louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06193590: Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures
Official title: Safety and Efficacy of a Suction Cervical Stabilizer Compared to the Standard Tenaculum for Intrauterine Procedures in the Clinic Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Device (IUD)
Abnormal Uterine Bleeding
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.


Eligibility criteria: Inclusion Criteria:

* • Age 18 years or older

  * Speaks and reads in English
  * Able to consent on their own
  * Will undergo any intrauterine procedure using the Carevix (for exposure group) or using Tenaculum (for Control Group)
  * Cervix at least 26 mm in diameter
  * Twenty providers performing this procedure

Exclusion Criteria:

* • Vaginal bleeding of unknown origin

  * Cervix less than 26 mm in diameter
  * Nabothian cyst on anterior lip of cervix
  * Cervical myomas
  * Cervical abnormalities
  * Pregnant

Primary outcomes:
measure: Patient-perceived Pain
timeFrame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
Secondary outcomes:
measure: Provider-perceived Bleeding
timeFrame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
measure: Provider-perceived Ease of Use
timeFrame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
measure: Provider-perceived Satisfaction
timeFrame: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Alissa Conklin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yaron M, Legardeur H, Barcellini B, Akhoundova F, Mathevet P. Safety and efficacy of a suction cervical stabilizer for intrauterine contraceptive device insertion: Results from a randomized, controlled study. Contraception. 2023 Jul;123:110004. doi: 10.1016/j.contraception.2023.110004. Epub 2023 Mar 11.
Clinical trial NCT02391090: FeNO After Hypoxia in Asthma Patients
Official title: Effects of Intermittent Hypoxia on the Asthmatic Inflammation of Asthma Patients - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
hypoxia
forced exhaled nitric oxide
inflammation
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Ludwig Boltzmann Institute for Lung Vascular Research
First posted: 2015-03-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Stable Asthma patients (GINA 1-2) stay 6 days in a row for 4 hours per day in a hypoxic chamber simulating 2800m above sea level. Study participants will be blinded to the treatment given and divided into a hypoxic and a sham group (about 360m above sea level).

Effects of this intermittent hypoxia on the asthmatic inflammation of these patients will be measured. The primary endpoint is the change in forced exhaled nitric oxide (FeNO) before and after the study. Secondary endpoints include blood parameters, lung function testing and questionnaires.


Eligibility criteria: Inclusion Criteria:

* stable Asthma (GINA 1-2)

Exclusion Criteria:

* autoimmune disease
* unstable Asthma (GINA 3-4)
* history of pneumonia/fever within 3 months
* place of residence \>1000m above sea level
* trip/vacation above \>2500m within 4 weeks
* cystic fibrosis
* diabetes mellitus
* immunodeficiency
* atopic dermatitis
* ciliary dyskinesia
* pregnancy
* chronic obstructive pulmonary disease
* history of smoking (\>1py)
* immunosuppression / systemic corticosteroids within 3 months
* cardiovascular diseases
* interstitial lung disease
* bronchopulmonary dysplasia

Primary outcomes:
measure: Change in forced exhaled nitric oxide after 6 days of hypoxia/sham
timeFrame: 1 week
Secondary outcomes:
measure: Change in blood parameters after 6 days of hypoxia/sham
timeFrame: 1 week
measure: Change in lung function parameters after 6 days of hypoxia/sham
timeFrame: 1 week
measure: Change in Quality of Life and Asthma questionnaires after 6 days of hypoxia/sham
timeFrame: 1 week
measure: Change in finger pulse oximetry
timeFrame: 1 week
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz, Department of Internal Medicine, Division of Pulmonology
name: Horst Olschewski, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06102590: Oxygen Extraction-guided Transfusion
Official title: Oxygen Extraction-guided Transfusion Strategy in Critically Ill Patients. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Transfusion
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In critically ill patients, optimized strategies for red blood cells transfusion (RBCT) are still controversial. Most recent guidelines suggest that clinical practice in ICU setting should follow a restrictive approach to RBCT (i.e., hemoglonim level \< 7.0 g/dL).In our previous study, oxygen extraction ratio (O2ER) has shown good performance as a marker to identify the correct timing for RBCT, potentially affecting 90-day mortality in non-bleeding, critically ill patients \[11\]. Moreover, our data suggested that an individualized strategy for RBCT may reduce the incidence of acute kidney injury (AKI), which is possibly related to a better delivery of oxygen and organ perfusion.


Eligibility criteria: Inclusion Criteria:

* Hb levels ≤ 9.0 g/dL (as confirmed through a blood test and/or through blood gas analysis)
* Presence of an arterial line and a central venous line (either jugular or subclavian), with confirmed correct position of the catheter tip at the atrio-caval junction (allowing correct estimation of central venous saturation, ScvO2).

Exclusion Criteria:

* Age \< 18 years;
* Pregnancy
* Clinical evidence of acute bleeding
* Diagnosis of haematological malignancy
* Diagnosis of sickle cell disease, or other diseases exposing the patient to chronic RCBTs
* Acquired or congenital disorders of coagulation
* Patients with ongoing AKI of stage 1 or worse and/or known chronic kidney disease (CKD) of stage G3a or worse, defined as glomerular filtration rate below 60 for a minimum of 3 months

Primary outcomes:
measure: Acute Kidney Injury (AKI)
timeFrame: 7-day after study inclusion
Secondary outcomes:
measure: 90-day mortality
timeFrame: 90-day after study inclusion
measure: proportion of patients undergoing RBCT, despite adequate/low O2ER
timeFrame: 28 days
measure: SOFA score variations
timeFrame: 5 days
measure: variations in myocardial-specific troponin
timeFrame: 24 hours after study inclusion
measure: days on vasopressors
timeFrame: 28 days
measure: Major Adverse Kidney Events by 90 days (MAKE90)
timeFrame: 90 days
measure: ICU mortality
timeFrame: through study completion, an average of 180 days
measure: In-hospital mortality
timeFrame: through study completion, an average of 180 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Hospital Erasme
city: Ferrara
country: Italy
facility: Università di Ferrara
city: Siena
country: Italy
facility: Anestesia e Rianimazione Cardio-Toraco-Vascolare
Study officials:
References:
Clinical trial NCT04773990: Efficacy of Balance Training by BBS on Gait Parameters and Balance in Patients With RLAS
Official title: Efficacy of Balance Training by Biodex Balance System on Gait Parameters and Balance in Patients With RLAS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprains
Lead sponsor: MTI University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2021-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Fifty subjects (power analysis) of both gender diagnosed with recurrent lateral ankle sprain patients will be assigned randomly into 2 groups.

* Group (A) will receive biodex balance training
* Group (B)will receive a physical therapy exercise protocol only
Primary purpose: TREATMENT

Brief summary: This study will be conducted to find out the effect of adding balance training on gait parameters, balance, and Sensory Interaction

Detailed description: LAS are not benign injuries. As many as 4 in 10 individuals will develop chronic ankle instability (CAI) after a first-time sprain, More than half of patients with osteoarthritis (OA) of the ankle report a history of a sport-related ankle injury, and 85% of those are LAS.

Eligibility criteria: Inclusion Criteria:

* The patient will be referred to the outpatient clinic of the orthopedic department, Faculty of physical therapy, MTI University. with a confirmed diagnosis of recurrent Lateral ankle sprain grade II
* Subjects will be excluded if they had one of the following criteria:

Previous musculoskeletal injury to the lower limb or lumbar spine including a fracture, a sprain, or an unstable joint other than the injured ankle.

Primary outcomes:
measure: Cadence
timeFrame: Before Treatment and after 6 weeks of treatment
measure: Gait time
timeFrame: Before Treatment and after 6 weeks of treatment
measure: Clinical Test of Sensory Integration
timeFrame: Before Treatment and after 6 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Physical Therapy
Study officials:
References:
Clinical trial NCT03350490: Bioinformation Therapy for Intestinal Cancer
Official title: Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Intestinal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Advanced Intestinal Cancer
Keywords: Cancer ablation
Life information rehabilitation therapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shengxin Biotechnology Institute, Beijing
First posted: 2017-11-22
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable intestinal cancer.

Detailed description: By enrolling patients with unresectable intestinal cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
* Body tumor 1-6, with at least one tumor length \> 2 cm
* KPS ≥ 70, lifespan ：3 - 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT04708990: DELP for Acute Hemorrhagic Stroke
Official title: DELP for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Single Centre, Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cerebral Hemorrhage
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) has been found to improve neurological function and life ability of AIS patients and approved for the treatment of AIS by China Food and Drug Administration (CFDA). Our recent study imply that the neuroprotective effect of DELP involved multiple neuroprotective mechanism such as anti-inflammation, free radical scavenging, and decreasing MMP-9. Based on the multiple mechanisms, we argue that DELP may exert neuroprotective effect on acute cerebral hemorrhage.


Eligibility criteria: Inclusion Criteria:

* Age: 18-80;
* Spontaneous cerebral hemorrhage;
* Deep supratentorial intracerebral hemorrhage (basal ganglia and thalamus) with hematoma volume 5-40ml;
* NIHSS: 4-22;
* Time from onset to DELP is less than 48 hours;
* Premorbid mRS 0 or 1;
* Signed informed consent;

Exclusion Criteria:

* Secondary cerebral hemorrhage (secondary to trauma, tumor, vascular malformation, hemorrhage transformation of ischemic stroke, etc.);
* Comatose patients on admission (GCS score 3-8 on the Glasgow Coma Scale);
* Patients with intracerebral hemorrhage ruptured into the ventricle;
* Planed surgery;
* Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
* Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
* Previous allergy to heparin or calcium;
* hypoproteinemia;
* Unsuitable for this clinical studies assessed by researcher.

Primary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 2
timeFrame: Day 90
Secondary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 1
timeFrame: Day 90
measure: Changes in national institutes of health stroke scale (NIHSS)
timeFrame: 48 hours
measure: changes of hematoma volume compared with the baseline
timeFrame: 48 hours
measure: changes of edema volume around hematoma compared with the baseline
timeFrame: 48 hours
measure: the occurence of death due to any cause
timeFrame: Day 90
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
References:
Clinical trial NCT06658990: Effect of Ultrasound Positioning Assisted Cheek Needle Therapy on Postoperative Recovery Quality of Patients with Radical Resection of Lung Cancer
Official title: Effect of Ultrasound Positioning Assisted Cheek Needle Therapy on Postoperative Recovery Quality of Patients with Radical Resection of Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the effect of ultrasound positioning assisted buccal acupuncture on postoperative pain and recovery quality of patients undergoing thoracoscopic radical resection


Eligibility criteria: Inclusion Criteria:

1. Tracheal intubation under general anesthesia
2. Young and middle-aged patients aged 18-65 years
3. BMI: 18.5-28kg /m2

Exclusion Criteria:

1. head and facial trauma, infection, disease
2. more than 2 kinds of coronary heart disease, hypertension, stroke, diabetes, immune disease and other diseases before surgery

Primary outcomes:
measure: Number of additional analgesics
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Wang Mengyao
state: Jiangsu
Study officials:
References:
Clinical trial NCT00117390: Evaluation of the Optimal Technique for Determination of Renal Function of Critically Ill Patients
Official title: Evaluation of the Optimal Technique for Determination of the Renal Function of Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Function
Critical Illness
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the optimal technique for determination of the renal function of critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Intensive care patient
* Given informed consent
* Arterial infusion
* A bladder catheter

Exclusion Criteria:

* Diurese \< 400 mL/d

Primary outcomes:
measure: Comparison of the determination of the renal function by other means than the golden standard, inulin clearance
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Eric Hoste, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02865590: Clinical and Histological Evaluation of Deproteinizated Bovine Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift.
Official title: Clinical and Histological Evaluation of Demineralized Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift: Double Blind, Parallel, Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus Floor Augmentation
Keywords: Maxillary Sinus/surgery
Bone Substitutes
Radiography, Panoramic
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The sinus infiltration technique for sinus floor elevation has been used successfully when a reduced vertical height is available in the posterior maxilla. However, the effect of the different graft material on the volume and on the quality of new bone formed has not been fully investigated. The aim of this study is to evaluate the clinical and histological effect of a test material, lyophilized equine bone (Bio-gen®), compared with control material, deproteinized bovine bone (Endobon®), in the sinus lift techniques with lateral approach.


Eligibility criteria: Inclusion Criteria:

* bilateral atrophy of the maxilla;
* bone ridge \<= 6mm

Exclusion Criteria:

* severe systemic diseas (ASA III -IV) bisphosphonate therapy or a history of up to 3 years history of radiation therapy to neck and head area sinusitis pregnancy subjects not able to consent to participate in the study.

Primary outcomes:
measure: Histomorphometric Evaluation of New Bone Formation.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of L'Aquila
name: GIUSEPPE MARZO, DMD
role: STUDY_CHAIR
References:
Clinical trial NCT00314990: VITRO-Trial. B Vitamins and the Secondary Prevention of Venous Thrombosis
Official title: Homocysteine Lowering by B Vitamins and the Secondary Prevention of Deep-Vein Thrombosis and Pulmonary Embolism. A Randomized, Placebo-Controlled, Double Blind Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep-Vein Thrombosis
Pulmonary Embolism
Keywords: Venous thrombosis
Deep-vein thrombosis
Pulmonary embolism
Homocysteine
B-vitamins
Folate
Vitamin B12
Vitamin B6
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Heart Foundation
First posted: 2006-04-17
Enrollment: 620
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The VITRO (Vitamins and Thrombosis) study investigated the effect of homocysteine lowering by daily supplementation of B-vitamins on the risk reduction of deep-vein thrombosis and pulmonary embolism. Patients between 20 to 80 years old with a first objectively confirmed proximal deep-vein thrombosis or pulmonary embolism in the absence of major risk factors and a homocysteine concentration above the 75th percentile of a reference group were asked to participate (hyperhomocysteinemic group). A similar study was conducted in a random sample of patients with a homocysteine below the 75th percentile of the reference group (normohomocysteinemic group). After informed consent patients were randomized to daily multivitamin supplementation (5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin) or placebo and were followed for 2.5 years. End-points were objectively diagnosed recurrent deep-vein thrombosis or pulmonary embolism.


Eligibility criteria: Inclusion Criteria:

* objectively confirmed proximal deep-vein thrombosis or pulmonary embolism
* idiopathic thrombosis (i.e. absence of major risk factors (major surgery, known malignant disease, pregnancy and puerperium or immobility for more than three weeks)
* age between 20 to 80 years

Exclusion Criteria:

* obligatory use of vitamin B

Primary outcomes:
measure: Recurrent symptomatic DVT or recurrent PE.
Secondary outcomes:
Other outcomes:
Locations:
city: The Hague
country: Netherlands
facility: Leyenburg Hospital (currently HAGA-hospital)
Study officials:
affiliation: Radboud University Medical Center
name: Martin den Heijer, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Gerard MJ Bos, MD PhD
role: STUDY_DIRECTOR
References:
citation: den Heijer M, Willems HP, Blom HJ, Gerrits WB, Cattaneo M, Eichinger S, Rosendaal FR, Bos GM. Homocysteine lowering by B vitamins and the secondary prevention of deep vein thrombosis and pulmonary embolism: A randomized, placebo-controlled, double-blind trial. Blood. 2007 Jan 1;109(1):139-44. doi: 10.1182/blood-2006-04-014654. Epub 2006 Sep 7.