AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT04791566
Drug: Physiologic saline
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 100 mL Physiologic saline administered as a single preoperative i.v., infusion over 10-15 min prior to general anaesthesia
Trial: NCT04878614
Drug: Levothyroxine Tablet
RxNorm normalized name: levothyroxine Oral Tablet
DrugBank: Levothyroxine (DB00451)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Standard clinical management
Trial: NCT04878614
Drug: Levothyroxine Sodium
RxNorm normalized name: Levothyroxine Sodium
DrugBank: Levothyroxine (DB00451)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Liquid levothyroxine through enteral feeding tube
Trial: NCT05009732
Drug: GT0918
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 300mg once daily orally
Trial: NCT05009732
Drug: Standard of care
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Local standard of care per written policies or guidelines
Trial: NCT05009732
Drug: Matching placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo
Trial: NCT06663189
Drug: treatment withdrawal
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will STOP their DMT
Trial: NCT04700280
Drug: GLPG3970
FDA approved: no
EMA approved: no
PMDA approved: no
Description: GLPG3970 film-coated tablet.
Trial: NCT04700280
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo film-coated tablet.
Trial: NCT05477160
Drug: STAR-0215 (SC)
RxNorm normalized name: STAR FRUIT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: STAR-0215 will be administered as an SC bolus injection.
Trial: NCT05477160
Drug: Placebo (SC)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be administered as an SC bolus injection.
Trial: NCT05477160
Drug: STAR-0215 (IV)
RxNorm normalized name: STAR FRUIT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: STAR-0215 will be administered as an IV bolus injection.
Trial: NCT05477160
Drug: Placebo (IV)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be administered as an IV bolus injection.
Trial: NCT04932941
Drug: MP1032
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Hard gelatin capsules for oral administration.
Trial: NCT04932941
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo capsules matched to MP1032 for oral administration.
Trial: NCT05109650
Drug: BAT6026
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV infusions
Trial: NCT05109650
Drug: BAT1308
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ⅳ infusions
Trial: NCT05753670
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects randomized to the control arm will receive a single dose of a placebo tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.
Trial: NCT04333472
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo orally every 12 hours for up to 28 days
Trial: NCT04761705
Drug: JV-GL1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Experimental Treatment
Trial: NCT06665165
Drug: AMX0114
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Antisense oligonucleotides (ASOs) are a type of medicine that treats diseases by intercepting the mRNA messages sent within the cell, resulting in fewer specific proteins being made. AMX0114 is an ASO that targets the mRNA messenger that instructs the body to create a protein called calpain-2. Calpain-2 has been linked to the degeneration and death of neurons in many neurological diseases, including people living with sporadic ALS. AMX0114 is designed to reduce the levels of calpain-2, with the goal of slowing down the process that leads to neuron injury and death.
Trial: NCT05748119
Drug: MEB-1170
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Depending on the dosage, either 20 mg, 40 mg capsules, or a combination of both
Trial: NCT05748119
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Equivalent number and size of capsules containing placebo
Trial: NCT05787002
Drug: Rosuvastatin
RxNorm normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Rosuvastatin will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.
Trial: NCT04940949
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo - powder for solution for infusion
Trial: NCT06616207
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo (Double distilled water matched in color and taste) will be applied topically by the graduate student to all tooth surfaces at the consultation appointment before the placement of fixed appliances and at 3, 6, and 9 months after appliance placement.
Trial: NCT05914545
Drug: FZ-AD004
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dose Escalation：Subjects will receive an intravenous infusion of FZ-AD004 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.~Dose Expansion：Subject will receive a single dose of FZ-AD004 at 1-2 dose level on Day1 of each cycles.
Trial: NCT05733624
Drug: SCAI-001 0.01% eyedrop
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BID for 12weeks
Trial: NCT05733624
Drug: SCAI-001 0.02% eyedrop
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BID for 12weeks
Trial: NCT05733624
Drug: Restasis 0.05% eyedrop
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BID for 12weeks
Trial: NCT04158349
Drug: mFOLFIRI
FDA approved: no
EMA approved: no
PMDA approved: no
Description: mFOLFIRI is a standardized chemotherapy regimen utilizing 5-fluorouracil, leucovorin, and irinotecan administered on day one of a 14-day cycle. 5-Fluorouracil, leucovorin, and irinotecan should be prepared and administered per the package insert and local institutional guidelines.
Trial: NCT05450328
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The control group will receive two syringes of 4mL of Normal Saline, before CPB start.~The placebo will be administered via an ultrasonic nebulizer (Aeroneb Professional Nebulizer System, Aerogen Ltd, Galway, Ireland, registration number: 66728) over a period of 20 minutes. This type of nebulizer is used routinely at the Montreal Heart Institute and can hold a maximum of 8 mL of solutions.
Trial: NCT04737343
Drug: Azathioprine Tablets
RxNorm normalized name: Azathioprine Tablets
DrugBank: Azathioprine (DB00993)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients included into this study will be treated with Azathioprine tablets 100mg QD for 18 months.
Trial: NCT05364931
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo administered subcutaneously once daily
Trial: NCT05070702
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Hard Capsule
Trial: NCT06409650
Drug: KX-826 dosed at 2.5mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2.5mg of the investigational drug to be applied topically to scalp once daily for 24 weeks
Trial: NCT06409650
Drug: KX-826 dosed at 2.5mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2.5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks
Trial: NCT06409650
Drug: Matching placebo to KX-826
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo applied topically to scalp once daily for 24 weeks
Trial: NCT06409650
Drug: Matching placebo to KX-826
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo applied topically to scalp twice daily for 24 weeks
Trial: NCT05023577
Drug: Clarithromycin
RxNorm normalized name: Clarithromycin
DrugBank: Clarithromycin (DB01211)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 0.5g bid
Trial: NCT04601038
Drug: CORT108297
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 120mg of a selective glucocorticoid receptor antagonist, taken as 2 tablets daily for 2 weeks
Trial: NCT04601038
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo taken as 2 tablets daily for 2 weeks
Trial: NCT05380323
Drug: LY3541105
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered SC.
Trial: NCT05380323
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered SC.
Trial: NCT05877079
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will wear hand and foot wraps with lotion without menthol (20 grams each) for 5 min. Patients will wear the wraps for 5 days per week. The total duration is 4 weeks.
Trial: NCT05472818
Drug: [11C]APP311
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For each \[11C\]APP311 (UCB-J) PET scan, up to 20 mCi of \[11C\]APP311 (UCB-J) will be administered by infusion pump. All participants will receive at least two \[11C\]APP311 (UCB-J) PET scans approx. 4 weeks days apart. Approximately 8 CUD participants will be asked to return for a third \[11C\]APP311 (UCB-J) PET scan after an additional 4 weeks following their second scan.
Trial: NCT04715763
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Gelatin capsules filled with an inactive ingredient
Trial: NCT05382728
Drug: TY-9591
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The dose of TY-9591 is 160 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment.~Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
Trial: NCT05717582
Drug: androgen deprivation therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients receive systemic ADT.
Trial: NCT05009966
Drug: SYSA1801 for injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SYSA1801 will be administered intravenously (IV) on Day 1 of every 21-day cycle. Individual subjects may continue study treatment until there is evidence of disease progression (clinical or radiologic) judged by Investigators, unacceptable toxicity or other reasons for treatment discontinuation.
Trial: NCT05240131
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo is administered orally twice a day.
Trial: NCT04652284
Drug: Clarithromycin
RxNorm normalized name: Clarithromycin
DrugBank: Clarithromycin (DB01211)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 500 mg
Trial: NCT05110807
Drug: TQB3617
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TQB3617 is a BET inhibitor.
Trial: NCT05382728
Drug: placebo TY-9591
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The dose of placebo TY-9591 is 160 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment.~Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
Trial: NCT04873531
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For the NS group, neostigmine normal saline (0.09 cc/kg; the same volume of the group N) will be administered just after tracheal intubation.~Investigators evaluate the quality of signal of IONM during the surgery.
Trial: NCT05909423
Drug: Influenza vaccine
RxNorm normalized name: Influenza vaccine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intratumoral influenza vaccine treatment, administered via endoscopic procedure
Trial: NCT04750135
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT04274023
Drug: TSR-042
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TSR-042 is an IgG4 humanized monoclonal antibody that binds with high affinity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2.
Trial: NCT05376670
Drug: Intravesical aminoglycoside instillations
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Overnight instillation of an aminoglycoside (CIC), varying treatment regimens
Trial: NCT05281185
Drug: standard half-life FVIII concentrates with weight-based dosing
FDA approved: no
EMA approved: no
PMDA approved: no
Description: standard half-life FVIII concentrates with weight-based dosing, that current patients' regimen before enrolling in this study
Trial: NCT05037591
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo lactose powder (1.68 g/70kg BW day-1).
Trial: NCT04885972
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Vehicle solution
Trial: NCT05681312
Drug: systemic proteolytic enzyme (Tibrolin)
RxNorm normalized name: PROTEOLYTIC ENZYME
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg)
Trial: NCT04920903
Drug: COR588
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Increasing doses of COR588 will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase.
Trial: NCT04920903
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase.
Trial: NCT06195163
Drug: No pretreatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: No pretreatment prior to the ovarian stimulation in the control group.
Trial: NCT00000824
Drug: Lymphocytes, Activated
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04882319
Drug: HP-5000 Topical Patch
RxNorm normalized name: Capzasin-HP Topical Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: HP-5000, placebo and saline will be administered simultaneously
Trial: NCT04882319
Drug: HP-5000 Placebo Patch
FDA approved: no
EMA approved: no
PMDA approved: no
Description: HP-5000, placebo and saline will be administered simultaneously
Trial: NCT05161806
Drug: SOK583A1 (40 mg/mL)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration
Trial: NCT05352165
Drug: Other individualized treatments
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Other individualized treatments based on organoids drug sensitivity
Trial: NCT04646889
Drug: AR882 Single Dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single dose of AR882
Trial: NCT04646889
Drug: AR882 Multiple Dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: AR882 taken once daily for 14 days
Trial: NCT06322394
Drug: high-dose BXOS110
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3.0 mg/kg, maximum dose not exceeding 300 mg，Participants received one administration by intravenous infusion.
Trial: NCT01659515
Drug: Arbekacin Sulfate
RxNorm normalized name: arbekacin sulfate
DrugBank: Arbekacin (DB06696)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous arbekacin in a total daily dose of 5-7 mg/kg
Trial: NCT06322394
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Does not contain any test drug active ingredients，Participants received one administration by intravenous infusion.
Trial: NCT06051565
Drug: Polysaccharide superparamagnetic iron oxide injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Polysaccharide superparamagnetic iron oxide injection can be used for the treatment of iron-deficiency anemia and for magnetic resonance imaging enhancement.
Trial: NCT05989724
Drug: SON-DP
RxNorm normalized name: prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Solution for IV administration
Trial: NCT05727072
Drug: LY3848575
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered IV.
Trial: NCT05727072
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered IV.
Trial: NCT05727072
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered SC.
Trial: NCT04666298
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subcutaneously injected on Day 1, 90, and 270.
Trial: NCT04665375
Drug: DOR/3TC/TDF
FDA approved: no
EMA approved: no
PMDA approved: no
Description: switch antiretroviral regimen to doravirine/lamivudine/tenofovir disoproxil fumarate once daily for 1 year
Trial: NCT05387707
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral Placebo tablets administered twice daily
Trial: NCT05387707
Drug: Vehicle Cream
RxNorm normalized name: vehicle cream base no.160
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Vehicle Cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
Trial: NCT05029401
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo to the IMP (DMX-1002)
Trial: NCT05375305
Drug: SHR8554 Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SHR8554 Injection; high dose
Trial: NCT05375305
Drug: SHR8554 Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SHR8554 Injection; low dose
Trial: NCT04975074
Drug: Iron
RxNorm normalized name: Iron
DrugBank: Iron (DB01592)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: One of each type of iron was taken orally according to the instructions and followed every two weeks
Trial: NCT05907330
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will administer the study drug once a day after a meal
Trial: NCT05337774
Drug: [18F]PI-2620
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The participant will be injected with 5 mCi (185 MBq) \[18F\]PI-2620 via a short line which will be placed in an intravenous line in an antecubital vein. Subjects will be placed in the scanner after injection and dynamic scans will be acquired for 0 to 60 minutes post injection.
Trial: NCT06326502
Drug: ETN101
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral administration
Trial: NCT05195749
Drug: 101-PGC-005 ('005) + SOC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Three consecutive days of '005 administration
Trial: NCT05195749
Drug: Placebo + SOC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Three consecutive days of placebo administration
Trial: NCT05480592
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally as a tablet
Trial: NCT05060432
Drug: SOC chemotherapies
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SOC chemotherapies in 1L mNSCLC
Trial: NCT00000674
Drug: Leucovorin calcium
RxNorm normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00000674
Drug: Clindamycin
RxNorm normalized name: Clindamycin
DrugBank: Clindamycin (DB01190)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT04436978
Drug: Guideline-directed therapy
RxNorm normalized name: direct blue 2
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Guideline-directed therapy (edoxaban + P2Y12 inhibitor, aspirin limited to in-hospital use or up to 30 days in selected high-risk patients)
Trial: NCT05372874
Drug: Direct Acting Antivirals
RxNorm normalized name: DIRECT ACTING ANTIVIRALS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: hepatitis C patients will be treated by direct acting antiviral drugs (DAAs)for 12 weeks.
Trial: NCT05346783
Drug: TJO-083
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Diquafosol ophthalmic sodium solution, 1 drop 3 times a day
Trial: NCT06495164
Drug: Aromatase inhibitor
RxNorm normalized name: Aromatase inhibitor
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Aromatase inhibitor
Trial: NCT05154630
Drug: TQB2858 injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TQB2858 is a Programmed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β(TGF-β) double antibody.
Trial: NCT06120556
Drug: GLP-1 receptor agonist
RxNorm normalized name: GLP-1 receptor agonist
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients initiating a GLP-1 receptor agonist (i.e. liraglutide, dulaglutide, semaglutide) will be included in the study.
Trial: NCT03744663
Drug: Suboxone® SL
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day induction phase, the subject will be started on the treatment to which they were randomized to two groups one of which will be Suboxone® SL.
Trial: NCT06120816
Drug: Nitric Oxide
RxNorm normalized name: Nitric Oxide
DrugBank: Nitric Oxide (DB00435)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Nitric Oxide Releasing Mouthwash will be self-administered by the participant three times throughout the day for 21 days. The intervention solution will be poured into their mouth from a medication cup containing 20 mL of the solution. Total exposure to study intervention will be a maximum of 63 treatments totaling 1,260 mL. All participants will be monitored for 7 days post-last treatment dose (to Day 28).
Trial: NCT03744663
Drug: Sublocade®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day induction phase, the subject will be started on the treatment to which they were randomized, either Suboxone® SL or Sublocade®. Subjects with significant opioid craving (\> 20 mm on the Opioid Craving Visual Analog Scale) or withdrawal (a score of \> 12 on the Clinical Opiate Withdrawal Scale) after 14 days of treatment will be started on Sublocade® only at the consensus of the research team. Otherwise they will undergo an additional 7 day titration period. Study drug with Sublocade® group: Patients assigned to this group will receive the study drug (300 mg subcutaneously) every 4 weeks for a total of 6 doses along with weekly therapy. The location and specifications of its application will follow the recommendations by the FDA previously published.
Trial: NCT06031454
Drug: Rosuvastatin
RxNorm normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: oral
Trial: NCT06031454
Drug: Leritrelvir
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral