AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT00869050
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Trial: NCT01711229
Drug: IV acetaminophen
RxNorm normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ofirmev will be given 15 minutes prior to going to the OR
Trial: NCT01711229
Drug: oral acetaminophen
RxNorm normalized name: acetaminophen Oral Capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral acetaminophen will be given preoperatively
Trial: NCT00610441
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01173029
Drug: Anti-hypertensive drug treatment
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anti-hypertensive drug treatment was non-investigational. Drug regimen, including which drug and the number of drugs prescribed, was left at discretion of the physician who carried primary assistance.
Trial: NCT02388594
Drug: ZFN Modified CD4+ T Cells
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02388594
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01869361
Drug: Indomethacin
RxNorm normalized name: Indomethacin
DrugBank: Indomethacin (DB00328)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Study drug
Trial: NCT01869361
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Control drug
Trial: NCT00042068
Drug: Meloxicam
RxNorm normalized name: Meloxicam
DrugBank: Meloxicam (DB00814)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00777179
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT00787787
Drug: capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given PO
Trial: NCT04671082
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TID
Trial: NCT00554398
Drug: MK-0518 400mg twice a day
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Raltegravir, MK-0518
Trial: NCT01445522
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT04492709
Drug: AZD5718
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The subjects will receive oral AZD5718 tablet once daily starting on Day 2 to Day 6 in Treatment Period 2 and on Day 7 co-administered with midazolam in Treatment Period 3.
Trial: NCT02696499
Drug: PA101B
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 40 mg PA101B administered via inhalation twice daily for 7 weeks
Trial: NCT02696499
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo administered via inhalation twice daily for 7 weeks
Trial: NCT02256267
Drug: LY2835219
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT01386541
Drug: BYK324677
FDA approved: no
EMA approved: no
PMDA approved: no
Description: capsules, administered orally
Trial: NCT01587638
Drug: cardio selective betablocker
FDA approved: no
EMA approved: no
PMDA approved: no
Description: atenolol, metoprolol succinate, and metoprolol tartrate
Trial: NCT03093389
Drug: BIA 6-512
RxNorm normalized name: Oatmeal 10 mg in 1 mL TOPICAL CREAM [BIA Eczema Relief]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The investigational products consisted of capsules containing BIA 6-512 25 mg, 50 mg, 100 mg and 150 mg. Products were administered orally, with approximately 240 mL of water in case of Doses 1 and 13, and at least 150 mL of water in case of Doses 2 to 12. First dose (Dose 1) and last dose (Dose 13) were administered in fasting of at least 8 hours and subject remained fasted until to 2.5 h post-dose. Meals were not served within 1 hour prior and 1 hour after investigational product administration in Doses 2 to 12
Trial: NCT03093389
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo capsules
Trial: NCT03359057
Drug: ethinyl estradiol + levonorgestrel + folic acid
RxNorm normalized name: estradiol / ethinyl estradiol / levonorgestrel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One coated tablet of ethinyl estradiol + levonorgestrel + folic acid, 0.02 mg + 0.10 mg + 0.4 mg for 21 days in 3 cycles (12 weeks).
Trial: NCT03359057
Drug: Folic Acid
RxNorm normalized name: Folic Acid
DrugBank: Folic acid (DB00158)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: One coated tablet of folic acid 0.4 mg for 7 days in 3 cycles (12 weeks).
Trial: NCT04573426
Drug: Acetaminophen
RxNorm normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1,000mg liquid acetaminophen
Trial: NCT04573426
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Liquid placebo solution
Trial: NCT00493636
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Trial: NCT00493636
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
Trial: NCT02282371
Drug: BYL719
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01741532
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A deferiprone matching placebo oral solution will be given twice daily for 18 months.
Trial: NCT02741570
Drug: Fluorouracil/Adrucil
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01151605
Drug: insulin infusion
RxNorm normalized name: iLet Insulin Infusion 10-Pack Kit Inset
FDA approved: no
EMA approved: no
PMDA approved: no
Description: insulin to be infused at 3.5 units/hour along with Dextrose 12.5% at a rate to achieve blood glucose levels between 80-120mg/dl
Trial: NCT01151605
Drug: Saline Infusion
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Saline will be infused at 100ml/hr
Trial: NCT03453255
Drug: Chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Description: chidamide, decitabine, homoharringtonine, cytarabine
Trial: NCT00932620
Drug: SIMVASTATIN 40 mg
RxNorm normalized name: simvastatin 40 MG
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: SIMVASTATIN 40 mg/day for 3 months
Trial: NCT00932620
Drug: SIMVASTATIN/EZETIMIBE 10/10 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SIMVASTATIN/EZETIMIBE 10/10 mg/day for 3 months
Trial: NCT01845584
Drug: NPB-01
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02370537
Drug: Epanova® (omega-3 carboxylic acids)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 4 g (administered orally as 4 x 1 g capsules)
Trial: NCT02370537
Drug: Omacor® (omega-3-acid ethyl esters)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 4 g (administered orally as 4 x 1 g capsules)
Trial: NCT00303446
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matched placebo
Trial: NCT00979368
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
Trial: NCT01777555
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03415698
Drug: Standard Medical Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics.
Trial: NCT00689000
Drug: CHR-2797 (tosedostat): Aminopeptidase inhibitor
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Phase I: Once daily, oral ingestion of CHR-2797 capsules (60mg, 90mg, 130mg or 180mg) depending on cohort~Phase II: Once daily, oral ingestion of 130mg CHR-2797 (recommended dose from Phase I) until progressive disease or withdrawal from the study
Trial: NCT00593853
Drug: Matched Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Run in period of 5mg QD,PO for 2 weeks followed by 5mg BID,PO for 8 weeks (full daily dose of 10mg). Followed by a 2 week taper period of 5mg QD,PO to complete 12 week cycle.
Trial: NCT00004446
Drug: fluoxetine
RxNorm normalized name: Fluoxetine
DrugBank: Fluoxetine (DB00472)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02068846
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
Trial: NCT02093988
Drug: Topical TXA
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02093988
Drug: Intravenous TXA
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04205851
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Saline
Trial: NCT03411252
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sugar pill manufactured to mimic Mirabegron
Trial: NCT01967823
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Trial: NCT03690739
Drug: PLD
RxNorm normalized name: PLD1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administration according to investigator's discretion
Trial: NCT03690739
Drug: PLD
RxNorm normalized name: PLD1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administration 30 mg/m² q21
Trial: NCT01332188
Drug: AC-170 0.05%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 drop in each eye at 3 separate times during a 21 day period
Trial: NCT01332188
Drug: AC-170 0.1%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 drop in each eye at 3 separate times during a 21 day period
Trial: NCT01332188
Drug: AC-170 0.24%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 drop in each eye at 3 separate times during a 21 day period
Trial: NCT01332188
Drug: AC-170 0%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 drop in each eye at 3 separate times during a 21 day period
Trial: NCT01364805
Drug: Intravenous Vitamin C
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The first 5 study visits will all take place in the General Clinical Research Center (GCRC). During these visits you will receive IV doses of Vitamin C. The dose of Vitamin C will be started at 25 grams and may be increased up to 125 grams over a two week period. There may be changes in the amount of Vitamin C that you receive based on your blood test levels. The study staff will go over this in more detail with you. The amount of fluid you receive depends on the dose and can be from 2 1/3 cups to 5 cups.
Trial: NCT00951522
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhaled placebo in sterile saline
Trial: NCT00827281
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dosage prior to sessions 3, 4 \& 5
Trial: NCT01689623
Drug: TMC435
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Type=exact number, unit=mg, number=150, form=capsule, route=oral. TMC435 will be administered at a dose of 150 mg once daily from Day 4 until Day 15.
Trial: NCT01689623
Drug: Simvastatin
RxNorm normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Type=exact number, unit=mg, number=40, form=tablet, route=oral. Simvastatin will be administered as a single oral 40-mg on Day 1 and Day 13.
Trial: NCT00369226
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Infusion for a total of 4 doses
Trial: NCT00525733
Drug: FTC 200 mg/TDF 300mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)
Trial: NCT03659149
Drug: CKD-333 formulation I
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 tablet administered before the breakfast(single-dose)
Trial: NCT03659149
Drug: CKD-333 formulation II
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 tablet administered before the breakfast(single-dose)
Trial: NCT02238314
Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI)
RxNorm normalized name: Non-nucleoside reverse transcriptase inhibitors
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02238314
Drug: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
RxNorm normalized name: Non-nucleoside reverse transcriptase inhibitors
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02947165
Drug: PDR001
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anti-PD-1 antibody tested on a Q3W regimen or alternative Q4W regimen.
Trial: NCT02638207
Drug: NewGam
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In the Dose-evaluation Phase, all patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5, 1.0 or 2.0 g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days). If a patient is randomized to receive the low or medium NewGam dose, the same volume with the same infusion rate as would have been applied in case the patient would have been randomized to 2.0 g/kg NewGam will be used, thus supplemented with an authorized 0.9% w/v isotonic sodium chloride solution as appropriate and detailed in the following infusion bag split to maintain the blinding
Trial: NCT02472223
Drug: Betadine 5%
RxNorm normalized name: Betadine 5% Topical Spray
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage.~Betadine 5% exposure to the ocular surface is limited to 2 minutes in-office administration, followed by saline lavage per labeling instructions.
Trial: NCT02969681
Drug: ascorbic acid
RxNorm normalized name: Ascorbic Acid
DrugBank: Ascorbic acid (DB00126)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1.5g/kg/day, D1-3, every 2 weeks
Trial: NCT02969681
Drug: Chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Description: * mFOLFOX6~* Oxaliplatin 85 mg/m² d1 concurrent with~* Leucovorin 400 mg/m², followed by~* Bolus 5FU 400 mg/m² , followed by~* Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks~with or without bevacizumab 5mg/kg, every 2 weeks
Trial: NCT01735669
Drug: Remifentanil
RxNorm normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00150228
Drug: CP-526,555 (varenicline)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02165293
Drug: RO7033877 + Bronchoscopy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Days 1, 2, and 3: 2.5 mg/kg RO7033877 infused IV over 2 hours, every 8 hours for a total of 7 doses; BAL procedure on Day 3.
Trial: NCT02435680
Drug: MCS110
FDA approved: no
EMA approved: no
PMDA approved: no
Description: taken by I.V
Trial: NCT02521233
Drug: Candesartan + Chlorthalidone (8mg+12,5mg)
RxNorm normalized name: candesartan cilexetil 8 MG
DrugBank: Candesartan cilexetil (DB00796)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02521233
Drug: Candesartan + Chlorthalidone (8 mg + 25 mg)
RxNorm normalized name: chlorthalidone 25 MG
DrugBank: Chlorthalidone (DB00310)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02521233
Drug: losartan+hydrochlorothiazide
RxNorm normalized name: hydrochlorothiazide / losartan
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01777542
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive twice daily subcutaneous injections of a saline solution (placebo).
Trial: NCT01386242
Drug: Recombinant anti-tumor and anti-virus protein for injection
RxNorm normalized name: Anti Bac
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Recombinant anti-tumor and anti-virus protein for injection,10μg,im,twice per week for first 2 weeks, followed by 20μg, im, twice per week after 2 weeks
Trial: NCT01386242
Drug: Recombinant anti-tumor and anti-virus protein for injection
RxNorm normalized name: Anti Bac
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Recombinant anti-tumor and anti-virus protein for injection, 10μg/1mL,im,three times per week for first 2 weeks, followed by 20μg,im, three times per week after 2 weeks.
Trial: NCT01386242
Drug: Recombinant anti-tumor and anti-virus protein for injection
RxNorm normalized name: Anti Bac
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, three times per week for first week, followed by 20μg for two weeks, and followed by 30μg for a week, and followed a maintenance dose of 40μg, the frequency of administration is three times per week.
Trial: NCT03217084
Drug: MI varnish GC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MI Varnish GC is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. MI Varnish also contains RECALDENT. Open the unit-dose package of Varnish. Use the applicator brush to thoroughly mix Varnish. Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. The treatment period for Varnish is minimally 4 hour.
Trial: NCT03217084
Drug: White varnish 3M
RxNorm normalized name: WHITE CURRANT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: White varnish 3M is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. Clinpro White Varnish contains an innovative tri-calcium phosphate.Open the unit-dose package of Varnish and dispense the entire content onto the round application guide provided with the packet. Use the applicator brush to thoroughly mix Varnish. Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. The treatment period for Varnish is minimally 4 hour.
Trial: NCT01741831
Drug: No intervention
FDA approved: no
EMA approved: no
PMDA approved: no
Description: This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally for a period of 24 weeks. For treatment naive (never received treatment for AIDS) patients: Darunavir 800 mg will be adminstered along with ritonavir 100 mg once daily. For experienced patients: Darunavir 600 mg will be administered along with ritonavir 100 mg twice daily.
Trial: NCT04006210
Drug: Oral IR-LD/CD
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Encapsulated LD/CD 100mg/25mg
Trial: NCT04006210
Drug: Placebo for Oral IR-LD/CD
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Encapsulated Placebo for LD/CD 100mg/25mg
Trial: NCT00338273
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablets, Oral, 0 mg, Once daily, 8 weeks.
Trial: NCT00554619
Drug: GSK1325760A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2.5mg, 5mg or 10mg/day, po, GSK1325760A treatment will be continued until its approval by the MHLW.
Trial: NCT00571636
Drug: Fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: The experimental drug will be diluted according to each NICU scheme and administered as an attach dose of 1 mcg/kg in 30' followed by continuous i.v. infusion of 1 mcg/kg/h. Infusion of the experimental drug has to begin within 24 hrs from the beginning of MV and has to be continued until the end of MV and not after 7 days of life. If the newborn is still on MV after the 7th day of life he/she will be treated for pain according to local protocols.~Open label boluses of Fentanyl during the study phase will be administered, in both groups when the EDIN pain score is \> 6 and before performing the following invasive procedures:Peripherally inserted central venous catheter positioning;Re-intubation;Lumbar puncture;Pneumothorax or hydrothorax drainage.
Trial: NCT00571636
Drug: 5% glucose solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ev continuous infusion
Trial: NCT00343369
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00343369
Drug: doxorubicin hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00343369
Drug: mercaptopurine
RxNorm normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00343369
Drug: methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00343369
Drug: prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT04589351
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo
Trial: NCT01800942
Drug: Azithromycin and Placebo
RxNorm normalized name: cefixime and azithromycin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single oral dose of 2g of Azithromycin will be given to the women in labour