louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03454061: Effects of a Physical Education Programme in Preschool Children
Official title: The Development of Motor Skills by a Physical Education Programme in Preschool Children: a Preschool-based Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Child Development
Keywords: sport
physical activity
education
fundamental motor skills
childhood
exercise
health
training
intervention
gross motor development
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 119
Sex: ALL
Minimum age (years): 40
Maximum age (years): 67
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Unlike other European countries, Italian kindergartens do not include the physical education teacher in the school organic personnel. This is frequently associated with the lack of opportunities to perform physical education by preschool children. The aim of this study was to analyse the effects of a specific 16-week-long physical education programme (PEP) of 16-week length on the development of locomotor and object control skills in preschool children.

Detailed description: We conducted a school-based non-randomised controlled trial to evaluate the effect of a specific 16-week-long physical education program (PEP) on the quotient of gross motor development (QGMD) in preschool children. This study involved 119 children who were clustered in a control group (CG, n= 29, age: 52.1±8.65 months; height: 1.1±0.07 m, body weight: 19.2±5.55 Kg, BMI: 16.9±3.16) and an intervention group (IG, n= 90, age: 57.4±9.42 months; height: 1.1±0.06 m, body weight: 19.3±3.65 Kg, BMI: 16±1.75). Participants were assessed for locomotor ability and object control skills using the Italian version of gross motor development test, before and after the experimental period.

Eligibility criteria: Inclusion Criteria

* preschool children

Exclusion Criteria:

* Age \< 40 months
* Age \> 67 months

Primary outcomes:
measure: Quotient of gross motor development change
timeFrame: Change from Baseline at 16 weeks
Secondary outcomes:
measure: BMI
timeFrame: Change from Baseline at 16 weeks
measure: Weight
timeFrame: Change from Baseline at 16 weeks
measure: Height
timeFrame: Change from Baseline at 16 weeks
measure: Object control skills change
timeFrame: Change from Baseline at 16 weeks
measure: Locomotion skills change
timeFrame: Change from Baseline at 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Palermo
name: Marianna Bellafiore
role: STUDY_DIRECTOR
References:
citation: Tabacchi G, Battaglia G, Alesi M, Paoli A, Palma A, Bellafiore M. Food literacy predictors and associations with physical and emergent literacy in pre-schoolers: results from the Training-to-Health Project. Public Health Nutr. 2020 Feb;23(2):356-365. doi: 10.1017/S1368980019002404. Epub 2019 Sep 2.
Clinical trial NCT02843061: Combination of Rituximab and NK Immunotherapy for B Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: B-cell Lymphoma Recurrent
Keywords: B lymphoma
Rituximab
NK immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 30
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 is the safety and efficacy of Rituximab plus NK immunotherapy to recurrent B lymphoma.

Detailed description: By enrolling patients with B lymphoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Rituximab and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree evaluated by the RECIST
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival (PFS)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Institute in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital, Guangzhou
name: Jibing Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01706861: A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical Excision
Official title: A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid LEsions Treated Adjunctive to suRgical Excision. PMCS: EURO-KLEAR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Earlobe Keloids
Lead sponsor: Halscion, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-15
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to reduce the recurrence rate, volume, appearance and/or symptoms associated with keloid scarring in subjects undergoing surgical excision of keloids as compared to the scientific literature.


Eligibility criteria: Inclusion Criteria:

* Patients electing to undergo keloid excision procedure
* Patients able and willing to give written informed consent

Exclusion Criteria:

* Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin.

Primary outcomes:
measure: The incidence of device related adverse events
timeFrame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
measure: Recurrence of keloid post scar excision
timeFrame: Assessed at 1, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
measure: Subject Dermatology Life Quality Index (DLQI)
timeFrame: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
measure: Device Performance Evaluation
timeFrame: Assessed at Day 1
Other outcomes:
Locations:
city: Nassau
country: Bahamas
facility: University of the West Indies
city: Katowice
country: Poland
facility: Angelius Szpital Proviat
city: Krakow
country: Poland
facility: Oddzial Leczenia Oparzen Chirugil Plastysznej
city: Warsaw
country: Poland
facility: Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS"
city: Warsaw
country: Poland
facility: Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej
city: Edgbaston
country: United Kingdom
facility: The Westbourne Centre
state: Birmingham
Study officials:
affiliation: The Westbourne Centre
name: Sam Bella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04884061: Narrow Band Imaging Bronchoscopy During SARS-CoV2 Infection
Official title: Description of the Vasculature Pattern of the Bronchial Tree During Infection With SARS-CoV2 by Narrow Band Imaging Bronchoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Bronchoscopy
Narrow-band Imaging
Keywords: Covid19
bronchoscopy
Narrow-band imaging
bronchial vasculature
Acute vascular distress syndrome
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients who undergo bronchoscopy with image and/or videos recording of NBI aspect of the proximal bronchial tree (carina, right and left upper lobe). Three groups of patients will be selected: 1) Patients hospitalized with SARS-CoV2 infection proven by RT-PCR test ; 2) patients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2) ; 3) Patients who have had bronchoscopy performed as part of the assessment of a distal pulmonary nodule (RT-PCR negative for SARS-CoV2).

Brief summary: Vascular modifications have been described during SARS-CoV2 infection, especially a dilatation of the bronchial arteries. Within the airway wall, small branches of the bronchial arteries cross the muscle layer to develop a submucosal network. The Narrow Band Imaging technique is used during bronchoscopy to achieve a maximum contrast of vessels and the surrounding mucosa. Therefore, it enables to observe the microvessel structure and its distribution in the bronchial mucosa. The aim of this study is to describe the vasculature pattern of the bronchial tree during infection with SARS-CoV2.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo bronchoscopy with image and/or videos recording of NBI aspect of the proximal bronchial tree (carina, right and left upper lobe).
* Patients hospitalized with SARS-CoV2 infection proven by RT-PCR test
* patients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2)
* Patients who have had bronchoscopy performed as part of the assessment of a distal pulmonary nodule (RT-PCR negative for SARS-CoV2).

Exclusion Criteria:

* Patients under legal protection
* Patients who refuses the use of his personal medical data

Primary outcomes:
measure: Variation of the vasculature pattern of the bronchial mucosa between the three patient groups
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT00564161: VEGF as a Prognostic Factor for White Matter Damage in Preterm Infants
Official title: VEGF as a Prognostic Factor for White Matter Damage in Preterm Infants
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Preterm Infants With White Matter Damage
Preterm Infants Developing Normally
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-11-27
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: preterm infants.

Brief summary: We hypothesize that misexpression of vascular endothelial growth factor (VEGF) in the Cerebrospinal fluid of preterm infants can be used as a biomarker to predict the risk for developing white matter damage.


Eligibility criteria: Inclusion Criteria:

* Preterm infants undergoing lumbar puncture.

Exclusion Criteria:

* Preterm with IVH or known infection or meningitis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Talya Dor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05959161: Study on Brain Network Mechanism of Deep Brain Stimulation for Parkinson's Disease
Official title: Study on Brain Network Mechanism of Deep Brain Stimulation for Parkinson's （A Retrospective Study）
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Parkinson Disease
Deep Brain Stimulation
Non-motor Symptoms
Lead sponsor: Tianjin Huanhu Hospital
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 100
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary Parkinson's disease were followed up for 1 year after deep brain stimulation, and the imaging data were intact

Brief summary: As a surgical intervention, DBS can effectively relieve PD tremor, rigidity, bradykinesia and other symptoms. How to better screen patients suitable for DBS treatment and conduct reasonable preoperative and postoperative evaluation is crucial to judge the treatment effect and prognosis. The clinical symptom evaluation of PD patients can be divided into motor symptom evaluation and non-motor symptom evaluation. The motor symptoms of PD patients were evaluated by UPDRS III. The evaluation of non-motor symptoms in PD patients was mainly divided into three aspects: cognitive status, emotional status, and sleep status. Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) were used to assess the cognitive status of PD patients. The Hamilton Depression Scale (HAMD) was used to assess the patients' depression status. The Hamilton Anxiety Scale (HAMA) was used to assess the patients' anxiety status. The PD Sleep Scale 2nd version, The PD Sleep Scale 2nd version, PDSS - 2), and rem Sleep Behavior Disorder Questionnaire (sweet HK) (Rapid Eye Movement Sleep behaviors Disorder Questionnaire - Hong Kong, RBDQ - HK) to assess Sleep conditions.


Eligibility criteria: Inclusion Criteria:The clinical diagnosis of PD is consistent with the United Kingdom Parkinson's Disease Society Brain Bank criteria, with disease duration over 5 years, age under 75, acute levodopa motor response ≥30%, and indication for STN-DBS. -

Exclusion Criteria: patients with severe cognitive impairment, severe psychiatric disorders, acute levodopa motor response less than 30%, atypical parkinsonism, and contraindications to surgery -

Primary outcomes:
measure: motor symptom
timeFrame: 2023.1 to 2025.12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00557661: Safety Study of CD-NP in Heart Failure
Official title: A Multi-Center, Ascending Dose Trial to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CD-NP Infusions in Patients With Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congestive Heart Failure
Keywords: Heart failure
CD-NP
Lead sponsor: Nile Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label study designed to determine the safety, tolerability and pharmacodynamics of CD-NP infusions in heart failure patients.


Eligibility criteria: Key Inclusion Criteria:

* Male or female ≥18 years of age diagnosed with NYHA class III or IV heart failure in the last six months
* Female patients must be post-menopausal or surgically sterile
* Diagnosed heart failure with left ventricular ejection fraction \<40% obtained within the prior 6 months with at least one symptoms or signs of volume overload

Key Exclusion Criteria:

* Women who are pregnant, breast-feeding or of child-bearing potential
* Clinically unstable patients
* Major surgical procedures within 30 days of entry
* Febrile temp \> 100 degrees F)
* Symptomatic carotid disease, critical carotid stenosis, or stroke within 3 months prior to study entry
* Currently on IV vasoactive support (e.g., heart transplant candidate)
* History of unexplained syncope within the past 3 months
* History of organ transplantation
* Comorbidities such as clinically significant cardiac valvular stenosis, aortic valvular disease, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, infiltrative disease, uncorrected congenital heart disease, acute coronary syndrome, restrictive heart failure, or any other condition which, in the opinion of the Investigator, would prevent a patient's participation in the study.
* Participation in a clinical trial of any investigational therapy or device within 30 days prior to randomization.
* Treatment with nesiritide within 14 days prior to dosing.
* Inability to effectively communicate with study personnel.

Primary outcomes:
measure: To assess the safety and tolerability of CD-NP infusions in patients with heart failure
timeFrame: 28 days
Secondary outcomes:
measure: To evaluate the effect of CD-NP infusions on urinary flow rate, urinary sodium and potassium excretion
timeFrame: 24 hrs
Other outcomes:
Locations:
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: Steven Goldsmith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03494361: Evaluation of Dysphagia by 6-chnnel Surface Electromyography
Official title: Evaluation of Dysphagia by 6-chnnel Surface Electromyography and Preliminary Study for Design 6-channel Electrical Stimulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deglutition Disorders
Keywords: deglutition disorders
electromyography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants

Brief summary: The natural process of aging affects a few very specific timing parameters such as swallow reaction time and hyoid one movement velocity.

Many swallow timing and bolus transit parameters appear to be unaffected by aging. We want to know the changes of kinematic variables according to the aging process.

First hypothesis: There are probably be a protection mechanism that blocks functional loss progressing to kinematic abnormality. Muscle activation sequence change (i.e duration or amplitude) of the oropharyngeal muscles play an important role.

Second hypothesis: Age-related differences in muscle activation patterns will also appear differently depending on the characteristics of swallowed food.

Detailed description: Inclusion criteria

Inclusion criteria of healthy older adults : Age \> 60, without dysphagia, comorbidity

Inclusion criteria of young control group

: Age \< 60, without dysphagia, comorbidity

No prior history of swallowing difficulty or history of central nervous system disease, and none were taking medication that are known to affect swallowing.

Surface EMG was performed at bilateral suprahyoid, thyrohyoid, sternothyroid and pharyngeal constrictors. The latency of activation and termination was checked.

Eligibility criteria: Inclusion Criteria of old group

* Age \> 60, without dysphagia, comorbidity

Inclusion Criteria of young control group

* Age \< 60, without dysphagia, comorbidity

Primary outcomes:
measure: Latency
timeFrame: once at study, when patient enrolled
Secondary outcomes:
measure: duration
timeFrame: once at study, when patient enrolled
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06259461: Machine Learning to Construct an Association Model for Lung Cancer and Environmental Hormone
Official title: Identifying the Risk of Lung Cancer Linked to Environmental Hormones
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Neoplasms
Keywords: Environmental Substance
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 128
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study focused on lung cancer cases and investigated the association with exposure to environmental hormones

Brief summary: To apply machine learning to construct an association model regarding lung cancer and environmental hormones to more comprehensively identify factors that may lead to lung cancer and to improve existing lung cancer nursing assessments.

Detailed description: The present study is exploratory, and its design was divided into three stages: Stage 1 explored the environmental hormonal risk factors for lung cancer and constructed an association model using machine learning algorithms. Stage 2 validated the results of the association model with better predictive results in clinical settings. Stage 3 involved recommendations for reconstructing nursing assessments based on the results of the clinical model validation. The three stages are summarized as follows.

Eligibility criteria: Inclusion Criteria:

1. 20 years or older;
2. conscious, without mental disorders;
3. able to use Mandarin to communicate, had a smartphone or tablet computer and could operate it by themselves,
4. and were willing to participate in the study after the reasons for participation were explained and a consent form was signed, indicating their consent.

Exclusion Criteria:

* The exclusion criteria were those who could not understand the content of the nursing assessment questions and those with mental disorders.

Primary outcomes:
measure: identify factors that may lead to lung cancer and environmental hormones.
timeFrame: the database research samples from May 2014 to December 2020.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taipei university of nursing and health science
city: Taipei
country: Taiwan
facility: National Taiwan University, Cancer Center
Study officials:
References: