AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT01306032
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00003777
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01478594
Drug: mFOLFOX6
FDA approved: no
EMA approved: no
PMDA approved: no
Description: mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m\^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, leucovorin calcium 400 mg/m\^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, fluorouracil 400 mg/m\^2 administered as an intravenous bolus over 5 to 15 minutes on Days 1 and 15, then 2400 mg/m\^2 continuous intravenous infusion over 46 hours on Days 1 to 3 and 15 to 17.
Trial: NCT00813917
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 12 weeks of placebo (double blinded) by mouth twice per day
Trial: NCT04354441
Drug: Placebo oral tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo that is identical in appearance to the study medication will be taken twice a day for 10 days. It will be couriered to participants upon giving consent. They will start taking the medication immediately.
Trial: NCT00623285
Drug: Placebo/Lactose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching Placebo orally,60 minutes pre-operatively. Patients will receive the first dose post-operatively 12 hours after the initial dose was taken (+ 6 hours) given that patient is able to swallow and then they will receive placebo twice a day through the first 2 post-operative days for a total of six doses. If the patient is unable to swallow and NG tube is in place, the medication can be dissolved in water and administered through the NG tube.
Trial: NCT01328496
Drug: Preparative Regimen
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1.
Trial: NCT01691053
Drug: Spironolactone
RxNorm normalized name: Spironolactone
DrugBank: Spironolactone (DB00421)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 50mg once daily
Trial: NCT01691053
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT02641314
Drug: metronomic therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: * Propranolol 0.5 mg/kgxd p.o. day 1,~  1. mg/kgxd p.o. day 2,~ 2. mg/kgxd p.o. day 3-365 (maximum total daily dose: 120 mg) divided in 2 doses per day~* Celecoxib 400 mg/m2xd p.o.; day 1-365 (maximum total daily dose: 800 mg) divided in 2 doses per day~* Cyclophosphamide cycle 1, day1: loading dose: 500 mg/m2 intravenous 1-h-infusion, single dose day 2-365 25 mg/m2xd p.o (maximum total daily dose: 50 mg) as single daily dose~* Vinblastine 3 mg/m2xd i.v. (maximum total daily dose: 6 mg) administered day 1 and 15 (every two weeks) as single daily dose~* Etoposide 25 mg/m2xd p.o.; day 1-21 weeks 1-3, 9-11, 17-19, 25-27 (maximum total daily dose: 50 mg) as single daily dose
Trial: NCT01637818
Drug: Opiate
RxNorm normalized name: Squill opiate
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Postoperative pain therapy
Trial: NCT01637818
Drug: non-steroidal anti-inflammatory drug
RxNorm normalized name: Surpass Anti-Inflammatory
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Postoperative pain therapy
Trial: NCT02204033
Drug: 186 Re - labelled hMAb BIWA 4
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02204033
Drug: unlabelled hMAb BIWA 4 - medium dose
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04952051
Drug: Enalapril Folic Acid Tablets Combined With amlodipine
RxNorm normalized name: enalapril / felodipine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg
Trial: NCT03990090
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered SC
Trial: NCT00002707
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 600 mg/m2 IV every 21 days for 4 cycles
Trial: NCT00002707
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 60 mg/m2 IV every 21 days fo 4 cycles
Trial: NCT04328012
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: administered 14 days
Trial: NCT03673956
Drug: Tobramycin
RxNorm normalized name: Tobramycin
DrugBank: Tobramycin (DB00684)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
Trial: NCT02220361
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: received 20 ml intravenous physiological saline The infusion were completed in 30 minutes.
Trial: NCT02578472
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching Placebo will be administered orally.
Trial: NCT00650598
Drug: valdecoxib
RxNorm normalized name: Valdecoxib
DrugBank: Valdecoxib (DB00580)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: valdecoxib 40 mg (two 20-mg tablets) loading dose by mouth on Day 1 followed by 20 mg twice daily (BID) on Days 2-6
Trial: NCT00650598
Drug: diclofenac
RxNorm normalized name: Diclofenac
DrugBank: Diclofenac (DB00586)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days
Trial: NCT00395213
Drug: Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medications
RxNorm normalized name: serotonin
DrugBank: Serotonin (DB08839)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment with SSRIs or SNRIs
Trial: NCT03854851
Drug: Naldebain
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In Naldebain group, patients will be injected with Naldebain (150 mg/2 ml, IM injection) between 12 and 24 hours prior to surgery.
Trial: NCT03854851
Drug: Morpine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In Morphine group, patients will receive morphine as needed after surgery.
Trial: NCT02593968
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02147509
Drug: 0.02% Fm, SH
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sjogren's Syndrome patients with severe dry eye
Trial: NCT02147509
Drug: 0.02% Fm, SH, 0.05% CsA
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sjogren's Syndrome patients with severe dry eye
Trial: NCT02147509
Drug: 0.02% Fm, SH, AS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sjogren's Syndrome patients with severe dry eye
Trial: NCT01488409
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0 mg by mouth (PO) three times daily
Trial: NCT00705159
Drug: loteprednol etabonate and tobramycin
RxNorm normalized name: Loteprednol Etabonate and Tobramycin Ophthalmic Suspension
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.
Trial: NCT03028285
Drug: arginine sodium succinate
RxNorm normalized name: Arginine
DrugBank: Arginine (DB00125)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Healthy volunteers will receive the experimental drug (arginine sodium succinate 1.4% solution; Unifusol) intravenously at 3 different combinations of dose and infusion rate under the close monitoring of vital signs and other safety parameters.
Trial: NCT00705159
Drug: Tobramycin
RxNorm normalized name: Tobramycin
DrugBank: Tobramycin (DB00684)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Topical ocular administration of Tobramycin QID for 14 days.
Trial: NCT00859807
Drug: Flavoquine®, Camoquin® Suspension
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment A 15.3 mL (50 mg/5 mL) AQ suspension single dose. Treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis) single dose.
Trial: NCT00993304
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In the first 3-week period, the treatment will be with placebo. Subsequently, a wash-out period of 3 to 9 weeks occurs and then a second period of one week with 0.6 mg, one week with 1.2 mg and one week with 1.8 mg of liraglutide. At the end of each of the 2 treatment periods, a high fat meal test will be performed.
Trial: NCT01192204
Drug: 10% FBR containing bioadhesive gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months
Trial: NCT01313884
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Starting dose 75 mg/m2 to a maximum of 450mg/m2
Trial: NCT03044652
Drug: Estriol Cream 0.1%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.5 g of the reference product Estriol Cream 0.1% will be applied intravaginally once daily in the evening for the first 3 weeks. Subsequently, the frequency will be reduced to twice a week for the last 3 weeks for all patients in this treatment group.
Trial: NCT01542255
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest
Trial: NCT02077803
Drug: CANA/MET XR FDC, Formulation 2, 50 mg/1000 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Each tablet contains 50 mg of canagliflozin and 1000 mg of metformin HCl granulate, formulation 2, to be taken orally.
Trial: NCT01180764
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo matching active lovaza, 1 g capsules, 4 capsules po daily
Trial: NCT03228498
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo b.i.d plus Nimodipine 30 mg t.i.d
Trial: NCT01928082
Drug: Transdermal estradiol
RxNorm normalized name: estradiol Transdermal System
DrugBank: Estradiol (DB00783)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day
Trial: NCT03511820
Drug: Lipo-AB® (amphotericin B) liposome
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1. Name: Lipo-AB® (amphotericin B) liposome for injection~2. Dosage form: Lyophilized powder 50 mg/vial~3. Dose: Based on approved package insert and physician's discretion Recommended initial dose: 3 mg/kg/day~4. Dosing schedule:~All patients will receive Lipo-AB® based on the approved package insert and physician's clinical decision.
Trial: NCT00546234
Drug: long acting beta agonist
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Turbohaler, 6 \& 12 mcg
Trial: NCT00744848
Drug: SKY0402
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single administration 300 mg SKY0402 in a 40-mL injection volume
Trial: NCT03148756
Drug: Standard of Care
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Trial: NCT04101578
Drug: Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment regimens are determined according to the physician's judgment and preferences of the patients.
Trial: NCT05567393
Drug: TAK-951 Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TAK-951 placebo-matching SC injection
Trial: NCT03734562
Drug: Antiarrhythmic drug
RxNorm normalized name: ANTIARRHYTHMICS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Amiodarone or sotalol therapy
Trial: NCT00314080
Drug: Botulinum AntiToxin
RxNorm normalized name: Botulinum antitoxin
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01690104
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01270958
Drug: Avamys aqueous nasal spray 110mcg
RxNorm normalized name: ethylcellulose aqueous dispersion type A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: At the visit 1, subjects who fulfill the inclusion criteria are eligible to be included in the group to self-administer intranasal treatment of fluticasone furoate aqueous nasal spray 110 mcg once daily for 6 week. The subjects are instructed to administer two sprays from the device into each nostril once daily every morning. Administration of the dose will be performed by alternately spraying one spray to each nostril followed by a second spray to each nostril. Subjects will not be permitted to take any anti-allergy or rhinitis medication during the screening or treatment period.~Throughout the study, subjects will document their study drug administration/compliance, any medical conditions experienced, and any concomitant medications taken.
Trial: NCT01256203
Drug: Solar Protection Formula SPF® 60
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Solar Protection Formula SPF® 60 (2 mg/cm²) will be topically applied on a randomly predetermined specific skin area on the back of each subject on four separate occasions over 3 months. The same skin area will never be exposed more than once to the sunscreen.
Trial: NCT01619163
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01619163
Drug: Prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: low dose, 7.5 mg/day
Trial: NCT02322099
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sugar pill manufactured to mimic alendronate 70 mg tablet administered weekly for a total of 14 weeks, commencing 2 weeks prior to ART
Trial: NCT01601470
Drug: LCZ696
FDA approved: no
EMA approved: no
PMDA approved: no
Description: LCZ696 400mg QD was administered alone for 4 days and in combination with sildenafil for 1 day
Trial: NCT04129086
Drug: Usual Care
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.
Trial: NCT03513250
Drug: hyoscine-n-butylbromide
FDA approved: no
EMA approved: no
PMDA approved: no
Description: one ampoule of 20 mg of hyoscine-n-butylbromide (Buscopan, 20mg/Ampoule, CID/Boehringer ) will be administered intravenously immediately before the end of the cesarean section.
Trial: NCT03513250
Drug: control group
RxNorm normalized name: meningococcal group B vaccine Prefilled Syringe [Trumenba]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: an equal volume(1 ml ) of normal saline will be administered before the end of cesarean section.
Trial: NCT01160861
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Repeating ascending dose
Trial: NCT02223429
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Trial: NCT02726126
Drug: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy
RxNorm normalized name: lidocaine
DrugBank: Lidocaine (DB00281)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02420795
Drug: Akt/ERK Inhibitor ONC201
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT00587444
Drug: Heparin
RxNorm normalized name: Heparin
DrugBank: Heparin (DB01109)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 300u/kg of heparin for CPB ACT performed. If ACT is \< 480 seconds a bolus of 5000u heparin will be given. ACT will be repeated and bolus given until ACT is\>480 seconds
Trial: NCT00003691
Drug: doxorubicin hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01293006
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: one tablet matching suvorexant, orally, once daily, for 4 consecutive days
Trial: NCT03201848
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo given to subject will be adjusted by body weight (\<10kg, Placebo given to subject will be adjusted by body weight(\<10kg, half a bag, 2 times a day; 10-20kg; 1 bag, 2 times a day; 20-30kg, 1.5 bag, 2 times a day; 30-50kg, 2 bags, 2 times a day; ≥50kg, 3 bags, 2 times a day;) .
Trial: NCT03201848
Drug: Huaiqihuang Granule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Huaiqihuang Granule given to subject will be adjusted by body weight (\<10kg, half a bag, 2 times a day; 10-20kg; 1 bag, 2 times a day; 20-30kg, 1.5 bag, 2 times a day; 30-50kg, 2 bags, 2 times a day; ≥50kg, 3 bags, 2 times a day)
Trial: NCT02759562
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered via subcutaneous injection
Trial: NCT01945268
Drug: inactivated trivalent influenza vaccine
RxNorm normalized name: diphtheria toxoid vaccine, inactivated
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.5 ml dose injected intramuscularly
Trial: NCT03948451
Drug: [14C]AZD5718 Oral Suspension
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 200 mg dose of \[14C\]AZD5718 Oral Suspension
Trial: NCT03101527
Drug: Omega-3 PUFA supplementation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects received 2.2g of eicosapentaenoic acid (EPA) and 1.2g docosahexaenoic daily for the duration of the study
Trial: NCT03029676
Drug: opioid
RxNorm normalized name: OPIOIDS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: analgetic, sedative
Trial: NCT00550277
Drug: LBH589
FDA approved: no
EMA approved: no
PMDA approved: no
Description: LBHLBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring (Section 3.5.2), all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles.
Trial: NCT02293824
Drug: Caffeine
RxNorm normalized name: Caffeine
DrugBank: Caffeine (DB00201)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given per standard of care.
Trial: NCT00703170
Drug: Pegylated liposomal doxorubicin
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04503850
Drug: Alpha Blockers
RxNorm normalized name: ALPHA BLOCKERS/RELATED
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Alpha blocker daily and evaluation of erectile function using international index of erectile function 5 scoring system
Trial: NCT01925391
Drug: Tono-pen XL Applanation tonometer + Ocu-film +
RxNorm normalized name: dexamethasone phosphate Ophthalmic Solution [Ocu-Dex]
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01362699
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Form=tablet, route=oral administration. One tablet once daily for 7 days.
Trial: NCT01765946
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03954990
Drug: Placebo Oral Tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 4 tablets
Trial: NCT03954379
Drug: Standard of Care (ACB, SA, peri-op pain management)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: INTERVENTION BEFORE SURGERY~Adductor Canal Block will be done using Adductor canal catheter (tube in the thigh) + injection of freezing medication~INTERVENTION DURING SURGERY~IV propofol for sedation~INTERVENTION AFTER SURGERY~Injection of salty water through the tube in the thigh x 2
Trial: NCT03954379
Drug: IPACK and multi-modal analgesic regimen
RxNorm normalized name: Anacin Aspirin Regimen
FDA approved: no
EMA approved: no
PMDA approved: no
Description: INTERVENTION BEFORE SURGERY~1. Adductor Canal Block will be done using Adductor canal catheter (tube in the thigh) + injection of freezing medication~2. iPACK block ( infiltration between Popliteal Artery and posterior Capsule of the Knee) - injection of freezing medication in the back of the knee~INTERVENTION DURING SURGERY~1. IV dexmedetomidine~2. IV ketamine Both for sedation~INTERVENTION AFTER SURGERY~1. injection of freezing medication through the tube in the thigh x 2~2. IV dexamethasone 8 mg 1 day after surgery
Trial: NCT00000361
Drug: Corticosteroids
RxNorm normalized name: CORTICOSTEROIDS
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00000361
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00294684
Drug: Corticosteroids
RxNorm normalized name: CORTICOSTEROIDS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop