louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06909929: High-Dose Intravenous Lipid for Very Preterm or Very Low Birth Weight Infants Effects on Growth
Official title: Pemberian Lipid Intravena Dosis Tinggi Untuk Bayi Sangat Prematur Atau Berat Lahir Sangat Rendah Terhadap Pertumbuhan
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Very Preterm Birth
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 70
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a RCT study conducted in Cipto Mangunkusumo Hospital in very preterm infants. The investigators compared early intravena lipid start with 2 gram per body weight and 1 gram per body weight and observed the time to reach birth weight.

Detailed description: Neonates with \<32 weeks gestation age or \<1500 gram birth weight gets early intravena lipid start with 2 gram per body weight and 1 gram per body weigh then observed the time to reach birth weight

Eligibility criteria: Inclusion Criteria:

* birth weight below 1500 gram or gestational age below 32 weeks

Exclusion Criteria:

* mayor congenital abnormalities

Primary outcomes:
measure: return to birth weight
timeFrame: day
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: Central Jakarta
Study officials:
affiliation: Cipto Mangunkusumo Hospital, Jakarta, Central Jakarta 10430
name: Putri MT Marsubrin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03639129: Improving Characterization of Calcifications With Contrast-Enhanced Mammography
Official title: Improving Characterization of Calcifications With Contrast-Enhanced Mammography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mammography
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study protocol is to assess whether contrast-enhanced mammography (CEM) will increase the accuracy of characterization of microcalcifications detected on screening mammography prior to biopsy as either benign, high risk, or malignant.


Eligibility criteria: Inclusion Criteria:

* Women with calcifications detected on screening mammogram for which biopsy is recommended following characterization on diagnostic mammography.
* At least 30 years of age.
* Able to understand and willing to sign an IRB-approved written informed consent document
* GFR ≥ 30 mL/min/1.73 m2

Exclusion Criteria:

* Pregnant
* Prior history of allergy or hypersensitivity reaction to iodinated contrast
* History of chronic renal disease (including dialysis, kidney transplant, single kidney, renal cancer, or renal surgery)
* Patients with known thyroid disorders, pheochromocytoma or sickle cell anemia

Primary outcomes:
measure: Evaluate risk characterization of screen-detected calcifications by CEM
timeFrame: Up to 30 days after the CEM
Secondary outcomes:
measure: Rate of detection of additional sites of disease in the same or contralateral breast on CEM
timeFrame: At the time of the CEM (day 1)
measure: Ability of CEM to determine whether accuracy for cancer detection varies as a function of breast density
timeFrame: At the time of the CEM (day 1)
measure: Ability of whether CEM accuracy for cancer detection varies as a function of the morphology of calcifications as depicted on screening and diagnostic mammography
timeFrame: At the time of the CEM (day 1)
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Matthew Covington, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04008329: A Registered Cohort Study on Amyotrophic Lateral Sclerosis
Official title: A Registered Cohort Study on Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis
natural history
genetics
prognostic factors
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALS patients who are diagnosed in the First Affiliated Hospital of Fujian Medical University

Brief summary: Amyotrophic lateral sclerosis (ALS) is a kind of motor neuron degeneration disorder without effective therapy. This registered cohort study will provide further insights into the clinical course of ALS, and investigate disease-relative risk factors and the genetic background of Chinese ALS patients.

Detailed description: Amyotrophic lateral sclerosis (ALS) is the most common form of motor neuron disease (MND), which is characterized with highly clinical heterogeneity and no effective treatment is available now. The purpose of this registered cohort is to observe the natural history of ALS patients in China, and then identify some factors correlated with disease progression. Besides, ALS-related gene mutations will be screened and explore novel disease causing gene as well.

Eligibility criteria: Inclusion Criteria:

* Amyotrophic Lateral Sclerosis patients fulfilling the El Escorial criteria (including definite, probable and possible)
* Progressive muscular atrophy
* Primary lateral sclerosis
* Progressive bulbar palsy

Exclusion Criteria:

* History of serious head trauma or neuropsychiatric disease
* Decline to participate

Primary outcomes:
measure: Age at death
timeFrame: 10 years
measure: Age of endotracheal intubation or tracheotomy
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Ning Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04777929: The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia
Official title: The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phthalate Exposure
Preeclampsia
Estrogen
Progestin
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants include pregnant women meeting the inclusion criteria.

Brief summary: Phthalates are a group of ubiquitous synthetic endocrine-disrupting chemicals. Fetal and neonatal periods are particularly susceptible to endocrine disorders, which prenatal exposure to phthalates causes. There is increasing evidence concerning the potential endocrine disrupting for phthalate exposure during pregnancy. Prenatal exposure phthalates would disrupt the level of sex hormone in pregnant women, which results in preeclampsia. The relationship of prenatal phthalate exposure with maternal and neonatal outcomes in human beings was often sex-specific associations. Because of the potentially harmful influence of prenatal phthalate exposure, steps should be taken to prevent or reduce phthalate exposure during pregnancy.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Term pregnancy with the gestational age of 37-40 weeks

Exclusion Criteria:

* Maternal systemic diseases (hypertension disorders, immunological diseases) or pregnant complications (polyhydramnios, oligohydramnios, diabetes mellitus, intrahepatic cholestasis of pregnancy)
* Delivery before 37 weeks or after 40 weeks

Primary outcomes:
measure: Phthalates in urine
timeFrame: 37 weeks to 40 weeks gestation
Secondary outcomes:
measure: The female progesterone
timeFrame: 37 weeks to 40 weeks gestation
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Ying Hua
role: STUDY_DIRECTOR
References:
Clinical trial NCT01434329: S8600-S9031-S9333-A, Study of DNA in Samples From Patients With Acute Myeloid Leukemia
Official title: S8600-S9031-S9333-A, Identification of Differentially Methylated Genomic Regions That Are Prognostically Significant in AML
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: untreated adult acute myeloid leukemia
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled on S8600, S9031 or S9333 who consented to use of specimens for future research

Brief summary: RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This research trial studies DNA in samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* To identify differentially methylated regions (DMRs) associated with overall survival (OS) of acute myeloid leukemia (AML) patients with normal cytogenetics.
* To develop and evaluate in an independent validation set a prognostic score for OS based on the identified DMR.
* To determine whether the prognostic score can group patients into risk groups based on OS.

OUTLINE: Archived blood or bone marrow samples are analyzed for DNA methylation alterations by CHARM array-based genome assay. Each patient's clinical data is also collected.

Eligibility criteria: DISEASE CHARACTERISTICS:

* De novo acute myeloid leukemia (AML) patients with normal cytogenetics treated with curative therapy who survived at least 28 days after therapy started
* Samples will be taken from the following studies: SWOG-8600, SWOG-9031, SWOG-9333, SWOG-9500, SWOG-S9918, SWOG-S0106, and SWOG-S0112

  * Blood or marrow specimens can be used

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Identification of DMRs associated with OS
timeFrame: immediate
measure: Development and evaluation of a prognostic score of OS based on DMRs identified
timeFrame: immediate
measure: Prognostic score able to group AML patients into risk groups
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Min Fang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06495229: Study of CM310 in Adolescent Subjects With Atopic Dermatis
Official title: A Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of CM310 in Adolescent Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 180
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
* Subjects who must complete the evaluation of Week 18 of the main study.
* With Atopic Dermatitis.

Exclusion Criteria:

* Any major surgery planned during the research period.
* Subjects with potential fertility do not agree to adopt efficient contraceptive measures throughout the entire study period; Pregnant or breastfeeding women, or women planning to conceive or breastfeed during the study period.
* With any circumstance that the subject is not suitable to participate in this study.

Primary outcomes:
measure: Adverse events
timeFrame: up to week 52
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06363929: Continuous Glucose Monitoring in Neonatal Hyperinsulinism
Official title: A Study to Evaluate the Accuracy of Continuous Glucose Monitors in Neonates With Hyperinsulinism.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyperinsulinism
Hypoglycemia Neonatal
Lead sponsor: MemorialCare Health System
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2024-04-12
Enrollment: 15
Sex: ALL
Minimum age (years): 24
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit

Brief summary: The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly.


Eligibility criteria: Inclusion Criteria:

* Age: 0-90 days old
* Gestational Age: \> 28 weeks gestational age
* Diagnosis of hyperinsulinism based on critical sample and/or glucagon challenge

Exclusion Criteria:

* Diffuse skin disease such that placement of a Dexcom G6 sensor would be difficult to secure
* Infants colonized or infected with multi-drug resistant organisms (i.e. MRSA, VRE, ESBL producing bacteria)
* Infants on hypothermic protocols
* Infants expected to remain in the NICU \<24 hours
* Infants enrolled in a competing clinical trial
* Family/team have decided to limit or redirect from aggressive NICU technological support
* Ward of the state

Primary outcomes:
measure: Mean absolute relative difference (MARD)
timeFrame: Through study completion, about 2 years
Secondary outcomes:
measure: Mean absolute difference (MAD)
timeFrame: Through study completion, about 2 years
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Miller Children's Hospital
state: California
Study officials:
References:
Clinical trial NCT00641329: CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD
Official title: Phase III Evaluation of the Safety and Efficacy of CLONICEL (Clonidine HCl Sustained Release) as Add-on to Psychostimulant Medication vs. Psychostimulant Medication Alone in Children and Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Keywords: ADHD
ADD
Attention Deficit Hyperactivity Disorder
Attention Deficit
Clonidine
CLONICEL
Addrenex
Lead sponsor: Addrenex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 198
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a safe and effective add-on to psychostimulant therapy in children and adolescents with attention deficit hyperactivity disorder (ADHD).


Eligibility criteria: Inclusion Criteria:

* Age 6-17 years, inclusive
* Diagnosis of ADHD
* Currently on a stable psychostimulant regimen for ADHD
* Lack of adequate response to stable psychostimulant regimen
* Ability to swallow tablets

Exclusion Criteria:

* Clinically significant illnesses or abnormalities upon evaluation
* Conduct Disorder
* Intolerance to clonidine
* History of seizures or syncope

Primary outcomes:
measure: ADHDRS-IV Total Score
timeFrame: Week 5
measure: Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs
timeFrame: Throughout Treatment and Follow-up Period
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: El Centro
country: United States
state: California
city: Irvine
country: United States
state: California
city: San Diego
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Lauderhill
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Bardstown
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: St. Louis
country: United States
state: Missouri
city: Clementon
country: United States
state: New Jersey
city: Chapel Hill
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: Wharton
country: United States
state: Texas
city: Clinton
country: United States
state: Utah
city: Kirkland
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Addrenex Pharmaceuticals
name: Moise Khayrallah, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05563129: Teaching First Aid and Trauma Management to School Students
Official title: The Importance of Teaching First Aid and Trauma Management to Primary School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma-related Wound
Head Injury
Choking
Nose Bleed
Child, Only
Emergencies
Keywords: first aid training, children
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 192
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This proposal aims to describe research that will utilize first aid in primary education students and will attempt to identify the frequency with which the training should be repeated and the type of trainer who will carry out the training program.

Detailed description: The training concerns courses with theoretical knowledge and practical skills related to first aid. Taking into account children's cognitive and psychological development, students will be trained in the following topics: calling an ambulance, managing bleeding, handling an unconscious patient, drowning, and managing a head injury. Classroom teachers and specialized staff will teach classes. The evaluation of knowledge and skills will be done with a questionnaire. The evaluation will take place before and immediately after the training, two months and seven months after the training.

Eligibility criteria: Inclusion Criteria:

* Students at primary schools and kindergarten, 4-9 years old

Exclusion Criteria:

* Students over 9 years old

Primary outcomes:
measure: Number of participants that know first aid
timeFrame: 1 day pre the training
measure: Number of participants that learnt first aid
timeFrame: 1-day post the training
measure: Comparing the results of the training about the facilitators' performance
timeFrame: 2 months post the training
measure: Number of participants that retain the first aid knowledge
timeFrame: 7 months post the training
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: George Alexiou
Study officials:
References:
Clinical trial NCT01444729: Post Approval Commitment Study
Official title: A Non-Interventional Post Approval Commitment Study To Evaluate The Outcomes Of The Various Treatment Options For Dupuytren's Contracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dupuytren's Contracture
Keywords: 'Dupuytren's contracture'
'xiapex'
'surgery'
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-10-03
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Adults with a palpable cord eligible for the treatment of Dupuytren's contracture

Brief summary: An agreement has been made to conduct a post-approval commitment study that provides supplementary information relating to the use of Xiapex® as well as other non-pharmacological treatments for Dupuytren's contracture by health care professionals in a real world clinical setting.

Detailed description: phase 4, open label, multi-center, prospective non-interventional descriptive

Eligibility criteria: Inclusion Criteria:

* Adults with a palpable cord eligible for the treatment of Dupuytren's contracture

Exclusion Criteria:

none

Primary outcomes:
measure: clinical treatment success as assessed by goniometry
timeFrame: an expected average of 5 weeks
measure: treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires
timeFrame: an expected average of 5 weeks
Secondary outcomes:
measure: Treatment option as determined by treating physician in consultation with patient
timeFrame: at day 1
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Auxilium Investigational Site
city: Drammen
country: Norway
facility: Auxilium Investigational Site
city: Malaga
country: Spain
facility: Auxilium Investigational Site
state: Andalucia
city: Alcorcon
country: Spain
facility: Auxilium Investigational Site
state: Madrid
city: Majadahonda
country: Spain
facility: Auxilium Investigational Site
state: Madrid
city: Pamplona
country: Spain
facility: Auxilium Investigational Site
state: Navarra
city: Valladolid
country: Spain
facility: Auxilium Investigational Site
Study officials:
affiliation: Endo
name: Veronica Urdaneta
role: STUDY_DIRECTOR
References: