TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02124265
Drug: CeraLyte 90
Normalized name: Electrolytes Oral Powder for Suspension [CERALYTE 90]
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1. This is a prospective pilot study of patients with moderate-major burn wounds (20-65% TBSA).~2. Patients who meet inclusion/exclusion criteria will be enrolled in the study upon admission to the Burn Unit.~3. Fluid requirements will be calculated according to the Parkland Formula (4 cc/kg/% Total Body Surface Area) administered over 24 hours since time of injury.~5. Patients will be monitored according to standard of care.~a. If gastric residuals are \>300cc, ORT will be stopped and only IV fluid resuscitation will be used.
Study: NCT02981082
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sugar pill manufactured to mimic Dimethyl Fumarate (DMF)
Study: NCT02601989
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Per oral intake of placebo for six weeks
Study: NCT01245946
Drug: Conventional therapy
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Conventional therapy: Topical adapalene gel 0.1% at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.
Study: NCT03148860
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: subjects will receive once weekly 15 mg (3 capsules) MTX
Study: NCT00748982
Drug: AZD1305
Approvals — FDA: no, EMA: no, PMDA: no
Description: iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
Study: NCT00748982
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
Study: NCT01875939
Drug: Oral WCK2349
Approvals — FDA: no, EMA: no, PMDA: no
Description: The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study.
Study: NCT01455935
Drug: Anti-platelets and statin
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03129945
Drug: Indomethacin
Normalized name: Indomethacin
DrugBank: Indomethacin (DB00328)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment.
Study: NCT01023945
Drug: ASP1941
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral
Study: NCT04673474
Drug: Hemay022
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive a single oral dose of Hemay022 tablet in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fed condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
Study: NCT04673474
Drug: Hemay022
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive a single oral dose of Hemay022 tablet in fed condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fasted condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
Study: NCT04463420
Drug: PHR160 Spray
Approvals — FDA: no, EMA: no, PMDA: no
Description: One puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days.
Study: NCT04463420
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: participants will receive a placebo spray every hour. This process will continue for 10 days.
Study: NCT04463420
Drug: Standard treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days
Study: NCT03003494
Drug: Spiolto® Respimat®
Approvals — FDA: no, EMA: no, PMDA: no
Description: observations taken in a period of approximately 6 weeks
Study: NCT01741519
Drug: LDLL600
Approvals — FDA: no, EMA: no, PMDA: no
Description: Comparison of 3 different doses LDLL600 in long-term infusion. 54 PK samples, BP and ECG measurement time points, several local tolerability measurement time points.
Study: NCT03503370
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants randomized to the placebo will wash their feet using COMFORT BATH CLOTHS to wipe down their feet each day and then apply supplied chlorhexidine-compatible over-the-counter moisturizer.
Study: NCT03773172
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The placebo will mimic the active treatment.
Study: NCT00400660
Drug: GSK615915A
Approvals — FDA: no, EMA: no, PMDA: no
Description: GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
Study: NCT00400660
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will also receive placebo inhaler.
Study: NCT01364688
Drug: no drug
Approvals — FDA: no, EMA: no, PMDA: no
Description: no drug
Study: NCT00511875
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo taken once daily for 24 months
Study: NCT02460692
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administration of vaporized cannabis plus either dronabinol or placebo pill
Study: NCT05251831
Drug: Intradermal injection
Normalized name: Dryvax Intradermal Injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient's own platelets.
Study: NCT01316094
Drug: ASP1941
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral
Study: NCT01316094
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral
Study: NCT02460692
Drug: Vaporized Cannabis 3.7% THC/5.6% CBD
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administration of vaporized cannabis plus either dronabinol or placebo pill
Study: NCT02390102
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Saline solution 0.9%
Study: NCT01237041
Drug: Placebo First
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo po four times on one of the inpatient days, then Niacin 500 mg po four times on another inpatient day
Study: NCT04333095
Drug: Normal Saline Flush, 0.9% Injectable Solution_#1
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy
Study: NCT00421720
Drug: Sufentanil
Normalized name: Sufentanil
DrugBank: Sufentanil (DB00708)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00421720
Drug: Remifentanil
Normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02355938
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 dose of placebo every 6 hours x 2 doses
Study: NCT02635802
Drug: Remifentanil
Normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: a loading dose 1.0-2.0μg/kg remifentanil,intravenous injection slowly,time \>1min,then 5μg/kg·h pumping if the operation can not be done in 5 minutes.~Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after the loading.We should maintain the CPOT≤2 and RASS 0～2,if it is not up to the standard,increasing the pumping rate 0.5 μg/kg·h every 2-5min.
Study: NCT02160301
Drug: Acetaminophen
Normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: no, EMA: no, PMDA: no
Description: PO
Study: NCT02160301
Drug: Acetaminophen
Normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV
Study: NCT02160301
Drug: Celecoxib
Normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: PO
Study: NCT04176419
Drug: Acetaminophen
Normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1,000 mg orally at time of check-in to the preoperative unit
Study: NCT04176419
Drug: Placebo Acetaminophen
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1,000 mg orally at time of check-in to the preoperative unit
Study: NCT00569439
Drug: D5NS
Normalized name: Dextrose 5% in Normal Saline
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5% Dextrose in Normal Saline (6.25 gr/hr) at 125 cc/hr
Study: NCT00569439
Drug: D10NS
Normalized name: Dextrose 10% in Normal Saline
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10% Dextrose Solution (12.5 gr/h) in Normal Saline at 125 cc/hr
Study: NCT04597931
Drug: Zoledronic Acid
Normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: IV Zoledronic acid 5 mg
Study: NCT02481856
Drug: SQ tree SLIT-tablet
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02481856
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04176419
Drug: Celecoxib
Normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 200 mg orally at time of check in to the preoperative unit
Study: NCT00000431
Drug: PDGF-B/Ad5
Approvals — FDA: no, EMA: no, PMDA: no
Description: This is a dose finding study to evaluate the safety of a single injection of PDGF dna in an adenoviral vector.
Study: NCT03764072
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Capsules for oral administration.
Study: NCT02944552
Drug: polyene phosphatidylcholine capsule 456mg
Normalized name: phosphatidylcholine, soybean
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients in the positive drug control group administrated polyene phosphatidylcholine capsules 456mg and two bicyclol blank analog tablets orally, three times daily for 4-8 weeks.
Study: NCT00809471
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 30 minutes orally prior to initiation of sexual activity
Study: NCT02355028
Drug: LHA510 vehicle
Normalized name: Neisseria meningitidis group B strain NZ98/254 outer membrane vesicle
Approvals — FDA: no, EMA: no, PMDA: no
Description: Inactive ingredients used as a placebo comparator
Study: NCT00471341
Drug: Celecoxib
Normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00471341
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04731090
Drug: IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.
Study: NCT00410735
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0 mg BID for 12 weeks
Study: NCT04285255
Drug: Fentanyl
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: opioids anaesthesia
Study: NCT01057810
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Study: NCT05973305
Drug: Trusopt 20 mg/ml
Normalized name: Trusopt 20 MG/ML Ophthalmic Solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: dosing schedule t.i.d.
Study: NCT01592331
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single oral dose
Study: NCT01592331
Drug: RO5508887
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single oral dose
Study: NCT03187548
Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste
Normalized name: caseins
Approvals — FDA: no, EMA: no, PMDA: no
Description: Application of CPP-ACP on one premolar once every 2 weeks for 3 months.
Study: NCT01905202
Drug: Secretrol
Normalized name: gonorrheal urethral secretion human
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04512196
Drug: Normal Saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Normal saline contains 0.9% sodium chloride.
Study: NCT01931475
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally
Study: NCT02794792
Drug: Ipragliflozin L-proline
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral
Study: NCT02794792
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral
Study: NCT00596817
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: capsules, daily, orally
Study: NCT02156908
Drug: D-serine
Normalized name: D-Serine
DrugBank: D-Serine (DB03929)
Approvals — FDA: no, EMA: no, PMDA: no
Description: D-serine 60 mg/kg
Study: NCT00443079
Drug: Matched placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 pill 3 times daily x 6 weeks
Study: NCT03991962
Drug: mFOLFIRINOX
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks
Study: NCT01417091
Drug: BPS804
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01351792
Drug: Foster® 100/6 µg/unit dose
Approvals — FDA: no, EMA: no, PMDA: no
Description: Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP extrafine 400 µg plus FF 24 µg).
Study: NCT01351792
Drug: Symbicort® Turbohaler® 200/6 μg/actuation
Approvals — FDA: no, EMA: no, PMDA: no
Description: Symbicort® Turbohaler® (budesonide 200 μg plus formoterol fumarate 6 μg/actuation), 2 inhalations b.i.d. (daily dose of BUD 800 μg plus FF 24 μg).
Study: NCT01901601
Drug: Topical Anesthesia
Normalized name: Gelato Anesthetic
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00691912
Drug: liposomal Doxorubicin
Approvals — FDA: no, EMA: no, PMDA: no
Description: 20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d
Study: NCT03106363
Drug: Placebo alcohol
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
Study: NCT04080024
Drug: SN132D
Approvals — FDA: no, EMA: no, PMDA: no
Description: Novel manganese-based macromolecular MRI contrast agent
Study: NCT01578473
Drug: Testosterone Pellets
Normalized name: testosterone pellets
Approvals — FDA: no, EMA: no, PMDA: no
Description: subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months
Study: NCT01873430
Drug: Melatonin
Normalized name: Melatonin
DrugBank: Melatonin (DB01065)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT03618173
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV saline serum at the dose of 0,2mL/kg maximum 8mL
Study: NCT04141501
Drug: Placebo oral capsule
Normalized name: Placebo Oral Capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: single dose of mannitol (100%)
Study: NCT04786340
Drug: Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: WST-057
Study: NCT04786340
Drug: Placebo: WST-057 4mL topical solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT02766803
Drug: Simvastatin and micronized trans-resveratrol
Normalized name: simvastatin and ezetimibe
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04138472
Drug: fentanyl
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: intravenous fentanyl at 2mcg/kg in 100ml saline over 10 minutes in induction room.
Study: NCT01989143
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will receive single intravenous doses of PF-06480605 matching placebo solution in a dose escalation format.
Study: NCT01989143
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will receive three subcutaneous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).
Study: NCT01989143
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will receive three intravenous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).
Study: NCT02973724
Drug: Remifentanil
Normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The concentration of remifentanil was determined by biased-coin up and down design, starting from 1.0 ng/ml (0.4 ng/ml as a step size)
Study: NCT03356639
Drug: ASP6981
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral
Study: NCT03356639
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral
Study: NCT01416974
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Patients will first receive a single infusion of therapy conditioning with cyclophosphamide.
Study: NCT01421823
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2 weeks local treatment with placebo ointment
Study: NCT04606394
Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D
Normalized name: TRELEGY ELLIPTA 100/62.5/25MCG INH 30D
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administration of Trelegy in all patients
Study: NCT04606394
Drug: Ventolin 90Mcg/Actuation Inhalation Aerosol
Normalized name: Ventolin 90mcg/actuation Inhalation Aerosol
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2 hours after the administration of Trelegy, administer Ventolin in all patients
Study: NCT00552084
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo supplements will be taken daily for 24 weeks.
Study: NCT02946918
Drug: Levothyroxine
Normalized name: Levothyroxine
DrugBank: Levothyroxine (DB00451)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps. Initial dose 1.5-1.8 mcg per kg, orally and daily
Study: NCT00557011
Drug: NRP104
Approvals — FDA: no, EMA: no, PMDA: no
Description: 30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
Study: NCT00557011
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo capsule taken once daily in the morning
Study: NCT04240704
Drug: JBH492
Approvals — FDA: no, EMA: no, PMDA: no
Description: Anti-CCR7 antibody-drug conjugate (ADC)
Study: NCT04203641
Drug: Doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A treatment cycle will be 28 days, with patients receiving doxorubicin on Days 2, 9, 16 and 23
Study: NCT03169881
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: normal saline for IV administration, or sham dosing. Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital.
Study: NCT00436475
Drug: Calcium Carbonate 400 mg orally twice daily
Normalized name: calcium carbonate 400 MG
DrugBank: Calcium carbonate (DB06724)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Calcium Carbonate 400 mg orally twice daily
Study: NCT00436475
Drug: Calcium-Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Calcium-Placebo
Study: NCT02065375
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04374981
Drug: Celecoxib 100mg
Normalized name: CELECOXIB 100MG CAP
DrugBank: Celecoxib (DB00482)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Tablets
Study: NCT03277729
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT01665950
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.
Study: NCT01665950
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.
Study: NCT00976976
Drug: docetaxel, capecitabine, cisplatin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Docetaxel 60 mg/m2 IV (day 1) every 21 days capecitabine 1,875 mg/m2/day PO, divided two (day 1-day14) every 21 days Cisplatin 60 mg/m2 IV (day 1) every 21 days
Study: NCT01844648
Drug: NH004 Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intra-oral slow dissolving muco-adhesive thin film
Study: NCT00650247
Drug: Imitrex® Tablets 100 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 100mg, single dose fed
Study: NCT02365389
Drug: Conventional MTZ vaginal gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: Conventional MTZ vaginal gel (Tricho gel 0.8%, Sedico, Egypt) twice daily for 5 days
Study: NCT02125786
Drug: ^1^8F-Fluorodeoxyglucose
Approvals — FDA: no, EMA: no, PMDA: no
Description: This is a contrast media that will be given intravenously to aid in tumor visualization.
Study: NCT02125786
Drug: ^1^1C-methionine
Approvals — FDA: no, EMA: no, PMDA: no
Description: This is a contrast media that will be given intravenously to aid in tumor visualization.
Study: NCT01018550
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT02216656
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration
Study: NCT02216656
Drug: KRN1493
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration
Study: NCT02040857
Drug: Aromatase Inhibitor
Normalized name: Aromatase inhibitor
Approvals — FDA: no, EMA: no, PMDA: no
Description: Endocrine Therapy
Study: NCT02881320
Drug: B/F/TAF (Adult Strength)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 50/200/25 mg FDC tablets administered orally once daily without regard to food.
Study: NCT02881320
Drug: B/F/TAF (Low Dose)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 30/120/15 mg FDC tablets administered orally once daily without regard to food.