AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT01327547 — intervention group
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
Study NCT01327547 — intervention group
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 group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Memantine
Study NCT00283309 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Memantine
Study NCT00283309 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Riluzole
Study NCT00283309 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Riluzole
Study NCT01982071 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Micafungin
Description: Intravenous (IV)
Study NCT03849872 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ONO-5788
Description: Investigational Drug
Study NCT03503799 — intervention group
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 group
Intervention type: OTHER
Intervention: Non- interventional
Description: Translational, observational study
Study NCT03849872 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [14C]-ONO-5788
Description: Investigational Drug
Study NCT03806049 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Niraparib
Description: given orally once daily
Study NCT03806049 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Description: given as iv infusion every three weeks
Study NCT03806049 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TSR042
Description: Given as IV infusion every three weeks
Study NCT03806049 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Carboplatin
Description: given as iv infusion every three weeks
Study NCT03806049 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Paclitaxel
Description: given as iv infusion every three weeks
Study NCT02459509 — intervention group
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 group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Atezolizumab
Description: Atezolizumab 1200 mg IV over 60 minutes every 3 weeks
Study NCT04262154 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Abiraterone
Description: Abiraterone 1000 mg daily
Study NCT04262154 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Prednisone 5 mg daily
Study NCT04262154 — intervention group
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.
Study NCT04262154 — intervention group
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)
Study NCT04262154 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Enzalutamide
Description: 160 mg once daily
Study NCT04262154 — intervention group
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 group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD8931
Description: Tablet Oral bid
Study NCT00900627 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: IV once weekly for 3 weeks followed by a week off (repeated cycles)
Study NCT00900627 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Paclitaxel
Description: IV once weekly for 3 weeks followed by a week off (repeated cycles)
Study NCT00900627 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Oral bid (twice daily)
Study NCT04027790 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Epi proColon
Description: Analysis of DNA methylation status for Septin9 and additional biomarkers
Study NCT00830947 — intervention group
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 group
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.
Study NCT03372057 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Duvelisib
Description: Duvelisib PO 75 mg BID in 28-day cycles.
Study NCT00830947 — intervention group
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 group
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
Study NCT03172117 — intervention group
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 group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Low dose Atorvastatin
Description: 80mg atorvastatin followed by two 20mg daily atorvastatin
Study NCT01306565 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: High dose atorvastatin
Description: 80mg daily atorvastatin for 72 hours
Study NCT01672983 — intervention group
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 group
Intervention type: OTHER
Intervention: Integrated care for cardiovascular risk management
Description: Disease management program for the prevention of cardiovascular diseases
Study NCT03750279 — intervention group
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 group
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.
Study NCT02417428 — intervention group
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.
Study NCT02417428 — intervention group
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.
Study NCT02417428 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: without exercise
Description: No exercise program will be assigned to participants.
Study NCT02417428 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: without exercise
Description: No exercise program will be assigned to participants.
Study NCT01497743 — intervention group
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 group
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.
Study NCT03750279 — intervention group
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.
Study NCT03750279 — intervention group
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 group
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 group
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 group
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.
Study NCT03094897 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PET/CT
Description: Imaging with 18F-Al-NOTA-MATBBN PET/CT.
Study NCT04125511 — intervention group
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 group
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 group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: GoalKeeper
Description: Mobile-health communication tool for parents of children with medical complexity
Study NCT03372057 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Duvelisib
Description: Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase)
Study NCT01415622 — intervention group
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.
Study NCT01415622 — intervention group
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 group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Standard Care
Description: Standard Clinical Care
Study NCT00672542 — intervention group
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 group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methylprednisolone
Description: Methylprednisolone 125 mg iv pre-operatively
Study NCT00968578 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Saline iv pre-operatively in equivalent volume (placebo)
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IV amikacin
Description: 5-7.5 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: IV amikacin
Description: 5-7.5 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PO azithromycin
Description: 250 mg once daily
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: PO azithromycin
Description: 250 mg once daily
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IV ceftazidime
Description: 50 mg/kg every 8 hours, up to 2 grams every 8 hours
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: IV ceftazidime
Description: 50 mg/kg every 8 hours, up to 2 grams every 8 hours
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PO ciprofloxacin
Description: 500 mg every 12 hours if weight \<50 kg 750 mg every 12 hours if weight ≥50 kg
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: PO ciprofloxacin
Description: 500 mg every 12 hours if weight \<50 kg 750 mg every 12 hours if weight ≥50 kg
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IV meropenem
Description: 40 mg/kg every 8 hours, up to 2 grams every 8 hours
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: IV meropenem
Description: 40 mg/kg every 8 hours, up to 2 grams every 8 hours
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IV piperacillin-tazobactam
Description: 100 mg/kg of piperacillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: IV piperacillin-tazobactam
Description: 100 mg/kg of piperacillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IV ticarcillin-clavulanate
Description: 100 mg/kg of ticarcillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: IV ticarcillin-clavulanate
Description: 100 mg/kg of ticarcillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IV tobramycin
Description: 2.5-3.3 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site
Study NCT00153634 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: IV tobramycin
Description: 2.5-3.3 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site
Study NCT01959555 — intervention group
Intervention type: OTHER
Intervention: No treatment given
Description: Patients will not be treated with any specific product. Data collection only.
Study NCT00744146 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Protexia
Description: Single 50 mg IM dose
Study NCT00744146 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Protexia
Description: Single 100 mg dose
Study NCT00744146 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Protexia
Description: Two 250 mg doses, IM, one at Day 1 and one at Day 72
Study NCT00744146 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Protexia
Description: Single 500 mg dose, IM
Study NCT00744146 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Protexia
Description: Single 750 mg dose, IM
Study NCT01497743 — intervention group
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 group
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 group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: IV Ondansetron 4mg
Description: IV ondansetron 4mg
Study NCT04654429 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Higher OT temperature range
Description: OT temperature set to 19-22 degree celsius
Study NCT04654429 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: IV Normal Saline 2cc will be given
Study NCT04654429 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: IV Normal Saline 2cc will be given
Study NCT04654429 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Lower OT temperature Range
Description: OT temperature set to 17-19 degree celsius
Study NCT04654429 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Lower OT temperature Range
Description: OT temperature set to 17-19 degree celsius
Study NCT01300273 — intervention group
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 group
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).
Study NCT00421863 — intervention group
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).