AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT00723528
Drug: Ustekinumab 90 mg (CP)
RxNorm normalized name: Ustekinumab
DrugBank: Ustekinumab (DB05679)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
Trial: NCT02071212
Drug: Ticagrelor
RxNorm normalized name: Ticagrelor
DrugBank: Ticagrelor (DB08816)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Loading dose 180 mg . Maintainance dose 90 mg BID
Trial: NCT00723528
Drug: Ustekinumab 45 mg (After CP)
RxNorm normalized name: Ustekinumab
DrugBank: Ustekinumab (DB05679)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 45 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
Trial: NCT02998112
Drug: fecal microbiota transplantation
DrugBank: Fecal microbiota (DB17743)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fecal microbiota which was purified from fresh stool defecated by a healthy donor
Trial: NCT00723528
Drug: Ustekinumab 90 mg (After CP)
RxNorm normalized name: Ustekinumab
DrugBank: Ustekinumab (DB05679)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Trial: NCT01519804
Drug: onartuzumab
RxNorm normalized name: Onartuzumab
DrugBank: Onartuzumab (DB11746)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 15 mg/kg iv, Day 1 of each 21-day cycle
Trial: NCT02998112
Drug: Saline
RxNorm normalized name: Salinex
DrugBank: Sodium chloride (DB09153)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00429234
Drug: Dasatinib
RxNorm normalized name: Dasatinib
DrugBank: Dasatinib (DB01254)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Starting dose 70 mg by mouth daily for Week 1. Cycle is 28 days, except Cycle 1 which is 8 weeks.
Trial: NCT00429234
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Starting dose of 800 mg/m\^2 by vein once weekly over 30 minutes beginning Cycle 1 Day 1. All other cycles once weekly for 7 weeks on Days 8, 15, 22, 29, 36, and 43. Cycle is 28 days, except Cycle 1 which is 8 weeks.
Trial: NCT00327327
Drug: imexon
RxNorm normalized name: Imexon
DrugBank: Imexon (DB05003)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 30-60 minutes IV, days 1,8,15 every 28 days
Trial: NCT00327327
Drug: gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 30 minutes IV, days 1,8,15 every 28 days
Trial: NCT01519804
Drug: paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
Trial: NCT01071122
Drug: Nifedipine (Adalat, BAYA1040) and Valsartan
RxNorm normalized name: atenolol and nifedipine
DrugBank: Valsartan (DB00177)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily
Trial: NCT01071122
Drug: Nifedipine (Adalat, BAYA1040)
RxNorm normalized name: Nifedipine
DrugBank: Nifedipine (DB01115)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Nifedipine 60mg, Once daily
Trial: NCT01071122
Drug: Valsartan
RxNorm normalized name: Valsartan
DrugBank: Valsartan (DB00177)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Valsartan 160mg, Once daily
Trial: NCT00507234
Drug: formoterol fumarate inhalation solution
RxNorm normalized name: formoterol fumarate Inhalation Solution
DrugBank: Formoterol (DB00983)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT00016419
Drug: cyclosporine
RxNorm normalized name: Cyclosporine
DrugBank: Cyclosporine (DB00091)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3 mg/kg bid days 5-94 then taper to 0 at day 124 PO
Trial: NCT00569374
Drug: Modafinil
RxNorm normalized name: Modafinil
DrugBank: Modafinil (DB00745)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: subjects attend clinic for the first week in order to receive meds; oral, 200mg/day doses for three days for initiation doses; increased to oral 400mg/day for the remainder of the trial (weeks 2-6); washout period during week 7
Trial: NCT01317927
Drug: Belinostat, Warfarin
DrugBank: Warfarin (DB00682)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1000 mg/m2 injection infusion given in a 30 min period plus Warfarin 5mg PO
Trial: NCT02829268
Drug: dantrolene sodium
RxNorm normalized name: Dantrolene Sodium
DrugBank: Dantrolene (DB01219)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions.~There is a screening period up to 56 days, a 6-month treatment period with an optional extension phase up to 24 months, and a 4-week safety follow-up period. Study assessments include medical \& medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.
Trial: NCT02347501
Drug: Sitagliptin (Januvia)
RxNorm normalized name: sitagliptin Oral Tablet [Januvia]
DrugBank: Sitagliptin (DB01261)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Sitagliptin 100mg tablet once daily (or 50mg once daily for participants with moderate kidney disease) for twenty four weeks in patients due to undergo NBUVB light therapy.
Trial: NCT00765648
Drug: nicardipine intravenous
DrugBank: Nicardipine (DB00622)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: nicardipine intravenous 5 mg/hour titrated every 5 minutes by 2.5 mg/hour until target systolic blood pressure range (TSBPR) is reached or maximum dose of 15 mg/hour is achieved.Following achievement of target systolic blood pressure range the infusion rate should be decreased to 3 mg/hour
Trial: NCT00765648
Drug: Labetalol
RxNorm normalized name: Labetalol
DrugBank: Labetalol (DB00598)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Labetalol: bolus therapy to start at 20 mg intravenous injection over 2 minutes, may repeat 20mg, 40mg or 80mg injections every 10 minutes until target systolic blood pressure range(TSBPR)is reached or a maximum of 300 mg is injected.
Trial: NCT02305823
Drug: Aripiprazole
RxNorm normalized name: Aripiprazole
DrugBank: Aripiprazole (DB01238)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT02305823
Drug: Quetiapine
RxNorm normalized name: Quetiapine
DrugBank: Quetiapine (DB01224)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02305823
Drug: Ziprasidone
RxNorm normalized name: Ziprasidone
DrugBank: Ziprasidone (DB00246)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00002349
Drug: Stavudine
RxNorm normalized name: Stavudine
DrugBank: Stavudine (DB00649)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00672932
Drug: raltegravir
RxNorm normalized name: Raltegravir
DrugBank: Raltegravir (DB06817)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 400 mg two times daily for three months
Trial: NCT01282606
Drug: SI-6603
RxNorm normalized name: isopropyl alcohol
DrugBank: Isopropyl alcohol (DB02325)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
Trial: NCT02599714
Drug: Palbociclib
RxNorm normalized name: Palbociclib
DrugBank: Palbociclib (DB09073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: cyclin dependent kinase inhibitor
Trial: NCT00002549
Drug: busulfan
RxNorm normalized name: Busulfan
DrugBank: Busulfan (DB01008)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02599714
Drug: Fulvestrant
RxNorm normalized name: Fulvestrant
DrugBank: Fulvestrant (DB00947)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Fulvestrant hormonal therapy as background
Trial: NCT00002549
Drug: cytarabine
RxNorm normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00002549
Drug: daunorubicin hydrochloride
RxNorm normalized name: Daunorubicin Hydrochloride
DrugBank: Daunorubicin (DB00694)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00002549
Drug: etoposide
RxNorm normalized name: Etoposide
DrugBank: Etoposide (DB00773)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00002549
Drug: idarubicin
RxNorm normalized name: Idarubicin
DrugBank: Idarubicin (DB01177)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00002549
Drug: mesna
RxNorm normalized name: Mesna
DrugBank: Coenzyme M (DB09110)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00002549
Drug: mitoxantrone hydrochloride
RxNorm normalized name: Mitoxantrone Hydrochloride
DrugBank: Mitoxantrone (DB01204)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00213421
Drug: Dermoval
RxNorm normalized name: clobetasol propionate Topical Ointment [Dermovate]
DrugBank: Clobetasol propionate (DB01013)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: group 1 elevated corticosteroids : attack treatment 2 tubes of 10g (4t/d) decreasing treatment : one month: 2 tubes/J (2t/d); 2 months : 2 tubes 1d sur 2 (1d/j); 4 months : 2 tubes 2 fois /week (0,6t/d); 4 months : 2 tubes 1 fois /week (0,3t/d)fois /week (0,3t/d) group 2 low corticosteroids : for paucibullous form with weight \< 45kg attack treatment 1 tubes of 10g (1t/d)decreasing treatment 1 month : 1 tube every 2d (0,5t/d; 1 month : 1 tubes 2 fois /week (0,3t/d) 1 month : 1 tubes 1 fois/week (0,15t/d); for paucibullous form with weight \> 45kg or for multibullous form with weight \< 45kg attack treatment 2 tubes of 10g (2t/d)decreasing treatment 1 month : 2 tubes every 2j (1t/d; 1 month : 2 tubes 2 fois /week (0,6t/d) 1 month : 2 tubes 1 fois /week (0,3t/d)and for multibullous form attack with weigth \> 45kg treatment 3 tubes of 10g (3t/d)decreasing treatment 1 month : 3 tubes every 2days (1,5t/d) 1 month : 3 tubes 2 fois /week (1t/j)1 mois : 3 tubes 1 fois /week (0,45t/d)
Trial: NCT02019290
Drug: Midazolam
RxNorm normalized name: Midazolam
DrugBank: Midazolam (DB00683)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Single oral doses will be given on Days 1 and 15, after an overnight fast.
Trial: NCT02019290
Drug: bitopertin
RxNorm normalized name: Bitopertin
DrugBank: Bitopertin (DB12426)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: An oral dose will be given daily in the morning from Days 2-15. On Days 14 and 15, bitopertin will be given after an overnight fast; on Days 2-13, bitopertin will be given under fed conditions.
Trial: NCT00803803
Drug: Pilocarpine Concentration
RxNorm normalized name: Pilocarpine
DrugBank: Pilocarpine (DB01085)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Varying concentration 0.5 to 8%
Trial: NCT00803803
Drug: Pilocarpine Frequency
RxNorm normalized name: Pilocarpine
DrugBank: Pilocarpine (DB01085)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1 to 4 times daily
Trial: NCT03567642
Drug: Osimertinib
RxNorm normalized name: Osimertinib
DrugBank: Osimertinib (DB09330)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Osimertinib 80mg daily
Trial: NCT03567642
Drug: Platinum
RxNorm normalized name: platinum
DrugBank: Platinum (DB12257)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cisplatin 60mg/m2 or Cisplatin 45mg/m2 Carboplatin AUC 5 or Carboplatin AUC 4
Trial: NCT03567642
Drug: Etoposide
RxNorm normalized name: Etoposide
DrugBank: Etoposide (DB00773)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Etoposide 100mg/m2 or Etoposide 80mg/m2
Trial: NCT00182442
Drug: Olanzapine & Quetiapine
DrugBank: Olanzapine (DB00334)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00740493
Drug: warfarin
RxNorm normalized name: Warfarin
DrugBank: Warfarin (DB00682)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 18 months of warfarin therapy
Trial: NCT00740493
Drug: placebo of warfarin
DrugBank: Warfarin (DB00682)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 18 months of placebo of warfarin therapy
Trial: NCT01220076
Drug: tamoxifen
RxNorm normalized name: Tamoxifen
DrugBank: Tamoxifen (DB00675)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00122629
Drug: peg-interferon alfa-2b
RxNorm normalized name: Interferon Alfa-2B
DrugBank: Interferon alfa-2b (DB00105)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00122629
Drug: ribavirin
RxNorm normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00122629
Drug: amantadine
RxNorm normalized name: Amantadine
DrugBank: Amantadine (DB00915)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01945528
Drug: US-guided tenotomy with lidocaine
DrugBank: Lidocaine (DB00281)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Blood will be drawn from the patient from the patient's unaffected arm. Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; lidocaine will be delivered in multiple depots during the procedure
Trial: NCT00119886
Drug: Botulinum toxin
RxNorm normalized name: Botulinum toxin
DrugBank: Botulinum toxin type B (DB00042)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01888263
Drug: Lamotrigine
RxNorm normalized name: Lamotrigine
DrugBank: Lamotrigine (DB00555)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
Trial: NCT02665143
Drug: Nintedanib and AML induction
DrugBank: Nintedanib (DB09079)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid).
Trial: NCT04064632
Drug: Rilpivirine + darunavir/cobicistat
DrugBank: Darunavir (DB01264)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Switch to a dual ART
Trial: NCT04097600
Drug: Oral semaglutide
DrugBank: Semaglutide (DB13928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Oral semaglutide current formulation and oral semaglutide new formulation, each in 3 different strengths, administered once daily during 6 treatment periods, each lasting 12 weeks
Trial: NCT02430870
Drug: TAK-648
RxNorm normalized name: TAK-243
DrugBank: TAK-243 (DB15013)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TAK-648 solution
Trial: NCT02979015
Drug: alirocumab SAR236553 (REGN727)
DrugBank: Alirocumab (DB09302)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Pharmaceutical form: Solution for injection~Route of administration: Subcutaneous
Trial: NCT00208026
Drug: Pimecrolimus 1% Cream
RxNorm normalized name: PIMECROLIMUS 1% CREAM,TOP
DrugBank: Pimecrolimus (DB00337)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Open label single arm
Trial: NCT00105196
Drug: Aripiprazole+ ADT
RxNorm normalized name: Aripiprazole
DrugBank: Aripiprazole (DB01238)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
Trial: NCT03804359
Drug: Rituximab
RxNorm normalized name: Rituximab
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: In the personalized arm, the patient will be treated in function of the CysR activity result during the inclusion visit.
Trial: NCT03037372
Drug: ART, Atorvastatin
DrugBank: Atorvastatin (DB01076)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: ART, Atorvastatin
Trial: NCT02516046
Drug: Flortaucipir F18
RxNorm normalized name: Flortaucipir
DrugBank: Flortaucipir (DB15033)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 370 megabecquerel (MBq) IV single-dose
Trial: NCT00491816
Drug: Erlotinib with neoadjuvant chemotherapy
DrugBank: Erlotinib (DB00530)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 150 mg orally (PO) once daily on days 3 to 14, given with cycle 1 to 6 or 3 to 6 of neoadjuvant chemotherapy
Trial: NCT03025880
Drug: Pembrolizumab
RxNorm normalized name: Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Pembrolizumab at a dose of 200mg as an intravenous (IV) 30 minutes infusion on day 1 of each 21-day cycle. Treatment will be repeated on day 1 of each 21-day cycle until objective disease progression, clinical progression (under investigator criteria), unacceptable toxicity, death or withdrawal of consent, whichever occurs first. Patients completing 24 months of uninterrupted treatment with pembrolizumab or 35 administrations of study medication will stop pembrolizumab treatment (though may continue with gemcitabine). Subjects who stop pembrolizumab after 24 months may be eligible for up to one year of additional pembrolizumab treatment if they progress after stopping it.
Trial: NCT03025880
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Gemcitabine at a dose of 1,250mg/m2 as an intravenous (IV) 60 minutes infusion on day 1 and 8 of each 21-day cycle. Treatment will be repeated on day 1 of each 21-day cycle until objective disease progression, clinical progression (under investigator criteria), unacceptable toxicity, death or withdrawal of consent, whichever occurs first.
Trial: NCT03705065
Drug: Bupivacaine HCl
RxNorm normalized name: bupivacaine HCl
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Bupivacaine HCl without epinephrine 0.25%, 60 mL (30 mL per pectoral pocket)
Trial: NCT02183688
Drug: High dose ASA
RxNorm normalized name: high-density polyethylene
DrugBank: Poly(lactic acid) (DB15037)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02183688
Drug: Low dose paracetamol
RxNorm normalized name: ethinyl estradiol
DrugBank: Ethinylestradiol (DB00977)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02183688
Drug: High dose paracetamol
RxNorm normalized name: high-density polyethylene
DrugBank: Poly(lactic acid) (DB15037)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01370915
Drug: Pregabalin (Lyrica)
RxNorm normalized name: Pregabalin
DrugBank: Pregabalin (DB00230)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Patients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later
Trial: NCT03982485
Drug: Apatinib
RxNorm normalized name: Apatinib
DrugBank: Rivoceranib (DB14765)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week
Trial: NCT03982485
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle
Trial: NCT03982485
Drug: Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle
Trial: NCT01285037
Drug: Cetuximab
RxNorm normalized name: Cetuximab
DrugBank: Cetuximab (DB00002)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Cetuximab given via IV infusion once weekly, 400mg/m2 for first dose and 250mg /m2 for subsequent doses. If LY2801653 treatment is stopped due to toxicity after a minimum of 4 cycles, cetuximab may be continued until disease progression. In the event cetuximab treatment is stopped, participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Trial: NCT01285037
Drug: Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Cisplatin given via IV infusion once a week for 2 weeks and then every 3 weeks. If the LY2801653 is terminated for LY2801653-related toxicity after a minimum of 4 cycles, cisplatin may be continued as monotherapy until progression of disease. Participants discontinuing cisplatin therapy may be allowed to continue single agent LY2801653 if they are receiving clinical benefit.
Trial: NCT01285037
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Gemcitabine given via IV infusion once a week for 2 weeks and then every 3 weeks. If the LY2801653 is terminated for LY2801653-related toxicity after a minimum of 4 cycles, gemcitabine may be continued as monotherapy until progression of disease. Participants discontinuing gemcitabine therapy may be allowed to continue single agent LY2801653 if they are receiving clinical benefit.
Trial: NCT01285037
Drug: Ramucirumab
RxNorm normalized name: Ramucirumab
DrugBank: Ramucirumab (DB05578)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Ramucirumab given via IV infusion every 2 weeks in a 28-day treatment cycle. Treatment with ramucirumab may continue until excessive toxicity or evidence of disease progression. In the absence of disease progression, treatment with LY2801653 may continue even if ramucirumab is discontinued provided no dose limiting toxicity related to LY2801653 is present. In the event that LY2801653 is discontinued, treatment with ramucirumab may be continued if there is no dose limiting toxicity related to ramucirumab.
Trial: NCT01361048
Drug: oral metronidazole
RxNorm normalized name: Metronidazole
DrugBank: Metronidazole (DB00916)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 2 gm oral once
Trial: NCT03436225
Drug: Dexamethasone orally.
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Administered orally (0.15mg /kg / dose) twice daily for 3 to 5 days.
Trial: NCT03436225
Drug: Dexamethasone parenteral.
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Administered parenteral (0.15mg /kg / dose) twice daily for 3 to 5 days.
Trial: NCT03436225
Drug: Inhaled nebulized Budesonide.
DrugBank: Budesonide (DB01222)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Administered for inhalation (1 mg/ 2ml) twice daily for 3 to 5 days.
Trial: NCT01370915
Drug: Vitamin complex (placebo)
RxNorm normalized name: vitamin B complex
DrugBank: Thiamine (DB00152)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later