louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03192254: Understanding Mechanisms of Health Behavior Change
Official title: Understanding Mechanisms of Health Behavior Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Diet Modification
Incentives
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically fruit and vegetable consumption. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and another providing delayed rewards (i.e. rewards received at the end of the study period), with a control condition in which no rewards are offered. Study participants will provide reports of their fruit and vegetable consumption each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their fruit and vegetable consumption. Following the three week reporting and reward period, participants will complete two additional assessments, measuring psychological constructs and behavior engagement following the cessation of rewards. The study will also examine how cognitive and anthropomorphic factors may contribute to intervention response and the effects on psychological constructs.


Eligibility criteria: Inclusion Criteria:

* Consume fewer than 3 servings/day of fruits and vegetables
* Daily access to internet for 3 weeks following baseline session
* Have or are willing to create an account on PayPal
* BMI greater than or equal to 25, from self-reported height and weight

Exclusion Criteria:

-

Primary outcomes:
measure: Fruit and vegetable consumption, servings per week
timeFrame: 3 Weeks
measure: Fruit and vegetable consumption, servings per week
timeFrame: 5 Weeks
measure: Perceived behavioral control scale score
timeFrame: 3 Weeks
measure: Perceived behavioral control scale score
timeFrame: 5 Weeks
measure: Attitude scale score
timeFrame: 3 Weeks
measure: Attitude scale score
timeFrame: 5 Weeks
Secondary outcomes:
measure: Intrinsic motivation scale score
timeFrame: 3 Weeks
measure: Intrinsic motivation scale score
timeFrame: 5 Weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
References:
Clinical trial NCT05598554: The Effects of Telerehabilitation And Chair-based Yoga In The Elderly
Official title: The Effects of Chair-Based Yoga With Telerehabilitation on Function and Quality of Life in Elderly Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telerehabilitation
Chair-based Yoga
Elderly People
Keywords: depression
quality of life
quality of sleep
pain
chair-based yoga
Telerehabilitation
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to investigate the effects of chair-based yoga with rehabilitation on quality of life is affected in elderly people. Depending on the changes in the body as a result of aging, people's quality of life is affected. In order to increase or protect the quality of life in elderly people, telerehabilitation practices are emphasized. Telerehabilitation is a promising system for the elderly thanks to its advantages.

As a practice, chair-based yoga, a modified form of yoga, was preferred. Chair-based yoga makes yoga more doable and safe for older people. Chair-based yoga with telerehabilitation was performed with the participants. Pain level, sleep status, functional capacity, quality of life, mental health and depression were followed by evaluations at the beginning and end of the process.


Eligibility criteria: Inclusion Criteria:

* 65 years and over,
* Having a Standardized Mini Mental Test Score of 24 and above,
* physically active (self-sustaining),

Exclusion Criteria:

* severe cardiopathy,
* uncontrolled hypertension,
* mental disorder,
* Presence of any health condition that may prevent functional autonomy test such as hearing and vision,
* have mental disorders and dementia,
* people with any unstable medical condition

Primary outcomes:
measure: Senior Fitness Test (SFT)
timeFrame: 6 weeks
measure: Nottingham Health Profile (NHP)
timeFrame: 6 weeks
Secondary outcomes:
measure: Charlson Comorbidity Index
timeFrame: 6 weeks
measure: Barthel Index for Activities of Daily Living
timeFrame: 6 weeks
measure: Mini Mental State Assessment
timeFrame: 6 weeks
measure: Yesavage Geriatric Depression Scale
timeFrame: 6 weeks
measure: Tinetti Balance and Gait Test
timeFrame: 6 weeks
measure: Clinical Frailty Scale
timeFrame: 6 weeks
measure: Pittsburgh Sleep Quality
timeFrame: 6 weeks
measure: Mc Gill Pain Questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University Topkapi Campus
state: Balıkesir
Study officials:
affiliation: sevval.bak19@gmail.com
name: Şevval Bakır
role: PRINCIPAL_INVESTIGATOR
affiliation: guldenizy@yahoo.com
name: Gül D Yelvar
role: STUDY_DIRECTOR
References:
Clinical trial NCT03499054: Breathing Exercises to Improve Fatigue and Quality of Life in Hemodialysis Patients
Official title: Breathing Exercises to Improve Fatigue and Quality of Life in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Breathing Exercises
Fatigue
Keywords: Breathing exercises
fatigue
quality of life
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized hemodialysis patients in hospital
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breathing exercises to improve fatigue and quality of life in hemodialysis patients

Detailed description: Patients receiving haemodialysis have poor physical function, psychological status and quality of life than the general population.Fatigue is a debilitating symptom in haemodialysis patients Exercise training may improve these parameters for haemodialysis patients.

A 3-month randomized control trial with baseline、Week 4、Week 12 measurement periods was conducted. Exercise group was taught to Breathing exercise week and Usual care for three months. The control group received usual routine care.

A total of 86 patients participated in this study, with 43 patients in the Exercise group and 43 patients in the control group Methods: Hemodialysis Fatigue scale 、 WHOQOL-BREF 、 HADS_ Anxiety

、 HRV

Eligibility criteria: Inclusion Criteria:

1. diagnosed by end-stage renal disease, regular hemodialysis three times a week and up to six months or more
2. Adults over 20 years of age.
3. Consciousness.
4. can be used to communicate in Taiwanese, accept questionnaire interviews or self-filling questionnaire.
5. no chest pain or shortness of breath symptoms.
6. No lower extremity disability and ability to walk on their own.
7. agree to take respiratory exercise intervention measures, have the intention to participate in this study and signed a consent form.

Exclusion Criteria:

1. unstable vital signs, or serious heart disease: such as the diagnosis of myocardial infarction, unstable angina pectoris, cardiopulmonary disease and other patients.
2. A complication occurs, such as aspiration pneumonia.
3. history of arrhythmia, as well as taking heart rate medication.
4. Physician's advice is not suitable for exercise, such as bone and joint problems.
5. There is a temporary double vena cava catheter placed.

Primary outcomes:
measure: fatigue
timeFrame: A 3-month
Secondary outcomes:
measure: quality of life
timeFrame: A 3-month
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References:
Clinical trial NCT04286854: Echocardiographic Assessment of the Right Ventricle in Healthy Subjects During Stress Test in the Mexican Population
Official title: Echocardiographic Assessment of the Right Ventricle in Healthy Subjects During Stress Test in the Mexican Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Echocardiography, Stress
Reference Values
Keywords: Echocardiography, Stress
Right ventricle
Mexican population
Lead sponsor: Hospital Beneficencia Espanola de Puebla
Sponsor class: NETWORK
Collaborators: name: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
First posted: 2020-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -The sample will be selected from a group of volunteers.

Brief summary: The echocardiographic indices of the right ventricle function vary significantly with demographic and anthropometric of each population factors and are associated with poor prognosis in several cardiovascular diseases.

This study aims to investigate exercise-induced changes in echocardiographic indices of the right ventricle function in healthy volunteers and establish the reference values to the Mexican population.


Eligibility criteria: Inclusion Criteria:

* Healthy men or women
* Age ≥18 years and \< 45.
* No history or symptoms of cardiovascular or lung disease
* No cardiovascular risk factors, that is, arterial systemic hypertension, smoking, diabetes, dyslipidemia
* No ongoing or previous cardio or vasoactive treatment
* Normal ECG
* Normal physical examination
* Able to use the semi-supine exercise bicycle
* Able to give informed consent

Exclusion Criteria:

* Tricuspid regurgitation more than mild
* Poor acoustic window.
* Professional sports activity
* Pregnancy
* Obesity (body mass index \[BMI\], ≥30 kg/m2).
* No knowledge of serum lipid or glucose levels at any time
* Inability to provide consent

Primary outcomes:
measure: Response of diastolic and systolic function of the right ventricle during stress test by echocardiography in a healthy Mexican Cohort
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Puebla
country: Mexico
facility: Hospital Beneficencia Española de Puebla
Study officials:
References:
Clinical trial NCT04242654: Doppler Ultrasound Compared With Stethoscope to Assess Heart Rate (HR)
Official title: A Randomized-Controlled Trial of Handheld Doppler Ultrasound Compared With Auscultation by Stethoscope to Assess Heart Rate During the Resuscitation of High-risk Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Resuscitation
Keywords: Doppler ultrasound
heart rate
neonatal resuscitation
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 32
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized controlled trial comparing heart rate measurement by Doppler ultrasound or auscultation with a stethoscope in newborn infants who require stabilization or resuscitation immediately after birth. Enrolled subjects will be randomly assigned to have their heart rate (HR) obtained by stethoscope (ST) or by Doppler ultrasound (DO). Neonates will be resuscitated in accordance with the Neonatal Resuscitation Program (NRP) guidelines.

Detailed description: Obtaining a baby's heart rate (HR) is an important part of neonatal resuscitation in the delivery room and helps the medical team decide how to treat the baby. When babies do not breathe well on their own, the medical team places electrocardiogram (ECG) leads on the baby's chest to obtain an accurate HR rapidly that can be seen by the entire team. Before the ECG leads are placed on the baby's chest, the Neonatal Resuscitation Program (NRP) guidelines suggest that medical team members listen to the baby's HR using a stethoscope for 6 seconds. However, it can take longer than 6 seconds for medical team members to obtain a HR which can delay a baby's care. The purpose of this study is to determine if Doppler ultrasound is a useful, alternative tool, aside from a stethoscope, that can be used to quickly obtain a baby's HR, particularly in high-risk babies. The primary objective will be the time that it takes to obtain a baby's HR by Doppler ultrasound as compared to listening to a baby's HR with a stethoscope. With this study, the investigators will be able to understand if Doppler ultrasound is a useful tool in the resuscitation of babies who are high risk.

Eligibility criteria: Inclusion Criteria:

* All neonates admitted to the transitional nursery for resuscitation after delivery

Exclusion Criteria:

* Neonates with congenital heart disease, congenital diaphragmatic hernia
* Neonates whose mothers present and will have imminent delivery

Primary outcomes:
measure: Time to obtain HR (in seconds)
timeFrame: Up to approximately 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Tina Leone A. Leone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03801954: Implementation of Nutrition Education Videos for Patients Undergoing Radical Cystectomy
Official title: Implementation of Nutrition Education Videos for Patients Undergoing Radical Cystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Nutrition
Diet
Radical cystectomy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present to the University of Kansas Urology clinic for bladder cancer will be screened for participation in the study.

Brief summary: By doing this study the investigators hope to learn if educational videos focusing on nutrition for bladder cancer patients are a good and effective way to help people improve their nutrition and recovery after radical cystectomy (RC).

Detailed description: Bladder Cancer is the fifth most common cancer in the USA. The primary treatment for invasive bladder cancer is chemotherapy followed by RC. Patients undergoing this surgery are at risk for complications. Being malnourished can increase the risk of mortality by three times. The patients also suffer from taste alterations after chemotherapy and gastrointestinal disturbances such as diarrhea and constipation. These can lead to poor nutritional intake and malabsorption of nutrients.

This study is being done to develop an educational video series for patients undergoing RC and assess their impact. The videos are created to address the nutritional needs of these patients and improve their outcomes after surgery.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with bladder cancer and scheduled to undergo a radical cystectomy or has undergone a radical cystectomy OR be the caregiver of a patient diagnosed with bladder cancer who is scheduled to undergo a radical cystectomy or has undergone a radical cystectomy

Exclusion Criteria:

* 1. Patients who are under 18 years old are not allowed to participate

Primary outcomes:
measure: Evaluate content of three educational video series
timeFrame: Week 2
measure: Patient Feedback Regarding Videos
timeFrame: Week 2
measure: Patient Attention During Videos
timeFrame: Week 2
measure: Test feedback instrument with patients
timeFrame: Week 2
measure: Assess implantation of video series
timeFrame: Week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Eugene Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03846154: Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Mental Health Symptoms
Official title: Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Trauma-related Mental Health Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Aggressive Behaviour
Parental Maltreatment
Days Spent at the Landfill
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: Vivo international e.V.
name: Psychologues sans Frontières Burundi
name: Université Lumière de Bujumbura
First posted: 2019-02-19
Enrollment: 96
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children living at the landfills of Bujumbura are often exposed to maltreatment, including emotional neglect and physical abuse, and traumatic experiences. Furthermore, they grow up in severe poverty. Addressing trauma-related mental health issues and aggressive behaviour by Narrative Exposure Therapy (FORNET), familial communication by family visits, interaction difficulties of children by a group intervention, poverty by financial support and economic training for mothers, medical problems by medical assistance, legal conflicts by legal advice, and providing access to school, we aimed at reintegrating those children within the Burundian school system and improving familial relationships.

The investigators want to provide evidence, that mental health interventions are an integral part of assisting children and families affected by poverty and violence.


Eligibility criteria: Inclusion Criteria:

* Spending days at the landfills of Bujumbura

Exclusion Criteria:

* Psychotic symptoms

Primary outcomes:
measure: Change of load of traumatic symptoms measured via the University of California at Los Angeles Posttraumatic Stress Disorder Reaction Index (scale administered by Clinicians)
timeFrame: baseline; 5 months follow-up; 9 months follow-up
measure: Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence Checklist
timeFrame: baseline; 5 months follow-up; 9 months follow-up
measure: Change of experienced parental maltreatment measured via a shortened version of the Maltreatment and Abuse Chronology of Exposure (MACE)
timeFrame: baseline; 5 months follow-up; 9 months follow-up
measure: Change of number of days spent at the landfill
timeFrame: baseline; 5 months follow-up; 9 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Bujumbura
country: Burundi
facility: vivo international & Psychologues sans Frontières mental health center
state: Bujumbura Mairie
Study officials:
References:
Clinical trial NCT01556854: Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke
Official title: Comparative Effectiveness of Different Neuroprotectants Among Patients With Acute Ischemic Stroke in Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Keywords: ginkgo leaves
butylphthalide
edaravone
citicoline
cerebrolysin
piracetam
Neuroprotectants
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
First posted: 2012-03-16
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of consenting patients who are on neuroprotectant injection for the treatment of acute IS during hospitalization.

Brief summary: The primary objective of this study is to compare effectiveness of five different neuroprotectants, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.

The secondary objectives of the study are as follows:

* To compare safety of five different neuroprotectents, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.
* To compare cost-effectiveness of five different neuroprotectents, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.

Detailed description: Study Population:The study population will consist of consenting patients who are on neuroprotectant injection for the treatment of acute IS during hospitalization. Hospitals may contribute differing numbers of patients to the total sample size. Primary analyses will be conducted on the total sample size only.

Assessment of Outcomes:The outcome measures in this study include effectiveness, safety and cost measures.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Ischemic stroke confirmed by brain CT or MRI within 14 days of the index event
* Neuroprotectents administrated during hospitalization
* Direct admission based on physician evaluation or arrival through the emergency department
* Ability of patient or legally authorized representative (primarily spouse, parents, adult children, otherwise indicated) to provide informed consent.

Primary outcomes:
measure: Effectiveness Outcome Measures
timeFrame: 3 years
Secondary outcomes:
measure: Safety Outcome Measures
timeFrame: 3 years
measure: Cost-effectiveness Outcome Measures
timeFrame: 2011.7-2014.6
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tiantan hospital
state: Beijing
Study officials:
References: