louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03227289: Acute Respiratory Distress Syndrome(ARDS) in Neonates
Official title: Pregnancy Risk Factors Promote Conversion From Neonatal Respiratory Distress Syndrome(NRDS) to Acute Respiratory Distress Syndrome(ARDS) : a Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
NRDS
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 28
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The gestational age was less than 37 weeks;

Brief summary: Acute respiratory distress syndrome in neonates has been defined in 2015. Earlier identification and successful intervention into the potential pregnancy associated risk factors for the conversion from NRDS to ARDS is one of the most important components of ARDS prevention.

Detailed description: Pregnancy risk factors (PRF), such as intrahepatic cholestasis during pregnancy(ICP), hypertensive disorder complicating pregnancy(HDCP) and gestational diabetes mellitus(GDM), are related to NRDS, ARDS and subsequent death. Meantime, it has also been proven that the prevention of PRF reduces the risk of NRDS and ARDS. However, few study reported the relations between PRF and the conversion from NRDS to ARDS, and it also remains unknown whether treating PRF can reduce the progression from NRDS to ARDS.

We have found that PRF were related to the increase and deterioration of NRDS in a Chinese cohort. The aims of the present study were: 1). to report the effects of PRF on the conversion from NRDS to ARDS. 2). to clarify whether PRF treatment could prevention from conversion from NRDS to ARDS in a Chinese population.

Eligibility criteria: Inclusion Criteria:

1. The gestational age was less than 37 weeks;
2. These neonates were diagnosed with NRDS; The diagnosis of NRDS was based on clinical manifestations and chest X-ray findings. The clinical signs and symptoms of NRDS were respiratory distress, tachypnea, nasal flaring, groan, and cyanosis after birth. The typical X-ray picture of RDS showed a grain shadow, air bronchogram or white lung.
3. informed parental consent has been obtained

Exclusion Criteria:

1. parents' decision not to participate;
2. major congenital anomalies;
3. died or left the neonatal intensive care unit(NICU) within 24 hour.

Primary outcomes:
measure: the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS
timeFrame: within 28 days
measure: clarify whether PRF treatment could prevention from conversion from NRDS to ARDS
timeFrame: within 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Pediatrics, Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Shi Yuan, PhD,MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04952389: Acupuncture Therapy for COVID-Related Olfactory Loss
Official title: Acupuncture Therapy for COVID-Related Olfactory Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Olfactory Dysfunction
COVID-19
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is looking at the role of acupuncture as a treatment for olfactory dysfunction in patients who tested positive for COVID-19.


Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Patients with post-viral olfactory dysfunction \> 4 weeks.
* History of positive COVID-19 PCR.

Exclusion Criteria:

* Less than 18 years of age.
* Active sinus infection.
* New diagnosis of untreated CRS.
* Prior diagnosis of dementia or Parkinson's disease.
* Prior head trauma or neurosurgical procedure resulting in olfactory loss.
* Patients who do not speak or read English.
* Patients unable to understand and sign the study consent.

Primary outcomes:
measure: Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores
timeFrame: Baseline, post-treatment approximately 12 weeks
Secondary outcomes:
measure: Change in Patient-reported Subjective Olfactory Loss
timeFrame: Baseline, post-treatment approximately 12 weeks
measure: Change in Sino-Nasal Outcome Test (SNOT-22)
timeFrame: Baseline, post-treatment approximately 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Janalee Stokken, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05065489: Resting State Electroencephalogram for Psychotic Disorders
Official title: Self-control, Appetite and Psychotic Diagnose: a Resting State EEG Cross Section Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Bipolar Disorder
Depression
Keywords: electroencephalography
Eating behavior
self control
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were recuited for single center, second xiangya hospital psychiatry department. Both inpatients and outpatients were recuited.

Brief summary: Electroencephalography (EEG) has been proposed as a neurophysiological biomarker to delineate psychotic disorders. Meanwhile, the increased appetite, which might related to self-control process, has been an increasing concern for the management of psychotic disorders. In this cross-section study, investigators collect the resting state EEG data, self-control related scale, eating behaviour questionnaire and psychotic syndrome related assessement and try to find the connection between those measurers, in order to provide novel understanding on the mechanism of psychotic diseases.


Eligibility criteria: Inclusion Criteria:

Diagnosed with schizophrenia or bipolar disorder or MDD in accordance with DMS-5 Informed Consent

Exclusion Criteria:

Diagnosed with other mental disease in accordance with DSM-5 Comorbid with other severe physiological disease Drug or alcohol abuse Pregnant or lactating

Primary outcomes:
measure: resting state EEG
timeFrame: baseline
Secondary outcomes:
measure: Three factor eating questionnaire
timeFrame: baseline
measure: Barratt Impulsivity Scale
timeFrame: baseline
measure: Self-Control Scale
timeFrame: baseline
measure: The positive and negative syndrome scale
timeFrame: baseline
measure: Hamilton anxiety rating scale
timeFrame: baseline
measure: Hamilton depression rating scale
timeFrame: baseline
measure: Young manic rating scale
timeFrame: baseline
Other outcomes:
Locations:
city: Changsha
country: China
facility: Mental Health Institute of 2nd Xiangya Hospital,CSU
state: Hunan
Study officials:
References:
Clinical trial NCT03062189: Binge Drinking Among Youngs is a Risk Factor for Alcohol Use Disorders
Official title: Binge Drinking Among Young Students is a Risk Factor for the Development of Alcohol Use Disorders: Results From an Epidemiologic-observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Binge Drinking
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 2704
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 2,704 subjects attending high school in three italian cities

Brief summary: The purpose of this study was to assess drinking habits and patterns of alcohol consumption, smoking habits, use of illicit drugs and the prevalence of binge drinking and alcohol use disorders among Italian young students. Furthermore to investigate the correlation between binge drinking and alcohol use disorders.

Detailed description: This study was performed on 2,704 subjects attending high school, through the administration of questionnaires regarding socio-demographic data, anthropometric characteristics, pattern and amount of alcohol intake, smoking habits, use of illicit drugs and physical activity were administered to students. Moreover mood and anxiety were evaluated through AUDIT, STAI-Y1, STAY-Y2 and ZUNG. The aim of the study was to assess drinking habits and patterns of alcohol consumption, smoking habits, use of illicit drugs and the prevalence of binge drinking and alcohol use disorders among Italian young students. Furthermore to investigate the correlation between binge drinking and alcohol use disorders.

Eligibility criteria: Inclusion Criteria:

* Subjects attending high school of three italian cities (Rome, Latina, Frosinone)
* Subjects aged between 13 and 19 years
* Subjects that accept the interview

Exclusion Criteria:

* Subjects that don't accept the interview

Primary outcomes:
measure: Binge drinking behavior
timeFrame: 1 year
Secondary outcomes:
measure: Amount of alcoholic beverage consumed
timeFrame: 1 year
measure: Type of alcoholic beverage consumed
timeFrame: 1 year
measure: Frequency of alcohol consumption
timeFrame: 1 year
measure: Alcohol consumption outside meals
timeFrame: 1 year
measure: Frequency of alcohol drinking outside meals
timeFrame: 1 year
measure: Amount of cigarettes smoked
timeFrame: 1 year
measure: Frequency of cigarettes smoked
timeFrame: 1 year
measure: Type of illicit drugs used
timeFrame: 1 year
measure: Frequency of illicit drugs used
timeFrame: 1 year
measure: Diagnosis of Alcohol Use Disorder
timeFrame: 1 year
measure: STAI score
timeFrame: 1 year
measure: Zung-SDS
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Catholic University of Sacred Heart, Rome
name: Giovanni Addolorato, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01560689: Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation
Official title: Open-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchiolitis Obliterans
Allogeneic Stem Cell Transplantation
Keywords: bone marrow transplantation
obstructive lung disease
bronchodilators
inhaled steroids
late-onset pulmonary complication
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether inhaled Budesonide/formoterol is effective in the treatment of bronchiolitis obliterans after allogeneic stem cell transplantation.

Detailed description: Bronchiolitis obliterans (BO) is a life-threatening pulmonary late-onset complication following allogenic stem cell transplantation (SCT), commonly attributed to graft versus host disease (GVHD), and carries a poor prognosis. Although immunosuppressive treatments (IS) represents the main therapeutic approach in this disorder, these medications are rarely efficient and alternative approaches are strongly needed. Because, the combination of inhaled steroids and long-acting bronchodilator are known to decrease respiratory symptoms, prevent exacerbations and improve lung function in chronic obstructive pulmonary diseases with bronchiolar component, they may have beneficial effects in BO. Thus, the investigators conducted a pilot open-labeled trial to evaluate the therapeutic effects of inhaled Budesonide/Formoterol combination (400/12 µg twice a day) without modifying systemic IS received by the patients.

Eligibility criteria: Inclusion Criteria:

* adult allogeneic stem cell transplant recipients with clinical respiratory signs assumed to be secondary to BO, without extra-thoracic extensive graft versus host disease

Exclusion Criteria:

* Extensive extra thoracic GVH necessitating increasing immunosuppressive treatments

Primary outcomes:
measure: pulmonary function tests
timeFrame: 1 month
measure: Dyspnea based on NYHA classification
timeFrame: 1 month
Secondary outcomes:
measure: pulmonary function test
timeFrame: 7 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Saint Louis APHP
Study officials:
affiliation: Pneumology Department, Hopital Saint Louis
name: bergeron-lafaurie Anne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05517889: Repeatability and Stability of Healthy Skin Features on OCT
Official title: Assessing the Stability and Repeatability of OCT Features in Healthy Skin: a Test-retest Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optical Coherence Tomography
Artificial Intelligence
Radiomics
Keywords: Optical coherence tomography
OCT
Artificial intelligence
AI
Radiomics
Test-retest
Imaging
Dermatology
Skin
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University (Precision medicine The D-lab)
First posted: 2022-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 30 healthy volunteers (colleages from the department of dermatology (MUMC+) and precision medicine (UM) will be asked to participate in this study. They must have at least three naevi.

Brief summary: A test-retest study on the stability and repeatability of healthy skin features on OCT


Eligibility criteria: Inclusion Criteria:

* At least18 years of age

Exclusion Criteria:

* Unable to sign informed consent

Primary outcomes:
measure: Repeatable hand-crafted radiomics-features
timeFrame: Interval of 10 minutes
measure: Interclass Correlation Coefficient (ICC)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
Study officials:
References:
Clinical trial NCT03868189: Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial
Official title: Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electromyoneurography
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Echo-nerve tracking during an electroneuromyographic (ENMG) examination by identifying the optimal stimulation site would reduce the stimulation intensities delivered to the patient and thus improve the tolerance of this examination.


Eligibility criteria: Inclusion Criteria:

* Patient requiring an electroneuromyogram whose indication allows the application of a standard protocol of examination.
* Patient that has given his/her free and informed consent.
* Patient that signed the consent form.
* Patient with an health insurance plan.
* The patient is at least 18 years old (≥).
* he patient is under 80 years old (≤).

Exclusion Criteria:

* Patient with symptoms of neuropathy during the screening.
* Patient whose Neurological severity score (NSS) score is ≥ 3.
* Patient whose neurological examination is abnormal and suggestive of neuropathy.
* Patient presenting a pathology that could cause neuropathy (e.g. diabetes, renal failure, etc.).
* Patient already participating in a category 1 research study (Jardé law).
* Patient in an exclusion period determined by another study.
* Patient under the protection of justice, under guardianship or under curatorship.
* Patient refusing to sign the consent form.
* Patient for which it is impossible to provide information about the study.
* Pregnant patient, parturient, or breastfeeding.

Primary outcomes:
measure: Supra-maximal stimulation intensity delivered by stimulation site on sensory nerves
timeFrame: Day 0
Secondary outcomes:
measure: Supra-maximal stimulation intensity delivered by stimulation site on the motor nerves
timeFrame: Day 0
measure: Sensitivity Amplitude per collection site
timeFrame: Day 0
measure: Motor Amplitude per collection site
timeFrame: Day 0
measure: Total number of explored muscles
timeFrame: Day 0
measure: Number of explored unusual muscles
timeFrame: Day 0
measure: Overall examination time between the beginning of the stimulation and the end of the myography examination
timeFrame: Day 0
measure: Average time per explored site (total duration divided by the number of explored nerves and muscles)
timeFrame: Day 0
measure: Score of satisfaction
timeFrame: Day 0
measure: Measurement of felt pain
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nîmes University Hospital
city: Nîmes
country: France
facility: CHU Nîmes
Study officials:
affiliation: Nîmes University Hospital
name: Sarah COUDRAY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05871489: Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens
Official title: Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens Through Improved Epidemiologic Methods
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Tuberculosis, Multidrug-Resistant
HIV
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Partners in Health
name: Socios En Salud Sucursal, Peru
First posted: 2023-05-23
Enrollment: 800
Sex: ALL
Minimum age (years): 0
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will prospectively follow an observational cohort patients with confirmed MDR-TB who initiate one of the following MDR-TB regimens of interest: (1) an individualized 18-24 month all-oral regimen containing BDQ and/or DLM, designed according to 2019 WHO guidance (Lesotho); or (2) a standardized, shortened all-oral regimen containing BDQ or DLM.

Brief summary: This is a multisite prospective cohort study of patients with multidrug- or rifampin-resistant tuberculosis who are treated with an all-oral shortened regimen under routine program conditions in one of three countries (Peru, Lesotho, Kazakhstan).


Eligibility criteria: Inclusion Criteria:

* All patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an all-oral treatment regimen (short or long) under routine or operational conditions, per local country guidance, will be included.

Exclusion Criteria:

* Exclusions are based on local guidance in each country. Currently, individuals with fluoroquinolone resistant tuberculosis are excluded from all-oral shortened treatment.

Primary outcomes:
measure: End-of-treatment outcome
timeFrame: 9-12 months after treatment initiation
measure: Final tuberculosis treatment outcome
timeFrame: 6-24 months after treatment completion
measure: Adverse events of interest
timeFrame: Tuberculosis treatment, an average of 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Partners In Health, Kazakhstan
city: Maseru
country: Lesotho
facility: Partners In Health, Lesotho
city: Lima
country: Peru
facility: Socios En Salud
Study officials:
References:
Clinical trial NCT01671189: Automated SMS-Based Appointment Validation Tool
Official title: An Automated SMS-Based Reminder and Rescheduling Tool to Improve Appointment Adherence Rates and Glycemic Control Among Diabetes Patients in San Mateo County
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus Type 2
Adult-onset Diabetes
Lead sponsor: Medic Mobile
Sponsor class: INDUSTRY
Collaborators: name: San Mateo Medical Center
First posted: 2012-08-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Medic Mobile conceptualized and proposed the creation of an SMS-based appointment validation tool to automate appointment confirmation and rescheduling. Working in parallel with the San Mateo Medical Center (SMMC) electronic medical records (EMR) system, the software tool will automate reminders that request text responses from patients to either confirm or request to reschedule their upcoming appointments. While simple in concept, this tool aims to free up scarce clinical resources which are currently allocated to daily patient phone call reminders. With funding from a Bay Area foundation, the investigators will develop and pilot this open-source software tool in a 12-month randomized-controlled trial, slated to begin in October 2012. The endpoints of the study will aim to demonstrate improvements in both appointment adherence and glycemic control.


Eligibility criteria: Inclusion Criteria:

* Belong to Willow Clinic or Fair Oaks Clinic under the San Mateo Medical Center
* Have a diagnosis of type 2 diabetes as indicated by ICD-9 code of 249.xx or 250.xx
* Have a most recent hemoglobin A1c (HbA1c) level greater than 7%
* Are at least 18 years of age
* Have access to cell phone
* Are literate or live with a friend/family member who is literate and willing to handle associated text messages

Exclusion Criteria:

* Have a terminal illness and prognosis of less than one year
* Are unable to demonstrate the ability to reply to an SMS and lack an appropriate proxy
* Are pregnant or expect to be pregnant in the next 6-9 months

Primary outcomes:
measure: Glycemic Control (hemoglobin A1c)
timeFrame: 6-9 months post-enrollment
Secondary outcomes:
measure: Appointment Adherence Rate
timeFrame: 6-9 month post-enrollment
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: San Mateo Medical Center
state: California
Study officials:
affiliation: Medic Mobile
name: Nadim Mahmud
role: PRINCIPAL_INVESTIGATOR
References: