TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04877613

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: single dose of CART-GFRa4 cells
Description: Intravenous infusion of lentiviral transduced autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity towards GFRa4 with fludarabine and cyclophosphamide.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: single dose of CART-GFRa4 cells
Description: Intravenous infusion of lentiviral transduced autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity towards GFRa4 with fludarabine and cyclophosphamide.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: single dose of CART-GFRa4 cells
Description: Intravenous infusion of lentiviral transduced autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity towards GFRa4 with fludarabine and cyclophosphamide.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: single dose of CART-GFRa4 cells
Description: Intravenous infusion of lentiviral transduced autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity towards GFRa4 with fludarabine and cyclophosphamide.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Lymphodepletion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Lymphodepletion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Lymphodepletion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Lymphodepletion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Lymphodepletion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Lymphodepletion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Lymphodepletion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Lymphodepletion
Study: NCT05826639

Intervention type: PROCEDURE
Intervention: Temperature-sensitive radiofrequency ablation
Description: Endobiliary radiofrequency ablation prior to ERCP-guided biliary stenting that utilizes a temperature-sensitive endobiliary RFA catheter

Intervention type: OTHER
Intervention: No intervention
Description: No intervention
Study: NCT05160181

Intervention type: OTHER
Intervention: Yogatherapy
Description: Description: Retrospective study on medical file of patients seen in consultation for chronic pain with prescription of Yogatherapy
Study: NCT04827407

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Efferon LPS hemoperfusion
Description: Hemoperfusion using continuous extracorporeal LPS adsorption with Efferon LPS therapeutic device during a period of 24h immediately following admission to the intensive care unit
Study: NCT05554133

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: High Resolution Microendoscope (HRME)
Description: The High Resolution Microendoscope (HRME) take pictures of a very small area of the lining of the mouth, about the size of a pencil tip, but at high magnification.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Optical Mapping Scope
Description: The optical mapping scope displays a wide area of the lining of the mouth (about the size of the top of a soda can) by shining different colors of light into the mouth and taking pictures.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Proflavine hemisulfate
Description: A coloring substance (a fluorescent dye which glows green in the dark), called proflavine hemisulfate, will be painted on areas of the mouth with a cotton tip applicator to help improve the pictures
Study: NCT06157515

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Breath-actuated vibrating mesh nebulizer
Description: The intervention utilizes a breath-actuated vibrating mesh nebulizer system consisting of a controller module with microphone for respiratory phase detection and algorithm for inspiration triggering. This interfaces with the vibrating mesh nebulizer module which incorporates a micro-pump chip using piezoelectric effects to eject fluid through a mesh aperture plate holes. By detecting the onset of inspiration based on characteristic acoustic patterns using machine learning models, the controller module sends signals activating the piezoelectric vibration mechanism to generate aerosol only during the inspiratory phase through precision timing control, shutting off mist during expiration. The core module is attached to a standard commercial vibrating mesh nebulizer using the standard adult reusable mouthpiece interface.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Continuous vibrating mesh nebulizer
Description: When the continuous vibrating mesh nebulizer powered on, the micro-pump chip provides sustained vibrations onto the aperture plate, forcing fluid through micron-scale pores under pressure to continuously produce aerosol throughout inspiration and expiration phase.
Study: NCT04973449

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AZD1222
Description: 10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AZD1222
Description: 10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AZD1222
Description: 10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.
Study: NCT06453785

Intervention type: DEVICE
Group type: OTHER
Intervention: Promaxo portable MRI
Description: The Promaxo portable MRI is an FDA cleared MRI device for MR-guided procedures. It uses a novel truly open MRI with an unobstructed field of view and central aperture for robotic guided intervention and has a limited footprint allowing it to be places in a standard operating theatre or large clinic room. The strength of magnet is also low enough that special precautions and equipment are not to take biopsies.
Study: NCT04973449

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AZD1222
Description: 10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AZD2816
Description: 10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AZD2816
Description: 10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AZD2816
Description: 10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AZD2816
Description: 10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AZD2816
Description: 10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.
Study: NCT04969939

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
Description: NNC0165-1875 will be co-escalated once-weekly subcutaneously with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Semaglutide 2.4 mg and placebo 2.0 mg
Description: NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
Description: NNC0165-1875 will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Semaglutide 2.4 mg and placebo 1.0 mg
Description: NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Study: NCT05452486

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: English APD assessment
Description: Materials presented in English

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: English APD assessment
Description: Materials presented in English

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Spanish APD assessment
Description: Materials presented in Spanish

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Spanish APD assessment
Description: Materials presented in Spanish
Study: NCT04699864

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Screening of DR and DME with artificial intelligence using NeoRetina
Description: Macula-centered eye color fundus photos will be acquired by DIAGNOS team using a non-mydriatic digital camera (without pupil dilation). After a numerical treatment, retinal images will be analyzed by NeoRetina artificial intelligence (AI) algorithm in order to find eye lesions characteristics of diabetic retinopathy (DR) and diabetic macular edema (DME). The severity of DR and DME will be graded by NeoRetina according to the ''Early Treatment Diabetic Retinopathy Study'' (ETDRS) international classification standards.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Routine ophthalmological evaluation of DR and DME
Description: Standard of care eye examination (blind assessment) will be performed by an ophthalmologist of the CHUM in order to find lesions characteristics of diabetic retinopathy (DR) and diabetic macular edema (DME). The severity of DR and DME will be graded by the doctor according to the ''Early Treatment Diabetic Retinopathy Study'' (ETDRS) international classification standards.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Manual grading of DR and DME by CHUM ophthalmologists based on retinal photographies acquired by Diagnos
Description: Ophthalmologists of the CHUM will revise the macula-centered eye color photos acquired by DIAGNOS in order to find lesions characteristics of diabetic retinopathy (DR) and diabetic macular edema (DME). The severity of DR and DME will be graded (blind assessment) according to the ''Early Treatment Diabetic Retinopathy Study'' (ETDRS) international classification standards.
Study: NCT05546853

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NP137
Description: NP137 will be administrated at the first day of each cycle (CnD1) of 14 days as an IV infusion at 9 or 14 mg/kg.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Description: Oxaliplatin will be administreted at the first day of each cycle (CnD1) of 14 days as an IV infusion at 85 mg/m²

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irinotecan
Description: Irinotecan will be administreted at the first day of each cycle (CnD1) of 14 days as an IV infusion at 150 mg/m²

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Calcium levofolinate
Description: Calcium levofolinate will be administreted at the first day of each cycle (CnD1) of 14 days as an IV infusion at 100 mg/m²

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5 FU
Description: 5 FU will be administreted at the first day of each cycle (CnD1) of 14 days as an IV infusion at 2400 mg/m2 as a continuous intravenous infusion over 46 hours.
Study: NCT06250205

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Obicetrapib
Description: oral administration

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Obicetrapib
Description: oral administration

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)
Description: oral administration

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Drospirenone / Ethinyl Estradiol (COC)
Description: oral administration
Study: NCT05432648

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Green bean puree
Description: Green bean contains both soluble and insoluble fiber, which may have different extent of influence on the gut microbiome. Using a real food rather than a purified fiber such as pectin is more practical and more acceptable to families.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Green bean puree
Description: Green bean contains both soluble and insoluble fiber, which may have different extent of influence on the gut microbiome. Using a real food rather than a purified fiber such as pectin is more practical and more acceptable to families.
Study: NCT04261244

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: preoperative radiotherapy
Description: preoperative radiotherapy instead of postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: postoperative radiotherapy
Description: postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
Study: NCT04711746

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: blood sample
Description: Blood sample withdrawal in order to perform DNA sequencing

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: blood sample
Description: Blood sample withdrawal in order to perform DNA sequencing
Study: NCT06151288

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 31 valent pneumococcal conjugate vaccine
Description: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 31 valent pneumococcal conjugate vaccine
Description: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 31 valent pneumococcal conjugate vaccine
Description: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: 20 valent pneumococcal conjugate vaccine
Description: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
Study: NCT05818085

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABP-671
Description: Low, medium or high dose (Part 1); Selected dose(s) (Part 2)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Allopurinol
Description: Standard of care according to American College of Rheumatology (ACR) guideline for the management of gout

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: ABP-671 matching placebo
Study: NCT05962541

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PDD-TURBT with hexaminolevulinate (Hexvix®)
Description: In order to undergo PDD-TURBT, all eligible patients in the experimental arm will be administered the photosensitizer hexaminolevulinate (85 mg in 50 ml of phosphate buffered saline, Hexvix®) on an inpatient setting through a urethral catheterization of the participant's bladder. During the PDD-TURBT surgery, the bladder will be illuminated with blue light (wavelength 380-450 nm). The operating rooms of the participant institutions will therefore need to have the specialized equipment consisting in the blue-light source (POWER LED SAPHIRA \[TM\]).

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Power Led Saphira (TM)
Description: This is a light source based on LED technology. It can be used for both White Light (WL) and fluorescence applications in blue light (i.e., Photodynamic diagnosis PDD) for visualizing tumor lesions during trans-urethral resection of bladder tumors (PPD- TURBT).
Study: NCT05823571

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Itacitinib
Description: A standard 3+3 design will be used to evaluate the safety of itacitinib plus different immunosuppression regimens. This study has four predefined Regimens that will be explored in the optimal Regimen-finding phase and are listed in Table 2 of the protocol. Itacitinib will be given in conjunction with each of four different regimens for immunosuppression. Regimen 1 is the current standard for our BMT patients, with a duration of MMF from day 5-35. Regimen 2 will decrease the duration of MMF from 35 to day 25. Regimen 3 will decrease the duration of MMF from 35 to day 15. Regimen 4 will eliminate MMF altogether. We will start with Regimen 1, which combines itacitinib with the current standard of immunosuppression. Progression through cohorts (Regimens) will be based on a standard 3+3 design to find the optimal regimen.
Study: NCT06065449

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Radiation Therapy
Description: Arm 1: standard 8 Gy delivered in a single fraction or 20 Gy delivered in 5 fractions~Arm 2: 16 Gy delivered in a single fraction or 27 Gy delivered in 3 fractions prescribed to planning target volume (PTV).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Radiation Therapy
Description: Arm 1: standard 8 Gy delivered in a single fraction or 20 Gy delivered in 5 fractions~Arm 2: 16 Gy delivered in a single fraction or 27 Gy delivered in 3 fractions prescribed to planning target volume (PTV).
Study: NCT05511415

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxytocin
Description: Oxytocin solution, 20nM concentration

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxytocin
Description: Oxytocin solution, 20nM concentration

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxytocin
Description: Oxytocin solution, 20nM concentration

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxytocin
Description: Oxytocin solution, 20nM concentration

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxytocin
Description: Oxytocin solution, 20nM concentration

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexmedetomidine
Description: Dexmedetomidine (10-9M to 10-4M)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexmedetomidine
Description: Dexmedetomidine (10-9M to 10-4M)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexmedetomidine
Description: Dexmedetomidine (10-9M to 10-4M)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexmedetomidine
Description: Dexmedetomidine (10-9M to 10-4M)
Study: NCT06559696

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: internal mammary nodal irradiation
Description: chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: No internal mammary node irradiation
Description: chest wall/whole breast and supraclavicular +-axillary irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).
Study: NCT06339099

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Conventional physical therapy program
Description: This program included active resisted strengthening exercises for pelvis girdle and lower limb muscles, stretching exercises of tight muscles of lower limbs; hip flexors, hamstrings and calf muscle, balance activities from standing and walking and gait training exercises.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Conventional physical therapy program
Description: This program included active resisted strengthening exercises for pelvis girdle and lower limb muscles, stretching exercises of tight muscles of lower limbs; hip flexors, hamstrings and calf muscle, balance activities from standing and walking and gait training exercises.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Loaded gait training
Description: An extra weight was added around the distal legs during gait training in the intervention group. This weight began at 0.5 kg and was gradually increased every two weeks to a maximum of 2 kg
Study: NCT06335849

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: LYB004 25µg
Description: Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: LYB004 50µg
Description: Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: SHINGRIX
Description: Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.
Study: NCT06347705

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 2141-V11 Antibody
Description: 2141-V11 Antibody: Intratumor injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 2141-V11 Antibody
Description: 2141-V11 Antibody: Intratumor injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 2141-V11 Antibody
Description: 2141-V11 Antibody: Intratumor injection
Study: NCT05713630

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tranexamic acid (TXA)
Description: GD-Tranexamic Acid 500 mg oral tablet over-encapsulated to match the placebo. Sandoz-Tranexamic Acid 100 mg/mL solution for injection via intravenous (IV) added to a 100mL infusion bag of NaCl 0.9% and infused by slow intravenous injection over 20 minutes.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo 500 mg consisting of an identical capsule to over-encapsulated tranexamic acid oral tablet entirely filled with microcrystalline cellulose, and sealed. Placebo 100 mg/mL solution for injection via intravenous (IV) consisting of 0.9% sodium chloride (saline).