louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06670469: Flipped Learning and Escape Room Method on Nursing Students
Official title: The Effect of Flipped Learning and Escape Room Method on Nursing Students' Infection Control Knowledge and Learning Skills: a Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nursing Students
Keywords: Escape room
Flipped learning
Infection control
Nursing Students
Lead sponsor: Bilecik Seyh Edebali Universitesi
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nursing students

Brief summary: The impact of interactive education methods on nursing education will be evaluated.

Detailed description: This study aims to evaluate the effects of reverse learning and escape room methods on nursing students' infection control knowledge and learning skills. The study is an original study in terms of focusing on infection control with relevant interactive methods. The study will contribute to the literature in terms of the development of knowledge-based skills such as providing hand hygiene, opening sterile bundles, opening and placing sterile materials in sterile bundles, wearing and removing personal protective equipment, and disposing of waste materials within the scope of infection control. In addition, the questions to be answered in the study are listed below.

Eligibility criteria: Inclusion Criteria:

* Receiving training on infection control for the first time

Exclusion Criteria:

* Having received training on infection control before
* Not attending the final test, follow-up test
* Not attending class

Primary outcomes:
measure: Number of participants to measure the rate of influence on knowledge level with reverse learning and escape room teaching methods
timeFrame: 01/11/2024-15/12/2024
Secondary outcomes:
Other outcomes:
Locations:
city: Bilecik
country: Turkey
facility: Bilecik Seyh Edebali University
Study officials:
References:
Clinical trial NCT04307069: Management of Prelabor Rupture of the Membranes at Term
Official title: Comparison Between Two Protocols for Management of Prelabor Rupture of the Membranes at Term
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fetal Infection
Chorioamnionitis
Endometritis
Cesarean Section Complications
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 524
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).

Detailed description: Prelabor rupture of the membranes (PROM) refers to rupture of the fetal membranes prior to the onset of regular uterine contractions.

PROM at term can be managed actively by induction of labor or expectantly by waiting for the onset of a spontaneous labor. Several studies have shown an association between expectant management and higher rates of maternal and neonatal adverse outcomes, especially infections. Furthermore, expectant management has been shown to increase the risk for cesarean deliveries (CD), chronic lung disease, cerebral palsy and neonatal mortality. It is suggested that the risk for those complications increase proportionally with the longer the duration of ruptured membranes. Others disagree with those associations.

In this study the investigators will investigate whether early administration of oxytocin is superior to expectant management of 24 hours in patients with PROM at term, in terms of time to delivery and maternal and neonatal adverse outcomes, regardless of bishop score.

Eligibility criteria: Inclusion Criteria:

1. Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
2. Women at gestational age 370/7 or more.
3. Vertex presentation.

Exclusion Criteria:

1. Age 18 and under.
2. High order gestation.
3. Women with contraindication for a vaginal delivery.
4. Active labor.
5. Documented fetal anomalies.
6. Known or suspected intrauterine infection (temperature \> 38 degrees, leucocytosis).
7. Non reassuring fetal heart rate tracing.
8. Positive group B streptococcus status.

Primary outcomes:
measure: Maternal infectious morbidity
timeFrame: Up to 48 hours postpartum
Secondary outcomes:
measure: Length of latent and active phases of labor.
timeFrame: During Labor
measure: Adverse maternal outcome
timeFrame: Up to 48 hours postpartum
measure: Adverse neonatal outcome
timeFrame: Up to 48 hours postpartum
Other outcomes:
Locations:
city: Ramat Yishai
country: Israel
facility: Rambam
Study officials:
affiliation: Rambam Medical Health Center
name: Gal Bachar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03152669: The Extended Salford Lung Study ("Ex-SLS") Data Access Project
Official title: The Extended Salford Lung Study ("Ex-SLS") Data Access Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Keywords: asthma
Chronic obstructive pulmonary disease
Salford Lung Study
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-05-15
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who were randomised for treatment in the original SLS studies

Brief summary: The Salford Lung Study (SLS) subjects represent a group of COPD and asthma patients whose disease is extremely well-characterised over a short time period. Subjects in the SLS originally consented for information relevant to the study to be shared with the sponsor (GSK). These data were limited to three years prior to randomisation and the twelve-month interventional treatment period. Broadened access to patients' data would allow SLS subjects' entire disease journey to be researched, presenting a rare opportunity to improve scientific and clinical understanding of COPD/asthma disease risk, treatment and progression. This proposal seeks to collect additional subject-level data from SLS patients via their electronic medical records (encompassing past and future data for up to 10 years from the date of consent) and via a one-off patient questionnaire administered at the time of consent.


Eligibility criteria: Inclusion Criteria:

* Subjects who were randomized to treatment in the original SLS studies
* Subjects who are able to, and choose to, provide written consent for the additional information to be collected.

Exclusion Criteria:

* Subjects who were lost to follow-up/moved away, withdrew consent or died during or subsequent to the original SLS studies.
* Subjects considered (at the discretion of the investigator) as too ill to participate or without the mental capacity to provide informed consent.

Primary outcomes:
measure: Retrospective EMR data
timeFrame: Up to 10 years
measure: Prospective EMR data
timeFrame: Up to 10 years
measure: Risk factor questionnaire
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Meeraus W, Fry M, Yeatman R, Pimenta JM, Astrom J, Barth A, McCorkindale S, Jones R, Leather D. Key Learnings from Running an Extension Study to a Real-World Effectiveness Trial: The Extended Salford Lung Study. Adv Ther. 2021 Sep;38(9):4847-4858. doi: 10.1007/s12325-021-01827-2. Epub 2021 Aug 6.
Clinical trial NCT03631069: Detecting Dementia in the Retina Using Optical Coherence Tomography
Official title: Detecting Dementia in the Retina: a Big Data Machine Learning Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dementia Alzheimers
Dementia
Dementia, Vascular
Dementia Senile
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 280000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over the age of 40 who have undergone an optical coherence tomography scan at Moorfields Eye Hospital NHS Foundation Trust.

Brief summary: This retrospective case control explores the retinal features of dementia associated with neurodegenerative diseases, particularly Alzheimer's disease. By linking a pseudonymised dataset of three-dimensional retinal scans, called optical coherence tomography, with nationally held data on dementia, corresponding characteristics will be evaluated through descriptive statistics and machine learning techniques.

Detailed description: By 2025, it is estimated that approximately 1 million people in the United Kingdom (UK) will suffer from dementia, a syndrome associated with progressive decline in brain function. While there is currently no cure for most types of dementia, early diagnosis can help patients receive the appropriate treatment and support to help maintain mental function.

The focus of this project is to identify changes in retinal structure associated with dementia. In collaboration with bioinformatics experts at University College London (UCL), the investigators propose to analyse our repository of \>1 million retinal scans, termed optical coherence tomography (OCT), performed regularly on patients since 2008. OCT scans will be linked at a patient level to data from the Hospital Episode Statistics (HES) database to identify those who have been diagnosed with dementia or went on the develop dementia. Thus, a pseudonymised classified dataset of retinal scans will be generated for qualitative and quantitative analysis. The primary objective is to characterise changes in the layers of the retina associated with dementia. Machine learning techniques may also be employed to identify novel patterns of retinal change associated with dementia.

Eligibility criteria: Inclusion Criteria:

All patients over the age of 40 who have undergone an optical coherence tomography scan at Moorfields Eye Hospital NHS Foundation Trust

Exclusion Criteria:

Poor quality image

Primary outcomes:
measure: Retinal nerve fiber layer thickness
timeFrame: 1 year
measure: Ganglion cell layer thickness
timeFrame: 1 year
measure: Macular volume
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
affiliation: University College, London
name: Pearse Keane, MD FRCOphth
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03868969: Clinical Efficacy of Fosfomycin Trometamol Per os in the Treatment of Documented Male Urinary Tract Infections With ESBL-producing Enterobacteriaceae With ESBL Producing Enterobacteriaceae and Resistance Associated With Fluoroquinolones and Cotrimoxazole (FOSF'HOM)
Official title: Clinical Efficacy of Fosfomycin Trometamol Per os in the Treatment of Documented Male Urinary Tract Infections With ESBL-producing Enterobacteriaceae With ESBL Producing Enterobacteriaceae and Resistance Associated With Fluoroquinolones and Cotrimoxazole (FOSF'HOM)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Urinary Tract Infections
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study was to evaluate the clinical and microbiological efficacy of fosfomycin trometamol (FT) per os in the treatment of documented male urinary tract infections with ESBL-producing enterobacteriaceae


Eligibility criteria: Inclusion Criteria:

* clinical suspicion of urinary tract infection (UTI) defined by the presence of at least one of these signs: fever \> 38°C and/or sus-pubic pain and/or dysuria and/or pollakiuria and/or urinary burns and/or macroscopic hematuria and/or acute urinary retention and/or pain with the rectal examination and/or confusion
* And urinary analysis with leukocyturia \> 10 / mm3, bacteriuria \> 10\^3 CFU/mL with ESBL producing enterobacteriaceae and resistance associated with fluoroquinolones (FQ) and cotrimoxazole (CTX) but sensitive to fosfomycin.

Exclusion Criteria:

* allergy to fosfomycin and/or trometamol
* Presence of material in the urinary tract
* Severe immunosuppression
* Chronic prostatitis
* Prostate abscess
* Acute pyelonephritis
* Hemodynamic instability
* Chronic renal failure (clearance \<60 mL/min)
* Prior antibiotic therapy, with an antibiotic sensitive on the antibiotic susceptibility test except: amoxicillin - clavulanic acid, cefixime, nitrofurantoin.
* Co-treatment with metoclopramide

Primary outcomes:
measure: Number of patients with no signs of urinary tract infection
timeFrame: 28 days
Secondary outcomes:
measure: Number of patients with persistence of clinical signs of urinary tract infection
timeFrame: 3 days
measure: Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis
timeFrame: 3 months
measure: Number of patients with digestive, cutaneous disturbance
timeFrame: 28 days
Other outcomes:
Locations:
city: Besançon
country: France
facility: BOUILLER
Study officials:
References:
Clinical trial NCT03328169: Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors
Official title: Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Insomnia
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.

Detailed description: The investigators are recruiting breast cancer survivors with stage I-III or Eastern Cooperative Oncology Group 0-1 breast cancer to enroll in a group-delivered behavioral trial for insomnia. The investigators are comparing mindfulness-based therapies delivered in an alternative medicine context to cognitive behavioral therapy for insomnia. The intervention is 9 weeks, for two hours weekly.

Eligibility criteria: Inclusion Criteria:

* American Joint Committee on Cancer (AJCC) Stage I-III or Eastern Cooperative Oncology Group (ECOG) 0-1 breast cancer
* completed active treatment (surgery, radiation, chemotherapy) at least three months prior
* within 5 years of treatment or still on adjuvant therapy
* Completes informed consent to participate

Exclusion Criteria:

* sleep apnea or restless leg syndrome
* practicing mindfulness techniques \>1/wk

Primary outcomes:
measure: Change in Insomnia
timeFrame: Nine weeks
measure: Change in Insomnia
timeFrame: Nine weeks
Secondary outcomes:
measure: Change in cognitive function
timeFrame: Nine weeks
measure: Change in cognitive function
timeFrame: Nine weeks
measure: Change in Fatigue
timeFrame: Nine weeks
measure: Change in Insomnia
timeFrame: Nine weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: GW Center for Integrative Medicine
state: District of Columbia
Study officials:
References:
Clinical trial NCT03633669: Effect of Real-world Tight Control Management of Inflammatory Bowel Disease
Official title: Effect of Real-world Tight Control Management of Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 0
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: Inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, is a condition that causes inflammation in the gastrointestinal tract. The disease goes through periods of remission and flare. Biomarkers such as fecal calprotectin have been proposed as a tool to monitor disease activity. Fecal calprotectin is a test that measures the amount of inflammation in the stool. Monitoring fecal calprotectin levels can assist gastroenterologists in making decisions regarding patients' IBD treatment such as whether to increase the dose of medications. A recent study showed that frequent measurement of fecal calprotectin every 3 months, also called the tight-control strategy, was associated with improved clinical outcomes in IBD patients. The purpose of this study is to assess whether the tight-control monitoring strategy, which includes fecal calprotectin monitoring every 3 months, improves clinical outcomes in IBD when performed in the real world compared to routine clinical practice.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Crohn's disease or ulcerative colitis based on clinical, endoscopic, radiologic or histologic criteria.
2. Followed by a gastroenterologist at Hamilton Health Sciences, St. Joseph's Healthcare Hamilton, and London Health Sciences
3. Aged 18 or older
4. In clinical remission according to the clinical symptom assessment (Partial Mayo score \< 2 or Harvey-Bradshaw Index \< 4)
5. Currently treated with adalimumab

Exclusion Criteria:

1. Current abdominal abscess
2. Inability or unwillingness to provide informed consent
3. Any other condition, which in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study

Primary outcomes:
measure: Rate of Relapse
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Clinical symptom relapse
timeFrame: 12 months
measure: Incidence of Hospitalizations
timeFrame: 12 months
measure: Incidence of change in medical therapies
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02869269: A Study of Circulating Immune Cell Activity Changes in Blood of Colorectal Cancer Patients
Official title: A Study of Circulating Immune Cell Activity Changes in Blood of Colorectal Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing colorectal surgery

Brief summary: Previous studies have shown that colorectal cancer patients' prognosis and overall survival was related with immune cell expression in patients' tissue. However, the circulating immune cell activity changes in patients' blood has few studies. The purpose of this study is to analyze the variation of circulating immune cell activity in colorectal patients' blood which is classed as clinical staging.

Detailed description: The patients were classed as clinical staging

1. Early (stage1+2) and Late(stage3+4)
2. regional lymph node metastasis
3. Distant metastasis
4. TNM stage

Eligibility criteria: Inclusion Criteria:

* patient who was planned to undergo colorectal cancer surgery.

Exclusion Criteria:

* age \< 20 years old
* history of hypersensitivity reaction in propofol or sevoflurane
* history of previous cancer
* patient with ongoing inflammation

Primary outcomes:
measure: Circulating helper T cell activity
timeFrame: preoperative time
Secondary outcomes:
measure: Cytotoxic T cell and natural killer cell activity
timeFrame: preoperative time
Other outcomes:
measure: CD4 and Treg cell activity and change of percentage of CD39 and CD73
timeFrame: preoperative time
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Seong-Hyop Kim, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02770469: Culturally Tailored Educational and Support Program to Increase Quality of Life Among Korean Breast Cancer Survivors
Official title: Behavioral Intervention to Reduce Breast Cancer Disparity Among Underserved Koreans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Korean Americans
Survivorship
Quality of Life
Coping Skills
Perceived Stress
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-05-12
Enrollment: 86
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of the TOGETHER (Together Overcome and Get Empowered Through Health Education and Relationships) program was to examine the effectiveness of one of the first linguistically and culturally tailored intervention programs to increase quality of life among Korean American breast cancer survivors.

Detailed description: This study employed a randomized trial design, consisting of a standard and enhanced intervention group. Participants attended seven weekly sessions and one follow-up session that lasted for about 2 hours each. All sessions were conducted by two Korean female bilingual licensed clinical psychologists.

The specific aims of this study were to: (1) Implement and evaluate the effects of tailored intervention on perceived stress, coping and quality of life among Korean American breast cancer survivors; and (2) Conduct a process evaluation to assess the feasibility and fidelity of the intervention, which will provide data that can inform the development of future interventions.

Eligibility criteria: Inclusion Criteria:

* Living in Maryland, Northern Virginia, or the Washington D.C. metropolitan area
* Have been diagnosed with breast cancer
* Have had surgery, completed treatment within the last two years, or still receiving adjuvant therapies

Exclusion Criteria:

* Unable to understand Korean

Primary outcomes:
measure: Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: changes in quality of life during baseline, 7 weeks, and 14 weeks
Secondary outcomes:
measure: Cancer Behavior Inventory- Brief Version (CBI-B)
timeFrame: changes in self-efficacy for coping with cancer during baseline, 7 weeks, and 14 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: changes in stress during baseline, 7 weeks, and 14 weeks
measure: Additional items to assess improvement in skills/knowledge covered by the intervention program
timeFrame: changes in responses during baseline, 7 weeks, and 14 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland School of Public Health
name: Sunmin Lee, ScD
role: PRINCIPAL_INVESTIGATOR
References: