TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00003392
Drug: paclitaxel
Normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 170 mg/m2 IV day 1
Study: NCT03168256
Drug: Apremilast 30mg
Normalized name: APREMILAST 30MG TAB
DrugBank: Apremilast (DB05676)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Apremilast tablets, 30mg BID for 16 weeks
Study: NCT00564954
Drug: Dex-methylphenidate hydrochloride extended-release (Focalin XR)
Normalized name: methylphenidate hydrochloride Extended Release Suspension
DrugBank: Methylphenidate (DB00422)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 20 mg capsule orally once a day for 7 days
Study: NCT01133431
Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet
DrugBank: Glimepiride (DB00222)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: From day 1 to day 4, CKD-501 0.5mg is administered daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg and glimepiride 4mg is co-administered to overnight-fasting Group 1 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 placebo and glimepiride 4mg in Group 1.
Study: NCT01133431
Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet
DrugBank: Glimepiride (DB00222)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: From day 1 to day 4, CKD-501 placebo is administered daily to Group 2 patients during period 1. Then on day 5,CKD-501 placebo and glimepiride 4mg is co-administered to overnight-fasting Group 2 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 0.5mg and glimepiride 4mg in Group 2.
Study: NCT00506701
Drug: Tadalafil
Normalized name: Tadalafil
DrugBank: Tadalafil (DB00820)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 40 mg tablet
Study: NCT00437333
Drug: Metformin cloridrate
DrugBank: Metformin (DB00331)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT01514188
Drug: INNO-206
Normalized name: INNO-305
DrugBank: INNO-305 (DB06025)
Approvals — FDA: no, EMA: no, PMDA: no
Description: INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
Study: NCT01861912
Drug: Arsenic trioxide intravenous infusion
DrugBank: Arsenic trioxide (DB01169)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Arsenic trioxide intravenous infusion: arsenic trioxide powder 0.15mg/Kg/d(maxim 10mg/d) dissolved in 250ml 0.9%NaCl solution is used for intravenous infusion.Every course will last for 3 weeks and the next course will be continued after 1 week suspension.Intravenous infusion will be suspended 3 days before and 7\~14 days after TACE.
Study: NCT01861912
Drug: lipiodol
Normalized name: Lipiodol
DrugBank: Ethiodized oil (DB00965)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Lipiodol is used to dissolve arsenic trioxide for TACE,with the dosage decided according to the volume of the target lesion.
Study: NCT01861912
Drug: NaCl solution
Normalized name: sodium chloride
DrugBank: Linaclotide (DB08890)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 250ml NaCl solution is used to dissolve the arsenic trioxide for intravenous infusion.
Study: NCT00252122
Drug: Ketamine
Normalized name: Ketamine
DrugBank: Ketamine (DB01221)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Ketamine. 0.2 mg/kg, intravenously
Study: NCT02493426
Drug: Intranasal Oxytocin
Normalized name: Oxytocin
DrugBank: Oxytocin (DB00107)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT03886701
Drug: Doravirine (DOR)
DrugBank: Doravirine (DB12301)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents.
Study: NCT03886701
Drug: Rifapentine (RPT)
Normalized name: Rifapentine
DrugBank: Rifapentine (DB01201)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Rifamycin anti-tuberculosis agent indicated for the treatment of latent and active tuberculosis infection.
Study: NCT03886701
Drug: Isoniazid (INH)
Normalized name: Isoniazid
DrugBank: Isoniazid (DB00951)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Anti-tuberculosis agent indicated for the treatment of latent and active tuberculosis infection.
Study: NCT02408796
Drug: OTO-201
Normalized name: DB-OTO
DrugBank: DB-OTO (DB18278)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00199147
Drug: Cytarabine
Normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00199147
Drug: Etoposide
Normalized name: Etoposide
DrugBank: Etoposide (DB00773)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00199147
Drug: Idarubicin
Normalized name: Idarubicin
DrugBank: Idarubicin (DB01177)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00199147
Drug: G-CSF
Normalized name: G-CSF
DrugBank: Filgrastim (DB00099)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT00199147
Drug: Fludarabine
Normalized name: Fludarabine
DrugBank: Fludarabine (DB01073)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04173325
Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
DrugBank: Nivolumab (DB09035)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer.
Study: NCT04173325
Drug: Irinotecan Injection [Camptosar]
Normalized name: irinotecan Injection [Camptosar]
DrugBank: Irinotecan (DB00762)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer.
Study: NCT00712322
Drug: Darifenacin
Normalized name: Darifenacin
DrugBank: Darifenacin (DB00496)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Following a 7-day washout period, participants received darifenacin liquid oral suspension up to 14 days.
Study: NCT01449201
Drug: PF-00299804
Normalized name: PF-05089771
DrugBank: PF-05089771 (DB14856)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 45 mg P.O. Daily (28-day treatment as one treatment cycle)
Study: NCT03760848
Drug: Aramchol
Normalized name: Aramchol
DrugBank: Aramchol (DB11860)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Aramchol 600 mg
Study: NCT03760848
Drug: Midazolam
Normalized name: Midazolam
DrugBank: Midazolam (DB00683)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Midazolam 2 mg
Study: NCT03760848
Drug: Atorvastatin
Normalized name: Atorvastatin
DrugBank: Atorvastatin (DB01076)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: atorvastatin 40 mg
Study: NCT01755494
Drug: Saxagliptin 5 mg
Normalized name: sAXagliptin 5 MG
DrugBank: Saxagliptin (DB06335)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Saxagliptin oral tablet 5mg, single dose
Study: NCT01755494
Drug: Metformin XR 500 mg
Normalized name: metformin Extended Release Suspension
DrugBank: Metformin (DB00331)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Metformin XR oral tablet 500 mg, single dose
Study: NCT00100412
Drug: Graded dobutamine infusions
DrugBank: Dobutamine (DB00841)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00100412
Drug: Graded phenylephrine injections
Normalized name: phenylephrine Injection
DrugBank: Phenylephrine (DB00388)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01236443
Drug: HPPH
Normalized name: HPPH
DrugBank: 2-(1-Hexyloxyethyl)-2-devinyl pyropheophorbide-a (DB15243)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 3 mg/m2 IV
Study: NCT00839397
Drug: Paroxetine
Normalized name: Paroxetine
DrugBank: Paroxetine (DB00715)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Subjects will take the treatment phase medication once daily after an evening meal. All subjects will be maintained at Dose Level II (20 mg/day) for the first 2 weeks. If a sufficient clinical response (1. Very much improved or 2. Much improved based on the CGI Global Improvement) is achieved, the subject will continue on the same dose level. When the clinical response is not sufficient but the investigational product is well tolerated, the dose will be increased to Dose Level III (30 mg/day) and then to Dose Level IV (40 mg/day) at intervals of at least 2 weeks until a sufficient response is reached. Once a sufficient response is obtained, the treatment will be continued at that dose. The treatment phase will last for a total of 52 weeks. In those patients receiving Dose Level III or IV, dosage reductions to the next lowest level (Dose Level II or III) consequent to an adverse event are permitted.~Dosage adjustment will be made at the discretion of the PI or Sub-PI
Study: NCT01860625
Drug: Donepezil patch
DrugBank: Donepezil (DB00843)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00369486
Drug: 40mg triamcinolone
Normalized name: triamcinolone
DrugBank: Triamcinolone (DB00620)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
Study: NCT00369486
Drug: 40mg triamcinolone + laser
Normalized name: triamcinolone
DrugBank: Triamcinolone (DB00620)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser
Study: NCT00369486
Drug: 20mg triamcinolone + laser
DrugBank: Triamcinolone (DB00620)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser
Study: NCT01392963
Drug: botulinum toxin type A neurotoxin complex
Normalized name: Botulinum toxin type A
DrugBank: Botulinum toxin type A (DB00083)
Approvals — FDA: no, EMA: yes, PMDA: yes
Description: 29-40 U injection
Study: NCT00402116
Drug: enzastaurin
Normalized name: Enzastaurin
DrugBank: Enzastaurin (DB06486)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Phase 1 - 250 mg Cohort 1 with one dose escalation allowed to 500 mg for Cohort 2, oral, daily, 6 weeks then twelve 28 day cycles~Phase 2 - Phase 1 established dose, oral, daily, 6 weeks then twelve 28 day cycles
Study: NCT00402116
Drug: temozolomide
Normalized name: Temozolomide
DrugBank: Temozolomide (DB00853)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 75 milligrams per meter squared (mg/m\^2), oral, daily, 6 weeks then 200 mg/m\^2, oral, daily, twelve 28 day cycles
Study: NCT00330317
Drug: letrozole
Normalized name: Letrozole
DrugBank: Letrozole (DB01006)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 2.5mg letrozole once-daily
Study: NCT01689779
Drug: 100,000 IU cholecalciferol
DrugBank: Cholecalciferol (DB00169)
Approvals — FDA: no, EMA: no, PMDA: no
Description: active drug
Study: NCT00719875
Drug: Vorinostat
Normalized name: Vorinostat
DrugBank: Vorinostat (DB02546)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: BID days -7, 1-7 and 15-21, 200 mg
Study: NCT02026687
Drug: Intrathecal
Normalized name: Lioresal Intrathecal
DrugBank: Baclofen (DB00181)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01423123
Drug: Paclitaxel
Normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 80 mg/m2 IV on days 1, 8, and 15 every 28 days until disease progression.
Study: NCT01423123
Drug: Neratinib
Normalized name: NERATINIB
DrugBank: Neratinib (DB11828)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Dose level 1: 120 mg/day orally; Dose level 2: 160 mg/day orally; Dose level 3: 240 mg/day orally; Dose level 4: 200 mg/day orally.
Study: NCT02237157
Drug: Gemcitabine, local delivery
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Intra-arterial targeted drug delivery
Study: NCT00548080
Drug: MK0991, caspofungin acetate / Duration of Treatment:
DrugBank: Caspofungin (DB00520)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02145091
Drug: Moderately-high dose of psilocybin
Normalized name: high-density polyethylene
DrugBank: Psilocybin (DB11664)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral dose of a moderately-high dose of psilocybin.
Study: NCT02145091
Drug: Moderately-low dose of psilocybin
Normalized name: low-density polyethylene
DrugBank: Psilocybin (DB11664)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral dose of a moderately-low dose of psilocybin.
Study: NCT02145091
Drug: Very-low dose of psilocybin
DrugBank: Psilocybin (DB11664)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral dose of a very-low dose of psilocybin.
Study: NCT02373449
Drug: Ketamine
Normalized name: Ketamine
DrugBank: Ketamine (DB01221)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Part of standard care. To be performed over five consecutive days (Monday to Friday) for six hours per day. A therapeutic range of 0.5 to 2.0 mg/kg/hour is targeted.
Study: NCT02755649
Drug: Dupilumab
Normalized name: Dupilumab
DrugBank: Dupilumab (DB12159)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT01085071
Drug: Potassium Chloride
Normalized name: Potassium Chloride
DrugBank: Potassium chloride (DB00761)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: KCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L)
Study: NCT01085071
Drug: Potassium Chloride
Normalized name: Potassium Chloride
DrugBank: Potassium chloride (DB00761)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: KCl is continuously administered and titrated towards a Normal-low Potassium (4.0 mmol/L)
Study: NCT03420911
Drug: Midazolam
Normalized name: Midazolam
DrugBank: Midazolam (DB00683)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT03541928
Drug: HSV-Tk
Normalized name: HSV-TK
DrugBank: Nalotimagene carmaleucel (DB19155)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Injection of the HSV-tk gene therapy product in four quadrants of prostate to enhance the immune system via bystander effect in which cytotoxicity is conferred to non-transduced neighboring cells. In vivo bystander effects are likely due to a combination of host immunological responses and to gap junction-mediated transport of phosphorylated prodrug metabolites to surrounding cells.
Study: NCT03541928
Drug: Valacyclovir
Normalized name: Valacyclovir
DrugBank: Valaciclovir (DB00577)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The recommended dose for this trial is 2 g orally t.i.d. for 14 days (day 1 to day 15 and days 31 to 45). This dose has been calculated to give a similar AUC as 10 mg/kg of intravenous acyclovir administered every 8 hours. This is the same dose regimen used in a previous phase I clinical trial of ADV/HSV-tk plus acyclovir and topotecan in patients with recurrent ovarian cancer.
Study: NCT03541928
Drug: Bicalutamide
Normalized name: Bicalutamide
DrugBank: Bicalutamide (DB01128)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The recommended dose for Bicalutamide therapy in combination with an LHRH analogue is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that Bicalutamide be taken at the same time each day.~The use of an oral antiandrogen with medical castration for the treatment of prostate cancer is referred to as combined androgen blockade (CAB). Compared with LHRH-agonist monotherapy, CAB with bicalutamide did not reduce overall QoL but provided an early improvement in QoL related to lower urinary tract symptoms and pain.
Study: NCT03541928
Drug: Leuprolide Acetate
Normalized name: Leuprolide Acetate
DrugBank: Leuprolide (DB00007)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Leuprolide acetate 7.5 mg depot injection will be injected monthly for a total of 2 months.
Study: NCT01289483
Drug: fospropofol
Normalized name: Fospropofol
DrugBank: Fospropofol (DB06716)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
Study: NCT02089659
Drug: Doravirine
Normalized name: Doravirine
DrugBank: Doravirine (DB12301)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Following an overnight fast, a single tablet of 100 mg doravirine was be administered orally
Study: NCT03251170
Drug: Ketamine
Normalized name: Ketamine
DrugBank: Ketamine (DB01221)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Patients will receive :1 mg/Kg ketamine for induction of anesthesia
Study: NCT03251170
Drug: Midazolam
Normalized name: Midazolam
DrugBank: Midazolam (DB00683)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Patients will receive 0.05 mg/Kg midazolam
Study: NCT01739049
Drug: Liraglutide
Normalized name: Liraglutide
DrugBank: Liraglutide (DB06655)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: liraglutide
Study: NCT00470392
Drug: Imiquimod
Normalized name: Imiquimod
DrugBank: Imiquimod (DB00724)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
Study: NCT00470392
Drug: Clobetasol
Normalized name: Clobetasol
DrugBank: Clobetasol (DB11750)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
Study: NCT02784041
Drug: single adductor-canal-block
Normalized name: Ivy Block
DrugBank: Bentoquatam (DB00516)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Single adductor-canal-block is performed before the surgery. A 12Hz linear ultrasound transducer is placed on the medial part of the thigh with the leg slightly externally rotated. The femoral artery was identified in short axis in the adductor canal, underneath the sartorius muscle. After skin disinfection , an 18-gauge needle (B.Braun Medical, Melsungen, Germany) is inserted in-plane from the lateral side of the transducer. The needle tip was placed underneath the sartorius muscle, just lateral to the artery and saphenous nerve, using 2-3 ml of saline to ensure correct placement. 25 ml of 0.35% ropivacaine is slowly injected with repeated aspiration.
Study: NCT02784041
Drug: periarticular infiltration
Normalized name: Autologous tumor infiltrating lymphocytes
DrugBank: Lifileucel (DB17107)
Approvals — FDA: no, EMA: no, PMDA: no
Description: The periarticular infiltration of multimodal agents will involve the preparation of a mixture of 100 ml solution. The mixture contains 30ml (300mg) ropivacaine, 0.5ml (5 mg) morphine, 2 ml (50 mg) flurbiprofen and 0.5 ml of 1:1000 epinephrine, and then is diluted with 0.9% normal saline to a total volume of 100ml. 50 ml of mixture will be injected into the anterior, medial and lateral soft tissues after the implantation of the joint prostheses. The remaining 50 ml of mixture will be injected into intraarticular space after the closure of articular capsule.
Study: NCT01499368
Drug: Famotidine
Normalized name: Famotidine
DrugBank: Famotidine (DB00927)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Famotidine 40mg/day
Study: NCT00046241
Drug: Extended-release bupropion hydrochloride
Normalized name: bupropion Extended Release Oral Tablet
DrugBank: Bupropion (DB01156)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01499368
Drug: Omeprazole
Normalized name: Omeprazole
DrugBank: Omeprazole (DB00338)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Omeprazole 20mg/day
Study: NCT01068262
Drug: Odanacatib
Normalized name: Odanacatib
DrugBank: Odanacatib (DB06670)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks
Study: NCT00576108
Drug: KD7040 Topical Gel
Normalized name: KD7040
DrugBank: KD7040 (DB05214)
Approvals — FDA: no, EMA: no, PMDA: no
Description: KD7040 topical gel
Study: NCT00794339
Drug: 64Cu-ATSM
Normalized name: 64Cu-dotatate
DrugBank: Copper oxodotreotide Cu-64 (DB15873)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00794339
Drug: FDG
Normalized name: 18F-FDG
DrugBank: Fludeoxyglucose (18F) (DB09502)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT04414618
Drug: Opaganib
Normalized name: Opaganib
DrugBank: Opaganib (DB12764)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
Study: NCT03495921
Drug: Irinotecan
Normalized name: Irinotecan
DrugBank: Irinotecan (DB00762)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Injectable formulation of irinotecan was distributed from central supplier. 1 Cycle (5 doses of 50 mg/m2 per syringe) was drawn into provided oral syringes and dispenses to the subject with instructions to refrigerate until administration.
Study: NCT03495921
Drug: Temozolomide
Normalized name: Temozolomide
DrugBank: Temozolomide (DB00853)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Dose: 100 mg/m2 daily, oral Schedule: Days 1-5, every 21 days Administered at least 1 hour before Irinotecan.
Study: NCT01857479
Drug: Inhaled budesonide
Normalized name: budesonide Inhalation Suspension
DrugBank: Budesonide (DB01222)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: The control group will receive only nebulized budesonide 1 mg b.i.d. thrice a week for four months. Patients will also receive a metered dose inhaler of formoterol/budesonide (6/200) at a dose of 2 puffs b.i.d. and as and when required \[max 10 puff/day\]. The first dose will be administered under direct supervision. If the first dose is tolerated, therapy would be continued for the total duration of the study (4 months). The patient will be advised to clean the nebulizer chamber with soap and water after each administration to avoid contamination.
Study: NCT01857479
Drug: Inhaled amphotericin
Normalized name: amphotericin
DrugBank: Amphotericin B (DB00681)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Amphotericin B deoxycholate (50 mg) will be dissolved in 10 mL sterile water for injection (5 mg/mL). The solution remains stable for at least 7 days at 2°C to 8°C. Ten milligrams of the drug (2 mL) will be nebulized over 10-15 minutes twice in a day for three times a week (Effective dose: 10 mg b.i.d. thrice a week) using a jet nebulizer. Nebulized budesonide will be administered at a dose of 1 mg b.i.d. thrice a week after nebulization with amphotericin B. The total duration of therapy would last 4 months. Patients will also receive a metered dose inhaler of formoterol/budesonide (6/200) at a dose of 2 puffs b.i.d. and as and when required \[max 10 puff/day\].~The first dose will be administered under direct supervision.
Study: NCT01520870
Drug: PF-299804 (Dacomitinib)
Normalized name: DACOMITINIB
DrugBank: Dacomitinib (DB11963)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end.
Study: NCT02473198
Drug: Exparel
Normalized name: Exparel
DrugBank: Bupivacaine (DB00297)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Prior to cementing of the prosthesis (minimum 20 minutes later), injection with mixture of 40 mL normal saline solution and 20mL 1.3% Exparel.