TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04129528
Drug: CFZ533
Approvals — FDA: no, EMA: no, PMDA: no
Description: First dose is administered via intravenous infusion, subsequent doses are administered subcutaneously.
Study: NCT04417660
Drug: M7824
Normalized name: M7824
Approvals — FDA: no, EMA: no, PMDA: no
Description: Bintrafusp alfa will be administered at a dose of 1200 mg intravenously once every two weeks until disease progression or development of intolerable adverse events.
Study: NCT04197934
Drug: EGFR/EGFRvIII Inhibitor WSD0922-FU
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given PO
Study: NCT01749228
Drug: Etodolac Capsules USP 300 mg
Normalized name: etodolac Oral Capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: 300 mg capsule once a day
Study: NCT01749228
Drug: Etodolac
Normalized name: Etodolac
DrugBank: Etodolac (DB00749)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 500 mg tablet once a day
Study: NCT01643889
Drug: Treatment A (domperidone 10 mg)
Normalized name: Hongo Killer Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 domperidone 10 mg capsule four times a day (q.i.d.) + 1 domperidone placebo capsule q.i.d. on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin placebo capsule in the morning of Day 1.
Study: NCT01643889
Drug: Treatment C (placebo)
Normalized name: Hongo Killer Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2 domperidone placebo capsules four times a day (q.i.d.) on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin placebo capsule in the morning of Day 1.
Study: NCT01643889
Drug: Treatment D (moxifloxacin)
Normalized name: Hongo Killer Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2 domperidone placebo capsules four times a day (q.i.d.) on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin 400 mg capsule in the morning of Day 1.
Study: NCT04069026
Drug: BAY2416964
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral application of study drug daily in a predefined dose escalation scheme.
Study: NCT04069026
Drug: BAY2416964
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral application of study drug daily at the dose defined in the dose escalation scheme to determine the recommended phase 2 dose (RP2D).
Study: NCT01299636
Drug: PM060184
Approvals — FDA: no, EMA: no, PMDA: no
Description: PM060184 administered intravenously (i.v.) over 10 minutes at a starting dose of 4 mg/m2/day on three consecutive days q2w (on Days 1-3 and 15-17) every 28 days.
Study: NCT00469443
Drug: Leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles
Study: NCT00469443
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
Study: NCT00052013
Drug: PTK787/ZK 222584
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02536209
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03091920
Drug: IW-1973
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral Tablet
Study: NCT03091920
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral Tablet
Study: NCT03143855
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered twice daily for for 5 days
Study: NCT00097474
Drug: Hydrocortisone
Normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Hydrocortisone will be given alone or in combination with Melatonin to see if symptoms of jet lag are alleviated
Study: NCT00097474
Drug: Melatonin
Normalized name: Melatonin
DrugBank: Melatonin (DB01065)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Melatonin will be given alone or in combination with Hydrocortisone to see if symptoms of jet lag are alleviated
Study: NCT00097474
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT03709264
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo: standard treatment
Study: NCT04023669
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: IV
Study: NCT02576951
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered SC
Study: NCT03511118
Drug: clindamycin
Normalized name: Clindamycin
DrugBank: Clindamycin (DB01190)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Study: NCT03511118
Drug: azithromycin
Normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Study: NCT03511118
Drug: Doxycycline
Normalized name: Doxycycline
DrugBank: Doxycycline (DB00254)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Study: NCT03511118
Drug: Rosuvastatin
Normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Study: NCT03511118
Drug: Hydrocodone
Normalized name: Hydrocodone
DrugBank: Hydrocodone (DB00956)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Study: NCT00465894
Drug: Intra Vaginal Estradiol Cream
Normalized name: estradiol Vaginal Cream
Approvals — FDA: no, EMA: no, PMDA: no
Description: 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.
Study: NCT03773978
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally.
Study: NCT01186263
Drug: MAA for diagnostic SPECT imaging
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intraarterial application of 5ml containing 500.000 particles with an activity of 150MBq.
Study: NCT01186263
Drug: Diagnostic B20- SPECT imaging.
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intraarterial application of 5ml containing 150.000 particles with an activity of 150 MBq.
Study: NCT03537586
Drug: Adenosine
Normalized name: Adenosine
DrugBank: Adenosine phosphate (DB00131)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: An intravenous infusion of adenosine (140 μg/kg/min) will be administered via a large peripheral or central vein to induce steady-state maximal hyperemia.
Study: NCT03537586
Drug: Heparin
Normalized name: Heparin
DrugBank: Heparin (DB01109)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Heparin may be used as an alternative to bivalirudin at the discretion of the interventional cardiologist.
Study: NCT03732274
Drug: TEW-7197
Approvals — FDA: no, EMA: no, PMDA: no
Description: TEW-7197 will be administered orally for 5 days per week (5D/W) at the same time in the morning and evening (BID) approximately 12 hours apart. Durvalumab will be administered as a dose of 1500 mg every 4weeks.
Study: NCT04686474
Drug: Azadirachta indica leaves extract containing ointment intervention.
Approvals — FDA: no, EMA: no, PMDA: no
Description: Azadirachta indica leaves extract containing ointment, white petroleum, bee wax, stearyl alcohol
Study: NCT00988494
Drug: Placebo ophthalmic solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: Topical ocular application
Study: NCT00004563
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.
Study: NCT00004563
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching gelcaps 25 mgs
Study: NCT03715556
Drug: 0.9% physiological solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administration of 0.9% physiological solution.
Study: NCT03773640
Drug: Sonophoresis
Approvals — FDA: no, EMA: no, PMDA: no
Description: The control group ( II) consisted of 20 patients treated with occlusion splints and sonophoresis procedures. For the area of mastication muscles 0.9 W/cm² treatments were applied, the duty factor was 80%, the treatment time was 10 minutes, and the medical substance was 25%Voltaren gel.
Study: NCT00437112
Drug: Human Insulin Inhalation Powder
Normalized name: insulin, regular, human Inhalation Powder
Approvals — FDA: no, EMA: no, PMDA: no
Description: patient specific dose, inhaled, before meals, 24 weeks
Study: NCT01056822
Drug: 1
Normalized name: My1
Approvals — FDA: no, EMA: no, PMDA: no
Description: Continue with same dose of MMF as patient was taking before randomisation
Study: NCT04505774
Drug: P2Y12
Normalized name: Purinergic receptor subtype P2Y12 antagonist
Approvals — FDA: no, EMA: no, PMDA: no
Description: added P2Y12 inhibitor
Study: NCT01688362
Drug: Corticosteroid
Normalized name: CORTICOSTEROIDS
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later. For the first injection patients will have 15ml of blood drawn. This blood will then be discarded in a biohazard container. A 6ml solution of 4ml 0.25% Bupivacaine, 1ml 40mg Kenalog, and 1ml 4mg Dexamethasone will be prepared. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the steroid solution using a 22g needle. A dry sterile dressing will be placed at the injection site.~For the second injection two weeks later patients will have 15 ml of blood drawn. This blood will then be discarded in a biohazard container. Using the same technique as in Visit 2, the investigator will inject a 6 ml solution of 2 ml sterile normal saline with 4 ml 0.25% Bupivacaine to the shoulder using ultrasound. A dry sterile dressing will be placed at the injection site.
Study: NCT01633762
Drug: meropenem, gentamicin, vancomycin (together)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 4 days antibiotic treatment, per oral, once daily: vancomycin 500 mg (Vancomycin Hospira), powder for concentrate; gentamycin 40 mg (Hexamycin®), solution; meropenem 500 mg (Meropenem Hospira), powder for concentrate; The three drugs are dissolved and combined to a cocktail (with approximately 100 ml of apple juice)
Study: NCT01423500
Drug: VP16, ATG
Approvals — FDA: no, EMA: no, PMDA: no
Description: patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1
Study: NCT01423500
Drug: VP16, ATG
Approvals — FDA: no, EMA: no, PMDA: no
Description: patients with MMD-transplantation (8/10)receive VP16 60mg/kg/d on day -4, ATG from day -3 to day-1 20mg/kg/d
Study: NCT00033332
Drug: zoledronic acid
Normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT02688712
Drug: LY2157299
Approvals — FDA: no, EMA: no, PMDA: no
Description: Small molecule inhibitor of transforming growth factor-beta signaling pathway
Study: NCT02688712
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Antimetabolite chemotherapy
Study: NCT02688712
Drug: Fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Antimetabolite chemotherapy
Study: NCT00762164
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Simvastatin 20 milligrams
Study: NCT02405689
Drug: Remifentanil
Normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02234882
Drug: Rosuvastatin
Normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT04196231
Drug: IDegLira
Approvals — FDA: no, EMA: no, PMDA: no
Description: IDegLira will be started at 16 dose steps (16 U insulin degludec plus 0.58 mg liraglutide, once daily). On the basis of prebreakfast self-monitored blood glucose measurements doses of IDegLira will be titrated individually twice per week to achieve a prebreakfast plasma glucose of 80-130 mg/dL by use of an algorithm (adding 2 dose steps for prebreakfast plasma glucose \>130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 dose steps for prebreakfast plasma glucose \< 80 mg/dL). The daily dose of IDegLira could be titrated to 50 dose steps (50 U insulin degludec plus 1.8 mg liraglutide).
Study: NCT01780883
Drug: melatonin
Normalized name: Melatonin
DrugBank: Melatonin (DB01065)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01780883
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets of Circadin®
Study: NCT04196231
Drug: IGlarLixi
Approvals — FDA: no, EMA: no, PMDA: no
Description: IGlarLixi will be started at 10 dose steps (10 U insulin glargine plus 5 mcg lixisenatide, once daily). On the basis of prebreakfast self-monitored blood glucose measurements, doses of IGlarLixi will be titrated individually once per week to achieve a prebreakfast plasma glucose of 80-130 mg/dL by use of an algorithm (adding 2 dose steps for prebreakfast plasma glucose \>130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 dose steps for prebreakfast plasma glucose \< 80 mg/dL). The daily dose of IGlarLixi could be titrated to 60 dose steps (60 U insulin degludec plus 20 mcg lixisenatide).
Study: NCT03563716
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Study: NCT04521478
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT02829060
Drug: Gentamicin, 5mg/kg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Peri-operative dose: 5 mg/kg of ideal body weight, IV
Study: NCT02829060
Drug: Gentamicin, 80 mg, 7d
Approvals — FDA: no, EMA: no, PMDA: no
Description: 7 day course, 80 mg daily, IM or IV
Study: NCT04300231
Drug: injectable saline
Approvals — FDA: no, EMA: no, PMDA: no
Description: 40 mL
Study: NCT02485834
Drug: capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: oral 800 mg/m\^2 BID
Study: NCT04196231
Drug: Insulin/Canaglifozin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients in this arm will continue the basal insulin used before the randomization, with dosage titration on the basis of the following algorithm: adding 2 units for prebreakfast plasma glucose \>130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units for prebreakfast plasma glucose \< 80 mg/dL. Moreover, they will be assigned to canaglifozin, according to the current clinical practice and the drugs' data sheet. Canagliflozin will be started at 100 mg daily per oral administration, and augmented to 300 mg/per day if required (HbA1c \>7.5 after 12 weeks).
Study: NCT00742612
Drug: ARC1779 Injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: Study drug treatment will be initiated 1 hour prior to the induction of anesthesia with a loading dose given over 1 hour in 3 successively increasing, 20-minute step infusions. The ARC1779 treatment group will be dosed to achieve a target ARC1779 steady-state plasma concentration of 3 Ug/mL, using a loading dose infusion sequence of 0.0015 mg/kg/min for 20 minutes, 0.003 mg/kg/min for the next 20 minutes, and then 0.006 mg/kg/min for the final 20 minutes; thereafter, their maintenance infusion rate is to be 0.0006 mg/kg/min.
Study: NCT01064388
Drug: AZD9742
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV infusion, 15 days
Study: NCT01064388
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV infusion, 15 days
Study: NCT03745326
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Days -7 and -6: Cyclophosphamide 60 mg/kg/day x 2 days IV in 250 mL D5W infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Study: NCT03139305
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous infusion of saline for 72 hours
Study: NCT04046445
Drug: ATP128
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5-6 SC injections
Study: NCT03522246
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets will be administered twice daily
Study: NCT03522246
Drug: Placebo IV Infusion
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV placebo will be administered once every 4 weeks
Study: NCT04032964
Drug: DOXORUBICIN
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Doxorubicin 75 mg/m2 will be administered on day 1 of each 21-day cycle
Study: NCT01391962
Drug: Acetaminophen
Normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Analgesic for hand foot syndrome as needed.
Study: NCT01391962
Drug: Levothyroxine
Normalized name: Levothyroxine
DrugBank: Levothyroxine (DB00451)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Replacement therapy for participants with increases in thyroid-stimulating hormone.
Study: NCT03041740
Drug: Perfluorooctyl Bromide
Normalized name: perfluorooctyl triethoxysilane
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects in the PFOB group will receive PFOB partial liquid ventilation instilled via side port of endotracheal tube (2.5 mL/kg/day) across 10 treatment days.
Study: NCT00392327
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00054886
Drug: SU-011,248
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01404819
Drug: Standard anesthesia
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients undergo standard anesthesia (remifentanil with propofol)
Study: NCT02525757
Drug: MPDL3280A
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1200 mg by vein every 3 weeks up to 1 year after completing consolidation chemotherapy.~Group 1: MPDL3280A given after receiving standard chemotherapy and radiation for 6-7 weeks, followed by a 3-4 week rest period.~Group 2: MPDL3280A given with standard chemotherapy, and radiation therapy for 6-7 weeks followed by a rest period of 3-4 weeks, during which time participants receive 1 dose of MPDL3280A but no chemotherapy or radiation.
Study: NCT02546986
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered orally daily on days 1-14 of each 21-day cycle.
Study: NCT03944434
Drug: Aromatase Inhibitors, non steroideal
Approvals — FDA: no, EMA: no, PMDA: no
Description: letrozole 2.5 mg/day orally or anastrozole 1 mg/day orally
Study: NCT03775109
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 100ml 5% Dextrose
Study: NCT03816696
Drug: GSK3640254
Approvals — FDA: no, EMA: no, PMDA: no
Description: GSK3640254 will be available as 100 mg capsules. Subjects will be administered GSK3640254 200 mg QD via the oral route.
Study: NCT04421677
Drug: Phenylbutyrate Oral Tablet
Normalized name: phenylbutyrate Oral Tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: Phenylbutyrate, an orally active chemical chaperone approved by the US Food and Drug Administration for treatment of urea cycle disorders, mimics the function of intracellular molecular chaperones in preventing protein aggregation and oligomerization.
Study: NCT04196231
Drug: Insulin/Dapaglifozin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients in this arm will continue the basal insulin used before the randomization, with dosage titration on the basis of the following algorithm: adding 2 units for prebreakfast plasma glucose \>130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units for prebreakfast plasma glucose \< 80 mg/dL. Moreover, they will be assigned to dapaglifozin, according to the current clinical practice and the drugs' data sheet. Dapagliflozin will be started at 10 mg daily per oral administration
Study: NCT04196231
Drug: Insulin/Empaglifozin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients in this arm will continue the basal insulin used before the randomization, with dosage titration on the basis of the following algorithm: adding 2 units for prebreakfast plasma glucose \>130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units for prebreakfast plasma glucose \< 80 mg/dL. Moreover, they will be assigned to empaglifozin, according to the current clinical practice and the drugs' data sheet. Empagliflozin will be started at 10 mg daily per oral administration, and augmented to 25 mg/per day if required (HbA1c \>7.5 after 12 weeks).
Study: NCT01007383
Drug: LEO 27847
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: First in man
Study: NCT04196231
Drug: Basal Bolus
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients in this arm will continue the basal insulin (glargine, degludec or glargine-300) used before the randomization. The insulin titration will be guided by the medical staff, according to the following algorithm: adding 2 units of basal insulin for prebreakfast plasma glucose \>130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units of basal insulin for prebreakfast plasma glucose \< 80 mg/dL. The short acting insulin analogue (lispro, aspart or glulisine) will be started at the dosage of 4 units before meals (3 times per day) and will be titrated twice a week until achieving pre-prandial glucose values ranging from 80-130 mg/dL.
Study: NCT02183220
Drug: Acetylsalicylic acid (ASA)
DrugBank: Acetylsalicylic acid (DB00945)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02183220
Drug: Metamizol placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02183220
Drug: ASA placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04052516
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo oral capsule
Study: NCT04521413
Drug: CFI-402411
Approvals — FDA: no, EMA: no, PMDA: no
Description: CFI-402411 is administered orally once daily. The starting dose is 80 mg/day for escalation arms and the recommended dose for the expansion arms.
Study: NCT03820804
Drug: Sapropterin
Normalized name: Sapropterin
DrugBank: Sapropterin (DB00360)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: A pharmacological treatment for patients with Phenylketonuria, used alone or in combination with dietary treatment.
Study: NCT04205812
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
Study: NCT02723539
Drug: MBN-101
Approvals — FDA: no, EMA: no, PMDA: no
Description: Topical application