louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02859688: Can Epimutations be Inherited? How to Manage Patients With Imprinting-related Diseases Who Wish to Become Parents
Official title: Can Epimutations be Inherited? How to Manage Patients With Imprinting-related Diseases Who Wish to Become Parents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epimutation
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1 patient SRS, the father of the patient SRS and 5 control patients : healthy men, age-matched

Brief summary: Like genetic mutations, DNA methylation anomalies or epimutations can disrupt gene expression and lead to human diseases.

However, unlike genetic mutations, epimutations can in theory be reverted through developmental epigenetic re-programing, which should limit their transmission across generations. Following the request for a parental project of a patient diagnosed with Silver-Russell syndrome (SRS), and the availability of both somatic and spermatozoa DNA from the proband and his father, we had the exceptional opportunity to evaluate the question of inheritance of an epimutation. We provide here for the first time evidence for efficient reversion of a constitutive epimutation in the spermatozoa of an SRS patient, which has important implication for genetic counseling.


Eligibility criteria: Inclusion Criteria:

* Men who have been informed about the study
* Patients over 18 years old
* Fertile
* Matched for age with Silver Russel syndrome (SRS) patients

Exclusion Criteria:

* Adults under guardianship
* Patients without national health insurance cover
* Patients with psychomotor development diseases or pulmonary, cardiac, renal or metabolic diseases (including type 1 and 2 diabetes before the pregnancy), inflammatory and systemic diseases, hypertension, neurological diseases, chronic hepatitis B or C, infection with human immunodeficiency virus (HIV).

Primary outcomes:
measure: Analysis of levels of methylation of deoxyribonucleic acid (DNA) measured by cloning/ sequencing and/or pyrosequencing for genes susceptible to imprinting (GSI)
timeFrame: Through the study completion up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT06686888: The Impact of Short-Chain Fatty Acids on Gut Hormone Release After Delivery in the Small and Large Intestine of Healthy Volunteers
Official title: The Impact of Short-Chain Fatty Acids on the Gut Hormone Release After Delivery in the Small Intestine and Colon
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Satiety Hormones
Short-chain Fatty Acids
Satiety and Appetite
Intestinal Absorption
Metabolism
Glucose Homeostasis
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this crossover study is to evaluate the impact of short-chain fatty acids (SCFA) on the gut hormone release after administration in the small intestine or colon in healthy participants. The main question it aims to answer is whether the site of administration of SCFA affects the gut hormone release. On test days participants will ingest capsules filled with SCFA that are specifically delivered in the small intestine or the colon. Subsequently, blood samples are collected at regular time points.


Eligibility criteria: Inclusion Criteria:

* male and female
* healthy
* normal BMI (18.5-25 kg/m\^2)
* age within 18-50 years

Exclusion Criteria:

* Chronic gastrointestinal disorders such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, chronic constipation (less than 3 stools a week) and chronic frequent diarrhoea (more than 3 stools a day)
* Previous abdominal surgery, except from appendectomy
* Being on a weight loss, gluten-free, lactose-free, or vegan diet
* The donation of blood during the last 3 months or suffering from low blood haemoglobin levels
* The use of antibiotics or other medication that affects the gastrointestinal tract 3 months preceding the study and/or during the study
* The use of prebiotics or probiotics 2 weeks preceding the study and/or during the study
* Pregnancy, lactation or wish to become pregnant during the study period
* Previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)

Primary outcomes:
measure: The release of gut hormones
timeFrame: 8 hours
Secondary outcomes:
measure: The glycemic and insulinemic response
timeFrame: 8 hours
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References:
Clinical trial NCT04277988: Effect of Crossed Legged Position on Ultrasound Measured Posterior Longitudinal Ligament Length in Parturients.
Official title: A Comparison of the Ultrasound Measured Posterior Longitudinal Ligament Length in Parturients in the Standard Sitting and Crossed Leg Positions: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Maternal Analgesia
Ultrasonography Lumbar Spine
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant patients at term in the Labour and Delivery Suite, as well as those booked for elective cesarean sections who meet the inclusion criteria.

Brief summary: To investigate if sitting in flexed cross legged position for neuraxial techniques in term pregnant patients widens the size of the ultrasound acoustic window as measured by the visualized posterior longitudinal ligament length, during lumbar spine ultrasonography using longitudinal paramedian view, in comparison to the standard sitting flexed position.

Detailed description: This is a prospective observational study involving a total of 30 healthy term gestation pregnant patients with singleton fetuses.Patients will be randomly allocated to sit crossed leg or in standard position first. Using ultrasonography, the acoustic window for lumbar spinal anesthesia at L3-4 will be evaluated in both traditional sitting and crossed leg positions. Ultrasonography will be performed sequentially to measure the best visualized length of posterior longitudinal ligament,ligamentum flavum and interlaminar distance in the paramedian view.The scanned image will be saved to be remeasured by a third observer. Patients will be asked to score their comfort level while sitting in both positions.

Eligibility criteria: Inclusion Criteria:

Term gestation Singleton pregnancy 18 years or older Patients having elective cesarean delivery or induction of labor or in early labor

Exclusion Criteria:

* Allergy to ultrasound jelly
* Spinal Deformities/Previous spinal surgery
* No contraindication to neuraxial placement
* Any fetal concerns
* Morbid obesity
* Language barrier

Primary outcomes:
measure: PLL length
timeFrame: Up to Five minutes
Secondary outcomes:
measure: LF length
timeFrame: Up to Five minutes
measure: ILD length
timeFrame: Up to Five minutes
measure: Patient Comfort
timeFrame: Up to 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Western University
name: Indu Singh, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00615888: Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair
Official title: Prospective Randomized Controlled Trial to Evaluate Fast Track Recovery in Elective Open Infrarenal Aortic Aneurysm Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm
Keywords: elective open repair
complications
morbidity and mortality
fast track patient management
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2008-02-14
Enrollment: 100
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: Fast track programs have been introduced in many surgical fields to minimize postoperative morbidity and mortality. Morbidity after elective open infrarenal aneurysm repair is as high as 30%, mortality ranges up to 10%. In terms of open infrarenal aneurysm repair no randomized controlled trials exist to introduce and evaluate such patient care programs.

Detailed description: Prospective randomization of patients admitted with infrarenal aortic aneurysm who undergo elective open repair in a "traditional" and "fast track" treatment arm. Main differences consist in preoperative bowel washout (none vs. 3L cleaning solution) and analgesia (patient controlled analgesia vs. patient controlled epidural analgesia: PCA vs. PCEA). Study endpoints are morbidity and mortality, need for postoperative mechanical ventilation and length of stay (LOS) on intensive care unit (ICU).

Eligibility criteria: Inclusion Criteria:

* infrarenal aortic aneurysm
* given written informed consent

Exclusion Criteria:

* contraindication for epidural anesthesia
* suprarenal clamping

Primary outcomes:
measure: Morbidity and mortality after open infrarenal aortic aneurysm repair
timeFrame: 2 years
Secondary outcomes:
measure: LOS of ICU treatment, need for postoperative mechanical ventilation, day of discharge
timeFrame: 2 years
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
References:
citation: Muehling BM, Ortlieb L, Oberhuber A, Orend KH. Fast track management reduces the systemic inflammatory response and organ failure following elective infrarenal aortic aneurysm repair. Interact Cardiovasc Thorac Surg. 2011 May;12(5):784-8. doi: 10.1510/icvts.2010.262337. Epub 2011 Feb 22.
citation: Muehling B, Schelzig H, Steffen P, Meierhenrich R, Sunder-Plassmann L, Orend KH. A prospective randomized trial comparing traditional and fast-track patient care in elective open infrarenal aneurysm repair. World J Surg. 2009 Mar;33(3):577-85. doi: 10.1007/s00268-008-9892-2.
Clinical trial NCT01815788: Evaluation of Efficacy and Patient Acceptance of Sound Amplifier Téo First, in Mild and Moderate Presbycusis Patient 60 Years of Age and Older, With no Previous Hearing Aid
Official title: Evaluation of Efficacy and Patient Acceptance of Sound Amplifier Téo First, in Mild and Moderate Presbycusis Patient 60 Years of Age and Older, With no Previous Hearing Aid.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild and Moderate Presbycusis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 31
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A personal sound amplifying device (PASP) like Teo First is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities. Nevertheless, a lot of mild and moderate impaired hearing people don't want to buy and wear all day a real hearing aid.

The goal of our study is to evaluate the benefit of such a device for mild and moderate presbycusis patient 60 years of age and older, with no previous hearing aid.


Eligibility criteria: Inclusion Criteria:

* Wish to increase hearing
* Moral commitment to use the device
* Ability to understand the study
* Mild and moderate presbycusis (20 to 50 dB average hearing loss at 500, 1000, 2000 Hz and 4000 Hz)
* Patient 60 years of age and older,
* No previous hearing aid

Exclusion Criteria:

* Inability to use the device
* Previous use of a hearing aid
* local intolerance

Primary outcomes:
measure: Audiometric tests (pure tone and speech) in silence and noise, with and without Teofirst
timeFrame: 7 to 15 days after the first use of Teofirst
Secondary outcomes:
measure: audiometric and mental tests
timeFrame: D7 to 15 and D 40
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Nicolas GUEVARA, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sacco G, Gonfrier S, Teboul B, Gahide I, Prate F, Demory-Zory M, Turpin JM, Vuagnoux C, Genovese P, Schneider S, Guerin O, Guevara N. Clinical evaluation of an over-the-counter hearing aid (TEO First(R)) in elderly patients suffering of mild to moderate hearing loss. BMC Geriatr. 2016 Jul 9;16:136. doi: 10.1186/s12877-016-0304-4.
Clinical trial NCT06767488: Breathomics in the Diagnosis and Prediction of Radiotherapy-Induced Oropharyngeal Mucositis in Head and Neck Tumors
Official title: Breathomics in the Diagnosis and Prediction of Radiotherapy-Induced Oropharyngeal Mucositis in Head and Neck Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Tumors
Breathomics
Volatile Organic Compounds
Radiotherapy-induced Oral Mucositis
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with head and neck tumors requiring radiotherapy.

Brief summary: Radiotherapy-Induced Oropharyngeal Mucositis (RIOM) is one of the most distressing side effects for patients with head and neck tumors during radiotherapy, requiring clinical physicians to manage it according to the severity of mucositis to alleviate symptoms and improve quality of life. However, traditional diagnosis of RIOM overly relies on subjective evaluation, lacks early sensitivity, and existing biomarker diagnostic methods suffer from insufficient efficacy, invasiveness, and inconsistent results. This study aims to explore the diagnostic and predictive value of exhaled breathomics in RIOM of head and neck tumors. By collecting exhaled breath samples from head and neck tumor patients undergoing radiotherapy and analyzing volatile organic compounds (VOCs) using breath detection technology, we aim to develop and validate a non-invasive diagnostic and predictive model based on exhaled breathomics. The study will identify specific VOCs as potential biomarkers, providing new tools for early diagnosis, timely prediction, and personalized treatment of RIOM.


Eligibility criteria: Inclusion Criteria:

* Voluntarily sign informed consent. Over 18 years of age. Histologically confirmed head and neck tumors, treated with radiotherapy or chemoradiotherapy.

ECOG PS Score: 0/1/2.

Exclusion Criteria:

* Lung disease such as lung cancer, tuberculosis, and lung infections. Inhalation anesthesia within 3 months. Inhalation medication within 3 months. Postoperative laryngeal cancer. Concurrent serious uncontrolled medical conditions such as unstable heart disease requiring treatment, poorly controlled diabetes mellitus (fasting blood glucose \> 1.5 x upper limit of normal).

Participation deemed inappropriate in the judgment of the investigator.

Primary outcomes:
measure: Different grades radiotherapy-induced oral mucositis
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
measure: Start and duration of radiotherapy-induced oral mucositis
timeFrame: Through study completion, up to 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang hospital, Southern medical university
state: Guangdong
Study officials:
References:
Clinical trial NCT02018588: Tryptophan Requirement of Healthy School Age Children
Official title: Tryptophan Requirement of Healthy School Age Children Determined by the Indicator Amino Acid Oxidation Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: requirements
amino acid
tryptophan
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 7
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our objective is to determine the requirement for the amino acid tryptophan in school age children using the indicator amino acid technique.

Detailed description: Seven healthy children will participate in the study. The children will participate as an outpatient basis with study days carried out in the Physiological Research Unit at the Hospital of Sick Children, Toronto, Canada. Inclusion criteria include: being healthy, not taking any medications, no recent weight changes, no history of significant illness, willing to participate in the study. Exclusion criteria were the presence of illness, significant weight change, not acceptance of the diet. Prior to enrolment, each subject will have to fill 3 days food record form to ensure his or her normal dietary behavior. The study will be explained to subjects and their parents/guardians, benefits and potential risks will be explained as well and written assent, from the children, and consent from parents will be obtained. Subjects will receive financial compensations. Each subject will receive compensation for participation. Each parent/guardian will be reimbursed for the transpiration/parking expenses and a meal each study day.

Eligibility criteria: Inclusion Criteria:

* Healthy children age 6-10 inclusive

Exclusion Criteria:

* significant recent illness

Primary outcomes:
measure: Requirement of tryptophan in school age children
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto, Canada
name: Paul B Pencharz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Mokbel A, Courtney-Martin G, Elango R, Ball RO, Pencharz PB, Tomlinson C. Tryptophan Requirement in School-Age Children Determined by the Indicator Amino Acid Oxidation Method is Similar to Current Recommendations. J Nutr. 2019 Feb 1;149(2):280-285. doi: 10.1093/jn/nxy250.
Clinical trial NCT00723788: Magnetic Resonance Imaging (MRI) of Appendicitis in Children
Official title: Magnetic Resonance Evaluation of Appendicitis in Children Aged 8-18
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: Appendicitis
Children
Magnetic Resonance Imaging
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 21
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Study to find out if MRI can diagnose appendicitis in children as well as or better than CT scan and/or ultrasound scan performed at the same time. No additional contrast material or sedation will be used to perform the MRI.


Eligibility criteria: Inclusion Criteria:

* Age 8-18 years, referred from emergency department for suspected appendicitis and receiving either CT scan or ultrasound of the abdomen for diagnosis

Exclusion Criteria:

* Failure to pass MRI metal screening. Claustrophobia or need for sedation due to inability to hold still.

Primary outcomes:
measure: Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up
timeFrame: during diagnostic procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Pranav K Vyas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hormann M, Paya K, Eibenberger K, Dorffner R, Lang S, Kreuzer S, Metz VM. MR imaging in children with nonperforated acute appendicitis: value of unenhanced MR imaging in sonographically selected cases. AJR Am J Roentgenol. 1998 Aug;171(2):467-70. doi: 10.2214/ajr.171.2.9694477.
citation: Hormann M, Puig S, Prokesch SR, Partik B, Helbich TH. MR imaging of the normal appendix in children. Eur Radiol. 2002 Sep;12(9):2313-6. doi: 10.1007/s00330-002-1351-0. Epub 2002 May 9.
citation: Pedrosa I, Levine D, Eyvazzadeh AD, Siewert B, Ngo L, Rofsky NM. MR imaging evaluation of acute appendicitis in pregnancy. Radiology. 2006 Mar;238(3):891-9. doi: 10.1148/radiol.2383050146.
citation: Incesu L, Coskun A, Selcuk MB, Akan H, Sozubir S, Bernay F. Acute appendicitis: MR imaging and sonographic correlation. AJR Am J Roentgenol. 1997 Mar;168(3):669-74. doi: 10.2214/ajr.168.3.9057512.
Clinical trial NCT01794988: Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study
Official title: Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Acute Pain
Low Back Pain
Back Pain
Functional Magnetic Resonance Imaging (fMRI)
Cognitive Behavioral Therapy
Pain Education
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2013-02-20
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: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether a psycho-therapeutic approach, group Cognitive Behavioral Therapy (CBT) plus a relapse prevention program, Therapeutic Interactive Voice Response (TIVR), modifies the dysfunctional sensory, emotional, and cognitive neural circuitry associated with chronic pain.


Eligibility criteria: Inclusion Criteria:

* At least 12 months of muscular-skeletal, non-neuropathic pain

Exclusion Criteria:

* Malignancy causing or influencing chronic pain
* Radiation or chemotherapy, or metastatic cancer of any type
* Reflex Sympathetic Dystrophy (RSD) and/or neuropathic pain
* Neurological disorders such as epilepsy or stroke, or other medical conditions
* Psychiatric disorders
* Opioid medication use for pain management
* Past year history of illicit drug use that can result in altered cognition
* Pregnancy
* Exceeding weight limit of the MRI scanner
* Incompatible implants due to MRI safety
* Awaiting pain related surgical procedure
* Involved in pain-related litigation

Primary outcomes:
measure: Pain
timeFrame: Seven Months
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont College of Medicine, MindBody Medicine Clinic
state: Vermont
Study officials:
affiliation: Faculty, University of Vermont College of Medicine
name: Magdalena Naylor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: