AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT02652481 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: ImageReady MR Conditional Defibrillation System
Description: ImageReady MR Conditional Defibrillation System Components:~Device Name Device Model Number Pulse Generators Phase I and II Phase II Only \* CRT-D (IS1/DF4/IS4) VR ICD (DF4) DR ( dual chamber) ICD (IS1/DF4) ORIGEN™ MINI ICD ORIGEN EL ICD ORIGEN X4 CRT INOGEN™ MINI ICD INOGEN EL ICD INOGEN X4 CRT DYNAGEN™ MINI ICD DYNAGEN EL ICD DYNAGEN X4 CRT-D AUTOGEN ™ MINI ICD\* AUTOGEN EL ICD\* AUTOGEN X4 CRT-D\* Right Atrial Leads and Accessories FINELINE™ II Sterox FINELINE II Sterox EZ Suture Sleeves for FINELINE II Leads INGEVITY™ MRI\* Suture Sleeve for INGEVITY MRI\* IS-1 Lead Port Plug 7145 Right Ventricular Leads and Accessories RELIANCE 4-FRONT™ (DF4)\* Suture Sleeve for RELIANCE 4-FRONT leads\*; ENDOTAK RELIANCE™ (DF4) Left Ventricular Leads and Accessories ACUITY™ X4 (IS4) Suture Sleeve for ACUITY X4 leads~\* May only be used internationally outside the US
Study NCT01803308 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SB9200
Description: Part A open-label, single ascending doses of SB9200 from 100mg - 1500mg.
Study NCT01803308 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SB9200
Description: Part B randomised 6:2 (active:placebo) using recommended Part B starting dose, and ascending to up to 1500mg for 7-14 days of dosing.
Study NCT01803308 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Part B randomised 6:2 (active:placebo) using anhydrous lactose capsules identical to active comparator, minus active ingredient.
Study NCT00474695 — intervention group
Intervention type: DRUG
Intervention: Lucentis
Description: 0.05 mg intravitreal injection
Study NCT01624675 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Risperidone
Description: Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing >= 45 kg was 3.0 mg. For subjects weighing >=45 kg, the maximum daily dose was 3.0 mg.
Study NCT01624675 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects will receive placebo matching with risperidone orally up to 8 weeks.
Study NCT04407390 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Nicotinamide riboside
Description: The patients will receive 1 g of nicotinamide riboside or placebo orally every morning for 14 days.
Study NCT04407390 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study NCT03311373 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Regimen A
Description: 2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure
Study NCT03311373 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Regimen B
Description: 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure
Study NCT03358069 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Emergence agitation scale
Description: Emergence agitation scale: PAED scale > 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ
Study NCT03311373 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Regimen C
Description: 2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure
Study NCT03311373 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Regimen D
Description: 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure
Study NCT00979836 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Calcium Dobesilate
Description: 500 mg/ three times/day for 6 months (capsules)
Study NCT00979836 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Calcium Dobesilate
Description: 500 mg/ three times/day for 6 months (capsules)
Study NCT03565081 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PWS elastic band training group
Description: PWS participants received 9 sets exercises for the major muscle groups, over 24 weeks, three times a week, for a total of 72 sessions.
Study NCT02330133 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Women's Reproductive Health
Description: Targeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections
Study NCT02330133 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Online sexual health content
Description: Online general text-based information about reproductive health issues and strategies for preventing sexually transmitted infections
Study NCT04454658 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABBV-744
Description: Tablet; Oral
Study NCT04454658 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Navitoclax
Description: Tablet; Oral
Study NCT04454658 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ruxolitinib
Description: Tablet; Oral
Study NCT02855931 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Middle turbinate resection
Study NCT02149251 — intervention group
Intervention type: GENETIC
Intervention: Pre-genetic diagnosis
Study NCT03234205 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: MRI scan
Description: MRI standard protocol with addition of:~* a second clinical respiratory belt besides belt usually installed for clinical examination~* a second clinical electrocardiogram sensor besides sensor usually installed for clinical examination~* 12 sequences during free respiration are added lasting supplementary 15 minutes~* Use of cardiac antennae usually used for cardiac MRI scans
Study NCT02657031 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prochlorperazine
Description: prochlorperazine 10 mg IV
Study NCT02657031 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketamine
Description: Ketamine 0.3 mg/kg IV
Study NCT02657031 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Diphenhydramine
Description: Diphenhydromine 25 mg IV
Study NCT02657031 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ondansetron
Description: Ondansetron 4 mg IV
Study NCT02657031 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Normal Saline
Description: Normal Saline 500 cc IV Bolus
Study NCT02657031 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Normal Saline
Description: Normal Saline 500 cc IV Bolus
Study NCT02624362 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Therapeutic Suggestion
Description: suggestions about potential beneficial effects of the odor are given
Study NCT02624362 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Asthmogenic Suggestion
Description: suggestions about potential negative effects of the odor are given
Study NCT01653197 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Curiosity
Description: The recipient will be prompted to scratch off for answer to question.
Study NCT01653197 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Curiosity linked to Action
Description: The recipient will be prompted to scratch off for answer only after he/she makes an appointment.
Study NCT02624362 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Phenylethyl Alcohol odor
Description: Over the course of 15 minutes, participants, receive 15 short sniffs of Phenylethyl Alcohol odor
Study NCT01239030 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methylphenidate Hydrochloride Extended Release Capsules
Description: Biphentin Methylphenidate ER Once-A-Day Capsules
Study NCT00555009 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Genotropin
Description: Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks.
Study NCT00555009 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.
Study NCT04472975 — intervention group
Intervention type: DRUG
Intervention: Exposure to one or more disease-modifying drug(s)(DMDs) used to treat MS
Description: Individuals with MS exposed to one or more DMDs (beta-interferon, glatiramer acetate, natalizumab, fingolimod, dimethyl fumarate, teriflunomide, alemtuzumab, daclizumab or ocrelizumab; regardless of dose, frequency or duration of treatment) between 1st January 1996 and 31st March 2018 in five Canadian provinces.
Study NCT02717975 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Use of catheter valve before 'trial removal of catheter'
Description: The investigators are comparing two groups of patients (Group A) Trial removal of urinary catheter in patients with urinary retention after applying catheter valve and closing it 3-4 hours before catheter removal.
Study NCT02717975 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Trial removal of catheter in patients with urinary retention
Description: The investigators are comparing two groups of patients (Group B) Trial removal of urinary catheter in patients with urinary retention without using catheter valve - 'Traditional method'
Study NCT03443869 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letermovir
Description: LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) once daily for 28 weeks
Study NCT03443869 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Valganciclovir
Description: 900 mg VGCV tablet orally, once daily for 28 weeks
Study NCT03443869 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Acyclovir (ACV)
Description: 400 mg over-encapsulated ACV tablet orally, every 12 hours for 28 weeks
Study NCT03443869 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo to ACV
Description: Over-encapsulated placebo tablet orally, every 12 hours for 28 weeks
Study NCT03443869 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo to LET
Description: Placebo to LET tablet orally, once daily for 28 weeks
Study NCT03443869 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo to VGCV
Description: Placebo to VGCV tablet orally, once daily for 28 weeks
Study NCT04052399 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: anodal transcranial direct current stimulation
Description: Anodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network.~The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes.
Study NCT04052399 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: cathodal transcranial direct current stimulation
Description: Cathodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network.~The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes.
Study NCT04052399 — intervention group
Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: transcranial direct current stimulation
Description: Single blind sham stimulation (ramp-up ramp-down stimulation will be applied for 30 seconds)
Study NCT00301106 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: adenovirus-mediated human interleukin-12
Description: The purified ADV-hIL12 is suspended in formulation buffer (10mM Tris, pH 7.5/~1mM MgCl2/ 150mM NaCl/ 10% glycerol) and aliquoted into 1ml cryovials. The filled vials are stored at or below -60 degC.
Study NCT03322462 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Flortaucipir F18
Description: 370 megabecquerel (MBq) IV single-dose
Study NCT03322462 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Brain PET Scan
Description: positron emission tomography (PET) scan of the brain
Study NCT03486080 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dutogliptin Tartrate
Description: Active treatment
Study NCT03486080 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Filgrastim Injectable Product
Description: Active treatment
Study NCT03486080 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebos
Description: placebo control
Study NCT04532008 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Group based treatment
Description: 12 sessions of group based therapy that included cognitive restructuring, behavioral activation, and interpersonal therapy
Study NCT02417142 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Exenatide
Description: Exenatide SQ 2mg/week for 24 weeks.
Study NCT02417142 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo SQ 1x/week for 24 weeks.
Study NCT01239030 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylphenidate Hydrochloride Extended Release Capsules
Description: Biphentin Methylphenidate ER Once-A-Day Capsules
Study NCT01239030 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo capsules
Study NCT03211286 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tranexamic Acid
Description: 1 g of intravenous tranexamic acid in 100 mL of saline solution
Study NCT02948322 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CMRI
Description: Myocardial Imaging (CMRI) will be performed in patients (at baseline and 6 month after treatment) and healthy volunteers (baseline)
Study NCT03211286 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Saline Solution
Description: saline solution 100 mL intravenous
Study NCT03211286 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Saline Solution
Description: saline solution 100 mL intravenous
Study NCT02948322 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: CMRI
Description: Myocardial Imaging (CMRI) will be performed in patients (at baseline and 6 month after treatment) and healthy volunteers (baseline)
Study NCT02948322 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gadolinium
Description: gadolinium injection will be performed during CMRI in patients and healthy volunteers.
Study NCT00645099 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: olanzapine
Description: 10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
Study NCT00645099 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paliperidone ER
Description: 6-mg or 9-mg tablet once daily flexible dosing for 6 months
Study NCT02948322 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Gadolinium
Description: gadolinium injection will be performed during CMRI in patients and healthy volunteers.
Study NCT02948322 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: OGTT
Description: Growth Hormon (GH) secretion and metabolic status of the acromegalic will be evaluated by an measure of plasma glucose, insulin and GH (OGTT), and insulin-like growth factor-1 (IGF-I) will be measured in patients and healthy volunteers.
Study NCT02948322 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: OGTT
Description: Growth Hormon (GH) secretion and metabolic status of the acromegalic will be evaluated by an measure of plasma glucose, insulin and GH (OGTT), and insulin-like growth factor-1 (IGF-I) will be measured in patients and healthy volunteers.
Study NCT02539095 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CartiZol
Description: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
Study NCT02539095 — intervention group
Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Normal saline
Description: 1. Supplementation of fluid and electrolytes (sodium or chlorine deficiency)~2. Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
Study NCT02044978 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Zoledronate-coated dental implant
Study NCT04170699 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Port-a-cath replacement
Description: Implantation of a subcutaneous venous port-a-cath
Study NCT00962000 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Dialysis Flow Rate Start 600mL/min
Description: ABAB sequence where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
Study NCT00962000 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Dialysis Flow Rate Start 800mL/min
Description: BABA sequence where B represents three consecutive treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min.
Study NCT00880282 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: cixutumumab
Description: Given IV
Study NCT00880282 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: temsirolimus
Description: Given IV
Study NCT00880282 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: Correlative studies
Study NCT00880282 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study NCT01539109 — intervention group
Intervention type: BEHAVIORAL
Group type: SHAM_COMPARATOR
Intervention: Rehabilitation
Description: Patients will receive training upon tasks of daily living. Patients will perform these exercises in our laboratory under the supervision of qualified personnel.
Study NCT01539109 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Rehabilitation
Description: Patients will receive training upon tasks of daily living. Patients will perform these exercises in our laboratory under the supervision of qualified personnel.
Study NCT01539109 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Noninvasive brain stimulation: tDCS
Description: TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (2mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration. In the present study, tDCS will be delivered to patients in the experimental group for 2 hr each day for 5 days a week for 2 weeks in conjunction with therapy for the affected hand.
Study NCT01539109 — intervention group
Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: Sham tDCS: placebo noninvasive brain stimulation
Description: Placebo set-up for noninvasive brain stimulation will be similar to that for the active tDCS; sponge electrodes would be placed on the scalp and connected to a batter-operated device. Patients will not receive the effective level of direct current as would delivered in active tDCS intervention. But patients will not be able to decipher whether they are receiving active or placebo tDCS.
Study NCT02153736 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: SPEEDI Intervention
Description: Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities.
Study NCT04380922 — intervention group
Intervention type: OTHER
Intervention: Periodontal screening
Description: Periodontal data collection (PPD, REC, CAL)
Study NCT01634126 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: 1 FIT kit
Description: Patient receives 1 FIT
Study NCT01634126 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: 2 FIT kit
Description: Patient receives 2 FIT kits
Study NCT01938612 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MEDI4736
Description: MEDI4736 will be administered by IV infusion every 14, 21 or 28 days.
Study NCT01938612 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tremelimumab
Description: tremelimumab is administered by IV infusion every 4 weeks
Study NCT00500942 — intervention group
Intervention type: BEHAVIORAL
Intervention: Questionnaire
Description: Questionnaires about the pain level experienced during and after standard procedures are performed in the IR.
Study NCT00378989 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Consultation at the occupational health services
Description: Consultation at the occupational health services
Study NCT04568135 — intervention group
Intervention type: OTHER
Intervention: survey
Description: survey
Study NCT04726020 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Intensive monitoring
Description: periodic and planned monitoring nurse intervention with phone call
Study NCT04726020 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Standard monitoring
Description: standard monitoring of adverse event reaction