AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT05017584
Drug: Hyperbaric bupivacaine
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The dose for the first subject (A#X) will be 12 mg 0.75% hyperbaric bupivacaine. Two possible outcomes will be recorded: satisfactory or unsatisfactory anesthesia which is determined by occurrence of intraoperative pain and the need for intraoperative analgesia supplementation. Satisfactory analgesia will be defined as a sensory block to the T8 dermatome and the patient shall require no further supplementation for discomfort during her procedure. Unsatisfactory analgesia will be defined as a block not achieving a T8 dermatomal level or when a patient requests additional medication for discomfort at any time during her procedure.~The dose for the next (A#X+1) will be adjusted based on the outcome from previous subjects respectively using up-down sequential allocation method with a biased-coin design. This process will continue in similar fashion with dose adjustments for next subjects to be based on outcome from subjects immediately prior.
Trial: NCT06090656
Drug: Bevacizumab combined with Sintilimab
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Bevacizumab combined with sintilimab, sindilizumab 200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions
Trial: NCT05418348
Drug: GTX-104
RxNorm normalized name: toremifene
DrugBank: Toremifene (DB00539)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: new formulation of nimodipine injection for IV infusion
Trial: NCT05418348
Drug: Nimodipine Capsules
RxNorm normalized name: Nimodipine Capsules
DrugBank: Nimodipine (DB00393)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Nimodipine capsules (reference formulation)
Trial: NCT05292742
Drug: Pyrotinib+Trastuzumab+Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Patients in the experimental arm will receive trastuzumab + pyrotinib + capecitabine
Trial: NCT05292742
Drug: Trastuzumab+Pertuzumab/Trastuzumab
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Trastuzumab: Initial loading dose of 8 mg/kg followed by 6 mg/kg every 3 weeks. One year of trastuzumab treatment (including: neoadjuvant phase and adjuvant phase) Pertuzumab: 840 mg loading dose followed by 420 mg fixed dose
Trial: NCT06541184
Drug: Ziconotide [Prialt]
DrugBank: Ziconotide (DB06283)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Intrathecal injection of ziconotide, using an internal pump, surgically inserted by a trained neurosurgeon or anesthesiologist, under general anesthesia.
Trial: NCT01637168
Drug: Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin
DrugBank: Ginkgo biloba (DB01381)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A tablet, 2 times daily (12/12 hours).
Trial: NCT01637168
Drug: Ginkgo Biloba (Tebonin®)
DrugBank: Ginkgo biloba (DB01381)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A tablet, 2 times daily (12/12 hours).
Trial: NCT05464719
Drug: Loncastuximab Tesirine
RxNorm normalized name: Loncastuximab tesirine
DrugBank: Loncastuximab tesirine (DB16222)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given by IV
Trial: NCT06559969
Drug: Epidural administered opioid
RxNorm normalized name: epidermal growth factor
DrugBank: Nepidermin (DB14145)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Hydromorphone will be added to the bupivacaine in the epidural and will have a continuous infusion along with the ability for the patient to receive epidural boluses of the medications by a patient controlled epidural administration pump
Trial: NCT05672108
Drug: Ethiodized Oil
RxNorm normalized name: ethiodized oil
DrugBank: Ethiodized oil (DB00965)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given IA
Trial: NCT05672108
Drug: Mitomycin
RxNorm normalized name: Mitomycin
DrugBank: Mitomycin (DB00305)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IA
Trial: NCT06085144
Drug: Galcanezumab
RxNorm normalized name: Galcanezumab
DrugBank: Galcanezumab (DB14042)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Receiving either 120mg or 300mg injections.
Trial: NCT05688241
Drug: Donor-derived ex-vivo expanded EBV Tscm CTL
RxNorm normalized name: Allogeneic, ex-vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells - cultured fraction (CF)
DrugBank: Omidubicel (DB17132)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cryopreserved cells will be thawed and infused at three time points. Dosing will be 2x10e6 EBV CTLs per kg of body weight. No prior lymphodepletion will be performed.
Trial: NCT05639647
Drug: BAT
RxNorm normalized name: RibaTab
DrugBank: Equine Botulinum Neurotoxin E Immune FAB2 (DB13897)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BAT will be selected by the investigator and administered iv as appropriate for the selected drug(s)
Trial: NCT03301805
Drug: BLEX 404
RxNorm normalized name: Bleximenib
DrugBank: Bleximenib (DB19328)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BLEX 404 Oral Liquid is administered twice daily during the Gemcitabine monotherapy period. The dose of Gemcitabine 1,000 mg/m2 IV fusion at Day 1, 8, 15 of every cycle~* 28 days a cycle.
Trial: NCT05036759
Drug: 68Ga-FAPI
RxNorm normalized name: 68Ga-DOTATOC
DrugBank: Dotatate gallium Ga-68 (DB13925)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: intravenously injected with 68Ga-FAPI
Trial: NCT05295589
Drug: Copanlisib Hydrochloride
DrugBank: Copanlisib (DB12483)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT05295589
Drug: Olaparib
RxNorm normalized name: Olaparib
DrugBank: Olaparib (DB09074)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given PO
Trial: NCT05295589
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given IV
Trial: NCT05295589
Drug: Topotecan Hydrochloride
RxNorm normalized name: Topotecan Hydrochloride
DrugBank: Topotecan (DB01030)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT05596708
Drug: Telitacicept
RxNorm normalized name: Telitacicept
DrugBank: Telitacicept (DB18312)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for 104 weeks.
Trial: NCT00432822
Drug: tetrahydrobiopterin (BH4)
RxNorm normalized name: 6R-BH4
DrugBank: Sapropterin (DB00360)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT04819971
Drug: Tirelizumab
RxNorm normalized name: Tislelizumab
DrugBank: Tislelizumab (DB14922)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: tislelizumab (intravenously, 200 mg on day 1 of every cycle for 4 preoperative and 12 postoperative cycles)
Trial: NCT04819971
Drug: Trastuzumab
RxNorm normalized name: trastuzumab
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Trastuzumab(intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1 of every cycle for 4 preoperative and 12 postoperative cycles)
Trial: NCT04819971
Drug: Docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: docetaxel (intravenously, 50 mg/m2 on day 1 of every cycle for 3 preoperative cycles)
Trial: NCT04819971
Drug: S1
RxNorm normalized name: LS11
DrugBank: LS11 (DB05918)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: S1 (orally, 400mg/m2 BID on day 1\~14 of every cycle for 3 preoperative and 3 postoperative cycles )
Trial: NCT04819971
Drug: Oxaliplatin
RxNorm normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Oxaliplatin(intravenously, 100 mg /m2 on day 1 of every cycle for 3 preoperative cycles ;130mg /m2 on day 1 of every cycle for 3 postoperative cycles.
Trial: NCT05997056
Drug: nab-sirolimus
RxNorm normalized name: Sirolimus
DrugBank: Sirolimus (DB00877)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Prospective phase 2 single arm, open-label, multi-institutional study to determine the efficacy and safety prospective of nab-sirolimus administered by IV infusion
Trial: NCT03953170
Drug: Teduglutide
RxNorm normalized name: Teduglutide
DrugBank: Teduglutide (DB08900)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Teduglutide (Gattex, Shire) was approved by the FDA in 2012 for use in adult patients with short bowel syndrome requiring parenteral support only.~The results of this study will not be used to justify a change of indication, or dose currently approved for Teduglutide, and will not be used to advertise the drug. This study meets all of the requirements for exemption from the IND regulations and an IND exemption has been confirmed by the FDA.
Trial: NCT00215124
Drug: Filgrastim
RxNorm normalized name: Filgrastim
DrugBank: Filgrastim (DB00099)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT05486026
Drug: Duloxetine 30 MG
RxNorm normalized name: duloxetine 30 MG
DrugBank: Duloxetine (DB00476)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: patient in first group (case) will receive duloxetine tablet 30mg for two weeks then titrated up to duloxetine 30mg BID. Patients will be instructed to take the medication with meals. The for 13 weeks
Trial: NCT05125068
Drug: AT-1501
RxNorm normalized name: AT-III
DrugBank: Antithrombin III human (DB11598)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Trial: NCT06076681
Drug: TNP-2198
RxNorm normalized name: TNP-2092
DrugBank: TNP-2092 (DB16312)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: On Days 1 to 14, all subjects in each group received TNP-2198 capsule within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
Trial: NCT06076681
Drug: Rabeprazole Sodium
RxNorm normalized name: Rabeprazole Sodium
DrugBank: Rabeprazole (DB01129)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: On Days 1 to 14, all subjects in each group received rabeprazole within 30 minutes before breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes before breakfast.
Trial: NCT06076681
Drug: Amoxicillin
RxNorm normalized name: Amoxicillin
DrugBank: Amoxicillin (DB01060)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: On Days 1 to 14, all subjects in each group received Amoxicillin capsule within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
Trial: NCT06026397
Drug: SK10
RxNorm normalized name: Sildenafil
DrugBank: Sildenafil (DB00203)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants will be randomized to receive oral suspension of SK10 powder, includes SAD on Day 1 and 14-days MAD from Day 4 to Day 17.
Trial: NCT05901974
Drug: Venetoclax
RxNorm normalized name: Venetoclax
DrugBank: Venetoclax (DB11581)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28);
Trial: NCT05901974
Drug: azactidine
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: azacitidine 75 mg/m2 subcutaneously once daily on days 1-7
Trial: NCT04929483
Drug: BIO89-100
RxNorm normalized name: Bio89-100 (long-acting glycopegylated fibroblast growth factor 21 (fgf21) analogue)
DrugBank: Pegozafermin (DB19062)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subcutaneous injection
Trial: NCT00002129
Drug: Vesnarinone
RxNorm normalized name: VESNARINONE
DrugBank: Vesnarinone (DB12082)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT05631626
Drug: CTx-1301 - Dexmethylphenidate 25mg
RxNorm normalized name: dexmethylphenidate hydrochloride 25 MG
DrugBank: Methylphenidate (DB00422)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 25mg CTx-1301 (Dexmethylphenidate tablet)
Trial: NCT05631626
Drug: CTx-1301 - Dexmethylphenidate 37.5mg
DrugBank: Methylphenidate (DB00422)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 37.5mg CTx-1301 (Dexmethylphenidate tablet)
Trial: NCT05631626
Drug: CTx-1301 - Dexmethylphenidate 50mg
DrugBank: Methylphenidate (DB00422)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 50mg CTx-1301 (Dexmethylphenidate tablet)
Trial: NCT05003648
Drug: Pramipexole
RxNorm normalized name: Pramipexole
DrugBank: Pramipexole (DB00413)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants will be started on 0.125 mg pramipexole for the first week. If this dose is well tolerated but not effective, the dose can be increased to 0.25 mg for the following week. If this dose is well tolerated but not effective, the dose can be further increased to 0.5 mg for the remainder of the 2-month period.
Trial: NCT05385068
Drug: Niraparib
RxNorm normalized name: Niraparib
DrugBank: Niraparib (DB11793)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Niraparib 200 or 300mg\* QD PO continually;~\*The starting dose of niraparib was individualized based on patients' bodyweight and baseline platelet count; 200 mg QD for Patients with baseline body weight \<77 kg or platelets count \<150,000/μL;300 mg QD for Patients with baseline body weight ≥77 kg and platelets count ≥150,000/μL.~For patients who had experienced grade 4 adverse events from previous use of PARPi, niraparib staring dose was 200 mg QD.~Anlotinib 10mg QD PO from Day 1 to 14 of every 21-day cycle
Trial: NCT04913896
Drug: PD-1 inhibitor
RxNorm normalized name: Anti-pd-1 checkpoint inhibitor pf-06801591
DrugBank: Sasanlimab (DB18849)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SOX regimen for 3 cycles and/or PD-1 inhibitor before surgery
Trial: NCT00005118
Drug: Indinavir sulfate
RxNorm normalized name: Indinavir Sulfate
DrugBank: Indinavir (DB00224)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00005118
Drug: Ritonavir
RxNorm normalized name: Ritonavir
DrugBank: Ritonavir (DB00503)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT05909267
Drug: L-dopa/Carbidopa
DrugBank: Carbidopa (DB00190)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patients and healthy controls will receive one time administration of L-dopa/Carbidopa (100/25 mg).
Trial: NCT03564548
Drug: Morphine sulfate or Hydromorphone or Oxycodone
RxNorm normalized name: Medicated Pad or Tape
DrugBank: Morphine (DB00295)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Group assigned to morphine sulfate or hydromorphone or oxycodone
Trial: NCT05483322
Drug: LAM-002A
RxNorm normalized name: lamotrigine
DrugBank: Lamotrigine (DB00555)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 25mg capsules
Trial: NCT03395392
Drug: NRX-101
RxNorm normalized name: NRX-1074
DrugBank: INBRX-101 (DB18384)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NRX-101, a fixed dose combination of D-cycloserine+lurasidone will be given twice a day by mouth
Trial: NCT03395392
Drug: Lurasidone HCl
RxNorm normalized name: lurasidone HCl
DrugBank: Lurasidone (DB08815)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Lurasidone HCl will be given twice a day by mouth
Trial: NCT05704556
Drug: VX-548
RxNorm normalized name: VX-121
DrugBank: Vanzacaftor (DB18373)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablets for oral administration.
Trial: NCT05105698
Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)
DrugBank: Dapagliflozin (DB06292)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Subjects will check-in a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.(fasting)
Trial: NCT05105698
Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)
DrugBank: Dapagliflozin (DB06292)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Subjects will check-in a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.(fed)
Trial: NCT04440592
Drug: MT-7117
RxNorm normalized name: lipase
DrugBank: Pancrelipase (DB00085)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MT-7117
Trial: NCT06403865
Drug: Cabotegravir, Rilpivirine Drug Combination
DrugBank: Rilpivirine (DB08864)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Treatment switch to CAB+RPV LA
Trial: NCT05064319
Drug: Gabapentin
RxNorm normalized name: Gabapentin
DrugBank: Gabapentin (DB00996)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive gabapentin 2-3 times a day for a total of 17 days.
Trial: NCT05243355
Drug: Envafolimab and Chemotherapy and Recombinant Human Endostatin
RxNorm normalized name: Recombinant human endostatin
DrugBank: Endostatin (DB06423)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Envafolimab: 300 mg，D1，Q3W,until PD or intolerable toxicity Chemotherapy: Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w; Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles in total.~Recombinant Human Endostatin：210mg，CIV 72h，d1-3，Q3W，4-6 cycles in total.
Trial: NCT04941664
Drug: 0.5% levobupivacaine
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: This study adopts a Modified Narayana rule (MNR), a sequential up-and-down pharmacodynamics method (UDM) to estimate the minimum effective local anesthetic volume of 90% (MELVA90) of cases of the aforementioned local anesthetic (LA), in order to produce the surgical anesthesia of the patients scheduled for shoulder surgeries. Based on the principal investigator's clinical experience, the initial volume of 8ml will be used. Depending on the success or failure of the superior trunk block, which is defined as the readiness for surgery at 30 minutes after the block, the volume for the next patient will be adjusted up or down by 2ml. The upper dose limit of the study to minimize the potential for local anesthetic systemic toxicity will be 16ml and the lower dose limit will be 4ml, which will be of no clinical importance.
Trial: NCT04547946
Drug: dabrafenib + trametinib
RxNorm normalized name: Dabrafenib
DrugBank: Trametinib (DB08911)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: There was no treatment allocation. Patients administered adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) by prescription that had started before inclusion of the patient into the study could be enrolled.
Trial: NCT05123196
Drug: MT-8554
RxNorm normalized name: lipase
DrugBank: Pancrelipase (DB00085)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral Capsule
Trial: NCT06617325
Drug: DZP
RxNorm normalized name: Diazepam
DrugBank: Diazepam (DB00829)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points.
Trial: NCT05593588
Drug: Fisetin
RxNorm normalized name: FISETIN
DrugBank: Fisetin (DB07795)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 20 mg per kilogram (kg) of body weight supplied in 100 mg capsules and administered orally on days 0, 1, 28, and 29
Trial: NCT05203432
Drug: Atropine
RxNorm normalized name: Atropine
DrugBank: Atropine (DB00572)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 0.01% atropine
Trial: NCT06036511
Drug: Ketamine Hydrochloride
RxNorm normalized name: Ketamine Hydrochloride
DrugBank: Ketamine (DB01221)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: This is a single arm, open-label, prospective cohort clinical trial.~No blinding is required for this trial.~A total of 14 adult patients with PTSD will be recruited from UNM outpatient clinics and undergo rsfMRI and behavioral assessment prior to ketamine treatment. They will complete baseline scan at day one, a preparatory session (initial part of KAP), IM ketamine treatment, then within 24 hours, an integration session to take advantage of neuroplasticity for optimal therapeutic progress. Each participant will have two complete KAP sessions (preparation, treatment, and integration) followed by rsfMRI within approximately 24 hours, and again approximately two weeks after the completion of the second KAP session. Patients will also have repeat clinical assessments after each treatment. Changes in PTSD symptoms will be correlated with changes in connectivity at each rsfMRI.
Trial: NCT05640453
Drug: Pregabalin
RxNorm normalized name: Pregabalin
DrugBank: Pregabalin (DB00230)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube.
Trial: NCT04933565
Drug: ORG-129
RxNorm normalized name: ORG-34517
DrugBank: ORG-34517 (DB05423)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ORG-129 oral capsules
Trial: NCT05640453
Drug: Dexmedetomidine
RxNorm normalized name: Dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min)
Trial: NCT05412082
Drug: 5-fluorouracil
RxNorm normalized name: 5-fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 5-FU dose of 400 mg/m2 will be administered intravenously (IV) over 5-15 minutes beginning on Day 1; then a dose of 2400 mg/m2 via continual infusion (CI) over 4446-478 hours total dose during Days 1 and 2 of every 14-day cycle, for 4 to 6 cycles.~During SMART TNT Plan I, 5-FU dose of 225 mg/m2 per day will be administered via CI on Day 1 radiation therapy, delivered either 5 or 7 days per week.
Trial: NCT05412082
Drug: Oxaliplatin
RxNorm normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Oxaliplatin dose of 85 mg/m2 will be administered intravenously (IV) on Day 1 of each 14-day cycle for 4 - 6 cycles.
Trial: NCT05412082
Drug: Irinotecan
RxNorm normalized name: Irinotecan
DrugBank: Irinotecan (DB00762)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Irinotecan dose of 180 mg/m2 will be administered intravenously (IV) on Day 1 of each 14-day cycle for 4 to 6 cycles, prior to SMART TNT Plan I radiation therapy.