AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT03423121
Drug: Tauroursodeoxycholic Acid
RxNorm normalized name: tauroursodeoxycholic acid
DrugBank: Tauroursodeoxycholic acid (DB08834)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
Trial: NCT04102007
Drug: Risankizumab
RxNorm normalized name: RISANKIZUMAB
DrugBank: Risankizumab (DB14762)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
Trial: NCT00352300
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT00352300
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given IV
Trial: NCT00692003
Drug: Zonisamide
RxNorm normalized name: Zonisamide
DrugBank: Zonisamide (DB00909)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) \<12 years old: 1 mg/kg; \>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)
Trial: NCT03289143
Drug: Semorinemab
RxNorm normalized name: Semorinemab
DrugBank: Semorinemab (DB15234)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive Semorinemab intravenously (IV).
Trial: NCT00203385
Drug: Divalproex
RxNorm normalized name: DIVALPROEX
DrugBank: Valproic acid (DB00313)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Depakote up to 2000mg/d
Trial: NCT00305877
Drug: gemcitabine hydrochloride
RxNorm normalized name: Gemcitabine Hydrochloride
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT00098800
Drug: fenretinide
RxNorm normalized name: FENRETINIDE
DrugBank: Fenretinide (DB05076)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04554303
Drug: S-amlodipine 2.5mg
DrugBank: Amlodipine (DB00381)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral administration, 1 tablet per day
Trial: NCT04554303
Drug: Amlodipine 5mg
RxNorm normalized name: LEVAMLODIPINE 5MG TAB
DrugBank: Amlodipine (DB00381)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral administration, 1 tablet per day
Trial: NCT00041340
Drug: imatinib mesylate
RxNorm normalized name: Imatinib Mesylate
DrugBank: Imatinib (DB00619)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Given orally
Trial: NCT04435743
Drug: Lenalidomide
RxNorm normalized name: Lenalidomide
DrugBank: Lenalidomide (DB00480)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Lenalidomide is given as any following dosage:~1. 25mg, PO QD, Day 1-10 in every 21 days for 6 cycles;~2. 15mg, PO QD, Day 1-14 in every 21 days for 6 cycles;~3. 25mg, PO QD, Day 1-10 in every 21 days for 1 year;~4. 25mg, PO QD, Day 1-21 in every 28 days for 1 year;~5. 25mg, PO QD, Day 1-10 in every 28 days for 12 cycles;~6. 20mg, PO QD, Day 1-21 in every 28 days for 12 cycles.
Trial: NCT00659282
Drug: biphasic insulin aspart
RxNorm normalized name: Insulin Aspart
DrugBank: Insulin aspart (DB01306)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.
Trial: NCT00030147
Drug: Raloxifene
RxNorm normalized name: Raloxifene
DrugBank: Raloxifene (DB00481)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 60 mg a day orally administered
Trial: NCT00030147
Drug: Rimostil
RxNorm normalized name: Linostil
DrugBank: Dimetacrine (DB08996)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1000 mg twice a day administered orally
Trial: NCT02248896
Drug: Telmisartan
RxNorm normalized name: Telmisartan
DrugBank: Telmisartan (DB00966)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01056614
Drug: fludarabine phosphate
RxNorm normalized name: Fludarabine Phosphate
DrugBank: Fludarabine (DB01073)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT01056614
Drug: busulfan
RxNorm normalized name: Busulfan
DrugBank: Busulfan (DB01008)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT01056614
Drug: tacrolimus
RxNorm normalized name: Tacrolimus
DrugBank: Tacrolimus (DB00864)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV and orally
Trial: NCT00387088
Drug: Tiotropium
RxNorm normalized name: Tiotropium
DrugBank: Tiotropium (DB01409)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02280993
Drug: DHAP
RxNorm normalized name: DHAP
DrugBank: Dihydroxyacetone phosphate (DB04326)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DHAP
Trial: NCT02280993
Drug: Brentuximab Vedotin
RxNorm normalized name: Brentuximab Vedotin
DrugBank: Brentuximab vedotin (DB08870)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Brentuximab Vedotin
Trial: NCT03775993
Drug: Human growth hormone
RxNorm normalized name: Human growth hormone
DrugBank: Somatotropin (DB00052)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administration of growth hormone
Trial: NCT00800735
Drug: Pegylated-interferon alfa-2a
RxNorm normalized name: Pegylated-interferon alfa 2a
DrugBank: Peginterferon alfa-2a (DB00008)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Pegylated-interferon alfa-2a was administered subcutaneously once weekly.
Trial: NCT00800735
Drug: Ribavirin
RxNorm normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Participants received ribavirin with food, as the bioavailability of ribavirin is increased when taken with food. Ribavirin was administered as split doses, that is, 2 doses were given 12 hours apart, 1 in the morning and 1 in the evening. Participants received either 1000 or 1200 mg ribavirin per day according to body weight: 400 mg (2 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing \< 75 kg or 600 mg (3 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing ≥ 75 kg.
Trial: NCT02805790
Drug: Elamipretide
RxNorm normalized name: Elamipretide
DrugBank: Elamipretide (DB11981)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 4 weeks of treatment with 40 mg elamipretide administered once daily subcutaneously
Trial: NCT03392181
Drug: 18F-DCFPyL
RxNorm normalized name: 18F-DCFPyL
DrugBank: Piflufolastat F 18 (DB14805)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: To determine whether PET/MR utilizing PYL improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.
Trial: NCT02318017
Drug: Methylphenidate
RxNorm normalized name: Methylphenidate
DrugBank: Methylphenidate (DB00422)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Before neurocognitive testing, Methylphenidate/Placebo will be given
Trial: NCT02953184
Drug: Taxotere
RxNorm normalized name: Taxotere
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 100mg/m2 IV drop during the last 4 cycles every three week
Trial: NCT02953184
Drug: Dexrazoxane (DZR)
RxNorm normalized name: Dexrazoxane
DrugBank: Dexrazoxane (DB00380)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: DZR will be administrated for protecting Cardiac toxicity in the group of Active comparator.
Trial: NCT02953184
Drug: vitamin B
RxNorm normalized name: VITAMIN B
DrugBank: Cyanocobalamin (DB00115)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Vitamin B will be administrated for protecting HFS in PLD group
Trial: NCT01176760
Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor
RxNorm normalized name: Fibrinolysis inhibitor
DrugBank: Aprotinin (DB06692)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3
Trial: NCT00281970
Drug: cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00054587
Drug: docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: on day D1 of each cycle : dose: 75 mg/m², route: i.v. injection over 1 hour, every 3 weeks
Trial: NCT00054587
Drug: Epirubicin
RxNorm normalized name: Epirubicin
DrugBank: Epirubicin (DB00445)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 100 mg/m², D1 and every 3 weeks
Trial: NCT00281970
Drug: docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT05157087
Drug: Omalizumab
RxNorm normalized name: Omalizumab
DrugBank: Omalizumab (DB00043)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab prescription. Responders were defined as individuals with at least 4 administrations of omalizumab.
Trial: NCT04179110
Drug: Pembrolizumab and Ramucirumab
RxNorm normalized name: Ramucirumab
DrugBank: Ramucirumab (DB05578)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Patients will receive Pembrolizumab 200 mg \& Ramucirumab 10 mg/kg every 3 weeks.
Trial: NCT01244711
Drug: quetiapine
RxNorm normalized name: Quetiapine
DrugBank: Quetiapine (DB01224)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.
Trial: NCT01130181
Drug: Cholecalciferol
RxNorm normalized name: Cholecalciferol
DrugBank: Cholecalciferol (DB00169)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU
Trial: NCT02731287
Drug: Timolol
RxNorm normalized name: timolol
DrugBank: Timolol (DB00373)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks
Trial: NCT01119287
Drug: Dexamethasone 0.1% ophthalmic suspension
RxNorm normalized name: Dexamethasone 0.1% Ophthalmic Suspension
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Maxidex
Trial: NCT01119287
Drug: Olopatadine hydrochloride 0.1% ophthalmic solution
RxNorm normalized name: Olopatadine Hydrochloride 0.1% Ophthalmic Solution
DrugBank: Olopatadine (DB00768)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patanol
Trial: NCT02546882
Drug: saline
RxNorm normalized name: Salinex
DrugBank: Sodium chloride (DB09153)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1 ml saline was injected for 1 cm2 area.
Trial: NCT00700648
Drug: insulin aspart
RxNorm normalized name: Insulin Aspart
DrugBank: Insulin aspart (DB01306)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Intravenous NovoRapid dose \& frequency as decided by treating physician
Trial: NCT01291108
Drug: bimatoprost
RxNorm normalized name: Bimatoprost
DrugBank: Bimatoprost (DB00905)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
Trial: NCT01291108
Drug: bimatoprost vehicle
RxNorm normalized name: Bimatoprost
DrugBank: Bimatoprost (DB00905)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.
Trial: NCT04321616
Drug: Hydroxychloroquine
RxNorm normalized name: Hydroxychloroquine
DrugBank: Hydroxychloroquine (DB01611)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Hydroxychloroquine will be given orally (in the ICU in gastrointestinal tubes) with 800 mg x 2 loading dose followed by 400 mg x 2 every day for a total of 10 days.
Trial: NCT04321616
Drug: Remdesivir
RxNorm normalized name: remdesivir
DrugBank: Remdesivir (DB14761)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Remdesivir will be given intravenously 100 mg daily for the duration of the hospitalization and up to 10 days total course. A loading dose of 200 mg at inclusion will be given.
Trial: NCT04851574
Drug: Sugammadex Injection
RxNorm normalized name: sugammadex Injection
DrugBank: Sugammadex (DB06206)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Sugammadex was administered in the dose of 0.5 Mg/kg or 1.0 Mg/kg or 2.0 Mg/kg to reverse neuromuscular blockade.
Trial: NCT01468311
Drug: BEAM
RxNorm normalized name: Beam
DrugBank: Tricyclazole (DB02891)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
Trial: NCT02626169
Drug: Clopidogrel
RxNorm normalized name: Clopidogrel
DrugBank: Clopidogrel (DB00758)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Clopidogrel 75 mg once a day by mouth for 30 days
Trial: NCT02626169
Drug: Ticagrelor
RxNorm normalized name: Ticagrelor
DrugBank: Ticagrelor (DB08816)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ticagrelor 90 mg twice daily by mouth for 30 days
Trial: NCT00680628
Drug: Tenecteplase + Enoxaparin
RxNorm normalized name: Tenecteplase
DrugBank: Tenecteplase (DB00031)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: \<60Kg=30mg; ≥60Kg to \<70Kg=35mg; ≥70Kg to \<80Kg=40mg; ≥80Kg to \<90Kg=45mg; ≥90Kg=50mg
Trial: NCT00680628
Drug: 0.9% Saline + Enoxaparin
DrugBank: Enoxaparin (DB01225)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Enoxaparin: 1 mg/kg within 12 hours before receiving saline.
Trial: NCT01531998
Drug: Lenalidomide
RxNorm normalized name: Lenalidomide
DrugBank: Lenalidomide (DB00480)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Induction Phase: 25 mg by mouth daily on Days 1-14. Maintenance Phase: at last tolerated dose from Induction Phase day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg.
Trial: NCT01531998
Drug: Bortezomib
RxNorm normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Induction Phase: 1.3 mg/m2 by vein daily on Days 1, 4, 8 and 11.~Maintenance Phase: 1.3 mg/m2 by vein or last tolerated dose on Day 1 and Day 8.
Trial: NCT01531998
Drug: Siltuximab
RxNorm normalized name: Siltuximab
DrugBank: Siltuximab (DB09036)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Induction Phase Starting Dose: 11 mg/kg by vein on Day 1.~Maintenance Phase: 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy.
Trial: NCT01531998
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Induction Phase: 20 mg by mouth on Days 1, 2, 4, 5, 8, 9, 11, 12.~Maintenance Phase: 20 mg by mouth on Days 1, 2, 4, 5, 8, 9, 11, 12. If participant still on Dexamethasone, when entering Maintenance Phase, dose reduced to 20 mg a week.
Trial: NCT02604459
Drug: propofol
RxNorm normalized name: Propofol
DrugBank: Propofol (DB00818)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: propofol per protocol
Trial: NCT02604459
Drug: sevoflurane
RxNorm normalized name: Sevoflurane
DrugBank: Sevoflurane (DB01236)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: maintenance of anesthesia with inhaled sevoflurane
Trial: NCT03999580
Drug: vitamin D3
RxNorm normalized name: Vitamin D3
DrugBank: Cholecalciferol (DB00169)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3000 or 4000 UI/ day:~Weight at inclusion \< 40 kg : 1 ml per day of the selected concentration at induction and 1ml per day of the selected concentration at maintenance.~Weight at inclusion ≥ 40 kg : 1 ml per day of the selected concentration at induction and 1 ml per day of the selected concentration at maintenance~600 UI/ day:~Weight at inclusion \< 40 kg :1 ml per day of the selected concentration (600 IU) at induction and 1 ml per day of the selected concentration (600 IU) at maintenance.~Weight at inclusion ≥ 40 kg : 1 ml per day of the selected concentration (600 IU) at induction and 1 ml per day of the selected concentration (600 IU) at maintenance
Trial: NCT00205764
Drug: Melphalan
RxNorm normalized name: Melphalan
DrugBank: Melphalan (DB01042)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01138475
Drug: Paricalcitol
RxNorm normalized name: Paricalcitol
DrugBank: Paricalcitol (DB00910)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1 microgram by mouth daily for 6 weeks
Trial: NCT01138475
Drug: Cholecalciferol
RxNorm normalized name: Cholecalciferol
DrugBank: Cholecalciferol (DB00169)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 5000 IU (international units) by mouth daily for 6 weeks
Trial: NCT00219089
Drug: aliskiren
RxNorm normalized name: Aliskiren
DrugBank: Aliskiren (DB09026)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00893841
Drug: quetiapine (Seroquel) XR
RxNorm normalized name: quetiapine Extended Release Oral Tablet
DrugBank: Quetiapine (DB01224)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: tablets and caplets, take with liquid before bedtime
Trial: NCT00893841
Drug: quetiapine (Seroquel) XR
RxNorm normalized name: quetiapine Extended Release Oral Tablet
DrugBank: Quetiapine (DB01224)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: tablets, take with liquid before bedtime
Trial: NCT00893841
Drug: pramipexole dihydrochloride
RxNorm normalized name: Pramipexole Dihydrochloride
DrugBank: Pramipexole (DB00413)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: tablets and caplets, take with liquid before bedtime
Trial: NCT03486353
Drug: FF-10501-01
RxNorm normalized name: FF-10501-01
DrugBank: FF-10501-01 (DB17554)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: FF-10501-01 round film-coated tablets are immediate release and come in 3 dosage strengths: 50 mg (tan), 100 mg tablets (red) and 200 mg (yellow). Each tablet contains the active ingredient (FF-10501-01 white crystalline powder) and other excipients. All dosage strengths are packaged 32 tablets to a bottle. FF-10501-01 should be stored at room temperature (20 - 25 °C).
Trial: NCT03486353
Drug: Azacitidine
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: azacitidine at a dose of 75 mg/m2 either subcutaneously (SC) or intravenously (IV) x 7 days every 28 days
Trial: NCT02132403
Drug: IMPRIME PGG
RxNorm normalized name: Imprime PGG
DrugBank: Odetiglucan (DB17468)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Imprime PGG at assigned doses administered on days 1, 8, 15, and 22 of a 28-day (4 week) cycle.
Trial: NCT02132403
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Gemcitabine on days 1, 8, and 15, at assigned doses, of a 28-day (4 week) cycle.
Trial: NCT04389073
Drug: Vinorelbine 40mg
DrugBank: Vinorelbine (DB00361)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Two tablets per day, three times a week. Vinorelbine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
Trial: NCT04389073
Drug: Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Cisplatin 50mg/m2 IV infusion every 3 weeks. Cisplatin will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
Trial: NCT03064074
Drug: Fresolimumab
RxNorm normalized name: Fresolimumab
DrugBank: Fresolimumab (DB12396)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The purpose of this study is to determine if fresolimumab is safe as a treatment for OI. We will evaluate the safety of a single dose of fresolimumab in the 1st stage of the study. We will evaluate the safety of multiple doses of fresolimumab in the 2nd stage of the study. The Investigators will evaluate the effect of the two doses of fresolimumab in Stage 1 on markers of bone turnover and determine the dose that shows the greatest reduction in bone turnover markers compared to no treatment. This dose will be chosen for the repeat dose studies. If there were no significant changes between the bone turnover markers with either dose, the 4 mg/kg dose will be chosen for the repeat dose study.
Trial: NCT00413439
Drug: Isavuconazole
RxNorm normalized name: Isavuconazole
DrugBank: Isavuconazole (DB11633)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous solution or oral capsules
Trial: NCT03767257
Drug: Colesevelam Pill
RxNorm normalized name: colesevelam Pill
DrugBank: Colesevelam (DB00930)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: For treatment with colesevelam, the starting dose will be 1250 mg (2 x 625 mg) with food which can be increased to 6 tablets max per day based on efficacy and tolerability. Coleveselam should not be taken within 4 hours before or after lenalidomide and other interacting medications. All participants will be given a pill diary to record intake of colesevelam. The effect of colesevelam on lenalidomide-associated diarrhea will be evaluated after 1, 2, 4, 12 weeks after start of treatment. If the diarrhea does not respond to the starting dose of colesevelam, the dose can be increased every 2 days to 2 tablets two times per day (2 x 625 mg BID) and later to 3 tablets two times per day (3 x 625 mg BID). The colesevelam dose can be decrease to 1 tablet per day if there has been improvement of diarrhea but emergence of side effects.
Trial: NCT01951053
Drug: JNJ-40411813
RxNorm normalized name: JNJ-40411813
DrugBank: JNJ-40411813 (DB12059)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.
Trial: NCT01951053
Drug: Citalopram
RxNorm normalized name: Citalopram
DrugBank: Citalopram (DB00215)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.