TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02736591
Drug: DHEA
Normalized name: DHEA
DrugBank: Prasterone (DB01708)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Women will receive oral DHEA 25 mg t.d.s. 12 weeks before ICSI.
Study: NCT04443881
Drug: Anakinra 149 MG/ML Prefilled Syringe [Kineret]
Normalized name: anakinra 149 MG/ML Prefilled Syringe [Kineret]
DrugBank: Anakinra (DB00026)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Anakinra (100 mg/ 6 hours) i.v infusión during 15 days
Study: NCT01859962
Drug: PPI-668
Normalized name: PPI-1040
DrugBank: PPI-1040 (DB17620)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01859962
Drug: BI 207127 Dose 1
Normalized name: BI 2536
DrugBank: BI 2536 (DB16107)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01859962
Drug: BI 207127 Dose 2
Normalized name: BI 2536
DrugBank: BI 2536 (DB16107)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01859962
Drug: Faldaprevir
Normalized name: Faldaprevir
DrugBank: Faldaprevir (DB11808)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01859962
Drug: Ribavirin
Normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01932502
Drug: Initial conversion and titration
Normalized name: donepezil
DrugBank: Donepezil (DB00843)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Initial conversion will occur over two weeks followed by upward titration of up to 10mg increment per week toward the target dose. Down titration of up to 10mg will be allowed during the study.
Study: NCT00347425
Drug: Aripiprazole
Normalized name: Aripiprazole
DrugBank: Aripiprazole (DB01238)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Study: NCT01996657
Drug: Warfarin
Normalized name: Warfarin
DrugBank: Warfarin (DB00682)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00347425
Drug: Olanzapine
Normalized name: Olanzapine
DrugBank: Olanzapine (DB00334)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Study: NCT00347425
Drug: Risperidone
Normalized name: Risperidone
DrugBank: Risperidone (DB00734)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Study: NCT00347425
Drug: Quetiapine
Normalized name: Quetiapine
DrugBank: Quetiapine (DB01224)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Study: NCT00347425
Drug: Ziprasidone
Normalized name: Ziprasidone
DrugBank: Ziprasidone (DB00246)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Study: NCT00347425
Drug: Aripiprazole
Normalized name: Aripiprazole
DrugBank: Aripiprazole (DB01238)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Study: NCT02802644
Drug: Sitagliptin
Normalized name: Sitagliptin
DrugBank: Sitagliptin (DB01261)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Sitagliptin is indicated to control hyperglycemia in type 2 diabetic patients.
Study: NCT02802644
Drug: Non DPP-4 Inhibitor
Normalized name: Fibrinolysis inhibitor
DrugBank: Aprotinin (DB06692)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: This group patients is permitted to take any other oral anti-hyperglycemic agents except sitagliptin.
Study: NCT03000530
Drug: SAGE-217
Normalized name: SAGE
DrugBank: Sage (DB10982)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02219776
Drug: Benzoyl Peroxide solution Plus Chlorhexidine Scrub
Normalized name: benzoyl peroxide Topical Solution
DrugBank: Chlorhexidine (DB00878)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Subjects will be provided instructions on how to use and apply the chlorhexidine using a scrub brush and 1.5 oz bottle of 10% benzoyl peroxide emollient application
Study: NCT03632226
Drug: 18F-OGA-1
Normalized name: (18F)-Fluoride
DrugBank: Fluoride ion F-18 (DB09398)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04262804
Drug: Margetuximab
Normalized name: Margetuximab
DrugBank: Margetuximab (DB14967)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Margetuximab IV
Study: NCT04262804
Drug: Trastuzumab
Normalized name: trastuzumab
DrugBank: Trastuzumab (DB00072)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Trastuzumab IV
Study: NCT04262804
Drug: Chosen Chemotherapy (Capecitabine)
Normalized name: menthol
DrugBank: Menthol (DB14123)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Capecitabine tablet
Study: NCT04262804
Drug: Chosen Chemotherapy (Vinorelbine )
Normalized name: menthol
DrugBank: Menthol (DB14123)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Vinorelbine IV
Study: NCT04262804
Drug: Chosen Chemotherapy (Gemcitabine )
Normalized name: menthol
DrugBank: Menthol (DB14123)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Gemcitabine IV
Study: NCT00347425
Drug: Olanzapine
Normalized name: Olanzapine
DrugBank: Olanzapine (DB00334)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Study: NCT00347425
Drug: Risperidone
Normalized name: Risperidone
DrugBank: Risperidone (DB00734)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Study: NCT00347425
Drug: Quetiapine
Normalized name: Quetiapine
DrugBank: Quetiapine (DB01224)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Study: NCT00347425
Drug: Ziprasidone
Normalized name: Ziprasidone
DrugBank: Ziprasidone (DB00246)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Study: NCT01932502
Drug: Conversion schedule - Week 1
Normalized name: Serum prothrombin conversion accelerator
DrugBank: Coagulation factor VII human (DB13150)
Approvals — FDA: no, EMA: no, PMDA: no
Description: The following will be the initial conversion schedule from clonazepam to Onfi:~Week 1: 50% reduction of clonazepam and starting dose of Onfi, replacing the reduced clonazepam dose with the conversion rate of clonazepam 0.5mg=Onfi 10mg.
Study: NCT01932502
Drug: Conversion schedule - Week 2
Normalized name: Serum prothrombin conversion accelerator
DrugBank: Coagulation factor VII human (DB13150)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold.
Study: NCT01932502
Drug: Conversion schedule - Week 3
Normalized name: Serum prothrombin conversion accelerator
DrugBank: Coagulation factor VII human (DB13150)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated.
Study: NCT02804815
Drug: Aspirin 100mg
Normalized name: Aspirin
DrugBank: Acetylsalicylic acid (DB00945)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Aspirin 100mg
Study: NCT02804815
Drug: Aspirin 300mg
Normalized name: ASPIRIN 300MG TAB
DrugBank: Acetylsalicylic acid (DB00945)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Aspirin 300mg
Study: NCT00822224
Drug: MEOPA
Normalized name: homeopathic drugs
DrugBank: Nitrous oxide (DB06690)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: inhalation of MEOPA during the painful care
Study: NCT00553358
Drug: Lapatinib
Normalized name: Lapatinib
DrugBank: Lapatinib (DB01259)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Small molecule receptor tyrosine kinase inhibitor
Study: NCT00553358
Drug: Paclitaxel
Normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: antimicrotubule agent
Study: NCT00865241
Drug: Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg
Normalized name: glyburide / metformin hydrochloride Oral Tablet
DrugBank: Metformin (DB00331)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: A: Experimental Subjects received Alpharma formulated products under fasting conditions
Study: NCT00655512
Drug: pimecrolimus 1% cream
Normalized name: PIMECROLIMUS 1% CREAM,TOP
DrugBank: Pimecrolimus (DB00337)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Study: NCT00655512
Drug: clobetasol-17-propionat 0,05% cream
DrugBank: Clobetasol (DB11750)
Approvals — FDA: no, EMA: no, PMDA: no
Description: twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Study: NCT02851394
Drug: Levobupivacaine
Normalized name: Levobupivacaine
DrugBank: Levobupivacaine (DB01002)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02851394
Drug: levobupivacaine
Normalized name: Levobupivacaine
DrugBank: Levobupivacaine (DB01002)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02851394
Drug: tramadol
Normalized name: Tramadol
DrugBank: Tramadol (DB00193)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02109718
Drug: Open Dressings with Petrolatum Jelly
Normalized name: petrolatum
DrugBank: Petrolatum (DB11058)
Approvals — FDA: no, EMA: no, PMDA: no
Description: participants randomized to this arm had their wounds dressed with a thin layer (1mm) of petrolatum gel applied over the burn wound and instructed to reapply the gel as needed in the event of gel coming off.
Study: NCT02109718
Drug: Silver Sulfadiazine Gauze Dressing Group
Normalized name: Silver Sulfadiazine
DrugBank: Sulfadiazine (DB00359)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Participants randomized to this arm had their wounds dressed using the standard methods at the Burn Center. An initial layer of fine mesh gauze is applied that is laden with a 2mm layer of silver sulfadiazine cream. This is covered with layers of moist gauze and an outer layer of dry gauze, secured by wrapping with rolled gauze. The dressing extends at least 1 inch beyond the wound edge.
Study: NCT03288480
Drug: PT-112
Normalized name: PT-2385
DrugBank: PT-2385 (DB16055)
Approvals — FDA: no, EMA: no, PMDA: no
Description: This is a single arm study
Study: NCT04547504
Drug: Pembrolizumab
Normalized name: Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Pembrolizumab 200 mg once every 3 weeks for a maximum of 35 cycles or until disease progression, death, unacceptable toxicity, or the Investigator's or the patient's decision to stop.
Study: NCT04547504
Drug: Pembrolizumab and Chemotherapy drugs
DrugBank: Pembrolizumab (DB09037)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: An induction therapy followed by a maintenance therapy.~4 induction cycles every 3 weeks associating, on the first day of each cycle:~* Cisplatin 75mg/m² or carboplatin AUC 5mg/mL/min, pemetrexed 500mg/m² and pembrolizumab 200mg for non squamous NSCLC.~* Carboplatin AUC 6mg/mL/min, paclitaxel 200mg/m² and pembrolizumab 200mg for squamous NSCLC.~After the 4 induction cycles, a maintenance therapy will be possible for patients who are responding or stable:~* Non squamous NSCLC: pembrolizumab and pemetrexed combination or either drug as monotherapy.~* Squamous NSCLC: pembrolizumab monotherapy.~For pembrolizumab: treatment may be continued for a maximum of 35 cycles or until disease progression, death, unacceptable toxicity, or following the Investigator's or the patient's decision to stop.~For pemetrexed, treatment may be continued until disease progression, death, unacceptable toxicity, or following the Investigator's or the patient's decision to stop.
Study: NCT06585319
Drug: Collagen-polyvinylpyrrolidone
Normalized name: Collagen-polyvinylpyrrolidone
DrugBank: Collagen-polyvinylpyrrolidone (DB16525)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2 ml intramuscular q24 h
Study: NCT06585319
Drug: Pirfenidone 1200 mg
Normalized name: Pirfenidone
DrugBank: Pirfenidone (DB04951)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 1,200 mg of oral q12 h
Study: NCT02963922
Drug: Liraglutide 3.0 mg
DrugBank: Liraglutide (DB06655)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Injected subcutaneously (s.c., under the skin) once daily
Study: NCT03554200
Drug: Empagliflozin
Normalized name: Empagliflozin
DrugBank: Empagliflozin (DB09038)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Standard of Care + Empagliflozin: 10 mg (tablets) once daily
Study: NCT02784535
Drug: Atomoxetine
Normalized name: Atomoxetine
DrugBank: Atomoxetine (DB00289)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: norepinephrine transporter inhibitor
Study: NCT01839799
Drug: Gemcitabine
Normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15
Study: NCT01839799
Drug: Abraxane
Normalized name: Abraxane
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 125 mg/m2 IV over 30 minutes, day 1, 8, 15
Study: NCT01116700
Drug: Dexmedetomidine
Normalized name: Dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Dexmedetomidine will be administered to 2 groups: (1) Seizure disordered patients on anticonvulsants and (2) Healthy volunteers (Control group)
Study: NCT02297945
Drug: metyrapone
Normalized name: Metyrapone
DrugBank: Metyrapone (DB01011)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Single arm study
Study: NCT04412642
Drug: Methoxyflurane, MEOF
DrugBank: Methoxyflurane (DB01028)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: As soon as possible following enrollment and initial procedures, the patient will be supplied with a PENTHROX™ kit which includes one inhaler containing 3 mL of MEOF for pain management. A member of the research team will train the patient to self-administer MEOF. PENTHROX™ is an approved (trademarked) product in Canada and is commercially available in a combination blister pack with one 3 mL sealed bottle and one PENTHROX™ inhaler with the Activated Carbon (AC) chamber.
Study: NCT03735368
Drug: Dexmedetomidine Injection
Normalized name: dexmedetomidine Injection
DrugBank: Dexmedetomidine (DB00633)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion
Study: NCT03735368
Drug: Pregabalin Oral Capsule
Normalized name: pregabalin Oral Capsule
DrugBank: Pregabalin (DB00230)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: 150 mg pregabalin Oral Capsule
Study: NCT01469975
Drug: OTSA101-DTPA-90Y level 1
Normalized name: DTPA
DrugBank: Pentetic acid (DB14007)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Part 2 of the study 1.5 mg of OTSA101-DTPA radiolabelled with 370MBq of 90Y will be administered IV as a single injection on Day 0.
Study: NCT00585910
Drug: Atomoxetine and OROS Methylphenidate
DrugBank: Atomoxetine (DB00289)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Subjects must have at least attempted to tolerate a dose of 1.2 mg/kg of atomoxetine. If tolerated, they must remain on this dose for at least two weeks. OROS methylphenidate will be target dosed and titrated to a maximum dose of 54 mg.
Study: NCT01469975
Drug: OTSA101-DTPA-90Y level 2
Normalized name: DTPA
DrugBank: Pentetic acid (DB14007)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Part 2 of the study 1.5 mg of OTSA101-DTPA radiolabelled with 1110 MBq of 90Y will be administered IV as a single injection on Day 0.
Study: NCT01469975
Drug: OTSA101-DTPA-90Y level 3
Normalized name: DTPA
DrugBank: Pentetic acid (DB14007)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Part 2 of the study 3 mg of OTSA101-DTPA radiolabelled with 2220 MBq of 90Y will be administered IV as a single injection on Day 0.~This third dose level evaluation will be based on safety and preliminary efficacy data.
Study: NCT00580047
Drug: Alendronate
Normalized name: alendronate
DrugBank: Alendronic acid (DB00630)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 70mg weekly
Study: NCT02820298
Drug: Bexagliflozin
Normalized name: BEXAGLIFLOZIN
DrugBank: Bexagliflozin (DB12236)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Bexagliflozin tablet, 20 mg
Study: NCT02020551
Drug: Lidocaine Spray
Normalized name: lidocaine Mucosal Spray
DrugBank: Lidocaine (DB00281)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT04632056
Drug: Beovu
Normalized name: Beovu
DrugBank: Brolucizumab (DB14864)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: There is no treatment allocation. Patients administered Beovu by prescription that have started before inclusion of the patient into the study were enrolled.
Study: NCT01836809
Drug: nesiritide
Normalized name: nesiritide
DrugBank: Nesiritide (DB04899)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours.
Study: NCT01656187
Drug: Memantine 10 mg capsule
DrugBank: Memantine (DB01043)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Memantine oral capsule was initiated at 5 mg/day at Randomization (Week 0), then titrated to 5 mg twice a day at Week 2, then increased to 10 mg in the morning and 5 mg in the evening at Week 3, and then to 10 mg twice a day (intervention dose) at Weeks 4-24. For the participants in the Placebo, then Memantine arm, the same titration schedule was maintained after the 4-week washout period (Week 28-52).
Study: NCT01656187
Drug: Memantine-matched Placebo capsule
DrugBank: Memantine (DB01043)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Memantine-matched oral Placebo capsule was initiated at Randomization (Week 0) and maintained Weeks 0-24 in a manner consistent with the active drug titration schedule. The number of placebo capsules matched the number of active drug capsules at each titration checkpoint. For the participants in the Memantine, then Placebo arm, the same titration schedule was maintained after the 4-week washout period (Week 28-52).
Study: NCT02879669
Drug: Pemetrexed/cisplatin (carboplatin)
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01339156
Drug: P3914
Normalized name: Pemetrexed
DrugBank: Pemetrexed (DB00642)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Part A:~The subjects will be fasted overnight for at least 10 hrs.The drug will be administered orally to each subject in sitting posture.~Part B:~Dosing will start on Day 1. Each subject will receive the investigational product under fasting conditions for 14 days (Days 1 to 14).~The investigational product will be administered orally to each subject with 240 mL of water.~Part C:~Dosing will take place on Day 1 of each study period. Each subject will receive a single oral dose.~For administration of P3914 tablets subjects will be required to fast for 10 hrs prior to dosing.~Part D:~Patients will be fasted for at least 4-6 hrs. The investigational product will be administered orally to each subject in sitting posture on day 1 within 6 hrs of first administration of anesthesia (day of dental surgery).
Study: NCT01436045
Drug: Insulin glulisine
Normalized name: Insulin Glulisine
DrugBank: Insulin glulisine (DB01309)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)
Study: NCT01436045
Drug: Saline
Normalized name: Salinex
DrugBank: Sodium chloride (DB09153)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)
Study: NCT01825785
Drug: Romosozumab
Normalized name: ROMOSOZUMAB
DrugBank: Romosozumab (DB11866)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Administered by subcutaneous injection
Study: NCT03167645
Drug: Human albumin
Normalized name: Human albumin
DrugBank: Albumin human (DB00062)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Substitution according to pre-specified dosage
Study: NCT01837199
Drug: Metronidazole plus Amoxicillin
Normalized name: Metronidazole
DrugBank: Metronidazole (DB00916)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: All subjects will receive scaling and root planing combined with systemic metronidazole (400 mg) and amoxicillin (500 mg). Both antibiotics were administered T.I.D. for 14 days.
Study: NCT00228813
Drug: Granulocyte Colony Stimulating Factor
Normalized name: Granulocyte colony stimulating factor
DrugBank: Filgrastim (DB00099)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: FILGRASTIM: G-CSF (NEUPOGEN®) is administered as a short IV infusion over 30 minutes or subcutaneously. It is given beginning on day -3 for 3 days to the donor prior to the bone marrow harvest.~Drug Information: FILGRASTIM: G-CSF (Neupogen®) Formulation: G-CSF is available as a preservative-free solution for injection in 1.0 ml and 1.6 ml vials containing 300 mcg/ml.~Administration: G-CSF 5 mcg/kg/d will be given subcutaneously or as a short I.V. infusion over 30 minutes.~Recombinant GM-CSF at the dose of 250 mcg/m2 will be given intravenously from day +7 to help white counts recovery. The drug will be diluted in NS at a concentration of at least 10 mcg/ml.~Drug Information: Sargramostim (Leukine) Formulation: 250 mcg, 500 mcg lyophlized powder for injection
Study: NCT01179659
Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
DrugBank: Pantoprazole (DB00213)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Single dose crossover BE study
Study: NCT01836328
Drug: Parenteral /oral methadone ratio 1:2
DrugBank: Methadone (DB00333)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: See arm/group descriptions
Study: NCT01836328
Drug: Parenteral /oral methadone ratio 1:1.2
DrugBank: Methadone (DB00333)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: See arm/group descriptions
Study: NCT03985189
Drug: ME-401
Normalized name: LIMOSILACTOBACILLUS FERMENTUM ME-3
DrugBank: Lactobacillus fermentum (DB16542)
Approvals — FDA: no, EMA: no, PMDA: no
Description: \[Phase 1 study (DLT evaluation)\] ME-401 will be administered at 2 dosages as 45 mg (Cohort 1) or 60 mg (Cohort 2), daily oral administration, QD, and the trial will be initiated at Cohort 1, and medical specialists and the Efficacy and Safety Assessment Committee as needed will decide whether the Cohort will be shifted to the next stage based on their assessment of the safety and tolerability.~\[Roll over study\] 60 mg ME-401 will be administrated on intermittent schedule (1 week on and 3 week off in every 4-week cycle)and will continue until the prescribed mediation in ME-401-004 study is completed or discontinuation criteria are met.
Study: NCT01285492
Drug: Tiotropium
Normalized name: Tiotropium
DrugBank: Tiotropium (DB01409)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tiotropium (18 μg o.d.), delivered via Handihaler®
Study: NCT01375777
Drug: Ezetimibe
Normalized name: Ezetimibe
DrugBank: Ezetimibe (DB00973)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Administered orally once a day
Study: NCT00839306
Drug: Rabeprazole ER
DrugBank: Rabeprazole (DB01129)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 50 mg capsule, taken orally, once daily for 26 weeks.
Study: NCT00839306
Drug: Ranitidine
Normalized name: Ranitidine
DrugBank: Ranitidine (DB00863)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 150 mg capsule, taken orally, twice daily for 26 weeks.
Study: NCT03362853
Drug: Nemonoxacin 500Mg Capsule
Normalized name: nemonoxacin
DrugBank: Nemonoxacin (DB06600)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Receive a single dose in a fasting state