AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT05464745
Drug: PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral, generic fixed-dose combination of perindopril tert-butylamine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure)
Trial: NCT05464745
Drug: Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral, innovative fixed-dose combination of perindopril arginine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure)
Trial: NCT05818514
Drug: [11C]AZ14132516
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Injection of radioligand for PET examinations
Trial: NCT05607329
Drug: Chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Description: chemotherapy
Trial: NCT06398925
Drug: OCT461201 50 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral capsule
Trial: NCT06398925
Drug: OCT461201 100 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral capsule
Trial: NCT06398925
Drug: OCT461201 150 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral capsule
Trial: NCT06398925
Drug: OCT461201 450 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral capsule
Trial: NCT06398925
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo capsule
Trial: NCT04558931
Drug: CellProtect
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In vitro expanded and activated autologous NK cells
Trial: NCT05549557
Drug: IMM40H
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IMM40H is a monoclonal antibody with a molecular generated from ImmuneOnco's antibody platform. IMM40H targets CD70 (a tumor cell marker).
Trial: NCT05054543
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.9% Sodium Chloride
Trial: NCT04831099
Drug: Testosterone gel
RxNorm normalized name: Androgel 1.62% Metered Dose Pump Testosterone Gel
DrugBank: (1,2,6,7-3H)Testosterone (DB14093)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The route of administration is transdermal.
Trial: NCT04831099
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The route of administration is transdermal
Trial: NCT04825431
Drug: TAS-205, [14C]TAS-205
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single oral administration under fasted conditions on day 1
Trial: NCT06280534
Drug: Test drug XT1061 capsules and placebo,Single dose group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Eight people took capsules of the test drug XT1061 and two people took a placebo.
Trial: NCT06280534
Drug: Test drug XT1061 capsules and placebo，Multiple dosing group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: D1-D7 were administered under fasting conditions for 7 consecutive days, of which D1-D6 were administered BID and D7 was administered once in the morning under fasting conditions only.Eight people took capsules of the test drug XT1061 and two people took a placebo.
Trial: NCT06280534
Drug: Test drug XT1061 capsules and placebo，Food Impact Group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Eight people in group A took the test drug XT1061 capsules and two people took placebo, and all eight people in group B took the test drug XT1061 capsules.
Trial: NCT05440136
Drug: Placebo (SC)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered SC.
Trial: NCT05440136
Drug: Placebo (IV)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered IV.
Trial: NCT05933980
Drug: Rego+Tori+Cele
FDA approved: no
EMA approved: no
PMDA approved: no
Description: combination of Toripalimab,regorafenib and celecoxib
Trial: NCT05740917
Drug: XZB-0004
FDA approved: no
EMA approved: no
PMDA approved: no
Description: XZB-0004 orally Twice daily of every 28-day cycle
Trial: NCT04821323
Drug: Indomethacin
RxNorm normalized name: Indomethacin
DrugBank: Indomethacin (DB00328)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Indomethacin capsules will be administered orally.
Trial: NCT06095791
Drug: Immunomodulators with FDA approval on the 1st January 2023.
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Disproportionnality analysis studying the association between immunomodulators with FDA approval on the 1st January 2023 and atrial fibrillation in the World Health Organization pharmacovigilance database.
Trial: NCT05798416
Drug: Exercise under inhalation CO2
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants perform shuttle walk test at high altitude while using the novel portable device for inhalation of CO2
Trial: NCT05352828
Drug: Autologous CD30.CAR-T
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dose: 2 x 10e8 cells/m2
Trial: NCT00324831
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00324831
Drug: doxorubicin hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT04738773
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT04315636
Drug: Surfactant nebulisation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 200 mg/kg body weight nebulised surfactant (Poractant alfa, Chiesi Farmaceutici SpA, Parma, Italy) via a customised vibrating membrane nebuliser (eFlow neonatal nebuliser system, PARI Pharma, Starnberg).
Trial: NCT05215743
Drug: Antioxidant therapy
RxNorm normalized name: antioxidant 119
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Active therapy
Trial: NCT05215743
Drug: NaCl 0.9%
RxNorm normalized name: DEXTROSE 5%/NACL 0.9% INJ
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT05420246
Drug: Ainuovirine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The regimen including Ainuovirine will be given to HIV-1 infected/AIDS patients.
Trial: NCT05620576
Drug: LY3857210
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT05620576
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT05565768
Drug: HZN-457
FDA approved: no
EMA approved: no
PMDA approved: no
Description: HZN-457 will be given in one subcutaneous administration
Trial: NCT05565768
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be given in one subcutaneous administration
Trial: NCT00487123
Drug: Valsartan+/- Hydrochlorothiazide
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT05905484
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single dose of matching placebo will be administered.
Trial: NCT04064346
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo
Trial: NCT04784533
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral dosing
Trial: NCT05978102
Drug: Standard treatment（SoC）
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Depending on the treatment stage of enrolled subjects, the investigator will determine the standard treatment regimen and dosage with reference to the CSCO or other current guidelines.
Trial: NCT06172920
Drug: Aldolan
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients are receiving meperidine under thoracic surgery
Trial: NCT00002342
Drug: Tecogalan sodium
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04732949
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution
Trial: NCT05141721
Drug: GRT-C901
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A patient-specific neoantigen cancer vaccine administered via intramuscular (IM) injection as prime and single boost at a dose of 1x10\^12 viral particles 2 times over the course of the first year.
Trial: NCT05141721
Drug: GRT-R902
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A patient-specific neoantigen cancer vaccine boost, administered via IM injection at a dose of 30ug 4 times over the course of the first year.
Trial: NCT05141721
Drug: Fluoropyrimidine plus leucovorin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fluoropyrimidine (infusional 5-FU or capecitabine) and leucovorin administered as maintenance therapy per standard of care.
Trial: NCT05164458
Drug: IBI 308 injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IBI308 IV 200mg Q3W Day1
Trial: NCT05164458
Drug: IBI 389 Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IBI 389 IV Q2\~Q3W Day 1
Trial: NCT04836299
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will be randomly assigned to receive a single of placebo.
Trial: NCT04809220
Drug: Oral antihyperglycemics
RxNorm normalized name: ANTIHYPOGLYCEMICS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT05471050
Drug: TAC
RxNorm normalized name: TAC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tacrolimus is given at a dose of 0.03mg/kg·d, and the dose is adjusted to maintain the trough concentration of tacrolimus at approximately 3-5 ng/mL for 12 weeks.
Trial: NCT05354128
Drug: Thrombolytic
RxNorm normalized name: THROMBOLYTICS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard intravenous thrombolysis.
Trial: NCT05687435
Drug: Changyanning tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Changyanning Tablet is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd，composed of Euphorbia humifusa, golden ear grass, camphor tree root, Elsholtzia splendens and maple leaves. It is mainly used for the treatment of acute and chronic intestinal diseases caused by various reasons.~If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation.
Trial: NCT06063486
Drug: Placebo Administration
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT05242081
Drug: Sufentanil
RxNorm normalized name: Sufentanil
DrugBank: Sufentanil (DB00708)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Sufentanil 0.2-0.3μg/kg for induction and remifentanil 0.05-0.15μg/kg/min for maintenance
Trial: NCT04829487
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo capsules
Trial: NCT05351346
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Trial: NCT05351346
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Trial: NCT04026984
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching Placebo tablets
Trial: NCT05277246
Drug: NaOCI
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NaOCI
Trial: NCT05349149
Drug: Saline 9%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The infusion of saline will serve as placebo for tocilizumab, allowing us to determine the role of IL-6 in regulating energy stores following acute exercise
Trial: NCT04917055
Drug: ropivacaine 0.25% with epinephrine and 6mg dexamethasone
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Regional Nerve block behind the knee for posterior knee pain following total knee arthroplasty using ultrasound guidance, to be done distally between femoral chondyles
Trial: NCT02434835
Drug: [14C]KWA-0711
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT05625035
Drug: Lianhua Qingwen capsules
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Lianhua Qingwen capsules: 4 capsules once, three times daily
Trial: NCT06300333
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: use low dose of Methotrexate in treatment of un distectopic tubal pregnancy
Trial: NCT00000796
Drug: Streptomycin sulfate
RxNorm normalized name: Streptomycin Sulfate
DrugBank: Streptomycin (DB01082)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00000796
Drug: Amikacin sulfate
RxNorm normalized name: Amikacin Sulfate
DrugBank: Amikacin (DB00479)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00000796
Drug: Pyridoxine hydrochloride
RxNorm normalized name: Pyridoxine Hydrochloride
DrugBank: Pyridoxine phosphate (DB02209)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT04685564
Drug: RBD1016
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sentinel cohort design is used in each cohort: each cohort will be administered in two batches, the first 2 subjects will receive RBD1016 or placebo respectively, and safety assessment will be done on D8±1. After safety is confirmed through SRC assessment, the remaining 6 subjects will be randomly assigned to receive RBD1016 or placebo in a ratio of 5:1. SRC will assess the safety after all the subjects in each cohort complete the 28-day safety observation and the subjects may proceed to the next dose cohort with permission.~Only after all the subjects in the previous dose cohort have completed the safety assessment by SRC (observed for 28 days) may the next dose cohort be initiated with permission.
Trial: NCT04685564
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: the same as RBD1016
Trial: NCT06130332
Drug: PD-1 with chemotherapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tirellizumab+Carboplatin+albumin-bound paclitaxel:2 courses Tirellizumab,+Carboplatin+albumin-bound paclitaxel Tirellizumab (IV), dose= 200mg , day=1 , cycle length: 21 days. Carboplatin (IV), dose=300mg/m2, day= 1, cycle length: 21 days. albumin-bound paclitaxel (IV), dose=260mg/m2, day= 1, cycle length: 21 days.~Intervention: Drug: Tirellizumab, Carboplatin, albumin-bound paclitaxel:2 cycles Surgery：Enlarged local excision，excision with the safe margin 1.0-1.5cm away from the original tumor
Trial: NCT04847388
Drug: Substance like alcohol, marijuana, etc.
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cohort study
Trial: NCT05813158
Drug: Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block)
RxNorm normalized name: meningococcal group B vaccine Prefilled Syringe [Trumenba]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will preoperatively receive low concentration-high volume ultasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room ) one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline} for each patient
Trial: NCT05813158
Drug: Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)
RxNorm normalized name: meningococcal group B vaccine Prefilled Syringe [Trumenba]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will preoperatively receive high concentration-low volume ultasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room (one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% } for each patien).
Trial: NCT04327986
Drug: M7824
RxNorm normalized name: M7824
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous (IV) on Days 1 and 15 of every cycle
Trial: NCT06492811
Drug: GAT@F nanoenzyme hydrogel complex
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The wound condition was recorded by taking photos each time the dressing was changed. The diabetic wound was routinely treated with a dressing change, after which GAT@F nanoenzyme hydrogel complex was applied externally and a secondary dressing - medical surgical gauze was added. According to existing clinical data, it is recommended to use no more than 10ml per dressing change.
Trial: NCT05366439
Drug: Placebo Comparator
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Parallel Assignment
Trial: NCT04145258
Drug: Placebo of aspirin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Two placebo tablets with the same appearance of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)
Trial: NCT04145258
Drug: WHO TBM treatment
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 months of (R-H-Z-E) + 7 months of (R-H)
Trial: NCT04145258
Drug: Intensified TBM treatment
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 months of (HDR-L-H-Z-E) + 7 months of (R-H), with HDR=high-dose rifampicin and L=linezolid
Trial: NCT05563064
Drug: Karika Syrup
RxNorm normalized name: Phragmites karka whole extract
FDA approved: no
EMA approved: no
PMDA approved: no
Description: To evaluate the effects of Karika syrup on complete blood count specifically thrombocytes (platelets) collected from blood samples of patients after treatment of 15 days long period.
Trial: NCT04916795
Drug: Vupanorsen
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 80 mg subcutaneous injection
Trial: NCT05769959
Drug: RO7515629
FDA approved: no
EMA approved: no
PMDA approved: no
Description: RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.
Trial: NCT05507983
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo, sodium chloride 0.9%
Trial: NCT05768477
Drug: Baxter therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ketamine or Linisol baxter therapy
Trial: NCT04988217
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Nebulized placebo
Trial: NCT04944901
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo oral formulation
Trial: NCT05041933
Drug: outsourcing of chemotherapy to Hospital at Home
RxNorm normalized name: acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: outsourcing of chemotherapy to Hospital at Home
Trial: NCT05277311
Drug: LongShengZhi capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: LongShengZhi capsules, orally, 5 capsules each time, three times a day.
Trial: NCT05277311
Drug: LongShengZhi capsule placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: LongShengZhi capsules placebo, orally, 5 capsules each time, three times a day.
Trial: NCT05595993
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Study participants will be allocated to receive oral administration of placebo.
Trial: NCT05861505
Drug: Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B)
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard first line systemic treatment:~CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B~CAPOX 4x (12 weeks) FOLFOX/FOLFIRI 6x (12 weeks)~Maximum 4 cycles of CAPOX or 6 cycles of FOLFOX/FOLFIRI +/- bevacizumab regardless of the location of primary tumor or RAS/BRAF mutation
Trial: NCT05437289
Drug: Placebo IM
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.
Trial: NCT05437289
Drug: Placebo IM
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In cohort 2, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.
Trial: NCT05437289
Drug: Placebo IV
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
Trial: NCT05437289
Drug: Placebo IV
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In cohort 4, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
Trial: NCT05324163
Drug: X0002 Spray
FDA approved: no
EMA approved: no
PMDA approved: no
Description: X0002 spray 17.5mg, twice a day; Celecoxib placebo 200mg, once a day
Trial: NCT05324163
Drug: Celecoxib capsules
RxNorm normalized name: Celecoxib Capsules
DrugBank: Celecoxib (DB00482)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: X0002 spray placebo 17.5 mg, twice a day; Celecoxib capsule 200mg, once a day
Trial: NCT05324163
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: X0002 spray placebo 17.5 mg, twice a day; Celecoxibplacebo 200mg, once a day
Trial: NCT04743661
Drug: Liothyronine
RxNorm normalized name: Liothyronine
DrugBank: Liothyronine (DB00279)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Liothyronine (or equivalent) will be given as premedication for 131I-omburtamab to prevent thyroid accumulation. Liothyronine (or equivalent) will be administered at 25 µg PO, NG, or G-tube (if weight \< 25 kg) or 50 µg PO, NG, or G-tube (if weight ≥ 25 kg) daily starting on Day 1 of Radioimmunotherapy (for Stratum 1 patients) or Day 1 of Dosimetry (for Stratum 2 patients), with a mandated minimum of 7 days before each 131I-omburtamab injection and 14 days after each 131I-omburtamab injection. On the day of the 131I-omburtamab injection, administer any time before the injection.
Trial: NCT04743661
Drug: Antipyretic
RxNorm normalized name: ANTIPYRETICS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: An antipyretic (e.g., oral acetaminophen \[15 mg/kg, 650 mg maximum\] or equivalent) will be given as premedication for 131I-omburtamab within 1 to 3 hours before each 131I-omburtamab injection.
Trial: NCT04743661
Drug: anti-emetics
RxNorm normalized name: Anti Bac
FDA approved: no
EMA approved: no
PMDA approved: no
Description: An anti-emetic (e.g., IV ondansetron \[0.25 mg/kg, 16 mg maximum\] or equivalent) will be given as premedication for 131I-omburtamab within 1 to 3 hours before each 131I-omburtamab injection.
Trial: NCT05547321
Drug: OMTX705
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The investigational product is OMTX705 administered as monotherapy.