TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04544228

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: General anesthesia
Description: Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium.~Anaesthesia will be maintained with inhaled sevoflurane 2-2.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium 0.1 m\\kg will be provided every 30 minutes.~The residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: General anesthesia
Description: Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium.~Anaesthesia will be maintained with inhaled sevoflurane 2-2.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium 0.1 m\\kg will be provided every 30 minutes.~The residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes.
Study: NCT02775877

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: clomiphene

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: HMG
Study: NCT03242187

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Trans-anal total mesorectal excision(TaTME)
Description: Trans-anal total mesorectal excision(TaTME) will be offered to patients in this group (assisted by minilaparoscopy to control the IMA and splenic flexure mobilisation)

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Lap. TME
Description: Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection
Study: NCT02590874

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Duloxetine
Description: Duloxetine 30 mg per day for 2 weeks. Duloxetine 60 mg per day for 4 months. Duloxetine 30 mg per day for 2 weeks.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo 30 mg per day for 2 weeks. Placebo 60 mg per day for 4 months. Placebo 30 mg per day for 2 weeks.
Study: NCT00477607

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: alpha-lipoic acid
Description: Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Audiology
Description: otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Audiology
Description: otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: laboratory biomarker analysis
Description: Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
Study: NCT03792529

Intervention type: OTHER
Intervention: detect gene mutations of ctDNA and ctRNA
Description: Samples were collected from patients at baseline, during therapy and after disease progression, and gene mutations of ctDNA and ctRNA were detected in the samples.

Intervention type: OTHER
Intervention: detect gene mutations of ctDNA and ctRNA
Description: Samples were collected from patients at baseline, during therapy and after disease progression, and gene mutations of ctDNA and ctRNA were detected in the samples.

Intervention type: OTHER
Intervention: detect gene mutations of ctDNA and ctRNA
Description: Samples were collected from patients at baseline, during therapy and after disease progression, and gene mutations of ctDNA and ctRNA were detected in the samples.
Study: NCT02144207

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Glidescope

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Glidescope
Study: NCT00645281

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tolterodine extended release
Description: Tolterodine ER capsule 4 mg daily for 12 weeks
Study: NCT04006262

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab 10 MG/ML
Description: Neo-adjuvant treatment : 240 mg intravenous (I.V.) in 30 minutes - every 2 weeks - 6 cycles~- Adjuvant treatment : 480mg I.V. in 30 minutes - every 4 weeks - 9 cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ipilimumab 200 MG in 40 ML Injection
Description: Neo-adjuvant treatment : 1mg/kg over 30 minutes every 6 cycles - 2 cycles
Study: NCT03254212

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Titration of nocturnal oxygen needs to prevent desaturations
Description: Oximetry recordings will be performed using a Pulse Oximeter. Two O2 titration sessions will be conducted at home in random order one week apart. One will consist of a stepwise night-to-night increase in O2 flow for up to 4 nights with supplemental O2, each at flow rates of 1L/min, 2L/min, 3L/min and 4L/min, respectively. During the other titration session, an automatic O2 delivery system will be used for 4 consecutive nights with O2 flow allowed to vary from 0 to 4 L/min with a 95 ± 2% SpO2 target. At the end of the titration periods, oxygen concentrators will be set at the lowest flow rate (1L/min to 4L/min) that maintained oxyhemoglobin saturation to \> 90% (Tsat90%) for ≥ 98% of the estimated sleep period and reduced the oxygen desaturation index 3% (ODI3) to \< 5/hour according to conventional O2 titration. If these targets are not reached, the lowest flow rate will be selected that minimizes the ODI3. These procedures will be repeated at week 5 and 11.
Study: NCT03786692

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Arm A
Description: Carboplatin + Pemetrexed + Bevacizumab + Atezolizumab

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Arm B
Description: Carboplatin + Pemetrexed + Bevacizumab
Study: NCT02920541

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: S 055746
Description: S 055746, per os administration, from 50 to 2000 mg once a day during a 21-day cycle. Participants will receive 21-day cycles of treatment until a discontinuation criterion is met.
Study: NCT03806231

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Outpatient Dinoprostone 10mg
Description: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Inpatient Dinoprostone 10 mg
Description: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.
Study: NCT00520481

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMC-A12 (Cixutumumab)
Description: 10 mg/kg i.v. infusion over 1 hour every 2 weeks or 20 mg/kg i.v. infusion over 1 hour every 3 weeks.
Study: NCT00102141

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Description: Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Description: Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Description: Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Description: 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo, given as tablets orally once daily in the morning for 8 weeks
Study: NCT00508287

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BMS-686117
Description: Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
Study: NCT04544228

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bupivacaine +ketamine
Description: 30 ml bupivacaine 0.25% + 1 ml ketamine (50mg) in Serratus Anterior Plane Block.
Study: NCT00508287

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Byetta
Description: Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
Study: NCT00074997

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Single intravenous infusion of placebo.

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: OZ1
Description: Single intravenous infusion of OZ1.

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: CD34+ cells
Description: Autologous CD34+ cells.

Intervention type: GENETIC
Group type: PLACEBO_COMPARATOR
Intervention: CD34+ cells
Description: Autologous CD34+ cells.
Study: NCT04206176

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ticagrelor
Description: Ticagrelor 45mg twice daily per oral administration
Study: NCT04046848

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OCTA101
Description: OCTA101 is composed of OCTA8 (human-cl rhFVIII - Nuwiq Intermediate 2 Q-Eluate) and OCTA12 (recombinant human VWF fragment dimer).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OCTA101
Description: OCTA101 is composed of OCTA8 (human-cl rhFVIII - Nuwiq Intermediate 2 Q-Eluate) and OCTA12 (recombinant human VWF fragment dimer).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OCTA101
Description: OCTA101 is composed of OCTA8 (human-cl rhFVIII - Nuwiq Intermediate 2 Q-Eluate) and OCTA12 (recombinant human VWF fragment dimer).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OCTA101
Description: OCTA101 is composed of OCTA8 (human-cl rhFVIII - Nuwiq Intermediate 2 Q-Eluate) and OCTA12 (recombinant human VWF fragment dimer).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OCTA101
Description: OCTA101 is composed of OCTA8 (human-cl rhFVIII - Nuwiq Intermediate 2 Q-Eluate) and OCTA12 (recombinant human VWF fragment dimer).
Study: NCT03149289

Intervention type: DRUG
Intervention: Antiviral drugs
Description: sofosbuvir, ribavirin, daclatasvir, ledipasvir, simeprevir, paritaprevir, dasabuvir, ombitasvir
Study: NCT02733341

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cangrelor

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ticagrelor
Study: NCT04146675

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: TRICOT JERSEY VANISE DOUBLE FACE
Description: Short sleeve t-shirt : TRICOT JERSEY VANISE DOUBLE FACE  THERMOLACTYL EVOLUTION  with ceramic fibers.~A Tinetti test will be performed while wearing the T-shirt, as well as an evaluation of the equilibration on posturography platform under static conditions and an assessment of dynamic equilibrium and locomotion in motion analysis.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: TRICOT JERSEY SIMPLE
Description: Short sleeve t-shirt : TRICOT JERSEY SIMPLE The comparator T-shirt has the same weight, the same appearance, and will be used by patients in the same way and under the same conditions as the T-shirt with ceramic fibers.
Study: NCT04437875

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Gam-COVID-Vac Lyo
Description: adenoviral-based vaccine against SARS-CoV-2

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Gam-COVID-Vac Lyo
Description: adenoviral-based vaccine against SARS-CoV-2

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Gam-COVID-Vac Lyo
Description: adenoviral-based vaccine against SARS-CoV-2
Study: NCT02091375

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GWP42003-P 20 mg/kg/day Dose
Description: GWP42003-P was an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) dissolved in the excipients, sesame oil and anhydrous ethanol (79 mg/mL), with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo control
Description: Placebo oral solution contained the excipients, sesame oil and anhydrous ethanol (79 mg/mL), with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
Study: NCT00989456

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Self management education programme
Description: The structured patient educational self - management programme consists of 6 weekly sessions à 2 hours. The educational programme will take place prior to one of the two weekly training sessions.~After the initial period of 8 weeks participants are encouraged to practicing self- management on their own for a period of 9 months. They receive,in addition to standard follow - up, an offer of extra follow - up consisting of regular contact with their group supervisors in primary health care. During the last month of the intervention year educational self - management will be offered twice and focus on themes that the participants wish to refresh.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: exercise only
Description: 6 week waiting list, followed by two weekly training sessions. After the initial period of 8 weeks participants are encouraged to practicing self- management on their own for a period of 9 months. They receive,in addition to standard follow - up, an offer of extra follow - up consisting of regular contact with their group supervisors in primary health care.
Study: NCT02548000

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Resistance training
Description: The resistance training will be compound by 12 exercises for all body muscles, performed three times per week. The intensity of training will be measure by maximum repetitions from 12 until 8 repetitions with 2-3 series. The loads will increase for keep the maximum strength as the capacity of patients. The blood pressure and the casual glycemic will be measure before and after the training in each session. Before to start the exercises, patients will perform a warming on treadmill for 10 minutes and after the training will perform some stretching exercises for muscles groups trained.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Stretching control
Description: The stretching session will be composed by stretching and joint mobilization exercises for all body muscles and will happen only one time per week.
Study: NCT04833725

Intervention type: DEVICE
Intervention: wearable devices
Description: All patients use wearable devices and IoT technology for information collection and data management. Specifically, we build standards from the analysis of sleep monitoring information, and we form an OSA screening model by applying machine learning algorithms.
Study: NCT00387010

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fentanyl Buccal Tablets
Description: Fentanyl buccal tablets (FBT) placed in the buccal cavity above a rear molar until disintegrated, approximately 14-25 minutes.~Dose titration: Participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg as needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated.~Open-label: Once the successful dose of FBT was identified (100, 200, 400, 600, or 800 mcg), participants were dispensed a 4-week supply at the successful dose. Participants were not to use FBT for more than 6 BTP episodes or take more than 8 FBT daily.
Study: NCT02556619

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Early Palliative Care/Symptom Control
Description: 1. Establish palliative care goals~   1. Determination of Medical Power of Attorney~  2. Discuss/plan code status/advance directives~  3. Document palliative care goals~2. Symptom Assessment and Control~   1. Pain-treatment with opioid and non-opioid medications~  2. Itching-H2 blockers, steroids~  3. Nutrition-appetite stimulated with Megace, review low sodium diet~  4. Ascites/edema- optimize ascites management with Lasix or Aldactone. In refractory cases intermittent paracentesis can be performed~  5. Nausea- treated with anti-emetics~  6. Jaundice and Body Image- counselling regarding symptoms~3. End-of-Life Care~   1. Discuss religious preferences~  2. Assess for distress- ensure interaction with Cancer Resource Center~  3. Hospice- charity Hospice options for select patients.
Study: NCT03931317

Intervention type: DRUG
Group type: OTHER
Intervention: Latanoprostene bunod 0.024% QD
Description: This is a randomized, single-center, investigator-masked, 2-period, 8-week treatment study with washout and crossover between treatment periods. There will be 2 treatments in this study: latanoprostene bunod 0.024% QD and timolol maleate 0.5% BID.

Intervention type: DRUG
Group type: OTHER
Intervention: Timolol maleate 0.5% BID
Description: This is a randomized, single-center, investigator-masked, 2-period, 8-week treatment study with washout and crossover between treatment periods. There will be 2 treatments in this study: latanoprostene bunod 0.024% QD and timolol maleate 0.5% BID.
Study: NCT03603470

Intervention type: OTHER
Group type: OTHER
Intervention: EOS imagery
Description: Whole body EOS imaging in seated and standing position

Intervention type: OTHER
Group type: OTHER
Intervention: EOS imagery
Description: Whole body EOS imaging in seated and standing position
Study: NCT03265548

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Video Laryngoscope
Description: The use of video laryngoscopy
Study: NCT00705718

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Endurant Stent Graft System
Description: Abdominal Aortic Aneurysm Repair

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Endurant Stent Graft System
Description: Abdominal Aortic Aneurysm Repair
Study: NCT04965441

Intervention type: PROCEDURE
Intervention: Computer-assisted surgery
Description: Preoperative head and neck computed tomography (CT) and lower extremity CT angiography were acquired for all patients. In the CAS group, CT images (slice thickness\<1 mm) were imported into a 3D surgical planning software (Proplan, Version 2.0/3.0 Materialise, Leuven, Belgium). Virtual surgical planning was performed to determine the mandibular and fibular resection and cut margins with localization of the optimal angles for performing osteotomies. After that, surgical guides were designed utilizing a 3D designing software (3-Matic, Version 9.0-13.0, Materialise, Leuven, Belgium). The generated virtual templates were exported in Standard Tessellation Language (STL) format and printed with a professional 3D printer (Connex 350, Stratasys, Eden Prairie, MN, USA). The reconstructive plates were pre-bent on a 3D printed planned mandibular model.
Study: NCT01243502

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 0.01% CT327 (or placebo)
Description: Cream (10 g) was applied at an even thickness over a test area on the back of 10 x 10 cm to give an exposure of 1000 μg/dm2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 0.001% CT327 (or placebo)
Description: Cream (10 g) was applied at an even thickness over a test area on the back of 10 x 10 cm to give an exposure of 100 μg/dm2.
Study: NCT02416531

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Clobetasol propionate
Description: Clobetasol propionate 0.05% ointment applied once daily at a dose of 1 g/application (1 g sachets) for 4 weeks.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Photodynamic therapy
Description: Methylene blue 0.01% intralesional, λ = 660 ± 10 nm, P = 100 mW, PD = 510 mW/cm2, E = 4 J, ED = 20 J/cm2, t = 40 s, once a week for 4 weeks

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Low level laser therapy
Description: λ = 660 ± 10 nm, P = 100 mW, PD = 510 mW/cm2, E = 4 J, ED = 20 J/cm2, t = 40 s, once a week for 4 weeks
Study: NCT03104426

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Darbepoetin Alfa
Description: Darbepoetin alfa dosage 10microg/kg once a week for 8 weeks
Study: NCT02008747

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Magnesium sulphate
Description: Continuous application of magnesium sulphate applied 40 mg/kg ideal body weight by bolus before the operation started, followed by a continuous infusion of 10 mg/kg ideal body weight/h for 24 hours
Study: NCT01385488

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: self-monitor arm volume
Description: bioelectrical impedance
Study: NCT02580474

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daclatasvir plus Asunaprevir
Study: NCT02231593

Intervention type: OTHER
Intervention: SAGIT
Description: SAGIT is a Clinician-Reported Outcomes (ClinROs) tool
Study: NCT04599933

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CSF-1
Description: One drop bilaterally twice daily for approximately 2 weeks.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Vehicle
Description: One drop bilaterally twice daily for approximately 2 weeks.
Study: NCT03890627

Intervention type: DEVICE
Intervention: Thoracic bio-reactance
Description: Cardiac output variation measured by thoracic bio-reactance, between inclusion and one year after hemodynamic evaluation by right cardiac catheterization, to discriminate stable patients from those that degrade.
Study: NCT02167815

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Mepilex XT
Description: Experimental arm

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: standard care
Study: NCT00483106

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ritalin
Description: 0.25 mg/kg bid, orally for 7 consecutive days

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: taken orally twice a day for 7 consecutive days