louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04661449: Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants
Official title: Childhood Health Outcomes in Term, Large-for-gestational-age Infants: Effects of Lifestyle Intervention in the Postnatal First Year
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Overweight
Keywords: large for gestational age
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 138
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Large-for-gestational-age (LGA) infants have a higher risk of metabolic disease later in life, and their postnatal growth in early childhood may be associated with long-term adverse outcomes. The purpose of this study is to explore whether comprehensive lifestyle intervention in the first year after birth in LGA infants will reduce the rate of overweight/obesity at childhood and improve neurodevelopmental outcomes and its possible mechanism.

Detailed description: Term LGA infants will be randomly divided into two groups shortly after birth: intervention group and control group. Infants in intervention group will attend the follow-up clinic and motor development assessment and guidance will be provided every three months in the first year. Other lifestyle interventions include feeding guidance and healthcare education. Infants in control group will routinely attend the follow-up clinic every six months. Primary outcome is the rate of overweight/obesity at two years old and seven years old. Neurodevelopmental assessment, carotid intima-media thickness (CIMT) and blood pressure at childhood will also be evaluated. The association of the outcome of LGA infants at two years old and the biomarkers in cord blood will be investigated, which includes serum leptin, insulin, insulin-like growth factors -1 (IGF-1), blood lipid series and adiponectin.

Eligibility criteria: Inclusion Criteria:

* term
* large-for-gestational-age infants

Exclusion Criteria:

* major genetic disorder
* congenital anomalies
* severe digestive disease

Primary outcomes:
measure: Rate of overweight/obesity at 2 years old
timeFrame: at 2 years old
measure: Rate of overweight/obesity at 7 years old
timeFrame: at 7 years old
Secondary outcomes:
measure: Neurodevelopmental assessment at 2 years old
timeFrame: at 2 years old
measure: Carotid intima-media thickness (CIMT) at 2 years old
timeFrame: at 2 years old
measure: Association of BMI at 2 years old with biomarkers in cord blood
timeFrame: at 2 years old
measure: Association of BMI at 7 years old with biomarkers in cord blood
timeFrame: at 7 years old
measure: Blood pressure at 7 years old
timeFrame: at 7 years old
measure: Carotid intima-media thickness (CIMT) at 7 years old
timeFrame: at 7 years old
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03971149: EMPOWER Study, a Personalized Home Care Intervention for Older Heart Failure Patients
Official title: Examining the Feasibility of EMPOWER - A Personalized Adherence Enhancement Intervention for Older Post-discharge Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 0
Sex: ALL
Minimum age (years): 60
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 see how investigators may best improve treatment adherence and disease management for heart failure after hospital discharge. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of future hospitalizations. In this study, a trained nurse interventionist will work with the participants to develop a personalized adherence enhancement strategy for heart failure diagnosis. The personalized adherence enhancement strategy is called EMPOWER.


Eligibility criteria: Inclusion Criteria:

* diagnosis of moderate/severe heart failure at hospital admission, defined by ICD codes (ICD-9 428 or ICD-10 150), New York Heart Association class III/IV, and left ventricular ejection fraction less than or equal to 40% (i.e., echocardiography)
* discharge from heart failure-led hospitalization to home health care in approximately the previous week
* intact or mildly impaired cognitive function (Montreal Cognitive Assessment eligibility scores greater than or equal to 18)
* primary residence in four counties within 30 minutes distance to the University of Rochester

Exclusion Criteria:

* end-of-life prognosis in the following 6 months that make it difficult to examine the changes in heart failure outcomes
* currently receiving hospice care
* conditions that impact the receipt of the intervention such as active suicidal ideation that is identified at baseline using the Geriatric Depression Scale and the Geriatric Suicide Ideation Scale
* being non-English speaking
* having serious visual and or hearing impairment

Primary outcomes:
measure: Mean change in medication adherence
timeFrame: week 1 to week 4
measure: Mean change in medication adherence
timeFrame: week 1 to 3 months
measure: mean change in adherence to low-sodium diet
timeFrame: week 1 to week 4
measure: mean change in adherence to low-sodium diet
timeFrame: week 1 to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: UR Medicine Home Care
state: New York
Study officials:
affiliation: University of Rochester
name: Jinjiao Wang, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01377649: Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease (PAD)
Official title: Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with peripheral arterial disease who are referred for diagnostic angiography and/or revascularization procedures

Brief summary: Contrast ultrasound is a technique that can quantify blood flow in the tissues of the body by ultrasound detection of microbubble contrast agents that behave in the circulation similar to red blood cells. In this study, the investigators hypothesize that contrast ultrasound of blood flow in the leg (thigh and calf) at rest and during stress produced by medications that mimic exercise (vasodilator stress) can provide information on the location and severity of peripheral vascular disease (blockages of the blood vessels in the leg). The investigators will also determine whether symptom improvement after revascularization (procedures to open up or bypass the blockages) is directly related to the improvement in blood flow.


Eligibility criteria: Inclusion Criteria:

1. Known or suspected PAD
2. Lower extremity angiography or MRA planned or performed within 6 months

Exclusion Criteria:

1. Age \<19 y.o.
2. Pregnant or lactating females
3. Hypersensitivity to ultrasound contrast agent, dipyridamole, or regadenoson
4. Severe reactive airways disease
5. Evidence right-to-left shunt (identified on screening echo)
6. NYHA Class III or IV heart failure.
7. Planned amputation
8. Unstable coronary artery disease or severe aortic stenosis

Primary outcomes:
measure: Quantitation of Perfusion
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT00619749: Polyphenols and Endothelial Function
Official title: Polyphenols Rich Fruit Juice Effects on Endothelial Function and Exercise Capacity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sedentary Subjects
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2008-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine whether fruit juice rich in polyphenols might increase exercise capacity and memory in healthy sedentary subjects.Both parameters might be improved because of the anti-oxidant effects of polyphenols.


Eligibility criteria: Inclusion Criteria:

* sedentary

Exclusion Criteria:

* diabetes

Primary outcomes:
measure: Flow-mediated dilatation
timeFrame: 2 years
Secondary outcomes:
measure: Exercise, capacity memory
timeFrame: 2 years
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Physiologie et Explorations Fonctionnelles Hôpitaux Universitaires
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Bernard geny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03458949: Pilot Study in a Company in Maine-et-Loire to Evaluate the Feasibility, Acceptability, and Impact on the Participation Rate of Awareness of Colorectal Cancer Screening by Occupational Health Teams
Official title: Pilot Study in a Company in Maine-et-Loire to Evaluate the Feasibility, Acceptability, and Impact on the Participation Rate of Awareness of Colorectal Cancer Screening by Occupational Health Teams
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-03-08
Enrollment: 1400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The main objective of this pilot study is to implement an awareness campaign for colorectal cancer screening in the workplace, in partnership with the staff of the occupational health service of one of the largest companies in Maine-Loire , and to evaluate the impact of this action on the participation rate of colorectal cancer screening among employees.


Eligibility criteria: Inclusion Criteria:

* The study population is made up of the employees of the CHU d'Angers included in the target population of organized colorectal cancer screening in the Maine-et-Loire so employees aged 50 and over.

Exclusion Criteria:

* The criteria for non-inclusion are those of organized screening for colorectal cancer taking into account the active population:
* Age \<50 years and\> 67 years
* Personal or family history of polyps or colorectal cancer
* Personal history of intestinal disease already undergoing colonoscopy surveillance (chronic inflammatory bowel disease, HNPCC syndrome, familial adenomatous polyposis)
* Known genetic disease with risk of developing colorectal cancer.

Primary outcomes:
measure: variation of the rate of participation in colorectal cancer screening
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Santé au Travail CHU Angers
Study officials:
affiliation: University Hospital, Angers
name: François-Xavier Caroli-Bosc, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04196049: Removal of Massive Subretinal Organized Blood Clot With Fragmatome
Official title: Removal of Massive Subretinal Organized Blood Clot With Fragmatome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Keywords: organized blood clot
fragmatome
exudative age related macular denegeration
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 3
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with massive subretinal hemorrhage from age related macular degeneration and organized subretinal blood clot were managed by inferior retinectomy

Brief summary: By using the ultrasound power delivered by fragmatome, the hard, organized blood clot could be removed easily.


Eligibility criteria: Inclusion Criteria:

* Patients with massive subretinal hemorrhage from age related macular degeneration
* Patients had organized subretinal blood clot were managed by inferior retinectomy.

Exclusion Criteria:

* Patients without massive subretinal hemorrhage
* Patients were not age related macular degeneration.

Primary outcomes:
measure: Visual acuity
timeFrame: Before operation, 1 weeks after operation, 1 month after operation.
measure: spherical equivalent
timeFrame: Before operation
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
References:
Clinical trial NCT03781349: TENS of MENS for Rotator Cuff Tear
Official title: Comparative Efficacy on Pain of Two Non-pharmacological Treatments (TENS or MENS) in Patients With Partial Rotator Cuff Tears. A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to clarify the effectiveness of physiotherapeutic intervention through the TENS or MENS in conjunction with kinesiotherapy in patients with partial thickness rotator cuff tear.

Detailed description: The primary characteristic of a rotator cuff tear is pain, while muscle weakness appears as a secondary feature, leading to further disability.

The aim of this study was to clarify the effectiveness of physiotherapeutic intervention through the TENS or MENS in conjunction with kinesiotherapy in patients with partial thickness rotator cuff tear.

Eligibility criteria: Inclusion Criteria:

* Patients suffering shoulder pain because of partial thickness rotator cuff tear, confirmed with MRI and ultrasound scanning.
* Patients not receiving any recent pharmacotherapy with NSAIDs during the last month, or surgery at the shoulder area at any time point,
* The referral orthopedic had suggested physiotherapy.

Exclusion Criteria:

* Patients with open wounds or skin diseases in the shoulder area
* pregnant women
* patients with any type of neoplastic disease
* patients with pacemakers or serious cardiovascular diseases including arrhythmia, - patients with collagen diseases
* history of shoulder surgery

Primary outcomes:
measure: Pain intensity: NRS
timeFrame: up to 3 months after intervention
measure: Disability
timeFrame: up to 3 months after intervention
Secondary outcomes:
measure: quality of patients' life: EQ 5D
timeFrame: up to 3 months after intervention
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Study officials:
References:
Clinical trial NCT04249206: Outcome of Endodontic Treatment in Patient Treated With a Hydraulic Sealer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Apical Periodontitis
Keywords: root canal obturation
hydraulic sealer
single cone
endodontic outcome
Lead sponsor: Cittadella Universitaria
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate and compare, clinically and radiographically, the outcome of non surgical primary/secondary root canal treatment using a hydraulic sealer or a zinc oxide-eugenol sealer.


Eligibility criteria: Inclusion Criteria:

* a permanent, single or multi-rooted mature tooth
* clinical diagnosis of irreversible pulpitis
* diagnosis of apical periodontitis

Exclusion Criteria:

* subjects with immune-compromised status
* subjects with an overall poor prognosis for their treatment

Primary outcomes:
measure: Periapical Healing
timeFrame: 4 year
Secondary outcomes:
measure: tooth survival
timeFrame: 4 year
Other outcomes:
Locations:
Study officials:
References:
citation: Bardini G, Casula L, Ambu E, Musu D, Mercade M, Cotti E. A 12-month follow-up of primary and secondary root canal treatment in teeth obturated with a hydraulic sealer. Clin Oral Investig. 2021 May;25(5):2757-2764. doi: 10.1007/s00784-020-03590-0. Epub 2020 Sep 28.
Clinical trial NCT01820806: Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects
Official title: Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects Following a Single Oral Administration of [14C] GLPG0634
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2013-03-29
Enrollment: 6
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This will be a study in 6 healthy male subjects, each receiving a single oral dose of 100 mg \[14C\]-radiolabeled GLPG0634.

The study aims to establish the elimination pathways of GLPG0634 and their relative significance and to assess the metabolite profile of GLPG0634 in plasma and in excreta.

Furthermore, the pharmacokinetics (PK) of the main metabolites in plasma relative to GLPG0634 will be evaluated.

This study will also provide safety and tolerability information for GLPG0634.


Eligibility criteria: Inclusion Criteria:

* male, between 40 and 65 years of age, inclusive
* within BMI range 18 to 30 kg/m2, inclusive

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking

Primary outcomes:
measure: The amount of total radioactivity in urine and faeces over time after a single dose of radiolabeled GLPG0634
timeFrame: Day -1 (pre-dosing) up to Day 10 post dosing
measure: The amount of GLPG0634 and its main metabolites in urine and faeces over time after a single dose of radiolabeled GLPG0634
timeFrame: Day -1 (pre-dosing) up to Day 10 post dosing
measure: Identification of metabolites over time in plasma, urine and faeces after a single dose of radiolabeled GLPG0634
timeFrame: Day -1 (pre-dosing) up to Day 10 post dosing
measure: The amount of radioactivity, GLPG0634 and its main metabolites in blood and plasma over time after a single dose of radiolabeled GLPG0634
timeFrame: Day 1 (pre-dosing) up to Day 8 post dosing
Secondary outcomes:
measure: Number of adverse events
timeFrame: Screening up to Day 10 post dosing
measure: Changes in vital signs as measured by heart rate, blood pressure and oral temperature
timeFrame: Screening up to Day 10 post dosing
measure: Changes in 12-lead ECG measures
timeFrame: Screening up to Day 10 post dosing
measure: Changes in physical exam measures
timeFrame: Screening up to Day 10 post dosing
measure: Changes in blood safety lab parameters
timeFrame: Screening up to Day 10 post dosing
measure: Changes in urine safety lab parameters
timeFrame: Screening up to Day 10 post dosing
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: Galapagos NV
name: Frédéric - Vanhoutte, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05716906: Melatonin and Sleep Spindles in Autism
Official title: The Effects of Melatonin on Sleep Spindles in Children With Autism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Melatonin
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. We hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. This communication is mediated by the thalamic reticular nucleus (TRN). Due to its small size and location deep in the brain, we cannot assess TRN function without invasive techniques. Fortunately, sleep spindles, a specific brain rhythm provide a noninvasive read-out of TRN function. In Aim 1 we will examine whether reduced sleep spindles are related to worse sleep quality, impaired selective attention during wake, and sensory sensitivities in children with autism. In Aim 2, we will determine whether melatonin, which is commonly used to improve sleep, also increases sleep spindles in autism. If successful, this study will introduce TRN as a target for treatment of sleep disruption and guide larger home-based sleep studies.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects with ASD
* 12-18 years of age
* English speaking
* Able to understand and respond to questionnaires in English

Exclusion Criteria:

* Pregnant or breastfeeding
* Substance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary)
* Chronic medical conditions that affect sleep
* Any unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease
* History of head injury resulting in prolonged loss of consciousness or other neurological sequelae
* IQ \<70
* Other neurological disorder, including seizure disorder
* Diagnosed sleep disorder
* Known genetic causes of ASD
* Currently taking melatonin or those who have had an adverse reaction to melatonin in the past

Primary outcomes:
measure: Change in sleep spindle density
timeFrame: Five nights of sleep over two weeks
Secondary outcomes:
measure: Change in sleep quality
timeFrame: Five nights of sleep over two weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Professor
name: Dara Manoach, PhD
role: PRINCIPAL_INVESTIGATOR
References: