louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05956808: Phonak Behind-The-Ear Quality Evaluation
Official title: Phonak Behind-The-Ear Quality Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2023-07-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This investigation model is a cross-over design, randomized, and is single-blinded.
Primary purpose: TREATMENT

Brief summary: Subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a Phonak BTE (Behind-The-Ear) hearing aid.

Detailed description: Speech intelligibility performance will be measured with a new generation BTE hearing aid and compared to a legacy hearing aid in adults with severe to profound hearing loss.

Eligibility criteria: Inclusion Criteria:

* Severe to profound hearing loss (4 frequency Pure Tone Average 65-94 dB)
* 18+ years old
* Good written and spoken English language skills
* Able to fill in a questionnaire conscientiously
* Experienced hearing aid user
* Able to produce a reliable hearing test result
* Able to describe listening impressions/experiences and the use of the hearing aids

Exclusion Criteria:

* Not willing to test the hearing aids
* Has auricle deformities that prevents secure placement of the hearing aids
* Has limited mobility and is not able to attend the appointments
* Not willing to wear the hearing aids for at least 8 hours per day
* Known hypersensitivity or allergy with synthetic materials
* Self reports symptoms of vertigo, dizziness, fluctuating hearing loss
* Hints of psychological problems
* Suffers from acute tinnitus in either one or both ears (occurrence less than 3 months)

Primary outcomes:
measure: Speech in Noise Test
timeFrame: Day 14 of the study
measure: Subjective measure of listening effort
timeFrame: Day 14 of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Phonak Audiology Research Center
state: Illinois
Study officials:
References:
Clinical trial NCT03208608: The RBANS-H in Older Adults With Normal Hearing or Age-related Hearing Loss
Official title: The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H) in Older Adults With Normal Hearing or Age-related Hearing Loss
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Normal Hearing
Keywords: RBANS-H
Older adults
Normal hearing
Cognition
Age-related hearing loss
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults aged 50 to 89 with hearing thresholds according to their age and without history of any neurological or otological diseases

Brief summary: The present cross-sectional study aims to examine the cognitive capabilities of older adults, aged 50 to 89, with normal hearing or age-related hearing loss by means of the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals (RBANS-H). Secondly, the correlations between cognition on the one hand and hearing and speech reception capabilities on the other hand are investigated. For this purpose, twenty participants are included in the age categories 50 to 59, 60 to 69, 70 to 79 and 80 to 89, bringing the total number to 80. Three questionnaires are administered to the participants: the Health Utilities Index-2/3 (HUI 2/3), Dizziness Handicap Inventory (DHI) and a general questionnaire on education and profession, medical history, hearing aid use and tinnitus. Also an audiological examination is performed, including pure tone audiometry, speech in quiet and speech in noise audiometry. Finally, cognition is assessed using the RBANS-H.


Eligibility criteria: Inclusion Criteria:

* Hearing: Air conduction hearing thresholds according to age, based on the ISO standards
* Age: 50 - 89

Exclusion Criteria:

* History of any neurological disease
* History of otological surgery or disease

Primary outcomes:
measure: RBANS-H total scaled score
timeFrame: Baseline
Secondary outcomes:
measure: RBANS-H index scores
timeFrame: Baseline
measure: Free field best aided speech in noise audiometry: Speech Reception Threshold (SRT)
timeFrame: Baseline
measure: Free field best aided speech in quiet audiometry (phoneme score): SRT
timeFrame: Baseline
measure: Free field best aided hearing thresholds: Fletcher Index (FI)
timeFrame: Baseline
measure: Health Utilities Index-2/3 (HUI 2/3)
timeFrame: Baseline
measure: Dizziness Handicap Inventory (DHI)
timeFrame: Baseline
measure: General questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Paul Van de Heyning, prof PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00725608: Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
Official title: Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-Related Disorders
Opiate Dependence
Drug Abuse
Keywords: Suboxone
Subutex
Buprenorphine
Naloxone
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 339
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients on substitution therapy for opioid dependence willing to switch to Suboxone

Brief summary: The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing. Subjects, for whom a therapy with Suboxone® is indicated and planned prior to study enrollment and who are willing to participate, will initiate therapy on Day 1 of the study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and determined by the treating physicians in accordance with the SmPC of Suboxone®. Data will be collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of Month 12.

Detailed description: Nonprobability sampling was done by invitation to volunteer.

Eligibility criteria: Inclusion Criteria:

* All patients on substitution therapy, that are willing to switch to Suboxone, can be included.
* Therapeutic indications and contraindications for Suboxone® must be taken into consideration when selecting patients.

Exclusion Criteria:

* According to product information
* In accordance with the product information pregnant women will be excluded.

Primary outcomes:
measure: Retention Rate
timeFrame: month 6, month 12
Secondary outcomes:
measure: Dosing of Suboxone (Buprenorphine Plus Naloxone)
timeFrame: day 1, month 6, month 12
measure: Dispensing of Suboxone (Buprenorphine Plus Naloxone)
timeFrame: month 6, month 12
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: (Multiple sites in Austria) => Coordinating CRO: H&P GmbH
Study officials:
affiliation: Medical University Vienna
name: Gabriele Fischer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02267408: Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Unstable Warfarin
Official title: A Single-site, Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Patients With Unstable Warfarin Effect.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hypoprothrombinemia
Keywords: Heart valve prosthesis
Anticoagulation
Warfarin
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Epitome Pharmaceuticals
First posted: 2014-10-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dosing of warfarin according to the Fearon algorithm or routine during 6 months for patients with unstable INRs
Primary purpose: TREATMENT

Brief summary: Patients on warfarin but with unstable international normalized ratio (INR) will be recruited to a randomized trial comparing dosing based on an algorithm (Fearon algorithm, named after the mathematician Michael Fearon), which uses historical data to estimate patients' sensitivity to warfarin and to dose changes as well as the lag time until a dose adjustment takes effect, or to the investigators standard management Main outcome is improvement in time in therapeutic range.

Detailed description: Patients with very variable INRs resulting in a low proportion of time in therapeutic range (TTR) have a higher risk of both bleeding complications and thromboembolic events. A good TTR is generally considered to be over 60% and "excellent TTR" is above 72% of time in range. The investigators will recruit patients with a TTR below 50%.

The Fearon algorithm provides a more thorough understanding of the individual responses to changes in warfarin dose and with a personalized nomogram for dose adjustments and timing of laboratory tests the investigators have an opportunity to improve the TTR and on a larger scale to reduce clinically important adverse events. Before embarking on a large randomized trial with this revised Fearon algorithm-derived nomogram this pilot study with a randomized, open-label design will be performed to demonstrate proof of principle.

Eligibility criteria: Inclusion Criteria:

* Patients with mechanical heart valve prosthesis managed for the warfarin therapy by the Thrombosis Service at HHS-General Hospital.
* Treated with warfarin for at least 1 year.
* Therapeutic INR range 2.0-3.0 or 2.5-3.5.
* TTR in the lowest quartile

Exclusion Criteria:

* Known poor compliance due to for example alcohol abuse or cognitive impairment
* Refusal to provide written informed consent

Primary outcomes:
measure: Improvement in TTR
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients with improvement in TTR
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Thrombosis Service, HHS-General Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Sam Schulman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01089608: Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis
Official title: Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (Pilot Phase II Clinical Study, Multicentre, Randomised, Double Masked, Comparative, 2 X 40 Patients)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blepharitis
Keywords: Azyter in patients affected by chronic blepharitis.
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
Collaborators: name: Keyrus Biopharma
name: VEEDA
First posted: 2010-03-18
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).

Detailed description: Currently, topical antibiotic ointments are used for blepharitis. They provide prolonged contact time with the lid margin but with little penetration into eyelid tissue. Azithromycin eye drops may offer on advantage over these preparations because azithromycin achieves sustained high concentration in various ocular tissues including the lid margin.

Patients will be treated during 7 days (1 drop twice daily the first day following by one drop once daily for 6 days) following by a period of 2 weeks without treatment. This therapeutic scheme will be repeated two times.

Efficacy will be evaluated by change from baseline (Day 0) to Day 63 Â± 3 Days of the global ocular discomfort evaluation (VAS).

Eligibility criteria: Inclusion Criteria:

-Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye

Exclusion Criteria:

* Monophtalmia
* Eyelid dysfunction
* Facial paralysis.
* Severe dry eye syndrome.
* Ocular metaplasia.
* Filamentous keratitis
* Schirmer test \< 5 mm.
* Best far corrected visual acuity \< 1/10.

Primary outcomes:
measure: Visual Analogue Scale (VAS - Ranges 0-100 mm)
timeFrame: Baseline and D63 (D63 minus baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: C.H.N.O des XV-XX
Study officials:
name: Christophe BAUDOUIN, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06194708: Reasons for Non-reversal of Temporary Stomas After Surgeries of Mid-low Rectal Cancer （NORESTO Study）
Official title: Reasons for Non-reversal of Temporary Stomas After Surgeries of Mid-low Rectal Cancer （NORESTO Study）on Behalf of Chinese Ostomy Collaboration Group (COCG-02)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In-hospital rectal cancer patients who underwent radical resection of the primary lesion

Brief summary: The goal of this observational study is to learn about in mid-low rectal patients who received temporary ostomies after surgery of the primary tumors. The main questions it aims to answer are:

* To explore the proportion of temporary stomas that cannot be reversed after radical surgery for mid-low rectal cancer and their main causes.
* To use the basic information we collected from patients before and during surgery to develop an individualized model for predicting the time of stoma reversal and explore the risk factors affecting stoma reversal.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed as rectal adenocarcinoma;
* The tumor is located within 12cm from the anal verge;
* Primary tumor is radically resected;
* The patient received a temporary ostomy during the in-hospital visit of the resection of the primary tumor.

Exclusion Criteria:

* The stoma was initially recognized as permanent stoma;
* Patients with distant metastasis;
* Patients with multi-primary colorectal cancer.

Primary outcomes:
measure: 1-year non-reversal rate of temporary stoma
timeFrame: 1 year after ostomy
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02400008: Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis
Official title: Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bilateral Vocal Fold Paralysis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Selective laryngeal bilateral reinnervation as a secondary treatment in patients with bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids ankylosis.

The surgical procedure is : functional reinnervation with the upper root of one phrenic nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right and left thyro -hyoid nerves (coming from the hypoglossi) on both sides.

Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid abduction, and residual dysphonia, a secondary vocal fold medialization is done by an endoscopic approach 12 months after reinnervation (included in the protocol).

Improvement is expected in voice and breathing, without aspiration.


Eligibility criteria: Inclusion Criteria:

* Patient with Bilateral vocal fold paralysis in a closure position 6 months to 36 months before.
* Patient who has been treated by endoscopic treatment without satisfying result (voice or breathing).
* Patient with passive mobile arytenoid at least on one side
* Tracheostomized or not
* Age \> 18 years old
* Good general situation

Exclusion Criteria:

* Long term vocal fold paralysis (more than 3 years with strong denervation)
* Ary-cricoid ankylosis or synechiae
* Age \>75 years
* Anaesthesiologist contra indication
* Strong respiratory disease history
* Severe coagulation troubles
* Ongoing neoplasia disease
* Cardiac pace maker
* Pregnant woman or without contraception
* Impairment of the freedom

Primary outcomes:
measure: Maximal phonation time
timeFrame: 18 Months
Secondary outcomes:
measure: Voice quality assessed using quality of life questionnaire
timeFrame: 18 Months
measure: Voice quality assessed using computerized analysis
timeFrame: 18 Months
measure: Voice quality assessed using swallowing scores
timeFrame: 18 Months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Jean-Paul MARIE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01133808: Effectiveness of Rotavirus Immunization in Nicaragua
Official title: Effectiveness of Rotavirus Immunization at the Community Level in Nicaragua
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diarrhea
Keywords: diarrhea
childhood
rotavirus
vaccine
Nicaragua
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Thrasher Research Fund
name: Fogarty International Center of the National Institute of Health
First posted: 2010-05-31
Enrollment: 667
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children under age 5 in Leon, Nicaragua

Brief summary: The purpose of the investigators study is to compare the rates of childhood diarrhea at the community level before and after the rotavirus vaccination program in León, Nicaragua. From preliminary studies, the investigators anticipate about a 28% reduction in diarrhea following the vaccination program among children who received the vaccine, and a smaller reduction in diarrhea among children who did not receive the vaccine, due to the effects of "herd immunity". In addition, the investigators will collect stool samples from children who develop diarrhea in order determine the etiology of childhood diarrhea in the post-rotavirus immunization era.


Eligibility criteria: Inclusion Criteria:

* Age under 5 years, inclusion in health and demographic surveillance system (CIDS) in Leon, Nicaragua

Exclusion Criteria:

* Parents do not consent to child's participation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Sylvia Becker-Dreps, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03811808: Multiple System Atrophy Multidisciplinary Clinic
Official title: Multiple System Atrophy Multidisciplinary Clinic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple System Atrophy (MSA)
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 18 years or older with diagnosis of possible or probable MSA

Brief summary: This is a prospective cohort study to examine the disease burden of multiple system atrophy and the impact of multidisciplinary care on quality of life and caregiver burden. Data will be collected through valid rating scales completed by patients and caregivers at home or in the MSA clinic.

Detailed description: Study Procedures:

Participants and caregivers will attend a multidisciplinary MSA clinic one day every four months. In addition to the standard of care, they will be asked to complete both online and paper questionnaires, including the following:

* UMSARS (Unified MSA Rating Scale)
* MSA QOL
* CES-D
* OHQ
* Compass-31
* BIC
* UPDRS
* SARA
* MDS Scale
* CGI
* MoCA

Participants will be part of the study as long as they are a patient of the MSA clinic, and will be contacted for follow-up information up to five years.

Eligibility criteria: Inclusion Criteria:

* Subject must be a patient in the UT Southwestern MSA clinic and be able to attend the multidisciplinary clinic every 4 months
* Patients with possible or probable MSA based on established criteria
* Subjects must be 18 years or older

Exclusion Criteria:

* Patients that are unable to give consent
* Minor patients (younger than age 18)
* Non-English speaking patients
* Subjects that are diagnosed with dementia

Primary outcomes:
measure: Multiple System Atrophy-Quality of Life (MSA-QoL)
timeFrame: at 5 year evaluation
Secondary outcomes:
measure: Unified Multiple System Atrophy Rating Scale (UMSARS)
timeFrame: at 5 year evaluation
measure: Caregiver Burden Index/ The Zarit Burden Interview
timeFrame: at 5 year evaluation
Other outcomes:
measure: Composite Autonomic Symptom Score (CONPASS 31)
timeFrame: at 5 year evaluation
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: at 5 year evaluation
measure: The Orthostatic Hypotension Questionnaire (OHQ)
timeFrame: at 5 year evaluation
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Steven Vernino, M.D.
role: PRINCIPAL_INVESTIGATOR
References: