AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT01759771
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo for at least one year
Trial: NCT03062358
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Normal saline solution administered as an IV infusion Q3W
Trial: NCT01174290
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: D5W 0.2mL IV q6h~Study drug will be continued until one of the following study withdrawal/termination criteria is met:~1. Delirium (ICDSC ≥ 4) develops. The diagnosis of delirium will be confirmed in all instances by the Psychiatric Consultation Service, Division of Psychiatry, Tufts Medical Center using DSM-IV criteria.~2. The patient is discharged from the ICU at Tufts MC.~3. 10 days of study drug administration occurs.~4. The subject experiences an adverse event potentially attributable to the study drug that is deemed, in the opinion of one of the physicians on the study team or the MICU team, to warrant discontinuation of therapy.
Trial: NCT02328963
Drug: mycophenolic acid
RxNorm normalized name: mycophenolic acid
DrugBank: Mycophenolic acid (DB01024)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Mycophenolic acid :~1080 mg bid for one month, then 720 mg bid~Cyclosporin A :~CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12.~Corticosteroids :~Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study~Basiliximab :Day 0: 20 mg ; Day 4: 20 mg
Trial: NCT01645423
Drug: Atorvastatin Calcium Tablets, 80 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited
Trial: NCT02515630
Drug: MMB
RxNorm normalized name: Methylmethionine sulfonium bromide
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Momelotinib (MMB) tablet administered orally once daily
Trial: NCT00425152
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00425152
Drug: leucovorin calcium
RxNorm normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02632526
Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A)
RxNorm normalized name: MESEMBRYANTHEMUM CRYSTALLINUM WHOLE
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral suspension single dose
Trial: NCT02632526
Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single and multiple doses
Trial: NCT02632526
Drug: AZD5718 placebo oral suspension
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single and multiple doses
Trial: NCT02632526
Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single and multiple doses
Trial: NCT01060579
Drug: AR-12286 0.5% ophthalmic solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: q.d. PM
Trial: NCT01060579
Drug: AR-12286 0.25% Ophthalmic solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: q.d. PM
Trial: NCT02818855
Drug: Collagen Matrix
RxNorm normalized name: Omeza Collagen Matrix
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A new collagen membrane
Trial: NCT00112047
Drug: FTC/TDF
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once daily, from Week 96 to 144
Trial: NCT00112047
Drug: FTC/TDF/EFV
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg, taken once daily, from Week 144 to 240
Trial: NCT01428843
Drug: FERRISAT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single infusion of 50 mg/ml of Ferrisat during inclusion visit.
Trial: NCT01428843
Drug: PLACEBO
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single infusion of Glucose 5% solution during inclusion visit
Trial: NCT03102762
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment.
Trial: NCT05380245
Drug: Clarithromycin 500 mg x 1Tablets
RxNorm normalized name: clarithromycin 500 MG
DrugBank: Clarithromycin (DB01211)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Name of medication of Intervention Formulation: Tablet Klaricid, 500 mg by Abbott, Lab Pvt. Ltd. (Karachi, Pakistan), Batch No: 81573XU; Mfg. date 10/2017.
Trial: NCT03006562
Drug: Subcutaneous Heparin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.
Trial: NCT04149444
Drug: Trifluridine/Tipiracil
RxNorm normalized name: TRIFLURIDINE/TIPIRACIL
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral medication
Trial: NCT00376831
Drug: Midazolam, Fentanyl
FDA approved: no
EMA approved: no
PMDA approved: no
Description: fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
Trial: NCT04860167
Drug: Diclofenac Sodium and Lignocaine 10 % spray
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Injection Diclofenac sodium was given in the preoperative area 30 minutes before the procedure and four squirts of 10% lignocaine were given 5 minutes prior to the start of the procedure
Trial: NCT04201782
Drug: There are no disallowed treatments
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Genetic: SB-728-T or SB-728mR-T No study drug is administered in this study. Subjects who received SB-728-T or SB-728mR-T in a previous trial will be evaluated in this trial for long-term safety and efficacy.
Trial: NCT05192265
Drug: Antimalarials, Artemether + Lumefantrine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Artemether-lumefantrine dispersible tablets (Coartem™, Novartis pharma) twice daily according to body weights. Each dispersible tablet of AL contains 20mg of artemether/120mg of lumefantrine).
Trial: NCT02518789
Drug: normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pretreatment：Intravenous injection normal saline equal quantity，completed within 15 minutes.
Trial: NCT02518789
Drug: midazolam，fentanyl，rocuronium
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anesthesia induction：Intravenous injection midazolam 0.03 \~ 0.05 mg/kg, fentanyl 5 \~ 8 g/kg, rocuronium 0.6 mg/kg
Trial: NCT02518789
Drug: propofol，remifentanil，cis atracurium
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anesthesia maintenance：Intravenous infusion of propofol 4 \~ 6 mg/kg/h, remifentanil 0.1 \~ 0.3 μg/kg/min, intermittent intravenous injection of cis atracurium 0.05 \~ 0.1mg/kg
Trial: NCT00350116
Drug: topical vitamin B12
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00456677
Drug: minocycline
RxNorm normalized name: Minocycline
DrugBank: Minocycline (DB01017)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: addition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen.
Trial: NCT00456677
Drug: Placebos
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Addition of oral placebo capsule in addition to standard of care regimen
Trial: NCT04619251
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT02835118
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Two oral doses of placebo for surotomycin in hard gelatin capsules per day, for 14 days
Trial: NCT01148147
Drug: Adenosine
RxNorm normalized name: Adenosine
DrugBank: Adenosine phosphate (DB00131)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Intracoronary adenosine administration (180 ug for LCA and 120 ug for RCA)
Trial: NCT01148147
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intracoronary Placebo administration
Trial: NCT00761228
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will receive a continues subcutaneous infusion of saline solution.
Trial: NCT01986075
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
Trial: NCT04294537
Drug: Postperative analgesia
RxNorm normalized name: Analgesic Balm GRX
FDA approved: no
EMA approved: no
PMDA approved: no
Description: During first 48 hours after surgery all patients wil receive paracetamol 15 mg/kg iv every 8 hours and ibuprofen 10 mg/kg orally (or through gastric tube) every 12 hours after surgery.~In case of severe pain tramadol 0,5 mg/kg will be administered iv every 8 hours.
Trial: NCT04693195
Drug: BLU-5937
RxNorm normalized name: Blu-Kote
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral administration of BLU-5937 tablets
Trial: NCT04693195
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral administration of matching placebo for BLU-5937 tablets
Trial: NCT02352168
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 putt/nostril,b.i.d
Trial: NCT04220762
Drug: WIN-1001X
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: This study has been designed as a randomized, double-blind, and placebo-controlled study.~Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
Trial: NCT01956890
Drug: PET
RxNorm normalized name: PETN
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 18F-FLT PET and MRI of the breast
Trial: NCT00773357
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo
Trial: NCT00791999
Drug: CDP870 400mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 400mg CDP870 given every 2 weeks until Week22 (SC)
Trial: NCT03562624
Drug: BAY98-7443
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Active ingredient content (in mg IND/LNG):~low dose 6.5 / 13.5; middle dose 12.5 / 13.5; high dose 15.4 / 13.5
Trial: NCT00791999
Drug: CDP870 200mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC)
Trial: NCT00791999
Drug: CDP870 100mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC)
Trial: NCT00791999
Drug: Placebo of CDP870
FDA approved: no
EMA approved: no
PMDA approved: no
Description: given every 2 weeks until Week22 (SC)
Trial: NCT02067949
Drug: Simvastatin
RxNorm normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: single oral tablet 40 mg / day If the patient is able to swallow; the tablet will be given orally. Otherwise, it will be crushed, suspended in water and administered via any existing enteral feeding or gastric drainage tube
Trial: NCT04220762
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: This study has been designed as a randomized, double-blind, and placebo-controlled study.~Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
Trial: NCT01929629
Drug: Part B
RxNorm normalized name: Hem-Care Premium 7-Part Blend Capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single doses food effect. Subjects to receive 2 single doses, one in fed and one in fasted.
Trial: NCT01725789
Drug: Ferinject®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \<50Kg .~Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients with a body weight \<50kg, administration of Ferinject® should be limited to 500mg at baseline . All patients with a serum ferritin value \<15ng/mL and Hb\<10g/dl at week 3 visit that a second dose (of 500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control Group:Placebo)
Trial: NCT01725789
Drug: normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight \<50 Kg.
Trial: NCT03907969
Drug: PLD
RxNorm normalized name: PLD1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The starting dose of PLD is 40 mg/m\^2, administered by intravenous infusion once every 4 weeks, for a maximum of 6 cycles
Trial: NCT00023868
Drug: FOLFIRI regimen
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04415983
Drug: Clarithromycin
RxNorm normalized name: Clarithromycin
DrugBank: Clarithromycin (DB01211)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Klacid twice daily
Trial: NCT04415983
Drug: Proton pump inhibitor
RxNorm normalized name: Proton pump inhibitor
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Omeprazoe twice daily
Trial: NCT00023868
Drug: doxorubicin hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00023868
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00023868
Drug: leucovorin calcium
RxNorm normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT03384277
Drug: Steroid
RxNorm normalized name: Steroid
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Methylprednisolone 0.8 mg/kg/day (or equivalent corticosteroid doses) for 3 weeks（then tapering gradually, 8 weeks in total）
Trial: NCT03384277
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: cyclophosphamide 2 mg/kg/day until inhibitor negative (no longer than five weeks)
Trial: NCT04664803
Drug: Cefecin Tab.
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04664803
Drug: Omnicef Cap.
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00926627
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: identical preparation as the study drug, but without the active substance, administered b.i.d.
Trial: NCT00862394
Drug: Foster
RxNorm normalized name: Foster and Thrive Biotin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)
Trial: NCT00862394
Drug: Foster
RxNorm normalized name: Foster and Thrive Biotin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)
Trial: NCT00031876
Drug: capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00964964
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo injected s.c. (under the skin) four times weekly
Trial: NCT00295165
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo subcutaneously once daily
Trial: NCT03480308
Drug: Fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block
Trial: NCT03534284
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inactive pill manufactured to mimic trazodone tablets.
Trial: NCT00372645
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT00830765
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2cc of placebo liquid formulated by pharmacy personnel at the University of Mississippi Medical Center injected IM weekly until 34 weeks' gestation has been reached or delivery, whichever occurs first.
Trial: NCT02122055
Drug: Fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Fentanyl 0.7-1μg/kg，prn pain assessment is done every 4 hours，maintain Behavioral Pain Scale（BPS） 0-2.
Trial: NCT00264147
Drug: etoricoxib
RxNorm normalized name: etoricoxib
DrugBank: Etoricoxib (DB01628)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.
Trial: NCT00264147
Drug: etoricoxib
RxNorm normalized name: etoricoxib
DrugBank: Etoricoxib (DB01628)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.
Trial: NCT00264147
Drug: etoricoxib
RxNorm normalized name: etoricoxib
DrugBank: Etoricoxib (DB01628)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.
Trial: NCT00264147
Drug: etoricoxib
RxNorm normalized name: etoricoxib
DrugBank: Etoricoxib (DB01628)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
Trial: NCT00264147
Drug: Comparator: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.
Trial: NCT00264147
Drug: etoricoxib
RxNorm normalized name: etoricoxib
DrugBank: Etoricoxib (DB01628)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
Trial: NCT00264147
Drug: Comparator: diclofenac
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.
Trial: NCT03717103
Drug: IBI188
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Part A: 0.1 mg/kg IV QW, 0.3 mg/kg IV QW, 1 mg/kg IV QW. Part B: 1mg/kg IV D1+3, 10, 20, 30 mg/kg IV D8 QW or 45mg/kg D8 IV Q3W.
Trial: NCT01100502
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Every 21 days by IV infusion
Trial: NCT00248482
Drug: Gleevec™
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Gleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease.
Trial: NCT04039724
Drug: HCP0605 + HGP0816
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04039724
Drug: HCP1305
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00828711
Drug: MVI 100
RxNorm normalized name: alpha-tocopherol acetate / ascorbic acid / biotin / dexpanthenol / ergocalciferol / folic acid / niacinamide / pyridoxine hydrochloride / riboflavin / thiamine hydrochloride / vitamin A / vitamin B12 / vitamin K1 Injectable Solution [MVI Pediatric]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Trial: NCT00828711
Drug: MVI 150
RxNorm normalized name: Briumvi 150 MG in 6 ML Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Trial: NCT00828711
Drug: MVI 200
RxNorm normalized name: alpha-tocopherol acetate / ascorbic acid / biotin / dexpanthenol / ergocalciferol / folic acid / niacinamide / pyridoxine hydrochloride / riboflavin / thiamine hydrochloride / vitamin A / vitamin B12 / vitamin K1 Injectable Solution [MVI Pediatric]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Trial: NCT01843127
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00095498
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo subcutaneous injection
Trial: NCT03274167
Drug: Placebo oral capsule
RxNorm normalized name: Placebo Oral Capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01494636
Drug: GSK2339345 (solution)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3, 6, 15, 30, 60 and 120 micrograms (proposed doses). 2 alternating cohorts of 6 subjects. Each subject to receive 3 ascending doses with washout of at least 48 hours between doses. Rinse, Gargle and Spit.