AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT00217308
Drug: Lactobacilli GR-1 and RC-14
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Probiotic Lactobacilli will be compared to placebo
Trial: NCT00821574
Drug: Fluvastatin
RxNorm normalized name: Fluvastatin
DrugBank: Fluvastatin (DB01095)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Fluvastatin: daily 80 mg, oral
Trial: NCT02703051
Drug: Placebo Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03735810
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral capsules
Trial: NCT01238783
Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Topical ocular dosed 3 times per day for 3 days
Trial: NCT02703051
Drug: Placebo Infusion
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01238783
Drug: AL-15469A 0.5%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Topical ocular dosed 3 times per day for 3 days
Trial: NCT01238783
Drug: AL-6515 0.3%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Topical ocular dosed 3 times per day for 3 days
Trial: NCT01238783
Drug: Vehicle
RxNorm normalized name: Drug vehicle
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Topical ocular dosed 3 times per day for 3 days
Trial: NCT01147601
Drug: Control (placebo) group
RxNorm normalized name: meningococcal group B vaccine Prefilled Syringe [Trumenba]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Control (placebo) group
Trial: NCT00002987
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00002987
Drug: doxorubicin hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00002987
Drug: prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02234687
Drug: Pomaglumetad Methionil 40mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pomaglumetad Methionil 40mg, one dose, one time
Trial: NCT02234687
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo, one dose, one time
Trial: NCT01493843
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo corresponding to 260 mg or 340 mg pictilisib will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, placebo will be taken once daily continuously.
Trial: NCT01474434
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: matching placebo tablets
Trial: NCT00158860
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo
Trial: NCT02104050
Drug: Placebo Gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 6 mL of Placebo Gel administered TID for 6 weeks
Trial: NCT02104050
Drug: OLT1177 Gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 6 mL of OLT1177 Gel (5%) administered TID for 6 weeks
Trial: NCT02069704
Drug: Avastin® (bevacizumab, reference product)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Active ingredient: Bevacizumab 25 mg/mL (strength: 100 mg/4 mL). 30-minute\* IV infusion (5 mg/kg) every 2 weeks, prior to administration of chemotherapy. Treatment will continue until disease progression, unacceptable toxicity, patient withdraws consent or death (whichever occurs first).~\*The first infusion will be given over 90 minutes. If the first infusion is well tolerated, the second infusion can be given over 60 minutes. If this infusion is well tolerated, subsequent infusions can be given over 30 minutes.~The FOLFOX (any) or FOLFIRI regimen will be chosen as per investigator's criteria based on the hospital standard of care.
Trial: NCT03704714
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT03704714
Drug: Doxorubicin Hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT00777803
Drug: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.
Trial: NCT00042718
Drug: levofloxacin, azithromycin, amoxicillin/clavulanate
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03500159
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Appearance and weight matched tablets without the active product ingredient
Trial: NCT04262154
Drug: GnRH analog
RxNorm normalized name: gonadotropin releasing factor analog-diphtheria toxoid conjugate Injectable Solution [Improvest]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Any GnRH analog that is commercially available, injectable, and long acting analog of the native LHRH peptide and is administered to subjects via intramuscular injection. For this study, any GnRH analog can be used and thee manufacturer's instructions for dose and frequency should be followed.
Trial: NCT00145717
Drug: Plant sterol enriched milk tea
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01710644
Drug: Placebo (Caramel in sterile water)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be taken with meals and snacks for 5 to 7 days
Trial: NCT04565847
Drug: Salbutamol 5mg/mL
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Nebulized salbutamol given prior to Mannitol-Induced Cough Challenge
Trial: NCT03565861
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous vehicle
Trial: NCT03565861
Drug: NP10679
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NP10679
Trial: NCT00653445
Drug: Rosuvastatin
RxNorm normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 40mg
Trial: NCT03394729
Drug: Xilytol tablet to limit dental biofilm
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The tablets will be offered in an exact number of days of use. Collection of total stimulated saliva and dental biofilm will be performed at the beginning of the study (before tablet consumption) and 7 days after the intervention. Saliva samples from each individual will be collected in separate containers as well as the biofilm samples, both at baseline and after 7 days.
Trial: NCT01476098
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SB-705498 placebo
Trial: NCT02111187
Drug: LDE225
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sonidegib was given as an oral drug at 800mg daily for 28 days prior to prostetoctomy
Trial: NCT01656733
Drug: Nicotrol Inhaler
RxNorm normalized name: Nicotrol Inhaler
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
Trial: NCT01656733
Drug: Placebo Inhaler
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
Trial: NCT00725933
Drug: BIIB028
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV infusion administered twice weekly until disease progression or unacceptable toxicity
Trial: NCT04242953
Drug: matching placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Part A: single oral administration~Part C: multiple oral administration (14 day dosing)
Trial: NCT00801931
Drug: Phenytoin
RxNorm normalized name: Phenytoin
DrugBank: Phenytoin (DB00252)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Fosphenytoin can be administered in D5W or 0.9% sodium chloride to a final concentration ranging from 1.5 to 25 mg PE/ml at a rate of 1-3 mg phenytoin sodium equivalents (PE)/kg/min up to 50-150 mg PE/minute.
Trial: NCT00801931
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide should be infused over one hour. The drug can be diluted in D5W, NS, or other solutions (100-250 mL) to a maximum concentration of 20 mg/mL.
Trial: NCT02784951
Drug: Freeze dried plasma (LyoPlas)
RxNorm normalized name: Freez Eez
FDA approved: no
EMA approved: no
PMDA approved: no
Description: (LyoPlas N-w (German Red Cross)
Trial: NCT00107380
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00107380
Drug: doxorubicin hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00697099
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe strictly identical in appearance but without active component~Subcutaneous injection
Trial: NCT04006145
Drug: Placebo oral tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo identical in appearance to active drug
Trial: NCT05030116
Drug: Shenqu Xiaoshi oral liquid
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Shenqu Xiaoshi oral liquid
Trial: NCT02811731
Drug: CKD-330 16/5mg - B
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04244175
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive CVL-865 matched placebo tablet orally BID during the treatment period.
Trial: NCT04037111
Drug: drug treatment
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg
Trial: NCT01415531
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dose-match placebo
Trial: NCT00262951
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: administered at a dose of 175 mg/m\^2/day continuous infusion (CI) for 38 days in Cycle 1 and then 500 mg/m\^2 intravenously (IV) each week for 6 weeks followed by a 2 week rest (1 cycle = 8 weeks)in Cycle 2 and 3
Trial: NCT03904628
Drug: TG02 capsules oral administration, BIW in every 28d
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TG02 capsules150mg oral administration, BIW in every 28d
Trial: NCT03191682
Drug: PRL3-ZUMAB
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The starting dose will be 0.3 mg/kg, administered Q2 weekly, with the subsequent dose levels being 0.9 mg/kg, 3.0 mg/kg, and 6.0 mg/kg, all administered on a Q2 weekly basis until disease progression. The investigator will monitor each subject for the occurrence of AEs. In event of infusion-related adverse events, the Investigator, in consultation with the PI, may increase the duration of the infusion over a period of up to 24 hours at their discretion. Dosing will continue in a standard 3+3 design for dose escalation.
Trial: NCT01364155
Drug: Placebo capsules
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02112942
Drug: IDX21459
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02112942
Drug: Matching Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03904628
Drug: TG02 capsules oral administration, BIW in every 28d
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TG02 capsules 200mg oral administration, BIW in every 28d
Trial: NCT03904628
Drug: TG02 capsules oral administration, BIW in every 28d
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TG02 capsules 250mg oral administration, BIW in every 28d
Trial: NCT04254679
Drug: Opioid analgesics
RxNorm normalized name: OPIOID ANALGESICS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain.~The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
Trial: NCT04686916
Drug: IP2018
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Test drug
Trial: NCT04686916
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT02706899
Drug: Placebo (for 33A)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo supplied in single-use vials matching 33A, IV push every 4 weeks
Trial: NCT04254679
Drug: Non-opioid analgesics
RxNorm normalized name: Non-opioid analgesics
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2).~The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
Trial: NCT00324675
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 tablets per day
Trial: NCT00374634
Drug: Standard rFSH dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard rFSH dose was 75 IU/day
Trial: NCT04226885
Drug: fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: nebulized fentanyl 2μg/kg body weigh
Trial: NCT01580423
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: capsule identical to aprepitant
Trial: NCT03658291
Drug: Sanjin tablets
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin simulants,0.1g, po bid, for 7 days.
Trial: NCT03658291
Drug: Sanjin tablets simulants
RxNorm normalized name: Staphylococcus simulans
FDA approved: no
EMA approved: no
PMDA approved: no
Description: levofloxacin ,0.1g, po bid, for 7 days+Sanjin tablets simulants,3 pills /time, 4 times/ day, for 7 days.
Trial: NCT02800928
Drug: CERC-501
RxNorm normalized name: CERCIS SILIQUASTRUM WHOLE
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CERC-501
Trial: NCT02428361
Drug: Biologically active human fecal material, OpenBiome
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fecal microbiota transplant
Trial: NCT01177813
Drug: Placebo identical to BI10773 high dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo tablets once daily
Trial: NCT01177813
Drug: Placebo identical to BI10773 low dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo tablets once daily
Trial: NCT01177813
Drug: BI10773
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BI 10773 high dose tablets once daily
Trial: NCT02716597
Drug: 25% Albumin
RxNorm normalized name: Flexbumin 25% Albumin (Human) Solution for Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02716597
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00292721
Drug: Celecoxib
RxNorm normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: celecoxib: loading and maintenance for 6 months
Trial: NCT01801735
Drug: Meloxicam Test Capsules
RxNorm normalized name: Meloxicam
DrugBank: Meloxicam (DB00814)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02325557
Drug: ADXS31-142
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ADXS31-142 IV infusion
Trial: NCT02344004
Drug: LAI (Liposomal Amikacin for Inhalation) 590 mg
RxNorm normalized name: laidlomycin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes.
Trial: NCT01748877
Drug: NXN-462
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Study drug is to be self-administered twice each day by the patient. Each day the first dose of study drug should be taken preferably one hour prior to, OR one hour after the first meal (breakfast) of the day. The second and final dose each day should be taken with a glass of water at least one hour after the last meal immediately before retiring to sleep.
Trial: NCT01435616
Drug: LY2605541
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00972205
Drug: CBT-1(Registered Trademark)
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: CBT-1 500 mg/m\^2 oral dose daily for 7 days in divided doses 3 times a day. Cycle days 1-7, repeated every 21 days. no antacids, H2 blocker, or gastric acid inhibiting agents will be administered within 4 hours before or after each daily dose.
Trial: NCT00151580
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 18 months oral placebo treatment
Trial: NCT01153958
Drug: Colposeptine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Colposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days
Trial: NCT04798703
Drug: ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 12 weekly intravesical instillations of ONCOFID-P-B™ (intensive treatment phase) followed by maintenance phase of the study, during which ONCOFID-P-B™ is furtherly administered once a month for 12 months in patients who achieved a complete response (CR) after the 12 weekly instillations.
Trial: NCT01181427
Drug: Cytochrome P450 inhibitor
RxNorm normalized name: Cytochrome P450 inhibitor
FDA approved: no
EMA approved: no
PMDA approved: no
Description: See arm description
Trial: NCT01554254
Drug: TXA127
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 300mcg/kg/day, subcutaneous injection for up to 28 days
Trial: NCT01868646
Drug: Subetta
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Each Subetta tablet contains a mixture of affinity purified polyclonal antibodies to β-subunit of the rINS (6 mg) and antibodies to eNOS (6 mg) in released-active form produced by the patented technology in accordance with the applicable European Pharmacopeia requirements.~Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day) for 36 weeks.~Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).
Trial: NCT01868646
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo (identical to Subetta in shape and taste tablet containing exсipients). Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day) for 36 weeks.~Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).
Trial: NCT01566253
Drug: Acetaminophen, ketoprofen, morphine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Acetaminophen 0.5g, maximum 4g by day, 48 hours ketoprofen 100 mg, twice a day, 48 hours Morphine 10 mg, maximum 90 mg by day, 36 hours
Trial: NCT01566253
Drug: Acetaminophen, ketoprofen,morphine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Acetaminophen 1g/100 ml IV, maximum 4g by 24 hours, 48 hours Ketoprofen IV, maximum 0,2 gram by 24 hours, 48 hours Morphine IV,maximum 60mg by 24 hours, 36 hours.
Trial: NCT04621513
Drug: western medicine
RxNorm normalized name: Medicaine Sting
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD
Trial: NCT01259336
Drug: treatment in cavitary pulmonary aspergillosis
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE)
Trial: NCT00350480
Drug: Combination Birth Control pills
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01592214
Drug: XF-73 in 2% Klucel gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: XF-73 in a modified 2% Klucel® gel formulation: Part 1, #1: concentration 0.5 mg/g, twice a day in volume 0.3 mL/naris/dose, total dose 0.6 mg; Part 1, #2: 2.0 mg/g concentration, twice a day in volume 0.3 mL/naris/dose, total dose 2.4 mg; Part 2, #1: Concentration 0.5 mg/g, 3 doses 8 hours apart on Day 1, total volume 1.8 ml, total dose 0.9 mg, 2 doses 12 hours apart on Days 2-5, total volume 1.2 ml and total dose 0.6 mg ; Part 2, #2: 2.0 mg/g, 3 doses 8 hours apart on Day 1, total volume 1.8 ml, total dose 3.6 mg, 2 doses 12 hours apart on Days 2-5,total volume 1.2 ml and total dose 2.4 mg.
Trial: NCT01592214
Drug: XF-73 in 4% Klucel gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: XF-73 in a 4% Klucel® gel formulation: Part 2 #3: concentration of 0.5 mg/g and volume of 0.3 mL/naris/dose in 3 doses 8 hours apart on Day 1 and 2 doses, 12 hours apart on Days 2 to 5. Total daily volume of 1.8 ml on Day 1 and 1.2 ml on Days 2 to 5; and total daily dose of 0.9 mg on Day 1 and 0.6 mg on Days 2 to 5.
Trial: NCT01955811
Drug: Administration of platelet concentrate and taking blood samples
RxNorm normalized name: platelet glycoprotein VI
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patient with the need of a platelet transfusion, will have 4 intervention points. 1. directly before the start of the transfusion a blood sample will be drawn. 2. Patient receives the platelet transfusion. 3. One hour after the end of transfusion a second blood sample will be drawn. 4. 24 h after the end of the platelet transfusion a further bloos sample will be collected. The first two samples will be (beside blood cell counts) spiked in-vitro with different amounts of Human fibrinogen and blood clotting tests will be performed. The same with the 3. blood sample, but without spiking steps.