TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03633318

Intervention type: DEVICE
Intervention: electrical impedance myography (EIM)
Description: EIM is a measure of impedance. EIM is a measure of the obstruction of flow of current through the tissue. It is a completely painless assessment of muscle health.

Intervention type: DEVICE
Intervention: electrical impedance myography (EIM)
Description: EIM is a measure of impedance. EIM is a measure of the obstruction of flow of current through the tissue. It is a completely painless assessment of muscle health.
Study: NCT01512355

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine
Description: After, induction of general anesthesia, dexmedetomidine 0.2 mcg/kg/hr continuous intravenous infused during the surgery

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo group
Description: normal saline_02mcg/kg/hr
Study: NCT00722514

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: patient education
Description: * complex individual antiinflammatory rehabilitation program during inpatient rehabilitation (physiotherapy, physical therapy, occupational therapy, health-promoting measures and more) and additionally~* Patient education 6 x 90 Minutes

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Standard Care
Description: * complex individual antiinflammatory rehabilitation program during inpatient~* complex individual medical rehabilitation (physiotherapy, physical therapy, occupational therapy, health-promoting measures and more) and additionally~* further 6 treatments from available disciplines(e.g. massage, electrotherapy, bath)
Study: NCT01539902

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Human Umbilical Cord derived MSCs
Description: Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Cyclophosphamide
Description: Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis
Study: NCT03821285

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Pulmonary Rehabilitation
Description: Pulmonary rehabilitation programme:15 aerobic-training sessions, 15 strength-training sessions for peripheral muscles, 3 face to face and/or Group educational sessions, if needed airways clearance techniques and/or inspiratory muscles training
Study: NCT02933645

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Actrapid
Description: Subjects administer 2 intranasal sprays into each nostril every minute for 4 minutes, a total of 16 sprays or 160 IU of fast-acting human insulin (Actrapid, Novo Nordisk A/S, Bagsvaerd, Denmark). The glass spray flasks are produced by AeroPump GmBH, Germany and give 0,1 ml of fluid per spray.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects administer 2 intranasal sprays into each nostril every minute for 4 minutes, a total of 16 sprays. Sprays contain Insulin Diluting Medium for Novorapid and Levemir (Novo Nordisk A/S, Bagsvaerd, Denmark). The glass spray flasks are produced by AeroPump GmBH, Germany and give 0,1 ml of fluid per spray. To account for the small amount of insulin absorbed into circulation after the insulin nasal sprays, on the placebo day subjects will be administered 2.5 mU/kg of additional intravenous insulin (Actrapid, Novo Nordisk A/S, Bagsvaerd, Denmark) over 15 minutes.

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: [18F]-FDG PET-CT
Description: All subjects will undergo two positron emission tomography (PET) studies. On both visits they are injected with 185 MBq \[18F\]-fluorodeoxyglucose and scanned with a combined PET and computed tomography scanner.

Intervention type: RADIATION
Group type: PLACEBO_COMPARATOR
Intervention: [18F]-FDG PET-CT
Description: All subjects will undergo two positron emission tomography (PET) studies. On both visits they are injected with 185 MBq \[18F\]-fluorodeoxyglucose and scanned with a combined PET and computed tomography scanner.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hyperinsulinemic euglycemic clamp
Description: All subjects will undergo two hyperinsulinemic euglycemic clamp studies. The insulin infusion will be administered intravenously at a steady rate of 0.25 mU/kg/min for approximately 170 minutes. Glucose will be administered intravenously as a 200 mg/ml fluid to at varying rate to maintain euglycemia.
Study: NCT00936468

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone
Description: One vaccination on Day 0 of Fluzone® vaccine at 45ug mixed with one of three doses (3.75ug, 7.5ug, 25ug) of JVRS-100 adjuvant versus Fluzone® vaccine at 45ug alone.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone
Description: One vaccination on Day 0 of Fluzone® vaccine at 45ug mixed with one of three doses (3.75ug, 7.5ug, 25ug) of JVRS-100 adjuvant versus Fluzone® vaccine at 45ug alone.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone
Description: One vaccination on Day 0 of Fluzone® vaccine at 45ug mixed with one of three doses (3.75ug, 7.5ug, 25ug) of JVRS-100 adjuvant versus Fluzone® vaccine at 45ug alone.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone
Description: One vaccination on Day 0 of Fluzone® vaccine at 45ug mixed with one of three doses (3.75ug, 7.5ug, 25ug) of JVRS-100 adjuvant versus Fluzone® vaccine at 45ug alone.
Study: NCT01471197

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Ipilimumab
Description: Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Pemetrexed
Description: IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
Study: NCT00104650

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: AMG 162- 180 mg q 4 weeks
Description: A 180 mg AMG 162 (SC) administered every 4 weeks for 6 doses in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 4 weeks for 26 doses.
Study: NCT01049529

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Docosahexaenoic acid
Description: DHA have oil form. Each neonate is receiving 75 mg/kg/day of DHA in 188 uL/kg/day in two doses per day, since two days before surgery and over six days following cardiovascular surgery

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo have oil form. Each neonate is receiving 188uL/kg/day of sunflower oil as placebo in two doses per day, since two days before surgery and over six days following cardiovascular surgery
Study: NCT01732315

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Email Notification
Description: This study will use a targeted email reminder/recall intervention that addresses specific aspects of adolescent under-immunization.
Study: NCT02698514

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sevoflurane
Description: Anesthesia was maintained with sevoflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Desflurane
Description: Anesthesia was maintained with desflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
Study: NCT02933645

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Hyperinsulinemic euglycemic clamp
Description: All subjects will undergo two hyperinsulinemic euglycemic clamp studies. The insulin infusion will be administered intravenously at a steady rate of 0.25 mU/kg/min for approximately 170 minutes. Glucose will be administered intravenously as a 200 mg/ml fluid to at varying rate to maintain euglycemia.
Study: NCT03470090

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Neuromuscular Exercises
Description: In the experimental group, the subjects who were taken into the study were taken to the neuromuscular exercise (NME) program after the pre-treatment evaluations. The subjects in this group were given classical physiotherapy and NME performed 6 days a week, 1 set of 10 times physiotherapist control. NME was including warming, neuromuscular exercises (balance, muscle strengthening, proprioception, sensorimotor system training, joint stabilization and postural control exercises) and cooling periods.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Conventional Group
Description: In the control group, the subjects who were taken into the study were taken to the classical physiotherapy (hotpack (HP), ultrasound (US), transcutaneous electrical stimulation (TENS)) and conventional exercises program after the pre-treatment evaluations.
Study: NCT04045379

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: LASER
Description: Use of the SmartXide Touch V²LR, Co2 Laser System to perform ambulatory intravaginal and vulvar application of LASER, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the LASER will be applied, according to the protocol of the manufactured.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Microablative Radiofrequency
Description: Use of Linly™ equipment to perform ambulatory intravaginal and vulvar application of fractionated microablative radiofrequency, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the radiofrequency will be applied, according to the protocol of the manufactured.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Estriol
Description: The patient will perform self application of this vaginal estriol daily for 2 weeks and after that the applications will occur twice a week.
Study: NCT03275285

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: isatuximab SAR650984
Description: Pharmaceutical form: solution for infusion~Route of administration: intravenous

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: carfilzomib
Description: Pharmaceutical form: solution for infusion~Route of administration: intravenous

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: carfilzomib
Description: Pharmaceutical form: solution for infusion~Route of administration: intravenous

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: dexamethasone
Description: Pharmaceutical form: tablets or solution for infusion~Route of administration: oral or intravenous

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dexamethasone
Description: Pharmaceutical form: tablets or solution for infusion~Route of administration: oral or intravenous
Study: NCT01653639

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Description: 50 IU/kg single dose using the 3000 IU vial size (600 IU/ml)

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Description: 50 IU/kg single dose using the 2000 IU vial size (400 IU/ml)
Study: NCT01397461

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: ozenoxacin placebo
Description: cream

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: retapamulin 1% ointment
Description: ointment

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ozenoxacin 1% cream
Description: 1% cream
Study: NCT04827888

Intervention type: PROCEDURE
Intervention: Orthopaedic surgery
Description: One of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486).

Intervention type: PROCEDURE
Intervention: Orthopaedic surgery
Description: One of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486).

Intervention type: PROCEDURE
Intervention: Orthopaedic surgery
Description: One of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486).

Intervention type: PROCEDURE
Intervention: Orthopaedic surgery
Description: One of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486).

Intervention type: PROCEDURE
Intervention: Orthopaedic surgery
Description: One of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486).
Study: NCT03632772

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Solifenacin 5Mg
Description: We compared the safety and therapeutic efficacy between Solifenacin and Mirabegron in men with benign prostate hyperplasia and having overactive bladder symptoms immediately after Transurethral Resection of the Prostate.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mirabegron 50 MG
Description: We compared the safety and therapeutic efficacy between Solifenacin and Mirabegron in men with benign prostate hyperplasia and having overactive bladder symptoms immediately after Transurethral Resection of the Prostate.
Study: NCT01131325

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nilotinib
Description: All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours
Study: NCT05722756

Intervention type: OTHER
Intervention: craniosacral therapy
Description: subtle form of applied touch, type of osteopathy
Study: NCT02637999

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEG IFN alfa-2a

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEG IFN alfa-2a
Study: NCT01884896

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Metoprolol Succinate ER Tablet 200 mg
Description: 1 \* 200 mg tablet per day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metoprolol Succinate ER Tablet 200 mg
Description: 1 \* 200 mg tablet per day

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 'TOPROL-XL®' ER Tablets 200 mg
Description: 1 \* 200 mg tablet per day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 'TOPROL-XL®' ER Tablets 200 mg
Description: 1 \* 200 mg tablet per day
Study: NCT00921791

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: HBPM
Description: Automatic oscillometric device for home blood pressure measurement and usual care.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: HBPM and Pharmaceutical care
Description: Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Pharmaceutical care
Description: consultations with the pharmacists

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Usual care
Description: Consultation with the physician.
Study: NCT02436616

Intervention type: DEVICE
Intervention: microEEG
Description: microEEG is a miniature, wireless, and battery-powered EEG device used to obtain EEG recording in challenging environment. All infants have an initial EEG at study enrollment. Follow up microEEGs will be performed at approximately 2-4 week intervals, depending on the Corrected Gestational Age (CGA).~If ABD events have not resolved at 34 weeks, an 8 hour recording will be performed prior to discharge or at 42 weeks CGA, whichever comes first. EEG will be assessed in 3 hour epochs. The EEG will be reviewed off line by two blinded neurologists and classified as normal or abnormal based on CGA and other findings. Follow up EEGs will be scored similarly, with emphasis on maturation.
Study: NCT03374579

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Fluid challenge
Description: Fluid challenge and measure change in co2 gap
Study: NCT00845351

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bexarotene
Description: bexarotene at 300 mg/m2/day
Study: NCT02637999

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: PEG IFN alfa-2a

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Myrcludex B

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Myrcludex B
Study: NCT01922141

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aliskiren
Description: Aliskiren 150 mg and aliskiren 300 mg tablets will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aliskiren
Description: Aliskiren 150 mg and aliskiren 300 mg tablets will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amlodipine
Description: Amlodipine 5 mg/10 mg will also be blinded and supplied centrally. For Aliskiren dual therapy arm , Amlodipine is in the regimen; where as for monotherapy arms, Amlodipine is an optional add-on therapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amlodipine
Description: Amlodipine 5 mg/10 mg will also be blinded and supplied centrally. For Aliskiren dual therapy arm , Amlodipine is in the regimen; where as for monotherapy arms, Amlodipine is an optional add-on therapy.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Amlodipine
Description: Amlodipine 5 mg/10 mg will also be blinded and supplied centrally. For Aliskiren dual therapy arm , Amlodipine is in the regimen; where as for monotherapy arms, Amlodipine is an optional add-on therapy.
Study: NCT02042807

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: MCS®

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: MCS®
Study: NCT03392922

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Uniblocker
Description: The BBs have more advantages than DLT: easier insertion especially in patients with difficult airway18 and no need to exchange the tube when mechanical ventilation is required after surgery.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Left-sided Double-lumen Tube
Description: the double-lumen tube (DLT) is the most commonly used device for OLV
Study: NCT00594334

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Risedronate
Description: Weekly Risedronate
Study: NCT02381366

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
Description: Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells:~Dose A: 10 million cells per kg / Dose B: 20 million cells per kg
Study: NCT02088359

Intervention type: OTHER
Intervention: Cycled light
Description: We covered the incubator with blanket for darkness approximately 12 hours.

Intervention type: OTHER
Intervention: Continue near darkness
Description: We covered the incubator with blanket all days.
Study: NCT02840019

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Investigational MRI coil designed for pregnant women
Description: The investigational MRI receiver coil designed specifically for pregnant women will be used during the 60 minute full research MRI scan. An MRI receiver coil is part of the MRI machine that is placed over the body part being imaged during every MRI scan. A coil is required to obtain MR images, yet there isn't one designed for pregnant women. This investigational MRI receiver coil for pregnant women will be tested to see if it helps improve image quality and take images faster.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: MRI Scan
Description: All participants will participate in an MRI scan. The add-on MRI scan will be 15 minutes. The full MRI scan will be 60 minutes.
Study: NCT03001141

Intervention type: OTHER
Intervention: Observational
Description: Device: MultiPoint Pacing will be enabled in enrolled patients at the discretion of the physician.
Study: NCT03344458

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TransCon hGH
Description: Once weekly subcutaneous injection of TransCon hGH
Study: NCT01133600

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cubicin
Description: dosed at 6 mg/kg body weight intravenously every 24 hours with a reduction to 6mg/kg every other day if CrCl is \<30ml/min.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Vancomycin
Description: dosed at 15mg/kg intravenously every 12 hours with adjustments for renal function.
Study: NCT01922141

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ramipril
Description: Ramipril 5 mg and ramipril 10 mg capsules will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydrochlorothiazide
Description: Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally. It is an optional add-on to each arm.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydrochlorothiazide
Description: Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally. It is an optional add-on to each arm.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hydrochlorothiazide
Description: Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally. It is an optional add-on to each arm.