AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT00611884 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec
Description: Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily
Study NCT00611884 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec
Description: Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily
Study NCT00611884 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec
Description: Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly
Study NCT00611884 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: metformin
Description: Tablets, 1500-2000 mg/day
Study NCT00611884 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: metformin
Description: Tablets, 1500-2000 mg/day
Study NCT01046578 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: 20 mg, one tablet a day for one day, starting on the day the dominant follicle reaches 12 mm in diameter
Study NCT01046578 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: 20 mg, one tablet a day for one day, starting on the day the dominant follicle reaches 18 mm in diameter
Study NCT01046578 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: 20 mg, one tablet a day for one day, starting 24-48 hours after ovulation of the dominant follicle is observed
Study NCT01046578 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: 2.5 mg, one tablet a day for five days, starting 24-48 hours after ovulation of the dominant follicle is observed
Study NCT01046578 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: 2.5 mg, one tablet a day for five days, starting on the day the dominant follicle reaches 18 mm in diameter
Study NCT04531787 — intervention group
Intervention type: DRUG
Intervention: Influenza vaccine
Description: influenza vaccine 0.5 ml intramuscularly each season: 2004-2005, 2005-2006, 2006-2007, 2007-2008 for season specific A/H1N1, A/H3N2, and B antigens
Study NCT02910414 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dehydrated alcohol
Description: Dehydrated Alcohol Injection, USP is used in the study.
Study NCT02910414 — intervention group
Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Peregrine System Kit (Sham Procedure)
Description: Pre-procedural diagnostic renal angiography only, performed for confirmation of anatomical eligibility prior to randomization
Study NCT04191824 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: APOL1 status
Description: Participants will be randomized to immediate versus delayed return of results for positive or negative APOL1 status.
Study NCT01301924 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Meglumine antimoniate
Description: Meglumine antimoniate is stored and ministered under actual conditions employed by health services in Brazil. Each patient will be included in one of the treatment groups with meglumine antimoniate IM:~High dose: 20 days of 20 mg/kg/day antimoniate meglumine. Low dose: 30 days of 5 mg/kg/day antimoniate meglumine.
Study NCT01301924 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meglumine antimoniate
Description: Meglumine antimoniate is stored and ministered under actual conditions employed by health services in Brazil. Each patient will be included in one of the treatment groups with meglumine antimoniate IM:~High dose: 20 days of 20 mg/kg/day antimoniate meglumine. Low dose: 30 days of 5 mg/kg/day antimoniate meglumine.
Study NCT02443324 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ramucirumab
Description: Administered IV
Study NCT02443324 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: Administered IV
Study NCT05006495 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: C3 laminectomy
Description: C3 laminectomy preserving semispinalis cervicis inserted into the axis.
Study NCT02889341 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: DHA
Study NCT05006495 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: C3 laminoplasty
Description: Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.
Study NCT02889341 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study NCT02646917 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Aesthetic Microneedling Treatment
Description: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring.
Study NCT01656681 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: THIAA
Description: A tablet containing 400 mg tetrahydro iso-alpha acids, 3 times a day
Study NCT01656681 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: Placebo tablet
Study NCT03568799 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: 18F-(2S,4R)4-fluoroglutamine
Description: Undergo 18F-(2S,4R)4-fluoroglutamine PET/CT
Study NCT01709266 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Probiotics
Study NCT01709266 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study NCT00347555 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Aluminum Phosphate
Description: 1.0 mg/mL (0.5 mg/0.5 mL per dose) aluminum as aluminum phosphate adjuvant; dosage 500 micrograms.
Study NCT01652976 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dasatinib
Description: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle
Study NCT01652976 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mFOLFOX6
Description: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
Study NCT03030326 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: heart rate variability biofeedback
Description: Patients learn to increase heart rate variability by breathing at the resonance frequency of the cardiovascular system, at approximately 6 breaths/min, varying among people.
Study NCT01611207 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Negative Pressure Wound Therapy
Description: KCI. V.A.C. Freedom; Acti V.A.C.; INFO V.A.C. to be used with the V.A.C. Granufoam (black), V.A.C. Granufoam Silver and V.A.C. WhiteFoam Smith \& Nephew: Renasys GO and Renasys EZ Plus to be used with the Renassys-F/P and Renassys-G Use of the medical devices and applicable consumption items according to manufacturers guidelines and FDA regulations.
Study NCT01611207 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard Wound Therapy
Description: Standard wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)
Study NCT00444821 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: AneuRx AAA stent graft / Talent AAA stent graft
Description: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Study NCT02483338 — intervention group
Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Assessment of pain
Description: Assessment of pain using FASS but without using this score to manage pain
Study NCT01562626 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: APS001F
Description: APS001F infusion on Days 1,2,3 of each 28 day cycle.
Study NCT01562626 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Flucytosine (5-FC)
Description: oral doses on Days 11-15 and 18-22, each 28 day cycle
Study NCT01562626 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 10% maltose
Description: 10% maltose infusion will be administered on Days 1-5, 8-12, and 15-19, each 28 day cycle.
Study NCT03550534 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Calcium Carbonate
Description: Calcium carbonate was obtained from Pharmacy Department, Faculty of Medicine, University of Indonesia. Subjects were randomized to receive calcium carbonate or placebo for 12 weeks.
Study NCT03550534 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo oral capsule
Description: Placebo oral capsule was also obtained from Pharmacy Department, Faculty of Medicine, University of Indonesia. Subjects were randomized to receive calcium carbonate or placebo for 12 weeks.
Study NCT00206102 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: quetiapine fumarate
Description: flexible dose oral
Study NCT00206102 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: risperidone
Description: flexible dose oral
Study NCT00906373 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg)
Description: intravenous infusions 10 mg/kg on Day 1 of each 3-week cycle
Study NCT00906373 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: IMC-A12 (cixutumumab) - 20 mg/kg
Description: intravenous infusions 20 mg/kg on Day 1 of each 3-week cycle
Study NCT00906373 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sorafenib
Description: 400 milligrams (mg) twice per day orally
Study NCT01645917 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Arctic Front Advance Cardiac CryoAblation system
Description: Standard of care ablation for indicated paroxysmal AF patients with Medtronic's Arctic Front Advance Cardiac CryoAblation system
Study NCT03434769 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Cyclophosphamide 60mg/Kg on day -6
Study NCT03434769 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Fludarabine 25mg/m\^2 IV on days -5 to -3
Study NCT03434769 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CAR-T Cells
Description: Chimeric antigen receptor T cells to be implemented in a 3 + 3 design on day 0~Level -1 (1 x 105 cells/kg)~Level 1 \[Starting dose\] (5 x 105 cells/kg)~Level 2 (1 x 106 cells/kg)~Level 3 (2 x 106 cells/kg)
Study NCT03990480 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: valsartan (160 mg/d)
Description: Group I treated with valsartan (160 mg/d, n = 100)
Study NCT03990480 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: amlodipine (10 mg/d).
Description: Group II amlodipine (10 mg/d, n = 100).
Study NCT02377180 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Intramuscular capsaicin injection
Description: Intramuscular injection of capsaicin: 50 mcg/0.5 ml
Study NCT02377180 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Suprascapular nerve block
Description: Injection of capsaicin 50 mcg/0.5 ml into the supraspinatus or trapezius muscle in randomized order, followed by suprascapular nerve block (ultrasound-guided) using Lidocaine 1%; nerve block is expected to be effective only in pain arising from the supraspinatus muscle. Trapezius pain serves as control condition.~Evaluates the diagnostic validity of suprascapular nerve block for muscle pain.
Study NCT02377180 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Local anesthetic infiltration
Description: Injection of capsaicin 50 mcg/0.5 ml into the supraspinatus muscle in two different sessions; suprascapular nerve block in one session and intramuscular local anesthetic infiltration in one session (in randomized order) using Lidocaine 1%; the aim is to investigate which procedure provides faster and more efficient pain relief. Compares effectivity of suprascapular nerve block vs. intramuscular local anesthetic infiltration.
Study NCT01810250 — intervention group
Intervention type: DEVICE
Intervention: Endurant Stent Graft
Study NCT02251613 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Olopatadine HCl ophthalmic solution, 0.1%
Study NCT02251613 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Epinastine HCl ophthalmic solution, 0.05%
Study NCT02940561 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate - Amneal
Description: Methotrexate Tablets, USP contain an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate, USP and are round, biconvex, yellow tablets, scored in half on one side, engraved with A above the score and 1 below
Study NCT02503722 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies
Study NCT02940561 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methotrexate - DAVA
Description: Methotrexate Tablets, USP contain an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate and are round, convex, yellow tablets, scored in half on one side, engraved with M above the score, and 1 below
Study NCT02503722 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Osimertinib
Description: Given PO
Study NCT02503722 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pharmacological Study
Description: Correlative studies
Study NCT02503722 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sapanisertib
Description: Given PO
Study NCT01173744 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Gamma-3 Nail
Description: Gamma-3 Nail (stryker)
Study NCT01173744 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: DHS
Description: DHS (Zimmer)
Study NCT02881827 — intervention group
Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Low level laser therapy
Description: Supported by the physical phenomenon of stimulated emission postulated by Albert Einstein in 1916 the laser (light amplification by Stimulated Emission of Radiation) is a device consisting of solid source materials, liquid or gas that produces beams of light when excited by a source of energy. This bright feature is a particular type of electromagnetic radiation, which differs from that emitted by conventional incandescent sources. These are the effects attributable to LLLT analgesic, anti-inflammatory and biostimulates and has been widely used due to low power densities and wavelengths with a penetration capacity in tissues without the generation of photothermal effects, which makes its feasible use multiple applications in Health area.
Study NCT04172948 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Oculus go headset/virtual reality headset
Description: 10 minute virtual reality tutorial on diaphragmatic breathing, a game in practicing diaphragmatic breathing, and two scenarios in which the patient can also practice diaphragmatic breathing.
Study NCT04172948 — intervention group
Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Diaphragmatic breathing
Description: 10 minute tutorial on diaphragmatic breathing by a medical professional.
Study NCT04172948 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Diaphragmatic breathing
Description: 10 minute tutorial on diaphragmatic breathing by a medical professional.
Study NCT00347555 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 0.5 mL normal saline placebo. Sodium phosphate buffer (10 mM sodium phosphate and 150 mM sodium chloride).
Study NCT00347555 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: EBA-175 RII-NG Malaria Vaccine
Description: White, translucent, cloudy, nonparticulate liquid suspension. Recombinant Plasmodium falciparum erythrocyte-binding antigen 175 kDa Region II-nonglycosylated (EBA-175 RII-NG) absorbed to aluminum phosphate adjuvant; dosage levels 5, 20, 80, and 160 micrograms.
Study NCT03017248 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketamine
Description: ketamine
Study NCT02881827 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Simulation of treatment with the device switched off
Study NCT03017248 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebos
Description: 0.9% normal saline
Study NCT03017248 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Morphine
Description: Morphine
Study NCT03017248 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Morphine
Description: Morphine
Study NCT00366548 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
Study NCT00366548 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: 13 valent pneumococcal conjugate vaccine without Polysorbate 80
Study NCT02797704 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aflibercept
Description: Eylea (aflibercept) Injection is a prescription medicine administered by injection into the eye.
Study NCT02881827 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Control
Description: A scientific control group allows the experimental study of a variable at a time, and is a vital part of the scientific method. In a controlled experiment, two identical experiments are conducted. In one, the treatment - tested factor - is applied. In another - control - the tested factor is not applied.~For example, when testing a drug, it is important to carefully check the suspected drug effects are produced by the drug. Doctors can it with a double-blind study in a clinical trial: two (statistically) identical groups of patients are compared, one gets the drug and the other receives a placebo. Neither subjects nor investigators know which group receives the actual drug, which serves to prevent bias and isolating effects of such drugs.
Study NCT00952237 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GM-CSF
Description: GM-CSF (Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor) The dose and duration of GM-CSF (7.5 mcg/kg/day) was selected. If used alone, this dose and duration would result in effective mobilization. GM-CSF will be started on Day #7 and will continue until completion of leukapheresis.~G-CSF will be started (5mcg/kg/d) on Day #7 and will be given each morning. G-CSF will continue until completion of leukapheresis.
Study NCT00952237 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IL-2
Description: IL-2 dose escalation: IL-2 will be administered as a single daily subcutaneous injection each evening until completion of leukapheresis.~Escalation of the dose of IL-2 will be performed using the below schema with the following levels. Patients will be started on Level 1. (Level 0 is included since, if toxicity is meet in Level 1, the dose will be decreased to Level 0).~Level 0 - 3 x 105 i.u./m2/day for 11 days Level 1 - 6 x 105 i.u./m2/day for 11 days Level 2 - 1 x 106 i.u. /m2/day for 11 days as above Level 3 - 1.5 x 106 i.u. /m2/day for 11 days as above Level 4 - 2 x 106 i.u. /m2/day for 11 days as above
Study NCT02742896 — intervention group
Intervention type: OTHER
Intervention: Erectile dysfunction
Description: The changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm.~The changes of cognitive function by using validated assessment form-The Montreal Cognitive assessment (MoCA) 1 year after conversion to sinus rhythm.
Study NCT03425630 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Argicolina
Description: 8 weeks
Study NCT03157154 — intervention group
Intervention type: OTHER
Intervention: Non interventional study
Description: A query form to all concerned patients by each investigating centre will be send
Study NCT03463941 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Peer Support Dyad Intervention
Description: Phase I: At baseline and at post-intervention, participant height, weight, BMI, fruit and vegetable intake and exercise habits will be measured. Participants will complete surveys and meet each week to learn about nutrition and exercise.~Phase II: Dyads will attend a communication training session to discuss 1) benefits of working with a partner; 2) supportive communication tips; and 3) expected activities for the next 8 weeks, including filling out daily logs. After the training session, the dyads will work together to achieve their health goals. The dyads will return to the church for two check in sessions. At these sessions, participants will turn in their logs, and be weighed. At the end of the intervention, BMI will be reassessed, and surveys and interviews will be completed.
Study NCT01087411 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Motivational Interviewing
Description: The method motivational interviewing according to Miller and Rollnik is used as an behavioral intervention to support the child and family in their own behavioral change towards a more physically active life style.
Study NCT01087411 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Physical activity
Description: Group sessions with different kinds of physical activity is arranged for the participants in the intervention program.
Study NCT01087411 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Supplementation with fish liver oli capsules
Description: This group will receive capsules containing omega-3 and omega-6 fatty acids and vitamine E. The dosage is six capsules daily containing omega-3 (558 mg of eico-pentaenoic-acid, EPA, and 174 mg of docosahexaenoic acid, DHA), omega-6 (60 mg of γ-linolenic acid, GLA) plus 9.6 mg vitamin E (in natural form, d-α-tocopherol), gelatin and glycerol. Participants will be instructed to eat three capsules each morning and evening.
Study NCT01087411 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo oil capsules
Description: This group will receive capsules containing rape seed oil. Participants will be instructed to lead their life in the same manner as before the intervention but eat three capsules each morning and evening.