TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04293172

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Brilinta
Description: Patients in the open-label Run-in period (patients aged 6 to \<24 months only) will receive ticagrelor 5 mg twice a day (body weight 6 to ≤9 kg), 10 mg twice a day (body weight \>9 to ≤12 kg) or 15 mg twice a day (body weight \>12 to ≤24 kg) for 14 days.~The double-blind IP will be based on 5 weight bands:~* 6 to ≤9 kg: ticagrelor 5 mg or matching placebo, twice a day~* \>9 to ≤12 kg: ticagrelor 10 mg or matching placebo, twice a day~* \>12 to ≤24 kg: ticagrelor 15 mg or matching placebo, twice a day~* \>24 to ≤48 kg: ticagrelor 30 mg or matching placebo, twice a day~* \>48 kg: ticagrelor 45 mg or matching placebo, twice a day

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Patients in the open-label Run-in period (patients aged 6 to \<24 months only) will receive ticagrelor 5 mg twice a day (body weight 6 to ≤9 kg), 10 mg twice a day (body weight \>9 to ≤12 kg) or 15 mg twice a day (body weight \>12 to ≤24 kg) for 14 days.~The double-blind IP will be based on 5 weight bands:~* 6 to ≤9 kg: ticagrelor 5 mg or matching placebo, twice a day~* \>9 to ≤12 kg: ticagrelor 10 mg or matching placebo, twice a day~* \>12 to ≤24 kg: ticagrelor 15 mg or matching placebo, twice a day~* \>24 to ≤48 kg: ticagrelor 30 mg or matching placebo, twice a day~* \>48 kg: ticagrelor 45 mg or matching placebo, twice a day
Study: NCT00726258

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: ketamine
Description: ketamine with various concentrations

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: physiological serum
Study: NCT00909220

Intervention type: BEHAVIORAL
Intervention: Behavioral Activation
Description: Behavioral Activation included up to 16 weekly 50 minute psychotherapy sessions using BA (Addis \& Martell, 2004; Martell et al., 2001, 2010). Techniques included functional analyses to identify the antecedent and consequential aspects of low mood, and interventions such as monitoring daily activities, assessing pleasure/satisfaction and competence achieved via activities, assigning tasks that induce mastery or pleasure, and reducing skill deficits. Clinicians included postdoctoral fellows in clinical psychology (n = 2) or licensed clinical psychologists (n = 2).
Study: NCT04542811

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Acupuncture
Description: Acupuncture is a complementary therapy modality which is used by needle inserted the specific points on the body.
Study: NCT04290377

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: BMI-assisted motor imagery OT
Description: As the goal of the intervention is to promote finger extension in participants who are unable to extend his/her finger due to stroke, the pneumatic glove provides extension assist when appropriate brain activity is present. The brain activity is obtained by Functional Near-Infrared Spectroscopy (fNIRS). Hypothetically, this will repeatedly induce brain activation that is related to finger extension.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Motor imagery OT
Description: In Motor imagery OT, Subjects try to extend their fingers (imagine) without BMI assistance. All other setting is equal to BMI-assisted motor imagery OT.
Study: NCT03573570

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Fortified rice kernels
Description: The proposed project will leverage the existing state-run public distribution system (PDS) to provide fortified rice through Fair Price Shops (FPS) using a domestically manufactured rice grain (Fortified Rice Kernels: FRK). FRKs are grains made from rice flour, enriched with iron, zinc, Vitamin A, Vitamins B1, B3, B6, B9 and B12, and shaped like a conventional grain of rice. It is mixed into conventional rice in specified ratio of 1:100. The proposed study will be conducted as a cluster-randomized controlled trial, with baseline and follow-up surveys conducted 12-15 months apart. In the interim, 110 Treatment FPS, and all households receiving rice from them, will be randomly assigned to receive fortified rice, and another 110 randomly assigned Control FPS, and the households receiving rice from them, will continue receiving conventional rice and represents the status quo. This study will be conducted in one sub-district of Tamil Nadu with a population of about 1/2 million people.
Study: NCT04150653

Intervention type: DEVICE
Intervention: Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE)
Description: Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE)
Study: NCT03545633

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Treatment with High Intensity Focused ElectroMagnetic system.
Description: The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area.~Visible contractions will be induced by the device.
Study: NCT02187029

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-06743649
Description: Daily dosing (dose level 1) tablet for 14 days

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Daily dosing (tablet) for 14 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-06743649
Description: Daily dosing (dose level 2) tablet(s) for 14 days

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Daily dosing (tablets) for 14 days
Study: NCT03349489

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise 1
Description: Participants will be admitted at the research center at 14:00. At 14:30, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise 2
Description: Participants will be admitted at the research center at 14:00. At 15:20, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.
Study: NCT02154906

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: DFDBA

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: autologous platelet rich fibrin
Study: NCT03181659

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Manual Therapy, Therapeutic Education, Therapeutic Exercice
Description: They will receive 8 sessions (2 sessions per week) of joint and neural manual therapy, and will receive 4 sessions (1 session per week) of neuroscience education in which mirror therapy and image observation. The therapeutic exercise program is based on stabilization of the lumbopelvic region.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Manual Therapy, Therapeutic Education, Therapeutic Exercice
Description: They will receive 8 sessions (2 sessions per week) of joint and neural manual therapy, and will receive 4 sessions (1 session per week) of neuroscience education in which mirror therapy and image observation. The therapeutic exercise program is based on stabilization of the lumbopelvic region.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Therapeutic Education, Therapeutic Exercice
Description: They will receive a total of 8 sessions (2 sessions per week) of therapeutic exercise based on the stabilization of the lumbopelvic region and will receive 4 sessions (1 session per week) of neuroscience education in which mirror therapy and image observation.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Therapeutic Education, Therapeutic Exercice
Description: They will receive a total of 8 sessions (2 sessions per week) of therapeutic exercise based on the stabilization of the lumbopelvic region and will receive 4 sessions (1 session per week) of neuroscience education in which mirror therapy and image observation.
Study: NCT00620269

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erlotinib
Description: Erlotinib 150 mg p.o. daily x21 days every 3 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erlotinib
Description: Erlotinib 150 mg p.o. daily x21 days every 3 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Induction or consolidation IP chemotherapy
Description: Irinotecan 65mg/m2 + Cisplatin 30mg/m2 IV on D1,D8 every 3 weeks X 3 cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Induction or consolidation IP chemotherapy
Description: Irinotecan 65mg/m2 + Cisplatin 30mg/m2 IV on D1,D8 every 3 weeks X 3 cycles

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: CCRT with IP chemotherapy (Irinotecan + Cisplatin)
Description: Irinotecan (60mg/m2) + cisplatin (30mg/m2) IV on D1 \& 8 every 3 weeks X 2 cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CCRT with IP chemotherapy (Irinotecan + Cisplatin)
Description: Irinotecan (60mg/m2) + cisplatin (30mg/m2) IV on D1 \& 8 every 3 weeks X 2 cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CCRT with IP chemotherapy (Irinotecan + Cisplatin)
Description: Irinotecan (60mg/m2) + cisplatin (30mg/m2) IV on D1 \& 8 every 3 weeks X 2 cycles

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: CCRT
Description: CCRT :Concurrent Thoracic Radiotherapy (2.4 Gy/fr, Total 60 Gy, 25fr over 5 weeks)

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: CCRT
Description: CCRT :Concurrent Thoracic Radiotherapy (2.4 Gy/fr, Total 60 Gy, 25fr over 5 weeks)

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: CCRT
Description: CCRT :Concurrent Thoracic Radiotherapy (2.4 Gy/fr, Total 60 Gy, 25fr over 5 weeks)

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: CCRT
Description: CCRT :Concurrent Thoracic Radiotherapy (2.4 Gy/fr, Total 60 Gy, 25fr over 5 weeks)
Study: NCT01782521

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: No primer
Description: Primer not used when bonding orthodontic brackets
Study: NCT00867737

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Advair HFA MDI 115/21
Description: Two puffs from MDI twice daily for 4 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Symbicort 160/4.5 pMDI
Description: Symbicort 160/4.5 pMDI~Two puffs from MDI twice daily for 4 weeks
Study: NCT04626804

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community
Description: testing the usability, perceptions, and acceptability of R/S among dyads of older adults with early Alzheimer's disease and other related dementias
Study: NCT01958242

Intervention type: OTHER
Group type: NO_INTERVENTION
Intervention: Preoperative blood harvesting
Description: There is no true intervention, there is a protocol of preoperative blood harvesting ,and post operative administration of the same blood/
Study: NCT01793636

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2014
Description: AZD2014 vs Everolimus

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Everolimus
Description: comparing PFS in patients treated with AZD2014 vs Everolimus
Study: NCT04490785

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: MRI
Description: 1 MRI 5 days after surgery (-1; +4 days), with intravenous administration of gadolinium

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Postoperative dosage of released troponin
Description: Dosage of troponin I Hs H4, H8, H12, H24, H48, and H72 after the aortic cross-unclamping.
Study: NCT04451811

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OPL-002
Description: Spray dried dispersion and tablet formulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OPL-002
Description: Spray dried dispersion and tablet formulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OPL-002
Description: Spray dried dispersion and tablet formulation
Study: NCT01472029

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab
Description: Pre-operative treatment 4 cycles and post-operative treatment 4 cycles:~Trastuzumab 4 mg/kg BW (6 mg loading dose at 1st administration), iv over 1 h on day 1 of each 14 day cycle~Docetaxel 50 mg/m², iv over 2 h on day 1 of each 14 day cycle~Oxaliplatin 85 mg/m² in 500 ml G5%, iv over 2h on day 1 of each 14 day cycle~Leucovorin 200 mg/m² in 250 ml NaCl 0,9%, iv over 1 h on day 1 of each cycle~5-FU 2600 mg/m², iv over 24 h on day 1 of each 14 day cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Post-operative treatment trastuzumab mono therapy
Description: Trastuzumab mono therapy for 9 cycles:~Trastuzumab 6 mg/kg BW, iv over 1 h on day 1 of each 21 day cycle
Study: NCT04513353

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Rehabilitation using Digital Healthcare System (Uincare Homeplus)
Description: Uincare Homeplus is a device using infrared, kinect camera and motion capture technology to track 3D motion of the patients' posture and joint articulations. It also has embedded exercise training software dedicated to total knee arthroplasty post-op rehabilitation at home.~Home-based self-rehabilitation using brochure for 3 weeks post surgery (same as the active comparator)~Home-based self-rehabilitation using digital healthcare system(Uincare Homeplus) for 3 to 12 weeks post surgery.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Conventional Rehabilitation
Description: Home-based self-rehabilitation using brochure for 12 weeks post surgery.
Study: NCT03810651

Intervention type: OTHER
Group type: OTHER
Intervention: Proton beam radiation using pencil beam scanning
Description: Proton beam radiation using pencil beam scanning, characterized by Bragg peak dose deposition and high conformality of dose to target regions
Study: NCT04218474

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
Description: -sural nerve harvest ,and use it as conduit between injured mental nerve and the normal one
Study: NCT01601613

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: activated recombinant human factor VII
Description: 100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: 100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
Study: NCT02911194

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: a2 milk
Description: replace all milk with a2 milk

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: a1 containing milk
Description: use a1 containing milk
Study: NCT04005716

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tislelizumab, Carboplatin /Cisplatin, Etoposide
Description: Tislelizumab (200 mg IV Q3W) in combination with chemotherapy consisting of etoposide (100 mg/m² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg/m² IV Q3W or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 IV Q3W) for 4 cycles. Then maintenance consists of Tislelizumab Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Carboplatin / Cisplatin, Etoposide
Description: Placebo Q3W in combination with chemotherapy consisting of etoposide (100 mg/m² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg/m² IV Q3W or carboplatin AUC 5 IV Q3W) for 4 cycles. Then maintenance consists of Placebo Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent.
Study: NCT03437941

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CORT125281
Description: CORT125281 is supplied as capsules for oral dosing

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CORT125281
Description: CORT125281 is supplied as capsules for oral dosing

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CORT125281
Description: CORT125281 is supplied as capsules for oral dosing

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CORT125281
Description: CORT125281 is supplied as capsules for oral dosing

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CORT125281
Description: CORT125281 is supplied as capsules for oral dosing

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CORT125281
Description: CORT125281 is supplied as capsules for oral dosing

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Enzalutamide (Xtandi)
Description: Enzalutamide will be taken orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Enzalutamide (Xtandi)
Description: Enzalutamide will be taken orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Enzalutamide (Xtandi)
Description: Enzalutamide will be taken orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Enzalutamide (Xtandi)
Description: Enzalutamide will be taken orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Enzalutamide (Xtandi)
Description: Enzalutamide will be taken orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Enzalutamide (Xtandi)
Description: Enzalutamide will be taken orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo capsules to match the appearance of the CORT125281
Study: NCT02367352

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alisertib
Description: Alisertib tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alisertib
Description: Alisertib tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alisertib
Description: Alisertib tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: Paclitaxel intravenous solution

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: Paclitaxel intravenous solution

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: Paclitaxel intravenous solution
Study: NCT01006525

Intervention type: DRUG
Intervention: zolpidem
Description: placebo or zolpidem (10mg)daily for one year
Study: NCT04658563

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: High Density Exercise Training Program - Yoga
Description: A total of 8 weeks will be applied in our study, each session of the high-density yoga program will be started with 10 minute pranayama (breath) exercises as it is in classical yoga as a preliminary preparation for the participation of individuals; the program will be completed by applying 10-20 minutes warming-stretching movements, 40 minutes surya namaskar (SN) sets, 20-30 minutes dynamic yoga asanas and 10 minutes savasana. Participants will be encouraged to study the perceived difficulty levels between 14 and 17 using the Borg scale during the sessions
Study: NCT04142099

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: skin to skin contact 60 min group
Description: Newborns are exposed to maternal and child skin within five minutes of birth for 60 min.
Study: NCT03349489

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Dexcom G4 Platinum
Description: The Dexcom G4 Platinum will be used to measure continuous glucose levels.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Dexcom G4 Platinum
Description: The Dexcom G4 Platinum will be used to measure continuous glucose levels.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Insulin
Description: Participant's usual fast-acting insulin analog will be used.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Insulin
Description: Participant's usual fast-acting insulin analog will be used.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Insulin pump
Description: Participant's insulin pump will be used to infuse insulin.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Insulin pump
Description: Participant's insulin pump will be used to infuse insulin.
Study: NCT04142099

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: skin to skin contact 20min group
Description: Newborns are exposed to maternal and child skin within five minutes of birth for 20 min.
Study: NCT04592497

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: AF ablation
Description: Prospective, single-center, non-randomized, open label, two arm study. After informed consent, 60 consecutive subjects who are scheduled to undergo AF ablation will be enrolled in the study in two equally sized groups of 30 subjects each. One group will undergo the procedure with assistance THERMOCOOL SMARTTOUCH SF-5D QDOT system and the other with the standard Thermocool Smartouch SF system. Data will be collected from all subjects during the ablation procedure and post procedure for a period of 12 months. Data will be anonymized by removing patient protected health information, only initials will be used.
Study: NCT01066663

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pyrimethamine
Description: Taken orally once a day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pyrimethamine
Description: Taken orally once a day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pyrimethamine
Description: Taken orally once a day
Study: NCT01687283

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: fluticasone propionate inhalation solution
Description: 1 mg BID inhalation for 12 weeks with one possible chance to change to 0.5 mg BID

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: budesonide suspension
Description: 2 mg BID inhalation for 12 weeks with one possible chance to change to 1 mg BID
Study: NCT04361097

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Faecal microbiota transplant
Description: Both groups will receive frozen capsules to be ingested orally (constituted of TMF or placebo according to the randomization) with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Both groups will receive frozen capsules to be ingested orally (constituted of TMF or placebo according to the randomization) with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.