louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03799016: An Observational Study on Incidence, Natural History and Treatment Patterns of Venous Thromboembolism in Taiwan
Official title: An Observational Study on Incidence, Natural History and Treatment Patterns of Venous Thromboembolism in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-01-10
Enrollment: 104215
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: The research question addressed by this study is primarily on the clinical epidemiology of VTE in Taiwan. The study aims to estimate the incidence of VTE and describe natural history of VTE, including long term clinical outcomes in adult Taiwanese population, utilizing population-based electronic health data in Taiwan.


Eligibility criteria: Inclusion Criteria:

* The source population was the adult population in Taiwan. The legal age for definition as an adult (without additional research ethics review requirement) in Taiwan is 20; therefore all National Health Insurance (NHI) enrollees age 20 or older at any time during the study period were evaluated for VTE.

Exclusion Criteria:

* Person-time before an eligible subject turned 20 were not evaluated.
* Study subjects having inconsistent data on gender and unrealistic date of birth (birth year before 1890 and after 2015) were identified and excluded from the analysis.

Primary outcomes:
measure: Incident VTE
timeFrame: 4 years
measure: Potential risk factors that occurred before the incident VTE events
timeFrame: 4 years
measure: Usage patterns of anticoagulants among incident VTE patients were evaluated during incident VTE hospital admission and after discharge
timeFrame: 4 years
measure: All-cause mortality
timeFrame: 4 years
measure: Major bleeding
timeFrame: 4 years
measure: Recurrent VTE
timeFrame: 4 years
measure: Adherence of oral anticoagulant treatment was also evaluated with the calculation of MPR within 6 months and 12 months after discharge.
timeFrame: Up to 6 and 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06105216: The Effect of Crossword and Word Search Puzzles on Nursing Students' Parenteral Medication Administration Knowledge
Official title: The Effect of Crossword and Word Search Puzzles on Nursing Students' Parenteral Medication Administration Knowledge: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Education
Medicatioon Administration Knowledge
Puzzle
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 220
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study was conducted in a pretest-posttest parallel-group, randomized controlled design.The population of the study consisted of students (n=220) enrolled in the Fundamentals of Nursing course at the Faculty of Nursing of a public university in the 2022-2023 academic year.According to the exclusion criteria, 56 students were excluded from the study. One hundred sixty-four students who met the inclusion criteria were randomized to the intervention I (n = 82) and control groups (n = 82) by stratified block randomization after the completion of baseline measures. The study was completed with 164 students. The theoretical lecture was carried out by a researcher who was an expert faculty member in Fundamentals of Nursing. All students completed the pretest after attending the theoretical lecture. In the laboratory practice after the theoretical lecture, all students were divided into small groups and practiced parenteral medication administration skills one-to-one under the guidance of the instructor. Students in the intervention group received hard copies of the puzzles at the end of the laboratory practice. All students completed the posttest again at the end of the laboratory practice. Students were supervised during the tests and were not allowed to consult any books, the internet, or any other source of information.


Eligibility criteria: Inclusion Criteria:

(1) Register for the Fundamentals of Nursing course for the first time.

Exclusion Criteria:

1. not communicate in Turkish
2. graduate from any health-related university in the past.

Primary outcomes:
measure: Medication Administration Knowledge Questionnaire
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gülcan Eyüboğlu
state: Yenimahalle
Study officials:
References:
Clinical trial NCT04673916: Treatment Protocols for Patients With Symptomatic Oral Lichen Planus
Official title: Analysis of the Efficacy of Two Treatment Protocols for Patients With Symptomatic Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lichen Planus, Oral
Preneoplastic Condition
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 61
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups of patients
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to compare the therapeutic efficacy of clobetasol propionate 0.05% oral gel versus an anti-inflammatory mouthwash in an oral solution for the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects.

Detailed description: Forty patients were assigned (20 patients per group), through a randomized design, to receive clobetasol (clobetasol gel 0.05%), or an anti-inflammatory mouthwash (mouthwash which contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric Proanthocyanidins) for 3-months. At baseline (T0) and after 3 months (T1), patients were subjected to clinical and oral assessments and were evaluated for the symptoms (Numerical Pain Scale, NRS score) and signs (Thongprasom's score) of OLP. Data were calculated using T-test for the dependent variable, Wilcoxon test and Mann-Witney u test.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years;
* clinical diagnosis and histological diagnosis of OLP on the basis of WHO criteria;
* presence of symptoms related to OLP.

Exclusion Criteria:

* presence of systemic conditions that may have affected the study results;
* state of pregnancy or breastfeeding;
* histological signs of dysplasia;
* drugs inducing a lichen response (ACE-inhibitors, β-blockers, etc.);
* treatment of OLP in the six months prior to the start of the programme;
* presence of extraoral lesions (genital, skin and other)
* history of previous immunodeficiency or HIV seropositivity;
* previous allogeneic bone marrow transplantation;
* presence of systemic lupus erythematosus or other autoimmune diseases.

Primary outcomes:
measure: Clinical Mucosal healing
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
References:
citation: Santonocito S, Polizzi A, De Pasquale R, Ronsivalle V, Lo Giudice A, Isola G. Analysis of the Efficacy of Two Treatment Protocols for Patients with Symptomatic Oral Lichen Planus: A Randomized Clinical Trial. Int J Environ Res Public Health. 2020 Dec 23;18(1):56. doi: 10.3390/ijerph18010056.
Clinical trial NCT05053516: the Standardized Training Program for Social Workers
Official title: Development and Effectiveness Evaluation of the Standardized Training Program for Social Workers for Drug Treatment Based on Industry Needs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Workers
Educational Problems
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Now, there are few researches on the ability of social workers who work with drug addicts / drug users in China, and the sample size is small and the content is not deep enough.The existing studies suggest that the professional knowledge and ability of social workers who work with drug addicts / drug users are insufficient and the vocational training is not standardized. On the other hand, the ability of social workers who work with drug addicts / drug users workers is related to the effectiveness of anti-drug in communities. So the large sample survey will help to understand the current working status and working ability of social workers who work with drug addicts / drug users in China.The development of the standardized training programs for social workers who work with drug addicts / drug users can improve the professional knowledge and ability of anti-drug social workers, so as to better help community drug rehabilitation personnel and finally reduce the relapse rate.


Eligibility criteria: Inclusion Criteria:

- aged between 20 and 65;no gender limitation;those who agree to participate in the study and sign the informed consent.

Exclusion Criteria:

- inability to use online training.

Primary outcomes:
measure: Comprehensive competency assessment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00658216: Brain Natriuretic Peptide (BNP) Usefulness In Elderly Dyspneic Patients (BED)
Official title: Usefulness of Measuring Plasma Brain Natriuretic Peptide for Diagnosis and Prognosis in Very Elderly Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Diagnosis and prognosis
Very elderly population
Heart failure
Brain natriuretic peptide
Observational prospective study
Older
Dyspneic patients aged 80
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 390
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Defined population

Brief summary: The purpose of this study is to test the usefulness of measuring plasma brain natriuretic peptide (BNP) for diagnosis and prognosis in very elderly dyspneic patients.

Detailed description: Measurement of BNP concentration is approved for use in the diagnosis of heart failure (HF) in elderly patients below 80 years of age. The value of plasma BNP assays as diagnostic tools has not been determined in very elderly populations because the plasma BNP increases with age. This large, multicenter, prospective, observational, study in 300 participants is aimed to prospectively test the usefulness of measuring plasma BNP for diagnosis of HF in dyspneic patients aged 80 and older.

Eligibility criteria: Inclusion Criteria:

* acute dyspnea
* crackles on lung auscultation,
* hypoxemia,
* right-sided signs.

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: Plasma BNP levels at T0 to test the optimal values of measuring plasma BNP for diagnosis of HF in patients older than 80 years.
timeFrame: 6 months
Secondary outcomes:
measure: Plasma BNP levels at 3 times (T0, T48, Tend) to test the usefulness of measuring plasma BNP : 1.at T0 : in diagnosing HF using a 2-threshold up-and down-approach
timeFrame: 6 months
measure: 2.at T48 : in diagnosing and prognosing HF using a 2nd assay after 48 hours of treatment
timeFrame: 6 months
measure: 3.at Tend : in prognosing HF using a 3rd assay after the acute phase (composite criteria)
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Broca Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier Hanon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Komajda M, Hanon O, Aupetit JF, Benetos A, Berrut G, Emeriau JP, Friocourt P, Galinier M, De Groote P, Jondeau G, Jourdain P, Forette F. Management of heart failure in the elderly: recommendations from the French Society of Cardiology (SFC) and the French Society of Gerontology and Geriatrics (SFGG). J Nutr Health Aging. 2006 Sep-Oct;10(5):434-44.
Clinical trial NCT03515616: Evaluation of Labour Progress by PC Angle
Official title: Evaluation of Role of TP US in Progress of Labour by PC Angle & OS Angle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Labour
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
First posted: 2018-05-03
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - primigravida who is pregnant full term with no medical disorders

Brief summary: - Ultrasound during first stage of labour has a very important role in prediction of mode of delivery

Detailed description: -Operative delivery and cs delivery are increasing nowadays so US during labour is vital to predict these interventions

Eligibility criteria: Inclusion Criteria:

* primigravida
* pregnant full term
* no medical disorders

Exclusion Criteria:

* multigravida
* any medical disorders
* preterm labour

Primary outcomes:
measure: the number of participants who will deliver by NVD without instrumental intervention
timeFrame: within 36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasralainy Hospital
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy, M.s.c
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05866016: Effect of Skill Birth Attendant Training to Improve the Competency of Service Providers
Official title: Effectiveness of Modular Skilled Birth Attendant Training to Improve the Competencies of Service Providers and Maternal Newborn Health in Nepal: A Randomized Control Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Competencies of Midwives
Cost-benefit Analysis of Modular Training
Lead sponsor: Ministry of Health Gandaki Province, Nepal
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health and Population, Nepal
name: Ludwig-Maximilians - University of Munich
First posted: 2023-05-19
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The competencies of skilled birth attendants who receive modular training will be compared with those of skilled birth attendants who receive existing standard training.
Primary purpose: OTHER

Brief summary: This clinical trial's primary goal is to compare birth attendants' competencies. It aims to answer the questions:

* Does the new modular training package enhance the competencies of skilled birth attendants?
* Does the competencies of skilled birth attendants relates to improving maternal and neonatal health outcomes in Nepal?
* Is this training module a cost-effective intervention?

Participants' knowledge, attitude, and skills will be assessed and it will be compared with standard training groups: Researchers will compare the competencies of birth attendants who receive modular training versus standard training to see if an increment in competencies is associated with maternal and neonatal health outcomes.


Eligibility criteria: Inclusion Criteria:

* Health workers should be Auxiliary Nurse Midwives and Nurses working in birthing centers where at least 10 birth managed in the last year
* Health workers (Auxiliary Nurse Midwives and Nurses) who are committed to providing maternal and neonatal health services and priority for permanent service holders.
* Who passes at least the first module (Online module) to participate in modular training

Exclusion Criteria:

* Health workers (Auxiliary Nurse Midwives ad Nurses) who do not provide maternal and neonatal health service
* Health workers other than Auxiliary Nurse Midwives and Nurses though they provide maternal neonatal health services in government health facilities
* Health workers working in private health facilities

Primary outcomes:
measure: Effectiveness assessment of modular skilled birth attendant training package
timeFrame: "1 year"
Secondary outcomes:
measure: Cost-benefit analysis
timeFrame: "2 years"
Other outcomes:
Locations:
city: Pokhara
country: Nepal
facility: Health Directorate
state: Gandaki
city: Pokhara
country: Nepal
facility: Khim Bahadur Khadka
state: Gandaki
Study officials:
affiliation: MoHP, HD, Gandaki
name: Khim Bahadur Khadka, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06707116: Health Literacy As a Mediator Between Gender, Illness Identity, and Self-Efficacy
Official title: The Mediating Role of Health Literacy in the Relationship Between Gender Differences, Illness Identity, and Self-Efficacy Patients with Cardiac Diseases: a Structural Equation Model
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Diseases
Keywords: Health Literacy
Gender Differences
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients aged 30 years and older who have been diagnosed with cardiac diseases, such as coronary artery disease, heart failure, or arrhythmias. These individuals are actively receiving regular medical care for their cardiac conditions and are living in the community or non-acute care settings.

The population includes both male and female participants to explore gender differences in illness identity, health literacy, and self-efficacy. Participants are expected to have a baseline level of health literacy sufficient to comprehend and complete the study surveys, as the research focuses on the mediating role of health literacy.

Brief summary: The goal of this observational study is to understand the role of health literacy in shaping the relationship between gender differences, illness identity, and self-efficacy in geriatric patients with cardiac diseases. The main question it aims to answer is:

Does health literacy mediate the relationship between gender, illness identity, and self-efficacy in elderly cardiac patients?

Participants with diagnosed cardiac conditions, will complete online surveys assessing their health literacy, illness identity, and self-efficacy over a one-year period. Structural Equation Modeling (SEM) will be used to analyze the relationships among these variables.


Eligibility criteria: Inclusion Criteria:

* Adults aged 30 years or older.
* Diagnosed with a cardiac disease (e.g., heart failure, coronary artery disease, arrhythmia).
* Able to provide informed consent.
* Sufficient health literacy to complete surveys in the study language.
* Currently under regular medical care for their cardiac condition.

Exclusion Criteria:

* Individuals with a cognitive impairment or diagnosis of dementia that could interfere with survey participation.
* Patients with co-morbid terminal illnesses that significantly impact life expectancy (e.g., advanced cancer).

Primary outcomes:
measure: Illness Identity Questionnaire (IIQ)
timeFrame: 1 month
Secondary outcomes:
measure: Cardiac Self-Efficacy Scale
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00734916: Immune Modulation by Parenteral Lipids
Official title: Immune Modulation by Omega-3 Versus Omega-6 Based Parenteral Lipids in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections
Total Parenteral Nutrition
Keywords: total parenteral nutrition
infections
Infectious complications related to parenteral nutrition
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Immune modulating properties of parenteral lipid emulsions seem to contribute to the increased risk for infections which remains associated with the use of total parenteral nutrition. Emulsions based on soy bean oil (SO) are the oldest and still most widely used lipid source in TPN formulations but their high content of omega-6 polyunsaturated fatty acids (PUFAs) may be a drawback. Fish oil-based lipid emulsions (FO), rich in omega-3 PUFAs, has been approved for parenteral nutrition in many countries. Mainly retrospective studies on clinical outcomes in septic and postoperative patients have suggested clinical benefits with the inclusion of FO in parenteral nutrition regimens. The exact mechanisms behind the beneficial immunological effects of parenteral FO have, however, not yet been elucidated.

Objective:

To evaluate the effects of intravenous infusion of a FO-based lipid emulsion and a SO-based emulsion on immune function as evidenced by effects on peripheral blood leukocyte counts and functions and on the susceptibility to oxidative stress.

Study design:

Randomized placebo controlled cross-over pilot study with healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Adult (\>18 yrs of age)
* Healthy
* Willingness to give written informed consent

Exclusion Criteria:

* Smoking \> 5 cigarettes/day
* Diet with \> 2 portions of fatty fish per day
* Use of oral fish oil or vitamin substrates
* History of metabolic disorder (especially diabetes or lipid disorders)
* History of allergic, inflammatory of immunological disease
* History of pulmonary, cardiovascular, renal or hematological disease
* Medication use

Primary outcomes:
measure: leukocyte counts
timeFrame: T=0, T=4 days, T=11 days
measure: leukocyte functions
timeFrame: T=0, T=4 days and T=11 days
measure: (anti-)oxidant status
timeFrame: T=0, T=4 days, T=11 days
Secondary outcomes:
measure: plasma and leukocyte cell membrane (phospho)lipid composition.
timeFrame: T=0, t=4 and T=11 days
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Geert JA Wanten, MD, MSc, PhD
role: STUDY_DIRECTOR
References: