louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06897592: The Effect of Enneagram on Midwifery Students Communication, Self-confidence and Emotional Intelligence
Official title: The Effect of Enneagram Training on Midwifery Students Communication, Self-confidence and Emotional Intelligence Levels: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Enneagram
Keywords: communication
self-confidence
emotional intelligence
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized study with an application and a control group.
Primary purpose: OTHER

Brief summary: This research was planned to evaluate the effects of Enneagram training on the communication skills, self-confidence and emotional intelligence levels of midwifery students. In this study, planned as a quasi-experimental randomized controlled research, with pre-test-post-retention(permanence) test will be used. Enneagram training will last 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the research,
* Midwifery department 2nd-3rd-4th grade student.

Exclusion Criteria:

* Having experienced an acute traumatic event (loss of parents, divorce, accident, etc.),
* Having a psychological disorder,
* Having received training on Temperament or Enneagram.
* Requesting to withdraw from the study at any stage of the study,
* Not attending more than one training session.

Primary outcomes:
measure: The effect of 8-week Enneagram training on students communication skills
timeFrame: The training will last 8 weeks. At the end of the training, the final test of the Health Professionals Communication Skills Scale was administered.
measure: The effect of 8-week Enneagram training on students Self-Confidence.
timeFrame: The training will last 8 weeks. At the end of the training, the final test of the Self-Confidence Scale was administered.
measure: The effect of 8-week Enneagram training on students emotional intelligence trait
timeFrame: The training will last 8 weeks. At the end of the training, the final test of the Emotional Intelligence Trait Scale was administered.
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
state: Kütahya
Study officials:
affiliation: Kutahya Health Sciences University
name: Ebru Ertaş, Msc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eskisehir Osmangazi University
name: Nebahat Özerdoğan, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00909792: Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
Official title: Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-05-28
Enrollment: 259
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.


Eligibility criteria: Inclusion Criteria:

* Be at least 35 years of age
* Best-corrected distance visual acuity of at least 20/40 in each eye.
* Spectacle add between +0.75D and +1.50D (inclusive).
* Able to be fit in available study sphere powers (-1.00 to -5.00D)
* Currently wearing soft contact lenses at least 5 days a week.
* Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Astigmatism ≥ 1.00D.
* Currently wearing either of the study products.
* Other protocol inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
timeFrame: After 1 week of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04930692: A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"
Official title: A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Sentinel Lymph Node
Keywords: Breast cancer
Sentinel lymph nodes
CT-Lymphography
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main hypothesis of this study is that contrast-enhanced CT lymphography can be used for preoperative visualization of sentinel lymph nodes in breast cancer patients. We assume that CT lymphography is a high-sensitivity and high-specificity method for sentinel lymph nodes' mapping in breast cancer patients. We also assume that positive predictive value and negative predictive value for identification of presence or absence of metastases in sentinel lymph nodes (SLN) will be high enough for preoperative diagnosis of SLN metastases in breast cancer patients. This study will use CT lymphography with periareolar injection of iopamidol and standard protocols of sentinel lymph nodes biopsy using intraoperative indocyanine green (ICG) fluorescence.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years;
* Signed informed consent;
* Histologically confirmed breast cancer

Exclusion Criteria:

* Iodine allergy;
* Presence of distant metastases of breast cancer;
* Body mass index more than 40;
* Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
* Suspected pregnancy;
* Severe hypothyroidism;
* Bronchial asthma in the stage of decompensation;
* Decompensated diabetes;
* Kidney or hepatic failure.

Primary outcomes:
measure: Sensitivity and specificity of contrast-enhanced CT lymphography
timeFrame: 8 months
measure: Preoperative detection of sentinel lymph nodes metastases
timeFrame: 8 months
Secondary outcomes:
measure: Objective criteria for metastatic lesions of sentinel lymph nodes
timeFrame: 8 months
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State University Hospital
Study officials:
affiliation: Saint Petersburg State University Hospital
name: Ruslan Ahmedov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00803192: Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions
Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Famotidine 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability
Keywords: bioavailability
famotidine
Lead sponsor: Perrigo Company
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fed conditions.


Eligibility criteria: Inclusion Criteria:

* healthy men or women 18 years of age or older
* body mass index below 30.0 kg/m2
* willing to participate and sin a copy of the informed consent form

Exclusion Criteria:

* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* history of allergic response to heparin, famotidine, other H2-receptor antagonists, or other related drugs
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* smoking more than 25 cigarettes per day

Primary outcomes:
measure: Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05940792: Immediate Effect of Non-Elastic Taping on Gait Balance in Stroke Patients
Official title: Immediate Effect of Non-Elastic Taping on Gait Balance in Stroke Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: balance
gait
immediate
stroke
taping
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After a stroke, most patients have poor ankle control and difficulty walking. Considering that proper foot placement will provide a more balanced and controlled gait, the aim of this study was to investigate the immediate effect of non-elastic ankle taping providing eversion support on gait balance in stroke patients.

Detailed description: The study included 30 stroke patients. Participants were randomly assigned to two groups: intervention group(n=15) and the control group(n=15). The control group received 45 min of conventional physiotherapy. The intervention group received 45 min of conventional physiotherapy after nonelastic taping, which provides eversion support. The gait balance of both groups was evaluated using the Dynamic Gait Index before and after treatment. . Pre- and post-intervention data were statistically analyzed and compared.

Eligibility criteria: Inclusion Criteria:

* having a stroke diagnosis at least 6 months ago,
* being between the ages of 18 and 75,
* having a spasticity grade of 0, 1, 1+, 2 according to the Modified Ashworth Scale,
* having no cooperation problems and being mobilized without support.

Exclusion Criteria:

* orthopedic problems such as surgical intervention, fracture history, presence of cognitive, visual, or cardiovascular diseases
* skin sensitivity in the foot and ankle that may affect gait.

Primary outcomes:
measure: Dynamic Gait Index (DGI)
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Uskudar University
Study officials:
affiliation: Uskudar University
name: Beyzanur Dikmen Hoşbaş
role: PRINCIPAL_INVESTIGATOR
affiliation: Uskudar University
name: Berna Karamancıoglu
role: STUDY_CHAIR
References:
Clinical trial NCT03386292: Urinary and Anal Incontinence in Tunisian Women
Official title: Prevalence and Risk Factors for Urinary and Anal Incontinence in Tunisian Middle Aged Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Woman
Keywords: prevalence
urinary incontinence
anal incontinence
risk factors
women
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female doctors and nurses working at Sahloul Hospital, Taher Sfar Hospital and Fattouma Bourguiba Hospital

Brief summary: The publications on prevalence and risk factors of urinary and anal incontinence in women were performed mainly in Europe and America. Consequently, result extrapolation to Tunisian population may not be a good practice which justifies this study and demonstrates its importance.

Detailed description: A cross-sectional study will be conducted among female doctors and nurses randomly selected from 3 large hospitals in the center of Tunisia. The prevalence of urinary incontinence and anal incontinence will be measured using validated questionnaires.

Eligibility criteria: Inclusion Criteria:

* Professional seniority in the current service over than 6 months
* Subject has given his consent

Exclusion Criteria:

* Resident
* Intern
* An ongoing pregnancy
* A recent birth (less than 6 months)
* A psychiatric disease
* An acute or chronic kidney disease
* Neurological disease

Primary outcomes:
measure: Prevalence of urinary incontinence
timeFrame: 1 month
measure: Prevalence of anal incontinence
timeFrame: 1 month
Secondary outcomes:
measure: Risk factors for urinary and anal incontinence
timeFrame: 1 month
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Faculty of Medecine
Study officials:
References:
Clinical trial NCT03255044: Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure
Official title: Impact of Lipophilic Versus Hydrophilic Statin Administration on The Clinical Outcome and Cardiac Markers of Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: statin
hydrophilic
lipophilic
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a controversy whether statins are beneficial in patients with heart failure or not. Trials in which lipophilic statins have been used revealed positive results, unlike major studies where hydrophilic statins were administered. This trial is designed to compare the effects of lipophilic versus hydrophilic statin use in patients with heart failure.


Eligibility criteria: Inclusion Criteria:

* older than 18 years (of both sexes)
* diagnosed with stable chronic heart failure NYHA class II-III
* ejection fraction \< 40 % as assessed by 2D echocardiography
* who have been optimized on Guideline Directed treatment for heart failure for at least a month prior to enrolling.

Exclusion Criteria:

* Known hypersensitivity to statin
* Treatment with statins during the past month prior to study.
* Serum creatinine \> 3 mg/dl
* Significant liver disease: liver enzymes 2.5 folds the upper normal limit
* Malignancy
* Pregnancy or lactation

Primary outcomes:
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 6 months
measure: Left Ventricular End-diastolic volume (LVEDV)
timeFrame: 6 months
measure: Left Ventricular End-systolic volume (LVESV)
timeFrame: 6 months
measure: cardiac markers
timeFrame: 6 months
Secondary outcomes:
measure: Minnesota Living with Heart Failure Questionnaire( MLHFQ)
timeFrame: 6 months
measure: Packer composite outcome
timeFrame: 6 months
Other outcomes:
measure: Incidence of major adverse cardiac events
timeFrame: 6 months
measure: Incidence of Hospitalization
timeFrame: 6 months
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital Cardiology Rehab Unit
Study officials:
References:
citation: El Said NO, El Wakeel LM, Khorshid H, Darweesh EAG, Ahmed MA. Impact of lipophilic vs hydrophilic statins on the clinical outcome and biomarkers of remodelling in heart failure patients: A prospective comparative randomized study. Br J Clin Pharmacol. 2021 Jul;87(7):2855-2866. doi: 10.1111/bcp.14695. Epub 2021 Jan 3.
Clinical trial NCT00712244: DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus
Official title: DisCoVisc Versus Competitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Discovisc
Ophthalmic Viscosurgical Device
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-07-09
Enrollment: 112
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices (OVDs) (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.


Eligibility criteria: Inclusion Criteria:

* operable cataracts in at least one eye

Exclusion Criteria:

* Endothelial Cell Count (ECC) ≤1500cells/mm2
* Intraocular Pressure (IOP) \> 21mm Hg
* previous ocular inflammation
* systemic or ocular conditions affecting corneal endothelium

Primary outcomes:
measure: Corneal Endothelial Cell Loss
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Percent Gain in Corneal Thickness.
timeFrame: 1 week and month after surgery
measure: Aqueous Signs - Corneal Edema
timeFrame: 1 day after surgery
measure: Aqueous Signs - Aqueous Flare
timeFrame: 1 Day after Surgery
measure: Aqueous Signs - Aqueous Cells
timeFrame: 1 day after surgery
measure: Intraocular Pressure (IOP)
timeFrame: 1 day after surgery
measure: Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy
timeFrame: Time of surgery
measure: Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification
timeFrame: Time of Surgery
measure: Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion
timeFrame: Time of Surgery
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Study Locations
state: Texas
Study officials:
References:
Clinical trial NCT00497744: A Pharmacokinetic Study of Cefepime After Administration Into Dialysate in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis
Official title: Research Study on the Pharmacokinetic Profile of Intraperitoneal Cefepime in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritonitis
Keywords: CAPD peritonitis
Peritoneal Dialysis, Continuous Ambulatory
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2007-07-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 4 males and 2 females, of age 57.83 +/-11.63 years with urinary creatinine clearance of 0.87+/-2.06ml/min/1.73m2 and admitted for CAPD peritonitis were enrolled. After collection of peritoneal dialysate for cell count and microbiological work-up, all subjects were loaded with 2g cefepime IP and dwelled for 6 hours. This was followed by 250mg cefepime in each subsequent 6-hourly peritoneal dialysis exchange. Plasma cefepime levels were determined at time 0, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120 hrs. Pharmacokinetic analyses were then performed.

Brief summary: Cefepime is a broad-spectrum antibiotic used in treating CAPD peritonitis. However, medical knowledge has been lacking with regard to its pharmacokinetic profile after it has been administered intraperitoneally. The current study aims at determining the drug level at different time after the drug has been added into the peritoneal fluid in patients with CAPD peritonitis. The results of this study will finally leads to rational prescription of this drug at correct dosages.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years \& has been put on CAPD for \>= 4 weeks before entering into the study

Exclusion Criteria:

* Known hypersensitivity to cefepime or other cephalosporin; CAPD peritonitis \<= 28 days before being enrolled into the study
* Antibiotic treatment within 1 week prior to entry into the study
* Severe exit site or tunnel infection on the day of presentation
* Any conditions that prompt early removal of Tenckhoff catheter irrespective of clinical response to antibiotic treatment
* Abdominal malignancy; Any surgical causes of peritonitis
* Suspected or known fungal or tuberculous peritonitis
* History of dementia or known mental incompetency

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Caritas Medical Centre
city: Hong Kong
country: China
facility: Princess Margaret Hospital
Study officials:
affiliation: Department of Medicine and Geriatrics, Caritas Medical Centre
name: Sze Kit Yuen, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00785044: Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event
Official title: An Open-label, Multicentre, Phase 3 Study to Demonstrate the Prognostic Usefulness of 123I-mIBG Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event During 24 Months Followup
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Keywords: Heart Failure
MIBG
123I-mIBG
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 471
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart Failure Participants who participated in: MBG311 (NCT00126425) and MBG312/312C (NCT00126438).

Brief summary: The study was designed to study the utility of meta-iodobenzylguanidine (123I-mIBG) imaging to identify those participants with heart failure who would experience an adverse cardiac event during 24 months of follow-up from the administration date of 123I-mIBG in previous studies MBG311 or MBG312.


Eligibility criteria: Inclusion Criteria:

* The subject was a Heart Failure subject who signed informed consent for MBG311, MBG312, or MBG312C.
* The subject was administered 123I-mIBG in MBG311, MBG312, or MBG312C.
* The subject completed the late planar imaging assessments (at a minimum) required by the protocols for MBG311, MBG312, or MBG312C.
* The subject agreed to allow the investigator access to medical records, including those relating to subject death should this occur.

Exclusion Criteria:

* The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.
* The subject was considered lost-to-follow-up (6 months without contact) in MBG311, MBG312, or MBG312C.

Primary outcomes:
measure: Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status
timeFrame: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: John Strohmeyer
role: STUDY_DIRECTOR
References: