AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT04546347
Drug: AZD9833 film-coated tablet A Dose 1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dose 1 AZD9833 film-coated tablet A Dose 1
Trial: NCT04546347
Drug: AZD9833 Oral Solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: AZD9833 Oral Solution
Trial: NCT04546347
Drug: AZD9833 film-coated tablet A Dose 2
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dose 1 of AZD9833 film-coated tablet A Dose 2
Trial: NCT01978028
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03089203
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 300 mg/m2/day given over 3 days
Trial: NCT01536379
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be given as an intravenous solution over a 1 hour time period administered every 4 weeks for 24 weeks (with an additional dose at Week 2)
Trial: NCT01984008
Drug: Picosulfate sodium, magnesium oxide, citric acid
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00846755
Drug: Levothyroxine, Propylthiouracile
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Drugs were titrated to render euthyroid pregnant patients with thyroid disease
Trial: NCT02071355
Drug: TMC435 100 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive TMC435 100 mg capsule once daily from Day 1 to Day 7 after food.
Trial: NCT02071355
Drug: TMC435 150 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive TMC435 150 mg capsule once daily from Day 1 to Day 7 after food.
Trial: NCT04991181
Drug: 400 mg BIA 5-1058
RxNorm normalized name: Oatmeal 10 mg in 1 mL TOPICAL CREAM [BIA Eczema Relief]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Capsules, oral administered to subjects between 08:00 and 09:00 hours in the morning of Day 1after an overnight fast of at least 10 hours. The study drug was swallowed together with 240 mL tap water (room temperature).
Trial: NCT00312494
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo with mood stabilizer (either lithium or divalproex)
Trial: NCT01862887
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablet, PH-797804 matched placebo, single dose
Trial: NCT03669835
Drug: Standard therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For hepatitis virus C genotype 1: sofosbuvir 400 mg + lepidavir 90 mg for 12 weeks OR sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks; For hepatitis virus C genotypes 2 and 3: sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks.
Trial: NCT02187588
Drug: Eschscholtzia Californica - low dose
RxNorm normalized name: Eschscholzia californica extract
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02187588
Drug: Eschscholtzia Californica - high dose
RxNorm normalized name: Eschscholzia californica extract
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02187588
Drug: Ibuprofen
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02187588
Drug: Eschscholtzia Californica - low dose Placebo
RxNorm normalized name: Eschscholzia californica extract
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02187588
Drug: Eschscholtzia Californica - high dose Placebo
RxNorm normalized name: Eschscholzia californica extract
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02187588
Drug: Ibuprofen Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00009048
Drug: IV Levodopa
RxNorm normalized name: Levodopa
DrugBank: Levodopa (DB01235)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT03160833
Drug: HMPL-453
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral administrative
Trial: NCT00422266
Drug: Omega 3 fatty acids and plant sterol enriched drink
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03121092
Drug: ACEI or ARB
RxNorm normalized name: Medicated Pad or Tape
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) - commonly used anti-hypertensive medications
Trial: NCT03989440
Drug: AXER-204
FDA approved: no
EMA approved: no
PMDA approved: no
Description: human NoGo Trap fusion protein
Trial: NCT03989440
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Phosphate buffered saline formulation
Trial: NCT02369081
Drug: Spironolactone
RxNorm normalized name: Spironolactone
DrugBank: Spironolactone (DB00421)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Spironolactone 25mg tablet orally once daily for 6 weeks, followed by Spironolactone 50mg tablet orally once daily for a further 6 weeks.
Trial: NCT03878914
Drug: Corticosteroids
RxNorm normalized name: CORTICOSTEROIDS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will be divided into two groups based on time to remission with initial standard dose of corticosteroids. Patients who respond within 10 days (Group A) will receive a total of 8 weeks of corticosteroid therapy whereas those who respond between 10 days to 28 days (Group B) will receive ≥12 weeks ((maximum of 16 weeks) of corticosteroid therapy.
Trial: NCT02207790
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: E2609 low-dose and placebo in healthy Japanese subjects, E2609 mid-dose and placebo in healthy Japanese subjects, E2609 high-dose and placebo in healthy Japanese subjects, E2609 mid-dose and placebo in healthy White subjects
Trial: NCT01210365
Drug: Diurisa®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Furosemide 40 mg + amiloride chloride 10 mg.The patient will swallow onde tablet per day in whole form on an empty stomach with some liquid during 4 weeks.
Trial: NCT01210365
Drug: Lasix ®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One group of patients will receive furosemide 40mg .The patient will swallow the tablet in whole form on an empty stomach with some liquid.
Trial: NCT00873509
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo liquid, in 1 ml, once per day in the evening for the first week of administration and thereafter twice a day 12 hours apart for the entire study
Trial: NCT02369081
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo treatment for 12 weeks.
Trial: NCT00465972
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo capsule nightly for duration of study
Trial: NCT02784821
Drug: Antibiotics
RxNorm normalized name: Antibiotics
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.
Trial: NCT01139450
Drug: 0417
RxNorm normalized name: estradiol 0.00417 MG/HR
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Topical 0417 test product applied twice daily for 4 weeks
Trial: NCT01139450
Drug: Vehicle of 0417 test product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Vehicle of 0417 test product applied twice daily for 4 weeks
Trial: NCT01517009
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 1875 mg/m2 in two equally divided doses day 1-14, repeated every three weeks, in total 4 cycles
Trial: NCT01277523
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 actuations once daily
Trial: NCT04608500
Drug: FMX103 minocycline foam 1.5%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage form description: Foam containing minocycline HCl 1.5%. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 7.5 mg (1.5% active) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.
Trial: NCT02695745
Drug: Celecoxib capsules
RxNorm normalized name: Celecoxib Capsules
DrugBank: Celecoxib (DB00482)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 400 mg (2 capsules of 200 mg each) taken orally x 1 dose
Trial: NCT02695745
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose
Trial: NCT00919776
Drug: prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: prednisolone 40mg daily then reducing regimen over 16 weeks
Trial: NCT01899638
Drug: UMEC/VI 125/25 mcg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Combination in high dose
Trial: NCT01899638
Drug: UMEC/VI 62.5/25 mcg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Combination in low dose
Trial: NCT01899638
Drug: UMEC 62.5 mcg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: LAMA mono in low dose
Trial: NCT01899638
Drug: VI 25 mcg
RxNorm normalized name: Typhim VI 25 MCG per 0.5 ML Prefilled Syringe
FDA approved: no
EMA approved: no
PMDA approved: no
Description: LABA mono
Trial: NCT02670655
Drug: MAL application
RxNorm normalized name: maleate
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Immediately after AFL treatment, an approximately 1-mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue.
Trial: NCT01157507
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One single injection of placebo
Trial: NCT00174915
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo, orally, once daily for up to 28 weeks.
Trial: NCT00642707
Drug: Placebo Comparator
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03295981
Drug: Zoledronic Acid
RxNorm normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
Trial: NCT00112502
Drug: Celecoxib
RxNorm normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 400 mg orally twice a day continuous dosing
Trial: NCT04312477
Drug: Modified Gegen Qinlian Decoction
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Modified Gegen Qinlian Decoction contains Pueraria lobata 24g, Scutellaria baicalensis 9g, Coptis chinensis 9g, artillery ginger 9g, talc 9g, roasted licorice 6g, and granules are prepared according to 10:1 production process.
Trial: NCT01941927
Drug: GSK2141795
FDA approved: no
EMA approved: no
PMDA approved: no
Description: GSK 2141795 is an ATP competitive subnanomolar pan-AKT inhibitor. In order to measure the true potency of GSK 2141795, potency (Ki\*) values were determined in a filter binding assay using lower enzyme concentrations (0.1, 0.7, and 0.2 nM for human AKT1, AKT2, and AKT3, respectively). Using a sandwich ELISA, GSK 2141795 inhibited phosphorylation of GSK-3β in BT474 and LNCaP cell lines with EC50 values of 143 and 34 nM, respectively. Since phosphorylation of GSK-3β can be modulated by other enzymes (PKA, PKC, and RSK),cellular activity of GSK 2141795 was evaluated using a phospho-PRAS40 ELISA. GSK 2141795 inhibited the phosphorylation of PRAS40 with EC50 values of 39 and 55 nM for BT474 and LNCaP cells, respectively.
Trial: NCT02130674
Drug: Dipeptiven
RxNorm normalized name: palmitoyl dipeptide-7
FDA approved: no
EMA approved: no
PMDA approved: no
Description: two groups: group 1: continuous infusion for 24 hours group 2: continuous infusion for 5 days
Trial: NCT02648009
Drug: Hyperpolarized (13) Pyruvate Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MRI with Hyperpolarized Pyruvate (13) Injection
Trial: NCT03873298
Drug: Inhaled nitric oxide
RxNorm normalized name: nitric oxide Inhalant Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhaled nitric oxide delivered through a pulsatile nitric oxide drug delivery system
Trial: NCT00993863
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single dose
Trial: NCT00993863
Drug: ibuprofen 400 mg
RxNorm normalized name: ibuprofen 400 MG
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: single dose
Trial: NCT01941654
Drug: Oral TKI
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00593177
Drug: PTH (1-34) Gel / Placebo Gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Topical dosing of gel twice daily for eight weeks.
Trial: NCT03303053
Drug: Prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tablet prednisolone 30 mg daily for week 1, 20 mg daily for week 2, 10 mg daily for week 3 and 5 mg daily for week 4, Tablet carbimazole 30 mg daily, Tablet propanolol 40 mg twice daily for 4 weeks
Trial: NCT03303053
Drug: Standard treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Carbimazole 30 mg daily and propanolol 40 mg twice daily for 4 weeks
Trial: NCT02608268
Drug: PDR001
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anti-human PD-1 monoclonal antibody. PDR001 administered via intravenous (i.v.) infusion either every 2 weeks (Q2W) or every 4 weeks (Q4W).
Trial: NCT02628600
Drug: LAI 590 mg
RxNorm normalized name: laidlomycin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: LAI 590 mg QD: administered by inhaling drug product that had been aerosolized in an investigational eFlow nebulizer over approximately 14 minutes
Trial: NCT02628600
Drug: Multi-drug regimen
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Multidrug antimycobacterial regimen from study INS-212
Trial: NCT00104728
Drug: ZD1839
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03880045
Drug: Topical TA
RxNorm normalized name: Doak 2% Topical Tar Oil
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%
Trial: NCT04649216
Drug: PCO371
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PCO371 Capsule
Trial: NCT04649216
Drug: [14C]PCO371
FDA approved: no
EMA approved: no
PMDA approved: no
Description: \[14C\]PCO371 Oral solution
Trial: NCT04649216
Drug: [14C]PCO371
FDA approved: no
EMA approved: no
PMDA approved: no
Description: \[14C\]PCO371 Solution for infusion
Trial: NCT06090123
Drug: TPN171H
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sequence 1：Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6.~Sequence 2：Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10.
Trial: NCT04248712
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Contains no active ingredient
Trial: NCT03759639
Drug: IB1001
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IB1001 (N-Acetyl-L-Leucine) is a modified amino-acid ester that is orally administered.
Trial: NCT00399568
Drug: IV Acetaminophen
RxNorm normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous acetaminophen 1 g/100 mL
Trial: NCT00399568
Drug: IV Placebo 100 mL solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
Trial: NCT02524236
Drug: Botox injection in the prostate
RxNorm normalized name: onabotulinumtoxinA Injection [Botox]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: transrectal access of prostatic injection
Trial: NCT00861757
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PO, QD (30 min after meal) for 12 weeks
Trial: NCT03308968
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo matching to fremanezumab will be administered per schedule specified in the arm.
Trial: NCT03998514
Drug: CB4211 Dose 1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered by subcutaneous injection
Trial: NCT03998514
Drug: CB4211 Dose 2
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered by subcutaneous injection
Trial: NCT03998514
Drug: CB4211 Dose 3
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered by subcutaneous injection
Trial: NCT03998514
Drug: CB4211 Dose 4
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered by subcutaneous injection
Trial: NCT03998514
Drug: CB4211 Dose 5
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered by subcutaneous injection
Trial: NCT03998514
Drug: CB4211 Dose 6
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered by subcutaneous injection
Trial: NCT03998514
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered by subcutaneous injection
Trial: NCT04256174
Drug: AK120 or placebo- Part 1- Cohort 1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dose of 15mg AK120 or placebo is administered subcutaneously to healthy subjects
Trial: NCT04256174
Drug: AK120 or placebo- Part 1- Cohort 2
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dose of 50mg AK120 or placebo is administered subcutaneously to healthy subjects
Trial: NCT04256174
Drug: AK120 or placebo- Part 1- Cohort 3
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dose of 150mg AK120 or placebo is administered subcutaneously to healthy subjects
Trial: NCT04256174
Drug: AK120 or placebo- Part 1- Cohort 4
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dose of 300mg AK120 or placebo is administered subcutaneously to healthy subjects
Trial: NCT04256174
Drug: AK120 or placebo- Part 1- Cohort 5
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dose of 600mg AK120 or placebo is administered subcutaneously to healthy subjects
Trial: NCT04256174
Drug: AK120 or placebo- Part 2- Cohort 1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Multiple low doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis
Trial: NCT04256174
Drug: AK120 or placebo- Part 2- Cohort 2
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Multiple medium doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis
Trial: NCT04256174
Drug: AK120 or placebo- Part 2- Cohort 3
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Multiple high doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis
Trial: NCT04256174
Drug: AK120 or placebo- Part 2- Cohort 4
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Multiple high doses of AK120 or placebo are administered subcutaneously as a bi-weekly dose for a total of three doses to subjects with moderate-to-severe atopic dermatitis.
Trial: NCT02681653
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Equally matched placebo for 7 days to patients of septic shock admitted to ICU
Trial: NCT01195818
Drug: RAS Inhibitors
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Clinical trial testing the effect of RAS inhibitors (Ramipril or Irbesartan)on sickle cell disease patients wit hyperfiltration and albuminuria for a six month period followed by one month wash out period. Drug will be given after the first GFR measurement on a daily basis with a full dose given after the first month.
Trial: NCT04054206
Drug: MN-166
RxNorm normalized name: Mn 2+
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MN-166 (ibudilast) is an orally available small molecule drug currently being investigated for human treatment in multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma, and alcohol and drug use disorders.
Trial: NCT01589146
Drug: Heparin, Low-Molecular-Weight
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 4 weeks heparin prophylaxis
Trial: NCT01527422
Drug: Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Rituximab will be administered on day 1 of courses 1-6 at 375 mg/m2 concurrently with CHOP-R.All patients will receive antiemetics priorchemotherapy.Courses will be repeated every 14 days.If blood counts don't allow re-treatment on day 14 the counts will be repeated at least twice per week until recovery allows re-treatment.The aim is to achieve a dose that will be as close as possible to 250 mcg and that will result in grade 0 or grade 1A or 1B toxicity at the most. The dose of PEG-Filgrastim will initially be fixed at 3 mg until dose level +3 is reached (which includes 250 mcg Leukine) at which time the dose of Neulasta will be escalated if necessary. All patients will receive Neulasta as a subcutaneous injection on the day 3.
Trial: NCT00603941
Drug: CS-7017
RxNorm normalized name: MyoGesic-CS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: At Phase 1, CS-7017 will be tested in combination with paclitaxel at the following dosage levels: 0.15, 0.30, or 0.50 mg BID. At Phase 2, CS-7017 will be administered at the recommended phase 2 dose (RP2D).
Trial: NCT01642901
Drug: Zoledronic acid
RxNorm normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 5 mg zoledronic acid infused intravenously over two hours (2.5mg per hour), given only once, within 21 days of acute traumatic spinal cord injury.
Trial: NCT01642901
Drug: normal saline 0.9%
RxNorm normalized name: BD Posiflush Normal Saline 0.9% Prefilled Syringe Solution for Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Infusion of equivalent volume of 0.9% normal saline to that of the reconstituted zoledronic acid, given only once over two hours, occurring within 21 days of acute traumatic spinal cord injury
Trial: NCT00864175
Drug: INCB007839
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 100 mg BID
Trial: NCT00864175
Drug: INCB007839
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 200 mg BID
Trial: NCT00864175
Drug: INCB007839
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 300 mg BID
Trial: NCT00422188
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered via intralipomal injection.