louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05980468: The Effect of Music Therapy on Nurses
Official title: The Effect of Music Therapy on Nurses' Comfort Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music Therapy
Keywords: nurse
comfort
music therapy
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study was planned to examine the effect of music therapy on the comfort levels of nurses. In the study, data will be collected by using Descriptive Characteristics Information Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria will be in the intervention or control group will be determined by simple randomization. Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the participants again.

Detailed description: This study was planned to examine the effect of music therapy on the comfort levels of nurses. This study will be conducted as a randomized controlled experimental study. In the sample calculation, it was determined that for Power = 0.8 (beta = 0.2), alpha = 0.05 and effect size = 0.7, the sample size should be 66, 33 for the intervention group and 33 for the control group. In the study, data will be collected by using Descriptive Characteristics Information Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria will be in the intervention or control group will be determined by simple randomization. Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the participants again. Research data will be analyzed in SPSS-25 package program.

Eligibility criteria: Inclusion Criteria:

* Have at least one year of working experience
* Have not participated in any music therapy session before
* No hearing problems
* Absence of neurological/psychiatric disorders
* Nurses who volunteered to participate in the study will be included in the study.

Exclusion Criteria:

* Those who use another relaxation methods,
* Nurses who do not agree to participate in the study will not be included in the study.

Primary outcomes:
measure: Comfort
timeFrame: 5 weeks after first meeting
Secondary outcomes:
Other outcomes:
Locations:
city: Talas
country: Turkey
facility: Sevda Korkut
state: Kayseri
Study officials:
affiliation: TC Erciyes University
name: Sevda Korkut
role: PRINCIPAL_INVESTIGATOR
affiliation: Karamanoğlu Mehmetbey University
name: Ayşe Topuz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04832568: Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery
Official title: Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Delirium
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing cardiovascular surgery

Brief summary: Postoperative delirium is common in patients undergoing cardiovascular surgery and associated with poor outcomes. However the pathogenesis of postoperative delirium is poorly understood. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of postoperative delirium in patients undergoing cardiovascular surgery using electroencephalogram.


Eligibility criteria: Inclusion Criteria:

1. age of at least 18 years
2. normal cognitive function at the time of enrollment evidenced by a Mini-Mental State Examination (MMSE) score of more than 24 of 30
3. Chinese Mandarin as the native language
4. providing informed consent

Exclusion Criteria:

1. pre-existing delirium assessed according to the Confusion Assessment Method (CAM)
2. history of neurological or psychiatric disease
3. impaired vision or auditory function which may effect the assessments
4. unwillingness to participate in the study

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: After surgery through to postoperative day 7
Secondary outcomes:
measure: Relative power of each brain waves
timeFrame: During the stay of the patient in the operating room, after surgery through to postoperative day 7
measure: Duration of delirium
timeFrame: After surgery through to postoperative day 7
measure: Severity of delirium
timeFrame: After surgery through to postoperative day 7
measure: Worst daily pain scores at rest
timeFrame: After surgery through to postoperative day 7
measure: Worst daily pain scores with exertion (deep breathing and cough)
timeFrame: After surgery through to postoperative day 7
measure: Length of stay in the Intensive Care Unit (ICU)
timeFrame: through study completion, an average of 5 days
measure: Length of hospital stay
timeFrame: through study completion, an average of 10 days
Other outcomes:
measure: Biomarkers
timeFrame: before and after surgery in operating room, after surgery through to postoperative day 7
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT06032468: ARC Intellicare for Telerehabilitation
Official title: ARC Intellicare for Telerehabilitation in Neurological Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Multiple Sclerosis
Stroke
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Early feasibility study
Primary purpose: TREATMENT

Brief summary: In the last 5 years, the available literature evidence has indicated that, in terms of clinical efficacy, telerehabilitation can give comparable results compared to face-to-face rehabilitation. Studies of post-stroke patients have revealed some benefits of telerehabilitation, such as the ability for patients to self-record pain, mood and activity. Telerehabilitation has comparable efficacy to face-to-face rehabilitation for the recovery of some abilities, such as motor function, Activities of Daily Living (ADL), and independence; it is less effective, however, for the recovery of balance control. Published reviews concerning, in particular, neurological/neurodegenerative diseases show that telerehabilitation systems are effective in maintaining and/or improving some motor aspects, such as balance and gait, and non-motor aspects, such as mood and quality of life; they also increase patient satisfaction, so in the long term they appear to be beneficial, convenient and satisfying for patients and operators.

ARC Intellicare is a device undergoing certification as a Class I Medical Device (DM), already clinically tested during two uncontrolled clinical feasibility studies: ARCANGEL study (post-stroke, ClinicalTrials.gov Identifier: NCT03787433) and RICOMINCIARE study (post-COVID19 and Parkinson's disease, ClinicalTrials.gov Identifier: NCT05074771).


Eligibility criteria: Inclusion Criteria:

* patients with diagnosis of Parkinson's disease with Hoehn\&Yahr staging 1-3
* diagnosis of multiple sclerosis with extended disability scale score 3.5-6
* diagnosis of ischemic stroke in the past 12 months

Exclusion Criteria:

* history of falls
* dementia
* epilepsy

Primary outcomes:
measure: Efficacy outcome: Six minutes walking test (6MWT)
timeFrame: 8 weeks
measure: Efficacy outcome: Borg scale
timeFrame: 8 weeks
measure: safety outcome: adverse event frequency
timeFrame: 8 weeks
measure: Usability outcome: adherence to prescription
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: policlinico Universitario A Gemelli
state: Rome
Study officials:
References:
Clinical trial NCT04428346: A Trial to Assess the Effect of an Intervention Integrating Contingency Management (Financial Incentives) to Enhance Hepatitis C Treatment Uptake Following Dried Blood Spot Hepatitis C RNA Testing Among People With Recent Injecting Drug Use Attending Needle and Syringe Programs
Official title: A Pilot Two-arm, Individual-level, Randomised Controlled Trial to Assess the Effect of an Intervention Integrating Contingency Management (Financial Incentives) to Enhance Hepatitis C Treatment Uptake Following Dried Blood Spot Hepatitis C RNA Testing Among People With Recent Injecting Drug Use Attending Needle and Syringe Programs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C, Chronic
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2020-06-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A pilot two-arm, individual-level, randomised controlled trial to assess the effect of an intervention integrating contingency management (financial incentives) to enhance hepatitis C treatment uptake following dried blood spot hepatitis C RNA testing among people with recent injecting drug use attending needle and syringe programs: the AMPLIFY study


Eligibility criteria: Inclusion Criteria:

1. Participants have voluntarily signed the informed consent form
2. 18 years of age or older
3. Recent injecting drug use (previous six months)

Exclusion Criteria:

1) Inability or unwillingness to provide informed consent

Primary outcomes:
measure: The proportion of participants who initiate Hepatitis C Virus treatment within 12 weeks of testing
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility of recruitment through a peer-based referral incentivization scheme
timeFrame: 6 months
measure: Time to HCV treatment initiation
timeFrame: 6 months
measure: Time to HCV treatment completion
timeFrame: 6 months
measure: Time to visit to confirm viral cure (e.g. sustained virological response, SVR12)
timeFrame: 6 months
measure: Participant perceptions and acceptability of being involved in a contingency management study will be assessed by study questionnaire
timeFrame: 6 months
measure: Feasibility of a contingency management intervention to enhance hepatitis C treatment uptake
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00699946: Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement Surgery
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: delirium, atypical antipsychotics, olanzapine, orthopedic
Lead sponsor: The New England Baptist Hospital
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 495
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study we wanted to determine if perioperative administration of olanzapine prior to knee or hip replacement surgery in high risk patients would prevent the onset of postoperative delirium.

Detailed description: Postoperative delirium is a serious and common (20% to 60%) complication in orthopedic surgery patients. In this study we investigate whether prophylactic administration of olanzapine can prevent delirium from occurring after knee or hip replacement in high-risk patients \> 65 years of age. This is a randomized, double-blind, single center, placebo-controlled study.

Eligibility criteria: Inclusion Criteria:

* High risk for delirium age \> 65 history of delirium medical comorbidities ability to give informed consent

Exclusion Criteria:

* Dementia Alcohol abuse Current use of an antipsychotic Allergy to olanzapine

Primary outcomes:
measure: incidence of delirium
timeFrame: days in hospital
Secondary outcomes:
measure: Complications, length of stay, hospital costs
timeFrame: days
Other outcomes:
Locations:
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
Study officials:
affiliation: New England Baptist Hospital
name: Susan Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larsen KA, Kelly SE, Stern TA, Bode RH Jr, Price LL, Hunter DJ, Gulczynski D, Bierbaum BE, Sweeney GA, Hoikala KA, Cotter JJ, Potter AW. Administration of olanzapine to prevent postoperative delirium in elderly joint-replacement patients: a randomized, controlled trial. Psychosomatics. 2010 Sep-Oct;51(5):409-18. doi: 10.1176/appi.psy.51.5.409.
Clinical trial NCT00140946: A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients (0476-075)
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Two-Period, Parallel-group Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.


Eligibility criteria: Inclusion Criteria:

* Males or females between the ages of 18 and 70 with asthma

Primary outcomes:
measure: Percentage of days of asthma exacerbations
Secondary outcomes:
measure: Percentage of asthma free days
measure: Percentage of nocturnal awakenings
measure: Beta agonist use
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Vaquerizo MJ, Casan P, Castillo J, Perpina M, Sanchis J, Sobradillo V, Valencia A, Verea H, Viejo JL, Villasante C, Gonzalez-Esteban J, Picado C; CASIOPEA (Capacidad de Singulair Oral en la Prevencion de Exacerbaciones Asmaticas) Study Group. Effect of montelukast added to inhaled budesonide on control of mild to moderate asthma. Thorax. 2003 Mar;58(3):204-10. doi: 10.1136/thorax.58.3.204.
Clinical trial NCT05948046: The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency
Official title: The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Convergence Insufficiency
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent patients with insufficient astringency

Brief summary: This trial is an observational cohort study. Patients aged 8-15 years with symptomatic convergence insufficiency and 150 patients with symptomatic convergence insufficiency who had not received visual training were selected from the Tianjin Eye Hospital Optometry Center and received 1 course of visual training treatment. Self-assessment and other assessments were combined, and the patient and guardian questionnaires were collected. The EQ-5D-Y and CHU9D scales were used to evaluate Chinese patients' health-related quality of life with symptomatic convergence insufficiency. The feasibility of the EQ-5D-Y and CHU9D scales in assessing the health-related quality of life of Chinese patients with symptomatic convergence insufficiency was analyzed. To assess the effectiveness of visual training on visual symptoms and improvement of quality of life in patients with symptomatic convergence insufficiency


Eligibility criteria: Inclusion Criteria:

* 8\~15 years old
* Monocular best corrected visual acuity at distance and near was more than 0.8
* Near exophoria 4Δ greater than distance exophoria
* NPC ≥ 6cm
* PFV ≤15△BO
* Stereogram ≤500 ''
* Score of CISS questionnaire ≥16 or COVD questionnaire≥20

Exclusion Criteria:

* present constant strabismus, nystagmus or vertical phoria at distance or near.
* developmental delay or ocular surgery
* Myopia≤ -6.00D, Hyperopia ≥ +5.00D, Astigmatism ≥ 4.00D
* Monocular Amplitude of accommodation\<5D
* Other diseases except myopia

Primary outcomes:
measure: Changes in EuroQol five dimensions questionnaire(EQ-5D-5L) score
timeFrame: The changes between baseline and 3 months
measure: Changes in shortForm 6D(SF-6D) questionnaire score
timeFrame: The changes between baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
References:
Clinical trial NCT01863446: Effects of Light on Melatonin and Contractions in Pregnant Women
Official title: Effects of Light on Melatonin and Contractions in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Pregnancy
Melatonin
Contractions
Light
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard University
name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-05-29
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Specific Aim: Test the hypothesis that ocular light exposure will suppress melatonin secretion and reduce uterine contractions in women at late term pregnancies.

Secondary aim. Test the hypothesis that ocular light exposure will reduce self-reported uterine contractions in women at late term pregnancies.


Eligibility criteria: Inclusion Criteria:

* pregnant at 35-40 weeks
* first pregnancy

Exclusion Criteria:

* pregnancy-related complications
* twin or higher pregnancy
* using medication that affects the sympathetic nervous system

Primary outcomes:
measure: Melatonin Area Under the Curve (AUC)
timeFrame: 4 hours of light exposure.
Secondary outcomes:
measure: Uterine Contractions
timeFrame: 4 hours of light exposure
Other outcomes:
measure: Subjective Assessment of Uterine Contractions
timeFrame: 4 hours of light exposure
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Elizabeth B Klerman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01385046: Project Fit:a School- and Community-based Obesity Intervention
Official title: Project Fit:a School- and Community-based Intervention to Address Physical Activity and Healthy Eating Among Low-income Elementary School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: physical inactivity
poor diet
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
name: United States Department of Agriculture (USDA)
First posted: 2011-06-29
Enrollment: 403
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Project FIT is a collaboration between the public school system, local health systems, physicians, neighborhood associations, businesses, faith-based leaders, community agencies and university researchers to develop a multi-faceted approach to promote physical activity and healthy eating toward the general goal of preventing and reducing childhood obesity among children in Grand Rapids, MI, USA. There are four overall components to Project FIT: school, community, social marketing, and school staff wellness - all that focus on: 1) increasing access to safe and affordable physical activity and nutrition education opportunities in the schools and surrounding neighborhoods; 2) improving the affordability and availability of nutritious food in the neighborhoods surrounding the schools; 3) improving the knowledge, self-efficacy, attitudes and behaviors regarding nutrition and physical activity among school staff, parents and students; 4) impacting the 'culture' of the schools and neighborhoods to incorporate healthful values; and 5) encouraging dialogue among all community partners to leverage existing programs and introduce new ones.


Eligibility criteria: Inclusion Criteria:

* enrolled in participating school district in grades 1-5.

Exclusion Criteria:

* None

Primary outcomes:
measure: Physical activity measured by pedometer.
timeFrame: 2 years
measure: Healthy eating index quantified by the Food Frequency Questionnaire.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Grand Rapids Public Schools
state: Michigan
Study officials:
affiliation: Michigan State University
name: Denise Holmes, PhD
role: STUDY_CHAIR
References:
citation: Eisenmann JC, Alaimo K, Pfeiffer K, Paek HJ, Carlson JJ, Hayes H, Thompson T, Kelleher D, Oh HJ, Orth J, Randall S, Mayfield K, Holmes D. Project FIT: rationale, design and baseline characteristics of a school- and community-based intervention to address physical activity and healthy eating among low-income elementary school children. BMC Public Health. 2011 Jul 29;11:607. doi: 10.1186/1471-2458-11-607.