louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06817408: Dynamics of Organ Damage and Immune Exhaustion During Sepsis
Official title: Cell-free DNA Epigenomics to Track the Dynamics of Organ Damage and Immune Exhaustion During Sepsis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Keywords: Sepsis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2025-02-10
Enrollment: 1000
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 who've developed a shocked state or clinical concern that are going thru the Emergency Department.

Brief summary: This is a prospective, non-randomized study investigating if organ damage and immune changes can be measured by liquid biopsy NGS through advanced analytical methods.

Detailed description: To determine the sample size needed to derive a signature matrix to identify novel biomarkers in sepsis, investigators performed a mathematical modeling exercise of the lower limits of sensitivity of this liquid biopsy approach. The detection limit of cell-free nucleic acid analysis is determined in part by the number of independent transcripts or "reporters" that are interrogated. Using an established and independently validated binomial model that was previously applied to the prediction of circulating tumor nucleic acid detection limits, investigators estimated the probability of cell-free nucleic acid detection in sepsis patients based on the number of unique tissue-specific reporters (i.e., hepatic transcripts that may reflect disease severity). This yields a result of n=18 per group to achieve 0.90 power at alpha=0.05. The investigators will thus plan to analyze data from n=18 per cell/tissue type to derive the signature matrix for this project.

Eligibility criteria: Inclusion Criteria:

• Patients who've developed a shocked state (Hypotension or Lactate grade \>4) or Clinical Concern

Exclusion Criteria:

* \<18 years of age
* Pregnant Women
* Nursing women

Primary outcomes:
measure: Patient Survival
timeFrame: From date of patient enrollment until date of death for any cause or up to 1 year after patient enrollment date, whichever comes first.
Secondary outcomes:
measure: ICU Time
timeFrame: Up to 1 year after patient enrollment date
measure: Hospital Stay Duration
timeFrame: Up to 1 year after patient enrollment date
measure: Renal Replacement Therapy
timeFrame: Up to 1 year after patient enrollment date
measure: Ventilator and Vasopressor Free Days
timeFrame: Up to 1 year after patient enrollment date
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Aadel A Chaudhuri, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06892808: Impact of Periodontal Therapy on AF Recurrence Post-Ablation in High-Inflammatory Burden Patients
Official title: Effectiveness of Non-Surgical Periodontal Therapy on Atrial Fibrillation Recurrence After Radiofrequency Ablation in Patients with Atrial Fibrillation and High-Inflammatory Burden Periodontitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Periodontitis
Keywords: Atrial Fibrillation
Periodontitis
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: The First People's Hospital of Hefei City
name: The Second People's Hospital of Anhui Province
First posted: 2025-03-25
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of Non-Surgical Periodontal Therapy versus Background Periodontal Care in Reducing Atrial Fibrillation Recurrence in Patients with AF and Periodontitis: A Randomized Trial with Two Arms (Background Therapy Group vs. Conventional Non-Surgical Therapy Group).


Eligibility criteria: Inclusion Criteria:

- Age ≥18 years. Diagnosed with atrial fibrillation (AF) and undergoing first-time catheter ablation.

Diagnosed with periodontitis (2017 World Workshop classification) and periodontal inflamed surface area (PISA) \>500 mm².

Willing and able to provide written informed consent.

Exclusion Criteria:

- Requiring periodontal surgical intervention, e.g., flap surgery, bone grafting. Non-surgical periodontal therapy (e.g., scaling and root planing) within the past 6 months.

Active systemic infection, e.g., sepsis, tuberculosis. Current immunosuppressive therapy, e.g., post-transplant medications, long-term corticosteroids.

Chronic hepatitis B or HIV infection. Chronic systemic antibiotic use (\>4 weeks). Pregnancy or lactation. Anticipated survival \<12 months.

Primary outcomes:
measure: Atrial fibrillation (AF) episodes lasting ≥30 seconds occurring
timeFrame: From 3 months post-ablation (end of blanking period) to the 12-month follow-up.
Secondary outcomes:
measure: Composite atrial arrhythmia recurrence
timeFrame: During the period from 3 months post-ablation to 12-month follow-up.
measure: Antiarrhythmic drug usage
timeFrame: At 12 months.
measure: Change in Periodontal Inflamed Surface Area (PISA)
timeFrame: At 12 months
measure: Probing depth (PD) reduction ≥2 mm in ≥50% of sites.
timeFrame: At 12 months.
measure: Bleeding on probing (BOP) rate reduction ≥30%.
timeFrame: At 12 months.
measure: Clinical attachment level (CAL) stability (change ≤1 mm).
timeFrame: At 12 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Xuhui
Study officials:
References:
Clinical trial NCT06697808: Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics
Official title: Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics (CUPID-Peds)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Keywords: head injury
imaging
pediatrics
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 169
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients in the Emergency Department or Pediatric Intensive Care Unit due blunt head trauma.

Brief summary: To improve patient selection for head CT, a safe and high sensitivity screening neuroimaging modality is needed. Currently many clinicians must make treatment decisions based solely on the patients clinical exam, which has low sensitivity and specificity and low inter-rater reliability. This study is being done to learn more about B-mode cranial point-of-care ultrasound (cPOCUS). Ultrasound has several advantages. It is a safe, non- invasive, low-cost, fast and portable bedside tool without ionizing radiation exposure.

Detailed description: B-mode cranial point-of-care ultrasound (cPOCUS) being used in this study is an innovative, low-risk, inexpensive solution for diagnosing clinically significant intracranial pathology in children presenting with blunt head trauma which could be valuable for resource- austere environments. Traumatic brain injury remains a leading cause of death and disability in children. In addition, those who present with suspected acute brain injury in resource-austere environments may be at high risk of long-term neurologic sequelae or death. Early neuroimaging to identify traumatic brain injury and guide interventions is key to preventing their neurologic morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

* Patients requiring a head computed tomography (CT) as the standard of care
* Seen in the pediatric Emergency Department or Pediatric Intensive Care Unit at Atrium Health Wake Forest Brenner Children's Hospital or Levine Children's Hospital

Exclusion Criteria:

* Patients with open skull fractures
* Previous hemicraniectomy
* Existing surgical defect in the skull
* Patients being transitioned to comfort care

Primary outcomes:
measure: Diagnostic Accuracy of Cranial Point-of-Care Ultrasound
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest Baptist
name: Denise Fraga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05807308: The Effect of Technology-Based Cognitive and Artistic Therapeutic Activities on the Mental Status of Children With Cancer
Official title: Technology-Based Cognitive and Artistic Therapeutic Activities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Children Followed up With Cancer Diagnosis
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This research will be carried out to determine the effects of technology-based cognitive and artistic therapeutic activities on the mental state of children receiving cancer treatment. The research will be conducted in a single-blind parallel group randomized controlled trial design. A program consisting of six two-week sessions will be implemented. The program will include many artistic activities such as therapeutic and drawing.

Detailed description: In the study, a program consisting of technology-based cognitive and artistic activities will be applied to children followed up with cancer diagnosis. Therapeutic and artistic activities within the program (drawing, mandala, etc.). The program will be implemented in 6 sessions in two weeks. At the beginning and end of the program, children's anxiety and spiritual well-being levels will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 9-18,
* Those receiving cancer treatment,
* At least two months have passed since the start of treatment,
* Those who have internet access on their smartphone or computer

Exclusion Criteria:

* Those who have experienced an important life event other than illness (parents' divorce, death, moving, etc.) in the last six months,
* Those who have not received chemotherapy treatment,
* In the terminal period,
* Children with a severe psychological diagnosis

Primary outcomes:
measure: Spielberger State-Trait Anxiety Inventory for children
timeFrame: Change from Baseline level of Spielberger State-Trait Anxiety to 2 weeks (change is being assessed)
measure: Adolescent Spiritual Well-Being Scale
timeFrame: Change from Baseline level of Adolescent Spiritual Well-Being Scale to 2 weeks (change is being assessed)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
Clinical trial NCT04275908: Classification and Assessment of Mental Health Performance Using Schematics
Official title: Classification and Assessment of Mental Health Performance Using Schematics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide Ideation
Suicidal Intention
Suicide and Depression
Lead sponsor: Clarigent Health
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital Medical Center, Cincinnati
name: University of Cincinnati
First posted: 2020-02-19
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty sites across Southwest Ohio will be recruited, including schools (using the school-based therapists), community mental health centers, and colleges/universities (counseling centers). Approximately 150 therapists across 30 sites will be recruited to enroll students from their current caseloads.

Brief summary: This is an open enrollment study to collect data for the optimization of smartphone-based algorithms for the early detection of mental health and suicidal risk in a student population. Approximately 2000 students, ages 8-23, will be recruited by therapists across 30 schools and mental health centers.


Eligibility criteria: Inclusion Criteria:

* Currently a client receiving services from mental health agency at a school or outpatient, or at a college/university counseling center
* Age ≥ 8 years and \< 23years
* Able to provide informed consent, parental permission or assent
* English as a primary language

Exclusion Criteria:

* Participants with communication disorders (linguistic or articulation)
* Any minor participants for whom parental or legal guardian consent cannot be obtained.
* History of any other serious medical or psychiatric condition that would interfere with the ability of the patient to complete the study or would make it ethically unfeasible to enroll them
* Participants with an intellectual disability that the therapist deems a barrier to participation

Primary outcomes:
measure: Algorithm development
timeFrame: 3 years
measure: App optimization
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mason
country: United States
facility: Clarigent Health
state: Ohio
Study officials:
affiliation: Clarigent Health
name: Lesley Rohlfs
role: STUDY_DIRECTOR
References:
Clinical trial NCT05478408: Correlation of Mukbang Video Watching Behavior,Internet Addition and Mental Health Among General Population
Official title: Correlation of Mukbang Video Watching Behavior,Internet Addition and Mental Health Among General Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mukbang
Keywords: Mukbang
Mental Health
Internet Addiction
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 2918
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: General Population

Brief summary: This study will describe the general population's current situation of watching "Mukbang" videos, their mental health status and the level of Internet addiction tendency by means of an online survey, and analyze their correlations. It provides a theoretical basis for promoting healthy psychological development and standardizing management of "Mukbang" videos.

Detailed description: Mental health issues have always been the focus of health management. The Lancet Global Commission on Mental Health and Sustainable Development also recommends a broad cross-sectoral approach to mental health issues. With the rapid development of short videos and self-media, watching "Mukbang" is a behavioral way for netizens to alleviate mental health problems such as anxiety and depression. However, watching "Mukbang" can be Internet addictive. At present, there is no research to predict the addictive behavior caused by "Mukbang", and there is no relevant research to explore its addiction mechanism. Although it has been clear that Internet addiction and mental health disorders are significantly related, there is no clear statement on whether there is a common risk factor, a mediating effect, or a causal relationship between the two. The behavior of watching "Mukbang" videos may be in a mediating position between the two. This study will further explore the relationship between the three based on the use and satisfaction theory.

Eligibility criteria: Inclusion Criteria:

* Internet users over the age of 18;
* Be able to read and communicate in Chinese.

Exclusion Criteria:

* Those who can not complete communication due to serious mental or physical diseases such as deafness, unclear consciousness caused by mental illness, etc.;

Primary outcomes:
measure: Features of Watching "Mukbang" Videos
timeFrame: Baseline
measure: Mental Health
timeFrame: Baseline
measure: Internet Addiction
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: XIAW
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Wei Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05261308: Customized Polyamide Prosthesis. for Mid Shaft Clavicle Fracture
Official title: New Polyamide Prosthesis for Treatment of Non-union Mid Shaft Clavicle Fracture: A Case Report
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Adherence and Compliance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Herein we describe the management of a patient who presented with progressive brachial plexopathy following the initial nonoperative management of a mid shaft clavicular fracture by using 3 D customized polyamide prosthesis.

Detailed description: we made surgery to fix the new polyamide prosthesies in the clavicle.

Eligibility criteria: Inclusion Criteria:

* fracture midshaft clavicle

Exclusion Criteria:

* normal clavicle

Primary outcomes:
measure: American shoulder and elbow surgeons score Special Score for shoulder pain and function
timeFrame: after 2 and half years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sahar Abdalbary
state: Select State/province
city: Cairo
country: Egypt
facility: Sahar
Study officials:
affiliation: Nahda University, Faculty of Physical Therapy
name: Sahar Abdalbary, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01642108: Treatment With Sitagliptin in Non-obese Japanese Patients With Type 2 Diabetes Mellitus
Official title: The Effect of Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, on Glycemic Control and Inappropriate Glucagon Secretion in Non-obese Japanese Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Niigata Medical Center
Sponsor class: OTHER
Collaborators: name: Nagaoka Red Cross Hospital
First posted: 2012-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes mellitus (T2DM) results from early phase insulin secretory defect and insulin resistance. Studies have shown that most of the populations in which insulin resistance is considered to be the primary pathogenetic cause of diabetes, have a higher degree of obesity than those of primary insulin defect. Meanwhile, defective early insulin secretion plays a predominant role in the non-obese subtype of T2DM which includes majority of Japanese patients.

Sitagliptin is a dipeptidyl peptidase-4 (DPP-IV) inhibitor as indicated for the treatment of T2DM. Sitagliptin increases plasma concentrations of active glucagon-like peptide-1 (GLP-1) and active glucose-dependent insulinotropic peptide (GIP) two- to three-fold in patients with T2DM. The effect of sitagliptin on GLP-1 results in lower fasting and postprandial glucose concentrations through increases in glucose dependent insulin release and suppression of inappropriate glucagon secretion. Namely, several mechanistic studies using standardized meal showed that sitagliptin improved glucose control with decreased glucagon levels and increased insulin concentration in obese or overweight T2DM patients with BMI \> 25 kg/m2. However, how sitagliptin affects islet function, including glucagon secretion in non-obese patients with low insulin secretion are not known. Therefore, the investigators will examine the effect of sitagliptin on glycemic control and the mechanism involved using a standardized test meal in non-obese Japanese patients with T2DM whose BMI levels are \< 25 kg/m2.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients
* non-obese patients

Exclusion Criteria:

* patients treated with insulin therapy
* patients aged less than 20 years and more than 90 years

Primary outcomes:
measure: HbA1c
timeFrame: One month
Secondary outcomes:
measure: Glucagon secretion
timeFrame: One month
Other outcomes:
Locations:
city: Niigata
country: Japan
facility: Nobumasa Ohara
Study officials:
References:
Clinical trial NCT04190238: Efficiency of the Super Inductive System in Spasticity Treatment
Official title: Efficiency of the Super Inductive System in Spasticity Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spasticity, Muscle
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: case-control study
Primary purpose: TREATMENT

Brief summary: The aim of the study is to see whether a physical therapy program can relieve pain, decrease spasticity and increase muscle contraction force by using the super inductive system (high frequency electromagnetic field). It is a longitudinal, prospective study, of 60 patients with spasticity after stroke. No new treatment method is tested, as the Super inductive system is approved for physical therapy by the Ministry of Health.

Detailed description: The 60 patients will be submitted to 2 treatment groups: 30 patients will receive 10 sessions of the superinductive system on the antagonist muscles, and 30 patients will receive 10 sessions the superinductive system on the agonist and antagonist muscles. All patients will also receive the standard kinetotherapy program for spasticity. The patients will be evaluated at the beginning of the treatment, at 10 days and at 30 days by using the functional MAS index and Barthel index.

Eligibility criteria: Inclusion Criteria:

* spasticity after stroke

Exclusion Criteria:

* spasticity of other causes

Primary outcomes:
measure: change in MAS functional index
timeFrame: day 0, day 10, day 30
measure: change in Barthel index
timeFrame: day 0, day 10, day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Clinical Rehabilitation Hospital
Study officials:
affiliation: University of Medicine and Pharmacy Iuliu Hatieganu
name: Viorela M Ciortea, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: