TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01214057
Drug: Propofol and Remifentanyl
Normalized name: Propofol
DrugBank: Propofol (DB00818)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
Study: NCT01214057
Drug: Sevoflurane and Remifentanyl
Normalized name: Sevoflurane
DrugBank: Sevoflurane (DB01236)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
Study: NCT04556656
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pridopidine-matching placebo hard gelatin capsule
Study: NCT00088556
Drug: TLK286
Approvals — FDA: no, EMA: no, PMDA: no
Description: Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²
Study: NCT00595374
Drug: insulin NPH
Normalized name: insulin NPH human isophane
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02543229
Drug: OPT-302
Normalized name: Glau-Opt
Approvals — FDA: no, EMA: no, PMDA: no
Description: OPT-302 will be administered by intravitreal injection once every month for 3 months
Study: NCT02543229
Drug: Lucentis™
Approvals — FDA: no, EMA: no, PMDA: no
Description: Lucentis™ (0.5 mg) will be administered by intravitreal injection once every month for 3 months
Study: NCT00255424
Drug: ferumoxytol or oral iron
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01856686
Drug: BP22042013
Approvals — FDA: no, EMA: no, PMDA: no
Description: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
Study: NCT02107963
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1800mg/m2/d X 2 days as a lymphodepleting regimen
Study: NCT04300920
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching oral placebo tablet three times daily for 24 months.
Study: NCT03020030
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Standard of Care
Study: NCT00468312
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Two sprays in each nostril in the morning
Study: NCT01937104
Drug: Remifentanil
Normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Adjuvant continuous administration~- adjust effect site concentration to maintain changes of vital sign below 20%
Study: NCT03020030
Drug: Doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Standard of Care
Study: NCT03020030
Drug: HYDROCORTISONE
Normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Standard of Care
Study: NCT03020030
Drug: LEUCOVORIN CALCIUM
Normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Standard of Care
Study: NCT03020030
Drug: MERCAPTOPURINE
Normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Standard of Care
Study: NCT03020030
Drug: METHOTREXATE
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Standard of Care
Study: NCT02795949
Drug: De-escalation(short-spectrum antibiotic)
Normalized name: sangre de grado
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pharmaceutical form: solution for infusion
Study: NCT01029405
Drug: AN2728
Approvals — FDA: no, EMA: no, PMDA: no
Description: Ointment B, 2% or 0.5% applied once or twice daily
Study: NCT01029405
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Ointment B Vehicle applied once or twice daily
Study: NCT05592873
Drug: Neoadjuvant chemoradiotherapy (CRT)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients with histological diagnosis of locally advanced rectal adenocarcinoma \[clinical T3-T4N0M0 or T(any)N+M0\] were treated with neoadjuvant CRT followed by curative intent elective surgery between January 2014 and December 2019.
Study: NCT00409175
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months
Study: NCT00430183
Drug: LHRH agonist
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given intramuscularly
Study: NCT00703703
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablet once daily
Study: NCT03986073
Drug: TQ-F3083 blank analog capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks.
Study: NCT03986073
Drug: TQ-F3083 blank analog capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks.
Study: NCT01845987
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4
Study: NCT01264575
Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine
Normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
Approvals — FDA: no, EMA: no, PMDA: no
Description: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine
Study: NCT01264575
Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine
Normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
Approvals — FDA: no, EMA: no, PMDA: no
Description: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine
Study: NCT01264575
Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine
Normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
Approvals — FDA: no, EMA: no, PMDA: no
Description: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine
Study: NCT01264575
Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine
Normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
Approvals — FDA: no, EMA: no, PMDA: no
Description: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine
Study: NCT01264575
Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine
Normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
Approvals — FDA: no, EMA: no, PMDA: no
Description: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine
Study: NCT01264575
Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg
Normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
Approvals — FDA: no, EMA: no, PMDA: no
Description: intrathecal bupivacaine 11 mg with epinephrine 100 mcg
Study: NCT01264575
Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine
Normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
Approvals — FDA: no, EMA: no, PMDA: no
Description: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine
Study: NCT01264575
Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine
Normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
Approvals — FDA: no, EMA: no, PMDA: no
Description: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine
Study: NCT01264575
Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
Normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
Approvals — FDA: no, EMA: no, PMDA: no
Description: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
Study: NCT01277406
Drug: FOLFIRI
Approvals — FDA: no, EMA: no, PMDA: no
Description: i.v. administration
Study: NCT01264575
Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine
Normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
Approvals — FDA: no, EMA: no, PMDA: no
Description: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine
Study: NCT01264575
Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine
Normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
Approvals — FDA: no, EMA: no, PMDA: no
Description: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine
Study: NCT01264575
Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine
Normalized name: bupivacaine / epinephrine Injection [Sensorcaine with Epinephrine]
Approvals — FDA: no, EMA: no, PMDA: no
Description: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine
Study: NCT04793932
Drug: mFOLFIRINOX
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oxaliplatin, folinic acid, irinotecan and 5-Fluoruracil will be administered on day 1 and 15 every 28 days
Study: NCT04793932
Drug: short-course chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: other two months of chemotherapy after surgery
Study: NCT04793932
Drug: long-course chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: other two months of chemotherapy before surgery
Study: NCT03339297
Drug: Standard of Care
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered according to local institutional guidelines, physician preference, and patient need.
Study: NCT03203005
Drug: IMA970A plus CV8102 and Cyclophosphamide
Approvals — FDA: no, EMA: no, PMDA: no
Description: Study treatment starts with a single intravenous infusion of 300mg/m2 Cyclophosphamide.~Three days later patients start vaccination therapy with IMA970A plus CV8102 Each vaccination consists of a dose of 6.80 milligrams (mg) IMA970A (containing approx. 400 micrograms \[µg\] of each individual peptide) followed by a dose of 50 µg CV8102. First IMA970A is injected intradermally (i.d.) and about 10 minutes later CV8102 is injected i.d. at the same vaccination site in close proximity. Patients will receive 4 vaccinations at weekly intervals followed by 5 vaccinations at 3-weekly intervals for a total duration of about 4.5 months.
Study: NCT00504127
Drug: Naproxen 500 mg bid
Normalized name: naproxen 500 MG
DrugBank: Naproxen (DB00788)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Naproxen 500 mg bid
Study: NCT00504127
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo
Study: NCT00603772
Drug: Atralin (tretinoin) gel, 0.05%
Approvals — FDA: no, EMA: no, PMDA: no
Description: Assess photoallergic reactions for tretinoin 0.05% and vehicle, measured as skin reactions following induction and challenge.
Study: NCT03726996
Drug: Desipramine
Normalized name: Desipramine
DrugBank: Desipramine (DB01151)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Study drug (desipramine) provided in tablet form to be taken daily.
Study: NCT01535976
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo Comparator: Placebo~.9 normal saline infusion
Study: NCT02012582
Drug: VAS203
Approvals — FDA: no, EMA: no, PMDA: no
Description: i.v. infusion
Study: NCT03967691
Drug: Saline 0.9%
Normalized name: CVS Saline 0.9% Nasal Mist
Approvals — FDA: no, EMA: no, PMDA: no
Description: 100 ml NaCl 0.9% will be infused over 1 hour
Study: NCT01147133
Drug: Kardogrel
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1x75 mg
Study: NCT04391985
Drug: SOF plus (OBV/PTV/r) plus RBV
Approvals — FDA: no, EMA: no, PMDA: no
Description: They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.
Study: NCT04375735
Drug: Bovine Lipid Extract Surfactant
Normalized name: bovine lipid extract surfactant
Approvals — FDA: no, EMA: no, PMDA: no
Description: BLES will be administered in doses of 50mg/kg ideal bodyweight, at a concentration of 27mg/ml so a total volume of approximately 2ml/kg will be administered. The material will be instilled via the suction catheter through the ET tube so that the ventilation circuit is not broken. Half of the material will be instilled with the patient positioned on their left and right sides, with a pause to allow 5 min of MV between. The procedure will be repeated at, 24 and 48 hours while intubated, so the patient will receive up to 3 doses. To minimize aerosol generation, all patients will be paralyzed during surfactant administration and the ventilator will be paused. The proposed administration technique, surfactant concentration, volume and dosing schedule is based on previous studies, and has shown to be safe in patients with ARDS.
Study: NCT01947062
Drug: Intravenous Cisplatin & etoposide along with oral cyclophosphamide
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will be treated with oral cyclophosphamide at a daily dose of 50mg. Patients will also receive standard intravenous cisplatin and etoposide based chemotherapy, for a total of six cycles, delivered at three-weekly intervals. In each cycle, the dose of cisplatin will be at 50mg/m2 on days 1 \& 2. The dose of etoposide will be 100mg/m2 on days 1, 2 \& 3.
Study: NCT03981614
Drug: Trifluridine and Tipiracil Hydrochloride
Normalized name: tipiracil / trifluridine
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given PO
Study: NCT01783860
Drug: Azithromycin
Normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01783860
Drug: Doxycycline
Normalized name: Doxycycline
DrugBank: Doxycycline (DB00254)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00572468
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 40 mg of simvastatin
Study: NCT02723786
Drug: 1) basiliximab 2) mycophenolate mofetil (MMF) OR azathioprine 3) tacrolimus 4) corticosteroids
Approvals — FDA: no, EMA: no, PMDA: no
Description: This immunosuppressant regimen may be revised based on the clinical judgment of the investigator including titration of tacrolimus levels.
Study: NCT00603642
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subcutaneously administered, once a week, for 12 weeks
Study: NCT03168529
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules not containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
Study: NCT01102972
Drug: Reyataz + Norvir + Truvada
Approvals — FDA: no, EMA: no, PMDA: no
Description: atazanavir 300mg + ritonavir 100mg + tenofovir 300mg/emtricitabine 200mg
Study: NCT04560244
Drug: SHR1701
Approvals — FDA: no, EMA: no, PMDA: no
Description: PD-L1 / TGF-β RII double antibody
Study: NCT00559182
Drug: Comparator: MK-8033
Approvals — FDA: no, EMA: no, PMDA: no
Description: MK-8033 will be administered as an oral formulation in sequentially rising dose levels starting at 50 mg and continuing at 100% dose increments until dose level 4 (800 mg total daily dose). Dose levels 5 to 11 will be escalated at \~40% dose increments until 3000mg (total daily dose). The daily dose of MK-8033 will be divided into two equal doses. MK-8033 will be administered in a first cycle of 14 days (continuous drug administration from Day 1 through Day 14), followed by a 1 week drug holiday (Cycle 1, Day 15 through Day 21). Subsequent cycles of MK-8033 will be administered for 14 days (Cycles 2 to 4) and 28 days (Cycle 5 and beyond).~Enrollment in Parts A and B has been completed.
Study: NCT01296269
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: contains all the ingredients as in the oxytocin and vasopressin conditions, save for the active ingredient, one time intranasal administration, 5 puffs in each nostril
Study: NCT01906879
Drug: triple, quadruple, non-bismuth quadruple therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: triple therapy, quadruple therapy, non-bismuth quadruple therapy
Study: NCT01227824
Drug: GSK1349572 (dolutegravir)
Approvals — FDA: no, EMA: no, PMDA: no
Description: GSK1349572 50 mg taken once daily with or without food
Study: NCT04503733
Drug: Q4W GMA301 IV injections (300 mg)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Study: NCT04503733
Drug: Q4W GMA301 IV injections (600 mg)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Study: NCT04503733
Drug: Q4W GMA301 IV injections (1000 mg)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Study: NCT04503733
Drug: Q4W GMA301 IV injections (1800 mg)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Study: NCT04457531
Drug: LiuWeiLuoBi Granule
Approvals — FDA: no, EMA: no, PMDA: no
Description: LiuWeiLuoBi Granule is a Chinese medicine made from 6 herbal medicine, including Shaji(Sea-buckthorn), Honghua (Safflower), Jinyinhua(Honeysuckle),etc.
Study: NCT00792818
Drug: Ibuprofen
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1,200 mg/days (oral) divided into 3 times for 28 days
Study: NCT02494583
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Capecitabine 1000 mg/m\^2 twice daily by oral tablet on Day 1-14 of each 3-week cycle.
Study: NCT04441762
Drug: Intravenous Ketorolac Tromethamine
Normalized name: Ketorolac Tromethamine
DrugBank: Ketorolac (DB00465)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 30 mg ketorolac single dose
Study: NCT04441762
Drug: Intranasal Ketorolac Tromethamine
Normalized name: Ketorolac Tromethamine
DrugBank: Ketorolac (DB00465)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 30 mg ketorolac single dose
Study: NCT02119676
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5 mg matching placebo tablets to be administered by mouth
Study: NCT00288743
Drug: to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL.
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02104388
Drug: SJP-0035 Ophthalmic Solution
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01935882
Drug: Artemether-lumefantrine combination
Normalized name: ARTEMETHER/LUMEFANTRINE
DrugBank: Lumefantrine co-artemether (DB13085)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00118456
Drug: AEE788
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01465685
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: capsules identical to MDMA or methylphenidate
Study: NCT03344523
Drug: Iron protein succinylate oral solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: Iron protein succinylate oral solution
Study: NCT03757390
Drug: Exforge® tab 5/160mg, Crestor® tab 10mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: co-administration of Amlodipine 5mg/Valsartan 160mg(combination drug) and Rosuvastation 10mg
Study: NCT03757390
Drug: CJ-30060 5/160/10mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fixed-dose combination drug containing Amlodipine 5mg and Valsartan 160mg and Rosuvastatin 10mg
Study: NCT01031836
Drug: MEDI-545
Normalized name: Medi-Lyte
Approvals — FDA: no, EMA: no, PMDA: no
Description: Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.~Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.
Study: NCT01031836
Drug: MEDI-545
Normalized name: Medi-Lyte
Approvals — FDA: no, EMA: no, PMDA: no
Description: Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.~Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses
Study: NCT01031836
Drug: MEDI-545
Normalized name: Medi-Lyte
Approvals — FDA: no, EMA: no, PMDA: no
Description: Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.~Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.
Study: NCT01031836
Drug: MEDI-545
Normalized name: Medi-Lyte
Approvals — FDA: no, EMA: no, PMDA: no
Description: Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.~Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.
Study: NCT01031836
Drug: MEDI-545
Normalized name: Medi-Lyte
Approvals — FDA: no, EMA: no, PMDA: no
Description: Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.~Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses
Study: NCT01031836
Drug: MEDI-545 600
Normalized name: Medi-Lyte
Approvals — FDA: no, EMA: no, PMDA: no
Description: Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses.~Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses.
Study: NCT03973528
Drug: traditional Chinese medicine: tonifying kidney Wan
Approvals — FDA: no, EMA: no, PMDA: no
Description: traditional Chinese medicine : tonifying kidney Wan
Study: NCT02617446
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV of matching saline solution
Study: NCT01330017
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days
Study: NCT00216424
Drug: Capecitabine (Xeloda)
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00362180
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: subcutaneous injections
Study: NCT03785652
Drug: LY03005 extended-release tablets 40 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: LY03005 extended-release tablets 40 mg group :40mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfas
Study: NCT03785652
Drug: LY03005 extended-release tablets 120 mg group
Approvals — FDA: no, EMA: no, PMDA: no
Description: LY03005 extended-release tablets 120 mg group :~120mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast