AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT02751996
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04003441
Drug: DWP14012 tablet A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A
Trial: NCT04003441
Drug: DWP14012 tablet B
RxNorm normalized name: ACTION B-100 TAB
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B
Trial: NCT03481036
Drug: Direct Acting Antivirals
RxNorm normalized name: DIRECT ACTING ANTIVIRALS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sofosbuvir and Daclatasvir
Trial: NCT03481036
Drug: DAAs in Cirrhotics Genotype 2/3
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sofosbuvir and Daclatasvir with weight based ribavirin
Trial: NCT03481036
Drug: DAAs in Cirrhotics Genotye 1,4,5,6
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sofosbuvir and Ledipasvir with weight based ribavirin
Trial: NCT00268164
Drug: lactobacilus acidophilus & bifidobacterium animalis/lactis
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03875261
Drug: Cannabinoid treatment
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants are treated with cannabinoid derivates with a dose between 1 to 12 puffs, each puffs contains 2,7 mg of delta-9-tetrahidrocannabinol and 2,5 mg of cannabidiol.
Trial: NCT00176332
Drug: rosuvastatin
RxNorm normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01923818
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04598607
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3, 4 or 5 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3\~8.
Trial: NCT00634166
Drug: Topical Antimicrobial/Antifungal Medications
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin; Nystatin; Fluconazole; Piperacillin Sodium with Tazobactam.
Trial: NCT02656121
Drug: Ovulatory Agent
FDA approved: no
EMA approved: no
PMDA approved: no
Description: only Clomophine Citrate
Trial: NCT00219271
Drug: Zoledronic acid
RxNorm normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT02570854
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will be dosed with a matching placebo (vehicle control) via up to 30 minutes intravenous infusion.
Trial: NCT01740986
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablet, b.i.d
Trial: NCT00819221
Drug: AZD2281
FDA approved: no
EMA approved: no
PMDA approved: no
Description: capsules, oral, bd, 2 months
Trial: NCT00819221
Drug: liposomal doxorubicin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: once every 4 weeks at 40mg/m2
Trial: NCT02016560
Drug: florbetapir F 18
RxNorm normalized name: Florbetapir F 18
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02423577
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo dry powder administered by nasal inhalation
Trial: NCT01341405
Drug: Celecoxib
RxNorm normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: capsule, celecoxib 200 mg, once daily for 28 days
Trial: NCT01500005
Drug: Baby D3 drops
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2000-4000 iu per day
Trial: NCT02615366
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00818298
Drug: ziprazidone
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Up to and including the time of the third PET scan, subjects will be titrated to 60 mg BID of ziprazidone. Thereafter they will receive 20-80 mg BID of ziprazidone, according to clinical effectiveness and side effects.
Trial: NCT00214682
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A placebo tablet was the attention control intervention for the folic acid + vitamin B12 intervention group. Participants received 1 bottle x 200 tablets in 6-month supplies at baseline, 6 months, 12 months, and 18 months. Adherence was monitored by telephone interviews (6 weeks, 6-, 12-, and 24 months) and 10 brief telephone tracking calls (1 - 5 weeks, and 4-, 8-, 13-, 18-, and 22-months) during which participants counted their left-over tablets.
Trial: NCT01181830
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: administration of 8.1 mmol bid of placebo
Trial: NCT03310593
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo intervention.
Trial: NCT02156596
Drug: IV Serum Saline
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 50 ml of SS is given by IV root over 30 minutes
Trial: NCT02156596
Drug: Nebulised Serum Saline
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3 nebulisations of 5ml SS each are given over 30 minutes
Trial: NCT02194205
Drug: COMBIVENT HFA
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02194205
Drug: Placebo HFA
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02194205
Drug: COMBIVENT CFC
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02194205
Drug: Placebo CFC
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01103011
Drug: ND0611
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Continuous delivery of ND0611
Trial: NCT00452543
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo, 2 capsules PO TID, for 12 weeks
Trial: NCT01103011
Drug: ND0611
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Solution of ND0611 delivered continuously
Trial: NCT00996216
Drug: Antiviral therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.
Trial: NCT01852110
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo to MK-7622 capsule
Trial: NCT01852110
Drug: AChEI
RxNorm normalized name: By Ache
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One of the following AChEIs, as prescribed by the participant's primary care physician:~Donepezil: 10 mg total daily dose, administered orally~Rivastigmine: 9.5 or 13.3 mg/24 hours, administered by transdermal patch; or 6-12 mg total daily dose administered orally~Galantamine: 16-24 mg total daily dose, administered orally
Trial: NCT00709514
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT02413008
Drug: estriol
RxNorm normalized name: Estriol
DrugBank: Estriol (DB04573)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.005% estriol vaginal gel
Trial: NCT02413008
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo vaginal gel
Trial: NCT01385423
Drug: Preparative Regimen
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fludarabine 25 mg/m\^2 x 5 days start day -6, Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (\*if \< 4 months from prior transplant, omit day -4 dose)
Trial: NCT00299455
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.
Trial: NCT02026479
Drug: Ginaton
RxNorm normalized name: Genaton
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 40mg/pill, 3times/day,oral
Trial: NCT01590199
Drug: RAD001
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01590199
Drug: SOM230
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01437722
Drug: 1% SPL7013 Gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: vaginal gel
Trial: NCT01437722
Drug: 3% SPL7013 Gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: vaginal gel
Trial: NCT01437722
Drug: placebo gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: vaginal gel
Trial: NCT02085317
Drug: acetylcholine Iontophoresis
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Using a protocol similar to the one developed by Rossi and co-workers (Rossi et al., 2008), ACh (Acetylcholine - Sigma-Aldrich, St. Louis, USA) was delivered by 9 iontophoretic pulses of 0.1 mA for 20 s with 60 s interval between pulses using a drug delivery electrode filled with 0.1 ml of 1% ACh solution, attached to the dorsal aspect of the second left finger by a double-sided adhesive disc.
Trial: NCT01516515
Drug: Vehicle gel
RxNorm normalized name: vehicle gel base no.61
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo
Trial: NCT01516515
Drug: SR-T100 with 2.3% of SM
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2.3% of SM in Solanum undatum plant extract
Trial: NCT00391404
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT01062360
Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine
RxNorm normalized name: ACETYLSALICYLIC ACID
DrugBank: Acetylsalicylic acid (DB00945)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Single oral dose of 1 to 2 Aspirin Complex sachets, each containing granules of 500 mg Acetylsalicylic Acid (ASA) and 30 mg Pseudoephedrine (PSE), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Trial: NCT01062360
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
RxNorm normalized name: ACETYLSALICYLIC ACID
DrugBank: Acetylsalicylic acid (DB00945)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Single oral dose of 1 to 2 sachets Acetylsalicylic Acid, each containing granules of 500 mg Acetylsalicylic Acid (ASA), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Trial: NCT01062360
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single oral dose of 1 to 2 sachets, each containing Placebo granules, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Trial: NCT00760578
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Once daily, oral
Trial: NCT02828072
Drug: usual drug therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02989194
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single intravenous infusion of placebo
Trial: NCT00107445
Drug: EF5
RxNorm normalized name: Hb 76(EF5), Met-thr
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT02583698
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04687878
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: twice a day, intranasally, every day for 12 weeks
Trial: NCT04525664
Drug: Clarithromycin 500mg
RxNorm normalized name: CLARITHROMYCIN 500MG TAB
DrugBank: Clarithromycin (DB01211)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 500 mg per os twice daily for 14 consecutive days.
Trial: NCT01070745
Drug: Indomethacin
RxNorm normalized name: Indomethacin
DrugBank: Indomethacin (DB00328)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Three doses of intravenous (IV) indomethacin at 0.2 mg/kg/dose given over 30 minutes, at intervals of 12 hours
Trial: NCT01070745
Drug: Ibuprofen
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 10 mg/kg infused over 30 minutes, followed by two doses of 5mg/kg each at 24 hour intervals
Trial: NCT00903695
Drug: Memory XL
FDA approved: no
EMA approved: no
PMDA approved: no
Description: An over-the-counter vitamin nutriceutical patented by Univ. of Mass. that contains folic acid 400 mg, Vit. B12 6 ug, alpha-tocopherol 30 IU, S-adenosyl methionine (SAM) 400 mg, N-acetyl cysteine (NAC) 600 mg, \& acetyl-L-carnitine (ALCAR) 500 mg; 2 pills per day for 12 months
Trial: NCT00903695
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo comparator
Trial: NCT00351117
Drug: Lactose
RxNorm normalized name: Lactose
DrugBank: Lactose (DB04465)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: lactose in gelatin capsule that same as St. John's wort
Trial: NCT01082120
Drug: AZD1656
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablets orally, twice daily for 10 days
Trial: NCT03355027
Drug: Rosuvastatin 20Mg Tablet
RxNorm normalized name: rosuvastatin 20 MG
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients will be instructed to take once daily at night. Rosuvastatin only to be prescribed if atorvastatin and simvastatin are not previously tolerated. Patient may be required to complete a 4 week run-in period on a statin prior to entering the study (dependent on eligibility)
Trial: NCT03355027
Drug: Rosuvastatin 40Mg Tablet
RxNorm normalized name: rosuvastatin 40 MG
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients will be instructed to take once daily at night. Rosuvastatin only to be prescribed if atorvastatin and simvastatin are not previously tolerated. Patient may be required to complete a 4 week run-in period on a statin prior to entering the study (dependent on eligibility)
Trial: NCT01011634
Drug: Intravenous moderate sedation versus oral medication
RxNorm normalized name: Tavist Non-Sedating
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg)
Trial: NCT01102400
Drug: MEDI-575
RxNorm normalized name: Medi-Lyte
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MEDI-575 will be administered weekly or every 3 weeks as IV infusion as part of a 21-day treatment cycle. One or two doses will be selected for expansion part
Trial: NCT03045627
Drug: AraC
RxNorm normalized name: Carac
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: ARA-C subcutaneously in a 12-hour infusion on days 1 through 14
Trial: NCT03045627
Drug: Peg-G-CSF
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PEG-G-CSF 6mg subcutaneously on days 0.
Trial: NCT02929927
Drug: 2.5%NaClO
FDA approved: no
EMA approved: no
PMDA approved: no
Description: use 2.5% NaClO as irrigants
Trial: NCT00166114
Drug: Desipramine
RxNorm normalized name: Desipramine
DrugBank: Desipramine (DB01151)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
Trial: NCT01601626
Drug: Pyridoxine
RxNorm normalized name: PYRIDOXINE
DrugBank: Pyridoxine phosphate (DB02209)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 25 mg orally once daily from entry to Week 24.
Trial: NCT01572454
Drug: Remifentanil infusion
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery
Trial: NCT00892749
Drug: ASP1585
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral
Trial: NCT04629170
Drug: SYNB8802
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SYNB8802 is formulated as a nonsterile solution intended for oral administration
Trial: NCT03549897
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo Product
Trial: NCT03549897
Drug: 90 mcg Reference Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE \[TEVA RESPIRATORY, LLC\]
Trial: NCT01380873
Drug: Period I : HKB0701, Period II : HKB0701 and SLM0807, Period III : CJ30001
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01380873
Drug: Period I : HKB0701 and SLM0807, Period II : CJ30001, Period III : HKB0701
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01380873
Drug: Period I : CJ30001, Period II : HKB0701, Period III : HKB0701 and SLM0807
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03251768
Drug: rHSA-GCSF 2.4mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Human Serum Albumin GCSF 2.4mg at day 3 and day 7
Trial: NCT03549897
Drug: 180 mcg Reference Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE \[TEVA RESPIRATORY, LLC\]
Trial: NCT03549897
Drug: 90 mcg Test Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 90 mcg Test Product - ALBUTEROL SULFATE HFA \[AMNEAL IRELAND LIMITED\]
Trial: NCT03355027
Drug: Simvastatin 80mg
RxNorm normalized name: SIMVASTATIN 80MG TAB
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patients will be instructed to take once daily at night. Patient may be required to complete a 4 week run-in period on a statin prior to entering the study (dependent on eligibility)
Trial: NCT01654367
Drug: Zoledronic Acid and Aromatase Inhibitors
RxNorm normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy
Trial: NCT01674270
Drug: LHRH Agonist
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00777478
Drug: capiri-sutent
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A dose escalating study in a 3 + 3 design will be performed. At MTD dose 14 additional patients will be treated. First, the optimal dose of sunitinib in a continuous schedule will be determined, thereafter, further dose escalation of capecitabine and irinotecan will be investigated.
Trial: NCT03905603
Drug: rhCG
FDA approved: no
EMA approved: no
PMDA approved: no
Description: rhCG (Ovidrel) 250 mcg will be given once during the study.
Trial: NCT01613326
Drug: Placebo to NVA237
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo to NVA237 50 μg once a day delivered via SDDPI
Trial: NCT00361738
Drug: AVE2268
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02245828
Drug: QCC374
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single and multiple ascending doses of QCC374
Trial: NCT02245828
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo comparator
Trial: NCT02200081
Drug: MGN1703
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00857558
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: orally administration once a day for 12 weeks
Trial: NCT01526135
Drug: mFolfirinox
FDA approved: no
EMA approved: no
PMDA approved: no
Description: mFolfirinox every 14 days, 12 cycles, 24 weeks.~mFolfirinox : Oxaliplatin (Eloxatin®) 85 mg/m² D1 over 2 hours, followed by Irinotecan (Campto®) 150 mg/m² D1 over 90 minutes to begin 30 min. after the Folinic acid infusion is started.~Folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid is used), IV infusion over 2 hours.~5-FU 2.4 g/m² IV continuous infusion over 46 hours (1200 mg/m²/ day)
Trial: NCT04162210
Drug: Pom/dex (Pomalidomide plus low dose Dexamethasone)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pomalidomide and Dexamethasone will be administered.
Trial: NCT01323205
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo capsule (s) orally twice daily with a meal for 4 weeks.
Trial: NCT01323205
Drug: Antipsychotic medication
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol Hydrochloride, Clotiapine, Pipamperone Hydrochloride, Benperidol, Flupentixol, Fluphenazine Decanoate, Melperone Hydrochloride, or Chlorpromazine Hydrochloride) will be continued in Part B.
Trial: NCT03803267
Drug: Fentanyl NCS
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Fentanyl (1µg/Kg)
Trial: NCT03803267
Drug: Anesthesia Maintenance
RxNorm normalized name: Dental Resources Perio Maintenance Rinse
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhalational isoflurane in oxygen/air mixture
Trial: NCT00993707
Drug: CTX-100 (formerly ETX-100) (hyaluronic acid)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3 mL of either 0.01%, 0.03% CTX-100 (formerly ETX-100), or placebo will be dispensed into the PARI LC STAR nebulizer and inhaled using the PARI Ultra II compressors.~Number of cycles: if the study drug (0.01% CTX-100 Inhalation Solution or placebo) bid is well tolerated in the first cohort, the second cohort of subjects will begin dosing with 0.03% CTX-100 Inhalation Solution or placebo in the same manner as the first cohort.
Trial: NCT03803267
Drug: Muscle Relaxation
RxNorm normalized name: ActivOn Joint & Muscle
FDA approved: no
EMA approved: no
PMDA approved: no
Description: atracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia
Trial: NCT04370431
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo control for Part A of the study
Trial: NCT04370431
Drug: TTYP01, 60 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TTYP01 oral tablets (30 mg edaravone per tablet)
Trial: NCT04370431
Drug: TTYP01, 120 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TTYP01 oral tablets (30 mg edaravone per tablet)
Trial: NCT04370431
Drug: Radicut® (ampoule), 30 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: An intravenous dose of edaravone injection, containing 30 mg edaravone in a 20 mL ampoule, will be administered at a dose of 30 mg over 30 minutes
Trial: NCT04370431
Drug: Radicut® (bag) , 60 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: An intravenous dose of edaravone injection, containing 30 mg edaravone in a 100 mL injection bag, will be administered at a dose of 60 mg over 60 minutes
Trial: NCT04370431
Drug: TTYP01, up to 120 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TTYP01 oral tablets (30 mg edaravone per tablet). The fixed oral dose level of TTYP01 will depend on the results obtained in Part B of the study (no more than 120 mg)