louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05383963: Evaluation of Parameters Collected From Routine Data for the Diagnosis of Sepsis and Septic Shock and Their Influence on Time to Diagnosis and Patient Outcome
Official title: Evaluation of Parameters Collected From Routine Data for the Diagnosis of Sepsis and Septic Shock and Their Influence on Time to Diagnosis and Patient Outcome (QUICK-SEPSIS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Septic Shock
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intensive care unit patients (female, male, miscellaneous) from the age of 18 years with an intensive care stay of \> 24 hours in an intensive care unit since 01. 01. 2007 from the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)

Brief summary: Retrospective observational study to develop a Machine Learning Algorithm to evaluate parameters collected from routine data for the diagnosis of sepsis and septic shock and their influence on time to diagnosis and patient outcome.

Detailed description: Retrospective routine data from the medical records of the department of anesthesiology and operative intensive care from 01. 01. 2007 to 31. 12. 2021 are analyzed in digital form.

The first step is the development of a machine learning algorithm (MLA). This MLA will be validated and analyzed for his predictive value with regard to early diagnosis of sepsis/septic shock depending on the conceptual value of detection variables (Sepsis-3 vs. SIRS). Further analysis will focus on improvement of accuracy for the MLA and the effect of these detection variables on quality of treatment processes and also on economic consequences like cost and revenue.

Timeline:

1. Conception and development of the ML Algorithm (6 months)
2. Identification and diagnostic validation of sepsis patients (6 months)
3. Secondary analyses (36 months)

Eligibility criteria: Inclusion Criteria:

* age \>= 18 years
* ICU stay of \> 24 hours

Exclusion Criteria:

* none

Primary outcomes:
measure: Sepsis/septic shock
timeFrame: 01.01.2007 -31.12.2021
Secondary outcomes:
measure: Predictive accuracy
timeFrame: 01.01.2007 -31.12.2021
measure: Diagnostic accuracy
timeFrame: 01.01.2007 -31.12.2021
measure: Performance indicators
timeFrame: 01.01.2007 -31.12.2021
measure: Case costs
timeFrame: 01.01.2007 -31.12.2021
measure: Revenues
timeFrame: 01.01.2007 -31.12.2021
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04657263: Impact of the COVID-19 Pandemic on Vaccination
Official title: Impact of the COVID-19 Pandemic on Vaccination in Patients at Risk of Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: People over 18 years old
vaccines
immunization schedule
Infection
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population was composed of person at risk of infection cared for in participating centers

Brief summary: The vaccination policy is drawn up in France by the French Minister of Health, who makes public the vaccination schedule after the opinion of the High Authority of Health.

Currently according to the 2019 immunization schedule, the dTP vaccine is the only mandatory in the general population with recalls in adults aged 25, 45, 65 and every 10 years. In 2011, the Ministry of Health estimated that only 50.5% of the general population was up to date against dTP.

Two vaccines are recommended for person at risk of infection according to the current vaccine schedule: the flu vaccine and the pneumococcal vaccine. In fact, influenza and pneumococcal disease are more frequent and more serious in patients with chronic diseases (diabetes, cardiac insufficiency..) compared to the general population.

The vaccination coverage rate of at-risk populations is dramatically below the vaccination coverage targets set by the Ministry of Health. Indeed, there are many barriers to vaccination, medical and para-medical barriers, but also individual barriers.

The current COVID-19 pandemic has identified people at risk of severe infection and death risk, particularly those with co-morbidities (diabetes, cardiovascular disease, etc.). Thus, this pandemic may have contributed to change in patients' perceptions regarding both the risk of infection and the potential interest and benefit of vaccination.


Eligibility criteria: Inclusion criteria:

* Person at risk of infection according to french 2019 immunization schedule
* Patients aged above 18 years old

Exclusion criteria:

- Patient \< 18 years

Primary outcomes:
measure: number of persons at risk of infection up to date with their mandatory and recommended vaccinations during COVID19 pandemic
timeFrame: 1 day
Secondary outcomes:
measure: Number of persons at risk of infection accepting COVID19 vaccination
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Cyril BREUKER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02572063: Omics4Aging: Stratification of Frailty Population
Official title: Omics4Aging: Stratification of Frailty Population Based on Nutrients Profiling and Metabolic Profiling at Baseline
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malnutrition
Intellectual Frailty of Aging
Bone Fragility
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-10-08
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 frail elderly free living healthy individuals, males and females, age 65-79.

Brief summary: The overall objective of the study is to stratify a frailty population based on nutrients profiling (amino acids, vitamins, minerals, fatty acids) and metabolic profiling (low molecular weight metabolites in urine and plasma) at baseline.

Detailed description: This exploratory study will investigate ways to better characterize the frailty phenotype by a combination of i) geriatric assessment (here only: frailty criteria according to Fried), ii) clinical surrogate markers (including those of inflammation), iii) body composition, iv) nutritional profiling, v) metabolite profiling using a metabolomics approaches.

Eligibility criteria: Inclusion Criteria:

Unless otherwise specified, subjects who fulfill all of the following will be included:

1. Caucasian
2. Male or female between the ages of 65 and 79 years old
3. Three or more Fried Frailty Criteria (as diagnosed by investigator)
4. Informed consent obtained

Exclusion Criteria:

Any of the following criteria would render a subject ineligible for inclusion:

1. Dementia (previously diagnosed by general practitioner)
2. Hb1c (glycate Haemoglobin) \>7.5% (\>58 mmol/mol).
3. End stage disease (1 year after last chemotherapy treatment for cancer)
4. Drug abuse (alcohol - assessed by investigator)
5. Medications: no antibiotic treatment (for at least 4 weeks), immune suppressants, and or chronic use of corticosteroids
6. Currently participating or having participated in another clinical or nutritional intervention trial during the last 3 month
7. Chronic active inflammatory disease (e.g. rheumatoid arthritis, vasculitis, lupus erythematosus and Crohn's disease)
8. Chronic Active hepatitis
9. Kidney failure in Dialysis treatment
10. Any other condition that in the judgment of the lead investigator would not allow the subject to complete the study protocol

Primary outcomes:
measure: Comparison of Metabonomics, at baseline, among frail population.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Dr. Miriam Capri
Study officials:
affiliation: University of Bologna
name: Miriam Capri, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01997463: Supervised Asthma Medication in Schools (SAMS)
Official title: The Cost Effectiveness of School-Based Supervised Asthma Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Childhood Asthma
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-11-28
Enrollment: 442
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.

Detailed description: This research is being done to test if children with asthma will have fewer asthma symptoms if they are monitored at school to make sure they take their inhaled steroid medication (ICS) every day and take the medication the right way. All of the children with asthma in the school will be asked to participate. In the first year in one-half of the schools, children and school staff will participate in a standardized asthma education program presented by the American Lung Association (ALA). Children will have daily monitoring of their inhaled asthma medication. The other half of schools will continue with the usual treatment of children with asthma. In the second year of the study, all schools and children will have the asthma education program and monitoring. Parents will be queried quarterly for information about their child's asthma.

Eligibility criteria: Inclusion Criteria:

* A child with asthma attending a Tucson Unified School District elementary school selected for the study.

Exclusion Criteria:

* No asthma.
* Not attending a Tucson Unified School District elementary school selected for the study.

Primary outcomes:
measure: The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona and the Tucson Unified School District
state: Arizona
Study officials:
affiliation: University of Arizona, Mel and Enid Zuckerman College of Public Health
name: Lynn B Gerald, Ph.D., MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerald JK, Fisher JM, Brown MA, Clemens CJ, Moore MA, Carvajal SC, Bryson D, Stefan N, Billheimer D, Gerald LB. School-supervised use of a once-daily inhaled corticosteroid regimen: A cluster randomized trial. J Allergy Clin Immunol. 2019 Feb;143(2):755-764. doi: 10.1016/j.jaci.2018.06.048. Epub 2018 Aug 14.
Clinical trial NCT01448863: Metabolomic Embryo Profiles of Obese in Vitro Fertilization (IVF) Patients and Their Relationship With Polycystic Ovary Syndrome (PCO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Obesity
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 45 women divided into three groups: A)15 Obese women without Polycystic Ovarian Syndrome: BMI \> 30 kg/m2 , age \< 38 years old, normal basal hormonal profile (FSH, LH, estradiol, testosterone, androstenedione, insulin, SHBG, glucose, AMH, and antral follicle count(\> 5 FA for each ovary), menses every 25-35 days.

B)15 Obese women with Polycystic Ovarian Syndrome: BMI \> 30 kg/m2, age \< 38 years old, basal hormonal profile with or without hyperandrogenism and ultrasound ovary aspect of PCO.

C)15 Fertile women (egg-donors): BMI 20-24.9 kg/m2. All the patients have normal uterine conditions, are not smokers, without endometriosis or hidrosalpinx. All the male partners have sperm parameters: count(\> 5 mill/ml,15% motility,\> 0% normal morphology)and BMI \< 28 kg/m2.

Brief summary: The present study aims to elucidate if there is a metabolomic profile alteration in the embryos of obese women in order to understand if the reduced implantation rate observed in these patients is directly related to this factor. Furthermore, the investigators seek to establish if there is any difference between obese women with Polycystic Ovary Syndrome (PCO) and without PCO. The investigators compare these metabolomic profile embryos with embryos of egg-donation programme.


Eligibility criteria: Inclusion Criteria:

* BMI \> 30 kg/m2
* Age \< 38 years old
* Non smokers
* First IVF cycle (groups 2 \& 3, not Control group)
* Normal uterus (seen by ultrasound)
* normal basal hormonal profile(FSH,LH,estradiol,testosterone,androstenedione, insulin, SHBG, glucose, AMH)
* Antral follicle count(\> 5 FA for each ovary)
* Menses every 25-35 days.

Exclusion Criteria:

* \< 5 or \> 20 oocytes retrieved after stimulation cycle
* estradiol \>3000 pg/ml or progesterone \> 1,5 ng/ml on the hCG day.
* \< 2 evolutive embryos in the culture medium.

Primary outcomes:
measure: Metabolic profile of culture media of Day 3 embryos
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
References:
citation: Bellver J, De Los Santos MJ, Alama P, Castello D, Privitera L, Galliano D, Labarta E, Vidal C, Pellicer A, Dominguez F. Day-3 embryo metabolomics in the spent culture media is altered in obese women undergoing in vitro fertilization. Fertil Steril. 2015 Jun;103(6):1407-15.e1. doi: 10.1016/j.fertnstert.2015.03.015. Epub 2015 Apr 29.
Clinical trial NCT06447363: Assessment of Green Dentistry Knowledge, Attitude and Implementation and Its Association With Sociodemographic Factors Among Dental Professionals in Cairo University.
Official title: Assessment of Green Dentistry Knowledge, Attitude and Implementation and Its Association With Sociodemographic Factors Among Undergraduate and Postgraduate Dental Students in Cairo University: A Cross Sectional Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Green Dentistry
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 553
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Dental professionals (Undergraduate and postgraduate students), Faculty of Dentistry, Cairo University through the academic year 2024-2025.

Brief summary: Environmental pollution is one of the serious issues causing global warming. Each and every individual is responsible for this situation and should make an effort and contribute in keeping the planet green and make it a better place to live for future generations. With escalating contamination of natural resources due to mounting waste generation across industries, including healthcare, the global shift towards ecological sustainability becomes imperative.

The aim of this study is to endeavors to evaluate the knowledge, behavior, and implementation of eco-friendly dental strategies among dental professionals (undergraduate and postgraduate dental students) in the Faculty of Dentistry, Cairo University, and its association with sociodemographic data utilizing self-reporting questionnaire in preparation for the implementation of eco-friendly dental practices.


Eligibility criteria: Inclusion Criteria:

* Dental professionals (Undergraduate and postgraduate students), Faculty of Dentistry, Cairo University through the academic year 2024-2025.

Exclusion Criteria:

* Dental students from other universities.
* Internship dental students.

Primary outcomes:
measure: Knowledge
timeFrame: 1 year
Secondary outcomes:
measure: Attitude and implementation
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05758363: Effect of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals
Official title: Randomized Clinical Trial to Evaluate the Efficacy of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized, parallel, two-arm, placebo-controlled, double-blind, multicenter clinical trial is to evaluate the efficacy of a dietary supplement on weight loss and psychological well-being in overweight individuals.

Detailed description: The duration of the study will be 6 months during which the investigational product or placebo will be consumed according to the assignment.

Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).

Eligibility criteria: Inclusion Criteria:

* Adults (age: 30 - 70 YO)
* BMI over 25 kg/m2.
* Subjects who are smokers or non-smokers, but in any case who do not modify their nicotinic habits during their participation in the study.

Exclusion Criteria:

* Subjects with eating disorders.
* BMI less than 25 Kg/m2.
* History of allergic hypersensitivity or poor tolerance to any component of the products under study.
* Participation in another clinical trial in the three months prior to the study.
* Unwillingness or inability to comply with clinical trial procedures.
* Pregnant woman.
* Participants with an active daily exercise activity.
* Subjects whose condition makes them ineligible for the study at the investigator's discretion.

Primary outcomes:
measure: Evaluation of weight loss
timeFrame: From baseline to 6 months later
Secondary outcomes:
measure: Quality of life by WHOQOL-BREF
timeFrame: From baseline to 6 months later
measure: Quality of life by SF-36
timeFrame: From baseline to 6 months later
measure: Depression
timeFrame: From baseline to 6 months later
measure: Stress
timeFrame: From baseline to 6 months later
measure: Anxiety
timeFrame: From baseline to 6 months later
measure: Dietary intake
timeFrame: From baseline to 6 months later
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM San Antonio Catholic University of Murcia
Study officials:
References:
Clinical trial NCT06111963: Role of Inflammatory Markers in Sepsis
Official title: Role of Inflammatory Markers Measured Using Flow Cytometry in the Diagnosis and Prognosis of Sepsis in Surgical Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diagnostic
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postoperative patients

Brief summary: A diagnostic and prognostic study, in which the expression of CD64 in activated neutrophils and CD64 and IL17A regulatory T cells in patients with sepsis will be evaluated as a probable marker for sepsis as a primary objective


Eligibility criteria: Inclusion Criteria:

* Cancer patients admitted to the surgical ICU following cancer related surgeries and diagnosed with sepsis

Exclusion Criteria:

* Refusal of patient or patient guardian to participate.
* Intraoperative massive blood loss and massive blood transfusion
* Patients with impaired preoperative kidney or liver function tests

Primary outcomes:
measure: To evaluate the expression CD4
timeFrame: 7 days
measure: To evaluate the expression CD25
timeFrame: 7 days
measure: To evaluate the expression IL17
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Y Elsabeeny
Study officials:
affiliation: National Cancer Institute, Cairo University
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01125163: Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
Official title: Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Keywords: very low birth weight infants
anemia
iron supplementation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 150
Sex: ALL
Minimum age (years): 24
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine feeding with routine iron-fortified milk (formula or fortified mother's milk), as compared to routine iron fortified milk, increase hematocrit at 36 weeks adjusted postmenstrual age (or at discharge if sooner)?

Detailed description: Fortified mother's milk or fortified formula is routine practice in neonatal units and is not an intervention.

Eligibility criteria: Inclusion Criteria:

* Birth weight \<1500 grams
* Tolerating iron fortified preterm formula or fortified human milk at 120cc/kg/day by 8 weeks of age
* \</= 32 weeks adjusted post-menstrual age at the time of enrollment

Exclusion Criteria:

* Cyanotic heart disease
* Bowel resection prior to enrollment

Primary outcomes:
measure: Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)
timeFrame: at 36 weeks adjusted postmenstrual age
Secondary outcomes:
measure: Number of Participants Who Received Red Cell Transfusions During Intervention Period
timeFrame: from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital, Texas Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Tiffany Taylor, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taylor TA, Kennedy KA. Randomized trial of iron supplementation versus routine iron intake in VLBW infants. Pediatrics. 2013 Feb;131(2):e433-8. doi: 10.1542/peds.2012-1822. Epub 2013 Jan 21.