AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT04572997
Drug: Apremilast
RxNorm normalized name: Apremilast
DrugBank: Apremilast (DB05676)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Apremilast was taken orally twice daily (except Day 1). Patients received tablets in blister/bottles sufficient for one month. To mitigate potential gastrointestinal side effects (primarily mild-to-moderate nausea and diarrhoea), dose titration was implemented in this study in accordance with the Summary of Product Characteristics (SmPC). A titration pack included tablets of 10, 20 and 30 mg for a period of one month. During the first 5 days, the dosage was up-titrated. The initial dose on day 1 was 10 mg in the morning; this was increased to 10 mg in the morning and evening on day 2. The evening dose was further increased by 10 mg (to 20 mg) on day 3. On day 4, the morning dose was increased to 20 mg, so that 20 mg was taken twice daily, and on day 5 the evening dose was increased to 30 mg. From Day 6 onwards, patients received the 30 mg dose twice a day. Subsequent packs included only tablets of 30 mg strength.
Trial: NCT00801086
Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01)
DrugBank: Tempol (DB12449)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 200mL gel applied daily prior to radiation dose and removed immediately thereafter.
Trial: NCT00801086
Drug: alcohol-based gel
RxNorm normalized name: benzoyl peroxide
DrugBank: Benzoyl peroxide (DB09096)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 200mL gel applied daily prior to radiation dose and removed immediately thereafter
Trial: NCT02515656
Drug: POLYGYNAX®
DrugBank: Poly(lactic acid) (DB15037)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01232569
Drug: Tocilizumab 162 mg
RxNorm normalized name: tocilizumab 162 MG in 0.9 ML Auto-Injector
DrugBank: Tocilizumab (DB06273)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Tocilizumab will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.
Trial: NCT01136746
Drug: Insulin glargine
RxNorm normalized name: Insulin Glargine
DrugBank: Insulin glargine (DB00047)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)
Trial: NCT02435797
Drug: Nicorandil
RxNorm normalized name: nicorandil
DrugBank: Nicorandil (DB09220)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the right (or left) femoral artery or radial artery using the Seldinger method.The guidewire was passed into the culprit lesion. Subjects in the NicorandilGroup were then given 2 mg intracoronary nicorandil through the lesions via thrombus aspiration catheter, and an additional intracoronary dose of 2 mg nicorandil before stent implantation. A minimum 5-min interval occurred between the first and second doses of nicorandil to reduce adverse effects.
Trial: NCT02603861
Drug: Modafinil
RxNorm normalized name: Modafinil
DrugBank: Modafinil (DB00745)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Modafinil administered orally.
Trial: NCT00318981
Drug: Concerta
RxNorm normalized name: Concerta
DrugBank: Methylphenidate (DB00422)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00405912
Drug: St. John's Wort-900 mg/day
DrugBank: St. John's Wort (DB01323)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: St. John's Wort - 300 mg tables -3 times per day
Trial: NCT00405912
Drug: St. John's Wort-1800mg/day
DrugBank: St. John's Wort (DB01323)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: St. John's Wort - 600 mg tables - 3 times per day
Trial: NCT03730662
Drug: Tirzepatide
RxNorm normalized name: Tirzepatide
DrugBank: Tirzepatide (DB15171)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Administered SC.
Trial: NCT03730662
Drug: Insulin Glargine
RxNorm normalized name: Insulin Glargine
DrugBank: Insulin glargine (DB00047)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Administered SC
Trial: NCT01965145
Drug: Gevokizumab
RxNorm normalized name: Gevokizumab
DrugBank: Gevokizumab (DB12119)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sterile solution administered subcutaneously
Trial: NCT03022045
Drug: risankizumab
RxNorm normalized name: RISANKIZUMAB
DrugBank: Risankizumab (DB14762)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: risankizumab administered by subcutaneous injection
Trial: NCT01906658
Drug: Repository corticotropin injection
RxNorm normalized name: Repository Corticotropin Injection
DrugBank: Corticotropin (DB01285)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks
Trial: NCT01204593
Drug: INSULIN GLARGINE
RxNorm normalized name: Insulin Glargine
DrugBank: Insulin glargine (DB00047)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day at bedtime
Trial: NCT01204593
Drug: INSULIN GLULISINE
RxNorm normalized name: Insulin Glulisine
DrugBank: Insulin glulisine (DB01309)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal
Trial: NCT01359514
Drug: Pregabalin
RxNorm normalized name: Pregabalin
DrugBank: Pregabalin (DB00230)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 5 weeks
Trial: NCT01202097
Drug: Salmeterol/Fluticasone
DrugBank: Salmeterol (DB00938)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT01202097
Drug: Seretide
RxNorm normalized name: seractide
DrugBank: Fluticasone propionate (DB00588)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT01359514
Drug: Duloxetine
RxNorm normalized name: Duloxetine
DrugBank: Duloxetine (DB00476)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 5 weeks
Trial: NCT04838145
Drug: Ribavirin + Pleconaril
RxNorm normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Randomized to treatment with study drugs (ribavirin and pleconaril)
Trial: NCT02503306
Drug: AVANAFIL
RxNorm normalized name: Avanafil
DrugBank: Avanafil (DB06237)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Pharmaceutical form:tablets Route of administration: oral
Trial: NCT00912054
Drug: DuoTrav APS
RxNorm normalized name: AP-101
DrugBank: AP-101 (DB17947)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: travoprost APS 40 micrograms/ml / timolol 5 mg/ml, Eye Drops, Solution, once daily
Trial: NCT00912054
Drug: Xalacom
DrugBank: Timolol (DB00373)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: XALACOM® (latanoprost 50 micrograms/ml / timolol 5 mg/ml) Eye Drops, Solution
Trial: NCT03470103
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
RxNorm normalized name: Eylea
DrugBank: Aflibercept (DB08885)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Use of intravitreal aflibercept in routine clinical practice in Latin America
Trial: NCT03564379
Drug: JNJ-42165279
RxNorm normalized name: JNJ-42165279
DrugBank: JNJ-42165279 (DB15173)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 25 mg JNJ-42165279 tablet will be administered orally.
Trial: NCT02986659
Drug: Metformin
RxNorm normalized name: Metformin
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT01537900
Drug: Grazoprevir
RxNorm normalized name: Grazoprevir
DrugBank: Grazoprevir (DB11575)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: GZR 100 mg tablet by mouth q.d. for 7 days.
Trial: NCT00540384
Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
RxNorm normalized name: Darbepoetin Alfa
DrugBank: Darbepoetin alfa (DB00012)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Trial: NCT01250847
Drug: Quetiapine(Seroquel-XR) 50~800mg a day
DrugBank: Quetiapine (DB01224)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The only ARMS subjects will be given 50\~800mg Seroquel-XR once daily for total of 12 weeks.
Trial: NCT01940523
Drug: Topical Tranexamic Acid
RxNorm normalized name: Tranexamic Acid
DrugBank: Tranexamic acid (DB00302)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.
Trial: NCT01940523
Drug: Intravenous Tranexamic Acid
RxNorm normalized name: Tranexamic Acid
DrugBank: Tranexamic acid (DB00302)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Trial: NCT01120561
Drug: trastuzumab-MCC-DM1
RxNorm normalized name: Trastuzumab-MCC-DM1
DrugBank: Trastuzumab emtansine (DB05773)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Intravenous repeating dose
Trial: NCT02915354
Drug: Etanercept
RxNorm normalized name: Etanercept
DrugBank: Etanercept (DB00005)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Etanercept must be discontinued. Cotherapy with disease modifying anti-rheumatic drugs or non-steroidal anti-inflammatory drugs could be continued if maintained at a stable dose for at least 4 weeks.
Trial: NCT03704571
Drug: Polyethylene Glycol
RxNorm normalized name: Polyethylene Glycol
DrugBank: Polyethylene glycol (DB09287)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens.~In the control group, all the patients are given routine regimens.
Trial: NCT00978497
Drug: Peginterferon
RxNorm normalized name: PEGINTERFERON
DrugBank: Peginterferon alfa-2a (DB00008)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 180 μg dose via subcutaneous injection weekly
Trial: NCT00978497
Drug: Ribavirin
RxNorm normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: oral 1000 mg/day for patients who weighed \< 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg
Trial: NCT00000578
Drug: beclomethasone
RxNorm normalized name: Beclomethasone
DrugBank: Beclomethasone dipropionate (DB00394)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02512861
Drug: Bupivacaine
RxNorm normalized name: Bupivacaine
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:~Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs
Trial: NCT04493138
Drug: Azacitidine
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given SC or IV
Trial: NCT04493138
Drug: Quizartinib
RxNorm normalized name: quizartinib
DrugBank: Quizartinib (DB12874)
FDA approved: no
EMA approved: no
PMDA approved: yes
Description: Given PO
Trial: NCT02296723
Drug: Valganciclovir Hydrochloride
RxNorm normalized name: Valganciclovir Hydrochloride
DrugBank: Valganciclovir (DB01610)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Valganciclovir Hydrochloride Tablets 450 mg
Trial: NCT04567602
Drug: PAH medication
RxNorm normalized name: PAH
DrugBank: Aminohippuric acid (DB00345)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: There will be no specific interventions.
Trial: NCT04335591
Drug: 75 mg linzagolix tablet
RxNorm normalized name: linzagolix
DrugBank: Linzagolix (DB17083)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For oral administration once daily
Trial: NCT04335591
Drug: 200 mg linzagolix tablet
RxNorm normalized name: linzagolix
DrugBank: Linzagolix (DB17083)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For oral administration once daily
Trial: NCT04335591
Drug: Placebo tablet to match 75 mg linzagolix tablet
RxNorm normalized name: linzagolix
DrugBank: Linzagolix (DB17083)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For oral administration once daily
Trial: NCT04335591
Drug: Placebo tablet to match 200 mg linzagolix tablet
RxNorm normalized name: linzagolix
DrugBank: Linzagolix (DB17083)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For oral administration once daily
Trial: NCT04335591
Drug: Add-back capsule (E2 1 mg / NETA 0.5 mg)
RxNorm normalized name: Pep-Back
DrugBank: Caffeine (DB00201)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: For oral administration once daily
Trial: NCT00302406
Drug: methylphenidate hydrochloride
RxNorm normalized name: Methylphenidate Hydrochloride
DrugBank: Methylphenidate (DB00422)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00302406
Drug: OROS methylphenidate hydrochloride (CONCERTA)
RxNorm normalized name: methylphenidate hydrochloride Extended Release Oral Tablet [Concerta]
DrugBank: Methylphenidate (DB00422)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT04394234
Drug: Warfarin
RxNorm normalized name: Warfarin
DrugBank: Warfarin (DB00682)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Data of participants newly exposed to warfarin from 19-Oct-2010 to 31-Dec-2018 will be assessed. No study drug treatment will be administered as part of this observational study.
Trial: NCT04033458
Drug: JNJ-64140284
RxNorm normalized name: JNJ-42847922
DrugBank: Seltorexant (DB14961)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive JNJ-64140284 orally.
Trial: NCT02254681
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02254681
Drug: Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02431702
Drug: Aripiprazole
RxNorm normalized name: Aripiprazole
DrugBank: Aripiprazole (DB01238)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Aripiprazole will be administered in accordance with the label or Investigator's discretion
Trial: NCT02431702
Drug: Haloperidol
RxNorm normalized name: Haloperidol
DrugBank: Haloperidol (DB00502)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Haloperidol will be administered in accordance with the label or Investigator's discretion
Trial: NCT02431702
Drug: Olanzapine
RxNorm normalized name: Olanzapine
DrugBank: Olanzapine (DB00334)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Olanzapine will be administered in accordance with the label or Investigator's discretion
Trial: NCT02431702
Drug: Oral Paliperidone ER
RxNorm normalized name: paliperidone Extended Release Oral Tablet
DrugBank: Paliperidone (DB01267)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Paliperidone Extended Release (ER) tablets 1.5 to 12 milligram (mg) per day will be administered orally.
Trial: NCT02431702
Drug: Perphenazine
RxNorm normalized name: Perphenazine
DrugBank: Perphenazine (DB00850)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Perphenazine will be administered in accordance with the label or Investigator's discretion
Trial: NCT02431702
Drug: Quetiapine
RxNorm normalized name: Quetiapine
DrugBank: Quetiapine (DB01224)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Quetiapine will be administered in accordance with the label or Investigator's discretion
Trial: NCT02431702
Drug: Oral Risperidone
RxNorm normalized name: Risperidone
DrugBank: Risperidone (DB00734)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Risperidone tablets 1-6 mg per day will be administered orally.
Trial: NCT02431702
Drug: Paliperidone Palmitate Injection (PP1M)
RxNorm normalized name: Paliperidone Palmitate
DrugBank: Paliperidone (DB01267)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Participants will receive 5 doses of PP1M. First dose at a starting dose of 234 mg on Day 1 and a second dose of 156 mg on Day 8 and then 78 to 234 mg (in 3 flexible doses), every month up to Day 92.
Trial: NCT02431702
Drug: Paliperidone Palmitate Injection (PP3M)
RxNorm normalized name: Paliperidone Palmitate
DrugBank: Paliperidone (DB01267)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Paliperidone Palmitate injection (PP3M) will be administered once every 12 weeks intramuscularly. The initial dose will be calculated as 3.5 fold multiple of the final PP1M dose administered on Day 92 (or Day 176). Dose will be increased based on Investigator's discretion.
Trial: NCT02446457
Drug: Lenalidomide
RxNorm normalized name: Lenalidomide
DrugBank: Lenalidomide (DB00480)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given PO
Trial: NCT00922441
Drug: Fimasartan 60 mg group
RxNorm normalized name: Streptococcus viridans group
DrugBank: Fimasartan (DB09279)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fimasartan 60 mg
Trial: NCT00922441
Drug: Fimasartan 120 mg group
DrugBank: Fimasartan (DB09279)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fimasartan 120 mg
Trial: NCT01887990
Drug: Ketamine
RxNorm normalized name: Ketamine
DrugBank: Ketamine (DB01221)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: single dose IV 0.2 mg/kg ketamine
Trial: NCT01930877
Drug: Lidocaine
RxNorm normalized name: Lidocaine
DrugBank: Lidocaine (DB00281)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Lidocaine iv bolus followed by infusion
Trial: NCT03248713
Drug: Mifepristone
RxNorm normalized name: Mifepristone
DrugBank: Mifepristone (DB00834)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Mifepristone 600mg 2 tablets will be compared to the placebo
Trial: NCT02621047
Drug: Alectinib
RxNorm normalized name: Alectinib
DrugBank: Alectinib (DB11363)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Participants will receive alectinib as per the dosage schedule mentioned in arm description.
Trial: NCT01388478
Drug: R-pramipexole
DrugBank: Pramipexole (DB00413)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
Trial: NCT03694119
Drug: Phenelzine
RxNorm normalized name: Phenelzine
DrugBank: Phenelzine (DB00780)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Phenelzine
Trial: NCT03694119
Drug: Tyramine
RxNorm normalized name: tyramine
DrugBank: Tyramine (DB08841)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tyramine
Trial: NCT03405441
Drug: JNJ-55375515 Dose Level 1
RxNorm normalized name: peanut allergenic extract
DrugBank: Peanut (DB10553)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive JNJ-55375515 orally at a Dose level 1 in Part 1 of study.
Trial: NCT03694119
Drug: ozanimod placebo
DrugBank: Ozanimod (DB12612)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: ozanimod placebo
Trial: NCT03694119
Drug: ozanimod
RxNorm normalized name: Ozanimod
DrugBank: Ozanimod (DB12612)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: ozanimod
Trial: NCT03405441
Drug: JNJ-55375515 Dose Level 2
RxNorm normalized name: peanut allergenic extract
DrugBank: Peanut (DB10553)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive JNJ-55375515 orally at a Dose level 2 in Part 1 of study.
Trial: NCT03405441
Drug: JNJ-55375515 Dose Level 3
RxNorm normalized name: peanut allergenic extract
DrugBank: Peanut (DB10553)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive JNJ-55375515 orally at a Dose level 3 in Part 1 of study.
Trial: NCT03405441
Drug: JNJ-55375515 Dose Level 4
RxNorm normalized name: peanut allergenic extract
DrugBank: Peanut (DB10553)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive JNJ-55375515 orally at a Dose level 4 in Part 1 of study.
Trial: NCT03405441
Drug: JNJ-55375515 Dose Level 5
RxNorm normalized name: peanut allergenic extract
DrugBank: Peanut (DB10553)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive JNJ-55375515 orally at a Dose level 5 in Part 1 of study.
Trial: NCT03405441
Drug: JNJ-55375515 Dose Level 6
RxNorm normalized name: peanut allergenic extract
DrugBank: Peanut (DB10553)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive JNJ-55375515 orally at a Dose level 6 in Part 1 of study.
Trial: NCT01359878
Drug: Fibrinogen Concentrate
RxNorm normalized name: Fibrinogen concentrate human
DrugBank: Fibrinogen human (DB09222)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 gram intra venous
Trial: NCT02188277
Drug: Xeomin
RxNorm normalized name: Xeomin
DrugBank: Botulinum toxin type A (DB00083)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Description: Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).~Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
Trial: NCT01002911
Drug: Cefazolin, Bacitracin, Cefalexin
DrugBank: Bacitracin (DB00626)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Single does of Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision, Bacitracin wash, Cefalexin 250-500 mg TID
Trial: NCT01002911
Drug: Cefazolin
RxNorm normalized name: Cefazolin
DrugBank: Cefazolin (DB01327)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision