louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06643546: Effects of Simulation Practices on Breastfeeding Knowledge and Skills of Nursing Students
Official title: The Effect of Different Simulation Applications Used in Breastfeeding Education on Breastfeeding Knowledge, Skills and Clinical Self-Efficacy of Nursing Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Use of Different Simulation Techniques in Breastfeeding Education
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 157
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Objective: This study evaluated the effectiveness of breastfeeding education using different simulation techniques on nursing students' breastfeeding knowledge, counseling skills, and clinical self-efficacy.

Method: The study sample consisted of 157 nursing students. Data were collected using a sociodemographic questionnaire, the Breastfeeding Assistance Clinical Preparedness Scale, the Breastfeeding Knowledge Form, the Clinical Self-Efficacy in Performance Scale, and the Breastfeeding Counseling Skills Checklist.

Conclusion: We expect that simulation and standardized patient-based breastfeeding education will effectively improve nursing students' readiness for breastfeeding assistance, breastfeeding knowledge, breastfeeding counseling skills, and clinical self-efficacy in breastfeeding performance.


Eligibility criteria: Inclusion Criteria:

having taken a gynecology and obstetrics nursing course, volunteering to participate in the research, and not having received formal training on breastfeeding.

Exclusion Criteria:

voluntarily withdrawing from the research and not participating in any stages of the research.

Primary outcomes:
measure: Breastfeeding Assistance Clinical Readiness Scale
timeFrame: before training, 1 hour after training, 4 weeks after
measure: Breastfeeding Information Form
timeFrame: before training, 1 hour after training, 4 weeks after
measure: Self-efficacy scale in clinical performance
timeFrame: before training, 1 hour after training, 4 weeks after
measure: Breastfeeding Counseling Skills List
timeFrame: 4 week after training
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Nursing Faculty
Study officials:
References:
Clinical trial NCT03279146: A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
Official title: Open-Label, Part-Randomized Study Designed to Evaluate the PK Profile of Tenofovir Exalidex (TXL) Following Single Dose of Oral Formulations in Comparison to a Reference IR TXL Tablet in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: ContraVir
Sponsor class: UNKNOWN
First posted: 2017-09-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Drug: Tenofovir Exalidex (TXL) oral formulations Other names: Lipid conjugateTFV
Primary purpose: OTHER

Brief summary: This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy subjects

Detailed description: This is a Phase 1 study to evaluate the PK profile of different oral formulations of TXL following single dose administration in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Age:18-55 Capable of giving written informed consent Capable of completing study requirements

Exclusion Criteria:

* History or medical condition which could impact patient safety History of drug or alcohol abuse within past 2 years Positive result for HIV, HBV, or HCV Participation in another clinical trial within the past 90 days

Primary outcomes:
measure: Evaluation of pharmacokinetics of single dose oral formulations of TXL in fasted state
timeFrame: up to four days post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: ContraVir Pharmaceuticals
name: John Sullivan-Bolyai, MD, MPH
role: STUDY_CHAIR
References:
Clinical trial NCT01395446: Application of an Electronic Nose in the Early Detection of ASpergillosis
Official title: The Application of an Electronic Nose in the Early Detection of ASpergillosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Invasive Aspergillosis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients that will undergo treatment for a hematological malignancy expected to result in grade 4 neutropenia of prolonged duration

Brief summary: The purpose of this study is to establish the accuracy with which the eNose can discriminate patients with invasive pulmonary aspergillosis from controls.


Eligibility criteria: Inclusion Criteria:

Patients that

1. are 18 years of age or older
2. will undergo treatment for a hematological malignancy expected to result in grade 4 neutropenia (according to CTCAE 3.0, i.e. \<0.5 x 109 neutrophils/L) of prolonged duration (i.e., more than 7 days), e.g. hematopoietic stem cell transplantation or induction/consolidation treatment for acute myeloid leukaemia
3. have given written informed consent

Exclusion Criteria:

1. a previously diagnosed invasive mycosis
2. the inability to perform the breathing manoeuvre needed for eNose-analysis of exhaled air

Primary outcomes:
measure: accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Department of Hematology, Academic Medical Center
Study officials:
References:
Clinical trial NCT04436146: The Effect of Laryngeal Manual Therapy as a Management of Globus
Official title: The Effect of Laryngeal Manual Therapy as a Management of Globus(Sensation of a Lump in the Throat )- COMPARATIVE PROSPECTIVE STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Globus
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 70
Sex: ALL
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 purpose of this study is to assess the effect of laryngeal manual therapies in the treatment of globus (sensation of a lump in the throat).

Detailed description: This is a prospective study that include patients who met the inclusion criteria.

Data collection includes patients age,gender,clinical manifistations,laboratory parameters and treatment.

An endoscopic examination will be done by an expert Otolaryngologist. for each patients we will perform one session of laryngeal manual massage therapy by an expert in the field .

Eligibility criteria: Inclusion Criteria:

* patients more than 18 years old
* male and females
* patients complaning from Globus without an organic cause
* patients who underwent throat endoscopy and was normal.
* Patients who received conventional drug therapy without benefit.
* Globus complaints more than two months .

Exclusion Criteria:

* below 18
* Patients diagnosed with reflux(as a cause to globus)
* Patients who considered at high risk of reflux according to REFLUX SYMPTOM INDEX (RSI) more than 13
* patients who diagnosed with reflux and improved after anti-reflux manegment .
* patients with laryngeal disease/finding that can explain the globus.
* patients with organic cause that can explain the globus .

Primary outcomes:
measure: Change From symptomatic to asymptomatic patient
timeFrame: baseline and week 1
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: HaEmek Medical Center, Israel
name: Miki Paker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02447146: Resistance Training in Patients With Parkinson's Disease.
Official title: Effects of Resistance Training on Bradykinesia and Physical Function in Patients With Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2015-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a controlled trial to assess the effects of resistance training on bradykinesia and physical function in patients with Parkinson's Disease. Forty patients diagnosed with Parkinson Disease stage 1 to 3 of the Hoehn and Yahr scale took part in the study and were allocated into 2 groups; Training Group performed a 9-week RT program twice a week while the Control Group attended lectures on the disease.


Eligibility criteria: Inclusion Criteria:

* Medical neurologist confirmation of 1-3 Hoehn and Yahr stages,
* age between 50 and 80 years old;
* and physician attested to participate in the resistance training program.

Exclusion Criteria:

* Diagnostic of any other neurological disease, cardiovascular disease, hematologic or orthopedic disorders;
* and motor fluctuations or severe dyskinesia that could affect their ability to perform the experimental protocol.

Primary outcomes:
measure: Bradykinesia measured with Unified Parkinson's Disease Rating Scale, section III
timeFrame: One time point; after the end of 9-week resistance training
measure: Functional Performance measured with Ten Meters Walk Test.
timeFrame: One time point; after the end of 9-week resistance training
Secondary outcomes:
measure: Muscle strength measured with isokinetic peak torque.
timeFrame: One time point; after the end of 9-week resistance training
Other outcomes:
Locations:
Study officials:
affiliation: College of Physical Education - University of Brasilia
name: Ricardo Oliveira, PhD
role: STUDY_DIRECTOR
References:
citation: Dibble LE, Hale TF, Marcus RL, Droge J, Gerber JP, LaStayo PC. High-intensity resistance training amplifies muscle hypertrophy and functional gains in persons with Parkinson's disease. Mov Disord. 2006 Sep;21(9):1444-52. doi: 10.1002/mds.20997.
citation: Falvo MJ, Sirevaag EJ, Rohrbaugh JW, Earhart GM. Resistance training induces supraspinal adaptations: evidence from movement-related cortical potentials. Eur J Appl Physiol. 2010 Jul;109(5):923-33. doi: 10.1007/s00421-010-1432-8. Epub 2010 Mar 21.
citation: Fisher BE, Wu AD, Salem GJ, Song J, Lin CH, Yip J, Cen S, Gordon J, Jakowec M, Petzinger G. The effect of exercise training in improving motor performance and corticomotor excitability in people with early Parkinson's disease. Arch Phys Med Rehabil. 2008 Jul;89(7):1221-9. doi: 10.1016/j.apmr.2008.01.013. Epub 2008 Jun 13.
citation: Allen NE, Canning CG, Sherrington C, Fung VS. Bradykinesia, muscle weakness and reduced muscle power in Parkinson's disease. Mov Disord. 2009 Jul 15;24(9):1344-51. doi: 10.1002/mds.22609.
Clinical trial NCT01914146: Insulin Therapy and Falls Due to Orthostatic Hypotension
Official title: Insulin Therapy and Falls Due to Orthostatic Hypotension (Pilot Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Orthostatic Hypotension
Diabetes
Syncope
Keywords: Diabetes
Insulin
Orthostatic Hypotension
Falls
Syncope
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In the proposed study, the investigators examine in older adults with Type 2 diabetes the impact of beginning insulin therapy on the orthostatic drop in blood pressure as well as the response of arterial blood pressure and Doppler measures of cerebral blood flow during upright tilt. The investigators hypothesize that in older adults with Type 2 diabetes, the cardiovascular effects of insulin would precipitate or worsen orthostatic intolerance not present at baseline.

Detailed description: Before and 2 weeks after the start of standard insulin therapy several tests will be done:

* orthostatic hypotension will be tested for with 3 orthostatic maneuvers
* vasovagal syncope will be tested with 2 tilt table tests, one augmented with 400ug of nitroglycerin
* MCA velocity will be measured with a transcranial doppler
* Heart Rate and Blood Pressure will be measured throughout the test with a Finometer and Power Lab on a beat to beat basis

Eligibility criteria: Inclusion Criteria:

* All subjects must be 65 years of age or older
* All must have been diagnosed with Type 2 diabetes for at least 5 years
* All subjects must be insulin-naïve on recruitment
* All subjects must be eligible to start insulin therapy (long or intermediate acting) as determined by their diabetologist

Exclusion Criteria:

* Anemia, as determined by serum hematocrit
* Abnormal liver function tests
* Elevated creatinine
* Smoker
* Musculoskeletal or neurological condition that would preclude tilt table testing or orthostatic vitals

Primary outcomes:
measure: 1. Presence or absence of orthostatic hypotension
timeFrame: 1 day
Secondary outcomes:
measure: 1. The nadir of middle cerebral artery (MCA) velocity
timeFrame: 1 day
measure: 2. The presence or absence of a positive augmented tilt table test
timeFrame: 1 day
measure: 3. The nadir of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during tilt table test.
timeFrame: 1 day
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kenneth M Madden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01021046: Deep Anterior Lamellar Keratoplasty (DALK) Using Acellular Corneal Tissue Promotes Corneal Allograft Survival in High Risk Patients
Official title: Deep Anterior Lamellar Keratoplasty Using Acellular Corneal Tissue Promotes Corneal Allograft Survival in High Risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycerin Cryopreserved Acellular Corneal Tissue
Deep Anterior Lamellar Keratoplasty
High Risk Keratoplasty
Keywords: deep anterior lamellar keratoplasty
rejection
high risk patients
acellular corneal tissue
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2009-11-26
Enrollment: 78
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 study whether deep anterior lamellar keratoplasty (DALK) using acellular tissue will promote corneal graft survival in high risk patients.


Eligibility criteria: Inclusion Criteria:

* severe bacterial keratitis
* Herpes simplex keratitis
* severe fungal keratitis
* partial limbal deficiency after chemical burn

Exclusion Criteria:

* posterior stroma involved in severe bacterial and fungal keratitis
* dry eye
* glaucoma or intraocular pressure greater than 21 mmHg
* amblyopia
* retinal abnormalities
* patients with severe systemic diseases not good for ocular surgery

Primary outcomes:
measure: rejection
Secondary outcomes:
measure: laser scanning in vivo confocal microscopy
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital, Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Eye Hospital, Wenzhou Medical College, China
name: Wei Chen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li J, Yu L, Deng Z, Wang L, Sun L, Ma H, Chen W. Deep anterior lamellar keratoplasty using acellular corneal tissue for prevention of allograft rejection in high-risk corneas. Am J Ophthalmol. 2011 Nov;152(5):762-70.e3. doi: 10.1016/j.ajo.2011.05.002. Epub 2011 Jul 30.
Clinical trial NCT06729346: Is the Normal Looking Bladder Mucosa on WL Cystoscopy During TURBT Really Normal and Can NBI Detect Hidden Tumor
Official title: Can Narrow-band Imaging Detect CIS/Tumor in Normally Looking Bladder Mucosa on White Light Cystoscopy During Transurethral Resection of Bladder Tumor?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transition Cell Cancer
Lead sponsor: Armed Forces Institute of Urology, Rawalpindi
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: any patient who presented with armed forces institute of urology with bladder tumor .

Brief summary: As every urologist does transurethral resection of bladder tumor. So there are instances in which the operating surgeon is not sure whether the normal-looking mucosa or the inflammatory changes are really benign or if we are missing the CIS/bladder cancer.

Detailed description: This is basically the observational study. in which we want to clarify that the normal-looking mucosa on white light cystoscopy is normal in reality or we are missing CIS/bladder tumor.

Eligibility criteria: Inclusion Criteria:

any patient with bladder tumor

-

Exclusion Criteria:

* any patient whose age is less than 18 years any patient whose age is more than 75 years

Primary outcomes:
measure: to prove suspicious-looking mucosa on NBI has a bladder tumor on histopathology..
timeFrame: At the time of TURBT
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of Urology
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of Urology
state: Punjab
Study officials:
affiliation: armed forces institute of urology
name: azmat ullah, consultant urologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04343846: Eruption Status of Primary Teeth in Low Birth Weight Children in Comparison to Normal Birth Weight Childern
Official title: Eruption Status of Primary Teeth and BMI in Low Birth Weight Children in Comparison to Normal Birth Weight Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eruption Statues of Primary Teeth in LBW Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 72
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy children aged from 6 months to 36 months

Brief summary: determine the status of eruption of primary teeth and physical growth in children aged from 6 to 36 months with low birth weight in comparison to normal birth weight

Detailed description: Timing of eruption of primary teeth is an urgent question for every mother especially in low birth weight children. Although, the timing of eruption of primary teeth and their sequence of eruption shown to be under the genetic control , pre-natal maternal conditions, early childhood metabolic and nutritional factors along with socioeconomic states have been associated with the timing of eruption of primary teeth.

Many factors may affect the timing of eruption. Literature showed that factors like gender, race and physical growth may influence emergence of tooth in child mouth but there is scarce information on Egyptian children .

Eligibility criteria: Inclusion Criteria:

* Healthy children.
* Children aged from 6 to 36 month.

Exclusion Criteria:

* Refusal of participation from the parents.
* Medically compromised children.
* Major illness.
* The child had special needs.
* Any systemic disease.
* Any congenital deformity that may affect teeth eruption.

Primary outcomes:
measure: status of eruption of primary teeth
timeFrame: 1 year
Secondary outcomes:
measure: child physical growth
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Shaweesh AI, Al-Batayneh OB. Association of weight and height with timing of deciduous tooth emergence. Arch Oral Biol. 2018 Mar;87:168-171. doi: 10.1016/j.archoralbio.2017.12.030. Epub 2017 Dec 29.
citation: Soliman NL, El-Zainy MA, Hassan RM, Aly RM. Relationship of deciduous teeth emergence with physical growth. Indian J Dent Res. 2012 Mar-Apr;23(2):236-40. doi: 10.4103/0970-9290.100433.
Clinical trial NCT05127746: Phase 1 Clinical Trial of DA-5207 in Healthy Adults
Official title: An Open-label, Randomized, Cross-over, Multiple Dose, Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of DA-5207 Transdermal Delivery System in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults


Eligibility criteria: Inclusion Criteria:

* Health Volunteers (Age: 19\~55 years)
* Body Weight: Male≥55kg, Female≥50kg
* 18.5 ≤BMI≤ 25.0

Exclusion Criteria:

* Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
* Allergy or Drug hypersensitivity
* Clinically significant Medical History
* AST, ALT\>Upper Normal Range\*1.25, eGFR\<60mL/min/1.73m²
* Heavy caffeine intake
* Heavy alcohol intake (more than 210g/week)
* Heavy smoker (more than 10 cigarettes/day)

Primary outcomes:
measure: AUC
timeFrame: 29-36 days
measure: Css,max
timeFrame: 0-36 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
state: Jeonbuk
Study officials:
References:
Clinical trial NCT03988946: Cephea Transseptal Mitral Valve System FIH
Official title: Cephea Mitral Valve and Transseptal Delivery System FIH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: Cephea Valve Technologies
Sponsor class: INDUSTRY
First posted: 2019-06-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.


Eligibility criteria: MVARC

Primary outcomes:
measure: Safety as measured by freedom from major adverse events
timeFrame: 30 days
measure: Performance
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
Study officials:
affiliation: Cephea Valve Technologies
name: Helen J Scotch
role: STUDY_DIRECTOR
References: