AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT02986503
Drug: Doxorubicin+cisplatin+ifosfamide
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Chemotherapy for Good responder high grade osteosarcoma
Trial: NCT02986503
Drug: Doxorubicin+cisplatin+ifosfamide+methotrexate
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Chemotherapy for Poor responder high grade osteosarcoma
Trial: NCT03596944
Drug: Statin
RxNorm normalized name: Statin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Prescribed with statins for primary prevention
Trial: NCT01173692
Drug: Minocycline
RxNorm normalized name: Minocycline
DrugBank: Minocycline (DB01017)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 100 mg twice daily (200 mg) by mouth , every day for 7 weeks starting first day of radiation therapy.
Trial: NCT01173692
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Twice daily by mouth, every day for 7 weeks starting at first day of radiation therapy.
Trial: NCT03967223
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide will be used as the lymphodepleting chemotherapy.
Trial: NCT00850174
Drug: Oxcarbazepine
RxNorm normalized name: Oxcarbazepine
DrugBank: Oxcarbazepine (DB00776)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 600 mg Tablet
Trial: NCT00850174
Drug: Trileptal®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 600 mg Tablet
Trial: NCT01333332
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Capecitabine
Trial: NCT02363803
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Normal saline, approved for hypovolemia, and homeostasis.
Trial: NCT03092232
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching Placebo for PF-06865571 for each cohort.
Trial: NCT04146883
Drug: Antibiotics
RxNorm normalized name: Antibiotics
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Post-procedural one-day iv cefazolin then 3-day prophylactic cephalexin
Trial: NCT00578552
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo pill - non active sugar pill designed to look alike to the gabapentin medication
Trial: NCT03575403
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive placebo capsules.
Trial: NCT04202679
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Trial: NCT04202679
Drug: Moisturizers
RxNorm normalized name: SPF 8 Lip Moisturizers KIT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form:~Route of administration: Topical
Trial: NCT04202679
Drug: Topical calcineurin inhibitors
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form:~Route of administration: Topical
Trial: NCT01982318
Drug: VitroGro® ECM
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01982318
Drug: Dulbecco's Phosphate Buffered Saline
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00489307
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo PO twice daily x 14 days
Trial: NCT01629381
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 10 mg os once daily for 1 week
Trial: NCT02169115
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo, s.c., every 4 weeks
Trial: NCT01534520
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: KY Jelly
Trial: NCT00868348
Drug: Ketorolac
RxNorm normalized name: Ketorolac
DrugBank: Ketorolac (DB00465)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac
Trial: NCT01186471
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo - three times daily during each treatment period
Trial: NCT04066023
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
Trial: NCT04362007
Drug: ASTX660
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment of ASTX660 for r/r ATLL
Trial: NCT05468060
Drug: PA1010
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo as control
Trial: NCT03097107
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Randomly assigned patients will receive placebo orally once each morning before breakfast for 12 weeks
Trial: NCT03018834
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PLACEBO 100 mg/daily subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months.
Trial: NCT04107675
Drug: Liposomal Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Liposomal Placebo is administered with the same new technology of nebulizing liquid drugs used for L-CsA, creating an aerosol with a low ballistic momentum and a high percentage of droplets in a respirable size range of 3-5 μm
Trial: NCT00857389
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 5 mg/m2 by vein on Days 1, 3 and 6 and Day +11 post transplant. The Day 11 methotrexate dose may be held as indicated if mucositis is present.
Trial: NCT01552694
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral, matching placebo daily for 2 months
Trial: NCT01965522
Drug: Melatonin
RxNorm normalized name: Melatonin
DrugBank: Melatonin (DB01065)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Melatonin 20mg taken orally once daily. This is in the form of one capsule which contains two pills of melatonin, 10 mg each.
Trial: NCT01965522
Drug: Placebo (melatonin)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Overencapsulated placebo capsule which contains an inert substance. The capsule appears identical to the capsule which contains melatonin tablets.
Trial: NCT01965522
Drug: Placebo (vitamin D)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Overencapsulated placebo capsule which contains an inert substance. The capsule appears identical to the capsule which contains vitamin D tablets.
Trial: NCT00749645
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo 30mg tabs, 3/day, 105 days continuously.
Trial: NCT04456296
Drug: Aveed Injectable Product
RxNorm normalized name: Aveed Injectable Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Testosterone undecanoate administered by intramuscular injections.
Trial: NCT02004119
Drug: KHK4577
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02004119
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01766128
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The second arm will receive placebo
Trial: NCT00904800
Drug: AZD0837
FDA approved: no
EMA approved: no
PMDA approved: no
Description: tablet, oral, once daily, 1+5 days
Trial: NCT00904800
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT00857389
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Post haploidentical stem cell transplant participants: 50 mg/kg by vein on Days + 3 and + 4.
Trial: NCT00356850
Drug: Azithromycin
RxNorm normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01469559
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects randomized to placebo are provided with 1.1 milliliters of normal saline at randomization (week 5). The study completes at week 11. The total treatment period is 6 weeks. The dosing is prescribed to be taken 30 minutes after the morning meal (breakfast)and 30 minutes after the evening meal (supper). Subjects are asked to consume their meals and take their doses of study treatment within the same time frame each day. The amount of normal saline in the study treatment vial (1.1 milliliters) is identical in volume to the active insulin being used in the study .
Trial: NCT03668509
Drug: SHR1459
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral adminstration, single dose
Trial: NCT01790503
Drug: PLX3397
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02681679
Drug: 0.1% bromfenac ophthalmic solution
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00359905
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: once daily for 12 weeks
Trial: NCT00683163
Drug: Ibandronate
RxNorm normalized name: ibandronate
DrugBank: Ibandronate (DB00710)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 150mg by mouth once monthly
Trial: NCT00374803
Drug: Mycophenolic Acid (Myfortic)
RxNorm normalized name: mycophenolic acid
DrugBank: Mycophenolic acid (DB01024)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: * Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~* Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).
Trial: NCT01027611
Drug: proparacaine HCL 0.5%
RxNorm normalized name: PROPARACAINE HCL 0.5% SOLN,OPH
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01235559
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral doses, once a day for 52 weeks
Trial: NCT03226522
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT00362024
Drug: MK0952
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00362024
Drug: Comparator: Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02712476
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: mannitol alone is compared with placebo
Trial: NCT05470972
Drug: Ethanol Injection
RxNorm normalized name: ethanol Injection
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The AEST procedure was performed as follows: vaginal walls were cleansed using vaginal povidone-iodine, a 17 gauge, 30-cm length needle was inserted through the posterior vaginal fornix into the pouch of Douglas, and the cyst was aspirated till complete disappearance of the cyst on the ultrasound scanner. The collected cystic fluid was collected into a plastic tube without an anticoagulant. The needle was maintained in its place, the syringe was removed and the cyst was flushed with saline solution until obtaining a clear liquid. Then, 96% ethanol was injected as 60% of the volume of the aspirated fluid to guard against over distension or rupture of the cyst and/or ethanol diffusion into the pelvis. The collected fluid was divided into three sterile tubes for cytological and bacteriological examinations and the study investigations. Patients were allowed to be completely recovered and were discharged home.
Trial: NCT00807196
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 300mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen
Trial: NCT03154645
Drug: Ibuprofen
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: non-steroidal anti-inflammatory drug
Trial: NCT00651820
Drug: Collagenase Santyl Vehicle
RxNorm normalized name: collagenase Topical Ointment [Santyl]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.
Trial: NCT00069927
Drug: Adderall-XR®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Adderall-XR® 10 mg/day for 3-12 weeks depending on subject's response
Trial: NCT00069927
Drug: Concerta®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Concerta® 18 mg/day for 3-12 weeks depending on subject's response
Trial: NCT00584025
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo equivalent of 100 - 500 mg levetiracetam IV q 15 min
Trial: NCT01854047
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Solution for injection, Subcutaneous injection
Trial: NCT01854047
Drug: ICS/LABA therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose
Trial: NCT00625989
Drug: Aeroallergen
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00054704
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT02303366
Drug: MK-3475
RxNorm normalized name: vitamin MK 7
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MK-3475 (200mg IV) on day 1 every 3 weeks for a total of 8 cycles.
Trial: NCT00758836
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00758836
Drug: ibuprofen
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01019889
Drug: SCRT
RxNorm normalized name: ExoSCRT Derma Signal Kit SRLV KIT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 4 capsules,three times daily, for 7days or within symptom disappearance
Trial: NCT01019889
Drug: YPS
RxNorm normalized name: Lypsyl
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 4 capsules, three times daily, for 7days or within symptom disappearance
Trial: NCT01019889
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 4 capsules, three times daily, for 7days or within symptom disappearance
Trial: NCT00592930
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01077596
Drug: Regular TCA (Tricyclic antidepressants) use
RxNorm normalized name: TRICYCLIC ANTIDEPRESSANTS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Regular use of TCA is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.
Trial: NCT01077596
Drug: Regular use of any other antidepressant
RxNorm normalized name: ANTIDEPRESSANTS,OTHER
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Regular use of any other antidepressants is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date. An other antidepressant would be any antidepressant other than bupropion, a SSRI or a TCA.
Trial: NCT00430196
Drug: BOTOX®
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01880593
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects in this arm take placebo pills at night for duration of the study.
Trial: NCT02445339
Drug: XR-NTX+CM (Extended-Release Naltrexone plus Care Management)
RxNorm normalized name: Extended Release Suspension
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
Trial: NCT01161615
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Application of up to two patches for up to 7 days.
Trial: NCT04003350
Drug: Meloxicam
RxNorm normalized name: Meloxicam
DrugBank: Meloxicam (DB00814)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Meloxicam 15 mg as need once per day
Trial: NCT01820208
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses)
Trial: NCT01101022
Drug: SPD489
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 capsule per day (30, 50 or 70 mg), daily throughout the double-blind treatment period (10 weeks)
Trial: NCT00816595
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT00036517
Drug: PHY906
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00934492
Drug: Placebo dispersible tablet
RxNorm normalized name: placebo Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo dispersible tablets 120/240mg daily for six consecutive months.
Trial: NCT00552565
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo
Trial: NCT01688934
Drug: Naproxen 500-mg capsules
RxNorm normalized name: naproxen 500 MG
DrugBank: Naproxen (DB00788)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Taken orally twice daily
Trial: NCT01688934
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
Trial: NCT04167267
Drug: DWP14012 tablet A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A
Trial: NCT04167267
Drug: DWP14012 tablet B
RxNorm normalized name: ACTION B-100 TAB
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B
Trial: NCT03555929
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 80 minutes after achievement of axillary block, if the surgery is not ended, patients will be randomly assigned to one of the two groups : DEXA or Control. Injection will be done 90minutes after achievement of axillary block.
Trial: NCT02701296
Drug: Ropivacaine with Epinephrine
RxNorm normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
Trial: NCT04092751
Drug: PRA
RxNorm normalized name: PRAI
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single oral 20-mg dose of PRA on Day 1 AM
Trial: NCT01136382
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: pMDI, inhalation, bid, 6 weeks
Trial: NCT02639741
Drug: Melatonin
RxNorm normalized name: Melatonin
DrugBank: Melatonin (DB01065)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated
Trial: NCT01309542
Drug: Desvenlafaxine Succinate
RxNorm normalized name: Desvenlafaxine Succinate
DrugBank: Desvenlafaxine (DB06700)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months
Trial: NCT03349775
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One capsule by mouth twice a day, followed by an increase to two capsules by mouth twice a day for a total of 3 months
Trial: NCT00000570
Drug: pulmonary surfactant
RxNorm normalized name: Pulmonary surfactant
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03416270
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo once daily for 12 weeks
Trial: NCT04106882
Drug: Ketones
RxNorm normalized name: Ketonal
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Supplement administered mid-scan.
Trial: NCT00262223
Drug: Pill placebo
RxNorm normalized name: placebo Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01892722
Drug: Placebo capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo capsule required for double-dummy masking to blind formulations.
Trial: NCT01892722
Drug: Placebo i.m. injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo i.m. injection required for double-dummy masking to blind formulations.
Trial: NCT03977233
Drug: Leucovorin
RxNorm normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 400 mg/m2 in 100 cc dextrose solution given with irinotecan by IV on Day 1 of each 14-day cycle
Trial: NCT04186819
Drug: rhPSMA-7.3 (18F) Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Radioligand for PET CT scanning
Trial: NCT04224558
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Stem Cell Mobilization:~Cyclophosphamide (CY) infused intravenously over 1 hour: 50 mg/kg (25 mg/kg/day on 2 consecutive days)
Trial: NCT04224558
Drug: Acetaminophen
RxNorm normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Preparative/Conditioning Regime r-ATG premedication according to institutional guidlines
Trial: NCT04224558
Drug: lymphocyte immune globulin
RxNorm normalized name: lymphocyte immune globulin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Preparative/Conditioning Regime In patients who develop severe allergic reactions to rATG (Thymoglobulin), it may be substituted by horse ATG (hATG, ATGAM, Pharmacia \& Upjohn, Kalamazoo, MI). The recommended dose of hATG is 25 mg/kg/day for 3 doses.
Trial: NCT00029874
Drug: Minocycline
RxNorm normalized name: Minocycline
DrugBank: Minocycline (DB01017)
FDA approved: yes
EMA approved: no
PMDA approved: no