louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05197803: Clinical Study of Released Unitron RIC and BTE Hearing Aid Models
Official title: Clinical Study of Released Unitron RIC (Receiver in Canal) and BTE (Behind the Ear) Hearing Aid Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Sonova Canada Inc.
First posted: 2022-01-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One similar intervention; 2 groups based on hearing aid model.
Primary purpose: TREATMENT

Brief summary: The present study will confirm the clinical benefit of 2 different released hearing aid models for speech understanding (in noise). Participants with mild to severe hearing impairment will be fit binaurally with Unitron hearing aids and will perform a standardized speech discrimination test in noise with and without hearing aids.

Detailed description: Each participant will be asked to wear a set of BTE and RIC hearing aids and complete the Hearing in Noise Test (HINT) aided and unaided. The investigators will be assessing their speech intelligibility in noise for each condition during the same appointment to determine the SNR50 (the Signal-to-Noise ratio necessary for a participant to recognize the speech material correctly 50 percent of the time).

Eligibility criteria: Inclusion Criteria:

* Adults (18+ years) with hearing impairment (N2 - N6 hearing loss).
* Healthy outer ear.
* Symmetrical hearing loss.
* Ability to answer questions and repeat sentences.
* Informed consent as documented by signature.
* Willingness to wear different style of hearing aids.
* Willingness to wear a binaural fitting.
* Willingness to wear closed domes.
* Willingness to adhere to COVID protocols including correct mask use, completing screening for each visit

Exclusion Criteria:

* Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational product).
* Limited mobility/not able to come to scheduled visits.
* Inability to produce reliable hearing test result.
* Visible congenital or traumatic deformity of the outer ear.
* History of active drainage from the ear in the previous 90 days.
* Abnormal appearance of the eardrum and ear canal.
* Acute or chronic dizziness.
* Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz.
* Known psychological problems.

Primary outcomes:
measure: Speech Intelligibility Test in Noise
timeFrame: 2 hours appointment
Secondary outcomes:
Other outcomes:
Locations:
city: Kitchener
country: Canada
facility: Unitron Hearing
state: Ontario
Study officials:
affiliation: jinyu.qian@sonova.com
name: Jinyu Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06649903: Cervical Spinal Manipulation and Visteral Osteopathy for Mechanical Neck Pain
Official title: Comparison of Cervical Spinal Manipulation and Visceral Osteopathy Techniques in People with Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: neck pain treatment
visceral osteopathy
servical spinal manupilation
osteopathy
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a randomized controlled study.
Primary purpose: TREATMENT

Brief summary: This study compares two treatment techniques, cervical spinal manipulation (CSM) and visceral osteopathy (VO), in patients with mechanical neck pain (MNP). The aim of the study was to evaluate the effects of these treatments on pain levels, neck mobility, and muscle strength in both the neck and upper extremities.

Detailed description: The purpose of this study is to compare the acute effects of cervical spinal manipulation (CSM) treatment and visceral osteopathy (VO) techniques on pain, cervical range of motion (ROM), muscle strength, and grip strength in individuals with mechanical neck pain (MNP).

The study is going to include a total of 30 subjects aged 18-60 diagnosed with MNP. The subjects are randomly divided into two groups. The CSM group received high-velocity, low-amplitude (HVLA) spinal manipulation, while the other group underwent VO techniques. Each treatment technique is going to be applied in only one session. Pain intensity is assessed using the Visual Analog Scale (VAS). Cervical ROM and the craniovertebral angle (CVA) are evaluated using a goniometer. Neck and elbow muscle strength are measured with a hand-held dynamometer, and grip strength is assessed using a hand-grip dynamometer.

Eligibility criteria: Inclusion Criteria:

* Participants is included if they had neck pain present for at least one week, reduced cervical ROM, a manual muscle test score of 4 or higher for the neck muscles, and no neurological pain in the neck.

Exclusion Criteria:

* Exclusion criteria included individuals with rheumatic diseases, a history of spinal surgery, neck fractures, tumors in the neck region, vertebrobasilar artery insufficiency, blood clotting disorders, or inadequate mental capacity.

Primary outcomes:
measure: VAS pain scale
timeFrame: At baseline and immediately following the intervention session.
measure: Microfet 2 Dynamometer
timeFrame: At baseline and immediately following the intervention session.
Secondary outcomes:
measure: Hand Dynamometer
timeFrame: At baseline and immediately following the intervention session.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Atlas University
state: Kagıthane
city: İstanbul
country: Turkey
facility: Atlas University
state: Kağıthane
Study officials:
References:
Clinical trial NCT00108303: Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes
Official title: Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes in Individuals Extensively Diagnosed and Genotyped
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: schizophrenia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-15
Enrollment: 538
Sex: ALL
Minimum age (years): 1
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with schizophrenia, their relatives, and controls

Brief summary: Schizophrenia has long been known to be an illness with significant evidence for a genetic predisposition. The purpose of this study is to determine the genetic abnormalities that cause childhood and adult onset schizophrenia.

Detailed description: It is known from genetic linkage and gene expression studies that the alpha 7 nicotinic receptor gene is abnormally expressed in people with schizophrenia. The immediate objectives of this proposal support the long-term objectives of a comprehensive description of the pathophysiology of schizophrenia and new drug treatments by carefully defining the physiological genotype-phenotype relationship for a single candidate gene. Subjects and family members with a mental illness or who appear to have a mental illness will be asked to undergo an interview, perform some mental tests and have a blood, urine, and saliva sample taken one time.

Eligibility criteria: Inclusion Criteria:

* Individuals thought to have schizophrenia or schizoaffective disorder, be the parent of such an individual, or be in the matched control group of unrelated individuals not thought to have schizophrenia or schizoaffective disorder

Exclusion Criteria:

* Unable to give informed consent;
* Psychotic disorder judged to be secondary to substance abuse, psychotic disorder that appears to be secondary to a known medical or neurological disorder, or severe mental retardation

Primary outcomes:
measure: Genetic Linkage
timeFrame: ten years
measure: Heritability Coefficient
timeFrame: 5 years
measure: Log of the ODDS of Linkage
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver
state: Colorado
Study officials:
affiliation: VA Eastern Colorado Health Care System, Denver
name: Robert Freedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05656703: Anesthesia Depth Increases Delirium Incidence
Official title: Monitoring of Anesthesia Depth Reduces the Incidence of Postoperative Delirium and Preserves Memory Abilities Better in the High Risk Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Anesthesia Awareness
Keywords: bispectral index monitoring
anesthesia depth
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 130
Sex: ALL
Minimum age (years): 70
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised-controlled, double blind study, monocentric
Primary purpose: PREVENTION

Brief summary: This study aimed to determine whether targeting bispectral index (BIS) readings of 55 (light anaesthesia) was associated with a lower incidence of delirium, dementia (POD), POCD and mortality but higher rates of awareness and complications than a standard of care anaesthesia blinded to depth monitoring.

Detailed description: Design: Randomised-controlled, double blind study, monocentric Setting: Level 2 medical center, major surgery (non cardiac) Ethics: Ethical approval for this study (Ethikkommission II der Ruprecht-Karls-Universität Heidelberg 2013-627N-MA) was provided by the Ethical Committee II University Medicine Mannheim, University of Heidelberg, Germany (Chairperson Prof W. Striebel) on Mai 12th 2008.

Patients: n=130, aged \> 70y Intervention: Light anesthesia (BIS 55 +/-5) vs. Standard of Care (BIS- blinded) Main outcome measures: Incidence of awareness, delirium, postoperative cognitive deficit (POCD), dementia (POD), memory (MAT with a computerized score for verbal working\&short term, figural working\&short term memories and well as attention level) Second aims: mortality, complications

Eligibility criteria: Inclusion Criteria:

* scheduled for major surgery above 60 min duration
* informed consent

Exclusion Criteria:

* emergency surgery with large blood loss and/or preoperative cardiovascular instability, scheduled regional or neuraxial anesthesia, language barriers with the unability to understand a German audio tape, unability or unwillingness to consent,hearing disabilities

Primary outcomes:
measure: postoperative delirium by NUDESC
timeFrame: 6 to 24 months
measure: postoperative dementia and cognitive deficit By MMSE and MAT Test
timeFrame: 6 to 24 months
measure: awareness, memory function
timeFrame: 1 to 3 days postoperative
Secondary outcomes:
measure: mortality and morbidity
timeFrame: 6 to 24 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine MAnnheim, University of Heidelberg, Germany
state: Baden-Wuerttemberg
Study officials:
References:
Clinical trial NCT05674903: Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain
Official title: Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain: A Pilot Study of Target Engagement and Analgesic Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Pain
Chronic Pain Syndrome
Widespread Chronic Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging and CVAS and PROMIS numerical rating scales of pain.


Eligibility criteria: Inclusion Criteria:

1. Age 18-65, any gender
2. Primary diagnosis of generalized chronic pain or widespread chronic pain.
3. Moderate-to-severe chronic pain lasting at least 2 months
4. Stated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study
5. For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
6. Capacity to provide informed consent; provision of a signed and dated consent form

Exclusion Criteria:

1. History of serious brain injury or other neurologic disorder
2. Poorly managed general medical condition
3. Pregnant or breast feeding
4. Implanted device in the head or neck
5. MRI intolerance or contraindication
6. Brain stimulation (e.g., VNS, TMS) in the past month
7. Lifetime history of a serious suicide attempt (Hooley et al., 2014)
8. Clinically inappropriate for participation in the study as determined by the study team

Primary outcomes:
measure: Target engagement: brain activation
timeFrame: 1 day At MRI study visit
measure: Target engagement: brain connectivity
timeFrame: 1 day At MRI study visit
measure: Pain intensity: momentary change
timeFrame: 1 day At stimulation visit
measure: Pain intensity: subjective state
timeFrame: 1 day At stimulation visit
measure: Depression scale: subjective state
timeFrame: 1 day At stimulation visit
measure: Anxiety scale: subjective state
timeFrame: 1 day At stimulation visit
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT02103803: Assessing Eye Tracking Features Following Sports-Related Concussion
Official title: Assessing Eye Tracking Features Following Sports-Related Concussion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: concussion
sports-related concussion
mild traumatic brain injury (mTBI)
eye tracking
oculometrics
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Lee Family Foundation
First posted: 2014-04-04
Enrollment: 11
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty subjects with diagnosed concussion will be recruited from the adolescent and adult population seen in the Comprehensive Concussion Program at Mayo Clinic Arizona.

Brief summary: This proposal aims to describe the oculometric features present during King-Devick (K-D) testing for subjects who experienced sports-related concussion. The investigators aim to better describe the underlying oculomotor anomalies present in this cohort that lead to increased K-D test time. Understanding these anomalies will allow for better understanding of the effects of sports-related concussion and may provide a rapid and reliable metric for diagnosing concussion as well as monitoring long-term recovery.

Detailed description: This proposal aims to describe the oculometric features present during K-D testing for subjects who experienced sports-related concussion. The investigators aim to better describe the underlying oculomotor anomalies present in this cohort that lead to increased K-D test time. Understanding these anomalies will allow for better understanding of the effects of sports-related concussion and may provide a rapid and reliable metric for diagnosing concussion as well as monitoring long-term recovery.

The main objectives include:

1. Describing the oculometric deficits present in subjects with acute sports-related concussion.
2. Analyzing and quantifying the oculometric changes that occur during subject recovery.
3. Identifying possible oculometric features as potential biomarkers that may lead to reliable, rapid method for recognizing acute concussion.

Eligibility criteria: Inclusion criteria:

* Over the age of 8 years, and able to provide informed consent / assent.
* Have documented diagnosis of sports-related concussion within two weeks of the event.
* Currently demonstrating post-concussion symptoms.

Exclusion criteria:

- Alcohol consumption within 48 hours of evaluation.

Primary outcomes:
measure: Change in time to complete King-Devick Test
timeFrame: Baseline to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Gaurav Pradhan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Jan Stepanek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Jamie Bogle, AuD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01054703: Clinical Evaluation of the Ethmoid Sinus Spacer
Official title: Clinical Evaluation of the Safety and Feasibility of the Ethmoid Sinus Spacer and Access System With Drug (SPACER)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sinusitis, Chronic Rhinosinusitis
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2010-01-22
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system


Eligibility criteria: Inclusion Criteria:

1. Age \> 21 years old
2. Both male and female
3. Ethmoid disease on CT scan
4. At least one non-ethmoid sinus requiring treatment
5. Failed medical management and symptomatic

Exclusion Criteria:

1. Previous ethmoid surgery
2. Not sufficient room for placement of Spacer
3. Patient requires septoplasty
4. Has received steroid treatment with in 2 weeks
5. Extensive sinonasal osteoneogenesis preventing device placement
6. Sinonasal tumors or obstructive lesions
7. History of facial trauma that distorts sinus anatomy
8. Asthmatic patients with aspirin sensitivity
9. Pregnant or lactating females

Primary outcomes:
measure: Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant
timeFrame: Procedural and 6 weeks post-implant
Secondary outcomes:
measure: Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures
timeFrame: 1 wk, 2wk, 4wk, 6wk
Other outcomes:
Locations:
city: Savannah
country: United States
facility: Georgia Nasal and Sinus Institute
state: Georgia
Study officials:
affiliation: Georgia Nasal and Sinus Institute
name: Fred Kuhn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04478903: Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management
Official title: Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Primary Patient Caregiver
Cancer
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 62
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: Retrieval of information and contact details of primary caregivers included in the 2014 study along with the patient's vital status

Brief summary: Cancer is a disease that requires long-term management, especially now that medical advances have transformed most cancers from an acute to a chronic condition. Most of the time, therefore, the help provided by family and friends is long-term.

The negative impact of oncological care on the quality of life of family caregivers has already been studied. The UCOGB carried out a study in 2014 on the primary caregivers of cancer patients aged 70 and over at inclusion and at 3 and 6 months of oncogeriatric care. This study showed that several factors were significantly related to the caregiver's quality of life: the caregiver's age, perception of burden and patient autonomy (18). However, the evolution of quality of life and burden at 5 years has, to our knowledge, never been evaluated.


Eligibility criteria: Inclusion Criteria:

* Person who does not object to being included in the study
* Primary caregiver of a cancer patient aged 70 years and over who is managed in one of the centres participating in the study, with a request for an oncogeriatric consultation between 01/06/2014 and 18/03/2015.
* Age ≥ 18 years old
* Good command of the French language

Exclusion Criteria:

* Refusal or linguistic or psychological inability to answer the questionnaires.
* Caregiver whose general condition does not allow him/her to answer a questionnaire
* Death of the caregiver.

Primary outcomes:
measure: To determine the quality of life of the primary caregiver of cancer patients 70 years of age and older, 5 years after initial management.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01180803: Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: LUNG DISEASES, OBSTRUCTIVE
Keywords: COPD - long term oxygenotherapy
COPD patients with respiratory failure
Lead sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of oxygen therapy delivered by systems using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing exercise-induced hypoxemia in patients with COPD.


Eligibility criteria: Inclusion Criteria:

* COPD on necessity of long term oxygen therapy
* Able to give their written consent

Exclusion Criteria:

* Unstable patients with COPD
* Patients with restrictive respiratory disease
* Patients with cardiac or neurologic disease contre-indicating the different evaluations

Primary outcomes:
measure: oxygen saturation during 6 minutes walking test
timeFrame: 1 day
Secondary outcomes:
measure: Walking distance during the 6 minutes walking test
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Fédération ANTADIR
Study officials:
References: