AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT00004873
Drug: cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00004873
Drug: docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00004873
Drug: epirubicin hydrochloride
RxNorm normalized name: Epirubicin Hydrochloride
DrugBank: Epirubicin (DB00445)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00501345
Drug: Aspirin
RxNorm normalized name: Aspirin
DrugBank: Acetylsalicylic acid (DB00945)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 325 mg by mouth on Day 1 only, followed by 160 mg by mouth daily
Trial: NCT01921751
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 1000 mg/m2 weekly as a 30 minute infusion after nab-Paclitaxel, three weeks on and 1 week off \[1 cycle = 4 weeks\]
Trial: NCT00003186
Drug: isosulfan blue
RxNorm normalized name: Isosulfan Blue
DrugBank: Isosulfan blue (DB09136)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00522886
Drug: Cetuximab
RxNorm normalized name: Cetuximab
DrugBank: Cetuximab (DB00002)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Eligible patients will be given 2 cycles(of 21 days) of carboplatin (AUC 5) day 1 and gemcitabine (1250 mg/m2) days 1,8. Patients without progressive disease will be entered in the phase I dose-escalation part of the study. Chest radiation will be given concurrently with cetuximab, cisplatin and vinorelbine, which will be escalated in 3 steps until dose-limiting toxicity occurs.~14 days after the last gemcitabine (=day 43), radiotherapy is started : First 3 weeks: 1.5 Gy BID to a dose of 45 Gy in 30 fractions, then 2 Gy QD to a mean lung dose of 19 Gy. Cetuximab: 400 mg/m2 7 days before radiotherapy (= day 36) and during the course of radiotherapy a weekly dose 250 mg/m2. Cetuximab will be delivered at the same days as chemotherapy.~Cisplatin(all steps): 50 mg/m2 days 43, 50; 40 mg/m2 day 64.~Vinorelbine:~Step 1: 10 mg/ m2 days 43, 50; 8 mg/m2 days 66 and 73. Step 2: 20 mg/ m2 days 43, 50; 8 mg/m2 days 66 and 73. Step 3: 20 mg/ m2 days 43, 50; 15 mg/m2 days 66 and 73.
Trial: NCT01921751
Drug: nab-Paclitaxel
RxNorm normalized name: NAB-PACLITAXEL COMPONENT PACLITAXEL
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 125 mg/m2 weekly as a 30-40 minute infusion, three weeks on and 1 week \[1 cycle = 4 weeks\]
Trial: NCT01846611
Drug: Trabectedin
RxNorm normalized name: Trabectedin
DrugBank: Trabectedin (DB05109)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 1.1 mg/m\^2 administered intravenously over approximately 3 hours on Day 1 of each 21-day treatment cycle.
Trial: NCT01785459
Drug: 0.5% bupivacaine
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection.
Trial: NCT00552175
Drug: Duloxetine hydrochloride - 40 mg
RxNorm normalized name: Duloxetine Hydrochloride
DrugBank: Duloxetine (DB00476)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: duloxetine 40 mg taken orally every day
Trial: NCT00552175
Drug: Duloxetine hydrochloride - 60 mg
RxNorm normalized name: Duloxetine Hydrochloride
DrugBank: Duloxetine (DB00476)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: duloxetine 60 mg taken orally every day
Trial: NCT01853566
Drug: growth hormone
RxNorm normalized name: Growth hormone
DrugBank: Somatotropin (DB00052)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: GH group intervention: use of GH - initial dose of 0.5 UI/day (0.2 mg/day), with readjustments to 1.0 UI/day (0.4 mg/day) and 1.5 UI/day (0.6 mg/day) after 1 and 2 months of treatment, respectively. The last GH dose will be maintained until the end of the study. These GH dosages were based on the dose used for adults of the same age with GHD. Subjects will be re-evaluated after 6 months of GH therapy or placebo according to muscle strength and body composition .The other group received placebo using the same scheme as the GH group.
Trial: NCT01496131
Drug: Goserelin
RxNorm normalized name: Goserelin
DrugBank: Goserelin (DB00014)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: ADT (Goserelin) will be administered at a dose of 10.8 milligrams (mg) subcutaneously every 3 months for 24 months for the high risk group and for 6 months in the intermediate risk group, starting 2-3 months prior to radiation therapy.
Trial: NCT01496131
Drug: Tecemotide (L-BLP25)
RxNorm normalized name: L
DrugBank: Tecemotide (DB12568)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tecemotide (L-BLP25) will be administered at a dose of 918 microgram (mcg) as subcutaneous injection every 2 weeks for 5 doses followed by every 6 weeks for an additional 4 doses, starting 2-3 months prior to radiation therapy and on the same day that ADT began.
Trial: NCT04018339
Drug: Bardoxolone methyl
RxNorm normalized name: Bardoxolone methyl
DrugBank: Bardoxolone methyl (DB05983)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Bardoxolone methyl 5 mg capsules
Trial: NCT01846611
Drug: DOXIL
RxNorm normalized name: Doxil
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 30 mg/m\^2 administered intravenously over approximately 90 minutes on Day 1 of each 21-day treatment cycle.
Trial: NCT01378858
Drug: Varenicline
RxNorm normalized name: Varenicline
DrugBank: Varenicline (DB01273)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
Trial: NCT02431936
Drug: Prazosin
RxNorm normalized name: Prazosin
DrugBank: Prazosin (DB00457)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Double blind placebo controlled cross over trial to determine effectiveness of alpha adrenergic blocker in reducing sodium retention during stress.
Trial: NCT01833611
Drug: Entecavir
RxNorm normalized name: Entecavir
DrugBank: Entecavir (DB00442)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: entecavir 0.5mg qd
Trial: NCT00964743
Drug: DepoCyt
RxNorm normalized name: DepoCyt
DrugBank: Cytarabine (DB00987)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients were to receive DepoCyt through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses.
Trial: NCT00964743
Drug: Sorafenib
RxNorm normalized name: Sorafenib
DrugBank: Sorafenib (DB00398)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patients received oral sorafenib at 400 mg twice a day
Trial: NCT00625469
Drug: bosentan
RxNorm normalized name: Bosentan
DrugBank: Bosentan (DB00559)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 62.5mg orally bid for first month, followed by 125mg bid thereafter
Trial: NCT00939783
Drug: Dimebon
RxNorm normalized name: Dimebon
DrugBank: Latrepirdine (DB11725)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablet for oral administration
Trial: NCT01425827
Drug: duloxetine HCL
RxNorm normalized name: duloxetine HCl
DrugBank: Duloxetine (DB00476)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 60 mg/day duloxetine for 16 weeks
Trial: NCT01628471
Drug: decitabine in combination with genistein
RxNorm normalized name: decitabine, combinations
DrugBank: Decitabine (DB01262)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: decitabine IV infusion ( 10 hrs total), doses from 60 to 500 mg/m2 + fixed daily oral dose of 300 mg genisteine
Trial: NCT00658762
Drug: PD 0332334
RxNorm normalized name: dolutegravir
DrugBank: Dolutegravir (DB08930)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper
Trial: NCT00658762
Drug: PD 0332334
RxNorm normalized name: dolutegravir
DrugBank: Dolutegravir (DB08930)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
Trial: NCT00658762
Drug: paroxetine
RxNorm normalized name: Paroxetine
DrugBank: Paroxetine (DB00715)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper
Trial: NCT02258620
Drug: dinitrate isosorbide
DrugBank: Isosorbide (DB09401)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: dinitrate isosorbide (cedocard\*) by continuous intra venous (1 to 5 mg/h) dinitrate isosorbide (cedocard\*) 5 mg by intra arterial direct in the sheat
Trial: NCT02258620
Drug: nitroglycerine
RxNorm normalized name: Nitroglycerine
DrugBank: Nitroglycerin (DB00727)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: nitroglycerine dermal patch 15 mg/24h : 67,2 mg/21 cm2
Trial: NCT01286090
Drug: Cisapride
RxNorm normalized name: Cisapride
DrugBank: Cisapride (DB00604)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: One 10-mg tablet taken orally 4 times a day for up to 8 weeks.
Trial: NCT00030121
Drug: recombinant human atrial natriuretic polypeptide
DrugBank: Poly(lactic acid) (DB15037)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00770718
Drug: Prothrombin Complex Concentrate
RxNorm normalized name: Prothrombin complex concentrate
DrugBank: Factor IX Complex (Human) (DB11330)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 5 patients will receive PCC based on ideal body weight. Each patient will receive 30 i.u./kg ideal body weight as is rounded to the nearest dispensed vial size. Vials are dispensed as 5mL (500 i.u.), 10mL (1000 i.u.), or 10mL (1500i.u.). INR will be drawn at 20 minutes post-administration and, if normalized (≤1.3), 2 hours post-administration and every 2 hours for 6 hours total. The INR will also be checked 24 hours post-administration. If at any time, the INR is \>1.3, then PCC will be readministered at the same dose and the INR will again be checked 20 minutes after administration and every 2 hours for 6 hours total and again at 24 hours post-administration. A maximum total of 60 iu/kg can be administered.
Trial: NCT02776189
Drug: Dexmedetomidine
RxNorm normalized name: Dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: intravenous dexmedetomidine 1 mcg per kg body weight over 10 minutes followed by infusion of dexmedetomidine at dose of 1 mcg per kg body weight per hour till end of procedure
Trial: NCT00251030
Drug: Nelfinavir and Omeprazole
DrugBank: Nelfinavir (DB00220)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03225456
Drug: Syntocinon
RxNorm normalized name: Syntocinon
DrugBank: Oxytocin (DB00107)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Intra-nasal oxytocin
Trial: NCT04239833
Drug: SH-1028 tablets
RxNorm normalized name: Glutathione-SH
DrugBank: Glutathione (DB00143)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The initial dose of SH-1028 tablets is 200 mg once daily . A cycle of treatment is defined as 21 days of once daily treatment.~Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
Trial: NCT04239833
Drug: Gefitinib
RxNorm normalized name: Gefitinib
DrugBank: Gefitinib (DB00317)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The initial dose of Gefitinib is 250 mg once daily . A cycle of treatment is defined as 21 days of once daily treatment.~Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label SH-1028 tablets (crossover to active SH-1028 tablets).
Trial: NCT02776189
Drug: propofol
RxNorm normalized name: Propofol
DrugBank: Propofol (DB00818)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: intravenous propofol 2mg per kg body weight followed by infusion of propofol at a dose of 100 mcg per kg body weight per min till end of procedure
Trial: NCT02776189
Drug: Midazolam
RxNorm normalized name: Midazolam
DrugBank: Midazolam (DB00683)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Intra nasal midazolam 0.2 mg per kg body weight before intravenous canulation
Trial: NCT04239833
Drug: Placebo Gefitinib
DrugBank: Gefitinib (DB00317)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The initial dose of Gefitinib is 250 mg once daily . A cycle of treatment is defined as 21 days of once daily treatment.
Trial: NCT00018733
Drug: paroxetine
RxNorm normalized name: Paroxetine
DrugBank: Paroxetine (DB00715)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01650350
Drug: Naltrexone
RxNorm normalized name: Naltrexone
DrugBank: Naltrexone (DB00704)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 4.1 Low Dose Naltrexone (LDN) LDN, 5 mg/day, at approximately 9pm, on an empty stomach, until disease progression, unacceptable toxicity, need for initiation of narcotic analgesia, or removal from protocol treatment according to section 12.0. (1 cycle = 28 days).~LDN, 5mg/ml, will be prepared by the Lifespan hospital pharmacy for patient use for this study.
Trial: NCT02711852
Drug: Duvelisib
RxNorm normalized name: Duvelisib
DrugBank: Duvelisib (DB11952)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Administered as oral capsules
Trial: NCT04899271
Drug: Ladarixin
RxNorm normalized name: Ladarixin
DrugBank: Ladarixin (DB16212)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 400 mg b.i.d. for 13 cycles of 14 days on/14 days off
Trial: NCT00455689
Drug: Leuprolide acetate
RxNorm normalized name: Leuprolide Acetate
DrugBank: Leuprolide (DB00007)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection~Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women.
Trial: NCT01298752
Drug: Mapracorat
RxNorm normalized name: Mapracorat
DrugBank: Mapracorat (DB12041)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.
Trial: NCT03552393
Drug: Mircera
RxNorm normalized name: Mircera
DrugBank: Methoxy polyethylene glycol-epoetin beta (DB09107)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The initial dose of Mircera will be one of nine starting doses corresponding to the prefilled syringe strengths based on the total weekly erythropoiesis-stimulating agent (ESA) dose during the screening period.
Trial: NCT02414152
Drug: anakinra
RxNorm normalized name: ANAKINRA
DrugBank: Anakinra (DB00026)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response
Trial: NCT00359281
Drug: atorvastatin
RxNorm normalized name: Atorvastatin
DrugBank: Atorvastatin (DB01076)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Atrovastatin 20 mg and AEGR-733 10 mg or 60 mg
Trial: NCT00359281
Drug: ezetimibe
RxNorm normalized name: Ezetimibe
DrugBank: Ezetimibe (DB00973)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Ezetimibe 10 mg and AEGR-733 10 mg
Trial: NCT00359281
Drug: fenofibrate
RxNorm normalized name: Fenofibrate
DrugBank: Fenofibrate (DB01039)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Micronized Fenofibrate 145 mg and AEGR-733 10 mg
Trial: NCT00359281
Drug: dextromethorphan
RxNorm normalized name: Dextromethorphan
DrugBank: Dextromethorphan (DB00514)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Dextromethorphan 30 mg and AEGR-733 10 mg
Trial: NCT00359281
Drug: Extended Release Niacin
RxNorm normalized name: niacin Extended Release Oral Capsule
DrugBank: Niacin (DB00627)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1000 mg ER niacin and AEGR-733 10 mg
Trial: NCT00448903
Drug: Bemiparin
RxNorm normalized name: Bemiparin
DrugBank: Bemiparin (DB09258)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Bemiparin sodium
Trial: NCT01891500
Drug: Nitrogen Gas
RxNorm normalized name: nitrogen Gas for Inhalation
DrugBank: Nitrogen (DB09152)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Placebo gas (bioinert), Patients randomized to bioinert inhaled gas at OI 10-15.
Trial: NCT01891500
Drug: Crossover iNO
RxNorm normalized name: INO
DrugBank: Inosine (DB04335)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patients who deteriorate (OI \>20 on two consecutive blood gases) will be unblinded. If they are receiving placebo gas, they will be started on iNO and make up the crossover cohort.
Trial: NCT00864643
Drug: Lapaquistat acetate and atorvastatin
RxNorm normalized name: atorvastatin and amlodipine
DrugBank: Atorvastatin (DB01076)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Lapaquistat acetate 100 mg, tablets, orally, once daily and atorvastatin 10 mg or 20 mg, tablets, orally, once daily for up to 6 weeks.
Trial: NCT00864643
Drug: Atorvastatin
RxNorm normalized name: Atorvastatin
DrugBank: Atorvastatin (DB01076)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Lapaquistat acetate placebo-matching tablets, orally, once daily and atorvastatin 10 mg or 20 mg, tablets, orally, once daily for up to 6 weeks.
Trial: NCT03491579
Drug: Epacadostat
RxNorm normalized name: epacadostat
DrugBank: Epacadostat (DB11717)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Epacadostat orally two times daily (BID) for two cycles (28 days each) in combination with standard induction chemotherapy (Cladribine and Cytarabine)
Trial: NCT03491579
Drug: Cladribine
RxNorm normalized name: Cladribine
DrugBank: Cladribine (DB00242)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Standard chemotherapy
Trial: NCT03491579
Drug: Cytarabine
RxNorm normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Standard chemotherapy
Trial: NCT01557712
Drug: ketamine venlafaxine
DrugBank: Venlafaxine (DB00285)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: After a washout period of 7 days of psychotropic medications with the exception of cyamemazine and hydroxyzine:~* Intravenous injection on day 0 to 0.5 mg / kg of ketamine~* D0 to D4: 75 mg of venlafaxine~* D4 to D14: 150 mg per day of venlafaxine~* D14 to D42: 150 mg daily of venlafaxine to 375 mg per day of venlafaxine if patient not responder
Trial: NCT01557712
Drug: Venlafaxine
RxNorm normalized name: Venlafaxine
DrugBank: Venlafaxine (DB00285)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: After a washout period of 7 days of psychotropic medications with the exception of cyamemazine and hydroxyzine:~* Intravenous injection on day 0 to 0.5 mg / kg of placebo (saline serum)~* D0 to D4: 75 mg of venlafaxine~* D4 to D14: 150 mg per day of venlafaxine~* D14 to D42: 150 mg daily of venlafaxine to 375 mg per day of venlafaxine if patient not responder
Trial: NCT02100761
Drug: Voriconazole
RxNorm normalized name: Voriconazole
DrugBank: Voriconazole (DB00582)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patients with creatinine clearance at least 50 ml/min will be treated with voriconazole by intravenous drip infusion at the dose of 6 mg/kg twice daily on the first day (Day 1) and 4 mg/kg twice daily from day 2 onward. The IV treatment is at least 7 days. Then switch to 200 mg orally twice daily between meals. The total treatment duration is at least 14 days Patients with creatinine clearance \<50 ml/min will be treated with oral voriconazole (loading dose of 400 mg twice daily followed by maintenance dose of 200 mg twice daily between meals for at least 14.0 days).
Trial: NCT01619982
Drug: Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride
DrugBank: Vancomycin (DB00512)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Cefazolin 25 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery and Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion) For patients younger than 1 month of age, a one-time repeat dose of 15 mg/kg can be given intraoperatively 12 hours after the beginning of the first vancomycin dose if the procedure is \> 12 hours in duration. For patients equal to or older than 1 month, a one-time repeat dose of 15 mg/kg (max 1.5 grams) will be given intra-operatively 8 hours after the beginning of the first vancomycin dose if the procedure is \> 8 hours in duration.
Trial: NCT01846611
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 20 mg administered intravenously on Day 1 of each 21-day treatment cycle approximately 30 minutes prior to study drug infusion.
Trial: NCT01846611
Drug: DOXIL
RxNorm normalized name: Doxil
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 50 mg/m\^2 administered intravenously over approximately 90 minutes on Day 1 of each 28-day treatment cycle.
Trial: NCT00280553
Drug: bupivicaine
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: PCA and bupivicaine infusion for up to five days
Trial: NCT02144753
Drug: psyllium (15 g)
RxNorm normalized name: psyllium
DrugBank: Plantago seed (DB11097)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Psyllium (an over-the-counter fiber) to be taken as three (5g each) packets of the fiber per day, one 5g packet in the morning (one hour before eating breakfast) and the other two 5g packets in the afternoon and evening.Fasting required for the morning dose and recommended with afternoon and evening dose.
Trial: NCT01945164
Drug: XL999
RxNorm normalized name: XL999
DrugBank: XL999 (DB05014)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The treatment will consist of 4-week cycles in which the subject will receive XL999 administered as a 4-hour IV infusion every other week. The subject will continue to receive 4-week cycles of XL999 in the absence of progressive disease, unacceptable drug-related toxicity, and as long as the drug is available.