AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT01516255 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: moxifloxacin
Description: Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where a single dose of 400 mg moxifloxacin (tablets) is administered as positive control
Study NCT01516255 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where single dose of oral placebo is administered
Study NCT01516255 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: electrocardiogram (ECG)
Description: 24 hours serial ECG is collected before initial dose of 0.6 mg liraglutide, on the last dosing day of 1.2 mg liraglutide and on the last dosing day of 1.8 mg liraglutide
Study NCT01516255 — intervention group
Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: electrocardiogram (ECG)
Description: 24 hours serial ECG is collected before initial dose of 0.6 mg liraglutide, on the last dosing day of 1.2 mg liraglutide and on the last dosing day of 1.8 mg liraglutide
Study NCT01516255 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: electrocardiogram (ECG)
Description: Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected
Study NCT01516255 — intervention group
Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: electrocardiogram (ECG)
Description: Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected
Study NCT03915847 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Single layer closure
Description: Uterine incision will be approximated with continuous unlocked suture, including a narrow band of the endometrial layer, without trimming incision edges.
Study NCT03915847 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Double layer closure
Description: The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.
Study NCT03915847 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Doble layer closure with trimming
Description: Uterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.
Study NCT02381093 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Modified BLS course
Description: BLS using CI
Study NCT02381093 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard BLS Course
Description: Usual BLS teaching
Study NCT01502683 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: No aortic clamping
Description: No aortic clamp used in this group. The aortic clamp is a standard cardiac surgical instrument used during cardiac operations, not a specific device used for this study.
Study NCT01502683 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: partial occluding clamp
Description: The partial-occluding clamp is a standardized instrument used during coronary artery bypass surgery, it is not a specific device for this study.
Study NCT01502683 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: single cross clamp
Description: The proximal anastomoses performed under single clamp is an alternative method during coronary artery bypass surgery. The single clamp essentially means that whole operation is done using the cross clamp, which is a standard instrument during cardiac operations, not a specific device for this study.
Study NCT01502683 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: cross clamp and partial occluding clamp
Description: Both an aortic cross clamp and partial occluding clamp are used in this arm. Neither the cross clamp nor the partial clamp are specific devices for this study but are standard cardiac surgical instruments used during coronary artery bypass surgery and cardiac surgery.
Study NCT03581604 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Allergy work-up
Description: Allergy work-up
Study NCT03581604 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Blood samples
Description: Blood samples
Study NCT03468062 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine
Description: Patients assigned in Dexmedetomidine or Placebo group are given Dexmedetomidine or normal saline after induction of anesthesia.
Study NCT03468062 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Dexmedetomidine
Description: Patients assigned in Dexmedetomidine or Placebo group are given Dexmedetomidine or normal saline after induction of anesthesia.
Study NCT00666900 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Low Strength IDP-107
Description: Once a day for 12 weeks
Study NCT00666900 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: High Strength IDP-107
Description: Once a day for 12 weeks
Study NCT00666900 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Comparator
Description: Once a day for 12 weeks
Study NCT02976077 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: RC2S+
Description: new cognitive remediation program
Study NCT02976077 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: active comparator
Description: cognitive remediation program
Study NCT00601263 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Anti-Asthma Herbal Medical Intervention (ASHMI)
Description: We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days.
Study NCT00601263 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Anti-Asthma Herbal Medical Intervention (ASHMI)
Description: We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days.
Study NCT00623259 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MVA-mBN120B
Study NCT02244970 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Mindfulness
Description: Mindfulness is the awareness that emerges from paying attention to the present moment without judgment. In this study, subject in this arm will receive 7 weeks of MBI with a focus on tackling anxiety, depressed mood, and attention deficits among early psychosis participants. The elements of 7-week program included mindful-breathing, indoor and outdoor mindful-walking, mindful-eating, mindul-drawing, tree-of-life exercise and closing celebration.
Study NCT02244970 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Psychoeducation
Description: Participants in the psychoeducation group will receive seven weeks of psychoeducation sessions which include basic knowledge related to 1) General mental health, 2) Knowledge of psychosis, 3) Treatment and community resources, 4) Recovery and relapse prevention, 5) Healthy lifestyle, 6) Social skills training, and finally a closing celebration at week 7.
Study NCT03134677 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bupivacaine
Description: 2 ml of hyperbaric bupivacaine (0.5%) was given intrathecally to patients in a sitting position by midline attempt between the L3 and L4 intervertebral space.ECG recordings were performed at preoperative, 5, 15, and 30 minutes after initial anesthesia and 30 minutes post-operatively.
Study NCT03134677 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sevoflurane
Description: General anesthesia was maintained with 2-3% sevoflurane. ECG recordings were performed at preoperative, 5, 15, and 30 minutes after initial anesthesia and 30 minutes post-operatively.
Study NCT01423591 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: infliximab
Description: Infliximab 5 mg/kg. i.v. at week 0, 2, 6, 14 y 22.
Study NCT01423591 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: inactive powder
Description: Inactive powder. i.v. at week 0, 2, 6, 14 y 22.
Study NCT01549704 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Ropivacaine
Description: Arm RP is receiving 30 ml of ropivacaine 7,5 mg/ml at first blockade (ACB) and after 45 minutes another blockade (ACB) with placebo (saline 30 ml).~Arm PR is receiving 30 ml of placebo (saline) at first blockade (ACB) and after 45 minutes another blockade (ACB)with ropivacaine.
Study NCT01549704 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Saline
Description: please see intervention description for ropivacaine
Study NCT01363570 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Ranibizumab
Description: Intra-vitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2. For those requiring additional injections, patients will receive monthly treatment up to a maximum of 6 months total.
Study NCT01805453 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Losartan
Description: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide ) + Losartan or placebo (Arm A or B) 50mg\*2/day until the halting for any reason
Study NCT01805453 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason
Study NCT00140010 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: erythropoietin beta
Description: 30,000 units in 6 mL of 0.9% saline IV for 15 minutes every other day for 3 doses within 72 hours after aneurysmal subarachnoid hemorrhage
Study NCT01824927 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: First eye (FE)
Description: Phacoemulsification cataract extraction surgery
Study NCT01824927 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: First eye (FE)
Description: Phacoemulsification cataract extraction surgery
Study NCT01824927 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Second eye (SE)
Description: Phacoemulsification cataract extraction surgery
Study NCT01824927 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Second eye (SE)
Description: Phacoemulsification cataract extraction surgery
Study NCT01824927 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Steroids eye drops
Description: Use steroids eye drops to decrease the pain.
Study NCT00357110 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fulvestrant
Description: intramuscular injection
Study NCT00357110 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Anastrozole
Description: 1 mg oral tablet
Study NCT00357110 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Anastrozole
Description: 1 mg oral tablet
Study NCT02239874 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Vitamin D and fish oil placebo
Description: Vitamin D3 (cholecalciferol), 2000 IU per day and fish oil placebo
Study NCT02239874 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Fish oil and vitamin D placebo
Description: 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])
Study NCT02239874 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Vitamin D placebo and fish oil placebo
Description: placebo
Study NCT02239874 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Vitamin D and fish oil
Description: Vitamin D3 (cholecalciferol), 2000 IU per day and 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])
Study NCT02388126 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: 3T multiparametric MRI
Description: Magnetom Verio 3T, Erlangen, Germany
Study NCT02388126 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Transrectal ultrasound
Description: Bk Medical Pro Focus Ultraview 2202 system
Study NCT00961467 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Revlimid, Melphalan, Prednisone, Thalidomide
Description: Thalidomide was administered at 50 mg/day.
Study NCT00961467 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Revlimid, Melphalan, Prednisone, Thalidomide
Description: Thalidomide was administered at 100 mg/day.
Study NCT03312023 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]
Description: 1 pill once daily for 12 weeks for Group A
Study NCT03312023 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sofosbuvir 400 MG [Sovaldi]
Description: 1 pill once daily for 12 weeks for Group C
Study NCT03312023 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ledipasvir 90 MG
Description: 1 pill once daily for 12 weeks for Group D
Study NCT04393194 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vaginal Cream with Applicator [Dose Form]
Description: Patients with symptomatic POP will be assigned as outpatients. After the initial pessary fitting, the patients will be followed up in 2 weeks. If the prolapse is supported, no discomfort, and the patient decides to continue to use the pessary, the pessary fitting is successful. Patients with successful ring pessary fitting, who agree to participate and sign written consent, will be randomized into the vaginal estrogen group and the placebo group. The patients will be followed up every 3 months after wearing pessary combined with vaginal medication, until 1 year after wearing the pessary.
Study NCT04393194 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Vaginal Cream with Applicator [Dose Form]
Description: Patients with symptomatic POP will be assigned as outpatients. After the initial pessary fitting, the patients will be followed up in 2 weeks. If the prolapse is supported, no discomfort, and the patient decides to continue to use the pessary, the pessary fitting is successful. Patients with successful ring pessary fitting, who agree to participate and sign written consent, will be randomized into the vaginal estrogen group and the placebo group. The patients will be followed up every 3 months after wearing pessary combined with vaginal medication, until 1 year after wearing the pessary.
Study NCT03011567 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Acetaminophen
Description: Participants will receive acetaminophen for postpartum mild pain relief
Study NCT03011567 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ibuprofen
Description: Participants will receive ibuprofen for postpartum mild pain relief
Study NCT02897050 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Docetaxel
Description: Docetaxel 75mg/m2, iv, d1 or 100mg/m2, iv, d1
Study NCT02897050 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: Docetaxel 75mg/m2, iv, d1 or 100mg/m2, iv, d1
Study NCT02897050 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capecitabine
Description: Capecitabine 1200mg/m2/d, po, d1-d21
Study NCT02897050 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide (tablet)
Description: Cyclophosphamide 50 mg/d, po, d1-d21
Study NCT02897050 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fluorouracil
Description: Fluorouracil 500mg/m2, iv, d1
Study NCT02897050 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fluorouracil
Description: Fluorouracil 500mg/m2, iv, d1
Study NCT02897050 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Epirubicin
Description: Epirubicin 100mg/m2, iv, d1
Study NCT02897050 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Epirubicin
Description: Epirubicin 100mg/m2, iv, d1
Study NCT02897050 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclophosphamide (injection)
Description: Cyclophosphamide 500mg/m2, iv, d1
Study NCT02897050 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide (injection)
Description: Cyclophosphamide 500mg/m2, iv, d1
Study NCT02274805 — intervention group
Intervention type: PROCEDURE
Intervention: Adults presenting for surgery in the neck area
Study NCT03916679 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: anti-MESO CAR-T cells
Description: Retroviral vector-transduced autologous T cells to express anti-MESO CARs
Study NCT01478997 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Flexsure Capsules
Description: Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days
Study NCT01478997 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Capsules
Description: Carboxy Methyl Cellulose
Study NCT03473600 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Cryotherapy
Description: Liquid Nitrogen spray
Study NCT03473600 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Triamcinolone acetonide injection
Description: Intralesional Triamcinolone Acetonide injection
Study NCT04215484 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: serum BNP assessment
Description: serum BNP assessment in pregnant women with placenta previa, associated or not to a suspected abnormal placental invasion, compared to a control group
Study NCT02420951 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bupivacaine
Description: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
Study NCT02420951 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: No Intervention
Description: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
Study NCT04317391 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Pain management program
Description: Mindfulness based stress reduction
Study NCT04110925 — intervention group
Intervention type: GENETIC
Group type: OTHER
Intervention: Genetic Mutations
Description: DNA sequencing for mutations to be obtained by bloodwork within 6 months of diagnosis, or by accessing diagnostic bone marrow aspirate slides.
Study NCT04110925 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Inflammatory and lipid markers
Description: Bloodwork to be done for lipid profile, c-reactive protein (CRP), and multiplex chemokine/cytokine analysis.
Study NCT04110925 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Computed Tomography (CT) of the heart
Description: Sunnybrook Patients with no history of cardiovascular disease \[ex: past/present coronary artery disease (CAD), peripheral vascular disease (PVD), angina, myocardial infarction (MI), stroke, transient ischemic attack (TIA), or stents\], not pregnant, and able to undergo CT will receive a CT of the heart to look for and quantify any occult coronary artery disease.
Study NCT04004156 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PerQdisc® Nucleus Replacement Device.
Description: All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
Study NCT01531673 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VX-661
Study NCT04130789 — intervention group
Intervention type: OTHER
Intervention: compare data patterns by data-driven algorithms to determine sepsis
Description: compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to reliably determine sepsis
Study NCT04130789 — intervention group
Intervention type: OTHER
Intervention: compare data patterns by data-driven algorithms to predict sepsis-related mortality
Description: compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to to predict sepsis-related mortality
Study NCT03801161 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pentavalent vaccine. It is a combination of five different antigens (Hepatitis B (HBV)/ Haemophilus influenzae type b (HiB) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)).
Description: Pentavalent vaccine is being recommended to provide infants at 6wk, 10wk and 14wk of age. This vaccine also induces plasma CRP >5 mg/L in infants within 24 hours of immunization.
Study NCT01699607 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amphetamine
Description: All subjects will receive amphetamine to induce elevated dopamine levels in the brain at 0.5mg/kg
Study NCT01855724 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine-Pazopanib
Study NCT03942523 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Behavior Change Communication to promote hygiene behavior
Description: Behavior Change Communication sessions will be used to promote knowledge and practices among young children and to prevent communicable diseases.~This will include, capacity building of teachers and students, health awareness sessions at the school and improving school physical environment
Study NCT01157390 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Infant formula
Description: Name: Infant formula with high proportion of palmitic acid in the sn-2 position Dosage \& frequency: Fed as need Duration: at least 3 months
Study NCT01157390 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Breast feeding
Description: Breast feeding
Study NCT01628081 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Alga Dunaliella Bardawil placebo
Description: Dosage Regimen and Treatment Groups~* Daily oral administration of:~* Dunaliella, 6 capsules/day (3 capsules in the morning, 3 in the evening).~* Placebo, 6 capsules/day (3 capsules in the morning, 3 in the evening).