AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT01179217
Drug: L-glutamine
RxNorm normalized name: L-Glutamine
DrugBank: L-Glutamine (DB00130)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended.
Trial: NCT01179217
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration.
Trial: NCT00945529
Drug: inhaled nitric oxide (iNO)
RxNorm normalized name: nitric oxide Inhalant Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
Trial: NCT03633084
Drug: RBM-007 Injectable Solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: (No additional description)
Trial: NCT03094195
Drug: EMA401
FDA approved: no
EMA approved: no
PMDA approved: no
Description: EMA401
Trial: NCT03094195
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT02224443
Drug: normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Group C , Normal saline infusion will be given with the same infusion volume as group A and B
Trial: NCT02224443
Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Maintenance of anesthesia :Continuous pump infusion 0.05\~0.1mg.kg-1.h-1cisatracurium besylate,4\~8mg.kg-1.h-1propofol,0.1\~0.2μg.kg-1.min-1 remifentanil and sevoflurane inhalation with 0.6%\~1.0%
Trial: NCT02034682
Drug: Volulyte 6%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: During elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Volulyte 6% to the cardiopulmonary bypass circuit.
Trial: NCT02034682
Drug: Geloplasma
FDA approved: no
EMA approved: no
PMDA approved: no
Description: During elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Geloplasma to the cardiopulmonary bypass circuit.
Trial: NCT00729183
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo tablets to odanacatib taken orally once weekly for 24 months.
Trial: NCT00729183
Drug: Calcium supplement
RxNorm normalized name: Calcium supplement
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Calcium supplement 500 mg tablet taken orally once daily (up to \~1200 mg total) for 24 months.
Trial: NCT00772499
Drug: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
RxNorm normalized name: amlodipine / hydrochlorothiazide / olmesartan medoxomil Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablets and capsules for oral administration once or twice daily for up to 52 weeks
Trial: NCT00772499
Drug: atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
RxNorm normalized name: atenolol / chlorthalidone / hydralazine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablets and capsules for oral administration once or twice daily for up to 52 weeks
Trial: NCT02526615
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients received either placebo, metformin or rosiglitazone
Trial: NCT02260193
Drug: AKB-6548
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Trial: NCT02260193
Drug: AKB-6548
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Trial: NCT04931433
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Group B will receive saline of similar volume and rate as Group A
Trial: NCT01857921
Drug: Pravastatin 20mg/day for 12 months after randomization
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients with mono antiplatelet therapy with aspirin who had had received CABG previously fulfilling all enrollment criteria will be randomly assigned to the type of two groups. Randomization of statin therapy will be done 1:1 to one of two different groups on the web-based program:~1. Test group:~   * Atorvastatin 40 mg and trimetazidine MR 70 mg daily for 12 months after randomization~2. Control group:~   * Pravastatin 20mg daily for 12 months after randomization
Trial: NCT02260193
Drug: AKB-6548
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.
Trial: NCT02815657
Drug: SP2086
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12
Trial: NCT01543399
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: patients of the placebo group will use placebo one a day for 30 days
Trial: NCT01357161
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo to adavosertib, capsule, orally, BID for a total of 5 doses, starting on Day 1 of each 3-week cycle
Trial: NCT02793817
Drug: KPI-121 1% Ophthalmic Suspension dosed BID
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02793817
Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04065074
Drug: FX006 32 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Extended-release 32 mg FX006 IA injection
Trial: NCT03576755
Drug: Spironolactone 100mg
RxNorm normalized name: SPIRONOLACTONE 100MG TAB
DrugBank: Spironolactone (DB00421)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Spironolactone capsules will be prepared from USP grade powder at a dose of 100 mg.
Trial: NCT03576755
Drug: Placebo oral capsule
RxNorm normalized name: Placebo Oral Capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo capsules of the same color, mass, and appearance to the spironolactone capsules will be filled using microcrystalline cellulose powder.
Trial: NCT02374814
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT02839226
Drug: AR/101
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02839226
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01291602
Drug: CAZ104
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV Solution
Trial: NCT01291602
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV saline
Trial: NCT02305849
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral tablet
Trial: NCT02305849
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Oral tablet/capsule
Trial: NCT04597125
Drug: NAH therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive continuous NAH (either Abiraterone acetate plus prednisone/prednisolone \[AAP\] or enzalutamide) by mouth (per os) daily
Trial: NCT04664972
Drug: Docetaxel +doxorubicin+ cyclophosphamide
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The control group was treated with TAC (docetaxel 75 mg / m2 + adriamycin 50 mg / m2 + cyclophosphamide 500 mg / m2) for 6 cycles, 21 days was a cycle.
Trial: NCT01791049
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02782052
Drug: Nebulized Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administration at V3 or V4 or V5 in a random order:~* Placebo (P; sterile 0.9% sodium chloride solution)~* Or nebulized ipratropium bromide (IB; 0.5mg/2mL) alone~* Or nebulized combination ipratropium bromide with salbutamol (IB+SALB; 0.5mg/2mL + 2.5mg/2.5mL).
Trial: NCT00620256
Drug: AL-37807 ophthalmic suspension, 0.1%
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03783000
Drug: BI 425809 mixed with [C-14]-BI 425809
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment R
Trial: NCT00245050
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Arm II: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
Trial: NCT00245050
Drug: doxorubicin HCL liposome
RxNorm normalized name: DOXORUBICIN HCL LIPOSOME 2MG/ML INJ
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV, 40mg/m2
Trial: NCT00152477
Drug: CDP791 10mg/kg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CDP791 20mg/mL vial CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
Trial: NCT00152477
Drug: CDP791 20mg/kg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CDP791 20mg/kg CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
Trial: NCT02160665
Drug: Vehicle
RxNorm normalized name: Drug vehicle
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Vehicle of Test product (G \& W Laboratories, Inc.)
Trial: NCT02160665
Drug: Reference: Tazorac Cream, 0.05%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Reference: Tazorac (tazarotene) Cream, 0.05% (Allergan, Inc.)
Trial: NCT02429219
Drug: Saline Irrigation with Ethanol
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Saline Irrigation with Ethanol (alcohol)
Trial: NCT00825942
Drug: C-KAD Ophthalmic Solution
RxNorm normalized name: urea c-13 Oral Solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 4 drops applied daily for 180 days
Trial: NCT01611688
Drug: NNC0215-0384
FDA approved: no
EMA approved: no
PMDA approved: no
Description: I.v.(intravenous) dose-escalation. Highest dose planned for i.v. administration is 10 mg/kg
Trial: NCT01611688
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered i.v.(intravenous) or s.c. (subcutaneous, under the skin).
Trial: NCT01611688
Drug: NNC0215-0384
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The s.c. (subcutaneous, under the skin) part will not start until at least two i.v. dose levels have been evaluated for safety and pharmacokinetics. Highest dose planned for s.c. administration is 4 mg/kg
Trial: NCT00964041
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo by mouth, weekly, one hour before any assessments, each week for eight weeks.
Trial: NCT04026009
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive 2 doses (0.5 mL each) of Placebo, administered intramuscularly in the deltoid, at a 0, 1-month dose interval.
Trial: NCT01581034
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of placebo will be taken. One capsule contains 403mg.
Trial: NCT02182661
Drug: Ba253BINEB
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01059682
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo orally once daily
Trial: NCT03086291
Drug: Simvastatin
RxNorm normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days
Trial: NCT01083212
Drug: AZD1656
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dose,oral tablet
Trial: NCT01083212
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral tablet bid on day 1-5
Trial: NCT01541943
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Once daily, administered orally, 8 week
Trial: NCT02529462
Drug: Treatment As Usual
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Clinicians treat psychiatric patients in a naturalistic way, following their routine procedures, without access to the pharmacogenetic information provided by the NEUROPHARMAGEN test
Trial: NCT02973295
Drug: Silymarin
RxNorm normalized name: silymarin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Capsules contains 100 mg of silymarin
Trial: NCT02340208
Drug: L-DOS47
RxNorm normalized name: L
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A treatment cycle will be 21 days with patients receiving L-DOS47 on cycle Days 1 and 8.
Trial: NCT03482648
Drug: BBT-401-1S, Single dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dose of BBT-401-1S, 7 dose levels, oral capsule
Trial: NCT03482648
Drug: BBT-401-1S, Multiple doses
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Multiple doses of BBT-401-1S, 7 days, 3 dose levels, oral capsule
Trial: NCT03482648
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo matched to BBT-401-1S, oral capsule
Trial: NCT01979666
Drug: placebo patch
FDA approved: no
EMA approved: no
PMDA approved: no
Description: control group patients will get a placebo patch
Trial: NCT03878381
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The placebo will be a formula with no active ingredients
Trial: NCT04136327
Drug: GLPG1972 film-coated tablets
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single oral dose of GLPG1972
Trial: NCT04136327
Drug: [14C]-GLPG1972 solution for infusion
FDA approved: no
EMA approved: no
PMDA approved: no
Description: a 15-minute IV infusion \[14C\]-GLPG1972
Trial: NCT04136327
Drug: [14C]-GLPG1972 oral solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single oral dose of \[14C\]-GLPG1972
Trial: NCT01180894
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03170115
Drug: Placebo Oral Tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: chemoradiotherapy with capecitabine and placebo Placebo daily during chemoradiotherapy
Trial: NCT06362473
Drug: Lipid-lowering treatments
RxNorm normalized name: guggul lipids
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04486430
Drug: Neu2000KWL
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1st infusion of 500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 250 mg at intervals of 12 hours
Trial: NCT04486430
Drug: Neu2000KWL
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1st infusion of 750mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours
Trial: NCT04486430
Drug: Neu2000KWL
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1st infusion of 1500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours
Trial: NCT04486430
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1st infusion of the same volume of saline in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of the same volume of saline at intervals of 12 hours
Trial: NCT03393819
Drug: DuraPrep
RxNorm normalized name: DuraPrep
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DuraPrep surgical solution
Trial: NCT00909155
Drug: Fluoxetine
RxNorm normalized name: Fluoxetine
DrugBank: Fluoxetine (DB00472)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d
Trial: NCT00449644
Drug: TMC207
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 or 22 weeks.
Trial: NCT00449644
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 or 22 weeks.
Trial: NCT00349921
Drug: adenosine
RxNorm normalized name: Adenosine
DrugBank: Adenosine phosphate (DB00131)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Adenosine-a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms-has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain.
Trial: NCT00349921
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: inactive substance
Trial: NCT00449644
Drug: Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
RxNorm normalized name: Anacin Aspirin Regimen
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks.
Trial: NCT01212679
Drug: nomral saline
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.
Trial: NCT00018954
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00665054
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo tablets orally prior to sexual activity
Trial: NCT00018954
Drug: doxorubicin hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00724685
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: saline
Trial: NCT01660854
Drug: Malarone treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Three days: 4 tablets 250/100mg per day
Trial: NCT00018954
Drug: mercaptopurine
RxNorm normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00018954
Drug: methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01096368
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT03070223
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One tablet taken once daily, orally with or without food for the entire time participant was in REPRIEVE follow-up.
Trial: NCT02305017
Drug: BIA 9-1067
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 9-1067 50 mg
Trial: NCT01905228
Drug: CBL0137
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All doses are administered intravenously on Days 1, 8 and 15 of every 28 day cycle.~Number of Cycles: 2 or until progression or unacceptable toxicity develops
Trial: NCT00753103
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Daily oral 2 mg/kg or pulsed intravenous 15mg/kg every 2-3 weeks for 3-6 months (until patient has been in remission for 3 months).
Trial: NCT00753103
Drug: Prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Daily oral 1mg/kg tapered over 12 months
Trial: NCT00753103
Drug: Azathioprine
RxNorm normalized name: Azathioprine
DrugBank: Azathioprine (DB00993)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Daily oral 2 mg/kg started once patient is in remission and cyclophosphamide has been discontinued.
Trial: NCT01202188
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo to match capsules for inhalation delivered via SDDPI.
Trial: NCT01677598
Drug: No intervention
FDA approved: no
EMA approved: no
PMDA approved: no
Description: No intervention will be administered during study. This will be an observational study in patients using ustekinumab as label-recommended or other/missed dose interval in Asia-Pacific countries
Trial: NCT03296137
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 2 doses (60 mg/kg) prior to TIL infusion
Trial: NCT00089024
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 2700 mg/m5 IV over 24 hr after gemcitabine weeks 1 \& 2; Repeat one 3-week cycle starting day 22