TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01426347
Drug: Placebo sugar pill
Normalized name: placebo Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.
Study: NCT04276090
Drug: Hepatic artery infusion pump floxuridine and dexamethasone
Normalized name: Floxuridine
DrugBank: Floxuridine (DB00322)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Study: NCT00130065
Drug: Sulfadoxine-pyrimethamine/folic acid
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03617835
Drug: R - Low dose of BI 655130
Normalized name: R
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.
Study: NCT03617835
Drug: T2 - Low dose of BI 655130
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
Study: NCT04324294
Drug: EUS enhanced with contrast to evaluate pancreas
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive intravenous contrast during EUS to assess whether it improves the evaluation of pancreas.
Study: NCT01007968
Drug: LBH589
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00641758
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo 100mg twice daily
Study: NCT01805817
Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral contraceptive pills
Study: NCT03371823
Drug: Hypertensives
Normalized name: ANTIHYPERTENSIVES
Approvals — FDA: no, EMA: no, PMDA: no
Description: ANG II increases the synthesis of ET-1 and alters ET-A/B receptor expression, thus affecting ET-1 bioavailability. Losartan is an ANG II receptor antagonist which attenuates ET-1 production. Losartan 50 mg daily is administered for 14 days to hypertensive women. FMD is used to measure endothelial function. Pulse Wave Analysis and Pulse Wave Velocity assesses arterial stiffness and wave reflection. Laser Doppler flowmetry with cutaneous microdialysis is used to examine vascular function when ET-A and ET-B receptor antagonists is perfused via intradermal microdialysis fibers. ET-1 production and ET-B receptor expression in endothelial cells collected from an antecubital vein will be assessed. Skin punch biopsy samples will be used to assess for protein expression of ET-A and ET-B receptors.
Study: NCT00932646
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo Respimat once daily and placebo Foradil
Study: NCT00391339
Drug: Bryophyllum p.
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04170296
Drug: EN3835
Approvals — FDA: no, EMA: no, PMDA: no
Description: Collagenase Clostridium Histolyticum (CCH)
Study: NCT02498379
Drug: Cu[64]-25%CANF-Comb
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous injection of 4-8 mCi of Cu\[64\]-25%CANF-Comb with PET-CT scans performed 1-4 hours, 5-10 hours, and 22-26 hours or 46-50 hours after injection.
Study: NCT04733196
Drug: Essential oils
Normalized name: essential oils
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Study: NCT03016793
Drug: β- tricalcium phosphate
Normalized name: tricalcium phosphate
DrugBank: Calcium citrate (DB11093)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: β- tricalcium phosphate is a bone graft used for surgical repair of bony defects
Study: NCT03016793
Drug: β- tricalcium phosphate alone
Normalized name: tricalcium phosphate
DrugBank: Calcium citrate (DB11093)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: β- tricalcium phosphate is a bone graft used for surgical repair of bony defects
Study: NCT01267669
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Emergency EVL plus placebo infusion for 5 days
Study: NCT02538315
Drug: [18F]FDOPA PET/CT
Approvals — FDA: no, EMA: no, PMDA: no
Description: Implantation of fetal dopaminergic stem cell transplantation by neuro-surgeon followed by \[18F\]FDOPA PET/CT imaging
Study: NCT02201901
Drug: SOF/VEL
Approvals — FDA: no, EMA: no, PMDA: no
Description: 400/100 mg tablets administered orally once daily
Study: NCT00372853
Drug: CP-675,206
Approvals — FDA: no, EMA: no, PMDA: no
Description: CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
Study: NCT00372853
Drug: SU011248
Approvals — FDA: no, EMA: no, PMDA: no
Description: SU011248 administered at a dose of 37.5mg/day every day.
Study: NCT00372853
Drug: SU011248
Approvals — FDA: no, EMA: no, PMDA: no
Description: SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.
Study: NCT03210649
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1\~D14
Study: NCT00814515
Drug: NOVA22007
Approvals — FDA: no, EMA: no, PMDA: no
Description: Vehicle
Study: NCT01288781
Drug: Lactose monohydrate
Normalized name: Lactose Monohydrate
Approvals — FDA: no, EMA: no, PMDA: no
Description: During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.
Study: NCT00895726
Drug: APD209
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral tablets twice per day for 56 days
Study: NCT01186328
Drug: EZN-3042
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dose will be assigned at study entry. To be given as a 2 hour intravenous infusion on days -5, -2, 8, 15, 22 and 29. Dose levels: L0 (level zero): 1.5 mg/kg, L1: 2.5 mg/kg, L2: 5 mg/kg, L3: 6.5 mg/kg
Study: NCT01186328
Drug: Doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 60 mg/m2/day given intravenous infusion (IV) over 15 minutes on day 1.
Study: NCT00113815
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo
Study: NCT02779348
Drug: BIA 3-202
Normalized name: Oatmeal 10 mg in 1 mL TOPICAL CREAM [BIA Eczema Relief]
Approvals — FDA: no, EMA: no, PMDA: no
Description: Nebicapone tablets 200 mg
Study: NCT02414009
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Patients in Arm A will receive capecitabine at the oral dose of 1500 mg/mq/die refracted in two daily doses from day 1 to day 14 every 28 days
Study: NCT02414009
Drug: Fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Patients in Arm B will receive FOLFIRI chemotherapy starting Day 1 q2w (every cycle) starting on Day 1 of Cycle 1. FOLFIRI consists of irinotecan (starting dose of 180 mg/m2) on day one only; 5-FU (starting bolus and 22-hour infusional doses of 400 mg/m2 and 600 mg/m2, respectively), and leucovorin (racemic, starting dose of 200 mg/m2 or L-form, starting dose of 100 mg/m2) for two consecutive days.
Study: NCT02414009
Drug: Leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Patients in Arm B will receive FOLFIRI chemotherapy starting Day 1 q2w (every cycle) starting on Day 1 of Cycle 1. FOLFIRI consists of irinotecan (starting dose of 180 mg/m2) on day one only; 5-FU (starting bolus and 22-hour infusional doses of 400 mg/m2 and 600 mg/m2, respectively), and leucovorin (racemic, starting dose of 200 mg/m2 or L-form, starting dose of 100 mg/m2) for two consecutive days.
Study: NCT00321685
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given PO
Study: NCT00321685
Drug: Fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00321685
Drug: Leucovorin Calcium
Normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT01186328
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given intrathecally to patients with CNS1 or CNS2 disease at the dose defined by age below on days 15 and 36:~1-1.99 years: 8 mg 2-2.99 years: 10 mg 3-8.99 years: 12 mg~Greater than or equal to 9 years: 15 mg~Given as part of the Triple intrathecal therapy to patients with CNS 3 disease at the doses defined by age below on days 8, 15, 22 and 29:~1. - 1.99 years: 8 mg~2. - 2.99 years: 10 mg~3. - 8.99 years: 12 mg~Greater than or equal to 9 years: 15 mg
Study: NCT01186328
Drug: Hydrocortisone
Normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Given as part of the Triple intrathecal therapy to patients with CNS 3 disease at the doses defined by age below on days 8, 15, 22 and 29:~1. - 1.99 years: 8 mg~2. - 2.99 years: 10 mg~3. - 8.99 years: 12 mg~Greater than or equal to 9 years: 15 mg
Study: NCT04854538
Drug: Ekmasonid
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 extended release tablet contains 9 mg Budesonide
Study: NCT01267825
Drug: Standard medical care
Approvals — FDA: no, EMA: no, PMDA: no
Description: Naproxen + Oxycodone/ Acetaminophen
Study: NCT00674635
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: matching placebo
Study: NCT01486615
Drug: meloset (melatonin)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 3 mg melatonin tablet 1-2 hour prior surgery
Study: NCT01486615
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: similar looking placebo tablet
Study: NCT02219698
Drug: Ibuprofen
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01382940
Drug: methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 10 to 25 mg/week (oral or parenteral)
Study: NCT01382940
Drug: acetaminophen
Normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 gram acetaminophen administered orally 30 to 60 minutes prior to the start of each study drug infusion
Study: NCT00000469
Drug: lovastatin
Normalized name: Lovastatin
DrugBank: Lovastatin (DB00227)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00566813
Drug: Islet Cell Transplant
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1-3 allogeneic islet transplants; two doses of basiliximab 20 mg iv.; sirolimus po trough levels 10-15 ng/ml X 3 months, then 7-10 ng/ml; tacrolimus po trough levels 3-6 ng/ml
Study: NCT00566813
Drug: Islet Cell Transplant plus
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1-3 allogeneic Islets of Langerhans transplantations; two doses of basiliximab 20 mg iv.; sirolimus po daily to maintatin serum levels 12-15 ng/mL for 3 months, and 7-10 ng/mL thereafter; tacrolimus po twice daily to maintain serum levels 3-6 ng/mL; etanercept 50 mg IV before islet transplant, 25 mg subcutaneously post-transplant days 3, 7, 10; exenatide subcutaneously 5 mcg pre-transplant and twice daily for I week, then increased to 10-mcg twice daily for 6 months after the last islet transplant.
Study: NCT04303507
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT04249336
Drug: Fluoro-Calcium-Phospho-Silicate based dentifrices
Normalized name: Calcium Silicate
DrugBank: Calcium silicate (DB13829)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Bio-Active glass based formulation
Study: NCT04259359
Drug: Insect Venom
Normalized name: insect venom
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will be treated with bee venom immunotherapy (protocol can be selected by patient). Blood samples are taken before starting VIT to determine specific immunoglobulin E (sIgE) Levels for bee venom components. Patients are sting challenged and the outcome will be recorded.
Study: NCT00563589
Drug: mycophenolate mofetil, methotrexate, cyclosporin
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00563589
Drug: Methotrexate and cyclosporin
Normalized name: Cyclosporine
DrugBank: Cyclosporine (DB00091)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00781742
Drug: AZD6765
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV once per dosing day, multiple times during the treatment period
Study: NCT00781742
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.9% saline IV once per dosing day multiple times during the treatment period
Study: NCT02127320
Drug: Rosuvastatin 20mg
Normalized name: ROSUVASTATIN 20MG CAP,SPRINKLE
DrugBank: Rosuvastatin (DB01098)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02127320
Drug: Rosuvastatin 20mg + Ezetimibe 10mg
Normalized name: ezetimibe / rosuvastatin
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00590564
Drug: Sho-saiko-to
Approvals — FDA: no, EMA: no, PMDA: no
Description: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks unless occurrence of unacceptable adverse events or patient withdrawal. Patients will be seen for clinical follow-up at three month intervals: at 3, 6, 9, and 12 months, and assessed for compliance and asked about side effects and pulmonary symptoms. At each clinic visit, a comprehensive metabolic profile will be performed. At the 6-month clinic visit, a CBC will be performed. At the 12-month clinic visit, quantitative HCV-RNA by PCR will be obtained (Viromed Labs, Inc., 6101 Blue Circle Drive, Minneapolis, MN 5534). Within 4 weeks after the 12-month clinic visit (after 52 weeks of SST therapy), the second liver biopsy will be scheduled and performed.
Study: NCT00656201
Drug: Crinone 8% Vaginal Gel
Normalized name: Crinone 8% Vaginal Gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
Study: NCT03430544
Drug: Placebo oral capsule
Normalized name: Placebo Oral Capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: PLACEBO Group: Visually identical placebo capsules will be supplied by the University of Pennsylvania Investigational Drug Service, with a dosing regimen matching the cariprazine groups.
Study: NCT03102489
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Nasal spray
Study: NCT02356705
Drug: saline placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: intranasal saline given as placebo
Study: NCT02453061
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Safflower oil orally administered at 1g/kg/day
Study: NCT01033292
Drug: BSI-201
Normalized name: CENTRAL LINE DRESSING ERASE BSI CHANGE KIT MEDLINE #BSIPICC1000
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV infusion, 5.6 mg/kg
Study: NCT02357888
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oromucosal - Single dose
Study: NCT02557126
Drug: URC102
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02557126
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00162708
Drug: CDDP, 5 Fu
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01475461
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: double-dummy placebo tablets administered once-daily for 84-days
Study: NCT02643719
Drug: Standard of Care
Approvals — FDA: no, EMA: no, PMDA: no
Description: Standard discharge instruction sheet plus standard of care medication as prescribed by treating physician. The clinical team will be instructed to address post-discharge care as appropriate
Study: NCT04197076
Drug: EGFR-TKI, ALK inhibitor, ROS1 inhibitor
Approvals — FDA: no, EMA: no, PMDA: no
Description: targeted therapy EGFR-TKI, ALK inhibitor, ROS1 inhibitor
Study: NCT04197076
Drug: investigator decided
Normalized name: INVESTIGATIONAL AGENTS
Approvals — FDA: no, EMA: no, PMDA: no
Description: chemotherapy
Study: NCT02095990
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00027521
Drug: electroporation therapy
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01694810
Drug: 2% NVN1000 Topical Gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2% NVN1000 Topical Gel once daily for 4 weeks
Study: NCT01694810
Drug: 4% NVN1000 Topical Gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: 4% NVN1000 4% Topical Gel applied once daily 4 weeks
Study: NCT01694810
Drug: 8% NVN1000 Topical Gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: 8% NVN1000 Topical Gel applied once daily for 4 weeks
Study: NCT00807521
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo for dexamethasone
Study: NCT00082537
Drug: Comparator: AmBisome
Approvals — FDA: no, EMA: no, PMDA: no
Description: Duration of Treatment: 28-90 days
Study: NCT01951768
Drug: Garamycin Sponge (Gentamicin-Collagen sponge)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)
Study: NCT01951768
Drug: Systemic Antibiotic
Approvals — FDA: no, EMA: no, PMDA: no
Description: Antibiotics options per protocol:~Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h
Study: NCT00462722
Drug: Ibuprofen
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 400 mg with each exercise session (up to 5 days per week) for 9 months
Study: NCT00462722
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: with each exercise session (up to 5 days per week) for 9 months
Study: NCT02670538
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo capsule one per day orally.
Study: NCT02450812
Drug: Radium-223-dichloride (Xofigo, BAY88-8223)
Approvals — FDA: no, EMA: no, PMDA: no
Description: according to Summary of Product Characteristics
Study: NCT03603639
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive E2730-matched placebo capsule, orally.
Study: NCT01896180
Drug: ALZ-1101
Approvals — FDA: no, EMA: no, PMDA: no
Description: ALZ-1101 Ophthalmic Solution
Study: NCT02934204
Drug: methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00607672
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT02100540
Drug: II RDC 0.3mg capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: II RDC 0.3mg capsule
Study: NCT02100540
Drug: III RDC 0.6mg capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: III RDC 0.6mg capsule
Study: NCT03103022
Drug: Acetaminophen
Normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral acetaminophen \[160 mg/5ml concentration\] will be administered every 6 hours with dose of 15 mg/kg/dose for a total of twelve doses
Study: NCT03103022
Drug: ibuprofen
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Oral ibuprofen \[100 mg/5 ml\] at 10 mg/kg/dose on first day followed by 5 mg/kg/dose at 24 and 48 hours for a total of three doses
Study: NCT02057575
Drug: PG324 Ophthalmic Solution 0.01%
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 drop in the evening (PM), once daily (QD), both eyes (OU)
Study: NCT02057575
Drug: PG324 Ophthalmic Solution 0.02%
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 drop in the evening (PM), once daily (QD), both eyes (OU)
Study: NCT02839785
Drug: Ibuprofen
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: the child will take orally 30 minutes before each session of physiotherapy 10mg/kg of Ibuprofen (not to exceed 400 mg) in liquid form or placebo.
Study: NCT02839785
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: the child will take orally 30 minutes before each session of physiotherapy 10mg/kg of Ibuprofen (not to exceed 400 mg) in liquid form or placebo.
Study: NCT00786643
Drug: Leucovorin (LV)
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Leucovorin 200mg/m\^2 was administered over 2 hours on day 1 and day 2 of each cycle.
Study: NCT01807182
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00711308
Drug: acenocoumarol
Normalized name: acenocoumarol
DrugBank: Acenocoumarol (DB01418)
Approvals — FDA: no, EMA: no, PMDA: no
Description: acenocoumarol for 6 months
Study: NCT02341456
Drug: AZD1775
Approvals — FDA: no, EMA: no, PMDA: no
Description: AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small-molecule inhibitor of the WEE1 kinase that sensitizes tumour cells to cytotoxic agents and is being developed for the treatment of advanced solid tumours and p53 pathway deficient malignancies. Gemcitabine is a nucleoside analog used as chemotherapy.
Study: NCT01077362
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: SC injections
Study: NCT03893825
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo matching to TV-46000 will be administered per schedule specified in the arm description.
Study: NCT00696488
Drug: Fluorouracil 0.5%
Normalized name: FLUOROURACIL 0.5% CREAM,TOP
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions
Study: NCT02390843
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The starting dose of simvastatin will be 140 mg/m\^2/dose BID for 21 days for the first group. Dose escalation for subsequent groups will be 180 mg/m\^2/dose BID, 225 mg/m\^2/dose BID, and 290 mg/m\^2/dose BID. If the maximum tolerated dose (MTD) has been exceeded at the first dose level, then the subsequent cohort of subjects will be treated at a dose of 100 mg/m2/dose BID (dose level 0). Simvastatin will be administered orally twice daily, approximately 12 hours apart. Feeding tube (nasogastric tube or gastrostomy tube, NOT a jejunum localized tube) administration is allowed. If a subject vomits a dose of simvastatin, it will not be repeated.