TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00669643
Drug: PB 6 doses - Rifampicin, Clofazimine and Dapsone
DrugBank: Dapsone (DB00250)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Adult: 6 doses;~1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine;~Children: 6 doses;~1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine
Study: NCT00669643
Drug: MB 12 doses - Rifampicin, Clofazimine and Dapsone
DrugBank: Dapsone (DB00250)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Adult: 12 doses;~1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine;~Children: 12 doses;~1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine
Study: NCT00669643
Drug: MB 6 doses - Rifampicin, Clofazimine and Dapsone
DrugBank: Dapsone (DB00250)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Adult: 6 doses~1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine~Children: 6 doses~1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine
Study: NCT00402532
Drug: Everolimus
Normalized name: Everolimus
DrugBank: Everolimus (DB01590)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Initial dosage 2 x 0.75 mg/d
Study: NCT04326868
Drug: Benzimidazole Anthelmintic
Normalized name: benzimidazole
DrugBank: Benzimidazole (DB02962)
Approvals — FDA: no, EMA: no, PMDA: no
Description: The participants diagnosed positive will be randomly assigned to one of the following treatment arms of the study. Parents or guardians of eligible children will be asked to bring them to the CERMEL (clinic). after a brief clinical examination child fulfilling inclusion criteria will be randomly assigned to one of the following treatment regimens of the study.
Study: NCT02487771
Drug: DHA
Normalized name: DHA
DrugBank: Doconexent (DB03756)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 600 mg DHA capsule
Study: NCT02897726
Drug: NVP-1402
Normalized name: NVP
DrugBank: Nevirapine (DB00238)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Oral
Study: NCT02897726
Drug: NVP-1402R
Normalized name: NVP
DrugBank: Nevirapine (DB00238)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Oral
Study: NCT00401544
Drug: darbepoetin alfa
Normalized name: Darbepoetin Alfa
DrugBank: Darbepoetin alfa (DB00012)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Darbepoetin alfa administered by subcutaneous injection.
Study: NCT02307591
Drug: Best Supportive Care + Amiodarone
DrugBank: Amiodarone (DB01118)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: This treatment will be provided to patients in the experimental arm only in addition to best supportive care scheme .~During the first 3 days of treatment, the drug must be administered in Glucose 5% solution. Deliver through the largest possible vein inserting a long catheter (if possible a CVP line).~Day 1. Dose: 20 mg/kg/die i.v. deliver a loading dose of 5mg/kg in the 1st hour, followed by continuous infusion during the remaining 23 hours.~Example: 20 mg /kg of Amiodarone in 500 cc of Glucose 5%. Deliver 125 ml during the 1st hour followed by 16 ml/hour for the remaining 23 hours.~Day 2 - Day 3. Dose: 20 mg/kg/die i.v. Continuous infusion over 24 hrs. Example: Glucose 5% 500 ml containing 20 mg/kg of Amiodarone (infusion speed = 21 ml/hour).~Day 4 to Day 10. If no significant diarrhea and/or vomiting, shift to oral intake of Amiodarone as follows:~* Adults: 200 mg tablets, 3 times a day, according to the body weight (30mg/Kg)~* Children \< 29 kg: 5 mg/kg 3 times a day
Study: NCT01949233
Drug: Irbesartan 150-300mg capsules daily for 6 months
Normalized name: irbesartan 300 MG
DrugBank: Irbesartan (DB01029)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00598611
Drug: desloratadine
Normalized name: Desloratadine
DrugBank: Desloratadine (DB00967)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: singel dose, oral, 20 mg
Study: NCT00598611
Drug: desloratadine
Normalized name: Desloratadine
DrugBank: Desloratadine (DB00967)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: single dose, oral, 5 mg
Study: NCT01949233
Drug: Irbesartan placebo capsules daily for 6 months
Normalized name: PLACEBO CAP/TAB
DrugBank: Irbesartan (DB01029)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02946073
Drug: buprenorphine
Normalized name: Buprenorphine
DrugBank: Buprenorphine (DB00921)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT04495504
Drug: Ropivacaine
Normalized name: Ropivacaine
DrugBank: Ropivacaine (DB00296)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter Continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
Study: NCT01565668
Drug: AC220
Normalized name: Quizartinib
DrugBank: Quizartinib (DB12874)
Approvals — FDA: no, EMA: no, PMDA: yes
Description: oral
Study: NCT00046501
Drug: Lantus (insulin glargine [rDNA origin] injection)
Normalized name: Insulin glargine (rDNA origin)
DrugBank: Insulin glargine (DB00047)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00046501
Drug: Humulin N
Normalized name: HumuLIN N
DrugBank: Insulin human (DB00030)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00046501
Drug: Humulin L
Normalized name: HumuLIN L
DrugBank: Insulin human (DB00030)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00046501
Drug: Lispro
Normalized name: Lispro PRC
DrugBank: Insulin lispro (DB00046)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00483834
Drug: Bevacizumab
Normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 7.5mg/kg, IV, day 1 of each cycle
Study: NCT00483834
Drug: Irinotecan
Normalized name: Irinotecan
DrugBank: Irinotecan (DB00762)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 200mg/m\^2, IV, day 1 each cycle
Study: NCT04340128
Drug: Meglumine antimoniate
Normalized name: meglumine antimoniate
DrugBank: Meglumine antimoniate (DB13732)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intra-lesional injection once a week, 0.1/cm2
Study: NCT04340128
Drug: Meglumine antimoniate
Normalized name: meglumine antimoniate
DrugBank: Meglumine antimoniate (DB13732)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intra-lesional injection twice a week, 0.1/cm2
Study: NCT00006002
Drug: dexamethasone
Normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00006002
Drug: semaxanib
Normalized name: Semaxanib
DrugBank: Semaxanib (DB06436)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01379976
Drug: Acetylcarnitine
Normalized name: Acetylcarnitine
DrugBank: Acetylcarnitine (DB08842)
Approvals — FDA: no, EMA: no, PMDA: no
Description: ALC or placebo will be administered concurrently with CHT at 1000 mg sachet three times every day (before meals).~Treatment should be administered for a maximum of 6 cycles for both arms unless progression or unacceptable toxicity, or treatment refusal.
Study: NCT02635074
Drug: Cytarabine
Normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT02635074
Drug: Ibrutinib
Normalized name: Ibrutinib
DrugBank: Ibrutinib (DB09053)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Given PO
Study: NCT02635074
Drug: Idarubicin
Normalized name: Idarubicin
DrugBank: Idarubicin (DB01177)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT03468933
Drug: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)
Normalized name: Tissue plasminogen activator, recombinant
DrugBank: Plasminogen (DB16701)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
Study: NCT01842113
Drug: Rifaximin
Normalized name: Rifaximin
DrugBank: Rifaximin (DB01220)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Rifaximin 550mg by mouth twice a day
Study: NCT01842113
Drug: Lactulose
Normalized name: Lactulose
DrugBank: Lactulose (DB00581)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Lactulose 30ml by mouth three times a day
Study: NCT01842113
Drug: Lactulose Placebo
DrugBank: Lactulose (DB00581)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Lactulose Placebo 30ml three times a day
Study: NCT01842113
Drug: Rifaximin Placebo
Normalized name: Rifaximin
DrugBank: Rifaximin (DB01220)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Rifaximin Placebo twice a day
Study: NCT02661100
Drug: Pembrolizumab
Normalized name: Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 200mg/kg by IV infusion on Day 1 of each 3 week cycle. Given until disease progression
Study: NCT00446069
Drug: Morphine Sulphate
Normalized name: Morphine sulphate
DrugBank: Morphine (DB00295)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks
Study: NCT03515382
Drug: Itraconazole
Normalized name: Itraconazole
DrugBank: Itraconazole (DB01167)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A single oral dose of itraconazole.
Study: NCT03515382
Drug: Voriconazole
Normalized name: Voriconazole
DrugBank: Voriconazole (DB00582)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A single oral dose of voriconazole.
Study: NCT02231281
Drug: cART(TDF/AZT+3TC+LPV/r)
Normalized name: prilocaine
DrugBank: Carteolol (DB00521)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Standard antiretroviral therapy for HIV infection
Study: NCT02750007
Drug: HS-20004
Normalized name: HS-CoM
DrugBank: Coenzyme M (DB09110)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01022294
Drug: Nitrousoxide-oxygen and atmospheric air
Normalized name: air
DrugBank: Oxygen (DB09140)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Nitrousoxide-oxygen and atmospheric air
Study: NCT01022294
Drug: Atmospheric air; nitrousoxide-oxygen
DrugBank: Oxygen (DB09140)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Atmospheric air; nitrousoxide-oxygen
Study: NCT05492487
Drug: Mirena
Normalized name: Mirena
DrugBank: Levonorgestrel (DB00367)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Mirena Intrauterine System (Mirena-IUS) is a levonorgestrel-releasing intrauterine system. Mirena consists of a T-shaped polyethylene frame (T-body) with a steroid reservoir (hormone elastomer core) around the vertical stem. The reservoir consists of a white or almost white cylinder, made of a mixture of levonorgestrel and silicone (polydimethylsiloxane), containing a total of 52 mg levonorgestrel. Mirena is approved for intrauterine contraception and in 2009 to treat heavy periods for women who choose intrauterine contraception. Mirena is often used off-label for the treatment of endometrial hyperplasia. Levonorgestrel is a progestogen used in a variety of contraceptive products. Low doses of levonorgestrel can be administered into the uterine cavity with the Mirena intrauterine delivery system. Mirena has mainly local progestogenic effects in the uterine cavity.
Study: NCT05492487
Drug: Megace
Normalized name: Megace
DrugBank: Megestrol acetate (DB00351)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Megestrol acetate (Megace) is a synthetic derivative of the natural occurring steroid hormone, progesterone. It is licensed for the treatment of anorexia, cachexia or unexplained weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS) and palliative treatment of advanced breast or endometrial cancer. Megace is often used off-label for the treatment of endometrial hyperplasia. While the precise mechanism by which Megace produces its antineoplastic effects against endometrial carcinoma and endometrial hyperplasia is unknown at the present time, inhibition of pituitary gonadotrophin production and resultant decrease in estrogen secretion may be factors. There is evidence to suggest a local effect as a result of the marked changes brought about by the direct instillation of progestational agents into the endometrial cavity.
Study: NCT00535847
Drug: Telaprevir
Normalized name: Telaprevir
DrugBank: Telaprevir (DB05521)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Tablet
Study: NCT00535847
Drug: Ribavirin
Normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Tablet
Study: NCT00535847
Drug: Pegylated interferon alfa 2a
Normalized name: Pegylated-interferon alfa 2a
DrugBank: Interferon alfa (DB05258)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Solution for Injection
Study: NCT00727844
Drug: Immediate Start Linezolid
Normalized name: Linezolid
DrugBank: Linezolid (DB00601)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00727844
Drug: Delayed Start Linezolid
Normalized name: Linezolid
DrugBank: Linezolid (DB00601)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT03034018
Drug: suvorexant
Normalized name: Suvorexant
DrugBank: Suvorexant (DB09034)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 10-20 mg taken at bedtime for four weeks
Study: NCT02552238
Drug: Lumason
Normalized name: Lumason
DrugBank: Sulfur hexafluoride (DB11104)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Lumason (sulfur hexafluoride-type A microspheres) an ultrasound contrast agent was administered as 2 single 2-mL IV injections during rest and stress echocardiography
Study: NCT03105986
Drug: JNJ-64041575
Normalized name: JNJ-42847922
DrugBank: Seltorexant (DB14961)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Two 500-mg tablets administered as a single oral dose under fasted conditions on Day 1 or Day 22.
Study: NCT03105986
Drug: Probenecid
Normalized name: Probenecid
DrugBank: Probenecid (DB01032)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: One 500-mg tablet administered as a single oral dose with a total of 30 doses (2 doses on Day -1/21 starting in the evening followed by 4 doses per day on the rest of the days).
Study: NCT03538483
Drug: Bupivacaine Hcl 0.25% Inj
Normalized name: BUPIVACAINE HCL 0.25% INJ
DrugBank: Bupivacaine (DB00297)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 30 ml %0,25 bupivacaine
Study: NCT03538483
Drug: Bupivacaine HCl Inj 0.25%
DrugBank: Bupivacaine (DB00297)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 20 ml %0,25 bupivacaine
Study: NCT01677143
Drug: Bupivacaine 5mg/ml
DrugBank: Bupivacaine (DB00297)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 5 ml in trocar area
Study: NCT04085224
Drug: Somatropin
Normalized name: Somatropin
DrugBank: Somatotropin (DB00052)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: LG Somatropin
Study: NCT04180072
Drug: Atezolizumab
Normalized name: Atezolizumab
DrugBank: Atezolizumab (DB11595)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Atezolizumab 1200 mg IV on day 1 every 3 weeks
Study: NCT04180072
Drug: Bevacizumab
Normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Bevacizumab 15 mg/kg IV on day 1 every 3 weeks
Study: NCT01489124
Drug: Imipenem
Normalized name: Imipenem
DrugBank: Imipenem (DB01598)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 0.5 g of imipenem every 6 hrs administrated by 0.5-hr infusion for 3 days
Study: NCT01489124
Drug: Imipenem
Normalized name: Imipenem
DrugBank: Imipenem (DB01598)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 0.5 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days
Study: NCT01489124
Drug: Imipenem
Normalized name: Imipenem
DrugBank: Imipenem (DB01598)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 1 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days
Study: NCT02780024
Drug: Metformin
Normalized name: Metformin
DrugBank: Metformin (DB00331)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Metformin,
Study: NCT00591058
Drug: TM-601
Normalized name: TM-601
DrugBank: Chlorotoxin (DB15210)
Approvals — FDA: no, EMA: no, PMDA: no
Description: TM-601, administered intravenously (IV), once/week for 3 weeks
Study: NCT00378443
Drug: prednisone + Inhibace/Cozaar
DrugBank: Prednisone (DB00635)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT04077255
Drug: Anti-EGFR antibody in combination with weekly paclitaxel
Normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Intravenous GC-1118 in combination with weekly paclitaxel for EGFR-amplified cancer cancers as a second-line therapy
Study: NCT00465933
Drug: AIDA
Normalized name: Hb Aida
DrugBank: Elaidamide (DB03784)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00581542
Drug: moxifloxacin
Normalized name: Moxifloxacin
DrugBank: Moxifloxacin (DB00218)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 1-2 drops three times a day for 8-10 days.
Study: NCT00581542
Drug: polytrim
Normalized name: Polytrim
DrugBank: Trimethoprim (DB00440)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 1-2 drops four times a day for 8-10 days.
Study: NCT02678585
Drug: Nalbuphine
Normalized name: Nalbuphine
DrugBank: Nalbuphine (DB00844)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 53 patients received intravenous regional lidocaine plus nalbuphine
Study: NCT00061763
Drug: Deferasirox
Normalized name: Deferasirox
DrugBank: Deferasirox (DB01609)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT02678585
Drug: Lidocaine
Normalized name: Lidocaine
DrugBank: Lidocaine (DB00281)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 53 patients received intravenous regional lidocaine
Study: NCT03873415
Drug: BMS-986165
Normalized name: BMS dasatinib
DrugBank: Dasatinib (DB01254)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Oral administration
Study: NCT00593125
Drug: levetiracetam
Normalized name: Levetiracetam
DrugBank: Levetiracetam (DB01202)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will not be blind to the subject's medication administration. The medication will be discontinued over a two-week period
Study: NCT00116272
Drug: Etanercept
Normalized name: Etanercept
DrugBank: Etanercept (DB00005)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Pregnant women previously exposed to etanercept during the first trimester. Etanercept was not administered in this non-interventional study.
Study: NCT03068819
Drug: CIML NK Cell Infusion
Normalized name: Duo Fusion
DrugBank: Famotidine (DB00927)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: -Day 0
Study: NCT01996358
Drug: Succinylcholine
Normalized name: Succinylcholine
DrugBank: Succinylcholine (DB00202)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Anaesthesia is induced and maintained with propofol (1-2 mg/kg) and remifentanil (0,5 µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. After induction of anaesthesia the patient receives muscle relaxant according to the study group.
Study: NCT01996358
Drug: Rocuronium 0,3
DrugBank: Rocuronium (DB00728)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.
Study: NCT01996358
Drug: Rocuronium 0,6
DrugBank: Rocuronium (DB00728)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.
Study: NCT00150124
Drug: MTZ+LT4
Normalized name: LT4
DrugBank: Levothyroxine (DB00451)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00150124
Drug: Methimazole
Normalized name: Methimazole
DrugBank: Methimazole (DB00763)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00525941
Drug: NBI-34060
Normalized name: NBI-98782
DrugBank: NBI-98782 (DB16905)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10 mg capsules; dosed as needed for falling back asleep after a bothersome awakening provided there are at least 4 hours remaining in bed; no more than one dose per night.
Study: NCT03536949
Drug: RVL-1201
Normalized name: ALLANTOIN 5 g in 100 mL TOPICAL CREAM [RVLAIM SILICONE SCAR Cream]
DrugBank: Allantoin (DB11100)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: RVL-1201 ophthalmic solution, 0.1%
Study: NCT03642860
Drug: Triheptanoin
Normalized name: Triheptanoin
DrugBank: Triheptanoin (DB11677)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Daily treatment with Triheptanoin oil for 14 days (7 days titration period in addition to 7 days full dose period with 1g/kg/day).
Study: NCT01425970
Drug: INX-08189
Normalized name: DNA (RECOMBINANT LENTIVIRUS VECTOR INXN-2004-TRANSDUCED HUMAN AUTOLOGOUS DYSTROPHIC EPIDERMOLYSIS BULLOSA DERMAL FIBROBLAST CELL FCX-007 INTEGRATED PROVIRAL HUMAN COLLAGEN TYPE VII TRANSGENE COL7A1 PLUS 5'-HUMAN CYTOMEGALOVIRUS PROMOTER/UTR-AND 3'-LTR/PO
DrugBank: Dabocemagene autoficel (DB17878)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet, Oral, 25 mg, Once daily (QD), 12 weeks
Study: NCT01425970
Drug: INX-08189
Normalized name: DNA (RECOMBINANT LENTIVIRUS VECTOR INXN-2004-TRANSDUCED HUMAN AUTOLOGOUS DYSTROPHIC EPIDERMOLYSIS BULLOSA DERMAL FIBROBLAST CELL FCX-007 INTEGRATED PROVIRAL HUMAN COLLAGEN TYPE VII TRANSGENE COL7A1 PLUS 5'-HUMAN CYTOMEGALOVIRUS PROMOTER/UTR-AND 3'-LTR/PO
DrugBank: Dabocemagene autoficel (DB17878)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet, Oral, 50 mg, Once daily (QD), 12 weeks
Study: NCT01425970
Drug: INX-08189
Normalized name: DNA (RECOMBINANT LENTIVIRUS VECTOR INXN-2004-TRANSDUCED HUMAN AUTOLOGOUS DYSTROPHIC EPIDERMOLYSIS BULLOSA DERMAL FIBROBLAST CELL FCX-007 INTEGRATED PROVIRAL HUMAN COLLAGEN TYPE VII TRANSGENE COL7A1 PLUS 5'-HUMAN CYTOMEGALOVIRUS PROMOTER/UTR-AND 3'-LTR/PO
DrugBank: Dabocemagene autoficel (DB17878)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet, Oral, 100 mg, Once daily (QD), 12 weeks
Study: NCT01425970
Drug: Ribavirin
Normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Tablet, Oral, 500 or 600 mg weight dependent, Twice daily (BID), 12 weeks
Study: NCT01425970
Drug: INX-08189
Normalized name: DNA (RECOMBINANT LENTIVIRUS VECTOR INXN-2004-TRANSDUCED HUMAN AUTOLOGOUS DYSTROPHIC EPIDERMOLYSIS BULLOSA DERMAL FIBROBLAST CELL FCX-007 INTEGRATED PROVIRAL HUMAN COLLAGEN TYPE VII TRANSGENE COL7A1 PLUS 5'-HUMAN CYTOMEGALOVIRUS PROMOTER/UTR-AND 3'-LTR/PO
DrugBank: Dabocemagene autoficel (DB17878)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet, Oral, 200 mg, QD, 12 weeks
Study: NCT01425970
Drug: Daclatasvir
Normalized name: Daclatasvir
DrugBank: Daclatasvir (DB09102)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Tablet, Oral, 60 mg, QD, 12 weeks