TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00451412

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Certoparin
Description: 3000 U anti XA of certoparin in 0.3 ml solution, once daily

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Unfractionated Heparin
Description: solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily
Study: NCT02711449

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylprednisolone
Description: 125 mg methylprednisolone as an intravenously bolus injection approximately 30 minutes prior to skin incision.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: 0.9% Saline
Description: 0,9% Saline as an intravenously bolus injection approximately 30 minutes prior to skin incision.
Study: NCT03181594

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: ClariFix Device
Description: Cryoablation in the nasal passageway using the ClariFix Device
Study: NCT02504138

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Desflurane balanced anesthesia
Description: Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Propofol total intravenous anesthesia
Description: Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion
Study: NCT02148497

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Multi-colored Placido disk imaging
Description: The multi-colored Placido disk instrument records the tear surface using video imaging.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Multi-colored Placido disk imaging
Description: The multi-colored Placido disk instrument records the tear surface using video imaging.
Study: NCT01683682

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BIBF 1120
Description: 2 x 150 mg capsules, oral, daily (Start dose)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vinorelbine
Description: 25 mg/m2 i.v. on day 1 and 8 (three-week cycle)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: AUC 5 i.v. on day 1 (three-week cycle)
Study: NCT00312039

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Elvucitabine
Description: Elvucitabine 10 mg QD for 14days
Study: NCT00718237

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
Description: Rotateq orally administered 3 times

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Comparator: Comparator: Placebo (unspecified)
Description: Placebo orally administered 3 times
Study: NCT04148729

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: ESP block
Description: Ultrasound guided ESP block will perform with 15 ml bupivacaine+ 5 ml lidocaine at the T10 level bilaterally. 0.1 microgram morphine (IV) and diclofenac sodium 75 mg intramuscularly will perform for postoperative analgesia.
Study: NCT02722291

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)
Study: NCT04867148

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Inertial measurement unit sensor-based gait analysis system
Description: Gait analysis was performed on 20-m long corridor to collect gait data on more than 23 strides. The gait protocol was performed with an IMU sensor-based gait analysis system (DynaStab™, JEIOS, South Korea) consisting of a shoe-type data logger (Smart Balance1 SB-1, JEIOS, South Korea) and a data acquisition system (DynaStab-Spotfire1, Tibco Spotfire 7.10). The shoe-type data logger included an IMU sensor (IMU-3000™, InvenSense, USA) that measured tri-axial acceleration (up to ± 6 g) and tri-axial angular 136 velocity (up to ± 500˚ s-1) along three orthogonal axes.12,16 The IMU sensors were installed in both shoe outsoles, and the data were transmitted wirelessly to a data acquisition system via Bluetooth®. Shoe sizes were adapted to each participant, with available sizes ranging from 225 mm to 280 mm. The local coordinate system for the IMU sensors included the 140 anteroposterior, mediolateral, and vertical directions.
Study: NCT00800514

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: amantadine
Description: amantadine twice daily
Study: NCT00312039

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lamivudine
Description: Lamivudine 300 mg QD for 14 days
Study: NCT01171963

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GSK Biologicals' liquid human rotavirus vaccine 444563
Description: Oral administration

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Oral administration

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Infanrix™
Description: Intramuscular administration

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Infanrix™
Description: Intramuscular administration

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)
Description: Oral administration

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)
Description: Oral administration
Study: NCT00693290

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: low residue diet
Description: Fleet (usual preparation) plus diet sheet for low residue diet
Study: NCT01507051

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Warfarin (Coumadin)
Description: Days -6 and -5: 10 mg warfarin (Coumadin) once daily, dosage lower if the INR is already high on day -5; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin (Coumadin) once daily, dosage depending on INR

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Warfarin (Coumadin)
Description: Days -6 and -5: 10 mg warfarin (Coumadin) once daily, dosage lower if the INR is already high on day -5; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin (Coumadin) once daily, dosage depending on INR

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Description: Days 0 to 3: 20 mg rivaroxaban once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Description: Days 0 to 3: 20 mg rivaroxaban once daily

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Days 0 to 3: 1 tablet placebo, identical to active tablet

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Vitamin K (Konakion)
Description: Day 5: 10 mg vitamin K (Konakion) once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vitamin K (Konakion)
Description: Day 5: 10 mg vitamin K (Konakion) once daily
Study: NCT04881435

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Hydrogen gas therapy
Description: Hydrogen gas therapy three times one day for 5 days

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Hydrogen gas therapy
Description: Hydrogen gas therapy three times one day for 5 days
Study: NCT01158274

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gamma-secretase/Notch signalling pathway inhibitor RO4929097
Description: Given orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: capecitabine
Description: Given orally

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study: NCT01108029

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: memantine
Description: 2 tablets of 10 mg of memantine 1 time a day in the morning

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: 2 tablets of placebo 1 time a day in the morning
Study: NCT04471363

Intervention type: BEHAVIORAL
Intervention: Cancer-Specific Exercise education
Description: An audio-recorded PowerPoint presentation created by the study team on the benefits of exercise for survivors, caregivers and romantic couples.
Study: NCT04226027

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: T2.coach
Description: T2.coach is a smartphone app for low-burden capture of diet and blood glucose (BG) levels and for reviewing past records, integrated with FitBit for captured of physical activity and sleep. All captured data are sent to the computational inference engine that uses machine learning methods and expert system to formulate personalized behavioral goals. Examples of behavioral goals include the following: For high carbohydrate breakfasts, reduce your carbs to be about 1 carb choice. Examples of 1 carb choice are 1 slice of whole wheat toast, 1 cup of oatmeal, or 1 apple. The T2.coach chatbot companion uses text messages to help individuals set goals that are consistent with evidence based guidelines for diabetes self-management, inferences on data captured with T2.coach, and their own preferences, as well as send individuals goal reminders and prompts for reflection on goal achievement.
Study: NCT00840099

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL
Description: 1 x 600 mg/42.9 mg/5 mL, single-dose fed

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension
Description: 1 x 600 mg/42.9 mg/5 mL, single-dose fed
Study: NCT03919058

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Baseline activity (control regime)
Description: This is a baseline measurement of physical activity during which subjects will be instructed not to change activity patterns during four days and to note all activities they perform.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Increased sitting time (sit regime)
Description: Participants have to spend 14h of their day sitting, 1h walking and 1h standing, for four consecutive days. According to the compendium of Ainsworth et al. (2011), this corresponds with a daily workload of activities (DWA) of 27 metabolic equivalents (MET's) per day.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Increased sitting time (sit regime)
Description: Participants have to spend 14h of their day sitting, 1h walking and 1h standing, for four consecutive days. According to the compendium of Ainsworth et al. (2011), this corresponds with a daily workload of activities (DWA) of 27 metabolic equivalents (MET's) per day.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Non-exercise physical activity (sit less regime)
Description: Each day (4 days in total) will consist of 3h walking, 4h standing and 9h sitting. These time frames are chosen to result in a comparable DWA increase as the exercise regime compared to the sit regime (+7 MET's)27. The additional 2h of walking and 3h of standing, compared to the sitting regime, will be done in a minimum of four bouts with a time interval of \> 1h. The subjects will be instructed to walk on a slow pace. i.e. 2-3 km/h (e.g. walking during shopping and work related walking in an office).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Non-exercise physical activity (sit less regime)
Description: Each day (4 days in total) will consist of 3h walking, 4h standing and 9h sitting. These time frames are chosen to result in a comparable DWA increase as the exercise regime compared to the sit regime (+7 MET's)27. The additional 2h of walking and 3h of standing, compared to the sitting regime, will be done in a minimum of four bouts with a time interval of \> 1h. The subjects will be instructed to walk on a slow pace. i.e. 2-3 km/h (e.g. walking during shopping and work related walking in an office).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Structured exercise (exercise regime)
Description: One hour of sitting in the sit regime will be replaced with 1 training session (1h) on a cycle ergometer in the research center. The remaining hours of each day (4 days in total) have to be spent as follows: 13h sitting, 1h walking and 1h standing for daily care. The intensity of the training session (50-60% of Wmax) results in a DWA of 34.5 MET's according to the compendium of physical activities. Duration of training sessions will be adapted individually with ActivPAL data of the sit less and sit regime to identically match DWA increase between the sit less and exercise regime, compared to the sitting regime.
Study: NCT02921893

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ixazomib Citrate
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ixazomib Citrate
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide
Description: Given PO

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies
Study: NCT03276247

Intervention type: OTHER
Intervention: observation
Description: observation

Intervention type: OTHER
Intervention: observation
Description: observation

Intervention type: OTHER
Intervention: observation
Description: observation

Intervention type: OTHER
Intervention: observation
Description: observation

Intervention type: OTHER
Intervention: observation
Description: observation

Intervention type: OTHER
Intervention: observation
Description: observation

Intervention type: OTHER
Intervention: observation
Description: observation

Intervention type: OTHER
Intervention: observation
Description: observation
Study: NCT01512823

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Education
Description: Interactive educational intervention:~* 4 hour education session (with notes and 'evidence packs'); presentations, small group discussion tasks and practice of particular skills - 2 hour session (1 week later)~* Emailed notes from second session~* Telephonic/email follow-up (reminders)~Didactic educational intervention:~- 4 hour education session (with notes and 'evidence packs'; questions answered but no discussion or application of skills

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Education
Description: Interactive educational intervention:~* 4 hour education session (with notes and 'evidence packs'); presentations, small group discussion tasks and practice of particular skills - 2 hour session (1 week later)~* Emailed notes from second session~* Telephonic/email follow-up (reminders)~Didactic educational intervention:~- 4 hour education session (with notes and 'evidence packs'; questions answered but no discussion or application of skills
Study: NCT03988803

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 425809
Description: Film coated tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Memantine
Description: Film coated tablet
Study: NCT03513822

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ketamine 10 MG/ML
Description: Ketamine infusion 1mg/kg with electric syringe during 2 hours.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ketamine 10 MG/ML
Description: Ketamine infusion 1mg/kg with electric syringe during 2 hours.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebos
Description: Sodium chloride infusion with the same rate, electric syringe during 2 hours.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebos
Description: Sodium chloride infusion with the same rate, electric syringe during 2 hours.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Midazolam 1 MG/ML
Description: Bolus of Midazolam 1mg before each perfusion.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Midazolam 1 MG/ML
Description: Bolus of Midazolam 1mg before each perfusion.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Midazolam 1 MG/ML
Description: Bolus of Midazolam 1mg before each perfusion.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Midazolam 1 MG/ML
Description: Bolus of Midazolam 1mg before each perfusion.
Study: NCT03738605

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Microablative Fractional CO2 Laser Therapy
Description: 5 laser therapies intravaginally administered will be applied at monthly intervals.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Microablative Fractional CO2 Laser Therapy
Description: 5 laser therapies intravaginally administered will be applied at monthly intervals.
Study: NCT02110953

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: irinotecan-eluting beads
Description: Receive irinotecan hydrochloride-eluting beads via hepatic artery embolization

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: hepatic artery embolization
Description: Receive irinotecan hydrochloride-eluting beads via hepatic artery embolization
Study: NCT02068820

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: ISB dye and standard white light imaging
Description: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: ISB dye and standard white light imaging
Description: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: ICG dye and FireFly fluorescence imaging
Description: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.
Study: NCT04546282

Intervention type: OTHER
Intervention: Description of the molecular alterations detected in blood samples of patients treated by osimertinib
Description: Description of the molecular alterations detected in blood samples of patients treated by osimertinib. This test is usualyy performed routinely to detect conventional mutations including EGFR T790M. We performed panel of genes screeining based on next generation sequencing. Thius, iIn some cases, new mutations can be detected by this assay.
Study: NCT00214097

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiotherapy
Description: Daily radiation to prescribed dose

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiotherapy
Description: Daily radiation to prescribed dose

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiotherapy
Description: Daily radiation to prescribed dose
Study: NCT04368520

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Vitamin D3
Description: 800 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Vitamin D3
Description: 3,200 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Hypromellose capsules, given daily for 3 months
Study: NCT02708693

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Triamcinolone Acetonide
Description: ultrasound-guided injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Triamcinolone Acetonide
Description: ultrasound-guided injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort)

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: thermoplastic wrist splint
Description: thermoplastic wrist splint with wrist placed in a neutral position

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lidocaine hydrochloride
Description: ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: lidocaine hydrochloride
Description: ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)
Study: NCT02671526

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Computerized plasticity-based adaptive cognitive training
Study: NCT00731978

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Restricted intraoperative fluid management
Description: Intraoperative fluid management guided by Sto2.
Study: NCT00658762

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PD 0332334
Description: Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PD 0332334
Description: Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: paroxetine
Description: Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Capsules, oral, BID, 8 weeks, with 2 week taper
Study: NCT04393818

Intervention type: BEHAVIORAL
Group type: SHAM_COMPARATOR
Intervention: Intervention App
Description: Participants allocated to the intervention App will receive access to a fully operational mobile phone App. The App will be used to deliver psychoeducational materials (written and audio-visual), including: emotional training (mindfulness, moral harm, skills to manage emotions), lifestyles behaviour promotion (physical activity, diet, substance abuse, sleep disorders), work environment, and social support.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Intervention App
Description: Participants allocated to the intervention App will receive access to a fully operational mobile phone App. The App will be used to deliver psychoeducational materials (written and audio-visual), including: emotional training (mindfulness, moral harm, skills to manage emotions), lifestyles behaviour promotion (physical activity, diet, substance abuse, sleep disorders), work environment, and social support.
Study: NCT05514860

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Cryoballoon-based PVI
Description: Patients randomized to first-line cryoballoon (CB) ablation will have the pulmonary vein isolation procedure performed according to standard clinical practice using the Arctic Front Cryoballoon ablation catheter. No anti-arrhythmic drugs will be prescribed in this arm.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Anti-Arrhythmic Drug Therapy
Description: Antiarrhythmic drug therapy (Class I - flecainide, propafenone; Class III - sotalol, dronedarone) will prescribed and monitored based on local clinical practice, and according to guideline-suggested drug management for symptomatic patients with paroxysmal AF.
Study: NCT02354339

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Irvingia gabonensis
Description: Intervention will be administered 30 minutes before meals

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Intervention will be administered 30 minutes before meals
Study: NCT01832350

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nuedexta (20/10)
Description: Drug: Nuedexta (20/10) administered orally, two times a day, every 12 hours, during a 26-week period.