TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT05014711
Drug: Fentanyl
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Before infusion, fentanyl is given 0.3 g/kg slowly intravenous injection more than 60 seconds, and the initial dose is 0.025ug/kg/min. The dosage is adjusted to achieve the target depth of analgesia and sedation (CPOT \< 3, RASS -2 to 1), with each change 0.025ug/kg/min and the maximum dose 0.15ug/kg/min.
Study: NCT02984293
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo once daily for 28 days.
Study: NCT01879722
Drug: TAK-063 Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: TAK-063 placebo-matching tablets
Study: NCT02468180
Drug: Lauromacrogol
Normalized name: Lauromacrogol
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02580305
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Once-daily, tablets, orally
Study: NCT02828540
Drug: HT047 High-dose group
Approvals — FDA: no, EMA: no, PMDA: no
Description: HT047 2250mg, three times a day dosing schedule, 3 tablets per dose
Study: NCT00481624
Drug: Epoetin Alfa plus Iron
Normalized name: epoetin alfa
DrugBank: Erythropoietin (DB00016)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 1. One (1) injection of Procrit®, by needle, inserted just under the skin;~2. 125 mg of ferric gluconate (an iron injection product), through an IV injection into a vein.~These injections will take approximately 10-15 minutes to complete. Both will be administered every 3 weeks for a total of 4 cycles, unless the study doctor decides that a change in the amount of Procrit® and iron is necessary once the hemoglobin level rises or is above a certain amount.~In addition to Procrit® and the intravenous iron, the subject will also receive platinum-containing chemotherapy every 3 weeks for 4 cycles as per standard of care for their lung cancer treatment. Radiation therapy will be allowed during this regimen if it is part of the subject's treatment plan.
Study: NCT00003601
Drug: tretinoin
Normalized name: Tretinoin
DrugBank: Tretinoin (DB00755)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01237275
Drug: SSRI treated group
Normalized name: Streptococcus viridans group
Approvals — FDA: no, EMA: no, PMDA: no
Description: characterize in arm of a study (SSRI treated group)
Study: NCT02453464
Drug: Leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Leucovorin: IV solution, IV over 2 hours, 400 mg/m², Every 14 days, Until disease progression/toxicity
Study: NCT01469793
Drug: DMOT4039A
Approvals — FDA: no, EMA: no, PMDA: no
Description: DMOT4093A will be administered by intravenous infusion on either a Q3W or a Q1W dosing schedule, in 21-day cycles.
Study: NCT01216982
Drug: Lovaza, omega-3 fatty acid ethyl ester
Approvals — FDA: no, EMA: no, PMDA: no
Description: Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day
Study: NCT01812434
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 20 mg three times daily for 28 days
Study: NCT00774930
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: deep s.c. injection of placebo (0.9% saline solution) every 4 weeks (±3 days) for 16 weeks, then deep s.c. injection of lanreotide 120 mg, every 4 weeks (±3 days).
Study: NCT01216982
Drug: Placebo, visually identical to Lovaza
Approvals — FDA: no, EMA: no, PMDA: no
Description: Three 1g corn oil capsules/day for three months
Study: NCT01236534
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: matching placebo twice daily for 21 days.
Study: NCT01079663
Drug: Placebo chip
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00085059
Drug: boronophenylalanine-fructose complex
Normalized name: Fructose
DrugBank: Fructose (DB04173)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01100853
Drug: VIVITROL injection and VIVITROL Placebo Injection , 24 weeks
Approvals — FDA: no, EMA: no, PMDA: no
Description: Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Study: NCT02528526
Drug: OXY111A
Approvals — FDA: no, EMA: no, PMDA: no
Description: OXY111A intravenous infusion
Study: NCT02546648
Drug: Rosuvastatin or matching placebo
Normalized name: INV-CSP #2002 METFORMIN OR PLACEBO
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects who are not on a statin will also be randomized to Rosuvastatin or Rosuvastatin placebo. 40mg preoperatively, followed by 20mg postoperatively (4-6 hours after surgical close) and 20mg/day for 30 days postoperatively.
Study: NCT01034163
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT01725685
Drug: FF/UMEC 400/500 mcg
Approvals — FDA: no, EMA: no, PMDA: no
Description: FF/UMEC will be available as 100/125 mcg strength administered as 4 inhalations from a DPI
Study: NCT02355678
Drug: Local anesthetic infiltration
Normalized name: Gelato Anesthetic
Approvals — FDA: no, EMA: no, PMDA: no
Description: Using 25 G-3.5 cm curved needle
Study: NCT02355678
Drug: General anesthesia
Normalized name: Ethers for general anesthesia
Approvals — FDA: no, EMA: no, PMDA: no
Description: Induction by intravenous fentanyl (1.5 µg kg-1) and propofol (2.5 mg kg-1) followed by endotracheal intubation facilitated by atracurium (0.5 mg kg-1).~Maintenance with sevoflurane 1-3%, fentanyl (1-2 µg kg-1), nitrous oxide 70% and oxygen 30%.
Study: NCT02355678
Drug: Paracetamol Suppository
Approvals — FDA: no, EMA: no, PMDA: no
Description: If Visual Analogue Scale was less than 4
Study: NCT02832401
Drug: Caffeine
Normalized name: Caffeine
DrugBank: Caffeine (DB00201)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02832401
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00752557
Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.
Study: NCT00752557
Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL.
Study: NCT00702780
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5mg/day for 2 weeks, 10mg/day for 2 weeks and 20mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period)
Study: NCT01486940
Drug: insulin NPH
Normalized name: insulin NPH human isophane
Approvals — FDA: no, EMA: no, PMDA: no
Description: Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
Study: NCT01486940
Drug: human soluble insulin
Normalized name: Recombinant human soluble insulin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals
Study: NCT01128452
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: HPMC Placebo capsules, once daily for 28 days
Study: NCT03107429
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo was a sugar based placebo placed in a capsule.
Study: NCT00122434
Drug: BEA 2180 BR
Normalized name: Respa-BR
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02960412
Drug: Normal Saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Normal saline given intraoperatively as placebo
Study: NCT02932436
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: amount of Placebo corresponding to empagliflozin 10 mg per os daily for 12 weeks
Study: NCT03150082
Drug: GR37547 tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single tablet of GR37547 should be taken orally with 240 mL of water. GR37547 500 mg tablet will be a white to off white capsule shape with break line on upper side and embossed GSK500on lower side.
Study: NCT02487446
Drug: QVA149
Approvals — FDA: no, EMA: no, PMDA: no
Description: QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI)
Study: NCT02487446
Drug: Placebo (QVA149)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI
Study: NCT02168829
Drug: Acetylsalicylic acid
Normalized name: ACETYLSALICYLIC ACID
DrugBank: Acetylsalicylic acid (DB00945)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02810587
Drug: Topical antibiotics following injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: Either receive or not receive topical antibiotics following intravitreous injection
Study: NCT04137198
Drug: Sufentanil
Normalized name: Sufentanil
DrugBank: Sufentanil (DB00708)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses
Study: NCT00726544
Drug: ARC1779 Injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper. Treatment with ARC1779 Injection is to be given at low dosage that is intended to produce target steady-state ARC1779 plasma concentrations during infusion of 3μg/mL.
Study: NCT00726544
Drug: ARC1779 Injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper. Treatment with ARC1779 Injection is to be given at low dosage that is intended to produce target steady-state ARC1779 plasma concentrations during infusion of 12μg/mL.
Study: NCT01759771
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo for at least one year
Study: NCT03062358
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Normal saline solution administered as an IV infusion Q3W
Study: NCT01174290
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: D5W 0.2mL IV q6h~Study drug will be continued until one of the following study withdrawal/termination criteria is met:~1. Delirium (ICDSC ≥ 4) develops. The diagnosis of delirium will be confirmed in all instances by the Psychiatric Consultation Service, Division of Psychiatry, Tufts Medical Center using DSM-IV criteria.~2. The patient is discharged from the ICU at Tufts MC.~3. 10 days of study drug administration occurs.~4. The subject experiences an adverse event potentially attributable to the study drug that is deemed, in the opinion of one of the physicians on the study team or the MICU team, to warrant discontinuation of therapy.
Study: NCT02328963
Drug: mycophenolic acid
Normalized name: mycophenolic acid
DrugBank: Mycophenolic acid (DB01024)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Mycophenolic acid :~1080 mg bid for one month, then 720 mg bid~Cyclosporin A :~CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12.~Corticosteroids :~Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study~Basiliximab :Day 0: 20 mg ; Day 4: 20 mg
Study: NCT01645423
Drug: Atorvastatin Calcium Tablets, 80 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited
Study: NCT02515630
Drug: MMB
Normalized name: Methylmethionine sulfonium bromide
Approvals — FDA: no, EMA: no, PMDA: no
Description: Momelotinib (MMB) tablet administered orally once daily
Study: NCT00425152
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00425152
Drug: leucovorin calcium
Normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02632526
Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A)
Normalized name: MESEMBRYANTHEMUM CRYSTALLINUM WHOLE
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral suspension single dose
Study: NCT02632526
Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single and multiple doses
Study: NCT02632526
Drug: AZD5718 placebo oral suspension
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single and multiple doses
Study: NCT02632526
Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single and multiple doses
Study: NCT01060579
Drug: AR-12286 0.5% ophthalmic solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: q.d. PM
Study: NCT01060579
Drug: AR-12286 0.25% Ophthalmic solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: q.d. PM
Study: NCT02818855
Drug: Collagen Matrix
Normalized name: Omeza Collagen Matrix
Approvals — FDA: no, EMA: no, PMDA: no
Description: A new collagen membrane
Study: NCT00112047
Drug: FTC/TDF
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once daily, from Week 96 to 144
Study: NCT00112047
Drug: FTC/TDF/EFV
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg, taken once daily, from Week 144 to 240
Study: NCT01428843
Drug: FERRISAT
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single infusion of 50 mg/ml of Ferrisat during inclusion visit.
Study: NCT01428843
Drug: PLACEBO
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single infusion of Glucose 5% solution during inclusion visit
Study: NCT03102762
Drug: Normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment.
Study: NCT05380245
Drug: Clarithromycin 500 mg x 1Tablets
Normalized name: clarithromycin 500 MG
DrugBank: Clarithromycin (DB01211)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Name of medication of Intervention Formulation: Tablet Klaricid, 500 mg by Abbott, Lab Pvt. Ltd. (Karachi, Pakistan), Batch No: 81573XU; Mfg. date 10/2017.
Study: NCT03006562
Drug: Subcutaneous Heparin
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.
Study: NCT04149444
Drug: Trifluridine/Tipiracil
Normalized name: TRIFLURIDINE/TIPIRACIL
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral medication
Study: NCT00376831
Drug: Midazolam, Fentanyl
Approvals — FDA: no, EMA: no, PMDA: no
Description: fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
Study: NCT04860167
Drug: Diclofenac Sodium and Lignocaine 10 % spray
Approvals — FDA: no, EMA: no, PMDA: no
Description: Injection Diclofenac sodium was given in the preoperative area 30 minutes before the procedure and four squirts of 10% lignocaine were given 5 minutes prior to the start of the procedure
Study: NCT04201782
Drug: There are no disallowed treatments
Normalized name: Hongo Killer Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: Genetic: SB-728-T or SB-728mR-T No study drug is administered in this study. Subjects who received SB-728-T or SB-728mR-T in a previous trial will be evaluated in this trial for long-term safety and efficacy.
Study: NCT05192265
Drug: Antimalarials, Artemether + Lumefantrine
Approvals — FDA: no, EMA: no, PMDA: no
Description: Artemether-lumefantrine dispersible tablets (Coartem™, Novartis pharma) twice daily according to body weights. Each dispersible tablet of AL contains 20mg of artemether/120mg of lumefantrine).
Study: NCT02518789
Drug: normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pretreatment：Intravenous injection normal saline equal quantity，completed within 15 minutes.
Study: NCT02518789
Drug: midazolam，fentanyl，rocuronium
Approvals — FDA: no, EMA: no, PMDA: no
Description: Anesthesia induction：Intravenous injection midazolam 0.03 \~ 0.05 mg/kg, fentanyl 5 \~ 8 g/kg, rocuronium 0.6 mg/kg
Study: NCT02518789
Drug: propofol，remifentanil，cis atracurium
Approvals — FDA: no, EMA: no, PMDA: no
Description: Anesthesia maintenance：Intravenous infusion of propofol 4 \~ 6 mg/kg/h, remifentanil 0.1 \~ 0.3 μg/kg/min, intermittent intravenous injection of cis atracurium 0.05 \~ 0.1mg/kg
Study: NCT00350116
Drug: topical vitamin B12
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00456677
Drug: minocycline
Normalized name: Minocycline
DrugBank: Minocycline (DB01017)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: addition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen.
Study: NCT00456677
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: Addition of oral placebo capsule in addition to standard of care regimen
Study: NCT04619251
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT02835118
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Two oral doses of placebo for surotomycin in hard gelatin capsules per day, for 14 days
Study: NCT01148147
Drug: Adenosine
Normalized name: Adenosine
DrugBank: Adenosine phosphate (DB00131)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Intracoronary adenosine administration (180 ug for LCA and 120 ug for RCA)
Study: NCT01148147
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intracoronary Placebo administration
Study: NCT00761228
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive a continues subcutaneous infusion of saline solution.
Study: NCT01986075
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
Study: NCT04294537
Drug: Postperative analgesia
Normalized name: Analgesic Balm GRX
Approvals — FDA: no, EMA: no, PMDA: no
Description: During first 48 hours after surgery all patients wil receive paracetamol 15 mg/kg iv every 8 hours and ibuprofen 10 mg/kg orally (or through gastric tube) every 12 hours after surgery.~In case of severe pain tramadol 0,5 mg/kg will be administered iv every 8 hours.
Study: NCT04693195
Drug: BLU-5937
Normalized name: Blu-Kote
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration of BLU-5937 tablets
Study: NCT04693195
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration of matching placebo for BLU-5937 tablets
Study: NCT02352168
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 putt/nostril,b.i.d
Study: NCT04220762
Drug: WIN-1001X
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: This study has been designed as a randomized, double-blind, and placebo-controlled study.~Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
Study: NCT01956890
Drug: PET
Normalized name: PETN
Approvals — FDA: no, EMA: no, PMDA: no
Description: 18F-FLT PET and MRI of the breast
Study: NCT00773357
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo
Study: NCT00791999
Drug: CDP870 400mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 400mg CDP870 given every 2 weeks until Week22 (SC)
Study: NCT03562624
Drug: BAY98-7443
Approvals — FDA: no, EMA: no, PMDA: no
Description: Active ingredient content (in mg IND/LNG):~low dose 6.5 / 13.5; middle dose 12.5 / 13.5; high dose 15.4 / 13.5
Study: NCT00791999
Drug: CDP870 200mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC)
Study: NCT00791999
Drug: CDP870 100mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC)
Study: NCT00791999
Drug: Placebo of CDP870
Approvals — FDA: no, EMA: no, PMDA: no
Description: given every 2 weeks until Week22 (SC)
Study: NCT02067949
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: single oral tablet 40 mg / day If the patient is able to swallow; the tablet will be given orally. Otherwise, it will be crushed, suspended in water and administered via any existing enteral feeding or gastric drainage tube
Study: NCT04220762
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: This study has been designed as a randomized, double-blind, and placebo-controlled study.~Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
Study: NCT01929629
Drug: Part B
Normalized name: Hem-Care Premium 7-Part Blend Capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single doses food effect. Subjects to receive 2 single doses, one in fed and one in fasted.
Study: NCT01725789
Drug: Ferinject®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \<50Kg .~Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients with a body weight \<50kg, administration of Ferinject® should be limited to 500mg at baseline . All patients with a serum ferritin value \<15ng/mL and Hb\<10g/dl at week 3 visit that a second dose (of 500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control Group:Placebo)
Study: NCT01725789
Drug: normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight \<50 Kg.
Study: NCT03907969
Drug: PLD
Normalized name: PLD1
Approvals — FDA: no, EMA: no, PMDA: no
Description: The starting dose of PLD is 40 mg/m\^2, administered by intravenous infusion once every 4 weeks, for a maximum of 6 cycles