TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04117581

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Vitamin D3
Description: 5000 IU (125 μg) vitamin D3 capsules daily over 12 weeks (84 days)

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Inert filler capsules daily over 12 weeks (84 days)
Study: NCT00712036

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Interim
Description: Methadone maintenance with emergency counseling only for up to 4 months

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Comprehensive
Description: Methadone treatment with counseling as usual

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Restored
Description: Methadone maintenance with counseling provided by a clinician with a lower than usual caseload
Study: NCT00703521

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Rabies vaccine
Description: 1.0 mL IM day 0,7,28 and 1 year
Study: NCT03775343

Intervention type: DIAGNOSTIC_TEST
Intervention: Neurocognitive Test Battery
Description: neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.

Intervention type: DIAGNOSTIC_TEST
Intervention: Neurocognitive Test Battery
Description: neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.

Intervention type: DIAGNOSTIC_TEST
Intervention: Neurocognitive Test Battery
Description: neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.

Intervention type: DIAGNOSTIC_TEST
Intervention: Blood sampling
Description: Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid

Intervention type: DIAGNOSTIC_TEST
Intervention: Blood sampling
Description: Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid
Study: NCT00969644

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Somatropin
Description: s.c injections once daily 10-30 mícrogram/kg/day

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pegvisomant
Description: s.c. injections once daily (10-15 mg/day)
Study: NCT03655054

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: eCoin Tibial Nerve Stimulation
Description: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Study: NCT03077438

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate
Description: 0.5 milliliter (mL), Intramuscular
Study: NCT00003479

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Description: Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).
Study: NCT01890850

Intervention type: OTHER
Intervention: Retrospective database study using administrative claims data
Description: Data collection from OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans.

Intervention type: OTHER
Intervention: Retrospective database study using administrative claims data
Description: Data collection from OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans.
Study: NCT03124875

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: LimFlow System
Description: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.
Study: NCT04840537

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP
Description: endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage
Study: NCT01371812

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK2239633
Description: Drug will be orally administered at the doses and time points detailed in the 'arms' section.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK2239633
Description: Drug will be orally administered at the doses and time points detailed in the 'arms' section.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo will be orally administered to 4 subjects in each treatment period of each cohort.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo will be orally administered to 4 subjects in each treatment period of each cohort.
Study: NCT03102255

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Sniffing position
Description: All procedure is done under sniffing position.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Sniffing position
Description: All procedure is done under sniffing position.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Nasal tip lifting
Description: Before inserting the endotracheal tube to patient's nose, the researcher lift up the nose tip.
Study: NCT01293175

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Whole grains
Description: Subjects will consume whole grains at dose of 80 g/die, for two months
Study: NCT03415841

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: mHealth remote monitoring devices
Description: Blood Pressure and wearable vital signs monitor, Biovotion and Kardia mobile application
Study: NCT03766555

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Microwave ablation
Description: Microwave ablation will be performed in operation theatre under general anesthesia via laparoscopic or open approach according to the tumors' locations. In case of open approach, it will be done via a right subcostal incision with possible upper midline extension was necessary. After diagnostic laparoscopy in laparoscopic approach and exploratory laparotomy in open approach to exclude the presence of extra-hepatic disease, operative ultrasound (Aloka, Tokyo, Japan) will be performed to exclude preoperatively undetected lesion; guide insertion of the microwave applicator; and monitor the whole ablation process. Surrounding organs were cooled by constant irrigation of ice-cold saline to prevent thermal injury. The ablation will be carried out according to the standard protocol with the aim to create a 1cm ablation margin around the tumor. The insertion track will be burnt after ablation in order to prevent bleeding and tumor seeding.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Liver resection
Description: Liver resection will be performed as described previously. Liver parenchymal transection would be performed with CUSA (cavitron ultrasonic surgical aspirator) and TissueLink (a radiofrequency saline-linked dissecting sealer) in both arms. Vascular staplers would be used to divide major vascular pedicles. Fibrin glue (Tisseel) spray would be applied to the parenchymal cut surface of the liver before closure of abdomen.
Study: NCT00569699

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: S-1, Bevacizumab
Description: S-1 is administered orally on days 1 to 28 of a 42-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA \<1.25 m2), 50 mg (BSA \>1.25 to \<1.50 m2), or 60 mg (BSA \>1.50 m2).~Bevacizumab 5 mg/kg (body weight) is administered by intravenous infusion on days 1, and 15.
Study: NCT03077438

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Description: 0.5 mL, Intramuscular
Study: NCT00811798

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cervarix
Description: Subjects will receive three doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Study: NCT01676844

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oral thin film therapy (Potassium acid phosphate oral thin films)
Description: Orally dissolving thin film. White, square oral thin film. 15 mm x 15 mm surface area. 1-2 mm film thickness. No markings.~Place a single OTF on the tongue, inside cheek or palate and allow to dissolve.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Standard therapy (Potassium acid phosphate oral solution)
Description: Each millilitre contains approximately 136mg Monobasic Potassium Phosphate Ph.Eur. (KH2PO4) equivalent to 1mmol Potassium (39mg) and 1mmol Phosphate (31mg Phosphorus). Manufacturer: Specials Products Ltd., Surrey, UK.
Study: NCT03547869

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Active tDCS
Description: Active tDCS will be adminestered

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Sham tDCS
Description: Sham tDCS will be administered
Study: NCT03682445

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: exercise
Description: Aerobic tyep of exercise will be made at different intensities in 2 groups.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: exercise
Description: Aerobic tyep of exercise will be made at different intensities in 2 groups.
Study: NCT03849898

Intervention type: PROCEDURE
Intervention: Surgery
Description: Surgical fracture treatment

Intervention type: OTHER
Intervention: Non-Surgical fracture treatment
Description: Non-Surgical fracture treatment
Study: NCT02173327

Intervention type: DEVICE
Group type: OTHER
Intervention: Continuously helm CPAP
Description: 6 hours

Intervention type: DEVICE
Group type: OTHER
Intervention: Intermittent Mask CPAP
Description: 10min every 2 hour for 18 hours
Study: NCT01980368

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Educational Intervention
Description: Receive readings and attend book club

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise Intervention
Description: Receive Tai Chi Easy class, DVD, and exercise manual

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Questionnaire Administration
Description: Ancillary studies
Study: NCT01621477

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: clofarabine
Description: Given on Day -9 and Day -8 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Description: Given on Day -9 and Day -8 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent
Study: NCT01073891

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Moxifloxacin (Avelox, BAY12-8039)
Description: Single oral dose of moxifloxacin (Avelox, BAY12-8039) IR (immediate release) tablet 400 mg under fasting conditions

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Moxifloxacin (BAY12-8039)
Description: Single oral dose of moxifloxacin (BAY12-8039) oral suspension 400 mg under fasting conditions

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Moxifloxacin (BAY12-8039)
Description: Single oral dose of moxifloxacin (BAY12-8039) oral suspension 400 mg under fed conditions
Study: NCT03647982

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meditoxin
Description: injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meditoxin
Description: injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meditoxin
Description: injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meditoxin
Description: injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meditoxin
Description: injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meditoxin
Description: injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Botox
Description: injection of Botox into the intradermal of each contralateral upper back in equal doses
Study: NCT02808052

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Minocin (minocycline) for Injection
Description: 200mg IV Minocin given over 1 hour
Study: NCT02439151

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: New lung ventilation strategy
Description: New ventilation strateg: pressure assist control mode; inspiratory pressure was lowered to keep Ppeak less than 25cmH2O; set the PEEP at such a level that expiratory transpulmonary pressure stays between 0 and 5 cmH2O; respiratory rate of 10 breaths per minute; FiO2 less than 0.5.

Intervention type: DEVICE
Group type: OTHER
Intervention: Conventional ventilation strategy
Description: Conventional ventilation strategy: pressure assist control mode; keep the Ppeak between 20 and 25 cmH2O; set PEEP between 10 and 15 cmH2O; respiratory rate of 10 breaths per minute; FiO2 less than 0.5.
Study: NCT02689739

Intervention type: PROCEDURE
Intervention: venous duplex ultrasound
Description: Venous duplex ultrasound

Intervention type: PROCEDURE
Intervention: venous duplex ultrasound
Description: Venous duplex ultrasound
Study: NCT03386136

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 100% Oxygen
Description: To provide hospitalized ileus or pseudo-obstruction patient with 100% oxygen via non-rebreather face mask, for 6 hours
Study: NCT01184638

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sevoflurane
Description: 1-8% sevoflurane for maintaining the whole period of general anesthesia

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Propofol
Description: 1-4 mg/kg/h of propofol during the whole period of general anesthesia
Study: NCT02578966

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Motivational Interview

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Traditional health education
Study: NCT03647982

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Botox
Description: injection of Botox into the intradermal of each contralateral upper back in equal doses

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Botox
Description: injection of Botox into the intradermal of each contralateral upper back in equal doses

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Botox
Description: injection of Botox into the intradermal of each contralateral upper back in equal doses

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Botox
Description: injection of Botox into the intradermal of each contralateral upper back in equal doses

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Botox
Description: injection of Botox into the intradermal of each contralateral upper back in equal doses
Study: NCT00299975

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MaZiRenWan (MZRW) Low dose
Description: Dissolved MaZiRenWan (MZRW) granule (2.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MaZiRenWan (MZRW) Median dose
Description: Dissolved MaZiRenWan (MZRW) granule (5.0g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MaZiRenWan (MZRW) High dose
Description: Dissolved MaZiRenWan (MZRW) granule (7.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
Study: NCT03545165

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 177Lu-PSMA-617
Description: \[1.85 GBq (50 mCi) - 9.25 GBq (250 mCi)\]

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 177Lu-J591
Description: \[1.35 GBq/m2 or 36.5 mCi/m2\]

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 68Ga-PSMA-HBED-CC
Description: \[185 ±74MBq or 5 ±2 mCi\]
Study: NCT02637739

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: hysteroscope
Description: Women of PUL with β-hCG \> 1000 IU/L or abnormal β-hCG trend (increase \< 66% or decrease \< 15%) were offered HSC.
Study: NCT01621477

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: busulfan
Description: Given on Day -7 and Day -6 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Plerixafor
Description: Given on Day -7 and Day -6 (Day 0 is first stem cell infusion). Drug class: Hematopoietic Stem Cell Mobilizer

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cyclophosphamide
Description: Given on Day -5 and Day +4 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent; immunosuppressive agent.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: antithymocyte globulin (rabbit)
Description: Given on Day -4, Day -3, Day -2, and Day -1 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: stem cells
Description: Patients undergo T cell replete Hematopoietic stem cell infusion on Day 0 and Day +1. Patients undergo natural killer (NK) cell transplantation on day +6 (Day 0 is first stem cell infusion).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tacrolimus
Description: Given on Day +11 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mycophenolate mofetil
Description: Given on Day +11 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent.
Study: NCT00789997

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prednisone
Description: prednisone 40 mg daily for 10 days or placebo prednisone

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etanercept
Description: etanercept 50 mg subcutaneous given on the day of randomization and one week later or placebo subcutaneous injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: levofloxacin
Description: Levofloxacin 750 mg daily for 10 days.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: levofloxacin
Description: Levofloxacin 750 mg daily for 10 days.
Study: NCT04019574

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CR845 0.5 mcg/kg IV
Description: 0.5 mcg/kg IV CR845

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CR845 3 mcg/kg IV
Description: 3 mcg/kg IV CR845

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Moxifloxacin 400 mg Oral Tablet
Description: 400 mg Oral Moxifloxacin
Study: NCT06801951

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: acute resistance exercise with oral nutrition supplementation
Description: acute bout of resistance exercise on an isokinetic exercise machine of each limb (i.e., right and left arm and right and left leg) allowing control of velocity and force. Immediately upon completion, 1 serving of liquid nutrition supplement will be consumed. An additional serving of the liquid nutrition supplement will be sent home for consumption in the evening.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: acute resistance exercise with oral nutrition supplementation
Description: acute bout of resistance exercise on an isokinetic exercise machine of each limb (i.e., right and left arm and right and left leg) allowing control of velocity and force. Immediately upon completion, 1 serving of liquid nutrition supplement will be consumed. An additional serving of the liquid nutrition supplement will be sent home for consumption in the evening.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: stable tracer infusion
Description: stable isotopes Such as L-\[ring-13C6\]-Phenylalanine, L-\[ring-D4\]Tyrosine, L-\[Methyl-D3\]Tau-Methylhistidine, trans-\[2,5,5-D3\]4-Hydroxy-L-proline, L-\[Guanido-15N2\]-Arginine, L-\[4,4,5,5-D4-5-13C\]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-\[1,2-13C2\]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-\[methyl-D3\]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-\[3,3,4,4-D4\]Homocysteine, L-\[1,2-13C2\]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-\[Dimethyl-13C2\]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-\[3,4-methyl-13C3\]isovaleric acid, 13C3-glycerol is given IV simultaneously

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: stable tracer infusion
Description: stable isotopes Such as L-\[ring-13C6\]-Phenylalanine, L-\[ring-D4\]Tyrosine, L-\[Methyl-D3\]Tau-Methylhistidine, trans-\[2,5,5-D3\]4-Hydroxy-L-proline, L-\[Guanido-15N2\]-Arginine, L-\[4,4,5,5-D4-5-13C\]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-\[1,2-13C2\]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-\[methyl-D3\]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-\[3,3,4,4-D4\]Homocysteine, L-\[1,2-13C2\]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-\[Dimethyl-13C2\]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-\[3,4-methyl-13C3\]isovaleric acid, 13C3-glycerol is given IV simultaneously
Study: NCT06801977

Intervention type: GENETIC
Intervention: Genome-wide genotyping
Description: Whole blood from the participants was used to extract DNA for genotyping.

Intervention type: GENETIC
Intervention: Genome-wide genotyping
Description: Whole blood from the participants was used to extract DNA for genotyping.
Study: NCT04258033

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PLB1001
Description: PLB1001 is a capsule in the form of 25 mg and 100mg, twice daily.
Study: NCT01381315

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Injection of isotope
Description: On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur \<3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in any of the above mentioned scenarios.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Axillary lymph node dissection
Description: The one-year lymphedema rate among subjects undergoing axillary lymph node dissection with or without sentinel lymph node biopsy is ≥ 0.13. With our sample size of 58 subjects undergoing ALND, we will reject that hypothesis in favor of the alternative-that the lymphedema rate is \<0.13 for subjects undergoing ALND-if lymphedema is confirmed in three or fewer (ie, 0, 1, 2, or 3) subjects.