TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03299517
Drug: Antiarrythmic Drugs
Normalized name: ANTIARRHYTHMICS
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patient will be randomly randomized 1: 1 for the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes.
Study: NCT01279538
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous (IV) infusion
Study: NCT01803399
Drug: GSK1322322 1200 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: GSK1322322 will be supplied as white to slightly colored lyophilized powder 400 mg/vial for injection. Single dose of GSK1322322 1200 mg (3 vials) will be administered IV over 60 minutes
Study: NCT01803399
Drug: GSK1322322 3000 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: GSK1322322 will be supplied as white to slightly colored lyophilized powder 400 mg/vial for injection. Single dose of GSK1322322 3000 mg (8 vials) will be administered IV over 60 minutes
Study: NCT01803399
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be supplied as 0.9% sodium chloride solution. Single dose of placebo will be administered IV over 60 minutes
Study: NCT00003243
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00003243
Drug: pegylated liposomal doxorubicin hydrochloride
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02344628
Drug: Azithromycin
Normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Comparison of two different dosing strategies for the treatment of yaws
Study: NCT02673593
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01762540
Drug: Glucocorticoids
Normalized name: GLUCOCORTICOIDS
Approvals — FDA: no, EMA: no, PMDA: no
Description: Prednisolone 37.5 mg x1 for 5 days
Study: NCT01762540
Drug: Calcium Supplement
Normalized name: Calcium supplement
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT01797198
Drug: ASP3652
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral
Study: NCT00174616
Drug: Oxaliplatin, capecitabine, radiotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: * Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses~* Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks~* Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks
Study: NCT03681652
Drug: Azathioprine
Normalized name: Azathioprine
DrugBank: Azathioprine (DB00993)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Children with Crohn's disease who are treated with azathioprine for post-operative prophylaxis following ileo-cecal resection
Study: NCT03681652
Drug: Anti-TNF Drug
Normalized name: Anti Bac
Approvals — FDA: no, EMA: no, PMDA: no
Description: Children with Crohn's disease who are treated with anti-TNF monotherapy for post-operative prophylaxis following ileo-cecal resection
Study: NCT01324505
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.
Study: NCT01324505
Drug: Microgyn®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Microgyn® will be given as once daily oral dosing in two periods, each of 8 days' duration. One tablet contains levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg.
Study: NCT01031030
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01031030
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01031030
Drug: methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00000494
Drug: indomethacin
Normalized name: Indomethacin
DrugBank: Indomethacin (DB00328)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01977209
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02353260
Drug: Docetaxel,Cisplatin,Fluorouracil
Approvals — FDA: no, EMA: no, PMDA: no
Description: Squamous cell carcinoma of head and neck: Docetaxel(75mg/m²,d1/21d,2 cycles);Cisplatin(75mg/m²,d1/21d,2 cycles);Fluorouracil(750mg/m²/d,d1-5/21d, 2 cycles)
Study: NCT02064439
Drug: BAY 59-7939
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10 mg tablet once daily for 12 months
Study: NCT02064439
Drug: BAY 59-7939
Approvals — FDA: no, EMA: no, PMDA: no
Description: 20 mg tablet once daily for 12 months
Study: NCT00279552
Drug: Recombinant human intrinsic factor
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00938522
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the placebo group received 200 mg of placebo 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months.
Study: NCT03437707
Drug: Intravenous paracetamol
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 g paracetamol will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Study: NCT03437707
Drug: Intravenous ibuprofen
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 800 mg ibuprofen (diluted with 250 ml saline) will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Study: NCT04080323
Drug: Dinoprostone 3 mg
Normalized name: dinoprostone 3 MG
DrugBank: Dinoprostone (DB00917)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery
Study: NCT02234583
Drug: DS-5565
Normalized name: Uretron DS
Approvals — FDA: no, EMA: no, PMDA: no
Description: DS-5565 15 mg tablet for oral administration
Study: NCT04080323
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 vaginal tablet of placebo 60 minutes before surgery
Study: NCT00649012
Drug: Actos® Tablets 45 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 45mg, single dose fed
Study: NCT00752375
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: * Placebo matching Trimethoprim Sulfamethoxazole (2mg/kg Trimethoprim component)for children more than 3 months of age~* Placebo matching amoxicillin 10mg/kg once per day for children under 3 months of age~* Placebo matching nitrofurantoin (1mg/kg) once per day for children with a sulfa allergy.
Study: NCT02134314
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose at 24 hours post-operatively. Total: 2 doses
Study: NCT00344682
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5mg - 20mg PO daily over 8 weeks
Study: NCT00257192
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo matching the oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing \<45 kg, the doses will range from 20 mg BID to 40 mg BID.
Study: NCT04641364
Drug: recombinant human albumin injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: single dose or multiple doses of intravenous infusion
Study: NCT04641364
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single dose intravenous infusion of 0.9% sodium chloride injection
Study: NCT00875784
Drug: IMITREX® (4mg)
Approvals — FDA: no, EMA: no, PMDA: no
Description: sumatriptan succinate injection (4mg) administered using the IMITREX STATdose System®
Study: NCT00875784
Drug: IMITREX® (6mg)
Approvals — FDA: no, EMA: no, PMDA: no
Description: sumatriptan succinate injection (6mg) administered using the IMITREX STATdose System®
Study: NCT00875784
Drug: IMITREX Tablet 100mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet
Study: NCT01123278
Drug: Testosterone
Normalized name: Testosterone
DrugBank: (1,2,6,7-3H)Testosterone (DB14093)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Testosterone transdermal gel 50 mg/day (5 gr)
Study: NCT03429543
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 film-coated tablet of either Linagliptin or Empagliflozin matched placebo once daily.
Study: NCT01035255
Drug: LCZ696 200 mg BID
Approvals — FDA: no, EMA: no, PMDA: no
Description: LCZ696 200 mg BID
Study: NCT01461954
Drug: FST-100 Vehicle
Normalized name: Neisseria meningitidis group B strain NZ98/254 outer membrane vesicle
Approvals — FDA: no, EMA: no, PMDA: no
Description: FST-100 Vehicle
Study: NCT03347331
Drug: [18F]F13640
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2 Radiotracer injections and PET scan acquisition of 90 min distant from 1 to 3 weeks: For each exam: 150 MBq + 1 MBq/kg of \[18F\]F13640 at t=0 min
Study: NCT03575520
Drug: Doxorubicin/Cyclophosphamide(AC) treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: doxorubicin 60mg/m2 IV every 2 weeks cyclophosphamide 600mg/m2 IV every 2 weeks~Four cycles of dose dense AC treatment will be given every 2 weeks.
Study: NCT01599468
Drug: saline serum
Approvals — FDA: no, EMA: no, PMDA: no
Description: The Placebo group received normal saline with the same volumes
Study: NCT03823417
Drug: Normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Normal saline infusion
Study: NCT03369301
Drug: Gammanorm
Approvals — FDA: no, EMA: no, PMDA: no
Description: Gammanorm given per standard of care
Study: NCT03369301
Drug: Other Subcutaneous Immunoglobulins
Normalized name: immunoglobulin A
Approvals — FDA: no, EMA: no, PMDA: no
Description: Other Subcutaneous Immunoglobulins given per standard of care
Study: NCT01373567
Drug: TINEFCON
Approvals — FDA: no, EMA: no, PMDA: no
Description: Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.
Study: NCT00003943
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 3 gm/m2
Study: NCT00047281
Drug: celecoxib
Normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00047281
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01727726
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: tablet/capsule
Study: NCT00543829
Drug: doxorubicin, docetaxel, tamoxifen
Approvals — FDA: no, EMA: no, PMDA: no
Description: Every 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion) with tamoxifen (30 mg tablet p.o. for 5 years post surgery)
Study: NCT00543829
Drug: doxorubicin, docetaxel
Approvals — FDA: no, EMA: no, PMDA: no
Description: Every 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion)
Study: NCT06261138
Drug: Transarterial chemoembolization
Approvals — FDA: no, EMA: no, PMDA: no
Description: A 5-French RH catheter was then introduced to the celiac artery, superior mesenteric and artery common hepatic artery for angiography to determine tumor location, quantity, size, and vascularity. After confirmation by C-arm cone-beam computed tomography (CBCT), chemoembolization was administered by superselective catheterization of the branches of the tumor-feeding arteries using a 2.8-French coaxial microcatheter. For cTACE, oxaliplatin, raltitrexed and an emulsion containing idarubicin and ethiodized oil were infused for over 20 minutes, followed by combined embolization with blank embolic microspheres. For DEB-TACE, DC/LC Beads® (Biocompatibles, Farnham, Surrey, UK), as drug carriers and embolic materials, were loaded with doxorubicin hydrochloride and mixed with nonionic contrast medium. Real-time assessment of embolization was performed with the assistance of CBCT.
Study: NCT04072146
Drug: Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Cross over bioavailability study
Study: NCT03901612
Drug: saline 09%
Approvals — FDA: no, EMA: no, PMDA: no
Description: Continuous post operative regional analgesia
Study: NCT00668434
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo capsules will look the same as the study medication but will not contain active medicine.
Study: NCT04238663
Drug: EU approved Avastin®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
Study: NCT04238663
Drug: US licenced Avastin®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
Study: NCT03596177
Drug: MEDI0382
Approvals — FDA: no, EMA: no, PMDA: no
Description: MEDI0382 will be administered subcutaneously, titrated up to 300 μg for 42 days (100 μg for 4 days, followed by 200 μg for 4 days, and finally 300 μg for 34 days) in double-blind treatment period.
Study: NCT04050592
Drug: Estradiol
Normalized name: Estradiol
DrugBank: Estradiol acetate (DB13952)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Active intervention is estradiol. Hormone therapy (HT) of all 150 participants will be standardized to 2.0 mg of oral estradiol (E2) without progestogen for six weeks prior to randomization. After that participants will be randomized into three groups (A, B, C) of equal size.
Study: NCT03596177
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered subcutaneously for 16 days in the single-blind treatment period in both MEDI0382 and placebo arms, and SC injection of placebo matched to MEDI0382 for 42 days in double-blind treatment period in placebo arm.
Study: NCT03184909
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo capsules of look alike inert substance for control
Study: NCT00406575
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.
Study: NCT03790982
Drug: Placebo of AD-35 60mg /AD-35 30mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo 60mg, oral, 1st 26 weeks; AD-35 30mg +Placebo of AD-35 30mg oral 2nd 26 weeks.
Study: NCT03790982
Drug: Placebo of AD-35 60mg /AD-35 60mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo 60mg, oral, 1st 26 weeks; AD-35 60mg oral, 2nd 26 weeks.
Study: NCT01921257
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02362711
Drug: NPC-16 Standard Dosing Regimen Group
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02362711
Drug: NPC-16 Continuous Dosing Regimen Group
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02362711
Drug: Placebo Group
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01061515
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01734941
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00092040
Drug: Comparator: risedronate / Duration of Intervention: 12 mo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01073527
Drug: hypertonic saline-salbutamol combination
Approvals — FDA: no, EMA: no, PMDA: no
Description: hypertonic saline 5% with 0.5cc salbutamol
Study: NCT00683579
Drug: Early Treatment with HAART
Normalized name: Hongo Killer Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: HAART with possibility of de-intensification
Study: NCT00683579
Drug: HAART Treatment - standard care
Approvals — FDA: no, EMA: no, PMDA: no
Description: Initiation of HAART per DHHS guidelines, i.e. starting treatment and CD4+ T cells less than 350 cells/mm3 or HIV RNA \>100,000 copies/ml
Study: NCT02199886
Drug: BIBH 1
Approvals — FDA: no, EMA: no, PMDA: no
Description: labeled with eight to ten millicurie of 131I
Study: NCT03790982
Drug: AD-35 30 mg + Placebo of AD-35 30 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: AD-35 30 mg + Placebo of AD-35 30 mg AD-35 30 mg + Placebo of AD-35 30 mg, Oral, 52 weeks.
Study: NCT01699594
Drug: Methacholine Chloride
Normalized name: Methacholine Chloride
Approvals — FDA: no, EMA: no, PMDA: no
Description: Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)
Study: NCT02167633
Drug: Glucocorticoids
Normalized name: GLUCOCORTICOIDS
Approvals — FDA: no, EMA: no, PMDA: no
Description: All patients referred with clinical suspicion of metastatic spinal cord compression will receive high dose glucocorticoids. Dose adjusted to risc of side effects.
Study: NCT04376541
Drug: Fentanyl
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: amount of fentanyl used in both groups
Study: NCT01605071
Drug: Estradiol
Normalized name: Estradiol
DrugBank: Estradiol acetate (DB13952)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 1 week of transdermal estradiol (0.15mg)~1 week of transdermal placebo
Study: NCT02401750
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matches both experimental drugs
Study: NCT00624572
Drug: chlorexidine
Approvals — FDA: no, EMA: no, PMDA: no
Description: Chlorexidine gel 1% during 7 days inside root canals
Study: NCT03811223
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo subcutaneous injection every 2 weeks for 12 weeks
Study: NCT01294735
Drug: MK-4827
Normalized name: vitamin MK 7
Approvals — FDA: no, EMA: no, PMDA: no
Description: MK-4827 in combination with temozolomide utilizing a number of doses and schedules for both drugs will be explored to determine a preliminary MTD. The preliminary MTD will then be confirmed in participants with melanoma and glioblastoma multiforme.
Study: NCT02874690
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo pill identical in appearance to methylphenidate
Study: NCT01670513
Drug: IDP-118 Low Strength
Approvals — FDA: no, EMA: no, PMDA: no
Description: 8 weeks
Study: NCT00648076
Drug: Depakote ER® Tablets 500 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 500mg, single dose fed
Study: NCT04344405
Drug: Steroid Drug
Approvals — FDA: no, EMA: no, PMDA: no
Description: control
Study: NCT00436566
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00032019
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 750 mg/sq m IV infusion on Day 5 Cycle 1 Subsequent cycle dosage based on previous cycle or day 1 treatment toxicities
Study: NCT00032019
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 10 mg/sq m/day continuous IV infusion on Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and Day 1 treatment toxicities
Study: NCT04504032
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
Study: NCT01504854
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily.
Study: NCT00578864
Drug: Doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given together with cyclophosphamide for cycle 3 and 5 of induction chemotherapy Day 1 and 2~* Hours 0 to 6: Cyclophosphamide 2000 mg/m2 (67 mg/kg if \< 12 kg) with Mesna 400 mg/m2 (13 mg/kg if \< 12 kg) in D5½NS 600 mL/m2 IV over 6 hours to run at 100 mL/m2/hr~* Hours 6 to 6.25: Doxorubicin 37.5 mg/m2 (1.25 mg/kg if \< 12 kg) IV over 15 minutes
Study: NCT00578864
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Cycle 3 and 5 with doxorubicin
Study: NCT00578864
Drug: Hematopoietic Factor
Normalized name: Hematopoietic factor
Approvals — FDA: no, EMA: no, PMDA: no
Description: Standard weight-based dosing after cycle 3 and 5 and if needed for neutropenic recovery after cycles 1,2 and 4
Study: NCT00771459
Drug: Isotonic NaCl
Normalized name: ISOTON
Approvals — FDA: no, EMA: no, PMDA: no
Description: Local infiltration analgesia
Study: NCT00210015
Drug: INS37217 Nasal Spray
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02183025
Drug: Meloxicam 15 mg
Normalized name: meloxicam 15 MG
DrugBank: Meloxicam (DB00814)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02183025
Drug: Placebo matching 7.5 mg meloxicam
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02183025
Drug: Placebo matching 15 mg meloxicam
Normalized name: meloxicam 15 MG
DrugBank: Meloxicam (DB00814)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02183025
Drug: Placebo matching 500 mg mefenamic acid
Normalized name: placebo 500 MG
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02191202
Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
Normalized name: Non-nucleoside reverse transcriptase inhibitors
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01729403
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: orally daily, 16 weeks
Study: NCT00745485
Drug: zoledronic acid
Normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT03969901
Drug: IMI/REL
Approvals — FDA: no, EMA: no, PMDA: no
Description: Age-based dosing:~* 12 to \<18 years, IMI 500 and REL 250 mg, IV infusion every 6 hours~* 2 to \<12 years, IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours~* 3 months to \<2 years, IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours~* Birth to \<3 month, IMI 15 and REL 7.5 mg/kg, IV infusion every 8 hours NOTE: Participants with cIAI or cUTI may be switched to oral therapy after at least 3 days of IV study intervention.
Study: NCT01667575
Drug: Clarithromycin
Normalized name: Clarithromycin
DrugBank: Clarithromycin (DB01211)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: antibiotic of the quadruple therapy