louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04222803: VIRal Hepatitis and GAllstone Disease Study
Official title: Viral Hepatitis and Gallstone Disease Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Gallstone Attack
Viral Hepatitis
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with and without ultrasound or computed tomography-verified gallstone disease will be compared for biomarkers of ongoing viral hepatitis (i.e. anti-HAV IgM, HBsAg, HCV Core antigen and HEV RNA).

Brief summary: The study aims to investigate possible associations between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease.

Detailed description: Patients seeking care at emergency room at Sahlgrenska University Hospital, Gothenburg, Sweden undergoing ultrasound or computed tomography for suspected gallstone disease, will be asked if they wish to participate in the study. If they agree, a serum sample will be draw for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA. The proportion of patients with vs. without ultrasound or computed tomography-verified gallstone disease will be evaluated regarding possible ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection).

Eligibility criteria: Inclusion Criteria:

* Acute abdominal pain entailing an abdominal ultrasound or computed tomography for suspected gallstone disease at the emergency room at Sahlgrenska University Hospital, Gothenburg
* Written informed consent
* Ability to obtain 9 mL serum for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA

Exclusion Criteria:

* Not willing to give written informed consent
* Age below 18 years

Primary outcomes:
measure: Association between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease
timeFrame: 1 day
measure: Association between ongoing hepatitis A virus infection and ultrasound or computed tomography-verified gallstone disease
timeFrame: 1 day
measure: Association between ongoing hepatitis B virus infection and ultrasound or computed tomography-verified gallstone disease
timeFrame: 1 day
measure: Association between ongoing hepatitis C virus infection and ultrasound or computed tomography-verified gallstone disease
timeFrame: 1 day
measure: Association between ongoing hepatitis E virus infection and ultrasound or computed tomography-verified gallstone disease
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: Södra Älvsborgs Sjukhus
Study officials:
affiliation: Göteborg University
name: Martin Martin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01910103: Comparison of Diagnostic Performance of Digital Breast Tomosynthesis and Ultrasound in Women With Dense Breasts
Official title: Comparison of Diagnostic Performance of Digital Breast Tomosynthesis and Ultrasound in Women With Dense Breasts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: Breast Neoplasms/radiography
Mammography/methods
Mass Screening
Tomography, X-Ray Computed/methods
Predictive Value of Tests
False Positive Reactions
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-07-29
Enrollment: 825
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing mammography and breast US for screening or diagnostic purpose

Brief summary: Diagnostic performance of digital breast tomosynthesis (DBT) would be not inferior to the that of breast ultrasound in women with dense breast.

Detailed description: 1. Patients with dense breast will be examined for the detection of breast cancer by imaging studies.
2. The imaging including digital breast tomosynthesis (DBT), physician-performed bilateral whole breast ultrasonography will be performed according to a standard protocol.Interpretation will be conducted independently and classified according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists.
3. Definitive information about the presence of malignancy will be obtained by biopsy directed by the imaging method best depicting the lesion with 14-g or 11-g needle devices or needle localized excision. The absence of breast cancer was determined by means of biopsy, the absence of positive findings on repeat imaging and clinical examination, or both at follow-up.
4. The diagnostic yield of digital breast tomosynthesis (DBT) compared to ultrasonography will be assessed.

Eligibility criteria: Inclusion Criteria:

* Women aged at 20 years
* Women who had heterogeneously dense or extremely dense parenchyma, either by prior mammography report or by review of prior mammograms
* Signed study-specific informed consent prior to registration

Exclusion Criteria:

* Had breast surgery
* Had breast core biopsy performed within the prior 6 months on the study

Primary outcomes:
measure: Diagnostic performance (AUC: area of under ROC curve) of DBT and US
timeFrame: one year
Secondary outcomes:
measure: Diagnostic sensitivity, sensitivity, negative predictive value, and positive predictive value of DBT and US for detecting breast cancer.
timeFrame: One year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Radiology, Seoul National University Hospital
Study officials:
affiliation: Department of Radiology, Seoul National University Hospital
name: Jung Min Chang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03064503: Myocardial Fibrosis, Function and Aging
Official title: Myocardial Fibrosis and Changes of Myocardial Function Related to Aging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: myocardial fibrosis
cardiac function
ageing
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In normal ageing, the impact of myocardial fibrosis on myocardial function is unclear as diastolic function is reported to change according to age. The objective is to explore the relationship between myocardial function changes, with local (T1 and diffusion) fibrosis measures with Magnetic Resonance Imaging (MRI) as well as global measures of fibrosis (skin auto-fluorescence and collagen blood-biomarkers).


Eligibility criteria: Inclusion Criteria:

* physical activity ≤ 3 x(30') per week
* no history of smoking, diabetes, myocardial infarction, heart failure, hypertension (\<140 or \<90 mmHg) and no anti-hypertensive or cardiovascular-related medications
* no familial history of early myocardial ischemia
* body mass index (BMI) \<30kg/m2
* normal routine lipid blood analysis
* glycemia \<1.26g/l
* normal electrocardiogram (ECG)

Exclusion Criteria:

* arrhythmia
* hepatic insufficiency
* pregnancy
* claustrophobia
* MRI contrast allergy,
* general contraindications to MRI such as pacemaker, etc.

Primary outcomes:
measure: Regional myocardial strain
timeFrame: The day of MRI
Secondary outcomes:
measure: MRI T1 value
timeFrame: The day of MRI, before gadolinium injection
measure: MRI T1 value
timeFrame: The day of MRI, 15 minutes after gadolinium injection
measure: Apparent Diffusion Coefficient (ADC) with MRI
timeFrame: The day of MRI
measure: Blood carboxy-terminal propeptide of procollagen type I (PICP) rate
timeFrame: The day of MRI
measure: Blood amino-terminal propeptide of procollagen type III (PIIINP) rate
timeFrame: The day of MRI
measure: Advanced Glycation End-products (AGE) rate
timeFrame: The day of MRI
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Département de Radiologie, CHU Saint-Etienne - Hôpital Nord
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Pierre CROISILLE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06822803: Effects of an Urban-gardening Nutrition Intervention for Food Insecure College Students
Official title: Effects of an Urban-gardening Nutrition Intervention for Food Insecure College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Obesity Prevention
Keywords: College student food insecurity
Gardening nutrition intervention
college students
nutrition education
social cognitive theory
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if an urban gardening nutrition education program can have positive health effects on food insecure college students. The main question it aims to answer is to determine whether an 8-week urban-gardening nutrition intervention can improve fruit and vegetable intake, nutrition knowledge, Body Mass Index (BMI) and body fat percentage in college students with food insecurity.

Participants will:

Fill out a questionnaire regarding demographics, food insecurity, fruit and vegetable intake, nutrition knowledge, self-efficacy and health beliefs.

Allow researchers to measure height, weight and body fat percentage Participate in a 1-hour education cooking or gardening session once a week for 8 weeks Receive text message reminders for meeting dates


Eligibility criteria: Inclusion Criteria:

* Must be enrolled at FIU
* Age 18+ years old
* Literate in English
* Food insecure

Exclusion Criteria:

* Students who are student athletes
* Women who are pregnant or planning to become pregnant in the next 6 months

Primary outcomes:
measure: Change from Baseline in the Mean Fruit and Vegetable Intake at 8 Weeks
timeFrame: From enrollment to the end of interventiont at 8 weeks
measure: Change from Baseline in the Mean Stress Scores at 8 Weeks
timeFrame: From enrollment to the end of interventiont at 8 weeks
measure: Change from Baseline in the Mean Life Satisfaction Scores at 8 Weeks
timeFrame: From enrollment to the end of interventiont at 8 weeks
measure: Change from Baseline in the Mean Body Mass Index Scores at 8 Weeks
timeFrame: From enrollment to the end of interventiont at 8 weeks
Secondary outcomes:
measure: Change from Baseline in the Mean Nutrition Knowledge Scores
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Change from Baseline in the Mean Self Efficacy, Outcome Expectation and Reciprocal Determinism
timeFrame: From enrollment to the end of intervention at 8 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
References:
Clinical trial NCT05984043: Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences
Official title: Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity, Adolescent
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
name: University of Colorado, Denver
First posted: 2023-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Adverse childhood experiences (ACEs), referring to traumatic experiences occurring before 18 years of age (e.g., abuse/neglect), are associated with a 30-70% increased risk of developing adolescent and adult obesity and obesity-related cardiometabolic comorbidities, which may be due to dysregulation in stress-related physiology and engagement in stress-related behaviors. While adolescents with ACEs have a 2.25 times increased risk of obesity, standard-of-care lifestyle (e.g., nutrition/physical activity) interventions do not typically incorporate trauma-informed care, including assessment and therapeutic attention to effects of ACEs. Heart rate variability (HRV) biofeedback is an evidence-based, relatively brief, mind-body intervention targeting the stress physiology that can be dysregulated in adolescents with ACEs. The objective of this proposal is to adapt and test a 4-session HRV biofeedback protocol for 12-17-year-olds with BMI\>85th percentile and ACEs. First (Phase 1), we will iteratively adapt a 4-session HRV biofeedback facilitator protocol with n=3-5 adolescents with overweight/obesity and ACEs, using adolescent quantitative and qualitative feedback to hone and optimize HRV biofeedback for this population (Aim 1). Next (Phase 2), we will conduct a randomized waitlist-controlled pilot study of n=30 adolescents with overweight/obesity and ACEs to assess acceptability and feasibility (Aim 2) and to describe changes in theorized targets of biofeedback (Aim 3).


Eligibility criteria: Inclusion Criteria:

* Four or more ACEs
* BMI at or above the 85th percentile;

Exclusion Criteria:

* Major renal, hepatic, endocrinologic, rheumatologic, cardiac, or pulmonary medical problem likely to affect mood or weight
* Medications affecting mood or weight (e.g. anti-anxiety/depressants/psychotics, stimulants, mood stabilizers, insulin sensitizers, weight loss)

Primary outcomes:
measure: Facilitator Protocol
timeFrame: Year 1
measure: Feasibility/Acceptability
timeFrame: Year 1
measure: Stress Physiology
timeFrame: Year 2
measure: Stress Eating
timeFrame: Year 2
measure: Inflammatory Biomarkers
timeFrame: Year 2
measure: Insulin Sensitivity
timeFrame: Year 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01942343: Akathisia in Post Operative Outpatients Surgery
Official title: Etude de l'Effet du dropéridol et de l'Ondansetron Sur l'Incidence de l'Akathisie Post opératoire en Chirurgie Ambulatoire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Akathisia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 300
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: PREVENTION

Brief summary: The main objective of this study is to evaluate the incidence of akathisia with Droperidol, the prophylactic treatment of post operative nausea and vomiting, used at two different doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to compare the number of observed akathisia (Barnes score \> 1) in the Droperidol arms (0,625 mg and 1,25 mg) versus Ondansetron 4 hours after recovery from anesthesia.The assumption is that there is a greater risk of akathisia among patients taking Droperidol in prevention of NPVO, that among patients taking Ondansetron.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 and under 65 year-old
* Having a moderate to severe POVN (post operative vomiting and nausea) risk, meaning with at least two risk factors in the simplified Apfel score
* Outpatient surgery associated to a general anesthesia
* Patient having signed an informed consent- Patient having a social protection

Exclusion Criteria:

* Contraindication to Droperidol
* Contraindication to Ondansetron
* Patients usually treated with benzodiazepine or having been treated with benzodiazepine within 2 days prior to anesthesia
* Psychiatric and Neurodegenerative diseases
* Severe Anxiety
* Contraindication to general anesthesia or one of its components
* Allergy to propofol
* Inability to get informed (patient in an emergency situation, difficulties to understand)
* Patient under judicial protection
* Patient under tutorship or curatorship
* Pregnancy reported by the patient- Breastfeeding
* Patient in an exclusion period

Primary outcomes:
measure: Incidence of akathisia
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
state: Alsace
Study officials:
References:
citation: Charton A, Greib N, Ruimy A, Faitot V, Noudem Y, Joshi GP, Meyer N, Diemunsch P. Incidence of akathisia after postoperative nausea and vomiting prophylaxis with droperidol and ondansetron in outpatient surgery: A multicentre controlled randomised trial. Eur J Anaesthesiol. 2018 Dec;35(12):966-971. doi: 10.1097/EJA.0000000000000821.
Clinical trial NCT04219943: Conservative Versus Surgical Treatment of Impacted Femoral Neck Fracture in Patient 75 Years Old and Older
Official title: Conservative Versus Surgical Treatment of Impacted Femoral Neck Fracture in Patient 75 Years Old and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fractures
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 154
Sex: ALL
Minimum age (years): 75
Maximum age (years): 97
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and effectiveness of conservative treatment in treatment of patients over 75 years with impacted femoral neck fracture.

Detailed description: The study is to compare clinical outcomes between conservative treatment, internal fixation, and hemiarthroplasty in patients over 75 years with impacted femoral neck fracture. All the 3 groups were evaluated by hip pain(visual analogue scale,VAS), hip function(Harris hip score,HHS), health related quality of life(European Quality of Life-5 Dimensions index scores, Eq-5d). All thses parameters were assessed at admission and 1-, 3-, 6- 12-, 24- and 36 months after intervention. Operation duration and blood loss were recorded. Mortality, union rate, complications and re-operation were also monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

Patients \>75 years old who were diagnosed with impacted femoral neck fracture with confirmation of mutual embedding and close combination of the fracture ends by CT or MRI scanning(including Garden 1 and 2 and varus impacted FNF) were eligible for the inclusion.

Exclusion Criteria:

Patients \<75 years old, pathological fracture, nonimpacted or displaced fracture, unable to walk previously, avascular necrosis of femoral head, previous symptomatic hip pathology (such as arthritis), infection, a history of fracture in the studied hip, deformity of lower limb.

Primary outcomes:
measure: visual analog scale
timeFrame: 36 months
measure: Harris hip score
timeFrame: 36 months
measure: Eq-5d index scores
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wei P, Xu Y, Gu Y, Geng D, Yao Q, Wang L. Conservative vs Surgical Treatment of Impacted Femoral Neck Fracture in Patients 75 Years and Older. J Am Geriatr Soc. 2020 Oct;68(10):2214-2221. doi: 10.1111/jgs.16535. Epub 2020 May 15.
Clinical trial NCT04448743: Role of Microparticles in Covid-19 Infection
Official title: Role of Circulating Microparticles in Covid-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: microparticles
microvesicles
vessel
vasculature
endothelium
coagulation
thrombosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Covid-19 patients
* patients with coronary artery disease
* healthy volunteers

Brief summary: Among the distinctive features of Covid-19, numerous reports have stressed the importance of vascular damages associated with coagulopathy onset. Microparticles (MPs) shed by apoptotic/stimulated cells are reliable markers of vascular damage released upon pro-inflammatory conditions and behave as active participants in the early steps of clot formation. In addition, MPs carry ACE1 and ACE2, the cell-entry receptor for SARS-Cov2 in the vasculature and up-regulate ACE1 expression in neighbouring endothelial cells. This may contribute to unopposed angiotensin II accumulation which further exacerbate tissue injury and promote both inflammation and thrombosis. The aim of the study is to evaluate the impact of circulating MPs on ACE2 expression, the cell-entry receptor for SARS-Cov2 on endothelial cells.

Detailed description: Circulating MPs will be isolated from Covid-19 patients with lupus anticoagulant, from coronary artery diseases patients and from healthy volunteers without cardiovascular risk factors. Quantification of MPs will be realized by prothrombinase assay. Primary endothelial cells (ECs) from porcine coronary artery or porcine pulmonary artery will be isolated and cultured. ECs will be exposed to circulating MPs. Phenotypical changes (ACE2 expression, cytoadhesins, cytokines, tissue factor expression) of ECs will be examined. Susceptibility of ECs to SARS-COV-2 infection will be determined.

Eligibility criteria: Inclusion Criteria:

* COVID-19 patients: age \> 18 yr
* SARS-COV-2 infection within 12 months and positive lupus anticoagulant
* Patients with cardiovascular risk factors: at least among
* Hypertension, Dyslipidemia, Diabetes mellitus, obesity, smoker, Healthy volunteers

Exclusion Criteria:

* Significant comorbidities (active cancer, auto-immune diseases...)

Primary outcomes:
measure: Western blot measurement of ACE2 receptor expression in porcine cells
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Olivier MOREL
Study officials:
References: