TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01862003
Drug: Fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 400 mg/m2 (IV bolus) of Fluorouracil on day 1 of each 2-weekly cycle, to be given after completion of Irinotecan and Folinic acid.
Study: NCT01862003
Drug: Fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 2400 mg/m2 (IV) continuous infusion of Fluorouracil given over 46 hours - infusion to start after 5FU bolus.
Study: NCT02137343
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT02137343
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: A chemo-therapy prodrug that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.
Study: NCT03017001
Drug: intravenous w-3 PUFA
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients in this groups received during the operation (intraoperative) a dose of intravenous w3-PUFA
Study: NCT00312286
Drug: 851B
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Study: NCT00312286
Drug: 851B
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 851B 1.5% formulation, gel, topically, twice a week for 1 cycle.
Study: NCT00312286
Drug: 851B
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 851B 1.5% formulation, gel, topically, twice a week for 2 cycles.
Study: NCT00312286
Drug: 851B
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 851B 3.0% formulation, gel, topically, once a week for 1 cycle.
Study: NCT00312286
Drug: 851B
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 851B 3.0% formulation, gel, topically, once a week for 2 cycles.
Study: NCT00312286
Drug: 851B
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 851B 3.0% formulation, gel, topically, twice a week for 1 cycle.
Study: NCT00312286
Drug: 851B
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 851B 3.0% formulation, gel, topically, twice a week for 2 cycles.
Study: NCT00312286
Drug: 851B
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 851B placebo-matching gel, topically, once a week for 1 cycle.
Study: NCT00312286
Drug: 851B
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 851B placebo-matching gel, topically, twice a week for 1 cycle.
Study: NCT00312286
Drug: 851B
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 851B placebo-matching gel, topically, once a week for 2 cycles.
Study: NCT00312286
Drug: 851B
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 851B placebo-matching gel, topically, twice a week for 2 cycles.
Study: NCT01483170
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo fexinidazole
Study: NCT03765931
Drug: Doxycycline
Normalized name: Doxycycline
DrugBank: Doxycycline (DB00254)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The investigators conducted a non-inferiority, open-label, randomized controlled trial in patients aged \> 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature \> 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (2:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investigators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature \< 37.5°C.
Study: NCT02880319
Drug: Stereotactic Body Radiation Therapy (SBRT)
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02090764
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04684420
Drug: Glucophage® XR RM Test
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants received a single oral dose of 500 mg of test Glucophage® XR RM tablet under fasting or fed conditions.
Study: NCT04684420
Drug: Glucophage® XR Reference
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants received a single oral dose of 500 mg of reference Glucophage® XR tablet under fasting or fed conditions.
Study: NCT00651287
Drug: quinapril 20 mg plus hydrochlorothiazide 12.5 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 20 mg plus hydrochlorothiazde 12.5 mg daily (Accuzide tablets) for 6 weeks
Study: NCT02327169
Drug: MLN2480
Approvals — FDA: no, EMA: no, PMDA: no
Description: MLN2480 tablets.
Study: NCT02327169
Drug: MLN0128
Approvals — FDA: no, EMA: no, PMDA: no
Description: MLN0128 capsules.
Study: NCT01047540
Drug: AIC316
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration
Study: NCT01047540
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration
Study: NCT02836249
Drug: TAF
Normalized name: Altafed
Approvals — FDA: no, EMA: no, PMDA: no
Description: TAF 25 mg tablet administered orally once daily
Study: NCT02836249
Drug: TAF Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: TAF placebo tablet administered orally once daily
Study: NCT02836249
Drug: TDF Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: TDF placebo tablet administered orally once daily
Study: NCT03950856
Drug: V114
Normalized name: Pneumococcal 15-valent Conjugate Vaccine
Approvals — FDA: no, EMA: no, PMDA: no
Description: 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.
Study: NCT03950856
Drug: Prevnar 13™
Approvals — FDA: no, EMA: no, PMDA: no
Description: 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F in each 0.5. mL dose.
Study: NCT04104789
Drug: Kovanaze Nasal Spray
Normalized name: Kovanaze Nasal Product
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intra-nasal local anesthetic
Study: NCT04429919
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: During the 10-day double-blind treatment period (Days 1 to 10), subjects will take 4 capsules of the IMP orally once daily in the morning before breakfast.
Study: NCT02160808
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02194153
Drug: Metalyse weight-adjusted
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01395745
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered weekly via subcutaneous injection for 52 weeks
Study: NCT02038036
Drug: Best Available Therapy
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib.
Study: NCT01573117
Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
Study: NCT01972659
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
Study: NCT02410187
Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc)
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Physicians can choose all the options available chemotherapy, hormon therapy, target therapy etc.~Use of chemotherapy schemes containing potent enhancers of radiation damage (e.g. gemcitabine,adriamycin) are discouraged within the first month after SBRT.
Study: NCT00834197
Drug: REMERON SolTab® 15 mg Orally Disintegrating Tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 x 15 mg, single-dose non-fasting
Study: NCT00988247
Drug: Placebo Nasal Aerosol
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo nasal aerosol administered daily for 30-weeks (or 52-weeks, depending upon investigator site).
Study: NCT03802396
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
Study: NCT01107886
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04194242
Drug: HEC96719 tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.1、0.2、0.5、1、2、3、4 mg HEC96719 tablet in day1
Study: NCT04194242
Drug: Placebo tablet
Normalized name: placebo Oral Tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.1、0.2、0.5、1、2、3、4 mg Placebo tablet in day1
Study: NCT01471665
Drug: GSK2190915 100mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor. Dosing will occur once daily for up to 16 days.
Study: NCT02724202
Drug: 5-flurorouracil
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fluorouracil is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. Fluorouracil is classified as an antimetabolite.
Study: NCT03262961
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01246960
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered intravenously
Study: NCT01246960
Drug: Leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Administered intravenously
Study: NCT02829372
Drug: CD3/HER2 bispecific monoclonal antibody
Approvals — FDA: no, EMA: no, PMDA: no
Description: Increasing doses, IV on day 1 and 15 of each 28 day cycle
Study: NCT00980044
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral Medication
Study: NCT01471665
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered once daily for up to 16 days.
Study: NCT01409096
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Inactive ingredient matching the active medication in appearance.
Study: NCT02301897
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Study: NCT01605994
Drug: Placebo matching with BMS-933043
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01605994
Drug: Antacid Buffer Predose Solution
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01347814
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Homeopathic (Sugar) pill-Placebo
Study: NCT00314977
Drug: Doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: doxorubicin (arm A:60 mg/m2) and arm B: 50 mg/m2)
Study: NCT00314977
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Cyclophosphamide: (arm A; 6000 mg/m2) an (arm B: 500 mg/m2)
Study: NCT01067807
Drug: 25 mg Proellex
Normalized name: guaiacolsulfonate / hydrocodone bitartrate Oral Solution [Prolex DH]
Approvals — FDA: no, EMA: no, PMDA: no
Description: 25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) \[Original\], single dose
Study: NCT01067807
Drug: 25 mg Proellex
Normalized name: guaiacolsulfonate / hydrocodone bitartrate Oral Solution [Prolex DH]
Approvals — FDA: no, EMA: no, PMDA: no
Description: 25 mg - given as one 25 mg capsule (coated with microcrystalline cellulose, new formulation) (coated), single dose
Study: NCT01067807
Drug: 25 mg Proellex
Normalized name: guaiacolsulfonate / hydrocodone bitartrate Oral Solution [Prolex DH]
Approvals — FDA: no, EMA: no, PMDA: no
Description: 25 mg - given as one 25 mg capsule (blended with microcrystalline cellulose, new formulation) \[Blended\], single dose
Study: NCT01067807
Drug: 50 mg Proellex
Normalized name: guaiacolsulfonate / hydrocodone bitartrate Oral Solution [Prolex DH]
Approvals — FDA: no, EMA: no, PMDA: no
Description: 50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) \[Blended\], single dose
Study: NCT03474276
Drug: Azythromycin
Normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Administration of azythromycin to the child at inclusion (3 days) 20 mgs/kgs/day : three days
Study: NCT03116126
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: inactive oral daily tablet
Study: NCT00004128
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT03135860
Drug: Inhaled Nitric Oxide 30mcg/kg IBW/hr
Approvals — FDA: no, EMA: no, PMDA: no
Description: Inhaled Nitric Oxide 30 mcg/kg IBW/hr will be administered through the INOPulse Device open label for 4 weeks
Study: NCT01702298
Drug: Sitagliptin 100 mg/simvastatin 40 mg FDC
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks
Study: NCT02522767
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02494596
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Participants will receive capecitabine on Days 1 to 14 of each 3-week cycle as 825, 1000, or 1250 mg/m\^2 PO twice daily. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.
Study: NCT01186757
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT00573768
Drug: Diclofenac diethylamine 2.32% gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: Diclofenac diethylamine 2.32% gel twice daily
Study: NCT00573768
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Vehicle 2 times daily
Study: NCT00573768
Drug: Diclofenac diethylamine 2.32% gel / Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily
Study: NCT02576288
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: No anti-inflammatory properties
Study: NCT04183686
Drug: Placebo (SAD)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single dose of matching placebo; soft capsules for oral use.
Study: NCT04183686
Drug: Placebo (MAD)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Multiple doses of matching placebo; soft capsules for oral use.
Study: NCT02321475
Drug: EGb761®
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03322566
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo administered orally twice daily.
Study: NCT03202394
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intervention involves aerosolized delivery of either the active drug or placebo by the Aeroneb Pro nebulizer.
Study: NCT02736071
Drug: Celecoxib
Normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Women will receive oral Celecoxib 200mg 2 hours before the procedure
Study: NCT02736071
Drug: Placebo 1
Normalized name: placebo 125 MG
Approvals — FDA: no, EMA: no, PMDA: no
Description: Women will receive an oral placebo similar to Tramadol 2 hours before the procedure
Study: NCT02736071
Drug: Placebo 2
Normalized name: Ethinyl Estradiol/Norethindrone Acetate;Placebo 20 MCG-1 MG; NA Oral Tablet, Disintegrating
Approvals — FDA: no, EMA: no, PMDA: no
Description: Women will receive an oral placebo similar to Celecoxib 2 hours before the procedure
Study: NCT03503409
Drug: AG-120
Approvals — FDA: no, EMA: no, PMDA: no
Description: 500 mg/day Oral of AG-120. AG-120 will be dispensed on Day 1 of each treatment cycle
Study: NCT02448381
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.
Study: NCT00054262
Drug: T900607
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00833690
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 500 mg of inactive substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing adjusted algorithmically to parallel that in the inosine arms
Study: NCT00833690
Drug: inosine
Normalized name: Inosine
DrugBank: Inosine (DB04335)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a mildly elevated serum urate range of 6.1 - 7.0 mg/dL
Study: NCT00833690
Drug: inosine
Normalized name: Inosine
DrugBank: Inosine (DB04335)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a moderately elevated serum urate range of 7.1 - 8.0 mg/dL
Study: NCT01438918
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets once a day for 2 years
Study: NCT02011347
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00645658
Drug: Testim, 1% testosterone gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects apply contents of gel packet (Testim, 1% testosterone gel) to skin daily.
Study: NCT02947048
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00304161
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 40 to 80 mg orally once daily for 8 weeks
Study: NCT04316416
Drug: control group
Normalized name: meningococcal group B vaccine Prefilled Syringe [Trumenba]
Approvals — FDA: no, EMA: no, PMDA: no
Description: 24 hours morphine consumption will be recorded using the patient controlled analgesia device with intravenous morphine.
Study: NCT04256655
Drug: cohort 1 0.225g
Approvals — FDA: no, EMA: no, PMDA: no
Description: Drug: CDX 6114 CDX-6114 for oral administration is formulated in phosphate buffer, which also includes mannitol and poloxamer.The vehicle solution provided is identical to the CDX-6114 oral solution except for the active drug. Matching Placebo The placebo oral dosing solution will also be supplied as an oral solution and will be made up of the phosphate buffer diluent and the caramel flavoring.
Study: NCT04256655
Drug: Cohort 2 0.75g
Approvals — FDA: no, EMA: no, PMDA: no
Description: Drug: CDX 6114 CDX-6114 for oral administration is formulated in phosphate buffer, which also includes mannitol and poloxamer.The vehicle solution provided is identical to the CDX-6114 oral solution except for the active drug. Matching Placebo The placebo oral dosing solution will also be supplied as an oral solution and will be made up of the phosphate buffer diluent and the caramel flavoring.
Study: NCT04256655
Drug: Cohort 3 2.25 g
Approvals — FDA: no, EMA: no, PMDA: no
Description: Drug: CDX 6114 CDX-6114 for oral administration is formulated in phosphate buffer, which also includes mannitol and poloxamer.The vehicle solution provided is identical to the CDX-6114 oral solution except for the active drug. Matching Placebo The placebo oral dosing solution will also be supplied as an oral solution and will be made up of the phosphate buffer diluent and the caramel flavoring.
Study: NCT03728478
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Methotrexate will be administered subcutaneously, in a single weekly dose of 15 mg/m2 (max 20 mg).
Study: NCT03728478
Drug: Intra-articular corticosteroid injections
Approvals — FDA: no, EMA: no, PMDA: no
Description: Triamcinolone hexacetonide and methylprednisolone acetate doses depend on the affected joint.
Study: NCT02287779
Drug: SHP626
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02287779
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02577809
Drug: Fentanyl
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 25mcg Fentanyl added to the spinal anaesthetic
Study: NCT02577809
Drug: Hyperbaric Bupivicaine
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1.8ml 0.5% spinal bupivicaine with dextrose
Study: NCT02577809
Drug: Indomethacin
Normalized name: Indomethacin
DrugBank: Indomethacin (DB00328)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 100mg Indomethacin suppository
Study: NCT01169779
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Study: NCT03477422
Drug: CSE-1034 (Ceftriaxone + Sulbactam + EDTA)
Normalized name: PHOSPHORIC ACID 1500 mg in 10 L / BENZALKONIUM CHLORIDE 400 mg in 10 L / N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) 400 mg in 10 L TOPICAL LIQUID [StepSept CSE-200]
Approvals — FDA: no, EMA: no, PMDA: no
Description: CSE-1034 (Ceftriaxone + Sulbactam + EDTA) was Experimental in this study and is a combination of Ceftriaxone 1000mg, Sulbactam 500mg and EDTA 37mg available as dry powder for reconstitution. Patients were given either CSE-1034 or placebo through IV route four times daily, strictly adhering to the time interval. Time of the first dose (Drug) was considered 0th hr, the second dose (Placebo) was given at 8th hour from first dose, third dose (Drug) at 12th hour from first dose and the fourth dose (Placebo) at 16th hour from first dose. The infusion was initiated within ± 30 min of schedule time.
Study: NCT04049513
Drug: Cyclophosphamide and Fludarabine lymphodepleting chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Cyclophosphamide 500 mg/m\^2 IV on days -5 to -3, inclusive. Fludarabine 30 mg/m\^2 IV on days -5 to -3, inclusive
Study: NCT01188967
Drug: GSK598809
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral dose of 60 mg/day for a treatment period six weeks
Study: NCT01188967
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT00189475
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00244985
Drug: pegylated liposomal doxorubicin hydrochloride
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV
Study: NCT00416507
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes