louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04122508: Are Dental Neglect and the Siblings Risk Factors in Children
Official title: Are Dental Neglect and the Presence of Siblings Risk Factors for Oral Health in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behavior, Child
Caries,Dental
Neglect, Child
Anxiety
Keywords: anxiety
siblings
dental caries
oral health
child abuse
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children who presented for the first time to the Faculty of Dentistry in Rize

Brief summary: Neglect insidiously affects a child's overall health in all aspects. The aim of this study was to determine whether the presence of siblings caused dental neglect, and whether there was a relationship between dental neglect and anxiety.

Detailed description: Dental neglect is an intentional failure of parents or caregivers to take precautions and fulfil necessary dental treatment, and has a close relationship with dental caries and anxiety. Oral health status of the children was evaluated using the DMFT/dmft, PUFA/pufa, and OHI-S indices. In addition, the parents completed the Dental Neglect Scale (DNS) and a questionnaire, and the Modified Child Dental Anxiety Scale (MCDASf) was administered to the children to assess their dental anxiety.

Eligibility criteria: Inclusion Criteria:

* Aged between 6 and 12 years old
* Being healthy
* Being volunteer for the study

Exclusion Criteria:

* Systemic and mental disorders
* Syndromes or other major health diseases
* Cooperation problems

Primary outcomes:
measure: the effects of presence of siblings on dental neglect
timeFrame: for eight months from the beginning of the study
measure: the effects of presence of siblings on oral health
timeFrame: for eight months from the beginning of the study
measure: the effects of presence of siblings on dental caries
timeFrame: for eight months from the beginning of the study
measure: the effects of presence of siblings on untreated caries
timeFrame: for eight months from the beginning of the study
Secondary outcomes:
measure: to evaluate whether there was a correlation between dental neglect and anxiety in children
timeFrame: for eight months from the beginning of the study
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Training and Research Hospital
Study officials:
affiliation: Recep Tayyip Erdogan University Training and Research Hospital
name: Sema Aydınoglu, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06692608: Effects of an Isometric Training Session on Post-exercise Neuromuscular Function When Compared to Dynamic Strength Training
Official title: Effects of an Isometric Training Session on Post-exercise Neuromuscular Function When Compared to a Dynamic Strength Training Session in Youth Soccer Players
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Strength Training Effects
Keywords: strength
isometric
dynamic
soccer
Lead sponsor: University of Maia
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The existing literature shows that maximum strength can be improved through both dynamic and isometric strength training. However, there is a perception that dynamic training has a negative effect on short-term neuromuscular performance in soccer players. Hence, the aim of this study was to compare the neuromuscular impairment after isometric and dynamic training sessions in young soccer players.


Eligibility criteria: Inclusion Criteria:

* soccer players
* Competing at national level

Exclusion Criteria:

* Injured or recently injured athletes

Primary outcomes:
measure: countermovement jump
timeFrame: baseline (pre-test), 30 minutes and 24 hours post intervention
measure: bar velocity
timeFrame: baseline (pre-test), 30 minutes and 24 hours post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01887808: Repeat Insult Patch Test of Skin Irritation/Sensitization for Cetaphil Dermacontrol Oil Control Moisturizer SPF 30
Official title: Cetaphil Dermacontrol Oil Control Moisturizer SPF 30- 100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-occlusive Patch)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Irritation
Keywords: Determine
Hypoallergenicity
Cetaphil DermaControl Oil Control Moisturizer SPF 30
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine if Cetaphil DermaControl Oil Control Moisturizer SPF 30 proves to be a contact sensitizer or irritant in certain individuals


Eligibility criteria: Inclusion Criteria:

* Not currently under a doctor's care
* Free of dermatological or systemic disorder which would interfere with the results
* Free of any acute or chronic disease
* Will complete a preliminary medical history form and are in general good health
* Can read, understand, and sign informed consent

Exclusion Criteria:

* Under 18 years old
* Currently under doctor's care
* Currently taking any medication
* History of acute or chronic disease
* Diagnosed with chronic skin allergies
* Pregnant or lactating

Primary outcomes:
measure: area of erythema and edema to test reaction of skin to product
timeFrame: 3 consecutive weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AMA Laboratories
name: Mayya Tastene, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03798808: Family and Web-based Nutrition Intervention to Increase Vegetable, Fruit, and Dairy Intakes in Children
Official title: The Impact of an Innovative Family and Web-based Nutrition Intervention to Increase Vegetable, Fruit, and Dairy Intakes in Children With Overweight or Obesity: A Single-blinded Randomized Family Clustered Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Keywords: vegetables, fruits, dairy, children, habits
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 43
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Considering the high prevalence of childhood obesity worldwide, effective interventions are needed . Parental involvement in interventions and the use of web-based modalities appear to be promising approaches. The aim of the study was to evaluate the efficacy of an innovative family and Web-based nutrition intervention called "Family Nutriathlon" on consumption of vegetables and fruit and dairy products and/or alternatives and on diet quality among children and their parents.

Detailed description: Forty-three families, with at least one child with a BMI \>85th percentile, participated in either the intervention (n=24) or control group (n=19) over an 8-week period. Families in the intervention (Family Nutriathlon) will participated in a nutrition challenge that aimed to increase their consumption and variety of fruits and vegetables and dairy products by recording their daily intakes using a Web-based platform. Families in the control group received recommendations based on general nutrition guidelines. Three follow-ups with a dietitian once every two weeks via Skype to assess progress were scheduled. A three-day food record was completed at baseline (week 0), immediately after (week 8) and 6 months after the intervention. A two-way repeated measures analysis of variance was used to assess changes in consumption of fruits and vegetables and dairy products, diet quality and dietary intakes between groups and over time.

Eligibility criteria: All inclusion/exclusion criterion were the same between the two projects (including the intervention) except for the inclusion of a child living with obesity or overweight.

Children were aged between 8 and 16 years, but there was no age limit for parents.

Primary outcomes:
measure: Dietary intakes and diet quality
timeFrame: 8 weeks
Secondary outcomes:
measure: Anthropometric measurements
timeFrame: Weeks 0, 9 and 18-36 (follow-up)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03480308: Effect of Addition of Fentanyl or Dexamethasone or Both to Bupivacaine in Paravertebral Block for Patients Undergoing Major Breast Surgery
Official title: Effect of Addition of Fentanyl or Dexamethasone or Both to Bupivacaine in Paravertebral Block for Patients Undergoing Major Breast Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paravertebral Block
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will receive ultrasound guided paravertebral block and stratified into 3 groups according to medication used :

Group 1 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg Group 2 : bupivacaine (0.5%) 20 ml , dexamethasone 4 mg Group 2 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg
Primary purpose: TREATMENT

Brief summary: This study evaluated the analgesic efficacy of fentanyl and dexamethasone in combination with bupivacaine for single-shot paravertebral block (PVB) in patients undergoing major breast surgery.

Detailed description: This study evaluated the analgesic efficacy of fentanyl and dexamethasone in combination with bupivacaine for single-shot paravertebral block (PVB) in patients undergoing major breast surgery.

Patients will receive ultrasound guided paravertebral block and stratified into 3 groups according to medication used :

Group 1 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg Group 2 : bupivacaine (0.5%) 20 ml , dexamethasone 4 mg Group 2 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg

Eligibility criteria: Inclusion Criteria:

* Age: 18-70 years.
* Sex: females
* ASA physical status: I-II.
* Operation: major breast surgery

Exclusion Criteria:

* - Patient refusal.
* History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
* Coagulation disorders.
* Infection at the puncture site
* Allergy to study medications.
* Chronic use of pain medications.
* Respiratory tract in¬fection within the last 2 weeks.
* Neurological deficit

Primary outcomes:
measure: Time to first analgesic request
timeFrame: one day postoperative
measure: pain assessment
timeFrame: one day postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Amonios Khalil gerges
Study officials:
affiliation: Faculty of medicine-Assiut university-Egypt
name: Amonios khalil
role: STUDY_DIRECTOR
References:
Clinical trial NCT02713308: Impact of MultiPoint Pacing Technology in CRT Patients With Reduced RV-to-LV Delay
Official title: Impact of MultiPoint Pacing Technology in CRT Patients With Reduced RV-to-LV Delay
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Resynchronization Therapy
Lead sponsor: Monaldi Hospital
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with standard indication to CRT-D system implantation

Brief summary: Observational, retrospective and perspective study with acute and chronic endpoints

Detailed description: Study to assess the benefit from Multipoint Pacing (MPP) in presence of RV-to-LV delay\<80ms in terms of rate of CRT responder patients at 6 Months from CRT-D system implantation

Eligibility criteria: Inclusion Criteria:

* Indication to CRT-D system implantation according to current guidelines or CRT-D system already implanted in patient scheduled to CRT-D system implantation according to current guidelines

Exclusion Criteria:

* Right Bundle Branch Block
* Severe Irreversible Renal Failure (eGFR\<30)
* NYHA IV
* Atrio-Ventricular Block above the 1st grade
* Prosthetic Valves
* Atrial Fibrillation at implantation

Primary outcomes:
measure: Rate of CRT responder patients
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Monaldi Hospital
city: Naples
country: Italy
facility: Università della Campania "Luigi Vanvitelli"
Study officials:
affiliation: Monaldi Hospital
name: Antonio D'Onofrio, MD
role: STUDY_CHAIR
References:
citation: Solimene F, Nigro G, Canciello M, Tavoletta V, Shopova G, Calvanese R, Rago A, La Rosa C, Nappi F, Viscusi M, Urraro F, Manzo G, Gallo P, Andriani A, Rovaris G, Palmisano P, Innocenti S, D'Onofrio A. Design and rationale of the Impact of MultiPoint pacing in CRT patients with reduced RV-to-LV delay (IMAGE-CRT) study. J Cardiovasc Med (Hagerstown). 2020 Mar;21(3):250-258. doi: 10.2459/JCM.0000000000000928.
Clinical trial NCT00581308: Long-term Safety Study of the GORE® HELEX® Septal Occluder
Official title: GORE® HELEX® Septal Occluder Post-Approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septal Defect, Atrial
Keywords: atrial septal defect, septal occluder, HELEX
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 215
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).

Detailed description: The GORE® HELEX® Septal Occluder is an approved medical device indicated for the transcatheter closure of atrial septal defects (ASDs). The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs). This is an FDA Condition of Approval Study. All subjects enrolled in this study will be followed for long-term safety and efficacy of the occluder device through 5 years.

Eligibility criteria: Inclusion Criteria:

* ASD less than or equal to 18 mm.

Exclusion Criteria:

* Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events.
* Unable to accommodate device delivery catheter.

Primary outcomes:
measure: Efficacy
timeFrame: 12 months
measure: Efficacy
timeFrame: 36 months
measure: Efficacy
timeFrame: 60 months
measure: Safety
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Joe DiMaggio Children's Hospital
name: Larry A Latson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02849808: Long Term Cornea Graft Survival Study
Official title: Long Term Cornea Graft Survival Study (Étude Bisontine d'Estimation de la Survie à Long Terme à Partir Des données de Suivi Internes au CHRU : Evaluation Epidémiologie Clinique)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Fuchs' Endothelial Dystrophy
Keywords: Corneal Transplantation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent one or more keratoplasties since january 1983 at the University Hospital of Besançon

Brief summary: Corneal transplantation have been performed for several decades, follow-up time in some centers now exceeds 30 years. Published long term (10 years and up) graft survivals vary considerably from center to center. These variations may be explained by differences in case-mix and surgical techniques used.

The investigators aim to better understand the factors associated with long term graft survival.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent one or more keratoplasties since january 1983.
* Age 18 and older

Primary outcomes:
measure: Graft survival
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Ophthalmology Departement, CHU Besançon
Study officials:
affiliation: Opthalmology Department, CHU Besançon
name: Bernard Delbosc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bidaut-Garnier M, Monnet E, Prongue A, Montard R, Gauthier AS, Desmarets M, Mariet AS, Ratajczak C, Binda D, Saleh M, Delbosc B. Evolution of Corneal Graft Survival Over a 30-Year Period and Comparison of Surgical Techniques: A Cohort Study. Am J Ophthalmol. 2016 Mar;163:59-69. doi: 10.1016/j.ajo.2015.12.014. Epub 2015 Dec 17.
Clinical trial NCT00287508: Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)
Official title: Emboshield and Xact Post Approval Carotid Stent Trial Using the Emboshield® BareWire™ Rapid Exchange Embolic Protection System and Xact® Rapid Exchange Carotid Stent System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carotid Artery Disease
Carotid Stenosis
Stroke
Atherosclerosis
Keywords: Carotid stenting
Carotid endarterectomy
Carotid artery disease with severe narrowing of the artery
Stroke prevention
cerebral infarction
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2006-02-07
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To collect clinical outcome and device performance data on the FDA 510(k)-cleared Emboshield® BareWire™ Rapid Exchange Embolic Protection System and FDA-approved Xact® Rapid Exchange Carotid Stent System when used under commercial use conditions by a broad group of physicians entering the study with differing carotid artery stenting experiences.

Detailed description: This is a multi-center, observational, single arm, post-approval study enrolling the following study population:

* Subjects with neurological symptoms and \>= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram (visual estimate), or
* Subjects without neurological symptoms and \>= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram (visual estimate)
* The endpoint for the 1500 subjects enrolled will be a 30-day composite of death, stroke and myocardial infarction (MI).
* For the 500 subjects with 12 month follow-up, the endpoint will be a composite of stroke, death and MI at 30 days and ipsilateral stroke at 12 months (31-365 days).

Eligibility criteria: Inclusion Criteria:

* Subjects who agree to participate in this study and have signed the IRB approved informed consent form.
* Subjects who are willing to have the Emboshield and/or the Xact inserted into the their vasculature.

Exclusion Criteria:

* There are no exclusion criteria for this study.

Primary outcomes:
measure: The endpoint for the 1500 subjects enrolled will be a 30-day composite of death, stroke and myocardial infarction (MI).
measure: For the 500 subjects with 12 month follow-up, the endpoint will be a composite of stroke, death and MI at 30 days and ipsilateral stroke at 12 months (31-365 days).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Abbott Medical Devices
name: Don E Schwarten, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06207708: Sarcopenia in Head and Neck Cancer Patients Treated with Curative Hadrontherapy
Official title: Role of Baseline Sarcopenia in Determining Acute Toxicity for Head and Neck Cancer Patients Treated with Curative Hadrontherapy: a Prospective Monoinstitutional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: particle therapy
head neck cancer
sarcopenia
hadrontherapy
Lead sponsor: CNAO National Center of Oncological Hadrontherapy
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A sample of 70 patients of which 40% showing baseline sarcopenia will be recruited. The population is composed by head and neck patients treated with particle therapy, both carbon ions and protons.

Brief summary: The study focuses on the impact of sarcopenia on acute and late toxicities in head and neck tumor affected patients treated with particle therapy.

Detailed description: To evaluate in HNC patients treated with particle therapy the impact of SP (measured by low skeletal muscle mass at the C3 vertebral body) on toxicity profile assessed according to NCI's Common Terminology Criteria for Adverse Events CTCAE (version 5.0), defined as:

* Acute toxicity: within 3 months from the beginning of particle RT
* Late toxicity: more than 6 months after the end of particle RT. To investigate possible association between SP and nutritional

Eligibility criteria: Inclusion Criteria:

* All HNC histologies and stages
* Histological and/or radiological diagnosis of head and neck tumors
* The patient is able to give consent
* Definitive/postoperative treatment with curative intent
* Age \>18 years
* KPS\> 80

Exclusion Criteria:

* Plurimetastiatic disease
* Palliative intent and re-irradiation treatments
* Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires

Primary outcomes:
measure: skeletal muscle strength mass (SMM)
timeFrame: before starting hadrontherapy treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: CNAO
state: Pv
Study officials:
affiliation: CNAO National Center of Oncological Hadrontherapy
name: Rossana Ingargiola, MD
role: PRINCIPAL_INVESTIGATOR
References: