TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00719472

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: During Cycle 1 rituximab was administered at an initial rate of 50 mg/hour. In the absence of infusion toxicity during Cycle 1, the infusion rate was escalated by 50 mg/h increments every 30 minutes to a maximum rate of 400 mg/hour. In case of infusion-related reactions, the infusion was interrupted or the infusion rate reduced. In case of Grade 3/4 infusion reactions, the rituximab infusion was discontinued and medical treatment provided. If the rituximab infusion in Cycle 1 was tolerated without a serious adverse event (AE) or Grade 3/4 infusion-related AE, as judged by the investigator, infusions in Cycle 2 onwards were administered as follows: 20% of the total dose was given over 30 minutes and the remaining 80% of the dose was given over the next 60 minutes, for a total infusion time of 90 minutes. Commercial preparations of rituximab were used.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)
Description: Commercial preparations of CHOP were used. Prednisone was administered prior to rituximab infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CVP (cyclophosphamide, vincristine, prednisone)
Description: Commercial preparations of CVP were used. Prednisone was administered prior to rituximab infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Analgesic/antipyretic and antihistamine drugs
Description: An analgesic/antipyretic (eg, acetaminophen) and an antihistamine (eg, diphenhydramine) were administered 30 minutes before each infusion of rituximab.
Study: NCT01240824

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: aminophylline
Description: One of three escalating doses of aminophylline (3 mg/kg, 6 mg/kg and 9 mg/kg) administered intravesically
Study: NCT02570048

Intervention type: DEVICE
Intervention: Mutebutton intervention
Description: Participants are asked to use the MuteButton daily for 30-40 minutes.They receive 'pink noise' through headphones and transcutaneous stimulation on the tongue using a 'lollypop' sensor that sits on the anterior section (tip) of the tongue.
Study: NCT04129463

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Subscleral Trabeculectomy (SST) with Iris incarceration
Description: Subscleral Trabeculectomy with Iris Incarceration using iris forceps and scissors

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Conventional trabeculotomy
Description: Conventional trabeculotomy in Buphthalmous using rigid Hans trabeculotome
Study: NCT00993148

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: maraviroc
Description: 150 mg tab by mouth once daily for 96 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: darunavir
Description: 800 mg tab by mouth once daily for 96 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ritonavir
Description: 100 mg capsule by mouth once daily for 96 weeks
Study: NCT02792530

Intervention type: OTHER
Group type: OTHER
Intervention: Dietary consultation
Description: Dietary consultation for sodium restriction to decrease dietary intake to 2 grams/day less than the patients consume currently
Study: NCT04055623

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections
Description: For the first 6-months of the study: T-regulatory cells taken from a patient, increased in number in a lab, and returned through monthly intravenous (IV) infusions back to same patient + 3 times per week subcutaneous Interleukin-2 injections

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Monthly placebo infusions + 3 times per week placebo injections
Description: For first 6-months of study: monthly placebo infusions + 3 times per week subcutaneous placebo injections

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections
Description: For the second 6-months of the study: all participants will receive T-regulatory cells taken from the patient, that have been increased in number in a lab, and returned through monthly intravenous (IV) infusions back to same patient (Treg cell owner) + 3 times per week subcutaneous Interleukin-2 injections.
Study: NCT03805152

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Neuronox(R)
Description: Injection botulinum toxin intramuscular for affected neck muscle

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dysport (R)
Description: Intramuscular injection
Study: NCT02970162

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amifampridine Phosphate

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Oral Tablet
Study: NCT00695097

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rituximab
Description: Rituximab infusion on Day 1 and Day 15

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: No Rituximab
Description: No Rituximab
Study: NCT02302339

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: glembatumumab vedotin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: glembatumumab vedotin and varlilumab

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: glembatumumab vedotin and CDX-301
Study: NCT00776074

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leuprorelin (GF)
Description: Leuprorelin (GF) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leuprorelin (GC)
Description: Leuprorelin (GC) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Study: NCT03978546

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Humphrey Visual Field Test
Description: SITA Standard and 24-2 and 10-2 visual field tests

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Humphrey Visual Field Test
Description: SITA Standard and 24-2 and 10-2 visual field tests

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Optical Coherence Tomography (OCT) Scan
Description: Circle and Wide Angle Scans

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Optical Coherence Tomography (OCT) Scan
Description: Circle and Wide Angle Scans

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Smart Perimetry - Henson 9000
Description: 24+10-2 Smart Supra test

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Smart Perimetry - Henson 9000
Description: 24+10-2 Smart Supra test
Study: NCT02177565

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: carrier plus in vitro expanded autologous BMSCs
Description: The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: carrier plus in vitro expanded autologous BMSCs
Description: The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container
Study: NCT01538758

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Us guided needling
Description: Us guided needling is a therapeutical technique treating calcifying tendinitis of the shoulder. Calcifications in the rotator cuff tendon are visualised with ultrasound. Under ultrasound guidance a 20 gauge needle is inserted in the calcification. Lidocaine 1% in a 1cc syringe is injected in the calcification and aspirated. The calcification is flushed until the fluid is clear. Sometimes it is not possible to flush the calcification. In this case the calcification will be fragmented.~After flushing or fragmentation of the calcification, 20 mg triamcinolone with 1cc lidocaine 1% will be injected in de subacromial bursa under us guidance.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: corticosteroid injection
Description: Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.
Study: NCT02932852

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Lipoaspiration
Description: The patient will have a liposuction surgery from which the autologous ADAS cell to transplant in the cornea will be obtained.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Lipoaspiration
Description: The patient will have a liposuction surgery from which the autologous ADAS cell to transplant in the cornea will be obtained.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Lipoaspiration
Description: The patient will have a liposuction surgery from which the autologous ADAS cell to transplant in the cornea will be obtained.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Transplantation
Description: The ophthalmologist will carry out the transplantation of the ADAS cells with or without scaffold in the intrastromal cornea of the patient

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Transplantation
Description: The ophthalmologist will carry out the transplantation of the ADAS cells with or without scaffold in the intrastromal cornea of the patient

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Transplantation
Description: The ophthalmologist will carry out the transplantation of the ADAS cells with or without scaffold in the intrastromal cornea of the patient
Study: NCT03767413

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: PNF
Description: proprioceptive neuromuscular facilitation training

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: PNFMP
Description: proprioceptive neuromuscular facilitation training and mental practice technique
Study: NCT00829504

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ropinirole HCl 0.25 mg Tablets
Description: 1 x 0.25 mg

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Requip® 0.25 mg Tablets
Description: 1 x 0.25 mg
Study: NCT03622476

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: concentrated FVIII
Description: Intervention if the assessment considers that the treatment is inadequate
Study: NCT03983356

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Training program
Description: An internet based training program will be offered to GPs. We will also offer face-to-face seminars with academic psychiatrists.
Study: NCT01539460

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: minimally invasive surgery
Description: Subcutaneous fat and apocrine sweat glands were removed by suction under tumescent anesthesia,and the remaining tissue and glands, tightly attached to the epidermis-dermis interface, were completely removed with scissors through the initial small incision.
Study: NCT01469611

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: JX-594
Description: Infusion Procedure:JX-594 will be administered on the designated treatment days at a dose of either 1 x 106, 1 x 107 or 3 x 107 pfu per kg. Virus infusion should occur over 60 minutes (+/- 5 minutes). The final infusion volume of virus plus diluent will be approximately 250 mL.
Study: NCT06137495

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Sensitization to House dust mites
Description: The SPT is performed at the time of diagnosis and after six-months follow-up period. Serum specific IgE is measured by immunoblotting, chemiluminescence, and ImmunoCAP assays
Study: NCT02750917

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lornoxicam
Description: At the end of surgery patients in group LORNOXICAM received one pill of 8 mg lornoxicam every 12 hours in the surgery day and first postoperative day.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Etoricoxib
Description: At the end of surgery patients in the ETORICOXIB group received one pill of 120 mg etoricoxib at the end of surgery and a second one after 24 hours. This group also received placebo pills at 12 h, between the active pills.
Study: NCT01955421

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erlotinib 100mg qd

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gefitinib 250mg qd
Study: NCT02306317

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard procedure
Description: FiO2 manually controlled by nursing

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Experimental procedure
Description: FiO2 manually controlled by parents, after training.
Study: NCT03501719

Intervention type: DRUG
Intervention: Number of drugs in the ART regimen
Description: Triple therapy vs. dual therapy vs. monotherapy

Intervention type: DRUG
Intervention: Number of drugs in the ART regimen
Description: Triple therapy vs. dual therapy vs. monotherapy

Intervention type: DRUG
Intervention: Number of drugs in the ART regimen
Description: Triple therapy vs. dual therapy vs. monotherapy
Study: NCT02462135

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Virtual interactive memory training
Description: Training sessions of the VIMT group are divided into initial training and booster training. Each training session is 45 minutes/day, 3 sessions/week, for 12 weeks for both initial training and booster training (36 sessions each). The training content of the four memory training include: (1) spatial encoding memory training task, (2) updating-spatial memory training task, (3) updating-visual memory training task, and (4) rehearsal-visuospatial memory training task.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Passive information activities
Description: The active control group (Passive information activities) only accepts the initial training phase, which training content of the two types to include: (1) listening to audio books, and (2) reading online newspaper.
Study: NCT03688594

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: NIPT Test
Description: This test is based onto capture and high throw put sequencing adapted to cell free plasmatic DNA of pregnant women in order to detect point mutation present in her fetus. This approach has been previously described for others clinical applications such as liquid biopsy in cancers but not for NIPT analysis.
Study: NCT04214938

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization
Description: Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization
Description: Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization
Description: Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization
Description: Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort.
Study: NCT04440527

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Preserflo / Innfocus Microshunt
Description: The Microshunt features an 8.5-mm tube with an outer diameter of 350 µm and a 70-µm diameter lumen. Implantation creates a subconjunctival bleb and lowers intraocular pressure by increasing aqueous humor outflow.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Trabeculectomy
Description: Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.
Study: NCT02559999

Intervention type: OTHER
Group type: OTHER
Intervention: Painful tonic stimuli

Intervention type: OTHER
Group type: OTHER
Intervention: non-painful stimuli
Study: NCT01340846

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Warfarin
Description: Warfarin dosed at 15mg on Day 1 and Day 22

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketoconazole
Description: Ketoconazole dosed at 400mg daily on Days 19 through 22

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemfibrozil
Description: Gemfibrozil dosed at 600mg twice daily on Days 19 through 22

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK2118436 150mg
Description: GSK2118436 dosed at 150mg twice daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK2118436 150mg
Description: GSK2118436 dosed at 150mg twice daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK2118436 75mg
Description: GSK2118436 dosed at 75mg twice daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK2118436 75mg
Description: GSK2118436 dosed at 75mg twice daily
Study: NCT04375085

Intervention type: DEVICE
Group type: OTHER
Intervention: Percutaneous Coronary Intervention
Description: Percutaneous Coronary Intervention
Study: NCT00740311

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: MBCP gel TM
Description: alveoli filling with an injectable calcium phosphate after extraction of mandibular molar or pre molar
Study: NCT00812019

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59
Description: Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 0% of MF59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59
Description: Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 25% of MF59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59
Description: Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 50% of MF59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59
Description: Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 100% of MF59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59
Description: Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 0% of MF59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59
Description: Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 25% of MF59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59
Description: Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 50% of MF59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59
Description: Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 100% of MF59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59
Description: Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 0% of MF59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59
Description: Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 25% of MF59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59
Description: Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 50% of MF59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59
Description: Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 100% of MF59.
Study: NCT01699438

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mesalazine
Description: 2400 mg q.d. for 8 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 3 tablets q.d. for 8 weeks
Study: NCT01302990

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Dose given at Day 0
Description: Dose given by intramuscular administration (0.5 mL)

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Dose given at Day 0
Description: Dose given by intramuscular administration (0.5 mL)

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Dose given at Day 0
Description: Dose given by intramuscular administration (0.5 mL)

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Dose given at Day 0
Description: Dose given by intramuscular administration (0.5 mL)

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Dose given at Day 0
Description: Dose given by intramuscular administration (0.5 mL)
Study: NCT04349332

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Helmet non-invasive ventilation (NIV)
Description: After application of the helmet, arterial blood gas sampling will be utilized to follow gas-exchange; Noninvasive support will be reduced progressively in accordance to clinical improvement and will be discontinued if patient maintains respiratory rate \<30breaths/min and PaO2 \>75mm Hg with FiO2 0.5 without ventilatory support. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.