AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT01371747
Drug: patiromer
RxNorm normalized name: Patiromer
DrugBank: Patiromer (DB09263)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cohorts 1, 2 and 3 - Patiromer starting dose: 16.8 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response. (Stratum 2)
Trial: NCT01371747
Drug: patiromer
RxNorm normalized name: Patiromer
DrugBank: Patiromer (DB09263)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cohorts 1, 2 and 3 - Patiromer starting dose: 16.8 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response (Stratum 1)
Trial: NCT02132234
Drug: Adalimumab
RxNorm normalized name: Adalimumab
DrugBank: Adalimumab (DB00051)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: biological treatment according to rheumatologic indication
Trial: NCT01371747
Drug: patiromer
RxNorm normalized name: Patiromer
DrugBank: Patiromer (DB09263)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cohorts 1, 2 and 3 - Patiromer starting dose: 25.2 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response (Stratum 1)
Trial: NCT01371747
Drug: patiromer
RxNorm normalized name: Patiromer
DrugBank: Patiromer (DB09263)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cohorts 1, 2 and 3 - Patiromer starting dose: 25.2 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response. (Stratum 2)
Trial: NCT02132234
Drug: Certolizumab
RxNorm normalized name: certolizumab
DrugBank: Certolizumab pegol (DB08904)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: biological treatment according to rheumatologic indication
Trial: NCT02132234
Drug: Infliximab
RxNorm normalized name: Infliximab
DrugBank: Infliximab (DB00065)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: biological treatment according to rheumatologic indication
Trial: NCT01371747
Drug: patiromer
RxNorm normalized name: Patiromer
DrugBank: Patiromer (DB09263)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cohorts 1, 2 and 3 - Patiromer starting dose: 33.6 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response. (Stratum 2)
Trial: NCT01371747
Drug: losartan
RxNorm normalized name: Losartan
DrugBank: Losartan (DB00678)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: losartan dose: 100 mg/d, oral, once daily (initiated during Run-In Period; Cohort 1)
Trial: NCT03507088
Drug: Fluoroestradiol (18F)
RxNorm normalized name: fluoroestradiol (18F)
DrugBank: Fluoroestradiol F-18 (DB15690)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A FES-PET/(CT) will be performed twice during protocol execution. Patients will be injected with approximately 222 MBq 18F-FES each time.
Trial: NCT00411411
Drug: Januvia
RxNorm normalized name: Januvia
DrugBank: Sitagliptin (DB01261)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 200 mg t.i.d
Trial: NCT01415102
Drug: PF-05212372
RxNorm normalized name: PF-05089771
DrugBank: PF-05089771 (DB14856)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhaled. Dose Level 1: 50 ug
Trial: NCT01415102
Drug: PF-05212372
RxNorm normalized name: PF-05089771
DrugBank: PF-05089771 (DB14856)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Trial: NCT01415102
Drug: PF-05212372
RxNorm normalized name: PF-05089771
DrugBank: PF-05089771 (DB14856)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Trial: NCT01415102
Drug: PF-05212372
RxNorm normalized name: PF-05089771
DrugBank: PF-05089771 (DB14856)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Trial: NCT01415102
Drug: PF-05212372
RxNorm normalized name: PF-05089771
DrugBank: PF-05089771 (DB14856)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Trial: NCT01415102
Drug: PF-05212372
RxNorm normalized name: PF-05089771
DrugBank: PF-05089771 (DB14856)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Trial: NCT01415102
Drug: PF-05212372
RxNorm normalized name: PF-05089771
DrugBank: PF-05089771 (DB14856)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Trial: NCT00581165
Drug: Etanercept
RxNorm normalized name: Etanercept
DrugBank: Etanercept (DB00005)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: recommended dose of enbrel is 25mg administered twice weekly.
Trial: NCT00805467
Drug: Fostamatinib Disodium (R935788)
DrugBank: Tamatinib (DB07159)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
Trial: NCT02965040
Drug: Roxadustat
RxNorm normalized name: roxadustat
DrugBank: Roxadustat (DB04847)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Description: Oral
Trial: NCT00002780
Drug: carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00002780
Drug: thiotepa
RxNorm normalized name: Thiotepa
DrugBank: Thiotepa (DB04572)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT03167268
Drug: Lycopene
RxNorm normalized name: Lycopene
DrugBank: Lycopene (DB11231)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00318903
Drug: Irinotecan (drug)
DrugBank: Irinotecan (DB00762)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 50 mg/m2 of Irinotecan will be administered intravenously over 60-90 minutes following a Taxotere infusion each week for 3 weeks. After a break, Irinotecan will then be given for 3 consecutive weeks at 45 mg/m2 in conjunction with radiotherapy.
Trial: NCT00318903
Drug: Taxotere (drug)
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Taxotere at 35 mg/m2 is given intravenously over 1 hour each week for three consecutive weeks. After a one-week break, patients will receive Taxotere at a 25 mg/m2 dose for the first three weeks of a 5-6 week radiotherapy regimen.
Trial: NCT01104584
Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
RxNorm normalized name: Gadobutrol
DrugBank: Gadobutrol (DB06703)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: A single bolus injection of gadobutrol 1.0 M; 0.1 mmol/kg body weight
Trial: NCT02370498
Drug: paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 80 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
Trial: NCT00064467
Drug: Extended-release bupropion (HCl)
RxNorm normalized name: bupropion Extended Release Oral Tablet
DrugBank: Bupropion (DB01156)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03817567
Drug: recombinant anti-EGFR monoclonal antibody
RxNorm normalized name: Anti-VEGF monoclonal antibody
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Experimental: Recombinant Anti-EGFR Monoclonal Antibody（SCT200）. Initially, SCT200 6.0mg/kg will be administered at day 1 every week for a maximum of 6 cycles. After 6 cycles SCT200 8.0mg/kg will be administered at day 2 every weeks until disease progression.
Trial: NCT00948662
Drug: SAM-760
RxNorm normalized name: SAM
DrugBank: Ademetionine (DB00118)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day
Trial: NCT00948662
Drug: ketoconazole
RxNorm normalized name: Ketoconazole
DrugBank: Ketoconazole (DB01026)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ketoconazole oral tablets, 200 mg bid, 14 days
Trial: NCT01263691
Drug: Control
RxNorm normalized name: Control
DrugBank: Chloroxylenol (DB11121)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Saline control
Trial: NCT03428412
Drug: TCM and conventional drug
RxNorm normalized name: cytarabine and daunorubicin
DrugBank: Daunorubicin (DB00694)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: All patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.~The Experimental group will receive TCM according to the TCM syndrome. Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days.~Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days.~Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days.
Trial: NCT00256113
Drug: Saredutant succinate (SR48968C)
RxNorm normalized name: succinate
DrugBank: Saredutant (DB06660)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01264094
Drug: Clevudine
RxNorm normalized name: clevudine
DrugBank: Clevudine (DB06683)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: clevudine 30 mg qd
Trial: NCT00121069
Drug: Escitalopram
RxNorm normalized name: Escitalopram
DrugBank: Escitalopram (DB01175)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00696787
Drug: Desvenlafaxine Sustained Release (DVS SR)
RxNorm normalized name: desvenlafaxine Extended Release Oral Tablet
DrugBank: Venlafaxine (DB00285)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02874404
Drug: Ibrutinib
RxNorm normalized name: Ibrutinib
DrugBank: Ibrutinib (DB09053)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given PO
Trial: NCT02874404
Drug: PI3K-delta Inhibitor TGR-1202
RxNorm normalized name: .DELTA.-TOCOPHEROL
DrugBank: Tocopherol (DB11251)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT00005050
Drug: oxaliplatin
RxNorm normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01332812
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: a dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia
Trial: NCT00869765
Drug: D-Cycloserine
RxNorm normalized name: D-Cycloserine
DrugBank: Cycloserine (DB00260)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 100 mg D-cycloserine once every weekday taken 2 hours before tDCS session.
Trial: NCT00702156
Drug: Bisoprolol
RxNorm normalized name: Bisoprolol
DrugBank: Bisoprolol (DB00612)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.
Trial: NCT03598738
Drug: Esomeprazole 40mg
RxNorm normalized name: esomeprazole 40 MG
DrugBank: Esomeprazole (DB00736)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Esomeprazole 40mg oral tablet, once a day
Trial: NCT01911845
Drug: Ribavirin (RBV)
RxNorm normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Tablet
Trial: NCT01772797
Drug: AUY922
RxNorm normalized name: AUY922
DrugBank: AUY922 (DB11881)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: AUY922 is an intravenous infusion that will be administered by the investigative site to the patient on a weekly basis.
Trial: NCT02765763
Drug: 2-Minute Reveal Masque
RxNorm normalized name: TAGETES MINUTA FLOWER OIL
DrugBank: Veal (DB10612)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02765763
Drug: Null Formula 2-Minute Reveal Masque
DrugBank: Veal (DB10612)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00040131
Drug: IL-10
RxNorm normalized name: IL-10
DrugBank: Interleukin-10 (DB12880)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03042091
Drug: Polyethylene Glycol
RxNorm normalized name: Polyethylene Glycol
DrugBank: Polyethylene glycol (DB09287)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given orally
Trial: NCT03042091
Drug: Neomycin
RxNorm normalized name: Neomycin
DrugBank: Neomycin (DB00994)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given orally
Trial: NCT03042091
Drug: Metronidazole Hydrochloride
RxNorm normalized name: metronidazole hydrochloride
DrugBank: Metronidazole (DB00916)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given orally
Trial: NCT03059797
Drug: Anlotinib
RxNorm normalized name: Anlotinib
DrugBank: Anlotinib (DB11885)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
Trial: NCT00593905
Drug: Sitaxsentan
RxNorm normalized name: Sitaxsentan
DrugBank: Sitaxentan (DB06268)
FDA approved: no
EMA approved: yes
PMDA approved: no
Description: Sitaxsentan sodium 100 mg tablet every morning
Trial: NCT00593905
Drug: Bosentan, Ambrisentan
DrugBank: Bosentan (DB00559)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Bosentan 125 mg tablet twice daily Ambrisentan 5-10 mg tablet once daily
Trial: NCT00171951
Drug: Pasireotide
RxNorm normalized name: Pasireotide
DrugBank: Pasireotide (DB06663)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Pasireotide 600 μg or 900 μg was administered as an SC injection.
Trial: NCT02441660
Drug: Capsaicin 8% Patch
RxNorm normalized name: CAPSAICIN 8% PATCH KIT,4
DrugBank: Capsaicin (DB06774)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Applied topically for 1 hour
Trial: NCT02441660
Drug: Low Dose Capsaicin 0.025% Well Patch
DrugBank: Capsaicin (DB06774)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00004757
Drug: acyclovir
RxNorm normalized name: Acyclovir
DrugBank: Acyclovir (DB00787)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01611857
Drug: Tivantinib
RxNorm normalized name: Tivantinib
DrugBank: Tivantinib (DB12200)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients with advanced solid tumors will be treated with oral Tivantinib (120, 240, or 360 mg BID) daily for 14 days in cycles of 14 days.
Trial: NCT00582010
Drug: nitrogen gas
RxNorm normalized name: nitrogen Gas for Inhalation
DrugBank: Nitrogen (DB09152)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: inhaled
Trial: NCT04350450
Drug: Hydroxychloroquine
RxNorm normalized name: Hydroxychloroquine
DrugBank: Hydroxychloroquine (DB01611)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 400 mg tablet
Trial: NCT00314951
Drug: Fidaxomicin
RxNorm normalized name: Fidaxomicin
DrugBank: Fidaxomicin (DB08874)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 200 mg oral capsules two times daily (q12h regimen)
Trial: NCT00314951
Drug: Vancomycin
RxNorm normalized name: Vancomycin
DrugBank: Vancomycin (DB00512)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 125 mg capsules q6hr (4 times a day)
Trial: NCT00314951
Drug: Matching Placebo to Fidaxomicin
RxNorm normalized name: Fidaxomicin
DrugBank: Fidaxomicin (DB08874)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)
Trial: NCT03201445
Drug: Filgotinib
RxNorm normalized name: Filgotinib
DrugBank: Filgotinib (DB14845)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Description: 200 mg tablet administered orally once daily
Trial: NCT06632574
Drug: paclitaxel cationic liposomes
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Paclitaxel cationic liposomes is a modified new drug. In this study, administration is performed through arterial catheter infusion.
Trial: NCT00486031
Drug: Balsalazide Disodium
RxNorm normalized name: BALSALAZIDE DISODIUM
DrugBank: Balsalazide (DB01014)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02934191
Drug: Oxycodone
RxNorm normalized name: Oxycodone
DrugBank: Oxycodone (DB00497)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Oxycodone may be used every 4 hours post-operatively to treat breakthrough pain. The most commonly prescribed dose is 0.075mg/kg/dose (suspension) every 4 hours as needed.
Trial: NCT04166565
Drug: Daratumumab
RxNorm normalized name: Daratumumab
DrugBank: Daratumumab (DB09331)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Daratumumab 16 mg/kg will be administered by i.v. infusion. Daratumumab will be administered weekly in Cycles 1 and 2, then every 2 weeks for Cycles 3-6, and thereafter every month up to 36 months.
Trial: NCT04166565
Drug: Bortezomib
RxNorm normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Bortezomib 1.5 mg/m2 bortezomib will be administered by a subcutaneous injection once weekly (Days 1, 8, 15 and 22) in all cycles.
Trial: NCT04166565
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Dexamethasone will be administered on Days 1, 2, 8, 9, 15, 16, 22 and 23 in all cycles. On daratumumab infusion days dexamethasone may be administered i.v. or p.o. approximately 1 hour before the daratumumab infusion. On days when daratumumab is not administered, dexamethasone is to be administered p.o.
Trial: NCT01890863
Drug: Fluticasone Propionate / Salmeterol Xinafoate DISKUS
DrugBank: Fluticasone propionate (DB00588)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Fluticasone propionate and salmeterol xinafoate combination as a dry powder inhaler for oral inhalation with unit dose strength of 100/50 mcg (available in blister pack) administered via DISKUS (Ddpi) device.
Trial: NCT01890863
Drug: Fluticasone Propionate / Salmeterol Xinafoate ROTACAP
DrugBank: Fluticasone propionate (DB00588)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Fluticasone propionate and salmeterol xinafoate combination as a dry powder inhaler for oral inhalation with unit dose strength of 100/50 mcg (available in blister pack) administered via ROTAHALER (Rdpi) device.
Trial: NCT01228019
Drug: Niacin (+) laropiprant
RxNorm normalized name: Niacin
DrugBank: Niacin (DB00627)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Niacin (+) laropiprant (TREDAPTIVE) prescribed according to the current local label
Trial: NCT03766607
Drug: Trastuzumab
RxNorm normalized name: trastuzumab
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days
Trial: NCT03766607
Drug: Ramucirumab
RxNorm normalized name: Ramucirumab
DrugBank: Ramucirumab (DB05578)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Ramucirumab 8 mg/kg administered intravenously on days 1 and 15 every 28 days
Trial: NCT03766607
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Paclitaxel 80 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days
Trial: NCT01931878
Drug: incobotulinumtoxinA
RxNorm normalized name: incobotulinumtoxinA
DrugBank: Botulinum toxin type A (DB00083)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Description: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections.
Trial: NCT01157988
Drug: ibritumomab tiuxetan (Zevalin)
RxNorm normalized name: ibritumomab tiuxetan
DrugBank: Ibritumomab tiuxetan (DB00078)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: During Zevalin treatment, rituximab 250 mg/m2 will be administered with the same methods mentioned above on days 1 and 8. On day 8, within 4 hours following completion of the rituximab dose, 90Y Zevalin at a dose of 0.4 mCi/kg actual body weight for patients with a platelet count \> 150,000/L and 0.3 mCi/kg actual body weight for patients with a platelet count of 100,000 - 149,000/L will be injected intravenously over a period of 10 minutes. The maximum allowable dose of 90Y Zevalin is 32 mCi regardless of the patient's body weight. 90Y Zevalin should be administered within 4 hours after radiolabeling of Zevalin with 90Y.
Trial: NCT01682811
Drug: Part 1 Levulan injection
RxNorm normalized name: Levulan
DrugBank: Aminolevulinic acid (DB00855)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Control or treatment lesions will be injected with Levulan vehicle only or active drug and incubated under occlusion for 3 or 24 hrs. A minimum of three lesions per group on the same subject will be treated. Lesions will then be excised in the normal manner, sectioned vertically, and checked for Protoporphyrin IX using fluorescence microscopy.
Trial: NCT01682811
Drug: Part 1 Levulan surface application
RxNorm normalized name: Levulan
DrugBank: Aminolevulinic acid (DB00855)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Control or treatment lesions will be painted with Levulan vehicle only or active drug, allowed to dry, and incubated under occlusion for 3 or 24 hrs. A minimum of three lesions per group on the same subject will be treated. Lesions will then be excised in the normal manner, sectioned vertically, and checked for Protoporphyrin IX using fluorescence microscopy.
Trial: NCT01682811
Drug: Part 1 Levulan surface application twice
RxNorm normalized name: Levulan
DrugBank: Aminolevulinic acid (DB00855)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Control or treatment lesions will be painted twice with Levulan vehicle only or active drug, allowed to dry between and after applications, and incubated under occlusion for 3 hrs. A minimum of three tumors per group on the same subject will be treated. Lesions will then be excised in the normal manner, sectioned vertically, and checked for Protoporphyrin IX using fluorescence microscopy.
Trial: NCT01682811
Drug: Part 1 Levulan surface application twice with microneedling
RxNorm normalized name: Levulan
DrugBank: Aminolevulinic acid (DB00855)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Control or treatment lesions will be prepared with microneedling, painted twice with Levulan vehicle only or active drug, allowed to dry between and after applications, and incubated under occlusion for 24 hrs. A minimum of three tumors per group on the same subject will be treated. Lesions will then be excised in the normal manner, sectioned vertically, and checked for Protoporphyrin IX using fluorescence microscopy.