louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06548698: The Impact of Escape Room Experience in Nursing Students
Official title: The Impact of Escape Room Experience on Problem Solving and Professional Behavior Levels in Nursing Students: An Interventional Educational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Education
Keywords: nursing students
nursing education
escape room
problem solving
professional behavior
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Gamification is an applied, team-based approach in which students are actively involved. This study was conducted to evaluate the effect of escape room experience on the level of problem solving skills and professional behavior in nursing students.

This study was completed in a randomized controlled trial with 43 final year nursing students from a university. Students were randomized into intervention (n=22) and control (n=21) groups. In this study, data were collected with the Game Experience Scale, Problem Solving Inventory, and Nursing Students Professional Behavior Scale. The data obtained from the study were evaluated with SPSS 24.0. Descriptive statistics; number (n), percentage (%), mean (X), standard deviation (SD) were given. Statistical significance level was evaluated as p\<0.05. The students in the intervention group analyzed the breast cancer surgery case with the escape room experience. The students were divided into groups of 5 and tried to complete the tasks given by the researchers within 30 minutes. During the escape room practice, the researchers were present in the rooms as observers and evaluated the participants.


Eligibility criteria: Inclusion Criteria:

* Active students in the spring semester of the 2023-2024 academic year,
* A fourth-year nursing student,
* To take the surgical diseases nursing intern practice module,
* Preparing an individualized patient care plan for at least one surgical patient,
* Students who have previously prepared and presented at least one surgical patient-specific case with group work

Exclusion Criteria:

* Those who have lessons they did not take in 1st-3rd classes,
* Never planned care for surgical patients in previous clinical practice,
* Students who refused to participate in the study

Primary outcomes:
measure: Problem solving level
timeFrame: 5 week
measure: professional behavior level
timeFrame: 5 week
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Health Sciences
Study officials:
References:
Clinical trial NCT01316198: Effects of Xanthophylls on Optical Density
Official title: Alteration of Optical Density and Plasma Xanthophylls After Short Term Supplementation With Macular Carotenoids in Patients With AMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Macular Degeneration
Keywords: human study
AMD
lutein
zeaxanthin
optical density
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study was to investigate the influence of a intervention with lutein und zeaxanthin from crucifers on the optical density of the macular pigment of patients with non exudative age-related maculopathy. It is hypothesized that the applied study beverage elevates plasma concentrations of the administered xanthophylls and the optical density after 4 weeks of intervention.


Eligibility criteria: Inclusion Criteria:

* patients with non exudative age-related maculopathy

Exclusion Criteria:

* intake of dietary supplements containing lutein and zeaxanthin

Primary outcomes:
measure: Optical density of macular pigment in AMD patients
timeFrame: 10 weeks
Secondary outcomes:
measure: Concentration of xanthophylls in plasma of AMD patients
timeFrame: 10 weeks
measure: blood lipids
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University
state: Thuringia
Study officials:
affiliation: Friedrich Schiller University Jena, Institute of Nutrition, RG Bioactice Plant Products
name: Volker Boehm, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05507398: The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer
Official title: Comparative Clinical Study Evaluating the Anti-tumor Effect of Metformin Versus Atorvastatin as an Adjuvant Therapy With Chemotherapy in Patients With Non-metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer Female
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at evaluating and comparing the anti-tumor effects of metformin and statins (hydroxyl-methyl-glutaryl-CoA reductase inhibitors) in patients with non-metastatic breast cancer (stage I, II, \& III).

Detailed description: Worldwide, BC is the most frequently diagnosed life-threatening cancer in women. In EGYPT, breast cancer is the foremost oncologic problem, contributing to 20% of all cancers and 43% of female cancers. Metformin and atorvastatin have anti-tumor effects. To date, there are limited data to investigate and compare the anti-tumor effect between metformin and statins in patients with breast cancer.

Eligibility criteria: Inclusion Criteria:

* Patients with radiologically and histologically (biopsy) confirmed diagnosis of breast cancer and with stage I, II, and stage III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
* Patients with no contraindication for chemotherapy, metformin, or statins
* Females aged ≥ 18 years old
* Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score

Exclusion Criteria:

* Patients with metastatic breast cancer (stage IV)
* Pregnant or lactating women.
* Patients with hepatic or renal impairment.
* Patients with myopathy.
* Patients with any condition predispose to acidosis (COPD, heart failure, ....)
* Patients who had dementia, mental retarded, and any psychiatric condition that would prohibit the understanding or signing of informed consent.

Primary outcomes:
measure: Improvement in the overall response rate
timeFrame: 6 months
measure: Improvement in the pathological response
timeFrame: 6 monthes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tanta university, faculty of pharmacy
name: ahmed elabd, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00754598: Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
Official title: A Multicenter, Controlled Clinical Trial to Evaluate the Hologic 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
digital mammography
tomosynthesis
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 1183
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief summary: This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States. Subjects were from either a Screening population or a biopsy population and were imaged first on a conventional 2D full filed digital mammography system then on a 3D tomosynthesis system.

The resulting images from the this portion of the study were then randomized into a reader study.

The purpose of this clinical study was to compare the 3-D tomosynthesis system used in conjunction with a conventional 2-D digital imaging system (2-D plus 3-D images) to the conventional 2-D digital imaging system (2-D images), and to determine whether the 2-D plus 3-D images compared to the 2-D images alone would:

1. Reduce the recall rate And/or
2. Improve ROC area due to improved breast cancer detection and/or improved lesion classification.


Eligibility criteria: Inclusion Criteria:

* Female
* Any ethnic origin
* No contraindication for screening mammography

Exclusion Criteria:

* Significant breast trauma
* Pregnancy
* Lactating
* Breast implants
* Previous breast cancer
* Previous surgical biopsy
* Placement of an internal breast marker
* Unable to understand and or execute written informed consent

Primary outcomes:
measure: To detect a 20% reduction in the recall rate when comparing the recall rate using the BIRADS 0 scores of the 2-D plus 3-D images to the 2-D images.
timeFrame: 10-12 months
Secondary outcomes:
measure: To detect a 0.05 increase in the area under the ROC curve when comparing 2-D plus 3-D images to the 2-D images.
timeFrame: 10-12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Iowa City
country: United States
facility: University of Iowa Medical Center
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Pittsburgh
country: United States
facility: Magee Women's Hospital
state: Pennsylvania
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth Rafferty, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01309698: Drug Interaction of Vildagliptin (LAF237) With Voglibose in Japanese Patients With Type 2 Diabetes
Official title: An Open-label, Randomized and Crossover Study to Assess the Effect of Co-administration of Vildagliptin and Voglibose on the Steady-state Pharmacokinetics / Pharmacodynamics in Japanese Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Drug interaction
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients with inadequately controlled on diet therapy and exercise therapy (HbA1c in the range 6.5 to 10.0% inclusive by NGSP)

Exclusion Criteria:

* Fasting plasma glucose ≥ 270 mg/dL A history of Type 1 diabetes or secondary forms of diabetes Treatment of anti-diabetic agents including GLP-1 analogues within 8 weeks or insulin within 6 months prior to screening Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Pharmacokinetics of vildagliptin
timeFrame: Up to 12 hours post-dose
Secondary outcomes:
measure: Pharmacodynamic parameters (dipeptidyl peptidase IV (DPP-4) activity, glucagon-like peptide-1(GLP-1), glucose, insulin, glucagon)
timeFrame: Up to 4 hours or 12 hours post-dose
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Yamaguchi M, Saji T, Mita S, Kulmatycki K, He YL, Furihata K, Sekiguchi K. Pharmacokinetic and pharmacodynamic interaction of vildagliptin and voglibose in Japanese patients with Type 2 diabetes. Int J Clin Pharmacol Ther. 2013 Aug;51(8):641-51. doi: 10.5414/CP201902.
Clinical trial NCT04416698: Understanding Risk Perception, Behaviour, and Attitudes Related to Other New Tobacco Products Among Youth
Official title: Helping Youth to Quit Smoking by Understanding Their Risk Perception, Behaviour, and Attitudes Related to Electronic Cigarettes and Other New Tobacco Products
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smoking Cessation
Keywords: Youth smokers smoking cessation, tobacco products
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 390
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth smokers

Brief summary: To understand the risk perception, behaviour, and attitudes related to electronic cigarettes and other tobacco products among youth.

Detailed description: Phase I Individual qualitative interviews will be conducted to understanding the needs and concerns of youth smokers of e-cigarette or other new tobacco products, including their risk perceptions, and the behaviour, attitudes, and experiences related to these products.

Phase II The findings from the interview in phase I will guide the development of a structure questionnaire for a cross-sectional survey to further explore the behaviour, attitudes, and experiences related to e-cigarette or other new tobacco products among youth.

The findings of this study have important implications for research and clinical practice. Understanding how youth smokers perceive the risks of using e-cigarette and other new tobacco products, and their behaviour, attitudes, experiences related to smoking to help them achieve smoking abstinence. Moreover, the results of this study can understand the misconceptions about e-cigarette and other new tobacco product among youth, increase their perception of the risks of continued smoking and benefits of quitting.

Eligibility criteria: Inclusion Criteria:

* Youth smokers who contacted the Youth Quitline will be eligible to be included in this study if they (1) are ethnic Chinese; (2) are aged ≤ 25 years; (3) are ever user of e-cigarette or any new tobacco products; and (4) spoke Cantonese.

Exclusion Criteria:

* psychologically or physically unable to communicate

Primary outcomes:
measure: Smoking behaviors in phase I
timeFrame: Baseline
measure: Smoking behaviors in phase II
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
state: Pokfulam
Study officials:
affiliation: The University of Hong Kong
name: Ho Cheung William Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01177098: Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 561
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: This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Patient has ocular hypertension or glaucoma in both eyes
* Requires IOP-lowering therapy in each eye

Exclusion Criteria:

* Active or recurrent eye disease that would interfere with interpretation of study data in either eye
* History of any eye surgery or laser in either eye within 6 months
* Required chronic use of other eye medications during the study
* Anticipated wearing of contact lenses during the study.
* Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days

Primary outcomes:
measure: Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
timeFrame: Baseline, Week 12
measure: Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
timeFrame: Week 2
measure: Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
timeFrame: Week 6
measure: Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Sydney
country: Australia
state: New South Wales
city: Brno
country: Czech Republic
city: Leipzig
country: Germany
city: Budapest
country: Hungary
city: Tel Aviv
country: Israel
city: Saint-Petersburg
country: Russian Federation
city: Valencia
country: Spain
city: London
country: United Kingdom
state: England
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Goldberg I, Gil Pina R, Lanzagorta-Aresti A, Schiffman RM, Liu C, Bejanian M. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial. Br J Ophthalmol. 2014 Jul;98(7):926-31. doi: 10.1136/bjophthalmol-2013-304064. Epub 2014 Mar 25.
Clinical trial NCT05853198: Circulating Tumor DNA as Surgical Biomarker in Patients With PancrEatic Adenocarcinoma for Statement of Resectability
Official title: Circulating Tumor DNA as Surgical Biomarker in Patients With PancrEatic Adenocarcinoma for Statement of Resectability
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PDAC - Pancreatic Ductal Adenocarcinoma
Keywords: biomarker
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective is the evaluation of the prognostic value of ctDNA (circulating tumor DNA) as a marker of surgical futility in patients with operable PDAC.

Detailed description: In the era of personalized medicine and treatments guided by tumor biology, no specific tumor marker has real prognostic value. This is the reason why the search for a specific marker through a noninvasive blood test that can give indications on the usefulness of the resectability of pancreatic adenocarcinoma would be very valuable. Our project proposes the evaluation of ctDNA during various treatment courses of patients with PDAC in order to evaluate its efficacy as a prognostic and predictive marker of response to treatment.

Eligibility criteria: Inclusion Criteria:

1. Patients with PDAC with indication to surgical resection, including those undergoing upfront surgery or surgery following induction treatment. Non resectable patient defined as a patient with surgical indication at standard preoperative clinical, biological and morphological evaluation, but eventually not resected because of advanced disease or contraindications revealed during surgical exploration will be excluded
2. Non-metastatic status confirmed by an abdomen CT-scan (as our routine clinical practice).
3. Patients able to give a specific informed consent.
4. Age ≥ 18 years.

Exclusion Criteria:

1. Non resectable patient defined as a patient with surgical indication at standard preoperative clinical, biological and morphological evaluation, but eventually not resected because of advanced disease or contraindications revealed during surgical exploration will be excluded (drop-out)
2. Non-controlled congestive heart failure.
3. Non-treated angina.
4. Recent myocardial infarction (in the previous year).
5. Non-controlled AHT (SBP \>160 mm or DBP \> 100 mm, despite optimal drug treatment).
6. Long QT.
7. Major non-controlled infection.
8. Severe liver failure.
9. Age \< 18 years.
10. Informed consent not signed.
11. Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception.

Primary outcomes:
measure: Disease relapse
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona
Study officials:
References:
Clinical trial NCT03526198: Quantification of Distribution of the Mass Center for a Controlled Force Platform Reaction to the Ground
Official title: Quantification of Distribution of the Mass Center for a Controlled Force Platform Reaction to the Ground
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance
Keywords: Force plate
Center of mass
Lead sponsor: Universidade Cruzeiro do Sul
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study developed a controlled soil reaction force platform that provided controlled mechanical stimuli to quantify the distribution of the center of mass as a function of the angular variation of the ankle in the elderly in the upright position.

Detailed description: Usually the balance evaluation the center of mass displacement for the analysis of postural control is assessed by means of force platforms. However, most of these devices are stationary, that is the patient is the dynamic element which can generate an evaluation with high subjectivity index. Therefore, this study aimed at developed a reaction force to the ground platform which provides mechanical stimuli controlled to quantify the distribution of the mass center as a function of the angular variation in the elderly ankle in the upright position. The construction of the prototype was divided into 3 steps, based on the two-dimensional movement of the ankle joint. In the 1st stage the construction of the mechanical assembly; in the 2nd stage development of the electronics; and 3rd stage the development of the supervisory system (control system). The force plataform was evaluated following the engineering functional tests such as: characterization and calibration of the sensors, the definition of the transfer function and accuracy of tests of angular movements (+ 10 ° and -10 ° to the movements of inversion and eversion, + 15 and -15º to the movements of dorsiflexion and plantar flexion). For the tests with volunteers were selected 30 volunteers.

Eligibility criteria: Inclusion Criteria:

* We included in this study individuals male and female
* Age ranging from 20 to 85 years
* Asymptomatic individuals
* Must walk without the use of an attachment
* Do not present motor deficit that makes the study impossible

Exclusion Criteria:

* Decompensated congestive heart failure
* Neurological or neurological diseases that interfere with significant neuromotor
* Individuals who did not agree to participate in the study

Primary outcomes:
measure: Mass distribution
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: