TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00249691
Drug: Placebo + Cognitive Behavioral Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo twice a day
Study: NCT01287039
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo (20 mM sodium acetate, 7% sucrose), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered. Each patient received a specific volume of placebo to match the volume of reslizumab on the basis of the patient's body weight.
Study: NCT01374126
Drug: Azithromycin + Artesunate
Normalized name: Artesunate
DrugBank: Artesunate (DB09274)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Combination of azithromycin + artesunate
Study: NCT03840616
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered once weekly starting on Day 14.
Study: NCT01327261
Drug: Levodopa + benserazide
Normalized name: benserazide / levodopa
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single oral dose of either Experimental or Active Comparator. Levodopa 200 mg/benserazide 50 mg tablets,with 200 mL of water.
Study: NCT00500747
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Four doses sterile saline (0.5 mL total volume) at 0, 4, 24, and 28 weeks.
Study: NCT01561430
Drug: LY2886721
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01561430
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04476719
Drug: ATAFENOVIR 200 MG KAPSUL
Approvals — FDA: no, EMA: no, PMDA: no
Description: A 200 mg capsule 0ral administration with 240 ml water
Study: NCT04476719
Drug: ARBIDOL 100 MG KAPSUL
Approvals — FDA: no, EMA: no, PMDA: no
Description: Two 100 mg capsules will be administrated with 240 ml water orally.
Study: NCT03161964
Drug: Placebo oral capsule
Normalized name: Placebo Oral Capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo capsule over-encapsulated to match propranolol for blinding
Study: NCT00158600
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo Comparator; qow for 78 weeks.
Study: NCT03976583
Drug: Cpp-Acp
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Remineralising agent
Study: NCT03947671
Drug: Acetaminophen
Normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Acetaminophen will be administered as it would be per standard of care
Study: NCT01672112
Drug: Codeine
Normalized name: Codeine
DrugBank: Codeine (DB00318)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Oral Codeine 60mg 6hrly/prn
Study: NCT01327703
Drug: Panzytrat® 25,000
Approvals — FDA: no, EMA: no, PMDA: no
Description: Panzytrat® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day in either first treatment period or second treatment period.
Study: NCT01327703
Drug: Kreon® 25,000
Approvals — FDA: no, EMA: no, PMDA: no
Description: Kreon® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 Ph.Eur. units lipase/kg body weight/day in either first treatment period or second treatment period.
Study: NCT01247246
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT02408068
Drug: Immediate release hydrocortisone: fasted
Approvals — FDA: no, EMA: no, PMDA: no
Description: single dose of 20mg immediate release hydrocortisone in the absence of food
Study: NCT02408068
Drug: Chronocort: fed
Approvals — FDA: no, EMA: no, PMDA: no
Description: single dose of 20mg modified release hydrocortisone in the presence of food
Study: NCT01340768
Drug: Sulfonylurea
Normalized name: Sulfonylurea
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.
Study: NCT03069950
Drug: FLUOROURACIL
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 5-Fluouracil (5FU) (1200 mg/m2/day continuous infusion over two days)
Study: NCT03069950
Drug: Leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Leucovorin (LV) (400 mg/m2 IV over 30 min to an hour)
Study: NCT02472535
Drug: MBX-8025 50 mg, 100 mg or 200 mg (Dose Escalation Period 3)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 or 2 capsules once a day for 4 weeks~(MBX-8025 50 mg, 100 mg or two (2) 100 mg capsules)
Study: NCT00822341
Drug: TG-0054
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.10, 0.14, 0.28, 0.56, 1.12, 2.24, 3.14, and 4.40 mg/kg of TG-0054/placebo via 15 min IV infusion
Study: NCT01008852
Drug: SBI-087
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate
Study: NCT01008852
Drug: SBI-087
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate
Study: NCT01008852
Drug: SBI-087
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate
Study: NCT01008852
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
Study: NCT00731003
Drug: Oxitriptan
Normalized name: Oxitriptan
DrugBank: Oxitriptan (DB02959)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 100 mg 5-Hydroxytryptophan will be administered orally.
Study: NCT00145275
Drug: zoledronic acid
Normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT00731003
Drug: Placebo capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo for 5-HTP
Study: NCT00644449
Drug: azithromycin SR (Zithromax; compound: CP-62,993)
Normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: azithromycin 2.0 g by mouth in the form of a slurry for 1 dose
Study: NCT03485053
Drug: IOP Injection / MPB-1514
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dilute with 5% Dextrose solution (D5W)
Study: NCT00657228
Drug: Intravenous heparin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous heparin as an adjunct for the treatment of anaphylactic/anaphylactoid reactions in the Emergency Department.~To determine if a single bolus of intravenous unfractionated heparin (in conjunction with standard therapy) given to patients with anaphylactic/anaphylactoid reactions results in a faster time to recovery when compared to standard therapy alone.
Study: NCT04145583
Drug: HSK3486
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sequence 1: Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
Study: NCT02996760
Drug: Growth Factor, Platelet-Derived
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0,5 mL, vaginal use , 3 dose number
Study: NCT00085423
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Cyclophosphamide (60 mg/kg/d; Baxter, Deerfield, IL) intravenously (IV) for 2 days with sodium 2- mercaptoethanesulfonate (Mesna; Sicor, Irvine, CA) at 20% of cyclophosphamide dose IV 15 minutes before and 40% of the cyclophosphamide dose orally at 2 and 6 hours after the initiation of chemotherapy.
Study: NCT02949934
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01844739
Drug: NVN1000 4% Gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: Applied topically twice daily
Study: NCT01844739
Drug: Vehicle Gel
Normalized name: vehicle gel base no.61
Approvals — FDA: no, EMA: no, PMDA: no
Description: Applied topically twice daily
Study: NCT03880916
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Phase I (preemptive): 2weeks before operation (Placebo for 2weeks) Phase II (maintenance): 6weeks after operation (Placebo for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)
Study: NCT02390141
Drug: ZP4207
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02390141
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01124344
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral Solution, Oral, 0 mg, Once Daily, 14 days
Study: NCT02994940
Drug: Acetaminophen
Normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: no, EMA: no, PMDA: no
Description: already included in arm/group descriptions
Study: NCT02141035
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The control subjects will receive placebo tablets that are identical in appearance and taste to the active medication tid for 60 days
Study: NCT02651454
Drug: Daesiho-tang
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
Study: NCT02651454
Drug: Chowiseungcheng-tang
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd.
Study: NCT02651454
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
Study: NCT01321008
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 750 mg/m2 by vein over 1 hour on Day 1 of a 21 day cycle.
Study: NCT01321008
Drug: Doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 50 mg/m2 by vein over 15 minutes on Day 1 of a 21 day cycle.
Study: NCT02145312
Drug: BYL719
Approvals — FDA: no, EMA: no, PMDA: no
Description: BYL719 is an oral class I α-specific PI3K inhibitor belonging to the 2-aminothiazole class of compounds.
Study: NCT00395382
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: weekly orally
Study: NCT01321619
Drug: Daflon
Normalized name: Daflonex
Approvals — FDA: no, EMA: no, PMDA: no
Description: Drug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.
Study: NCT04203875
Drug: Orencia® (Abatacept)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Orencia® (Abatacept) will be administered once a week for 6 months subcutaneously (injection under the skin) with an option to continue to receive Abatacept weekly injections for an additional 6 months, for a total of 12 months if there is a positive response.
Study: NCT00026364
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00026364
Drug: leucovorin calcium
Normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00753220
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Cyclophosphamide i.v. given at day -3 (dose: 300mg/m2); Low-dose Cyclophosphamide pill given twice daily (dose: 25 mg, p.o., b.i.d. for 7 days on and 7 days off; a total of 6 cycles \[1 cycle = 4 weeks\] starting Week 2 after cryoablation and going to Week 26)
Study: NCT00613938
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 capsule q4-6 hrs for 3 days
Study: NCT03909295
Drug: LCZ696
Approvals — FDA: no, EMA: no, PMDA: no
Description: Starting dose was either 50 mg b.i.d. or 100 mg b.i.d. largely depending on the last dose level taken by the patient at the time of completing PARAGON-HF and patient condition. The dose level was gradually up-titrated with the goal of reaching the target dose of 200 mg b.i.d. as soon as tolerated by the patient
Study: NCT00939120
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily
Study: NCT01586169
Drug: triple co administration at once of the combination of Albendazole + ivermectin + azithromycin
Normalized name: OIL OF CAMPHOR
Approvals — FDA: no, EMA: no, PMDA: no
Description: Albendazole 400mg + ivermectin according to the height + azithromycin according to the height at once
Study: NCT01743131
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04840238
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets
Study: NCT00649688
Drug: Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 100/50mg, single dose fasting
Study: NCT00649688
Drug: Lopressor HCT® Tablets 100/50 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 100/50mg, single dose fasting
Study: NCT00703573
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo BID
Study: NCT00248547
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Study: NCT01576874
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo administered intranasally one time
Study: NCT02701166
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo 400mg per day
Study: NCT01629966
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,
Study: NCT04393766
Drug: Normal Saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: normal saline(crystalloids)
Study: NCT02981641
Drug: Sequential chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sequential chemotherapy
Study: NCT00770536
Drug: A1: AMG 386 10 mg/kg + Liposomal doxorubicin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Liposomal doxorubicin 50 mg/m2 IV Q4W in combination with AMG 386 10 mg/kg IV QW
Study: NCT01649466
Drug: LAF237
Approvals — FDA: no, EMA: no, PMDA: no
Description: Vildagliptin will be used as commercially available tablets of 50mg.
Study: NCT03916198
Drug: Normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Just after arthroscopic rotator cuff repair, 3cc normal saline will be injected, and 2 weeks after the surgery the same amount of the material will be injected.
Study: NCT01125748
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.
Study: NCT03603704
Drug: LY3209590
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered SC
Study: NCT03603704
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered SC
Study: NCT03118570
Drug: zoledronic acid (optional)
Normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Study: NCT03970837
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo matching GSK3196165 and Tofacitinib was administered.
Study: NCT03918109
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: single intratympanic injection of placebo
Study: NCT01055327
Drug: No anti-epileptic drug exposure
Normalized name: Anti Bac
Approvals — FDA: no, EMA: no, PMDA: no
Description: No exposure to anti-epileptic drugs in the first trimester of pregnancy (time period from first day of menstrual period to 12th week of gestation).
Study: NCT01689662
Drug: Tc 99m EC20
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01997229
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT04014855
Drug: Iron Supplement
Normalized name: Iron supplement
Approvals — FDA: no, EMA: no, PMDA: no
Description: in iron deficiency anemia
Study: NCT03514797
Drug: Bleaching Agents
Approvals — FDA: no, EMA: no, PMDA: no
Description: In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.
Study: NCT03776838
Drug: Intravenous Fentanyl guided by SoC+NOL
Approvals — FDA: no, EMA: no, PMDA: no
Description: Predeterminated bolus of IV Fentanyl will be given at the induction of anesthesia (2 mcg/kg), at the time of incision (1 mcg/kg). During surgery, administration of 0.5 mcg/kg of IV Fentanyl will be administred following a pre determinated algorithm based on NOL index + heart rate + mean arterial blood pressure variations.
Study: NCT03776838
Drug: Intravenous Fentanyl guided by SoC
Approvals — FDA: no, EMA: no, PMDA: no
Description: Bolus of IV Fentanyl at the discretion of a physician will be given at the induction of anesthesia, and at the time of incision. During surgery, administration of IV Fentanyl at the discretion of a physician will be administred following a pre determinated algorithm based on heart rate + mean arterial blood pressure variations.
Study: NCT03514797
Drug: Bleaching Agents
Approvals — FDA: no, EMA: no, PMDA: no
Description: At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.
Study: NCT01303705
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: CTX will be administered on day 1 (Friday only) at a dose determined by cohort assignment. The drug should be diluted per institutional standards. An added dose of IV fluids may help prevent bladder toxicity. In this protocol, CTX will be administered intravenously over 30 - 60 minutes.
Study: NCT04203056
Drug: ARI-ORAL
Normalized name: Ovis aries whole extract
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral aripiprazole
Study: NCT03003468
Drug: MK-3475
Normalized name: vitamin MK 7
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200mg IV
Study: NCT04568031
Drug: 0.9% (w/v) saline
Approvals — FDA: no, EMA: no, PMDA: no
Description: For subjects in placebo will have that route of Administration as Intramuscular 0.9% (w/v) saline on V2 and V6.
Study: NCT02833766
Drug: anti-EGFR-IL-dox
Normalized name: Anti Bac
Approvals — FDA: no, EMA: no, PMDA: no
Description: First-line treatment with anti-EGFR-IL-dox, given at a dose of 50 mg/m2 intravenous, on day 1 of each cycle, cycle length is 28 days
Study: NCT01565850
Drug: DRV
Normalized name: Urinal Male Drv RTLPC23201
Approvals — FDA: no, EMA: no, PMDA: no
Description: DRV 800 mg (2 × 400 mg tablets) administered orally once daily
Study: NCT01565850
Drug: DRV Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: DRV placebo tablet administered orally once daily
Study: NCT01471639
Drug: intranasal ketorolac
Approvals — FDA: no, EMA: no, PMDA: no
Description: 15 mg
Study: NCT03252418
Drug: Ascorbic Acid 500 MG
Normalized name: ascorbic acid 500 MG
DrugBank: Ascorbic acid (DB00126)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: ascorbic acid is vitamin that can cause gingival depigmentation
Study: NCT00446199
Drug: 0.5mg DRSP / 0.5mg E2 (BAY86-4891)
Approvals — FDA: no, EMA: no, PMDA: no
Description: One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).
Study: NCT00446199
Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
Approvals — FDA: no, EMA: no, PMDA: no
Description: One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).
Study: NCT00446199
Drug: Estradiol (E2 0.3mg)
Normalized name: Estradiol
DrugBank: Estradiol acetate (DB13952)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle).
Study: NCT00446199
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
Study: NCT02912845
Drug: KamRAB - HRIG
Approvals — FDA: no, EMA: no, PMDA: no
Description: wound infiltration or IM injection
Study: NCT01195792
Drug: GSK1521498
Approvals — FDA: no, EMA: no, PMDA: no
Description: GSK1521498 2mg or 5mg will be given for up to 35 days and subjects will be assessed weekly
Study: NCT00280462
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT01195792
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be given for up to 35 days and subjects will be assessed weekly
Study: NCT00321828
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 5-FU 400 mg/m2 IV bolus over 2-4 minutes then 2400 mg/m2 IV continuous infusion over 46 hours on day 1 every 14 days until excessive toxicity or disease progression
Study: NCT00321828
Drug: leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: leucovorin 400 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression
Study: NCT01590875
Drug: Adenosine arm
Normalized name: Adenosine
DrugBank: Adenosine phosphate (DB00131)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation.
Study: NCT00573157
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered at a dose of 150 mg SC twice weekly for 4 weeks followed by 150 mg SC once weekly for 48 weeks.
Study: NCT00573157
Drug: Corticosteroids
Normalized name: CORTICOSTEROIDS
Approvals — FDA: no, EMA: no, PMDA: no
Description: High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever is less will be administered for 4 Weeks and will be tapered to 7.5 to 10 mg/day up to Week 12.
Study: NCT02944383
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets administered orally once daily, for 12 weeks.