AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT04113772
Drug: Nitisinone
RxNorm normalized name: Nitisinone
DrugBank: Nitisinone (DB00348)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Measure bio equivalency/efficacy of nitinosine and orfadin
Trial: NCT04113772
Drug: Orfadin
RxNorm normalized name: Orfadin
DrugBank: Nitisinone (DB00348)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Orfadin
Trial: NCT01954615
Drug: ACT-281959 prodrug formulation I (Groups C to G doses to be defined)
RxNorm normalized name: C.I. 77266
DrugBank: Carbon black (DB11980)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01954615
Drug: ACT-281959 prodrug formulation II (Group G dose to be defined)
RxNorm normalized name: ACT-541468
DrugBank: Daridorexant (DB15031)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01954615
Drug: ACT-246475 (Group G dose to be defined)
RxNorm normalized name: ACT-246475
DrugBank: Selatogrel (DB15163)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01594021
Drug: Gelatin 500 mL
RxNorm normalized name: Gelatin
DrugBank: Gelatin (DB11242)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: intravenous administration
Trial: NCT01594021
Drug: Gelatin 50 mL
RxNorm normalized name: Gelatin
DrugBank: Gelatin (DB11242)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: intravenous administration
Trial: NCT00903929
Drug: Eltrombopag
RxNorm normalized name: Eltrombopag
DrugBank: Eltrombopag (DB06210)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: dose escalation
Trial: NCT00516737
Drug: Comparator: rizatriptan benzoate
DrugBank: Rizatriptan (DB00953)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Trial: NCT00511355
Drug: Levonorgestrel and Ethinyl Estradiol
RxNorm normalized name: Levonorgestrel and Ethinyl Estradiol KIT
DrugBank: Levonorgestrel (DB00367)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Levonorgestrel and Ethinyl Estradiol (LNG-EE) Tablets, 150 mcg LNG and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.
Trial: NCT02544932
Drug: dabigatran
RxNorm normalized name: Dabigatran
DrugBank: Dabigatran (DB14726)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months
Trial: NCT02544932
Drug: ribaroxaban
RxNorm normalized name: Rivaroxaban
DrugBank: Rivaroxaban (DB06228)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.
Trial: NCT02544932
Drug: Warfarin
RxNorm normalized name: Warfarin
DrugBank: Warfarin (DB00682)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.
Trial: NCT04797832
Drug: IV Sodium Ferric Gluconate Complex
RxNorm normalized name: sodium ferric gluconate complex
DrugBank: Sodium citrate (DB09154)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 125 mg of IV Iron per day to 3 to 5 days according to hospitalisation length.
Trial: NCT00585507
Drug: Fulvestrant
RxNorm normalized name: Fulvestrant
DrugBank: Fulvestrant (DB00947)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 500mg into the muscle on days 1, 15 and 29 and then every 28 days thereafter.
Trial: NCT02926950
Drug: Sotagliflozin (SAR439954)
RxNorm normalized name: sotagliflozin
DrugBank: Sotagliflozin (DB12713)
FDA approved: no
EMA approved: yes
PMDA approved: no
Description: Pharmaceutical form: tablet. Route of administration: oral.
Trial: NCT02588339
Drug: Panobinostat
RxNorm normalized name: Panobinostat
DrugBank: Panobinostat (DB06603)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Panobinostat (PANO) will begin 5 days (Day -5) before transplant day (Day 0). All participants will take PANO by mouth once a day, three times a week (48 hours apart), every week for 26 weeks (approximately 6 months). PANO will be provided by Novartis as 5-mg pink gelatin capsules.
Trial: NCT02588339
Drug: Sirolimus
RxNorm normalized name: Sirolimus
DrugBank: Sirolimus (DB00877)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Sirolimus will be given the day before transplant and continued daily for at least one year. SIR will be administered starting on day -1 and thereafter. Dosing will be adjusted to maintain therapeutic targets per Moffitt institutional standards.
Trial: NCT02588339
Drug: Tacrolimus
RxNorm normalized name: Tacrolimus
DrugBank: Tacrolimus (DB00864)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tacrolimus as an infusion or as a pill will begin 3 days before transplant (day -3) and following Moffitt institutional guidelines for dosing. Tacrolimus will be given for at least 50 days and participants will remain on Tacrolimus for as long as it is necessary per standard of care.
Trial: NCT00002764
Drug: ifosfamide
RxNorm normalized name: Ifosfamide
DrugBank: Ifosfamide (DB01181)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02926950
Drug: Metformin
RxNorm normalized name: Metformin
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Pharmaceutical form: tablet. Route of administration: oral.
Trial: NCT00099190
Drug: ARQ 501
RxNorm normalized name: ARQ 092
DrugBank: Miransertib (DB14982)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03682601
Drug: 5% sinecatechins ointment
DrugBank: Sinecatechins (DB01266)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Topical 5% sinecatechins ointment will be applied once daily.
Trial: NCT03682601
Drug: 10% sinecatechins ointment
DrugBank: Sinecatechins (DB01266)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Topical 10% sinecatechins ointment will be applied three times per week up to once daily.
Trial: NCT02499822
Drug: Nifedipine GITS
RxNorm normalized name: Nifedipine
DrugBank: Nifedipine (DB01115)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.
Trial: NCT02499822
Drug: Ramipril
RxNorm normalized name: Ramipril
DrugBank: Ramipril (DB00178)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.
Trial: NCT01121588
Drug: Crizotinib
RxNorm normalized name: Crizotinib
DrugBank: Crizotinib (DB08865)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule
Trial: NCT04105114
Drug: Buspirone
RxNorm normalized name: Buspirone
DrugBank: Buspirone (DB00490)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral Buspirone 7.5mg - 10mg daily during the treatment phase.
Trial: NCT01995071
Drug: Ribavirin (RBV)
RxNorm normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Tablet
Trial: NCT03881787
Drug: anti-EGFR monoclonal antibody
RxNorm normalized name: Anti-VEGF monoclonal antibody
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Recombinant anti-EGFR human mouse chimeric monoclonal antibody injection
Trial: NCT03881787
Drug: Cetuximab injection
RxNorm normalized name: cetuximab Injection
DrugBank: Cetuximab (DB00002)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Cetuximab injection
Trial: NCT04448587
Drug: Sitagliptin 100mg
RxNorm normalized name: Sitagliptin 100mg Oral tablet
DrugBank: Sitagliptin (DB01261)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Oral sitagliptin will be commenced at a dose of 100 mg BID. The dose will be increased by 100 mg every three days up to a maximal dose of 300 mg BID. In the case of significant drug related side effects or drug intolerance, the last tolerated dose will be resumed. Patients responding well to lower doses of sitagliptin, will not be given higher doses of the drug. Sitagliptin will be provided as long as deemed effective by the treating physician up to three months.
Trial: NCT01157078
Drug: TC-5214
RxNorm normalized name: TC-6987
DrugBank: TC-6987 (DB14854)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablet, oral, twice daily for 8 weeks
Trial: NCT01020474
Drug: pregabalin (Lyrica)
RxNorm normalized name: Pregabalin
DrugBank: Pregabalin (DB00230)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 75-450mg/day pregabalin dose optimised at start of study
Trial: NCT03987191
Drug: Multiple daily ijnection using Insulin Degludec and Insulin Aspart
RxNorm normalized name: insulin aspart, human / insulin degludec
DrugBank: Insulin aspart (DB01306)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Trial: NCT00372086
Drug: Rosiglitazone
RxNorm normalized name: Rosiglitazone
DrugBank: Rosiglitazone (DB00412)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01490567
Drug: Donepezil
RxNorm normalized name: Donepezil
DrugBank: Donepezil (DB00843)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 5 mg/day
Trial: NCT02070458
Drug: ixazomib
RxNorm normalized name: Ixazomib
DrugBank: Ixazomib (DB09570)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given PO
Trial: NCT02070458
Drug: mitoxantrone hydrochloride
RxNorm normalized name: Mitoxantrone Hydrochloride
DrugBank: Mitoxantrone (DB01204)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT02070458
Drug: etoposide
RxNorm normalized name: Etoposide
DrugBank: Etoposide (DB00773)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT02070458
Drug: cytarabine
RxNorm normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT04257461
Drug: Oxaliplatin
RxNorm normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Bichemotherapy: Oxaliplatine combined with Fluoropyrimidine.
Trial: NCT03187769
Drug: ALKS 3831
RxNorm normalized name: ALKS 29
DrugBank: ALKS 29 (DB05723)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Olanzapine + samidorphan, daily oral dosing
Trial: NCT03187769
Drug: Olanzapine
RxNorm normalized name: Olanzapine
DrugBank: Olanzapine (DB00334)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Daily oral dosing
Trial: NCT02485145
Drug: A/B
RxNorm normalized name: rBV A/B
DrugBank: Recombinant botulinum A/B vaccine (DB17830)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: This arm uses the test product first, which consists of Diclofenac 3%, Baclofen 2%, Orphenadrine 5%, and Bupivacaine 2% in a VersaPro cream. This is the A arm. The B arm is the second arm, and consists of the VersaPro cream alone.
Trial: NCT02485145
Drug: B/A
RxNorm normalized name: TJ-CD4B/ABL111
DrugBank: Givastomig (DB18618)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: This arm uses the placebo product first, which consists of the VersaPro cream alone. This is the B arm. The A arm is the second arm, which consists of the test product which consists of Diclofenac 3%, Baclofen 2%, Orphenadrine 5%, and Bupivacaine 2% in a VersaPro cream. This is the A arm.
Trial: NCT00742339
Drug: Terlipressin plus albumin
DrugBank: Terlipressin (DB02638)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The terlipressin will be give at the initial dose of 3 mg/24 hours by intravenous continuous infusion. If during the following 48 hours the serum value of creatinine will not change or will go down less than 25%, the dose of terlipressin will be increased to 6 mg/24 hours. If no response will ensue, the dose of terlipressin will be increased to the maximal dose of 12 mg/24 hours. Twenty percent human albumin solution will be administrate together with terlipressin at the dosage of 1 g/Kg of body weight, on first day, and then, to the dosage of 20-40 g/Kg in order to maintain the central venous pressure (CVP) between 10 and 15 cm H2O.The treatment with terlipressin and albumin will be maintained for 24 hours after complete or incomplete resolution. The length of the study in patients with complete and incomplete resolution will reach a maximum of 15 days. In the patients without response the treatment with the high dosage of terlipressin will go on for a maximum of 7 days.
Trial: NCT00742339
Drug: Midodrine plus octreotide plus human albumin
DrugBank: Octreotide (DB00104)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Midodrine will be give orally at the initial dose 7.5 tid together with octreotide at the initial dosage of 100 µg subcutaneously tid. If during the following 96 hours the serum value of creatinine will not change or will go down less than 25%, the dose of midodrine will be increased to 12.5 mg tid Twenty percent human albumin solution will be administrate together with midodrine and octreotide at the dosage of 1 g/Kg of body weight, on first day, and then, to the dosage of 20-40 g/Kg in order to maintain the central venous pressure (CVP) between 10 and 15 cm H2O.The treatment with terlipressin and albumin will be maintained for 24 hours after complete or incomplete resolution. The length of the study in patients with complete and incomplete resolution will reach a maximum of 15 days. In the patients without response the treatment with the high dosage of terlipressin will go on for a maximum of 7 days.
Trial: NCT03919435
Drug: Trimethoprim Sulfamethoxazole
RxNorm normalized name: sulfamethoxazole / trimethoprim
DrugBank: Trimethoprim (DB00440)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Dosage: 160mg-800mg Frequency: 2 times a day Dosage Form: Pill (oral) Duration: 4 weeks
Trial: NCT00835146
Drug: Ribavirin 200 mg tablets
RxNorm normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 1 x 200 mg, single-dose fasting
Trial: NCT04255056
Drug: Pyrotinib
RxNorm normalized name: Pyrotinib
DrugBank: Pyrotinib (DB14993)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pyrotinib is administered orally at 400 mg daily from day 1 of the first cycle to day 21 of the fourth cycle or to the day of surgery, within 30 minutes after breakfast.~Epirubicin (90 mg/m2), intravenously, every 21 days. Cyclophosphamide (600 mg/m2), intravenously, every 21 days.
Trial: NCT01065857
Drug: Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.
DrugBank: Sodium bicarbonate (DB01390)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 4 sachets containing Polyethylene glycol 3350 (59 gr), KCl (0.7425 gr), NaCl (1.465 gr), sodium sulphate anhydrous (5.685 gr), sodium bicarbonate (1.685 gr).
Trial: NCT00157976
Drug: Photrex (rostaporfin)
RxNorm normalized name: Rostaporfin
DrugBank: Rostaporfin (DB06659)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00082888
Drug: Tipifarnib
RxNorm normalized name: Tipifarnib
DrugBank: Tipifarnib (DB04960)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT02447666
Drug: Azacitidine
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT00488891
Drug: Paliperidone ER
RxNorm normalized name: Paliperidone ER
DrugBank: Paliperidone (DB01267)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Route = oral. Paliperidone ER will be prescribed to the patients at the investigator's discretion. Patient receive their medication according to usual care in their treatment setting ie, no study drug is provided
Trial: NCT03476603
Drug: Irbesartan
RxNorm normalized name: Irbesartan
DrugBank: Irbesartan (DB01029)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patients are tested for their normal prescription irbesartan medication
Trial: NCT00251537
Drug: LTB4
RxNorm normalized name: LTB4
DrugBank: Leukotriene B4 (DB12961)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02979665
Drug: Ranibizumab Ophthalmic
RxNorm normalized name: ranibizumab ophthalmic
DrugBank: Ranibizumab (DB01270)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Ranibizumab (trade name Lucentis among others) is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that has been approved to treat the wet type of age-related macular degeneration (AMD, also ARMD), a common form of age-related vision loss and diabetic macular edema (DME).
Trial: NCT03861234
Drug: BI 836880
RxNorm normalized name: BI-836880
DrugBank: BI-836880 (DB17484)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Solution for Intravitreal (IVT) injection
Trial: NCT01536054
Drug: sirolimus
RxNorm normalized name: Sirolimus
DrugBank: Sirolimus (DB00877)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given PO
Trial: NCT00812214
Drug: eszopiclone
RxNorm normalized name: Eszopiclone
DrugBank: Eszopiclone (DB00402)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 3 mg tablet every night at bedtime
Trial: NCT02564315
Drug: Nicotine Mini-Lozenge for 11 Months
RxNorm normalized name: nicotine
DrugBank: Nicotine (DB00184)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants receive up to 11 months of Nicotine Mini-Lozenges as part of this treatment (dosing based on their nicotine dependence as measured when they started the study: 4 mg if they smoked within 30 minutes of waking and 2 mg if they smoked more than 30 minutes after waking, as per the package insert), along with instructions for use.
Trial: NCT00940563
Drug: Imatinib
RxNorm normalized name: Imatinib
DrugBank: Imatinib (DB00619)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT04379739
Drug: Camrelizumab
RxNorm normalized name: Camrelizumab
DrugBank: Camrelizumab (DB14776)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: camrelizumab 200mg, q3w, i.v., 2-4 cycles;
Trial: NCT02184260
Drug: Metamizole
RxNorm normalized name: Metamizole
DrugBank: Metamizole (DB04817)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04374773
Drug: Dronabinol
RxNorm normalized name: Dronabinol
DrugBank: Dronabinol (DB00470)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 2.5 mg PO administered once prior to and once after 1 week of hormone therapy
Trial: NCT02564315
Drug: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge
RxNorm normalized name: nicotine
DrugBank: Nicotine (DB00184)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: All participants will receive 8-weeks of combination NRT (nicotine patch + nicotine mini-lozenge). Nicotine patch dosing will be based on current cigarettes smoked per day, per package insert: for those who currently smoke \>10 cigs/day=4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches, along with nicotine mini-lozenges; for those who currently smoke \<=10 cigs/day=6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches along with mini-lozenges. Mini-lozenge dosing will be based on how soon participants currently smoke after waking before their initial quit attempt and will be consistent with the package insert (4 mg for participants who smoke within 30 minutes of waking and 2 mg for participants smoke more than 30 minutes after waking).
Trial: NCT03144453
Drug: Sugammadex Injectable Product
RxNorm normalized name: sugammadex Injectable Product
DrugBank: Sugammadex (DB06206)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Patients receive sugammadex at the end of the surgery
Trial: NCT03135301
Drug: letrozole plus metformin
RxNorm normalized name: Letrozole
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: letrozole 5 milligram tablets plus metformin 850 milligram tablets
Trial: NCT03135301
Drug: letrozole
RxNorm normalized name: Letrozole
DrugBank: Letrozole (DB01006)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: letrozole 5 milligram tablets
Trial: NCT00452699
Drug: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
DrugBank: Fluticasone propionate (DB00588)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
Trial: NCT00452699
Drug: Fluticasone propionate 250 mcg BID
DrugBank: Fluticasone propionate (DB00588)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Fluticasone propionate 250 mcg BID
Trial: NCT01008280
Drug: baclofen
RxNorm normalized name: Baclofen
DrugBank: Baclofen (DB00181)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: baclofen 10 mg tid
Trial: NCT04404361
Drug: Pacritinib
RxNorm normalized name: Pacritinib
DrugBank: Pacritinib (DB11697)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 100 mg capsules
Trial: NCT00775580
Drug: Atenolol 100mg Tablets
RxNorm normalized name: Atenolol
DrugBank: Atenolol (DB00335)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02852382
Drug: Bupivacaine
RxNorm normalized name: Bupivacaine
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.
Trial: NCT02852382
Drug: morphine patient controlled analgesia
DrugBank: Morphine (DB00295)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: End of the surgery all of the patients in 3 groups will receive morphine patient controlled analgesia (PCA) including 1mg/ml morphine. The PCA was set to administer a bolus dose of 1 mg on demand with a lockout period of 10 minutes and maximum 25 mg for 4 hours.
Trial: NCT01334034
Drug: NNC 0123-0000-0338
RxNorm normalized name: NNC-55-0396 free base
DrugBank: NNC-55-0396 free base (DB17037)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will be randomised to receive a single dose of NNC 0123-0000-0338 (tablet), at 7 escalating dose levels. Progression to next dose level will be based on a safety evaluation.
Trial: NCT01334034
Drug: insulin glargine
RxNorm normalized name: Insulin Glargine
DrugBank: Insulin glargine (DB00047)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: As an open label active comparator, a single dose of insulin glargine will be administered subcutaneously (under the skin), at all dose levels. Insulin glargine dose remains the same at all dose levels.
Trial: NCT03572764
Drug: CPX-351
RxNorm normalized name: CPX
DrugBank: DPCPX (DB12946)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: -CPX-351 will be provided by Jazz Pharmaceuticals
Trial: NCT04111510
Drug: Tumor infiltrating lymphocytes (TIL) LN-145
RxNorm normalized name: Autologous tumor infiltrating lymphocytes
DrugBank: Lifileucel (DB17107)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The TIL autologous therapy with LN-145 is comprised of the following steps:~1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;~2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;~3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);~4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);~5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).