AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT03356561 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Participants will receive placebo via IM route.
Study NCT03356561 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Participants will receive placebo via IM route.
Study NCT03719937 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: weight on the anterior chest of the patient
Description: The investigators aim at assessing whether and to what extent an artificial increase in chest wall elastance, while the patient is in the supine position, may yield a significant benefit to oxygenation. The increase in chest wall elastance will be will be achieved placing a 100 g/kg weight on the anterior chest wall of the patient while he/she is in the supine/semirecumbant position. The weights will be placed on the patients' chest for 120 minutes, and then removed. A number of measurements will be recorded before and after the procedure.
Study NCT00981175 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Live attenuated Japanese encephalitis virus, then ChimeriVax diluent
Description: ChimeriVax™-JE, 0.5 mL subcutaneous on Day 0; ChimeriVax diluent 0.5 mL subcutaneous on Day 28
Study NCT00981175 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ChimeriVax diluent, then Live attenuated Japanese encephalitis virus
Description: ChimeriVax diluent, 0.5 mL subcutaneous on Day 0 and ChimeriVax™-JE, 0.5 mL subcutaneous on Day 28.
Study NCT03591536 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Pentoxifylline
Description: 400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery
Study NCT03591536 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: oral placebo tablets from 3 days before surgery and on the day of surgery
Study NCT02217553 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cholecalciferol
Description: The study participants will receive 180 soft gel cholecalciferol capsules, to be taken 2 capsules once a day for 90 days
Study NCT04200209 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Implementation of a quality indicator feedback mechanism
Description: 1. Audit and feedback: A summary of clinical performance and hospital safety culture over a specified period of time.~2. Benchmarking Achievable: benchmarks are calculated from the performance of all members of a peer group and represents a realistic standard of excellence attained by the top performers in that group (i.e. comparing to the top 10% of peers).~3. Educational outreach: A trained independent person or investigator will meet with health professionals or managers in their practice setting to provide information (e.g. feedback of quality indicators).~4. Action planning: The purpose of action planning is to support quality improvement efforts by identifying opportunities for improvement, strategies and steps to accomplish the work.
Study NCT02357277 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Budesonide
Description: inhaled glucocorticoid budesonide as dry powder inhaler
Study NCT03250195 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: PET/MRI
Description: PET/MRI scan
Study NCT02326246 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: multi-parametic MRI
Study NCT02011997 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: patients undergo cVATS segmentectomy
Study NCT02011997 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Patients undergo cVATS lobectomy
Study NCT03098901 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Tc99m-labeled pyrophosphate scan
Description: Intravenous injection of Tc99m-labeled pyrophosphate with consecutive whole body scan using gamma ray scanner for assessment of radioactive uptake in the heart. The results of the scan will be evaluated by a specialist in the field. The uptake will be graded using Perugini scale (0- no uptake, 1- uptake in heart less intense than in bones, 2-uptake in heart as intense as in bones, 3-uptake in heart more intense than in bones).
Study NCT02427763 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: hours of use (Essix)
Description: the patient will use de thermoplastic device during the night or during all day
Study NCT02427763 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: collect saliva
Description: the patient spit during 30 seconds in a small bottle
Study NCT02427763 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: collect biofilm
Description: a sterile swab is rubbed at the buccal surface of the upper teeth
Study NCT02427763 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: collect epithelium
Description: a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
Study NCT00486239 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: TLE Arm 1
Description: Behavioral/cognitive testing
Study NCT00486239 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Emotion Memory Test
Description: Behavioral/cognitive Measure
Study NCT00486239 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Emotion Memory Testing
Description: Behavioral/cognitive testing
Study NCT03502772 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pilates exercises
Description: Clinical Pilates training program will be given one session in a week for 8 weeks plus two days home exercise program. Group exercise sessions will be performed. The sessions will be supervised by a physiotherapist who is certified.
Study NCT03502772 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Home exercise program
Description: written exercises that matched the aims of the Pilates exercises, 3 times per week for 8 weeks. These exercises reflect routine clinical practice (flexibility, strength, and balance exercises).
Study NCT02357277 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Inhaler
Description: inhaled placebo
Study NCT03568786 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: End-inspiratory pause 10%
Description: Percentage of the total inspiratory time in which there is no gas flow. It is the period of time between the cessation of the inspiratory flow and the start of expiration. In this intervention arm it would correspond to a 10% of the total inspiratory time
Study NCT03568786 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: End-inspiratory pause 30%
Description: Percentage of the total inspiratory time in which there is no gas flow. It is the period of time between the cessation of the inspiratory flow and the start of expiration. In this intervention arm it would correspond to a 30% of the total inspiratory time
Study NCT01634750 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ManNAc
Description: Single dose
Study NCT01634750 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: ManNAc
Description: Single dose
Study NCT04071483 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Cervical transforaminal epidural steroid injection
Description: Cervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain.
Study NCT04071483 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Cervical transforaminal epidural steroid injection
Description: Cervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain.
Study NCT00580294 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxymorphone
Description: IV PO
Study NCT01655212 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Valganciclovir
Description: Infants will be treated with valganciclovir for 6 weeks, 32 mg/kg daily dose in two doses, oral solution.
Study NCT00419432 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Routine Observational Analysis (prior to procedure)
Description: Controls will undergo the standard orthopaedic surgery using the information from the physical examination and observational analysis of the gait alone.
Study NCT01728259 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pomalidomide
Description: Given PO
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Low Molecular Weight Sulfated Dextran (LMW-SD)
Description: Inhibitor of IBMIR
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Heparin
Description: Anticoagulation
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CellCept® (Mycophenolate mofetil) OR Rapamune® (Sirolimus)
Description: Cell proliferation inhibitor
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: CellCept® (Mycophenolate mofetil) OR Rapamune® (Sirolimus)
Description: Cell proliferation inhibitor
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prograf® (Tacrolimus) OR Cyclosporine
Description: Calcineurin inhibitor
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prograf® (Tacrolimus) OR Cyclosporine
Description: Calcineurin inhibitor
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Thymoglobulin® (Anti-thymocyte Globulin) - at first transplant
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Thymoglobulin® (Anti-thymocyte Globulin) - at first transplant
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Simulect® (Basiliximab) - at 2nd or 3rd transplant
Description: Monoclonal IL-2 receptor blocker
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Simulect® (Basiliximab) - at 2nd or 3rd transplant
Description: Monoclonal IL-2 receptor blocker
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Klexane® (Enoxaparinsodium)
Description: Anticoagulation Prophylaxis
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Klexane® (Enoxaparinsodium)
Description: Anticoagulation Prophylaxis
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Trombyl® or Albyl-E® (Acetylsalicylicacid- ASA)
Description: Anticoagulation Prophylaxis
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Trombyl® or Albyl-E® (Acetylsalicylicacid- ASA)
Description: Anticoagulation Prophylaxis
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Enbrel® (Etanercept)
Description: Anti-Inflammatory Therapy
Study NCT00789308 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Enbrel® (Etanercept)
Description: Anti-Inflammatory Therapy
Study NCT03283358 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Person-centered follow up
Study NCT04953520 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: ultrasound-CT fusion imaging
Description: The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of ultrasound-CT fusion imaging
Study NCT04953520 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: pure ultrasound guidance
Description: The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance
Study NCT00419432 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Routine Observational analysis supplemented with Gait Lab Information (prior to procedure)
Description: This experimental group will undergo standard orthopaedic surgery using the information from the physical examination, observational AND the gait laboratory analysis data
Study NCT00741221 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pemetrexed
Description: Pemetrexed (IV) 500 mg/m2 on day 1 every 3 weeks for 6 cycles
Study NCT00741221 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Description: Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles After the end of the 6 cycles Bevacizumab will be administered alone at the dose of 15 mgr/Kgr (IV) every 3 weeks until disease progression
Study NCT01728259 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bortezomib
Description: Given IV
Study NCT01728259 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dexamethasone
Description: Given PO
Study NCT01728259 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies
Study NCT01470339 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: duloxetine
Description: duloxetine 60mg once a day for 5 weeks
Study NCT03148925 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SELA-070
Description: Sub-cutaneous injection, multiple dose
Study NCT04192214 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: BC 007
Description: 1350 mg of BC 007
Study NCT02726776 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Suspension in a harness
Study NCT01470339 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: duloxetine
Description: duloxetine 60mg once a day for 5 weeks
Study NCT04185467 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Intervention (rehabilitation exercise)
Description: Patients in intervention group (exercise rehabilitation) will receive a multimodal program which includes a 90 minute program at the hospital gymnasium in a supervised environment a minimum of once but up to twice per week. Rehabilitation will include aerobic (brisk walking), resistance training and 30 minutes of 8 style Tai Chi. Participants will be advised to walk on days of non-attendance - this will be individualised with the aim to have participants increase to 30 minutes walking per day.
Study NCT03307447 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Secukinumab
Description: Secukinumab 300 mg subcutaneous injection
Study NCT00003995 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: trastuzumab
Study NCT00003995 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: irinotecan hydrochloride
Study NCT03607682 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Tumor Treating Fields (TTF) Therapy
Description: Undergo TTF therapy
Study NCT03607682 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: NovoTTF-200A Device
Description: Undergo TTF therapy
Study NCT03607682 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Quality-of-Life Assessment
Description: Ancillary studies
Study NCT02435173 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CDZ173
Description: CDZ173 10 and 70 mg capsules for oral administration.
Study NCT03148925 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Saline
Description: Sub-cutaneous injection, multiple dose
Study NCT02435173 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo capsules for oral administration
Study NCT04555213 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NOX66
Description: NOX66 Suppository
Study NCT04055298 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: SMASS-Triage
Description: SMASS-Triage is a web-based symptom checker developed by In4medicine Ltd. SMASS-Triage is based on a computerized transparent neural network, which was trained with the evidence of more than 1200 studies and the expertise of various panels of specialists in the field of preclinical medical triage. SMASS-Triage provides digitalized questionnaires of 87 frequent reasons of encounters (e.g. fever, cough, abdominal pain) and their associated red flags. The triage-result of SMASS-Triage encompasses the appropriate time-to-treat (T2T) and the adequate point-of-care (PoC).
Study NCT02726776 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Climbing
Study NCT00756444 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Panitumumab
Description: This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
Study NCT00756444 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cisplatin
Description: This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
Study NCT00756444 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 5FU
Description: This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
Study NCT04006457 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-06651600
Description: 50 mg oral tablets/capsules
Study NCT04006457 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Description: Single intramuscular injection administered to patients participating in the vaccine sub-study
Study NCT04006457 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Description: Single intramuscular injection administered to patients participating in the vaccine sub-study
Study NCT00001309 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Vitamin C
Description: Outpatient subjects will be encouraged to consume vitamin C in foods. As inpatients, vitamin C deficiency will be induced by placing subjects on a tightly restricted scorbutic diet. Plasma vitamin C will be monitored several times per week. When subjects have achieved a plasma ascorbate concentration of 5-10 micromolar, blood sampling and urine collection over 24 hours will be performed. After platelets and leukocytes are collected, ascorbate repletion will begin. Escalating doses of ascorbate will be administered orally and intravenously for the remainder of their inpatient admission. Total daily doses of 30mg, 60mg, 100mg, 200mg, 400mg, 1000mg and 2500mg will be given in two divided doses. Bioavailability of ascorbate will be determined at each dosage increment. When plasma ascorbate concentration reaches steady state for each dose, subjects will undergo 36 hr plasma sampling and a timed 48 hr urine collection.
Study NCT02688855 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Active Combined Magnetic Field OL1000 Bone Growth Stimulator
Description: Active CMF OL1000 Device
Study NCT02688855 — intervention group
Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Sham Combined Magnetic Field OL1000 Bone Growth Stimulator
Description: Sham CMF OL1000
Study NCT00265941 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cetuximab
Description: Cetuximab 400 mg/m\^2 IV loading dose 5-7 days before start of radiation therapy, then 250 mg/m\^2 IV weekly for 7 weeks
Study NCT00265941 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: cisplatin
Description: Cisplatin 100 mg/m\^2 IV on days 1 and 22
Study NCT00265941 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin
Description: Cisplatin 100 mg/m\^2 IV on days 1 and 22
Study NCT00265941 — intervention group
Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Accelerated Fractionation by Concomitant Boost
Description: 3DCRT 54 Gy in 30 1.8 Gy fractions over 6 weeks with boost 18 Gy in 12 1.5 Gy fractions for last 12 days, for a total of 72 Gy in 42 fractions over 6 weeks
Study NCT00265941 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Accelerated Fractionation by Concomitant Boost
Description: 3DCRT 54 Gy in 30 1.8 Gy fractions over 6 weeks with boost 18 Gy in 12 1.5 Gy fractions for last 12 days, for a total of 72 Gy in 42 fractions over 6 weeks
Study NCT00265941 — intervention group
Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Intensity-modulated radiation therapy
Description: 70 Gy in 35 2.0 Gy fractions over 6 weeks with 6 fractions per week (on Saturday or as second daily fraction) in 5 of the 6 weeks.
Study NCT00265941 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Intensity-modulated radiation therapy
Description: 70 Gy in 35 2.0 Gy fractions over 6 weeks with 6 fractions per week (on Saturday or as second daily fraction) in 5 of the 6 weeks.
Study NCT03425656 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Description: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
Study NCT03425656 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Description: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
Study NCT02859701 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AK002
Description: IV AK002
Study NCT02859701 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study NCT02424539 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FFNS
Description: FF as a aqueous suspension for intranasal inhalation with unit dose strength of 27.5 mcg per dose administered via a metered side-actuated nasal spray device.
Study NCT02424539 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo as a aqueous suspension to match the other study treatments minus the active component(s) for intranasal inhalation administered via a metered side-actuated nasal spray device.