AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT03281538
Drug: CR845
RxNorm normalized name: Difelikefalin
DrugBank: Difelikefalin (DB11938)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
Trial: NCT02313272
Drug: Pembrolizumab
RxNorm normalized name: Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Dose Escalation: The dose of pembrolizumab will be escalated per schema in a 3+3 fashion. The starting dose (i.e., dose level 1) will be 100 mg.~Dose Expansion: The pembrolizumab dose used in the dose expansion cohort will be maximum tolerated dose (MTD) determined from the dose escalation phase.
Trial: NCT02313272
Drug: Bevacizumab
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Initial cycle of bevacizumab must start within 10 days of registering to the trial. It will be given concurrent with radiation therapy. Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks. Doses will be adjusted if there is a \> 10% change in weight.
Trial: NCT00982592
Drug: oxaliplatin
RxNorm normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT00982592
Drug: vismodegib
RxNorm normalized name: Vismodegib
DrugBank: Vismodegib (DB08828)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Given PO
Trial: NCT00800150
Drug: fludarabine phosphate
RxNorm normalized name: Fludarabine Phosphate
DrugBank: Fludarabine (DB01073)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00800150
Drug: melphalan
RxNorm normalized name: Melphalan
DrugBank: Melphalan (DB01042)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00500110
Drug: Docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 30 mg/m\^2 by vein (IV) Weekly Over 60 Minutes on Days 1, 8, 15, and 22. This will be followed by 2 weeks with no docetaxel.
Trial: NCT00500110
Drug: Imatinib Mesylate
RxNorm normalized name: Imatinib Mesylate
DrugBank: Imatinib (DB00619)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 600 mg by mouth (PO) Daily x 42 Days.
Trial: NCT00500110
Drug: Leuprolide
RxNorm normalized name: Leuprolide
DrugBank: Leuprolide (DB00007)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Hormone injections given every other month or every 3 months, as determined by the doctor.
Trial: NCT00500110
Drug: Goserelin Acetate
RxNorm normalized name: Goserelin Acetate
DrugBank: Goserelin (DB00014)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Hormone injections given every other month or every 3 months, as determined by the doctor.
Trial: NCT00465283
Drug: Donepezil
RxNorm normalized name: Donepezil
DrugBank: Donepezil (DB00843)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment
Trial: NCT01302171
Drug: granulocyte colony stimulating factor (GCSF)
RxNorm normalized name: Granulocyte colony-stimulating factor pegfilgrastim
DrugBank: Filgrastim (DB00099)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 10mcg/kg per day 5 days
Trial: NCT02639559
Drug: BL-8040
RxNorm normalized name: BL-1020
DrugBank: BL-1020 (DB05687)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03123588
Drug: Ruxolitinib
RxNorm normalized name: Ruxolitinib
DrugBank: Ruxolitinib (DB08877)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ruxolitinib administered orally twice daily (BID) at the protocol-defined starting dose.
Trial: NCT03123588
Drug: Anagrelide
RxNorm normalized name: anagrelide
DrugBank: Anagrelide (DB00261)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Anagrelide administered orally at a starting dose of 1 mg BID.
Trial: NCT00741949
Drug: Propofol
RxNorm normalized name: Propofol
DrugBank: Propofol (DB00818)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Sedation in TCI with propofol
Trial: NCT00250861
Drug: Rituximab
RxNorm normalized name: Rituximab
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT00250861
Drug: Aldesleukin
RxNorm normalized name: Aldesleukin
DrugBank: Aldesleukin (DB00041)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00454402
Drug: Alfuzosin
RxNorm normalized name: Alfuzosin
DrugBank: Alfuzosin (DB00346)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01159353
Drug: Insulin glulisine
RxNorm normalized name: Insulin Glulisine
DrugBank: Insulin glulisine (DB01309)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Insulin glulisine 100 U/ml, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal
Trial: NCT01159353
Drug: Insulin aspart
RxNorm normalized name: Insulin Aspart
DrugBank: Insulin aspart (DB01306)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Insulin aspart: 100 U/mL, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal
Trial: NCT02487355
Drug: Dexmedetomidine
RxNorm normalized name: Dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Dexmedetomidine 1 μg/ kg
Trial: NCT02487355
Drug: Magnesium Sulphate
RxNorm normalized name: Magnesium sulphate
DrugBank: Magnesium sulfate (DB00653)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Magnesium Sulphate 50 mg
Trial: NCT02487355
Drug: Bupivacaine
RxNorm normalized name: Bupivacaine
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1ml/kg of 0.25%of bupivacaine
Trial: NCT02487355
Drug: Dexmedetomidine + Magnesium Sulphate + Bupivacaine
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Dexmedetomidine 1 μg/ kg + Magnesium Sulphate 50 mg + 1ml/kg of 0.25%of bupivacaine
Trial: NCT03701087
Drug: Vitamin D
RxNorm normalized name: Vitamin D
DrugBank: Vitamin D (DB11094)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2800 IU daily till 26 weeks of pregnancy
Trial: NCT00741221
Drug: Pemetrexed
RxNorm normalized name: Pemetrexed
DrugBank: Pemetrexed (DB00642)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Pemetrexed (IV) 500 mg/m2 on day 1 every 3 weeks for 6 cycles
Trial: NCT00741221
Drug: Bevacizumab
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles After the end of the 6 cycles Bevacizumab will be administered alone at the dose of 15 mgr/Kgr (IV) every 3 weeks until disease progression
Trial: NCT00756444
Drug: Panitumumab
RxNorm normalized name: Panitumumab
DrugBank: Panitumumab (DB01269)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
Trial: NCT00756444
Drug: Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
Trial: NCT01018056
Drug: Riluzole
RxNorm normalized name: Riluzole
DrugBank: Riluzole (DB00740)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
Trial: NCT04260607
Drug: Ketamine Hydrochloride
RxNorm normalized name: Ketamine Hydrochloride
DrugBank: Ketamine (DB01221)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Experimental Procedure~1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.~2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes.~3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention~4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.~5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.
Trial: NCT01716156
Drug: Grazoprevir
RxNorm normalized name: Grazoprevir
DrugBank: Grazoprevir (DB11575)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Grazoprevir, tablet, orally, 100 mg, once per day for 12 or 24 weeks, depending on Arm assignment
Trial: NCT01716156
Drug: Ribavirin
RxNorm normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Ribavirin capsules, orally, twice per day, at a total daily dose from 800 to 1400 mg based on participant weight
Trial: NCT03133780
Drug: Ketamine
RxNorm normalized name: Ketamine
DrugBank: Ketamine (DB01221)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patient will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
Trial: NCT03133780
Drug: Midazolam
RxNorm normalized name: Midazolam
DrugBank: Midazolam (DB00683)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patient will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
Trial: NCT02203760
Drug: Pazopanib plus Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or
Trial: NCT02203760
Drug: Pazopanib
RxNorm normalized name: Pazopanib
DrugBank: Pazopanib (DB06589)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Pazopanib 800 mg orally once daily
Trial: NCT03847090
Drug: Reloxaliase
RxNorm normalized name: Reloxaliase
DrugBank: Reloxaliase (DB15560)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day
Trial: NCT00609973
Drug: Ciprofloxacin
RxNorm normalized name: Ciprofloxacin
DrugBank: Ciprofloxacin (DB00537)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ciprofloxacin 500 mg oral bid for 6 months
Trial: NCT00560638
Drug: loteprednol etabonate ophthalmic suspension, 0.5%
DrugBank: Loteprednol etabonate (DB14596)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: TID
Trial: NCT00560638
Drug: loteprednol etabonate ophthalmic suspension, 0.5%
DrugBank: Loteprednol etabonate (DB14596)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: QID
Trial: NCT00560638
Drug: vehicle of loteprednol etabonate
RxNorm normalized name: Loteprednol Etabonate
DrugBank: Loteprednol etabonate (DB14596)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: TID or BID according to the randomization
Trial: NCT04268966
Drug: Brincidofovir
RxNorm normalized name: Brincidofovir
DrugBank: Brincidofovir (DB12151)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04308694
Drug: Pharmacy-based methadone administration and dispensing
DrugBank: Methadone (DB00333)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.
Trial: NCT02181738
Drug: Nivolumab
RxNorm normalized name: Nivolumab
DrugBank: Nivolumab (DB09035)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Specified dose on specified days
Trial: NCT02181738
Drug: Vinblastine
RxNorm normalized name: Vinblastine
DrugBank: Vinblastine (DB00570)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Specified dose on specified days
Trial: NCT02181738
Drug: Dacarbazine
RxNorm normalized name: Dacarbazine
DrugBank: Dacarbazine (DB00851)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Specified dose on specified days
Trial: NCT03128346
Drug: Hydromorphone Hydrochloride
RxNorm normalized name: Hydromorphone Hydrochloride
DrugBank: Hydromorphone (DB00327)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IV, Hydromorphone
Trial: NCT03128346
Drug: Aspirin
RxNorm normalized name: Aspirin
DrugBank: Acetylsalicylic acid (DB00945)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral Aspirin
Trial: NCT02794779
Drug: Oxytocin
RxNorm normalized name: Oxytocin
DrugBank: Oxytocin (DB00107)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Intravenous bolus infusion of oxytocin 3UI followed by re-asessment of uterine tone by obstetrician after 3 minutes. Infusion stops when uterine tone is adequate and is repeated if inadequate to the maximum of 9UI (3 bolus infusions). If uretine tone is inadequate after 9UI then other methods for preventing bleeding will be used.
Trial: NCT03412890
Drug: Relugolix
RxNorm normalized name: Relugolix
DrugBank: Relugolix (DB11853)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Relugolix 40-mg tablet administered orally once daily
Trial: NCT00375310
Drug: Gemcitabine, Sorafenib
DrugBank: Sorafenib (DB00398)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Gemcitabine is given IV~Sorafenib is given orally of varying doses:~1. Sorafenib 200 mg po qd ( during combination therapy)~2. Sorafenib 400 mg po qd ( during combination therapy)~3. Sorafenib 400 mg po bid ( during combination therapy)
Trial: NCT02737787
Drug: Nivolumab
RxNorm normalized name: Nivolumab
DrugBank: Nivolumab (DB09035)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Nivolumab will be administered intravenously as a 30-minute infusion per institutional guidelines on weeks 0, 2, 4, 6, 8, 10 and 12.
Trial: NCT00104715
Drug: docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00104715
Drug: goserelin acetate
RxNorm normalized name: Goserelin Acetate
DrugBank: Goserelin (DB00014)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01497093
Drug: Pomalidomide
RxNorm normalized name: Pomalidomide
DrugBank: Pomalidomide (DB08910)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Pomalidomide 1, 2, 3, or 4 mg will be taken orally on Days 1-14 of a 21-day cycle
Trial: NCT01497093
Drug: Bortezomib
RxNorm normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Bortezomib 1 or 1.3 mg/m2 will be administered intravenously or subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression
Trial: NCT01497093
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Dexamethasone 20 mg/day \[≤ 75 years old\] or 10 mg/day \[\> 75 years old\] will be taken orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression
Trial: NCT01853085
Drug: Bimatoprost Ophthalmic Solution
RxNorm normalized name: Bimatoprost Ophthalmic Solution
DrugBank: Bimatoprost (DB00905)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
Trial: NCT04757857
Drug: Rivaroxaban 10 mg
RxNorm normalized name: rivaroxaban 10 MG
DrugBank: Rivaroxaban (DB06228)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Rivaroxaban pharmaceutical form will be tablets of 10 mg
Trial: NCT03306121
Drug: CCRT+ PF
RxNorm normalized name: PF-06459988
DrugBank: PF-06459988 (DB14768)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients receive cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every four weeks for three cycles 4 weeks after radiotherapy.~Patients receive IMRT and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy (D1,D22,D43 of RT)
Trial: NCT00968942
Drug: Botulinum Toxin Type A
RxNorm normalized name: Botulinum toxin type A
DrugBank: Botulinum toxin type A (DB00083)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Description: RT001 (Botulinum Toxin Type A Topical Gel) Dose A applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas
Trial: NCT02726295
Drug: E. coli Nissle 1917(Mutaflor®)
DrugBank: Escherichia coli strain Nissle 1917 (DB16603)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00016302
Drug: prednisone
RxNorm normalized name: Prednisone
DrugBank: Prednisone (DB00635)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given orally
Trial: NCT00016302
Drug: vincristine sulfate
RxNorm normalized name: Vincristine Sulfate
DrugBank: Vincristine (DB00541)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT00016302
Drug: daunorubicin hydrochloride
RxNorm normalized name: Daunorubicin Hydrochloride
DrugBank: Daunorubicin (DB00694)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT00016302
Drug: asparaginase
RxNorm normalized name: Asparaginase
DrugBank: Asparaginase Escherichia coli (DB00023)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IM
Trial: NCT00016302
Drug: cytarabine
RxNorm normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV or SC
Trial: NCT00016302
Drug: dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given orally
Trial: NCT00016302
Drug: thioguanine
RxNorm normalized name: Thioguanine
DrugBank: Tioguanine (DB00352)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given orally
Trial: NCT00016302
Drug: nelarabine
RxNorm normalized name: Nelarabine
DrugBank: Nelarabine (DB01280)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT00016302
Drug: pegaspargase
RxNorm normalized name: pegaspargase
DrugBank: Pegaspargase (DB00059)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IM
Trial: NCT00576342
Drug: AL-3862+timolol ophthalmic suspension
DrugBank: Timolol (DB00373)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00576342
Drug: Dorzolamide+timolol ophthalmic solution
RxNorm normalized name: dorzolamide / timolol Ophthalmic Solution
DrugBank: Timolol (DB00373)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00487747
Drug: peginterferon alfa-2a [Pegasys]
DrugBank: Peginterferon alfa-2a (DB00008)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 180 micrograms sc weekly for 48 weeks
Trial: NCT00060255
Drug: busulfan
RxNorm normalized name: Busulfan
DrugBank: Busulfan (DB01008)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: iv
Trial: NCT01554852
Drug: Maintenance (intensive & non-intensive pathways) - lenalidomide maintenance
RxNorm normalized name: Dental Resources Perio Maintenance Rinse
DrugBank: Lenalidomide (DB00480)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Days 1-21 - lenalidomide 10 mg daily PO This cycle is repeated every 28 days
Trial: NCT01554852
Drug: Maintenance (intensive & non-intensive pathways - protocol v5.0 only) - lenalidomide plus vorinostat maintenance
RxNorm normalized name: Dental Resources Perio Maintenance Rinse
DrugBank: Lenalidomide (DB00480)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Days 1-21 - lenalidomide 10 mg daily PO Days 1-7 \& 15-21 - vorinostat 300mg PO This cycle is repeated every 28 days
Trial: NCT01554852
Drug: High dose melphalan therapy and autologous stem cell transplant (intensive pathway only)
RxNorm normalized name: Allogenic bone marrow-derived mesenchymal stem cells
DrugBank: Melphalan (DB01042)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: High dose melphalan therapy and autologous stem cell transplant to be given as per local practice
Trial: NCT00222261
Drug: aspirin
RxNorm normalized name: Aspirin
DrugBank: Acetylsalicylic acid (DB00945)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Aspirin 160 mg once daily for two years
Trial: NCT00222261
Drug: clopidogrel
RxNorm normalized name: Clopidogrel
DrugBank: Clopidogrel (DB00758)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: clopidogrel 75 mg once daily for two years
Trial: NCT02540434
Drug: RiaSTAP
RxNorm normalized name: RiaSTAP
DrugBank: Fibrinogen human (DB09222)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen
Trial: NCT03134638
Drug: SY-1365 (Part 1)
RxNorm normalized name: hydrogen peroxide
DrugBank: Hydrogen peroxide (DB11091)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Two dosing schedules will be evaluated in dose escalation and a dose(s)/schedule(s) will be determined for Part 2:~* Twice weekly: SY-1365 will be administered by intravenous infusion over 1 or 2 hours twice a week for 3 weeks of each 4 week (28 day) cycle.~* Weekly: SY-1365 will be administered by intravenous infusion over 1 or 2 hours once a week for 3 weeks of each 4 week (28 day) cycle.
Trial: NCT03134638
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Carboplatin will be administered on Day 1 of each 3 week (21-day) cycle (Part 2 only)
Trial: NCT03134638
Drug: Fulvestrant
RxNorm normalized name: Fulvestrant
DrugBank: Fulvestrant (DB00947)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Fulvestrant will be administered as an intramuscular (IM) dose of 500 mg every 2 weeks for the first 3 doses on Day 1 and Day 15 of the first 28-day cycle (Cycle 1), and on Day 1 of the second 28 day cycle (Cycle 2), and monthly thereafter starting on Day 1 of Cycle 3 (Part 2 only)
Trial: NCT03134638
Drug: SY-1365 (Cohort 2)
RxNorm normalized name: hydrogen peroxide
DrugBank: Hydrogen peroxide (DB11091)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: In combination with carboplatin, SY-1365 will be administered by intravenous infusion over 1 or 2 hours for 2 weeks of each 3 week (21-day) cycle (Part 2 only)
Trial: NCT01477840
Drug: Misoprostol
RxNorm normalized name: Misoprostol
DrugBank: Misoprostol (DB00929)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia