AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT02696967
Drug: CLR325
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CLR325 Concentrate for solution for infusion
Trial: NCT00940953
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: nasal spray, one spray per nostril from each of 2 bottles at time 0
Trial: NCT02740101
Drug: placebo treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: intranasal administration of placebo (40 IU)
Trial: NCT01956929
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo tablets for 2 weeks, then 4 weeks of washout period, then crossover to metformin.
Trial: NCT01471288
Drug: Carum Cravi
RxNorm normalized name: Arum palaestinum whole extract
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 40mg/kg of body weight
Trial: NCT01471288
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT02547818
Drug: ALZT-OP1a
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1) Mast cell stabilizer, 2) Neuroinflammatory microglial modulator, 3) A-beta oligomerization inhibitor, and 4) anti-inflammatory
Trial: NCT02547818
Drug: ALZT-OP1b
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anti-inflammatory
Trial: NCT00482053
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 100 mg/kg will be administered over 2 hours on day -2
Trial: NCT00482053
Drug: Acetaminophen
RxNorm normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pre-medication for rituximab and PBPC infusion. Administered at 650 mg by mouth 1 hour prior to infusion
Trial: NCT00482053
Drug: Hydrocortisone
RxNorm normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Pre-medication for the PBPC infusion. Administered at 100 mg intravenous 1 hour prior to infusion
Trial: NCT00225732
Drug: Intravenous ibuprofen
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 800 mg intravenous ibuprofen diluted in 250 milliliters of normal saline was administered every 6 hours for a total of eight doses over the first 48 hours.~Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)
Trial: NCT01099462
Drug: Ibuprofen
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Ibuprofen (10mg/kg BW) will be given orally if the temperature on presentation is higher than 38.0OC according to the decision of the attending physician.
Trial: NCT01385293
Drug: BKM120
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BKM120 at the maximum tolerated dose (MTD) of 100mg orally daily
Trial: NCT02224560
Drug: GWP42003-P
RxNorm normalized name: P
FDA approved: no
EMA approved: no
PMDA approved: no
Description: GWP42003-P was presented as an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 10 or 20 mg/kg/day.
Trial: NCT02224560
Drug: Placebo control
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo was presented as an oral solution containing 0 mg/mL CBD in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
Trial: NCT02198378
Drug: MEOPA and paracetamol
RxNorm normalized name: codeine and paracetamol
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The patient will be equipped with a facemask after he/she has been informed. The facemask is adapted to the patient. The patient breathes normally in the mask which is held in place by a member of the SMUR team who has received previous training in use of MEOPA. The gas flow received by the patient is adapted to his/her ventilation.
Trial: NCT00131248
Drug: Metaclopramide
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00131248
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03859934
Drug: Melatonin
RxNorm normalized name: Melatonin
DrugBank: Melatonin (DB01065)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Melatonin treatment
Trial: NCT03859934
Drug: Placebo Oral Tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo treatment
Trial: NCT02346058
Drug: Esarin Gel
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01673737
Drug: SAR260301
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form: film-coated tablets Route of administration: oral
Trial: NCT03172910
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Saline for injection
Trial: NCT00357006
Drug: Estradiol
RxNorm normalized name: Estradiol
DrugBank: Estradiol acetate (DB13952)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 100 mcg adjunctive transdermal estradiol
Trial: NCT00357006
Drug: Estradiol
RxNorm normalized name: Estradiol
DrugBank: Estradiol acetate (DB13952)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 200 mcg adjunctive transdermal estradiol
Trial: NCT05633758
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first placebo dose is given within six hours of administration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose.
Trial: NCT01663103
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)
Trial: NCT01917630
Drug: ALV003
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)
Trial: NCT01917630
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01656408
Drug: MK-8150
RxNorm normalized name: vitamin MK 7
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01656408
Drug: Placebo for MK-8150
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00996333
Drug: Gemcitabine, Docetaxel, Capecitabine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles.
Trial: NCT01420952
Drug: [11C]LY2428703
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00533936
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00533936
Drug: doxorubicin hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00533936
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT04524351
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Solid oral dosage form, capsule
Trial: NCT03446846
Drug: MIN-117 5.0 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 5.0 mg MIN-117 administered as two MIN-117 2.5 mg capsules as a single dose once daily
Trial: NCT03446846
Drug: MIN-117 2.5 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2.5 mg MIN-117 administered as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily
Trial: NCT03446846
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo administered as two Placebo capsules as a single dose once daily
Trial: NCT04139798
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Saline solution (0.6% sodium chloride solution)
Trial: NCT00120302
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching vehicle cream
Trial: NCT01841463
Drug: P1446A-05
FDA approved: no
EMA approved: no
PMDA approved: no
Description: - In the 'Dose escalation' phase patients will be co-administered P1446A-05 (150, 250, 350 mg qd) \& vemurafenib (720, 960 mg bid) in a cohort of 3 to 6 patients on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity. The next higher dose during the dose escalation phase will depend upon demonstrated safety in the previous dose group. The max tolerated dose (MTD) of P1446A-05 \& vemurafenib co-administered will be determined. In the 'Extension' phase, 60 patients with BRAF V600E/K mutations (40 patients naïve to selective BRAF inhibitor therapy, \& 20 progressing on selective BRAF inhibitor therapy) will be treated at the MTD on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity to determine efficacy of the co-administration. Additionally, there will be a cohort of 10 patients who consent for mandatory serial tumor biopsy samples \& undergo 'Monotherapy' for 14 days with P1446A-05 at the MTD of the co-administration.
Trial: NCT01281514
Drug: pegylated liposomal doxorubicin hydrochloride
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT00005804
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00088088
Drug: STA 4783
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01004991
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 750 mg/m2 on Day 8 of each of 6 cycles
Trial: NCT01004991
Drug: doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 50 mg/m2 on Day 8 of each of 6 cycles
Trial: NCT03524508
Drug: 5-FU/LV
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The recommended dose and regimen of dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 2 weeks
Trial: NCT00567814
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Twice daily
Trial: NCT00389259
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV placebo q4h
Trial: NCT00165191
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01393574
Drug: Melatonin
RxNorm normalized name: Melatonin
DrugBank: Melatonin (DB01065)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 3 mg for body weight \<40kg, 6 mg for body weight \>40kg, once a day 30-60 minutes before sleep
Trial: NCT04177862
Drug: Sublingual Sufentanil
RxNorm normalized name: sufentanil Sublingual Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 30 mcg of sublingual sufentanil
Trial: NCT04177862
Drug: IV Fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 50 mcg of IV fentanyl
Trial: NCT00544297
Drug: PEP005 gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Two day application, 0.05%
Trial: NCT03121053
Drug: hypotone saline
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00002496
Drug: chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00002496
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02894684
Drug: Standard Care
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 14 days of IV Colistin plus one of Tazocin/Ceftazidime/Meropenem/Aztreonam/Fosfomycin
Trial: NCT00048074
Drug: ibandronate [Bonviva/Boniva]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2mg iv every 2 months
Trial: NCT00048074
Drug: ibandronate [Bonviva/Boniva]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2.5mg po daily
Trial: NCT00048074
Drug: ibandronate [Bonviva/Boniva]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3mg iv every 3 months
Trial: NCT03443973
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo matching to gantenerumab will be administered as per the schedule specified in the respective arm.
Trial: NCT01887535
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo will be administered as an oral suspension formulation.
Trial: NCT03450122
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT02778789
Drug: TNF-alpha Inhibitor
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will be treated with TNF-Inhibitors either i.v. or s.c. according to the label
Trial: NCT02773641
Drug: Sterile Saline Solution
RxNorm normalized name: Blairex Sterile Saline Solution
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02851472
Drug: Inhaled Nitric Oxide
RxNorm normalized name: nitric oxide Inhalant Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Nitric oxide gas will be added to the inhaled gas mixture that the patient was already receiving at baseline, using standard of care gas delivery systems adapted specifically for this study.
Trial: NCT02851472
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo gas (nitrogen) will be added to the inhaled gas mixture that the patient was already receiving at baseline, using standard of care gas delivery systems specifically adapted for this study.
Trial: NCT01521403
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3x1 tablet per day for 10 days
Trial: NCT03333278
Drug: Thiamine
RxNorm normalized name: Thiamine
DrugBank: Thiamine (DB00152)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Thiamine 200mg every 12 hours i.v. while in ICU, until shock resolution for a maximum of ten days
Trial: NCT03333278
Drug: Hydrocortisone,
RxNorm normalized name: Hydrocortisone, Rectal
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Hydrocortisone 50mg every 6 hours i.v while in ICU, until shock resolution or for a maximum of 7 days, then tapered or stopped.
Trial: NCT00713518
Drug: 3 mg PF-04523655
RxNorm normalized name: fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00713518
Drug: 1 mg PF-04523655
RxNorm normalized name: fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02287311
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.~3 daily doses of cyclophosphamide (Cy: 500 mg/m2/day) together with fludarabine (Flu: 30 mg/m2) to induce lymphopenia, finishing at least 24 hours before CTL infusion.
Trial: NCT00501917
Drug: G-CSF with/without darbepoetin, peripheral blood stem cell infusion
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02170077
Drug: BIA 2-093
RxNorm normalized name: Oatmeal 10 mg in 1 mL TOPICAL CREAM [BIA Eczema Relief]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route
Trial: NCT02170077
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo tablets administered orally
Trial: NCT03141827
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo, nasal spray, single dose
Trial: NCT00533676
Drug: MK0524A, /Duration of Treatment : 8 Weeks
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00533676
Drug: Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00131261
Drug: PXD101
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03241901
Drug: Artemether-Lumefantrine Tab 20-120mg
RxNorm normalized name: Artemether/lumefantrine
DrugBank: Lumefantrine co-artemether (DB13085)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Artemether-Lumefantrine Tablet 20-120mg
Trial: NCT01939418
Drug: RAD001
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Afinitor 5mg qd. po.
Trial: NCT00296621
Drug: L-Glutamine
RxNorm normalized name: L-Glutamine
DrugBank: L-Glutamine (DB00130)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: L-Glutamine
Trial: NCT00296621
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo
Trial: NCT00787644
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo (inert tablet)
Trial: NCT01930006
Drug: MGCD265
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01369888
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 60 mg/m\^2, intravenous (IV) (in the vein) x 2 days
Trial: NCT04606602
Drug: SLN360
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SLN360 for subcutaneous (s.c.) injection
Trial: NCT04606602
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sodium chloride for subcutaneous (s.c.) injection
Trial: NCT00361348
Drug: Heparin
RxNorm normalized name: Heparin
DrugBank: Heparin (DB01109)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01798056
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.
Trial: NCT04328844
Drug: IOA-244
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IOA-244 will be administered orally once daily (QD)
Trial: NCT04172441
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo for dasiglucagon
Trial: NCT00670748
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Trial: NCT03172988
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Normal saline 2 ml is administered before anesthesia induction.
Trial: NCT04489173
Drug: trifluridine/tipiracil
RxNorm normalized name: TRIFLURIDINE/TIPIRACIL
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Study medication should be started within 3 days after completion of screening and continue until a study treatment discontinuation criterion is met.~Trifluridine/tipiracil will be administered orally BID on days 1 through 5, with the first dose administered in the morning of day 1 of each cycle and the last dose administered in the evening of day 5, followed by a recovery period from day 6 through day 7. Trifluridine/tipiracil will be administered orally BID on days 8 through 12, with the first dose administered in the morning of day 8 of each cycle and the last dose administered in the evening of day 12, followed by a recovery period from day 13 through day 28. Each cycle will be 28 days.
Trial: NCT04773366
Drug: Prednisone+Cytarabine+vincristine+Mercaptopurine
RxNorm normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Group 1 Consolidation continuation treatment (W7\~W22) . Prednisone 40mg/m2 d1-5 q3w (w7,10,13,16,19,22); VCR 1.5/m2 iv d1 q3w (w7,10,13,16,19,22); Cytarabine 100mg/m2 iv/IH d1-4 q3w (w7,10,13,16,19,22); 6-MP 50mg/m2/d,po,qn
Trial: NCT02864290
Drug: ASP1235
FDA approved: no
EMA approved: no
PMDA approved: no
Description: intravenous (IV) infusion
Trial: NCT04773366
Drug: Prednisone+Cytarabine+vincristine+Mercaptopurine
RxNorm normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Group 1 Maintenance continuation treatment (W25\~52) . Prednisone 40mg/m2 d1-5 q3w; Vincristine 1.5/m2 iv d1 q3w; Cytarabine 100mg/m2 iv/IH d1-4 q6w ×3 times (w25,31,37); 6-MP 50mg/m2/d,po,qn
Trial: NCT04773366
Drug: Prednisone+vincristine+Mercaptopurine
RxNorm normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Group 2 continuation treatment (W7\~W52) . Prednisone 40mg/m2 d1-5 q3w; VCR 1.5/m2 iv d1 q3w; 6-MP 50mg/m2/d,po,qn
Trial: NCT04070157
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.
Trial: NCT03638648
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Capecitabine 2500mg/m2/day, d1-d14, every 3 weeks a cycle for 8 cycles
Trial: NCT02096406
Drug: ACE/ARB continuation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ACE/ARB will be taken the morning of surgery with a sip of water
Trial: NCT02096406
Drug: ACE/ARB withdrawal
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ACE/ARB will be stopped 48 hours prior to surgery
Trial: NCT00735436
Drug: Gliadel/Avastin/CPT-11
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01342211
Drug: Statin
RxNorm normalized name: Statin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
Trial: NCT01745458
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matched placebo