AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT00549445 — intervention group
Intervention type: DRUG
Intervention: Placebo
Description: Daily
Study NCT00851786 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ZOSTAVAX
Description: Subcutaneous injection of 0.65 mL of ZOSTAVAX at Day 0 and Week 6
Study NCT00851786 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subcutaneous injection of 0.65 mL of placebo at Day 0 and Week 6
Study NCT01524146 — intervention group
Intervention type: PROCEDURE
Intervention: Photodynamic Therapy
Description: PDT is a therapeutic approach that specifically targets neoplastic cells.~• PDT involves three components:~1. Photofrin or a similar Photosensitizing agent that would be injected 3 days prior to laser activation of the agent.~2. Laser System - For laser energy delivery to activate the photosensitizing agent and induce tumor tissue necrosis~3. Optic Fiber - Delivery Fiber used along with the laser system to achieve Photoactivation of the photosensitizing agent.~Technique:~Subjects will be injected with Photofrin or similar drug. 3 days post injection, the subject will receive photodynamic therapy during an Endoscopic Retrograde cholangiopancreatography (ERCP) procedure. Subject will undergo stenting as part of standard of care procedure post photodynamic therapy.~Subject may undergo multiple photodynamic therapy sessions with a gap of at least 3 months.
Study NCT03963843 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Guided ICBT
Description: An 8-week internet- delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a spinal cord injury. In addition to the online program, a health educator with experience delivering ICBT will provide support by email once a week. The health educator will spend approximately 15 minutes per week/per client.
Study NCT03963843 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: SCI rehabilitation mental health education
Description: Participants will receive information provided to SCI patients in usual care at specialized SCI rehabilitation units (the Spinal Cord Injury Rehabilitation Evidence (SCIRE) Community handouts available at: https://scireproject.com/community/handouts/). The lessons will include information on spinal cord injury rehabilitation: 1)spinal cord injury basics, 2)mental health after SCI, 3)pain after SCI, 4)understanding rehabilitation 5)summary of lessons through an online platform over 8 weeks. A health educator will check in with participants once a week to answer any content related questions. The health educator will spend approximately 15 minutes per week/per client.
Study NCT02865655 — intervention group
Intervention type: PROCEDURE
Intervention: Hysteroscopic
Study NCT02987270 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dihydroartemisinin-piperaquine
Description: Dihydroartemisinin-piperaquine is an antimalarial in the artemisinin-based combination therapy class of drugs. It is the Kenya Ministry of Health second-line treatment for malaria in Kenya.
Study NCT00781833 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Radio Frequency Microstimulator
Description: Implantable peripheral muscle microstimulator, delivering controlled pulsatile stimulation to femoral nerves for knee extension and peroneal nerves for dorsiflexion.
Study NCT02663622 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Efprezimod alfa
Description: Acute GVHD prophylaxis
Study NCT02663622 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Acute GVHD prophylaxis
Study NCT02663622 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Methotrexate
Description: Acute GVHD prophylaxis
Study NCT02663622 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tacrolimus
Description: Acute GVHD prophylaxis
Study NCT02663622 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Tacrolimus
Description: Acute GVHD prophylaxis
Study NCT02663622 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 100 ml saline IV infusion.
Study NCT03020927 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Reciprocal Imitation Training (Therapist-Delivered)
Description: Naturalistic Developmental Behavioral Intervention aimed at improving social imitation skills.
Study NCT03020927 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Reciprocal Imitation Training (Therapist + Parent Delivered)
Description: Naturalistic Developmental Behavioral Intervention aimed at improving social imitation skills, using a combination of therapist-delivered intervention and parent training to deliver intervention in the home setting.
Study NCT01825967 — intervention group
Intervention type: OTHER
Intervention: C-reactive protein
Description: measured C-reactive protein in all patients with acute diverticulitis
Study NCT00653380 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxycycline Monohydrate
Description: Capsules, 100 mg, single-dose
Study NCT00653380 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Monodox
Description: Capsules, 100 mg, single-dose
Study NCT02112292 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tetrahydrocannabinol
Study NCT02112292 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cannabidiol
Study NCT02112292 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Study NCT04479202 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Berberine
Description: Patients in the intervention group received berberine daily, regardless of gastrointestinal symptoms.If the patient has a serious drug-related adverse event, the drug will be discontinued and the patient will be excluded from the study.
Study NCT04479202 — intervention group
Intervention type: DRUG
Group type: SHAM_COMPARATOR
Intervention: Montmorrillonite
Description: Patients in the control group were routinely not given special treatment.However, if the patient has diarrhea symptoms, montmorillonite powder should be given orally.
Study NCT00932321 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Norethindrone Acetate/Ethinyl Estradiol 24 Days
Description: One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets
Study NCT00932321 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Norethindrone Acetate /Ethinyl Estradiol 21 Days
Description: One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets
Study NCT01918956 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: PURETHAL Birch, 20.000 AUM/ml
Description: comparison of different up-dosing regimes
Study NCT01918956 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PURETHAL Birch, 20.000 AUM/ml
Description: comparison of different up-dosing regimes
Study NCT02727348 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Spinal anaesthesia
Description: Spinal anaesthesia with up to 3mls of 0.5% bupivacaine
Study NCT03042234 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Group Insulin-Resistant
Description: High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
Study NCT00559247 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BMS-650032 or Placebo
Description: Oral, Once daily, Single Dose
Study NCT02606331 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Piezosurgery
Description: Corticotomy cuts will be performed by this technique.
Study NCT03042234 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Group Insulin-Sensitive
Description: High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
Study NCT03460587 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Telerehabilitation
Description: The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.
Study NCT02606331 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: ER:YAG laser
Description: Corticotomy cuts will be performed by this technique.
Study NCT02775916 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CDZ173
Study NCT02775916 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study NCT00163020 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 17-alpha-hydroxyprogesterone caproate injectable
Description: 250mg of 17-alpha-hydroxyprogesterone caproate (+ preservatives) injectable weekly starting as early as 19wks gestation until 34.0wks gestation of delivery which ever comes first.
Study NCT00163020 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Weekly doses of placebo (NS + preservatives) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first.
Study NCT02814175 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: methotrexate (MTX)
Study NCT02814175 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: methotrexate (MTX)
Study NCT02814175 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: adalimumab (ADA)
Study NCT02814175 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: adalimumab (ADA)
Study NCT02501499 — intervention group
Intervention type: OTHER
Intervention: Breastfeeding Buddies
Description: a 2 hour breastfeeding workshop and if mother chooses, she is matched with a buddy who will contact her and offer breastfeeding support
Study NCT03556709 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Treadmill Ankle Robot Training
Description: This intervention employs the use of an adaptive ankle robot control system, during treadmill walking, over a 6-week intervention period.
Study NCT01286740 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FTC/RPV/TDF
Description: Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily
Study NCT05456971 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Art Filler Volume
Description: Midface correction with injectable hyaluronic acid based-filler
Study NCT05456971 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Art Filler Lips
Description: Lipscorrection with injectable hyaluronic acid based-filler
Study NCT00952341 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: aprepitant
Description: Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Study NCT00952341 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Comparator: Placebo to aprepitant
Description: Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Study NCT00952341 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: dexamethasone
Description: Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Study NCT00952341 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: granisetron
Description: Day 1: IV granisetron 3 mg prior to administration of cisplatin
Study NCT00952341 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: granisetron
Description: Day 1: IV granisetron 3 mg prior to administration of cisplatin
Study NCT00952341 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dexamethasone
Description: Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg
Study NCT00024089 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gefitinib
Study NCT01467076 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Aerosolized Normal Saline
Description: Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 \[150\], IPGE1 \[300\], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. Placebo will be administered over a maximum duration of 72 hours.
Study NCT01467076 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Inhaled PGE1
Description: Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 \[150\], IPGE1 \[300\], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours to determine the optimal dose and duration of therapy.
Study NCT01271361 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: primary PCI with thrombectomy
Description: thrombectomy is performed before implantation of a drug eluting stent
Study NCT01271361 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: primary PCI without thrombectomy
Description: no thrombectomy is performed before the implantation of a drug eluting stent
Study NCT02749253 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Sudarshan Kriya Yoga Tauma Relief Program (SKY).
Description: Sudarshan Kriya Yoga Trauma Relief Program (SKY) participants will undergo a 12-week training course in SKY conducted by certified instructors from the Art of Living Foundation
Study NCT04148794 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: echo-assisted advanced life support
Description: Integrated point-of-care ultrasound skill in to the setting of resuscitation, and critical condition patients.~Educate the participants to use these protocols and monitoring if there were improvement of patient's outcomes
Study NCT00990184 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Colesevelam
Description: colesevelam HCl 3.75 g once daily orally with the evening meal
Study NCT00990184 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: placebo
Description: tablet (s) orally given with evening meal
Study NCT02231619 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Baseline verbal instruction on LSUPT
Study NCT04149561 — intervention group
Intervention type: OTHER
Intervention: communication skill measurement with self report questionnaire
Description: Demographic information form, Communication Function Classification System, Functional Communication Classification System, The Gross Motor Function Classification System and Manual Ability Classification System will be filled in for the patients.
Study NCT03284840 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Assessement of nutritional status
Description: Nutritional status for vitamin D, folic acid, vitamin B12 and iron.
Study NCT03284840 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Thyroid size
Description: Thyroid size by ultrasound.
Study NCT02705885 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: lozenges containing IgY
Description: Patients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy
Study NCT02705885 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo IgY
Description: Placebo IgY
Study NCT02363153 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Diet and Exercise
Description: Exercise will consist of 2x/week aerobic exercise, 2x/week strength training and 1x/week core-stabilizing exercise.~Diet will be constructed so that 30% of the daily caloric goal will be protein, 35% fat, and 35% carbohydrates.
Study NCT03233997 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: FT21018
Description: An electronic cigarette
Study NCT03233997 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: FT21033
Description: An electronic cigarette
Study NCT03233997 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: FT21034
Description: An electronic cigarette
Study NCT03233997 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: FT21035
Description: An electronic cigarette
Study NCT02270112 — intervention group
Intervention type: DEVICE
Intervention: ECG
Description: Patients receive a 5 Minute ECG recording and have their pulse recorded by an iPhone.
Study NCT01740024 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 1 (Dose Response Skin Prick Tests)
Description: 3 different cat epithelium allergenic extracts at 3 different concentrations, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
Study NCT01429701 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: polymyxin B sulphate + prednisolone + benzocaine + clioquinol
Description: applied 3 times / day at lesion
Study NCT01429701 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: betamethasone + gentamicin + tolnaftato + cleoquinol
Description: applied 3 times / day at lesion
Study NCT01989247 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Self-management programme
Description: Seven weekly group-based sessions for people with anxiety and depressive symptoms
Study NCT03161106 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Nutrition
Description: Nutrional group-30 kcal/kg with 1.5 grm protein with protein supplements
Study NCT03161106 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lactulose
Description: Lactulose plus diet consumed by patient
Study NCT03161106 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Diet
Description: Protein Powder 15 to 20 gm/meal/day
Study NCT02745808 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HUC-MSCs
Description: The subjects will receive intracavernous injection of HUCMSC.
Study NCT02745808 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Injectable Collagen Scaffold + HUC-MSCs
Description: The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.
Study NCT01806909 — intervention group
Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: Ad4-H5-Vtn
Study NCT01277874 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Nasal CPAP
Description: NCPAP is delivered via nasal prongs placed into infant's nares. It may be delivered via ventilator or by bubble.
Study NCT01277874 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Oscillatory NCPAP
Description: Bird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations.
Study NCT02184858 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lisinopril, ACE-inhibitor
Description: Lisinopril 0.1mg/kg/d, titration with + 0.1mg/kg/d. Max; daily dose: 0.4mg/kg. CAVE: dose reduction in case of renal impairment
Study NCT01865448 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Omega-3 DHA
Description: Patients take daily 2 tablets of Docosahexaenoic Acid
Study NCT01865448 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Patients in control group take daily 2 placebo capsule
Study NCT01822418 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: agomelatine
Description: Augmentation of antipsychotic therapy with 25 to 50 mg agomelatine as a single oral dosage per day
Study NCT02625844 — intervention group
Intervention type: OTHER
Intervention: No intervention
Description: No intervention administered in this study.
Study NCT00952081 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Clevidipine
Description: Clevidipine (0.5 mg/ml in 20 % lipid solution) will be administered via peripheral vein using syringe pump; drug infusion will be initiated at 5 mg/hr (10ml/h) and titrated to effect up to a maximum rate of 32 mg/hr when SBP exceeds 130 mm Hg. The anesthesiologist will be allowed to administer the alternative antihypertensive treatment (e.g. labetalol, hydralazine) after achieving a maximum clevidipine infusion rate.
Study NCT04077853 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 17 Hydroxyprogesterone Capronate
Description: Intramuscular injection 250 mg
Study NCT02291419 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ticagrelor
Description: ticagrelor 90 mg bid
Study NCT02291419 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: aspirin
Description: aspirin 81 mg daily
Study NCT04427020 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Milk protein + GBI-30
Description: Both conditions matched flavor, color, and serving size
Study NCT04427020 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Milk protein
Description: Both conditions matched flavor, color, and serving size
Study NCT01347931 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Standard Oxygen Cannula
Description: Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder
Study NCT01874080 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Saxagliptin/Metformin
Study NCT05257291 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Melatonin
Description: Supplementation with 1 mg/day of melatonin for 1 year