louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04817423: Automated ICD Coding of Primary Diagnosis Based on Machine Learning
Official title: Automated ICD Coding of Primary Diagnosis Based on Machine Learning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2021-03-26
Enrollment: 74880
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admissions in Fuwai Hospital

Brief summary: This study aims to develop and validate machine learning model in ICD-10 coding of primary diagnosis related to cardiovascular diseases in Chinese corpus.

Detailed description: The accuracy and productivity of ICD coding has always been a concern of clinical practice. Errors of ICD codes may result in claim denials and missed revenue. However, ICD coding process is complex, time-consuming and error-prone. More experienced coders are in need, but there is an increasing lack of supply. Automated ICD coding has potential to facilitate clinical coders for improved efficiency and quality. Model performance of related studies is still far below coders and both the accuracy and interpretability need to be improved in great demand. Besides, studies in Chinese corpus are not sufficient.

In this study, the investigators will implement automated ICD coding study based on inpatient' data collected from electronic medical records from Fuwai Hospital, the world's largest medical center for cardiovascular disease. Feature engineering and machine learning methods will be used to develop classification models with good performance, interpretability and practicability for ICD codes of primary diagnosis.

Eligibility criteria: Inclusion Criteria:

* Admissions in Fuwai Hospital, from January 1, 2019, to December 31, 2020

Exclusion Criteria:

* Admissions stayed in nephrology department, Fuwai Hospital

Primary outcomes:
measure: ICD code of primary diagnosis
timeFrame: At the end of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Wei Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01472523: A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood
Official title: A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneuploidy, NIPT
Lead sponsor: Premaitha Health
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 1632
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Mothers attending clinic for routine screening. Followed up at around 1 years duration.

Brief summary: A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method.

Detailed description: A total of \~2000 participants have donated blood samples used for the development and validation of the IONA non-invasive prenatal screening test for Downs, Edwards and Patau syndrome. The IONA Test was CE marked Feb 2013. We are now recruiting a further 800 participants to provide blood samples to further develop and verify the test for other chromosomal abnormalities and to improve test efficiency.

Eligibility criteria: Inclusion Criteria:

* Patient/subject is willing and able to give informed consent for participation in the study.
* Female, aged 16 years or above.
* Currently pregnant at time of entry to the study.
* Pregnancy having been identified as 'high-risk' by screening test.

Exclusion Criteria:

* The patient/subject may not enter the study if ANY of the following apply:
* The participant herself has Down's Syndrome or other chromosomal abnormality.
* Children under 16
* Adults with learning disabilities
* Adults who are unconscious or very severely ill
* Adults who have a terminal illness
* Adults in emergency situations
* Adults suffering from a mental illness
* Adults with dementia
* Prisoners
* Young offenders
* Adults who are unable to consent for themselves
* Any person considered to have a particularly dependent relationship with investigators

Primary outcomes:
measure: Validation of method of novel analysis for Aneuploidy
timeFrame: 2013 Approx
Secondary outcomes:
measure: Optimization of existing methods for maximising ffDNA
timeFrame: up to July 2019
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Premaitha Health
Study officials:
affiliation: National Health Service, United Kingdom
name: Brenda Kelly, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03080623: Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Official title: Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Diagnoses Disease
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 1981
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: females with breast lesion who need to receive breast ultrasound to make differential diagnosis of benign and malignant lesion

Brief summary: This study proposed to construct an ultrasound-based diagnostic model for Differentiating Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and prospective part, which are designed for model construction and independent validation, respectively.This study aims to construct an easy-to-use ultrasound-based model, prove the efficacy of the model for identifying malignant breast lesion from benign lesion, and finally promote the application of this diagnostic model in more clinics.


Eligibility criteria: Inclusion Criteria:

* female
* with single breast lesion(maximum diameter\>0.8 cm)
* agree to receive follow-up in six months and take the second breast ultrasound six month after the first breast ultrasound, if a benign diagnosis is achieved at the first ultrasound
* sign the informed consent

Exclusion Criteria:

* lost to follow-up
* failed to take the second breast ultrasound six month after the first breast ultrasound

Primary outcomes:
measure: breast biopsy proved malignant or benign lesion
timeFrame: between breast ultrasound and biopsy(one week)
measure: two breast ultrasound identified benign lesion
timeFrame: between first detection of breast lesion and the second ultrasound(six month)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Haidian women and children's hospital of beijing
city: Beijing
country: China
facility: Shunyi women and children's hospital of Beijing Children's Hospital
city: Shijiazhuang
country: China
facility: Fourth Hospital of Heibei Medical Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Tao Ouyang
role: STUDY_CHAIR
References:
citation: Huo L, Tan Y, Wang S, Geng C, Li Y, Ma X, Wang B, He Y, Yao C, Ouyang T. Machine Learning Models to Improve the Differentiation Between Benign and Malignant Breast Lesions on Ultrasound: A Multicenter External Validation Study. Cancer Manag Res. 2021 Apr 16;13:3367-3379. doi: 10.2147/CMAR.S297794. eCollection 2021.
Clinical trial NCT02005523: Study of RNS60 on Pain and Function After Hip Labral Repair
Official title: Study of RNS60 on Post-operative Pain and Function in Patients Undergoing Hip Labral Repair or Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hip Labral Tear
Lead sponsor: Revalesio Corporation
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if use of RNS60 during hip labral repair surgery decreases pain and improves functional capacity post-operation.



Primary outcomes:
measure: Assessment of post-operative pain
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
state: Washington
Study officials:
References:
Clinical trial NCT02827123: A Comparison of McGrath MAC Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Endotracheal
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 84
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on the intubation time for orotracheal intubation in children.

The secondary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children.


Eligibility criteria: Inclusion Criteria:

* orotracheal intubation under general anesthesia

Exclusion Criteria:

* oral lesions, congenital anomaly, cervical spine instability, rapid sequence intubation

Primary outcomes:
measure: Intubation time
timeFrame: through intubation completion, an average of 30 second
Secondary outcomes:
measure: The degree of glottic exposure as assessed by Cormack and Lehane Grade
timeFrame: Up to 5 second after laryngoscopy passing the teeth
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
state: Seoum
Study officials:
References:
Clinical trial NCT03960723: Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures
Official title: Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Informed Consent
Keywords: Informed consent
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 18 years, who undergoing surgery and are admitted by CSI unit.

Brief summary: The Informed Consent (IC) of a medical procedure is the aceptation of a diagnostic or therapeutic procedure by the patient, after receiving the necessary and accurate information about it. Freedom, information and understanding have to be the main requirements in this proccess.

The main goal of this study is to assess if patients that are going to be operated at Hospital de la Santa Creu i Sant Pau in the CSI (Surgery without previous hospitalization) unit, really understood the information about the procedure.


Eligibility criteria: Inclusion Criteria:

* Undergoing surgery and admitted by CSI unit
* Provide written informed consent to participate in the study

Exclusion Criteria:

* Patients who need a legal representative to read, understand and sign the CI

Primary outcomes:
measure: Understanding degree
timeFrame: Before procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Institut de Recerca de l´Hospital de la Santa Creu i Sant Pau
name: Rosa Mª Antonijoan Arbos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00873223: Examination of the Effects of Liraglutide on the Mode of Action of Insulin Detemir
Official title: Insulin Detemir Co-administered With Liraglutide: An Open Label Trial to Assess Insulin Detemir and Liraglutide Pharmacokinetics and Pharmacodynamics Following Liraglutide Therapy in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-04-01
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States. The aim of this clinical trial is to investigate whether chronic liraglutide administration affects the mode of action (pharmacokinetics) of insulin detemir


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes
* BMI less than 45.0 kg/m2
* Insulin naive
* Currently treated with Oral Anti-Diabetic drugs (OADs) and metformin with a HbA1c between 7.0 and 9.5% or currently treated with metformin only with a HbA1c between 7.0 and 10.0%

Exclusion Criteria:

* Any clinically significant disease other than type 2 diabetes
* Currently using daily insulin
* Thiazolidinione use or other injectable diabetes medications within the last 3 months

Primary outcomes:
measure: Insulin detemir pharmacokinetics with and without liraglutide administration
timeFrame: at approx. 12 weeks (including screening, washout and evaluation period)
Secondary outcomes:
measure: Pharmacokinetics of liraglutide with and without insulin detemir
timeFrame: at approx. 12 weeks (including screening, washout and evaluation period)
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Novo Nordisk Investigational Site
state: California
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Morrow L, Hompesch M, Guthrie H, Chang D, Chatterjee DJ. Co-administration of liraglutide with insulin detemir demonstrates additive pharmacodynamic effects with no pharmacokinetic interaction. Diabetes Obes Metab. 2011 Jan;13(1):75-80. doi: 10.1111/j.1463-1326.2010.01322.x.
Clinical trial NCT01537523: To Investigate the Effect of Early Community-care Program on Fracture Hip Patient
Official title: To Investigate the Effect of Early Community-care Program on Physical and Depressive Aspects for Discharged Hospital Patient Suffered From Hip Fracture.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture
Keywords: physical
psychological
fracture hip
Lead sponsor: Hong Kong Healthcare Volunteer Organization
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The early community-care program is well-known rehabiliation for the fracture hip patient. For the discharged fracture hip patient from hospital, it is worth to investigate the effect of early mobilization program to improve their physical and psychological aspects.

Detailed description: 60 fractured hip patient will randomized allocated into intervention group and control group.

The community-care include nursing care, physiotherapy and home modification according to the condition of the patient.

The intervention will received community-care program for 12 weeks. Two sessions per week and total 24 sessions.

The control group will receive the traditional medication. The outcome measure include elderly mobility scale and happiness scale. The measurement will take at initial and completion of the program.

SPSS will be used for data analysis.

Eligibility criteria: Inclusion Criteria:

* fracture hip patients discharged from queen mary hospital

Exclusion Criteria:

* cognitive impairment

Primary outcomes:
measure: Elderly Mobility Scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Volunteer department
name: HO HO, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01901523: Coordinated Assessment of Notifications of Trials Containing Overt Published Errors
Official title: Phase II Study of Response of Medical Journal Editorial Boards to Notification of Serious Discrepancies in Published Clinical Trials in Human Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Discrepancy
Committee on Publication Ethics
Correction
Erratum
Retraction
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Clinical research, like all science, is self-correcting, with errors detected by the scientific community and communicated to the publishing journals, which then relay the information (and its resolution) to its readers. If this relaying process fails, science grinds to a halt. In this study we are testing its integrity.

Detailed description: This prospective study documents the outcome of notification to journal editorial boards (or equivalent authorities) of factually incorrect or inconsistent claims, in reports they have published.

Eligibility criteria: Inclusion Criteria:

* Report of a clinical trial in humans of treatment of heart disease with bone marrow derived stem cells
* Report containing discrepancy by reference to same report or another report

Exclusion Criteria:

* Discrepancy has already been corrected by an erratum

Primary outcomes:
measure: Time to correction, retraction, or other notification to the readership of discrepancy
timeFrame: 12 months
Secondary outcomes:
measure: Time to initial response from journal
timeFrame: 0-4 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: International Centre for Circulatory Health
Study officials:
affiliation: Imperial College London
name: Darrel P Francis, MA MD FRCP
role: STUDY_CHAIR
References:
citation: Francis DP, Mielewczik M, Zargaran D, Cole GD. Autologous bone marrow-derived stem cell therapy in heart disease: discrepancies and contradictions. Int J Cardiol. 2013 Oct 9;168(4):3381-403. doi: 10.1016/j.ijcard.2013.04.152. Epub 2013 Jul 2.
citation: Nowbar AN, Mielewczik M, Karavassilis M, Dehbi HM, Shun-Shin MJ, Jones S, Howard JP, Cole GD, Francis DP; DAMASCENE writing group. Discrepancies in autologous bone marrow stem cell trials and enhancement of ejection fraction (DAMASCENE): weighted regression and meta-analysis. BMJ. 2014 Apr 28;348:g2688. doi: 10.1136/bmj.g2688.
Clinical trial NCT01533623: The 1 Year Follow-up Objective Oral Appliance Compliance
Official title: The 1 Year Follow-up of Objective Measures of Oral Appliance Compliance for Treatment of Sleep-disordered Breathing (SDB): a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep-disordered Breathing
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will perform a 1-year clinical trial measuring objective compliance during mandibular advancement device (MAD) treatment.

The investigators will enroll 50 patients that received treatment with a titratable, duobloc MAD (RespiDent Butterfly®, RespiDent, Nijlen, Belgium) and participated in the original study "Objective versus subjective compliance with oral appliance therapy for obstructive sleep apnea hypopnea syndrome", registered at Clinical Trials.gov (NCT01284881).

Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Austria) are provided by the Handelsagentur Gschladt without any costs. The sampling interval of the recording will be done at a rate of 1 measurement per 15 minutes (every 900 seconds). Using this sample interval, the capacity of the active microsensor allows for data acquisition during a 100 day period.

A follow-up appointment is scheduled +/- 265 days after the start of the original study. A second follow-up visit is scheduled again 1 year after the start of the original study.

The objective measurement of MAD wear time (total hours of wear time and the mean hours of wear per night over the respective period) will be based on the assumption that the MAD has been worn when the chip records a temperature intraorally.

Detailed description: This clinical trial is an extension to trial 10/48/340, registered at Clinical Trials.gov (NCT01284881).

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of sleep-disordered breathing
* started treatment with a titratable, duobloc mandibular advancement device
* participated in original study 10/48/340 (3 month follow-up of compliance during treatment with mandibular advancement device)

Exclusion Criteria:

* dental exclusion criteria for mandibular advancement devices
* medical contra-indications for mandibular advancement devices

Primary outcomes:
measure: Safety and feasibility of measuring objective mean wearing time
timeFrame: 1 year
Secondary outcomes:
measure: therapeutic index
timeFrame: 1 year
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
Clinical trial NCT05657223: Factors Associated With the Complexity of Dental Implant Surgery After Alveolar Ridge Preservation: A Retrospective Cross-sectional Study
Official title: Attending Physician, Division of Periodontics, Department of Dentistry, Kaohsiung Medical University Hospital, Kaohsiung
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Complexity of Implant Surgery
Keywords: periodontitis, alveolar ridge preservation, implant surgery.
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 165
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Of 165 sites, dental implant surgery was performed at 156 sites. A total of 72 damaged sockets and 93 intact sockets were included.

Brief summary: Alcohol consumption, tooth position, and periodontitis-related tooth extraction affect the complexity of subsequent implant surgery after alveolar ridge preservation.

Detailed description: Materials and methods We retrospectively analyzed the dentition of 165 alveolar ridge preservation sites in 116 patients. The bone width at three different vertical levels was measured on cone beam computed tomography images, and a comparison of bone regeneration requirements for subsequent dental implant surgery was performed for different socket types.

Eligibility criteria: Inclusion Criteria:

* teeth extraction in the premolar and molar regions, who underwent flapless tooth extraction with alveolat ridge preservation (ARP) and filling with freeze-dried bone allograft (FDBA) and platelet-rich fibrin (PRF), who underwent cone beam computed tomography (CBCT) followed by dental implant surgery after tooth extraction, and with adequate oral hygiene

Exclusion Criteria:

* untreated periodontitis, systemic disease, or the of medication that influences bone metabolism

Primary outcomes:
measure: Alveolar bone width
timeFrame: 4~6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: