louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06448806: Mobile Health (M-health) Intervention to Reduce the Epigenetic Signature in Metabolic Syndrome (MetS)
Official title: Epigenetic Signature of Advance Glycation End Products (AGE) and Skin Autofluorescence As a Risk Predictor in Metabolically Healthy and Unhealthy Obese Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this interventional study is to learn about the improvement in body composition effects of lifestyle intervention in subjects with metabolic syndrome. The main question it aims to answer is:

Does life style intervention lower body fat% and gene methylation levels in subjects with metabolic syndrome? Participants will answer survey questions and get blood and body composition testing done at day 0, at 6 months and 12 months. Keep a diary of their food and activity and the number of times they use mobile health application.

Detailed description: This is same as above.

Eligibility criteria: Inclusion Criteria:

1. Less than 5 kg body weight fluctuation in the 6 months prior to recruitment.
2. Ideal body weight for height falling according to the South Asian Criteria as per WHO recommended i.e. Body Mass Index (BMI) of 18.5 to 22.9 kg/m2 (normal-weight) and above 23kg/m2 (overweight/ obese).
3. Any one of the following characteristics "according to the modified National Cholesterol Education Program (NCEP) ATPIII guidelines i) waist circumference ii) hyper triglyceridemia (triglycerides ≥150 mg/dl) or low High density lipoprotein (HDL) cholesterol (HDL cholesterol ≤40 mg/dl for men and ≤50 mg/dl for women iii) elevated blood pressure (systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg or current use of antihypertensive drugs) iv) impaired fasting glucose (fasting plasma glucose ≥100mg/dl) v) waist circumference (90 cm in men and 80 cm in women)".
4. Have access to a smart phone/mobile and not using the fitness application

Exclusion Criteria:

1. Age \<18 or above 65 year
2. Pregnant women
3. Individuals with other comorbidities such as cancers, hepatic and/or renal impairment, or on hormonal supplements and/or anti-inflammatory drugs etc.
4. Unfit for blood testing or no smart phone available

Primary outcomes:
measure: Weight in kilograms, height in meter (will be combined to report BMI in kg/m^2)
timeFrame: one year
measure: Advance glycation end product (U/mL) from serum
timeFrame: one year
measure: Body fat percentage
timeFrame: 1 year
Secondary outcomes:
measure: Methylation level of genes
timeFrame: 1 year
measure: Meal quality and calorie count
timeFrame: 1 year
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: DBBS
state: Sind
Study officials:
affiliation: Aga Khan University
name: Sadia Fatima, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01569906: Narrowband UVB for Children With Moderate to Severe Atopic Eczema
Official title: Narrowband Ultraviolet B Phototherapy in Children With Moderate to Severe Atopic Eczema- an Observational Prospective Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate to Severe Atopic Eczema
Keywords: Atopic Dermatitis
Lead sponsor: Royal Victoria Infirmary
Sponsor class: OTHER
Collaborators: name: British Skin Foundation
First posted: 2012-04-03
Enrollment: 58
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 3-16 years

Brief summary: To assess prospectively, the response of moderate to severe atopic eczema to a standard course of narrowband ultraviolet B phototherapy by using validated objective and subjective scoring systems.

Detailed description: Children with moderate to severe atopic eczema prescribed a course of narrowband UVB phototherapy were scored (using validated scoring systems) objectively and subjectively before, during and after the course of treatment, as well as 3 and 6 months post treatment (to determine length of remission). Their scores were compared to a control group. The control group comprised children with moderate to severe atopic eczema who were offered UVB but were unable to undertake the treatment.

Eligibility criteria: Inclusion Criteria:

* Children aged 3-16 years with moderate to severe atopic eczema (as defined by the modified Hannifin and Rajka criteria) in whom there is a clinical indication for phototherapy (as deemed by their specialist Dermatology consultant).

Exclusion Criteria:

* Children under the age of 3 years or any child who lacks the maturity needed to stand in the phototherapy cabinet unsupervised.
* Mild disease (defined as a Six Area Six Sign Atopic Dermatitis (SASSAD) score \<10)

Primary outcomes:
measure: Score at the end of treatment compared to the control group
timeFrame: 12 weeks
Secondary outcomes:
measure: Subjective scores at the end of treatment as compared to controls
timeFrame: 12 weeks
measure: objective scores at 3 months post treatment compared to controls
timeFrame: 3 months
measure: Association of filaggrin status with outcome
timeFrame: 12 weeks
measure: Subjective scores at 3 months post treatment compared to controls
timeFrame: 3 months
measure: Subjective scores at 6 months post treatment compared to controls
timeFrame: 6 months
measure: Objective scores at 6 months post treatment compared to controls
timeFrame: 6 months
Other outcomes:
Locations:
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
affiliation: Royal Victoria Infirmary
name: Aileen EM Taylor, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05875506: Efficacy of Ozone Gel, Doxycycline Saturated Chitosan Dressing Versus Alveogyl
Official title: Efficacy of Ozone Gel, Doxycycline Saturated Chitosan Dressing Versus Alveogyl in Pain Alleviation and Healing of Alveolar Osteitis in Diabetic Patients Double Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteitis
Dry Socket
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of ozone gel, doxycycline saturated chitosan dressing versus Alveogyl in pain alleviation and healing of alveolar osteitis in diabetic patients


Eligibility criteria: Inclusion Criteria:

* Patients over 20 years and under 60 years of age
* DM controlled by medication, presented to outpatient clinic with signs and symptoms of dry socket
* Only participant that are willing to control and record blood glucose level throughout the study period

Exclusion Criteria:

* Patients with any significant medical condition (besides DM)
* Alcoholic individuals
* Patients on drugs that affect the central nervous systems
* Patients who reported the use of drugs that might interfere with pain sensitivity
* Pregnant and lactating women
* Hypersensitivity to local anesthetics

Primary outcomes:
measure: Pain scores will be recorded on visual analog scale (VAS)
timeFrame: 7 days
Secondary outcomes:
measure: Healing score of the extraction socket
timeFrame: 21 days
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Dentistry, Minia University
Study officials:
References:
Clinical trial NCT04908306: IMAGE-HF: Project IIa Canadian CArdiomyopathy Registry for Device Therapy
Official title: IMAGE-HF: Project IIa - Canadian CArdiomyopathy Registry for Device Therapy (CanCARD-MR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 502
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for or being considered for primary prevention ICD, with or without CRT, will be recruited from the Electrophysiology services at each enrolling site

Brief summary: Delayed enhanced MRI in patients (of either ischemic or non-ischemic cause) being referred for primary prevention ICD

Detailed description: Device therapy using defibrillators and cardiac resynchronization therapy (CRT) is an important advance in the care of patients with acquired heart disease and heart failure. In specific groups these devices appear to significantly reduce the risk of sudden cardiac death and progression of heart failure. However, our ability to identify ideal candidates, and those who are most likely to respond and benefit from this therapy, is poor.

Preliminary studies using specialized Magnetic Resonance Imaging (MRI) appears to be one of the more valuable ways of predicting response to device therapy and holds substantial promise for patients with cardiomyopathy.

Large, prospective registries are necessary to explore its real-world utility for risk prediction across a broad spectrum of patients. Can-CARD MR is a national, multi-centre registry designed to address this particular need.

Eligibility criteria: Inclusion Criteria:

* .Any patient accepted for primary prevention ICD (+/-) CRT)

Exclusion Criteria:

* Known contra-indications to MRI.
* Recent myocardial infarction or revascularization procedure within the past 3 months.
* GFR (glomerular filtration rate) ≤ 30 ml. / min/ m2.

Primary outcomes:
measure: Occurrence of a)appropriate ICD therapy (shock or anti-tachycardia pacing (ATP)) or sudden cardiac death
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: David Birnie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06067906: Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients
Official title: Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-Eclampsia
Obesity
Keywords: pre-eclampsia
obesity
dissociated diet
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In view of the known link between pre-eclampsia, overweight/obesity and chronic kidney disease, the aim is to offer for obese and overweight patients to reduce their BMI without reducing lean body mass.

The POPADIPE project will make it possible to limit overweight or obesity by means of nutritional management chosen by the patient (hypocaloric or a dissociated diet). The latter has been the subject of little scientific investigation, particularly in relation to the management of post-pre-eclampsia.


Eligibility criteria: Inclusion Criteria:

* Person affiliated to social security
* Free, informed and written consent signed by the participant and the investigator (no later than the day of day of inclusion and before any examination required by the research)
* Patient over 18 years of age at the time of inclusion and \< 45 years of age
* Having had an pre-eclampsia in the last 5 years according to the definitions of the ISSHP 2018
* Patient with a BMI between 25 kg/m² and 40 kg/m² who accepts dietetic follow up
* Patient with a medical prescription for dietetic follow-up aimed at losing weight loss
* Patient with a balanced diet

Exclusion Criteria:

* Patients with a mental disability or language barrier that prevents them from understanding or consenting to the study
* Patients deprived of their liberty by judicial or administrative decision
* Patients under psychiatric care
* Patients subject to a legal protection measure
* Patients with cognitive disorders or defined eating disorders
* Patients who are pregnant or breast-feeding
* Patients undergoing steroid treatment and/or immunosuppression
* Have been on a low-calorie or dissociated diet for at least 6 months
* Patients with CKD stage ≥ 3A

Primary outcomes:
measure: Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia
timeFrame: 1 year after care
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References:
Clinical trial NCT01875406: a Diagnostic SIJ Injection Following a Composite of 3 Diagnostic Tests and a Pain Referral Diagram
Official title: Diagnosis of Sacroiliac Joint Pain: Predictive Value of a Diagnostic SIJ Injection Following a Composite of 3 Diagnostic Tests and a Pain Referral Diagram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Injection
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the predictive value of a composite of 3 simple clinically practical diagnostic tests (Mekhail's test, Patrick's and Thigh thrust) combined with a pain referral diagram in predicting response to a single diagnostic SIJ injection.

Detailed description: The purpose of this study is to determine the predictive value of a composite of 3 simple, clinically practical, diagnostic tests (Mekhail, Patrick's and Thigh thrust) combined with a pain referral diagram in predicting response to a single diagnostic SIJ injection. The goal is to test these 3 tests and compare their predictive value to the 6 tests commonly reported in the literature in order to provide a clinician with clinically practical special tests to aide in the diagnosis and treatment of SIJ mediated pain. . Specifically, we seek to evaluate the prognostic capacity for a series of three clinical tests (Mekhail's Test, thigh thrust and Patrick's Test) combined with a pain referral diagram to accurately predict the response (change in VAS) of a single diagnostic Sacroiliac joint and extra-capsular joint injection.

Eligibility criteria: Inclusion Criteria:

* any patient presenting with low back pain with or without radicular symptoms, regardless of prior history of back surgery from 18-90 years old whom after being evaluated by an independent clinician in the Cleveland Clinic pain clinic has been scheduled for a diagnostic SIJ injection.

Exclusion Criteria:

* any patient less than 18 or greater than 90 years old, has any medical condition that would not allow them to complete the study, diagnosis of any recent fractures in the lumbar spine, recent infection, pregnancy, taking anticoagulants.

Primary outcomes:
measure: validity of assessments
timeFrame: Day 1
Secondary outcomes:
measure: prognostic assessment
timeFrame: Day 1
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Maged Guirguis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01801306: A New Minimal-invasive Brain Tissue Probe Applying Near Infrared Spectroscopy
Official title: A New Multi-parameter Monitoring System Applying Near Infrared Spectroscopy and Indocyanine Green to Detect Cerebrovascular Events in Patients With Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spontaneous Subarachnoid Hemorrhage
Lead sponsor: NeMoDevices AG
Sponsor class: INDUSTRY
First posted: 2013-02-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To assess the feasibility of a new brain tissue probe for multi-parameter neuromonitoring (NeMo Probe) and the accuracy of measurement values.

To demonstrate the ability of the NeMo probe to detect changes in cerebral hemodynamics and oxygenation during cerebrovascular events monitored with established methods including brain tissue oxygenation tension and microdialysis


Eligibility criteria: Inclusion Criteria:

* Males and females aged 18-75 years (inclusive)
* Patients with high-grade subarachnoid hemorrhage (WFNS 4-5)
* Decreased level of consciousness with the need for intracranial pressure monitoring
* Successful exclusion of the ruptured aneurysm with clipping or coiling
* Women of childbearing potential must have a negative serum pregnancy test
* Written informed consent obtained by a legal representative

Exclusion Criteria:

* Significant kidney and/or liver disease
* Any severe unstable concomitant condition or disease (e.g. cancer, coronary disease) or chronic condition (e.g. psychiatric disorder, chronic obstructive pulmonary disease Grade II, chronic heart failure \> NYHA II)
* Cerebrospinal fluid infection or signs of meningoencephalitis
* Acute respiratory distress syndrome (ARDS), pulmonary edema
* Preexisting coagulation disorder
* Patients with current alcohol or drug abusus or dependence
* Patients with a history of hypersensitivity against indocyanine green or sodium iodine
* Patients with thyroid disease causing hyperthyroidism
* Breast-feeding women
* Patients committed to an institution based on official directive or court order

Primary outcomes:
measure: To assess the feasibility of the neuromonitoring system and accuracy of the measurement values
timeFrame: Day 90 after Removal of Medical Device
Secondary outcomes:
measure: To demonstrate the ability of the neuromonitoring system to detect cerebrovascular events in patients with subarachnoid hemorrhage
timeFrame: Day 90 after Removal of Medical Device
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Neurosurgery, University Hospital Heidelberg
Study officials:
affiliation: Department of Neurosurgery, University Hospital Heidelberg
name: Martin Seule, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06327906: A Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China
Official title: A Series of Studies Based on a Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Child Allergy
Neurodevelopmental Disorders
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 6000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 42
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The obstetrics department of Qilu Hospital of Shandong University recruit pregnant women. After the delivery of pregnant women, the newborns will included in the cohort.

Brief summary: In this study, a birth cohort was established to demonstrate the causal relationship between allergies and neurodevelopment disorders in infants and young children, and to find out the influencing factors of neurodevelopment disorders in early life.

Detailed description: In this study, a birth cohort was established, and infants were divided into two groups according to inclusion and exclusion criteria ( see study design ). One group was allergic group, and the other group was control group. The two groups will be followed up for up to 6 years, and specimens ( blood, urine, feces ) and test data ( height, weight, GESELL, etc. ) will be retained during the follow-up period. The outcome indicators were ASD, ADHD or LD, and DSM-5 was used as the diagnostic criteria.

Eligibility criteria: Inclusion Criteria:

* ①Allergic questionnaire results were positive.

  * The living area is Jinan City and its surrounding areas in Shandong Province, which is convenient for follow-up.

Exclusion Criteria:

* There is a clear diagnosis of brain developmental disorders

  * Psychological diseases

    * History of craniocerebral trauma or brain organic disease ④Major physical diseases ⑤Visual and auditory disorders ⑥ Epilepsy ⑦Intellectual disabilities

Primary outcomes:
measure: ASD
timeFrame: from 2023-11-15 to 2026-11-15
measure: ADHD
timeFrame: from 2023-11-15 to 2029-11-15
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: cao aihua, post-doctoral
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02797106: Management of Drooling in Children With Cerebral Palsy in France
Official title: Management of Drooling in Children With Cerebral Palsy: A French Survey of the Practices and Opinions of Health Professionals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Pathological Drooling
Keywords: Drooling
Cerebral palsy
Botulinium toxin
Practice survey of health professionals
Children
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: health care professionals potentially involved in assessment and/or treatment of drooling in children with Cerebral Palsy.

Brief summary: The study is a transversal, observational, descriptive survey of the practices and opinions of health professionals carried out nationally across France that aims to characterize children with cerebral palsy and pathological drooling and to describe care pathways, assessment and treatment of drooling.


Eligibility criteria: Inclusion Criteria:

* health professional known to assess and/or treat drooling
* health professional known to assess and/or treat children with Cerebral Palsy
* health professional exercising in France

Exclusion Criteria:

* health professional with an inactive e-mail address

Primary outcomes:
measure: Questionnaire on the assessment and treatment of drooling in children with Cerebral Palsy
timeFrame: Day 1 (At the time of the questionnaire mailing to the professionals)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CMCR des Massues -Croix Rouge Française, Lyon
name: Emmanuelle CHALEAT-VALAYER, MD
role: PRINCIPAL_INVESTIGATOR
References: