AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT00093509 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ifosfamide and mesna
Description: 2 gm / m2 ifosfamide mixed in 1000 cc D5W infused continuously over 24 hours daily for 6 days (144 hours); total ifosfamide dose 12 gm/ m2. For the day infusion only MESNA (sodium 2-mercapto-ethanesulphonate) is mixed with ifosfamide as above and given at 2.5 gm / m2 / 24 hours.
Study NCT00093509 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: hyperthermia treatment with an MRI Compatible Radiofrequency Extremity Hyperthermia Applicator
Description: Patients will receive hyperthermia throughout the course of radiotherapy delivered once weekly for a total of 5 treatments. Each treatment will last 1-2 hours with a goal of delivering a cumulative thermal dose of 10-100 CEM 43˚T90.
Study NCT00093509 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Description: External beam megavoltage (≥ 4 MV) beams will be used at SSD, SAD ≥ 70 cm at a dose rate of > 100 cGy/min. Fraction sizes of 180 cGy will be used 5 times per weeks in a continuous course. Total dose will be 45 Gy + 10%, consistent with sites being treated.
Study NCT04654897 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [14C]-NT-814
Description: 120 mg radioactive labeled elinzanetant (\[14C\]-NT-814) oral suspension containing NMT (not more than) 5.6 MBq (megabecquerel) \[14C\].
Study NCT02353962 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Neglect Exergames
Description: Exergames for rehabilitation of hemineglected stroke patients played with a haptic device on a computer. The intervention duration is three weeks. During this week the patients play daily a half hour on workdays. The treatening therapist will adjust the intensity according to the progress of the patient.
Study NCT03754803 — intervention group
Intervention type: OTHER
Intervention: HIV treatment satisfaction questionnaire
Description: The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility.
Study NCT02464397 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Stent
Description: In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion
Study NCT02464397 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Stent
Description: In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion
Study NCT02507986 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Single lead ECG device
Description: The single lead ECG device is a smartphone compatible handheld device that produces a single lead ECG after 30 seconds of measurement. It is non-invasive, electrically safe and easy to use.
Study NCT01453569 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sodium oligo-mannurarate 600mg
Description: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
Study NCT00951548 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Corn Starch. Dosage regimen is 2 sachets b.i.d. for 8 weeks
Study NCT03614364 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nanoxel
Description: D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks
Study NCT03614364 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: herzuma
Description: D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks
Study NCT00736944 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Abraxane
Description: 100 mg/m2 IVPB, Day 1, 8 and 15 of cycles 1, 2, and 3
Study NCT00736944 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cetuximab
Description: 400 mg/m2 IVPB, Day 1, cycle 1
Study NCT00736944 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cetuximab
Description: 250 mg IVPB, Day 8 and 15 cycle 1, Day 1, 8 and 15 of cycles 2 and 3
Study NCT01453569 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sodium oligo-mannurarate 900mg
Description: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
Study NCT01453569 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: simulant of sodium oligo-mannurarate capsule
Study NCT04212195 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Imaging and fluid biomarkers
Description: Magnetic resonance imaging of the brain and urine, blood and cerebrospinal fluid sampling
Study NCT02008838 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Synbiotic
Study NCT02008838 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study NCT01711320 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study NCT01711320 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Omeprazole
Study NCT02458157 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Furosemide (Furix)
Description: * Loading dose: 40 mg I.V.~* Infusion rate 40 mg/h~* Continued until neutral cumulative fluid balance is achieved (the overall treatment goal) or average negative fluid balance is below 1 ml/kg/h for 8 hours.
Study NCT02458157 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Continuous renal replacement therapy (CRRT)
Description: * Initiated in case of contraindications or inadequate effect of furosemide.~* Fluid removal is started at 2 ml/kg/h~* The efficacy is evaluated 3 times daily and removal rate increased by 0.5 ml/kg/h if the therapeutic goal is not achieved
Study NCT02458157 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Resuscitation
Description: The physiologic response to fluid removal is monitored with three variables indicating inadequate circulation. These are:~* Mottling beyond the edge of kneecaps~* Hypotension (MAP \< 50) resistant to inotropes and vasopressors~* Plasma lactate ≥ 4 mmol/l~Mottling and MAP are monitored continuously and lactate is measured routinely 4-6 times each day and on clinical indication. If one or more variable is present:~1. Fluid removal is paused~2. A crystalloid fluid bolus of 250-500 ml is given~3. Circulatory status is reevaluated within 30 minutes~4. Step 1-3 is repeated until signs of inadequate circulation have been resolved for minimum 1 hour~5. Fluid removal is restarted in 25% reduced dose for minimum 4 hours before evaluation of effect.
Study NCT02458157 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Usual Care
Description: All interventions are performed at the discretion of the treating physician apart from initiation of renal replacement therapy which is discouraged unless one or more of the following criteria are met:~* Hyperkalaemia (p-K+ > 6 mmol/l)~* Severe metabolic acidosis attributable to AKI (pH \< 7.25 and standard base excess \< -10 mmol/l) resistant to IV bicarbonate infusion~* Severe respiratory failure with PaO2/FiO2 \< 13 kPa and bilateral infiltrates/oedema on the chest x-ray.~* Progressive azotaemia and a blood urea nitrogen (BUN) > 25 mmol/l.
Study NCT00953043 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: lubiprostone
Description: Lubiprostone 24 micrograms, one dose daily for three days in 30 subjects
Study NCT00953043 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo medication given for three days
Study NCT00953043 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Bowel preparation
Description: Polyethylene glycol-based bowel preparation
Study NCT00953043 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Bowel preparation
Description: Polyethylene glycol-based bowel preparation
Study NCT04105205 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apramycin injection
Description: 30-min infusion
Study NCT02510014 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SUBOXONE sublingual film
Description: SUBOXONE (buprenorphine sublingual film) is used for induction therapy on Days -14 to -12. Participants then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to starting the Treatment Period.
Study NCT02510014 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RBP-6000
Description: Injections administered subcutaneously every 28 days on alternate sides of participant's abdomen starting at 300 mg. Subsequent doses of RBP-6000 could be adjusted down to 100 mg with the possibility of adjusting back up to 300 mg based on the medical judgment of the investigator. De novo subjects receive up to 12 injections and roll-over subjects receive up to 6 injections.
Study NCT00177463 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: L-carnosine
Description: an antioxidant and AGE inhibitor, 500 mg/day, increasing each week in titration reaching 2000 mg/day in 4 weeks and maintained for rest of trial
Study NCT00177463 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: L-carnosine
Description: an antioxidant and AGE inhibitor, 500 mg/day, increasing each week in titration reaching 2000 mg/day in 4 weeks and maintained for rest of trial
Study NCT01555827 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Ophthalmological examination & Questionnaire
Description: The following examinations will be performed, after pupil dilation:~* Examination with SD-OCT (macular scans, macular volume, peri-papillary scan, retinal autofluorescence, infer-red and red-free imaging)~* Colour photographs of the retinal, centered on the macula and on the optic nerve (digital non mydriatic retinal camera)~* Wide-field colour and autofluorescence imaging (Optomap)~* Measure of intra-ocular pressure (pneumotonometer)~The following informations will be collected through a standardized questionnaire, administered face-to-face during the inclusion visit, or at the moment of the verification of eligibility criteria:~* Age, gender~* educational level~* smoking~* cardiovascular diseases, current medications~* scores at neuropsychological tests
Study NCT01555827 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Ophthalmological examination & Questionnaire
Description: The following examinations will be performed, after pupil dilation:~* Examination with SD-OCT (macular scans, macular volume, peri-papillary scan, retinal autofluorescence, infer-red and red-free imaging)~* Colour photographs of the retinal, centered on the macula and on the optic nerve (digital non mydriatic retinal camera)~* Wide-field colour and autofluorescence imaging (Optomap)~* Measure of intra-ocular pressure (pneumotonometer)~The following informations will be collected through a standardized questionnaire, administered face-to-face during the inclusion visit, or at the moment of the verification of eligibility criteria:~* Age, gender~* educational level~* smoking~* cardiovascular diseases, current medications~* scores at neuropsychological tests
Study NCT00667056 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tacrolimus ointment
Description: topical
Study NCT02732691 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: JenaValve Pericardial TAVR System
Description: Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
Study NCT01321021 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Losartan, Diphenhydramine, Placebo
Description: placebo controlled crossover study with two arms: Losartan 40mg, Diphenhydramine 40mg
Study NCT00070616 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palifermin 6 x 60 μg/kg/day
Study NCT00070616 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palifermin 2 x 180 μg/kg/day
Study NCT00070616 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiotherapy
Study NCT00070616 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Chemotherapy
Study NCT03446352 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Psychomotor exercise program
Description: Each session includes: beginning ritual (5 min), warm-up (15 min), main section comprising the multimodal exercises (40 min), cool-down (10 min), and finishing ritual (5 min).~At the initial stage, the activation of different muscle groups will be performed, providing an elevation of the neurophysiological parameters. The main section (multimodal exercises) will be focused on the specific objectives through sensorimotor and neurocognitive activities. This section includes periods ranging 10-15 min of exercises mainly focused on motor stimulation- physical performance (cardiovascular, strength, balance, flexibility, agility and movement accuracy)- alternating with exercises mainly focused on cognitive stimulation- executive functions (planning ability, information processing speed, attention and dual-task performance).~At the cool-down the participants will normalize their physiological parameters. Finally, at the finishing ritual the participants share their sensations experienced.
Study NCT03446352 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Combined exercise program
Description: The EG2 intervention combines the psychomotor exercise program with a WBV program. The program integrates 3 sessions / week of 75 minutes (including the 6 minutes of WBV) on alternated days.~The WBV will integrate 3 sessions / week of 6 minutes each, with programed increased exercise time, series, and frequencies throughout the intervention.
Study NCT03998579 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: The CanMoRe programme
Description: An exercise intervention in Primary Health Care
Study NCT03998579 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Home exercise
Description: An active control group
Study NCT02340221 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Taselisib
Description: Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm.
Study NCT02340221 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo matching to taselisib was administered as per the schedule specified in the respective arm.
Study NCT02340221 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Fulvestrant
Description: Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.
Study NCT00667056 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo ointment
Description: topical
Study NCT01068756 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Dapagliflozin
Description: Tablets, Oral, 10 mg, 2 single oral 10 mg doses, 2 days
Study NCT01068756 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Rifampin
Description: Capsules, Oral, 600 mg, Once daily on days 4 to 11, 8 days
Study NCT00181753 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: standard vs. glutamine enteral or parenteral feeding.
Description: Patient in each group will continue on the same diet for > 3 days before we conduct stable isotope tracer measurements.
Study NCT02507986 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: 7-Day Holter monitor.
Description: The Holter is a conventional 7-Day Holter monitor.
Study NCT03763630 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: House dust-mite SLIT
Description: received 2000 standard treatment units of glycerinated HDM allergen extract (ALK-AbellÓ) per day. Normal saline was administered to the placebo group. 11 µg of HDM allergen (equal parts of Dermatophagoides pteronyssinus and Dermatophagoides farinae) administered twice daily as oral drops.
Study NCT03763630 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Normal saline
Description: Normal saline administered in same frequency and manner as intervention
Study NCT04105205 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo injection
Description: 30-min infusion
Study NCT02522832 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Titre 1
Description: Virus infection
Study NCT00181753 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Stable isotope tracer study
Description: 7 hours of primed constant infusion
Study NCT01182350 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Study NCT01182350 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erlotinib
Study NCT01182350 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: •
Study NCT01182350 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiation
Study NCT02522832 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Titre 2
Description: Virus infection
Study NCT02522832 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Titre 3
Description: Virus infection
Study NCT03398369 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: CMR/CTA Guidance for CRT
Description: The intervention is the use of CMR and CTA to determine the optimal pacing site in the left ventricle for cardiac resynchronization therapy (CRT) and guide left ventricular lead placement.
Study NCT03522350 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: EmbryoScope
Description: Standard of care arm
Study NCT03522350 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: EmbryoScope+
Description: Experimental arm
Study NCT01713439 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Injection of allogeneic neuroblastoma cells
Description: Patients will receive a fixed dose of IL-2 gene modified tumor cells (10\^7/kg, 10\^8 max) already shown to be safe from a previous protocol, and an escalating dose of Lptn transduced tumor cells, beginning at 10\^4/kg and rising to 10\^7/kg (10\^8 max). Patients will be assigned to an appropriate dose level for injection # 1. Injection #2 will contain 10 times more Lptn transduced cells than injection #1, until the max dose (10\^8) has been reached in the first injection. The dose of injections 3 through 8 will be the same as the dose of injection #2. Initial injection volumes will be \<1ml and should be injected in a single site. Only if these first patients show no undue local toxicity (including tumor cell growth) will multiple injection sites be used for subsequent high cell-dose studies.
Study NCT02878395 — intervention group
Intervention type: PROCEDURE
Intervention: Ileocolic resection
Study NCT01883921 — intervention group
Intervention type: OTHER
Intervention: Immunoglobulin Therapy
Study NCT02971501 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Description: Given IV
Study NCT02971501 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biopsy
Description: Undergo tumor biopsy
Study NCT02971501 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biospecimen Collection
Description: Undergo blood sample collection
Study NCT02971501 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Computed Tomography
Description: Undergo CT scan
Study NCT02971501 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Magnetic Resonance Imaging
Description: Undergo MRI
Study NCT04084938 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Prostate operation or prostate artery embolization
Description: As described above.
Study NCT02971501 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Osimertinib
Description: Given PO
Study NCT03067181 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Best Practice
Description: Undergo observation
Study NCT03067181 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biopsy
Description: Undergo a tumor biopsy
Study NCT03067181 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biospecimen Collection
Description: Undergo blood sample collection
Study NCT03067181 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Bleomycin Sulfate
Description: Given IV
Study NCT03067181 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: Given IV
Study NCT03067181 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Given IV
Study NCT03067181 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Computed Tomography
Description: Undergo a CT scan
Study NCT03067181 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Given IV
Study NCT03067181 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Magnetic Resonance Imaging
Description: Undergo MRI
Study NCT03067181 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pharmacogenomic Study
Description: Correlative studies
Study NCT03067181 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Pulmonary Function Test
Description: Undergo a pulmonary function test
Study NCT03067181 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Quality-of-Life Assessment
Description: Ancillary studies
Study NCT03067181 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies
Study NCT04591574 — intervention group
Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: Red Blood Cells (Transfusion)
Description: Participants will receive RBC transfusions in accordance with trial protocol (intervention group) or usual care, which is in accordance with the NICE guidelines
Study NCT04591574 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Red Blood Cells (Transfusion)
Description: Participants will receive RBC transfusions in accordance with trial protocol (intervention group) or usual care, which is in accordance with the NICE guidelines