louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06582823: Effects of a Health Belief Model-Based Community Educational Program to Increase the Awareness of Atrial Fibrillation Among Older Adults: a Randomized Controlled Trial
Official title: Effects of a Health Belief Model-Based Community Educational Program to Increase the Awareness of Atrial Fibrillation Among Older Adults: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 390
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this study is to evaluate the effects of a theory-based community educational program among older adults in the community on atrial fibrillation (AF) knowledge. It will also learn about their competency to detect irregular pulses and compliance to regular pulse check. The main questions it aims to answer are:

Do older adults in the community who received the Health Belief Model-based educational program have higher AF awareness?

Researchers will compare the educational program with the control, who receive an information leaflet about AF to see the effect on improving AF awareness.

Participants will:

Receive a 5-week Health Belief Model-based educational program or receive an information leaflet about AF.

Be reassessed immediately post-intervention and 3 month afterwards. Keep a logbook on their compliance to the advice of regular pulse palpation to detect AF pulse .


Eligibility criteria: Inclusion Criteria:

* adults aged 65 or older
* without a confirmed diagnosis of AF

Exclusion Criteria:

* cannot read Chinese
* with cognitive impairment (Abbreviated Mental Test ≤ 6)
* physical limitations in performing pulse palpation

Primary outcomes:
measure: Atrial Fibrillation Knowledge Scale
timeFrame: From enrollment to the end of study at 3 months
Secondary outcomes:
measure: Competency in differentiating regular and irregular pulses
timeFrame: From enrollment to the end of study at 3 months
measure: Compliance to performing self-screening of pulses
timeFrame: From enrollment to the end of treatment at 3 months
measure: Patient Health Questionanire-4 (PHQ-4)
timeFrame: From enrollment to the end of treatment at 3 months
measure: EuroQol Five Dimensions Five Levels (EQ-5D-5L)
timeFrame: From enrollment to the end of treatment at 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
Study officials:
affiliation: School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
name: Ryan Kin Ho HUI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01143623: Dose Response Effect of Probiotics for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults
Official title: Dose Response Effect of a Proprietary Probiotic Formula for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Antibiotic-associated Diarrhea
Keywords: antibiotic
diarrhea
probiotic
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2010-06-14
Enrollment: 510
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the dose response effect of probiotic capsules for the prevention of antibiotic-associated diarrhea (AAD).


Eligibility criteria: Inclusion Criteria:

* age 30-70 years
* initiating antibiotic therapy
* informed consent

Exclusion Criteria:

* current diarrhea
* life threatening illness
* habitual probiotic use

Primary outcomes:
measure: Incidence of antibiotic-associated diarrhea
timeFrame: 5 weeks after antibiotic discontinuation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
References:
Clinical trial NCT01902823: Effect of Cancer Nurse Navigators on Patient Outcomes
Official title: Pilot Test of the Effect of Cancer Nurse Navigators on Patient Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Lung Cancer
Breast Cancer
Colorectal Cancer
Prostate Cancer
Keywords: Nurse Navigator
Satisfaction with Care
Quality of Life
Symptom Distress
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
First posted: 2013-07-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is widespread anecdotal evidence that Cancer Nurse Navigators (CNNs) are highly valued by cancer patients, but no studies have evaluated the effects of CNNs on important patient-reported outcomes or indicators of quality of care. This study has two aims:

1. To assess the feasibility of studying the impact of Aurora CNN Program.
2. To pilot test the effects of CNN services on patient-reported outcomes and indicators of quality of care.


Eligibility criteria: Inclusion Criteria:

1. Adult (18 years of age or older)
2. Treated at Aurora St. Luke's or West Allis Medical Center
3. New or recurrent dx of lung, prostate, colorectal or breast cancer -

Exclusion Criteria:

1. Previously received CNN services at an Aurora treatment facility
2. Unable to read/write in English
3. Living in a nursing home/long term care facility
4. Not capable of completing study questionnaires -

Primary outcomes:
measure: Satisfaction with Care
timeFrame: Change from baseline, to 3 months to 6 months
Secondary outcomes:
measure: ED/Urgent care visits
timeFrame: Baseline, 3 months, 6 months
measure: Quality of Life
timeFrame: Baseline, 3 months, 6 months
measure: Distressed mood
timeFrame: Baseline, 3 months, 6 months
measure: Symptom Distress
timeFrame: Baseline, 3 months, 6 months
measure: The Inventory of Recent Life Experiences for Cancer Patients
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora St. Luke's Hospital
state: Wisconsin
city: West Allis
country: United States
facility: Aurora West Allis
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kristine Kwekkeboom, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Uniuversity of Wisconsin Madison
name: Sandra E Ward, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00455923: SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
Official title: SERETIDE vs FLIXOTIDE in Mild Persistent Asthma (GINAII)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: asthma
exacerbation
persistent
bronchial hyperresponsiveness
mild
GINAII
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-04
Enrollment: 100
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: An 18 months randomised double-blind study with two parallel arms with start dose of inhaled SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be up-titrated until well controlled is achieved, After 6 months the treatment continues without changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that the combination therapy with SERETIDE controls mild persistent asthma better than inhaled corticosteroids(FLIXOTIDE) alone.


Eligibility criteria: Inclusion Criteria:

* Willing to give informed consent.
* Males or females aged 18-70.
* Able to understand and complete dairy cards.
* Mild persistent asthma according to GINA. In addition, at randomisation subjects were required to have: 1. Day time symptoms more than once a week but not every day. 2. Night-time symptoms not more than once a week. 3. FEV1 \>80% predicted 4. PC20 \<8mg/mL

Exclusion Criteria:

* Change to regular asthma medication in 4-weeks prior to visit 1.
* Use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.
* Lower respiratory tract within 4 weeks of Visit 1
* Received investigational study drug within 4 weeks of visit
* Smoking history of \>10 pack years of more.
* Serious uncontrolled disease.
* Medical conditions or medications known to affect the assessments or endpoints.
* Evidence of alcohol or drug abuse.
* Known pregnancy or planned pregnancy.
* Known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
* Previous enrollment in the study

Primary outcomes:
measure: Number of Participants in Each Arm With a Need for an Increase in Study Medication
timeFrame: Up to 18 months
Secondary outcomes:
measure: Absolute Bronchial Hyper-responsiveness up to 18 Months
timeFrame: Up to 18 months
measure: Change in Bronchial Hyper-responsiveness From Baseline to 18 Months
timeFrame: Baseline (Day 0) to 18 months
measure: Number of Symptom-free Days and Nights Without Use of Rescue Medication
timeFrame: Up to 18 months
measure: Number of Exacerbations: in Total and by Degree of Severity
timeFrame: Up to 18 months
measure: Time to Increase of Study Medication
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Luleå
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05640323: Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
Official title: Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Arrhythmia
Keywords: medical device
validation
arrhythmia
ECG
pulse rate
Norbert Device
Norbert Health
Lead sponsor: Norbert Health
Sponsor class: INDUSTRY
Collaborators: name: Northwell Health
First posted: 2022-12-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will recruit subjects within an Emergency Department as well as through online internet bulletin boards.

Brief summary: The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).

Detailed description: The study design is to validate the pulse and heart rate accuracy as required per ISO 80601-2-61, Clause 201.12.1.104. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of types of arrhythmias including tachycardia, bradycardia, atrial fibrillation, bigeminy, trigeminy, and others.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 or over
* Ability to provide signed informed consent

Exclusion Criteria:

* Pregnant
* Otherwise deemed unsuitable to participate in the study based on judgment of the study investigator

Primary outcomes:
measure: Mean Average Error (MAE)
timeFrame: Up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Newlab
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
References:
Clinical trial NCT01070823: JC-Virus (JCV) Antibody Program
Official title: JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Sample Collection
JCV
PML
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: United BioSource, LLC
name: Elan Pharmaceuticals
First posted: 2010-02-18
Enrollment: 1096
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with relapsing Multiple Sclerosis (MS) receiving commercial Tysabri® (natalizumab) and patients being considered for such treatment.

Brief summary: The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay in a plasma matrix and to determine changes in anti-JCV antibody status over time.

Detailed description: This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.

Eligibility criteria: Key Inclusion Criteria:

* Relapsing multiple sclerosis (MS) patients interested in or considering beginning treatment with Tysabri® (natalizumab).

Key Exclusion Criteria:

* Patients participating in any other Tysabri® (natalizumab) clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Prevalence of serum anti-JC virus (JCV) antibody
timeFrame: Day 1
measure: Number of participants with a false negative test
timeFrame: Day 1
Secondary outcomes:
measure: Changes in JCV antibody status over time
timeFrame: Every 6 months for 2 Years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Cullman
country: United States
facility: Research Site
state: Georgia
city: Barrington
country: United States
facility: Research Site
state: Illinois
city: Brighton
country: United States
facility: Research Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04865523: Effectiveness of Manual Lymphatic Drainage in Patients With Fibromyalgia
Official title: Effectiveness of Manual Lymphatic Drainage in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Manual Lymphatic Drainage
Randomized clinical trial
Pain
Lead sponsor: Camilo Jose Cela University
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Manual Lymphatic Drainage is a widely used technique for lymphedema. However, the analgesic effects of this technique could be potentially useful for managing pain in patients with generalized widespread chronic pain, including patients with fibromyalgia.


Eligibility criteria: Inclusion Criteria:

* Women with diagnosis of Fibromyalgia.

Exclusion Criteria:

* Women with heart failure.

Primary outcomes:
measure: Pain pressure threshold
timeFrame: Baseline
measure: Pain pressure threshold
timeFrame: Immediately after the intervention
measure: Pain pressure threshold
timeFrame: Up to 15 days
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: Baseline
measure: Visual Analogue Scale
timeFrame: Immediately after the intervention
measure: Visual Analogue Scale
timeFrame: Up to 15 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Juan Antonio Valera-Calero
Study officials:
References:
Clinical trial NCT00283023: Oligodendrocyte Progenitor Cell Culture From Human Brain
Official title: Phase 1: Oligodendrocyte Progenitor Cell Culture From Human Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Demyelinating Diseases
Keywords: All selective craniotomy
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2006-01-27
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cell culture
Primary purpose: BASIC_SCIENCE

Brief summary: Recent developments in the understanding of stem- and progenitor cell differentiation raises hopes that brain damage in chronic neurological diseases may become repaired by systemic or focal transplantation of such cells. Clinical trials of stem- or progenitor cell transplantation in multiple sclerosis are currently premature. The researchers developed a protocol for human oligodendrocyte progenitor cell culture from human brain for the treatment of demyelinating disease.

Detailed description: Oligodendrocyte progenitor cell line were cultures and will be transplanted into the patient with Multiple sclerosis.

Eligibility criteria: Inclusion Criteria:

* Male or female 20-65 years of age
* Informed consent
* Has elective craniotomy surgery

Exclusion Criteria:

* HIV, hepatitis, and other central nervous system (CNS) infections
* Dementia, Alzheimer disease, and neurodegenerative disease

Primary outcomes:
measure: Number of oligodendrocyte progenitor cell differentiation
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Assistant Professor Subsai Kongsaengdao
Study officials:
affiliation: Division of Neurology, Department of Medicine, Rajavithi Hospital : Thailand
name: Subsai Kongsaengdao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005923: The Effect of Estrogen and Progesterone Levels on Knee and Ankle Joint Laxity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Joint Instability
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-06-26
Sex: ALL
Minimum age (years): 15
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY

Brief summary: The proposed research is an observational study designed to compare estrogen and progesterone serum levels with knee and ankle joint laxity, and muscle reaction time as a measure of neuromuscular function. Three groups of women athletes with differing estrogen and progesterone profiles (normal menstrual cycles, amenorrheic, and exogenous estrogen supplementation) and one control group (male collegiate athletes) will be used to compare differences in joint laxity and neuromuscular function. Blood levels of estrogen and progesterone will be measured at four time points across the menstrual cycle. Joint laxity and muscle reaction time will also be measured at each of these points. The investigator hypothesizes that knee and ankle joint laxity and muscle reaction time will significantly increase with increasing estrogen and progesterone levels.


Eligibility criteria: Inclusion Criteria:

* pre-collegiate or collegiate athletes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
Clinical trial NCT05986123: Safety and Efficacy of Topical Cream for Post-inflammatory Hyperpigmentation Skin Among Malaysians
Official title: Safety and Efficacy of Topical Cream Containing Natural Plant Extracts, Niacinamide, and Arbutin for Post-inflammatory Hyperpigmentation Skin Among Malaysians
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Aesthetic
Cosmetic
Post-inflammatory hyperpigmentation (PIH)
Lead sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study was conducted to determine safety and efficacy of topically applied cream containing combination of niacinamide, arbutin, Scutellaria Baicalensis Root Extract, Centella Asiatica Extract and Camellia Sinensis Leaf Extract for its skin brightening effect on post-inflammatory hyperpigmentation among the Malaysian population. The study duration is 20 weeks and the skin assessment will be carried out at baseline, week 4, week 8, week 12, week 16 and week 20.The main questions this study aims to answer are:

1. To determine the efficacy of topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.
2. To investigate the safety of topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.
3. To assess the participants satisfaction of using topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.


Eligibility criteria: Inclusion Criteria:

* Malaysia citizen
* Healthy adult, aged between 18 to 40 years old.
* Participants who have post-inflammatory hyperpigmentation on skin

Exclusion Criteria:

* Participants with skin disorders such as skin infection or skin inflammation.
* Participants who have undergone any skin and cosmetic treatments such as dermal fillers, botox, laser, chemical peels within the last 3 months.
* Participant who is taking isotretinoin for the past 6 or 12 months and immunocompromised patients.
* Pregnant, breastfeeding women or planned for pregnancy during the study period.

Primary outcomes:
measure: Change in skin spot level
timeFrame: Baseline, week 4, week 8, week 12, week 16 and week 20.
measure: Change in hyperpigmentation score
timeFrame: Baseline, week 4, week 8, week 12, week 16 and week 20.
measure: Adverse effect after using the topical cream.
timeFrame: Week 20
Secondary outcomes:
measure: Participant satisfaction after using the topical cream for 20 weeks.
timeFrame: Week 20
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
state: Selangor
Study officials:
References: