TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00731432
Drug: Placebo Patch
Approvals — FDA: no, EMA: no, PMDA: no
Description: Identical in shape and texture to treatment patch
Study: NCT04516564
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single dose of placebo is administered via intravenous infusion to healthy subjects
Study: NCT01598415
Drug: SAR113945
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pharmaceutical form:Injection~Route of administration: Intra-articular
Study: NCT01598415
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pharmaceutical form:Injection~Route of administration: Intra-articular
Study: NCT03131908
Drug: GSK2636771
Approvals — FDA: no, EMA: no, PMDA: no
Description: Phase I Starting Dose of GSK2636771: 300 mg by mouth given for 21 days.~Phase II Dose of GSK2636771: Maximum tolerated dose from Phase I.
Study: NCT04567173
Drug: Anti-SARS-CoV-2 convalescent plasma
Approvals — FDA: no, EMA: no, PMDA: no
Description: convalescent plasma derived from whole blood donors or standard pheresis from a volunteer who recovered from COVID-19
Study: NCT02962531
Drug: IX-01 caplets 1600 mg (4 x 400 mg), fasted
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral dose under fasted conditions
Study: NCT00569231
Drug: Candida Antigen
Normalized name: Candida antigen
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
Study: NCT00623116
Drug: Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below)
Approvals — FDA: no, EMA: no, PMDA: no
Description: clinical examination, biochemical profile, and genetic characterization. Possibility to stop hormone therapy with drugs containing testosterone (Atmos®, Testim®, Testogel®, Nebido®, Panteston®, Sustanon®), FSH (Gonal-F®, Puregon®), hCG (Pregnyl®), estrogenic compounds (such as Estrofem®, Divigel®, Estrena®, Climara®, Estradot®, Evorel®, Femseven®: Merimono®, Progynova®, Ovestin®, Zumenon®, Estrogel®, Femoston®, Femoston combi®, Divina®, Divitren®, Indivina®, Estalis sekvens®, Evorel sequi®, Novofem®, Trisekvens®, Activelle®, Estalis®, Evorel conti®, Kliogest®, Mericomb®, Mericomb Mite®, Merigest®: Angeliq®) for 3 mo to assess reversibility of GnRH-deficiency will be offered.
Study: NCT01314911
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
Study: NCT04213573
Drug: MI Varnish
Approvals — FDA: no, EMA: no, PMDA: no
Description: topical fluoride varnish with calcium and phosphate
Study: NCT00908063
Drug: Normal Saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Normal saline will be administered as one of three volume doses based on cohort assignment (1.0 mL/min; 2.0 mL/min; 3.0 mL/min). The infusion will be administered at a rate of 15mL/min and will begin within 12 hours of injury.
Study: NCT04060888
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive placebo matching to ustekinumab IV or SC.
Study: NCT03748524
Drug: Influenza Vaccine
Normalized name: Influenza vaccine
Approvals — FDA: no, EMA: no, PMDA: no
Description: Influenza Vaccine,Quadrivalent SIngle vaccination all participants at day 0
Study: NCT00700310
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily.
Study: NCT00400946
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01814501
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Administered intravenously. A bolus of 400 mg/m2 to be followed by a continuous infusion over 46 hrs at a dose of 2400mg/m2.
Study: NCT01814501
Drug: leucovorin calcium
Normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Leucovorin will be administered at a dose of 200 mg/m2 over 120 minutes prior to the 5-FU bolus. Leucovorin may be run simultaneously with irinotecan infusion via y-site connection.
Study: NCT02279823
Drug: CB-03-01 solution
Normalized name: BroveX CB
Approvals — FDA: no, EMA: no, PMDA: no
Description: Investigational drug solution
Study: NCT02279823
Drug: Placebo solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: Vehicle solution
Study: NCT00400946
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00400946
Drug: leucovorin calcium
Normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02414854
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
Study: NCT02414854
Drug: Inhaled corticosteroid (ICS) therapy
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)
Study: NCT00400946
Drug: mercaptopurine
Normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given orally
Study: NCT00400946
Drug: methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT04397354
Drug: No additional drugs(control Group)
Normalized name: Heparin group antithrombotic drugs
Approvals — FDA: no, EMA: no, PMDA: no
Description: Control group: No drugs will be injected middle ear with cochlear implantation
Study: NCT00400946
Drug: prednisolone
Normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00400946
Drug: therapeutic hydrocortisone
Normalized name: Moisturel Therapeutic
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01190098
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
Study: NCT03293511
Drug: intranasal placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 24 IU of of placebo nasal spray will be applied to each subject.
Study: NCT00398489
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02957682
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04622865
Drug: Best Supportive Care
Approvals — FDA: no, EMA: no, PMDA: no
Description: Best Supportive Care is best available therapy at the choice of the investigator, including, but not limited to, oxygenation, analgesics, anti-thrombotics, anti-viral drugs or biologics drugs.
Study: NCT01284725
Drug: mycophenolate mofetil or azathioprine
Normalized name: Mycophenolate Mofetil
DrugBank: Mycophenolate mofetil (DB00688)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01357031
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: It will be administered placebo capsules, identical to Melatonin (3mg) and Amitriptyline (25 mg) patients will take the study medication at bed time
Study: NCT00008554
Drug: GW433908
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00176852
Drug: Busulfan, Cyclophosphamide, ATG, GCSF
Approvals — FDA: no, EMA: no, PMDA: no
Description: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC \>2500 x 2 days.
Study: NCT04208581
Drug: Yiqi Huoxue Huatan granule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks.
Study: NCT04208581
Drug: Placebo Yiqi Huoxue Huatan granule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks.
Study: NCT00023192
Drug: T-Cell Depleted & CD34+Select/w/StemCell Enriched Product
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01982864
Drug: Gentamicin
Normalized name: Gentamicin
DrugBank: Gentamicin (DB00798)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The decision to introduce the antibiotic is made during a session or between two sessions according to both the clinicians usual procedure.~Depending on the number of injections, 8 to 10 blood samples will be drawn per patient. Clinical and biological data will be concomitantly collected (e.g., hemodialysis session duration, creatinine clearance...).~The number of blood sampling and the time schedule will be adapted to the prescription and the possible follow-up of the treatment after the first injection. Whatever the time is between the first injection and the following dialysis session, a sampling will be performed 30 minutes after the end of the injection (T1), 8h after the end of the injection (T2), juste before (TAD), in the middle (TMD) and at the end of the dialysis (TFD).
Study: NCT01501201
Drug: optimized medical management
Approvals — FDA: no, EMA: no, PMDA: no
Description: group receiving an optimized medical management, among patients with obesity and poorly controlled type 2 diabetes
Study: NCT00501826
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT03129256
Drug: Apatinib Mesylate tablet combined with S-1 capsules
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral use with low-dose Apatinib combined with S-1 until disease progression
Study: NCT00501826
Drug: Doxorubicin Hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT04360655
Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
Study: NCT00501826
Drug: Mercaptopurine
Normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given PO
Study: NCT00501826
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV and PO
Study: NCT01259518
Drug: TRIN2755
Approvals — FDA: no, EMA: no, PMDA: no
Description: In treatment schedule B (Group B), the starting dose to be investigated is 800mg, given once every 7 days in a 4 week cycle. Subsequent patients can only be included on a new dose level when the safety review from all patients included at the preceding dose level(s) at Day 28 after the start of the first infusion (end of Cycle 1) does not indicate relevant toxicity.
Study: NCT00174239
Drug: controlled-release levodopa / carbidopa
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00139646
Drug: Diclofenac
Normalized name: Diclofenac
DrugBank: Diclofenac (DB00586)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01187849
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Volunteers will be given Metformin or placebo for 1 month, once daily
Study: NCT01461057
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle
Study: NCT00866749
Drug: Intrathecal Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid
Study: NCT00866749
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Starting Dose 1g/m2 by vein in weeks 1 and 5
Study: NCT00866749
Drug: Mercaptopurine
Normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month
Study: NCT00866749
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10~+/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3
Study: NCT00866749
Drug: Doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 25 mg/m2 by vein in weeks 1, 2 and 3
Study: NCT00564824
Drug: Caffeine
Normalized name: Caffeine
DrugBank: Caffeine (DB00201)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Caffeine 200 mg tablet
Study: NCT00564824
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo pills
Study: NCT03184324
Drug: DWP14012
Approvals — FDA: no, EMA: no, PMDA: no
Description: tablet
Study: NCT03184324
Drug: DWP14012 placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: tablet
Study: NCT05037812
Drug: Multimodal injections
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5mg morphine, 500 micrograms epinephrine, and 4ml normal saline (superficial injection).~2.5mg morphine, 40 micrograms clonidine, 15mg ketorolac, and 4ml normal saline (deep injection).
Study: NCT00611871
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 40mg placebo, followed 2 hrs after with 60mg placebo
Study: NCT01362595
Drug: leucine
Normalized name: Leucine
DrugBank: Leucine (DB00149)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Dosage of leucine will be dependent on body surface area (BSA):~leucine 700 mg/m2/dose by mouth three times a day
Study: NCT03946670
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo is being administered i.v.
Study: NCT03946670
Drug: Hypomethylating agents
Approvals — FDA: no, EMA: no, PMDA: no
Description: Decitabine is being administered i.v. Azacitidine is being administered i.v or s.c.
Study: NCT02540720
Drug: Gamma globulin
Normalized name: Gamma globulin
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00146588
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
Study: NCT00146588
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given orally on days 4-17 of each 21-day treatment cycle for 12-18 weeks depending upon response.
Study: NCT03574324
Drug: TPF+CCRT
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients receive Neoadjuvant Docetaxel (75mg/m2 on day1 03:30-04:30) and cisplatin (75mg/m2 on day 1-5 10:00-22:00) and 5-FU(750mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 10:00-22:00)every 21 days for three cycles during radiotherapy
Study: NCT03567473
Drug: Nebulized Epinephrine
Normalized name: Epinephrine
DrugBank: Epinephrine (DB00668)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Two nebulized treatments of 3 mL 1:1000 epinephrine 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment
Study: NCT03567473
Drug: Oral placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Two doses of oral placebo, 0.6 mL/kg (maximum single dose 10 mL). One at the time of emergency department enrolment immediately prior to nebulized treatment and one at approximately 24 hour later . Oral placebo at Canadian sites is composed of OraBlendTM and in New Zealand and Australian sites will be a compounded solution.
Study: NCT03567473
Drug: MDI Epinephrine
Normalized name: Epinephrine
DrugBank: Epinephrine (DB00668)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Two doses of Epinephrine given by MDI plus spacer at 625 mcg (5 actuations of 125mcg) 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment.
Study: NCT04167280
Drug: placebo metered dose inhaler
Approvals — FDA: no, EMA: no, PMDA: no
Description: matched MDI to deliver inactive drug
Study: NCT01099280
Drug: SYNPITAN FORT 5 IU
Normalized name: Erythroped Forte
Approvals — FDA: no, EMA: no, PMDA: no
Description: A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved. Once started, oxytocin infusion was continued to delivery unless otherwise indicated. The pessary has been removed if it was still present 12 h after placement; or if worrisome FHR pattern persisted
Study: NCT04564118
Drug: Retrospective analysis of assigned treatment
Normalized name: Hongo Killer Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: analysis of treatment assigned by physicians within routine clinical practice
Study: NCT01099280
Drug: Propess,SYNPITAN FORT
Approvals — FDA: no, EMA: no, PMDA: no
Description: a single dose sustained-released dinoprostone into the posterior vaginal fornix. A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved
Study: NCT00674167
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Three cycles of chemotherapy will be administered before surgery with capecitabine at 750 mg/m² twice daily from day 1 to 14 in a 21 day treatment cycle.
Study: NCT02264301
Drug: Qingkailing injection 40 ml
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01637259
Drug: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors
Normalized name: Nucleoside and nucleotide reverse transcriptase inhibitors
Approvals — FDA: no, EMA: no, PMDA: no
Description: NRTI + PI
Study: NCT04535167
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be formulated for intravenous delivery
Study: NCT02396069
Drug: JPI-289
Approvals — FDA: no, EMA: no, PMDA: no
Description: PARP-1 inhibitor
Study: NCT02396069
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT00244166
Drug: prednisolone
Normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT04608513
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Soft capsules for oral administration
Study: NCT01946971
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03676959
Drug: ZKAB001 5mg/kg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5mg/kg/times bi-week IV administration of ZKAB001
Study: NCT03676959
Drug: ZKAB001 10mg/kg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10mg/kg/times bi-week IV administration of ZKAB001
Study: NCT03676959
Drug: ZKAB001 15mg/kg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 15mg/kg/times bi-week IV administration of ZKAB001
Study: NCT04213794
Drug: Doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Undergo HIPEC with doxorubicin and cisplatin
Study: NCT04225039
Drug: INCMGA00012
Approvals — FDA: no, EMA: no, PMDA: no
Description: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment
Study: NCT04225039
Drug: SRS
Normalized name: SRS-A
Approvals — FDA: no, EMA: no, PMDA: no
Description: administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy).
Study: NCT02916238
Drug: Fluoxetine
Normalized name: Fluoxetine
DrugBank: Fluoxetine (DB00472)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Fluoxetine prescribed and dispensed beginning at 10 mg daily; side effects and symptoms monitored biweekly; dosage increased to 20 mg., then by 20 mg. increments according to protocol algorithm based on PHQ-9 score to a maximum dose of 60 mg.
Study: NCT03456063
Drug: Placebo Comparator
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Study: NCT02902666
Drug: Paracetamol 500 mg/codeine phosphate hemihydrate 30 mg tablet
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03153410
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 200 mg/m\^2, intravenous (IV) infusion~Patients receive neoadjuvant immunotherapy consisting of cyclophosphamide and pembrolizumab on day 1, IMC-CS4 on days 1, 8, and 15, and GVAX on day 2 of Cycles 1 and 2 (3 weeks/cycle). Patients will then undergo pancreaticoduodenectomy 2-3 weeks later, followed by standard of care adjuvant chemotherapy at the discretion of the primary oncologist. Patients may then receive 4 cycles (3 weeks/cycle) of adjuvant immunotherapy (same regimen as Cycles 1 and 2). Disease free patients may receive an additional 12 booster cycles (3 weeks/cycle) of immunotherapy consisting of pembrolizumab on day 1 of all 12 booster cycles, as well as cyclophosphamide on day 1 and GVAX on day 2 of the 6th and 12th booster cycle.
Study: NCT00463268
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: identical placebo every 2 weeks
Study: NCT02187614
Drug: Diclofenac
Normalized name: Diclofenac
DrugBank: Diclofenac (DB00586)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02187614
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01892306
Drug: Treatment as usual
Normalized name: Hongo Killer Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: Existing optimized pharmacotherapy as delivered by treating psychiatrist
Study: NCT03408340
Drug: Standard of Care Anesthesia
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants in this arm will be induced for anesthesia with propofol 3mg/kg or ketamine 2mg/kg (if there is intravenous access) or sevoflurane with 1 mcg/kg of fentanyl and 1.2 mg/kg rocuronium once IV access is established. The patient will be intubated; intravenous and intra-arterial access will be obtained and the patient will be positioned for surgery. Fentanyl may be used as needed for additional analgesia and anesthesia will be maintained with sevoflurane. The skin will be infiltrated at the conclusion of surgery with less than 1 mL/kg of 0.25% bupivacaine with epinephrine 1:200,000.
Study: NCT04184492
Drug: NovoMix® 30 Penfill®
Approvals — FDA: no, EMA: no, PMDA: no
Description: biphasic insulin aspart 30 in doses 0.4 IU/kg