AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT02731287
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
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: NCT01291108
Drug: AGN-210669
RxNorm normalized name: VITEX AGNUS-CASTUS WHOLE
FDA approved: no
EMA approved: no
PMDA approved: no
Description: AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
Trial: NCT00414570
Drug: [18]F-FLT PET scan
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Injection of \[18\]F-FLT radiopharmaceutical followed by PET imaging.
Trial: NCT01175343
Drug: Gamma-Secretase Inhibitor RO4929097
RxNorm normalized name: .GAMMA.-OCTALACTONE
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT02472249
Drug: Norepinephrine intra-arteriel/hepatic
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A small dose (24 ug) of norepinephrine will be injected in the hepatic artery over 10 seconds. The half-life of the drug is 90 seconds..
Trial: NCT02604459
Drug: fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: fentanyl per protocol
Trial: NCT01138475
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inactive substance, one capsule daily for 6 weeks
Trial: NCT00893841
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo
Trial: NCT02132403
Drug: BTH1704
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BTH1704 at assigned doses administered on days 1, 8, 15, and 22 of a 28-day (4 week) cycle.
Trial: NCT04389073
Drug: Cyclophosphamide 50 mg
RxNorm normalized name: cyclophosphamide 50 MG
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 50 mg per day. Cyclophosphamide 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: Capecitabine 500Mg Oral Tablet
RxNorm normalized name: Capecitabine 500mg Oral tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 500mg three times a day. Capecitabine 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: NCT01951053
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.
Trial: NCT02539550
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT02745873
Drug: Ascorbic Acid
RxNorm normalized name: Ascorbic Acid
DrugBank: Ascorbic acid (DB00126)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ascorbic Acid (vitamin-c) 500 mg in tablet form was used.
Trial: NCT03394989
Drug: Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT
RxNorm normalized name: Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Comparator Arm: Dry powder inhaler
Trial: NCT01203709
Drug: low dose combination of MMF and Tac
RxNorm normalized name: Betagen brand of Betamethasone and Gentamicin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: mycophenolate mofetil 500mg BID + tacrolimus 2mg BID
Trial: NCT04255771
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Use a placebo as a comparison
Trial: NCT03997864
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Starting dose: 2mg at HS. Maximum dose: 15 mg at HS. Dosage will be increased 1 mg every 3 days until sleep is improved max dose is reached, or side effects are problematic.
Trial: NCT00437749
Drug: CBT-1
RxNorm normalized name: Cabergoline
DrugBank: Cabergoline (DB00248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: (50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6
Trial: NCT00246363
Drug: Silymarin
RxNorm normalized name: silymarin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Silymarin (milk thistle)
Trial: NCT00246363
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT04201080
Drug: Part A: TRV250-20mg/ml
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TRV250 SC Injections
Trial: NCT03695887
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inactive comparator
Trial: NCT01132482
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients receiving placebo will have sham dose escalation to maintain blinding.
Trial: NCT01763424
Drug: Calcipotriol plus Nicotinamide
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients applied calcipotriol 0.005% and nicotinamide 4% in combination (By LEO Pharmaceuticals, Ballerup, Denmark) for lesions of one side of the body. The patients uses the medications twice daily (in the morning and before sleeping) for 12 weeks; the total doses of medication used not more than 100 gram per week.
Trial: NCT04201080
Drug: Part B: TRV250 Dose 2
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dose 2of3 TRV250 SC injections
Trial: NCT04409834
Drug: Unfractionated Heparin IV
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of VTE
Trial: NCT04409834
Drug: Unfractionated heparin SC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Heparin 5,000 units administered subcutaneous three times daily
Trial: NCT04201080
Drug: Part B: TRV250 Dose 3
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dose 3of3 TRV250 SC injections
Trial: NCT04201080
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo SC injections
Trial: NCT00769054
Drug: Isotonic NaCl
RxNorm normalized name: ISOTON
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Local Infiltration with NaCl
Trial: NCT02345733
Drug: Antibiotic cocktail
FDA approved: no
EMA approved: no
PMDA approved: no
Description: We have postulating that antibiotic therapy can alter the microbiota clinically. Controlling the microbiota by antibiotics may allow for control of the disease without immune suppression
Trial: NCT01400009
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard Placebo made of Lactose 100 mg
Trial: NCT04055753
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Doxorubicin 75 mg/m2, IV over 5-15 min OR Continuous infusion over 48-72 hours
Trial: NCT00445094
Drug: Comparator: amikacin / Duration of Treatment: 3 Days
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00445094
Drug: Comparator: tazocin / Duration of Treatment: 3 Days
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01497197
Drug: GONAL-f®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen.
Trial: NCT01497197
Drug: Luveris®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Luveris® 150 IU per day lyophilized powder for subcutaneous injection.
Trial: NCT01114737
Drug: Sapropterin dihydrochloride
RxNorm normalized name: Sapropterin Dihydrochloride
DrugBank: Sapropterin (DB00360)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
Trial: NCT01114737
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
Trial: NCT02735018
Drug: Epinephrine 1:100,000
RxNorm normalized name: articaine HCl 4 % / epinephrine 1:100,000 Cartridge
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inferior alveolar nerve block with Epinephrine 1:100.000
Trial: NCT02735018
Drug: Epinephrine 1:200,000
RxNorm normalized name: articaine HCl 4 % / epinephrine 1:200,000 Cartridge
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inferior alveolar nerve block with Epinephrine 1:200.000
Trial: NCT00457392
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo daily by oral capsules in a continuous regimen
Trial: NCT03991910
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: the control group will be given placebo inside a capsule, so study participant won't be able to know the drug and doses inside the capsule (for masking). Placebo will be given until 5 days prior to Mitral valve replacement surgery.
Trial: NCT02820896
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive single or multiple doses of RO7105705 matching placebo IV.
Trial: NCT00696033
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: lorazépam placebo or Diazépam placebo
Trial: NCT02820896
Drug: RO7105705
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive single or multiple doses of RO7105705 IV or SC.
Trial: NCT04457986
Drug: Intravenous patient controlled analgesia (IV-PCA)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patient will receive intravenous patient controlled analgesia with tramadol
Trial: NCT03853044
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide 750 milligrams per square metre (mg/m\^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
Trial: NCT03853044
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Doxorubicin 50 mg/m\^2 IV, administered on Day 1 of each 21-day cycle.
Trial: NCT05124717
Drug: Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One tablet of the Reference product was administered orallyn with 240 mL of water.
Trial: NCT04749745
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The subject will receive paired-pulse TMS (ppTMS) procedure before and 30min after taking the drug orally, to assess motor cortex excitability, measured by surface electromyogram (EMG). The ppTMS procedure is administered by a TMS stimulator controlled a program software named Signal. The coil of the stimulator is placed above the scalp where the stimulation would activate the left primary motor cortex region that controls the right thumb. When a pulse stimulation is delivered by the coil, the EMG over a thumb muscle (abductor pollicis brevis) will record a motor-evoked potential on the tracing. Cross-over with L-theanine in two separate sessions at least 72 hours apart.
Trial: NCT02135627
Drug: TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01211561
Drug: Selenium, selenomethionine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will receive one 200 ug pill of Selenomethionine
Trial: NCT01211561
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will be given one 200 ug placebo pill each day for 6 months
Trial: NCT01926132
Drug: ascorbic acid 10g/20ml
RxNorm normalized name: Ascorbic Acid
DrugBank: Ascorbic acid (DB00126)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: ascorbic acid 10g/20cc intravenous injection for 40mins
Trial: NCT00399035
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: intravenous infusion
Trial: NCT00399035
Drug: XELOX (Capecitabine and Oxaliplatin)
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: intravenous oxaliplatin 130 mg/ m\^2(day 1) followed by oral capecitabine 1,000 mg/ m\^2twice daily (day 1 to day 15)
Trial: NCT01500317
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects received placebo three times per day (tid) for 48 hours.
Trial: NCT03419429
Drug: Simvastatin
RxNorm normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Simvastatin is a drug used orally for treatment of hypercholesterolemia. It assists in bone regeneration and has anti-inflammatory effect when applied locally in intrabony defects for periodontal therapy.
Trial: NCT00102661
Drug: Campath-1H
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 15 mg daily infused over 24 hours, continuous infusion x 7 days (Days 1 through 7). Each 15 mg dose prepared daily, immediately prior to starting the infusion. Starting day 10, CAMPATH-1H administered at dose of 30 mg subcutaneously three times weekly for 11 additional weeks.
Trial: NCT04357899
Drug: thrombolysis therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04357899
Drug: initiation of antiplatelets, oral anticoagulation and lipid lowering drugs for secondary prevention
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00337038
Drug: N-acetylcystein(drug)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: p.O t.Siran 200mg x1 during one weak
Trial: NCT01824290
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally by tablet for heavy and middle weight participants. Administered orally by suspension for light weight participants.
Trial: NCT01824290
Drug: ERA as specific PAH treatment
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan).
Trial: NCT03793686
Drug: PBCLN-003
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Investigational drug
Trial: NCT03793686
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT03341676
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sodium Chloride 0.9% w/v solution for injection
Trial: NCT02710877
Drug: Sufentanil 4 mcg
RxNorm normalized name: sufentanil
DrugBank: Sufentanil (DB00708)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Sufentanil 0,4 mcg/ml through peridural catheter
Trial: NCT02710877
Drug: Sufentanil 5 mcg
RxNorm normalized name: sufentanil
DrugBank: Sufentanil (DB00708)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Sufentanil 5 mcg through peridural catheter
Trial: NCT00362895
Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One drop in the study eye, single dose
Trial: NCT00362895
Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One drop in the study eye, single dose
Trial: NCT03152123
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: tablets over-capsuled
Trial: NCT00109148
Drug: MK0364
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02742129
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhaled, nebulized placebo vs. inhaled, nebulized inorganic sodium nitrite at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day.
Trial: NCT03314935
Drug: Leucovorin
RxNorm normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Leucovorin at the protocol-defined dose and regimen.
Trial: NCT04161690
Drug: Dexketoprofen Trometamol
RxNorm normalized name: Dexketoprofen trometamol
FDA approved: no
EMA approved: no
PMDA approved: no
Description: intravenous dexketoprofen 50mg or intrathecal
Trial: NCT01763437
Drug: Tetracycline
RxNorm normalized name: Tetracycline
DrugBank: Tetracycline (DB00759)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Chalazia randomized to the treatment arm will be injected with 0.05 mL of 2% tetracycline solution.
Trial: NCT02382354
Drug: remifentanil
RxNorm normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The predetermined effect-site concentration of remifentanil was started using modified Dixon's up-and-down method
Trial: NCT00646126
Drug: placebo tablet similar to active drug in shape and size
RxNorm normalized name: placebo Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage similar to active drug(standard three days regimen)
Trial: NCT00688857
Drug: Diazoxide choline
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily
Trial: NCT00688857
Drug: Diazoxide choline
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily
Trial: NCT01911455
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02575144
Drug: Clarithromycin
RxNorm normalized name: Clarithromycin
DrugBank: Clarithromycin (DB01211)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 500mg PO twice daily on days 1-28 for a 28-day cycle
Trial: NCT01298336
Drug: Clarithromycin
RxNorm normalized name: Clarithromycin
DrugBank: Clarithromycin (DB01211)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 500 mg twice a day seven days a week
Trial: NCT02406222
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Chemotherapy
Trial: NCT03092180
Drug: Intravenous Infusion
RxNorm normalized name: intravenous infusion pump accessory
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin
Trial: NCT03864068
Drug: Inositol
RxNorm normalized name: Inositol
DrugBank: Inositol (DB13178)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1gm/bid, 2gm/bid or 3gm/bid of Inositol powder
Trial: NCT04021290
Drug: DTG/3TC FDC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DTG/3TC FDC will be available as white, oval, film-coated tablets at a unit dose strength of 50 mg/300 mg. Participants will take DTG/3TC once daily via oral route.
Trial: NCT00539578
Drug: MK0777
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Duration of Treatment: 4 weeks
Trial: NCT00539578
Drug: Comparator: placebo (unspecified)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Duration of Treatment: 4 weeks
Trial: NCT04351594
Drug: Biofreeze 4 % Topical Gel
RxNorm normalized name: Biofreeze 4 % Topical Gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Biofreeze gel with active manufactured ingredient (Menthol 4%)
Trial: NCT01846702
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given as a SC injection.
Trial: NCT01846702
Drug: LY3084077
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given as a SC injection.
Trial: NCT04841993
Drug: Cannabis oil
RxNorm normalized name: Cannabis oil
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single administration of 15 drops (045 mL) of cannabis oil containing 1.8 mg THC and 3.8 mg CBD.
Trial: NCT00444106
Drug: Artemether-lumefantrine
RxNorm normalized name: artemether-lumefantrine
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00147576
Drug: CP-866,087
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01900665
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered IV
Trial: NCT02606630
Drug: ABT-555
RxNorm normalized name: ABT-925
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ABT-555 will be administered on Visit 4 in Part 2 only
Trial: NCT01039389
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: bid placebo
Trial: NCT01079312
Drug: fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Fentanyl citrate 50 mcg/ml,solution for injection,is a narcotic analgesic.In propofol infusion group 0.05 mg of fentanyl was administered intravenously before initiation of sedation. Additional 0.05 mg boluses of fentanyl were given if nociceptive stimulus was anticipated.
Trial: NCT01079312
Drug: sedative mixture
RxNorm normalized name: brown mixture
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml)
Trial: NCT01079312
Drug: remifentanil hydrochlorid
RxNorm normalized name: Remifentanil Hydrochloride
DrugBank: Remifentanil (DB00899)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)
Trial: NCT02167321
Drug: Arm A : standard neoadjuvant chemoradiotherapy group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: radiation : 45Gy±5.4Gy/28Fx/5.5weeks concurrent chemoradiotherapy : 5-FU (400 mg/m2, IV bolus on D1-3, D29-31), leucovorin (20 mg/m2, IV bolus on D1-3, D29-31), preoperative capecitabine : 825 mg/m² p.o. twice daily during XRT, postoperative FL : 5-FU (400 mg/m2, IV bolus)+leucovorin (20m g/m2, IV bolus) on days 1-5 of each 28 day postoperative capecitabine : 1250 mg/m² p.o. twice daily on days 1-14 of each 21 day cycle FOLFOX : oxaliplatin 85 mg/m2, IV over 2 hours on day 1 of each 14 day cycle, leucovorin 200 mg/m2, IV over 2 hours on day 1 of each 14 day cycle, 5-FU 400 mg/m2, IV bolus on day 1 followed by 1200mg/m2 IV over 24 hours on days 1 and 2 of each 14 day cycle