louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04086628: Influenza Vaccine in Children With Asthma
Official title: Evaluation of the Immunization Coverage Against Influenza in Children With Asthma Followed at the Hospital of Nancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma in Children
Influenza Vaccine
Immunization Coverage
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with asthma

Brief summary: The occurence of influenza can be a factor of imbalance of asthma. Asthma patients are recommended for annual influenza vaccination . However there is insufficient vaccination coverage of asthmatic patients despite this recommendation. The aim of this study is to evaluate the rate of influenza vaccination coverage of children with asthma aged from 6 month to 17 years of age followed in pediatric pneumology consultation at the university hospital of Nancy.

Detailed description: Using a questionnaire, the investigator will estimate the percentage of the asthmatic patients vaccinated against influenza. He will then compare the 2 groups of vaccinated and unvaccinated patients : comparison of patients characteristics, comparison of asthma characteristics (severity, asthma control...). He will also analyze the causes of vaccination or non-vaccination.

Eligibility criteria: Inclusion Criteria:

* asthmatic patients followed in pediatric pneumology consultation at university hospital of Nancy aged from 6 months to 17 years

Exclusion Criteria:

* asthmatic children who have been followed for less than 1 year

Primary outcomes:
measure: Percentage of asthmatic patients vaccinated against influenza
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Socio-demographic characteristics of patients
timeFrame: through study completion, an average of 6 months
measure: Age of patients (years)
timeFrame: through study completion, an average of 6 months
measure: Asthma severity (mild, moderate, severe asthma)
timeFrame: through study completion, an average of 6 months
measure: Asthma symptom control (well controled, partly controlled, uncontrolled)
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHRU nancy
name: Aurore Blondé, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03443128: Vinorelbine for Recurrent ALCL-2017
Official title: Phase II Study of Vinorelbine for Children with Recurrent Anaplastic Large Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anaplastic Large Cell Lymphoma
Vinorelbine
Keywords: Anaplastic Large Cell Lymphoma
Recurrent
Childhood
Adolescent
Treatment
Lead sponsor: Children's Cancer Group, China
Sponsor class: NETWORK
First posted: 2018-02-22
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficiency and safety of vinorelbine in the treatment of relapsed / advanced ALCL in children and adolescents.

Detailed description: Anaplastic large cell lymphoma (ALCL) is a rare non-Hodgkin's lymphoma, around 30% patients would get relapse. Vinorelbine(Navelbine) is a third-line treatment option for Hodgkin's disease(HD) after transplantation failed, while both HD and ALCL express CD30. When ALCL recurred, vinblastine monotherapy was used and the 5-year EFS up to 30%, 5-year OS up to 60%. In China vinblastine is unavailable. Vinorelbine is very similar to vinblastine in molecular formula, and is available in China. From November 2016 to March 2017, two patients with recurrent ALCL were recruited in the Department of Hematology and Oncology, Shanghai Children's Medical Center. They received vinorelbine monotherapy and achieved clinical remission (PET CR) at 8 weeks. One patient with bone marrow recurrence showed negative ALK / NPM by PCR . Based on this, the investigators will expand the sample to further investigate the therapeutic efficiency and safety of vinorelbine in children and adolescents with ALCL.

Eligibility criteria: Inclusion Criteria:

Children and adolescents with a clear diagnosis of recurrent / progressive ALCL at Shanghai Children's Medical Center or other centers since September 2017 include:

Diagnosed as ALCL, already received first-line treatment, but get disease progression; After receiving ALCL treatment has got CR then diagnosed relapse, need for pathological diagnosis.

Exclusion Criteria:

Patients with other systemic diseases, severe infections or critically illness.

Primary outcomes:
measure: Progression Rate
timeFrame: 4 weeks
measure: CR/CRu Rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
measure: Safety statistics: adverse reactions during the trial through NCI CTCAE version 4.0.
timeFrame: 2 years
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Yijin Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01567228: Delivering Geospatial Intelligence to Health Care Providers
Official title: Delivering Geospatial Intelligence to Health Care Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: obesity
overweight
dental caries
school problems
school failure
child BMI > 85th percentile
Needing dental preventive services
Needing academic support for school problems
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2012-03-30
Enrollment: 1076
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Physician counseling for physical activity, dental services, and academic support services such as tutoring could be improved through physician knowledge of local community resources and physician counseling directing patients to such services that are near the patient's residential address. This study will test the hypothesis that an electronic medical record enhanced with geographic information systems can improved physician counseling for physical activity, dental services, and academic support services by identifying services that are near the patient's residential address and informing MD's of such info at the point of care.


Eligibility criteria: Inclusion Criteria:

* Referrals to three community resources will be studied: dentists (children older than 1 year), after school tutoring services (children older than 7 years), and physical education programs (children older than 5 years).

Exclusion Criteria:

* Inability of parent to complete data collection instruments spoken (via telephone survey) or written in English or Spanish.
* Inability to participate in community based physical activity programs due to health related condition

Primary outcomes:
measure: Improved physician counseling
timeFrame: 6 months
Secondary outcomes:
measure: User experience and satisfaction
timeFrame: 24 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Wishard Health Services
state: Indiana
Study officials:
affiliation: Indiana University
name: Gilbert C Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03730428: Everolimus Related Pneumonitis in MBC
Official title: Drug-related Pneumonitis During mTOR Inhibitor Therapy in Patients With Metastatic Breast Cancer: A Radiographic Patternbased Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Everolimus
Pneumonitis
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

Brief summary: To study the drug-related pneumonitis during mTOR inhibitor therapy in patients with metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Postmenopausal woman (or premenopausal women treated with LHRHa) diagnosed with HR+，HER2- metastatic breast cancer
2. Treated with everolimus for at least one month in metastatic setting
3. With baseline and at least one follow-up chest CT during everolimus therapy.
4. Complete medical history

Exclusion Criteria:

1. Incomplete medical history
2. Radiographic imaging unavailable

Primary outcomes:
measure: radiographic pattern
timeFrame: 2 months
measure: PFS
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01512628: Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty
Official title: Hemostatic Changes After Colloid Fluid Administration During Total Hip Replacement Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Avascular Necrosis of Hip
Total Hip Replacement Arthroplasty
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators administered different kinds of colloids before transfusion of red blood cell to patient undergoing total hip replacement arthroplasty. The investigators will compare the differences of changes in rotational thromboelastometry (ROTEM) data among them.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as avascular necrosis of hip and undergoing total hip replacement arthroplasty

Exclusion Criteria:

* hematologic disease
* anticoagulant medication
* preoperative hemoglobin \< 10 g/dl
* renal disease
* pulmonary disease (pulmonary edema, effusion)
* cardiovascular disease (coronary heart disease, congestive heart failure)

Primary outcomes:
measure: INTEM parameters change from preoperative values at post-operation
timeFrame: 30 minutes before operation and 30 minutes after operation
measure: EXTEM parameters change from preoperative values at post-operation
timeFrame: 30 minutes before and 30 minutes after operation.
measure: FIBTEM parameters change from preoperative values at post-operation
timeFrame: 30 min before and 30 min after operation
Secondary outcomes:
measure: Infused total fluid volume
timeFrame: Participants will be followed for the duration of THRA operation in operating room, an expected average tiem of 3 hours
measure: Hemoglobin
timeFrame: 30 minutes before operation and 30 minutes after operation
measure: postoperative blood loss
timeFrame: postoperative 1 day and 2 day
measure: Hematocrit
timeFrame: 30 minutes before operation and 30 minutes after operation
measure: Platelet
timeFrame: 30 minutes before operation and 30 minutes after operation
measure: Prothrombin Time-Internatiolnal Normalized Ratio
timeFrame: 30 minutes before operation and 30 minutes after operation
measure: Activated Partial Thrombin Time
timeFrame: 30 minutes before operation and 30 minutes after operation
measure: electrolytes
timeFrame: 30 minutes before operation and 30 minutes after operation
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyounggi
Study officials:
References:
Clinical trial NCT03777228: Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study
Official title: Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Traumatic Brain Injury
Keywords: Traumatic brain injury, concussion, eye tracking, EEG, fMRI, DTI, Neurocognition
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
First posted: 2018-12-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited through USUHS, the Walter Reed National Military Medical Center, the National Intrepid Center of Excellence, Malcolm Grow Medical Center, the Washington DC VA Medical Center, VA outpatient treatment centers and Vet Centers in the greater Washington, D.C. area, Fort Belvoir, Fort Detrick and Fort Meade, public areas in the surrounding community, and in clinical settings such as such as concussion clinics, neurorehabilitation centers, and other local private practices.

Brief summary: This study was conducted to develop and validate integrated eye tracking and EEG measures for assessment of mild traumatic brain injury.


Eligibility criteria: Inclusion Criteria:

* age 18 -55, ability to use left and right hands and right foot to complete cognitive and motor tasks without adaptive equipment, and fluent in English

Exclusion Criteria:

* history of severe TBI, history of neurological illness unrelated to TBI, vision problems that are uncorrected by contacts or glasses, history of psychotic disorder, or current homicidal or suicidal ideation or intent

Primary outcomes:
measure: Saccadic RT
timeFrame: 1 day (single time point)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02829593: Measurement of Glucose Metabolism in Humans: Effect of Recurrent Hypoglycemia on Hypothalamic GABA
Official title: Measurement of Glucose Metabolism in Humans Using Magnetic Resonance at 7 Tesla: Effect of Recurrent Hypoglycemia on Hypothalamic GABA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Healthy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: You are invited to participate in a study designed to investigate the effects of diabetes mellitus, high and low glucose, and high blood insulin on the brain. You were selected as a possible participant because you fit into one of the following categories. a) you are either healthy and competent, are not pregnant and you have no known medical disease and therefore your glucose metabolism will be typical of a normal person, or b) you have diabetes.

Detailed description: Glucose is a major fuel for most organs in the human body, particularly the brain. How and where the body uses glucose is regulated by a number of hormones, for instance insulin and glucagon. In a number of diseases, in particular diabetes mellitus, the glucose supply to the brain may be different than normal, which may be a cause for reduced glucose awareness.

The purpose of this study is to determine the effects of altered glucose metabolism on the brain. For example, patients with long duration diabetes mellitus lose their ability to secrete the hormones necessary to protect them against hypoglycemia, which may be due to alterations in glucose availability to the human brain.

To measure these effects, we will use intravenous infusions of glucose and insulin.

Eligibility criteria: Inclusion Criteria:

* well controlled type 1 diabetes (hemoglobin A1c \<7.5%)
* age 18-65
* healthy controls

Exclusion Criteria:

* history of stroke, seizures, neurosurgical procedures, or arrhythmias
* use of drugs that can alter GABA metabolism (such as benzodiazepines).
* Subjects must also meet requirements for a study in the magnet, which includes weight less than 300 lbs and the absence of metallic substances in their body.

Primary outcomes:
measure: Change in Euglycemic GABA level in hypothalamus using MRI
timeFrame: Baseline to 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT03890393: A Clinical Observation on Electrophysiology in Headache Patients With Myofascial Trigger Points
Official title: Muscle Activity of Pericranial Muscles in Patients With Episodic or Chronic Headache vs Asymptomatic Controls: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myofascial Trigger Points
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients were recruited from the headache clinic of Neurology in the first affiliated hospital of Nanjing Medical University from January/2018 to October/2018. Their diagnosis of headache were made according to the third edition of International Classification of Headache Disorders (ICHD-III).

Brief summary: Through an observational, cross-sectional study, muscle activity was compared among 21 subjects with episodic headache, 17 subjects with chronic headache and 17 age-matched healthy controls. Muscle activity was bilaterally tested with needle electromyography at rest status, targeting at myofascial trigger points (MTrPs) in the frontal, temporal, sternocleidomastoid (SCM), splenius capitis, splenius cervicis and trapezius of each subject. Headache characteristics (intensity, frequency and duration), McGill Pain Questionnaire (MPQ) and Digital Span (DS) scales were secondary outcomes. The correlation between muscle activity and headache characteristics was also analyzed.

This study provides preliminary evidence of the relationship between muscle and the chronicity of headache.


Eligibility criteria: Inclusion Criteria:

1. Have at least one onset of headache in the last week,
2. Aged between 18-65 years,
3. No special treatment or invasive test on pericranial muscles in the last month, and no painkillers or muscle relaxants in the last week.

Exclusion Criteria:

1. History of surgery, trauma, tumor and spinal disease affecting the head and neck,
2. Being unable to cooperate with inspection and questionnaires for any reason (severe systemic disease, bleeder, communication barriers and so on),
3. People with definite mental disorders such as anxiety and depression.

Primary outcomes:
measure: Pericranial muscle activity
timeFrame: On the day the participant was enrolled
Secondary outcomes:
measure: Short Form of the McGill Pain Questionnaire(SF-MPQ)
timeFrame: Immediately after the enrollment
measure: Digital Span Test
timeFrame: Immediately after the enrollment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Wan Qi
role: STUDY_CHAIR
References:
Clinical trial NCT02160093: Impact of Chronic Disease Control and Aging Psychology on Outcomes of Frailty-Sarcopenia Syndrome in Ambulatory Geriatric Patients
Official title: Impact of Chronic Disease Control and Aging Psychology on Outcomes of Frailty-Sarcopenia Syndrome in Ambulatory Geriatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ambulatory Geriatric Outpatients at High Risk of Frailty
Keywords: sarcopenia
frailty
chronic disease control
aging psychology
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 151
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory geriatric outpatients aged 65 and over from NTUH

Brief summary: Pursuant to our previous longitudinal study (ClinicalTrials.gov ID: NCT02073370) in geriatric outpatients cooperated with the Department of Family Medicine, Department of Geriatrics and Gerontology, National Taiwan University Hospital, this study will be conducted to examine the impacts of the specific co-morbidities and ageing psychology on the outcomes of frailty/sarcopenia syndrome. The thresholds of specific chronic disease will be reviewed after frailty being considered in the elderly with co-morbidity condition. In addition, the conceptual framework and corresponding measuring instrument of "mental frailty" will be expected developed.


Eligibility criteria: Inclusion criteria : compatible one of following conditions

* functional decline in recent one year
* cognitive function decline
* depressive symptom
* mobility impairment
* fall in recent one year
* eating or feeding problems/weight loss
* co-morbid conditions≧5
* tracking by different physician ≧3 in recent half year
* polypharmacy≧8 in recent 3 months
* hospitalization ≧1 in recent one year
* emergency visits≧2 in recent one year
* aged ≧ 80

Exclusion criteria:

* non-ambulatory (bed-ridden) patients
* long-term residents at nursing homes
* patients with a life expectancy shorter than six months
* impairment in vision, hearing, or communicative ability
* making convenience of clinical evaluation during the study period impossible.

Primary outcomes:
measure: Operation instrument of mental frailty for older adults
timeFrame: Up to 2 years
Secondary outcomes:
measure: Compare the well chronic disease control and inappropriate condition on the dynamic frail transitions in ambulatory geriatric outpatients
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University, College of Medicine
name: Ching-Yu Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: