TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03681028
Drug: Individualized therapy
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1. For a given proposed individualized combination of drugs the first priority to establish doses will be to identify the same combination of drugs in a peer-reviewed journal article or presented as a reviewed abstract.~2. When a proposed individualized combination of drugs has not previously been reported, the process to establish doses will be to then identify individual members of the proposed combination that have been used in combination with other cytotoxic agents similar to those being considered for combination therapy.~3. When a proposed individualized combination of drugs has no available combination data, dosing guidelines will start with the FDA-approved package insert recommended dose.
Study: NCT02094794
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00239681
Drug: Rosuvastatin
Normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Oral
Study: NCT01712295
Drug: Salicylates
Normalized name: salicylates
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02641028
Drug: CERC-501
Normalized name: CERCIS SILIQUASTRUM WHOLE
Approvals — FDA: no, EMA: no, PMDA: no
Description: CERC-501
Study: NCT02641028
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT01275677
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT01275677
Drug: Doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT01275677
Drug: Doxorubicin Hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT03975296
Drug: patient controlled intravenous analgesia(PCIA)
Approvals — FDA: no, EMA: no, PMDA: no
Description: at the end of surgery, patient is administered a PCIA with morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.
Study: NCT01677949
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Days 1-5: Cyclophosphamide 300 mg/m\^2 as a 30-60 minute infusion
Study: NCT02446600
Drug: Pegylated Liposomal Doxorubicin Hydrochloride
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given IV
Study: NCT02046447
Drug: Primary Cervical Dystonia (Trihexyphenidyl)
Approvals — FDA: no, EMA: no, PMDA: no
Description: After the baseline testing these subjects will receive a dose of trihexyphenidyl 2 mg an hour prior to the second functional magnetic resonance imaging (fMRI) scan. This is to test the change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task after administration of trihexyphenidyl compared to change in BOLD contrast during a precision gripping task. The subjects will be done with the study after the second MRI scan has been completed.
Study: NCT04591535
Drug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS
Approvals — FDA: no, EMA: no, PMDA: no
Description: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS
Study: NCT02790073
Drug: SNF472
Approvals — FDA: no, EMA: no, PMDA: no
Description: SNF472 for calciphylaxis
Study: NCT01108042
Drug: Taxotere, Cisplatin, 5-Fluorouracil (5-FU)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Phase 1: Intravenous infusion of 40 mg/m² Taxotere and 40 mg/m² Cisplatin followed by 24 h-infusion of 2000 mg/m² 5-FU on day 1 and day 8 every 3 weeks. If possible an escalation to 50 mg/m² Taxotere and 50 mg/m² Cisplatin can be carried out. Phase 2: Optimal dose of phase 1 will be given.
Study: NCT03569475
Drug: Fluoxetine
Normalized name: Fluoxetine
DrugBank: Fluoxetine (DB00472)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Fluoxetine oral capsules
Study: NCT03569475
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo oral capsules
Study: NCT04256317
Drug: ASTX030 (cedazuridine + azacitidine)
Approvals — FDA: no, EMA: no, PMDA: no
Description: FDC Capsules for oral administration.
Study: NCT00660335
Drug: RG1068 (synthetic human secretin)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single-dose, IV infusion
Study: NCT03621982
Drug: ADCT-301
Approvals — FDA: no, EMA: no, PMDA: no
Description: intravenous infusion
Study: NCT01342887
Drug: pravastatin sodium
Normalized name: Pravastatin Sodium
DrugBank: Pravastatin (DB00175)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given PO
Study: NCT01028521
Drug: CM3.1-AC100
Approvals — FDA: no, EMA: no, PMDA: no
Description: Solution for sc injection, single ascending doses
Study: NCT01028521
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Solution for sc injection
Study: NCT03434613
Drug: Rosuvastatin
Normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Rosuvastatin 5mg 1T daily for 6 months
Study: NCT03434613
Drug: Rosuvastatin/ezetimibe combination
Approvals — FDA: no, EMA: no, PMDA: no
Description: Rosuvastatin 5mg / Ezetimibe 10mg combination 1T daily for 6 months
Study: NCT00108121
Drug: PEP005
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03183557
Drug: Zoledronic acid, Reclast®
Approvals — FDA: no, EMA: no, PMDA: no
Description: To examine the efficacy of zoledronic acid in osteoporosis
Study: NCT03183557
Drug: Zoledronic acid, Reclast® and active vitamin D, alfacalcidol®
Approvals — FDA: no, EMA: no, PMDA: no
Description: To examine the efficacy of zoledronic acid plus alfacalcidol in osteoporosis
Study: NCT02218489
Drug: KPI-121
Approvals — FDA: no, EMA: no, PMDA: no
Description: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Study: NCT01157377
Drug: AGN-214868
Normalized name: VITEX AGNUS-CASTUS WHOLE
Approvals — FDA: no, EMA: no, PMDA: no
Description: AGN-214868 injected into the bladder.
Study: NCT01157377
Drug: AGN-214868 placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: AGN-214868 placebo injected into the bladder.
Study: NCT00118703
Drug: GW685698X
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01759238
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 825mg/m2 per os bid
Study: NCT04211272
Drug: Rosuvastatin
Normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Rosuvastatin will be administrated as film-coated tablet in Part B.
Study: NCT02876003
Drug: G-202
Normalized name: krill/om-3/dha/epa/phospho/ast 500 mg-86 mg-25 mg-40 mg-202 mg-101 mcg ORAL CAPSULE
Approvals — FDA: no, EMA: no, PMDA: no
Description: G-202 administered by intravenous infusion (IV, in the vein) on Days 1, 2 and 3 of each 28-day cycle until progression or development of unacceptable toxicity
Study: NCT00927550
Drug: usual care
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients allocated to the control arm will receive usual pharmacological and non-pharmacological treatment as clinically indicated. Patients allocated to the control arm will not be allowed to receive lithium. Any other pharmacological treatment will be allowed.
Study: NCT02417064
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will self-administer matching placebo, intranasally, twice per week for 4 weeks as a fixed dose regimen in Double-Blind Induction Phase.
Study: NCT01574014
Drug: Hydrocortisone
Normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: 3 x 20 mg Hydrocortisone (oral, 60 min. before MRI1, 60 min. before exposition in CBGT1 and 60 min. before exposition in CBGT2)
Study: NCT01574014
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo (oral, 60 min. before MRI1, 60 min. before exposition in CBGT1 and 60 min. before exposition in CBGT2)
Study: NCT02453802
Drug: 0.9% Normal Saline
Approvals — FDA: no, EMA: no, PMDA: no
Description: Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet
Study: NCT02453802
Drug: 0.9% Normal Saline
Approvals — FDA: no, EMA: no, PMDA: no
Description: Topical 160 ml normal saline application after closure of joint capsule.
Study: NCT02918318
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes.
Study: NCT03345342
Drug: PP3M 350 mg eq.
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive intramuscular injection of PP3M 350 mg eq.
Study: NCT02437162
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16 in Group 1 and at Week 24 in Group 2 and Group 3.
Study: NCT03981744
Drug: Placebo IV
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive IV dosing of placebo at Week 24 in Group 1 and at Week 0 in Group 2.
Study: NCT03981744
Drug: Placebo SC
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive SC dosing of placebo at Weeks 8,16 and 24.
Study: NCT01240954
Drug: OSIRIS
Approvals — FDA: no, EMA: no, PMDA: no
Description: OSIRIS current practice
Study: NCT03185819
Drug: Intranasal Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive placebo as intranasal dose to match intranasal esketamine.
Study: NCT02108418
Drug: TG-2349 as a new capsule formulation
Approvals — FDA: no, EMA: no, PMDA: no
Description: single oral dose under fed condition
Study: NCT01355471
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: applied topically once daily
Study: NCT04338321
Drug: SSRI/SNRI
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will continue to take SSRI/SNRI that is approved for use in depression in their country of participation; off-label use of any SSRI/SNRI is not permitted. The continuing SSRI/SNRI dosage may be optimized throughout the study, at the investigator's discretion and based on the SmPC (or local equivalent, if applicable).
Study: NCT03246399
Drug: SM04690
Approvals — FDA: no, EMA: no, PMDA: no
Description: suspension formulation of SM04690, delivered via intradiscal injection (single injection)
Study: NCT02438787
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16 in Group 1.
Study: NCT02470299
Drug: Ketorolac
Normalized name: Ketorolac
DrugBank: Ketorolac (DB00465)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Ketorolac tromethine 15 mg or 30 mg doses will be administered via intravenous (IV) push undiluted over 15 - 30 seconds~Ketorolac will be dosed according to FDA approved recommendations. For planned three daily dose (IV) based on clinical scenario:~* Patients \< 65 years of age: Daily dose of 30 mg for three doses.~* Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: Daily dose of 15 mg for three doses~Blood and peritoneal fluid will be drawn prior to each dose (time 0, 24, 48, 72 hr) as well as at 6 hr after the first dose
Study: NCT02130271
Drug: Radioactive dye
Normalized name: amaranth dye
Approvals — FDA: no, EMA: no, PMDA: no
Description: The radioactive dye \[11C\]PBR28 will be administered through an intravenous line (IV).
Study: NCT03375203
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo will be administered once daily based upon dosing group.
Study: NCT03375203
Drug: JNJ-42847922, 5 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: JNJ-42847922 will be administered as 5 mg (2\*2.5 mg capsule) oral capsules once daily.
Study: NCT03375203
Drug: JNJ-42847922, 10 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: JNJ-42847922 will be administered as 10 mg oral capsule once daily.
Study: NCT03375203
Drug: JNJ-42847922, 20 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: JNJ-42847922 will be administered as 20 mg oral capsule once daily.
Study: NCT03277105
Drug: Dara SC
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
Study: NCT03277105
Drug: Dara IV
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive Dara IV 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
Study: NCT00309985
Drug: androgen-deprivation therapy
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: LHRH analogs are administered with a variety of techniques such as subcutaneously, intramuscularly, or insertion, while antiandrogens (flutamide and bicalutamide) were given orally.
Study: NCT03973047
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: capsule
Study: NCT03321526
Drug: Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Normalized name: serotonin
DrugBank: Serotonin (DB08839)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive SNRI antidepressant (such as duloxetine, milnacipran, levomilnacipran, venlafaxine, desvenlafaxine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).
Study: NCT00003511
Drug: Antineoplaston therapy (Atengenal + Astugenal)
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients with Multiple Myeloma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Study: NCT03097133
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive intranasal placebo two times per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25).
Study: NCT00302146
Drug: 15-0 H20
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02872818
Drug: 17β estradiol hemihydrate
Approvals — FDA: no, EMA: no, PMDA: no
Description: 4mg/kg/day for 20 days
Study: NCT04688320
Drug: Recombinant nonimmunogenic staphylokinase
Approvals — FDA: no, EMA: no, PMDA: no
Description: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds
Study: NCT00787813
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03666715
Drug: Oral Antipsychotics (OAPs)
Approvals — FDA: no, EMA: no, PMDA: no
Description: No study treatment will be administered as a part of this study. Participants will receive OAPs (such as olanzapine, risperidone, paliperidone, aripiprazole or quetiapine) as per their usual clinical practice.
Study: NCT03429595
Drug: ATx201
Approvals — FDA: no, EMA: no, PMDA: no
Description: ATx201 GEL
Study: NCT04204941
Drug: Doxorubicin HCl
Normalized name: doxorubicin HCl
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 75mg/m2 intravenous injection day 1 of each cycle for up to 6 cycles
Study: NCT04204941
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo administered orally twice daily in continuous 21-day cycles during cycles 1-6 and in continuous 28-day cycles during cycles 7 and beyond
Study: NCT01184859
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo melt tablet for sublingual administration
Study: NCT03098797
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: daily subcutaneous injection for 12 weeks
Study: NCT04517214
Drug: Adjuvant chemotherapy with Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Adjuvant chemotherapy after radiation
Study: NCT02203526
Drug: TEDDI
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Temozolomide, etoposide, doxil, dexamthasone, ibrutinib (TEDDI) given every 21 days for cycles 2-6 (Arm 1-A); given every 21 days for cycles 1-6 (Arms 1-B, 2, 3 and 4)
Study: NCT02203526
Drug: TEDD
Normalized name: ALCOHOL 75 mL in 100 mL TOPICAL GEL [LOCKE TEDDY]
Approvals — FDA: no, EMA: no, PMDA: no
Description: Temozolomide, etoposide, doxil, dexamthasone, (TEDD) given on first cycle (Arm 1-A)
Study: NCT02203526
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Methotrexate on days 1 and day 5 of cycles 2-6 (Arm 4)
Study: NCT03927677
Drug: Xanthine Oxidase Inhibitor
Normalized name: Xanthine oxidase inhibitor
Approvals — FDA: no, EMA: no, PMDA: no
Description: LC350189 200mg qd
Study: NCT02489266
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days.
Study: NCT03614221
Drug: Lindioil ointment
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each gram contains 200µg of indirubin. Apply 0.5 g of ointment per 10 cm x 10 cm of affected skin areas twice daily for 6 weeks.
Study: NCT03614221
Drug: Protopic ointment 0.1%
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each gram contains (w/w) 0.1% of tacrolimus. Apply 0.1 g of ointment per 10 cm x 10 cm of affected skin areas twice daily for 6 weeks.
Study: NCT04224493
Drug: Placebo oral tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Stage 2:~Placebo administered orally twice daily in continuous 28-day cycles. Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Study: NCT03067610
Drug: chemotherapy
Normalized name: Chemotherapy Glove SML
Approvals — FDA: no, EMA: no, PMDA: no
Description: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
Study: NCT02956122
Drug: methylprednisolone or equivalent steroid
Normalized name: Methylprednisolone
DrugBank: Methylprednisolone (DB00959)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The conventional steroid treatment (methylprednisolone or equivalent steroid) will be supplied by the investigators per their institutional practice.
Study: NCT00049335
Drug: capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1,000 mg/m\^2/dose (2,000 mg/m\^2/day) BID, PO, on Days 1-14 of 21 day cycle
Study: NCT03585556
Drug: Oral prednisolone
Normalized name: prednisolone Oral Solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: A 7 day tapering dose of oral prednisone will be taken at Day 30 by all patients
Study: NCT04119024
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT02170090
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Capecitabine 1250mg/m2
Study: NCT02137395
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: saline administration intravenously
Study: NCT03876002
Drug: [18F]PBR06
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will undergo PET imaging using 1 single intravenous (IV) injection of \[18F\]PBR06, a PET radioligand for evaluation of microglial activation in the brain. PBR06 will be injected intravenously as a bolus at a dose of no more than 5.5mCi (millicurie).
Study: NCT03449134
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.
Study: NCT04074746
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT01997489
Drug: Enzyme replacement
Approvals — FDA: no, EMA: no, PMDA: no
Description: Observational study of current treatment and with no comparative groups
Study: NCT00449436
Drug: Non-nucleoside reverse transcriptase inhibitor
Normalized name: Non-nucleoside reverse transcriptase inhibitors
Approvals — FDA: no, EMA: no, PMDA: no
Description: Non-nucleoside reverse transcriptase inhibitor
Study: NCT00449436
Drug: Boosted Protease Inhibitor
Normalized name: Protease inhibitors
Approvals — FDA: no, EMA: no, PMDA: no
Description: Boosted Protease Inhibitor
Study: NCT03151486
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive matching placebo in all cohorts.
Study: NCT03412877
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Days -7 and -6: Cyclophosphamide 60 mg/kg/day x 2 days IV in 250 mL D5W infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Study: NCT03412877
Drug: Pembrolizumab (KEYTRUDA(R))
Approvals — FDA: no, EMA: no, PMDA: no
Description: Arm 2: Pembrolizumab 2 mg/kg IV over approximately 30 minutes on Days -2, 21, 42, and 63.
Study: NCT01165359
Drug: ITX 5061
Approvals — FDA: no, EMA: no, PMDA: no
Description: For Part A of the study: 150 mg of ITX 5061, once a day for 3 days; 75 mg of ITX 5061, once a day for 3 days; or 25 mg of ITX 5061, once a day for 3 days.~For Part B of the study: 150 mg of ITX 5061, once a day for 14 days; 75 mg of ITX 5061, once a day for 14 days; or 25 mg of ITX 5061, once a day for 14 days.~For Part C of the study: 150 mg of ITX 5061, once a day for 28 days; 75 mg of ITX 5061, once a day for 28 days; or 25 mg of ITX 5061, once a day for 28 days.
Study: NCT01165359
Drug: Placebo ITX 5061
Approvals — FDA: no, EMA: no, PMDA: no
Description: For Part A of the study: placebo, once a day for 3 days.~For Part B of the study: placebo, once a day for 14 days.~For Part C of the study: placebo, once a day for 28 days.
Study: NCT00555997
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0mg Placebo per day. Dose increases and dose decreases may occur, but patient will remain at 0mg placebo
Study: NCT00130910
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Albendazole Placebo 400mg x 3 first dose observed
Study: NCT00668330
Drug: Ibandronate+alfacalcidol+calcium
Normalized name: alfacalcidol
DrugBank: Alfacalcidol (DB01436)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Ibandronate 150 mg monthly plus daily alfacalcidol (1ug)500mg plus calcium