louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06029205: Mindfulness Training in Nurses and Its Effect on Work Stress
Official title: The Effect of Conscious Awareness-Based Educatıon on Perceived Work Stress in Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Consciousness, Level Altered
Keywords: nurse
work stress
awareness
Lead sponsor: Çanakkale Onsekiz Mart University
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study, which was planned in the experimental design type, was to determine the effect of the mindfulness-based stress reduction training on nurses' job stress. The sample of the study consisted of 70 nurses (35 in the experimental group, 35 in the control group) working in a university hospital in Çanakkale. The mindfulness-based stress reduction training was carried out as a group, once a week, for 8 weeks in total.

Detailed description: One of the most important problems of nurses in Turkey is the stress they experience at work. This stress experienced in the workplace is accompanied by consequences such as depression, anxiety, and decreased job satisfaction. Therefore, it is clear that addressing the stress associated with the nursing profession is an urgent problem. The aim of the study, which was planned in the experimental design type, was to determine the effect of the mindfulness-based stress reduction training on nurses' job stress. The sample of the study consisted of 70 nurses (35 in the experimental group, 35 in the control group) working in a university hospital in Çanakkale. The mindfulness-based stress reduction training was carried out as a group, once a week, for 8 weeks in total. The Personal Information Form, the Job Stress Scale, the Mindful Attention Awareness Scale, and the Rosenbaum's Learned Resourcefulness Scale were used for data collection. A total of three follow-ups were conducted to the nurses before the training, at the end of the training, and 3 months after the training. Descriptive analysis, Chi-square test, Independent Samples T-test, Dependent Samples T-test, and one-way analysis of variance were used in the analysis of the research data.

Eligibility criteria: Inclusion Criteria:

* Working as a nurse in the relevant health practice and research hospital
* Not having participated in any mindfulness-based training program before

Exclusion Criteria:

* Working as an executive nurse
* Not attending any session of the 8-week training

Primary outcomes:
measure: The Effect of Conscious Awareness-Based Educatıon on Perceived Work Stress in Nurses
timeFrame: 8 week
measure: The Effect of Conscious Awareness-Based Education on Awareness in Nurses
timeFrame: 8 week
measure: Learned Resourcefulness Effect of Conscious Awareness-Based Education on Nurses
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Çanakkale
country: Turkey
facility: Çanakkale Onsekiz Mart Universty Hospital
Study officials:
References:
Clinical trial NCT03492905: Implementation of Internet-based Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia
Official title: Implementation of Internet-based Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Karolinska University
First posted: 2018-04-10
Enrollment: 15
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Results from a pilot study shows that outpatients of Children and Youth Psychiatry can improve their sleep and depressive symptoms by receiving internet-based cognitive behavioral therapy for insomnia (iCBT). This study is designed to evaluate implementation of the treatment in routine care.The study will evaluate aspects of the implementation process such as organizational attitudes towards iCBT before implementation, level of knowledge about the condition and intervention among health-care providers before and after the implementation, and clinical outcomes in routine care.


Eligibility criteria: Inclusion Criteria:

* To fulfill the diagnostic criteria for insomnia
* To have access to a computer with Internet connection
* No previous or ongoing CBT for insomnia

Exclusion Criteria:

* Ongoing manic or psychotic episode
* Being at high risk of triggering manic or psychotic episode
* Ongoing sleep apnea

Primary outcomes:
measure: Insomnia Severity Index (ISI; Morin, 1993)
timeFrame: Pre-treatment, weekly for seven weeks (during treatment), after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed)
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994)
timeFrame: Pre-treatment, after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed)
measure: Childrens Global Assessment Scale (C-GAS; Shaffer et al., 1983)
timeFrame: Pre-treatment, after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed)
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
state: Uppsala Län
Study officials:
affiliation: Uppsala University Hospital
name: Vendela Zetterqvist, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00869505: Study of Memantine Augmentation in Severe Obsessive-Compulsive Disorder
Official title: A Chart Review of Memantine Use in the Treatment of Obsessive-Compulsive Disorder at the OCD Institute
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive-Compulsive Disorder
Keywords: To evaluate the effectiveness of memantine as an augmenting agent for standard intensive residential treatment of severe obsessive-compulsive disorder (OCD)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: OCD Institute
name: Mclean Hospital
First posted: 2009-03-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprised 44 subjects who received standard treatment at the MGH/ McLean Hospital OCD Institute Intensive Residential Treatment (IRT) program, admitted between May 1999 and December 2007.

Brief summary: Memantine is a glutamate receptor antagonist that has been reported to reduce Obsessive-Compulsive Disorder (OCD) symptoms in case studies of treatment-resistant individuals. The investigators hypothesized that memantine is an effective augmenting agent to standard intensive residential treatment of severe OCD. An intent-to-treat, single-blinded, naturalistic case-control design is employed. The sample includes subjects receiving standard treatment at the McLean/ MGH Intensive Residential Treatment (IRT) program, half of whom also receive memantine augmentation. Admission, monthly and discharge measures of OCD, depression and psychosocial functioning are collected by raters blinded to augmentation status. Matched controls are selected based upon gender, initial OCD severity, psychosocial functioning, and timing of admission. Descriptive and comparative analyses are conducted via SPSS, statistical significance is defined at p\<0.05, clinically significant response is defined by a 25% reduction, and 'marked response' is defined by a 50% improvement in Yale-Brown Obsessive Compulsive severity (Y-BOCS) scores, using a last-observation-carried-forward approach. The Clinical Global Improvement (CGI) scale captures global clinical change.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients of IRT at the OCD Institute who agreed to augmentation with memantine.
* Consecutive patients of IRT at the OCD Institute who were not offered augmentation with memantine and who were matched according to OCD severity, gender, and psychosocial functioning.

Exclusion Criteria:

* Subjects offered memantine augmentation who did not provide voluntary consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: OCD Institute, McLean Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: S. Evelyn Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05475405: Scapulo-Thoracic Mobilization Compared to IASTM in Patients With Mechanical Neck Pain
Official title: Scapulo-Thoracic Mobilization Compared to IASTM in Patients With Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Neck Pain
Keywords: IASTM
scapulo-thoracic mobilization
mechanical neck pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 32 Participants were recruited in the study and divided into two groups. Group A was given intervention Scapulothoracic mobilization and Group B with IASTM.
Primary purpose: TREATMENT

Brief summary: SCAPULO-THORACIC MOBILIZATION COMPARED TO IASTM IN PATIENTS WITH MECHANICAL NECK PAIN

Detailed description: Mechanical neck pain is common musculoskeletal condition that causes work disabilities and is not self-limiting. One of the main causes for mechanical neck pain is forward head posture, which is common and but not ideal posture adopted by many workers and students who presents with head being anterior to the shoulder. Imbalances in the normal muscle function reported in such patients with inhibited deep neck flexors, serratus anterior and rhomboids and tightened pectoralis, upper trapezius and levator scapula.

Neck and scapula have some common muscle attachments and abnormal loads on cervical or thoracic spine change the biomechanics of muscles present in these regions, which eventually cause trigger points Management of scapulo-thoracic joint focuses on correcting posture, restoring flexibility of the scapula including the pectoralis minor, levator scapulae, rhomboids, mobilization and soft tissue techniques.

IASTM is ergonomically designed stainless steel tool, and has recently gained much popularity for elevating pain, reducing trigger points and improving ROMs because it has deeply penetrating power as compared to mobilization through hand. This technique works by both along the mobilizing muscle fibers or parallel to the muscle fibers.

Eligibility criteria: Inclusion Criteria:

* Age group 18 to 40 years
* Both gender groups
* Non radiating neck pain

Exclusion Criteria:

* History of cervical and thoracic spine surgery
* Vertibro-basilar insufficiency
* Sign of serious pathology like malignancy
* Signs of systemic inflammatory disorder
* Patient with diagnosed hypertension
* (scapular area pathology)

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 3 weeks
measure: NDI (neck disability index)
timeFrame: 3 weeks
measure: Goniometer
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Affan Iqbal, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00959205: The Efficacy and Safety of CARTO 3D Mapping System Versus Conventional Method in AF and VT
Official title: Phase Ⅳ Study of CARTO 3D Mapping System vs Conventional Method in AF & VT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2009-08-14
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
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 evaluate the efficacy and safety of electroanatomic imaging compared to conventional method in patients with VT.

Detailed description: To evaluate the efficacy and safety of electroanatomic imaging (CARTO) compared to conventional fluoroscopically guided activation mapping (Conventional) method in patients with Atrial Fibrillation and Substrate-dependent Ventricular Tachycardia To evaluate cost-effectiveness of CARTO 3D image system compared to conventional method in the same study subjects

Eligibility criteria: Inclusion Criteria:

* patients with AF or substrate-dependent VT

Exclusion Criteria:

* administering with anticoagulants

Primary outcomes:
measure: Fluoroscopic time
timeFrame: 24weeks
measure: Procedural duration
timeFrame: 24weeks
Secondary outcomes:
measure: Ablation time
timeFrame: 24weeks
measure: Procedural Success
timeFrame: 24weeks
measure: Clinical Success
timeFrame: 24weeks
measure: Radiation dose
timeFrame: 24weeks
measure: Morphology of ablation
timeFrame: 24weeks
measure: Complications
timeFrame: 24weeks
measure: Cost Effectiveness
timeFrame: 24weeks
measure: Survival Rate
timeFrame: 24weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea medical center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital/Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Korea medical center
name: Kim Young-Hoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00298805: A Quality of Life Study in Patients With Migraines
Official title: Dysphoric-like Disorder of Epilepsy, Is It Unique?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Migraine
Headache
Depression
Keywords: Migraine
Headache
Depression
Quality of Life
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Rush University Medical Center
name: GlaxoSmithKline
First posted: 2006-03-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Migraine patients will be recruited from the outpatient neurology clinics / offices.

Brief summary: The purpose of this study is to compare depressive characteristics in migraine patients to those observed in patients with epilepsy in a previous study, and determine whether those symptoms are unique to patients with epilepsy.

Detailed description: A form of depression known as dysphoric-like disorder is common in people with epilepsy, which may significantly affect the quality of life in these people, as shown in a previous study. However, it is unclear if this depressive disorder is unique to patients with epilepsy. In order to assess whether these symptoms are unique and idiosyncratic to the epilepsy population, in this multi-center study, these dysphoric depressive features will be contrasted to those seen in patients with other neurologic or psychiatric conditions. Migraine is selected as one of the comparison disorders because it shares with epilepsy characteristics of being a recurrent episodic central nervous system disorder, and our site will only enroll patients with migraine headaches.

Eligibility criteria: Inclusion Criteria:

* Male or female 18 years of age or older
* Have the diagnosis of migraine
* Have had no change in migraine medication(s) 30 days prior to study
* Achieve a satisfactory score on the Wide Range Achievement Test 3 (WRAT3) test at the screening visit
* Capable of completing self-reporting questionnaires
* Willing and able to provide written informed consent and comply with the study protocol

Exclusion Criteria:

* Presence of a clinically significant comorbidity of an unstable or progressive nature
* Presence of major depression
* Participation in an investigational drug study within the past 30 days
* Inability to communicate well with site study personnel

Primary outcomes:
measure: Dysphoric-like depressive characteristics in patient with epilepsy
timeFrame: N/A (cross-sectional study)
Secondary outcomes:
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: North Shore Long Island Jewish Health System
state: New York
Study officials:
affiliation: Rush University Medical Center
name: Andres M Kanner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02234505: Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces During Walking
Official title: Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trans-tibial Limb Loss
Keywords: prosthetics
amputation
gait stability
step variability
load cell
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Orthotic and Prosthetic Association
First posted: 2014-09-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In human gait there is a certain amount of variation between steps; some considered physiological and owed to variations in environment or posture, and some severe enough to be indicative of gait instabilities that may lead to stumbling and falling. In users of lower limb prosthetics, such gait instabilities are of especially great interest.

The study investigates the correlation between socket alignment quality and gait step-by-step variability in users of trans-tibial-prosthetics. It is hypothesized that a clearly defined range of step-by-step variability exists, and that therefore step-by-step variability is suitable as an outcome variable for the assessment of socket alignment.

A sample of ten persons with trans-tibial amputation will be recruited for this pilot study. Subjects will be asked to walk on different natural surfaces while the socket alignment is successively perturbed. Step-by-step variations in horizontal ground reaction forces and torsional moments will be measured and statistically compared.


Eligibility criteria: Inclusion Criteria:

* activity classification of K2 to K4
* experience in prosthesis use of at least one year
* stated ability to walk pain free for at least 30 minutes

Exclusion Criteria:

* age of less than 18 years
* acute or ongoing residual limb pain
* use of a prosthesis that is not suitable for installation of the load cell (e.g. is too short, or has non-removable cosmesis)

Primary outcomes:
measure: Step-by-step variability
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Bakery Square MSPO labs
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02033005: Newborn Feeding and Infant Phenotype
Official title: Newborn Feeding and Infant Phenotype
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Feeding
Keywords: Body Composition
Adipose Tissue
Intrahepatocellular Lipid
Infant
Magnetic Resonance Imaging
Magnetic Resonance Spectroscopy
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Chelsea and Westminster NHS Foundation Trust
First posted: 2014-01-10
Enrollment: 124
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, full term, appropriate weight for gestational age infants recruited on the postnatal ward at Chelsea and Westminster Hospital, London, UK.

Brief summary: Breast feeding is believed to be beneficial to long-term health but how these effects are mediated is unknown. I suggest that this may be through effects on body composition and metabolism.

I will compare adipose tissue and liver fat deposition in healthy, full term breast and formula fed infants babies shortly after birth and around 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy baby
* Term baby
* Appropriate weight for gestational age (UK - WHO 2009 growth charts)

Exclusion Criteria:

* Infants of diabetic mothers
* Infants of smokers
* Infants fed non-commercial or non-cows milk based infant formulae

Primary outcomes:
measure: Change in Total Adipose Tissue Volume
timeFrame: Between birth and 6-12 weeks age
Secondary outcomes:
measure: Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants.
timeFrame: Between birth and 6-12 weeks age
measure: Change in Intrahepatocellular Lipid Compared to Breastfed Infants.
timeFrame: Between birth and 6-12 weeks age
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
Study officials:
affiliation: Imperial College London
name: Neena Modi, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gale C, Thomas EL, Jeffries S, Durighel G, Logan KM, Parkinson JR, Uthaya S, Santhakumaran S, Bell JD, Modi N. Adiposity and hepatic lipid in healthy full-term, breastfed, and formula-fed human infants: a prospective short-term longitudinal cohort study. Am J Clin Nutr. 2014 May;99(5):1034-40. doi: 10.3945/ajcn.113.080200. Epub 2014 Feb 26.
Clinical trial NCT00668005: Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and Hypertension
Official title: A Randomized, Double-blind, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administration for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Men With Arterial Hypertension and Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Arterial hypertension
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-04-28
Enrollment: 388
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure


Eligibility criteria: Inclusion Criteria:

* Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
* Arterial hypertension adequately controlled
* Stable sexual relationship for \> 6 month

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy

Primary outcomes:
measure: Sexual Encounter Profile (SEP), questions 2 and 3
timeFrame: 12 weeks
Secondary outcomes:
measure: International Index of Erectile Function (IIEF) - EF (Erectile Function) domain
timeFrame: 12 weeks
measure: Global Assessment Questionnaire (GAQ)
timeFrame: 12 weeks
measure: Safety and tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: