louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01156805: Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study
Official title: Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Food Habits
Physical Activity
Keywords: Children
School-based program
Obesity
Lead sponsor: Hospital de Granollers
Sponsor class: OTHER
First posted: 2010-07-05
Enrollment: 509
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to evaluate the efficacy of an intervention on food habits and physical activity in school-age children.

Detailed description: A two-year cluster-randomised prospective study with two parallel arms was used to evaluate an intervention programme in children in their first year of primary schooling (5-6 years of age) in schools in the city of Granollers. The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test.

Eligibility criteria: Inclusion Criteria:

* Children born in 2000 who attended schools in Granollers City

Exclusion Criteria:

* Schoolchildren who need special diet for metabolic or digestive disorder, physical activity incapacity, no family acceptance or attendance to school was discontinued

Primary outcomes:
measure: Anthropometric Variables
timeFrame: every two years
Secondary outcomes:
measure: Height
timeFrame: every two years
measure: Father's Height
timeFrame: every two years
measure: Mother's Height
timeFrame: every two years
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Granollers
name: Assumpta Recasens, MD
role: STUDY_DIRECTOR
References:
citation: Recasens MA, Xicola-Coromina E, Manresa JM, Ullmo PA, Jensen BB, Franco R, Suarez A, Nadal A, Vila M, Recasens I, Perez MJ, Castell C, Llargues E. Impact of school-based nutrition and physical activity intervention on body mass index eight years after cessation of randomized controlled trial (AVall study). Clin Nutr. 2019 Dec;38(6):2592-2598. doi: 10.1016/j.clnu.2018.12.029. Epub 2019 Jan 24.
citation: Llargues E, Recasens MA, Manresa JM, Jensen BB, Franco R, Nadal A, Vila M, Recasens I, Perez MJ, Castell C. Four-year outcomes of an educational intervention in healthy habits in schoolchildren: the Avall 3 Trial. Eur J Public Health. 2017 Feb 1;27(1):42-47. doi: 10.1093/eurpub/ckw199. No abstract available.
Clinical trial NCT06502405: Research on the Application of Electrical Impedance Tomography in Bronchial Challenge Testing
Official title: Research on the Application of Electrical Impedance Tomography in Bronchial Challenge Testing
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients need to exclude or confirm a suspected diagnosis of asthma through bronchial challenge testing.

Brief summary: The purpose of this study was to examine whether electrical impedance tomography (EIT) was capable of identifying the deteriorated lung function on a regional level during bronchial challenge testing and whether EIT may provide additional information during bronchial challenge testing and identify spatial and temporal heterogeneity of regional lung function.

Detailed description: The content of this study includes:

1. Can EIT identify the uneven ventilation caused by airway contraction in patients during bronchial provocation tests.
2. Can EIT monitor airway contraction in patients before Spirometer examination after inhaling activators.
3. Can EIT observe uneven ventilation caused by airway contraction through tidal breathing after the patient inhales activator.

Eligibility criteria: Inclusion Criteria：

1. Patients suspected of asthma who require bronchial challenge testing.
2. The Bronchodilator responsiveness testing is negative.
3. patients with a pre-bronchodilator FEV1 \>60% predicted.
4. No contraindications for bronchial provocation test examination.
5. Fully understand the purpose and significance of this study, and voluntarily participate in the research.

Exclusion Criteria:

1. patients with a pre-bronchodilator FEV1≤60% predicted.

1. Contraindications for bronchial challenge testing.
2. Pregnant or lactating women.
3. After pacemaker surgery.

Primary outcomes:
measure: global inhomogeneity index （GI）
timeFrame: 1day
measure: forced expiratory volume in 1s (FEV1)
timeFrame: 1day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: Fei Xie, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01208805: Spinal Cord Evoked Potentials as a Tool to Investigate Sensorimotor Processing
Official title: Spinal Cord Evoked Potentials in Candidates for Dorsal Column Stimulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain.
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-09-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with epidural elektrodes for intractable pain (spinal cord stimulation)

Brief summary: The study first aim is to investigate the relationship between different patterns of electrode stimulation and peripheral sensory stimulation and spinal cord-evoked potentials to optimize spinal cord stimulation parameters . The second aim of the study is to investigate the role of the spinal cord in some aspects of cognitive-sensory-motor processing, specifically the presence of top-down attentional effects on the sensory analysis of an external stimulus at the spinal cord level.

The study will be performed on patients that will be implanted with a spinal epidural electrode because of chronic intractable pain. From these electrodes, spinal cord evoked potentials (SCEPs) will be recorded.


Eligibility criteria: Inclusion Criteria:

* Age: 18 - 70
* Candidates for spinal cord stimulation
* Epidural electrode at the the level of the cervical or thoracic spine.

Exclusion Criteria:

* Generalized sensory deficit interfering with the recording of spinal cord evoked potentials

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Brabant
Study officials:
References:
Clinical trial NCT00004705: Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: University of North Carolina
First posted: 2000-02-25
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic fibrosis.

II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic fibrosis.

Detailed description: PROTOCOL OUTLINE: Patients may be treated on any of three different regimens. Patients may be treated on more than one regimen, if they meet the eligibility requirements.

Patients on regimen A are adults and receive uridine triphosphate (UTP) by inhalation, followed immediately by bronchoscopy.

Patients on regimen B are children, aged 4 to 10 years. Patients receive up to 4 graded doses of UTP by inhalation on day 1. On day 2, patients receive a single dose of UTP. Patients receive amiloride followed by UTP by inhalation on day 3.

Patients on regimen C are children, aged 4 to 18 years. Patients inhale a radiolabelled (technetium 99m) monodisperse iron oxide aerosol. Radiation deposited in the patient's lungs is monitored. Patients are randomized to receive one of 4 different aerosols (vehicle; UTP; amiloride; or UTP plus amiloride), which is inhaled for 20 minutes. Patients are followed 24 hours after aerosol exposure.

Regimen D is a dose escalation study in which patients are aged 9 to 40 years. Patients receive either the vehicle or UTP by inhalation 3 times daily for 3 days. Cohorts of 4 patients each are entered at each dose level.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of mild to moderate cystic fibrosis Small production of daily airway secretions Stable pulmonary course --Prior/Concurrent Therapy-- Radiotherapy: No radiation within 12 months to cause patient to exceed annual limits Other: No chronic medication for reactive airways disease At least 12 hours since inhaled beta-adrenergic agonists At least 24 hours since systemic theophylline --Patient Characteristics-- FEV1 greater than 50% predicted Other: Not pregnant Must perform reproducible spirometry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina
name: Michael R. Knowles
role: STUDY_CHAIR
References:
Clinical trial NCT06558305: IL-6, IL-12, IL-15 and IL-23 Expression Levels in Rheumatoid Arthritis Patients
Official title: Effect of cDMARD and Baricitinib Therapy on IL-6, IL-12, IL-15 and IL-23 Expression Levels in Rheumatoid Arthritis Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rheumatoid Arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: this study will include 30 RA patients receiving cDMARDs, 30 RA patients receiving baricitinib and 20 healthy participants.

Brief summary: Rheumatoid Arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation and articular damage.

Continuous medical research has dramatically improved the outcomes for patients with RA. Traditional therapeutic approaches have relied on glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs) and disease modifying antirheumatic drugs (DMARDs) such as methotrexate, sulfasalazine or leflunomide. Glucocorticoids and NSAIDs interfere with the inflammatory cascades while DMARDs impede both the inflammatory and the destructive processes of RA.

These drugs, although efficient, are not specifically directed against inflammatory cells or cytokines and are associated with significant toxicity. The development of biologic DMARDs (bDMARDs), has been an important step forward. Their ability to neutralize specific cytokines or target distinct immune cells filled a gap in existing treatment options for RA. \[3\]. However, some patients still have only partial or no response to bDMARDs. More recently, a group of drugs has been developed that inhibit the janus kinase (JAK) family of intracellular tyrosine kinases, which transmit cytokine- mediated signals via the JAK-signal transducer and activator of transcription (STAT) pathway \[4\]. Baricitinib, with a selectivity to inhibit JAK1 and 2, has been FDA approved for RA in 2018 \[5\].

Many cytokines such IL-6, IL-12, IL-15, IL-23, (GM-CSF) and (IFNs) are associated with the pathogenesis of RA. These cytokines transduce signals via the JAK-STAT pathway.


Eligibility criteria: Inclusion Criteria:

* Age is at leasr18 years old,
* established RA diagnosis according to 2010 the American College of Rheumatology/European League against Rheumatism classification criteria

Exclusion Criteria:

* Associated autoimmune diseases,
* connective tissue diseases,
* chronic liver or kidney diseases or
* genetic diseases

Primary outcomes:
measure: assess the effect of cDMARD and Baricitinib (JAKi) therapy on gene expressions of IL-6, IL-12, IL-15 and, IL-23 in patients with RA relative to the healthy controls.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00154505: Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
Official title: Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Scoliosis
Spinal Cord Injury
Keywords: Scoliosis
Spinal Cord Injury
Lateral Trunk Support
Radiography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The effects of lateral trunk supports (LTS) in special seating on the spinal alignment of 17 spinal cord injured (SCI) subjects with scoliosis were studied using bi-planar radiographs. The LTS improved significantly the functional scoliotic spinal alignment in the frontal and sagittal planes regardless of the severity of scoliosis.

Detailed description: SCI patients often develop progressive scoliosis due to loss of muscular support to maintain good sitting posture. Special seating with LTS has been widely used in clinical practice to improve their sitting postures. However, little is known as to how this can affect the scoliotic curve.The purpose of this study was to investigate the effects of lateral trunk supports (LTS) in special seating on the spinal alignment of spinal cord injured (SCI) individuals with scoliosis.

Ten male and seven female SCI subjects with scoliosis sat on an experimental chair with and without LTS while radiographs of the spine in the anteroposterior and lateral directions were taken. Radiographs of the spine in the A-P and lateral directions were taken with a digital radiographic imaging system (Saturn 9000 M, Comed., Korea). For each direction, the complete image of the spine was obtained from separate x-ray images of the upper and lower trunk due to the limited field of view of the x-ray machine. The Cobb angles and scoliotic indices based on the anteroposterior radiographic images and the angles of the thoracic and lumber spine based on lateral were calculated.

Eligibility criteria: Inclusion Criteria:

* (1) C4-T12 SCI, (2) onset over 1 year, (3) sitting on the wheelchair more than 4 hours per day, (4) diagnosed thoracic or lumbar scoliosis through A-P radiographs, (5) flexible scoliosis, confirmed by supine and side-lying bending radiographs.

Exclusion Criteria:

* inflexible scoliosis

Primary outcomes:
measure: Spinal aligamnet(Cobb angle)
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School of Occupational Therapy, National Taiwan University
Study officials:
affiliation: National Taiwan University
name: Hui-Fen Mao, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01828398: tDCS and Robotic Therapy in Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Upper Extremity Impairments
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.

The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.


Eligibility criteria: Inclusion Criteria:

* Males and females subjects. Age \> 18 years.
* Diagnosis of first ischemic stroke
* Impairment of the upper limb
* Trunk control defined in the Trunk-Control Test (TCT), with a score \> 50.

Exclusion Criteria:

* anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
* Impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
* contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
* Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
* Neurological or psychiatric pathology
* severe cardio-pulmonary, renal, hepatic diseases
* Pregnancy

Primary outcomes:
measure: Fugl-Meyer Upper Extremity
timeFrame: A week prior to treatment beginning
Secondary outcomes:
measure: Box and Block Test
timeFrame: A week prior to treatment beginning
measure: Ashworth Modified Scale
timeFrame: A week prior to treatment beginning
measure: Motor Activity Log (MAL)
timeFrame: A week prior to treatment beginning
measure: Assessment of cortical excitability (TMS)
timeFrame: A week prior to treatment beginning
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
References:
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Clinical trial NCT01590498: Radiotherapy vs Observation for CRPC
Official title: Salvage Radiotherapy vs Observation for Castration Resistant Prostate Cancer in Central China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hormone Refractory Prostate Cancer
Keywords: Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Prostatic Diseases
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: the cancer hospital of Zhengzhou University
name: People's Hospital of Zhengzhou University
name: Xinyang Central Hospital
name: Zhoukou Central Hospital
name: the second people's hospital of kaifeng
First posted: 2012-05-03
Enrollment: 2000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: inpatients with CRPC in 9 hospitals

Brief summary: The purpose of the study is to determine whether radiotherapy improves cancer control and overall survival among patients with Castration resistant prostate cancer.


Eligibility criteria: Inclusion Criteria:

1. Eligible patients had histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of disease progression during hormonal therapy
2. Patients were receiving primary androgen-ablation therapy as maintenance therapy. At least four weeks had to have elapsed between the withdrawal of antiandrogens (six weeks in the case of bicalutamide) and enroll ment, so as to avoid the possibility of confounding as a result of the response to antiandrogen withdrawal.
3. Another requirement was disease progression, as indicated by increasing serum levels of PSA on three consecutive measurements obtained at least one week apart or findings on physical examination or imaging studies.
4. Normal cardiac function was required.

Exclusion Criteria:

1. patients had a Karnofsky performance-status score of at most 60 percent
2. prior treatment with cytotoxic agents or radioisotopes
3. with history of another cancer within the preceding five years, brain or leptomeningeal metastases, symptomatic peripheral neuropathy of grade 2 or higher, and other serious medical condition.

Primary outcomes:
measure: overall survival
timeFrame: From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or date of death from any cause, whichever came first, assessed up to 3 years.
Secondary outcomes:
measure: prostate cancer specific mortality
timeFrame: From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or death from prostate cancer or treatment complications, whichever came first, assessed up to 3 years.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: the first affiliated hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Liu Bingqian, MD Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00767598: The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors in Male Subjects
Official title: The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors(PDE5I) in Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics of Three PDE5Is
Healthy Subjects
Genetic Polymorphic CYP3A5
Keywords: CYP3A5
sildenafil
udenafil
vardenafil
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2008-10-07
Enrollment: 21
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In order to evaluate the effect of CYP3A5\*3 allele on the pharmacokinetics of sildenafil, udenafil, and vardenafil, the clinical trial using a single oral dose was conducted in Korean healthy male subjects whose genotype of CYP3A5 had been determined.

Detailed description: The aim of this study is to evaluate the different effect of the CYP3A5 genotype on the pharmacokinetics(PK) of sildenafil, udenafil, and vardenafil in healthy male subjects. Twenty one healthy male subjects with CYP3A5\*1/\*1, \*1/\*3, or \*3/\*3 were enrolled. An open-label 3-way crossover study was performed with a week washout. A single oral dose of PDE5I (100 mg sildenafil; 200 mg udenafil; 20 mg vardenafil) was administered, respectively. After a single oral dose of phosphodiesterase type 5 inhibitor (PDE5I), plasma levels of the parent and the major metabolite were measured up to 24 or 48 h.

Eligibility criteria: Inclusion Criteria:

* Healthy male subject whose CYP3A5 genotype was determined

Exclusion Criteria:

* Subject whose CYP3A5 genotype was not determined

Primary outcomes:
measure: Cmax, AUC
timeFrame: upto 24hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Inje University
name: Jae-Gook Shin
role: PRINCIPAL_INVESTIGATOR
References: