TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02337803

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Strength Training Program
Description: The strength training program consists of 6 exercises using resistance bands three times a week

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Usual Care
Description: Will continue daily physical activity and complete surveys online

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Usual Care
Description: Will continue daily physical activity and complete surveys online
Study: NCT01885000

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Brimonidine tartrate was applied cutaneously once daily for 8 days.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.
Study: NCT01267448

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Glipizide XL
Description: The control group will receive Glipizide XL (10mg orally) for a total duration of 12 weeks.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Saxagliptin + Metformin XR
Description: The intervention group will receive Saxagliptin 5 mg daily for a total duration of 12 weeks.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Metformin XR
Description: The intervention group will receive Metformin XR 1000 mg daily and will be automatically titrated weekly in 2 weeks to Metformin XR 2000 daily for a total duration of 12 weeks.
Study: NCT02186730

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Stressbusters
Description: cCBT

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Websites
Description: Self help websites
Study: NCT03893149

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Active-Start intervention
Description: Supervised exercise training. The intervention is a physical activity intervention that consist of 5 times per week before starting the first school-class (8:00-8:30 a.m.), 5 times per week. Each session was previously planned and described in a manual dedicated to the study. These sessions were designed by the research team and delivered by a graduate in Sport The intervention program included sports games adapted to the age of the participants, playground games, dance and other recreational activities. The intensity of the main part of the sessions was moderate-to-vigorous according to a previous study and this intensity was confirmed by accelerometry. Also, different activities favoring social interactions were designed to facilitate the interactions between the participants at the end of the sessions (cold-down).

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: No Intervention
Description: No-exercise
Study: NCT02580331

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: SRP and placebo
Description: Placement of placebo gel into classII furcation defects after scaling and root planing

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: SRP and 1% metformin
Description: Placement of 1% metformin gel into classII furcation defects after scaling and root planing
Study: NCT05953792

Intervention type: PROCEDURE
Intervention: Select the vertebra above sagittal stable vertebra as the distal fusion level
Description: The surgeries were performed by the same surgical team. Multi-level Ponte osteotomies were performed across the apex of the kyphosis after complete exposure of the spine, with resection of supra- and inter-spinous ligaments, ligamentum flavum, and the whole facet joints. After placement of the pedicle screws at the expected fusion levels, pre-contoured rods were attached to the screws followed by segmental compression. During rod placement, two to three rounds of compression in the area with Ponte osteotomies were employed to enhance kyphosis correction. Satellite rods were routinely added to long rods and implanted with duet screws. The final tightening was performed, and the posterior fusion was completed with a mixture of local and allogeneic bone. Due attention was given to preserving the posterior ligamentous structures at the upper and lower junctional areas.

Intervention type: PROCEDURE
Intervention: Select the vertebra above sagittal stable vertebra as the distal fusion level
Description: The surgeries were performed by the same surgical team. Multi-level Ponte osteotomies were performed across the apex of the kyphosis after complete exposure of the spine, with resection of supra- and inter-spinous ligaments, ligamentum flavum, and the whole facet joints. After placement of the pedicle screws at the expected fusion levels, pre-contoured rods were attached to the screws followed by segmental compression. During rod placement, two to three rounds of compression in the area with Ponte osteotomies were employed to enhance kyphosis correction. Satellite rods were routinely added to long rods and implanted with duet screws. The final tightening was performed, and the posterior fusion was completed with a mixture of local and allogeneic bone. Due attention was given to preserving the posterior ligamentous structures at the upper and lower junctional areas.
Study: NCT04722211

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: PS128
Description: daily ingestion of 2 capsules of Lactobacillus plantarum PS128 (\>10 billion CFU/capsule)
Study: NCT03596190

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: ultrasonographic diaphragmatic assessment
Description: Diaphragmatic dysfunction will be determined by intercostal diaphragm thickening. The available image will be saved.~Diaphragmatic motion assessments will be conducted on the side to be blocked both at baseline, and then every 5 minutes until patient leaves for operating room or 30 minutes (whatever is earlier).
Study: NCT03248362

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Transcutaneous posterior tibial nerve stimulation
Description: 12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of tibial nerve stimulation
Study: NCT04722211

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose
Study: NCT04687644

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Online education
Description: Education group

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Online education
Description: Education group
Study: NCT02417389

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cinacalcet
Description: During Phase 1 (months 1-12): oral administration; 30 mg twice/day (dose to be increased if needed).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alendronate
Description: During Phase 2 (months 13-24): oral administration; 70 mg once/week (in addition to cinacalcet 30 mg twice/day as during Phase 1).
Study: NCT03285256

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Experimental memory training
Description: The experimental memory training will be implemented as a computer program that uses state-of-the-art immersive technology to simulate prospective memory in everyday life in which one must remember to carry out tasks throughout the day, while engaging in current ongoing activity. Participants are asked to imagine they have a work-at-home job (ongoing activity), which is an independent program (CogMed QM) designed to train working memory, but that they also need to remember to carry out a number of tasks throughout the day. Using a touch screen, participants will need to touch objects in the simulated environment to appropriately interact with these stimuli according to their pre-assigned tasks.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Comparator memory training 1
Description: The first comparator memory training intervention will utilize the same overall structure and immersive computer environment as the experimental memory intervention, but will not challenge the same aspects of cognition.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Comparator memory training 2
Description: The second comparator memory training intervention will utilize the same overall structure and immersive computer environment as the experimental memory intervention, but will not challenge the same aspects of cognition.
Study: NCT01097304

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ursodiol
Description: Given PO

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies
Study: NCT03248362

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Sham stimulation
Description: 12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of of the lateral sub-malleolar area
Study: NCT00429364

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Losartan Potassium
Description: Losartan .3 - 1.4 mg/kg
Study: NCT02082678

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ondansetron
Description: Ondansetron is a serotonin receptor antagonist that is FDA-approved to treat nausea and vomiting caused by cancer therapy and surgery.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Inactive ingredient matching the active medication in appearance
Study: NCT00429364

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Atenolol
Description: Atenolol .5 - 4 mg/kg
Study: NCT02249702

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: gemcitabine + docetaxel

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: trabectedin
Study: NCT03603769

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Food supplement capsules containing Salmon-Polar Lipids
Description: Postprandial decreased Platelet activation/aggregation in subjects, after the food supplement capsule consumption

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo food supplement capsule
Description: Postprandial unaffected platelet activation/aggregation in subjects, after the food supplement capsule consumption
Study: NCT03846388

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: follicular stimulating hormone
Description: in the serum of our patients

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: follicular stimulating hormone
Description: in the serum of our patients
Study: NCT03390114

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: SHUTi
Description: SHUTi consists of six, 40-minute, weekly sessions during which the intervention components of stimulus control, sleep restriction, sleep hygiene, cognitive restructuring, and relapse prevention are delivered. Each SHUTi session has the same structure: the main content, a homework screen with options, and a summary of the main points.
Study: NCT03846388

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Anti-mullerian hormone
Description: in the serum of our patients

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Anti-mullerian hormone
Description: in the serum of our patients

Intervention type: RADIATION
Group type: OTHER
Intervention: Basal antral follicle count
Description: by ultrasound

Intervention type: RADIATION
Group type: OTHER
Intervention: Basal antral follicle count
Description: by ultrasound
Study: NCT03182322

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: intranasal insulin
Description: Total of 6 months treatment; daily for the first 7 intervention days and one day per week thereafter (formulation containing rH-insulin, benzalkonium chloride, glycerol and water)

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Total of 6 months treatment; daily for the first 7 intervention days and one day per week thereafter placebo (formulation containing benzalkonium chloride, glycerol and water)
Study: NCT03991494

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [14C]-pamiparib
Description: During the treatment phase, pamiparib 60 mg administered orally twice daily
Study: NCT00319735

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Radiation Therapy
Description: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Surgery
Description: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Tissue Sample
Description: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
Study: NCT02908906

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-63723283
Description: JNJ-63723283 will be administered by IV infusion or SC injection or infusion.
Study: NCT03609216

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Given IV

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pegfilgrastim
Description: Given SC

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pegfilgrastim
Description: Given SC

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Conventional Surgery
Description: Undergo bladder sparing
Study: NCT01597167

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Magnesium sulfate
Description: 4 grams magnesium sulfate in 100 ml IV over 4 hours

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Magnesium sulfate
Description: 4 grams magnesium sulfate in 100 ml IV over 4 hours
Study: NCT01037959

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Norfloxacin
Description: 400 mg/day (per os) for 6 months

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 1 pill/day (per os) for 6 months
Study: NCT00679445

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: NeoVista Ophthalmic System
Description: A single procedure using the NeoVioasta Ophthalmic System plus an injection of Lucentis.
Study: NCT03746561

Intervention type: DIAGNOSTIC_TEST
Intervention: deep learning
Description: detect and classify spinal stenosis by deep learning
Study: NCT01277640

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: dapivirine
Description: * dosage form: gel 0.05%~* dosage: 2.5g~* frequency: once daily~* duration: 7 days

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: matched placebo
Description: * dosage form: gel, no api~* dosage: 2.5g~* frequency: once daily~* duration: 7 days
Study: NCT03896451

Intervention type: DEVICE
Group type: OTHER
Intervention: Total knee endoprothesis
Description: Total knee endoprosthesis after knee joint osteoarthritis

Intervention type: DEVICE
Group type: OTHER
Intervention: Total knee endoprothesis
Description: Total knee endoprosthesis after knee joint osteoarthritis
Study: NCT01277640

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: universal placebo
Description: * dosage form: gel, HEC-based~* dosage: 2.5g~* frequency: once daily~* duration: 7 days
Study: NCT03514927

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Contrast-Enhanced Ultrasound
Description: Undergo CEUS

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: High-Intensity Focused Ultrasound
Description: Under go HIFU

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Multiparametric Magnetic Resonance Imaging
Description: Undergo mpMRI

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Radical Prostatectomy
Description: Undergo prostatectomy
Study: NCT04130802

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL
Description: OCS-01 eye drops

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL
Description: OCS-01 eye drops

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Vehicle eye drops

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Vehicle eye drops
Study: NCT00997009

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paclitaxel
Description: 175 mg/m2 IV day 1, every 21 days

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: paclitaxel
Description: 175 mg/m2 IV day 1, every 21 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: carboplatin
Description: AUC 5 IV day 1 every 21 days

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: carboplatin
Description: AUC 5 IV day 1 every 21 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cetuximab
Description: 400 mg/m2 IV, one week before starting carboplatin and paclitaxel; then 250 mg/m2 IV day 1, weekly
Study: NCT02665286

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Orphenadrine
Description: Orphenadrine 100mg PO BID x 7 days

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methocarbamol
Description: Methocarbamol 750mg 1-2 tabs po TID x 7 days

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Naproxen
Description: Naproxen 500mg PO BID x 7 days

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Naproxen
Description: Naproxen 500mg PO BID x 7 days

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Naproxen
Description: Naproxen 500mg PO BID x 7 days
Study: NCT01219803

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: High Dose GGQL Decoction
Description: The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc,5 times thick of low dose GGQL Decoction, 150ml/bag, twice in a day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mild dose GGQL Decoction
Description: The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc,3 times thick of low dose GGQL Decoction, 150ml/bag, twice in a day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Low dose GGQL Decoction
Description: The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc, 150ml/bag, twice in a day

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: The placebo was a kind of decoction,which including 4.5% low dose GGQL Decoction to feel bitter taste as other drugs, 150ml/bag, twice in a day
Study: NCT02665286

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days
Study: NCT03969888

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-3067
Description: Tablet taken orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-3067
Description: Tablet taken orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-3067
Description: Tablet taken orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-3067
Description: Tablet taken orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-3067
Description: Tablet taken orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-3067
Description: Tablet taken orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-3067
Description: Tablet taken orally.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo ABBV-3067
Description: Tablet taken orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-2222
Description: Capsule taken orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-2222
Description: Capsule taken orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-2222
Description: Capsule taken orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-2222
Description: Capsule taken orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-2222
Description: Capsule taken orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo ABBV-2222
Description: Capsule taken orally.
Study: NCT04295746

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Serious Game ShopAut
Description: The serious game ShopAut, is a three-dimensional game conceptually based on classic 3D life simulation games. ShopAut aims to teach players the procedure of a shopping activity; to reinforce object categorization and recognition in a supermarket; to improve attention, orientation, and problem-solving skills; and to help the player engage in simple economic transactions.~The intervention provides a virtual training with ShopAut to train, experiment, and practice behaviours and actions that can be then transferred in real-life contexts.
Study: NCT00154063

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2007

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT02663414

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Atlas Knee System
Description: The Atlas Knee System is an approved device (CE Marked) and is an extra-capsular knee implant specifically designed to treat patients with uni-compartmental, medial knee osteoarthritis (OA).
Study: NCT00625235

Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: VLED followed by a high protein or high carbohydrate diet

Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: VLED followed by a high protein or high carbohydrate diet
Study: NCT00931450

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: exemestane
Description: Given orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: exemestane
Description: Given orally
Study: NCT03969888

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo ABBV-2222
Description: Capsule taken orally.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo ABBV-2222
Description: Capsule taken orally.
Study: NCT00931450

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: sunitinib malate
Description: Given orally

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: Given orally
Study: NCT02123290

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DSM265 400mg
Study: NCT02859909

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: BT595

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: BT595
Study: NCT01518595

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: bosentan
Description: pts. will receive bosentan for 3 months

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: pts. will receive placebo for 3 months