AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT01327547
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
Trial: NCT00208923
Drug: Busulfan, Cyclophosphamide and Fludarabine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: * Bulsufan 1mg/kg/dose P.O. every 6 hours for 4 days. If intravenous, busulfan dose will be 0.8 mg/kg every 6 hours for 16 doses.~* Fludarabine 40 mg/m2 a day for 5 days via IV over 2 hours, dose based on weight.~* Cyclophosphamide given via IV over 1 hour at dose of 60 mg/kg/day for 2 consecutive days.
Trial: NCT03975166
Drug: Test Product
RxNorm normalized name: Patch test product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 inhalations in one study period
Trial: NCT04041310
Drug: KEYTRUDA®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: anti-PD-1 checkpoint inhibitor (200 mg; Q3W)
Trial: NCT00885118
Drug: Placebo (middle dose)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo tablets once a day
Trial: NCT00885118
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo tablets once a day
Trial: NCT00885118
Drug: Placebo (high dose)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo tablets once a day
Trial: NCT03975166
Drug: Reference Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 inhalations in one study period
Trial: NCT01535950
Drug: LFG316
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01535950
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.
Trial: NCT00885118
Drug: Placebo (low dose)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo tablets once a day
Trial: NCT01990326
Drug: XAF5 Gel
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01990326
Drug: Placebo Gel
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00795613
Drug: CONVENTIONAL ABVD
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ABVD(cycle repeats every 28 days) Doxorubicine25 mg/m2 iv days 1,15 Bleomicine10,000 units/m2 iv days 1,15 Vinblastine6 mg/m2 iv days 1,15 Dacarbazine375mg/m2 iv days 1,15 This will be given at full dose and on schedule,regardless of blood count.
Trial: NCT02105623
Drug: Rosuvastatin
RxNorm normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Risk factor control rosuvastatin 5mg/day for 24months
Trial: NCT01511627
Drug: General Anesthesia + Spinal anesthesia combined
RxNorm normalized name: Bos taurus spinal cord preparation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients will receive a preoperative multimodal analgesic regime:~* Tylenol® 975mg per os~* Naproxen® 500 mg per os~Patients will receive a spinal anesthetic with:~* Bupivacaine 0.5% 10 mg~* Fentanyl 10ug~* Epidural Morphine 150ug~After the spinal, a general anesthetic will be induced using:~* Midazolam 1 - 2 mg intravenously~* Fentanyl 1 - 2 ug/kg intravenously~* Propofol 1-3 mg/kg intravenously~* Rocuronium 0.3 - 0.9mg/kg intravenously~* followed by endotracheal intubation. Maintenance of anesthesia with sevoflurane, oxygen and air.~* Intraoperative Morphine 0 - 0.3mg/kg or Fentanyl 0 - 7.5ug/kg to maintain MAP and heart rate within 20% of baseline.~* Phenylephrine and Ephedrine can be used to support blood pressure and heart rate within 20% of baseline.~* Dexamethasone 4mg and Ondansetron 4mg intravenously~* Neostigmine 3mg and Glycopyrrolate 0.6mg intravenously Patients will receive a Morphine PCA to be initiated in the Post Anesthetic Care Unit (PACU).
Trial: NCT01511627
Drug: General Anesthesia (control group)
RxNorm normalized name: Streptococcus viridans group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients will receive a preoperative multimodal analgesic regime:~* Tylenol® 975mg per os~* Naproxen® 500 mg per os~Group I (General anesthetic) patients will receive a general anesthetic :~* Midazolam 1 - 2 mg intravenously~* Fentanyl 1 - 2 ug/kg intravenously~* Propofol 1-3 mg/kg intravenously~* Rocuronium 0.3 - 0.9mg/kg intravenously~* followed by endotracheal intubation. Maintenance of anesthesia with sevoflurane, oxygen and air.~* Intraoperative Morphine 0 - 0.3mg/kg or Fentanyl 0 - 7.5ug/kg. to maintain MAP and heart rate within 20% of baseline.~* Phenylephrine and Ephedrine can be used to support blood pressure and heart rate within 20% of baseline.~* Dexamethasone 4mg and Ondansetron 4mg intravenously~* Neostigmine 3mg and Glycopyrrolate 0.6mg intravenously~Patients will receive a Morphine PCA as per protocol that will be initiated in the Post Anesthetic Care Unit (PACU).
Trial: NCT02575859
Drug: adjuvant HIPEC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Closed-abdomen HIPEC with cisplatin (25 mg/m2/l of perfusate) and mitomycin-C (3•3 mg/m2/l of perfusate) at 42•5°C for 60 minutes. Perfusate volume: 4-6 l.
Trial: NCT00067509
Drug: emergency contraception (estrogen/progesterone)
RxNorm normalized name: Emergency contraceptives
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00511901
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01558011
Drug: Capecitabine, Oxaliplatin, Docetaxel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Capecitabine: 500 mg film coated tablets; Oxaliplatin: 50 mg/ 10 ml; Docetaxel: 20 mg / 0.5ml vial.~Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.
Trial: NCT02976701
Drug: DLBS1033
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02976701
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02976701
Drug: Standard therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard therapy which consists of: aspirin enteric-coated tablet 1 x 80 mg and clopidogrel film-coated tablet 1 x 75 mg daily for four weeks will be given to both arms.
Trial: NCT04780347
Drug: Albumin-bound paclitaxel plus capecitabine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Albumin-bound paclitaxel plus capecitabine: Albumin-bound paclitaxel 260mg/m2, IV , D1, q3w； capecitabine 1000 mg/m2, PO，bid, D1-14,q3w.
Trial: NCT04780347
Drug: capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: capecitabine: capecitabine 1000 mg/m2, PO，bid, D1-14,q3w.
Trial: NCT02631447
Drug: LGX818
FDA approved: no
EMA approved: no
PMDA approved: no
Description: LGX818 450 mg p.o. od
Trial: NCT02631447
Drug: MEK162
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MEK162 45 mg p.o. bid
Trial: NCT02106767
Drug: Rosuvastatin
RxNorm normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Rosuvastatin 20mg po x1
Trial: NCT02106767
Drug: Rosuvastatin plus rifampin
RxNorm normalized name: Rifampin
DrugBank: Rifampin (DB01045)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Rifampin 600mg IV infused over 30 minutes followed by rosuvastatin 20mg PO x1
Trial: NCT01747161
Drug: Botulin toxin
RxNorm normalized name: Botulin toxin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 50 I.E. Botulin toxin. Injections in 6 spots of the vestibulum vaginae (3 sessions (every 6 weeks))
Trial: NCT00413972
Drug: ezetimibe with simvastatin
RxNorm normalized name: ezetimibe / simvastatin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ezetimibe 10 mg with Simvastatin 10 mg once daily for a total of eight weeks
Trial: NCT00413972
Drug: Ezetimibe with Simvastatin
RxNorm normalized name: ezetimibe / simvastatin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ezetimibe 10 mg with Simvastatin 20 mg once daily for a total of eight weeks
Trial: NCT00413972
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo once daily for a total of eight weeks
Trial: NCT01759407
Drug: Ropivicaine
RxNorm normalized name: Ropivicaine-Sufentanil Citrate
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01759407
Drug: Epinephrine
RxNorm normalized name: Epinephrine
DrugBank: Epinephrine (DB00668)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT04018599
Drug: 40 mg MSB11022
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dose, as a solution, administered subcutaneously, using a pre-filled syringe.
Trial: NCT02354768
Drug: Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone
RxNorm normalized name: loperamide hydrochloride Oral Tablet [Maalox Anti-Diarrheal]
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03749356
Drug: TacroBell SR cap.
FDA approved: no
EMA approved: no
PMDA approved: no
Description: * Orally, once-daily in the morning~* After first dose 0.2mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3\~12ng/ml for 0 to 3months and then at 3\~8ng/ml for 3 to 6months of study treatment.
Trial: NCT01070030
Drug: Aliskiren/Amlodipine (150/5 mg/day, 300/10 mg/day) , Aliskiren/Amlodipine/Hydrochlorothiazide (300/10/12.5 mg/day, 300/10/25 mg/day)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The patients were asked for 2 week run-in phase with atenolol 50 mg qd(once a day), followed by 4 schedule visits with 4-week interval until patient achieved BP goal. The maximum follow up was 16-week treatment. At visit 2, the patients started receiving Aliskiren/Amlodipine (150/5mg per day) for 4 weeks. At visit 3, if the patients did not achieve blood pressure (BP) goal, patients were up titrated to Aliskiren/Amlodipine (300/10 mg/day) for 4 weeks. At visit 4, if the patients did not achieve BP goal, HCT 12.5 mg/day was added to Aliskiren/Amlodipine/HCT (300/10/12.5 mg/day) for 4 weeks. Finally at visit 5, if the patients did not achieve BP goal, HCT was up titrated to Aliskiren/Amlodipine/HCT (300/10/25 mg/day) for 4 weeks until visit 6. Once the patients achieved BP goal at any visit, they completed the study.
Trial: NCT02331251
Drug: Liposomal Doxorubicin
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00956748
Drug: Ciprodex and 2% NAC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administer 3 to 5 drops tid for 14 days. Continue treatment for another 14 days if otorrhea persists.
Trial: NCT01848951
Drug: Epidural
RxNorm normalized name: Epidural 17g 3.5"
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The skin will be disinfected with 2% chlorhexidine. Under sterile technique, the epidural will be placed. Epidural catheter will be placed at thoracic vertebral levels T5 to T10. Level chosen as clinically indicated. The epidural solution should contain institution's standard solution of Bupivicaine 0.05% and hydromorphone 10 mcg/cc. However, solution type should be clinically indicated.
Trial: NCT00790322
Drug: SBG
RxNorm normalized name: PSBG - Pregnancy specific beta 1-glycoprotein
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Soluble beta-1,3/1,6-glucan is a solution for oral use
Trial: NCT01700504
Drug: Axillary lavage with gentamicin solution
RxNorm normalized name: gentamicin Injectable Solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution
Trial: NCT02728518
Drug: Nebulized Amikacin
RxNorm normalized name: Amikacin
DrugBank: Amikacin (DB00479)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 400mg twice daily nebulized amikacin
Trial: NCT02728518
Drug: Intravenous Amikacin
RxNorm normalized name: Amikacin
DrugBank: Amikacin (DB00479)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 20mg/kg once daily intravenous amikacin
Trial: NCT00379249
Drug: Rosuvastatin
RxNorm normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT03330119
Drug: Alternate Management
FDA approved: no
EMA approved: no
PMDA approved: no
Description: With the alternate management protocol, the pre-operative order set is the same, with the addition of a single preoperative dose of acetaminophen 1 g IV x1, gabapentin 600 mg PO x1, and ondansetron 8 mg IV x1. Post-operatively, patients receive the same ketorolac 30mg x 9 doses every 6 hours, as well as acetaminophen 975 mg every 6 hours, both given standing. These two are timed so the patient is receiving one of the two medications every 3 hours during their inpatient stay. After 9 doses of ketorolac, the patient receives 600mg of ibuprofen PO, also given standing, instead of the ketorolac. If the patient requires narcotics, they may receive them on an as needed basis. IV fluids are running at 80 cc/ hour. Patients are encouraged to ambulate, including the evening of the surgery, have their foley catheter removed 12 hours post-operatively, and can have a regular diet immediately.
Trial: NCT02593500
Drug: Budesonida Pulmictan® 200 µg
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01244009
Drug: MK-4827
RxNorm normalized name: vitamin MK 7
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles.
Trial: NCT00114556
Drug: zoledronic acid
RxNorm normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT04720443
Drug: NIP292 tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NIP292 (oral tablet at 10 mg) or placebo
Trial: NCT04720443
Drug: NIP292 tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NIP292 (oral tablet at 30 mg) or placebo
Trial: NCT04720443
Drug: NIP292 tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NIP292 (oral tablet at 100 mg) or placebo
Trial: NCT04720443
Drug: NIP292 tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NIP292 (oral tablet at 300 mg) or placebo
Trial: NCT01491529
Drug: AFQ056
FDA approved: no
EMA approved: no
PMDA approved: no
Description: AFQ056 will be supplied as oral modified release tablets in 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.~Patients will be randomized in two groups by amantadine status.~* Group 1: Patients are not permitted to take amantadine within 2 weeks prior to the BL1 visit.~* Group 2: Patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during the remainder of the study.)
Trial: NCT01491529
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo for AFQ056 will be supplied as oral tablets.
Trial: NCT04720443
Drug: NIP292 tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NIP292 (oral tablet at 500 mg) or placebo
Trial: NCT04720443
Drug: NIP292 tablets
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NIP292 (oral tablet at dosage 1) or placebo
Trial: NCT04720443
Drug: NIP292 tablets
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NIP292 (oral tablet at dosage 2) or placebo
Trial: NCT03318744
Drug: Placebo Oral Tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo resembling aspirin tablet will be be given to participants in control arm.
Trial: NCT01548404
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subcutaneous injection altered between back of arms, abdomen and upper thighs.
Trial: NCT00002331
Drug: Clarithromycin
RxNorm normalized name: Clarithromycin
DrugBank: Clarithromycin (DB01211)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT04461483
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TAK-935 placebo-matching tablets
Trial: NCT00649662
Drug: Cipro® XR Tablets 1000 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1000mg, single dose fasting
Trial: NCT01294423
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo for Dapagliflozin 5mg/10mg oral dose
Trial: NCT00861978
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Coated placebo tablets (batch no. 01010177) that were identical in shape, size, taste and color were administered orally twice daily (morning and evening) with some liquid for 8 weeks.
Trial: NCT02070133
Drug: Simvastatin
RxNorm normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Simvastatin 40 mg once a day during 12 weeks
Trial: NCT02070133
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo once a day during 12 weeks
Trial: NCT04027920
Drug: Shenghua Decoction
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Three days' shenghua decoction treatment
Trial: NCT01521949
Drug: Acai Juice Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 ounces of Acai Juice Product twice daily.
Trial: NCT00002521
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02401360
Drug: China Crest® Pro-health 7 Complete Toothpaste
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Crest® pro-health manual toothbrush Crest® pro-health gum protection rinse
Trial: NCT02401360
Drug: China Crest® Cavity Protection Toothpaste
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Crest® meliliangje manual toothbrush
Trial: NCT04635839
Drug: Standard Dose of Unfractionated Heparin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 5,000 units subcutaneous unfractionated heparin every 12 hours
Trial: NCT04121195
Drug: Dose escalation
RxNorm normalized name: PALFORZIA Initial Dose Escalation KIT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The trial will enrol virologically suppressed HIV infected volunteers who are stable on ATV/r and 2 NRTI containing ART following stringent screening to rule out evidence of renal, hepatic or gastrointestinal dysfunction which may affect the PK evaluation. A steady-state PK (PK1) sample collection shall be done on day 7 (+/-3) after enrolment. RIF will be added at standard dose (600 mg once daily) with a further PK evaluation 14 days later (PK2); due to the potential risk of sub therapeutic PI concentrations and emergence of HIV drug resistant strains, these individuals will be given DTG 50 mg twice daily for the duration of the dose-escalation study. ATV/r dose will be increased in a single step to the total modelled dose (PK3), given as twice daily doses. Once at maximum ATV/r dose, RIF will be increased to 1200 mg once a day for a further seven days (PK4). RIF will then be stopped, ATV/r stepped down to 300/100mg once a day and DTG continued for a further one week.
Trial: NCT00435591
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ampoule or premix bag
Trial: NCT04635839
Drug: Gestational Age-Based Dose of Unfractionated Heparin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: * First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours~* Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours~* Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Trial: NCT00210470
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Single i.v. injection of low-dose (300 mg/m2) on Day 1
Trial: NCT00210470
Drug: Indomethacin
RxNorm normalized name: Indomethacin
DrugBank: Indomethacin (DB00328)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 21 days of oral indomethacin, 25 mg. 3 times daily
Trial: NCT00210470
Drug: Zinc
RxNorm normalized name: Zinc
DrugBank: Zinc acetate (DB14487)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 21 days of zinc gluconate (65 mg) as part of an oral multivitamin
Trial: NCT01008293
Drug: VSL#3
RxNorm normalized name: VSL#3
FDA approved: no
EMA approved: no
PMDA approved: no
Description: VSL#3 (2 capsules bid.for 2 months, Each containing 112.5 billion viable lyophilized bacteria). Each capsule contains 4 strains of Lactobacillus (L. casei, L. plantarum, L. acidophilus, and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, L. breve, and B. infantis), and 1 strain of Streptococcus salivarius subsp. thermophilus (designated hereafter as S. thermophilus)
Trial: NCT03279263
Drug: MLR-1023
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MLR-1023 Tablets
Trial: NCT01614197
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.
Trial: NCT01614197
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: PATIENTS WITH CNS 1 COURSES 2, 4, 6, 8: Give intrathecally to patients who were CNS1 at study entry day 1 of each course at the doses listed below.~* Age 1 - 1.99 give 8 mg of methotrexate~* Age 2 - 2.99 give10 mg of methotrexate~* Age 3 - 8.99 give 12 mg of methotrexate~* Age ≥ 9 give 15 mg of methotrexate~PATIENTS WITH CNS 2 or 3 DISEASE~-COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 6 and then weekly until the patient is CNS 1.~COURSES 2-8: Give intrathecally to patients who were CNS 3 at study entry on day 1 of each course.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age
Trial: NCT01614197
Drug: Hydrocortisone
RxNorm normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Given with Methotrexate and Cytarabine for patients with CNS 2 or 3 disease.~COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 6 and then weekly until the patient is CNS 1.~COURSES 2-8: Give intrathecally to patients who were CNS 3 at study entry on day 1 of each course.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age
Trial: NCT02532400
Drug: Neoadjuvant endocrine therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Goserelin: 3.6mg, d1, hypodermic injection , q28d\*7 plus exemestane: 25mg, po, qd\*24w, or anastrozole: 1mg, po, qd\*24w
Trial: NCT00258063
Drug: EVRA® transdermal contraceptive patch containing 6 mg of norelgestromin and 0.60 mg of ethinyl estradiol (versus CILEST® tablets).
FDA approved: no
EMA approved: no
PMDA approved: no