AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT01181050
Drug: NNC0142-0002
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).
Trial: NCT01181050
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).
Trial: NCT01895452
Drug: ALKS 9072, Low Dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intramuscular injection, given monthly
Trial: NCT01895452
Drug: ALKS 9072, High Dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intramuscular injection, given monthly
Trial: NCT02709928
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03783728
Drug: Pyridoxine 50 mg orally
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Once a week for 12 weeks using Video Directly Observed Therapy
Trial: NCT02909569
Drug: INCB039110
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All subjects will receive 400 mg PO QD for 12 weeks. If no clinical response after four weeks, dose will be increased to 600 mg PO QD. Total duration of subject participation will be six study visit over 20 weeks.
Trial: NCT03341910
Drug: DFD-03 Lotion, 0.1%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
Trial: NCT03341910
Drug: Tazorac Cream, 0.1%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
Trial: NCT03341910
Drug: DFD-03 Vehicle Lotion 0%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
Trial: NCT03341910
Drug: Tazorac Vehicle Cream 0%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
Trial: NCT02358369
Drug: Placebo Eye Drops
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo eye drops BID OU.
Trial: NCT02760017
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03655717
Drug: Ethanol
RxNorm normalized name: Ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral Ethanol, dosed to obtain a breath alcohol concentration (BrAC) of approximately 0.05 BrAC (equal to 1-2 standard drinks).
Trial: NCT03655717
Drug: Placebo ethanol
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo ethanol will consist of diet soda used in the active ethanol condition with 0.25ml ethanol floated on top to provide the odor of ethanol and blind the study drug.
Trial: NCT00999219
Drug: FK199B
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral
Trial: NCT04398199
Drug: Hypofractionated Radiation Therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The prescribed dose will be 70 Gy in 25 fractions. Participants will radiation therapy once a day for 25 days, Monday through Friday (around 5 weeks).
Trial: NCT01884857
Drug: 'TOPROL-XL®' ER Tablets 50 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 \* 50 mg tablet per day
Trial: NCT01810302
Drug: Preservative-free normal saline
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
Trial: NCT03001843
Drug: Narcotics
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The narcotic group will receive no ketamine but rather a more standard anesthetic
Trial: NCT01098838
Drug: LCL161
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01681576
Drug: LCZ696
FDA approved: no
EMA approved: no
PMDA approved: no
Description: LCZ696 400mg tablet once daily
Trial: NCT04138043
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo is 0.9 percent sodium chloride solution. It will be administered as SC injection to abdomen by study personnel. Three injections will be used to match active doses.
Trial: NCT04138043
Drug: GSK2330811
FDA approved: no
EMA approved: no
PMDA approved: no
Description: GSK2330811 will be available as SC injection 150 mg/mL.
Trial: NCT02435732
Drug: Placebo saline solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: saline solution
Trial: NCT02435732
Drug: Heparin
RxNorm normalized name: Heparin
DrugBank: Heparin (DB01109)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Added to the one of the arms receiving 200U/kg dose of CINRYZE
Trial: NCT03584087
Drug: Normal Saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TG 0 (0Hr)
Trial: NCT03368131
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 825\~1000mg/m2 bid d1-14
Trial: NCT01522040
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Simple saline drip, without active drug
Trial: NCT00546039
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Capsule
Trial: NCT03603834
Drug: mFOLFOXIRI
FDA approved: no
EMA approved: no
PMDA approved: no
Description: mFOLFOXIRI consists of the following combination of drugs:~1. Oxaliplatin, 85 mg/m2, IV over 2 hours~2. Leucovorin, 400 mg/m2, IV over 2 hours~3. Irinotecan, 150 mg/m2, IV over 90 minutes~4. 5 FU, 400 mg/m2, IV bolus~5. 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection~each 14 day cycle, for 6 cycles
Trial: NCT00587860
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
Trial: NCT00115700
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 1000 mg/m2 I.V. on day 1
Trial: NCT00115700
Drug: Prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 50 mg/m2 orally daily for days 1 - 5
Trial: NCT00995670
Drug: Simvastatin
RxNorm normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Simvastatin will be ingested to determine the efficacy of a statin to modulate the forearm response to glucose.
Trial: NCT00258206
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01928485
Drug: Sunphenon
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT04111107
Drug: Investigational Agent
RxNorm normalized name: INVESTIGATIONAL AGENTS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment will be administered on an inpatient or outpatient basis based on the type of medication selected. The investigatory will administer the drug as directed in the FDA approved label.
Trial: NCT01464242
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo 400mg orally 3 times a day for 20 days
Trial: NCT03512977
Drug: conservative treatment
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline
Trial: NCT03011450
Drug: Placebo (for K-877)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02907320
Drug: placebo MPFF
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01212770
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03717961
Drug: BOTOX® solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Botox solution + Saline serum + lidocaine/prilocaine cream + Nitrous oxide/oxygen (50%/50%)
Trial: NCT03717961
Drug: Placebo group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo + lidocaine/prilocaine cream + Nitrous oxide/oxygen (50%/50%)
Trial: NCT02483169
Drug: Placebo of aspirin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: same size and shape of active aspirin 100mg
Trial: NCT01214772
Drug: heparin
RxNorm normalized name: Heparin
DrugBank: Heparin (DB01109)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 5000 IU subcutaneously in the day of embryo transfer until 6 week after delivery
Trial: NCT01093729
Drug: HM11260C
FDA approved: no
EMA approved: no
PMDA approved: no
Description: HM11260C 0.5mcg/kg or Placebo
Trial: NCT01093729
Drug: HM11260C
FDA approved: no
EMA approved: no
PMDA approved: no
Description: HM11260C 2mcg/kg or Placebo
Trial: NCT01093729
Drug: HM11260C
FDA approved: no
EMA approved: no
PMDA approved: no
Description: HM11260C 4mcg/kg or Placebo
Trial: NCT01093729
Drug: HM11260C
FDA approved: no
EMA approved: no
PMDA approved: no
Description: HM11260C 8mcg/kg or Placebo
Trial: NCT01093729
Drug: HM11260C
FDA approved: no
EMA approved: no
PMDA approved: no
Description: HM11260C 14mcg/kg or Placebo
Trial: NCT00838110
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 10 mg TID for week 1 followed by 20 mg TID through Week 26
Trial: NCT00838110
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12
Trial: NCT01262651
Drug: Placebo (GA-0034)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01088932
Drug: SRX246
FDA approved: no
EMA approved: no
PMDA approved: no
Description: capsules
Trial: NCT01843426
Drug: Low-volume, low-concentration contrast (iodixanol - Visipaque 270) CT scan
FDA approved: no
EMA approved: no
PMDA approved: no
Description: An ECG-synchronized, contrast-medium enhanced CT study of the heart for the evaluation of the aortic root complex and general cardiac morphology will be obtained. This is immediately followed by a CT angiographic study of the chest, abdomen, and pelvis (beyond the femoral heads), which utilizes the same contrast bolus that is injected for evaluating the heart. This latter vascular study serves to evaluate the TAVR deployment catheter access route through the femoral, iliac, and aortic vascular stations. In clinical routine, we have been performing this type of study with total contrast media volumes ranging from 40-120 mL of iodinated contrast material.
Trial: NCT03588533
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: - Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks
Trial: NCT05630274
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally.
Trial: NCT01786512
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Modified release tablets matching to omecamtiv mecarbil
Trial: NCT02260648
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT04268472
Drug: GP30101
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
Trial: NCT04268472
Drug: Prezista®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
Trial: NCT03162224
Drug: MEDI0457
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MEDI0457 7 mg will be administered intramuscularly followed by electroporation (EP) using CELLECTRA®5P device.
Trial: NCT00760929
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: iv 9mg/kg weekly
Trial: NCT00760929
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: iv 16mg/kg every 3 weeks
Trial: NCT00760929
Drug: RG1507
FDA approved: no
EMA approved: no
PMDA approved: no
Description: iv 9mg/kg weekly
Trial: NCT00760929
Drug: RG1507
FDA approved: no
EMA approved: no
PMDA approved: no
Description: iv 16mg/kg every 3 weeks
Trial: NCT02634411
Drug: 8 days of effective antibiotic treatment
RxNorm normalized name: combinations of different antibiotics
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Antibiotics used for usual care in PA-VAP treatment : Penicillins, Cephalosporins, Monobactams, Carbapenems, Fluoroquinolones, Aminoglycosides (list not exhaustive).~Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against pseudomona aeruginosa of 8 days.
Trial: NCT02206503
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: This protocol is a phase II multicenter, open label study designed to determine whether the addition of Cyclophosphamide to Rd (CRd) treatment significantly increases response rates and prolonged the outcome (PFS, OS) in patients who experienced a biochemical relapse, without CRAB under Rd treatment. The treatment period includes: administration of the combination CRd for 9 cycles. In order to assess the efficacy and safety of treatment, patients will attend the study center visits at least every 2 weeks. The response will be assessed after each cycle. During the LTFU period, after development of confirmed PD, all patients are to be followed for survival every 1-3 months via telephone or office visit.
Trial: NCT01733004
Drug: MM-141
RxNorm normalized name: inositol 141 MG
DrugBank: Inositol (DB13178)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03135951
Drug: SPI-2012
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Supplied in prefilled, single-use syringes for subcutaneous injection and administered on Day 2 of each cycle.
Trial: NCT02277106
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02293902
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Dispensed according to local practice.
Trial: NCT02293902
Drug: Folic acid
RxNorm normalized name: Folic Acid
DrugBank: Folic acid (DB00158)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Dispensed according to local practice.
Trial: NCT00411736
Drug: Study medication, azithromycin or placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Granulate for syrup in the group under 8 years, 40 mg/ml. Dose: 5 mg/kg/day in one daily dose.
Trial: NCT00411736
Drug: Azithromycin or placebo tablets
RxNorm normalized name: placebo Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablets of 250 mg, azithromycin or placebo. Dosage: 1 tablet every other day for participants with a weight less than 40 kg´s. 1 tablet every day for participants weighing 40 kg´s or more.
Trial: NCT01008033
Drug: IDP-108
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Topical application once a day for 48 weeks
Trial: NCT01008033
Drug: Vehicle
RxNorm normalized name: Drug vehicle
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Topical application once a day for 48 weeks
Trial: NCT02541708
Drug: Ferrous sulfate + folic acid
RxNorm normalized name: ferrous sulfate / folic acid
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Three dried ferrous sulfate and folic acid tablets every morning 30 mins before the meal. If side effects occur the drug may be taken with the meal or in 2 separate doses per day. The treatment will be pursued for 3 months after correction of anemia
Trial: NCT00574080
Drug: Induction/Consolidation Adriamycin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 10 mg/m2 by continuous infusion Days 1-4
Trial: NCT00574080
Drug: InductionConsolidation Cyclophosphamide
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 400 mg/m2 by continuous infusion Days 1-4
Trial: NCT00574080
Drug: Transplant 1 Cyclophosphamide
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 800 mg/m2 by continuous infusion Days -3 and -2
Trial: NCT02256423
Drug: REFERENCE 1: Nurofen® 200 mg tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02256423
Drug: REFERENCE 2: Ibuprofen 200 mg soft gel capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02256423
Drug: ibuprofen 200 mg soft gel capsule
RxNorm normalized name: ibuprofen 200 MG
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00000392
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02491697
Drug: Capecitabine Monotherapy
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: All patients receive capecitabine monotherapy (2500 mg/m2 twice daily) for 2 weeks followed by a 1-week rest period.And the treatment is repeated every 3 weeks.
Trial: NCT04428359
Drug: Measles-Mumps-Rubella Vaccine
RxNorm normalized name: MEASLES/MUMPS/RUBELLA VIRUS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Group A patients will receive intralesional injection of upto 0.5 mL of reconstituted MMR vaccine into a single or a maximum of 5 warts at a time in case of multiple warts. Intralesional injection will be given every three weeks for a maximum of 5 doses or until complete resolution, whichever is earlier.
Trial: NCT04428359
Drug: Vit D
RxNorm normalized name: Tri-Vit Drops
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Group B patients will receive a maximum of 0.5 mL Inj. Vitamin D3 (600,000 IU; 15mg/ml) in each session after injection of IL lignocaine with 31 G insulin syringe. In cases of multiple warts, a maximum of 5 warts will be injected at a time. The session will be done at 3 weekly intervals for a maximum of 5 sessions or until complete resolution of warts, whichever is earlier
Trial: NCT02157506
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00794612
Drug: Dermacyd Femina Pocket BR (Lactic Acid)
RxNorm normalized name: Respa-BR
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dermacyd Femina Pocket BR (Lactic Acid) during 21 consecutive days
Trial: NCT03434951
Drug: Placebo - Concentrate
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume
Trial: NCT00345241
Drug: Systane Ocular Drops (OTC)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00345241
Drug: Placebo - Saline Drops
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00784810
Drug: Codeine/Paracetamol
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 15/500 and 30/500 mg codeine/paracetamol tablets, 2 tablets 6 hourly
Trial: NCT02085213
Drug: Matched Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matched placebo
Trial: NCT04061252
Drug: KHK4827
FDA approved: no
EMA approved: no
PMDA approved: no
Description: brodalumab 210mg Q2W, SC
Trial: NCT04061252
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Q2W, SC
Trial: NCT04260659
Drug: Remifentanil [Ultiva]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Remifentanil TCI Minto Model will be used during induction in dosis 6 ng/ml and intraoperatively appropriately to maintain hemodynamical stability.
Trial: NCT04260659
Drug: Fentanyl [Fentanyl WZF]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Rescue dosis of 100 mcg iv will be administered if hypertension \> 140/90 mmHg or tachycardia \> 120min occurs. If necessary rescue dosis may be repeated.
Trial: NCT00879606
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In the first part of this study, a single dose of Placebo was administered via intravenous infusion over 15 minutes. In the second part of this study, up to four doses of Placebo will be administered via intravenous infusion over 15 minutes.
Trial: NCT05041322
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects take placebo pills (twice a day) for 14 Days.
Trial: NCT02119416
Drug: Placebo Administration first
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All participants received each dose on two days and the order of administration was counterbalanced.~Order of Administration for Visits 1-6: 0mg, 1mg, 2mg, 0mg, 1mg, 2mg
Trial: NCT02119416
Drug: Low Caffeine Administration first (1mg/kg body weight)
RxNorm normalized name: Caffeine
DrugBank: Caffeine (DB00201)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: On two of the 6 visits, participants received a placebo (flattened sprite) added to their beverage.~Order of Caffeine Administration for Visits 1-6: 1mg, 2mg, 0mg, 1mg, 2mg, 0mg
Trial: NCT02119416
Drug: High Caffeine Administration first (2mg/kg body weight)
RxNorm normalized name: High molecular weight insulin human
DrugBank: Insulin human (DB00030)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: On two of the 6 visits, participants received a placebo (flattened sprite) added to their beverage.~Order of Caffeine Administration for Visits 1-6: 2mg, 0mg, 1mg, 2mg, 0mg, 1mg
Trial: NCT01575405
Drug: Universal HEC Placebo Gel Formulation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The Universal HEC Placebo Gel contains hydroxyethylcellulose as the gelling agent, purified water, sodium chloride, sorbic acid and sodium hydroxide. The gel is isotonic and formulated at a pH of 4.4 to avoid disrupting the normal vaginal pH and has minimal buffering capacity to avoid the inactivation of sexually transmitted pathogens. Hydroxyethylcellulose is used to approximate the viscosity of microbicide gel candidates. Each pre-filled applicator will deliver approximately 4 mL of HEC placebo gel. Six doses of this gel will be used to balance out the VF stage of the study.
Trial: NCT02965950
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: I.v. infusion
Trial: NCT01945606
Drug: Placebo (treatment 1)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral administration of placebo tablets
Trial: NCT02352558
Drug: BBI608
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will receive BBI608 orally twice daily, with doses separated by approximately 12 hours. The starting dose for all cohorts will be 240 mg twice daily. Subsequently, cohorts at alternate dose-levels (480 mg twice daily) may be enrolled as determined by the criteria for dose-escalation.