TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02105129
Drug: HMPL-523
Approvals — FDA: no, EMA: no, PMDA: no
Description: HMPL-523: Oral administration with a single dose of 5, 20, 50, 100, 200 and 300 mg in Part A, followed by multiple doses of selected strength in Part B Other Name: NA
Study: NCT02105129
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration
Study: NCT00759395
Drug: AZD2327
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet, Oral, Daily
Study: NCT00759395
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet, Oral, Daily
Study: NCT00509288
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Study: NCT02259595
Drug: HPN-07
Approvals — FDA: no, EMA: no, PMDA: no
Description: 500-1,500 mg oral capsules administered in a single dose
Study: NCT02259595
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo oral capsule
Study: NCT01350076
Drug: conventional liberal fluid regimen
Normalized name: Anacin Aspirin Regimen
Approvals — FDA: no, EMA: no, PMDA: no
Description: Control group will receive conventional liberal fluid regimen with crystalloid Liberal fluid regimen = Maintenance fluid + fasting fluid + dehydration + third space loss Maintenance fluid = (4X BW 1-10 kg) + (2X1BW11-20 kg) + (1X BW 0ver 21 kg) Fasting fluid = maintenance fluid X fasting duration
Study: NCT01350076
Drug: restricted fluid regimen
Normalized name: Anacin Aspirin Regimen Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Study group will receive restricted fluid regimen (the same as control group except third space replacement) plus goal directed fluid therapy to maintain adequate CO guided by USCOM as shown in diagram (figure 1).~Figure 1 goal directed fluid therapy SVV = Stroke volume variation SVI = Stroke volume index CI = Cardiac index
Study: NCT01169779
Drug: Sulfonylurea
Normalized name: Sulfonylurea
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sulfonylurea if given at screening, to be continued up to Week 24. In patients with a screening HbA1c \<8% the dose is decreased by 25% to 50% at randomization and then increased up to the screening dose between Week 4 and 12 as per fasting self-monitored plasma glucose (SMPG) values. In patients with a screening HbA1c \>=8%, the dose is not to be changed at randomization. In any case, after Week 12, sulfonylurea is to be continued at a stable dose.
Study: NCT01082939
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 250 mg/m\^2/day IV on Days 3-5; repeated every four weeks for a total of 6 planned cycles.
Study: NCT01466088
Drug: AZD3480
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects taking 30 mg AZD3480 will take one capsule of AZD3480 and two capsules of placebo for donepezil (to maintain blind) orally once a day.
Study: NCT05663684
Drug: Proparacaine Hydrochloride ophthalmic solution, USP 0.5%
Approvals — FDA: no, EMA: no, PMDA: no
Description: One drop instilled in one eye, randomly chosen, as topical anesthetic
Study: NCT00829244
Drug: GONAL f® prefilled pen
Approvals — FDA: no, EMA: no, PMDA: no
Description: GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only
Study: NCT00829244
Drug: GONAL f® prefilled pen
Approvals — FDA: no, EMA: no, PMDA: no
Description: GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to Day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to the center's standard practice.
Study: NCT03573050
Drug: RIV-TDS 13.3 mg/24 h
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5 consecutive transdermal patch applications, each with a nominal release rate of 13.3 mg/24 hours
Study: NCT03573050
Drug: Exelon® 13.3 mg/24 hours transdermal patch
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5 consecutive transdermal patch applications, each with a nominal release rate of 13.3 mg/24 hours
Study: NCT01370551
Drug: Estriol 0.03 mg, lyophylized lactobacillus
Approvals — FDA: no, EMA: no, PMDA: no
Description: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;
Study: NCT00375713
Drug: Standard topical steroid (1% hydrocortisone) ointment
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1% hydrocortisone ointment, applied 2-3 times a day to all affected areas
Study: NCT01019941
Drug: CKD-810, Taxotere inj.
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive docetaxel 75mg/㎡ on Day 1 of each cycle(1 cycle = 3 weeks) as a 1-hour IV infusion. At the 1st cycle, CKD-810 75mg/㎡ administered. If the hematologic or non-hematologic toxicity was not appeared when the 1st cycle intervention was finished, keep going the 2nd cycle intervention.
Study: NCT01019941
Drug: CKD-810, Taxotere inj.
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive docetaxel 75mg/㎡ on Day 1 of each cycle(1 cycle = 3 weeks) as a 1-hour IV infusion. At the 1st cycle, Taxotere inj. 75mg/㎡ administered. If the hematologic or non-hematologic toxicity was not appeared when the 1st cycle intervention was finished, keep going the 2nd cycle intervention.
Study: NCT00574015
Drug: hydrocodone/acetaminophen
Normalized name: hydrocodone/acetaminophen 5 mg-500 mg ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral hydrocodone 10 mg/acetaminophen 650 mg
Study: NCT02998190
Drug: Single Ascending Doses of placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02998190
Drug: Multiple Ascending Doses of placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04035031
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets, starch, oral, once daily for 7 days (7 tablets total)
Study: NCT02076711
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT00058747
Drug: Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02149966
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered by mouth (orally) each day for a period of 14 days.
Study: NCT00002487
Drug: methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02841163
Drug: Herbal medicine
Normalized name: Herbal medicine
Approvals — FDA: no, EMA: no, PMDA: no
Description: Herbal medicine was administered 2-3 times daily in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
Study: NCT03447873
Drug: Continue with triple therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: To continue with triple therapy
Study: NCT03447873
Drug: Switch to DTG + 3TC
Approvals — FDA: no, EMA: no, PMDA: no
Description: Switch to dolutegravir + lamivudine once daily
Study: NCT01542788
Drug: SOF
Normalized name: Kasof
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Study: NCT01542788
Drug: Placebo to match SOF
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo to match SOF was administered orally once daily.
Study: NCT01542788
Drug: Placebo to match RBV
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo to match RBV was administered orally twice daily.
Study: NCT01507740
Drug: Suntent
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study
Study: NCT00829998
Drug: Sonata® 10 mg Capsules
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 x 10 mg, single-dose fasting
Study: NCT00163293
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Ciclesonide placebo-matching metered-dose inhaler
Study: NCT00285779
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02466919
Drug: Clarithromycin
Normalized name: Clarithromycin
DrugBank: Clarithromycin (DB01211)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: H. pylori eradication therapy
Study: NCT00791648
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1.
Study: NCT02443935
Drug: MGN1703
Approvals — FDA: no, EMA: no, PMDA: no
Description: 60 mg s.c. twice weekly for 4 weeks
Study: NCT02443935
Drug: MGN1703
Approvals — FDA: no, EMA: no, PMDA: no
Description: 60 mg s.c. twice weekly for 24 weeks
Study: NCT00529542
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 placebo caplet per day for six weeks.
Study: NCT01872884
Drug: Sevorane Remifentanil
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sevorane Remifentanil
Study: NCT01872884
Drug: Remifentanil
Normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Remifentanil
Study: NCT02104193
Drug: simvastatin in addition to radiation therapy
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: simvastatin 80 mg tablet once daily during the radiation therapy period in addition to radiation therapy 30 Gy delivered in 10 fractions over 2 weeks
Study: NCT02746315
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04348474
Drug: Azithromycin Tablets
Normalized name: Azithromycin Tablets
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: All patients included in the study will receive AZT 500 mg per day for 5 days.
Study: NCT02793960
Drug: topical BPM31510 3.0% Cream
Approvals — FDA: no, EMA: no, PMDA: no
Description: Application of drug to lesions of epidermolysis bullosa
Study: NCT00793520
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Twice daily oral administration of placebo for 5 weeks.
Study: NCT04329884
Drug: intra-articular corticosteroid injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients who are randomized to receive intra-articular corticosteroid injections will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.
Study: NCT04461886
Drug: NPC-12G gel
Normalized name: ALCOHOL 377.5 mL in 500 mL TOPICAL GEL [ANIOSGEL 85 NPC]
Approvals — FDA: no, EMA: no, PMDA: no
Description: NPC-12G gel is containing 0.2% Sirolimus
Study: NCT02752542
Drug: Pharmacotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pharmacotherapy will be prescribed and adjusted by psychiatrists in 20-30 minute pharmacotherapy sessions once every two weeks. The manual-guided best-evidence pharmacotherapy will follow current guidelines for first, second and third line treatment.41 The primary focus will be on serotonin-reuptake inhibiting antidepressant (escitalopram 5-20mg, sertraline 50-200 mg daily) monotherapy, which may remain the only treatment for the majority of participants. Augmentation (aripiprazole 2-10mg, bupropione 150-450mg) will be offered to participants with partial response. The manual, developed as part of Canadian Biomarker Integration Network in Depression (CAN-BIND).43, also specifies admissible supportive therapeutic elements and prohibits CBT-specific techniques.
Study: NCT01090596
Drug: Naproxen
Normalized name: Naproxen
DrugBank: Naproxen (DB00788)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 500mg naproxen, twice daily for 7 days
Study: NCT01090596
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 tab,twice a day for a seven days
Study: NCT02260037
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00772057
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets given two times daily.
Study: NCT00995787
Drug: AZD1656
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dose titration of oral suspension of AZD165 during 3 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 6 days
Study: NCT00995787
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dose titration of oral suspension of placebo during 3 days given twice daily. Subjects will thereafter be for another 6 days
Study: NCT00931281
Drug: ABT-450
Normalized name: ABT-925
Approvals — FDA: no, EMA: no, PMDA: no
Description: capsules, QD or BID, 14 days, ascending doses
Study: NCT00931281
Drug: Placebo for ABT-450
Normalized name: ABT-925
Approvals — FDA: no, EMA: no, PMDA: no
Description: capsule, QD or BID, 14 days
Study: NCT00003249
Drug: chemotherapy
Normalized name: Chemotherapy Glove SML
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01144650
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive either a single total dose of 250 mg placebo IV and oral dosage
Study: NCT02385071
Drug: Treatment A
Normalized name: Nix Ultra Lice Treatment And Prevention Kit
Approvals — FDA: no, EMA: no, PMDA: no
Description: 150 milligram (mg) SMV capsule with water under fed conditions.
Study: NCT02385071
Drug: Treatment B
Normalized name: PanOxyl Acne Treatment Bar
Approvals — FDA: no, EMA: no, PMDA: no
Description: Treatment B (3\*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.
Study: NCT00710099
Drug: nitroprussiate iontophoresis
Approvals — FDA: no, EMA: no, PMDA: no
Description: nitroprussiate iontophoresis
Study: NCT04154722
Drug: Azithromycin Powder
Normalized name: azithromycin Powder for Oral Suspension
Approvals — FDA: no, EMA: no, PMDA: no
Description: syp azithromycin for10days
Study: NCT04243486
Drug: UHE-105
Approvals — FDA: no, EMA: no, PMDA: no
Description: Topical shampoo containing active drug
Study: NCT04243486
Drug: Vehicle
Normalized name: Drug vehicle
Approvals — FDA: no, EMA: no, PMDA: no
Description: Topical shampoo containing no active drug
Study: NCT03183310
Drug: Placebo - Concentrate
Approvals — FDA: no, EMA: no, PMDA: no
Description: an intravenous bolus injection of saline (NaCl 0.9%) will be administered . After an incubation period of 15 minutes esophageal sensitivity will be assessed by multimodal stimulation.
Study: NCT02896205
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will be given matching placebo for 6 months
Study: NCT01668680
Drug: CAPECITABINE, CELECOXIB and METHOTREXATE
Approvals — FDA: no, EMA: no, PMDA: no
Description: daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE
Study: NCT00841139
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 tablet bd
Study: NCT00557193
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00557193
Drug: Leucovorin Calcium
Normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00557193
Drug: Mercaptopurine
Normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given PO
Study: NCT00557193
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV, IT, or PO
Study: NCT00557193
Drug: Therapeutic Hydrocortisone
Normalized name: Moisturel Therapeutic
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given IT
Study: NCT04422496
Drug: HEC96719
Approvals — FDA: no, EMA: no, PMDA: no
Description: single-Dose Study: Each dose of HEC96719 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.~multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and multiple-dose study.
Study: NCT00548548
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, given until disease progression or unmanageable toxicity.
Study: NCT04326738
Drug: normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: N group received corresponding intravenous normal saline of1ml·kg-1 .
Study: NCT00189137
Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel
Normalized name: Ifosfamide
DrugBank: Ifosfamide (DB01181)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
Study: NCT04281667
Drug: Oral Antibiotics
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)
Study: NCT04281667
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)
Study: NCT00725985
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo matched to cladribine tablets were administered.
Study: NCT00725985
Drug: Rebif® new formulation (RNF)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants who converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received RNF subcutaneously at a dose of 44 microgram (mcg) three times a week. Participants who converted to CDMS during long-term follow-up (LTFU) period, received RNF subcutaneously at a dose of 44 mcg three times a week.
Study: NCT02546323
Drug: Rosuvastatin
Normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 20mg tablets, orally once daily for the duration of the 104-week treatment period
Study: NCT02546323
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo tablets, orally once daily for the duration of the 104-week treatment period.
Study: NCT00673920
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Oral or parenteral repeating dose
Study: NCT00673920
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous repeating dose
Study: NCT01071161
Drug: azithromycin
Normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: azithromycin, tablets, during 12 weeks, three times a week, 250mg
Study: NCT01071161
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo
Study: NCT00085527
Drug: depsipeptide
Normalized name: palmitoyl dipeptide-7
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03755193
Drug: SERM Viviant®Tablet 20mg and ELD Edirol®Tablet 0.75ug
Approvals — FDA: no, EMA: no, PMDA: no
Description: To examine the effects of SERM and ELD in osteoporosis patients
Study: NCT03755193
Drug: Bisphosphonates and ELD Edirol®Tablet 0.75ug
Approvals — FDA: no, EMA: no, PMDA: no
Description: To examine the effects of BP and ELD in osteoporosis patients
Study: NCT03755193
Drug: ELD Edirol®Tablet 0.75ug
Approvals — FDA: no, EMA: no, PMDA: no
Description: To examine the effects of ELD in osteoporosis patients
Study: NCT04306926
Drug: TQB2450
Approvals — FDA: no, EMA: no, PMDA: no
Description: TQB2450 1200mg administered IV on Day 1 of each 21-day cycle.
Study: NCT00024934
Drug: B-Lymphocyte Stimulator (BLyS)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01461460
Drug: TR-701 FA 1200 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 6 tablet of T-701 FA
Study: NCT01461460
Drug: TR-701 FA 200 mg plus Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 tablet of TR-701 FA with 5 tablet placebo
Study: NCT01461460
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 6 placebo tablets
Study: NCT03781479
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo Oral Tablet
Study: NCT04635852
Drug: Fentanyl
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02921256
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given PO
Study: NCT02921256
Drug: Fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT02921256
Drug: Leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT01448616
Drug: Placebo Vaginal Gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects - negative or positive - on study endpoints.
Study: NCT01448616
Drug: Vaginal TFV Gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tenofovir 1% gel (w/w) is a gel formulation of tenofovir. Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.
Study: NCT01448616
Drug: Placebo Tablets
Normalized name: placebo Oral Tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.
Study: NCT01983111
Drug: tramadol/acetaminophen
Normalized name: TRAMADOL/ACETAMINOPHEN
Approvals — FDA: no, EMA: no, PMDA: no
Description: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets.
Study: NCT00875446
Drug: PLACEBO
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT00875446
Drug: GSK1223249
Approvals — FDA: no, EMA: no, PMDA: no
Description: I.V Infusion