louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02856659: Evaluation of N6 Sound Processor in Group of Freedom Users
Official title: Evaluation of N6 Sound Processor in Group of Freedom Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sensory Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2016-08-05
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults and children 12 years of age and older.

Brief summary: Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To test speech understanding in each device and usability of upgrade.


Eligibility criteria: Inclusion Criteria:

* Subjects with sensorineural hearing loss
* 12 years of age and older
* Currently using Freedom Sound Processor
* Recipient of a Ci22M or CI24 series implant
* Minimum of 3 months experience with Freedom Sound Processor
* Prior documentation of sentence recognition in noise at a +10 SNR or better
* Native English speaker
* Willingness to participate and comply with requirements of protocol

Exclusion Criteria:

* Unable to complete test metrics
* Unrealistic expectations regarding possible benefits
* Additional handicaps that would prevent or restrict participation in audiological evaluations
* ABI cochlear implant recipient

Primary outcomes:
measure: Evaluation of N6 Sound Processor in Group of Freedom Users
timeFrame: 3 months of use
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cochlear
name: Lori O'Neil, Au.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01221259: A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed as a single ascending dose study in healthy subjects to evaluate safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) in plasma and Cerebrospinal (CSF) following single oral doses of E2212.


Eligibility criteria: Inclusion Criteria:

1. Healthy men and women of non-child bearing potential age 18 and 55 years old at the time of Screening;
2. Body mass index (BMI) 18 and 30 kg/m2 at Screening;
3. Are willing and able to comply with all aspects of the protocol; and
4. Provide written informed consent.

Exclusion Criteria:

1. Clinically important abnormalities on physical examination, vital signs or clinical laboratories.
2. History of serious medical illness
3. Smoking or use of tobacco-containing products within past 3 months
4. History of alcohol or drug abuse within past 2 years

Primary outcomes:
measure: To evaluate the safety and tolerability of single ascending oral doses of E2212 in healthy subjects.
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: Quintiles Phase One Service
name: Philip Lee, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02759159: The Study of Mechanism of Alzheimer's Disease Using Acupuncture Based on fMRI
Official title: The Study of Brain Functional Network Modulatory Mechanism of Alzheimer's Disease Using Acupuncture at the "Four-gate" Acupoints
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Alzheimer's disease (AD) is one of the major brain diseases which received more attention in recent years. The disconnection syndrome is the main pathophysiological mechanism leading to cognitive decline in AD patients. Both animal experiment and clinical observation have demonstrated that acupuncture can generate treatment effect on AD patients by moderating the neural pathway directly. However, the underlying mechanism remains unclear. By using resting state functional magnetic resonance imaging (fMRI) method, as well as acupuncture and neurology sciences, investigators will explore the multi-modality data analysis; compare brain connectivity and network parameters changes between pre- and post- acupuncture treatment; analyze the correlation between fMRI changes and neuropsychology test. The present study aims to elucidate the neural mechanism of acupuncture therapy on early AD, provide theoretical evidence from the perspective of functional connectivity.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Alzheimer's Disease Clinical diagnosis of MCI due to Alzheimer's Disease Drug therapy regularly

Exclusion Criteria:

Frontotemporal dementia Lewy body dementia Vascular dementia Severe depression Brain vascular disease Metabolic disease

Primary outcomes:
measure: brain functional connectivity
timeFrame: with in first week after the whole acupuncture treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu hospital
state: Beijing
city: Beijing
country: China
facility: Dongfang Hospital,Beijing University of Chinese Medicine
state: Beijing
Study officials:
References:
Clinical trial NCT06297759: The Validity and Reliability Study of Turkish Version of the Sense of Competence in Dementia Care Staff (SCIDS) Scale
Official title: The Validity and Reliability Study of Turkish Version of the Sense of Competence in Dementia Care Staff (SCIDS) Scale
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dementia
Keywords: dementia
Turkish version
dementia care staff
sense of competence in dementia care staff scale
validity
reliability
Lead sponsor: Yeditepe University
Sponsor class: OTHER
Collaborators: name: Acibadem University
First posted: 2024-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Working as a dementia care staff in Acıbadem Health Group

Brief summary: The purpose of the study is to adapt the SCIDS into the Turkish version and validate it in the social and cultural context of Turkey to assess staff competency in dementia care in the long-term care setting.

Detailed description: Most existing tools measuring care adequacy are targeted at family caregivers. Tools targeting formal dementia carers have focused primarily on dementia care knowledge, care attitudes and care workloads separately. There is less research investigating the assessment of competence in dementia care among formal healthcare staffs. There is no validated tool to accurately assess staff competency in dementia care in the long-term care setting in Turkey. Schepers et al. developed a scale dedicated to assessing Sense of Competence in Dementia Care Staff, including relationship building, maintaining personality, professionalism, and care challenges. Today, the scale has been used to evaluate the effectiveness of training programs and has demonstrated its applicability.

Eligibility criteria: Inclusion Criteria:

* Working as a dementia care staff for at least 1 year

Exclusion Criteria:

* Not volunteering

Primary outcomes:
measure: Sense of Competence in Dementia Care Staff Scale
timeFrame: Change from Baseline Scores at one week
Secondary outcomes:
measure: Caring Behaviors Inventory-24
timeFrame: Change from Baseline Scores at one week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01488500: Woodsmoke Exposure and Cardiovascular Function
Official title: Cardiovascular Effects of Experimental Exposure to Woodsmoke in Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Inflammation
Systemic Inflammation
Keywords: Wood smoke
inflammation
lung function
arterial stiffness
heart rate variability
Respiratory and systemic inflammation following exposure to woodsmoke in healthy volunteers
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Umeå University
First posted: 2011-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Air pollution is linked to respiratory and cardiovascular disease. Wood smoke is a common air in many parts of the world and previous studies indicate that wood smoke induce oxidative stress in the respiratory tract. It is not determined how different types of biomass combustion affect human health. In this study the investigators plan to investigate how inhalation of wood smoke and pellets smoke affect respiratory and cardiovascular health.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Use of regular medication except the oral contraceptive pill
* Current smokers
* Significant occupation exposure to air pollution
* Intercurrent illness

Primary outcomes:
measure: Respiratory inflammation
timeFrame: 24 hours after exposure to air or woodsmoke
Secondary outcomes:
measure: Central arterial stiffness
timeFrame: Baseline and for 1 hour after exposure
measure: Heart rate variability
timeFrame: 24 hours after the exposure
measure: Systemic inflammation
timeFrame: 24 hours after the exposure
measure: Lung function
timeFrame: Baseline and 24hrs after exposure
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
affiliation: Umeå University
name: Thomas Sandström, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muala A, Rankin G, Sehlstedt M, Unosson J, Bosson JA, Behndig A, Pourazar J, Nystrom R, Pettersson E, Bergvall C, Westerholm R, Jalava PI, Happo MS, Uski O, Hirvonen MR, Kelly FJ, Mudway IS, Blomberg A, Boman C, Sandstrom T. Acute exposure to wood smoke from incomplete combustion--indications of cytotoxicity. Part Fibre Toxicol. 2015 Oct 29;12:33. doi: 10.1186/s12989-015-0111-7.
citation: Langrish JP, Watts SJ, Hunter AJ, Shah AS, Bosson JA, Unosson J, Barath S, Lundback M, Cassee FR, Donaldson K, Sandstrom T, Blomberg A, Newby DE, Mills NL. Controlled exposures to air pollutants and risk of cardiac arrhythmia. Environ Health Perspect. 2014 Jul;122(7):747-53. doi: 10.1289/ehp.1307337. Epub 2014 Mar 25.
citation: Unosson J, Blomberg A, Sandstrom T, Muala A, Boman C, Nystrom R, Westerholm R, Mills NL, Newby DE, Langrish JP, Bosson JA. Exposure to wood smoke increases arterial stiffness and decreases heart rate variability in humans. Part Fibre Toxicol. 2013 Jun 6;10:20. doi: 10.1186/1743-8977-10-20.
Clinical trial NCT06308900: Non-technical Skills of Clinical Simulation in Physiotherapy Students
Official title: Evaluation of Non-technical Skills of Clinical Simulation in Physiotherapy Students and Analysis of the Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Physiotherapy
Students
Learning methodology
Clinical simulation
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Clinical simulation has gained great importance in recent times in health sciences. Since it is a pedagogical strategy that is being used more and more in health degrees and is very useful for the acquisition of both technical and non-technical skills.

However, if we focus on physiotherapy, the use of clinical simulation is a very new field and therefore requires great research. The investigators still do not have the consistency or experience as in other health branches such as medicine or nursing, in which they have been using simulators for years for the learning of all their students.

For all this, and for the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely abolished, the need for our research is justified, which will allow the acquisition of non-technical skills among novice students. in physiotherapy, without the need for contact with real patients.


Eligibility criteria: Inclusion Criteria:

* Second year students of the Physiotherapy Degree
* They do not have clinical experience with real patients.

Exclusion Criteria:

* Not wanting to sign to participate in the study.
* Not signing the informed consent

Primary outcomes:
measure: Ottawa Scale
timeFrame: 1 week, 2, week, 3 week
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: David Hernández-Guillén
Study officials:
affiliation: University of Valencia
name: David Hernández-Guillén
role: STUDY_DIRECTOR
References:
Clinical trial NCT00518700: Comfort Evaluation of a New MPS vs. Replenish in Contact Lens Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Corneal Staining
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2007-08-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To compare corneal staining after contact lens instillation with a new MPS vs. RepleniSH


Eligibility criteria: Inclusion Criteria:

1. Patients 18 yrs or older
2. Males or females
3. Any race or ethnic background
4. CL patients using MPS products currently
5. Patients using Contact Lenses habitually (at least 1 month)

Exclusion Criteria:

1. Corneal refractive surgery within 6 months of this study.
2. Contact lens use on day of examination.
3. Corneal ectasia.
4. Current use of Restasis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Private Practice
state: California
Study officials:
affiliation: Private Practice
name: Milton Hom, OD, FAAO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05463900: Microbial and Human Determinants of the Onset of IBD Flares
Official title: Microbial and Human Determinants of the Onset of IBD Flares on a National Scale - an Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ulcerative Colitis
Crohn Disease
Irritable Bowel
Crohns Disease Aggravated
Crohn Disease in Remission
Keywords: IBD
flare
UC
CD
HBI
SCCAI
stool
diarrhea
abdominal pain
inflammation
colon
rectum
Lead sponsor: Viome
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of up to 1000 Ulcerative Colitis participants and up to 1000 Crohn's Disease participants that are 18 years of age or older and that meet the inclusion criteria.

Brief summary: This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study is direct to participant and will not utilize clinical sites.

Detailed description: This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study will last approximately 3 years and will recruit up to 1000 Crohn's Disease participants and up to 1000 Ulcerative Colitis participants that will participant in the study for approximately 12 months. Participants will be sent at home sample collection kits and a study survey each month. If the survey responses indicate a participant is in a flare, they will be sent a sample collection kit and survey on a weekly basis until the flare is over and the monthly schedule resumes. The objective of the data analysis is to identify microbial functions that are predictive of the onset of a flare.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Able to provide written informed consent prior to screening
* Established diagnosis of small bowel or colonic Crohn's Disease (CD) or Ulcerative Colitis (UC)

Exclusion Criteria:

* Pregnant or breastfeeding
* Use of antibiotics within the last 3 months
* Bowel surgery in the past 3 months or planned bowel surgery during the 12-month study period

Primary outcomes:
measure: Names of species
timeFrame: 3 years
measure: Number of species
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bothell
country: United States
facility: Viome Life Sciences
state: Washington
Study officials:
affiliation: Viome
name: Momchilo Vuyisich
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06155500: Long-term Follow-up (LTFU) of Patients Treated With Genome-edited Autologous Hematopoietic Stem and Progenitor Cells (HSPC)
Official title: Long-term Follow-up (LTFU) of Patients Treated With Genome-edited Autologous Hematopoietic Stem and Progenitor Cells (HSPC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sickle Cell Disease
Keywords: Gene therapy
genome-edited hematopoietic stem and progenitor cellular therapy
sickle cell
autologous transplant
BCL11A
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-12-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Target population includes all patients who have received OTQ923 within the treatment protocol (CADPT03A12101) and have been monitored for at least 1 year post-infusion.

Brief summary: CADPT03A12001 is a prospective, multi-center study that is designed to follow all enrolled patients who have received treatment with OTQ923 for long-term safety and efficacy.

Detailed description: This study is monitoring patients treated with OTQ923, an investigational drug product of ex vivo genome-edited autologous hematopoietic stem and progenitor cells (HSPCs) that induces fetal hemoglobin (HbF) production, for a total of 15 years following infusion to monitor long-term safety and efficacy.

Eligibility criteria: Inclusion Criteria:

1. Accepted invitation to join based on prior treatment with gene therapy.
2. Patients must provide informed consent prior to their entry into this study.

Exclusion Criteria:

1. Completion of less than 1 year of safety follow-up in the treatment protocol (CADPT03A12101)

Primary outcomes:
measure: Number of participants with delayed adverse events that are suspected to be related to previous OTQ923 therapy
timeFrame: Up to 15 years
Secondary outcomes:
measure: Persistence of fetal hemoglobin expression
timeFrame: Up to 15 years
measure: WBC chimerism in peripheral blood
timeFrame: 5 years
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St Jude Childrens Rsrch Hospital
state: Tennessee
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00006500: Trends in Trans-Fatty Acid Intake Between 1980 and 1997
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-11-17
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To examine trends in trans-fatty acid intake by using newly available nutrient data to recalculate 24 dietary recalls from the Minnesota Heart Survey.

Detailed description: BACKGROUND:

In recent years concern has arisen about the potential health hazards of trans-fatty acids in the American diet. Dietary intake of trans-fatty acids has been linked to unhealthy shifts in serum lipid profiles and to coronary heart disease (CHD) in a number of studies. Although several studies have estimated intakes of trans-fatty acids in U.S. populations, presently data is lacking regarding trends in intake of trans-fatty acids in the population. Furthermore, it is unclear how trends in intake of trans-fatty acids may be related to changes in other dietary and non-dietary CHD risk factors and CHD mortality.

DESIGN NARRATIVE:

The study used newly available nutrient data to recalculate dietary data collected as part of the Minnesota Heart Survey (MHS) to examine trends in intake of trans-fatty acids. The MHS was an ongoing observational epidemiologic study of trends in risk factors and cardiovascular morbidity and mortality among independent cross-sectional probability samples of the Minneapolis-St. Paul, Minnesota, metropolitan area. Surveys were conducted in 1980-1982, 1985-1987, 1990-1992 and 1995-1997. Diet was among the CVD risk factors measured as part of each survey. In this research, 24-hour dietary recalls collected from MHS participants were recalculated using an updated food and nutrient database that included trans-fatty acid values (16:1, 18:1, 18:2, and total). Intake estimates resulting from recalculation were analyzed to examine temporal trends in trans-fatty acid intake between 1980 and 1997, and to examine the relationship of temporal trends in trans-fatty acid intake to temporal changes in other dietary and non-dietary CHD risk factors and changes in CHD mortality. The MHS data provided a unique opportunity to examine a dietary constituent only recently recognized as a potential risk factor for CHD.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Lisa Harnack
References:
citation: Harnack L, Lee S, Schakel SF, Duval S, Luepker RV, Arnett DK. Trends in the trans-fatty acid composition of the diet in a metropolitan area: the Minnesota Heart Survey. J Am Diet Assoc. 2003 Sep;103(9):1160-6. doi: 10.1016/s0002-8223(03)00976-3.