Normalized name: reductic acid
Approvals — FDA: no, EMA: no, PMDA: no
Description: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.
Study: NCT04195243
Drug: Placebo pill
Normalized name: placebo Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: The patient will take one pill, every 24 hr, during 7 days
Study: NCT01293058
Drug: Intravenous
Normalized name: INTRAVENOUS SETS
Approvals — FDA: no, EMA: no, PMDA: no
Description: Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness
Study: NCT03889626
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Capecitabine: 1000mg/m2 bid po, d1-14, q3w
Study: NCT02283996
Drug: Depot Methylprednisolone
Normalized name: Methylprednisolone
DrugBank: Methylprednisolone (DB00959)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine
Study: NCT00835224
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: A pill with an inactive substance that looks like the study drug.
Study: NCT00945035
Drug: etoricoxib
Normalized name: etoricoxib
DrugBank: Etoricoxib (DB01628)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.
Study: NCT00945035
Drug: Comparator: etoricoxib
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.
Study: NCT00319748
Drug: 852A
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.
Study: NCT02274389
Drug: No Intervention
Approvals — FDA: no, EMA: no, PMDA: no
Description: This is an observational study and participants did not receive any intervention in this study. Participants initiating bedaquiline (BDQ) treatment as decided by healthcare provider, will be prospectively observed.
Study: NCT01604824
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: SC injection in the abdomen
Study: NCT01316913
Drug: GSK573719/GW642444 125/25
Approvals — FDA: no, EMA: no, PMDA: no
Description: 125/25 mcg once-daily
Study: NCT01316913
Drug: GSK573719/GW642444 62.5/25
Approvals — FDA: no, EMA: no, PMDA: no
Description: 62.5/25 mcg once-daily
Study: NCT01316913
Drug: GSK573719
Approvals — FDA: no, EMA: no, PMDA: no
Description: 125 mcg once-daily
Study: NCT03564106
Drug: intraarticular radiofrequency + intraarticular methylprednisolone
Normalized name: Methylprednisolone
DrugBank: Methylprednisolone (DB00959)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: intraarticular radiofrequency + intraarticular methylprednisolone (30 mg)
Study: NCT03564106
Drug: intraarticular methylprednisolone
Normalized name: Methylprednisolone
DrugBank: Methylprednisolone (DB00959)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: intraarticular methylprednisolone (30 mg)
Study: NCT01972529
Drug: placebo (lower baseline platelet count)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 60 mg placebo (3 x 20 mg matching placebo tablets)
Study: NCT01972529
Drug: placebo (higher baseline platelet count)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 40 mg placebo (2 x 20 mg matching placebo tablets)
Study: NCT00617981
Drug: ThermoDox
Approvals — FDA: no, EMA: no, PMDA: no
Description: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
Study: NCT00948298
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3, will be given every 4 weeks.
Study: NCT00716092
Drug: Placebo (linagliptin)
Approvals — FDA: no, EMA: no, PMDA: no
Description: once daily for 28 days
Study: NCT00716092
Drug: Placebo (sitagliptin)
Approvals — FDA: no, EMA: no, PMDA: no
Description: once daily for 28 days
Study: NCT01208948
Drug: 1,2 dithiolane 3 valeric acid
Approvals — FDA: no, EMA: no, PMDA: no
Description: 600 mg alpha lipoic acid per day
Study: NCT00087958
Drug: XRP9881
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02571842
Drug: ACEI/ARB and corticosteroids
Approvals — FDA: no, EMA: no, PMDA: no
Description: * ACEI or ARB will be prescribed as high as tolerable dose.~* Prednisolone will be prescribed starting as 0.5 mg/kg/day then taper off to 5 mg/day within 6-8 weeks
Study: NCT01958814
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
Study: NCT02714595
Drug: Best Available Therapy
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Standard of care with either a polymyxin-based or non-polymyxin-based regimen as determined by the investigator and consisting of one to three marketed antibacterial agent(s).
Study: NCT00578955
Drug: 1% Azithromycin and 0.1% Dexamethasone
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
Study: NCT00578955
Drug: 1% Azithromycin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
Study: NCT02587390
Drug: Simvastatin 80 mg
Normalized name: simvastatin 80 MG
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 2x40 mg Simvastatin tablets orally once daily (QD) for 15 days
Study: NCT01896869
Drug: FOLFIRINOX
Approvals — FDA: no, EMA: no, PMDA: no
Description: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
Study: NCT00441701
Drug: Rescue medication
Normalized name: ALLERGENIC EXTRACT, MEADOW FESCUE POLLEN
Approvals — FDA: no, EMA: no, PMDA: no
Description: Salbutamol/albuterol - 2 puffs of salbutamol/albuterol approximately every 4 hours as needed for dyspnea relief
Study: NCT04786275
Drug: Fentanyl
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Standard dose of 2 ug/kg after tetanic stimulation.
Study: NCT04067726
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be made available as 1 mL sterile, non-pyrogenic water solution in a single-use prefilled syringe.
Study: NCT04067726
Drug: Calcium
Normalized name: Calcium
DrugBank: Calcium sulfate (DB15533)
Approvals — FDA: no, EMA: no, PMDA: no
Description: -Participants will be instructed to take calcium (at least 500 mg) daily for 12 months between baseline examination and 12- month mammographic breast density examination.
Study: NCT03841058
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: A pen to deliver a SC dose of placebo
Study: NCT00542399
Drug: Levemir twice a day
Approvals — FDA: no, EMA: no, PMDA: no
Description: Levemir twice a day
Study: NCT00568061
Drug: Nitric Oxide
Normalized name: Nitric Oxide
DrugBank: Nitric Oxide (DB00435)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Nitric oxide for inhalation
Study: NCT00568061
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Nitrogen gas (placebo) for inhalation
Study: NCT03315338
Drug: Placebo oral suspension
Approvals — FDA: no, EMA: no, PMDA: no
Description: Reference Therapy, Dose and Route of Administration:~Placebo suspension, orally administered.
Study: NCT03533114
Drug: Placebo Oral Solution
Normalized name: Placebo Oral Solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants randomized to Placebo will receive an oral solution at a volume and regimen equivalent to the JZP-258 dose taken at the end of the Stable Dose Period.
Study: NCT03475862
Drug: PTI-821 Non-manipulated
Normalized name: Tavist Non-Sedating
Approvals — FDA: no, EMA: no, PMDA: no
Description: PTI-821 (oxycodone) 40 mg capsule extended release capsule
Study: NCT03315338
Drug: CORT118335, 225mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: CORT118335 is supplied as capsules for oral dosing
Study: NCT03315338
Drug: CORT118335, 675mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: CORT118335 is supplied as capsules for oral dosing
Study: NCT00557544
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo per os
Study: NCT03315338
Drug: CORT118335, 600mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: CORT118335 is supplied as capsules for oral dosing
Study: NCT03315338
Drug: CORT118335, 630mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: CORT118335 is supplied as capsules for oral dosing
Study: NCT00557544
Drug: ketoprofen
Normalized name: Ketoprofen
DrugBank: Ketoprofen (DB01009)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: ketoprofen 1 mg/Kg
Study: NCT03315338
Drug: CORT118335, 375mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: CORT118335 is supplied as capsules for oral dosing
Study: NCT03315338
Drug: CORT118335, 100mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: CORT118335 is supplied as a suspension for oral dosing
Study: NCT03315338
Drug: CORT118335, 300mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: CORT118335 is supplied as a suspension for oral dosing
Study: NCT03315338
Drug: CORT118335, 900mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: CORT118335 is supplied as a suspension for oral dosing
Study: NCT03315338
Drug: CORT118335, 150mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: CORT118335 is supplied as a suspension for oral dosing
Study: NCT01028014
Drug: Lactose capsule
Normalized name: lactose Oral Capsule
DrugBank: Lactose (DB04465)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Lactose capsule 1 by mouth daily for 2 weeks
Study: NCT00244114
Drug: blood draw
Normalized name: dragon's blood extract
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single blood sample collected to perform histamine release assay.
Study: NCT00182455
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 25 - 400 mg/day x 12 weeks
Study: NCT03315338
Drug: CORT118335, 1500mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: CORT118335 is supplied as a suspension for oral dosing
Study: NCT03315338
Drug: Placebo oral capsule
Normalized name: Placebo Oral Capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo capsules, orally administered
Study: NCT03315338
Drug: CORT118335, dose to be determined
Approvals — FDA: no, EMA: no, PMDA: no
Description: CORT118335 is supplied as suspension for oral dosing
Study: NCT04046510
Drug: Ocytocin
Normalized name: Neurosecretory granule protease cleaving pro-ocytocin/neurophysin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administration of lower doses of Ocytocin in bolus and continuous infusion
Study: NCT03781362
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Capecitabine will be administered 1000 mg/m2 orally twice a day for 2 weeks followed by a 7-day rest period
Study: NCT01547143
Drug: IST and/or alloHCT
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1) Patients will be categorized by their initial serum ferritin level.~1. Mild ( ferritin\<3,000 μg/L): close observation~2. Moderate (ferritin: 3,000-10,000 μg/L):~   1. Initiation : cyclosporine 3mg/kg p.o.bid + dexamethasone 10mg/m2/d po. or i.v. (D1-3)~  2. continuation: cyclosporine 3mg/kg p.o. bid (D4-56) + dexamethasone 10mg/m2/d (D4-14), then tapering.~3. Severe (ferritin\>10,000 μg/L):~   1. initiation : etoposide 100mg/m2/d i.v. + cyclosporine 2mg/kg i.v. q 12hours + dexamethasone 20mg/m2/d i.v. (D1-3)~  2. continuation : etoposide 100mg/m2/day weekly (D15-49) + cyclosporine 2mg/kg i.v. q 12 hours? ? po. (D4-56) + dexamethasone 10mg/m2/d (D4-14), 5mg/m2/d (D15-28), 2.5mg/m2/d (D29-42), 1.25mg/m2/d (D43-56), then tapering off.~      2) AlloHCT for refractory or reactivated cases.
Study: NCT02457806
Drug: Placebo spray
Approvals — FDA: no, EMA: no, PMDA: no
Description: Aqueous solution to deliver 0.1 mL per unit
Study: NCT00703391
Drug: AZD9668
Approvals — FDA: no, EMA: no, PMDA: no
Description: 30mg oral tablets twice daily (bid) for 14 days
Study: NCT00703391
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matched placebo to 30mg oral tablet twice daily (bid) for 14 days
Study: NCT00738959
Drug: AZD0328
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral solution A single dose Day 1 followed by once daily doses on Day 3-7
Study: NCT03905642
Drug: Arikayce™
Approvals — FDA: no, EMA: no, PMDA: no
Description: Amikacin (aminoglycoside) in a liposomal formulation.
Study: NCT03221855
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Capsules 10mg orally each 8 hours for 7 days.
Study: NCT00779389
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo for 14-21 days.
Study: NCT01680861
Drug: Enteric Coated Mycophenolate Sodium (EC-MPS)
Normalized name: mycophenolic acid
DrugBank: Mycophenolic acid (DB01024)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: EC-MPS 720 mg PO BID - beginning on 1st postoperative day.
Study: NCT01680861
Drug: Corticosteroids
Normalized name: CORTICOSTEROIDS
Approvals — FDA: no, EMA: no, PMDA: no
Description: Corticosteroids will be given as per our center protocol, i.e., a bolus of 500 mg of Methylprednisolone intravenously at surgery and daily x2, followed by 1.0 mg/kg, then 0.5 mg/kg orally until weaned off completely by 7-10 days postoperatively - the plan is for corticosteroids to be discontinued by 7-10 days postoperatively in both groups.
Study: NCT01920932
Drug: doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV.
Study: NCT01920932
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV.
Study: NCT00827216
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: For all patients, a standardised volume of 10 ml of the study drug (will be diluted in 90 ml NaCl 0.9% (total volume, 100 ml). Both, the study drug and the 90 ml NaCl bag will be prepared by the pharmacy. Using sterile syringes, the investigator will withdraw from this solution as many millilitres as necessary to obtain a volume that corresponds to 1 ml per kg bodyweight of the patient (i.e. for a 67 kg patient, 33 ml would be with withdrawn). Thus, the maximum volume that can be administered to a patient will be 100 ml (i.e. for a patient weighing ≥100 kg). Twenty minutes prior to the scheduled induction of anaesthesia, patients will receive their study drug solution as an intravenous infusion during 5 min.
Study: NCT00827216
Drug: Erythromycin
Normalized name: Erythromycin
DrugBank: Erythromycin (DB00199)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: For all patients, a standardised volume of 10 ml of the study drug (will be diluted in 90 ml NaCl 0.9% (total volume, 100 ml). Both, the study drug and the 90 ml NaCl bag will be prepared by the pharmacy. Using sterile syringes, the investigator will withdraw from this solution as many millilitres as necessary to obtain a volume that corresponds to 1 ml per kg bodyweight of the patient (i.e. for a 67 kg patient, 33 ml would be with withdrawn). Thus, the maximum volume that can be administered to a patient will be 100 ml (i.e. for a patient weighing ≥100 kg). Twenty minutes prior to the scheduled induction of anaesthesia, patients will receive their study drug solution as an intravenous infusion during 5 min. The regimen corresponds to 3 mg/kg of erythromycin.
Study: NCT01521390
Drug: GSK573719 62.5 mcg (one strip)
Approvals — FDA: no, EMA: no, PMDA: no
Description: GSK573719 62.5 mcg delivered by 1 strip configuration of novel dry powder inhaler
Study: NCT01521390
Drug: GSK573719 62.5 mcg(two strips)
Approvals — FDA: no, EMA: no, PMDA: no
Description: GSK573719 62.5 mcg delivered by 2 strip configuration of novel dry powder inhaler
Study: NCT01521390
Drug: GSK573719 125 mcg (one strip)
Normalized name: Gel-One
Approvals — FDA: no, EMA: no, PMDA: no
Description: GSK573719 125 mcg delivered by 1 strip configuration of novel dry powder inhaler