AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT01627158
Drug: Charcoal and Symbicort Turbuhaler
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Charcoal and Symbicort Turbuhaler
Trial: NCT01646554
Drug: Modified FOLFOX6
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00834249
Drug: Effexor® 25 mg Tablets
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 x 25 mg, single-dose fasting
Trial: NCT03913559
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Intrathecal (IT) therapy
Trial: NCT03913559
Drug: Hydrocortisone
RxNorm normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Intrathecal (IT) therapy
Trial: NCT03913559
Drug: Acetaminophen
RxNorm normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 10 mg/kg (max 650 mg) PO x 1
Trial: NCT03644147
Drug: Acetaminophen
RxNorm normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Acetaminophen will be intravenously administrated to treatment group after the end of surgery.
Trial: NCT02466152
Drug: GSK2894512 Topical Cream
FDA approved: no
EMA approved: no
PMDA approved: no
Description: GSK2894512 will be supplied as white to off-white topical cream in doses of 2.0% (20 milligrams/gram \[mg/g\]) and 1.0% (10 mg/g)
Trial: NCT01013077
Drug: Optive
RxNorm normalized name: optive
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Use a minimum of 2 drops per day for 1 month.
Trial: NCT01370356
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo 2 oral tablets twice a day for 24 weeks (first week titration)
Trial: NCT01143753
Drug: RO5212054
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive RO5212054 at a starting dose of 200 milligrams (mg) orally once daily in each 21 day cycle. Dose levels for escalation will be decided based on the safety assessment of previous cohort. Dose escalations in increments of 50-100 percent are planned.
Trial: NCT01392534
Drug: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients treated with telmisartan/hydrochlorothiazide tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment
Trial: NCT00754832
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo capsules were identical to the study drug and were dose escalated to match the study drug. Subjects were maintained on placebo capsules for the remainder of the 6 week treatment period.
Trial: NCT02004262
Drug: Chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Investigator's choice of one of the following commercially available products: gemcitabine; capecitabine; fluorouracil with or without leucovorin; irinotecan; or erlotinib.
Trial: NCT02004262
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00808795
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo of NAC is to be orally administered at the dose of 600mg twice a day, starting 24h before the procedure (two doses before and two doses after the procedure).
Trial: NCT02813551
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02055820
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide 750 milligrams per square meter (mg/m\^2) administered intravenously (IV) on Day 1 of each 21-day cycle up to Cycle 6.
Trial: NCT02055820
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Doxorubicin 50 mg/m\^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.
Trial: NCT01032915
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo s.c weekly for 3 weeks then every 2 weeks
Trial: NCT04173988
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Chemotherapy for lymphodepletion
Trial: NCT02915523
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A pill containing no active drug ingredient.
Trial: NCT03977272
Drug: Combination drug
RxNorm normalized name: combination drugs used in erectile dysfunction
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly
Trial: NCT03977272
Drug: Chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Description: modified-FOLFIRINOX
Trial: NCT01247701
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide (50 mg/kg/dose) will be given IV on Days -5, - 4, -3, and -2 over 1 hour. The total dose to be given over 4 days is 200 mg/kg.
Trial: NCT00882063
Drug: P276-00
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will be enrolled at different dose levels of P276-00 to determine maximum tolerated dose of P276-00.Starting dose level of P276-00 is 50 mg/m2/day to be administered intravenously in 200 ml of 5% dextrose (D5W) over a period of 30 min from day 1 to day 5 every 21 days. This constitutes one cycle of P276-00. Six such cycles will be administered to subjects.
Trial: NCT01217632
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline.
Trial: NCT00431340
Drug: PXD101
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01204437
Drug: Epirubicin, Cyclophosphamide
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 4 cycles of chemotherapy with epirubicin plus cyclophosphamide (EC) on day 1 q22
Trial: NCT01204437
Drug: Cyclophosphamide, Methotrexate, 5 FU
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 6 cycles CMF on days 1 and 8 q29 Cyclophosphamide (500mg/qm), Methotrexate (40 mg/qm), 5 FU (600mg/qm)
Trial: NCT01204437
Drug: Capecitabine, Nab-Paclitaxel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 6 cycles of weekly nab-paclitaxel 100 mg/m2 on days 1, 8, 15 q22 with a week of rest every 6 weeks in combination with capecitabine 2000 mg/m2, days 1 - 14 orally, divided into 2 daily doses every 3 weeks for 6 cycles
Trial: NCT01743755
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo tablet, once daily for four consecutive days
Trial: NCT03130244
Drug: Best Medical Management
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters.
Trial: NCT02742285
Drug: Artemether + lumefantrine
RxNorm normalized name: ARTEMETHER/LUMEFANTRINE
DrugBank: Lumefantrine co-artemether (DB13085)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single adult dose of artemether-lumefantrine will be administered on a unique occasion together with food. Venous and capillary blood samples will be collected at 6 to 10 time points, as defined before drug administration with each volunteer.
Trial: NCT02128230
Drug: Inter-Therapy - MEL-20+CFZ-TD-PACE (75%)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given.~Regimen: CFZ 27 mg/m2 on days 1-2; MEL 5 mg/m2/d, T 200 mg/d, D 20 mg/d, P 7.5 mg/m2/d, A 7.5 mg/m2/d, C 75 mg/m2/d, and E 60 mg/m2/d on days 1-4.~Optional Bridging with T 50 mg/d and D 20 mg on day 1-4 every 21 days until 2nd transplant.
Trial: NCT02128230
Drug: Consolidation - CFZ-TD-PACE
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), adriamycin (A), cyclophosphamide (C) and etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter.~Regimen: CFZ 27 mg/m2 on days 1-2; T 200 mg/d, D 40 mg/d, P 7.5 mg/m2/d, A 7.5 mg/m2/d, C 300 mg/m2/d, and E 30 mg/m2/d on days 1-4.
Trial: NCT02128230
Drug: Maintenance - CFZ-R(T)-D
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) and lenalidomide (R) are capsules and dexamethasone (D) is a pill; all will be taken by mouth.~Regimen: For Cycles 1-12 CFZ 27 mg/m2/wk and D 12 mg/wk on days 1, 8, 15, \& 22; lenalidomide (R) 15 mg/d on days 1-21. For Cycles 13-24 CFZ 27 mg/m2/wk and D 12 mg/wk on days 1, 8, 15, \& 22. T may be substituted for R at 100 mg/day at the treating physician's discretion.
Trial: NCT01343303
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo tablet/capsule every 12 hours for 21 days
Trial: NCT01343303
Drug: Naproxen
RxNorm normalized name: Naproxen
DrugBank: Naproxen (DB00788)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 500 mg capsule every 12 hours for 21 days
Trial: NCT01717209
Drug: Nitric Oxide
RxNorm normalized name: Nitric Oxide
DrugBank: Nitric Oxide (DB00435)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: inhaled nitric oxide
Trial: NCT00595556
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT00933530
Drug: SRT2104
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, or 3.0 g/day) will be supplied as a powder which will be prepared by the Pharmacist/designee into a liquid suspension. The dosing vehicle is 1% (by weight) hypromellose acetate succinate in water, which is used as a suspension aid and a dispersant for the SRT2104. Test material will be administered orally, in a single dose and subsequently, once daily for seven consecutive days. A trained staff member will prepare individual solutions of test material that the subject will drink once daily in the clinic following a 10-hour (minimum) fast.
Trial: NCT00933530
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo (at the matched dosage as SRT2104) will be supplied as a powder which will be prepared by the Pharmacist/designee into a liquid suspension. Placebo will consist of titanium dioxide USP and prepared for oral administration identically to the SRT2104 investigational product. Test material will be administered orally, in a single dose and subsequently, once daily for seven consecutive days. The subjects enrolled will be blinded to treatment assignment. A trained staff member will prepare individual solutions of test material that the subject will drink once daily in the clinic following a 10-hour (minimum) fast.
Trial: NCT03024086
Drug: DWJ1252
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DWJ1252 and Placebo of Gasmotin
Trial: NCT03891173
Drug: L-DOS47
RxNorm normalized name: L
FDA approved: no
EMA approved: no
PMDA approved: no
Description: L-DOS47 lyophilized powder reconstituted and diluted for iv injection
Trial: NCT01561807
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02760368
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: sodium chloride 0.9% solution supplied in polypropylene plastic ampoules of 10 mL cartons to contain 10 ampoules
Trial: NCT01926912
Drug: No intervention
FDA approved: no
EMA approved: no
PMDA approved: no
Description: This is an observational study. Participants prescribed with paliperidone palmitate by the treating physician as per local labeling information in the hospital setting will be observed and data will be collected.
Trial: NCT03943147
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Specified dose on specified days
Trial: NCT00794677
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Blinded study medication (matched placebo) will be taken orally once daily in the morning on rising. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period.
Trial: NCT04707742
Drug: Vitis Xtra Forte©
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 15 ml 0,07% cetylpyridinium chloride, one minute rinse.
Trial: NCT00800137
Drug: low molecular weight heparin or unfractionated heparin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For elective patients with greater than 5 days pre-implant; discontinue oral anti-coagulation (coumadin) 5 days before the procedure. Full therapeutic doses of subcutaneous LMWH 3 days before the procedure.~Patients with less than 5 days to implant can be given vitamin K (up to 2 mg) at the investigator discretion and start full therapeutic doses of either subcutaneous LMWH or IV Unfractionated Heparin (choice is at investigator's discretion) when INR is below the upper limit of the prescribed therapeutic range for the patient (usually greater than or equal to 2; 2.5 for some valve patients) and surgery to proceed when INR is less than 1.6.~Last dose given in the morning(ie. \> 24 hours)of the day prior to the procedure.~Oral anti-coagulation (coumadin) will be resumed on the evening of the procedure.~Full dose LMWH or full dose IV heparin will be restarted 24 hours after surgery.
Trial: NCT02215356
Drug: Chemoradiotherapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles
Trial: NCT03119714
Drug: Placebo Oral Tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment with placebo bid for 14-16 days
Trial: NCT02017327
Drug: Lumigan 0.01%
RxNorm normalized name: Lumigan 0.01% Ophthalmic Solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.
Trial: NCT02017327
Drug: Lumigan 0.03% Unit Dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.
Trial: NCT03956862
Drug: GB001
RxNorm normalized name: Glebretinib
FDA approved: no
EMA approved: no
PMDA approved: no
Description: film-coated oral tablet
Trial: NCT03956862
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: film-coated oral tablet
Trial: NCT01718691
Drug: SyB L-0501
RxNorm normalized name: L
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A dose of 90 mg/m\^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.
Trial: NCT03666832
Drug: TEW-7197
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TEW-7197 1cycle 14days~-intake 5days, rest 2days
Trial: NCT05258474
Drug: controlled-ileocolonic-release nicotinamide (SAD/MAD/MD)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD)
Trial: NCT05258474
Drug: Immediate-release nicotinamide (SAD)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single-ascending dose (SAD)
Trial: NCT05258474
Drug: Placebo controlled-ileocolonic-release nicotinamide (SAD/MAD)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single- and multiple-ascending dose (SAD/MAD)
Trial: NCT05258474
Drug: Placebo Immediate-release nicotinamide (SAD)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single-ascending dose (SAD)
Trial: NCT03961230
Drug: Jueyin granules
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.
Trial: NCT03961230
Drug: Jueyin Granules Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.
Trial: NCT00485667
Drug: SKY0402
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subects received either 300mg or 450mg
Trial: NCT00485667
Drug: Placebo injection
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00485667
Drug: Placebo tablet
RxNorm normalized name: placebo Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00005832
Drug: R115777
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 300mg/dose BID, PO, Days 1-21, q 28days
Trial: NCT01310894
Drug: TOOKAD® Soluble
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TOOKAD® Soluble-VTP procedure will consist of an IntraVenous (IV) administration to patients using a 753nm laser light at a fixed power of 150mW/cm and a fixed energy at 200J/cm delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance
Trial: NCT02075463
Drug: GSK1278863
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Film coated tablets containing 1 mg, 2 mg, 5 mg or 25 mg of GSK1278863
Trial: NCT02075463
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo tablet for GSK1278863
Trial: NCT02054897
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Once weekly, administrated subcutaneously (s.c. under the skin)
Trial: NCT00732277
Drug: hydrocortisone
RxNorm normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Patients will be assigned to treatment with hydrocortisone at 100mg/m2/24 hours in 4 divided doses (25 mg/m2/q 6 hourly) for 8 doses (48 hours) in phase 1 of study (45 patients, 30 receive IMP) or 20 doses (120 hours) in phase 2 (45 patients, 30 receive IMP).
Trial: NCT00996268
Drug: GSK2212836
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment A - GSK2212836 test formulation 1, Treatment B - GSK2212836 test formulation 2, or Treatment C -GSK2212836 marketed formulation.
Trial: NCT02682784
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00996268
Drug: GSK2212836
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment D - low dose of GSK2212836 test formulation, Treatment E - medium dose of GSK2212836 test formulation, Treatment F - high dose of GSK2212836 test formulation, Treatment G - GSK2212836 marketed formulation, or Placebo.
Trial: NCT01187186
Drug: ASP1941
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral
Trial: NCT02215876
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Doxorubicin 60mg/m2 administered intravenously over 5 minutes on day 1 of a 14 of 21 days cycle IV for 4 cycles
Trial: NCT02215876
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide 600mg/m2 administered intravenously over 60 minutes on day 1 of a 14 of 21 days cycle IV for 4 cycles
Trial: NCT00363948
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Double-blind period (12 wk); Placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
Trial: NCT00447577
Drug: Loteprednol etabonate and tobramycin ophthalmic suspension
RxNorm normalized name: Loteprednol Etabonate and Tobramycin Ophthalmic Suspension
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
Trial: NCT00447577
Drug: Tobramycin and dexamethasone ophthalmic suspension
RxNorm normalized name: Tobramycin and Dexamethasone Ophthalmic Suspension
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
Trial: NCT01741948
Drug: Hormonal contraceptive
RxNorm normalized name: HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The study will follow patients who are first time users of HCs for a full year after initiation. Patients will be followed every 3 months via questionnaires, blood examinations, and gynecologic examination, in case dyspareunia evolves.~First appointment (before initiation of HCs):~Questionnaire FSFI (Female Sexual Function Index) questionnaire. Blood collection for hormones levels and extraction of mononuclear blood cells. A gynecologic exam intended to rule out existing problem which causing dyspareunia.~3,6,9,and 12 months after initiation of HCs or anytime if a patient has dyspareunia:~Questionnaire evaluating possible influence of HCs use (dyspareunia, lubrication and libido).~FSFI questionnaire. Blood collection Gynecologic examination, designated to assess the cause of pain, including assessment of vestibular tenderness, muscle tightness and tenderness, pressure-pain thresholds measurement using vulvar algesiometer, pH measurement and vaginal swab for microscopy.
Trial: NCT03351244
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 28 week treatment period
Trial: NCT01173224
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo: Cohort 1: 20mg DAS181 or placebo for 1 day (total dose of 20mg). Cohort 2: 20mg DAS181 or placebo for 10 consecutive days (total dose of 200mg). Cohort 3: 30mg DAS181 or placebo for 1 day (total dose of 30mg).