TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02229578
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects in this group will receive a nonpyrogenic solution of isotonic saline (Solution B) sprayed over the donor site. Prior to spraying of the Solution B, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.
Study: NCT01327612
Drug: Modified FOLFOX6
Approvals — FDA: no, EMA: no, PMDA: no
Description: The mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m² administered as a 2-hour intravenous (IV) infusion on day 1 and leucovorin 400 mg/m² racemate or 200 mg/m² levo-leucovorin administered as a 2-hour infusion on day 1, followed by a loading dose of 5-fluorouracil (5-FU) 400 mg/m² IV bolus administered on day 1, then 5-FU 2400 mg/m² via ambulatory pump administered for a period of 46 to 48 hours every 14 days.
Study: NCT01646385
Drug: non-biologic anti-rheumatic drugs
Normalized name: Anti Bac
Approvals — FDA: no, EMA: no, PMDA: no
Description: use as per routine clinical practice (methotrexate, azathioprine, cyclophosphamide, cyclosporine, leflunomide, other)
Study: NCT02045290
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01013142
Drug: MN-221 (Dose Group 1)
Normalized name: Mn 2+
Approvals — FDA: no, EMA: no, PMDA: no
Description: i.v. infusion of MN-221 (300 mcg) or placebo over 1 hour
Study: NCT01013142
Drug: MN-221 (Dose Group 2)
Normalized name: Mn 2+
Approvals — FDA: no, EMA: no, PMDA: no
Description: i.v. infusion of MN-221 (600 mcg) or placebo over 1 hour
Study: NCT01013142
Drug: MN-221 (Dose Group 3)
Normalized name: Mn 2+
Approvals — FDA: no, EMA: no, PMDA: no
Description: i.v. infusion of MN-221 (1,200 mcg) or placebo over 1 hour
Study: NCT04042077
Drug: Tigecycline
Normalized name: Tigecycline
DrugBank: Tigecycline (DB00560)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Powder for solution for infusion 50 mg, TID, for 5 to 14 days
Study: NCT03004404
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT02552459
Drug: Sufentanil
Normalized name: Sufentanil
DrugBank: Sufentanil (DB00708)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: sufentanil 150μg， intravenous administration during post-operative 72 hours.
Study: NCT00180713
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Simvastatin 40mg od for 1 month, then 80mg od for 11 months
Study: NCT00180713
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablet once daily.
Study: NCT01238536
Drug: Epidural local anesthetic injection
Normalized name: Gelato Anesthetic
Approvals — FDA: no, EMA: no, PMDA: no
Description: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Study: NCT03077620
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.
Study: NCT01335295
Drug: Flavocoxid
Normalized name: Flavocoxid
Approvals — FDA: no, EMA: no, PMDA: no
Description: Flavocoxid capsules TTD 500 mg/die or 1000 mg/die for 1 year
Study: NCT01100047
Drug: AZD5069
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral suspension
Study: NCT01100047
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral suspension
Study: NCT00309608
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets once daily
Study: NCT00004430
Drug: prednisolone
Normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01080300
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sugar pill
Study: NCT00150618
Drug: SPD503 (1 mg)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00150618
Drug: SPD503 (2 mg)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00150618
Drug: SPD503 (3 mg)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00975221
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally following the same tiitration regimen as the experimental arm.
Study: NCT00150618
Drug: SPD503 (4 mg)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00150618
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04358341
Drug: DOXOrubicin Liposome Injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: 25 mg/m2 ivdrip every 14 days
Study: NCT04358341
Drug: 5fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 400mg/m2 iv bolus and 2400 mg/m2 civ 46h every 14 days
Study: NCT01364402
Drug: Saline 0.9%
Normalized name: CVS Saline 0.9% Nasal Mist
Approvals — FDA: no, EMA: no, PMDA: no
Description: normal saline intravenously
Study: NCT04296747
Drug: induction chemotherapy
Normalized name: human sputum, Bordetella pertussis infected
Approvals — FDA: no, EMA: no, PMDA: no
Description: Toripalimab 240mg, d1; docetaxel 75mg/m2 d1; cisplatin 75mg/m2 d1, q21d, for 2 cycles
Study: NCT00424567
Drug: Cultured Bone Marrow Tissue
Normalized name: Sus scrofa bone marrow preparation
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00422734
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo tablet taken by mouth once a day for 12 weeks
Study: NCT04530578
Drug: Heparin sodium
Normalized name: Heparin Sodium
DrugBank: Heparin (DB01109)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Nebulized Heparin every 8 hours plus Subcutaneous Enoxaparin every 24hours
Study: NCT01303250
Drug: balanced 6% hydroxyethylstarch 130/0.4
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fluid administration and optimization based on cardiac output findings during surgery.
Study: NCT01303250
Drug: balanced crystalloid
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fluid administration and optimization based on cardiac output findings during surgery.
Study: NCT03127670
Drug: Solanum melongena peel extract 0.05%
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered topically twice daily for 12 weeks
Study: NCT02688530
Drug: IV Saline
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00763451
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
Study: NCT00727506
Drug: BIBW 2992
Approvals — FDA: no, EMA: no, PMDA: no
Description: BIBW 2992 once daily
Study: NCT00107523
Drug: pravastatin
Normalized name: Pravastatin
DrugBank: Pravastatin (DB00175)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00953732
Drug: Lesion count
Normalized name: scabies lesion lysate (human)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.
Study: NCT02296892
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Inactive control arm
Study: NCT02342925
Drug: RG1662
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration twice daily
Study: NCT02254421
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo to match presatovir administered orally or via nasogastric tube
Study: NCT02690844
Drug: Mucolox® alone
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5mL Mucolox® TID. Mixture swished around mouth for 3 minutes then spat out.
Study: NCT00544232
Drug: Epirubicin, Cyclophosphamide, Paclitaxel, dabepoetin alfa
Approvals — FDA: no, EMA: no, PMDA: no
Description: Epirubicin (150 mg/m2) d1, q14d - 3× followed by paclitaxel (225 mg/m2) d1, q14d - 3×, followed by CMF d1/d8, q28d - 3× Obligatory pegfilgratim 6 mg, subcutaneous injection on day 2 after epirubicin and/or paclitaxel and secondary prophylactic dose after CMF~+/- Darbepoetin alfa 1 × 4.5 μg/kg of body weight every two weeks with the start of the first dose of epirubicin (day 1) until 14 days after the last dose of CMF
Study: NCT02994771
Drug: Lymfactin® [1 x 10E11 vp]
Approvals — FDA: no, EMA: no, PMDA: no
Description: Lymfactin® \[1 x 10E11 vp\] will be administered as a single dose via perinodal injection in a volume of 2 mL.
Study: NCT00450229
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given PO
Study: NCT03344068
Drug: Chemotherapy
Normalized name: Chemotherapy Glove SML
Approvals — FDA: no, EMA: no, PMDA: no
Description: Nedaplatin 80mg/m2 d1+5-fluouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.
Study: NCT00594906
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
Study: NCT01033773
Drug: Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications.
Study: NCT02523690
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral or enteral, single dose. Oral or enteral, single dose two days later
Study: NCT00245960
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01791972
Drug: Placebo Spiromax
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) delivering placebo to match the experimental drug. Participants received one dose of two inhalations.
Study: NCT00245375
Drug: Tylenol #3
Normalized name: Tylenol #3 Oral Tablet
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00245375
Drug: Combination Tylenol and Ibuprofen
Normalized name: ibuprofen, combinations
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00632502
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo capsule to match navarixin to be taken by mouth once daily in the morning for 4 weeks.
Study: NCT00632502
Drug: Rescue medication
Normalized name: ALLERGENIC EXTRACT, MEADOW FESCUE POLLEN
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms
Study: NCT00570908
Drug: capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: concurrently
Study: NCT02193490
Drug: DNase
Normalized name: DNase
Approvals — FDA: no, EMA: no, PMDA: no
Description: DNase 0.1% eye drops four times a day for 8 weeks
Study: NCT02193490
Drug: Vehicle
Normalized name: Drug vehicle
Approvals — FDA: no, EMA: no, PMDA: no
Description: Drug vehicle eye drops four times a day for 8 weeks
Study: NCT03694977
Drug: MCS110/PDR001 combination
Approvals — FDA: no, EMA: no, PMDA: no
Description: MCS110 7.5mg/kg iv since 1st cycle PDR001 300 mg iv since 2nd cycle Q 3weeks
Study: NCT01129336
Drug: Zoledronic acid
Normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Patients with no bone metastasis (n=150) will receive Standard therapy plus Zoledronic acid administration 4 mg IV monthly during Months 1-18.
Study: NCT03525574
Drug: ELX/TEZ/IVA
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fixed-dose combination (FDC) tablet for oral administration.
Study: NCT01254565
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered intravenously at the end of hemodialysis
Study: NCT03989635
Drug: QAW039
Approvals — FDA: no, EMA: no, PMDA: no
Description: QAW039 450mg
Study: NCT00220623
Drug: antidepressant medications, flexible drug choice
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04262206
Drug: Placebo oral tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
Study: NCT01301599
Drug: alpha blocker monotherapy
Normalized name: ALPHA BLOCKERS/RELATED
Approvals — FDA: no, EMA: no, PMDA: no
Description: alpha blocker monotherapy group
Study: NCT01301599
Drug: 5 alpha reductase inhibitor monotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5 alpha reductase inhibitor monotherapy
Study: NCT02579772
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo: 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
Study: NCT02643147
Drug: Conventional Strategy
Approvals — FDA: no, EMA: no, PMDA: no
Description: The dosage of loop diuretics is done according to the presence of symptoms and signs of systemic congestion and current recommendations
Study: NCT04058834
Drug: NNC0385-0434
Approvals — FDA: no, EMA: no, PMDA: no
Description: Healthy volunteers and patients will receive one injection s.c. (subcutaneously, under the skin)
Study: NCT04058834
Drug: Placebo (NNC0385-0434)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Healthy volunteers will receive one injection s.c.
Study: NCT00707499
Drug: BMS747158
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single dose administration.
Study: NCT00379769
Drug: Sulfonylurea
Normalized name: Sulfonylurea
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sulfonylurea (SU) maximum permitted daily dose
Study: NCT01115686
Drug: Branched-chain aminoacids
Normalized name: Machilus thunbergii branch extract
Approvals — FDA: no, EMA: no, PMDA: no
Description: Branched-chain aminoacids will be orally administered in the form of capsules, at the rate of a capsule for physical 7 Kilograms weighty and a day. Every capsule containing 375 milligrams of branched-chain aminoacids.~The treatment will last 3 weeks.
Study: NCT01115686
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be orally administered in the form of capsules, at the rate of a capsule for physical 7 Kilograms weighty and a day.~The treatment will last 3 weeks.
Study: NCT00837590
Drug: Chronic salsalate
Normalized name: Salsalate
DrugBank: Salsalate (DB01399)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
Study: NCT00837590
Drug: Acute Salsalate
Normalized name: Salsalate
DrugBank: Salsalate (DB01399)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Subjects will receive a single oral dose of 2 gram of oral salsalate
Study: NCT00486668
Drug: doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 60 mg/m2 IV every 21 days for cycles 1-4
Study: NCT00486668
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 600 mg/m2 IV every 21 days for cycles 1-4
Study: NCT01986114
Drug: SM-13496
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00791921
Drug: Placebo of CDP870
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo given every 2 weeks until Week22 (SC)
Study: NCT00760513
Drug: Placebo oral capsule
Normalized name: Placebo Oral Capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: 4 grammes daily, oral capsule (olive oil)
Study: NCT00171236
Drug: Fluvastatin
Normalized name: Fluvastatin
DrugBank: Fluvastatin (DB01095)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01053247
Drug: 0416
Normalized name: CATH SET,FOLEY CATH 16FR 5ML B#300416A
Approvals — FDA: no, EMA: no, PMDA: no
Description: Topical 0416 test product applied twice daily for 2 weeks
Study: NCT01053247
Drug: Vehicle of 0416 test product
Approvals — FDA: no, EMA: no, PMDA: no
Description: Vehicle of 0416 test product applied twice daily for 2 weeks
Study: NCT04672512
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo matching CORT125329 lipid capsule formulation 1 or 2 for oral administration
Study: NCT01864863
Drug: HGP1206
Approvals — FDA: no, EMA: no, PMDA: no
Description: One Bosentan 125 mg tablet
Study: NCT00717678
Drug: Prograf-XL
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral
Study: NCT02061878
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The subjects will be administered three (3) capsules of Avicel PH on a twice daily basis (450 mg/day) for five days.
Study: NCT00068432
Drug: Celecoxib
Normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks.
Study: NCT00645177
Drug: Placebo for ABT-869
Normalized name: ABT-925
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle
Study: NCT04276259
Drug: Oral Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral placebo: to match the oral naltrexone.
Study: NCT04276259
Drug: IM Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: IM saline placebo: to match the i.v. buprenorphine.
Study: NCT00444275
Drug: Xolaam®
Approvals — FDA: no, EMA: no, PMDA: no
Description: This randomized study was conducted on parallel groups and included two phases:~* One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision~* One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed
Study: NCT02808975
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subcutaneous injections administered as described in arm description
Study: NCT00334867
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00334867
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT01561482
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The simvastatin dose at treatment initiation will be 20 mg once daily (dose level -1), taken at bedtime for 2 weeks. After these 2 weeks, the subject will have blood work and, if no AST/ALT/CPK elevation grade greater than 1, will be escalated to 40 mg once daily (dose level 0), taken at bedtime. If AST or ALT or CPK elevation grade greater than 1 during the first 2 weeks, the subject will be evaluated every 2 weeks until resolution of toxicity to grade less than or equal to 1, and then the simvastatin dose will be increased to dose level 0.
Study: NCT01458522
Drug: fPHT
Approvals — FDA: no, EMA: no, PMDA: no
Description: If after initial treatment with fPHT any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug, ie, the one not originally administered: the subject subsequently has another seizure within 24 hours following the 2-hour post-rebolus observation-only period; the subject does not receive a rebolus but has a seizure within 24 hours following the 2 hour post-bolus observation-only period; the subject experiences an AE that precludes further use of the first study drug.~If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary), and study assessments with the second drug, beginning with the Baseline assessments.
Study: NCT03111511
Drug: Drospirenone/Ethinylestradiol
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single dose of drospirenone/ethinylestradiol 3 mg/0.02 mg (OC) tablets on Days 1 and 21.
Study: NCT03251092
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT00848796
Drug: Heparin Leo and Hepalean
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dosage based on Heparin does response curve obtained from the Medtronic HMS plus
Study: NCT01226732
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Study: NCT00419302
Drug: Technosphere/Insulin
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00949377
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Normal saline
Study: NCT01160120
Drug: generic FDC of TDF/3TC/EFV
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients who were on individual TDF 3TC and EFV regimen before baseline will undergo TDM at baseline. Therapeutic drug monitoring (TDM) of generic FDC of TDF/3TC/EFV will be done after 4 weeks, to ensure steady state. At baseline and week 4 safety data will be obtained. In order to assess the efficacy and the long term safety of this drug, at week 12, 24 and 48 viral load, CD4 and safety parameters will be obtained.
Study: NCT03664037
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: each patient received 100 mL 0.9% NS IVI over 15 min (Placebo) 2 hours preoperatively
Study: NCT01429519
Drug: RPh201, botanical drug product
Approvals — FDA: no, EMA: no, PMDA: no
Description: topical, three times per week for a period of 4 consecutive weeks, followed by a single follow up visit 3 months post end of the last treatment day
Study: NCT03708237
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: Opaque gel capsules filled with methylcellulose 1500 filler
Study: NCT02833805
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily
Study: NCT03587766
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Drug: fexinidazole
Study: NCT01551303
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matched nasal spray placebo
Study: NCT01572324
Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine
Approvals — FDA: no, EMA: no, PMDA: no
Description: HAI of Oxaliplatin and Fluorouracil: Oxaliplatin 130mg/m2 in split daily doses for 3 days, Fluorouracil 3000 mg/m2 in split daily doses for 3 days. Intraarterial Oxaliplatin plus intravenous Leucovorin 200 mg/m2 simultaneously over 2 hours followed by intraarterial Fluorouracil over 22 hours on Days 1-3 of each cycle, repeat every 21 days. After 4-6 cycles of HAI, maintenance treatment continue, Maintenance of Oral capecitabine 1,000 mg/m2 twice a day from days 1-14, Cycles were repeated every 21 days.
Study: NCT03436160
Drug: WR826647
Approvals — FDA: no, EMA: no, PMDA: no
Description: 100 mcg Carbon-14 radio labeled WR826647 at an exposure no greater than 250 nCi per dose, administered both IV (bolus) and PO with a six half-life wash-out period between IV and PO administration. Interim analyses will be done at Day 14 following the IV dosing groups in order to assess half-lives of the three compounds to ensure the wash-out period between IV and PO dosing is at least six half-lives long.