louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04406701: Ceres: Eating Habits Among Lebanese Nurses
Official title: Impact of the Health Crisis and the Economic Situation in Lebanon on the Eating Habits of Lebanese Nurses.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eating Habits
Nurses
Lead sponsor: University of Paris 13
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: nurses working in hospitals

Brief summary: The main objective of this research is to study the impact of the health crisis and the economic situation in Lebanon on the eating habits of Lebanese nurses.

It is a descriptive, study among Lebanese nurses working in hospitals. It will be a self-administered survey on eating habits and their relationship with coping strategies and economic level among nurses. Analyses will be carried out using Statistical Package for Social Sciences (SPSS) 21 software.

The results of this study will make a unique and collective contribution to the areas of nursing management and the prevention of eating disorders among nurses.


Eligibility criteria: Inclusion Criteria:

* nurses working in hospitals

Exclusion Criteria:

* Maternity leave
* Pregnancy

Primary outcomes:
measure: Crowding index
timeFrame: 2 month
measure: Food Frequency Questionnaire (FFQ)
timeFrame: 2 month
measure: Brief Cope
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04825301: Application of Machine Learning Based Approaches in Emergency Department to Support Clinical Decision Managing SARS-CoV-2 Infected Patients
Official title: Application of Machine Learning Based Approaches in Emergency Department to Support Clinical Decision Managing SARS-CoV-2 Infected Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: Covid19
machine learning
prediction model
convolutional neural network
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 779
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: Italian caucasian patients aged over 18 years old SARS-CoV-2 infection confirmed by PCR

Brief summary: The aim of the study is to develop a prognostic prediction model based on machine learning algorithms in patients affected by coronavirus disease 2019 (COVID-19), the prediction model will be capable to recognize patient with favorable prognosis or patient with poor prognosis by intelligent systems data analysis.


Eligibility criteria: Inclusion Criteria:

* patients aged over 18 positive for COVID-19 by polymerase chain reaction assay for rhino-pharyngeal swab

Exclusion Criteria:

* Under 18 aged

Primary outcomes:
measure: COVID-19 clinical course
timeFrame: 2 months
Secondary outcomes:
measure: Application of machine learning algorithms on data of patients affected by COVID-19
timeFrame: 2 months
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: University of L'Aquila
Study officials:
References:
Clinical trial NCT00669968: Study of Value of Cardiac PET Scans With or Without CT Angiography and/or Measurement of Coronary Flow Reserve
Official title: PET Myocardial Perfusion Imaging With CT Angiography and Measurement of Coronary Flow Reserve: A Prospective Study of Effectiveness, Impact on Patient Management, Prognostic Value, and Downstream Costs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Coronary Artery Disease
Keywords: PET myocardial perfusion imaging
Cardiac PET
Rubidium
Coronary Artery CT Angiogram
Coronary Flow Reserve
Adenosine stress test
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
First posted: 2008-05-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo Rubidium PET adenosine stress test with or without CT angiography of coronary arteries and/or coronary flow reserve measurment at Kettering Medical Medical Center.

Brief summary: How does PET myocardial perfusion imaging involving CT angiography and measurement of coronary flow reserve affect patient care.

Detailed description: The purpose of this research is to determine how PET myocardial perfusion imaging involving CT angiography and measurement of coronary flow reserve affects patient care. This research will also compare the effectiveness of these scans to other similar tests and compare the cost-effectiveness of these scans to other similar tests over time.

Eligibility criteria: Inclusion Criteria:

* Patients referred to Kettering Medical Center for PET myocardial perfusion imaging with or without CTA and/or coronary flow reserve measurement.
* Patients over 18 years of age.

Exclusion Criteria:

* Patients who do not consent to participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
Study officials:
affiliation: Kettering Health Network
name: Nathaniel Dittoe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01390168: Internet-administrated Treatment of Anxiety Disorders
Official title: Tailored Internet-administrated Treatment of Anxiety Disorders - A Randomised Controlled Trial (NOVA II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depression
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 100
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: The purpose of this study is to determine whether tailored internet-administered cbt is a feasible treatment for anxiety disorders in clinical settings.


Eligibility criteria: Inclusion Criteria:

* over 18 years
* fulfill the criteria for at least one anxiety syndrome

Exclusion Criteria:

* ongoing psychological treatment
* suicidal prone
* ongoing alcohol addiction

Primary outcomes:
measure: Change from baseline in Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
timeFrame: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment
Secondary outcomes:
measure: Change from baseline in Beck Anxiety Inventory (BAI)
timeFrame: Two weeks pre treatment (baseline), two weeks post treatment, 12 months post treatment
measure: Change from baseline in Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
timeFrame: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment
measure: Change from baseline in Quality of Life Inventory (QOLI)
timeFrame: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioural Sciences and Learning, Linköping University
state: Östergötland
Study officials:
affiliation: Umeå University
name: Per Carlbring, Professor
role: STUDY_DIRECTOR
affiliation: Linkoeping University
name: Gerhard Andersson, Professor
role: STUDY_CHAIR
affiliation: Linkoeping University
name: Lise Bergman Nordgren, Ph D Student
role: STUDY_CHAIR
References:
citation: Nordgren LB, Hedman E, Etienne J, Bodin J, Kadowaki A, Eriksson S, Lindkvist E, Andersson G, Carlbring P. Effectiveness and cost-effectiveness of individually tailored Internet-delivered cognitive behavior therapy for anxiety disorders in a primary care population: a randomized controlled trial. Behav Res Ther. 2014 Aug;59:1-11. doi: 10.1016/j.brat.2014.05.007. Epub 2014 Jun 2.
citation: Nordgren LB, Andersson G, Kadowaki A, Carlbring P. Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial. Trials. 2012 Feb 9;13:16. doi: 10.1186/1745-6215-13-16.
Clinical trial NCT01979068: Vascular Inflammation Stratified by Body Size Phenotype
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Obesity
Metabolic Syndrome
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers who underwent a medical health check in the health promotion center in Korea University Guro Hospital

Brief summary: * Vascular Inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18FDG-PET is a promising novel tool for identifying and quantifying vascular inflammation within atherosclerotic plaque
* Recently, unique subsets of obese individuals, such as metabolically obese but normal weight (MONW) and metabolically healthy obese (MHO), have been getting an attention
* Therefore, the purpose of this study is to examine the relationship of vascular inflammation,measured by FDG-PET, with various body sized phenotypes


Eligibility criteria: Inclusion Criteria:

* Healthy patients for visiting routine medical check in our clinic

Exclusion Criteria:

* history of CVD (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
* stage 2 hypertension (resting blood pressure, ≥160/100 mmHg)
* history of inflammatory conditions that affect the study results
* taking medications that might affect inflammatory status, including steroid and non-steroidal anti-inflammatory drug within 6 months
* or malignancy or severe renal or hepatic disease

Primary outcomes:
measure: max TBR values stratified by the four body size phenotypes
timeFrame: 12 weeks
Secondary outcomes:
measure: Framingham risk scores according to the four body size phenotypes
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References:
citation: Yoo HJ, Kim S, Hwang SY, Hong HC, Choi HY, Seo JA, Kim SG, Kim NH, Choi DS, Baik SH, Choi KM. Vascular inflammation in metabolically abnormal but normal-weight and metabolically healthy obese individuals analyzed with (1)(8)F-fluorodeoxyglucose positron emission tomography. Am J Cardiol. 2015 Feb 15;115(4):523-8. doi: 10.1016/j.amjcard.2014.11.036. Epub 2014 Nov 29.
Clinical trial NCT00175968: Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity
Official title: Influence of Bed-Rest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: ECT

Brief summary: Aim of the study is to assess the impact of the factors ´bed rest´ and ´hypocaloric nutrition´ on endothelium-dependent vasoreactivity in healthy volunteers.

Detailed description: In a randomized, four-phase cross-over study the effect of simulated microgravity (13 days of bed rest), energetic restriction (-25%, fat reduced), and their combination on endothelium-dependent and -independent vasodilation will be compared with ambulatory control conditions. Using venous occlusion plethysmography cumulative intraarterial dose-response curves to endothelium-dependent (acetylcholine) and -independent (sodium nitroprusside) vasodilators will be constructed in 10 healthy male volunteers before and on day 13 of each of the four intervention periods.

Eligibility criteria: Inclusion Criteria:´

* Healthy, male volunteers, age: 18-40
* Able and willing to give written informed consent

Exclusion Criteria:

* Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, smoking, hyperhomocysteinaemia)
* Regular medication and/or treatment with drugs within the last 4-6 weeks (exclusion has to be decided in each case)
* Acute or chronic illness
* Participation in clinical trial/blood donation within 2 month before the study
* Nicotine during 1 year before the study; drug and/or alcohol abuse.

Primary outcomes:
measure: Drug-induced changes of forearm blood flow
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: DLR Institute of Aerospace Medicine
state: North-Rhine-Westphalia
Study officials:
affiliation: Heidelberg University
name: Walter E Haefeli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02795468: The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants
Official title: The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization, Peripheral
Keywords: Peripheral
Arterial
Catheterization
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 86
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators are trying to compare the ultrasound-guided technique vs. palpation method for radial arterial cannulation in infants.

Detailed description: In infants (\<12mo), radial arterial catheterization is sometimes difficult to perform. Moreover, repeated attempts itself would cause the arterial spasm or hematoma. The use of ultrasound as an adjunct to radial arterial cannulation has considered to be the best practice in adults and pediatrics. However, its usefulness or superiority for neonates and infants is not known. Therefore, we would compare ultrasound guided radial arterial cannulation with the usual palpation methods in infants undergoing cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* Infants under 12 months age undergoing cardiac surgery with radial arterial cannulation

Exclusion Criteria:

* Sign of a skin infection
* Wound near the puncture site
* abnormal circulation of the hand
* any vascular problem at radial or ulnar artery

Primary outcomes:
measure: First-pass success rate
timeFrame: Within 10 min from the start time of arterial cannulation using an angiocath
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jong Hwan Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang HP, Zhao WJ, Wen F, Li XY. Application of ultrasound-guided radial artery cannulation in paediatric patients: A systematic review and meta-analysis. Aust Crit Care. 2021 Jul;34(4):388-394. doi: 10.1016/j.aucc.2020.09.001. Epub 2020 Oct 21.
citation: Min JJ, Tay CK, Gil NS, Lee JH, Kim S, Kim CS, Yang JH, Jun TG. Ultrasound-guided vs. palpation-guided techniques for radial arterial catheterisation in infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):200-205. doi: 10.1097/EJA.0000000000000926.
Clinical trial NCT00621868: A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus
Official title: ASP1941 Phase II Clinical Study - A Double-blind, Placebo-controlled, Parallel-group, Dose-response Study in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus, Type 2
ASP1941
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 361
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of type 2 diabetes mellitus
* Fasting serum C-peptide level \> 0.6 ng/mL
* HbA1c between 7.0 and 10.0%
* Body Mass Index between 20 and 45 kg/m2

Exclusion Criteria:

* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300 mg/g)
* Dysuria and/or urinary tract infection
* Significant renal, hepatic or cardiovascular diseases
* Ketosis
* Hypertension
* Severe gastrointestinal diseases

Primary outcomes:
measure: HbA1c level
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood glucose level
timeFrame: 12 Weeks
measure: Safety
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaidou
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
citation: Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.
citation: Kashiwagi A, Kazuta K, Yoshida S, Nagase I. Randomized, placebo-controlled, double-blind glycemic control trial of novel sodium-dependent glucose cotransporter 2 inhibitor ipragliflozin in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2014 Jul;5(4):382-91. doi: 10.1111/jdi.12156. Epub 2013 Nov 28.
Clinical trial NCT03669068: Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY
Official title: Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: A Prospective, Multicentre, and Observational Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Bleeding
Cardiovascular Complication
Anticoagulants; Circulating, Hemorrhagic Disorder
Gastrointestinal Endoscopy
Keywords: Gastrointestinal endoscopy
Oral anticoagulants
Gastrointestinal bleeding
Cardiovascular event
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: University of Salamanca
name: Hospital Universitario Central de Asturias
name: Hospital Universitario 12 de Octubre
name: Puerta de Hierro University Hospital
name: Hospital del Mar
name: Hospital de Viladecans
name: Hospital Clinic of Barcelona
name: Hospital de Avilés
name: Hospital General de Villalba
name: Hospital General de Granollers
name: Hospital Sant Pau
First posted: 2018-09-13
Enrollment: 1602
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: Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran)

Brief summary: This observational study evaluates the safety of gastrointestinal endoscopy in patients on oral anticoagulants (Vitamin K antagonists, rivaroxaban, dabigatran, edoxaban, and apixaban). This registry aims to assess the incidence, characteristics and risk factors for cardiovascular and bleeding events associated with an endoscopic procedure. Besides, it aims to evaluate the differences between Vitamin K antagonists and DOACs users and to estimate the impact of anticoagulation withdrawal time on the primary and secondary outcomes.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years.
* Patients with preoperative use of oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatrán) undergoing gastrointestinal endoscopy.
* Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran) presenting with gastrointestinal bleeding, regardless of receiving gastrointestinal endoscopy.
* Signed informed consent.

Exclusion Criteria:

* Negative to participate in the study.

Primary outcomes:
measure: Incidence of Cardiovascular events
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of therapeutic endoscopy-related gastrointestinal bleeding
timeFrame: 3 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
References:
Clinical trial NCT00712868: Acceptability of Lactacyd Femina
Official title: Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-07-10
Enrollment: 559
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To demonstrate the safety and acceptability of the gynaecological formulation.


Eligibility criteria: Inclusion Criteria:

* Integral skin in the tested region

Exclusion Criteria:

* Pregnancy or breastfeeding women
* Use of anti-inflammatory or immune-suppression drugs
* Topical medication use at the tested region
* Active cutaneous gynaecological disease which may interfere in study results
* Personal history of allergic disease at the area to be treated
* Allergic or atopic history

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Clinical and local tolerability
timeFrame: After 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Col. Coyoacan
country: Mexico
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Judith Diaz, Md
role: STUDY_DIRECTOR
References:
Clinical trial NCT04835168: Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Eosinophilic Esophagitis
Lead sponsor: NImmune Biopharma
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed Phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.


Eligibility criteria: No patients enrolled

Primary outcomes:
measure: Incidence and severity of AEs
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: