TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03131375
Drug: Dexmedetomidine
Normalized name: Dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Group A and B: Anesthesia induction drugs:propofol, fentanyl, rocuronium . After induction of anesthesia: Group A receives a 50 ml NS infusion containing 1 mcg kg-1 Dexmedetomidine drug Group A and B: Atropine as an antisialagogue, dexamethasone, ondasetrone for the prevention of postoperative nausea and vomiting. Anesthesia maintainance: propofol, remifentanil and oxygen in air. End of surgery, the infusion of propofol and remifentanil stop and sugammadex for reversal of neuromuscular block is given. Postoperative analgesia by nalbuphine 0.2 mg kg-1 given before the end of surgery in Group B, and 0.16 mg kg-1 in Group A. Monitoring: ECG, NIBP, ETCO2, SpO2, Bispectral index , Train of four ratio.
Study: NCT02941601
Drug: Necitumumab
Normalized name: Necitumumab
DrugBank: Necitumumab (DB09559)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Administered IV
Study: NCT02941601
Drug: Gemcitabine
Normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Administered IV
Study: NCT00914511
Drug: avanafil 200mg
Normalized name: AVANAFIL 200MG ORAL TAB
DrugBank: Avanafil (DB06237)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: single dose tablet of 200mg avanafil
Study: NCT00914511
Drug: avanafil 200mg
Normalized name: AVANAFIL 200MG ORAL TAB
DrugBank: Avanafil (DB06237)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: single tablet dose of 200mg avanafil
Study: NCT02941601
Drug: Carboplatin
Normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Administered IV
Study: NCT00335088
Drug: Moxifloxacin and Povidone Iodine vs Povidone Iodine
Normalized name: Povidone-Iodine
DrugBank: Moxifloxacin (DB00218)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02015637
Drug: Delafloxacin
Normalized name: Delafloxacin
DrugBank: Delafloxacin (DB11943)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: single dose
Study: NCT02015637
Drug: Ceftriaxone
Normalized name: Ceftriaxone
DrugBank: Ceftriaxone (DB01212)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: single dose
Study: NCT02910882
Drug: PEGylated Recombinant Human Hyaluronidase (PEGPH20)
Normalized name: PEGylated recombinant human hyaluronidase PH20
DrugBank: Hyaluronidase (ovine) (DB00070)
Approvals — FDA: no, EMA: no, PMDA: no
Description: PEGPH20 Dosing (Cohort I, Dose Escalation, First 3 patients): Administered as an IV infusion over 10 minutes (+/- 2 Minutes), approximately 1mL/minute:~Dose level 1 - 1 mcg/kg; Dose level 2 - 1.6 mcg/kg; Dose level 3 - 3 mcg/kg.~PEGPH20 Dosing (Cohort II, Patients 4-10): Administered at a dose of 3 mcg/kg as an IV infusion over 10 minutes (+/- 2 Minutes), approximately 1mL/minute.~Dosing Schedule: Twice per week beginning Day #1 for 8 doses, then weekly until end of radiotherapy.
Study: NCT02910882
Drug: Gemcitabine
Normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Gemcitabine Dosing: Administered at a dose of 600 mg/m2 as an IV infusion over 30 - 60 minutes with standard antiemetic pre-medication. If administered on PEGPH20 day, Gemcitabine will be infused 2-4 Hours after PEGPH20 infusion is completed.~Dosing Schedule: Weekly, beginning Day #2, per standard regimen.
Study: NCT01100801
Drug: TS-1 with cisplatin
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01100801
Drug: TS-1 with oxaliplatin
Normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01046708
Drug: micronized progesterone
DrugBank: Progesterone (DB00396)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 600mg in 3 separate doses per day
Study: NCT00814502
Drug: Zolpidem CR
DrugBank: Zolpidem (DB00425)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects were randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
Study: NCT03709342
Drug: CM4620-IE
Normalized name: CM4620
DrugBank: CM4620 (DB16466)
Approvals — FDA: no, EMA: no, PMDA: no
Description: single IV infusion on Day 1 over 4 hours
Study: NCT00705432
Drug: Ribavirin (RBV)
Normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day administered orally, divided twice daily (BID).
Study: NCT03074513
Drug: Atezolizumab
Normalized name: Atezolizumab
DrugBank: Atezolizumab (DB11595)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00705432
Drug: Boceprevir
Normalized name: Boceprevir
DrugBank: Boceprevir (DB08873)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Boceprevir, 800 mg (4 x 200 mg capsules) administered orally TID.
Study: NCT03920150
Drug: Vitamin D3
Normalized name: Vitamin D3
DrugBank: Cholecalciferol (DB00169)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patient will be treated with 3 doses of alcoholic solution for 3 months.
Study: NCT03920150
Drug: Vitamin D oily capsules
DrugBank: Vitamin D (DB11094)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patient will be treated with 3 capsules for 3 months.
Study: NCT03920150
Drug: Vitamin D oily capsules
DrugBank: Vitamin D (DB11094)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patient will be treated with weekly capsules for an individually calculated number of weeks.
Study: NCT02454387
Drug: ONO-4474 Part A1
Normalized name: Zygomycin A1
DrugBank: Paromomycin (DB01421)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Healthy volunteers
Study: NCT02454387
Drug: ONO-4474 Part B
Normalized name: SODIUM CHLORITE 0.0256 kg in 1 kg TOPICAL SPRAY [Chlorsan 105 Part B]
DrugBank: Sodium citrate (DB09154)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Healthy volunteers
Study: NCT02454387
Drug: ONO-4474 Part C
Normalized name: Vitamin C
DrugBank: Ascorbic acid (DB00126)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Healthy volunteers
Study: NCT02454387
Drug: ONO-4474 Part D
Normalized name: D
DrugBank: Rosomidnar (DB17154)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Healthy volunteers
Study: NCT02331680
Drug: OPC-41061
Normalized name: OPC-14523
DrugBank: OPC-14523 (DB05422)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02185131
Drug: Mirtazapine
Normalized name: Mirtazapine
DrugBank: Mirtazapine (DB00370)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Study: NCT03126591
Drug: Olaratumab
Normalized name: Olaratumab
DrugBank: Olaratumab (DB06043)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Administered IV
Study: NCT03126591
Drug: Pembrolizumab (KEYTRUDA®)
Normalized name: pembrolizumab Injection [Keytruda]
DrugBank: Pembrolizumab (DB09037)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Administered IV
Study: NCT02115048
Drug: Letrozole
Normalized name: Letrozole
DrugBank: Letrozole (DB01006)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02115048
Drug: Afatinib
Normalized name: Afatinib
DrugBank: Afatinib (DB08916)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT03107871
Drug: Valganciclovir
Normalized name: Valganciclovir
DrugBank: Valganciclovir (DB01610)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
Study: NCT00234533
Drug: Somatropin (rDNA origin)
Normalized name: Somatropin (rDNA origin)
DrugBank: Somatotropin (DB00052)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.
Study: NCT01269021
Drug: mycophenolate mofetil plus lower dose of Prednisone
Normalized name: Mycophenolate Mofetil
DrugBank: Prednisone (DB00635)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: MMF 1.0-1.5g/d\*6mons Prednisone 0.4-0.6 mg/kg/d
Study: NCT01269021
Drug: Prednisone in full dose
Normalized name: Prednisone
DrugBank: Prednisone (DB00635)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 0.8-1mg/kg/d
Study: NCT00596466
Drug: pregabalin
Normalized name: Pregabalin
DrugBank: Pregabalin (DB00230)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: pregabalin
Study: NCT02113904
Drug: Adalimumab
Normalized name: Adalimumab
DrugBank: Adalimumab (DB00051)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 6 injections (one every 15 days during 3 months)
Study: NCT02672475
Drug: Galunisertib
Normalized name: Galunisertib
DrugBank: Galunisertib (DB11911)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given PO
Study: NCT02672475
Drug: Paclitaxel
Normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Given IV
Study: NCT00763035
Drug: Regadenoson
Normalized name: Regadenoson
DrugBank: Regadenoson (DB06213)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit.
Study: NCT00763035
Drug: Dobutamine
Normalized name: Dobutamine
DrugBank: Dobutamine (DB00841)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Each participant will receive dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit.
Study: NCT04417517
Drug: evorpacept
Normalized name: Evorpacept
DrugBank: Evorpacept (DB17573)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fusion protein that blocks CD47-SIRPalpha pathway
Study: NCT04417517
Drug: azacitidine
Normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Hypomethylating agent (HMA)
Study: NCT01521975
Drug: Telbivudine, Adefovir dipivoxil
DrugBank: Adefovir dipivoxil (DB00718)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: All patients will take Telbivudine 600 mg PO daily from baseline. Some patients will take Adefovir dipivoxil 10 mg PO daily if they meet the criteria of adding Adefovir dipivoxil.
Study: NCT01314508
Drug: Increlex
Normalized name: Increlex
DrugBank: Mecasermin (DB01277)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Increlex therapy will begin at 40 micrograms/kg/day twice a day. The dose will be escalated by 20 mcg twice a day every other week up to 100mcg/kg/week.
Study: NCT03741530
Drug: Glibenclamide Tablets
Normalized name: glibenclamide
DrugBank: Glyburide (DB01016)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Giving glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment.
Study: NCT01135251
Drug: dimiracetam
Normalized name: Dimiracetam
DrugBank: Dimiracetam (DB13018)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 400 mg capsules for oral use to be administered twice a day for a total of 8 weeks
Study: NCT01135251
Drug: sugar pill
Normalized name: Invert Sugar
DrugBank: Invert sugar (DB09344)
Approvals — FDA: no, EMA: no, PMDA: no
Description: capsules containing 400 mg of inert material will be orally administered twice a day, one pill for 2 weeks, 2 pills for other 2 weeks and 4 pills for the last 4 weeks.
Study: NCT04627402
Drug: Conbercept and TA
Normalized name: cytarabine and daunorubicin
DrugBank: Conbercept (DB12460)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravitreous injection of Conbercept and TA
Study: NCT04627402
Drug: Conbercept
Normalized name: Conbercept
DrugBank: Conbercept (DB12460)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravitreous injection of Conbercept
Study: NCT00180778
Drug: Low dose steroids
Normalized name: ethinyl estradiol
DrugBank: Ethinylestradiol (DB00977)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02131259
Drug: Afatinib dimaleate
Normalized name: afatinib dimaleate
DrugBank: Afatinib (DB08916)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: 20mg - 50mg
Study: NCT00093041
Drug: Zalutumumab
Normalized name: Zalutumumab
DrugBank: Zalutumumab (DB12202)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Weekly infusion
Study: NCT03982381
Drug: Metformin
Normalized name: Metformin
DrugBank: Metformin (DB00331)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Active comparator
Study: NCT02158546
Drug: ALKS 5461
Normalized name: ALKS 29
DrugBank: ALKS 29 (DB05723)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Study: NCT03982381
Drug: Dapagliflozin 10 MG
Normalized name: dapagliflozin 10 MG
DrugBank: Dapagliflozin (DB06292)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Experimental treatment
Study: NCT01068847
Drug: 2-4 of the drugs listed below
Normalized name: salicylic acid
DrugBank: Salicylic acid (DB00936)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Cycloserine: 500, 675, 750 mg oral capsules may possibly given. Naloxone: 0.15mg/70Kg or 0.2mg/70kg I.M. injection may possibly be given. Nifedipine: 10, 20 mg oral capsules may possibly be given. Placebo (sugar pill or microcrystalline cellulose): oral capsules may be given. Saline: I.M. injection may possibly be given. Tizanidine: 4, 8, 12 mg oral capsules may possibly be given. Verapamil: 30, 60, 120 mg oral capsules may possibly be given.
Study: NCT03869047
Drug: Dexmedetomidine +bupivacaine
DrugBank: Bupivacaine (DB00297)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: patients will receive combined general anesthesia and Quadratuslumborum block( transincisional ie before wound closure)with 19 mL of bupivacaine 0.20%plus 1 mic/kg of dexmedetomidine, total volume 20 ml
Study: NCT03869047
Drug: Bupivacaine
Normalized name: Bupivacaine
DrugBank: Bupivacaine (DB00297)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: patients will receive combined general anesthesia and quadratus lumborum block (transincisional) with 20 ml of bupivacaine 0.20% .
Study: NCT04467203
Drug: Fadanafil
Normalized name: Avanafil
DrugBank: Avanafil (DB06237)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Seven subjects in group A will receive treatment in the following order:~At Day 1, a single dose of Fadanafil 100mg will be administered orally after overnight fasting-\>~At Day 8, a single dose of Fadanafil 100mg will be administered orally with high fat meal;Seven subjects in group B will receive treatment in the following order:~At Day1, a single dose of Fadanafil 100mg will be administered orally with high fat meal-\> At Day 8, a single dose of Fadanafil 100mg will be administered orally after overnight fasting
Study: NCT00860860
Drug: IMP-288 labeled with In111 and Lu177
Normalized name: Albumin, blood serum, labeled with iodine-125
DrugBank: Albumin iodinated I-125 serum (DB09429)
Approvals — FDA: no, EMA: no, PMDA: no
Description: IMP-288: 100 microgram
Study: NCT00495352
Drug: Hihg-doseNRT, Low-dose NRT, bupropion
DrugBank: Bupropion (DB01156)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02057250
Drug: Sarilumab
Normalized name: Sarilumab
DrugBank: Sarilumab (DB11767)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Pharmaceutical form: Solution Route of administration: Subcutaneous
Study: NCT02057250
Drug: Sulfasalazine
Normalized name: Sulfasalazine
DrugBank: Sulfasalazine (DB00795)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Dispensed according to local practice.
Study: NCT02057250
Drug: Leflunomide
Normalized name: Leflunomide
DrugBank: Leflunomide (DB01097)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Dispensed according to local practice.
Study: NCT02057250
Drug: Hydroxychloroquine
Normalized name: Hydroxychloroquine
DrugBank: Hydroxychloroquine (DB01611)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Dispensed according to local practice.
Study: NCT03771664
Drug: SAGE-217
Normalized name: SAGE
DrugBank: Sage (DB10982)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered as capsules.
Study: NCT04096716
Drug: Tc-99m tilmanocept
Normalized name: TECHNETIUM TC-99M TILMANOCEPT
DrugBank: Technetium Tc-99m tilmanocept (DB09266)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tc-99m tilmanocept is a radioactive diagnostic agent.
Study: NCT03583892
Drug: Gabapentin
Normalized name: Gabapentin
DrugBank: Gabapentin (DB00996)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: One of the groups of patients was exposed to preoperative gabapentin. As the pain has a complex involvement of multiple mechanisms, multimodal analgesic techniques utilizing a number of drugs acting on different analgesic mechanisms are being used. In this case, some patients received gabapentin as a part of a multimodal analgesic technique.
Study: NCT00694941
Drug: ONO-2506PO
Normalized name: ONO-2952
DrugBank: ONO-2952 (DB14802)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1200mg QD / 5 years
Study: NCT03501498
Drug: Loperamide
Normalized name: Loperamide
DrugBank: Loperamide (DB00836)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Alters intestinal transit time.
Study: NCT03501498
Drug: Senna
Normalized name: Senna
DrugBank: Senna leaf (DB15889)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Alters intestinal transit time.
Study: NCT02120898
Drug: Imiquimod
Normalized name: Imiquimod
DrugBank: Imiquimod (DB00724)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Cream, generic formulation of the brand product.
Study: NCT00831181
Drug: 5-FU
Normalized name: 5-FU
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 5-FU: continuous infusion via portable pump during all RT (approximately 33 days)
Study: NCT00831181
Drug: Oxaliplatin
Normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Oxaliplatin: 50mg/m2 weekly dosing during RT (Day 1)
Study: NCT03418714
Drug: Salvinorin A
Normalized name: Salvinorin A
DrugBank: Salvinorin A (DB12327)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Salvinorin A, blinded doses
Study: NCT01465919
Drug: Mirtazapine
Normalized name: Mirtazapine
DrugBank: Mirtazapine (DB00370)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Mirtazapine will be administered at baseline, 1-week, 2-week, 4-week, 6-week, and 8-week, dosing between 7.5mg/day and 45mg/day, in patients with interferon induced depression.
Study: NCT01261299
Drug: Carbon-14-labeled carboplatin
Normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Patients are eligible for this study if they have non-small cell lung cancer or bladder cancer and will receive cisplatin or carboplatin-based chemotherapy for the treatment of cancer. They will receive one microdose of C-14-carboplatin approximately 4 hours before scheduled biopsy/surgery. One blood draw and a few milligrams of leftover tumor tissue will be taken for analysis of carboplatin-DNA adduct levels. The dose of carboplatin will be about 1/100th the therapeutic dose.
Study: NCT01635296
Drug: cytarabine
Normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 20 mg/m2 sc, Days 1 to 10 of each 28-day cycle
Study: NCT01635296
Drug: cytarabine
Normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1 gm/m2 iv, Days 1 to 6 of each 28-day cycle
Study: NCT00783068
Drug: Lipopolysaccharide E. Coli 113:H 10:K negative
DrugBank: Poly(lactic acid) (DB15037)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will be randomized to oral pre-treatment with GTS-21 (150 mg tid 3 days before LPS injection and an oral dose of 150 mg GTS-21 on the morning of the day of the experiment (07:00 AM). Subjects will then receive an oral dose of 150 mg GTS-21 or placebo at 08:00 AM and another oral dose of 150 mg GTS-21 or placebo at 1 hour before LPS administration (t=0). One hour after ingestion of the last dosage of the study drug, purified LPS prepared from E coli O:113 (2 ng/kg iv) will be injected intravenously.
Study: NCT01508312
Drug: brentuximab vedotin (SGN-35)
Normalized name: Brentuximab Vedotin
DrugBank: Brentuximab vedotin (DB08870)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Patients will receive 2 cycles of weekly brentuximab vedotin, 1.2mg/kg on days 1, 8, and 15 of each 28 day cycle. Patients with pre-treatment positive bone marrow biopsies will have repeat bone marrow biopsies if the PET scan is negative. FDG-PET/CT will be repeated after 2 cycles of treatment within 1 week of the last dose of cycle 2. Patients with persistent abnormalities on FDG-PET/CT following 2 cycles of brentuximab vedotin will receive 2 cycles of augmented ICE. The first cycle of augmented ICE will be initiated 7-14 days after the last dose of SGN-35. FDG-PET/CT will be repeated within 7-14 days following the second cycle of augmented ICE. Stem cell mobilization can be performed following the first or second cycle of augmented ICE.
Study: NCT00483717
Drug: Ketorolac tromethamine
Normalized name: Ketorolac Tromethamine
DrugBank: Ketorolac (DB00465)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
Study: NCT00561925
Drug: nevirapine IR
Normalized name: Nevirapine
DrugBank: Nevirapine (DB00238)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 200 mg BID
Study: NCT00561925
Drug: nevirapine XR
Normalized name: nevirapine Extended Release Oral Tablet
DrugBank: Nevirapine (DB00238)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 400 mg QD
Study: NCT01662102
Drug: Zevalin
Normalized name: Zevalin KIT
DrugBank: Ibritumomab tiuxetan (DB00078)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Zevalin administered intravenously.
Study: NCT01662102
Drug: Rituximab
Normalized name: Rituximab
DrugBank: Rituximab (DB00073)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Rituximab administered intravenously.
Study: NCT01910363
Drug: A2NTX
Normalized name: Aprepitant
DrugBank: Aprepitant (DB00673)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
Study: NCT01910363
Drug: BOTOX
Normalized name: Botox
DrugBank: Botulinum toxin type A (DB00083)
Approvals — FDA: no, EMA: yes, PMDA: yes
Description: Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
Study: NCT00417417
Drug: Rilonacept
Normalized name: Rilonacept
DrugBank: Rilonacept (DB06372)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Lyophilized rilonacept will be supplied by Regeneron Pharmaceuticals at 160 mg/vial and reconstituted with 2.3 mL of sterile water for injection by the Clinical Center Pharmacy Intravenous Admixture Unit. The formulation contains 80 mg/mL rilonacept, histidine, citrate, PEG 3350, polysorbate 20, glycine, arginine, and sucrose (pH 6.5). Matching placebo in the identical formulation will also be supplied, and also reconstituted with 2.3 mL of sterile water for injection. Each administration of study drug will consist of two syringes containing 2.0 mL in each syringe (320 mg total drug).