louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03664648: DV2-HBV-27: Observational Pregnancy Registry
Official title: HEPLISAV-B Pregnancy Registry: An Observational Study on the Safety of HEPLISAV-B Exposure in Pregnant Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pregnant
Keywords: Pregnant
Conceived
HBV Vaccine
Hepatitis B
Hepatitis B vaccine
HBV
Hepatitis
Registry
Prevention
Female volunteers
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
Collaborators: name: PPD, Part of Thermo Fisher Scientific
First posted: 2018-09-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women 18 years of age or older exposed to HEPLISAV-B within 28 days of conception or at any time during pregnancy.

Brief summary: Purpose of the study is to evaluate pregnancy outcomes among women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* HEPLISAV-B exposure within 28 days prior to conception or at any time during pregnancy

Exclusion Criteria:

* Less than 18 years of age
* HEPLISAV-B exposure greater than 28 days prior to conception

Primary outcomes:
measure: Rate of Major Congenital Malformations in Live-Born Infants.
timeFrame: Live-born infants will be followed to 12 months of age
measure: Rate of Still Births, Pre-Term, or Fetal Loss (Including Spontaneous Abortion) of any Gestational Age
timeFrame: Follow-up will end at the time of pregnancy outcome up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: PPD Registry Office, Recruiting Nationwide
state: North Carolina
Study officials:
References:
Clinical trial NCT01580748: Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Symptomatic Bronchiectasis
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is currently no effective treatment of bronchiectasis other than treating its complications such as infection, bleeding, etc. Roflumilast is a newly developed anti-inflammatory drug that has proven to be effective in stable COPD. We hypothesized that Roflumilast might be effective in symptomatic bronchiectasis patients


Eligibility criteria: Inclusion Criteria:

* Bronchiectasis on CT
* chronic (\>3 months) cough or sputum

Exclusion Criteria:

* needs hospitalization
* life expectancy of less than six months
* pregnancy or breast feeding
* history of acute respiratory infection within 4 weeks
* history of taking antibiotics within 4 weeks
* active hemoptysis
* %predicted FEV \< 30%
* severe liver disease (Child Pugh Class B or C)

Primary outcomes:
measure: change of CASA-Q score
timeFrame: 16 weeks
Secondary outcomes:
measure: change of FEV1
timeFrame: 16 weeks
measure: change of FVC
timeFrame: 16 weeks
measure: alanine transaminase
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeongi-do
Study officials:
References:
Clinical trial NCT04448548: Possible Roles of MDW in Infection Management in Emergency Care
Official title: Possible Roles of MDW in Infection Management in Emergency Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Sepsis
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult (18+ years), receiving care for suspected infection

Brief summary: A retrospective study to determine the potential value of MDW among other biomarkers in the diagnosis of infection.

Detailed description: MDW as a novel indicator can be useful in clinical practice in the emergency care. However, until now, no study has been published about MDW's general relationship and coherence with multiple, conventional laboratory tests for infections, such as PCT, C-reactive protein (CRP), WBC, neutrophil count (NC), neutrophil percentage and immature granulocyte count (IGC) together.

Eligibility criteria: Inclusion Criteria:

* adult (18+ years), receiving care for suspected infection

Exclusion Criteria:

* refuses to sign the consent form

Primary outcomes:
measure: MDW cutoff value for infection
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged, Emergency Department
Study officials:
References:
Clinical trial NCT01897948: The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children
Official title: The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Measurement of Docosahexaenoic Acid Levels in Pre-school Children
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: University of Kansas
name: John Colombo, PhD, The University of Kansas
First posted: 2013-07-12
Enrollment: 18
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate the relation to cognitive outcomes.


Eligibility criteria: Inclusion Criteria:

* Child is 3 years of age ± 90 days
* Weight for length is within 10th to 90th percentile as plotted on WHO growth charts
* Parent/caregiver reports that child consumes at least 6 oz of cow milk or cow milk-based beverages on a daily basis
* Parent is willing to exclude sources of DHA from child's diet during the study
* Parent agrees not to give vitamins to child during the study
* English is the primary language in the home
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* Gestational age at birth ≤ 36 weeks
* History of neuro/psychiatric conditions
* History of underlying metabolic or chronic disease
* Child is ill, has used antihistamines or diagnosed with an infection at time of cognitive testing
* History of suspected or known cow milk protein intolerance
* Child's diet contains sources of supplemental DHA more than one time per week
* Child is from a multiple birth and the sibling(s) are living in the same household
* Child is enrolled in another interventional clinical research study
* Use of antihistamines within 12 hours of cognitive testing

Primary outcomes:
measure: Red Blood Cell phospholipid weight percent of Docosahexaenoic Acid
timeFrame: 6 months
measure: Cognitive Measures - Executive Function, Language Development, and Behavior Assessment
timeFrame: 6 months
Secondary outcomes:
measure: Fatty Acid Desaturase (FADS) genotypes
timeFrame: Once
measure: Plasma Vitamin D levels
timeFrame: 6 months
measure: Iron levels in the blood
timeFrame: 6 months
measure: Blood Pressure
timeFrame: 6 months
measure: Heart Rate
timeFrame: 6 months
measure: Height and Weight
timeFrame: 6 months
measure: Recall of dietary intake at each study visit
timeFrame: 6 months
measure: Parental Product Assessment Questionnaire completed at Study Visit 2
timeFrame: once
measure: Medically-confirmed adverse events collected throughout the study period
timeFrame: 6 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Universty of Kansas Medical Center
state: Kansas
Study officials:
affiliation: Mead Johnson Nutrition
name: Carol Lynn Berseth, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02599948: FRench-speAking Icu (Intensive Care Unit) Nutritional Survey
Official title: FRench-speAking Icu (Intensive Care Unit) Nutritional Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Units (ICUs)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 1215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults hospitalized patients in ICU

Brief summary: Assessment of nutritional practices in french intensive care units.

Detailed description: Assessment of nutritional practices in french intensive care units.

Eligibility criteria: Inclusion Criteria:

* Adults hospitalized patients in intensive care units for an expected period of stay\> 3 days

Exclusion Criteria:

* Refuse to participate in the Protocol

Primary outcomes:
measure: Frequency of patients receiving parenteral nutrition within the first 10 days after ICU admission
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Pardo E, Lescot T, Preiser JC, Massanet P, Pons A, Jaber S, Fraipont V, Levesque E, Ichai C, Petit L, Tamion F, Taverny G, Boizeau P, Alberti C, Constantin JM, Bonnet MP; FRANS study group. Association between early nutrition support and 28-day mortality in critically ill patients: the FRANS prospective nutrition cohort study. Crit Care. 2023 Jan 7;27(1):7. doi: 10.1186/s13054-022-04298-1.
Clinical trial NCT03629548: Comparing Foley Catheter Balloon With Early Amniotomy for Induction of Labor at Term
Official title: Comparing Combined Foley Catheter Balloon and PGE2 Vaginal Ovule With Early Amniotomy and PGE2 for Induction of Labor at Term: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced Vaginal Delivery
Keywords: dinoprostone
early amniotomy
labor induction
foley bulb
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the intervention for induction of labor with low bishop scores . One group will be induced by transcervical Foley catheter balloon and vaginal PGE2 and other group will be induced by early amniotomy and PGE2 vaginal ovule for induction of labor at term.

Detailed description: An unfavorable cervix during induction decreases the success rate of labor induction and vaginal delivery. Therefore it is required to apply cervical ripening methods for unfavorable cervices. Application of transcervical Foley catheter is an effective mechanical method and has the advantages of lower cost and lowest rate of fetal heart rate changes due to tachysystole compared with PGE1 and PGE2. Despite the advantages of mechanical methods, PGE1 and PGE2 are reported to be more effective than mechanical methods to achieve vaginal delivery within 24 hours. Although there are a lot of studies comparing PGE1, PGE2 and transcervical Foley balloon catheter separately and PGE1 combined with transcervical Foley balloon catheter, less is known about combined usage of PGE2 and transcervical Foley balloon catheter. Early amniotomy is another effective method to ripen cervix. we aim to evaluate which method is superior to another.

Eligibility criteria: Inclusion Criteria:

1. singleton pregnancy,
2. gestational age ≥37 weeks,
3. intact membranes,
4. cephalic presentation,
5. bishop score ≤5,
6. had obstetrical indications for induction of labor,
7. had less than three uterine contractions in every 10 minutes.

Exclusion Criteria:

1. Patients who had contraindications for vaginal delivery,
2. previous uterine surgery,
3. fetal malpresentation,
4. multifetal pregnancy,
5. more than three contractions in 10 minutes,
6. contraindications to prostaglandins,

Primary outcomes:
measure: induction-to- delivery time
timeFrame: from the beginning of induction until the labor
Secondary outcomes:
measure: induction-to-active phase of labor time
timeFrame: from the beginning of induction until the labor
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Education and Research Hospital
state: Uskudar
Study officials:
affiliation: Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey
name: ahmet eser, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01073748: The Effect of Single Dose Paracetamol on the Lower Airways of Asthmatic and Healthy Children
Official title: The Effect of Paracetamol on Lower Airway Obstruction in Asthmatic Versus Non Asthmatic Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Asthma
Acetaminophen
paracetamol
FeNO
Spirometry
Lung function
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Asthma is a common inflammatory airway disease. Several researches have demonstrated a possible connection between asthma and exposure to paracetamol.

Our hypothesis is that even a single dose of paracetamol is sufficient to cause a measurable change in lung functions.

This trial aims to identify a possible effect of single dose paracetamol on lower airway function.

Detailed description: Asthma is a common inflammatory airway disease and its prevalence is on the rise all around the world, Most significantly in children under 5 years.

Paracetamol is one of the most common drugs used with children at thus age groups and several studies have proved a causative connection between exposure to paracetamol and asthma prevalence as well as other allergic conditions.

The mechanism is presumably by reduction of glutathione level, resulting in oxidative burst and formation of reactive oxygen species (ROS).

In addition, paracetamol maybe directly cytotoxic to pneumocytes if given in overdose.

The goal of this research is to identify and quantify the effect of single dose of paracetamol on lung functions of asthmatic and healthy subjects.

The study group will include 40 children aged 7-16 years, who are known to have asthma and a control group of 20 healthy children.

The children will be randomized to receive a dose of paracetamol or placebo, and lung functions will be measured by both spirometry and Fraction of expired Nitric Oxide (FeNO) test.

Each child will receive both paracetamol and placebo, randomly in to consecutive tests, thus children will serve as their own control.

Eligibility criteria: Inclusion Criteria:

* age: 7-16 years
* research group: children who have been diagnosed as asthmatic according to the American thoracic society (ATS) criteria
* control group: children who are not known to have asthma

Exclusion Criteria:

* paracetamol sensitivity
* children with any kind of chronic disease (except asthma)
* children with non asthma related chronic lung disease
* acute asthma attack
* children on systemic steroids

Primary outcomes:
measure: A measurable change in lung functions in response to paracetamol exposure.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: TASMC
name: Ruth Soferman, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03296748: Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence
Official title: Is There Any Value of Concomitant Repair of Asymptomatic Grade II Anterior Vaginal Wall Prolapse During Mid Urethral Sling Surgery for Stress Urinary Incontinence ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stress Urinary Incontinence
Keywords: asymptomatic cystocele.
stress urinary incontinence
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 123
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy .
Primary purpose: TREATMENT

Brief summary: The aim of our study is to assess the value of concomitant surgical correction of asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling for treatment of female patients with stress incontinence

Detailed description: female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.

Eligibility criteria: Inclusion Criteria:

* female patients
* genuine stress incontinence

  * asymptomatic cystocele

Exclusion Criteria:

* mixed incontinence

Primary outcomes:
measure: cure rate of stress incontinence
timeFrame: 3 months after surgery
measure: Denovo urgency
timeFrame: 3 months after surgery
Secondary outcomes:
measure: cure rate of stress incontinence
timeFrame: 6 months after surgery
measure: cure rate of stress incontinence
timeFrame: 12 months after surgery
measure: Denovo urgency
timeFrame: 6 months after surgery
measure: Denovo urgency
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainiy Hospital
Study officials:
References:
Clinical trial NCT01380548: Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia
Official title: A Double-blind, Placebo Controlled Study to Assess Efficacy of 5-Aminolevulinic Acid in Subjects With Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: SBI ALApromo Co., Ltd., Japan
First posted: 2011-06-27
Enrollment: 135
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in subjects with iron deficiency anemia.


Eligibility criteria: Inclusion Criteria:

* Premenopausal women with hemoglobin ≥ 9.0 g/dl and ≤ 12.0 g/dl
* Willing not to donate blood during the study
* Informed consent signed

Exclusion Criteria:

* History of porphyria, hemochromatosis, or viral hepatitis
* Anemia other than iron deficiency
* BMI ≤ 18 kg/m2 or ≥ 30 kg/m2
* Pregnant or nursing a child
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease
* Subjects who are taking medicines or functional food that may affect hemoglobin level

Primary outcomes:
measure: Hemoglobin level
timeFrame: Every 4 weeks (Overall 20 weeks)
Secondary outcomes:
measure: Serum ferritin level
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Transferrin level
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: MCV level
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: TIBC level
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Reticulocyte level
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Red blood cell level
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Hematocrit level
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Serum iron level
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Soluble transferrin receptor level
timeFrame: Week 0 (baseline) and Week 12
measure: Hepcidin-25 level
timeFrame: Week 0 (baseline) and Week 12
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
References:
Clinical trial NCT01665248: Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
Official title: Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Diseases
Keywords: 18-F Sodium Fluoride
Acute coronary syndrome
Stable Angina
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 21
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 is to evaluate the correlations between active calcification and vulnerable plaque.


Eligibility criteria: Inclusion Criteria:

* Age more than 20
* Acute coronary syndrome or stable angina

Exclusion Criteria:

* Contraindications to the use of heparin, aspirin, clopidogrel, stainless metal, contrast media
* Acute ST segment elevation myocardial infarction within 12hours, heart failure, cardiac shock
* Any serious medical comorbidity such that the subject's life expectancy is less than 24 months
* Ejection fraction less than 30
* Serum creatinine level of 1.5mg/dl and over
* Vasculitis
* Unwillingness or inability to cooperate or to give informed consent

Primary outcomes:
measure: Standardized 18F-NaF uptake value within the culprit plaque
timeFrame: At the time of diagnosis
Secondary outcomes:
measure: The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography
timeFrame: at the time of diagnosis
measure: The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography
timeFrame: at the time of diagnosis
measure: The relationship between 18F-NaF uptake value and biomarkers
timeFrame: at the time of diagnosis
measure: The relationship between 18F-NaF uptake value and invasive imagings
timeFrame: at the time of diagnosis
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Cheol Whan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: