AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT05384197
Drug: Extended regimen
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sulfamethoxazole-Trimethoprim (TMP-SMX) twice daily will be utilized as the first choice AP for 7 days with the last day of AP course being one day prior to intervention.~In patients with allergy or resistance to TMP-SMX, the following antibiotics will be considered in the following order: 100 mg Nitrofurantoin twice daily, 500 mg Ciprofloxacin twice daily or 200 mg Cefpodoxime twice daily.~Patients with positive culture which is sensitive only to parenteral antibiotics will receive culture-based intramuscular/intravenous antibiotics following the same schedule (7 days with the last day of AP course being one day prior to intervention)
Trial: NCT06045429
Drug: Oroxid®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients in experimental arm will receive usual best medical and nursing care with respect to VAP prevention including recently reviewed local ventilator bundle ; standard microbial surveillance (tracheal aspirate) will be performed twice a week (Monday, Thursday) and always ad hoc according to the clinical situation. This reflects current practice. Daily oral care will be provided using Oroxid® mouthwash.
Trial: NCT05027373
Drug: SSGJ-613
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SSGJ-613 injection is 200mg/2mL solution in a single vial.The solution is a clear to slightly opalescent, colorless to a slightly yellow tint.
Trial: NCT05027373
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo injection is 2mL excipient solution in a single vial.The solution is clear and colorless.
Trial: NCT05906511
Drug: 2mg Purified THC in an ethanolic solution
RxNorm normalized name: Aldex AN
DrugBank: Doxylamine (DB00366)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 2mg Purified THC in an ethanolic solution
Trial: NCT05906511
Drug: 4mg Purified THC in an ethanolic solution
RxNorm normalized name: Aldex AN
DrugBank: Doxylamine (DB00366)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 4mg Purified THC in an ethanolic solution
Trial: NCT05906511
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral placebo and/or vaporized saline
Trial: NCT05577455
Drug: Medical prescription before ovulation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Medical prescription before ovulation, modified two solstices pill and Si-Wu-Tang: 15g of Nv Zhen Zi (Fructus Ligustri Lucidi), 10g of Mo Han Lian (Yerbadetajo herb), 15g of Gou Qi Zi (Fructus lycii), 20g of Tu Si Zi (Semen cuscutae), 15g of Shu Di (Radix Rehmanniae Preparata), 10g of Dang Gui (Angelica sinensis), 10g of Bai Shao (Paeonia lactiflora Pallas), 20g of Sheng Shan Yao (Rhizoma Dioscoreae), 15g of Fu Pen Zi (Raspberry), and 15g of Shan Yu Rou (Fructus corni). The medical prescription is initiated on the fifth day of menstruation and is taken continuously for 10-15 days.
Trial: NCT06544473
Drug: 17-beta estradiol
RxNorm normalized name: 17-beta estradiol
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment with orally administered estrogen for 14 days
Trial: NCT06544473
Drug: 17-beta estradiol
RxNorm normalized name: 17-beta estradiol
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment with transdermally administered estrogen for 14 days
Trial: NCT05577455
Drug: Medical prescription after ovulation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Medical prescription after ovulation, modified Er Xian decoction for promoting fertilization and Si-Wu-Tang: 10g of Xian Mao (Curculigo orchioides), 15g of Xian Ling Pi (Epimedium Herb), 15g of Ba Ji Tian (Morinda officinalis), 20g of Tu Si Zi (Semen cuscutae), 15g of Nv Zhen Zi (Fructus Ligustri Lucidi), 15g of Zi Shi Ying (Fluoritum), 15g of Shu Di (Radix Rehmanniae Preparata), 10g of Dang Gui (Angelica sinensis), 10g of Bai Shao (Paeonia lactiflora Pallas), and 10g of Chuan Xiong (Szechwan Lovage Rhizome). The medical prescription is administered continuously for 10-15 days after ovulation, based on follicle development and endometrial growth monitored by ultrasound.
Trial: NCT05712200
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage Formulation: Liquid (in vial)~Dose Strength: Placebo to Abelacimab
Trial: NCT06584799
Drug: Micronized purified flavonoid fraction
RxNorm normalized name: RAYON,PURIFIED
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Micronized purified flavonoid fraction (MPFF) 1000. Active substance: micronized purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin). MPFF is a venotonic agent that also has angioprotective properties. It reduces venous distensibility and blood stasis, capillary permeability, and increases capillary resistance.~MOFF 1000 dosing regimen is 1000 mg once daily for 2 months.
Trial: NCT04974008
Drug: OST31-164
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients who will receive OST31-164 as a single agent every 3 weeks for 48 weeks with 4 doses constituting 1 treatment cycle (12 weeks per cycle). Each patient will receive treatment at a dose of 1x109 CFU until week 48 or until disease progression, unacceptable toxicity, or the patient meets any other treatment discontinuation criteria.
Trial: NCT05419401
Drug: [14C]AZD5363 (Capivasertib)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Solution for Infusion 20 µg/mL (NMT 37.0 kBq/5 mL) - 100 µg; 5 mL, Intravenous~Oral Solution, 400 mg (NMT 4.8 MBq) - 400mg; 100mL, oral, fasted
Trial: NCT05607108
Drug: ZEN003694
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ZEN003694 60mg po qd on a 5 days on 2 days off schedule in an every 21-day cycle
Trial: NCT05593055
Drug: Eplerenone
RxNorm normalized name: Eplerenone
DrugBank: Eplerenone (DB00700)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: After the Pre-Treatment Assessment, participants in the eplerenone arm will be given 50 mg eplerenone. At 2 weeks, eplerenone will be increased to 100 mg.
Trial: NCT05593055
Drug: Chlorthalidone
RxNorm normalized name: Chlorthalidone
DrugBank: Chlorthalidone (DB00310)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: After the Pre-Treatment Assessment, participants in the chlorthalidone arm will be given 12.5 mg chlorthalidone + 10 mEq potassium. At 2 weeks, chlorthalidone will be increased to 25 mg + 20 mEq potassium.
Trial: NCT05974046
Drug: [14C]IDV184001AN
FDA approved: no
EMA approved: no
PMDA approved: no
Description: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
Trial: NCT04597372
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be prepared by the IDS pharmacist (or contracted pharmacy) and encapsulated in identical appearing wraps. Subjects will be provided with 10 capsules to be taken daily.
Trial: NCT05949125
Drug: R-TM123
RxNorm normalized name: R
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous infusion over 20 days
Trial: NCT05583344
Drug: GSK4532990
FDA approved: no
EMA approved: no
PMDA approved: no
Description: GSK4532990 will be administered.
Trial: NCT05583344
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be administered.
Trial: NCT04677569
Drug: Azithromycin
RxNorm normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Oral tablet
Trial: NCT05652894
Drug: Investigator's Choice Chemotherapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Drug: bevacizumab 5mg/kg given by IV every 14 days. Other Name: Avastin~Drug: cetuximab 400 mg/sqm initial dose, then 250 mg/sqm once weekly thereafter. Other Name: Erbitux~Drug: oxaliplatin 8 5 mg/sqm by IV, day1. Component of mFOLFOX6.~Drug: irinotecan 180 mg/sqm by IV, day1.Component of FOLFORI.~Drug: calcium Folinate 400 mg/sqm by IV, day1.Component of mFOLFOX6 or FOLFORI.~Drug: 5-fluorouracil 400 mg/sqm, day1,followed by 2400 mg/sqm iv infusion over 46\~48 h.Component of mFOLFOX6 or FOLFORI.
Trial: NCT06499701
Drug: Ringer's Lactate
RxNorm normalized name: Ringer's lactate/gel dressing 2.2" TOPICAL KIT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ringer's Lactate is administered at a dose of 30ml/kg, with the first 20ml/kg given at a constant rate over the initial 30 minutes, followed by a 30-minute pause, and then an additional 10ml/kg over the next 15 minutes, completing the infusion within 75 minutes.
Trial: NCT04934891
Drug: ION547
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ION547 will be administered by SC injection.
Trial: NCT04934891
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ION547-matching placebo will be administered by SC injection.
Trial: NCT04976387
Drug: Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET
RxNorm normalized name: hydrocodone/acetaminophen 5 mg-325 mg ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients are instructed to take Hydrocodone/acetaminophen 5 mg-325 mg oral tablets every 6 hours as needed for treatment of severe pain
Trial: NCT04976387
Drug: Ibuprofen 600 mg
RxNorm normalized name: ibuprofen 600 MG
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients will take ibuprofen 600 mg every 6 hours as needed
Trial: NCT04976387
Drug: Acetaminophen 650 MG
RxNorm normalized name: acetaminophen 650 MG
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will take Tylenol 650mg every 6 hours as needed
Trial: NCT05318066
Drug: Ringer Lactate and Norepinephrine infusion
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Arm Fluids (FL)- 500 mL of ringer lactate over 10 minute prior to the administration of procedural medications.~Arm Vasopressor (VP)- Patients in this group would receive norepinephrine infusion at a dose of 0.08 μg/kg/min over 10 minutes prior and 5 minutes after tracheal intubation.
Trial: NCT06580782
Drug: Standard Dose Synthetic Pitocin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The participant will receive thestandard-dose synthetic oxytocin for labor induction or augmentation.
Trial: NCT05537987
Drug: ICP-723
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3+3 dose escalation
Trial: NCT04523922
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo (intranasal saline spray) self administered 30 minutes prior to each COPE session.
Trial: NCT06171932
Drug: Methylprednisolone,
RxNorm normalized name: methylprednisolone, micronized
FDA approved: no
EMA approved: no
PMDA approved: no
Description: No intervention required
Trial: NCT05989542
Drug: PLB1001
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 200mg BID Oral
Trial: NCT05611710
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Drug: Placebo, with visually matched clear syringes~* Adults (≥16 years) and children (12-16 years, \> 50Kg) will receive 2 syringes of placebo via IV route, twice daily for 4 days~* Children (12-16 years, \< 50Kg) will receive no more than 1 syringe of placebo via IV route, twice daily for 4 days
Trial: NCT04700709
Drug: Mycophenolate Mofetil Cap./Tab.
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Up to 1g BID(total 2g daily), PO
Trial: NCT01931501
Drug: Singulair® (Montelukast Sodium) Chewable Tablets 5mg
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT05785754
Drug: DCSZ11
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A monoclonal antibody that binds to CD93, DCSZ11 will be administered as a single intravenous (IV) infusion on Day 1 in each 21-day cycle.
Trial: NCT06267118
Drug: Hypertonic Saline Solution, 1 Ml
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dilute 0.3 ml hypertonic saline with 3 ml normal saline for nebulization
Trial: NCT05518838
Drug: OKN-007
FDA approved: no
EMA approved: no
PMDA approved: no
Description: OKN-007 is an intravenously administrated drug being developed as a novel anti-cancer therapy against gliomas.
Trial: NCT05737771
Drug: DWC202213
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DWC202213
Trial: NCT05737771
Drug: DWJ1563
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DWJ1563
Trial: NCT05737771
Drug: DWP16001
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DWP16001
Trial: NCT04837677
Drug: PRT1419
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PRT1419 will be administered by intravenous infusion
Trial: NCT05185011
Drug: TPN171H
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 10 mg TPN171H tablets，single dose
Trial: NCT06239298
Drug: ZG005 Powder for Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: intravenous infusion(IV), once every 3 weeks
Trial: NCT05205928
Drug: Outpatient therapy: 11 weeks of drug therapy with usual treatment + 4 weeks of closed-loop therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The blinded drug will be used with participant's routine therapy (+ continuous glucose monitoring if not already in use) for 11 weeks with follow-up from qualified research personnel concerning pump settings, side effects, and incremental dose increase. While continuing to use the medication, there are 4 weeks of closed-loop pump therapy and drug use; glycemic outcomes will be taken from the last 4 weeks. This will be followed by laboratory and anthropometric testing, followed by 2 weeks of wash-out.
Trial: NCT06066359
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given by (IV) vein
Trial: NCT06066359
Drug: NY-ESO-1 TCR/IL-15 NK
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given by (IV) vein
Trial: NCT02431715
Drug: [18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients will have their weight and baseline vital signs recorded.~The study subject will have an intravenous catheter inserted and receive a slow bolus intravenous dose of 185 - 370 MBq (5 -10mCi) 18F-FDOPA.~The patient will rest in a comfortable reclining chair in a warm, private shielded room for 45 to 60 minutes.~Patients are positioned supine and centered on the scanner bed for an average total scan time (CT and PET) of approximately 30 minutes.~Images will be interpreted by qualified and experienced physicians. Findings of significance from the PET/CT scan, and any incidental findings of significance from the CT scan, will be included in the single final report that will be issued to referring physicians.
Trial: NCT05834595
Drug: CKD-828, D064, D701
FDA approved: no
EMA approved: no
PMDA approved: no
Description: QD, PO
Trial: NCT05495425
Drug: NPC-12Y gel
RxNorm normalized name: SARS-CoV-2 (COVID-19) vaccine, mRNA spike protein
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NPC-12Y gel is applied twice a day for 12 weeks. After the double-blind evaluation period, NPC-12Y gel is applied twice a day for 52 weeks.
Trial: NCT05104476
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Solution for infusion
Trial: NCT05495425
Drug: NPC-12Y placebo gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NPC-12Y placebo gel is applied twice a day for 12 weeks. After the double-blind evaluation period, NPC-12Y gel is applied twice a day for 52 weeks.
Trial: NCT04923906
Drug: Aumolertinib
RxNorm normalized name: aumolertinib
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of every 21-day cycles up to 4\~6 cycles, followed by Aumolertinib 100mg QD with pemetrexed maintenance (500 mg/m2) on Day 1 of every 21-day cycles.~Dose may be reduced to allow for the management of investigational drug related toxicity.
Trial: NCT04923906
Drug: Placebo Aumolertinib
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo Aumolertinib 110 mg QD Dose may be reduced to allow for the management of investigational drug related toxicity.
Trial: NCT05655806
Drug: normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: given as placebo
Trial: NCT05656092
Drug: HIP0612
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Test drug
Trial: NCT06220838
Drug: SC-101
RxNorm normalized name: OXT-101
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All subjects will receive a single intravenous (IV) infusion of SC-101 once weekly.
Trial: NCT05776056
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: An inactive pill (placebo) will be taken twice daily.
Trial: NCT04936035
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo administered by SC injection
Trial: NCT05656092
Drug: HPP2202
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo drug
Trial: NCT05656092
Drug: RLD2204
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Reference drug
Trial: NCT05656092
Drug: HPP2201
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo drug
Trial: NCT06327646
Drug: Multiple Micronutrient Supplement Blister
RxNorm normalized name: Blister Armour
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MMS in a blister pack along with related job aids, counselling during ANC, etc.
Trial: NCT06352541
Drug: PRO-232
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Moxifloxacin 0.5% and Dexamethasone Phosphate 0.1%
Trial: NCT06678191
Drug: BDP/FF/G (Beclomethasone diprprionate, formoterol fumarate, glycopyrronium bromide) 172/5/9 μg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In accordance with the requirements of non-interventional studies, the assignment of patients to Trimbow 172/5/9 μg pMDI therapy should be made independently of the study, and patients should only be considered for inclusion in the study after a prior therapeutic decision has been made by a pulmonologist.
Trial: NCT05148702
Drug: Antibiotic - standard duration
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Clinician decided antibiotic and duration of treatment
Trial: NCT05473234
Drug: Azithromycin
RxNorm normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Trial: NCT06504446
Drug: NOC-110
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhalation powder
Trial: NCT04639310
Drug: XEN496
FDA approved: no
EMA approved: no
PMDA approved: no
Description: XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child TID.
Trial: NCT04639310
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child TID.
Trial: NCT05527834
Drug: VNRX-7145
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single oral dose
Trial: NCT04485039
Drug: calcium acetate oral tablet
RxNorm normalized name: calcium acetate Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: phosphate binder
Trial: NCT04918186
Drug: BA3021
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV
Trial: NCT05786443
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Empagliflozin-matching placebo dosed once-daily over 12 weeks. Administered as oral tablet.
Trial: NCT06779968
Drug: Intravenous patient-controlled analgesia
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For intravenous patient-controlled analgesia (PCA), fentanyl was administered at a dose of 2 mcg/kg, diluted in 100 mL of normal saline. The basal infusion rate was set at 2 mL/hr, with a PCA dose of 2 mL and a lockout interval of 15 minutes.
Trial: NCT06232759
Drug: Transarterial chemoembolization combined with Tyrosine Kinase Inhibitors and Tislelizumab
RxNorm normalized name: Tislelizumab
DrugBank: Tislelizumab (DB14922)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients with unresectable hepatocellular carcinoma were received transarterial chemoembolization combined with Tyrosine Kinase Inhibitors and Tislelizumab
Trial: NCT05425446
Drug: DONQ52
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subcutaneous (SC) injection
Trial: NCT05425446
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subcutaneous (SC) injection
Trial: NCT05478486
Drug: MSP008-22
FDA approved: no
EMA approved: no
PMDA approved: no
Description: It is single group assignment interventional model in this clinical trial, consisting of 5 cohorts of 3 patients in each, to be enrolled such that there exists an overall gender balance for the entire trial and to also ensure including minimum five (5) patients of TNBC and minimum five (5) male patients.~The trial will be initiated with dosing of a cohort of 03 patient with the Safe starting dose for MSP008-22. Dosing of the patients for the next higher dose cohort will initiate only after: (i) All 03 patients have been recruited in the lower dose Cohort and if a repeat Cohort at this dose level is recommended, another 03 patients have been recruited at same dose level (ii) all dosed patients have completed the allocated study cohort duration, (iii) safety and pharmacokinetic results have been reviewed by the Independent Dose Escalation Committee (DEC) and approved for dose escalation to next cohort.
Trial: NCT05794139
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablets
Trial: NCT06149676
Drug: Saccharomyces Boulardii 250 MG [Florastor]
RxNorm normalized name: Saccharomyces boulardii 250 MG [Florastor]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients will get the probiotic to be taken daily. If UTI occurs with a sensitive pathogen, we will treat with ciprofloxacin
Trial: NCT05010772
Drug: Decitabine and Cedazuridine
RxNorm normalized name: cedazuridine / decitabine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT06780670
Drug: Investigators choice of SoC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The control treatment in Phase III is investigator's choice of SoC
Trial: NCT06780670
Drug: AAA817
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The investigational treatment is AAA817
Trial: NCT06780670
Drug: AAA817
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Investigational treatment is the Dose B of AAA817
Trial: NCT06260514
Drug: APR-1051
RxNorm normalized name: PrameGel Reformulated Apr 2012
FDA approved: no
EMA approved: no
PMDA approved: no
Description: WEE1 Inhibitor