louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05512741: Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery
Official title: Evaluation of the Role of the Intestinal Microbiota in the Mechanism of Postoperative Ileum After Colorectal Surgery : a Preliminary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Ileus
Surgery-Complications
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-08-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 patients with POI and 10 patients without POI selected in the consecutive patients undergoing colorectal surgery during the period of inclusion.

Brief summary: Postoperative ileus (POI) after colorectal surgery is frequent and is a burden for national health authority because it increases the morbidity and the length of hospital stay.

Some of the stage of the mechanism of POI are known and are now targeted to reduce its occurence but despite these measures, POI still happens in 10-30% of surgeries.

The role of the intestinal microbiota in POI is unknown while it could be a new target to reduce its duration or its occurence.


Eligibility criteria: Inclusion Criteria:

* laparoscopic colorectal resection with anastomosis and without diverting stoma

Exclusion Criteria:

* risk of modification of the microbiota (terminal enterostomy, chronic inflammatory bowel disease, oesophageal or gastric surgery, vagal nerves lesion, beta lactamin allergy, bowel cleansing)
* postoperative complication

Primary outcomes:
measure: Composition of the feces microbiota before surgery
timeFrame: within the 2 last days before surgery
measure: Composition of the feces microbiota after surgery
timeFrame: up to the first postoperative stools, an average of 3 postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital, visceral and endocrine surgery department
Study officials:
References:
Clinical trial NCT02791841: Comparison of Interventions for Developmental Dyslexia
Official title: The Effectiveness of Intervention for Developmental Dyslexia: The Rhythmic Reading Training Compared With Hemisphere-Specific Stimulation and Action Video Games
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Dyslexia
Keywords: Reading
Developmental Dyslexia,
Music
Rhythm
Action Video Games
Hemisphere-Specific Stimulation
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: IRCCS Eugenio Medea
First posted: 2016-06-07
Enrollment: 33
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to compare the effectiveness of Rhythmic Reading Training (RRT), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and that of an intervention resulting from the combination of two yet validated treatments for DD, namely, Bakker's Visual Hemisphere-Specific Stimulation (VHSS) and the Action Video Game Training (AVG). Finally, the effectiveness of the administration of only AVG is intended to be compared to other treatments. All interventions are administered for 13 hours over 9 days to a group of Italian students with DD aged 8-12.


Eligibility criteria: Inclusion Criteria:

* having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice

Exclusion Criteria:

* presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)
* having been involved in previous reading intervention programs

Primary outcomes:
measure: Text reading
timeFrame: 3 weeks
measure: Word reading
timeFrame: 3 weeks
measure: Pseudo-word reading
timeFrame: 3 weeks
Secondary outcomes:
measure: Lexical access
timeFrame: 3 weeks
measure: Phonological awareness: phonemic blending
timeFrame: 3 weeks
measure: Phonological awareness: phonemic elision
timeFrame: 3 weeks
measure: Auditory attention
timeFrame: 3 weeks
measure: Rhythm perception and reproduction
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Unit of Child Psychopathology, Scientific Institute IRCCS 'Eugenio Medea'
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Alice Cancer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cancer A, Bonacina S, Antonietti A, Salandi A, Molteni M, Lorusso ML. The Effectiveness of Interventions for Developmental Dyslexia: Rhythmic Reading Training Compared With Hemisphere-Specific Stimulation and Action Video Games. Front Psychol. 2020 Jun 3;11:1158. doi: 10.3389/fpsyg.2020.01158. eCollection 2020.
Clinical trial NCT00914641: Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy Volunteers
Official title: A Randomized, Open-Label, Single Dose, Four Way Cross-Over Bioavailability Study Comparing Three Modified Release Formulations Of Apixaban Tablets To Apixaban Immediate Release Tablets In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Keywords: formulation; sustained release; modified release; extended release
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-06-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To estimate the pharmacokinetics of apixaban when administered as three different modified release formulation tablets relative to that when apixaban is administered as an immediate release tablet


Eligibility criteria: Inclusion Criteria:

* Healthy male or female patients
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* History or evidence of abnormal bleeding or clotting disorder

Primary outcomes:
measure: Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½)
timeFrame: 96 hours
measure: Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs, physical examinations, and ECGs.
timeFrame: per treatment period of 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06478641: Expanded Use in Persistent (B. Microti) Babesiosis
Official title: Expanded Access Protocol: Use of Tafenoquine for Treatment of Babesiosis in Immunocompromised Patients With Persistent Babesia Microti Despite Prior Treatment
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Persistent Babesiosis
Lead sponsor: 60 Degrees Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2024-06-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this expanded access protocol is to offer a potentially effective treatment (tafenoquine) to patients with persistent babesiosis, who have not responded to standard of care treatments, and who are immunocompromised and thus at risk for more serious complications. Tafenoquine will be self-administered orally as 2 x 100 mg dark pink coated tablets once daily (total daily dose 200 mg) with food on Days 1, 2, 3 \& 4 then weekly thereafter (starting on day 11) until the patient has two consecutive negative PCR tests for Babesia parasites and symptoms of babesiosis have resolved. Other standard of care treatments recommended in the 2020 IDSA Guideline on Diagnosis and Management of Babesiosis should also be included in the treatment regimen.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged ≥ 18 years
* Laboratory confirmed infection with B. microti and exhibiting clinical symptoms of babesiosis
* Able and willing to give written informed consent
* Able to take ARAKODA according to Prescribing Information
* If female willing to take birth control for 90 days
* Have risk factors for relapsing disease
* Azithromycin, atovaquone, and/or clindamycin administered in the last 12 months to treat babesiosis, and, in the opinion of the investigator, high likelihood that current infection represents a relapse or continuation of disease
* Willing to initiate or continue a standard of care antimicrobial regimen

Exclusion Criteria:

* Have any of the contraindications for ARAKODA
* Current or planned treatment with quinine while participating in the study
* Any concomitant significant illness unrelated to babesiosis
* Taking any excluded concomitant medication
* The patient is unable to tolerate medication by the oral route

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05252741: Levels of Pigment Epithelium-derived Factor in Patients With Psoriasis.
Official title: Evaluation Of Levels Of Pigment Epithelium-Derived Factor (PEDF) In Patients With Psoriasis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Psoriasis is an immune-mediated chronic inflammatory skin disease associated with increase interaction of inflammatory mediators like adipokines. Pigment epithelium-derived factor (PEDF) is one of the most abundant adipokines and have anti-angiogenesis effect. There is a study showed that PEDF level is up-regulated in the sera of psoriasis patients.


Eligibility criteria: Inclusion Criteria:

Patients with psoriasis and group of age and sex-matched healthy volunteers will be included as a control group.

Exclusion Criteria:

* Pregnancy.
* Patients with other inflammatory skin disorders.
* Patients on antioxidants or anti-inflammatory drugs.
* Patients on topical or systemic treatment for psoriasis in the last 4 weeks prior to enrollment in the study.
* Patients on systemic retinoids (Acitretin).
* Obesity: body mass index (BMI ) \> 30.
* Malignancies e.g squamous cell carcinoma.
* Viral warts.
* Diabetes.
* Hypertension.

Primary outcomes:
measure: changes in serum and tissue levels of (PEDF) in patients with psoriasis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine Sohag University
Study officials:
References:
Clinical trial NCT05788341: The Israeli Study for Islet Autoantibodies Screening in Families of Type-1 Diabetes Patients
Official title: The Israeli Study for Islet Autoantibodies Screening in Families of Type-1 Diabetes Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Keywords: Stage 1 diabetes
stage 2 diabetes
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Provention Bio, Inc.
First posted: 2023-03-28
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First degree relatives of people with TID

Brief summary: We aim at establishing a research program that will offer screening for the presence of Islet Autoantibodies (IA) in relatives of people with Type 1 Diabetes (T1D).

Relatives of people with diabetes, children, and adults from our clinic and all over Israel will be offered to participate in the study. The presence of IA will be evaluated using the Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods.. When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology and by a radio binding assay (RBA). People positive for one or more antibodies (stage 1 or 2 T1D) will be referred to attend an educational program at our center. This program will include diabetes education emphasizing DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. After the educational visit, people at risk of developing diabetes will be referred to further follow-up and evaluation under routine medical care at our center.


Eligibility criteria: Inclusion Criteria:

* First degree family member (sibling or parent) of a known T1D patient
* Age 2-45 years
* Signing an informed consent

Exclusion Criteria:

* Known diabetes of any kind (type 2, MODY)
* Have a previous history of being treated with insulin or oral diabetes medications.
* Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)

Primary outcomes:
measure: Positive Islet Autoantibodies
timeFrame: Screening visit
Secondary outcomes:
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schneider Children Medical Center of Israel
Study officials:
References:
Clinical trial NCT01864941: Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients
Official title: Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
MS
CCSVI
Zamboni
catheter venography
balloon angioplasty
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Multiple Sclerosis Society of Canada
First posted: 2013-05-30
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by adverse events occurring within 48 weeks of the procedure.

Detailed description: Overview of study objectives are:

* To determine the safety and tolerability of venoplasty of CCSVI in Multiple Sclerosis (MS).
* To determine the short term and long term impact on validated patient measures and by physician and radiologic reported MS outcomes.
* To determine the short term and long term recurrence rate of CCSVI for veins that have been treated with venoplasty

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive MS according to the McDonald criteria 2010
* Age 18 to 65 years inclusive
* Neurostatus (EDSS) score at screening from 0 to 6.5
* Fulfill ultrasound criteria for CCSVI

Exclusion Criteria:

* Previous venoplasty and/or stenting of extra cranial venous system

Primary outcomes:
measure: Adverse Events
timeFrame: 48 weeks
Secondary outcomes:
measure: Clinical Outcome
timeFrame: 48 weeks
measure: Clinical Outcome
timeFrame: 48 weeks
measure: Clinical Outcome
timeFrame: 48 weeks
measure: Clinical Outcome
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Coastal Health - University of British Columbia Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba Health Sciences Centre
state: Manitoba
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Québec - Hôpital de l'Enfant-Jésus
state: Quebec
Study officials:
affiliation: University of British Columbia
name: Anthony Traboulsee, MD
role: STUDY_DIRECTOR
References:
citation: Traboulsee AL, Machan L, Girard JM, Raymond J, Vosoughi R, Hardy BW, Emond F, Gariepy JL, Bone JN, Siskin G, Klass D, Isserow S, Illes J, Sadovnick AD, Li DK. Safety and efficacy of venoplasty in MS: A randomized, double-blind, sham-controlled phase II trial. Neurology. 2018 Oct 30;91(18):e1660-e1668. doi: 10.1212/WNL.0000000000006423. Epub 2018 Sep 28.
Clinical trial NCT06664541: Decision-Making and Quality of Life Surrounding Hematologic Disease and Gene Therapy
Official title: Decision-Making and Quality of Life Surrounding Hematologic Disease and Gene Therapy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Transfusion Dependent Beta Thalassemia
Sickle Cell Disease
Keywords: quality of life
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (ages 18+) or parents of pediatric patients (\<age 18) diagnosed with transfusion-dependent beta thalassemia or sickle cell disease and eligible to receive treatment for their disease with gene therapy.

Brief summary: Determine knowledge, attitudes, and beliefs among adult patients, and parents of pediatric patients, with transfusion dependent beta-thalassemia and sickle cell disease toward gene therapy to treat their or their child's illness, and to assess the likely impact of gene therapy on patients' quality of life.

Detailed description: The overarching aim of this research is to determine knowledge, attitudes, and beliefs among adult patients, and parents of pediatric patients, with transfusion dependent beta-thalassemia toward gene therapy to treat their or their child's disease, and to assess the likely impact of gene therapy on patients' quality of life. We will compare and contrast these findings to those obtained from a sample of adult patients and parents of pediatric patients with sickle cell disease. We will also assess perceptions of the pros/cons of gene therapy, including its financial and time costs.

Eligibility criteria: Inclusion Criteria:

* adult patients (ages 18+) or parents of pediatric patients (\<age 18) eligible to receive treatment for their disease with gene therapy

Exclusion Criteria:

* Non-English-speaking

Primary outcomes:
measure: Quality of Life
timeFrame: Past 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
Study officials:
References:
Clinical trial NCT00910741: NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia
Official title: Phase I/II Study of the Combination Therapy With NC-6004 and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer in Asian Countries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Locally Advanced and Metastatic Pancreatic Cancer
Keywords: pancreatic cancer
Gemcitabine
Lead sponsor: NanoCarrier Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Orient Europharma Co., Ltd.
First posted: 2009-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: 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 determine the recommended dose of NC-6004 according to the dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy, safety and tolerability.


Eligibility criteria: Inclusion Criteria:

* Patients with chemo-naive, advanced pancreatic cancer
* Nonresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer

Exclusion Criteria:

* Pulmonary fibrosis or interstitial pneumonia
* Marked pleural effusion or ascites above Grade 2
* Severe drug hypersensitivity
* Metastasis to the central nervous system and brain

Primary outcomes:
measure: Incidence of DLT and Response rate
timeFrame: DLT is evaluated for 3 weeks o the treatment, Response rate is evaluated at 7,13,19 and 25weeks of the treatment
Secondary outcomes:
measure: Overall survival
timeFrame: 1.5 year
Other outcomes:
Locations:
city: Singapore 169610
country: Singapore
facility: National Cancer Centre Singapore
city: Tainan
country: Taiwan
facility: Natinal Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Wu-Chou Su, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uchino H, Matsumura Y, Negishi T, Koizumi F, Hayashi T, Honda T, Nishiyama N, Kataoka K, Naito S, Kakizoe T. Cisplatin-incorporating polymeric micelles (NC-6004) can reduce nephrotoxicity and neurotoxicity of cisplatin in rats. Br J Cancer. 2005 Sep 19;93(6):678-87. doi: 10.1038/sj.bjc.6602772.
Clinical trial NCT01417741: Acupuncture and Nausea/Vomiting in Pediatric Patients
Official title: Is Intra-operative Acupuncture at P6 Plus IV Antiemetics More Effective Than IV Antiemetic Therapy Alone in Preventing Postoperative Vomiting in Pediatric Patients Following Tonsillectomy With or Without Adenoidectomy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Vomiting and Nausea
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 164
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus standard therapy on postoperative nausea and vomiting in pediatric patients undergoing tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either the treatment or the control group.

1. Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the induction of anesthesia
2. Control Group: Standard anti-emetic therapy only

This study will monitor nausea, retching, and vomiting events both directly after the surgery as well as the next day via a follow-up phone call to the parents of the study participant.


Eligibility criteria: Inclusion Criteria:

* ASA 1 to 3 physical status
* Undergoing Tonsillectomy and/or adenoidectomy
* Consent obtained from Parent/Guardian

Exclusion Criteria:

* Taking preoperative steroids, including inhalers
* Taking baseline anti-emetics
* History of motion sickness
* BMI \> 35 (morbid obesity)
* Severe OSA (Apnea/hypopnea Index \> 10)
* Have genetic abnormalities

Primary outcomes:
measure: Postoperative Nausea and Vomiting
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Angela Kendrick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Christine Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin CS, Deverman SE, Norvell DC, Cusick JC, Kendrick A, Koh J. Randomized trial of acupuncture with antiemetics for reducing postoperative nausea in children. Acta Anaesthesiol Scand. 2019 Mar;63(3):292-297. doi: 10.1111/aas.13288. Epub 2018 Nov 6.