louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06644391: Enhancing Diagnostic Accuracy in Fracture Identification on Musculoskeletal Radiographs Using Deep Learning
Official title: Enhancing Diagnostic Accuracy in Fracture Identification on Musculoskeletal Radiographs Using Deep Learning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures
Musculoskeletal
Lead sponsor: Carebot s.r.o.
Sponsor class: INDUSTRY
First posted: 2024-10-16
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes a retrospective cohort of pediatric and adult patients who underwent musculoskeletal radiographs between March 20 and May 8, 2023, in a single-center hospital setting.

Brief summary: This retrospective study aims to evaluate the effectiveness of artificial intelligence (AI) in identifying fractures on musculoskeletal X-rays. By comparing the performance of a deep learning AI model with that of experienced radiologists, we seek to understand how AI can help improve fracture detection accuracy in clinical settings. The study analyzed 600 X-rays from both pediatric and adult patients, focusing on identifying fractures across different body parts, including the foot, ankle, knee, hand, wrist, and more. The findings show that integrating AI can increase radiologists' sensitivity in detecting fractures, potentially improving patient outcomes by reducing the number of missed injuries.


Eligibility criteria: Inclusion Criteria:

* Patients aged 1 year or older.
* Musculoskeletal X-rays available in Digital Imaging and Communications in Medicine (DICOM) format.
* At least one digital plain radiograph of an appendicular body part, including the foot, ankle, knee, hand, wrist, elbow, shoulder, or pelvis.

Exclusion Criteria:

* Poor radiographic quality that precludes human interpretation.
* Radiographs of the lumbar, thoracic, and cervical spine, or facial/nasal bones.
* Radiographs that do not meet the inclusion criteria for appendicular body parts.

Primary outcomes:
measure: Sensitivity of AI Model Compared to Radiologists in Fracture Detection on Musculoskeletal X-rays
timeFrame: From March 2023 to May 2023 (Retrospective analysis period)
Secondary outcomes:
Other outcomes:
Locations:
city: Frýdek-Místek
country: Czechia
facility: Nemocnice ve Frýdku-Místku, p.o.
state: Moravskoslezský
Study officials:
References:
Clinical trial NCT05166291: The Effect of Needle-free Injection System During Palatal Anesthesia
Official title: The Effect of Needle-free Injection System Versus Traditional Anesthesia on Pain Perception During Palatal Infiltration Anesthesia in Children: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Anesthesia
Local Anesthesia
Keywords: needle-free injection system
pain perception
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Needle-free injection systems can contribute to the prevention of needle-related pain during palatal infiltration anesthesia (PIA) in children. Research with this topic on children is required.The purpose of this clinical study was to evaluate the effectiveness of the needle-free system versus traditional anesthesia on pain perception during PIA in children.The study was designed as a randomized, controlled cross-over clinical study with 48 children aged 6 to 12 years requiring dental treatment with PIA in bilateral maxillary primary molars. It has been revealed that the application of a needle-free system during PIA ensured a decrease in pain perception in children.


Eligibility criteria: Inclusion Criteria:

* In need of treatment of right and left primary molar teeth of maxilla,
* Does not have any systemic disorder,
* High level of communication that can provide logical answers to the questions we ask
* With parental consent,
* Volunteers who want to participate in the research
* 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

Exclusion Criteria:

* No need for treatment of right and left primary molar teeth of maxilla,
* Has a systemic condition
* Low level of communication that cannot provide reasonable answers to the questions we ask
* Without parental consent
* Do not want to participate voluntarily in the research
* Do not attend a check-in
* Patients not in the 6-12 age group

Primary outcomes:
measure: Wong-Baker Faces Pain Rating Scale (PRS)
timeFrame: 3 months
measure: Face, Legg, Cry, Consolability Scale (FLACC)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Okan University Faculty of Dentistry
Study officials:
References:
Clinical trial NCT02134691: Randomized Trial of Prolonged Exposure for the Treatment of Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder (PTSD)
Prolonged Exposure (PE)
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-05-09
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project will examine the impact of PE therapy for the treatment of PTSD with a sample of Latinos. The need to provide effective treatment to Spanish-speaking Latinos with PTSD is critical given the high prevalence of PTSD among Latinos. Furthermore, PTSD remains an under detected and under treated condition. Untreated PTSD has a substantial impact on health, functioning and quality of life. PE is one of the most empirically supported psychological interventions for PTSD. However, most studies that evidence the efficacy of PE have been conducted mainly with English-speaking Caucasian populations. This study has the potential to contribute to improvements in the well-being of Spanish-speaking Latinos with PTSD.


Eligibility criteria: Inclusion Criteria:

* 18 to \< 65 years
* Meet diagnostic criteria for PTSD
* Spanish speaker
* Allow recording of assessments and therapy

Exclusion Criteria:

* Significant current suicidal or homicidal ideation
* History of bipolar, schizophrenia or psychotic disorder
* Alcohol or drug abuse during the past three months
* Current high risk of being assaulted (i.e., living with domestic violence)
* Current psychotherapy to treat PTSD
* Unable to provide informed consent

Primary outcomes:
measure: Change in Clinician Administered PTSD Scales (CAPS)
timeFrame: 6 months
Secondary outcomes:
measure: Change in SF-12
timeFrame: 6 months
measure: Change in Sheehan Disability Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico, Medical Sciences Campus
Study officials:
affiliation: University of Puerto Rico Medical Sciences Campus
name: Mildred Vera, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02681991: Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patients With Chronic Renal Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Failure
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-02-15
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic renal failure.

120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl).

Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum indoxyl sulfate will be evaluated.


Eligibility criteria: Inclusion Criteria:

1. patients spontaneously written consent to participate in this clinical trial
2. men and women over age of 19
3. pre-dialysis patients with chronic renal failure stage patient for 3 months and patients for holding the stable state in serum creatinine 1.5mg/dl - 5.0mg/dl
4. patients who were no noticeable change for 12weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(medication and dose -related, diet therapy)

Exclusion Criteria:

1. patients with passes through the digestive tract disorders
2. patients with uncontrolled constipation symptoms
3. patients suffering from digestive tract ulcers and esophageal varices
4. patients with untreated severe hypertension (DBP ≥ 120mmHg)
5. patients hospitalized with angina pectoris, cardiovascular disease or diagnosed with serious arrhythmia or cerebrovascular disease within 6 months
6. patients with hepatic impairment (2 times greater than the upper limit of normal levels of AST, ALT)
7. subjects with dependency on alcohol
8. patients with current infections
9. pregnant women, nursing mothers
10. Patients with a possibility of pregnancy (However, negative case can be registered)
11. patients participating in another clinical trial in addition to the current clinical trial
12. Patient who do not fit the clinical trial participation the legal and mentally

Primary outcomes:
measure: change from baseline of Indoxyl sulfate at 8weeks
timeFrame: 0, 8weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Sevrance Hospital of Yonsei University
state: Gangnam-gu
Study officials:
affiliation: Gangnam Sevrance Hospital of Yonsei University
name: Hyeong-Cheon Park, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00846391: A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)
Official title: A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK8245 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Have Type 2 Diabetes Mellitus
* 18 to 65 years of age

Exclusion Criteria:

* History of Type 1 Diabetes or ketoacidosis
* Have been treated with lipid lowering medications 4 weeks before starting the study
* Have started on a weight loss program and not in the maintenance phase or have started weight loss medication within the last 12 weeks
* Have had surgery in the last 30 days
* History of active liver disease
* History of coronary heart disease or congestive heart failure
* Have had a stroke or transient ischemic neurological disorder in the past 6 months
* Are Human Immunodeficiency Virus (HIV) Positive

Primary outcomes:
measure: Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
timeFrame: Baseline and Week 4
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05753891: Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)
Official title: Trapeziectomy With Internal Brace Versus Ligament Reconstruction With Tendon Interposition; a Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Basilar Thumb Arthritis
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to compare two methods of trapeziectomy for basilar thumb arthritis. The first is trapeziectomy with ligament reconstruction and tendon interposition, which means removing the trapezium bone and filling the void with a tendon graft. This is the most commonly used procedure and the control group. The experimental group is trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal. This is using a device called the InternalBrace, produced by Arthrex.


Eligibility criteria: Inclusion Criteria:

* Patients of Henry Ford Orthopedic Service Line
* Symptomatic basilar thumb arthritis refractory to conservative management

Exclusion Criteria:

* Significant medical comorbidity precluding safe surgery, as determined by the operating surgeon. This may include cardiac disease, renal disease, liver disease, pulmonary disease, or heavy substance abuse.
* Requirement for additional procedures at the 1st carpometacarpal joint, including trapezoid excision-whole or partial-or metacarpal osteotomy. Of note other existing conditions requiring intervention on a separate surgical site such as concomitant carpal tunnel syndrome or trigger fingers will NOT be used as exclusion criteria.

Primary outcomes:
measure: Pinch Strength
timeFrame: 6 months post procedure
Secondary outcomes:
measure: PROMIS-UE
timeFrame: 6 months post procedure
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
Clinical trial NCT01409291: Impact of a Financial Success Education Program in Women and Children
Official title: Impact of a Financial Success Education Program on Perceived Financial Well-being, Hopefulness, Financial Competency, Financial Goal Achievement, Quality of Life, and Quantitative Health Outcomes in Women and Children: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Keywords: low socioeconomic status
stress
women
children
cortisol
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 64
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women enrolled in the Financial Success Program and their children

Brief summary: Many Americans are living paycheck to paycheck. This may lead to financial stress and an increase in overall stress. People under stress are more likely to smoke, consume alcohol, eat a poor diet, and experience depression or anxiety. Experiencing financial stress may also increase the risk for heart disease. The purpose of this research study is to test whether participating in the Financial Success Program improves health outcomes, in both the women participating and their children.


Eligibility criteria: Inclusion Criteria:

* Women 19 years or older enrolled in the Financial Success Program in fall 2011 and winter 2012 and/or a their child(ren) ages 3-18 years attending the daycare with their mother
* Women must be employed to be enrolled in the Financial Success Program
* Able and willing to provide informed consent

Exclusion Criteria:

* Women less than 19 years of age
* Women working a night time shift (due to variability in diurnal cortisol secretion)
* Known pregnancy or planned pregnancy (due to variability in blood pressure, glucose, weight, and lipids)
* Women are excluded from the Financial Success Program if they are living in a domestic violence situation or abusing alcohol or illicit drugs

Primary outcomes:
measure: Minutes of Exercise Per Week
timeFrame: 1 year
Secondary outcomes:
measure: Fast Food Meals Per Week
timeFrame: 1 year
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Kathleen Packard, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Packard KA, Kalkowski J, White N, Ryan-Haddad A, Black L, Flecky K, Furze J, Rusch L, Qi Y. Chapter 5: Impact of a financial education program in single, low-income women and their children. In: Public Health: Improving Health via Inter-Professional Collaborations Ed: Rosemary M. Caron and Joav Merrick. 2014.
citation: White N, Packard KA, Kalkowski J, Ryan-Haddad A, Flecky K, Furze J, Rusch L, Black L. Chapter 6: A novel financial education program in single women of low-income and their children In: Public Health: Improving Health via Inter-Professional Collaborations Ed: Rosemary M. Caron and Joav Merrick. 2014.
Clinical trial NCT00004791: Study of the Nutritional, Metabolic, and Body Composition Profile in Children and Adolescents With Epidermolysis Bullosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidermolysis Bullosa
Keywords: dermatologic disorders
epidermolysis bullosa
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Baylor College of Medicine
First posted: 2000-02-25
Enrollment: 15
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Characterize the nutritional and metabolic profile of children and adolescents with epidermolysis bullosa.

II. Determine patterns of body composition in these patients. III. Determine the energy requirements of these patients by measuring resting energy expenditure.

IV. Assess protein nutrition by measuring lean body mass.

Detailed description: PROTOCOL OUTLINE:

Data collected from a 5-day food diary are analyzed for protein, nutrient, and calorie intake. Nutritional, metabolic, and body composition are evaluated by indirect calorimetry, total body electrical conductivity, total body potassium, and lean body mass.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

* Epidermolysis bullosa
* Patient age: 2 months to 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baylor College of Medicine
name: William J. Klish
role: STUDY_CHAIR
References:
Clinical trial NCT01020591: The Effect of Osteopathic Manual Therapy on Vascular Supply
Official title: The Effect of Osteopathic Manual Therapy on the Vascular Supply to the Lower Extremity in Individuals With Knee Osteoarthritis, a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
manual therapy
osteopathy
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the use of osteopathic manual therapy can influence the vascular supply to the knee, knee range of motion, balance and knee pain, in a group of subjects with knee osteoarthritis. It is also the objective of this study to determine if there is a difference between the osteopathic evaluation and the combination of an osteopathic evaluation and treatment.


Eligibility criteria: Inclusion Criteria:

* Radiographic-confirmed knee osteoarthritis

Exclusion Criteria:

* Subjects who are unable to ambulate independently (without an aid) and safely the distance of a city block
* Subjects who have an uncontrolled medical condition (e.g. heart (angina) or respiratory condition (asthma))
* Subjects who have a neurological condition (e.g. Parkinson's, Multiple Sclerosis)
* Subjects who have both knees affected by osteoarthritis and have had previous surgery to both knees
* Subjects who have knee OA in only one knee and that knee has had previous knee surgery
* Subjects who have previous vascular surgery to either leg

Primary outcomes:
measure: Resistive Index (RI)
timeFrame: Participants attended one visit; The outcome measure (RI) was before and after an osteopathic session on the same day; The data collection of the 30 subjects took place between Jan to March 2010; each subject had outcomes measured on one day
Secondary outcomes:
measure: The Knee Flexion Active Range of Motion, Balance and Pain (VAS)
timeFrame: Jan 2010 to March 2010
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Wendy M Jardine, MScPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04052191: MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease
Official title: Intra-Coronary Administration of MCRcI® (Myo-Cardial Regenerative Cellular Injection) Improves Left Ventricular Function in Patients With Diffuse Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Coronary Artery Disease
Lead sponsor: Honya Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2019-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation.
Primary purpose: TREATMENT

Brief summary: Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.


Eligibility criteria: Inclusion Criteria:

* Patients with Diffuse Coronary Artery Disease
* Age 20\~80
* Participants have received proper medication
* Canadian Cardiovascular Society class II- IV Angina.

Exclusion Criteria:

* Age \<20 or \>80
* Pregnant or breast feeding
* Positive adventitious infection (such as HIV, hepatitis )
* History of Myocardial Infarction within past 3 months
* Severe aortic or mitral valve narrowing
* Short of breath unable to receive PCI examination or treatment
* Malignant tumor
* Hematopoietic dysplasia
* Severe organ disease with less than 1 year of life expectancy
* Chronic kidney disease with CCr\<20ml/min
* Kiney disease on renal dialysis.

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Left ventricle stroke volume
timeFrame: 12 months
measure: End diastolic volume
timeFrame: 12 months
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 12 months
measure: Severity of angina symptom using Canadian Cardiovascular Society grading.
timeFrame: 12 months
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: HONYA Medical Inc
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Fang Y Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: