AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT04551573
Drug: Rifapentine daily
RxNorm normalized name: Rifapentine
DrugBank: Rifapentine (DB01201)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: In addition to taking Biktarvy for four weeks, participants will also take Rifapentine dosed daily for four weeks (10mg/kg; 600 mg dose)
Trial: NCT04551573
Drug: Rifapentine weekly
RxNorm normalized name: Rifapentine
DrugBank: Rifapentine (DB01201)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: In addition to taking Biktarvy for four weeks, participants will also take Rifapentine dosed weekly for another four more weeks (15 mg/kg; 900mg dose)
Trial: NCT06124547
Drug: Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet (Test or reference)
Trial: NCT00002358
Drug: Sorivudine
RxNorm normalized name: Sorivudine
DrugBank: Sorivudine (DB11998)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT06354270
Drug: Stannous fluoride toothpaste
RxNorm normalized name: stannous fluoride Toothpaste
DrugBank: Stannous fluoride (DB11092)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Toothpaste containing 0.454 % weight/weight (w/w) SnF2.
Trial: NCT06354270
Drug: Regular fluoride toothpaste (Crest Cavity Protection)
RxNorm normalized name: sodium fluoride Toothpaste [Fluoridex]
DrugBank: Sodium citrate (DB09154)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Regular fluoride toothpaste containing 1100 parts per million (ppm) fluoride.
Trial: NCT00426114
Drug: Administration of an IV glucose-injection
RxNorm normalized name: glucose Injection
DrugBank: Dextrose, unspecified form (DB09341)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT05580172
Drug: RH324
RxNorm normalized name: Risperidone
DrugBank: Risperidone (DB00734)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: polymolecular
Trial: NCT00002250
Drug: CD4-IgG
RxNorm normalized name: Human IGG
DrugBank: Recombinant human CD4 immunoglobulin G (DB17812)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04194190
Drug: Individual Patient TCR-Transduced PBL
RxNorm normalized name: patent blue violet
DrugBank: Patent Blue (DB13967)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT05659290
Drug: Fruquintinib alternating with Bevacizumab plus Capecitabine
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Maintenance therapy with Fruquintinib 5mg, orally, once daily, d1-14, 2 weeks on/ 1 week off, q3w, followed by Bevacizumab 7.5 mg/kg, iv.gtt,d1,q3w + Capecitabine 850 mg/m2, orally, twice daily, d1-14, q3w; every 6 weeks as a treatment cycle; until unacceptable toxicity, withdrawal of informed consent, death, or other criteria for ending the study (whichever occurs earlier).
Trial: NCT04615962
Drug: Hydrocortisone Acetate 1% Cream
RxNorm normalized name: HYDROCORTISONE ACETATE 1% CREAM
DrugBank: Hydrocortisone (DB00741)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties.
Trial: NCT04615962
Drug: Mometasone Furoate
RxNorm normalized name: Mometasone Furoate
DrugBank: Mometasone furoate (DB14512)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Mometasone is a medium-strength corticosteroid.
Trial: NCT05659290
Drug: Bevacizumab plus Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Maintenance therapy with Bevacizumab 7.5 mg/kg, iv.gtt,d1,q3w + Capecitabine 850 mg/m2, orally, twice daily, d1-14, q3w; every 3 weeks as a treatment cycle; until unacceptable toxicity, withdrawal of informed consent, death, or other criteria for ending the study (whichever occurs earlier).
Trial: NCT04931511
Drug: Compound betamethasone Injection(Gluteal muscle injection)
RxNorm normalized name: Betamethasone
DrugBank: Betamethasone (DB00443)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Gluteal muscle injection(Compound betamethasone 1ml + Sodium Chloride Injection 4ml) + Subacromial Ultrasound Guided injection(Sodium Chloride Injection 5ml)
Trial: NCT05224401
Drug: Pivmecillinam and amoxicillin/clavulanic acid
DrugBank: Clavulanic acid (DB00766)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1 tablet pivmecillinam 400 mg and 1 tablet Amoxicillin/clavulanic acid 875/125 mg, three times daily.
Trial: NCT05224401
Drug: Standard treatment, ciprofloxacin, trimethoprim/sulfamethoxazole or ertapenem depending on susceptibility
DrugBank: Ertapenem (DB00303)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Ciprofloxacin 500 mg twice daily, trimethoprim/sulfamethoxazole 800 mg/160 mg twice daily or ertapenem 1 g once daily.
Trial: NCT04931511
Drug: Compound betamethasone Injection(Subacromial Ultrasound Guided injection)
RxNorm normalized name: Betamethasone
DrugBank: Betamethasone (DB00443)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Gluteal muscle injection (Sodium Chloride Injection 5ml)+ Subacromial Ultrasound Guided injection (corticosteroid 1ml+Sodium Chloride Injection 4ml)
Trial: NCT06065267
Drug: Levofloxacin 500Mg Oral Tablet
RxNorm normalized name: Levofloxacin 500mg Oral tablet
DrugBank: Levofloxacin (DB01137)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid
Trial: NCT04901065
Drug: Xylocaine
RxNorm normalized name: Xylocaine
DrugBank: Lidocaine (DB00281)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The study intervention was the administration of 10 mg of intranasal lidocaine in one nostril using 1 spray of 0.1mL of a 10% lidocaine solution 5 minutes before NPS. This was done using the standard long nozzle
Trial: NCT03934086
Drug: rimegepant
RxNorm normalized name: RIMEGEPANT
DrugBank: Rimegepant (DB12457)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: rimegepant 75 mg
Trial: NCT05909215
Drug: Dexmedetomidine 0.75 microgram/kg
DrugBank: Dexmedetomidine (DB00633)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Dexmedetomidine 0.75 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes
Trial: NCT05078463
Drug: 1 Finger Tip Unit (FTU) EMLA Cream (30-minute application time)
RxNorm normalized name: ginger allergenic extract
DrugBank: Ginger (DB10344)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 Finger Tip Units (FTU) EMLA applied for 30 minutes on the dorsal surface of the IV cannulated hand for blood transfusion
Trial: NCT05078463
Drug: 1 Finger Tip Unit (FTU) EMLA (15-minute application time)
RxNorm normalized name: ginger allergenic extract
DrugBank: Ginger (DB10344)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 Finger Tip Unit (FTU) EMLA applied for 15 minutes on the dorsal surface of the IV cannulated hand
Trial: NCT06092242
Drug: Tas-102(Suyuan) combined with bevacizumab
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Tas-102: po 35 mg/m2, bid, d1-5, d8-12, Q4 wks; bevacizumab: intravenous drip 5 mg/kg, D1, D15, Q4 wks.
Trial: NCT05274113
Drug: Dexamethasone 4mg
RxNorm normalized name: DEXAMETHASONE 4MG TAB
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 4 mg of Dexamethasone will be given before surgery
Trial: NCT05274113
Drug: Ropivacaine
RxNorm normalized name: Ropivacaine
DrugBank: Ropivacaine (DB00296)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ultrasound guided supraclavicular block with ropivacaine will be given to patients before surgery
Trial: NCT04767256
Drug: Dexamethasone and dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: General anesthesia was induced with sufentanil 0.5-0.8 ug/kg, propofol 1.5-2.0 mg/kg, and rocuronium 0.5-1.0 mg/kg. Intravenous dexamethasone 10 mg was injected and a 50-ml syringe containing dexmedetomidine 1 ug/kg in 0.9% saline was infused after induction of general anaesthesia over a 30-min period. Anesthesia was maintained by remifentanil and sevoflurane to keep the Narcotrend index reading between 40 and 60.
Trial: NCT04767256
Drug: Dexmedetomidine
RxNorm normalized name: Dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Intravenous dexmedetomidine 1 ug/kg was infused after induction of general anaesthesia over a 30-min period.
Trial: NCT04705727
Drug: Budesonide Formoterol Drug Combination
RxNorm normalized name: budesonide / formoterol
DrugBank: Formoterol (DB00983)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: This combination will be used to treat the asthma exacerbation, patients will take one inhalation of budesonide/formoterol Turbuhaler® 100/6 μg every 5 minutes (Maximum 12 inhalations).
Trial: NCT04705727
Drug: nebulisation of terbutaline
DrugBank: Terbutaline (DB00871)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patients will receive 0.1 mg/kg nebulized terbutaline 5 mg/2 ml of Terbutaline dilution diluted with 2 ml normal saline delivered by an air compressor nebuliser driven by oxygen at a flow rate of 8l/min. The duration of one dose will be approximately 20 minutes and a total of 3 doses will be administered.
Trial: NCT04860661
Drug: Esketamine
RxNorm normalized name: ESKETAMINE
DrugBank: Esketamine (DB11823)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: After delivery, the parturient was given a loading dose of esketamine, and then a small dose of esketamine was added into PCIA analgesia pump
Trial: NCT05120960
Drug: tepotinib
RxNorm normalized name: Tepotinib
DrugBank: Tepotinib (DB15133)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given by PO
Trial: NCT05120960
Drug: tepotinib plus osimertinib
RxNorm normalized name: Tepotinib
DrugBank: Osimertinib (DB09330)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given by PO
Trial: NCT05168774
Drug: Elamipretide
RxNorm normalized name: Elamipretide
DrugBank: Elamipretide (DB11981)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
Trial: NCT04683198
Drug: camrelizumab
RxNorm normalized name: Camrelizumab
DrugBank: Camrelizumab (DB14776)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6) and maintenance phase ,until PD.
Trial: NCT04683198
Drug: Apatinib Mesylate
RxNorm normalized name: mesylate
DrugBank: Rivoceranib (DB14765)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Apatinib capsules 250 mg given orally , once daily in 21-day cycle and maintenance phase,until PD.
Trial: NCT04683198
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6).
Trial: NCT04683198
Drug: Etoposide
RxNorm normalized name: Etoposide
DrugBank: Etoposide (DB00773)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4/6).
Trial: NCT05475821
Drug: ABBV-990
RxNorm normalized name: ABBV-514
DrugBank: ABBV-514 (DB17586)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral Tablet
Trial: NCT04777643
Drug: Cannabidiol
RxNorm normalized name: CANNABIDIOL
DrugBank: Cannabidiol (DB09061)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.
Trial: NCT05943327
Drug: Lu AG06474
RxNorm normalized name: Lu-DOTA-TATE
DrugBank: Lutetium Lu 177 dotatate (DB13985)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral Solution
Trial: NCT05943327
Drug: Lu AG06474
RxNorm normalized name: Lu-DOTA-TATE
DrugBank: Lutetium Lu 177 dotatate (DB13985)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Capsule
Trial: NCT00002333
Drug: Saquinavir
RxNorm normalized name: Saquinavir
DrugBank: Saquinavir (DB01232)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00002333
Drug: Zalcitabine
RxNorm normalized name: Zalcitabine
DrugBank: Zalcitabine (DB00943)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT04699604
Drug: Levocetirizine Dihydrochloride
RxNorm normalized name: Levocetirizine Dihydrochloride
DrugBank: Levocetirizine (DB06282)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: At the end of the HILD assessment participants will be randomized to Levocetirizine Dihydrochloride or placebo. Children will be randomized by an investigational pharmacist to add-on either Levocetirizine dihydrochloride/ Xyzal® (UCB, Inc.) immediate release oral solution 2.5mg/5ml (2.5mg in children 6-11 years of age; 5mg in children \>11 years per recommended doses) or placebo to their current asthma regimen.
Trial: NCT04897841
Drug: Liposomal bupivacaine
RxNorm normalized name: bupivacaine liposome
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20 mL prior to closing fascia, the active drug (bupivacaine) is encapsulated in a liposomal platform and released slowly over the course of days with an approximate 72 hour duration.
Trial: NCT04897841
Drug: Bupivacaine Hydrochloride
RxNorm normalized name: Bupivacaine Hydrochloride
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic
Trial: NCT06291103
Drug: Standard of care treatment (SOC regimen) with Tacrolimus
RxNorm normalized name: Tacrolimus
DrugBank: Tacrolimus (DB00864)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tacrolimus will be continued until kidney graft survival with objective of whole blood through levels between 6 and 8 ng/mL
Trial: NCT05347498
Drug: HR091506 tablets + placebo of febuxostat tablets
RxNorm normalized name: Febuxostat Tablets
DrugBank: Febuxostat (DB04854)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: HR091506 tablets 40mg qd + placebo of febuxostat tablets 40mg qd in Week 1 and 2, HR091506 tablets 80mg qd + placebo of febuxostat tablets 80mg qd in Week 3 and 4
Trial: NCT05347498
Drug: febuxostat tablets + placebo of HR091506 tablets
RxNorm normalized name: Febuxostat Tablets
DrugBank: Febuxostat (DB04854)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: febuxostat tablets 40mg qd + placebo of HR091506 tablets 40mg qd in Week 1 and 2, febuxostat tablets 80mg qd + placebo of HR091506 tablets 80mg qd in Week 3 and 4
Trial: NCT04330755
Drug: Saline Solution
RxNorm normalized name: Unisol 4 Saline Solution
DrugBank: Sodium chloride (DB09153)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT04330755
Drug: Levosimendan
RxNorm normalized name: levosimendan
DrugBank: Levosimendan (DB00922)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Levosimendan
Trial: NCT04330755
Drug: Magnesium Sulfate
RxNorm normalized name: Magnesium Sulfate
DrugBank: Magnesium sulfate (DB00653)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Magnesium Sulfate
Trial: NCT05233696
Drug: Nab-paclitaxel
RxNorm normalized name: NAB-PACLITAXEL COMPONENT PACLITAXEL
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: All patients are encouraged to receive nab-paclitaxel 100 mg/m2 IV D1 and D8 every 21 days (in combination with pembrolizumab) for at least 4-6 cycles per institutional standards and treating physicians' recommendations.
Trial: NCT05233696
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Paclitaxel can be substituted for nab-paclitaxel at the discretion of the treating physician 80 mg/m2 IV D1 and D8 every 21 days.
Trial: NCT05233696
Drug: Pembrolizumab
RxNorm normalized name: Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Patients will receive pembrolizumab 200 mg D1 every 21 days.
Trial: NCT04321694
Drug: KHK2455
RxNorm normalized name: KHK2455
DrugBank: KHK2455 (DB17524)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04851717
Drug: Remimazolam
RxNorm normalized name: remimazolam
DrugBank: Remimazolam (DB12404)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Remimazolam for intravenous sedation
Trial: NCT05518734
Drug: VX-708
RxNorm normalized name: VX-121
DrugBank: Vanzacaftor (DB18373)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Solution for intravenous (IV) administration.
Trial: NCT05518734
Drug: Itraconazole
RxNorm normalized name: Itraconazole
DrugBank: Itraconazole (DB01167)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Solution for oral administration.
Trial: NCT05518734
Drug: Midazolam
RxNorm normalized name: Midazolam
DrugBank: Midazolam (DB00683)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Solution for oral administration.
Trial: NCT05264129
Drug: Atogepant
RxNorm normalized name: Atogepant
DrugBank: Atogepant (DB16098)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral Tablet
Trial: NCT05264129
Drug: Ubrogepant
RxNorm normalized name: Ubrogepant
DrugBank: Ubrogepant (DB15328)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral Tablet
Trial: NCT04648696
Drug: Vancomycin CI
RxNorm normalized name: Vancomycin
DrugBank: Vancomycin (DB00512)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
Trial: NCT04648696
Drug: Vancomycin II
RxNorm normalized name: Vancomycin
DrugBank: Vancomycin (DB00512)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Trial: NCT05833893
Drug: XPO1 inhibitor
RxNorm normalized name: Fibrinolysis inhibitor
DrugBank: Aprotinin (DB06692)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: COPL + XPO1 inhibitor (Selinexor, 60 mg, po., d1,8,15)
Trial: NCT06121934
Drug: Carica Papaya Leaf Extract
RxNorm normalized name: Carica papaya leaf extract
DrugBank: Papaya (DB10658)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Active drug: CPLE 500mg 2 capsule t.i.d for 5 dayseive CPLE or placebo once daily for 5 days.
Trial: NCT04967508
Drug: SB17 (Proposed Ustekinumab Biosimilar)
RxNorm normalized name: Ustekinumab
DrugBank: Ustekinumab (DB05679)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Subjects randomised into SB17 group will receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40.~Starting at Week 28, subjects transited from Stelara® to SB17 will receive SB17 via subcutaneous injection.
Trial: NCT06693791
Drug: Romiplostim N01
RxNorm normalized name: Romiplostim
DrugBank: Romiplostim (DB05332)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Romiplostim N01 was administered subcutaneously once weekly from +1 day to +28 days after UCBT at a recommended starting dose of 5µg/Kg (maximum single dose not to exceed 250µg) for a total of 4 administrations, with the option of continuation of dosing/switching/discontinuing after +28 days, depending on the patient's platelet profile.
Trial: NCT04975269
Drug: Acetazolamide
RxNorm normalized name: Acetazolamide
DrugBank: Acetazolamide (DB00819)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Target dose: 500 mg / day
Trial: NCT06327321
Drug: Deucravacitinib
RxNorm normalized name: Deucravacitinib
DrugBank: Deucravacitinib (DB16650)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Throughout the study, there will be a total of six visits conducted: selection, inclusion, Week 12, Week 24, Week 36, and Week 48. In patients who volunteer, a skin biopsy will be performed on both the lesional and peri-lesional areas at baseline, Week 12 and Week 36. Serum and plasma samples will be collected at the screening visit, Week 12, Week 24, Week 36, and Week 48.
Trial: NCT04770753
Drug: Placebo Matching Mitapivat
RxNorm normalized name: Mitapivat
DrugBank: Mitapivat (DB16236)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tablets
Trial: NCT04770753
Drug: Mitapivat
RxNorm normalized name: Mitapivat
DrugBank: Mitapivat (DB16236)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tablets
Trial: NCT06738160
Drug: Narlumosbart
RxNorm normalized name: Narlumosbart
DrugBank: Narlumosbart (DB19002)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients who have not received any systemic therapy will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg/time, subcutaneous injection, is administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy/3F is used for spinal metastases, and 30Gy/5F or 35Gy/5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy was used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include progression-free survival, overall survival and safety. Sample size calculation used the Simon Two-Stage method. 27 subjects will be enrolled in this project, considering the dropout rate of 10%.
Trial: NCT05664971
Drug: Docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 60 or 75mg/m2 via IV infusion on Day 1 of a 21-day cycle, which may be maintained until disease progression
Trial: NCT05664971
Drug: Pemetrexed
RxNorm normalized name: Pemetrexed
DrugBank: Pemetrexed (DB00642)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 500mg/m2 via IV infusion on Day 1 of a 21-day cycle for 4 cycles; Subjects who have disease progression after 4 cycles may continue to receive maintenance treatment with pemetrexed
Trial: NCT05664971
Drug: Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 75mg/m2 via IV infusion on Day 1 of a 21-day cycle for 4 cycles
Trial: NCT05664971
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: AUC 5 via IV infusion on Day 1 of a 21-day cycle for 4 cycles
Trial: NCT05664971
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 175mg/m2 via IV infusion on Day 1 of a 21-day cycle for 4 cycles