TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02549586

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Autologous Hematopoietic Stem Cell Transplant
Description: Step 1: Participants will receive intravenous chemotherapy and cytokine-based treatment for mobilization of hematopoietic stem cells (HSC) into the circulation, followed by collection using peripheral vein leukopheresis. The HSC graft product will undergo ex vivo purification with CD34 selection using Miltenyil CliniMACS and cryopreserved.~Step 2: Intravenous busulphan, cyclophosphamide and anti-thymocyte globulin will be administered to participants to achieve immune ablation prior to the infusion of the participants' own thawed HSC graft product (HSC transplant). Routine supportive measures will be employed during the recovery from the chemotherapy and HSCT. Participants' immune suppression will be stopped at the time of immunoablative therapy and will be switched to everolimus which will be discontinued at 6 months post HSCT.
Study: NCT03735628

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Copanlisib
Description: Copanlisib: lyophilisate for reconstitution and further dilution for infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Copanlisib
Description: Copanlisib: lyophilisate for reconstitution and further dilution for infusion
Study: NCT04328961

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydroxychloroquine Sulfate
Description: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Ascorbic Acid
Description: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.
Study: NCT02244814

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Low Carbohydrate/Conventional
Description: Lower-carbohydrate/conventional diet (usual care)

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Low Carbohydrate/Conventional
Description: Lower-carbohydrate/conventional diet (usual care)

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Choosing Healthy Options in Carbohydrate Energy
Description: Choosing Healthy Options in Carbohydrate Energy

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Choosing Healthy Options in Carbohydrate Energy
Description: Choosing Healthy Options in Carbohydrate Energy
Study: NCT03735628

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: Nivolumab: concentrate for solution for infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: Nivolumab: concentrate for solution for infusion
Study: NCT04530435

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PEP flute
Description: Participants are advised to use a PEP flute at least three times daily at an appropriate resistance. Ideally, each session consists of 15 breaths (for approximately 1 minute) repeated twice at an upright position.
Study: NCT03735199

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PCL-TCP scaffold
Description: During the surgery, the scaffold will be shaped by cutting and shaving with a scalpel so as to fit the extraction socket snugly at the crestal half to two-thirds aspect. A collagen membrane will be placed over the scaffold at the crestal aspect of the socket. The periosteum of the buccal flap will then be incised to allow a tension-free primary closure with 4/0 Vicryl® suture.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Geistlich Bio-Gide collagen membrane
Description: A collagen membrane will be placed over the crestal aspect of the socket and the periosteum of the buccal flap will be incised to allow a tension-free primary closure with 4/0 Vicryl® suture.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Geistlich Bio-Gide collagen membrane
Description: A collagen membrane will be placed over the crestal aspect of the socket and the periosteum of the buccal flap will be incised to allow a tension-free primary closure with 4/0 Vicryl® suture.
Study: NCT01771692

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Extraction
Description: Extraction of teeth in the lower arch as part of the orthodontic treatment plan

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Extraction
Description: Extraction of teeth in the lower arch as part of the orthodontic treatment plan

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Non extraction
Description: Non extraction in the lower arch as part of the orthodontic treatment plan

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Non extraction
Description: Non extraction in the lower arch as part of the orthodontic treatment plan
Study: NCT00501592

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: INT-747
Description: 25 mg by mouth once daily, 50 mg by mouth once daily

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: INT-747
Description: 25 mg by mouth once daily, 50 mg by mouth once daily

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study: NCT01228760

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASG-5ME
Description: IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASG-5ME
Description: IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASG-5ME
Description: IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASG-5ME
Description: IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASG-5ME
Description: IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASG-5ME
Description: IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASG-5ME
Description: IV
Study: NCT03808493

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-438 OD
Description: TAK-438 OD tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-438 OD
Description: TAK-438 OD tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-438 OD
Description: TAK-438 OD tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-438 OD
Description: TAK-438 OD tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-438
Description: TAK-438 tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-438
Description: TAK-438 tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-438
Description: TAK-438 tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-438
Description: TAK-438 tablet
Study: NCT03741712

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SHR3680
Description: Tablet. Specifications of 80mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SHR2554
Description: Tablet. Specifications of 50mg and 200mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SHR2554
Description: Tablet. Specifications of 50mg and 200mg
Study: NCT01903135

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Blood test analysis in the clinical labs
Description: for specific measurement of plasmatic bicarbonate
Study: NCT01975545

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fluor varnish
Description: Dental varnish will be applied to one anterior superior teeth in a random side.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fluor varnish with nanoparticles
Description: Dental varnish with silver nanoparticles will be applied to one anterior superior teeth in a random side.
Study: NCT02743559

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Mechanical Stimulation using whole body vibration
Description: All participants will undergo whole body vibration (WBV) by standing on the LivMD WBV platform on 5 consecutive mornings
Study: NCT06176443

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: One anastomosis gastric bypass with combined fundoplication
Description: FundoRingOAGB
Study: NCT01903135

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Blood test analysis in the clinical labs
Description: for specific measurement of plasmatic bicarbonate

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Blood test analysis in the clinical labs
Description: for specific measurement of plasmatic bicarbonate
Study: NCT02321917

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: MECC system with rheoparin coating
Description: MECC system for extracorporeal circulation equipped with rheoparin coating.
Study: NCT02986672

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Calanus oil
Description: Omega-3 oil in form of calanus oil
Study: NCT01903135

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Pneumologist consult to establish the diagnosis of OHS
Description: complete respiratory check-up: Arterial blood gases analysis, spirometry, anthropometry, polygraphy or polysomnography.~Medical history, previous treatments.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Pneumologist consult to establish the diagnosis of OHS
Description: complete respiratory check-up: Arterial blood gases analysis, spirometry, anthropometry, polygraphy or polysomnography.~Medical history, previous treatments.
Study: NCT02986672

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Medical Paraffin
Description: 2ml per day
Study: NCT00127452

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: margarine spread
Description: Daily use of margarine spread (approximately 20 grams) during 40 months

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: margarine spread
Description: Daily use of margarine spread (approximately 20 grams) during 40 months

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: margarine spread
Description: Daily use of margarine spread (approximately 20 grams) during 40 months

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: margarine spread
Description: Daily use of margarine spread (approximately 20 grams) during 40 months
Study: NCT04362488

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Preoperative evaluation
Description: Preoperative evaluation using differents clinical evaluation tests, questionnaires, and instrument:~* Delos system (computerized oscillating platform)~* Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires~* modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Postoperative evaluation
Description: Postoperative evaluation at 4 months of follow up after surgery using differents clinical evaluation tests, questionnaires, and instrument:~* Delos system (computerized oscillating platform)~* Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires~* modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)
Study: NCT03682289

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ceralasertib
Description: Given orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ceralasertib
Description: Given orally
Study: NCT02743559

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Mechanical Stimulation using whole body vibration
Description: All participants will undergo whole body vibration (WBV) by standing on the LivMD WBV platform on 5 consecutive mornings
Study: NCT03682289

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ceralasertib
Description: Given orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Olaparib
Description: Given orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Durvalumab
Description: Given intravenously (IV)
Study: NCT00227344

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: RF ablation
Description: Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Antiarrhythmic drugs
Description: Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
Study: NCT02377752

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Olaratumab
Description: Administered IV

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Olaratumab
Description: Administered IV

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Olaratumab
Description: Administered IV

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Olaratumab
Description: Administered IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: Administered IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: Administered IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: Administered IV
Study: NCT03625947

Intervention type: OTHER
Intervention: Argon Plasma Coagulation
Description: Patients will be treated with Argon Plasma Coagulation. Argon plasma coagulation (APC) is a form of non contact electrocoagulation. APC utilizes electrically conductive argon plasma as a medium to deliver high-frequency current via a flexible probe. The argon plasma flow transfers electricity between the probe and the target tissue. Tracheobronchial access is obtained by passing the probe through the working channel of the bronchoscope. On arrival to the tissue, the application of energy causes uniform zones of desiccation, coagulation and devitalization in the areas receiving treatment, thus inducing hemostasis.
Study: NCT01558492

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle
Study: NCT04384484

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Loncastuximab Tesirine
Description: Intravenous Infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Loncastuximab Tesirine
Description: Intravenous Infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Intravenous Infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Intravenous Infusion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rituximab
Description: Intravenous Infusion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Gemcitabine
Description: Intravenous Infusion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxaliplatin
Description: Intravenous Infusion
Study: NCT03323463

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: F-FMISO PET/CT Scan
Description: All subjects on Cohort A and the first 100 subjects accrued to Cohort B will undergo a pre-treatment F-FMISO scan PET/CT scan pretreatment. For both Cohort A and Cohort B, FMISO scan will be repeated between the 5th-10th RT day if pre-treatment scan is hypoxic. If the repeat 18F-FMISOscan PET/CT demonstrates hypoxia, the subject will receive 70Gy concurrent with 2 cycles of chemotherapy. All subjects accrued onto Cohort B after 100 accruals will undergo only one 18F-FMISO scan done 5-10 treatment days after start of radiation therapy.
Study: NCT01104493

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Monovalent Frozen FluMist®
Description: Single dose of monovalent vaccine (240 subjects) by intranasal spray on Study Day 1.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Single dose of placebo (60 subjects) by intranasal spray on Study Day 1
Study: NCT01224431

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Buffered Lidocaine J-tip
Description: All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions were video recorded

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Buffered Lidocaine J-tip
Description: All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions were video recorded
Study: NCT00756860

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AMG 223
Description: 2 g AMG 223 (4 x 500 mg capsules ) TID on Days 1 through 7

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Renagel® (sevelamer hydrochloride)
Description: 2g Renagel® (2 x 800 mg capsules + 1 x 400 mg capsule) TID on Days 1 through 7
Study: NCT01514929

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ACHN-490 Injection
Description: 20mg/kg IV 30 minute infusion given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ACHN-490 Injection
Description: 15mg/kg IV 30 minute infusion given once

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Moxifloxacin
Description: 400mg oral pill given once

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo oral pill given once
Study: NCT01342796

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MF59C.1-adjuvanted subunit influenza vaccine
Description: 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Sub unit, Inactivated, Influenza vaccine
Description: 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
Study: NCT03902574

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Brexpiprazole ODT 2mg with water
Description: Brexpiprazole ODT 2mg is administered with water.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Brexpiprazole ODT 2mg without water
Description: Brexpiprazole ODT 2mg is administered without water.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Brexpiprazole conventional tablet 2mg
Description: Brexpiprazole conventional tablet 2mg is administered with water.
Study: NCT06176443

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: One anastomosis gastric bypass without combined fundoplication
Description: OAGB
Study: NCT02778685

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fulvestrant

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palbociclib
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palbociclib
Description: Given PO

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: Given IV

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: Given IV
Study: NCT02313675

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Acetaminophen
Study: NCT02240251

Intervention type: OTHER
Intervention: Prospective Chart Review
Description: The laser assisted IVC filter removal procedure itself is not part of this study. This is a prospective chart review for patients undergoing this procedure.
Study: NCT03503955

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Leap-Motion virtual reality games
Description: Games that Fizyosoft has prepared on Leap Motion equipment to improve hand and grip activities will be played individually and will focus on running hand, wrist and grip movements

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: fine motor skills activities
Description: activities that stimulate finger movements such as holding, reaching, catching, writing, and strengthening muscles
Study: NCT00556608

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Sinovial® (syringe containing sodium hyaluronate solution)
Description: 2 mL 0.8% sodium hyaluronate (16 mg) solution. 3 intra-articular injections once-a-week.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Synvisc® ( syringe containing Hylan G-F 20 solution)
Description: 2 mL 0.8% Hylan G-F 20 (16 mg) solution. 3 intra-articular injections once-a-week.
Study: NCT04123093

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Noxsano Bandage (Healthy Volunteers)
Description: Healthy volunteers will wear the study device (Noxsano Bandage) for 3 consecutive days (up to 72 hours), followed by weekly visits for 4 weeks of observation for tolerance, side effects, and/or adverse reactions.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Noxsano Bandage (Wound Care)
Description: Wound care subjects will have weekly study device (Noxsano Bandage) applications to a specific ulceration. For subjects that exhibit any reduction in wound surface area, this application will occur until the wound is healed, or for up to 3 months (whichever occurs first). For subjects that do not exhibit any reduction in wound size at 2 months, application will stop and standard treatment protocols will be pursued. At the conclusion of the treatment window (up to 3 months), subjects will be followed every 3 months for 12 consecutive months for observation of late side effects or adverse reactions (3 months of active treatment, 12 months of follow-up observation, 15 months total).
Study: NCT03723330

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: plant sterols
Description: Consumption a healthy eating pattern diet with a plant sterols-enriched food product

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: healthy diet
Description: Compliance with a healthy diet in accordance to the recommendation by the Singapore Health Promotion Board.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: healthy diet
Description: Compliance with a healthy diet in accordance to the recommendation by the Singapore Health Promotion Board.
Study: NCT02855866

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: thyroidectomy

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: thyroidectomy
Study: NCT03074591

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ferric Carboxymaltose 50Mg/Ml Inj 15Ml
Description: After baseline assessments patients will be randomised in a 1:1 ratio to receive Ferric Carboxymaltose IV or placebo/saline (normal saline: 0.9% w/v NaCl). In the Treatment group, Ferric Carboxymaltose will be administered according to the dosing schedule.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Saline Solution for Injection
Description: In the placebo/saline group, patients will receive the aequivalent number of normal saline infusions.
Study: NCT02313675

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketorolac Tromethamine