louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01682733: Endoscopic Gastric Reduction for Weight Management
Official title: Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obesity
Weight loss
Gastric reduction (volume)
BMI 30-40
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves durability of the procedure.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 30 and 40
* Age \>18 and ≤50
* Stable weight for 3 months (within 5% of BMI)
* Normal basic labs (CBC, chemistry profile, creatinine)
* Negative pregnancy test for females \>18 or ≤ 50

Exclusion Criteria:

* Diabetes
* Unstable coronary artery disease
* Heart failure
* Cardiac arrhythmia
* Cardiac valvular disease
* Obstructive of interstitial lung disease
* Females of child-bearing age \>18 or ≤ 50 who are pregnant or lactating
* Mallampati score of 4
* ASA 3 or above
* Previous gastric surgery
* Ulcer disease
* Gastroparesis,
* \> 5 cm Hiatal hernia
* Congenital anomalies of the GI tract
* Currently on or prescribed a medication known to affect weight within 3 months of study entry.

Primary outcomes:
measure: Change from baseline Bariatric Quality of Life (BQL) Questionaire
timeFrame: baseline to 3 months
Secondary outcomes:
measure: Change from baseline Three factor Eating Questionnaire (TFEQ-R21)
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Foundation
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barham K AbuDayyeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abu Dayyeh BK, Acosta A, Camilleri M, Mundi MS, Rajan E, Topazian MD, Gostout CJ. Endoscopic Sleeve Gastroplasty Alters Gastric Physiology and Induces Loss of Body Weight in Obese Individuals. Clin Gastroenterol Hepatol. 2017 Jan;15(1):37-43.e1. doi: 10.1016/j.cgh.2015.12.030. Epub 2015 Dec 31.
Clinical trial NCT01532154: Fampridine Pregnancy Exposure Registry
Official title: Fampridine Pregnancy Exposure Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis
Pregnancy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-02-14
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be pregnant female participants with multiple sclerosis who have been exposed to prolonged release fampridine since the first day of the last menstrual period or at any time during pregnancy. This information will be from ongoing fampridine clinical studies or the post-marketing setting. The outcome of the pregnancy must not be known at the time of report.

Brief summary: This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged-release fampridine since the first day of their last menstrual period prior to conception or at any time during pregnancy.

Detailed description: There are no mandatory physician visits. The registry will collect pregnancy outcome data from the participants health care provider during the prenatal follow up (6-7 months gestation), pregnancy outcome (4 weeks after estimated delivery date) and finally the pediatric follow up (at 4 weeks and 12 weeks post birth).

Eligibility criteria: Key Inclusion Criteria:

* Documentation that the patient was exposed to prolonged-release fampridine since the first day of her last menstrual period (LMP) prior to conception or at any time during pregnancy. (If exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure.)
* The outcome of the pregnancy must not be known at the time of report.

Key Exclusion Criteria:

* None

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Spontaneous abortions
timeFrame: < 22 weeks of gestation
measure: Elective or therapeutic terminations
timeFrame: Up to 9 months of pregnancy
measure: Ectopic pregnancy
timeFrame: Up to 9 months of pregnancy
measure: Fetal death including still births
timeFrame: >22 weeks of gestation or weighing 500 grams
measure: Live born infants
timeFrame: During delivery time ( at expected average 9 months of pregnancy)
measure: Premature births
timeFrame: Delivered before 37 Weeks of gestation
measure: Maternal death
timeFrame: During pregnancy, labor or delivery
measure: Neonatal death
timeFrame: Prior to 28 days of life
measure: Birth Defects
timeFrame: Delivery time (expected 9 months of pregnancy)
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Pitie Salpetriere
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03606954: Potency of Topical Corticosteroids in Combination Preparations
Official title: Evaluation of Topical Corticosteroids Potency in Combination Preparations in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Skin Toxicity
Lead sponsor: Ben-Gurion University of the Negev
Sponsor class: OTHER
Collaborators: name: Soroka University Medical Center
First posted: 2018-07-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Several combination topical drugs are available on the market. The potency of corticosteroids depends on a particular molecular structure and the skin penetration properties. Besides molecular structure, a penetration of a corticosteroid molecule correlates with physical properties of the vehicle which depend on physical properties of the vehicle constituents.

Vasoconstriction assay is considered as the gold standard for testing potency of topical corticosteroids.

Detailed description: Primary outcome: Change in Vasoconstriction index following application of topical corticosteroids that are incorporated with or without an antibiotic and/or antifungal drugs in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* No prior history of internal diseases that required vaccine-suppressing treatments
* Absence of an active skin disease.

Exclusion Criteria:

* Treatment with topical corticosteroids in the 4 weeks prior to the study
* Immune-suppressive treatment in the 4 weeks prior to the study
* Pregnancy or breast feeding

Primary outcomes:
measure: Vasoconstriction Index (VI) measured by Skin Color Reflectometry
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Soroka University Medical Center & Ben Gurion University
name: Raed Khoury, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00610454: Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures
Official title: Trial Evaluating the Safety and Tolerability of Levetiracetam Intravenous 15-minute Infusion, Administered in b.i.d. Regimen as an Adjunctive Antiepileptic Treatment in Subjects From 16 to 65 Years Suffering From Partial Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Levetiracetam
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-02-08
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects receiving LEV as adjunctive therapy to 1 or 2 other AEDs for partial onset seizures and subjects who are temporarily unable to take oral LEV, may require alternative routes of administration. The purpose of this trial was to evaluate the safety and tolerability of 1000 to 3000 mg/day LEV administered as a 15-min IV infusion b.i.d. after switching from the same oral dose.


Eligibility criteria: Inclusion Criteria:

* Adult
* in- or out-subjects suffering from partial onset seizures according to the ILAE classification of Epileptic Seizures;
* intake of levetiracetam as an adjunctive antiepileptic oral treatment in addition to one or two antiepileptic drugs (AED).

Exclusion Criteria:

* Had problems of venous accessibility;
* showed safety issues related to the administration of one of the concomitant AEDs requiring medical intervention;
* clinically significant ECG/lab abnormalities;
* administered vigabatrine;
* administered felbamate for less than 18 months;
* had contraindication to any component of the study medication treatment as IV formulation or known allergic reaction to or intolerance of pyrrolidone derivatives.

Primary outcomes:
measure: safety and tolerability of levetiracetam after switching from oral formulation to 15-minute IV infusion during repeated dosing (4 days b.i.d.)
timeFrame: Adverse events after each infusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Baulac M, Brodie MJ, Elger CE, Krakow K, Stockis A, Meyvisch P, Falter U. Levetiracetam intravenous infusion as an alternative to oral dosing in patients with partial-onset seizures. Epilepsia. 2007 Mar;48(3):589-92. doi: 10.1111/j.1528-1167.2006.00959.x. Epub 2007 Feb 22.
Clinical trial NCT04960033: Evaluating Fracture Risk Assessment Tools (FRAX) From Different Regions in Central South Chinese Postmenopausal Women
Official title: Central South University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis Fracture
Keywords: FRAX
osteoporosis
Chinese population
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 264
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017.

Brief summary: We evaluated fracture risk assessment tools (FRAXs) from different regions in Chinese postmenopausal women.

Detailed description: This cross-sectional study recruited 264 postmenopausal women aged ≥50 years in September 2017. Basic information, general condition, history of illness, family history, and clinical risk factors were evaluated via a questionnaire. All subjects underwent a bone mineral density examination of the femur and lumbar spine and thoracolumbar spinal X-ray. The 10-year major osteoporotic fracture (MOF) and hip fracture (HF) risks were calculated using FRAXs from mainland China, Hong Kong, Taiwan, and Asia-America. All data were analyzed using SPSS 17.0. Sensitivity, specificity, and likelihood ratio were used to compare the effectiveness of each FRAX.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017. Menopause was defined as the absence of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good health.

Exclusion Criteria:

* The criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs.

Primary outcomes:
measure: Osteoporosis fracture
timeFrame: 2017years
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: The 2nd Xiangya Hospital, Central South University
state: Hunan
Study officials:
References:
citation: Zhang Z, Ou Y, Sheng Z, Liao E. How to decide intervention thresholds based on FRAX in central south Chinese postmenopausal women. Endocrine. 2014 Mar;45(2):195-7. doi: 10.1007/s12020-013-0076-y. Epub 2013 Oct 22.
Clinical trial NCT05984433: Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture
Official title: Auricular Acupuncture As Part Of A Multimodal Analgesic Regimen For Reduction Of Opioid Analgesic Use After Surgery To Repair Lower Leg Fractures- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Fracture, Ankle
Pilon Fracture of Tibia
Foot Fracture
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial. Group 1 - acupuncture Group 2 - no acupuncture 70 patients per group
Primary purpose: TREATMENT

Brief summary: The purpose is to find out if incorporation of an intraoperative electro auricular acupuncture protocol when added to a standard multimodal analgesic regimen for patients undergoing surgery to repair lower leg fracture under spinal anesthesia will help reduce postoperative opioid use.


Eligibility criteria: Inclusion Criteria:

1. Patient ages 18-64
2. American Society of Anesthesiology Physical Status I, II or III
3. Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital

Exclusion Criteria:

1. Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
2. Allergy to any of the standard anesthetic agents
3. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
4. Patient or surgeon refusal

Primary outcomes:
measure: Total opioid analgesic use for 14 days after surgery
timeFrame: 14 days
Secondary outcomes:
measure: Pain scores
timeFrame: 14 days
measure: Incidence of side effects associated with opioid use
timeFrame: 14 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub Hospital
state: Texas
Study officials:
References:
Clinical trial NCT04000633: Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia
Official title: Nebulized Lidocaine Versus Placebo to Prevent Cough at Emergence From Anesthesia: a Double Blind Prospective Randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups comparaison between nebulized lidocaine versus placebo for prevention of cough at emergence from general anesthesia and post extubation sore throat
Primary purpose: PREVENTION

Brief summary: our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.

Detailed description: our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.

This randomized controlled study will compare the effect of Lidocaine and placebo nebulization in the immediate pre operative period in order to evaluate the effectiveness in reducing post extubation cough and sore throat.

Eligibility criteria: Inclusion Criteria:

* age\>18 years
* ASA status I or II

Exclusion Criteria:

* Unexpected difficult laryngoscopy
* Surgery\>3 hours

Primary outcomes:
measure: incidence of cough at emergence from general anesthesia
timeFrame: 30 minutes after the end of surgery
Secondary outcomes:
measure: incidence of sore throat
timeFrame: 24 hours after tracheal extubation
Other outcomes:
Locations:
city: La Marsa
country: Tunisia
facility: Mongi Slim Hospital
state: Tunis
Study officials:
affiliation: Mongi Slim Hospital
name: Mhamed Sami Mebazaa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01456533: Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients
Official title: Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyponatremia
Hypernatremia
Keywords: hyponatremia
hypernatremia
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Kantonsspital Aarau
First posted: 2011-10-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hospitalized patients with severe hypo or hypernatremia

Brief summary: Background: Hypo- and hypernatremia are common in hospitalized patients. The differential diagnosis of dysnatremia is challenging.

Osmotically inadequate secretion of antidiuretic hormone (ADH) is the predominant mechanism in most dysnatremic disorders. ADH measurement is cumbersome. It is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of ADH.

Objective: To evaluate the additional value of copeptin to improve a currently used algorithm in the differential diagnosis of (A) severe hypoosmolar hypo- and (B) severe hypernatremia.

Design: Prospective observational study.


Eligibility criteria: Inclusion Criteria:

* hyponatremia \<125 or hypernatremia \>155 mmol/L

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: diagnostic accuracy of copeptin within hospital stay
timeFrame: participants will be followed for up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Beat Müller
state: Aargau
city: Basel
country: Switzerland
facility: Mirjam Christ-Crain
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Mirjam Christ-Crain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kantonsspital Aarau, University Hospital Basel
name: Beat Müller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sailer CO, Winzeler B, Nigro N, Bernasconi L, Mueller B, Christ-Crain M. Influence of Outdoor Temperature and Relative Humidity on Incidence and Etiology of Hyponatremia. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1304-1312. doi: 10.1210/jc.2018-01507.
citation: Nigro N, Winzeler B, Suter-Widmer I, Schuetz P, Arici B, Bally M, Refardt J, Betz M, Gashi G, Urwyler SA, Burget L, Blum CA, Bock A, Huber A, Muller B, Christ-Crain M. Copeptin levels and commonly used laboratory parameters in hospitalised patients with severe hypernatraemia - the "Co-MED study". Crit Care. 2018 Feb 9;22(1):33. doi: 10.1186/s13054-018-1955-7.
Clinical trial NCT02837133: Effects of a Single Session of Integrated Yoga Therapy Compared With Other Relaxation Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Yoga
Lead sponsor: Hiroshima University
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 145
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Typically a course of yoga therapy for stress management takes place over a week, however, investigators are often asked to provide a single session for workers. The aim of this study is to assess the benefits of a single session of an integrated yoga program compared with other relaxation techniques for the staff of schools.


Eligibility criteria: Inclusion Criteria:

* school staff members, including school managers, teachers, school nurses, school office workers, nutritionists and cooks
* volunteers attending a stress management workshop

Exclusion Criteria:

* those who had any previous experience of practicing yoga or any relaxation procedures

Primary outcomes:
measure: Change of scores on the Subjective Units of Distress (SUD) scale
timeFrame: 1) immediately after the subjects arrived at the facility (baseline) and 2) immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04467333: Giessen Pulmonary Hypertension in Lung Cancer Registry
Official title: Giessen Pulmonary Hypertension in Lung Cancer Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Equivalent to the average of patients with lung cancer in Germany.

Brief summary: The aim of this study is to investigate the frequency and implications of pulmonary hypertension in lung cancer patients. To do so, data will be collected from all lung cancer patients at the university hospital Giessen. All data will be analyzed for possible hints of pulmonary hypertension as a comorbidity in lung cancer patients. All information will be generated from the regular guidelines based course of treatment and there will be no interventions. This study will serve as a prospective register for all lung cancer patients treated at the university hospital Giessen.


Eligibility criteria: Inclusion Criteria:

* Patient with lung cancer at the University of Giessen lung Cancer Center.

Exclusion Criteria:

-

Primary outcomes:
measure: Pulmonary function test measured via Spirometry.
timeFrame: 2 years
measure: sPAP values measured via Echocardiography.
timeFrame: 2 years
measure: Body mass index.
timeFrame: 2 years
measure: Overall Survival and Progression Free Survival measured in days.
timeFrame: 2 years
measure: Measurements of the pulmonary artery diameter (PA) and ascending aorta (AA) diameter measured via computed tomography scan. PA and AA will be measured in millimeters.
timeFrame: 2 years
measure: 6 Minute Walk Test in meters.
timeFrame: 2 years
measure: Modified Medical Research Council Scale (mMRC).
timeFrame: 2 years
measure: chronic obstructive pulmonary disease assessment test (CAT).
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University hospital Giessen
state: Hessen
Study officials:
affiliation: JLU Giessen
name: Bastian Eul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: JLU Giessen
name: Khodr Tello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pullamsetti SS, Kojonazarov B, Storn S, Gall H, Salazar Y, Wolf J, Weigert A, El-Nikhely N, Ghofrani HA, Krombach GA, Fink L, Gattenlohner S, Rapp UR, Schermuly RT, Grimminger F, Seeger W, Savai R. Lung cancer-associated pulmonary hypertension: Role of microenvironmental inflammation based on tumor cell-immune cell cross-talk. Sci Transl Med. 2017 Nov 15;9(416):eaai9048. doi: 10.1126/scitranslmed.aai9048.