AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT03161093
Drug: Naproxen
RxNorm normalized name: Naproxen
DrugBank: Naproxen (DB00788)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form: Capsule
Trial: NCT03161093
Drug: Naproxen-matching placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Capsule
Trial: NCT01415895
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: subjects will receive 1 placebo capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
Trial: NCT02966873
Drug: Inactive Placebo Oral Capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participant will receive 12 weeks of inactive placebo. The study medication will be provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Trial: NCT04196413
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide 500 mg/m2 per day IV for days -4, -3, -2
Trial: NCT03666000
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Specified dose on specified days
Trial: NCT03866408
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.
Trial: NCT03401593
Drug: midazolam with fentanyl
RxNorm normalized name: Midazolam
DrugBank: Midazolam (DB00683)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Radio-frequency catheter ablation is performed in the post-absorptive state after sedation with midazolam and fentanyl. Multipolar catheters were positioned in the coronary sinus, His, and the right atrium. The three-dimensional LA geometry was reconstructed using a CARTO or NavX electroanatomical mapping system. Circumferential pulmonary vein isolation was performed in all patients using a irrigated-tip catheter. A circular mapping catheter was used to confirm the isolation of the pulmonary veins. Successful ablation was defined by the elimination of all the pulmonary vein potentials along the antrum or inside the veins. If the AF was not terminated after elimination of all the pulmonary vein potentials, linear ablation and complex fragmented atrial electrogram ablation were performed.
Trial: NCT00744276
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo topically applied once daily for 4 treatment cycles
Trial: NCT00662454
Drug: ethinyl estradiol / levonorgestrel
RxNorm normalized name: ethinyl estradiol / levonorgestrel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.
Trial: NCT03084536
Drug: Celecoxib
RxNorm normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: * As per routine care~* Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.~* Naproxen will be substituted for celecoxib in patients with sulfa allergies.
Trial: NCT03084536
Drug: Acetaminophen
RxNorm normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: -As per routine care
Trial: NCT03084536
Drug: Fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: -As per routine care
Trial: NCT01856478
Drug: methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: intravenous bolus injection, once weekly
Trial: NCT00902603
Drug: Commercial Ventavis® (iloprost)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Commercial Ventavis® (iloprost) administered via portable nebulizer (I-neb® AAD® system using the power disc-6)
Trial: NCT01721057
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT03036904
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
Trial: NCT03036904
Drug: Doxorubicin Hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Doxorubicin Hydrochloride will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
Trial: NCT03617510
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Normal saline will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the Placebo was given 7 times,3 times/day,once every 8 hours.It means the Placebo was given 3 times on D3 and D4,once on D5.
Trial: NCT03719820
Drug: aggressive medical management
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Aspirin (100 mg daily) and Clopidogrel (75 mg daily) for 3 months and Rosuvastatin (20mg daily) for at least 6 months as well as traditional risk factors management
Trial: NCT03271528
Drug: Placebo oral capsule
RxNorm normalized name: Placebo Oral Capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
Trial: NCT00694707
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo was supplied in capsules.
Trial: NCT04081324
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT01721057
Drug: cDMARD
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Conventional disease-modifying anti-rheumatic drug as a background therapy
Trial: NCT02611804
Drug: Diclofenac sodium
RxNorm normalized name: Diclofenac Sodium
DrugBank: Diclofenac (DB00586)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02611804
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01251263
Drug: Estradiol or Placebo
RxNorm normalized name: INV-CSP #2002 METFORMIN OR PLACEBO
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Estradiol 1mg twice daily or placebo starting on the last day of OC and continuing during the HFI (total of 9 doses).
Trial: NCT01251263
Drug: Estradiol or Placebo
RxNorm normalized name: INV-CSP #2002 METFORMIN OR PLACEBO
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Estradiol 1mg will be taken twice daily starting with the last day of pills and the 4 days of the HFI(total of 9 doses)
Trial: NCT00121784
Drug: mycophenolate mofetil [CellCept]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1
Trial: NCT04082975
Drug: NVP-1203-R
RxNorm normalized name: R
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral dose for 7 days
Trial: NCT04082975
Drug: NVP-1203 placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral dose for 7 days
Trial: NCT04082975
Drug: NVP-1203-R placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral dose for 7 days
Trial: NCT00809809
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo swab
Trial: NCT00514774
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo 600mg twice daily for study days 0 through 28
Trial: NCT03594435
Drug: Placebo oral capsule
RxNorm normalized name: Placebo Oral Capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: matched to active drug, ibudilast
Trial: NCT02082899
Drug: Active Comparator EBI-005 5 mg/mL
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02082899
Drug: Placebo Comparator
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00789880
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administration of oral Vitamin D3 placebo
Trial: NCT00445705
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Part A: Placebo every 12 hours for 4 weeks
Trial: NCT03275792
Drug: D5-0.9%NS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Admission for intravascular volume expansion
Trial: NCT00285818
Drug: Placebo Oral Capsule
RxNorm normalized name: Placebo Oral Capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo is a capsule without a pharmacological active ingredient
Trial: NCT02938377
Drug: Recommendation and Counseling for Alcohol Pharmacotherapy
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care.
Trial: NCT00445705
Drug: AGN 203818
RxNorm normalized name: VITEX AGNUS-CASTUS WHOLE
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Part A: AGN 203818 60 mg every 12 hours for 4 weeks
Trial: NCT01177683
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Phase I and II components:~Pegylated liposomal doxorubicin, 30 mg/m2 IV over 1 hour, Day 4
Trial: NCT01475383
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: once daily dosing of placebo capsules following the dosing scheme described in 1.1.
Trial: NCT01475383
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: once daily dosing of placebo capsules following the dosing scheme described in 1.1
Trial: NCT01050491
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo, one per day, during one year. Bronchial fibroscopy
Trial: NCT04161027
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo capsule
Trial: NCT02478372
Drug: Local Infiltration Analgesia (LIA)
RxNorm normalized name: Analgesic Balm GRX
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine.
Trial: NCT00702689
Drug: Gleevec, STI571(Imatinib Mesylate)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m\^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m\^2 oral dose daily (increase to 130 mg/m\^2 daily after 28 days if well tolerated)
Trial: NCT03639883
Drug: AIV001
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intradermal injection
Trial: NCT03162783
Drug: ADX-102 Ophthalmic Lipid Solution (0.5%)
RxNorm normalized name: guggul lipids
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.
Trial: NCT01680185
Drug: Human insulin isophane, Humulin N (Eli Lilly)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: all covered above
Trial: NCT04124861
Drug: Drug free, IS monotherapy and GC combined with IS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Follow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month).
Trial: NCT04352946
Drug: Placebo oral tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo tablets 400mg daily
Trial: NCT05271539
Drug: Lucentis alone group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The Lucentis alone group received 3 monthly intravitreal injections of lucentis alone or less than 3 injections if the central foveal thickness reached 250 microns
Trial: NCT03383393
Drug: Intracoronary bolus of adenosine (adenocor), Integrilin (eptifibatide) or nitroglyzerin (nitronal)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: intracoronary drugs
Trial: NCT03860597
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: To assess the acute effects of MEM (0 vs. 20 mg) on measures of auditory processing fidelity, auditory learning and EAIP, in AP-medicated adult SZ patients and HS.
Trial: NCT00857428
Drug: oxymorphone
RxNorm normalized name: Oxymorphone
DrugBank: Oxymorphone (DB01192)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tablets
Trial: NCT00857428
Drug: Oxymorphone
RxNorm normalized name: Oxymorphone
DrugBank: Oxymorphone (DB01192)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 40 mg tablets
Trial: NCT01710046
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks
Trial: NCT02785172
Drug: IDP-118 Vehicle Lotion
RxNorm normalized name: Neisseria meningitidis group B strain NZ98/254 outer membrane vesicle
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Vehicle
Trial: NCT02785172
Drug: IDP-118 Vehicle Cream
RxNorm normalized name: Neisseria meningitidis group B strain NZ98/254 outer membrane vesicle
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Vehicle
Trial: NCT02785172
Drug: IDP-118 Lotion
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Lotion
Trial: NCT00417118
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral administration (capsules)
Trial: NCT01389271
Drug: Ventavis inhaled (Iloprost, BAYQ6256)
RxNorm normalized name: Ventavis Inhalant Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Since this study is an observational, inhaled iloprost dosage and frequency for each patient will be prescribed by physicians as medically required.
Trial: NCT01751893
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo
Trial: NCT04330300
Drug: Thiazide or Thiazide-like diuretics
RxNorm normalized name: Medicated Pad or Tape
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anti-hypertensive (Active Arm)
Trial: NCT04330300
Drug: Calcium Channel Blockers
RxNorm normalized name: CALCIUM CHANNEL BLOCKERS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anti-hypertensive (Active Arm)
Trial: NCT04330300
Drug: ACE inhibitor
RxNorm normalized name: ACE INHIBITORS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anti-hypertensive (Control Arm)
Trial: NCT01763190
Drug: SAR302503
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form:capsule~Route of administration: oral
Trial: NCT01193842
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT01193842
Drug: Doxorubicin Hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT02715401
Drug: HCP1303
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02715401
Drug: HGP1201
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02715401
Drug: HIP1402
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02760576
Drug: BAY 987521
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Each 50 cm\*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm\*2 test application.
Trial: NCT03025009
Drug: LY3192767
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered SC.
Trial: NCT03025009
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered SC.
Trial: NCT02024555
Drug: Azithromycin
RxNorm normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02024555
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
Trial: NCT02325648
Drug: HIPEC cytoreductive surgery
FDA approved: no
EMA approved: no
PMDA approved: no
Description: At least 30 minutes prior to the prospective conclusion of the surgery, 1 μg/kg of fentanyl is administered for postoperative analgesia and 0.075mg of palonosetron is IV-infused for the prevention of nausea and vomiting. Desflurane and remifentanil administration is ceased after the surgery is concluded, muscle relaxation is evaluated by train of four (TOP) monitoring using a nerve stimulator, and the neuromuscular blockade is reversed with 0.2 mg of glycopyrrolate and 1 mg of neostigmine. When the patient recovers consciousness and begins spontaneous respiration, extubation is performed and the patient is transferred to the ICU with monitoring of their vital signs.
Trial: NCT04066179
Drug: Prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Prednisolone 40 mg for initial 7 days
Trial: NCT01887223
Drug: Medical treatment
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Hypotensive eye drops are initialized one by one regarding intraocular pressure control. Nonspecific beta blocker and/or prostaglandin, followed by carbonic anhydrase inhibitors and/or selective alpha agonist.
Trial: NCT00767325
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Methotrexate administered in a dose of 15 mg/week or higher for at least 3 months and at a stable dose for at least 28 days prior to baseline
Trial: NCT01066481
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo three times daily for 6 months
Trial: NCT01987804
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01161108
Drug: Fast Release Melatonin (FR MLT)
RxNorm normalized name: melatonin Extended Release Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3mg capsules of melatonin will be used. The dose of FR MLT will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.
Trial: NCT01161108
Drug: Fast Release Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A matching FR MLT placebo will be compounded by the SickKids research pharmacy.~The dose of Fast Release Placebo will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.
Trial: NCT03930498
Drug: Chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cisplatin and Gemcitabine
Trial: NCT03483038
Drug: FOLFOX regimen
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
Trial: NCT01161108
Drug: Timed Release Melatonin (TR MLT)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3 mg capsules will be used.~The dose of TR MLT will be will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.
Trial: NCT01161108
Drug: Timed Release Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A matching TR MLT placebo will be compounded by the SickKids research pharmacy.~The dose of Timed Release Placebo will be will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.
Trial: NCT02550756
Drug: CTNX-4975
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00398294
Drug: MK0733, simvastatin / Duration of Treatment: 12 Weeks
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03571321
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Remission consolidation regimen:~* 1000 mg/m2 by intravenous infusion (IV) on Day 1 and Day 29~Delayed Intensification regimen:~* 1000 mg/m2 IV on Day 29
Trial: NCT03571321
Drug: Mercaptopurine
RxNorm normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Taken by mouth.~Remission consolidation regimen:~* 60 mg/m2 on Days 1-14 and 29-42~Maintenance Therapy:~* 75 mg/m2 on Days 1-84
Trial: NCT03571321
Drug: Methotrexate (Intrathecal Administration)
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Drug is given through a needle which is inserted in one of the spaces between the bones in the lower back (intrathecal \[IT\] administration).~Remission consolidation regimen:~* 15 mg on Days 1, 8, 15, and 22~Interim maintenance regimen:~* 15 mg on Days 1 and 31~Delayed Intensification regimen:~* 15 mg on Days 1, 29, and 36~Maintenance Therapy:~* 15 mg on Day 1~* 15 mg on Day 29 (First 4 courses only)
Trial: NCT03571321
Drug: Methotrexate (Intravenous Administration)
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Interim maintenance regimen:~* 100 mg/m2 IV on Days 1, 11, 21, 31, and 41
Trial: NCT03571321
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Delayed Intensification regimen:~* 25 mg/m2 IV on Days 1, 8, 15
Trial: NCT03571321
Drug: Methotrexate Oral Product
RxNorm normalized name: methotrexate Oral Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Taken by mouth.~Maintenance Therapy:~* 20 mg/m2 weekly (on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78)~* Not given on Day 29 of first 4 courses (on days when IT Methotrexate is given\]