louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04088760: TCRαβ+/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders
Official title: Safety and Efficacy of TCRαβ+/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders in Children and Adolescent/Young Adult Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Allogeneic Hematopoietic Cell Transplantation
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and efficacy of TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT) for malignant and non-malignant disorders in children and adolescent/young adult patients using the CliniMACS® immunomagnetic selection device (Miltenyi Biotec).

Detailed description: Acute graft versus host disease (GVHD) remains a significant cause of morbidity and mortality and is the biggest barrier to successful allogeneic hematopoietic cell transplantation (HSCT) outcomes. Improved methods of acute GVHD prevention are needed. TCRαβ+/CD19+ depletion of allogeneic hematopoietic stem cell products offers an opportunity to limit the risk of acute GVHD by removing TCRαβ+ T cells and CD19+ B cells which participate in acute GVHD initiation and perpetuation. The purpose of this study is to investigate the safety and efficacy of TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT) for malignant and non-malignant disorders in children and adolescent/young adult patients using the CliniMACS® immunomagnetic selection device (Miltenyi Biotec).

Eligibility criteria: Inclusion Criteria:

* Any patient being treated at Cincinnati Children's Hospital requiring an allogeneic HSCT who lacks an HLA-genotypically matched related donor. Genotypically matched related donors are allowed when there is a clinical desire to avoid the use of GVHD prophylaxis medications.

Exclusion Criteria:

* Prior allogeneic transplant with active acute or chronic GVHD, or life-threatening infection. Patients with a prior history of allogenic transplant without active GVHD or life-threatening infection can be considered.

Primary outcomes:
measure: Incidence of Infusion-related Reactions
timeFrame: 100 days
Secondary outcomes:
measure: Engraftment and Sustained Donor Chimerism
timeFrame: 28 days and 1 year
measure: Number of Participants With Acute GVHD
timeFrame: 100 days
measure: Number of Participants With Chronic GVHD
timeFrame: 1 year
measure: GVHD-free Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT01301560: Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis
Official title: Randomized Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Observation for Patients With Asymptomatic Cerebral Oligo-metastases in Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nonsmall Cell Lung Cancer
Keywords: Asymptomatic brain metastasis
NSCLC
GKS
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The need of radiosurgery is controversial for asymptomatic oligo brain metastasis for non small cell lung cancer (NSCLC).

Therefore, the investigators do a randomized study comparing overall survival between two groups with or without radiosurgery for asymptomatic oligo brain metastasis before palliative chemotherapy for NSCLC.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed non-small cell lung cancer with synchronous brain metastases
2. One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:

   * Well circumscribed tumor(s) with brain edema Grade 0-1
   * Maximum diameter ≤ 3.0 cm
3. No prior surgical treatment or RT for brain metastases
4. No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
5. Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0)
6. Age, 18 and over
7. ECOG performance status 0-1
8. Written informed consent

Exclusion Criteria:

1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. RTOG neurologic function status of 1\~4
4. Uncontrollable extracranial metastases

Primary outcomes:
measure: overall survival
timeFrame: 1 year after the enrollment of the last patient
Secondary outcomes:
measure: Time to CNS progression
timeFrame: 1 year after the enrollment of the last patient
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Lim SH, Lee JY, Lee MY, Kim HS, Lee J, Sun JM, Ahn JS, Um SW, Kim H, Kim BS, Kim ST, Na DL, Sun JY, Jung SH, Park K, Kwon OJ, Lee JI, Ahn MJ. A randomized phase III trial of stereotactic radiosurgery (SRS) versus observation for patients with asymptomatic cerebral oligo-metastases in non-small-cell lung cancer. Ann Oncol. 2015 Apr;26(4):762-768. doi: 10.1093/annonc/mdu584. Epub 2014 Dec 23.
Clinical trial NCT00702260: Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Ramipril or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, two-period, 7 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research
name: Daniel V Freeland, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00837460: Effect of Rehabilitation of Patients With a Central Nervous System Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hand
Rehabilitation
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Fondation Saint Luc
name: Fonds pour la recherche scientifique médicale (FRSM), Belgium
name: Association nationale d'aide aux personnes handicapées (ANAH)
First posted: 2009-02-05
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to analyse the prehensions deficits and the effect of prehension rehabilitation in central nervous system lesioned people


Eligibility criteria: Inclusion Criteria:

* Adult minimum 6mounth after first stroke
* Minimal prehension of both hands

Exclusion Criteria:

* Diabetuss
* Other Upper Limb pathologies
* MMSE \< 26

Primary outcomes:
measure: prehension functionality
timeFrame: 4 weeks before, just before, after first part and after the second part of rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: READ : Rehabilitation and physical medecine Unit
Study officials:
affiliation: Rehabilitation and physical medecine Unit - UCL
name: Delphine Dispa, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Rehabilitation and physical medecine Unit-UCL
name: Jean-Louis Thonnard, PhD
role: STUDY_DIRECTOR
affiliation: Rehabilitation and physical medecine Unit-UCL
name: Yannick Bleyenheuft, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Rehabilitation and physical medecine Unit-UCL
name: Thierry Lejeune, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06198660: PRT Versus CBT on Chronic Non Specific LBP
Official title: Positional Release Technique Versus Cognitive Behavioral Therapy on Chronic Non Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Non Specific Mechanical Low Back Pain
Keywords: positional release
cognitive behavioral therapy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare between the effect of positional release technique and cognitive behavioral therapy in patients with chronic non specific low back pain.

The main question aims to answer :Is there any differences of using positional release techniques versus cognitive behavioral therapy on patients with chronic low back pain?

Detailed description: Design of the study :

Pretest-posttest randomized controlled trial.

Subjects selection :

sixty patients their age between 25-45 years of both genders with chronic non specific low back pain will participate in this study according tosample size calculation.

Eligibility criteria: Inclusion Criteria:

* All patients will be clinically diagnosed with chronic non specific low back pain .
* Their ages will range from 20to40years old.
* body mass index will range from 18 to 30 kg/cm².
* Cognitive score will be 23 or above .
* Voluntary acceptance of participation in this study.

Exclusion Criteria:

* Lumbar canal stenosis
* Lumbar discogenic lesions
* Lumbar infections,tumors.arthiritis
* Patients with decreased range of motion due to congenital anamolies.
* Cognitive and emotional disturbances

Primary outcomes:
measure: pressure algometer
timeFrame: pre intervention and immediately after intervention
Secondary outcomes:
measure: the arabic version of oswestry disability questionnaire
timeFrame: pre intervention and immediately after intervention
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Horus University
state: New Damietta
Study officials:
affiliation: Cairo University
name: Nosaiba Eissa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04786860: The Success Rate of Cardiopulmonary Resuscitation in Patients Experiencing In-hospital Cardiac Arrest
Official title: The Success Rate of Cardiopulmonary Resuscitation in Patients Experiencing In-hospital Cardiac Arrest at Sanglah General Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest, Sudden
Cardiopulmonary Arrest
Cardiopulmonary Failure
In-hospital Cardiac Arrest
Keywords: in-hospital, cardiac arrest, resuscitation, success rate
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients

Brief summary: Cardiac arrest causes the heart to stop functioning to maintain circulation that provides oxygen to the brain. The global incidence of cardiac arrest is 50 to 60 per 100,000 people per year. The incidence of cardiac arrest in Indonesia in 2016 was 350,000 cases, in which 12% were successfully resuscitated, compared to the global success rate of 24.8%.

Cardiac arrest events urgently require CPR action that is useful to save lives in an emergency. The application of Code Blue aims to reduce the mortality rate and increase the rate of return of spontaneous circulation. The Code Blue team itself includes a set of teams who are trained in the handling of cardiorespiratory arrest.


Eligibility criteria: Inclusion Criteria:

* Patients with in-hospital cardiac arrest that were treated at Sanglah General Hospital

Exclusion Criteria:

* Patients who upon admission to the hospital already showing cardiac arrest rhythm
* Patients who were DOA (death-on-arrival)

Primary outcomes:
measure: Survivors
timeFrame: 6-hours after CPR is stopped
Secondary outcomes:
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Prof. Ngoerah General Hospital
state: Bali
city: Denpasar
country: Indonesia
facility: Sanglah General Hospital
state: Bali
Study officials:
References:
Clinical trial NCT02038660: Drug-Eluting Balloon Registry in Routine Clinical Practice
Official title: Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Angioplasty, Balloon
Keywords: Coronary Artery Disease
Angioplasty, Balloon
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: B. Braun Korea Co., Ltd.
First posted: 2014-01-16
Enrollment: 1500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with balloon angioplasty

Brief summary: The purpose of this study is to evaluate long-term effectiveness and safety of patients with coronary disease treated with drug eluting balloon in real world practice.


Eligibility criteria: Inclusion Criteria:

* After pre dilatation residual stenosis 30% and less and also without vessel dissection interrupted blood flow
* Age 20 and more
* Treated with Balloon angioplasty
* Signed informed consent and agreed to follow protocol

Exclusion Criteria:

* Allergy to paclitaxel, antiplatelet
* History of side effect to heparin, aspirin, thienopyridines
* History of bleeding tendency, coagulation disorder, blood transfusion reaction

Primary outcomes:
measure: Composite Event
timeFrame: 1year
Secondary outcomes:
measure: All cause death
timeFrame: 5year
measure: Cardiac death
timeFrame: 5year
measure: Myocardial infarction
timeFrame: 5year
measure: Composite event
timeFrame: 5year
measure: Composite event
timeFrame: 5year
measure: Target vessel revascularization
timeFrame: 5year
measure: Target lesion revascularization
timeFrame: 5year
measure: Stent thrombosis
timeFrame: 5year
measure: Stroke
timeFrame: 5year
measure: Procedural Success
timeFrame: 3day
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References:
Clinical trial NCT02540460: Multiple Ascending Dose, Phase 1 Clinical Study of LCB01-0371
Official title: A Phase I Clinical Study, Multiple Dose of LCB01-0371 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LigaChem Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371 after a multiple oral dose in healthy male subjects.

To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male subjects.

Detailed description: Double blind, randomized, placebo control, multiple dose, dose escalation study

Eligibility criteria: Inclusion Criteria:

1. Healthy male between 20 and 45 years of age at the time of screening
2. Subjects with body mass index (BMI) between 20 kg/m2 and 27 kg/m2 at the time of screening
3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days after study completion
4. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements.

Exclusion Criteria:

1. History of liver, kidney, alimentary, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, cardiovascular problem(s)
2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
3. History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics
4. History of drug abuse or positive result at urine drug screening
5. AST, ALT, r-GT, bilirubin(total) values over than 1.5 times of ULN

Primary outcomes:
measure: No of Adverse events
timeFrame: From date of randomization until follow up after 3 days from last hospital discharge
Secondary outcomes:
measure: Pharmacokinetics: Cmax(Peak plasma concentration)
timeFrame: 0(predose), 0.5, 1, 2, 4, 8 and 12hours
measure: Pharmacokinetics: AUC(Area under the curve)
timeFrame: 0(predose), 0.5, 1, 2, 4, 8 and 12hours
Other outcomes:
Locations:
city: Bundang
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Legochembioscience
name: Young Lag Cho, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Choi Y, Lee SW, Kim A, Jang K, Nam H, Cho YL, Yu KS, Jang IJ, Chung JY. Safety, tolerability and pharmacokinetics of 21 day multiple oral administration of a new oxazolidinone antibiotic, LCB01-0371, in healthy male subjects. J Antimicrob Chemother. 2018 Jan 1;73(1):183-190. doi: 10.1093/jac/dkx367.
Clinical trial NCT05302960: Recovering From COVID-19
Official title: Recovering From COVID-19: Community-based Remote Monitoring in COVID-19 (SARS-CoV 2) Cases: The OVER-COVID Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: SARS CoV 2 Infection
Keywords: monitoring, ambulatory
vital signs
remote monitoring
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: •Discharged from hospital with a RT-PCR SAR-CoV-2 positive swab result.

Brief summary: Following the success of pilot data trialling a virtual community-based remote monitoring model, using Bluetooth enabled pulse oximeters, which demonstrated a saving of 300 bed spaces over a three week period,9 a nationwide expansion is set to be implemented through NHS Digital. Participants who were on the virtual wards approximately 12 weeks after their admission and those referred to long-COVID outpatient clinics will be approached.

There is a particular lack of understanding as to whether post-COVID syndrome constitutes a singular disease process. It has been suggested that the post-COVID syndrome may be characterised into either an acute or chronic subtype, depending on whether symptoms extend beyond 12 weeks following initial diagnosis.7,10 However, it is not currently understood as to whether chronic post-COVID is either an extension of acute post-COVID or is a separate disease subtype that carries a distinct risk profile.

However, there remains a paucity in the literature depicting the recovery experience, risk factors for the development of post-COVID syndrome, management strategies, and qualitative experiences. This study aims to address these gaps


Eligibility criteria: INCLUSION CRITERIA

* Aged 18 years or over.
* Able to provide written consent.

EXCLUSION CRITERIA

* Any participants that withdraw their consent.
* Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team.
* Inability to cooperate or communicate with the research team.

Primary outcomes:
measure: Step count
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01496560: Open Prospective Study for Determination of Predictive Measures for Pain During Colonoscopy
Official title: Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy Using Moderate Sedation: A Prospective Randomized Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pain
Keywords: colonoscopy
pain
rectal balloon
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing screening colonoscopy

Brief summary: The aim of the study is to determine what precolonoscopic measures can be correlated to pain during colonoscopy

Detailed description: The aim of the work is to determine prdictive pre-endoscopic factors for pain during colonoscpy. These factors may be demographic, antrophometric, socio-ecomomic, related to previous medical staus or to anxiety levels.

We will try to find an objective parameter for prdiction of pain during colonoscopy, so pre-procedural intervantion will be applied in order to reduce the pain.

Eligibility criteria: Inclusion Criteria:

* age 18-70
* screening colonoscopy

Exclusion Criteria:

* Failed prior colonoscopy
* pain as a main referral indication
* complications during previous exam
* Inpatients
* Excision of more than 3 polyps
* Diagnosis ofCancer, IBD
* Incomplete exam

Primary outcomes:
measure: Pre-endoscopic Rectal balloon volumes
timeFrame: 1 year
Secondary outcomes:
measure: Demographic data
timeFrame: 1 year
measure: Pre-endocopic levels of anxiety
timeFrame: 1 year
Other outcomes:
Locations:
city: Ramat GAn
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Sheba Medical Center
name: Dan Carter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park DI, Kim HJ, Park JH, Cho YK, Sohn CI, Jeon WK, Kim BI, Ryu SH, Sung IK. Factors affecting abdominal pain during colonoscopy. Eur J Gastroenterol Hepatol. 2007 Aug;19(8):695-9. doi: 10.1097/01.meg.0000219097.32811.24.