TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00005979
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00005979
Drug: leucovorin calcium
Normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01092221
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo 1 capsule, 300 mg, BID
Study: NCT01597739
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Form=capsule; route=oral use; twice daily.
Study: NCT02612246
Drug: GLPG1972 single ascending doses
Approvals — FDA: no, EMA: no, PMDA: no
Description: single dose, oral solution
Study: NCT02612246
Drug: Placebo single dose
Approvals — FDA: no, EMA: no, PMDA: no
Description: single dose, oral solution, matching placebo
Study: NCT02612246
Drug: Placebo multiple doses
Approvals — FDA: no, EMA: no, PMDA: no
Description: multiple doses, daily for 14 days, oral solution
Study: NCT02141321
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00624845
Drug: OMS103HP
Approvals — FDA: no, EMA: no, PMDA: no
Description: Maximum 6 bags of OMS103HP irrigation solution
Study: NCT00624845
Drug: Vehicle
Normalized name: Drug vehicle
Approvals — FDA: no, EMA: no, PMDA: no
Description: Maximum of 6 bags of vehicle irrigation solution
Study: NCT00828282
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Treatment will be administered on an outpatient basis. Subjects will be given 7.5 mg/kg twice daily of Simvastatin for 7 days on a 21-day cycle with a goal of 6 cycles.
Study: NCT01710033
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tables twice daily (BID) for 28 days
Study: NCT01710033
Drug: CP-690,550 5 mg BID
Approvals — FDA: no, EMA: no, PMDA: no
Description: CP-690,550 5 mg BID for 28 days
Study: NCT01710033
Drug: CP-690,550 15 mg BID
Approvals — FDA: no, EMA: no, PMDA: no
Description: CP-690,550 15 mg BID for 28 days
Study: NCT01710033
Drug: CP-690,550 30 mg BID
Approvals — FDA: no, EMA: no, PMDA: no
Description: CP-690,550 30 mg BID for 28 days
Study: NCT04171687
Drug: RAPA113
Approvals — FDA: no, EMA: no, PMDA: no
Description: RAPA113 tablet
Study: NCT05795907
Drug: SAR443820
Approvals — FDA: no, EMA: no, PMDA: no
Description: Capsule / Oral
Study: NCT05795907
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching Capsule / Oral
Study: NCT01282073
Drug: Mycophenolate mofetil, low dose steroid
Approvals — FDA: no, EMA: no, PMDA: no
Description: Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 \~ 1000 mg bid per day (more than 50kg)~Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day~Duration: 48 weeks
Study: NCT00671307
Drug: rhu-pGelsolin
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV formulation of recombinant plasma gelsolin formulated as 10 mg/ml given as a single IV infusion over 1 hour
Study: NCT02491879
Drug: Ketoprofen
Normalized name: Ketoprofen
DrugBank: Ketoprofen (DB01009)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 2.5% Ketoprofen gel with a 2 g local use
Study: NCT02004626
Drug: Kollagenase
Approvals — FDA: no, EMA: no, PMDA: no
Description: Conduction of security tests: complete coagulation and glycosylated hemoglobin. Volunteers in childbearing age, with β-HCG (human chorionic gonadotropin) test.~Verification of anthropometric data, clinical evaluation, PU evaluation, randomization and treatment start.~Wash the wound with 0.9 % sterile saline solution; Apply of the investigational product directly in the devitalized tissue (necrotic tissue and Slough).~Cover the wound with sterile gauze and dry transparent film. The procedures for the exchange of bandages must be done every day, twice a day until the total debridement of devitalized tissue.~Photographic records.
Study: NCT01425814
Drug: LAS100977
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dry powder inhalation,Once daily, single dose
Study: NCT01425814
Drug: Reference
Normalized name: Loreal Preference Dark Auburn 4R
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dry powder inhalation (capsule),single dose
Study: NCT01425814
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose
Study: NCT03461718
Drug: Fentanyl
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Part of standard sedation regimen
Study: NCT00002529
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: cyclophosphamide 600 mg/m2 i.v. day 1) every 21 days
Study: NCT00002529
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: doxorubicin 60 mg/m2 i.v. day 1) every 21 days, intravenous.
Study: NCT00671307
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Vehicle control given as IV infusion over 1 hour
Study: NCT04276207
Drug: LY900014
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered by CSII
Study: NCT01697111
Drug: EE20/DRSP(BAY86-5300)
Approvals — FDA: no, EMA: no, PMDA: no
Description: One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day
Study: NCT01697111
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: One tablet (no active ingredient) / day and one tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day, for the first 24 weeks and the later 28 weeks, respectively
Study: NCT04943237
Drug: Anti-TNF agents
Normalized name: Anti Bac
Approvals — FDA: no, EMA: no, PMDA: no
Description: Group of patients using anti-TNF for the last 5 years.
Study: NCT04943237
Drug: Conventional therapy users for the last 5 years
Approvals — FDA: no, EMA: no, PMDA: no
Description: Group of patients not using anti-TNF. Group of patients using conventional therapy (non -steroid anti-inflammatory drugs and/or salazopyrin) for the last 5 years
Study: NCT01263119
Drug: LY2216684
Approvals — FDA: no, EMA: no, PMDA: no
Description: 18-mg LY2216684 oral dose
Study: NCT03101800
Drug: Azathioprine and Allopurinol
Normalized name: Azathioprine
DrugBank: Azathioprine (DB00993)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Low dose Azathioprine in combination with allopurinol 100 mg for 1 year
Study: NCT03101800
Drug: Azathioprine
Normalized name: Azathioprine
DrugBank: Azathioprine (DB00993)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Standard weight based azathioprine dosage
Study: NCT02138825
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Inactive dosed at 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration for 26 weeks
Study: NCT02415556
Drug: Regular Human Insulin
Normalized name: insulin, regular, human
Approvals — FDA: no, EMA: no, PMDA: no
Description: Regular human insulin 40 IU daily over 24 weeks
Study: NCT02415556
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intranasal sterile saline 40 IU daily over 24 weeks
Study: NCT01752049
Drug: placebo saline drops
Approvals — FDA: no, EMA: no, PMDA: no
Description: Applied twice daily for 12 weeks (84 days) or until disappearance of lesions to 1 cutaneous telangiectasias per patient.
Study: NCT01195974
Drug: GSK2248761
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200 mg GSK2248761 taken on Days 1 - 10 or Days 12 - 21
Study: NCT01020357
Drug: Caffeine citrate injection
Normalized name: Caffeine Citrate Injection
DrugBank: Caffeine (DB00201)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Loading dose: 20 mg/kg administered over at least 30 minutes via IV infusion or over at least 10 minutes via slow IV injection.~Daily maintenance dose (to commence at least 24 hours after loading dose): 5 mg/kg, administered over at least 10 minutes via IV infusion, or over at least 5 minutes via slow IV injection. Maintenance dose to be adjusted for body weight every 7 days. If indicated, maintenance dose may be increased to a maximum of 10 mg/kg. May be given orally once full enteral feeds are established.~Duration of treatment: discontinue after infant has tolerated at least 5 consecutive days without positive pressure support AND when the infant is judged by the attending clinician to be no longer a candidate for methylxanthine therapy.
Study: NCT01020357
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: normal saline
Study: NCT02429817
Drug: Technetium-99m - Diethylenetriaminepentaacetic acid
Approvals — FDA: no, EMA: no, PMDA: no
Description: 99mTc-DTPA solution placed on the nebulizer reservoir
Study: NCT00998257
Drug: EE20/DRSP (YAZ, BAY86-5300)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients under daily life treatment with YAZ according to local drug information.
Study: NCT02900430
Drug: Patients with antifungal prophylaxis
Approvals — FDA: no, EMA: no, PMDA: no
Description: Hospitalized patients between 2012 and 2015 received Posaconazole prophylaxis during neutropenia period induced by induction or salvage chemotherapy.
Study: NCT01475721
Drug: ADVAIR 100/50mcg
Approvals — FDA: no, EMA: no, PMDA: no
Description: fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
Study: NCT01475721
Drug: ADVAIR 250/50mcg
Approvals — FDA: no, EMA: no, PMDA: no
Description: fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
Study: NCT01475721
Drug: ADVAIR 500/50mcg
Approvals — FDA: no, EMA: no, PMDA: no
Description: fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months
Study: NCT05499026
Drug: Chenodeoxycholic Acid
Normalized name: Chenodeoxycholic acid
DrugBank: Chenodeoxycholic acid (DB06777)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Bile acid
Study: NCT01198587
Drug: Zinc Sulfate
Normalized name: Zinc Sulfate
DrugBank: Zinc acetate (DB14487)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.~For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.
Study: NCT01198587
Drug: Placebo oral capsule
Normalized name: Placebo Oral Capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Effervescent oral capsules with similar taste to treatment drug Zinc Sulfate is provided to each patient randomized to the placebo arms of the study
Study: NCT00986882
Drug: SAF312A
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00986882
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00986882
Drug: Ibuprofen
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT04167943
Drug: Dual cured resin modified tricalcium silicate cement
Normalized name: dicalcium silicate
Approvals — FDA: no, EMA: no, PMDA: no
Description: A resin based, dual cured tricalcium silicate based cement
Study: NCT00000395
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00002766
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00002766
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00002766
Drug: mercaptopurine
Normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00002766
Drug: methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00402987
Drug: Celecoxib
Normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
Study: NCT00402987
Drug: Celecoxib
Normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
Study: NCT00402987
Drug: celecoxib
Normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
Study: NCT00402987
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: dose 1 placebo followed 6-12 hours later by dose 2 placebo
Study: NCT00003816
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT02133573
Drug: Vaginal lubricant
Normalized name: Film, Multi Ingredient Vaginal Film [VCF VAGINAL LUBRICANT]
Approvals — FDA: no, EMA: no, PMDA: no
Description: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
Study: NCT02526914
Drug: Intranasal placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: di-sodium hydrogen phosphate, critic acid, sodium chloride, glycerin, benzalkonium chloride and aqua bidest.
Study: NCT00738296
Drug: ezetimibe (+) simvastatin
Normalized name: ezetimibe / simvastatin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive the combination of ezetimibe/simvastatin 10/20 mg o.d. with the possibility to increase the dose to 10/40 mg o.d. for 1 year. Tablets
Study: NCT00738296
Drug: simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Patients will receive 40mg od. With the possibility to escalate the dose to 80 mg o.d. if therapeutic goals not attained; for 1 year. Tablets
Study: NCT00738296
Drug: pravastatin
Normalized name: Pravastatin
DrugBank: Pravastatin (DB00175)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Patients will receive pravastatin 40 mg o.d. with the possibility to add up 10mg of ezetimibe daily if LDL-C goal is not achieved; for 1 year. Tablets
Study: NCT02431325
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01917318
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: During 8 weeks subjects will receive oral placebo
Study: NCT03218917
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered once per day for 24 weeks
Study: NCT01472250
Drug: Clinical chemo-drugs
Normalized name: DuoCare Clinical
Approvals — FDA: no, EMA: no, PMDA: no
Description: Clinical drugs will be selected by the investigator according to recommendations in Chinese and foreign guidelines and depending on clinical experience and the patient's individual conditions, including but not limited to the drugs listed below:~Platinum products: oxaliplatin, cisplatin Fluorouracil products: 5-fluorouracil, capecitabine, TS-1 Taxanes: paclitaxel, docetaxel
Study: NCT02489344
Drug: GZ/SAR402671
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pharmaceutical form:capsule~Route of administration: oral
Study: NCT02786407
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: In these studies,patients received placebo administered to 20 injection sites
Study: NCT03195569
Drug: QL1101
Approvals — FDA: no, EMA: no, PMDA: no
Description: targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
Study: NCT03195569
Drug: Avastin®
Approvals — FDA: no, EMA: no, PMDA: no
Description: targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
Study: NCT02065219
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord
Study: NCT00740181
Drug: chemotherapy
Normalized name: Chemotherapy Glove SML
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03464266
Drug: FTC/TDF
Approvals — FDA: no, EMA: no, PMDA: no
Description: The primary analysis will be separate comparisons of the annualized rates of change in BMD and TBS of the spine and hip between women using PrEP and DMPA concurrently versus women using DMPA only (comparison 1), women using PrEP only (comparison 2), and women using neither (comparison 3). Analyses will account for baseline BMD.
Study: NCT01908010
Drug: ABT-354
Normalized name: ABT-925
Approvals — FDA: no, EMA: no, PMDA: no
Description: ABT-354 Low Dose
Study: NCT01908010
Drug: ABT-354
Normalized name: ABT-925
Approvals — FDA: no, EMA: no, PMDA: no
Description: ABT-354 High Dose
Study: NCT01908010
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT01940419
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10 ml sodium chloride iv administered over 10 minutes just before surgery
Study: NCT00572819
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.
Study: NCT01955161
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Once daily, matching placebo capsules, orally
Study: NCT03229668
Drug: Placebo oral capsule
Normalized name: Placebo Oral Capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo oral capsule administered 1 hour prior to the surgical operation
Study: NCT02874092
Drug: MTX therapy
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01677988
Drug: Neo-adjuvant Chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1. Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles, for three (3) cycles with growth factor support.~2. Restaging # 1. (CT or MRI; use same modality as baseline staging unless otherwise indicated by Study Team)~   1. Progressive Disease (PD) → Off study. Subsequent treatment per patient's primary MD.~  2. Stable Disease (SD) or Tumor Response → Continue to Registration #2 for Chemoradiation.
Study: NCT01974284
Drug: percutaneous ethanol ablation
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The volume of 99% ethanol to be injected is calculated using a standardized formula. Ethanol is instilled with a needle under ultrasound guidance after administration of local anesthesia.
Study: NCT01332656
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pharmaceutical form:solution~Route of administration: intravenous
Study: NCT02594839
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: intravenous infusion of 400 mL saline
Study: NCT00484263
Drug: Hypertonic saline 6% -
Approvals — FDA: no, EMA: no, PMDA: no
Description: Hypertonic saline (6%) - 5mls twice a day via a nebuliser for 12 months
Study: NCT02665260
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo topical liquid
Study: NCT00267930
Drug: Placebo comparator
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01442987
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: once daily, P.O. 8week
Study: NCT00267176
Drug: lumiracoxib
Normalized name: Lumiracoxib
DrugBank: Lumiracoxib (DB01283)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00545779
Drug: Ibandronate
Normalized name: ibandronate
DrugBank: Ibandronate (DB00710)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 150 mg orally once monthly for 6 months
Study: NCT01005290
Drug: Combination pill
Normalized name: combinations
Approvals — FDA: no, EMA: no, PMDA: no
Description: A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.
Study: NCT03720470
Drug: Oral Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows:~1. In the arm Dupilumab Injection + Oral Placebo followed by Oral Placebo, the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20;~2. In the arms Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842 and Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842, subjects, take Oral Placebo from Day 1 until Week 16.
Study: NCT03720470
Drug: Injectable Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.
Study: NCT00916448
Drug: E. coli endotoxin
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2 ng/kg E. coli reference endotoxin 11:H 10:K negative intravenously
Study: NCT02959047
Drug: Matching placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: SQ every 2 weeks
Study: NCT03388619
Drug: ADT
Normalized name: Radtue
Approvals — FDA: no, EMA: no, PMDA: no
Description: After enrollment if clinically indicated (i.e., anti-androgen, gonadotropin releasing hormone agonist, or combination of both).
Study: NCT02408939
Drug: Stress-dose hydrocortisone
Normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Patients with postresuscitation shock received stress-dose (300 mg) of hydrocortisone for 7 days maximum followed by gradual taper and discontinuation over 48 hours after either the resolution of their hemodynamic instability or day 7 of treatment.
Study: NCT01237873
Drug: Ali/Amlo 150/2.5 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
Study: NCT01424735
Drug: Mycobacterium w.(Mw)-freeze dried extract 0.5ml
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.5 ml of Mw in 500ml 0.9% normal saline administered over two hours as an infusion. 2ml(4mg/ml) of dexamethasone administered two hours prior to Mw administration
Study: NCT00303498
Drug: Sitexsentin sodium
Approvals — FDA: no, EMA: no, PMDA: no
Description: sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period (10 weeks total) to a target study dose of 100 mg daily. During the Run-In Phase, if a subject was not able to tolerate upward dose titration to the target dose of 100 mg, the investigator may have elected to continue at the current dosage or reduce the dosage of sitaxsentan or placebo to the subject's immediate prior dose. During the Maintenance Phase, subjects received the highest titrated dose reached of study drug and continued it through the last day of Week M24 of the Maintenance Phase (14 weeks)- total study drug treatment duration= 6 months
Study: NCT00303498
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo identical to the study drug in description, dose and duration