louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06337227: Potential Role of Sirtuins As Epigenetic Biomarkers of the Patient with Atherosclerosis or Calcific Aortic Stenosis
Official title: Potential Role of Sirtuins As Epigenetic Biomarkers for the Clinical Management of the Patient with Atherosclerosis or Calcific Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atherosclerosis and Calcific Aortic Stenosis with and Without Diabetes
Lead sponsor: IRCCS SYNLAB SDN
Sponsor class: OTHER
Collaborators: name: Federico II University
First posted: 2024-03-29
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study plans to recruit 100 patients admitted to AOU Federico II Cardiac Surgery in Naples subject to surgical procedure with atherosclerosis and calcific aortic stenosis with and without diabetes over a 36-month period. Patients without atherosclerosis or aortic valve stenosis will be considered as a control population and where possible included in a statistical design paired for age and sex with the study population

Brief summary: The project aims to shed light on the role of Sirtuins, enzymes belonging to the third class of histone deacetylases (class III) involved in epigenetic modifications (deacetylation), focusing mainly on Sirtuin 6 (SIRT6), as a regulator of atherosclerosis and severe aortic valve stenosis through molecular-based and epigenetic studies in human VSMC cells.


Eligibility criteria: Inclusion Criteria:

* Patients with atherosclerosis or calcific aortic stenosis with and without diabetes older than 18 years of either sex;
* Patients without atherosclerosis undergoing surgical procedure for endocarditis;
* Patients who will have signed informed consent

Exclusion Criteria:

* Patients for whom biological material cannot be recovered for study purposes;
* Patients who refuse to participate in the study

Primary outcomes:
measure: To evaluate by analysis of data obtained from NGS techniques whether and which proteins belonging to the Sirtuin family may be deregulated in patients with atherosclerosis or calcific aortic stenosis
timeFrame: 36 months
Secondary outcomes:
measure: To evaluate the experimental results achieved in the clinical-diagnostic context
timeFrame: 36 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Irccs Synlab Sdn
Study officials:
References:
Clinical trial NCT01563627: Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy
Official title: Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where feasible, surgical removal of the home is the best therapeutic outcome.

Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical and experimental studies have shown that dysfunction of the blood-brain barrier (BBB) contributes to epileptogenesis and drug resistance. It is now recognized that cytokines exacerbate the excitability and permeability of the BBB, which was recently confirmed by studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have described an association between pathological angiogenesis and BBB permeability in the tissue of patients with excision of drug-resistant TLE. With experimental models, it was revealed an activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the BBB.

The investigators hypothesis is that the identification of factors involved in BBB permeability may designate potential targets for drug-resistant partial epilepsy.


Eligibility criteria: Inclusion Criteria:

* Patient with temporal lobe epilepsy (TLE)
* Patient with epilepsy for at least two years. Arm 1: Patient with drug-resistant TLE proved potentially a candidate for surgery.

Arm 2: Patient with TLE seizure-free for 12 months or more

Exclusion Criteria:

* Patient with a scalable general pathology may lead to increased inflammatory markers: neoplasia, chronic inflammatory diseases etc. ...
* Patient with neurological history other than epilepsy with evolutionary potential or likely to interfere with the inflammatory markers

Primary outcomes:
measure: Comparison of Biomarkers
timeFrame: 12 months after inclusion (day 0)
Secondary outcomes:
measure: permeability of the blood-brain barrier
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
References:
Clinical trial NCT05852327: Risk Stratifying COPD Exacerbations
Official title: Risk Stratifying COPD Exacerbations: a Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD Exacerbation
Lead sponsor: Pamela Youde Nethersole Eastern Hospital
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 subjects with COPD exacerbation

Brief summary: To identify clinical characteristics on presentation which predict differential outcomes in patients with exacerbation of COPD.

Detailed description: Exacerbations of COPD (ECOPD) are heterogenous but are often considered as a single clinical entity. Clinical characteristics on presentation may predict outcome of patients with ECOPD.

DECAF score was previously proposed to predict in-hospital mortality but has not been validated in Asian subjects. ROME classification was recently proposed to better risk stratify ECOPD according to symptoms, physiological parameters and laboratory findings on admission, but no prospective validation study is available so far.

This study aims to identify clinical characteristics on presentation to predict outcome of patients with ECOPD.

Eligibility criteria: Inclusion Criteria:

* Background history of COPD, defined by the GOLD 2023 guidelines
* Presented with exacerbation of COPD, defined by the GOLD 2023 guidelines
* Age \>= 18 years old
* Informed consent available

Exclusion Criteria:

* Age \< 18 years old
* No informed consent

Primary outcomes:
measure: In-hospital mortality
timeFrame: 3-month
measure: 3-month mortality
timeFrame: 3-month
measure: Recurrent ECOPD
timeFrame: 3-month
measure: Viral etiology
timeFrame: 3-month
measure: Bacterial etiology
timeFrame: 3-month
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Charles Wong
state: Other
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
Study officials:
References:
Clinical trial NCT02746627: Check It! Positive Psychology Intervention to Improve Adherence in Adolescents With T1D
Official title: Positive Psychology to Improve Adherence in Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned to Positive Affect - Phone, Positive Affect - Text, or Education groups for the duration of the study.
Primary purpose: TREATMENT

Brief summary: Problems with diabetes management in adolescents with type 1 diabetes are common - occurring at rates as high as 93% - and have serious health consequences, including poor blood sugar control and risk for later complications. Therefore, the investigators proposed to test a positive psychology intervention for adolescents with type 1 diabetes aimed at increasing motivation for diabetes management; specifically, to increase the frequency of blood glucose monitoring. This intervention will boost positive mood in adolescents (age 13-17) through tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a way to improve motivation for diabetes management. In addition, this study will explore the use of technology, by comparing telephone-administered vs. automated text-messaging versions of the intervention, to determine which mode of delivery is more appealing, convenient, and beneficial for adolescents in managing their diabetes.

Participants and parents will complete questionnaires on mood and diabetes management during a routine clinic visits at baseline, 3 months, and 6 months. Clinical measures of diabetes management will be collected from participants' electronic medical records.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 1 diabetes for at least 6 months
* HbA1c between 8-12%
* Speak and read English
* Caregiver living with child

Exclusion Criteria:

* Other uncontrolled health conditions

Primary outcomes:
measure: Glycemic Control (HbA1c)
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of Blood Glucose Monitoring
timeFrame: 6 months
measure: Diabetes-Related Quality of Life
timeFrame: 6 months
measure: Family Conflict
timeFrame: 6 months
measure: Positive Affect
timeFrame: 6 months
measure: Coping
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
citation: Savin KL, Hamburger ER, Monzon AD, Patel NJ, Perez KM, Lord JH, Jaser SS. Diabetes-specific family conflict: Informant discrepancies and the impact of parental factors. J Fam Psychol. 2018 Feb;32(1):157-163. doi: 10.1037/fam0000364.
Clinical trial NCT06841627: Osteopathic Manual Therapy (OMT) and Brain Structure and Function in Primary Headache Patients: a Pilot Study
Official title: Exploring the Mechanism of Osteopathic Manual Therapy (OMT) on Brain Structure and Function in Primary Headache Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Headaches (includes Migraines, Tension, Cluster Headaches)
Keywords: Migraine
Headaches
Osteopathic Manipulative Treatment
Brain
OMT
Lead sponsor: Edward Via Virginia College of Osteopathic Medicine
Sponsor class: OTHER
Collaborators: name: Auburn University MRI Research Center
First posted: 2025-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Chronic headaches are associated with changes in brain structure and function that may be associated with increased suffering and disability. Understanding how Osteopathic Manipulative Therapy (OMT) affects these changes would reveal new insight into how the brain processes pain and returns to normal function. Also, demonstrating these changes would provide evidence regarding how OMT causes a reduction in pain and disability, supporting the recommendation for OMT as a primary treatment option for headaches.


Eligibility criteria: Inclusion Criteria:

* current diagnosis of primary headache (migraine, tension-type, cluster) from a healthcare provider
* have experienced at least one headache episode a month for the previous 1 year (or longer)
* age of PH onset was less than 50 years, currently taking medication for headaches.

Exclusion Criteria:

* presence of headaches due to some other underlying medical condition (secondary headaches)
* traumatic brain injury
* fibromyalgia, epilepsy
* diagnosis of a neurodegenerative disorder
* history of brain tumor or cancer
* history of cervical radiculopathy (pinched nerve in the neck)
* currently undergoing manual therapy type treatment or have a a treatment within 2 weeks of enrollment(chiropractic, OMT, massage, PT)
* currently pregnant
* have had an injection to treat headaches within the previous 3 months from study enrollment
* contraindications to MRI.

Primary outcomes:
measure: Brain Structural and Functional Changes
timeFrame: From enrollment to the end of treatment at 5 weeks
Secondary outcomes:
measure: Headache Impact Test - 6 (HIT-6)
timeFrame: From enrollment to the end of treatment at 5 weeks
measure: Short Form -36 (SF-36)
timeFrame: From enrollment to the end of treatment at 5 weeks
measure: Depression Anxiety and Stress Scale 21 (DASS-21)
timeFrame: From enrollment to the end of treatment at 5 weeks
measure: Headache intensity
timeFrame: From enrollment to the end of treatment at 5 weeks
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University MRI Center and Edward Via College of Medicine
state: Alabama
Study officials:
affiliation: Edward Via College of Osteopathic Medicine
name: Daniel Cawley, DC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06582927: Mindfulness Training for First Responders
Official title: Mindfulness Training for First Responders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burnout
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Unlikely Collaborators Inc.
First posted: 2024-09-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The present study evaluates the efficacy of Mindfulness-Based Attention Training on measures targeting cognitive abilities and emotional well-being in first responders.


Eligibility criteria: Inclusion Criteria:

1. Individuals who are between 18 and 75 years of age
2. Individuals who are fluent English speakers
3. Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have Internet connection
4. Individuals who are willing and able to consent to participate in the study
5. Participants in all phases of the study must be individuals who are affiliated with the Los Angeles County Fire Department peer support group.

Exclusion Criteria:

1. Individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month

Primary outcomes:
measure: Change in resilience
timeFrame: Baseline to week 11
measure: Change in sustained attention
timeFrame: Baseline to week 11
Secondary outcomes:
measure: Change in positive affect
timeFrame: Baseline to week 11
measure: Change in negative affect
timeFrame: Baseline to week 11
measure: Change in perceived stress
timeFrame: Baseline to week 11
measure: Change in burnout
timeFrame: Baseline to week 11
measure: Change in attentional control
timeFrame: Baseline to week 11
measure: Change in decentering
timeFrame: Baseline to week 11
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Amishi Jha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05975827: Sterile Wound Care Liquid Dressing in Treatment of Diabetic Ulcer in Necrosis Stable Stage: a Randomized Control Trial
Official title: Sterile Wound Care Liquid Dressing in Treatment of Diabetic Ulcer in Necrosis Stable Stage: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Ulcers
Diabetic Ulcers in Necrosis Stable Stage
Keywords: Diabetic Ulcers
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate methods for promoting infection control, reducing tissue edema, and preventing excessive spread in diabetes foot ulcers in the necrosis stable stage. Additionally, it sought to explore potential indications for the use of aseptic wound care liquid dressings in these ulcers, with the goal of obtaining evidence-based medical data on their clinical efficacy.

Participants will be assigned with a 1:1 ratio into intervention group and control group.

Participants in the intervention group will be irrigated with sterile liquid dressing for each wound treatment on the basis of clinical standard treatment protocols for 2 weeks, until the end of the 2-week observation period. Participants in the control group will be irrigated with normal saline for each wound treatment for 2 weeks on the basis of the clinical standard diagnosis and treatment plan, until the end of the 2-week observation period.


Eligibility criteria: Inclusion Criteria:

1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, renal failure etc., which have not been corrected.
2. Poor glycemic control; fasting blood glucose \>15mmol/L; glycosylated hemoglobin \>12%.
3. Active bleeding within the wound that prevents implementation of standard basic treatment protocols.
4. Serum albumin \<20g/L; hemoglobin \<60g/L; platelets \<50×10\^9/L
5. Advanced malignant tumor patients
6. Autoimmune disease activity period
7. History of allergy to aseptic wound care liquid dressing
8. Patient unable to cooperate or has mental disorders
9. Pregnant and lactating women
10. Eye injuries and natural cavities such as ear canal, nasal cavity or abdominal cavity
11. Skin tumors
12. Active skin diseases
13. According to the researcher's judgment, patients who clearly have factors affecting wound healing that cannot be removed are not suitable for this study or cannot comply with the requirements of this study

Primary outcomes:
measure: 2-week reduction rate of wound area
timeFrame: 2-week
Secondary outcomes:
measure: 2-week wound healing rate
timeFrame: 2-week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01233427: Infant Feeding Study.09-68
Official title: The Infant Feeding Experience of New Mothers - a Descriptive Pilot Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Describe the Infant Feeding Attitudes
Intentions of a Sample of Expectant First-time Mothers
Estimate the Prevalence of Early Lactation Difficulties
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 24
Sex: FEMALE
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: breastfeeding moms

Brief summary: Characterize a population-based sample of first-time expectant mothers with regards to maternal metabolic health and their infant feeding experience.

Detailed description: The long range purpose of this pilot study is to inform the development of an NIH-funded randomized intervention trial designed to improve early breastfeeding outcomes for mothers planning to breastfeed. The purpose of the pilot study is to 1) described the prenatal infant feeding attitudes and intentions of population-based sample of expectant mothers from the same recruitment base as the future intervention trial, 2) characterize the metabolic health profiles of the sample and 3) estimate the prevalence of early lactation difficulties among the subset of this sample that initiates breastfeeding.

Eligibility criteria: Inclusion Criteria:

* First-time expectant mother, speaks English, receiving OB care at designated practice group

Exclusion Criteria:

* 1) Under 18 years old; 2)no access to local telephone 3) multiple gestation 4) history of major breast surgery

Primary outcomes:
measure: Early lactation difficulties
timeFrame: 1 year
Secondary outcomes:
measure: Infant feeding attitudes
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Laurie A Nommsen-Rivers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nommsen-Rivers LA, Dolan LM, Huang B. Timing of stage II lactogenesis is predicted by antenatal metabolic health in a cohort of primiparas. Breastfeed Med. 2012 Feb;7(1):43-9. doi: 10.1089/bfm.2011.0007. Epub 2011 Apr 27.
Clinical trial NCT00300027: Study of BMS-582664 in Combination With Either FOLFIRI or FOLFOX for Gastrointestinal (GI) Malignancies
Official title: A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Combination With 5-Fluorouracil/Leucovorin and Irinotecan or Oxaliplatin for Patients With Advanced or Metastatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Gastrointestinal Neoplasms
Keywords: Advanced Gastrointestinal Malignancies
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to define the recommended dose of BMS-582664 that could be safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy regimens in patients with advanced gastrointestinal malignancies and to evaluate the safety profile, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of these combinations.


Eligibility criteria: Inclusion Criteria:

* Good performance status
* Advanced colorectal, pancreatic, esophageal or gastric cancer
* Tissue for analyses
* Adequate bone marrow, hepatic, renal function
* 4-6 weeks since prior therapy
* Adequate protection for women of child bearing potential (WOCBP)

Exclusion Criteria:

* Brain metastasis
* Thromboembolic disease
* Cardiovascular disease

Primary outcomes:
measure: Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw)
measure: Echocardiogram every 2 cycles (q 2 cycles)
Secondary outcomes:
measure: Tumor response (q 2 cycles)
measure: PK parameters (during 1st cycle)
measure: PD markers (weekly)
measure: Fluorodeoxyglucose positron emission tomography (FDG-PET) (3 scans prior to C3)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Iowa City
country: United States
facility: Local Institution
state: Iowa
city: Durham
country: United States
facility: Local Institution
state: North Carolina
city: Temple
country: United States
facility: Local Institution
state: Texas
Study officials:
References: