TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02141854
Drug: FS MDPI
Normalized name: Derma-Smoothe FS
Approvals — FDA: no, EMA: no, PMDA: no
Description: FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate and salmeterol xinafoate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.~During the treatment period, participants were randomized to either fluticasone propionate/salmeterol MDPI 200/12.5 mcg or fluticasone propionate/salmeterol MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 mcg.~Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.
Study: NCT02141854
Drug: Placebo MDPI
Approvals — FDA: no, EMA: no, PMDA: no
Description: The placebo multidose dry powder inhaler (MDPI) was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart). Patients were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.
Study: NCT04737551
Drug: Adjuvant chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Chemotherapy regimens will be decided by physicians or MDT teams, basing on patients' physical status, income status, and/or desire. Toxicity was evaluated every cycle and efficacy was evaluated every two cycles. The treatment course of adjuvant chemotherapy was followed the recommendation of NCCN guideline.
Study: NCT00111046
Drug: Ibuprofen
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00006185
Drug: Avandia administration for 6-12 weeks
Normalized name: lavandin oil
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01091649
Drug: ABT-450
Normalized name: ABT-925
Approvals — FDA: no, EMA: no, PMDA: no
Description: Low dose ABT-450 / ritonavir see Arm Description for more information
Study: NCT01091649
Drug: ABT-450
Normalized name: ABT-925
Approvals — FDA: no, EMA: no, PMDA: no
Description: High dose ABT-450 / ritonavir See Arm Description for more information
Study: NCT00518739
Drug: MK2461
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will be administered oral MK2461 twice daily and will be treated for 28 day cycles. Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of MK2461. 60 mg dry filled capsules, escalating to 240 mg ( for dosing in Cohort 4 \& beyond).
Study: NCT02363322
Drug: B/Current Standard of Care Plus ZMapp
Approvals — FDA: no, EMA: no, PMDA: no
Description: Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus
Study: NCT00667628
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants received placebo (two matching tablets) at same frequency and duration of active treatment.
Study: NCT03756285
Drug: AZD4831
Approvals — FDA: no, EMA: no, PMDA: no
Description: AZD4831 tablet taken orally for 90 days.
Study: NCT03756285
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablet taken orally for 90 days.
Study: NCT03395704
Drug: LJPC-401
Approvals — FDA: no, EMA: no, PMDA: no
Description: LJPC-401 subcutaneous injection, up to 20 mg weekly for 16 weeks. The minimum weekly dose will be 5 mg and the maximum weekly dose of LJPC-401 will be 20 mg.
Study: NCT03395704
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.9% Sodium Chloride Injection, USP, or equivalent
Study: NCT03996993
Drug: Casodex, Axumin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive hormone therapy if Axumin positive area appears.
Study: NCT00430924
Drug: Eplerenone
Normalized name: Eplerenone
DrugBank: Eplerenone (DB00700)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Once daily administration for 8 weeks and 8 weeks control.
Study: NCT04547127
Drug: Standard Medical Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: SMT
Study: NCT00983944
Drug: EPOCH regimen
Normalized name: Anacin Aspirin Regimen Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given IV or orally
Study: NCT00983944
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV or orally
Study: NCT00983944
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV or orally
Study: NCT03452540
Drug: 1000mg DS102 (BID)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
Study: NCT02056743
Drug: CYP cocktail
Normalized name: estradiol cypionate / testosterone cypionate Injectable Solution [Duo-Cyp]
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions.
Study: NCT01380353
Drug: Diclofenac epolamine patch
Normalized name: Diclofenac Epolamine Patch
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patch (10cm X 14cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner \[B\].
Study: NCT01448317
Drug: Placebo (Solution)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pharmaceutical form: solution~Route of administration: subcutaneous
Study: NCT00330577
Drug: placebo (artificial tears)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00075634
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT00075634
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT01813630
Drug: Genotropin®
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04509635
Drug: Chemotherapy
Normalized name: Chemotherapy Glove SML
Approvals — FDA: no, EMA: no, PMDA: no
Description: The detailed regimen is determined by a multi-disciplinary team according to the previous use of chemotherapy.
Study: NCT01153386
Drug: Treprostinil diethanolamine
Normalized name: treprostinil 1 MG (as treprostinil diethanolamine) 12 HR Extended Release Oral Tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: Treprostinil diethanolamine sustained release oral tablets.
Study: NCT01906814
Drug: 3 cycles chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Chemotherapy: vincristine 0.05 mg/kg (or 1.5 mg/m2 for children ≥ 3 years of age) on Day 1, carboplatin 18.6 mg/kg (or 560 mg/m2 for children ≥ 3 years of age) on Day 1, etoposide 5.0 mg/kg/day (or 150 mg/ m2 for children ≥ 3 years of age) on Days 1 and 2 and 2. Cycles were repeated every 21 days for three cycles.
Study: NCT01906814
Drug: 6 cycles chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Chemotherapy: vincristine 0.05 mg/kg (or 1.5 mg/m2 for children ≥ 3 years of age) on Day 1, carboplatin 18.6 mg/kg (or 560 mg/m2 for children ≥ 3 years of age) on Day 1, etoposide 5.0 mg/kg/day (or 150 mg/ m2 for children ≥ 3 years of age) on Days 1 and 2 and 2. Cycles were repeated every 21 days for six cycles.
Study: NCT01839331
Drug: 4 mL Injection of Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 4 mL Injection of Placebo
Study: NCT01839331
Drug: 10 mL Injection of Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10 mL Injection of Placebo
Study: NCT04215172
Drug: Macrolides
Normalized name: Macrolides
Approvals — FDA: no, EMA: no, PMDA: no
Description: administration of azithromycin three times weekly for six months
Study: NCT01228669
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.
Study: NCT00443794
Drug: Thiazides
Normalized name: Thiazides, plain
Approvals — FDA: no, EMA: no, PMDA: no
Description: Capsule (blinded) oral administration once daily for 12 weeks
Study: NCT00443794
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Capsule (Blinded) for oral administration once daily for 12 weeks
Study: NCT00772980
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.
Study: NCT04177706
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants receiving the placebo study medication will receive saline twice per week for four weeks under clinical supervision.
Study: NCT00103935
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg
Study: NCT00103935
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg
Study: NCT00025090
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00366444
Drug: diclofenac potassium (XP21L)
Normalized name: Diclofenac Potassium
DrugBank: Diclofenac (DB00586)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 25 mg every 6 hours
Study: NCT00366444
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo every 6 hours
Study: NCT00025610
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00025610
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00574834
Drug: HCTZ-hydrochlorothiazide
Normalized name: Hydrochlorothiazide
DrugBank: Hydrochlorothiazide (DB00999)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: HCTZ 25 mg once daily for 6 months
Study: NCT00220740
Drug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2 g/kg body weight ideally over 2-4 days . Thereafter, study drug infusion (IGIV-C) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
Study: NCT00713609
Drug: Clindamycin gel
Normalized name: clindamycin Topical Gel
DrugBank: Clindamycin (DB01190)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 1% clindamycin phosphate applied topically once a day
Study: NCT00713609
Drug: Vehicle gel
Normalized name: vehicle gel base no.61
Approvals — FDA: no, EMA: no, PMDA: no
Description: Vehicle gel is an identical gel without the active ingredients
Study: NCT00713609
Drug: Vehicle cream
Normalized name: vehicle cream base no.160
Approvals — FDA: no, EMA: no, PMDA: no
Description: Vehicle cream is an identical cream without the active ingredients
Study: NCT01009060
Drug: GSK239512
Approvals — FDA: no, EMA: no, PMDA: no
Description: Histamine H3 Antagonist
Study: NCT01009060
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo to match GSK239512
Study: NCT00060528
Drug: Recombinant Fowlpox-GM-CSF
Normalized name: recombinant human GM-CSF
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00060528
Drug: Recombinant Human GM-CSF
Normalized name: recombinant human GM-CSF
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00220740
Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Albumin 25%, USP diluted with dextrose 5% to a final concentration of 0.1% as an intravenous infusion. Alternatively, it may be a bottled placebo of 0.1% Albumin (Human) in 0.2 M Glycine, 1.1 mm sodium caprylate, 0.25% sodium chloride. 2 g/kg body weight ideally over 2-4 days . Thereafter, infusion (placebo) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
Study: NCT00692042
Drug: AZD1704
Approvals — FDA: no, EMA: no, PMDA: no
Description: One dose, by mouth
Study: NCT03539406
Drug: Chemotherapy
Normalized name: Chemotherapy Glove SML
Approvals — FDA: no, EMA: no, PMDA: no
Description: Cyclofosfamide/fludarabine treatment
Study: NCT03259607
Drug: Nicorette Extra Mint 2 mg Gum
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
Study: NCT03259607
Drug: Nicorette Mint 2 mg Gum
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
Study: NCT00134199
Drug: CP-945,598
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02005549
Drug: capecitabine [Xeloda]
Approvals — FDA: no, EMA: no, PMDA: no
Description: 950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks
Study: NCT03272009
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo capsules for oral administration, identical in appearance to the EYP001a capsules
Study: NCT02546609
Drug: Leu-Met-Sil 0.5
Approvals — FDA: no, EMA: no, PMDA: no
Description: NS-0200 low dose
Study: NCT02546609
Drug: Leu-Met-Sil 1.0
Approvals — FDA: no, EMA: no, PMDA: no
Description: NS-200 high dose
Study: NCT04110054
Drug: Placebo to S-600918
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablets for oral administration
Study: NCT04363866
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: A placebo is a pill that looks like the study drug but has no real medicine in it.
Study: NCT00264628
Drug: GW679769
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02198313
Drug: BIIX 1 XX - D1
Normalized name: PHOSPHOLIPASE D1
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02198313
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01216644
Drug: Leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 200 mg/m², d1, i.v., every 2 weeks
Study: NCT00963469
Drug: Comparator: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo tablet orally once daily in the morning for 4 weeks
Study: NCT02546609
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT01719627
Drug: TVD 300/200 QD
Approvals — FDA: no, EMA: no, PMDA: no
Description: TVD 300/200 QD during 7 days
Study: NCT03080324
Drug: Fentanyl ev
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Fentanyl ev
Study: NCT03080324
Drug: Placebo sublingual
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo sublingual
Study: NCT03080324
Drug: Placebo ev
Approvals — FDA: no, EMA: no, PMDA: no
Description: Saline
Study: NCT02101281
Drug: rhNGF 20 µg/mL
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 drop for each eye, twice daily for 28 day
Study: NCT02101281
Drug: rhNGF 4 µg/mL
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 drop each eye, twice daily for 28 day
Study: NCT03450434
Drug: XC8 Oral Tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 tablet of XC8 in a dose according to the treatment group + 2 tablets of placebo (in total 3 tablets) once daily in the morning during 12 weeks of treatment period.
Study: NCT03450434
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo (in total 3 tablets) once daily in the morning during 12 weeks of treatment period.
Study: NCT03160638
Drug: Azithromycin 250 mg
Normalized name: azithromycin 250 MG
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Patients will be treated with azithromycin 250 mg once daily for 28 days. An azithromycin loading dose of 500 mg (two tablets of 250 mg) will be administered on day 1
Study: NCT00799552
Drug: RX-10045
Normalized name: BARRIER,SENSURA COLOPLAST #10045
Approvals — FDA: no, EMA: no, PMDA: no
Description: RX-10045 eye drop
Study: NCT00799552
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo eye drop
Study: NCT00002755
Drug: CMF regimen
Normalized name: Anacin Aspirin Regimen Pill
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00002755
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00002755
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00002755
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00002755
Drug: methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00448669
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04287985
Drug: Dose-Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Unit Dose Strength - 0.9%.
Study: NCT01571804
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: to receive two identical placebo capsules 1 hr before surgery
Study: NCT03762772
Drug: TAF/EVG Vaginal Insert
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 combination vaginal insert (20mg TAF/16mg EVG)
Study: NCT02638337
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet identical to the ospemifene tablet without drug
Study: NCT02988089
Drug: Clarithromycin susceptibility dependant strategy
Normalized name: Clarithromycin
DrugBank: Clarithromycin (DB01211)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. Antimicrobial susceptibility testing (AST) will be used to test the susceptibility of clarithromycin.~If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.
Study: NCT02988089
Drug: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline )
Normalized name: bismuth subcitrate, tetracycline and metronidazole
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients in this group will receive a a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, Colloidal Bismuth Pectin and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
Study: NCT02988089
Drug: amoxicillin and clarithromycin or amoxicillin and furazolidone
Normalized name: omeprazole, amoxicillin and rifabutin
Approvals — FDA: no, EMA: no, PMDA: no
Description: patients in the 6 antibiotics dependant group will use these intervention.
Study: NCT02293265
Drug: Short Acting Beta Agonist (SABA)
Normalized name: Short-acting sulfonamides
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants requiring a spirometry measurement will be administered a SABA in a metered dose inhaler (MDI) during the reversibility assessments
Study: NCT02008981
Drug: Siwu Tang
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: TCM formulation Siwu Tang consisting of 4 herbs ( Ligustici chuangxiong, Angelicae sinensis, Rehmanniae praeparata and Paeoniae alba) in tablet form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after.
Study: NCT05673746
Drug: treatment of physician choice, according to the standard of care
Approvals — FDA: no, EMA: no, PMDA: no
Description: treatment of physician choice, according to the standard of care for the treatment of chemotherapy-induced peripheral neuropathy, including neuropathic pain
Study: NCT00920972
Drug: Treatment Plan 1: Stratum 1
Approvals — FDA: no, EMA: no, PMDA: no
Description: Day -50 to -21: Hydroxyurea 30mg/kg PO q day Day -22: Campath-1H 3 mg IV or SQ... Day -21: Campath-1H 10 mg IV or SQ... Day -20: Campath-1H 15 mg IV or SQ... Day -19: Campath-1H 20 mg IV or SQ... Day -8: Fludarabine 30mg/m2 IV... Day -7: Fludarabine 30mg/m2 IV... Day -6: Fludarabine 30mg/m2 IV... Day -5: Fludarabine 30mg/m2 IV... Day -4: Fludarabine 30mg/m2 IV... Day -3: Melphalan 140 mg/m2 IV... (dose modifications for patients \<10 kgs) Procedure/Surgery: Hematopoietic stem cell infusion on Day 0...
Study: NCT00920972
Drug: Treatment Plan 2: Strata 2, 3, or 4
Approvals — FDA: no, EMA: no, PMDA: no
Description: Day -50 to -21: Hydroxyurea 30mg/kg PO q day... Day -22: Campath-1H 3 mg IV or SQ... Day -21: Campath-1H 10 mg IV or SQ... Day -20: Campath-1H 15 mg IV or SQ... Day -19: Campath-1H 20 mg IV or SQ... Day -8: Fludarabine 30mg/m2 IV... Day -7: Fludarabine 30mg/m2 IV... Day -6: Fludarabine 30mg/m2 IV... Day -5: Fludarabine 30mg/m2 IV... Day -4: Fludarabine 30mg/m2 IV... Day -4: Thiotepa 8mg/kg IV... Day -3: Melphalan 140 mg/m2 IV... (dose modifications for patients \<10 kgs) Procedure/Surgery: Hematopoietic stem cell infusion on day 0...
Study: NCT00920972
Drug: GVHD Regimen A: UCB Recipients
Approvals — FDA: no, EMA: no, PMDA: no
Description: Day -3: Begin Tacrolimus or cyclosporine Begin MMF Day -1: Abatacept 10mg/kg IV Day +5: Abatacept 10mg/kg IV Day +14: Abatacept 10mg/kg IV Day +28: Abatacept 10mg/kg IV Day +60: Abatacept 10mg/kg IV Day +100: Abatacept 10mg/kg IV
Study: NCT00920972
Drug: GVHD Regimen B: BM Recipients
Approvals — FDA: no, EMA: no, PMDA: no
Description: Day -3: Begin Tacrolimus or cyclosporine Begin MMF Day -1: Abatacept 10mg/kg IV Day +1: Methotrexate 7.5mg/m2 IV Day +3: Methotrexate 7.5mg/m2 IV Day +5: Abatacept 10mg/kg IV Day +6: Methotrexate 7.5mg/m2 IV Day +14: Abatacept 10mg/kg IV Day +28: Abatacept 10mg/kg IV Day +60: Abatacept 10mg/kg IV Day +100: Abatacept 10mg/kg IV Day +180: Abatacept 10mg/kg IV Day +270: Abatacept 10mg/kg IV Day +365: Abatacept 10mg/kg IV
Study: NCT00468273
Drug: Immune Globulin Intravenous (Human) Omr-IgG-am IGIV
Normalized name: GLOBULIN,IMMUNE (IV)
Approvals — FDA: no, EMA: no, PMDA: no
Description: IGIV infusions of 300-900 mg/kg every 3 or 4 weeks
Study: NCT01154387
Drug: Steroids
Normalized name: CORTICOSTEROIDS
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV methylprednisolone prior to first 3 doses of study drug; oral prednisone tapered to 5-10 mg over 6 months
Study: NCT01340066
Drug: UISH001
Approvals — FDA: no, EMA: no, PMDA: no
Description: sublingual dosing, 1 drop 3 times a day
Study: NCT01340066
Drug: matching placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: sublingual dosing,1 drop 3 times a day
Study: NCT04187898
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 600 mg/m\^2 IV infusion.~Administered on Day 1 of each cycle.
Study: NCT04481412
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 96% ethanol that will be applied once daily.