TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04675099

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: pCARE
Description: Mothering from the Inside Out is an evidence-based intervention delivered in substance use treatment settings that helps mothers with substance use disorders foster parent-child attachment, cope with stressful parenting situations, and promote their child's healthy development. This 3 month counseling intervention both improves parent-child attachment and decreases rates of drug relapse among mothers. The proposed mechanism of action targeted by the intervention is a change in parental reflective functioning, defined as the capacity to recognize and make sense of mental states (especially emotional states) and understand how they influence behavior and relationships.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard Early Intervention services
Description: The state of Massachusetts provides voluntary early childhood development services to substance-exposed infants through a system of Early Intervention programs. These programs offer coordinated services to all infants and toddlers with disabilities and those at risk for developmental delays in homes and child centers beginning at birth.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Standard Early Intervention services
Description: The state of Massachusetts provides voluntary early childhood development services to substance-exposed infants through a system of Early Intervention programs. These programs offer coordinated services to all infants and toddlers with disabilities and those at risk for developmental delays in homes and child centers beginning at birth.
Study: NCT00218595

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: DBT
Description: Dialectical behavior therapy plus opiate replacement medication.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: I/GDC
Description: Individual and group drug counseling plus opiate replacement medication.
Study: NCT00811733

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Ofatumumab
Description: Ofatumumab is a fully human antibody, targeting a unique epitope on the CD20 molecule expressed on human B cells.
Study: NCT06438614

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HITS
Description: Four doses of hu3F8, five doses each of irinotecan and temozolomide and five doses of GM-CSF. Irinotecan 50mg/m2/day IV will be administered from day 1-5concurrently with temozolomide 150mg/m2/day orally. Hu3F8 2.25mg/kg IV will be administered on days 2, 4, 9and11. GM-CSF 250mcg/m2/day SC will be administered on days 7-11

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Naxitamab + GM-CSF cycles
Description: Patients that achieve CR after 2 or 4 cycles of HITS will move on to 5 cycles of Naxitamab + GM-CSF cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NICE
Description: Patients that do not have an objective response (CR/PR) will receive NICE within 3 weeks from last dose. Each cycle of NICE consists of four doses of hu3F8, five doses of GM-CSF, one dose of carboplatin, and 3 doses each of ifosfamide and etoposide (table 2). Hu3F8 2.25mg/kg IV will be administered on days 2, 4, 9and 11. GM-CSF 250mcg/m2/day SC will be administered on days 7-11. Ifosfamide 1.5 gr/m2/day IV will be administered from day 1-3 concurrently with etoposide 100 mg/m2/day IV. Carboplatin 400 mg/m2/day IV will be administered on day 1
Study: NCT00459862

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative study

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pazopanib hydrochloride
Description: Given orally
Study: NCT02902588

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: ICG-PULSION
Description: Intravenous administration of indocyanine green

Intervention type: DEVICE
Group type: OTHER
Intervention: LiMON, Pulsion Medical Systems
Description: Application of near infrared light

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Gadolinium (Gadovist, Bayer, Germany)
Description: Injection of gadolinium
Study: NCT02094482

Intervention type: DEVICE
Group type: OTHER
Intervention: The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.
Description: The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. Two implants are placed underneath the rostral part of the palatal bone and continue into the upper part of the soft palate
Study: NCT03866577

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Biological: M254
Description: M254 administered as intravenous infusion

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Biological: M254
Description: M254 administered as intravenous infusion

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Biological: M254
Description: M254 administered as intravenous infusion

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Biological: M254
Description: M254 administered as intravenous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo administered as intravenous infusion

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Intravenous immunoglobulin (IVIg)
Description: IVIg administered as intravenous infusion

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Intravenous immunoglobulin (IVIg)
Description: IVIg administered as intravenous infusion
Study: NCT04261803

Intervention type: BIOLOGICAL
Intervention: salivary sample
Description: spit of saliva in a tube

Intervention type: BIOLOGICAL
Intervention: salivary sample
Description: spit of saliva in a tube

Intervention type: BIOLOGICAL
Intervention: blood test
Description: 2millilitter blood test

Intervention type: BIOLOGICAL
Intervention: blood test
Description: 2millilitter blood test
Study: NCT04157829

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Classic lamp
Description: Lamp without a scintilling
Study: NCT00750945

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Music and treadmill walking program
Description: Treadmill with Music cueing training 3 days/wk, plus home music cueing 3 days/wk x 4 weeks

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Treadmill walking program
Description: Treadmill training 3 days/wk, plus home walking 3 days/wk x 4 weeks

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Home program
Description: Home walking program 6 days/wk x 4 weeks
Study: NCT00022516

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 50 mg/day orally continuously for 1 year

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year
Study: NCT03237689

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydrocortisone
Description: Low dose hydrocortisone (10mg)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Oral Tablet
Description: capsules of starch 1500 powder
Study: NCT06649591

Intervention type: BEHAVIORAL
Intervention: Survey
Description: The intervention is an email based survey as described in the study description.

Intervention type: BEHAVIORAL
Intervention: Survey
Description: The intervention is an email based survey as described in the study description.

Intervention type: BEHAVIORAL
Intervention: Survey
Description: The intervention is an email based survey as described in the study description.
Study: NCT02094989

Intervention type: OTHER
Intervention: posture dependence of VCG-ECG-transformation
Study: NCT03969810

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Rounding Summary
Description: Written summary of rounds
Study: NCT03640910

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: OT Equators® (Rhein83)
Description: Attachment systems to retain an implant overdenture

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Locator® (Zest)
Description: Attachment systems to retain an implant overdenture
Study: NCT01083030

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Percutaneous transluminal angioplasty (PTA)
Description: Angioplasty of superficial femoral artery (SFA)

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: DCB
Description: Drug Coated Balloon Angioplasty
Study: NCT04266977

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: restrictive use of DEX, based on standardized clinical and radiological criteria.
Study: NCT03378999

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Rhodospirillum rubrum
Description: Capsules containing oven-dried Rhodospirillum rubrum

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Rhodospirillum rubrum
Description: Capsules containing oven-dried Rhodospirillum rubrum

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Rhodospirillum rubrum
Description: Capsules containing oven-dried Rhodospirillum rubrum

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Control
Description: Capsules containing microcrystalline cellulose
Study: NCT00444873

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
Description: Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
Description: Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
Description: Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
Study: NCT00567996

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Indacaterol 150 μg
Description: Indacaterol 150 μg once daily (o.d) inhaled

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Salmeterol 50 μg
Description: Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo to Indacaterol
Description: Placebo to Indacaterol inhaled via SDDPI.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo to Indacaterol
Description: Placebo to Indacaterol inhaled via SDDPI.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo to Salmeterol
Description: Placebo to salmeterol delivered via a proprietary dry powder inhaler

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo to Salmeterol
Description: Placebo to salmeterol delivered via a proprietary dry powder inhaler
Study: NCT03478345

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: endocrine disruptor chemical reduction intervention
Description: Participants will take part in a 4-week intervention consisting of a modified (shortened) version of the Diabetes Prevention Program diet and physical activity group education program, with instructions to reduce endocrine disruptor chemical exposure through changes in food handling and personal care products.
Study: NCT03271541

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bitopertin
Description: Bitopertin will be administered orally once daily at doses up to 120 milligrams (mg).
Study: NCT01679418

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Placement of a wound drain post surgery (Redon; Medicoplast)
Description: The wound drain, type Redon Drainage 3.0 mm in diameter

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: No-drain after surgery
Description: After surgery, no drain was put
Study: NCT03717974

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Telemedecine follow-up after an intervention at home of the mobile team
Description: After a first visit of the mobile team at home, patients are followed by telemedicine. Moreover, in case of pain, a specialized consultation by an algologist of La Sagesse will be realized.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Mobile team follow-up after an intervention at home of the mobile team
Description: After a first visit of the mobile team at home, patients are followed by mobile team. Moreover, in case of pain, a specialized consultation by an algologist of La Sagesse will be realized.
Study: NCT01851343

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bone Marrow Stromal Cell (BMSC) Infusion
Description: Subjects will receive 4 weekly BMSC infusions and be monitored for AEs as well as for clinical improvement and mucosal healing.
Study: NCT02056301

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hydromorphone
Description: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Morphine
Description: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
Study: NCT00727857

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pioglitazone and metformin
Description: Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pioglitazone
Description: Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Metformin
Description: Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
Study: NCT02041429

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ruxolitinib

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ruxolitinib

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ruxolitinib

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ruxolitinib

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Study: NCT02635438

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Unique Pharmaceutical Laboratories, India
Description: Clotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Roxane Laboratories Inc., USA
Description: Clotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days
Study: NCT03734224

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Adhesix mesh
Description: Adhesix mesh

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Progrip mesh
Description: Progrip mesh
Study: NCT00845910

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bevacizumab [Avastin]
Description: 7.5mg/kg iv on day 1 of every 3 week cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: capecitabine [Xeloda]
Description: 900mg/m2 po on days 1-14 of every 3 week cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: docetaxel
Description: 60mg/m2 iv on day 1 of every 3 week cycle
Study: NCT05122845

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Blood sample
Description: Blood test (10 tubes of 5mL) :~- 6 tubes for : complete blood count, platelets, reticulocyte count, TP-INR, AST, ALT, GGT ferritin, serum iron, CRP, transferrin, soluble transferrin receptors, transferrin saturation coefficient enzymatic creatinine, MDRD, ionogram calcemia, phosphoremia, PTH, 25 (OH) D3, 1.25 (OH) 2D3.~2 dry tubes 2 tube EDTA
Study: NCT00964691

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sulphadoxine-pyrimethamine
Description: 3 tablets of SP (500 mg sulfadoxine and 25 mg pyrimethamine per tablet) by mouth under supervision at enrolment, and 3 tablets of SP under supervision 4 to 12 weeks later in pregnancy (timing of second dose depends upon gestation at first dose)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Chloroquine prophylaxis
Description: 300 mg weekly by mouth from the enrolment date until delivery. Only the enrolment dose will be supervised.
Study: NCT02325882

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine
Description: Dexmedetomidine mixed fentanyl based intravenous PCA

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fentanyl 1
Description: conventional fentanyl-based epidural PCA

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fentanyl 2
Description: conventional fentanyl based intravenous PCA
Study: NCT03762226

Intervention type: DRUG
Intervention: Anti-VEGF
Description: Patients will undergo as part of the routine care 4 monthly anti-VEGF injections.
Study: NCT01849367

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Eldith Neuroconn tDCS device

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Eldith Neuroconn tDCS device
Study: NCT02051582

Intervention type: PROCEDURE
Intervention: Surgeons using fluoroscopy with laser pointer
Description: Surgeons will attempt to obtain a perfect anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped with a laser pointer.~A perfect view is considered the ability to obtain perfect circle views through a cannulated mini acutrak screw that will have been placed into the cadaver prior to data collection.~Surgeons will also be asked to wear three dosimeter badges: one on the collar, one on the waist, and a ring badge under a pair of regular sterile surgical gloves.

Intervention type: PROCEDURE
Intervention: Surgeons using fluoroscopy without laser pointer
Description: Surgeons will attempt to obtain a perfect anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped without a laser pointer.~A perfect view is considered the ability to obtain perfect circle views through a cannulated mini acutrak screw that will have been placed into the cadaver prior to data collection.~Surgeons will also be asked to wear three dosimeter badges: one on the collar, one on the waist, and a ring badge under a pair of regular sterile surgical gloves.
Study: NCT02768818

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Probiotic VIVOMIXX™
Description: The patients will be randomly assigned to the VIVOMIXX™ (intervention) or the control (placebo) group through a randomization list elaborated by a specific software.

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: The patients will be randomly assigned to the VIVOMIXX™ (intervention) or the control (placebo) group through a randomization list elaborated by a specific software.
Study: NCT03273101

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Mechanical assisted sit-to-stand training group
Description: Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Manual assisted sit-to-stand training group
Description: Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
Study: NCT01626001

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: 4D CT scans
Description: 4 (or 5 for Cohort 2) 4DCT scans performed. 1 scan performed while breath held for less than 20 seconds. CT scans take about 5 minutes each to complete.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: 4D CT scans
Description: 4 (or 5 for Cohort 2) 4DCT scans performed. 1 scan performed while breath held for less than 20 seconds. CT scans take about 5 minutes each to complete.
Study: NCT02119013

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Octeotride

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT05343780

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Heptex
Description: Dukung Anak 200 mg + Milk thistle 100 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Heptex
Description: Dukung Anak 200 mg + Milk thistle 100 mg
Study: NCT03394794

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Pelvic floor rehabilitation
Description: The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel.
Study: NCT05343780

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Rice bran
Description: Placebo
Study: NCT00718614

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Description: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Description: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Description: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Description: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Study: NCT03207269

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Dietary
Description: Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Dietary
Description: Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.
Study: NCT02448485

Intervention type: PROCEDURE
Intervention: Aortic Valve Intervention (surgical or transcatheter)
Description: Surgical or interventional aortic valve implantation
Study: NCT04145154

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Application of platelet rich plasma in chronic wounds of diabetic origin
Description: Application of plasma rich in autologous growht factors after advanced healing
Study: NCT02607293

Intervention type: DRUG
Intervention: Long GnRH agonist
Description: As a part of the ART regimen GnRH-agonist will be administered for about 14 to 20 days until down regulation is satisfied as judged by investigator.

Intervention type: DRUG
Intervention: GnRH antagonist
Description: As a part of ART regimen GnRH-antagonist will be initiated and regimen will be as routinely practiced by Investigators and according to licensed SmPC label.