TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04138095

Intervention type: DEVICE
Group type: OTHER
Intervention: Virtual Reality
Description: Participants will have access to an Oculus Quest Virtual Reality Headset every second day as an alternative to opioids for pain management and benzodiazepines for anxiety management
Study: NCT00726102

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Cereal
Description: Daily provision of cereal to infants from 6-18 mos

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: fortified rice cereal
Description: Daily provision of fortified cereal to infants 6-18 months of age
Study: NCT02709473

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Propofol
Description: Propofol will be used in either two arms. The injection sequence will be changed. In propofol arm of the study, general anesthesia will be started with 2 mg/kg propofol administered within 15 seconds. And, then remifentanil will be given. In remifentanil arm of the study, 2 mg/kg propofol will be applied within 15 seconds following remifentanil injection.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Propofol
Description: Propofol will be used in either two arms. The injection sequence will be changed. In propofol arm of the study, general anesthesia will be started with 2 mg/kg propofol administered within 15 seconds. And, then remifentanil will be given. In remifentanil arm of the study, 2 mg/kg propofol will be applied within 15 seconds following remifentanil injection.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Remifentanil
Description: Remifentanil will be used in either two arms. The injection sequence will be changed. In remifentanil arm, general anesthesia will be started with 2 μg/kg remifentanil administered within 30 seconds. And then propofol will be given. In propofol arm of the study the same dose will be applied within 30 seconds following propofol administration.
Study: NCT03403998

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercises
Description: The treatment will consist of an 8-week progressive exercise program of neck flexors and extensors exercises supervised by a physical therapist for 30-45 min twice a week per 8 weeks as described in Arm/group descriptions.
Study: NCT02709473

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Remifentanil
Description: Remifentanil will be used in either two arms. The injection sequence will be changed. In remifentanil arm, general anesthesia will be started with 2 μg/kg remifentanil administered within 30 seconds. And then propofol will be given. In propofol arm of the study the same dose will be applied within 30 seconds following propofol administration.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rocuronium
Description: Rocuronium will be used for either two study arms. Rocuronium will be given in a 0.8 mg/kg dosage in the first study subject. And then, if the intubation condition is acceptable, the dose of the rocuronium will be decreased by 0.1 mg/kg for the next patient. Otherwise, if the intubation condition is not acceptable, the rocuronium dosage will be increased by 0.1 mg/kg for the next patient. This will be continue for ten crossover points (the point that turn from unsuccessful intubation to successful intubation).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rocuronium
Description: Rocuronium will be used for either two study arms. Rocuronium will be given in a 0.8 mg/kg dosage in the first study subject. And then, if the intubation condition is acceptable, the dose of the rocuronium will be decreased by 0.1 mg/kg for the next patient. Otherwise, if the intubation condition is not acceptable, the rocuronium dosage will be increased by 0.1 mg/kg for the next patient. This will be continue for ten crossover points (the point that turn from unsuccessful intubation to successful intubation).
Study: NCT01963208

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ganaxolone
Description: 200 mg and 225 mg capsules; target dose 1800 mg/day dosed 900mg 2x/day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ganaxolone
Description: 200 mg and 225 mg capsules; target dose 1800 mg/day dosed 900mg 2x/day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ganaxolone
Description: 200 mg and 225 mg capsules; target dose 1800 mg/day dosed 900mg 2x/day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ganaxolone
Description: 200 mg and 225 mg capsules; target dose 1800 mg/day dosed 900mg 2x/day

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: placebo

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: placebo
Study: NCT04300062

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Rebiopsy
Description: Biopsy will be carry out with flexible bronchoscopy as usual practice under local anesthesia: under endobronchial ultrasound, punction under CT scan or ultrasonography, percutaneous pleural puncturing.
Study: NCT01262755

Intervention type: BEHAVIORAL
Intervention: Structured Interview
Description: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured.
Study: NCT04224428

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fexofenadine Pill
Description: fexofenadine tablets 60 mg once daily will be taken for six months

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo oral tablet
Description: lactose oral tablet
Study: NCT00199134

Intervention type: DRUG
Group type: OTHER
Intervention: Letrozole
Description: Size of the tumor is followed
Study: NCT02623049

Intervention type: OTHER
Intervention: New oral anticoagulant pharmacodynamic analysis (blood level assesment)

Intervention type: OTHER
Intervention: New oral anticoagulant pharmacodynamic analysis (blood level assesment)

Intervention type: OTHER
Intervention: New oral anticoagulant pharmacodynamic analysis (blood level assesment)

Intervention type: OTHER
Intervention: New oral anticoagulant pharmacodynamic analysis (blood level assesment)

Intervention type: OTHER
Intervention: New oral anticoagulant pharmacodynamic analysis (blood level assesment)

Intervention type: OTHER
Intervention: New oral anticoagulant pharmacodynamic analysis (blood level assesment)
Study: NCT03064438

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ACCU-D1
Description: ACCU-D1

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Vehicle
Description: Placebo Comparator
Study: NCT02709486

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tanezumab
Description: 2.5 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tanezumab
Description: 5 mg

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study: NCT03495401

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: fortified synbiotic milk
Description: 100 ml fortified (7,47 mg ferrous sulphate and 4,33 mg zinc acetate) synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides
Study: NCT03338348

Intervention type: DRUG
Group type: OTHER
Intervention: Vosaroxin
Description: Cycle 1-8: Dose Level 0: 70mg/m², Dose Level -1: 50mg/m², Dose Level -2: 40mg/m², IV over ten minutes, d 1+4 .

Intervention type: DRUG
Group type: OTHER
Intervention: Azacitidine
Description: Cycle 1-8 Azacitidine: 75 mg/m²/d subcutaneously, d 1-7;~Maintenance with single agent azacitidine at 75 mg/m²/d on days 1-7 until relapse or progression.
Study: NCT02790307

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: The Geko
Description: transcutaneous tibial nerve stimulation (stick on patch)

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: The Geko
Description: transcutaneous tibial nerve stimulation (stick on patch)
Study: NCT01900496

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Brentuximab vedotin
Description: Day 1 every three weeks (weeks 0, 3, 6, 9, ... 27): 1.8 mg/kg IV. Ten doses maximum.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Day 1 of weeks 12, 13, 14, 15, 18, 21, 24, and 27: 375 mg/m\^2 IV. Additional doses are given at three and six months post week 27.
Study: NCT03604341

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dronabinol 5mg Cap
Description: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects randomized to placebo and ibuprofen 800mg for pain
Study: NCT00901147

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: panobinostat and bortezomib
Description: oral panobinostat 30 mg 3 times per week AND intravenous bortezomib 1.3mg/m2 on days 1,4,8,11 per cycle
Study: NCT02810652

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Usual Care
Description: Usual Care participants will not meet with a geriatric clinician perioperatively, though they may receive a geriatric consult at their request or at the discretion of their treating cancer team.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Perioperative Geriatrics Intervention
Description: Patients randomized to the perioperative geriatrics intervention will undergo evaluation with a board-certified Massachusetts General Hospital (MGH) geriatric clinician, both pre- and post-operatively. The geriatric clinician visits will focus on the following issues: comorbidity, polypharmacy, nutrition, physical and mental function, and social support.
Study: NCT01234857

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ridaforolimus + dalotuzumab
Description: Ridaforolimus 20 mg once daily (QD) five days a week, with the possibility of escalation to 30 mg once daily (QD) after the first cycle and dalotuzumab intravenous infusion 10 mg/kg once weekly (QW). Treatment will continue until disease progression.
Study: NCT03495401

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: non-fortified synbiotic milk
Description: 100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides
Study: NCT01119638

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Escitalopram
Description: Patients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion.
Study: NCT01234857

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ridaforolimus + dalotuzumab
Description: Ridaforolimus 20 mg once daily (QD) five days a week, with the possibility of escalation to 30 mg once daily (QD) after the first cycle and dalotuzumab intravenous infusion 10 mg/kg once weekly (QW). Treatment will continue until disease progression.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: exemestane
Description: Exemestane 25 mg daily (QD). Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ridaforolimus
Description: Ridaforolimus 40 mg QD five days a week. Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval. Note: the Sponsor-recommended dose of ridaforolimus when administered as a single agent is 40 mg/day, but when given in combination with dalotuzumab, it is given at 30 mg/day.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dalotuzumab
Description: Dalotuzumab intravenous infusion 10 mg/kg QW. Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval.
Study: NCT02860845

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Boric acid and probiotics
Description: Vaginal capsules administered once a day during 7 days.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Antibiotic (Clindamycin)
Description: Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Antifungal (Clotrimazole)
Description: Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
Study: NCT03489616

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: rhGM-CSF
Description: rhGM-CSF is a stimulator of the growth and differentiation of hematopoietic progenitor cells committed to neutrophils, monocytes or eosinophils. rhGM-CSF can promote the maturation of dendritic cells and macrophage, increase their antigen presentation ability.
Study: NCT01815801

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Lungs were mechanically ventilated during subclavian vein catheterization
Description: Ventilated group
Study: NCT03489616

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pemetrexed
Description: Pemetrexed (brand name Alimta) is a chemotherapy drug manufactured and marketed by Eli Lilly and Company. Its indications are the treatment of pleural mesothelioma and non-small cell lung cancer.
Study: NCT02581878

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BAY1862864
Description: Radiopharmaceutical, injection: Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. In this dose-escalation part of the study, the radioactivity dose will start at 1.5 MBq and increase in steps of 1.5 MBq, with a antibody-chelator conjugate dose of 2 or 10 mg.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BAY1862864
Description: Radiopharmaceutical, injection: Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. In this dose-escalation part of the study, the radioactivity dose will start at 1.5 MBq and increase in steps of 1.5 MBq, with a antibody-chelator conjugate dose of 2 or 10 mg.
Study: NCT03489616

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Local Radiotherapy
Description: Radiotherapy promotes the release of tumor antigen

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Single agent
Description: Other chemotherapy drugs,such as Docetaxel, gemcitabine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Single agent
Description: Other chemotherapy drugs,such as Docetaxel, gemcitabine
Study: NCT03064958

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Herbs and spices
Description: Mix of commonly used herbs and spices

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Herbs and spices
Description: Mix of commonly used herbs and spices

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: High fat meal
Description: Meal containing 1000kcal and 45g fat

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: High fat meal
Description: Meal containing 1000kcal and 45g fat

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: High fat meal
Description: Meal containing 1000kcal and 45g fat
Study: NCT02581878

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BAY1862864
Description: Radiopharmaceutical, injection: Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. In this dose-escalation part of the study, the radioactivity dose will start at 1.5 MBq and increase in steps of 1.5 MBq, with a antibody-chelator conjugate dose of 2 or 10 mg.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BAY1862864
Description: Radiopharmaceutical, injection: Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. In this dose-escalation part of the study, the radioactivity dose will start at 1.5 MBq and increase in steps of 1.5 MBq, with a antibody-chelator conjugate dose of 2 or 10 mg.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BAY1862864
Description: Radiopharmaceutical, injection: Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. In this dose-escalation part of the study, the radioactivity dose will start at 1.5 MBq and increase in steps of 1.5 MBq, with a antibody-chelator conjugate dose of 2 or 10 mg.
Study: NCT02165618

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Medication review, based on but not limited to the RASP list
Description: Systematic approach:~1. Medication reconciliation~2. Applying the RASP list~3. Expert review (not based on the RASP list)~4. Multidisciplinary discussion
Study: NCT01119638

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Risperidone
Description: Patients in the risperidone group will receive 0.5 mgs/d for the first week and than 1.0 mg/d till completion.
Study: NCT02373904

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Photodynamic Bone Stabilization System
Description: Treatment of impending and actual pathological fractures of the humerus
Study: NCT00776789

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: skin to skin contact
Description: Infants randomized to SSC group were placed prone over the mother's chest immediately after birth. Skin-to-skin contact was continued for the next two hours. breastfeeding at the time of discharge.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Control group
Description: The infants who were allocated to the conventional care (control group) were kept by the mother's side and did not receive early SSC.
Study: NCT00736983

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: adalimumab
Description: 24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: ciprofloxacin
Description: 12 weeks; daily 2 x 500mg
Study: NCT02989181

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Continues Positive Airway Pressure (CPAP)
Description: Mask with positive airway pressure during exhalation which maintains the airway open
Study: NCT00109837

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: filgrastim
Description: As needed per physician discretion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cyclophosphamide
Description: Cyclophosphamide Consolidation: 650 mg/m2; IV; days 1, 15, 29 Post-consolidation course 3: 650 mg/m2; IV; day 1
Study: NCT01302925

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEP005 Gel
Description: PEP005 Gel 0.05% for 2 consecutive days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEP005 Gel
Description: PEP005 Gel 0.015% for 3 consecutive days
Study: NCT02205320

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: DRL_PG

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: DRL_PG

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: DRL_PG
Study: NCT04223700

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Ultrasound imaging & fluoroscopic confirmation
Description: The researchers use ultrasound to scan the left and right sides of the paravertebral sagittal imaging to identify trapezius, semispinalis, erector spinae muscle, transverse process and rhomboid muscle. The radiopaque marker is attached respectively to the skin of the inferior margin of the rhomboid muscle on the left and right thoracic spinal spines. Then, as the first step for the scheduled nerve block to the patient, thoracic vertebra level verification using C-arm is performed. At this time, left and right level of the transverse process of thoracic spine marked with the radiopaque marker are confirmed and recorded.
Study: NCT05414305

Intervention type: DRUG
Group type: OTHER
Intervention: Heparin & Alkalinized Lidocaine Bladder Instillation
Description: Bladder instillation instilled via catheter and to dwell for minimum of 30 minutes prior to spontaneous void
Study: NCT03420326

Intervention type: BEHAVIORAL
Intervention: Frailty status assessment
Description: The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status
Study: NCT00109837

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Description: Induction 2: 3 g/m2; IV over 3 hrs; days 1-5 Consolidation: 75 mg/m2/d; IV push; days 2-5 and 16-19 Post-consolidation course 3: 75 mg/m2/d; IV push; days 3-6 and 10-13

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: daunorubicin
Description: Induction: 60 mg/m2/d; IV; days 1, 2, and 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dexamethasone
Description: Induction 2: 0.1% QID; eye drops; days 1-6 Post consolidation course 2: 10 mg/m2/d; PO; days 1-28

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: doxorubicin
Description: Post consolidation: 25 mg/m2; IV; days 1, 8, 15, and 22

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: leucovorin
Description: For CNS during induction: 5 mg every 6 hrs for 4 doses; PO; days 1, 4, 8, 11, etx.; after methotrexate if WBC \< 3,000

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mercaptopurine
Description: Consolidation: 60 mg/m2; PO; days 1-28 Post-consolidation course 1: 60 mg/m2/d; PO; days 1-63 Post-consolidation course 4: 60 mg/m2/d; PO; daily for 2 yrs

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: methotrexate
Description: Consolidation: 12 mg; intrathecal or intraventricularly; days 2, 9, 16, and 23 Post-consolidation course 1: 20 mg/m2/wk; PO; days 1, 8 15, 22, 29, 36, 43, 50, 57 Post-consolidation course 4: 20 mg/m2; PO; weekly for 2 yrs
Study: NCT04138810

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: VCE
Description: Videoconference conducted according to a standard script which reviews the following key aspects of post-operative care: bowel functions, voiding functions, presence of vaginal bleeding, pain control, diet status, ambulatory status and any additional concerns. Standard post-operative instructions and precautions are reviewed as well.
Study: NCT00193219

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Description: 5 mg/kg IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cetuximab
Description: 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-fluorouracil
Description: 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin
Description: 350 mg IV
Study: NCT04138810

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Survey
Description: Measure of satisfaction regarding post-op visit.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Survey
Description: Measure of satisfaction regarding post-op visit.
Study: NCT01500577

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nimesulide
Description: Nimesulide 100 mg (capsules). 100mg/die every day for 1 year. Oral administration

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Simvastatin
Description: Simvastatin 20 mg (capsules). 20mg/die every day for 1 year. Oral administration

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo (capsules). 1 cps/die every day for 1 year. Oral administration
Study: NCT02008760

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Omega Krill with D3