louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06995365: Refining Risk Prediction Models for Older Adults Using Electronic Health Records
Official title: Patient-centered Precision Medicine Lab Result Communication for Older Adults - Validation and Refinement of an Existing Chronic Kidney Disease (CKD) Risk Model
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Predictive Modeling
Keywords: Lab Result Communication
Risk Stratification
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 18000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 65 and older who received care within the UCLA or UC Health system, have at least 5 years of clinical follow-up, and have had a serum creatinine test. Data are drawn from existing electronic health records.

Brief summary: This study aims to improve how lab results are communicated to older adults by refining a predictive model that uses electronic health record (EHR) data. The model was originally developed to estimate the risk of chronic kidney disease (CKD) progression. Researchers will use existing health data to test and improve the accuracy of the model and explore how it might be adapted for use in other health conditions. The study does not involve direct interaction with patients and is conducted entirely using de-identified data in a secure environment.


Eligibility criteria: Inclusion Criteria include, but are not limited to:

* being over the age of 65; having at least 5 years of clinical follow up; and having a serum creatinine lab test conducted

Exclusion Criteria:

* Patients younger than 65 years old
* Patients with less than 5 years of clinical follow-up
* Patients from health systems outside of the UC Health network.

Primary outcomes:
measure: Performance of the Risk Prediction Model
timeFrame: Up to 5 years of retrospective follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Health System
state: California
Study officials:
References:
Clinical trial NCT04937465: Explorative Study on a New Device' Ability to Register Hydration Change in Elderly Subjects During Rehabilitation.
Official title: CTR025 FAUN - Hydration Status
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Dehydrated, Water-Electrolyte Imbalance, Malnutrition
Lead sponsor: Mode Sensors AS
Sponsor class: INDUSTRY
Collaborators: name: Norwegian Computing Center, Oslo Norway
name: Lilleborg helsehus, Oslo, Norway
name: Nidarvoll helsehus, Trondheim, Norway
name: Ryen helsehus, Trondheim, Norway
name: Solvang helsehus, Oslo, Norway
name: Søbstad helsehus, Trondheim, Norway
name: Øya helsehus, Trondheim, Norway
First posted: 2021-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly people eligible for short term (3 - 5 weeks) rehabilitation because of either (i) malnutrition and or dehydration, or (ii) overhydration from heart failure treatment.

Brief summary: Test the ability of continuous measurements from a new sensor patch to set the hydration state in subjects who are malnourished/dehydrated or overhydrated or otherwise not optimally hydrated. Specifically, clinical examination, blood pressure, blood tests, and weight change at the admission and at the discharge will be used to establish the true hydration status of the subjects.


Eligibility criteria: Inclusion Criteria:

* Elderly patients eligible for rehabilitation

Exclusion Criteria:

* Subjects with end stage cancer

Primary outcomes:
measure: Hydration state
timeFrame: During rehabilitation period (3 - 5 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lilleborg helsehus
city: Oslo
country: Norway
facility: Ryen helsehus
city: Oslo
country: Norway
facility: Solvang helsehus
city: Trondheim
country: Norway
facility: Øya helsehus
city: Trondheim
country: Norway
facility: Nidarvoll helsehus
city: Trondheim
country: Norway
facility: Søbstad helsehus
Study officials:
References:
Clinical trial NCT06711965: Interactive Design of Patient-Specific Molds for Tissue Shaping
Official title: Interactive Design of Patient-Specific Molds for Tissue Shaping
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mastectomy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to develop clinical decision-support algorithms for designing participants-specific breast molds for tissue shaping. Autologous breast reconstruction is an important part of breast cancer rehabilitation for many participants. Our goal is to increase the efficiency of autologous breast reconstruction by helping the surgeon design participants-specific molds for shaping tissue into an acceptable breast form.

Detailed description: Primary Objective:

To evaluate the efficiency of autologous reconstruction performed with 3D-printed participants-specific breast molds designed using our clinical decision-support algorithms.

Secondary Objectives:

To assess the total number of times the mold was used by the surgeons in the intervention group.

To compare the intraoperative time for shaping tissue in control versus intervention group.

To collect information on the type of revisions for aesthetic purposes required in control versus intervention group.

To assess the number and type of complications experienced in control versus intervention group.

Eligibility criteria: Inclusion Criteria:

1. Patients 18 years of age or older
2. Patients who are willing and able to provide informed consent
3. Patients who are scheduled to undergo breast reconstruction with free flap (Deep Interior Epigastric Artery Perforator (DIEP) flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap)

Exclusion Criteria:

1. Patients whose surgical plan includes the use of stacked flaps (DIEP + other free flap, usually from the thigh or buttock)
2. Patients whose surgical plan includes the use of DIEP flap with vascularized lymph node transfer
3. Patients undergoing neoadjuvant radiation

Primary outcomes:
measure: Safety and Adverse eEents (AEs)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas M. D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ashleigh M Francis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02075866: Finnish Genetic Study for Arrhythmic Events
Official title: Finnish Genetic Study for Arrhythmic Events
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sudden Cardiac Death
Acute Coronary Event
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive victims of sudden cardiac death verified by medicolegal autopsy (cases).

Acute coronary event patients admitted to the Oulu University Hospital who survived to be discharged from the hospital (controls).

Brief summary: Finnish Genetic Study for Arrhythmic Events (FinGesture is a prospective case-control study assessing the characteristics and genetic background of consecutive series of autopsy verified out-of-hospital victims of SCD vs. survivors of an acute coronary event in a specific geographical area in northern Finland.


Eligibility criteria: Inclusion Criteria:

* Sudden cardiac death verified by medicolegal autopsy (cases)
* Acute coronary event (increased troponin levels/ECG markers of ischemia/angina pectoris; two out of three criteria) (controls).

Exclusion Criteria:

* Sudden death due to other causes (cases).
* Acute coronary event patients who died during hospitalization (controls).

Primary outcomes:
measure: sudden cardiac death
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
References:
Clinical trial NCT01999166: Phenotype/Genotype Correlation in a Family With Early Onset Osteoarthritis
Official title: Phenotype/Genotype Correlation in a Family With Early Onset Osteoarthritis: Contribution of Genetic in the Diagnosis and Early Management of Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Family With Early Onset Osteoarthritis

Brief summary: This study will investigate the genes responsible for osteoarthritis. Individuals with osteoarthritis known or suspected to be caused by a gene mutation (change) may be eligible for this study. Family members may also participate.

Patients will talk with investigators who will explain the study and its possible implications for the patient and family and answer questions. The patient's medical records will be reviewed, a personal and family history will be taken, and a physical examination will be done. Two procedures may be done including blood sampling (which will be used for DNA (genetic) studies) and X-rays (to define osteoarthritis grade).

If no known mutations responsible for osteoarthritis will be detected, participating family members will be interviewed by telephone about their personal and family health history and will have a blood sample drawn for DNA testing, and X-rays.

Detailed description: We will investigate the clinical manifestations and molecular genetic defects of human osteoarthritis. Families with osteoarthritis of known or suspected genetic basis will be enrolled. Individuals will undergo clinical assessment and genetic analyses for the purpose of: 1) definition and characterization of phenotype, 2) determination of the natural history of the disorder, and 3) genotype/phenotype correlation. Genetic linkage studies may be performed for disorders in which the genetic bases is not yet known.

Eligibility criteria: Inclusion Criteria:

* Individuals (and family members) with early onset osteoarthritis according to the following definition:

  * symptomatic OA before 50 years old
  * no obvious causes of OA (IMC \> 30, dysplasia,joint traumas)
  * at least three OA locations

Exclusion Criteria:

* Individuals younger than 18 years old.

Primary outcomes:
measure: Identification of new gene mutations associated with early onset of osteoarthritis using NGS (Next Generation Sequencing)
timeFrame: time of inclusion = Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU
Study officials:
affiliation: University Hospital, Caen
name: Christian MARCELLI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04656665: The Effectiveness of Aspirin on Preventing Pre-eclampsia
Official title: The Effectiveness of Low-dose Aspirin on Preventing Pre-eclampsia in High-risks Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pre-Eclampsia
Keywords: Pre-eclampsia, Aspirin
Lead sponsor: The Third Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will explore the effectiveness of low-dose aspirin on preventing pre-eclampsia in high-risks pregnant women by comparing the incidence of pre-eclampsia and pregnancy outcomes.

Detailed description: Currently，low-dose aspirin is a commonly used drug to prevent pre-eclampsia. Many guidelines recommend starting low-dose aspirin in early pregnancy in high-risks pregnant women. However, the applicable population and use method of aspirin are still controversial in clinical practice. This study will explore the effectiveness and use method of low-dose aspirin by comparing the incidence of pre-eclampsia and pregnancy outcomes.

Eligibility criteria: Inclusion Criteria:

* Age between 18-55 years
* Gestational age between 12-20 weeks of pregnancy
* High risk of developing pre-eclampsia

  * At least one of the following risk factors: Pre-eclampsia in a previous pregnancy , Multiple pregnancy，Diabetes Mellitus(Type 1 or 2), Chronic Hypertension，Renal disease, Autoimmune disease.
  * At least two of the following risk factors: Primiparity，Pre-pregnancy Body Mass Index ≥28kg/m2, Age ≥35 years, Family members have a history of pre-eclampsia.
* Maternal informed conset obtained

Exclusion Criteria:

* Contraindication to aspirin therapy (including but not limited to allergy and high bleeding risk)
* Patient with known intention to terminate pregnancy
* Fetal abnormalities detected （including but not limited to major fetal malformation and FGR）
* Severe heart, liver, renal disease who can not burden the experiment
* Alcohol and drug abuse
* Being in another drug experiment within 3 months

Primary outcomes:
measure: Incidence of pre-eclampsia
timeFrame: 1 year
Secondary outcomes:
measure: Preterm birth
timeFrame: 1 year
measure: Fetal growth restriction
timeFrame: 1 year
measure: Placental abruption 4/5000 Placental abruption
timeFrame: 1 year
measure: Postpartum hemorrhage
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06887465: Non-invasive and Continuous Blood Pressure Monitoring
Official title: Comparison of Non-Invasive Wearable Sensors to Radial Arterial Catheterization on Human Subjects
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Blood Pressure
Keywords: Blood pressure monitoring
Non-invasive Blood Pressure Monitoring
Lead sponsor: Vena Vitals
Sponsor class: INDUSTRY
Collaborators: name: Thomas Jefferson University
First posted: 2025-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery who have an arterial line and are in supine position

Brief summary: The goal of this observational study is to evaluate the accuracy and reliability of the VeriTrack non-invasive blood pressure monitor compared to radial arterial catheterization in adult surgical patients.

The main question it aims to answer is:

How well does VeriTrack measure continuous blood pressure compared to an arterial catheter?

Researchers will compare VeriTrack readings to arterial line measurements to determine if the VeriTrack provides comparable accuracy and clinical utility.

Participants will wear the VeriTrack device during surgery and have a radial arterial catheter placed as part of standard care.


Eligibility criteria: Inclusion Criteria:

* Patients whose blood pressure will be monitored using an arterial line during their procedure
* Patients who have a palpable dorsalis pedis pulse

Exclusion Criteria:

* Patients who have non-palpable dorsalis pedis pulses
* Patients whose limbs are inaccessible for placement of Vena Vitals Wearable
* Patients with known allergy to adhesives and/or silicone

Primary outcomes:
measure: Accuracy of the VeriTrack device in continuous blood pressure monitoring
timeFrame: 1-24 hours
Secondary outcomes:
measure: Blood Pressure Change Accuracy
timeFrame: 1-24 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00894465: Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Examining the Efficacy of Oral Midazolam in Reducing Anxiety in Children Undergoing Voiding Cystourethrogram
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vesicoureteral Reflux
Keywords: Midazolam
VCUG
Anxiety
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Society of Pediatric Urology
First posted: 2009-05-07
Enrollment: 44
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this research is to validate the common administration of oral midazolam to children prior to voiding cystourethrogram (VCUG) to see if this will significantly decrease children's anxiety and make the experience less traumatic.


Eligibility criteria: Inclusion Criteria:

* Age 2-6 years
* Toilet trained
* English speaking
* Already scheduled for VCUG

Exclusion Criteria:

* Allergic to midazolam
* Active UTI
* Known urethral stricture
* Known urethral reconstruction
* Has history of abnormal sensation in pelvic area
* Has history of sexual abuse
* Has severe developmental delay
* Has diagnosis of anxiety disorders

Primary outcomes:
measure: Anxiety Score From the Modified Yale Preoperative Anxiety Scale
timeFrame: Waiting room, before catheterization, and after catheterization
Secondary outcomes:
measure: Anxiety Score From the State-Trait Anxiety Inventory
timeFrame: At the time of the procedure
Other outcomes:
Locations:
city: ST Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Paul F Austin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06776965: Ultra Processed Foods Consumption and Impact in Rheumatic Diseases.
Official title: Impact of Ultra-processed Foods in a Population of Patients With Chronic Rheumatic Diseases (Rheumatoid Arthritis, Spondyloarthritis, Osteoarthritis).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Spondyloarthritis
Osteoarthritis
Keywords: Ultra-processed food
osteoarthritis
rheumatoid arthritis
spondyloarthritis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic rheumatological diseases (spondylitis, rheumatoid arthritis, osteoarthritis) and control population (also followed for any other pathology in the department).

Brief summary: Ultra-processed foods (UPF) represent one of the mainstays of today's diet. They are defined by the NOVA classification system. It was demonstrated that UPF consumption was associated with activity of inflammatory bowel diseases with underlying mechanisms not fully identified yet. It is suspected that UPF constituents could modify the gut microbiota, increase intestinal barrier permeability and directly engage immune surveillance systems, effects that could individually or synergistically increase the risk of immunomediated diseases. As some pathophysiological mechanisms are shared among IBD and rheumatic diseases, we have wondered if UPF consumption could be associated with increased risk of rheumatic disease and/or with their activity.

Our primary aim will be to study the pattern of UPF consumption in patients with rheumatic diseases. Our secondary objectives will be to study the activity of diseases according to UPF consumption.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* chronic rheumatic disease (Rheumatoid arthritis, spondyloarthritis, osteoarthritis)
* ability to perform questionnaires

Exclusion Criteria:

* Judicial protection measure
* Refusal to participate in the study
* Suffering from 2 rheumatic disease simultaneously

Primary outcomes:
measure: Describe the consumption of ultra-processed foods in patients with chronic inflammatory rheumatism
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Edouard Herriot Hospital
Study officials:
affiliation: Edouard Herriot Hospital
name: Maxime AUROUX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06640465: Comparing the Effects of Commercially Available Dietary Supplements on CoQ10 Concentrations
Official title: A Randomized, Placebo-Controlled Trial Comparing the Effects of Commercially Available Dietary Supplements on CoQ10 Concentrations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Wellness
Health
Keywords: Coenzyme Q10
CoQ10
Geranylgeraniol
GG
Ubiquinol
Ubiquinone
Lead sponsor: OvationLab
Sponsor class: NETWORK
First posted: 2024-10-15
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary purpose of this study is to compare the safety and effectiveness of commercially available dietary supplements believed to increase coenzyme Q10 (CoQ10) concentrations.

An 8-week, randomized, placebo-controlled clinical trial will be conducted comparing the effectiveness of four commercially available dietary supplements on increasing CoQ10 concentrations and self-reported health outcomes.


Eligibility criteria: Inclusion Criteria:

1. Adult males or females age ≥ 40 years
2. Ability to read and speak English

Exclusion Criteria:

1. Daily use within the past 2 months of any dietary supplements containing CoQ10 or geranylgeraniol (GG)
2. Taking a statin medication within the past 6 months
3. Current daily usage of H2 blockers or PPI medications
4. Current daily use of bisphosphonates
5. Current daily tobacco smoker
6. Known allergies to any substance in the study products
7. Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks
8. Current diagnosis of a chronic health condition (e.g., cancer, Crohn's disease) deemed clinically contraindicated for the study protocol.
9. Participant in a clinical trial in the previous 30 days.
10. Participants unable to provide consent

Primary outcomes:
measure: Plasma Coenzyme Q10
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Comprehensive metabolic panel
timeFrame: Baseline and 8 weeks
measure: Lipid panel
timeFrame: Baseline and 8 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health
timeFrame: Baseline and 8 weeks
measure: Profile of Mood States - Vigor Subscale
timeFrame: Baseline and 8 weeks
measure: Short Form 36 (SF-36) - Vitality Subscale
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: El Dorado Hills
country: United States
facility: True Health Center for Precision Medicine
state: California
city: Centennial
country: United States
facility: Cornerstone Health Community
state: Colorado
city: Palm Springs
country: United States
facility: CTMD Research
state: Florida
city: Eagle
country: United States
facility: Functional Medicine of Idaho
state: Idaho
city: Houston
country: United States
facility: New Dawn Wellness and Medical Center
state: Texas
city: Seattle
country: United States
facility: Vida Integrated Health
state: Washington
Study officials:
References: