AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT02623296
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Once daily administration of 2 matching placebo capsules from Day 1 to Day 13
Trial: NCT03875001
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
Trial: NCT02239679
Drug: Aminolevulinic Acid
RxNorm normalized name: Aminolevulinic Acid
DrugBank: Aminolevulinic acid (DB00855)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20% ALA applied to face for one hour prior to 10 J/cm2 blue light
Trial: NCT02644473
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Control
Trial: NCT02198963
Drug: 0.9% Physiological Saline, USP
FDA approved: no
EMA approved: no
PMDA approved: no
Description: negative control
Trial: NCT02300155
Drug: Pregvit®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Women were randomized to one of two groups. An information package was mailed to each woman, instructing her to commence supplementation with her assigned prenatal multivitamin, according to the product's standard dosing -twice daily for '35 mg' group
Trial: NCT02300155
Drug: Orifer F®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Women were randomized to one of two groups. An information package was mailed to each woman, instructing her to commence supplementation with her assigned prenatal multivitamin, according to the product's standard dosing-once daily for '60 mg' group
Trial: NCT00695305
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo
Trial: NCT02336646
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03324646
Drug: [11C]PS13
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A novel PET ligand to selectively image COX-1
Trial: NCT01182376
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be administered by the patient's team according to established guidelines.
Trial: NCT05327231
Drug: IN10018
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.
Trial: NCT01808573
Drug: capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT03181880
Drug: Standard of Care
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Brochodilators
Trial: NCT00382057
Drug: Testosterone
RxNorm normalized name: Testosterone
DrugBank: (1,2,6,7-3H)Testosterone (DB14093)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00822692
Drug: Trim/ Sulfa DS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: bactrim DS (800/160) two tablets PO BID x 7 days
Trial: NCT00822692
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: matched placebo 2 pills PO BID x 7 days
Trial: NCT05927597
Drug: INS1007
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral tablets.
Trial: NCT05927597
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral tablets.
Trial: NCT02797197
Drug: chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03633097
Drug: Usual care
FDA approved: no
EMA approved: no
PMDA approved: no
Description: patients after surgery receive usual care alone(Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet)
Trial: NCT01510782
Drug: Placebo to BI 655064
FDA approved: no
EMA approved: no
PMDA approved: no
Description: intravenous infusion of escalating doses
Trial: NCT01510782
Drug: Placebo to BI 655064
FDA approved: no
EMA approved: no
PMDA approved: no
Description: subcutaneous injection of escalating doses
Trial: NCT03953612
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo
Trial: NCT01593046
Drug: GSK1265744 LAP 800mg intramuscular injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 800mg Loading dose given at month 1 dose
Trial: NCT01593046
Drug: GSK1265744 LAP 200mg subcutaneous injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 200mg maintenance dose give at months 2 - 4
Trial: NCT01593046
Drug: GSK1265744 LAP 200mg intramuscular injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 200mg maintenance dose given at months 2 - 4
Trial: NCT01593046
Drug: GSK1265744 LAP 400mg intramuscular injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 400mg maintenance dose given at month 2 - 4
Trial: NCT01593046
Drug: TMC278 LA 1200mg intramuscular injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1200mg Loading dose given at month 3
Trial: NCT02852551
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01593046
Drug: GSK1265744 LAP 800mg intramuscular injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 800mg dose given quarterly (once every) 12 weeks
Trial: NCT00546585
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sterile normal saline for injection (0.9%); 0.5 ml volume sodium chloride injection. Subjects will receive 2 doses on Day 0 and Day 28.
Trial: NCT03110198
Drug: hydrocortisone sodium succinate
RxNorm normalized name: Hydrocortisone Sodium Succinate
DrugBank: Hydrocortisone succinate (DB14545)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: hydrocortisone sodium succinate rectal administration at bedtime 100mg/100 ml, once daily
Trial: NCT03101514
Drug: chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cisplatin 80-100mg/m2 was used every 3 weeks during radiotherapy.
Trial: NCT04363437
Drug: Usual Care
FDA approved: no
EMA approved: no
PMDA approved: no
Description: COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.
Trial: NCT03030911
Drug: Fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: The drug will be administered in both groups
Trial: NCT02193256
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02815293
Drug: AGN-195263
RxNorm normalized name: VITEX AGNUS-CASTUS WHOLE
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 drop of AGN-195263 will be instilled in each eye twice daily.
Trial: NCT02815293
Drug: Vehicle
RxNorm normalized name: Drug vehicle
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily.
Trial: NCT02442180
Drug: steroid
RxNorm normalized name: Steroid
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral prednisolone 40mg qd or iv methylprednisolone 32 mg if oral medication is not tolerable
Trial: NCT02442180
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: equivalent to G-CSF doses
Trial: NCT04154956
Drug: SAR408701
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: intravenous (IV) infusion
Trial: NCT02902913
Drug: Ibuprofen
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 400 mg of Ibuprofen
Trial: NCT02248792
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01597050
Drug: R932333
FDA approved: no
EMA approved: no
PMDA approved: no
Description: R393233 6% (60 mg/g), bid
Trial: NCT01597050
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo, bid
Trial: NCT03229954
Drug: iron isomaltoside (Monofer) intravenous infusion
RxNorm normalized name: Iron isomaltoside 1000
DrugBank: Iron isomaltoside 1000 (DB12208)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The investigational drug is a newest formulation of intravenous iron. The drug, iron isomaltoside (Monofer), will be infused one single high dose with infusion time more than 30 minutes (\< 1,000 mg) or 60 minutes (≥ 1,000 mg). The dosage is determined using the Ganzoni formula and divided when the calculated dose exceeds 20 mg/kg.~If the calculated dose exceeds 1,500 mg, the patient will be excluded from trial for patient safety.
Trial: NCT01200069
Drug: Placebo infusion
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3
Trial: NCT01200069
Drug: ibuprofen intravenous
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3
Trial: NCT01738295
Drug: Placebo administration
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03659929
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo
Trial: NCT02895256
Drug: Any treatment for cluster headache
RxNorm normalized name: cluster fig extract
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01185197
Drug: Prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician
Trial: NCT01226030
Drug: M2ES 7.5mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: M2ES 7.5mg
Trial: NCT01226030
Drug: M2ES 15mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: M2ES 15mg
Trial: NCT01226030
Drug: M2ES 30mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: M2ES 30mg
Trial: NCT01226030
Drug: M2ES 60mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: M2ES 60mg
Trial: NCT03975374
Drug: Tobramycin/dexamethasone opthalmic solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: To compare efficacy and safety in randomized patients recieving Tobradex versus Tobramycin/Dexamethasone opthamic Solution
Trial: NCT03975374
Drug: Tobradex Opthalmic Solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tobradex Opthalmic Solution
Trial: NCT01240148
Drug: AZD3161
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dose, intradermal injection
Trial: NCT01240148
Drug: AZD3161 Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01522625
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo, identical to TDF in appearance, once daily for 3years
Trial: NCT01843296
Drug: Fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00735085
Drug: SLV334
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1000mg SLV334 as a single dose
Trial: NCT00735085
Drug: SLV334
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1000mg SLV334 b.i.d. for one day
Trial: NCT00735085
Drug: SLV334
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2000mg SLV334 b.i.d. for one day
Trial: NCT00735085
Drug: SLV334
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2000mg SLV334 b.i.d. for three days
Trial: NCT00735085
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SLV334 Placebo arm
Trial: NCT02207634
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Trial: NCT02207634
Drug: Background Statin Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants were required to be on a stable, high- to moderate-intensity statin background therapy consisting of an effective statin dose, ie, at least atorvastatin 20 mg daily or equivalent, and where locally approved, highly effective statin therapy (defined as at least atorvastatin 40 mg daily or equivalent) was recommended.
Trial: NCT03032848
Drug: Estriol
RxNorm normalized name: Estriol
DrugBank: Estriol (DB04573)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: use of 1 gram per day
Trial: NCT03596658
Drug: SHR9549
FDA approved: no
EMA approved: no
PMDA approved: no
Description: If initial dosing of SHR9549 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose(MTD) is defined
Trial: NCT04122040
Drug: Roxithromycin 300 MG
RxNorm normalized name: roxithromycin 300 MG
DrugBank: Roxithromycin (DB00778)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Roxithromycin 300 mg oral per day
Trial: NCT04122040
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo one table oral once dialy
Trial: NCT00129389
Drug: Fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Arm A: FAC Arm B: FAC-wP
Trial: NCT00129389
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Arm A: FAC Arm B: FAC-wP
Trial: NCT00129389
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Arm A: FAC Arm B: FAC-wP
Trial: NCT02202226
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02125201
Drug: Fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: A neonate will recieve Fentanyl intranasal or intravenous 5 minutes before the procedure The nurse will check his pain scale If the pain scale will be more than 4 the neonate will recieve the second dose of Fentanyl
Trial: NCT02501018
Drug: SOC
RxNorm normalized name: Isocet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).
Trial: NCT02605915
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Doxorubicin will be administered at 60 mg/m\^2 every 2 weeks as an IV bolus over 3 to 5 minutes or as an infusion over 15 to 30 minutes.
Trial: NCT02605915
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide will be administered at 600 mg/m\^2 on Day 1 of each 21 day cycle as an IV bolus over 3 to 5 minutes or as an infusion, in accordance with local policy.
Trial: NCT02604407
Drug: SHP465 12.5mg capsules (one capsule daily)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: one capsule daily
Trial: NCT04611503
Drug: subretinal injection of rAAV.hPDE6A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The first 3 patients (C1) will receive the intermediate dose 1x1010 vg. After injection of the 3rd patient of C1, the DMC will give a go/no go decision. If 'nogo', a lower dose (5x109 vg) will be given to the next group of 3 patients (C2). The DMC will give a go/no go decision. In case of a go decision, 3 further patients (C3) will be treated with the same dose. In the case of a no-go decision, the next dose will be the minimal dose 1x109 vg. In case of a 'go' decision of the DMC after the third patient, the next 3 patients will receive a subretinal injection of vector at the highest dose 5x1010 vg. The DMC will give a go/no go decision after review of all safety data available at D30 of cohort 2. If safety data is considered favourably by the DMC, then 3further patients (cohort 3) will be treated with the same dose (5x1010 vg). Should any safety concerns arise, the last three patients (cohort 3) will receive the intermediate dose (1x1010 vg).
Trial: NCT02278328
Drug: STX209 (15mg)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A randomized acute dose-response design will be employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. Each participant will receive a single dose of placebo in random order and a single dose of STX209 from smallest to largest (15mg, and 30mg). MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate. The STX209 (15mg) intervention is the low dose
Trial: NCT02278328
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A randomized acute dose-response design will be employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. Each participant will receive a single dose of placebo in random order and a single dose of STX209 from smallest to largest (15mg, and 30mg). MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate. The placebo intervention is the non-active placebo control dose
Trial: NCT02278328
Drug: STX209 (30mg)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A randomized acute dose-response design will be employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. Each participant will receive a single dose of placebo in random order and a single dose of STX209 from smallest to largest (15mg, and 30mg). MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate. The STX209 (30mg) intervention is the high dose
Trial: NCT04623892
Drug: TQB2618 injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TQB2618 administered intravenously (IV) on Day 1 of each 21-day. The established dose of TQB2618 is diluted to 100 m with normal saline \[0.9% (w/v) sodium chloride solution\], and the infusion time is 60 ± 10 min.
Trial: NCT02691325
Drug: Placebo ELLIPTA DPI
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo ELLIPTA DPI contains lactose.
Trial: NCT04123405
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo to acetylcysteine
Trial: NCT04667624
Drug: LodineT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: •Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea
Trial: NCT00601887
Drug: Meloxicam
RxNorm normalized name: Meloxicam
DrugBank: Meloxicam (DB00814)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00004338
Drug: zinc acetate
RxNorm normalized name: Zinc Acetate
DrugBank: Zinc acetate (DB14487)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01666678
Drug: BAY98-7111
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fasting conditions
Trial: NCT01666678
Drug: Naproxen Sodium (Aleve, BAYH6689)
RxNorm normalized name: Naproxen
DrugBank: Naproxen (DB00788)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 2 x Naproxen Sodium 220 mg under fasting conditions
Trial: NCT01666678
Drug: BAY98-7111
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fed conditions
Trial: NCT00002704
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00002704
Drug: leucovorin calcium
RxNorm normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00002704
Drug: mercaptopurine
RxNorm normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00002704
Drug: methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00002704
Drug: therapeutic hydrocortisone
RxNorm normalized name: Moisturel Therapeutic
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03875781
Drug: Radiochemotherapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Arm B: Active comparator~* Intervention Name : modified FOLFIRINOX followed by preoperative standardized radiochemotherapy (control arm)~* Intervention Description : preoperative chemotherapy: Modified FOLFIRINOX regimen comprised oxaliplatin 85mg/m2 + irinotecan 180mg/m2 + Folinic acid 400 mg/m2 at day1, then 5-FU given as a continuous infusion over 46h every two weeks. Six cycles are planned preoperatively.followed by preoperative radiochemotherapy with concurrent capecitabine 825 mg/m2/12h 5 days/week and intensity modulated radiation therapy using a simultaneous integrated boost technique with 45 Gy in 25 fractions in pelvic volume and 50 Gy in 25 fractions to the tumor.
Trial: NCT02324582
Drug: Intravenous MK-3475/ Intravesical BCG
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 6 cycles (each cycle is 21 days) of pembrolizumab will be given over 9 weeks in combination with BCG. BCG treatment will begin on Day 1 of cycle 3 of pembrolizumab.
Trial: NCT00246324
Drug: Interferon beta 1a, oral doxycycline
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients took intramuscular interferon beta 1a, 30 micrograms, for 3 months then added oral doxycycline, 100 daily with the interferon for 4 months.
Trial: NCT02794285
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Trial: NCT01284452
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Normal saline 50 ml intravenous every 6 hours for 7 days
Trial: NCT01284452
Drug: Hydrocortisone
RxNorm normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Hydrocortisone 50 mg intravenous every 6 hours for 7 days
Trial: NCT02211417
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no