AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT01491035
Drug: Vortioxetine
RxNorm normalized name: Vortioxetine
DrugBank: Vortioxetine (DB09068)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
Trial: NCT01491035
Drug: Vortioxetine
RxNorm normalized name: Vortioxetine
DrugBank: Vortioxetine (DB09068)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
Trial: NCT00839059
Drug: lenalidomide
RxNorm normalized name: Lenalidomide
DrugBank: Lenalidomide (DB00480)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Dose escalation:~Level 0 to level 5, starting with level 1 = 25mg lenalidomide per os daily, Cohorts of 3 patients (to be expanded up to 6 if 1 DLT is observed among the first 3 patients) will be sequentially allotted to progressively higher dose levels of lenalidomide on the basis of the presence and severity of lenalidomide related toxicity encountered in the first cycle or lenalidomide related serious adverse reactions.~Duration of the first cycle: 56days, each following cycle will last 28 days
Trial: NCT00831636
Drug: CP-4055
RxNorm normalized name: CP
DrugBank: Captopril (DB01197)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: D1-5 and D8(+2)-12(+2) q4w
Trial: NCT04431648
Drug: DEFINITY
RxNorm normalized name: Definity
DrugBank: Perflutren (DB00556)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: MRI-guided ultrasound-stimulated microbubble-treatment
Trial: NCT00831636
Drug: CP-4055
RxNorm normalized name: CP
DrugBank: Captopril (DB01197)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IV administration day 1-5 and day 8-12 in a 4 week schedule
Trial: NCT00794976
Drug: Dexamethasone Iontophoretic Patch (low dose)
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00794976
Drug: Dexamethasone Iontophoretic Patch (high dose)
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00794976
Drug: Dexamethasone Passive Patch
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02037165
Drug: Pregabalin
RxNorm normalized name: Pregabalin
DrugBank: Pregabalin (DB00230)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Pregabalin hard capsule
Trial: NCT02037165
Drug: BI 1026706
RxNorm normalized name: BI 2536
DrugBank: BI 2536 (DB16107)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BI 1026706 oral solution
Trial: NCT02776514
Drug: Triamcort
RxNorm normalized name: triamcinolone acetonide Injectable Suspension [Triamcot]
DrugBank: Triamcinolone (DB00620)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Fluoroscopic guided injection in the knee joint
Trial: NCT02776514
Drug: Platelet-rich-plasma
RxNorm normalized name: Platelet Rich Plasma
DrugBank: Platelet Rich Plasma (DB19295)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00472875
Drug: Glibenclamide
RxNorm normalized name: Glibenclamide
DrugBank: Glyburide (DB01016)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00642460
Drug: tocilizumab [RoActemra/Actemra]
DrugBank: Tocilizumab (DB06273)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 8mg/kg (patients\>=30kg) or 12mg/kg (patients \<30kg) iv every 2 weeks. In Part III, administration frequency may be reduced to every 3 and every 4 weeks, respectively, according to an optional alternative dosing schedule.
Trial: NCT00974961
Drug: bupivacaine, levobupivacaine
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: intrathecal injection 15\~20mg(for Levobupivacaine) or 10\~15mg(for Bupivacaine) once
Trial: NCT01244061
Drug: Varenicline
RxNorm normalized name: Varenicline
DrugBank: Varenicline (DB01273)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Varenicline 1mg twice daily
Trial: NCT03297671
Drug: RhIg prophylaxis
RxNorm normalized name: Bacillus anthracis strain V770-NP1-R antigens
DrugBank: Anthrax vaccine (DB11003)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Two RhIg prophylaxis injections for Rh negative women
Trial: NCT04186598
Drug: Nifedipine 30 MG
RxNorm normalized name: nifedipine 30 MG
DrugBank: Nifedipine (DB01115)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: All participants will receive this intervention
Trial: NCT02680418
Drug: FDL169
RxNorm normalized name: FDL169
DrugBank: FDL169 (DB16878)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00766831
Drug: Hydromorphone
RxNorm normalized name: Hydromorphone
DrugBank: Hydromorphone (DB00327)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants will receive hydromorphone OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS will be continued as per Investigator's discretion for additional 84 days of extension phase.
Trial: NCT00281476
Drug: Simvastatine
RxNorm normalized name: Simvastatine
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT05361291
Drug: Lidocaine Hydrochloride
RxNorm normalized name: Lidocaine Hydrochloride
DrugBank: Lidocaine (DB00281)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Inferior alveolar nerve block
Trial: NCT00788593
Drug: EUR-1008 (APT-1008) High Dose
RxNorm normalized name: high-density polyethylene
DrugBank: Poly(lactic acid) (DB15037)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units will be given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Trial: NCT00788593
Drug: EUR-1008 (APT-1008) Low Dose
RxNorm normalized name: ethinyl estradiol
DrugBank: Ethinylestradiol (DB00977)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units will be given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Trial: NCT00766155
Drug: oxaliplatin
RxNorm normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT03912402
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: IV infusion
Trial: NCT03912402
Drug: Cisplatin (or carboplatin)
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IV infusion
Trial: NCT02040311
Drug: Topiramate 96 mg daily
DrugBank: Topiramate (DB00273)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02040311
Drug: Topiramate 192 mg daily
DrugBank: Topiramate (DB00273)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00449319
Drug: Daunorubicine
RxNorm normalized name: Daunorubicine
DrugBank: Daunorubicin (DB00694)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02286219
Drug: FS102
RxNorm normalized name: Fluticasone Salmeterol 102
DrugBank: Salmeterol (DB00938)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Experimental
Trial: NCT02340221
Drug: Taselisib
RxNorm normalized name: Taselisib
DrugBank: Taselisib (DB12108)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm.
Trial: NCT02340221
Drug: Fulvestrant
RxNorm normalized name: Fulvestrant
DrugBank: Fulvestrant (DB00947)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.
Trial: NCT00804830
Drug: Bevacizumab
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w
Trial: NCT00279240
Drug: Metformin
RxNorm normalized name: Metformin
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT02103764
Drug: Desogestrel
RxNorm normalized name: Desogestrel
DrugBank: Desogestrel (DB00304)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month
Trial: NCT02103764
Drug: Medroxyprogesterone acetate
RxNorm normalized name: Medroxyprogesterone Acetate
DrugBank: Medroxyprogesterone acetate (DB00603)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month
Trial: NCT00321594
Drug: belinostat
RxNorm normalized name: Belinostat
DrugBank: Belinostat (DB05015)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT00821002
Drug: Latanoprost
RxNorm normalized name: Latanoprost
DrugBank: Latanoprost (DB00654)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Comparison of punctal plug placement between upper and lower puncta
Trial: NCT00731549
Drug: Aripiprazole IM Depot
RxNorm normalized name: Aripiprazole
DrugBank: Aripiprazole (DB01238)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 300mg or 400mg
Trial: NCT01393730
Drug: Abiraterone acetate
RxNorm normalized name: ABIRATERONE ACETATE
DrugBank: Abiraterone (DB05812)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT01393730
Drug: Dutasteride
RxNorm normalized name: Dutasteride
DrugBank: Dutasteride (DB01126)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01393730
Drug: Prednisone
RxNorm normalized name: Prednisone
DrugBank: Prednisone (DB00635)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01404117
Drug: Laquinimod 0.6
DrugBank: Laquinimod (DB06685)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Laquinimod 0.6 capsule
Trial: NCT01404117
Drug: Laquinimod 1.2
DrugBank: Laquinimod (DB06685)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT00103402
Drug: Alfuzosin
RxNorm normalized name: Alfuzosin
DrugBank: Alfuzosin (DB00346)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00906113
Drug: Intra-arterial injection of melphalan
RxNorm normalized name: melphalan
DrugBank: Melphalan (DB01042)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Injection of 5 milligrams of melphalan into the ophthalmic artery once every 3 weeks for a total of 6 courses
Trial: NCT00906113
Drug: Injection of melphalan into the ophthalmic artery
RxNorm normalized name: melphalan Injection
DrugBank: Melphalan (DB01042)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Injection of 5 milligrams of melphalan into the ophthalmic artery in an eye affected by retinoblastoma
Trial: NCT01100879
Drug: Ferric carboxymaltose
RxNorm normalized name: Ferric Carboxymaltose
DrugBank: Ferric carboxymaltose (DB08917)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Subjects will receive a single dose of 1,000 mg iron as FCM infusion at baseline.~Subjects of bw ≤66 kg will receive a single dose of 500 mg iron as FCM infusion at baseline (Week 0) and at Visit 3 (Week 2).~Ferric carboxymaltose will be administered on the same day with chemotherapy treatment or within 24 hours before or after the chemotherapy. For subjects with bw ≤66 kg, if no chemotherapy planned for the visit 4 (Week 2), the second FCM dose should be infused independent of chemotherapy.
Trial: NCT01920542
Drug: Dexmedetomidine
RxNorm normalized name: Dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: administration of dexmedetomidine on dexemedetomidine group
Trial: NCT02677259
Drug: Micronized progesterone
DrugBank: Progesterone (DB00396)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01154959
Drug: Moxifloxacin, Isoniazid, Rifampicin Pyrazinamide, Ethambutol
DrugBank: Moxifloxacin (DB00218)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Moxifloxacin (400mg), Isoniazid (300mg daily, 600mg thrice weekly), Rifampicin (450mg, and 600mg for patients weighing 60kg or more), Pyrazinamide (1500mg), Ethambutol (800mg)
Trial: NCT01733147
Drug: Omega-3 polyunsaturated fatty acids
RxNorm normalized name: omega-3 polyunsaturated fatty acids
DrugBank: Omega-3 fatty acids (DB11133)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.
Trial: NCT02726919
Drug: Clobazam
RxNorm normalized name: Clobazam
DrugBank: Clobazam (DB00349)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Following a baseline of 12 weeks patients will be started on clobazam, administered orally in b.i.d. schedule. In patients in whom seizure diaries have been kept prospectively prior to study screening visit, retrospective baseline will be accepted. Patients will be titrated up to either seizure freedom, to side effects or to 40 mg/day, whichever comes first
Trial: NCT00646620
Drug: budesonide/formoterol (Symbicort)
DrugBank: Formoterol (DB00983)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT00646620
Drug: fluticasone/salmeterol (Advair Diskus)
DrugBank: Salmeterol (DB00938)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT00646620
Drug: albuterol (Ventolin)
RxNorm normalized name: Albuterol
DrugBank: Albuterol (DB01001)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02278419
Drug: Simeprevir
RxNorm normalized name: Simeprevir
DrugBank: Simeprevir (DB06290)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Simeprevir 150 mg capsule orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
Trial: NCT02278419
Drug: Sofosbuvir
RxNorm normalized name: Sofosbuvir
DrugBank: Sofosbuvir (DB08934)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Sofosbuvir 400 mg tablet orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
Trial: NCT01436565
Drug: MM-121 (SAR256212)
RxNorm normalized name: 2X-121
DrugBank: 2X-121 (DB16063)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form:solution~Route of administration: Intravenous
Trial: NCT03168321
Drug: IDP-123 Vehicle Lotion
RxNorm normalized name: Neisseria meningitidis group B strain NZ98/254 outer membrane vesicle
DrugBank: Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle (DB10786)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Vehicle Lotion
Trial: NCT02563821
Drug: Levobupivacaine
RxNorm normalized name: Levobupivacaine
DrugBank: Levobupivacaine (DB01002)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02563821
Drug: clonidine
RxNorm normalized name: Clonidine
DrugBank: Clonidine (DB00575)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02427295
Drug: Sandostatin (Octreotide Acetate)
RxNorm normalized name: Sandostatin
DrugBank: Octreotide (DB00104)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: For the patients outlined above (refer to 2), subjects who are not able to be treated by surgery alone:~* Dose: Sandostatin LAR® 20mg per 4 weeks for 3 months -\> If serum IFG-1 levels fails to normalize, the dose of LAR will be increased to 30 mg.~* Frequency: every 4 weeks.~* Route of administration: IM injection.
Trial: NCT00094094
Drug: axitinib
RxNorm normalized name: Axitinib
DrugBank: Axitinib (DB06626)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Axitinib (AG-013736) tablet administered orally at a dose of 5 milligrams (mg) twice daily (BID) in cycles of 4 weeks.
Trial: NCT01088919
Drug: pioglitazone hydrochloride
RxNorm normalized name: Pioglitazone Hydrochloride
DrugBank: Pioglitazone (DB01132)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: oral tablet
Trial: NCT00965055
Drug: Ezetimibe
RxNorm normalized name: Ezetimibe
DrugBank: Ezetimibe (DB00973)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 10 mg
Trial: NCT00965055
Drug: Atorvastatin
RxNorm normalized name: Atorvastatin
DrugBank: Atorvastatin (DB01076)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Visit 1: (atorvastatin open label challenge): Those who complete the initial screening and washout period will receive open label atorvastatin 10 mg daily for 6 weeks to verify compliance and confirm hyporesponse to statin therapy.~Visit 2: After 6 weeks of therapy repeat baseline fasting cholesterol. Those with LDL-c reduction of 25% or less will be able to proceed to next phase. Patients with greater than 25% LDL-C reduction will be excluded. We expect to randomize 80 patients~Visit 2a: Dispensing of first randomized drug allocation- all patients receive open label atorvastatin 10 mg with additional ezetimibe 10 mg or matching placebo. No blood test during this visit.~Visit 3, 4, 5: Dose titration to atorvastatin to 20 mg, 40 mg, 80 mg, respectively, after fasting blood test~Blood collected in visits 3, 4, and 5 will be stored for additional tests regarding cholesterol metabolism and inflammation.~Visit 6: Final cholesterol panel and conclusion of study period
Trial: NCT00683982
Drug: Nitazoxanide
RxNorm normalized name: Nitazoxanide
DrugBank: Nitazoxanide (DB00507)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Nitazoxanide 15mg/Kg/day twice day for 3 days
Trial: NCT01663727
Drug: Bevacizumab [Avastin]
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Intravenous repeating dose
Trial: NCT02011737
Drug: naftopidil 75mg
RxNorm normalized name: Naftopidil
DrugBank: Naftopidil (DB12092)
FDA approved: no
EMA approved: no
PMDA approved: yes
Trial: NCT00632411
Drug: Nicotine Patch
RxNorm normalized name: Nicotine Patch
DrugBank: Nicotine (DB00184)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants who smoke more than 20 cigarettes per day will use a 21-mg patch for 4 weeks, a 14-mg patch for the next 2 weeks, a 7-mg patch for the next 2 weeks, and then no patch.~Participants who smoke between 10 to 19 cigarettes per day will use a 14-mg patch for 4 weeks, a 7-mg patch for the next 4 weeks, and then no patch.~Participants who smoke between 5 to 9 cigarettes per day will use a 7-mg patch for 8 weeks and then no patch.~The proactive group will be given 8 weeks of patch treatment and the reactive group will be given 2 weeks of patch treatment.
Trial: NCT01663727
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Intravenous repeating dose
Trial: NCT00375492
Drug: exenatide
RxNorm normalized name: Exenatide
DrugBank: Exenatide (DB01276)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: subcutaneous injection, 5mcg or 10mcg, twice a day
Trial: NCT01937247
Drug: patient will be reversed with sugammadex 4mg/kg IV
DrugBank: Sugammadex (DB06206)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: The patient will be reversed with sugammadex 4mg/kg IV, and then extubated before being moved out of the OR
Trial: NCT00207948
Drug: Dose adjustment of Kaletra
DrugBank: Kale (DB14564)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Adjust the dose by up to +50% of reccomended dosa off the drug to meet target therapeutic concentrations
Trial: NCT01010022
Drug: 6% hydroxyethyl starch 130/0.4
DrugBank: Hydroxyethyl Starch (DB09106)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)
Trial: NCT01010022
Drug: 6% hydroxyethyl starch 70/0.5 (Salinhes®)
DrugBank: Hydroxyethyl Starch (DB09106)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)
Trial: NCT03346070
Drug: Sugammadex 2 mg/kg ABW
DrugBank: Sugammadex (DB06206)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by ABW) for reversal of moderate NMB.~Moderate NMB is defined as the reappearance of a second twitch (T2) in response to TOF stimulations.
Trial: NCT03346070
Drug: Sugammadex 2 mg/kg IBW
DrugBank: Sugammadex (DB06206)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by IBW) for reversal of moderate NMB.~Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations.
Trial: NCT03346070
Drug: Sugammadex 4 mg/kg ABW
DrugBank: Sugammadex (DB06206)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex (4 mg/kg by ABW) for reversal of deep NMB.~Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs).
Trial: NCT03346070
Drug: Sugammadex 4 mg/kg IBW
DrugBank: Sugammadex (DB06206)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants will receive a single i.v. bolus of Sugammadex (4 mg/kg by IBW) for reversal of deep NMB.~Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs).
Trial: NCT03346070
Drug: Neostigmine + Glycopyrrolate
RxNorm normalized name: glycopyrrolate / neostigmine Injectable Solution
DrugBank: Neostigmine (DB01400)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Neostigmine (50 µg/kg; 5 mg maximum) and Glycopyrrolate (10 µg/kg; 1 mg maximum), dosed according to participant ABW for reversal of moderate NMB.~Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations.
Trial: NCT03346070
Drug: Rocuronium or Vecuronium
DrugBank: Rocuronium (DB00728)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: To achieve NMB, participants received steroidal NMBA Rocuronium Bromide or Vecuronium Bromide administered via i.v. infusion and dosed according to participant ABW. NMBAs were concomitant medications used per label as adjunct to general anesthesia.