TrialPanorama/Dataset huggingface dataset:
Please assess the completion status of the following clinical trial:

Trial Title: A Low ChloridE hyperTonic Solution for Brain Edema

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Spontaneous SAH with an identified aneurysmal source as identified on neuroimaging obtained at admission to Emory University Hospital or with imaging at an outside hospital~* Age ≥ 18 years~Exclusion Criteria:~* SAH related to non-aneurysmal vascular anomaly~* SAH thought due to trauma~* SAH occurring in relation to another medical procedure (cardiac catheterization, LVAD placement, etc.)~* SAH with a negative workup for cause (angio-negative)~* Patients who arrive in a brain-death state or in a devastating clinical status that will be presumed to lead to brain death or early withdrawal of treatment~* Patient who suffer from end-stage renal disease at baseline and who are routinely treated with dialysis~* Known pregnancy

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Sodium chloride /sodium acetate (16.4%) (Type: EXPERIMENTAL): 50cc doses of sodium-chloride/sodium-acetate (16.4%) along with 30cc bag of dummy solution (PlasmaLyte).
- Sodium chloride (23.4%) (Type: ACTIVE_COMPARATOR): 30cc per dose of sodium chloride (23.4%) along with 50cc dummy solution bag (PlasmaLyte)

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients

Study Design Characteristics:
- Allocation: None
- Intervention Model: None
- Observational Model: CASE_ONLY
- Primary Purpose: None
- Time Perspective: PROSPECTIVE
- Masking: None
- Phase: None
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* Morbidly obese patients undergoing elective laparoscopic roux-en-Y gastric bypass~Exclusion Criteria:~* Prior history of gallbladder surgery

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Ultrasound Study Group (Type: None): Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Type 2 Diabetes.~* Treated with a sulfonylurea for at least 2 months.~* Inadequate blood sugar control.~* Are not on any other medications to lower blood sugar.~* No major heart, liver or kidney problems.~* Women not pregnant or breast feeding.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 77 Years
- Healthy Volunteers: f

Study Arms:
- Saxagliptin 2.5 mg + Glyburide 7.5 mg (A) (Type: EXPERIMENTAL): Metformin 500-2500 mg (as needed)
- Saxagliptin 5 mg + Glyburide 7.5 mg (B) (Type: EXPERIMENTAL): Metformin 500-2500 mg (as needed)
- Placebo + Glyburide 7.5 mg (C) (Type: PLACEBO_COMPARATOR): Metformin 500-2500 mg (as needed)

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery?

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Children and adolescents (age 10-21 yr) for elective Idiopathic scoliosis corrective surgery; posterior repair.~Exclusion Criteria:~* Preexisting coagulopathy, (INR\>1.4, PTT\>1.4xN, PT\>1.4xN, platelet count\<150,000/mm3), severe hematological disorders, hepatic failure, or renal failure. Ingestion of acetylsalicylate within 14 days or NSAIDs within 2 days of the scheduled surgery date; history of prior blood transfusion. Pre-donation of autologous blood. Patients having anterior-posterior repair.

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: 21 Years
- Healthy Volunteers: t

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery.
- Tranexamic acid (Type: ACTIVE_COMPARATOR): Tranexamic acid 100 mg/ml; 50 mg/kg loading dose = 0.5 ml/kg LD given over 15 minutes and 10 mg/kg/hr = 0.1 ml/kg/hr infusion for the duration of the surgery.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of gMG \[Myasthenia Gravis Foundation of America (MGFA) Class II-IVa\] at Screening~* Positive serology for acetylcholine receptor (AChR) autoantibodies~* QMG score ≥ 12 at Screening and Randomization~* No change in corticosteroid dose for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period~* No change in immunosuppressive therapy, including dose, for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period~Exclusion Criteria:~* Thymectomy within 6 months prior to Randomization or scheduled to occur during the 12 week Treatment Period~* History of meningococcal disease~* Current or recent systemic infection within 2 weeks prior to Randomization or infection requiring intravenous (IV) antibiotics within 4 weeks prior to Randomization

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- 0.1 mg/kg zilucoplan (RA101495) (Type: EXPERIMENTAL): None
- 0.3 mg/kg zilucoplan (RA101495) (Type: EXPERIMENTAL): None
- Placebo (Type: PLACEBO_COMPARATOR): None

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Age 14\~60 years old~* Allogenic hematological stem cell transplantation(HSCT) patients.~* Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or Alanine aminotransferase \< 2 upper limit of normal, and/or total bilirubin \< 2.5 upper limit of normal, creatinine \< upper limit of normal.~* Informed consent.~Exclusion Criteria:~* Evidence of proven, probable or possible fungal infection at the time of enrollment.~* Patients were receiving anti-fungal treatment with proven SFI before transplantation.~* A history of hypersensitivity to G-CSF or GM-CSF.

- Gender: ALL
- Minimum Age: None
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- rhGM-CSF group (Type: EXPERIMENTAL): subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) once daily
- rhG-CSF+rhGM-CSF group (Type: ACTIVE_COMPARATOR): a combination of 2-3μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) and 2-3μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) each
- rhG-CSF group (Type: ACTIVE_COMPARATOR): subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) once daily

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: None
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* 18 to 75 years old at time of surgery - adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patient.~* Elective spine surgery~* Two levels laminectomies or above with or without fusion or instrumentatioN~* General anesthesia~* Surgery performed at Cleveland Clinic with informed consent signed prior to sedation or anesthesia - consistent surgical team~Exclusion Criteria:~* contraindication to lidocaine such as substantial hepatic impairment (ALT or AST more than twice normal)~* renal impairment (serum creatinine \>2 mg/dl),~* seizure disorder requiring medication within 2 years~* planned epidural anesthesia or analgesia

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Perioperative placebo IV infusion besides the standard anesthesia care, including general anesthesia and postoperative patient controlled analgesia.
- Lidocaine (Type: ACTIVE_COMPARATOR): Perioperative intravenous lidocaine infusion besides the standard anesthesia care, including general anesthesia plus and post operative patient controlled analgesia.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE4
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* (ASA 1\&2),~* aging 18 to 65 years~* having anxiety VAS score of more than 2~* posted for general anaesthesia with estimated duration of \< 3 hours.~Exclusion Criteria:~* patients taking analgesics, sedatives, antiepileptics or antidepressants,~* suffering from obesity (BMI ≥ 28) or neuropsychiatric disease,~* having allergy to the study drugs

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: t

Study Arms:
- Melatonin (Type: PLACEBO_COMPARATOR): Premedication with 3 mg melatonin (Meloset) tablet orally 1-2 hour prior to anesthesia
- melatonin and alprazolam premedication (Type: PLACEBO_COMPARATOR): Premedication with 3 mg melatonin and 0.5 mg alprazolam (Stresnil) tablet orally 1-2 hrs prior to anesthesia
- alprazolam premedication (Type: PLACEBO_COMPARATOR): Premedication with 0.5 mg alprazolam (Alprax) tablet orally 1-2 hr prior to anesthesia
- placebo premedication (Type: ACTIVE_COMPARATOR): Premedication with a similar looking placebo tablet orally 1-2 hr prior to anesthesia

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Female from 9 to 15 years old.~* Good physical health.~Exclusion Criteria:~* Known allergy to any vaccine component.~* History of severe allergic reaction.~* Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.~* Pregnant subject.~* Immunocompromised or immunodeficient subject.~* Splenectomy.~* Receipt of medication / vaccine that may interfere with study assessment.~* Fever~* History of a positive test for HPV, prior receipt of HPV vaccine or prior participation to HPV trial.~* Any condition that might interfere with study assessment.

- Gender: FEMALE
- Minimum Age: 9 Years
- Maximum Age: 15 Years
- Healthy Volunteers: t

Study Arms:
- V503 (Type: EXPERIMENTAL): 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
- GARDASIL (Type: ACTIVE_COMPARATOR): Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Maximizing Outcomes in Treating Acute Migraine

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
Key Inclusion Criteria:~* Has an established diagnosis of migraine with or without aura.~* Has experienced an inadequate response to prior acute treatments.~Key Exclusion Criteria:~* Has previously received any investigational drug or device or investigational therapy within 30 days before Screening.~* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- AXS-07 (Type: EXPERIMENTAL): Taken once upon a qualifying migraine
- Meloxicam (Type: ACTIVE_COMPARATOR): Taken once upon a qualifying migraine
- Rizatriptan (Type: ACTIVE_COMPARATOR): Taken once upon a qualifying migraine
- Placebo (Type: PLACEBO_COMPARATOR): Taken once upon a qualifying migraine

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: DIAGNOSTIC
- Time Perspective: None
- Masking: DOUBLE
- Phase: None
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* Healthy ambulatory men and postmenopausal women~* Age 45 to 70~* Avoid alcohol, antacids, H2 blockers, proton pump inhibitors, or antihistamines during the study.~Exclusion Criteria:~* Ionized Ca++ level \<4.39 mg/dl or \>5.02 mg/dl (normal reference range 4.18- 5.02).~* 24-hour UCa++ excretion \>350 mg.~* Cr \>1.3.~* AST/ALT values \>10% beyond reference range.~* Hgb level \<11.7 g/dl in women and \<13.2 g/dl in men.~* MCV level \>102 UM3.~* Basal acid output \>5 mEq/h in men and \>3.8 mEq/h in women.~* Basal acid output \<1 mEq/h in men and \<0.2 mEq/h in women.~* Age \<45 or \>70.~* Premenopausal or \<1 year post-menopause.~* Individuals following vegan diets.~* Current EtOH abuse.~* Lidocaine allergy. Medications~* Antacids~* H2 blockers~* Proton pump inhibitors~* Carafate~* Anticholinergic agents (i.e. TCA)~* Cholinergic agents~* Antihistamines in the last 3 weeks~* Cogentin~* Adrenergic blockers~* Thiazide diuretics~* Antiplatelet drugs~* Oral and Inhaled Glucocorticoids~* Bisphosphonates~* Raloxifene, Tamoxifen~* Tobacco~* EtOH during study~* rPTH~* Calcitonin~* Ketoconazole/Itraconazole~* Calcitriol~* Paricalcitol~* Drisdol, Ergocalciferol~* Phosphate binders~* Anticoagulant~* Erythromycin~* Hormone replacement therapy except vaginal estrogen creams~Exclusion Diseases~* Achlorhydria~* Pernicious anemia~* Zollinger Ellison syndrome~* Congestive heart failure~* Esophageal strictures or motility problems~* History of a GI bleed~* Prior upper GI surgery~* Malabsorption~* History of GI malignancy~* GERD, gastritis, duodenitis~* Active peptic ulcer disease~* Gallbladder disease~* Liver disease~* Pancreatitis~* Current kidney stone~* Renal disease~* Current hypoparathyroidism or hyperparathyroidism~* Moderate to Severe coronary artery disease~* Aortic aneurysm~* Seizure disorder~* Current Arrhythmia

- Gender: ALL
- Minimum Age: 45 Years
- Maximum Age: 70 Years
- Healthy Volunteers: t

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Early Airway Response to Allergen in Asthmatics (MK-0000-176)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* History of mild to moderate Asthma~* In good general health (except for asthma)~* Stable and free of respiratory infection~* Nonsmoker~* Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control)~Exclusion Criteria:~* Nursing mother~* Recent or ongoing upper or lower respiratory tract infection~* Unable to refrain from or anticipates the use of any prescription and non-prescription drugs~* Consumes excessive amounts of alcohol or caffeine~* History of stroke, chronic seizures, or major neurological disorder~* History of cancer~* Received a vaccination within the past 3 weeks

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: EXPERIMENTAL): Placebo
- Montelukast (Type: EXPERIMENTAL): Montelukast
- Nedocromil (Type: EXPERIMENTAL): Nedocromil
- Mometasone (Type: EXPERIMENTAL): Mometasone

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Subjects with at least two teeth sensitive to cold, touch and air blow stimulus~* Sensitive teeth anterior to molars either due to erosions or abrasions with or without associated gingival recession~* Teeth with Linear Visual Analogue Scale (VAS) score of ≥ 4 and code 2 of Schiff Cold Air Sensitivity Scale on screening.~Exclusion Criteria:~* Subjects with worst pain response at 100mm on VAS.(Visual Analog Scale)~* Teeth with orthodontic or prosthetic appliances, Caries, restorations or cracks~* Localized or generalized gingivitis or pulpitis with heavy calculus~* Periodontal surgery in the preceding three months~* Patients using any desensitizing tooth paste or mouth wash up to six weeks before study and taking drugs like anti-inflammatory, sedatives, tranquilizers, analgesics in routine.~* Pregnant or breastfeeding females.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 50 Years
- Healthy Volunteers: t

Study Arms:
- BioMin F Dentifrices (Type: EXPERIMENTAL): Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
- Colgate Sensitive Pro relief Trade Mark Dentifrices (Type: ACTIVE_COMPARATOR): Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
- Sensodyne Rapid Action Trade Mark Dentifrices (Type: ACTIVE_COMPARATOR): Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
- Colgate Total Trade Mark (Type: PLACEBO_COMPARATOR): Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Treatment of Depression in Acute Coronary Syndrome (ACS) Patients

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: None
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* a current diagnosis of at least one of the following: major or minor depression, dysthymia according to DSM-IV criteria, and demoralization according to DCPR criteria~* Mini-Mental State Examination score higher than 24~* written informed consent provided by the patient to participate~Exclusion Criteria:~* history of bipolar disorder (DSM-IV criteria)~* major depression with psychotic features~* history of substance abuse or dependency during the previous 12 months~* serious suicide risk~* current use of antidepressants~* current treatment with any form of psychotherapy

- Gender: ALL
- Minimum Age: None
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Clinical Management (Type: NO_INTERVENTION): Control group
- CBT + WBT (Type: EXPERIMENTAL): Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Babesia Testing in Blood Donors

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* same as for donating blood~Exclusion Criteria:~* donor refusual to sign informed consent for this investigational babesia testing

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- retrospective (Type: EXPERIMENTAL): archived specimens from blood donors whose units have already been released and transfused into recipients will be tested. Attempts will be made to contact and obtain follow up specimens from both the donor and recipient of units initially testing positive for B.microti. the interventions are investigational diagnostic tests for B.microti (PCR and IFA).
- prospective, real time (Type: EXPERIMENTAL): specimens from current blood donors will be tested and those testing positive for B.microti will not be released and the units will be disgarded, and the donors notified and deferred from future blood donation. the interventions are investigational diagnostic tests for B.microti (PCR and IFA).

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete