AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT03977493
Drug: Xeomin
RxNorm normalized name: Xeomin
DrugBank: Botulinum toxin type A (DB00083)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Description: One injection of 2.5 to 40 U in each muscle. Injection repeated after 6 weeks if considered necessary
Trial: NCT01091012
Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous
RxNorm normalized name: sildenafil 20 MG
DrugBank: Sildenafil (DB00203)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg
Trial: NCT00447382
Drug: insulin aspart
RxNorm normalized name: Insulin Aspart
DrugBank: Insulin aspart (DB01306)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Injected s.c. (under the skin). Given as bolus insulin.
Trial: NCT00447382
Drug: insulin detemir
RxNorm normalized name: Insulin Detemir
DrugBank: Insulin detemir (DB01307)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: NN729 injected s.c. (under the skin). Given as basal insulin
Trial: NCT01279681
Drug: oxaliplatin
RxNorm normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT00741442
Drug: RDEA806
RxNorm normalized name: RDEA806
DrugBank: RDEA806 (DB05228)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Uricosuric agent for the treatment of gout
Trial: NCT00511238
Drug: carfilzomib
RxNorm normalized name: Carfilzomib
DrugBank: Carfilzomib (DB08889)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Subjects will receive carfilzomib 20 mg/m2 as an intravenous bolus over 2 minutes on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles. A maximum of 12 cycles will be administered.
Trial: NCT00511238
Drug: carfilzomib
RxNorm normalized name: Carfilzomib
DrugBank: Carfilzomib (DB08889)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Subjects will receive carfilzomib intravenously over up to 10 minutes on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles. In cycle 1, the dose is 20 mg/m2. If all doses are administered and well-tolerated over Cycle 1, beginning with Cycle 2 the dose will escalate to 27 mg/m2 cycle. A maximum of 12 cycles will be administered.
Trial: NCT01043991
Drug: Darbepoetin alfa
RxNorm normalized name: Darbepoetin Alfa
DrugBank: Darbepoetin alfa (DB00012)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02100475
Drug: insulin degludec/liraglutide
RxNorm normalized name: INSULIN DEGLUDEC/LIRAGLUTIDE
DrugBank: Liraglutide (DB06655)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin.~Dose individually adjusted.
Trial: NCT02100475
Drug: insulin aspart
RxNorm normalized name: Insulin Aspart
DrugBank: Insulin aspart (DB01306)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.
Trial: NCT05342272
Drug: Xylitol, Lactoperoxidase, Lysozyme, Lactoferrin
DrugBank: Xylitol (DB11195)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: At the beginning of the trial (t0) each patient received a print-out summarizing the instructions for use of the products: they were instructed to apply during a 28 days treatment period 1 to 2 cm of Biotene® Oral Balance gel to gums, oral mucosa membrane and tongue, repeating as many times as necessary, and to brush their teeth with GUM® Technique® Pro soft compact toothbrush (Sunstar Europe S.A., Etoy, Switzerland) using GUM® Hydral® Toothpaste (Sunstar Europe S.A., Etoy, Switzerland) at least twice a day. The first application was done by the participants themselves under the supervision of the same operator that provided them both oral and written usage instructions. They had to refrain from using any other commercial mouthrinse, toothpaste or saliva supplements during the trial.
Trial: NCT03530280
Drug: adductor canal block including bupivacaine
RxNorm normalized name: Ivy Block
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The preoperative placebo oral tablet and adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine
Trial: NCT00124982
Drug: Abatacept
RxNorm normalized name: Abatacept
DrugBank: Abatacept (DB01281)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.
Trial: NCT01874080
Drug: Saxagliptin/Metformin
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT01732770
Drug: Placebo to Denosumab
RxNorm normalized name: Denosumab
DrugBank: Denosumab (DB06643)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Administered by subcutaneous injection once every 6 months
Trial: NCT03009422
Drug: Local application pentostam
RxNorm normalized name: Pentosan polysulfate
DrugBank: Pentosan polysulfate (DB00686)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03009422
Drug: intra-lisional pentostam
RxNorm normalized name: Pentosan polysulfate
DrugBank: Pentosan polysulfate (DB00686)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00666224
Drug: Glatiramer Acetate (DB)
RxNorm normalized name: Glatiramer
DrugBank: Glatiramer (DB05259)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Double blind period (DB): glatiramer acetate (GA) by subcutaneous injection, 20mg, once daily, for up to 36 months or until conversion to clinically definite multiple sclerosis (CDMS).
Trial: NCT01862302
Drug: Haloperidol
RxNorm normalized name: Haloperidol
DrugBank: Haloperidol (DB00502)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery
Trial: NCT00906360
Drug: sunitinib malate
RxNorm normalized name: Sunitinib Malate
DrugBank: Sunitinib (DB01268)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Given orally or by percutaneous gastrostomy tube
Trial: NCT01402024
Drug: Aprepitant
RxNorm normalized name: Aprepitant
DrugBank: Aprepitant (DB00673)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The patient on study group with weight category of 15-40 kg will receive:~D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg and~The patient with weight category of 41-65 kg in study group will receive:~D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 125 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg
Trial: NCT00124982
Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
RxNorm normalized name: cyclosporine
DrugBank: Cyclosporine (DB00091)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).
Trial: NCT00124982
Drug: Anti-Tumor Necrosing Factor (TNF) Therapy
RxNorm normalized name: G 1 (anti-tumor agent)
DrugBank: Rosin (DB11165)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months
Trial: NCT00630864
Drug: Fx-1006A
RxNorm normalized name: Fx-1006A
DrugBank: Fx-1006A (DB05352)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: During Part 1, patients will receive Fx-1006A 20mg soft gelatin capsules once daily (at the same time each day) for two weeks. During Part 2, patients will receive Fx-1006A 20mg soft gelatin capsules once daily to complete a total of 12 months of dosing
Trial: NCT00666224
Drug: Glatiramer Acetate (OL)
RxNorm normalized name: Glatiramer
DrugBank: Glatiramer (DB05259)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Open label period (OL): glatiramer acetate (GA), 20 mg, subcutaneous injection, once daily, given for up to an additional 24 months.
Trial: NCT03521141
Drug: Nicotine patch
RxNorm normalized name: Nicotine Patch
DrugBank: Nicotine (DB00184)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: FDA-approved smoking cessation pharmacotherapy
Trial: NCT03521141
Drug: Varenicline
RxNorm normalized name: Varenicline
DrugBank: Varenicline (DB01273)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: FDA-approved smoking cessation pharmacotherapy
Trial: NCT00239889
Drug: Salmon calcitonin
RxNorm normalized name: Salmon calcitonin
DrugBank: Salmon calcitonin (DB00017)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01598909
Drug: Arnica
RxNorm normalized name: Arnica
DrugBank: Arnica montana (DB14297)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Application of Arnica ointment periorbitally
Trial: NCT02037516
Drug: Neostigmine
RxNorm normalized name: Neostigmine
DrugBank: Neostigmine (DB01400)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Neostigmine is used to reverse the effects of neuromuscular blocking agents
Trial: NCT00071643
Drug: Escitalopram
RxNorm normalized name: Escitalopram
DrugBank: Escitalopram (DB01175)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
Trial: NCT02593669
Drug: Subconjunctival dexamethasone and general anesthesia
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
Trial: NCT04631627
Drug: Aspirin
RxNorm normalized name: Aspirin
DrugBank: Acetylsalicylic acid (DB00945)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: With the result of risk assessment for high risk and the risk of pregnant women, with each research center stratified random aspirin drug intervention, for each center screening high-risk and accord with the standard drug intervention study phase into eliminate pregnant women by using stochastic indicator 1:1 randomly into low-dose aspirin to prevent group and observation group, for each center in screening for risk and comply with the drug intervention study phase into the exclusion standard 1:1 by random indicator method pregnant women randomly into low-dose aspirin to prevent group and observation group.
Trial: NCT02646592
Drug: Alfentanil
RxNorm normalized name: Alfentanil
DrugBank: Alfentanil (DB00802)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Bolus of alfentanil 10 µg/kg 5 minutes before skin incision
Trial: NCT02646592
Drug: sevoflurane or propofol
RxNorm normalized name: Sevoflurane
DrugBank: Propofol (DB00818)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00536380
Drug: 5-mg Desloratadine
RxNorm normalized name: desloratadine 5 MG
DrugBank: Loratadine (DB00455)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 5-mg desloratadine tablets, once daily for four weeks.
Trial: NCT00536380
Drug: 10-mg Desloratadine
RxNorm normalized name: Desloratadine
DrugBank: Loratadine (DB00455)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 10-mg desloratadine tablets, once daily for four weeks.
Trial: NCT00536380
Drug: 20-mg Desloratadine
RxNorm normalized name: Desloratadine
DrugBank: Loratadine (DB00455)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20-mg desloratadine tablets, once daily for four weeks.
Trial: NCT01117441
Drug: PEG-L-asparaginase
RxNorm normalized name: Peg/L-asparaginase
DrugBank: Pegaspargase (DB00059)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: see detailed protocol description
Trial: NCT01117441
Drug: cytarabine
RxNorm normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: see detailed protocol description
Trial: NCT01117441
Drug: daunorubicin hydrochloride
RxNorm normalized name: Daunorubicin Hydrochloride
DrugBank: Daunorubicin (DB00694)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: see detailed protocol description
Trial: NCT01117441
Drug: dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: see detailed protocol description
Trial: NCT00959595
Drug: EMLA cream
RxNorm normalized name: LIDOCAINE 25 mg in 1 g / PRILOCAINE 25 mg in 1 g TOPICAL CREAM [Emla Cream]
DrugBank: Lidocaine (DB00281)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The study subjects are treated either by 50 g of a local anesthetic agent containing 2.5% Lidocaine and 2.5% Prilocaine (EMLA®, AstraZeneca - Södertälje, Sweden) or a placebo cream, applied to the lower leg. The cream is applied under occlusive bandage (plastic foam and a tube) for 1.5 hours circumferential to the lower leg 10-12 cm distally of the tibial tuberosity and the malleolus at ankle level. Administration of the treatment cream as well as removal after 1,5 hour and at sensory assessment after 1.5 hour and 24 hours, and interviewing the patient about subjective experience from the treatment are performed by an independent research nurse, not involved in the sensory assessment.
Trial: NCT00959595
Drug: EMLA cream
RxNorm normalized name: LIDOCAINE 25 mg in 1 g / PRILOCAINE 25 mg in 1 g TOPICAL CREAM [Emla Cream]
DrugBank: Lidocaine (DB00281)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 50g applied according to description of intervention
Trial: NCT00913419
Drug: Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories
DrugBank: Cyclobenzaprine (DB00924)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00913419
Drug: Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme
DrugBank: Cyclobenzaprine (DB00924)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00546000
Drug: Fluticasone propionate 0.05% lotion
RxNorm normalized name: FLUTICASONE PROPIONATE 0.05% LOTION,TOP
DrugBank: Fluticasone propionate (DB00588)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Daily applications
Trial: NCT02161991
Drug: Aprepitant
RxNorm normalized name: Aprepitant
DrugBank: Aprepitant (DB00673)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.
Trial: NCT00406172
Drug: Bevacizumab
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT01117441
Drug: etoposide
RxNorm normalized name: Etoposide
DrugBank: Etoposide (DB00773)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: see detailed protocol description
Trial: NCT01117441
Drug: ifosfamide
RxNorm normalized name: Ifosfamide
DrugBank: Ifosfamide (DB01181)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: see detailed protocol description
Trial: NCT01183949
Drug: Bortezomib
RxNorm normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Part C will treat between 3-26 patients with a combination of bortezomib and AT7519M in a dose escalation design. The starting doses for the dose escalation are bortezomib 1 mg/m2 and AT7519M 14 mg/m2.
Trial: NCT01382238
Drug: Dolutegravir 50 mg tablet
RxNorm normalized name: dolutegravir
DrugBank: Dolutegravir (DB08930)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Dolutegravir is an experimental drug in the integrase inhibitor class for the treatment of HIV.
Trial: NCT01382238
Drug: Dolutegravir 50 mg oral granules
RxNorm normalized name: dolutegravir 50 MG
DrugBank: Dolutegravir (DB08930)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Dolutegravir is an experimental drug in the integrase inhibitor class for the treatment of HIV.
Trial: NCT04327726
Drug: Dexmedetomidine Nebulization
DrugBank: Dexmedetomidine (DB00633)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: ultrasonic nebulization of 1 µg/kg dexmedetomidine for PDPH treatment
Trial: NCT02641301
Drug: Sustained release morphine sulfate, 30 mg
DrugBank: Morphine (DB00295)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.
Trial: NCT00563459
Drug: carisbamate
RxNorm normalized name: carisbamate
DrugBank: Carisbamate (DB12338)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 400-1200 mg/day for 12 months
Trial: NCT00563459
Drug: topiramate
RxNorm normalized name: Topiramate
DrugBank: Topiramate (DB00273)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 200-400mg/day for 12 months
Trial: NCT00563459
Drug: levetiracetam
RxNorm normalized name: Levetiracetam
DrugBank: Levetiracetam (DB01202)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 1000-3000mg/day for 12 months
Trial: NCT00724984
Drug: PCI-24781
RxNorm normalized name: PCI-27483
DrugBank: PCI-27483 (DB13000)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Phase I Dose Escalation: Up to 5 cohorts will receive PCI-24781 orally at doses starting at 30mg/m2 two times a day approximately 4-6 hours apart (BID), up to 90mg/m2 administered 5 days/week during the first 21 days of each 28 day cycle until the maximum tolerated dose (MTD) is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle).~Phase II Efficacy Evaluation: All patients will receive PCI-24781 orally at the dosage and regimen determined in Phase I.
Trial: NCT01117441
Drug: prednisone
RxNorm normalized name: Prednisone
DrugBank: Prednisone (DB00635)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: see detailed protocol description
Trial: NCT01117441
Drug: thioguanine
RxNorm normalized name: Thioguanine
DrugBank: Tioguanine (DB00352)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: see detailed protocol description
Trial: NCT00705367
Drug: Abatacept
RxNorm normalized name: Abatacept
DrugBank: Abatacept (DB01281)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Infusion, Intravenous, 30mg/kg, single dose, Day 1
Trial: NCT00705367
Drug: Abatacept
RxNorm normalized name: Abatacept
DrugBank: Abatacept (DB01281)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Infusion, intravenous, 10 mg/kg, administered on Days 15 and 29 followed by doses every 4 weeks until the end of the study
Trial: NCT00385138
Drug: Cangrelor
RxNorm normalized name: Cangrelor
DrugBank: Cangrelor (DB06441)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: cangrelor bolus (30 mcg/kg) \& cangrelor infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion)
Trial: NCT00385138
Drug: clopidogrel
RxNorm normalized name: Clopidogrel
DrugBank: Clopidogrel (DB00758)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: clopidogrel capsules (600 mg) at end of PCI
Trial: NCT02363621
Drug: Ranibizumab 0.3 mg
RxNorm normalized name: ranibizumab 0.3 MG in 0.05 ML Injection
DrugBank: Ranibizumab (DB01270)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg
Trial: NCT02363621
Drug: Aflibercept 2.0 mg
DrugBank: Aflibercept (DB08885)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Patient will receive intravitreal injection of Aflibercept 2.0 mg
Trial: NCT01117441
Drug: vincristine sulfate
RxNorm normalized name: Vincristine Sulfate
DrugBank: Vincristine (DB00541)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: see detailed protocol description
Trial: NCT01117441
Drug: vindesine
RxNorm normalized name: vindesine
DrugBank: Vindesine (DB00309)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: see detailed protocol description
Trial: NCT01117441
Drug: daunoxome
RxNorm normalized name: DaunoXome
DrugBank: Daunorubicin (DB00694)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: see detailed protocol description; only given by patients with poor MRD-response during the high risk treatment
Trial: NCT00826111
Drug: Eszopiclone
RxNorm normalized name: Eszopiclone
DrugBank: Eszopiclone (DB00402)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Subjects receive 10 mg escitalopram daily for four weeks and 10 or 20 mg for an additional six weeks. Subjects also receive 3 mg eszopiclone.
Trial: NCT02805725
Drug: Phase 1: Trabectedin
DrugBank: Trabectedin (DB05109)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Phase I trial based on a dose escalating study design (3+3 traditional design) assessing four dose levels of Trabectedin in combination with metronomic cyclophosphamide (CP).~A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)
Trial: NCT02805725
Drug: Phase 2: Trabectedin
DrugBank: Trabectedin (DB05109)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Patients will be included in a single-arm phase II trial. Administrated dose will be the RP2D defined in the dose escalation part of the trial. The design will follow a two-stage Simon's optimal design.~All patients will be treated at the RP2D of trabectedin defined in the preliminary phase I trial with the same schedule as in the phase I trial.
Trial: NCT01117441
Drug: fludarabine
RxNorm normalized name: Fludarabine
DrugBank: Fludarabine (DB01073)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: see detailed protocol description; only given by patients with poor MRD-response during the high risk treatment
Trial: NCT01062945
Drug: Doxazosin
RxNorm normalized name: Doxazosin
DrugBank: Doxazosin (DB00590)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The dose of doxazosin needed to alter the effects of cocaine is unknown and preclinical animal studies have not been conducted. Because of this, initially we will study the effects of a low dose of doxazosin (4 mg daily) compared to placebo daily. Because this class of medication needs to be titrated upward due to the potential for hypotension, treatment will begin at 1 mg and increased by 1 mg increments every three days until 4 mg is reached on day 12.
Trial: NCT00910351
Drug: Ciprofloxacin (Cipro, BAYQ3939)
RxNorm normalized name: Ciprofloxacin
DrugBank: Ciprofloxacin (DB00537)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 25 mg inhaled Ciprofloxacin
Trial: NCT01610336
Drug: Gefitinib
RxNorm normalized name: Gefitinib
DrugBank: Gefitinib (DB00317)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Gefitinib 250 mg taken once daily
Trial: NCT00594126
Drug: Imetelstat Sodium (GRN163L)
RxNorm normalized name: Imetelstat
DrugBank: Imetelstat (DB14909)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 25% dose escalation infused over 2 hours weekly