TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02940769

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: light glasses
Description: light glasses

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: sham glasses (placebo)
Description: sham light glasses
Study: NCT03477942

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous Mesenchymal Stem Cells
Description: Bone marrow will be harvested from each individual patient's iliac crest, followed by stem cell isolation, expansion and preparation. Stem cell will be injected approximately 3-4 weeks after bone marrow harvest, injecting 50x10\^6 MSCs in the knee via a medial parapatellar approach under sterile technique in 8 patients with generalized knee OA or focal chondral defects.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous Mesenchymal Stem Cells
Description: Bone marrow will be harvested from each individual patient's iliac crest, followed by stem cell isolation, expansion and preparation. Stem cell will be injected approximately 3-4 weeks after bone marrow harvest, injecting 50x10\^6 MSCs in the knee via a medial parapatellar approach under sterile technique in 8 patients with generalized knee OA or focal chondral defects.
Study: NCT04671290

Intervention type: OTHER
Intervention: Any intervention
Description: No intervention

Intervention type: OTHER
Intervention: Any intervention
Description: No intervention
Study: NCT01327547

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Maraviroc
Description: 150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
Study: NCT00283309

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Memantine

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Memantine

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Riluzole

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Riluzole
Study: NCT01982071

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Micafungin
Description: Intravenous (IV)
Study: NCT03849872

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ONO-5788
Description: Investigational Drug
Study: NCT03503799

Intervention type: OTHER
Intervention: Observation
Description: Visit 1 Informed consent Medical history Demographics Result of EndoPredict® Test Status of menopause Disease status Tumor board decision Planned anti-tumor-therapy~Visit 2, 1 year after inclusion This visit will be documented at the study site Status of menopause Disease status Anti-tumor therapy Survival~Following visits For these visits, patients will be asked directly through the Center for Clinical Trials of the Philipps-University Marburg (KKS Marburg) via phone.~Status of Menopause Disease status Anti-tumor therapy Survival~Treatment after end of the study The patient will be treated during and after end of study by physician's choice.
Study: NCT03865355

Intervention type: OTHER
Intervention: Non- interventional
Description: Translational, observational study

Intervention type: OTHER
Intervention: Non- interventional
Description: Translational, observational study
Study: NCT03849872

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [14C]-ONO-5788
Description: Investigational Drug

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [14C]-ONO-5788
Description: Investigational Drug
Study: NCT03806049

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Niraparib
Description: given orally once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Niraparib
Description: given orally once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Description: given as iv infusion every three weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Description: given as iv infusion every three weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TSR042
Description: Given as IV infusion every three weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Carboplatin
Description: given as iv infusion every three weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Paclitaxel
Description: given as iv infusion every three weeks
Study: NCT02459509

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexmedetomidine
Description: Either 2mcg/kg or 4mcg/kg of intranasal dexmedetomidine will be given to assess efficacy of preoperative sedation

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexmedetomidine
Description: Either 2mcg/kg or 4mcg/kg of intranasal dexmedetomidine will be given to assess efficacy of preoperative sedation
Study: NCT04262154

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Atezolizumab
Description: Atezolizumab 1200 mg IV over 60 minutes every 3 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Abiraterone
Description: Abiraterone 1000 mg daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Prednisone 5 mg daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GnRH analog
Description: Any GnRH analog that is commercially available, injectable, and long acting analog of the native LHRH peptide and is administered to subjects via intramuscular injection. For this study, any GnRH analog can be used and thee manufacturer's instructions for dose and frequency should be followed.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Stereotactic Body Radiotherapy (SBRT)
Description: Intensity-modulated, image-guided, ultra-hypofractionated external beam radiotherapy (7.25-7.5 Gy x 5 to prostate and seminal vesicles QOD) will begin around 12 weeks (at Cycle 5 Day 1 (+/-5 days)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Enzalutamide
Description: 160 mg once daily

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Follow up
Description: Subjects who discontinue study treatment for reasons other than progression will be followed every 6 months (+/- 4 weeks) until a documented progression event (i.e., PSA, radiographic, or clinical progression). After a documented progressionevent (whether on treatment or during follow up), subjects will continue to be followed every 6 months (+/- 4 weeks) for overall survival via chart review and/or telephone call.
Study: NCT00900627

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD8931
Description: Tablet Oral bid

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: IV once weekly for 3 weeks followed by a week off (repeated cycles)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Paclitaxel
Description: IV once weekly for 3 weeks followed by a week off (repeated cycles)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Oral bid (twice daily)
Study: NCT04027790

Intervention type: DIAGNOSTIC_TEST
Intervention: Epi proColon
Description: Analysis of DNA methylation status for Septin9 and additional biomarkers

Intervention type: DIAGNOSTIC_TEST
Intervention: Epi proColon
Description: Analysis of DNA methylation status for Septin9 and additional biomarkers
Study: NCT00830947

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: OrthoAccel Device
Description: The OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Study: NCT03372057

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Duvelisib
Description: Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Duvelisib
Description: Duvelisib PO 75 mg BID in 28-day cycles.
Study: NCT00830947

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Sham Device
Description: Inactive sham device that is held in the mouth for 20 minutes.
Study: NCT03172117

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: human umbilical cord blood derived mesenchymal stem cells
Description: Low dose: 1 x 10\^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals~High dose: 3 x 10\^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: human umbilical cord blood derived mesenchymal stem cells
Description: Low dose: 1 x 10\^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals~High dose: 3 x 10\^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Normal saline 2mL
Description: Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations
Study: NCT01306565

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Low dose Atorvastatin
Description: 80mg atorvastatin followed by two 20mg daily atorvastatin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: High dose atorvastatin
Description: 80mg daily atorvastatin for 72 hours
Study: NCT01672983

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-450/ritonavir, ABT-267
Description: ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-450/ritonavir, ABT-267
Description: ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-450/ritonavir, ABT-267
Description: ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-450/ritonavir, ABT-267
Description: ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-450/ritonavir, ABT-267
Description: ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-450/ritonavir, ABT-267
Description: ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Study: NCT03428061

Intervention type: OTHER
Intervention: Integrated care for cardiovascular risk management
Description: Disease management program for the prevention of cardiovascular diseases
Study: NCT03750279

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise therapy
Description: * 5 min. warm up with light exercises for the lower limb prior to strength/endurance exercise therapy.~* Strength/endurance exercise therapy including level 1 or 2 per session:~Level 1: Pelvic lifts (2x15 rep.), one-legged knee bends (2x10 rep. per leg), hip abductions (2x10 rep. per leg). The participants may progress from level 1 to level 2.~Level 2: Pelvic lifts (3x15 rep.), one-legged knee bends (3x10 rep. per leg), hip abductions (2x10 rep. per leg), sideways slide (2x10 rep. per leg), and backwards slide (2x10 rep. per leg). The participants may regress from level 2 to level 1.
Study: NCT02417428

Intervention type: OTHER
Group type: OTHER
Intervention: Placebo
Description: Twelve weeks of oral placebo will be taken by half of the participants. Ten grams of placebo (maltodextrin white powder) will be mixed with a liquid and will be consumed once daily at lunch time.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise
Description: Participants will also take part in twelve weeks of HIIT (30s at 85% and up of maximal heart rate + 1m30sec at 60-75% of maximal heart rate (HR max). 3 times/ week during 30 continuous minutes. Each period are supervised and monitored using borg scale and polar system.

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Exercise
Description: Participants will also take part in twelve weeks of HIIT (30s at 85% and up of maximal heart rate + 1m30sec at 60-75% of maximal heart rate (HR max). 3 times/ week during 30 continuous minutes. Each period are supervised and monitored using borg scale and polar system.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: without exercise
Description: No exercise program will be assigned to participants.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: without exercise
Description: No exercise program will be assigned to participants.
Study: NCT01497743

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lactobacillus
Description: All randomized subjects will receive probiotic or matching placebo: 1 capsule orally twice daily, with meals) for the first 4 weeks. There will be a 6-week washout period, followed by 4 weeks of the alternate treatment. The subject will not be on study medication during this washout period.
Study: NCT03750279

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Exercise therapy
Description: * 5 min. warm up with light exercises for the lower limb prior to strength/endurance exercise therapy.~* Strength/endurance exercise therapy including level 1 or 2 per session:~Level 1: Pelvic lifts (2x15 rep.), one-legged knee bends (2x10 rep. per leg), hip abductions (2x10 rep. per leg). The participants may progress from level 1 to level 2.~Level 2: Pelvic lifts (3x15 rep.), one-legged knee bends (3x10 rep. per leg), hip abductions (2x10 rep. per leg), sideways slide (2x10 rep. per leg), and backwards slide (2x10 rep. per leg). The participants may regress from level 2 to level 1.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: LLLT
Description: - LLLT (60 mW mean output per probe, 904 nm wavelength) applied to the knee in adherence with the recommendations by World Association for Laser Therapy, in terms of dosage per treatment spot.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Sham LLLT
Description: - Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).
Study: NCT02435511

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: HealtheRx
Description: The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient.
Study: NCT02720887

Intervention type: PROCEDURE
Intervention: Nanoparticles load
Description: Pregnant women will have a sampling of amniotic fluid to measure load and composition of nanoparticles.
Study: NCT03094897

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 18F-Al-NOTA-MATBBN PET/CT
Description: 18F-Al-NOTA-MATBBN(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PET/CT
Description: Imaging with 18F-Al-NOTA-MATBBN PET/CT.
Study: NCT04125511

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 68Ga-FAPI
Description: Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of IgG4-RD by PET/CT.
Study: NCT01766518

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mycophenolate mofetil
Description: MY-REPT capsule 500\~1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation
Study: NCT03620071

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: GoalKeeper
Description: Mobile-health communication tool for parents of children with medical complexity
Study: NCT03372057

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Duvelisib
Description: Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase)
Study: NCT01415622

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PlasmaDerm
Description: plasma treatment 3 times a week for 8 weeks, 45 sec / cm² of Ulcus cruris size, in addition to standard care.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: standard care of Ulcera crurum
Description: standard care of Ulcera crurum: Mepithel gaze for non-exsudative wounds, Mepilex for exsudative wounds, followed by surgical hose treatment. Additionally, a standardized compression therapy with Ulcer X is applied.
Study: NCT03620071

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Standard Care
Description: Standard Clinical Care

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Standard Care
Description: Standard Clinical Care
Study: NCT00672542

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Proteasome siRNA and tumor antigen RNA-transfected dendritic cells
Description: The safety and toxicity of vaccination with tumor antigen RNA-transfected dendritic cells (DC), derived from either untransfected or siRNA-transfected monocytes, will be evaluated in subjects with metastatic melanoma. Subjects will undergo leukapheresis and monocytes will be isolated. These monocytes will then be left untreated (Study Arm A) or transfected with either control siRNA (Study Arm B) or siRNA targeting immunoproteasome subunits LMP2, LMP7, and MECL1 (Study Arm C), then differentiated into DC in vitro . After the induction of maturation, these DC will be transfected with RNA encoding defined melanoma antigens MART, MAGE-3, tyrosinase, and gp100. These RNA-transfected autologous DC will be cryopreserved, then used to vaccinate subjects with metastatic melanoma, each of whom will receive a total of six intradermal (ID) injections using 1x10e7 DC at each cycle, administered weekly.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Proteasome siRNA and tumor antigen RNA-transfected dendritic cells
Description: The safety and toxicity of vaccination with tumor antigen RNA-transfected dendritic cells (DC), derived from either untransfected or siRNA-transfected monocytes, will be evaluated in subjects with metastatic melanoma. Subjects will undergo leukapheresis and monocytes will be isolated. These monocytes will then be left untreated (Study Arm A) or transfected with either control siRNA (Study Arm B) or siRNA targeting immunoproteasome subunits LMP2, LMP7, and MECL1 (Study Arm C), then differentiated into DC in vitro . After the induction of maturation, these DC will be transfected with RNA encoding defined melanoma antigens MART, MAGE-3, tyrosinase, and gp100. These RNA-transfected autologous DC will be cryopreserved, then used to vaccinate subjects with metastatic melanoma, each of whom will receive a total of six intradermal (ID) injections using 1x10e7 DC at each cycle, administered weekly.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Proteasome siRNA and tumor antigen RNA-transfected dendritic cells
Description: The safety and toxicity of vaccination with tumor antigen RNA-transfected dendritic cells (DC), derived from either untransfected or siRNA-transfected monocytes, will be evaluated in subjects with metastatic melanoma. Subjects will undergo leukapheresis and monocytes will be isolated. These monocytes will then be left untreated (Study Arm A) or transfected with either control siRNA (Study Arm B) or siRNA targeting immunoproteasome subunits LMP2, LMP7, and MECL1 (Study Arm C), then differentiated into DC in vitro . After the induction of maturation, these DC will be transfected with RNA encoding defined melanoma antigens MART, MAGE-3, tyrosinase, and gp100. These RNA-transfected autologous DC will be cryopreserved, then used to vaccinate subjects with metastatic melanoma, each of whom will receive a total of six intradermal (ID) injections using 1x10e7 DC at each cycle, administered weekly.
Study: NCT00968578

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methylprednisolone
Description: Methylprednisolone 125 mg iv pre-operatively

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Saline iv pre-operatively in equivalent volume (placebo)
Study: NCT01959555

Intervention type: OTHER
Intervention: No treatment given
Description: Patients will not be treated with any specific product. Data collection only.
Study: NCT00744146

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Protexia
Description: Single 50 mg IM dose

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Protexia
Description: Single 100 mg dose

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Protexia
Description: Two 250 mg doses, IM, one at Day 1 and one at Day 72

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Protexia
Description: Single 500 mg dose, IM

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Protexia
Description: Single 750 mg dose, IM
Study: NCT01497743

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Lactobacillus
Description: All randomized subjects will receive probiotic or matching placebo: 1 capsule orally twice daily, with meals) for the first 4 weeks. There will be a 6-week washout period, followed by 4 weeks of the alternate treatment. The subject will not be on study medication during this washout period.
Study: NCT04202484

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium Capsules
Description: Toripalimab: 240mg IV Q3W;Tegafur,Gimeracil and Oteracil Porassium Capsules: 40mg/m2 Bid PO×14d Q3W;Oxaliplatin: 130mg/m2 IV Q3W
Study: NCT04654429

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: IV Ondansetron 4mg
Description: IV ondansetron 4mg

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: IV Ondansetron 4mg
Description: IV ondansetron 4mg

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Higher OT temperature range
Description: OT temperature set to 19-22 degree celsius

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Higher OT temperature range
Description: OT temperature set to 19-22 degree celsius

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: IV Normal Saline 2cc will be given

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: IV Normal Saline 2cc will be given

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Lower OT temperature Range
Description: OT temperature set to 17-19 degree celsius

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Lower OT temperature Range
Description: OT temperature set to 17-19 degree celsius
Study: NCT01300273

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Compound α-Ketoacid Tablet
Description: 30 patients will be treated with a LPD containing 0.6g protein/kg BW per day and 120-125 kJ/kg BW per day and supplemented with keto-amino acids (Ketosteril®, Fresenius Kabi) at a dosage of 100 mg/kg BW per day.
Study: NCT00421863

Intervention type: DRUG
Group type: OTHER
Intervention: Triatec 10 mg
Description: Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).

Intervention type: DRUG
Group type: OTHER
Intervention: Triatec 10 mg
Description: Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).

Intervention type: DRUG
Group type: OTHER
Intervention: Triatec HCT 5
Description: Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Study: NCT03865355

Intervention type: OTHER
Intervention: Non- interventional
Description: Translational, observational study