AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT04375046
Drug: Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2)
RxNorm normalized name: Recombinant human insulin-like growth factor 1
DrugBank: Recombinant human insulin-like growth factor 1 (DB18684)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In this study, the experimental group will receive 0.4 mg/kg rbACE2 IV
Trial: NCT05326516
Drug: Revumenib
RxNorm normalized name: Revumenib
DrugBank: Revumenib (DB18515)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive revumenib until meeting criteria for discontinuation.
Trial: NCT05267886
Drug: Dobutamine
RxNorm normalized name: Dobutamine
DrugBank: Dobutamine (DB00841)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Dobutamine administered according to its clinical dose stage for cardiogenic shock
Trial: NCT05267886
Drug: Milrinone
RxNorm normalized name: Milrinone
DrugBank: Milrinone (DB00235)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Milrinone administered according to its clinical dose stage for cardiogenic shock
Trial: NCT05383521
Drug: Tinidazole 56
RxNorm normalized name: Tinidazole
DrugBank: Tinidazole (DB00911)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.
Trial: NCT05383521
Drug: Tinidazole 42
RxNorm normalized name: Tinidazole
DrugBank: Tinidazole (DB00911)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.
Trial: NCT04746339
Drug: Apixaban 2.5 MG
RxNorm normalized name: apixaban 2.5 MG
DrugBank: Apixaban (DB06605)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Apixaban 2.5mg twice daily for 30 days
Trial: NCT04383262
Drug: Fosamprenavir Calcium
RxNorm normalized name: Fosamprenavir Calcium
DrugBank: Fosamprenavir (DB01319)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: A repurposing approach, prospective, placebo-controlled clinical trial of FOS-SA (used at 1,400 mg fosamprenavir calcium and 24.5 mg sodium alginate, twice daily) for 12 weeks in medically refractory patients with clinically diagnosed moderate/severe LPR (RSI \> 13, RFS \> 7 and MII-pH confirmed laryngeal reflux event\[s\]).
Trial: NCT05707169
Drug: mixture of 20 mL 2% lidocaine, 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L of 0.9% saline
DrugBank: Lidocaine (DB00281)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: mixture of 20 mL 2% lidocaine, 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L of 0.9% saline
Trial: NCT05301608
Drug: Psilocybin
RxNorm normalized name: Psilocybin
DrugBank: Psilocybin (DB11664)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 10 mg of psilocybin.
Trial: NCT05076786
Drug: Chidamide
RxNorm normalized name: Chidamide
DrugBank: Tucidinostat (DB06334)
FDA approved: no
EMA approved: no
PMDA approved: yes
Description: 20mg, administered orally. Week 1/2: twice a week (d0, d4, d7, d11); Week 3: stop. Repeat every 3 weeks for 4-6 cycles.
Trial: NCT05076786
Drug: Etoposide + Cisplatin/Carboplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Etoposide (100mg/m2; intravenous infusion; d1-3) + Cisplatin (75mg/m2; intravenous infusion; d1). Repeat every 3 weeks for 4-6 cycles.~OR Etoposide (100mg/m2; intravenous infusion; d1-3) + Cisplatin (25mg/m2; intravenous infusion; d1-3). Repeat every 3 weeks for 4-6 cycles.~OR Etoposide (100mg/m2; intravenous infusion; d1-3) + Carboplatin (AUC=5; intravenous infusion; d1). Repeat every 3 weeks for 4-6 cycles.
Trial: NCT02716090
Drug: Adapalene and Benzoyl peroxide Dalap Duo®
DrugBank: Adapalene (DB00210)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02716090
Drug: Adapalene and Benzoyl peroxide Epiduo®
DrugBank: Adapalene (DB00210)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT04844840
Drug: STP705
RxNorm normalized name: STP705 (small interfering RNA (siRNA) therapeutic directed against transforming growth factor-beta 1 (TGF-beta 1) and cyclo-oxygenase-2 (COX-2))
DrugBank: Cotsiranib (DB18404)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively
Trial: NCT05496764
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: we planned to inject steroid( 4 mg of dexamethasone acetate combined with 1% lidocaine into the carpal tunnels) directly into the carpal tunnel in group A
Trial: NCT05496764
Drug: Glucose Injection
RxNorm normalized name: glucose Injection
DrugBank: Dextrose, unspecified form (DB09341)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: inject10 ml glucose 5% into the carpal tunnel in group B
Trial: NCT05137678
Drug: glibenclamide
RxNorm normalized name: Glibenclamide
DrugBank: Glyburide (DB01016)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Glibenclamide was given orally or by nasal feeding
Trial: NCT04784000
Drug: Period 1: AT-527 550 mg
DrugBank: AT-527 (DB16451)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1
Trial: NCT04784000
Drug: Period 2: carbamazepine
DrugBank: Carbamazepine (DB00564)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Carbamazepine 100 mg twice daily (BID) Days 3 to 6, 200 mg BID on Days 9 to 11, 300 mg BID on Days 12 to 25
Trial: NCT04784000
Drug: Period 3: AT-527 550 mg + carbamazepine
DrugBank: Carbamazepine (DB00564)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
Trial: NCT04784000
Drug: Period 3: AT-527 1100 mg + carbamazepine
DrugBank: Carbamazepine (DB00564)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: AT-527 1100 mg tablet (2 x 550 mg tablets, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
Trial: NCT05073315
Drug: Adalimumab
RxNorm normalized name: Adalimumab
DrugBank: Adalimumab (DB00051)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Participants will receive subcutaneous (SC) injection of adalimumab
Trial: NCT00063206
Drug: DVS-233 SR
RxNorm normalized name: rAAVrh74.MHCK7.DYSF.DV
DrugBank: S-23 (DB07419)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT06005480
Drug: Mepivacaine
RxNorm normalized name: Mepivacaine
DrugBank: Mepivacaine (DB00961)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Injection of 1.5% Mepivacaine in nerve block
Trial: NCT05002816
Drug: Elotuzumab
RxNorm normalized name: elotuzumab
DrugBank: Elotuzumab (DB06317)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Elotuzumab will be administered via intravenous infusion at an established dose of 10 mg/kg on days 1, 8, 15, 22 every 28 days for cycles 1 and 2, followed by 20mg/kg on day 1 of each cycle thereafter, cycles repeated every 28 days.
Trial: NCT05073315
Drug: ABP 501
RxNorm normalized name: ABPC
DrugBank: Ampicillin (DB00415)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants will receive SC injection of ABP 501
Trial: NCT05166096
Drug: Rho-11
RxNorm normalized name: IGG, Rho (D)
DrugBank: Human Rho(D) immune globulin (DB11597)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will be administered 325 mg aspirin by rapid IV push
Trial: NCT05166096
Drug: aspirin 325mg
RxNorm normalized name: ASPIRIN 325MG CAP
DrugBank: Acetylsalicylic acid (DB00945)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Subjects will be administered 325 mg aspirin orally
Trial: NCT05002816
Drug: Belantamab mafodotin
RxNorm normalized name: belantamab mafodotin
DrugBank: Belantamab mafodotin (DB15719)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Belantamab mafodotin will be administered via IV infusion on day 1 of each 28 day cycle. There will be 3 dose levels for belantamab mafodotin, with the starting dose of 1.9 mg/kg IV at every 4 week interval. Up to 12 subjects will be treated at this dose level. If the initial dose is found to be too toxic, dose of belantamab mafodotin 1.9 mg/kg every 8 weeks will be tested, further dose reduction to 1.4mg/kg every 8 weeks will be administered. Following the dose evaluation, there will be a dose expansion cohort wtih 12 additional subjects. There is no dose escalation planned in this study.
Trial: NCT05590689
Drug: Gliolan
DrugBank: Aminolevulinic acid (DB00855)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: A repetitive dose of Gliolan will be administrated in combination with radiotherapy (radiodynamic therapy)
Trial: NCT06390956
Drug: Pirtobrutinib
RxNorm normalized name: Pirtobrutinib
DrugBank: Pirtobrutinib (DB17472)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered once daily as an oral medication.
Trial: NCT04779320
Drug: Vedolizumab IV
RxNorm normalized name: Vedolizumab
DrugBank: Vedolizumab (DB09033)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Vedolizumab IV
Trial: NCT05227703
Drug: CVL-231 15 mg
RxNorm normalized name: CVL-231
DrugBank: Emraclidine (DB18706)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CVL-231 15 mg, oral (tablet), once per day for 6 weeks
Trial: NCT05227703
Drug: Required CVL-231 30 mg
RxNorm normalized name: CVL-231
DrugBank: Emraclidine (DB18706)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CVL-231 30 mg, oral (tablet), once per day for 6 weeks
Trial: NCT06252675
Drug: Pirtobrutinib
RxNorm normalized name: Pirtobrutinib
DrugBank: Pirtobrutinib (DB17472)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given Orally (PO)
Trial: NCT05394116
Drug: Garetosmab
RxNorm normalized name: Garetosmab
DrugBank: Garetosmab (DB16379)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Garetosmab is supplied as a liquid drug product and will be administered IV.
Trial: NCT05498155
Drug: Neoadjuvant Olaparib monotherapy group
RxNorm normalized name: Olaparib
DrugBank: Olaparib (DB09074)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Neoadjuvant olaparib monotherapy (300 mg BID) for four to six 28-day cycles.
Trial: NCT05746442
Drug: Nicotine patch
RxNorm normalized name: Nicotine Patch
DrugBank: Nicotine (DB00184)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants will be provided with a 8 week supply of nicotine patches
Trial: NCT05176470
Drug: Fludarabine
RxNorm normalized name: Fludarabine
DrugBank: Fludarabine (DB01073)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT05389943
Drug: Oral administration of vitamin D3
RxNorm normalized name: vitamin D3
DrugBank: Vitamin D (DB11094)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: the effect of oral supplement in postmenopausal women.
Trial: NCT05389943
Drug: Vitamin D3 50000 UNT Oral Capsule
DrugBank: Vitamin D (DB11094)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In postmenopausal women with BMD less than 32 ng/ml
Trial: NCT06274801
Drug: Seralutinib
RxNorm normalized name: Seralutinib
DrugBank: Seralutinib (DB18072)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Capsule containing seralutinib
Trial: NCT05715814
Drug: Empagliflozin 25 MG
RxNorm normalized name: empagliflozin 25 MG
DrugBank: Empagliflozin (DB09038)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: PO once daily
Trial: NCT05540262
Drug: Edaravone
RxNorm normalized name: Edaravone
DrugBank: Edaravone (DB12243)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Edaravone injection 30mg three times a day
Trial: NCT05572684
Drug: NC410
RxNorm normalized name: Nivolumab
DrugBank: Nivolumab (DB09035)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: NC410 will be given intravenously (IV) every 2 weeks
Trial: NCT05572684
Drug: pembrolizumab
RxNorm normalized name: Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Pembrolizumab 400mg will be given IV every 6 weeks.
Trial: NCT06288360
Drug: Camrelizumab
RxNorm normalized name: Camrelizumab
DrugBank: Camrelizumab (DB14776)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 200 mg, intravenously, 20-60 min. 2 times, every 21 days
Trial: NCT06288360
Drug: Paclitaxel-albumin
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 260 mg/m² over 30 min, 3 times, every 21 days
Trial: NCT06288360
Drug: Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 4 h, 75-80 mg/m², 3 times, every 21 days
Trial: NCT06210607
Drug: HS-10511 Tablets
RxNorm normalized name: HS-CoM
DrugBank: Coenzyme M (DB09110)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: HS-10511 tablets for 5\~6 SAD cohorts and 4 MAD cohorts
Trial: NCT05778838
Drug: Midodrine Oral Tablet
RxNorm normalized name: midodrine Oral Tablet
DrugBank: Midodrine (DB00211)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patients will receive standard treatment in accordance to surviving sepsis campaign guidelines plus oral midodrine 10 mg/ 8 hours till the end of treatment (subject remaining vasopressor-free for 24 consecutive hours) or death.
Trial: NCT06533748
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given orally (PO) or intravenously (IV).
Trial: NCT06533748
Drug: Vincristine
RxNorm normalized name: Vincristine
DrugBank: Vincristine (DB00541)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV.
Trial: NCT06533748
Drug: Inotuzumab
RxNorm normalized name: INOTUZUMAB
DrugBank: Inotuzumab ozogamicin (DB05889)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given IV.
Trial: NCT06533748
Drug: Blinatumomab
RxNorm normalized name: Blinatumomab
DrugBank: Blinatumomab (DB09052)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given IV.
Trial: NCT06533748
Drug: Dasatinib
RxNorm normalized name: Dasatinib
DrugBank: Dasatinib (DB01254)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Given PO.
Trial: NCT06533748
Drug: Cytarabine
RxNorm normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV or IT.
Trial: NCT06533748
Drug: 6-Mercaptopurine
RxNorm normalized name: 6-Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given PO.
Trial: NCT06533748
Drug: Calaspargase
RxNorm normalized name: CALASPARGASE
DrugBank: Calaspargase pegol (DB14730)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV.
Trial: NCT06533748
Drug: Daunorubicin
RxNorm normalized name: daunorubicin
DrugBank: Daunorubicin (DB00694)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV.
Trial: NCT06533748
Drug: Thioguanine
RxNorm normalized name: Thioguanine
DrugBank: Tioguanine (DB00352)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given PO (participants intolerant to mercaptopurine).
Trial: NCT06431633
Drug: Zimberelimab
RxNorm normalized name: Zimberelimab
DrugBank: Zimberelimab (DB17505)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Zimberelimab is a fully human IgG4 monoclonal antibody targeting human PD-1. PD-1 is a type I transmembrane protein that is part of the immunoglobulin gene superfamily and the CD28 family of cell surface receptors. PD-1 is an inhibitory immune checkpoint protein that is expressed on activated B cells, T cells, and myeloid cells, and it plays a key role in limiting the activity of effector T cells.~Zimberelimab is formulated at 30 mg/mL in a buffer solution containing histidine/histidine-HCl buffer solution, sucrose, sodium chloride, and polysorbate 80, at pH 5.5. The investigational product is supplied as a vial contains 120 mg of active Zimberelimab at a concentration of 30mg/mL.~No premedication nor profilaxis is needed before Zimberelimab administration. Zimberelimab doses are administered by IV infusion over 60 minutes, followed by a 30- to 60-minute observation period, on D1 of each 21-day cycle.
Trial: NCT06431633
Drug: Sacituzumab govitecan
RxNorm normalized name: sacituzumab govitecan
DrugBank: Sacituzumab govitecan (DB12893)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Sacituzumab govitecan (SG) is an ADC composed of the following 3 components:~o The humanized monoclonal antibody hRS7 IgG1κ, which binds to Trop-2, a transmembrane calcium signal transducer that is overexpressed in many epithelial cancers.~o The camptothecin-derived agent SN-38, a topoisomerase I inhibitor. o A hydrolyzable linker, with the company designation as CL2A that links the humanized monoclonal antibody to SN-38.~Sacituzumab govitecan is approved globally for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and HR+ breast cancer.
Trial: NCT06431633
Drug: Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Cisplatin-based adjuvant chemotherapy~Cisplatin - CAS 15663-27-1, is a platinum coordination complex with potent anti-neoplastic activity. Induces apoptosis in cancer cells, possibly via caspase-3 activation.
Trial: NCT06431633
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cisplatin-based adjuvant chemotherapy Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center. Other Name: ATC code: L01XA02
Trial: NCT06514963
Drug: HRS-9813
RxNorm normalized name: HRS-1167
DrugBank: HRS-1167 (DB18703)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Specified dose on specified days
Trial: NCT06267001
Drug: Atezolizumab
RxNorm normalized name: Atezolizumab
DrugBank: Atezolizumab (DB11595)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Atezolizumab will be administered IV.
Trial: NCT06267001
Drug: Tiragolumab
RxNorm normalized name: Tiragolumab
DrugBank: Tiragolumab (DB16409)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tiragolumab will be administered IV.
Trial: NCT06503250
Drug: Atezolizumab
RxNorm normalized name: Atezolizumab
DrugBank: Atezolizumab (DB11595)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Observational Study
Trial: NCT06503250
Drug: Bevacizumab
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Observational Study
Trial: NCT05400876
Drug: Penpulimab injection
RxNorm normalized name: Penpulimab
DrugBank: Penpulimab (DB16747)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Penpulimab is an inhibitor of programmed cell death protein 1 (PD-1)
Trial: NCT05574101
Drug: Cemiplimab
RxNorm normalized name: CEMIPLIMAB
DrugBank: Cemiplimab (DB14707)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Participants will undergo baseline imaging, followed by two doses of neoadjuvant cemiplimab at a dose of 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days). Then, participants will receive concurrent cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) concurrently with RT to 70 Gy in 35 fractions over 7 weeks. Thereafter, participants will receive 38 weeks of cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) for a cumulative total of 12 months of cemiplimab.
Trial: NCT06161870
Drug: individualized vancomycin dosing based on the population pharmacokinetics (PK) model
RxNorm normalized name: Vancomycin
DrugBank: Vancomycin (DB00512)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The experimental group will be guided at the bedside with individualized vancomycin dosing by a drug dosimetry software tool that incorporates a PK model developed by Roberts JA et al. for data from sepsis patients. The model developed by Roberts JA et al. has been validated in multiple centers to have a good ability to predict the concentration-time data of patients. Once the basic information of participants such as gender, age, body weight, and creatinine clearance rate (CCR) is entered, the software tool can calculate the dosing regimen that is estimated to achieve the pharmacodynamic (PD) target. The area under the curve (AUC24) of 400-600mg·h/L is identified as the PD target of vancomycin.
Trial: NCT06494774
Drug: BI 1815368
RxNorm normalized name: BI 2536
DrugBank: BI 2536 (DB16107)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BI 1815368
Trial: NCT06161870
Drug: empirical vancomycin dosing
RxNorm normalized name: Vancomycin
DrugBank: Vancomycin (DB00512)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The control group will be administered empirically (15-20 mg/kg vancomycin infused intermittently every 8-12 hours depending on the actual body weight of participants).
Trial: NCT06059391
Drug: Granulocyte Colony-Stimulating Factor
RxNorm normalized name: Granulocyte colony-stimulating factor lenograstim
DrugBank: Filgrastim (DB00099)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Undergo stem cell mobilization with G-CSF
Trial: NCT06059391
Drug: Hematopoietic Cell Transplantation Conditioning Regimen
RxNorm normalized name: human cord blood hematopoietic progenitor cell
DrugBank: Human cord blood hematopoietic progenitor cell (DB11054)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Receive pre transplant conditioning
Trial: NCT06059391
Drug: Stem Cell Mobilization Therapy
RxNorm normalized name: Longeveron mesenchymal stem cells
DrugBank: Allogenic bone marrow-derived mesenchymal stem cells (DB18032)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Undergo stem cell mobilization with G-CSF
Trial: NCT04921956
Drug: Concizumab
RxNorm normalized name: concizumab
DrugBank: Concizumab (DB12820)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Injected under the skin (subcutaneous, sc) once daily, individual dose adjustment.
Trial: NCT06013969
Drug: Spesolimab
RxNorm normalized name: Spesolimab
DrugBank: Spesolimab (DB15626)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Spesolimab intravenous (i.v.) infusion
Trial: NCT04860830
Drug: BI 425809
RxNorm normalized name: BI 2536
DrugBank: BI 2536 (DB16107)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BI 425809
Trial: NCT04633252
Drug: Prednisone
RxNorm normalized name: Prednisone
DrugBank: Prednisone (DB00635)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: For mCSPC patients, prednisone is optional and if given, should be taken orally, at 5 mg once a day. For mCRPC patients, prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day as is the patient s preference.