TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00290433

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Cycle 1: 300 mg/m\^2 by vein Over 3 Hours Twice Daily on Days 1, 2, and 3.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mesna
Description: Cycle 1: 600 mg/m\^2 by vein Continuous Infusion Over Days 1, 2, and 3.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: Cycle 1: 1.4 mg/m\^2 by vein On Day 4 and 11.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Cycle 1 and 2: 200 mg/m\^2 by vein Over 2 Hours on Day 1, followed by 800 mg/m\^2 IV Over 22 Hours on Day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ara-C
Description: Cycle 1 and 2: 3 Gm/m\^2 Over 2 Hours Twice Daily On Days 2 and 3.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Cycle 1: 40 mg by vein or by mouth daily on Days 1-4 and 11-14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: G-CSF
Description: Cycle 1 and 2: 300 or 480 mcg subcutaneously 24 hours after end of Day 4 vincristine.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxil
Description: Cycle 1: 25 mg/m\^2 by vein Over 1 Hour on Day 2.
Study: NCT03655756

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: IFx-Hu2.0
Description: Subjects enrolled will receive a fixed IFx-Hu2.0 (plasmid DNA) dose of 0.1 mg injected in up to 3 lesions at a single time point (28-day follow-up post last injection).
Study: NCT04258943

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bosutinib
Description: Patients with R/I disease are enrolled at a dose of 400 mg/m2 (DL2B) based on tolerability and PK analysis. Once the RP2D for R/I patients (RP2DR/I) is determined in the Phase 1, subsequent patients with R/I disease will be enrolled at the RP2DR/I for this subpopulation for the Phase 2 component of the study (see section 1.6.3 and section 3 for details).~- Patients with newly diagnosed disease are being enrolled on Phase 2 component only, at RP2DND dose of 300 mg/m2. (see section 1.6.3 and section 3 for details)
Study: NCT03328663

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: CARE
Description: Promote effective coping and reduce caregiving burden.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: CARE
Description: Promote effective coping and reduce caregiving burden.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard Transplant Care
Description: Standard cared administered by the hospital.
Study: NCT03919708

Intervention type: DEVICE
Intervention: Retinal Birefringence Imager
Description: Device is a hand-help object approximately the size of a brick, and is held, by the user, 30cm away from the patient/subject. The subject peers in to an aperture that includes a fixation target that is in the shape of a smiley face. During this time, a ring of LED lights illuminates the eye and captures an image of the retina in approximately 3 seconds. The results instantaneously identify the presence of amblyopia / strabismus.

Intervention type: DEVICE
Intervention: Retinal Birefringence Imager
Description: Device is a hand-help object approximately the size of a brick, and is held, by the user, 30cm away from the patient/subject. The subject peers in to an aperture that includes a fixation target that is in the shape of a smiley face. During this time, a ring of LED lights illuminates the eye and captures an image of the retina in approximately 3 seconds. The results instantaneously identify the presence of amblyopia / strabismus.
Study: NCT03248401

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cilostazol
Description: Cilostazol 200 mg/day

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aspirin
Description: Aspirin 100 mg/day
Study: NCT00871312

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Topical wound oxygen therapy
Description: 90 minutes 4 days per week Active Topical Oxygen Therapy

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Topical wound oxygen Placebo
Description: 90 mins per day 4 days per week Placebo Therapy
Study: NCT00253630

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vorinostat
Description: Given PO
Study: NCT01780831

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Raltegravir
Description: RAL was given as oral granules for suspension.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Raltegravir
Description: RAL was given as oral granules for suspension.
Study: NCT02642133

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Lingual Frenotomy and/or maxillary labial frenectomy
Description: The procedure is performed with a 1064nm InGaAsP semiconductor diode laser which is a soft tissue laser with variable pulsed wave and wattage settings. The procedure was performed at 0.7-0.8 pulsed watts, 200 microseconds on and 100 microseconds off (actual wattage: 0.47 to 0.53 W) using a 300 micron laser fiber. The tongue is elevated using a grooved director while the laser tip is applied to the frenulum. If present, the anterior frenulum is divided until the submucosal portion of the tie is identified (this is the posterior tongue-tie). A small window in the central mucosa is made and the lateral mucosal walls of the posterior tongue-tie are released, taking care to not disturb the fascia of the underlying genioglossus muscle.
Study: NCT02360020

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: XLimus
Description: Techniques attempted for facilitating stent delivery in such a complex lesions are: maximize guide catheter support, optimize predilatation of the stenosis, use of a stiffer guidewire. Specific tricks include: a) buddy-wire; anchoring balloon; GuideLiner catheter. In case of severe calcification, rotational atherectomy was electively performed with the Rotablator® system (Boston Scientific Corporation, Natick, MA, U.S.A.). Following stent implantation, postdilatation is performed in all instances with a non-compliant balloon
Study: NCT03946709

Intervention type: OTHER
Group type: OTHER
Intervention: Action Observation
Description: Strength, voluntary activation, and cortical responses to three conditions will be measured: 1) action observation of very strong, forceful contractions of the hand and wrist flexors 2) action observation of very weak, feeble contractions of the hand and wrist flexors 3) no action observation. Experimental conditions will be randomized and counterbalanced.

Intervention type: OTHER
Group type: OTHER
Intervention: Action Observation
Description: Strength, voluntary activation, and cortical responses to three conditions will be measured: 1) action observation of very strong, forceful contractions of the hand and wrist flexors 2) action observation of very weak, feeble contractions of the hand and wrist flexors 3) no action observation. Experimental conditions will be randomized and counterbalanced.
Study: NCT02592850

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: osteopathic manipulative treatment
Description: This intervention will not be protocol-based but the treating D.O. will compulsory have to include the evaluation (and possible treatment) of temporo-mandibular joint disorders and cervical dysfunctions (semi-structured treatment). Specifically, OMT will focus on correcting those osteopathic dysfunctions found during the initial evaluation; both structural (including myofascial release and HVLA), visceral and craniosacral techniques will be administered as appropriate.~Duration: 45 minutes. Administered once a week for four weeks.

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: sham
Description: In this intervention, the operator will be restricted to the assessment of the cranial rhythmic impulse (CRI), temporo-mandibular joint disorders and cervical dysfunctions, spending a similar amount of time to that being spent on OMT-treated patients. Any found osteopathic dysfunction will not be corrected.~Duration: 45 minutes. Administered once a week for four weeks.
Study: NCT03992937

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vaginal Micronized Progesterone
Description: Micronized progesterone tablets at a dose of 200 mg once a day vaginally, for 12 days (Between 14'th-25'th days of the menstrual cycle) over three months.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Levonorgestrel-Intrauterine System
Description: Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day.
Study: NCT04712929

Intervention type: OTHER
Intervention: Fluconazole
Description: ( Tab Fluconazole 100 mg as a mouthwash ( tablet dissolved in 10 ml of drinking water and used as a rinse for 2 minute and swallowed) once a day for 14 days WHO criteria 5As and 5Rs for tobacco cessation

Intervention type: OTHER
Intervention: Fluconazole
Description: ( Tab Fluconazole 100 mg as a mouthwash ( tablet dissolved in 10 ml of drinking water and used as a rinse for 2 minute and swallowed) once a day for 14 days WHO criteria 5As and 5Rs for tobacco cessation
Study: NCT03155594

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Freestyle Libre
Description: Continuous glucose monitoring patch
Study: NCT01731652

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TMX-101
Study: NCT03961087

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Coenzyme Q10
Description: Coenzyme Q10 will be given twice

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: MECLOFENOXATE
Description: MECLOFENOXATE will be given as 500 mg once daily.
Study: NCT04442230

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: NasoVAX
Description: NasoVAX consists of replication-deficient adenovirus vectors in suspension

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Normal saline
Study: NCT01120496

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 3% hypertonic saline
Description: Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: normal saline
Description: Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline
Study: NCT03755648

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Treadmill training
Description: The motorized treadmill treatment parameters considered will be 50 Hertz, 10 Ampere and 220 Volts. The speed of treadmill will be controlled with a single finger tip allowing an individual to exercise in safe environment with sufficient space.The treadmill training will be provided by giving instructions first and then warm up will be given for 5 minutes prior to the training. The children will be upright with the feet flat on treadmill platform. The height of handrails will be adjustable according to every child thus keeping their gaze forward. The training will be ended at cool down period of 5 minutes.The treatment session will be thirty minutes for each group, six times a week for three months.

Intervention type: OTHER
Group type: OTHER
Intervention: traditional physical therapy
Description: Traditional therapy includes hot pack for 15 minutes and stretching for 20 minutes

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Delorme resistance exercise
Description: Delorme Resistance Training was also initiated with 5 minute warm up period. It was started with 10 Repetition Maximum and was gradually increased. The treatment session was thirty minutes for each group, six times a week for three months.
Study: NCT03105570

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Areola Sparing Mastectomy
Description: A small circular incision would be made to separate nipple from breast and an additional incision directly extended from nipple or located at other part of breast such as infra-mammary fold and subaxillary area would be made to remove the total mammary parenchyma. Routine implant based or flap base reconstruction would be performed subsequentially. Nipple reconstruction is optional.
Study: NCT02037737

Intervention type: DRUG
Intervention: Abatacept
Study: NCT04161833

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: OPERA
Description: All patients were required to take an OPERA® capsule (dietary supplement where α-lipoic acid, Boswellia Serrata, methylsulfonylmethane and bromelain are combined in a single capsule) once daily,from enrollment up to sixth months.
Study: NCT01797900

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: induction: Cisplatin: 80mg/m2, d1 and d22 concurrent: Cisplatin: 100mg/m2, d1, 22, 43 adjuvant: cisplatin: 75mg/m2, d1, d22, d43,d64

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cisplatin
Description: induction: Cisplatin: 80mg/m2, d1 and d22 concurrent: Cisplatin: 100mg/m2, d1, 22, 43 adjuvant: cisplatin: 75mg/m2, d1, d22, d43,d64

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: induction: paclitaxel 175mg/m2 d1,d22 adjuvant: paclitaxel 175mg/m2 d1,d22, d43,d64

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Paclitaxel
Description: induction: paclitaxel 175mg/m2 d1,d22 adjuvant: paclitaxel 175mg/m2 d1,d22, d43,d64

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: IMRT
Description: 69.96Gy-73.43Gy to gross tumor volume, 60Gy to high-risk clinincal target volume, 50Gy to lower risk clincial target volume

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: IMRT
Description: 69.96Gy-73.43Gy to gross tumor volume, 60Gy to high-risk clinincal target volume, 50Gy to lower risk clincial target volume
Study: NCT04232579

Intervention type: OTHER
Intervention: Therapeutic strategy
Description: Therapeutic strategy compatible with the guidelines and development of predictive biomarkers of the response to treatment.
Study: NCT04072458

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: L-Bcl-2 antisense oligonucleotide
Description: There will be 2 planned dose levels, 20, and 40 mg/m\^2. Successive cohorts of eligible patients with will be treated with BP1002. BP1002 is given as an intravenous infusion, twice weekly, as 8 doses per 28-day cycle. Cycles may be repeated every 4 weeks.
Study: NCT02798536

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LMB-100
Description: Administered intravenous (IV) on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles (Arms A1 and A2) or 2 cycles (Arms B1 and B2)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LMB-100
Description: Administered intravenous (IV) on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles (Arms A1 and A2) or 2 cycles (Arms B1 and B2)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LMB-100
Description: Administered intravenous (IV) on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles (Arms A1 and A2) or 2 cycles (Arms B1 and B2)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LMB-100
Description: Administered intravenous (IV) on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles (Arms A1 and A2) or 2 cycles (Arms B1 and B2)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nab-paclitaxel
Description: Arms B1 and B2 only. Administered intravenous (IV) on days 1 and 8 of each 21 day cycle for up to 6 cycles
Study: NCT02791490

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Oral tablet, once daily at approximately the same time each day

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Metformin IR
Description: All participants will take Met-IR as background medication. Initially, they will take 1 x 500 mg tablet Met-IR b.i.d. (1000 mg/day). After randomization, all participants will be titrated to 2 x 500 mg tablets of Met-IR b.i.d. (2000 mg/day).
Study: NCT02798536

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nab-paclitaxel
Description: Arms B1 and B2 only. Administered intravenous (IV) on days 1 and 8 of each 21 day cycle for up to 6 cycles
Study: NCT01119170

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Starter formula
Description: standard starter formula given from birth to 6 months of age

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: starter formula with D-lactate producing probiotics
Description: starter formula containing probiotics given from birth to 6 months of age
Study: NCT01679210

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Lifestyle Intervention
Description: Stage-matched physical activity and diet intervention materials and health education.
Study: NCT04234711

Intervention type: PROCEDURE
Intervention: Surgical strategy
Description: To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection

Intervention type: PROCEDURE
Intervention: Surgical strategy
Description: To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection
Study: NCT01895322

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OPC-41061
Study: NCT01121393

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Gemcitabine+Cisplatin
Description: Gemcitabine d1,8, Cisplatin d1, 21 days as a course, up to 6 courses.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BIBW 2992
Description: starting dose is 40 mg, in the event of no or minimal drug-related adverse events after one course, the dose will be increased to 50mg. in the event of certain drug related Adverse Event (AE), dose reduction will be increments of 10 mg, with the lowest dose being 20mg.
Study: NCT04523506

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Botulinum toxin(Botox)
Description: This study will evaluate the use of botulinum toxin for reduced oral aperture in scleroderma patients. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Botulinum toxin(Botox)
Description: This study will evaluate the use of botulinum toxin for reduced oral aperture in scleroderma patients. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase.
Study: NCT00731250

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SB-705498
Description: Subjects will be administered a single dose of 400 mg SB-705498

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects will be administered SB-705498 matching placebo tablets

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects will be administered SB-705498 matching placebo tablets

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects will be administered SB-705498 matching placebo tablets

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects will be administered SB-705498 matching placebo tablets

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Caspaicin
Description: Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Caspaicin
Description: Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Caspaicin
Description: Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Caspaicin
Description: Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose
Study: NCT01965262

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Hema-copolymer Lens
Description: contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Hema-copolymer Lens
Description: contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: etafilcon A Lens
Description: contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: etafilcon A Lens
Description: contact lens
Study: NCT04499872

Intervention type: OTHER
Intervention: Advance Care Plan with Trajectory Touchpoint Technique
Description: Advance Care Plan with Trajectory Touchpoint Technique
Study: NCT03420950

Intervention type: OTHER
Group type: OTHER
Intervention: Rapid sequence intubation: sedative first
Description: Sedative first

Intervention type: OTHER
Group type: OTHER
Intervention: Rapid sequence intubation: paralytic first
Description: Paralytic first
Study: NCT02452580

Intervention type: OTHER
Intervention: Family Centered Care
Description: Neonatal intensive care toward premature infants and their parents in a unit physically and culturally optimized for parent-infant interaction 24 hours a day 7 days a week from birth to discharge.
Study: NCT01272700

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: volume control
Description: Volume controlled ventilation of tidal volume 10 ml/kg

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: pressure control
Description: Pressure controlled ventilation for peak airway pressure to deliver tidal volume 10 ml/kg.
Study: NCT02302898

Intervention type: BEHAVIORAL
Intervention: Eating Behavior Evaluation
Description: Scores will be measured on binge eating behaviors and an increased craving for sweets.

Intervention type: BEHAVIORAL
Intervention: Eating Behavior Evaluation
Description: Scores will be measured on binge eating behaviors and an increased craving for sweets.

Intervention type: OTHER
Intervention: Measurement of Functional gastric volume
Description: The functional gastric volume is the amount of food or liquid that can be consumed to a feeling of comfortably full in one meal.

Intervention type: OTHER
Intervention: Measurement of Functional gastric volume
Description: The functional gastric volume is the amount of food or liquid that can be consumed to a feeling of comfortably full in one meal.

Intervention type: OTHER
Intervention: Measurement of gastric pouch and GJ size
Description: Anatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy.

Intervention type: OTHER
Intervention: Measurement of gastric pouch and GJ size
Description: Anatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy.
Study: NCT01544946

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 88% sucrose po
Description: 88% sucrose solution (Syrup B.P.)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo po
Description: sterile water
Study: NCT00870961

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: cholecalciferol
Description: Given orally

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Given orally
Study: NCT02706730

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OTO-104
Description: Single intratympanic injection of 12 mg OTO-104