TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01820078
Drug: Experimental arm
Normalized name: lidocaine
DrugBank: Lidocaine (DB00281)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)
Study: NCT01907984
Drug: Midazolam
Normalized name: Midazolam
DrugBank: Midazolam (DB00683)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00734344
Drug: Raltegravir
Normalized name: Raltegravir
DrugBank: Raltegravir (DB06817)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Raltegravir 400 mg. BID
Study: NCT00734344
Drug: Efavirenz
Normalized name: Efavirenz
DrugBank: Efavirenz (DB00625)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 600 mg once daily
Study: NCT00734344
Drug: Tenofovir disoproxil once daily
DrugBank: Tenofovir disoproxil (DB00300)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 300mg once daily
Study: NCT00734344
Drug: Tenofovir disoproxil twice daily
DrugBank: Tenofovir disoproxil (DB00300)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 300mg twice daily
Study: NCT00000585
Drug: penicillin
Normalized name: Penicillin
DrugBank: Nafcillin (DB00607)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00599326
Drug: Deferasirox
Normalized name: Deferasirox
DrugBank: Deferasirox (DB01609)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: 250 mg of deferasirox once daily for 6 months
Study: NCT03443960
Drug: Amrix 30 mg
Normalized name: Amrix 30 MG Extended Release Oral Capsule
DrugBank: Cyclobenzaprine (DB00924)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Subjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it.
Study: NCT03845348
Drug: Ketoconazole 2% Shampoo
Normalized name: Ketoconazole 2% Shampoo
DrugBank: Ketoconazole (DB01026)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Ketoconazole 2% Shampoo
Study: NCT03434119
Drug: Insulin glargine/Lixisenatide
Normalized name: INSULIN GLARGINE/LIXISENATIDE
DrugBank: Insulin glargine (DB00047)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Insulin glargine (100 units per milliliter \[U/mL\]) and lixisenatide (33 micrograms per milliliter \[mcg/mL\]) self administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting self-monitoring of plasma glucose (SMPG) of 80 to 100 milligrams per deciliter (mg/dL) (4.4 to 5.6 millimoles per liter \[mmol/L\]) while avoiding hypoglycemia.
Study: NCT03434119
Drug: Insulin glargine (HOE901)
Normalized name: Insulin Glargine
DrugBank: Insulin glargine (DB00047)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Insulin glargine 100 U/mL self-administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting SMPG of 80 to 100 mg/dL (4.4 to 5.6 mmol/L) while avoiding hypoglycemia.
Study: NCT01184014
Drug: NPH insulin plus Complete Insulin Orders
Normalized name: INSULIN,NPH,BEEF
DrugBank: Beef (DB10509)
Approvals — FDA: no, EMA: no, PMDA: no
Description: NPH dosed per study-specific algorithm which incorporates total daily dosage of steroid to determine NPH dose. Complete insulin orders include background, meal-time and correction factor.
Study: NCT00233935
Drug: defined green tea catechin extract
Normalized name: green tea extract
DrugBank: Green tea leaf (DB14307)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given PO
Study: NCT02528214
Drug: Dupilumab
Normalized name: Dupilumab
DrugBank: Dupilumab (DB12159)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
Study: NCT02528214
Drug: Albuterol/Salbutamol
DrugBank: Albuterol (DB01001)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral inhalation as needed.
Study: NCT02528214
Drug: Levalbuterol/Levosalbutamol
DrugBank: Albuterol (DB01001)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral inhalation as needed.
Study: NCT02079805
Drug: Azilsartan
Normalized name: Azilsartan
DrugBank: Azilsartan medoxomil (DB08822)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Azilsartan tablets
Study: NCT02079805
Drug: Telmisartan
Normalized name: Telmisartan
DrugBank: Telmisartan (DB00966)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Telmisartan tablets
Study: NCT01316133
Drug: tacrolimus
Normalized name: Tacrolimus
DrugBank: Tacrolimus (DB00864)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: oral
Study: NCT03246360
Drug: Modification for administration mode of cloxacillin antibiotic
Normalized name: combinations of different antibiotics
DrugBank: Oxacillin (DB00713)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: For intermittent administration, patients will benefit from cloxacillin treatment in conventional hospitalization, in accordance with national guidelines, at a dose of 150 mg / kg per day in 4 infusions, not exceeding the maximum daily dose of 12 g / day according to.~For continuous administration the same quantity of cloxacillin 150 mg / kg per day, without exceeding the maximum daily dose of 12 g / day, will be delivered by a self-propelled syringe in twice 12 hours. Patients randomly assigned to receive continuous administration will receive a dose of cloxacillin equivalent to the dose administered 4 times daily during iterative administration using a self-pulsating syringe. For the first day of the study, this loading dose will be subtracted from the 150 mg / kg dose to be administered continuously over the remaining 23 hours of the first day of the study and never exceed 12g / day.~Pharmacological dosages will be performed on the third and sixth day in both arms
Study: NCT02512718
Drug: Omegaven
Normalized name: Omegaven
DrugBank: Fish oil (DB13961)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Comparison of FOLE vs. SOLE
Study: NCT02512718
Drug: Soybean oil lipid emulsion
Normalized name: propofol lipid emulsion
DrugBank: Soybean oil (DB09422)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Comparison of FOLE vs. SOLE
Study: NCT00153049
Drug: Telmisartan
Normalized name: Telmisartan
DrugBank: Telmisartan (DB00966)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00153049
Drug: Hydrochlorothiazide
Normalized name: Hydrochlorothiazide
DrugBank: Hydrochlorothiazide (DB00999)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT03497923
Drug: Magnesium Sulfate
Normalized name: Magnesium Sulfate
DrugBank: Magnesium sulfate (DB00653)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: After reversal the obention of a TOF ratio of 0.9 is avaited. 10 minutes later patients will receive a perfusion of magnesium 60 mg kg-1 over 5 minutes.
Study: NCT00412087
Drug: cholecalciferol (vitamin D3)
Normalized name: cholecalciferol (vitamin D3)
DrugBank: Cholecalciferol (DB00169)
Approvals — FDA: no, EMA: no, PMDA: no
Description: randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
Study: NCT00412087
Drug: cholecalciferol
Normalized name: Cholecalciferol
DrugBank: Cholecalciferol (DB00169)
Approvals — FDA: no, EMA: no, PMDA: no
Description: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
Study: NCT00412087
Drug: cholecalciferol
Normalized name: Cholecalciferol
DrugBank: Cholecalciferol (DB00169)
Approvals — FDA: no, EMA: no, PMDA: no
Description: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.
Study: NCT00112073
Drug: bapineuzumab
Normalized name: Bapineuzumab
DrugBank: Bapineuzumab (DB11715)
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV, Q13w
Study: NCT02096744
Drug: Catapres-TTS-1
Normalized name: Catapres-TTS-1
DrugBank: Clonidine (DB00575)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Catapres-TTS-1 Oppanol
Study: NCT03617133
Drug: Systemic application of simultaneous chemotherapy
Normalized name: OIL OF CAMPHOR
DrugBank: Camphor (DB01744)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: According to international standard and evidence, simultaneous chemotherapy (CHT) (min. 5x40 mg/m2 cis Platinum) was prescribed in the EMBRACE protocol for all patients, who qualify for its administration. Certain rules were given for adaption according to international guidelines. 90-95% of EMBRACE patients received simultaneous CHT. Most of the EMBRACE cohort is consecutive patients representing the cervix cancer patient population in the respective centers. About 70% of patients received ≥5 cycles, while 30% received 0-4 cycles. CHT has impact on systemic control, which is pronounced in high risk patients (node positive and/or stage III/IV) with a 20% difference in systemic recurrence. A center effect has been found in the ability to administer chemotherapy with 15-85% of the patients receiving ≥5 cycles of CHT. To reach optimal outcome, particularly in the high risk group, the EMBRACEII protocol also focusses on appropriate administration of CHT following international guidelines.
Study: NCT00000255
Drug: Nitrous oxide
Normalized name: Nitrous Oxide
DrugBank: Nitrous oxide (DB06690)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01562574
Drug: activated recombinant human factor VII
Normalized name: Activated Recombinant Human Factor VII, Long Acting
DrugBank: Eptacog alfa pegol (activated) (DB11661)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
Study: NCT03799926
Drug: patiromer
Normalized name: Patiromer
DrugBank: Patiromer (DB09263)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
Study: NCT03799926
Drug: patiromer
Normalized name: Patiromer
DrugBank: Patiromer (DB09263)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
Study: NCT01175668
Drug: Clonidine
Normalized name: Clonidine
DrugBank: Clonidine (DB00575)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: This group of infants undergoing NAS will be treated with neonatal morphine sulfate and Clonidine as an adjunct medication to control the symptoms. Once stable Finnegan scores \<8 for 24h, NMS will be weaned by 10% daily till off, then Clonidine will be weaned off in a stepwise manner. Infant will not go home on any medication for NAS. NMS will be dosed as mg/kd/day divided q3h and Clonidine will be dosed as microgm/kg/day divided q6h based upon the initial Finnegan scores.
Study: NCT01175668
Drug: Phenobarbital
Normalized name: Phenobarbital
DrugBank: Phenobarbital (DB01174)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Infants in this arm will be treated as current standard practice with NMS and Phenobarbital. NMS will be weaned by 10% daily to completely off during the hospital stay. Infants will be discharged home on Phenobarbital.~NMS will be dosed as mg/kg/day divided q3h and Phenobarbital will be dosed as mg/kg/day divided q8h based on the Finnegan scores.
Study: NCT02096744
Drug: Catapres-TTS-1
Normalized name: Catapres-TTS-1
DrugBank: Clonidine (DB00575)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Catapres-TTS-1 Vistanex
Study: NCT01304836
Drug: Advagraf
Normalized name: Astagraf
DrugBank: Tacrolimus (DB00864)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: oral
Study: NCT01304836
Drug: Mycophenolate Mofetil
Normalized name: Mycophenolate Mofetil
DrugBank: Mycophenolate mofetil (DB00688)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: oral
Study: NCT01304836
Drug: Simulect
Normalized name: Simulect
DrugBank: Basiliximab (DB00074)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: IV
Study: NCT00817089
Drug: Naltrexone
Normalized name: Naltrexone
DrugBank: Naltrexone (DB00704)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 50 mg of naltrexone prior to challenge session
Study: NCT02277782
Drug: Hydromorphone
Normalized name: Hydromorphone
DrugBank: Hydromorphone (DB00327)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02277782
Drug: Hyperbaric bupivacaine
DrugBank: Bupivacaine (DB00297)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT03073889
Drug: Ropivacaine
Normalized name: Ropivacaine
DrugBank: Ropivacaine (DB00296)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00709722
Drug: NKT-01
Normalized name: NKTT-120
DrugBank: NKTT-120 (DB17730)
Approvals — FDA: no, EMA: no, PMDA: no
Description: SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.
Study: NCT02127801
Drug: REGN1908-1909
Normalized name: Immunoglobulin G4 [227-proline], anti-(Felis catus allergen Fel d1) (human monoclonal REGN1908 γ4-chain), disulfide with human monoclonal REGN1908 κ-chain, dimer
DrugBank: Freneslerbart (DB19080)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01465893
Drug: Vitamin D
Normalized name: Vitamin D
DrugBank: Vitamin D (DB11094)
Approvals — FDA: no, EMA: no, PMDA: no
Description: vitamin D ,50000 unit /week
Study: NCT01465893
Drug: Vitamin D withheld
DrugBank: Vitamin D (DB11094)
Approvals — FDA: no, EMA: no, PMDA: no
Description: do not receive anything
Study: NCT03799926
Drug: patiromer
Normalized name: Patiromer
DrugBank: Patiromer (DB09263)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)
Study: NCT03799926
Drug: patiromer
Normalized name: Patiromer
DrugBank: Patiromer (DB09263)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)
Study: NCT00493896
Drug: Fondaparinux
Normalized name: Fondaparinux
DrugBank: Fondaparinux (DB00569)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The dose for Arixtra is 2.5 mg once daily, subcutaneously.
Study: NCT00493896
Drug: Enoxaparin
Normalized name: enoxaparin
DrugBank: Enoxaparin (DB01225)
Approvals — FDA: no, EMA: no, PMDA: no
Description: The dose for Lovenox is 40 mg once daily, subcutaneously.
Study: NCT01380483
Drug: doxycycline monohydrate
Normalized name: Doxycycline Monohydrate
DrugBank: Doxycycline (DB00254)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Tablets, 100 mg, single, oral dose
Study: NCT01380483
Drug: doxycycline monohydrate
Normalized name: Doxycycline Monohydrate
DrugBank: Doxycycline (DB00254)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Capsule, 100 mg, single, oral dose
Study: NCT03799926
Drug: patiromer
Normalized name: Patiromer
DrugBank: Patiromer (DB09263)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)
Study: NCT00737841
Drug: Bifidobacterium breve
Normalized name: Bifidobacterium Breve
DrugBank: Bifidobacterium breve (DB16549)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks.
Study: NCT02280603
Drug: DA-4001C
Normalized name: DAS-181
DrugBank: DAS-181 (DB15313)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1ml by topical application twice a day
Study: NCT02280603
Drug: 5% minoxidil
Normalized name: MINOXIDIL 5 g in 100 mL TOPICAL LIQUID [ASDTOTIO 5% minoxidil]
DrugBank: Minoxidil (DB00350)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 1ml by topical application twice a day
Study: NCT03799926
Drug: patiromer
Normalized name: Patiromer
DrugBank: Patiromer (DB09263)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)
Study: NCT00762372
Drug: desflurane
Normalized name: Desflurane
DrugBank: Desflurane (DB01189)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: volatile liquid for inhalation
Study: NCT00762372
Drug: desflurane/nitrous oxide
DrugBank: Desflurane (DB01189)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: volatile liquid for inhalation with gas for inhalation
Study: NCT00762372
Drug: sevoflurane/nitrous oxide
DrugBank: Sevoflurane (DB01236)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: volatile liquid for inhalation and gas for inhalation
Study: NCT03593668
Drug: Metformin
Normalized name: Metformin
DrugBank: Metformin (DB00331)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: 2-week dose adjustment period（0-2weeks）\[before meals\] 0-2d： - ;250mg，po; -. 3-4d： - ;250mg，po; 250mg，po. 5-6d： 250mg，po; 250mg，po; 250mg，po. 7-9d: 250mg，po; 500mg，po; 250mg，po. 10-11d: 250mg，po; 500mg，po; 500mg，po. 12-14d: 500mg，po; 500mg，po; 500mg，po.~10-week dose stabilization period（3-12weeks） Metformin Hydrochloride Tablet 500mg tid po.
Study: NCT00728312
Drug: Aripiprazole
Normalized name: Aripiprazole
DrugBank: Aripiprazole (DB01238)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 12 week comparison of active medication (aripiprazole 5-15 mg per day) versus Placebo (placebo look-alike 5-15 mg per day)
Study: NCT02008383
Drug: Cabozantinib
Normalized name: Cabozantinib
DrugBank: Cabozantinib (DB08875)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: There will be three parts to this phase I study: 1) the Combination Dose Finding cohort; 2) the Combination Expansion cohort; and 3) the Monotherapy MET Amplified cohort.~Cabozantinib will start at a dose of 60 mg daily with reductions to 40 and 20 mg daily possible in the dose finding cohort. The combination expansion cohort dose will determined by the dose finding cohort. The Monotherapy MET Amplified cohort will recieve 60 mg Cabozantinib daily.
Study: NCT03591744
Drug: Bortezomib
Normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Given SC
Study: NCT03591744
Drug: Dexamethasone
Normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV and PO
Study: NCT03591744
Drug: Lenalidomide
Normalized name: Lenalidomide
DrugBank: Lenalidomide (DB00480)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Given PO
Study: NCT00364858
Drug: Cerezyme
Normalized name: Cerezyme
DrugBank: Imiglucerase (DB00053)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Cerezyme doses of 20-60U/kg every 2 weeks (Q2 Arm) or 40-120 U/kg every 4 weeks (Q4 Arm).
Study: NCT01665235
Drug: Amlodipine
Normalized name: Amlodipine
DrugBank: Amlodipine (DB00381)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )
Study: NCT01665235
Drug: Aspirin or Clopidogrel
DrugBank: Clopidogrel (DB00758)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: aspirin 100mg / d or Clopidogrel 75mg / d (anti-platelet agents)
Study: NCT01665235
Drug: Atorvastatin
Normalized name: Atorvastatin
DrugBank: Atorvastatin (DB01076)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Atorvastatin 10 - 40mg / d ( statin therapy)
Study: NCT02639702
Drug: Clozapine
Normalized name: Clozapine
DrugBank: Clozapine (DB00363)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Switching from twice-daily to once-daily clozapine dosing regimen
Study: NCT00326378
Drug: consolidation chemotherapy with Docetaxel plus cisplatin
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: definitive CCRT, and followed by consolidation chemotherapy with three cycles of docetaxel plus cisplatin
Study: NCT01704092
Drug: Dexmedetomidine
Normalized name: Dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02005471
Drug: Bendamustine
Normalized name: Bendamustine
DrugBank: Bendamustine (DB06769)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Bendamustine will be administered at a dose of 70 mg/m\^2 via IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Study: NCT02005471
Drug: Venetoclax
Normalized name: Venetoclax
DrugBank: Venetoclax (DB11581)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Venetoclax will be administered at an initial dose of 20 mg via tablet orally QD, incremented weekly up to a maximum dose of 400 mg during a 5-week ramp-up period. Venetoclax will be continued at 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to disease progression (PD) or 2 years, whichever occurs first.~R/C Substudy: venetoclax will be administered for 5-week dose ramp-up period to reach the target dose of 400 mg QD. Venetoclax will continue to be administered during the rituximab cycles until disease progression or for a maximum of 2 years from Cycle 1R/C Day 1 of the R/C Substudy.
Study: NCT02005471
Drug: Rituximab
Normalized name: Rituximab
DrugBank: Rituximab (DB00073)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Rituximab will be administered at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.~R/C Substudy: Following the venetoclax ramp-up period, rituximab will be administered for 6 cycles consisting of a single infusion on the first day of each 28-day cycle.
Study: NCT03130582
Drug: high-dose etoposide
DrugBank: Etoposide (DB00773)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: an epipodophyllotoxin, is one of the most common chemotherapy agents for lymphoma without reciprocal resistance with other kinds of agents.
Study: NCT00345774
Drug: PRX-08066
Normalized name: PRX-08066
DrugBank: PRX-08066 (DB05607)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03149783
Drug: Ropivacaine HCL
Normalized name: ropivacaine HCl
DrugBank: Ropivacaine (DB00296)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Ropivacaine injected after placement of catheters, then infused during the operation
Study: NCT03149783
Drug: sodium chloride
Normalized name: Sodium Chloride
DrugBank: Sodium chloride (DB09153)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Placebo
Study: NCT00201383
Drug: cisplatin
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00004093
Drug: carboplatin
Normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Carboplatin will be dosed at a target AUC of 5, and will be given on day 1 of each cycle
Study: NCT00004093
Drug: Gemcitabine
Normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of each 21-day cycle of induction chemo (following carboplatin on day 1).
Study: NCT00004093
Drug: paclitaxel
Normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Paclitaxel will be given on day 1 of each week for 6 weeks at a dose of 50 mg/m2.
Study: NCT00004093
Drug: vinorelbine
Normalized name: Vinorelbine
DrugBank: Vinorelbine (DB00361)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Vinorelbine will be given on day 1 of each week for 6 weeks at a starting dose of 10 mg/m2, escalating up to 15 mg/m2 if no dose limiting toxicities are observed.
Study: NCT00004093
Drug: Navelbine
Normalized name: Navelbine
DrugBank: Vinorelbine (DB00361)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Navelbine will be administered at a dose of 10-15 mg/m2 in 100 cc NS to be administered over 10 minutes I.V. (one dose weekly during radiation therapy)
Study: NCT01194804
Drug: Eculizumab
Normalized name: Eculizumab
DrugBank: Eculizumab (DB01257)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.
Study: NCT02807064
Drug: Bifidobacteria
Normalized name: BIFIDOBACTERIA
DrugBank: Bifidobacterium spp. (DB18530)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.5 ml per os all days for 2 months