louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01910922: Effect of Learning on Vegetable Acceptance by Toddlers
Official title: Learning Mechanisms of Food Preferences in 2-3 y. o. Toddlers in Nurseries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Preference
Keywords: vegetable acceptance
vegetable intake
vegetable liking
learning mechanisms
repeated exposure to flavor
flavor learning
replace salt with spice
Lead sponsor: Centre des Sciences du Goût et de l'Alimentation
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2013-07-30
Enrollment: 160
Sex: ALL
Minimum age (years): 17
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 2-3 years olds attending nurseries in Dijon city

Brief summary: The aim of this study is to understand the formation of food preferences from an early age.

Detailed description: The main purpose of this research is to compare the effectiveness of two mechanisms (mere exposure, flavour-flavour learning) in the short and medium term (up to six months after the learning phase) on 2-3 year-old children's vegetable acceptance. the research is conducted on children aged 2 to 3 years in daycares.

Eligibility criteria: Inclusion Criteria:

* children between 2 and 3 years,
* attending daycares
* returned signed consent form parents

Exclusion Criteria:

* children with food allergies or manifestations, chronic disease
* or being preterm (\<36 weeks gestational age at birth)

Primary outcomes:
measure: Vegetable intake and liking
timeFrame: baseline = Pre-exposure at one week before the beginning of the experimental manipulation (i.e. exposure phase)
Secondary outcomes:
Other outcomes:
measure: Vegetable intake and liking
timeFrame: exposure period: 4 weeks, twice a week
measure: Vegetable intake and liking
timeFrame: Measure at post-exposure one week after the end of the experimental manipulation (i.e. exposure phase)
measure: Vegetable intake and liking
timeFrame: 1-month follow-up, conducted one month after the end of the experimental manipulation (i.e. exposure phase)
measure: Vegetable intake and liking
timeFrame: 3-month follow-up conducted three months after the end of the experimental manipulation (i.e. exposure phase)
measure: Vegetable intake and liking
timeFrame: 6-month follow-up conducted six months after the end of the experimental manipulation (i.e. exposure phase)
Locations:
city: Dijon
country: France
facility: CESG
Study officials:
affiliation: Centre des Sciences du Goût et de l'Alimentation
name: Sophie Nicklaus, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre des Sciences du Goût et de l'Alimentation
name: Sylvie Issanchou, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06311422: A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different Materials
Official title: A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different Materials Using The Computer-Aided Design/ Computer-Aided Manufacture (Cad/Cam) System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endodontically Treated Teeth
Keywords: CAD/CAM
Endocrown
resin nanoceramic
zirconia-reinforced lithium silicate
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical performance of two different materials in endodontically treated teeth produced with CAD/CAM system will be evaluated and compared. After obtaining a signed informed consert form from all the patients, all restorations will be placed by a single clinician. All endocrown restorations will be produced using the same CAD/CAM system. 52 restorations will be fabricated using Lava Ultimate (LU, 3M Espe, Seefeld, Germany) blocks and 38 restorations will be fabricated using Celtra Duo (CD, Dentsply Sirona, York, PA, USA) blocks. All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12,36, 48, 60 months. Descriptive statistics will be performed using Chi-square and Fisher exact test.


Eligibility criteria: Inclusion Criteria:

* Good general health
* Patients older than 18
* Teeth must receive endodontic therapy before restoration
* The periodontal condition had to be stabilized before restoration
* No subject complained of discomfort in teeth
* Radiograph revealing alveolar bone resorption of less than a third and no shadow around the periapical tissues
* Participants who provided writen informed consent were recruited in collaboration

Exclusion Criteria:

* Any teeth with microcracks or fracture lines
* Affected teeth without completed root canal treatment
* The defect was less than ¼ of crown or more than ¾ of the crown and the margin of the residual crown was more than 1 mm below the gingival level
* Poor oral hygiene and periodontal status which persisted or worsened after periodontal therapy and education
* Bruxism or clenching patients
* Poor general health or pregnancy
* Patients who have read the informed consent form and refused to be included in the study

Primary outcomes:
measure: Clinical performance of two materials
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01043822: Pain and Emotional Expression in Children With Autism or Mental Retardation
Official title: Pain and Emotional Expression in Children With Autism or Mental Retardation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism
Mental Retardation
Keywords: Autism
mental retardation
pain
emotion
sensory profile
children
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 46 children with autism spectrum disorders, 46 children with mental retardation, 46 children without developmental disorder

Brief summary: The purpose of this study is to describe facial, behavioral and physiologic (heart rate) reactivity of children with autism aged 3 to 6 years old, during a painful stimulation (venepuncture). Children will be videotaped before, during and after a venepuncture. Each recording will be rated with the FACS (Facial Action Coding System) and the NCCPC (Non Communicating Children's Pain Checklist).

Detailed description: Children with autism will be matched with children with mental retardation and children without developmental disorder. Matching will be established according the developmental age of children with autism.

Eligibility criteria: Inclusion Criteria:

Group Autism:

* Child aged 3 to 6 years old
* Diagnosis of autistic disorder established according a pluridisciplinary staff (ICD-10 criteria, Vineland scales, ADOS, etc.)
* Admitted to children's neuropediatrics or genetics department for a venepuncture

Control group mental retardation:

* Child aged 3 to 6 years old .
* Diagnosis of mental retardation established according a pluridisciplinary staff (ICD-10 criteria, Vineland scales, ADOS, etc.)
* Admitted to neuropediatric or genetic department for a venepuncture

Control group without developmental disorder :

* Child aged 18 months to 5 years old.
* Admitted to pediatrics department for a venepuncture

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: Montpellier University Hospital
name: Amaria BAGHDADLI, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03027622: The Effects of Active Surveillance Protocol on Long Term Quality of Life in Patients With Mild Pericoronitis
Official title: The Effects of Active Surveillance Protocol on Long Term Quality of Life in Patints With Mild Pericoronitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pericoronitis
Keywords: quality of life
pericoronitis
third molar
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 55 patients diagnosed with pericoronitis affecting third molars

Brief summary: The complications that could occur during or after the extraction of the mandibular third molar teeth with pericoronitis affect patient's life quality considerably. Various scales are used to reveal how much the life quality of patients is affected this treatment. The aim of this study is to identify the long term life quality of patients through the OHIP-14 TR scale without removing the mandibular third molar teeth with mild pericoronitis.

Detailed description: Increasing the lenght stay in the mouth at a maximum rate and following the patient up after the necessary treatment and information procedures are completed. As a result of clinical and radiographical examinations fifty-five voluntary patients whose average age was 24 and who have semi or fully errupted vertical mandibular third molar teeth with the diagnosis of mild pericoronitis were included in the study.After the patients in the study filled out the form including their contact and demographic data and dental symptomsand completed OHIP-14 TR scale which last about 5 minutes, their curretage and operculectomy treatments were done under local anesthesia. The patients were invited for reexamination on seventh day after the treatment. Also, an active patient follow up about life quality was performed by phone at 1,3,6 month after the treatment using the self -assessment question form and the OHIP-14 TR scale.

Eligibility criteria: Inclusion Criteria:

* having the first episode of mild pericoronitis, having a good periodontal health, having an age between 18 and 25 years
* having a diagnosis of pericoronitis of a vertically erupted or semi erupted lower third molar, having no systemic discomfort and being in the ASA I and ASAII

Exclusion Criteria:

* having no lower third molar with a vertical position
* having a systemic discomfort
* having moderate to severe pericoronitis
* having a history antibiotics or NSAIID

Primary outcomes:
measure: Total score of OHIP-14 TR at the begining of experiment
timeFrame: first month
Secondary outcomes:
measure: Total score of OHIP-14 TR at third months
timeFrame: third months
measure: Total score of OHIP-14 TR at sixth months
timeFrame: sixth months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01562522: Evaluation of the Effect of Psycho-oncological Intervention on Well-being of Patients With Advanced Prostate Cancer on LHRH Analogs and Their Partners. A Randomized Controlled Pilot Study.
Official title: Evaluation of the Effect of Psycho-oncological Intervention on Well-being of Patients With Advanced Prostate Cancer on LHRH Analogs and Their Partners. A Randomized Controlled Pilot Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 6
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the protocol, is to assess the feasibility of conducting a larger trial to evaluate the effect of a psychological intervention on the well-being of patients on luteinizing hormone-releasing hormone (LHRH) analogs in the treatment of prostate cancer and their partners.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of prostate cancer on biopsy
* Locally advanced or metastasised prostate cancer in need of hormonal treatment.
* On LHRH analogue treatment for a minimum of 5 months (at inclusion)
* Having a female partner
* Patients and their partner are able to fill out questionnaires, attend group sessions and give consent

Exclusion Criteria:

* Serious psychiatric difficulties
* Life expectancy \< 12 months

Primary outcomes:
measure: Sufficient interest in participation
timeFrame: Up to the end of 16 weeks of the intervention period
measure: Preliminary improvement in well-being
timeFrame: After the intervention period of 16 weeks
Secondary outcomes:
measure: Change in quality of life questionnaire QLQ-C30 scores
timeFrame: Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
measure: Change in quality of life questionnaire QLQ-PR25 scores
timeFrame: Baseline(T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
measure: Difference in relationship satisfaction (Maudsley Marital Questionnaire)
timeFrame: Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
measure: Difference between level of depression and anxiety (HADS)
timeFrame: Baseline (T0) and 1 year (T2)
measure: Change in Hospital Anxiety and Depression Scale (HADS) scores
timeFrame: Baseline (T0), after the intervention period of 16 weeks (T1)
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Woerden
country: Netherlands
facility: Zuwe Hofpoort Ziekenhuis Woerden, Netherlands
Study officials:
affiliation: Ipsen
name: Medical Director Oncology
role: STUDY_DIRECTOR
References:
Clinical trial NCT03689322: Effects of WBV Associated With IMT on Inflammatory Markers, Body Composition, Muscle Strength and Thickness
Official title: Effects of Whole Body Vibration Associated With the Inspiratory Muscle Training Program on Inflammatory Markers, Body Composition, Muscle Strength and Thickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Keywords: aging
whole body vibration
respiratory muscle training
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 42
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aging generates immune, muscular and functional changes. In the pre-frail elderly these changes may be increased and, therefore, preventive interventions are indicated to minimize the consequences of sarcopenia in this population. This study aims to evaluate the effects of a whole body vibration training associated with the training of inspiratory muscles on the inflammatory, muscular and body composition outcomes in pre-frail elderly women.


Eligibility criteria: Inclusion Criteria:

* Elderly individuals able to walk without assistance
* Good understanding to carry out the proposed tests, evaluated through the Mini Mental State Examination (MMSE).

Exclusion Criteria:

* Contraindication or difficulty to perform evaluation procedures
* Users of medications that interfere with the cardiovascular and / or muscular system
* Smokers
* Neuromuscular or degenerative diseases
* Pulmonary comorbidities
* Heart diseases
* Labyrinthitis.

Primary outcomes:
measure: Respiratory Muscle Strength and Resistance
timeFrame: Change from Baseline respiratory muscle strength and resistance at 3 months
Secondary outcomes:
measure: Thickness of the quadriceps muscle
timeFrame: Change from Baseline thickness of the quadriceps muscle at 3 months
measure: Diaphragmatic thickness
timeFrame: Change from Baseline diaphragmatic thickness at 3 months
measure: Diaphragmatic mobility
timeFrame: Change from Baseline diaphragmatic mobility at 3 months
measure: Body Composition
timeFrame: Change from Baseline body composition at 3 months
measure: Inflammatory markers
timeFrame: Change from Baseline inflammatory markers at 3 months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambuco
state: Pernambuco
Study officials:
References:
Clinical trial NCT06095622: Chickpea Pulao Using Fenugreek Seeds and Indian Rennet for Improving Blood Glycaemic Levels
Official title: Formulation and Assessment of Chickpea Pulao Using Fenugreek Seeds and Indian Rennet for Improving Blood Glycemic Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus)
Keywords: Chickpea pulao
Fenugreek seeds
Indian rennet
Glucose modulating
Lead sponsor: University of Management and Technology Lahore
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 12
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study was to perform a clinical trial to compare the impact of herbal chickpea pulao (cooked Indian-Pakistani rice dish) on improving postprandial blood glucose levels in type-2 diabetic people. The main questions it aims to answer are:

* Whether Indian rennet and fenugreek seed extract can modulate blood sugar levels or not?
* At what concentration the flavor, taste, and blood sugar impact were acceptable?

Participants were provided with control and intervention herbal chickpea pulao for a period of 21 days and asked to provide feedback on taste, flavor, and over-acceptability, and their postprandial blood glucose levels were checked.


Eligibility criteria: Inclusion Criteria:

* People having Type-2 diabetes disease
* Must be able to consume chickpea rice pulao
* Must not be on vegan or keto diet

Exclusion Criteria:

* Healthy people without diabetes
* People with less than 18 years of age

Primary outcomes:
measure: Improvement in blood glucose levels
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Management and Technology
state: Punjab
Study officials:
References:
Clinical trial NCT03156322: Different Epidural Initiation Volumes
Official title: Effects of Different Epidural Initiation Volumes on Postoperative Analgesia in Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: cesarean section
combined spinal epidural anesthesia
patient controlled epidural analgesia
postoperative pain
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effect of different epidural initiation volumes on postoperative pain scores, local anesthetic requirements, and motor block in patients who undergo patient controlled epidural analgesia for postoperative pain after cesarean section.

Detailed description: 90 minutes after combined epidural spinal catheter insertion, three different volumes (5 mL, 10 mL, and 20 mL) are administered with a patient-controlled epidural analgesia (PCEA) device through the epidural catheter. For each group, 0.625% bupivacain + 2 μg/mL fentanyl, is administered.

The visual analog scale, first analgesic demand time, the number of PCEA requirement per hour, morphine requirement, nausea-vomiting, itching, motor block, hypotension, and total consumed analgesic, and ephedrine amounts of the patients are recorded in the recovery room and at postoperative 2, 4, 6, 12 hours.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology risks classification II
* Term pregnant

Exclusion Criteria:

* Multiple pregnancy
* Diabetes mellitus
* Hypertension
* Coagulopathy
* Severe cardiac, neurological and pulmonary disease
* Allergy to the study drugs
* Difficulty in understanding the use of the patient controlled analgesia device

Primary outcomes:
measure: Change in postoperative pain scores
timeFrame: up to 12 hours after cesarean delivery
Secondary outcomes:
measure: First analgesic demand time
timeFrame: up to 12 hours after cesarean delivery
measure: The number of analgesic requirement
timeFrame: up to 12 hours after cesarean delivery
measure: Morphine requirement
timeFrame: up to 12 hours after cesarean delivery
Other outcomes:
measure: Side effects associated with epidural analgesia
timeFrame: up to 12 hours after cesarean delivery
Locations:
city: Malatya
country: Turkey
facility: Inonu University Turgut Ozal Medical Center
Study officials:
affiliation: Prof Dr
name: Mahmut Durmus, Prof
role: STUDY_CHAIR
References:
citation: Sng BL, Woo D, Leong WL, Wang H, Assam PN, Sia AT. Comparison of computer-integrated patient-controlled epidural analgesia with no initial basal infusion versus moderate basal infusion for labor and delivery: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2014 Oct;30(4):496-501. doi: 10.4103/0970-9185.142842.