AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT00474799
Drug: MNS075
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MNS075 7.5mg q1h MNS075 15mg q3h
Trial: NCT01752699
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: patients with post-herpetic neuralgia take placebo to treat the pain symptoms.
Trial: NCT03642834
Drug: ICP-105
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 25mg, 100mg capsule
Trial: NCT00653172
Drug: NXL103
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 600mg orally twice daily
Trial: NCT00653172
Drug: comparator
FDA approved: no
EMA approved: no
PMDA approved: no
Description: comparator twice daily
Trial: NCT00653172
Drug: NXL103
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 500mg orally twice daily
Trial: NCT04055818
Drug: Nicotinamide
RxNorm normalized name: Nicotinamide
DrugBank: Nicotinamide (DB02701)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral nicotinamide (Vitamin B3) alone compared to THU Decitabine combination
Trial: NCT05031234
Drug: anaesthesia without opiates
RxNorm normalized name: threonine
DrugBank: Threonine (DB00156)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Anaesthesia without opiates for patients undergoing laparoscopic colectomy
Trial: NCT01928459
Drug: BGJ398
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
Trial: NCT01928459
Drug: BYL719
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BYL719 will be administered orally once daily on each day of the 28-day cycle.
Trial: NCT00964236
Drug: Sapropterin
RxNorm normalized name: Sapropterin
DrugBank: Sapropterin (DB00360)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Sapropterin (Kuvan) 20mg/kg/day taken once daily or as otherwise prescribed by physician as standard care.
Trial: NCT04160936
Drug: Marcaine Injectable Product
RxNorm normalized name: Marcaine Injectable Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Following PCNL under general anesthesia, patients will receive 0.25% Bupivacaine ( Marcaine) local anesthetic infiltration
Trial: NCT02328144
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients were assigned to two groups, one of them received oral metronidazole (study group) and the other, homologated placebo (control group) after hemorrhoidectomy. Then, postoperative pain was assessed by visual analog scale at 6 and 12hrs, 1, 4, 7 and 14 days.
Trial: NCT01760226
Drug: DA-EPOCH-R for DLBCL, PTLD, AND PMBCL
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Day 1: Rituximab IV~Days 1-4: After rituximab, etoposide, vincristine, and doxorubicin will be given in a vein over 96 hours as a continuous infusion.~Day 5: cyclophosphamide will be given in a vein~Days 1-5: prednisone given by mouth twice a day~G-CSF 5mcg/kg/day will be given under the skin from day 6 until ANC has improved.
Trial: NCT01760226
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: CNS negative patients with high CNS risk DLBCL will receive age based, intrathecal dosing of MTX on days 1 and 5 of cycles 3 - 6 only.~CNS positive patients will receive age based, intrathecal (within the spinal fluid) MTX twice weekly for 2 weeks past the first negative cytology with a minimum of 4 weeks treatment. Then, weekly for 6 weeks and then every 4 weeks for 6 months.~DLBCL/PTLD/PMBCL CNS prophylaxis for cycles 3-6 ONLY if:~* 2+ extranodal sites~* elevated LDH,~* MYC rearrangement OR~* bone or marrow disease.~ALL OTHERS receive IT MTX cycles 3-6.
Trial: NCT01760226
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Doxorubicin will be given at 10mg/m2/day on days 1-4 of the first cycle (dose based on patient height and weight). The doses in later cycles will be adjusted up or down based on the patient's blood test results.
Trial: NCT01760226
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide will be given on Day 5 of each cycle. In cycle 1, the dose will be 750 mg/m2 (based on patient height and weight), and the dose will be adjusted up or down for future cycles based on blood test results.
Trial: NCT00857766
Drug: ADVAIR DISKUS™ 250/50mcg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ADVAIR DISKUS™ 250/50mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS™ 250/50mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
Trial: NCT01988402
Drug: Placebo (sugar pill)
RxNorm normalized name: placebo Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02108704
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02555306
Drug: 0.5 mg of DE-122
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DE-122 Injectable Solution
Trial: NCT02555306
Drug: 1.0 mg of DE-122
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DE-122 Injectable Solution
Trial: NCT02555306
Drug: 2.0 mg of DE-122
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DE-122 Injectable Solution
Trial: NCT02555306
Drug: 4.0 mg of DE-122
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DE-122 Injectable Solution
Trial: NCT00089791
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo administered by subcutaneous injection
Trial: NCT01097811
Drug: Erythromycin
RxNorm normalized name: Erythromycin
DrugBank: Erythromycin (DB00199)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 250 mg orally q.i.d.
Trial: NCT00148122
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy.
Trial: NCT02022670
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sugar pill manufactured to mimic sodium nitrite capsules
Trial: NCT00879710
Drug: simvastatin or ezetimibe
RxNorm normalized name: ezetimibe / simvastatin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will be started on either simvastatin or ezetimibe (we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist.
Trial: NCT04004325
Drug: FT-4101 placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: FT-4101 placebo will be supplied as placebo capsule matching in size and color to all the active capsules and will be administered per the protocol defined frequency and dose level.
Trial: NCT01065649
Drug: Placebo arm
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo per oral for 21 days, equal to nortriptyline
Trial: NCT02189174
Drug: CLR457
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00822120
Drug: ABVD regimen
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00822120
Drug: BEACOPP regimen
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00822120
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00822120
Drug: doxorubicin hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01756924
Drug: IV or Oral standard of care antibiotics
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00051298
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00378300
Drug: Oral Probiotics
RxNorm normalized name: Rezyst Probiotic
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02540031
Drug: Additional oral preparation (3L of PEG+Asc, Coolprep®)
RxNorm normalized name: Digitalis preparation Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The interventional or experimental arm will receive 1l of additional PEG+Asc, Coolprep® on the day of colonoscopy~\* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
Trial: NCT02540031
Drug: Standard oral preparation (2L of PEG+Asc, Coolprep®)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The control arm will receive currently used oral preparation (2l of PEG+Asc, Coolprep®) for colonoscopy~\* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
Trial: NCT01235936
Drug: AKB-6548
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Different dose levels
Trial: NCT01499849
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: (4 X 0 mg capsules) 0 mg PO
Trial: NCT03736980
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 100% lactose
Trial: NCT04633148
Drug: Cyclophosphamide (Non-IMP)
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Intravenous infusion for 3 days
Trial: NCT03088800
Drug: Ibuprofen
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Oral Ibuprofen at 10 mg/kg dose
Trial: NCT02246075
Drug: EVP-6124
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01785446
Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumption
RxNorm normalized name: Cisatracurium
DrugBank: Cisatracurium (DB00565)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: In this intervention we compared the cisatracurium consumption, recovery index and sufentanil consumption between P2 and D. The reason we are comparing patients in group D with P2 is that because they belong to the same age group.
Trial: NCT01785446
Drug: Consumption of cisatracurium and sufentanil in different age groups.
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3.
Trial: NCT00291694
Drug: celecoxib
RxNorm normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Celecoxib 400 mg BID
Trial: NCT02950883
Drug: Active Treatment Group 7% Hypertonic Saline
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Drug: 7% Hypertonic Saline (HS) 4 mL of HS will be administered via inhalation twice daily for 48 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI compressor (PARI Vios® Pro in USA, PARI BOY SX in Australia and Europe).~Other Names:~Hyper-Sal™, inhaled saline
Trial: NCT02950883
Drug: Control Group 0.9% Isotonic Saline
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Drug: 0.9% Isotonic Saline (IS) 4 mL of IS will be administered via inhalation twice daily for 48 weeks The delivery system is the same as that for the test product.~Other Names: Normal saline
Trial: NCT00343408
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00343408
Drug: leucovorin calcium
RxNorm normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01800305
Drug: Pegylated rhEPO
RxNorm normalized name: antihemophilic factor (recombinant) pegylated Injection [Adynovate]
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02707198
Drug: kefir
RxNorm normalized name: KEFIRAN
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 4 ounces of kefir 3 times a day, with or without food.
Trial: NCT01189929
Drug: Abraxane®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Abraxane® which will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes once a week for 3 weeks in a row, followed by a week of rest.
Trial: NCT02831816
Drug: ZuraPrep
RxNorm normalized name: DuraPrep
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Apply topically.
Trial: NCT03745170
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 1000 mg/m\^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14
Trial: NCT03745170
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Weight\<60Kg: 3mg/kg Q3W Weignt\>=60Kg:200 mg Q3W on Day 1 by IV infusion
Trial: NCT06455488
Drug: Antiarrhythmic drug
RxNorm normalized name: ANTIARRHYTHMICS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Drug therapies
Trial: NCT02235298
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo pill taken once daily to mimic Dapagliflozin
Trial: NCT03565484
Drug: susceptibility guided therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will take a gastroscopy and 2 biopsies will be attained from antrum and gastric body for H.pylori culture and antimicrobial susceptibility testing (AST). The susceptibility of amoxicillin, clarithromycin, metronidazole, levofloxacin, furazolidone and tetracycline will be tested.Then patients with positive culture will be treated with a 14-day quadruple therapy for the H.pylori eradication. The regimen contains rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid, and two sensitive antibiotics determined by AST. Dose of two sensitive antibiotics are listed as follows : amoxicillin 1000mg bid, clarithromycin 500mg bid, tinidazole 500mg tid, levofloxacin 500mg qd, furazolidone 100mg bid, tetracycline 500mg qid.
Trial: NCT03565484
Drug: personal medication history guided therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will be treated with a 14-day emprical tailored quadruple therapy for the H.pylori eradication. The regimen contains rabeprazole 20mg bid， colloidal bismuth pectin 200mg bid and two antibiotics based on personal medication history. If the patient doesn't have levofloxacin history, he will be treated with amoxicillin 1000mg bid plus levofloxacin 500mg bid. Otherwise, he will be treated with amoxicillin 1000mg bid and furazolidone 100mg bid.
Trial: NCT03565484
Drug: salvage treatment for failed eradication
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: If the patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. The regimen contains rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid, tetracycline 500mg qid and furazolidone 100mg bid.
Trial: NCT02676011
Drug: Atropine mixed with second dose succinylcholine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Atropine (0.01 mg/kg) added to the second dose succinylcholine (1mg/kg) prepared to 5 ml syringe with normal saline
Trial: NCT02676011
Drug: Normal saline mixed with second dose succinylcholine
RxNorm normalized name: NS-2359
DrugBank: NS-2359 (DB05805)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline
Trial: NCT02463994
Drug: MPDL3280A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will receive 1,200 mg I.V. Q 3 weeks of MPDL3280A until progression.
Trial: NCT05364385
Drug: Infants in the control group (S/P group) receive placebo (Normal saline 1mL)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Infants in the control group (S/P group) will receive surfactant 2.5 mls/kg and placebo (Normal saline 1mL)
Trial: NCT04447287
Drug: ASP8062
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral
Trial: NCT04447287
Drug: Placebo ASP8062
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral
Trial: NCT00912964
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching mirabegron placebo tablets.
Trial: NCT01302158
Drug: ASP1941
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral
Trial: NCT00276601
Drug: mercaptopurine
RxNorm normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00276601
Drug: methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00276601
Drug: tretinoin
RxNorm normalized name: Tretinoin
DrugBank: Tretinoin (DB00755)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01511159
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dose by inhalation. Progression to open-label trial part will be based on safety data
Trial: NCT02394054
Drug: Intranasal placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter.
Trial: NCT02325466
Drug: Aspirin Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00357916
Drug: PEP005 Topical Gel (0.01% concentration)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02343094
Drug: PBA 7,5g/d
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment for 14 days with PBA
Trial: NCT02343094
Drug: PBA 15g/d
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment for 14 days with PBA
Trial: NCT02032836
Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL)
RxNorm normalized name: Iloprost
DrugBank: Iloprost (DB01088)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer
Trial: NCT02032836
Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)
RxNorm normalized name: Iloprost
DrugBank: Iloprost (DB01088)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 10 µg/mL iloprost nebulizer solution, inhaled with I-Neb nebulizer
Trial: NCT04196309
Drug: low molecular weight heparin
RxNorm normalized name: Low molecular weight heparin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: LMWH (tinzaparin) at body-weight-adjusted therapeutic dose (175 anti-Xa IU/kg subcutaneously once daily)
Trial: NCT04501744
Drug: Cohort 1 of M701
RxNorm normalized name: Oil of peppermint
DrugBank: Peppermint oil (DB11198)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients in Cohort 1 will receive 4 escalating doses (2, 5, 10 and 25 μg) of M701 on Days 1, 8, 15 and 22. The maintenance dose during extended treatment period is 25 μg.
Trial: NCT04501744
Drug: Cohort 2 of M701
RxNorm normalized name: Oil of peppermint
DrugBank: Peppermint oil (DB11198)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients in Cohort 2 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 25 μg, and the maintenance dose during core treatment period and extended treatment period is 50 μg.
Trial: NCT04501744
Drug: Cohort 3 of M701
RxNorm normalized name: Oil of peppermint
DrugBank: Peppermint oil (DB11198)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients in Cohort 3 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 50 μg, and the maintenance dose during core treatment period and extended treatment period is 100 μg.
Trial: NCT04501744
Drug: Cohort 4 of M701
RxNorm normalized name: Oil of peppermint
DrugBank: Peppermint oil (DB11198)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients in Cohort 4 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 100 μg, and the maintenance dose during core treatment period and extended treatment period is 200 μg.
Trial: NCT04501744
Drug: Cohort 5 of M701
RxNorm normalized name: Oil of peppermint
DrugBank: Peppermint oil (DB11198)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients in Cohort 5 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 150 μg, and the maintenance dose during core treatment period and extended treatment period is 300 μg.
Trial: NCT04501744
Drug: Cohort 6 of M701
RxNorm normalized name: Oil of peppermint
DrugBank: Peppermint oil (DB11198)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients in Cohort 6 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 200 μg, and the maintenance dose during core treatment period and extended treatment period is 400 μg.
Trial: NCT04501744
Drug: Cohort 7 of M701
RxNorm normalized name: Oil of peppermint
DrugBank: Peppermint oil (DB11198)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients in Cohort 7 will receive a starting doseon Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 250 μg, and the maintenance dose during core treatment period and extended treatment period is 500 μg.
Trial: NCT05249153
Drug: low dose of dexmedetomidine with sufentanil
FDA approved: no
EMA approved: no
PMDA approved: no
Description: low dose of dexmedetomidine in PCIA (0.05ug/kg/h sufentanil with 0.05ug/kg/h dexmedetomidine infusion, 0.05ug/kg sufentanil with 0.05ug/kg dexmedetomidine bolus)
Trial: NCT05249153
Drug: high dose of dexmedetomidine with sufentanil
FDA approved: no
EMA approved: no
PMDA approved: no
Description: high dose of dexmedetomidine in PCIA (0.05ug/kg/h sufentanil with 0.1ug/kg/h dexmedetomidine infusion, 0.05ug/kg sufentanil with 0.1ug/kg dexmedetomidine bolus)