louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05821998: Effect of Thoracic Block Technique on Arterial Blood Gases in Children With Atelectasis on Mechanical Ventilation
Official title: Effect of Thoracic Block Technique on Arterial Blood Gases, Vital Signs and Lung Compliance in Children With Atelectasis on Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Intensive Care Unit
Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Statement of the problem:

• Does the thoracic block technique has effect on arterial blood gases, vital signs and lung compliance in children with atelectasis on mechanical ventilation? Null hyposis there is no effect of thoracic block technique on arterial blood gases, vital signs and lung compliance in children with atelectasis on mechanical ventilation.

Detailed description: Subjects:

The study targets the children from both sexes.diagnosed with atelectasis in intensive care unit. Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study,

Study design:

Randomized controlled clinical trial. Children will receive intervention type randomly, 22 child received percussion, vibration, modified postural drainage and the other 22 child will receive percussion, vibration, modified postural drainage and thoracic block technique.

Children will be assessed by measuring heart rate, respiratory rate,which reflect the physiological status, arterial blood gases which include partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2) and oxygen saturation (SaO2) and dynamic lung compliance which reflect clinical improvement of chest condition before and after ten days of receiving intervention

Eligibility criteria: Inclusion Criteria:

1. age range from 4 months to 4 years.
2. diagnosed with pneumonia, receiving mechanical ventilation.
3. start from second day of admission to intensive care unit
4. have unilateral mild to moderate atelectasis according to medical referral.
5. should be vitally stable during the session.

Exclusion Criteria:

The children were excluded from the study if they had one of the following:

1. medically unstable ( examples: tachycardia and tachypnea)
2. uncontrolled convulsion.
3. rib fracture.
4. pneumothorax -

Primary outcomes:
measure: Assessment of oxygenation status
timeFrame: 10 days for each participant
measure: Assessment of ventilation status
timeFrame: 10 days for each participant
measure: Assessment of dynamic lung compliance
timeFrame: 10 days for each participant
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Alaa Abdallah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04905498: Promoting Resilience to Food Commercials Decreases Susceptibility to Unhealthy Food Decision-Making
Official title: Developmental Decision Making Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Adolescent
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Missouri, Kansas City
First posted: 2021-05-27
Enrollment: 49
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate how food commercials influence food choices in children and their parents.

Detailed description: The proposed research will investigate food decision-making in youth. Childhood obesity is a risk factor for health issues, thus preventing adverse effects of childhood obesity by promoting healthy eating habits and providing effective interventions are important. Television food commercials advertising calorie-dense and high in salt and sugar foods are known to contribute unhealthy food choices and obesity. Thus the proposed study will examine how the advertising intervention focusing on increasing advertising knowledge and changing affective attitudes toward commercials impacts susceptability to commercials and food decisions in youth.

Eligibility criteria: Inclusion Criteria:

* Children had to be between 8-12.9 years old (including 8 year olds, NOT including 13 year olds.
* Had to be able to speak English as their primary language.
* Self-reported normal hearing and vision.

Exclusion Criteria:

* Did not speak English
* Data from children with history of neurological conditions, clinically significant psychopathology, or learning disabilities reported by parents (e.g., Attention Deficit Hyperactivity Disorder, depression) will be excluded.

Primary outcomes:
measure: Food Choice Change
timeFrame: Pre (day 0) and post intervention (day 7-10).
measure: Food Tastiness Change
timeFrame: Pre (day 0) and post intervention (day 7-10).
measure: Food Health Change
timeFrame: Pre (day 0) and post intervention (day 7-10).
Secondary outcomes:
measure: Level of Self-Control, as Measured by the Self-Control Scale
timeFrame: Children completed this item at the baseline visit (pre intervention).
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Amanda S Bruce, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ha OR, Killian HJ, Davis AM, Lim SL, Bruce JM, Sotos JJ, Nelson SC, Bruce AS. Promoting Resilience to Food Commercials Decreases Susceptibility to Unhealthy Food Decision-Making. Front Psychol. 2020 Dec 2;11:599663. doi: 10.3389/fpsyg.2020.599663. eCollection 2020.
Clinical trial NCT04310098: CADASIL Registry Study
Official title: Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cadasil
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed in hosipital and their's family

Brief summary: The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) and related disorders in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CADASIL , to optimize clinical management.


Eligibility criteria: Inclusion Criteria:

1. Sign informed consent.
2. Age\>18
3. Clinical diagnosis of patients with CADASIL,and confirmed by genetic test or skin biopsy
4. Asymptomatic NOTCH3 mutation carriers
5. Relatives of CADASIL patients or carriers
6. Unrelated healthy controls

Exclusion Criteria:

1. Unable to cooperate with inspectors
2. Serious systemic illness, such as heart, liver, kidney disease or major mental illness
3. Contraindications for imaging examination

Primary outcomes:
measure: Overall outcomes in CADASIL patients
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 20years
Secondary outcomes:
measure: The correlation of genotype and phenotype
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 20years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology , First Affiliated Hospital Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT01076998: Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Eye Ointment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
artificial tears
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the comfort and blurriness of the investigational lubricant eye drop with a marketed artificial tear ointment.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of dry eye

Exclusion Criteria:

* Must not have worn contact lenses within 12 hours preceding enrollment
* Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment

Primary outcomes:
measure: Three-minute visual blur profile
timeFrame: Through 3 minutes (post-instillation)
measure: Overall Acceptability
timeFrame: Immediately upon instillation
Secondary outcomes:
measure: Drop Comfort Upon Instillation
timeFrame: Immediately upon installation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02990598: Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)
Official title: Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Anemia
Keywords: Hydroxyurea
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Controls and Women taking Hydroxyurea prescribed by treating physician and lactating

Brief summary: To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a single dose to lactating women


Eligibility criteria: Inclusion Criteria:

* Lactating females, ≥ 18.0 years of age, at the time of enrollment
* Willingness to limit the baby's exposure to hydroxyurea through breastmilk, such as healthy volunteers using the "pump and dump" technique or avoiding direct breastfeeding or collection of pumped milk for at least 8 hours after taking the hydroxyurea dose. This applies only to healthy controls or women with sickle cell who are not already taking hydroxyurea. Women with sickle cell already taking hydroxyurea may continue to breastfeed their infants.

Exclusion Criteria:

* Persons with known allergies to hydroxyurea
* Failure to sign informed consent, or inability to undergo informed consent process
* Persons for whom it is not feasible or medically advisable to obtain the specimens necessary for this study

Primary outcomes:
measure: Hydroxyurea Concentration
timeFrame: 31-Dec-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Russell Ware, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01412398: Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan
Official title: Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Ambulatory Peritoneal Dialysis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperphosphatemia
Keywords: Fosrenol
Hyperphosphatemia
Continuous Cyclic Peritoneal Dialysis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-09
Enrollment: 446
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited.

Brief summary: This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. This study is also all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing continuous ambulatory peritoneal dialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

* Patients who are contraindicated based on the product label

Primary outcomes:
measure: Incidence of adverse drug reactions in subjects who received Fosrenol
timeFrame: After Fosrenol administration, up to 1 year
measure: Incidence of serious adverse events in subjects who received Fosrenol
timeFrame: After Fosrenol administration, up to 1 year
Secondary outcomes:
measure: Incidence of adverse drug reactions in subpopulation with baseline data [such as demographic data, concomitant disease, duration of treatment, maximum daily dose] and dose of Fosrenol
timeFrame: After Fosrenol administration, up to 1 year
measure: Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL]
timeFrame: After Fosrenol administration, up to 1 year
measure: Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL]
timeFrame: After Fosrenol administration, up to 1 year
measure: Clinical test value collections [calciotropic hormones, bone turnover markers]
timeFrame: After Fosrenol administration, up to 1 year
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01707498: Robust Intelligent Keyboard for Quadraplegic Patients
Official title: Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quadraplegia
Keywords: BCI
TETRAPLEGIA
COMMUNICATION
P300
ASSISTIVE TECHNOLOGIE
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: University of Versailles
First posted: 2012-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is multi-center prospective randomized trial evaluating the effectiveness of a new brain-computer interface for communication of quadriplegic patients in a clinical context. This performance of this will compared to traditional assistive technology (scanning system) and to performance of a healthy volunteer population.

Detailed description: The evaluation aims to estimate the performance of BCIs in patient and healthy subjects in a clinical setting (primary objective) and to compare this performance with an existing assitive technology adapted to the target population of this study (scanning system). A quadriplegic patient population (n = 10) evaluated the two techniques and a population of healthy subjects (n = 10) evaluated the BCI only.

When a subject meets all the eligibility criteria and is not discarded by any non-inclusion criteria, he is included in the study. The order of the two techniques to be compared is randomized.

Eligibility criteria: Inclusion Criteria:

Healthy volunteers:

* Informed consent
* Adults aged more than 18yo
* Passed complete medical check-up (heart-rate, blood pressure,...)
* Negative pregnancy test

Quadripleagic patients:

* Informed consent
* Adults aged more than 18years
* Passed medical exam
* Negative pregnancy test
* Full medical checkup
* haemodynamic stability

Exclusion Criteria:

Healthy volunteers:

* history of epilepsy or seizure
* auditory or visual deficit
* atopic scalp dermatitis
* hypersensitivity to gold
* curator/guardianship/under protection of judicial authority
* unable to understand the information note and/or to cooperate
* no social security
* can't read

Quadripleagic patients:

* history of epilepsy or seizure
* auditory or visual deficit
* cerebral lesion
* atopic scalp dermatitis
* hypersensitivity to gold
* curator/guardianship/under protection of judicial authority
* unable to understand the information note and/or to cooperate
* no social security
* can't read
* included in a different clinical trial with exclusion period

Primary outcomes:
measure: BIT RATE IN BIT PER MINUTE(bpm)
timeFrame: 15 MINUTES
Secondary outcomes:
measure: Installation time (seconds)
timeFrame: 60 mns
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
affiliation: CIC IT 805
name: LOUIS MAYAUD, ENGINEER
role: STUDY_DIRECTOR
References:
Clinical trial NCT05766098: Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
Official title: Caratterizzazione Del Profilo Mutazionale Nel Tumore Papillare Della Tiroide Tramite Tecnologia Mass-ARRAY
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Papillary Thyroid Cancer
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with papillary thyroid cancer, operated and followed by our Center of Excellence for the Diagnosis and Treatment of Thyroid Tumors

Brief summary: Somatic mutations in the MAP (mitogen-activated protein) kinase pathway have been found in about 80% of papillary thyroid tumors (PTCs). The evaluation of the PTC mutational profile is crucial for the definition of the prognosis and for predicting the effects of targeted and personalized therapies. Molecular characterization by mass spectrometry (Mass ARRAY) allows the search for multiple mutations in a single experiment, in a sensitive, fast and economic way. A Mass ARRAY platform (PTC-MA) was developed, capable of identifying the presence of the most common somatic point mutations and rearrangements in PTC (Pesenti et al., Endocrine 2017). The aim of the study is to characterize the mutational profile of a large series of papillary thyroid carcinomas (PTC). Tumor samples will be analyzed using our PTC-MA platform. The molecular profile of PTCs will be correlated with the clinical and prognostic characteristics of the patients.


Eligibility criteria: Inclusion Criteria:

* patients with papillary thyroid cancer
* patients whose tumor tissue can be recovered for genetic analysis

Exclusion Criteria:

* patients who did not give consent
* patients lost to follow-up
* tumor samples not suitable for genetic analysis

Primary outcomes:
measure: Mutational profile of PTCs
timeFrame: years 1-8
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
state: MI
Study officials:
affiliation: Istituto Auxologico Italiano-Milan, Italy
name: Laura Fugazzola, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pesenti C, Muzza M, Colombo C, Proverbio MC, Fare C, Ferrero S, Miozzo M, Fugazzola L, Tabano S. MassARRAY-based simultaneous detection of hotspot somatic mutations and recurrent fusion genes in papillary thyroid carcinoma: the PTC-MA assay. Endocrine. 2018 Jul;61(1):36-41. doi: 10.1007/s12020-017-1483-2. Epub 2017 Dec 6.
Clinical trial NCT04164498: Noise in Critical Care Units.Impact on Critically Ill Patients and Healthcare Personnel
Official title: Noise in Critical Care Units.Impact on Critically Ill Patients and Healthcare Personnel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Noise; Adverse Effect
Keywords: Noise ICU
delirium
depression
burnout
music
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study noise level in the ICU and its effect on both patients and healthcare personnel.

Use music and study same effects on same patients and healthcare personnel.

Detailed description: Level of noise is measured and investigate its effects on delirium prevalence. sleep quality score. hemodynamics of patients.

burnout and depressive symptoms of healthcare personnel

Eligibility criteria: Inclusion Criteria:

* patients admitted to ICU fully conscious and can answer the questionnaires of the study

Exclusion Criteria:

* confused patients

Primary outcomes:
measure: sleep quality: Richard Campbell sleep questionnaire
timeFrame: 1 month
measure: delirium
timeFrame: in hospital up to 2 months
measure: Burnout syndrome
timeFrame: 1 month
measure: Depression symptoms
timeFrame: 1 month
Secondary outcomes:
measure: length of stay in icu
timeFrame: in hospital 1 year
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Mohamed Amin Fakher
state: Cairo
Study officials:
References:
Clinical trial NCT01310998: Acute Psychological Effects of High Intensity Exercise With Schizophrenia
Official title: Acute Psychological Effects of High Intensity Exercise in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
high intensity exercise
interval training exercise
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2011-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to study the acute psychological effects in patients with schizophrenia after one session of high intensity exercise.

Detailed description: We will examine if there is an acute effect of one high intensity session of physical exercise (4x4 intervals) on psychological variables state mood, state anxiety, well-being and psychological distress. This possible effect will be examined in three groups, one group being the main group that the other two groups will be compared up against. Group 1: Patients with schizophrenia and other psychotic illnesses. Group 2: people with non-psychotic diagnosis. Group 3: people without any psychological diagnosis.

Eligibility criteria: Inclusion Criteria:

* They will be allocated into groups by their diagnoses

Exclusion Criteria:

* Not being able to complete the exercise

Primary outcomes:
measure: Positive and negative affects
timeFrame: baseline and 2 days postintervention
Secondary outcomes:
measure: state anxiety
timeFrame: baseline and 2 days postintervention
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Treningsklinikken
Study officials:
affiliation: Employee at AFFU at St Olavs Hospital
name: Einar Vedul-Kjelsås, dr.philos
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heggelund J, Kleppe KD, Morken G, Vedul-Kjelsas E. High aerobic intensity training and psychological States in patients with depression or schizophrenia. Front Psychiatry. 2014 Oct 30;5:148. doi: 10.3389/fpsyt.2014.00148. eCollection 2014.