louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06200090: Empathy and Emotional Regulation: A Multi-National Cross-Sectional Study
Official title: Empathy and Emotional Regulation as Protective Factors Against Burnout Among Nursing Students: A Multi-National Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Empathy
Emotional Regulation
Burnout
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 1987
Sex: ALL
Minimum age (years): 17
Maximum age (years): 27
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Undergraduate nursing students from the five full-time levels

Brief summary: Significant levels of psychological disorders and psychological distress among higher education students have been reported worldwide (Galdino et al., 2020), given that during these years there is a peak in prevalence of many mental disorders, particularly major depressive disorder (18.5% to 21.2%), generalized anxiety disorder (18.6% to 16.7%) and drug use disorder (45.9% to 59.8%). (Auerbach et al., 2018). Additionally, compared to other major students, medical school and nursing students experienced higher levels of burnout due to the complex curriculum and pressure for professional performance (Ling et al., 2014). Altogether, this evidence show that nursing students frequently experience psychological and emotional problems such as academic exhaustion, stress, depression, and anxiety during their four years of completing their degree (Hwang \& Kim, 2022).

To the best of our knowledge, this study is the first of its kind that addresses the issue of burnout and its relation to empathy and emotional regulation among nursing students at the middle east. Analyzing burnout syndrome among undergraduate nursing students may provide support for managers to implement prevention and management strategies in relation to the syndrome, in order to ensure health and well-being during the professional training process, as well as providing training for nurses engaged and prepared to provide quality care. Thus, this study aims to investigate the burnout syndrome among nursing students and its relation to empathy and emotional regulation.


Eligibility criteria: Inclusion Criteria:

* Undergraduate nursing students from the five full-time levels

Exclusion Criteria:

-

Primary outcomes:
measure: Maslach Burnout Inventory-Student Survey (MBI-SS)
timeFrame: Baseline
Secondary outcomes:
measure: Jefferson Scale of Empathy-Health Profession Student version (JSE-HPS)
timeFrame: Baseline
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Baseline
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Nursing
state: Dakhlyia
Study officials:
References:
Clinical trial NCT02190890: Dry Needling Dosage in the Treatment of Myofascial Neck Pain
Official title: Effects of Different Deep Dry Needling Dosages on Pain and Postneedling Soreness in the Treatment of Patients With Cervical Myofascial Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study are (1) to determine the effectiveness of different dry needling dosages in the treatment of myofascial trigger points in the upper trapezius muscle in patients with myofascial neck pain, (2) to assess postneedling soreness and tenderness and (3) evaluate the influence of psychological factors on the perception of postneedling soreness.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of an active myofascial trigger point. Neck pain: Superior to 3 cm in VAS

Exclusion Criteria:

* Neck area: Fracture, radiculopathy, previous surgery, previous needling treatment in the last 6 months, previous analgesic medication (24 hours), psychiatric disease

Primary outcomes:
measure: Pain
timeFrame: 1 week
measure: Postneedling soreness
timeFrame: 1 week
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: 1 week
measure: Cervical range of motion
timeFrame: 1 week
measure: Neck disability
timeFrame: 1 week
measure: Pain in cervical range of motion
timeFrame: 1 week
measure: Psychological factors
timeFrame: Pre-intervention
measure: Psychological factors
timeFrame: Pre-intervention
measure: Psychological factors
timeFrame: Pre-intervention
measure: Psychological factors
timeFrame: Pre-intervention
Other outcomes:
Locations:
Study officials:
References:
citation: Martin-Pintado-Zugasti A, Fernandez-Carnero J, Leon-Hernandez JV, Calvo-Lobo C, Beltran-Alacreu H, Alguacil-Diego I, Gallego-Izquierdo T, Pecos-Martin D. Postneedling Soreness and Tenderness After Different Dosages of Dry Needling of an Active Myofascial Trigger Point in Patients With Neck Pain: A Randomized Controlled Trial. PM R. 2018 Dec;10(12):1311-1320. doi: 10.1016/j.pmrj.2018.05.015. Epub 2018 May 29.
Clinical trial NCT01776190: Low-dose UVA1 Radiation in Cutaneous Lupus Patients
Official title: Low-dose UVA1 Radiation in Cutaneous Lupus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cutaneous Lupus Erythematosus
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Daavlin Corporation
First posted: 2013-01-28
Enrollment: 6
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 investigators are conducting an open-label clinical trial determining the effects of UVA1 phototherapy on cutaneous lupus (CLE) patients. Past research on systemic lupus (SLE) subjects indicates that this treatment is likely to be effective in treating cutaneous lupus with few side effects. The fact that most CLE patients are seen at dermatology clinics also increases the usefulness of this study because there is a large probability that phototherapy treatment will be accessible for many of the patients that stand to benefit from it.

Detailed description: Study subjects will receive low dose (20 J/cm2) UVA1 phototherapy treatment three times per week for 10 weeks. Each treatment will take less than 30 minutes. This period will be followed by an eight-week observation phase to assess longer term effects of the treatment. Patients will be assessed for disease activity, and blood studies and photos will be completed prior to, during, and after phototherapy treatment. Optional skin biopsies of affected and unaffected skin will be performed at the beginning and end of the active treatment phase.

Eligibility criteria: Inclusion Criteria:

* You must be 18 years or older with a diagnosis of cutaneous lupus.
* You must have at least two active areas of cutaneous lupus.
* You will need to come in three days a week for a 10-week period.
* You will need to participate in four physician visits and blood draws.

Exclusion Criteria:

* You do not have a diagnosis of cutaneous lupus.
* You have less than two active areas of cutaneous lupus.
* You are unable to come in three days a week for treatment for a 10-week period.

Primary outcomes:
measure: Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Damage Score
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Benjamin F Chong, MD, MSCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02618590: A Retrospective Study About Treatment Strategy After First/Second Line EGFR-TKI Failure
Official title: Which Treatment Strategy is Best in Non-small Cell Lung Cancer Patients Harboring EGFR Mutant Type After First/Second Line EGFR-TKI Failure, a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Small Cell Lung Cancer
Keywords: non-small cell lung cancer
EGFR mutant type
first/second line EGFR-TKI
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with stage IV non-small cell lung cancer (NSCLC) harboring EGFR mutant type (19 and/or 21 exon mutation), and took EGFR-TKI as first/second line therapy.

Brief summary: This is a multi-center retrospective study, designing to access the best treatment strategy in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2). PD1 is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist 1.1 criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter what second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.


Eligibility criteria: Inclusion Criteria:

* Patients who was confirmed stage IV (according to International Association for the Study of Lung Cancer（IASLC） TNM staging, 2009) non-small cell lung cancer (NSCLC) by histology or cytology between year 2009 to 2013, harboring EGFR mutant type (19 and/or 21 exon mutation).
* Appraisable disease, that is there must be at least one lesion with the longest diameter\>10mm according to Recist 1.1 criterion (by contrast CT).
* Patients who take EGFR-TKI as first/second line therapy.

Exclusion Criteria:

* Patients who has taken EGFR-TKI before.
* Patients who take EGFR-TKI as third or more line.
* Patients who take EGFR-TKI concurrent with chemotherapy or other anti-tumor drug.
* The evaluated lesions has treated with radiotherapy before or concurrent with EGFR-TKI.
* Patients whose EGFR expression is positive by immunochemical and/or EGFR amplification is positive by Fluorescence In Situ Hybridization(FISH), without mutation detection evidence.

Primary outcomes:
measure: Progression Free Survival 2 (PFS2)
timeFrame: 6 months
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University of cancer center
state: Guangdong
Study officials:
affiliation: associate chief physician
name: li-kun Chen, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092690: MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)
Official title: A Multicenter, Double-Blind, Randomized, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 1902
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to assess the safety and efficacy of an investigational drug as compared to an approved drug to reduce specific cholesterol levels.

Detailed description: The duration of treatment is 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Elevated cholesterol

Exclusion Criteria:

* Unstable medical conditions or significant heart problems within 3 months prior to first study visit.

Primary outcomes:
measure: Plasma LDL-C averaged across all doses after 6 weeks
Secondary outcomes:
measure: Plasma LDL-C for each dose; plasma HDL-C averaged across all doses
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Ballantyne CM, Abate N, Yuan Z, King TR, Palmisano J. Dose-comparison study of the combination of ezetimibe and simvastatin (Vytorin) versus atorvastatin in patients with hypercholesterolemia: the Vytorin Versus Atorvastatin (VYVA) study. Am Heart J. 2005 Mar;149(3):464-73. doi: 10.1016/j.ahj.2004.11.023.
citation: Pearson T, Ballantyne C, Sisk C, Shah A, Veltri E, Maccubbin D. Comparison of effects of ezetimibe/simvastatin versus simvastatin versus atorvastatin in reducing C-reactive protein and low-density lipoprotein cholesterol levels. Am J Cardiol. 2007 Jun 15;99(12):1706-1713. doi: 10.1016/j.amjcard.2007.01.062. Epub 2007 May 2.
Clinical trial NCT02051790: Evaluation of Reader Training Processes
Official title: Evaluation of Reader Training Processes by Comparing Clinical Interpretations to Centralized Expert Reads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-01-31
Enrollment: 241
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.


Eligibility criteria: Inclusion Criteria:

- Scan obtained for clinical reasons

Exclusion Criteria:

- None

Primary outcomes:
measure: Agreement Between Expert Panel and Clinical Practice Reads
timeFrame: Scan acquired 50-60 minutes post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: Avid Radiopharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT05813990: Reconstructive Ear Surgery in Pediatrics
Official title: Reconstructive Ear Surgery in Pediatric Population. Cross Sectional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ossicle Chain Disarticulation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is

1. Evaluation of preoperative degree of hearing loss in pediatric population.
2. Evaluation of types and prevalence's of ossicular disruptions due to chronic otitis media and trauma.
3. Assessment of best candidates for hearing restoration surgeries.
4. Comparing different surgical techniques for hearing restoration in various ossicular disorders .
5. Evaluation of degree of surgical restoration of the sound transmitting mechanism of the middle ear in pediatric population.

Detailed description: Conductive hearing loss (CHL) results from impaired transmission of sound from the external auditory canal across the middle ear structures to the cochlea of the inner ear. A variety of disorders can affect the sound transmission pathway at the level of the ear canal, tympanic membrane, and ossicles prior to reaching the hearing organ.

Ossiculoplasty is the surgical restoration of the sound transmitting mechanism of the middle ear. Ossiculoplasty has been performed as early as the 1950s.A myriad of prosthetics and surgical techniques have been described over the last half-century, with no overall consensus on the ideal method of treatment.

Pediatric population are commonly known to develop conductive hearing loss secondary to various conditions such as chronic otitis media, otitis media with effusion, atelectatic otitis media and head trauma. Various methods have been fashioned to restore hearing in such patients however no consensus to the most optimum method for hearing restoration has been well established

Eligibility criteria: Inclusion Criteria:

1. patients aged ≤ 18years with CHL.
2. patients who are candidate for ossiculoplasty as surgical treatment for them.

Exclusion Criteria:

1. Patients with preoperative sensory neural hearing loss (SNHL).
2. Patient with intra operative complications.
3. Patients with intracranial and intratemporal complications.
4. Patients with stapes foot plate fixation, broken graft and missed patients.
5. Patients \>18years.
6. Patients who unfit for surgery.

Primary outcomes:
measure: reconstuctive ear surgery in pediartic population
timeFrame: 2m,6m and 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
citation: Kamrava B, Roehm PC. Systematic Review of Ossicular Chain Anatomy: Strategic Planning for Development of Novel Middle Ear Prostheses. Otolaryngol Head Neck Surg. 2017 Aug;157(2):190-200. doi: 10.1177/0194599817701717. Epub 2017 May 2.
Clinical trial NCT05551390: Effect of One-time Versus Three-times of Umbilical Cord Milking on Neonatal Hemoglobin in Late Preterm
Official title: Effect of One-time Versus Three-times of Umbilical Cord Milking on Neonatal Hemoglobin in Late Preterm: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Umbilical Cord Milking
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 162
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Late preterm pregnant women (34-36+6 week's gestation) that exclude placenta accrete/percreta, placenta previa, placental abruption, congenital anomaly and hydrops fetalis, were randomized in a 1:1 ratio to either one-time or three-times UCM.
Primary purpose: PREVENTION

Brief summary: To compare the neonatal hemoglobin (Hb) in late preterm between one-time versus three-times of umbilical cord milking (UCM)

Detailed description: This was a double-blind randomized controlled trial that performed between May 2021 to March 2022 at the Obstetrics and Gynecology Department of Queen Savang Vadhana Memorial Hospital. Late preterm pregnant women (34-36+6 week's gestation) that exclude placenta accrete/percreta, placenta previa, placental abruption, congenital anomaly and hydrops fetalis, were randomized in a 1:1 ratio to either one-time or three-times UCM. The primary outcome was neonatal Hb level at 48-72 hour after birth.

Eligibility criteria: Inclusion Criteria:

* Late preterm pregnant women (34-36+6 week's gestation)

Exclusion Criteria:

* placenta accrete
* placenta percreta
* placenta previa
* placental abruption
* congenital anomaly
* hydrops fetalis

Primary outcomes:
measure: The primary outcome was neonatal Hb level
timeFrame: 48-72 hour after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: Wachira Prachakittikul
state: Chonburi
Study officials:
References:
Clinical trial NCT04580290: Jewel ACL Post Market Clinical Follow Up Study
Official title: The JewelACL Post Market Clinical Follow Up Study - Multicentre Study of at Least 5 Years Follow up, Looking at Clinical Outcomes in Patients Treated With the JewelACL for Anterior Cruciate Ligament (ACL) Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: Xiros Ltd
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who have had the JewelACL device used to reconstruct the ACL, between the period of 01 October 2010 to 31 December 2014.

Brief summary: The objective of the study is to assess re-rupture rates and patient outcomes from subjects with at least 5 year follow up, treated with the JewelACL device for ACL reconstruction. The impact of fixation type and autograft augmentation will also be assessed. All adverse events related to the JewelACL device will be recorded. This study is Sponsored by Xiros.


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years
* Patients previously implanted with the JewelACL for Anterior Cruciate Ligament (ACL) reconstruction (Primary JewelACL cases only, no revision cases)

Exclusion Criteria:

* Age less than 18 years
* Any implantations for non-indicated conditions, as stated in the Instructions For Use Instructions for use (IFU)
* Revision cases

Primary outcomes:
measure: Occurrence of Re-ruptures
timeFrame: Five Year
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Med-Polonia
Study officials:
References:
Clinical trial NCT02459990: Congenital Malformations and Maternal Use of Anti-hypertensive Medication in the United Kingdom
Official title: Congenital Malformations and Maternal Use of Anti-hypertensive Medication in the United Kingdom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension malformation fetal mortality
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-06-02
Enrollment: 22000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who may become pregnant ages 18-50 in the UK.

Brief summary: Assess Fetal Mortality and Malformations in Women treated with antihypertensive medication during preganancy. Mother - Child pairs will be analysed in a cohort selected from the UK in the CPRD database. Years covered are 1997 to 2014. Aim is to assess the risk of Antihypertensive treatment in women.

Detailed description: Women with chronic hypertension are at risk of experiencing severe complications such as adverse effects of fetal growth, survival, and renal function during pregnancy. General recommendations advocate the treatment of high blood pressure during pregnancy to decrease these risks to the mother and child, with extreme caution. Many studies assessing the risk of congenital malformations in infants whose mothers were treated with anti-hypertensive medication have been inconclusive, in part due to the variability of the original data sources and possibly the robustness of the analyses.2 Studies regarding this health issue have been unable to stratify anti-hypertensive medications sufficiently to truly assess the risk per drug class, Angiotensin II Receptor Antagonists/Blockers (ARBs) and Angiotensin-converting-enzyme inhibitor (ACE inhibitor) in particular.We will attempt to assess the prescription rate of ARBs and ACE inhibitors among women with very high blood pressure in the United Kingdom (UK) and estimate the risk of serious foetal outcomes in women treated with ARBs and/or ACEs and who may also have the following co-morbid conditions: Diabetes Types I or II, Diabetic Nephropathy, and Congestive Heart Failure.

Eligibility criteria: Inclusion Criteria: age and gender -

Exclusion Criteria:

-

Primary outcomes:
measure: Incident cases of Fetal Mortality among hypertensive women
timeFrame: up to 17 years
measure: Incident cases of Fetal Malformation among hypertensive women
timeFrame: up to 17 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
References: