louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05872035: Smartphone Enabled Hearing Study
Official title: Smartphone Enabled Hearing Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing
Lead sponsor: Apple Inc.
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2023-05-24
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Validation of non-inferiority between headphone amplification settings determined by a participant and settings established by audiologist best practices in individuals 18 years or older.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Proficient in written and spoken English, defined by self-report
* Mild- to moderate- hearing loss as measured by pure tone audiometry (PTA) reference test, or self-report of perceived hearing loss and 15-25 dB HL (by 4PTA)
* Participants have access to stable internet connection

Exclusion Criteria:

* Ear anatomy non-conducive to comfortable wear of headphone
* Active ear disease
* Cerumen impaction that cannot be removed
* Sudden loss of hearing (in the preceding 90 days), defined by self-report
* Self Report of loud environmental sound exposure (e.g., concert; construction site; fireworks) without hearing protection within 72 hours of reference PTA assessed at Clinic Visit 1
* Tinnitus that impacts one's daily life, defined by self-report
* Use of cochlear implants
* Self-reported issues with small or confined spaces such as a single-person enclosed booth, and/or claustrophobia
* Health technology, fitness, media outlet employees (or spouse of employees), or employees of CRO/sites contracted to execute this study
* User noted preference to not wear headphone consistently, or charge headphone and smartphone consistently, during field-use
* Hearing loss \>60 dB HL at 0.25-3kHz and \>65 dB HL at 4kHz in either ear; assessed during PTA
* Hearing loss that requires electroacoustic settings which are not acoustically stable in the participant's ear per audiologist judgement
* Current regular use of hearing aids
* Active treatment, or treatment in the past 6 months, with either a chemotherapeutic drug for cancer, or radiation therapy to the head or neck region
* Active treatment, or treatment in the past 6 months, with parenteral aminoglycoside antibiotics
* In the Investigator's opinion, unable to adhere to study procedures

Primary outcomes:
measure: International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results
timeFrame: Approximately 18-31 days upon enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: IQVIA
state: Kansas
Study officials:
References:
Clinical trial NCT03382535: Female Teacher's Voice During Teaching
Official title: The Well-being of Female Teacher's Voice During Teaching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Voice Disorder
Keywords: Voice disorder
Teacher's voice
Voice SPL (Voice sound pressure level)
Voice F0 (Voice fundamental frequency)
Voice therapy
Voice accumulator
Activity noise
Classroom
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Tampere University
name: Oulu University Hospital
name: Umeå University
name: Sonvox AB
First posted: 2017-12-26
Enrollment: 54
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly divided into three groups. Group 1: Voice therapy. Group 2: Voice therapy with carryover strategies (supplementary tasks and reminders).

Group 3. Controls. No treatment during control period. After the control period participants are having Voice therapy or Voice therapy with carryover strategies.
Primary purpose: TREATMENT

Brief summary: Two voice therapy methods are compared. Activity noise levels and vocal load of teachers during teaching in primary school classrooms are evaluated. Acoustic and Workshop Interventions are implemented in order to reduce noise level during lesson.

Detailed description: Due to the voice disorders, teachers are a major customer group for voice therapy. The main part of the study is comparison of two voice therapy methods.

There are several factors in the classroom that increase teacher's risk of voice disorders. One of the most significant is high noise level during lessons. This study explores the noise conditions the teachers are working in and how these conditions are related to the voice parameters and symptoms.

Finally, the study aims to determine whether classroom noise level can be lowered by improving classroom acoustics and by noise reducing workshops for teachers and pupils.

Eligibility criteria: Inclusion Criteria:

* Female teachers or teachers of special needs children from elementary schools
* Voice symptoms and willingness to participate in voice therapy
* Mother tongue Finnish
* No hearing loss, no need to use a hearing aid
* Non-smoking
* No neurological diseases
* No voice therapy during past year
* Successful phoniatric examination with rigid laryngoscopy or nasal endoscopy

Exclusion Criteria:

* Mother tongue other than Finnish
* Need to use a hearing aid
* Need for medical treatment in the larynx
* Abnormalities of the larynx
* Vocal cord paresis
* Laryngitis
* Posterior hypertrophy

Primary outcomes:
measure: The change of the well-being of the teachers' voice.
timeFrame: Up to one week before the interventions, up to one week after the interventions, 6 months after the interventions, 1 year and 2 years after the interventions and up to one week after the control time (concerning control group).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ooulu
name: Sirpa M Pirilä, MA
role: STUDY_CHAIR
References:
Clinical trial NCT00795535: Heart Rate Variability in Trauma Patients
Official title: Heart Rate Variability in Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 95
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: All trauma patients

Brief summary: The purpose of this study is to develop new triage tool for trauma patients based on HRV. EKG will be prospectively measured in trauma patients in two locations: in the prehospital setting (the field and during transport by helicopter) and in the hospital setting. In each case HRV will be derived from the EKG signal, will be correlated with other non-invasive signals (e.g. near infrared spectroscopy (NIR), and bispectral EEG (BIS)), along with other routinely measured variables (blood pressure, respiratory rate, pulse oximetry, etc), will be correlated with injury severity and day of discharge. An algorithm will be constructed using multiple linear regression. The hypotheses are:

1. reduced HRV in the field correlates with bad outcome;
2. the specificity and efficiency of HRV as a screening tool can be improved by controlling factors such as heart rate, age, gender, respiratory rate, and pulse oxygen saturation;
3. an easy to interpret HRV index can be derived that can be used for trauma triage or diagnosis.

Detailed description: The eligible study population will be comprised of patients who meet level 1 trauma criteria and are transported by helicopter to Ryder Trauma Center or who are already admitted to the trauma center for presumptive traumatic brain injury. In addition to the EKG, trauma patients may also be connected to either an non-invasive NIR Monitor, which provides real-time information about perfusion status and/or a bispectral EEG monitor, which provides real-time information about brain metabolic activity.

Eligibility criteria: Inclusion Criteria:

* Patients who meet level 1 trauma criteria and are transported by helicopter to Ryder Trauma Center
* An additional study population will be comprised of patients already admitted to the trauma center for presumptive Traumtaic Brain Injury

Exclusion Criteria:

* None

Primary outcomes:
measure: Base Deficit </= -6
timeFrame: Upon arrival to the hospital
measure: Serious Injury
timeFrame: Upon arrival to the hospital
measure: Life Saving Intervention in the Operating Room.
timeFrame: Upon arrival to the hospital
measure: SDNN: Standard Deviation of the Normal-to-normal R-R Interval
timeFrame: Upon arrival to the hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Ryder Trauma Center
state: Florida
Study officials:
affiliation: University of Miami
name: Kenneth G Proctor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Proctor KG, Atapattu SA, Duncan RC. Heart rate variability index in trauma patients. J Trauma. 2007 Jul;63(1):33-43. doi: 10.1097/01.ta.0000251593.32396.df.
Clinical trial NCT04263935: Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma
Official title: Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Gene Abnormality
Keywords: Lymphoma
Driver Gene Abnormalities
Disease Prognosis
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-11
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Including demographic characteristics / clinical characteristics / pathological characteristics / treatment and efficacy evaluations.

Brief summary: Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma

Detailed description: This trial is a prospective non-interventional observational study. The Chinese patients with lymphoma were included and the study data on driver gene abnormalities, demographic characteristics, clinicopathological characteristics and treatment were collected to evaluate the relevance of efficacy and disease prognosis.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed as lymphoma (according to WHO 2017 classification criteria)
2. Life expectancy no less than 3 months
3. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Other malignant tumor history or active malignant tumor need be treated
2. Researchers determine unsuited to participate in this trial

Primary outcomes:
measure: Incidence of driver gene abnormalities
timeFrame: from the day of the first patient was included to the date of the end of this trial, assessed up to 36 months
Secondary outcomes:
measure: objective response rate
timeFrame: from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months
measure: 5-year overall survival
timeFrame: from the date of the first patient was included to the date of the end of this trial, assessed up to 5 years
measure: Clinicopathological Characteristics
timeFrame: from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Yanyan Liu, M.D. Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04092335: Evaluation of Adam's Forward Bend Test and Smartphone Application in Screening of Adolescent Idiopathic Scoliosis
Official title: Evaluation of Adam's Forward Bend Test and Smartphone Application in Screening of Adolescent Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 840
Sex: MALE
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male students with age range 10-15 years

Brief summary: Scoliosis is a lateral curvature of the spine when the Cobb´s angle more than 10˚ on the frontal plane. Curve detection before skeletal maturation gives a good opportunity for early treatment or prevention of curve progression. Purpose of this study was to evaluate Adam's Forward Bend Test and Scoliometer HD in screening of Adolescent Idiopathic Scoliosis

Detailed description: The student was asked to stand erect, knees straight, feet at the same level and hands freely hanging.

They was observed from the back for shoulders, pelvic, and knees level. Student was asked to bend forward with his knees straight, feet together and hands freely and loosely hanged(Forward Bend Test).

Scoliosis was detected with rib cage rotation and hump appearance (positive test).

Absence of hump appearance means negative test. After Forward Bend, the students were screened using the Scoliometer HD Application.

The students were asked to bend forward with arms dangling and palms pressed together. The smart phone (Scoliometer HD) was placed on the student back with the central dark area in the application placed on the spinous processes of the lumber and thoracic regions to measure the angle of trunk rotation. Students with a scoliometer HD reading ≥7 degrees (≥20 ̊ Cobb's angle) were referred to orthopedic consultation and their parents were informed about the findings of the screening by the school manager and social worker.

Then the data were collected for statistical analysis

Eligibility criteria: Inclusion Criteria:

* Age range from 10 to 15 year.
* Males ( parents of girls refused their participation).
* Students who have structural scoliosis.

Exclusion Criteria:

* Congenital deformities.
* Neuromuscular disorder (Cerebral palsy and spinal muscle atrophy).
* Syndromic disorders (Muscular dystrophy, Osteogenesis imperfect and spinabifida).

Primary outcomes:
measure: Appearance of hump measured by Forward Bend Test
timeFrame: 20 minutes
measure: Angle of trunk rotation (ATR) measured by Scoliometer HD application
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
Study officials:
affiliation: Lecturer,Cairo University
name: Nasr A. Abdelkader, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04488835: Pulsed Electromagnetic Field Therapy Versus Transcutaneous Electrical Nerve Stimulation in on Post-herpetic Neuralgia of the Sciatic Nerve
Official title: A Comparative Study Between Pulsed Electromagnetic Field Therapy and Transcutaneous Electrical Nerve Stimulation in Management of Post-herpetic Neuralgia of the Sciatic Nerve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuralgia,Postherpetic
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and purpose: Post-herpetic neuralgia (PHN) is the most frequent chronic complication of herpes zoster, resulting in post- infectious severe neuropathic pain. Due to drug resistance severe pain; patients with PHN suffer from reduced physical activities, social and psychological manifestations as well as decrease in the quality of life. The purpose of this research was to evaluate the efficacy of pulsed electromagnetic field therapy (PEMFT) versus transcutaneous electrical nerve stimulation (TENS) in the treatment of post-herpetic neuralgia of the sciatic nerve.

Methods: In an eight weeks period of treatemnt, 52 patients were randomly and equally assigned into two groups. Both groups received conventional physical therapy treatment protocol. Moreover, group (A) has an additional TENS application and group (B) had PEMFS application. TENS and the PEMFT were applied once daily, three times per week for 20 minutes for each session. Assessment performed pre and post intervention using visual analogue scale (VAS) and estimation of the carbamazepine intake (CMI).


Eligibility criteria: Inclusion Criteria:

* Age from 30-40 years
* History of herpes zoster more than 90 days
* Visual analogue scale is greater than or equal 5 out on a scale from 0 to 10
* All patients were on pain medication "Carbamazepine"

Exclusion Criteria:

* uncooperative behavior
* Intellectual disability to complete the self-evaluation questionnaires

Primary outcomes:
measure: neuralgia
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Eid
Study officials:
affiliation: Cairo University
name: Marwa Eid, Ass.prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01652235: Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study
Official title: Study Assessing Safety and Effectiveness of Perivisceral Aortic Aneurysm Treatment With the Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® and the Effects on Organ and Extremity Perfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Keywords: Abdominal aortic aneurysm
Endovascular
Fenestration
Juxtarenal
Off-the-shelf
Pararenal
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2012-07-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic aneurysms.


Eligibility criteria: Inclusion Criteria:

* Abdominal aortic aneurysm \> 5.0 cm or 2 times the normal aortic diameter
* Abdominal aortic aneurysm with history of growth \> 0.5 cm in 6 months
* Penetrating juxtarenal aortic ulcer \> 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

* Age \< 18 years
* Life expectancy \< 2 years
* Pregnant or breast feeding
* Inability or refusal to give informed consent
* Unwilling or unable to comply with the follow-up schedule
* Additional medical restrictions as specified in the Clinical Investigation Plan
* Additional anatomical restrictions as specified in the Clinical Investigation Plan

Primary outcomes:
measure: Technical Success:
timeFrame: Immediately post graft deployment
measure: Procedural Success
timeFrame: Within 30 days post graft deployment
measure: Treatment Success
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai-West
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital System
state: New York
Study officials:
affiliation: Mount Sinai-West
name: James F. McKinsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00400335: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
Official title: An Open Label Study to Evaluate the Impact of Novel Fixed-dose Testosterone/Dutasteride Combinations on the Relative Bioavailability of the Individual Dutasteride and Testosterone Components
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypogonadism
Hypogonadism, Male
Keywords: Testosterone
Men
Hypogonadism
Dutasteride
DHT
Androgen deficiency
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-16
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride


Eligibility criteria: Inclusion criteria:

* Are healthy.
* Have a BMI within range of 19-32 kg/m2.
* Have not taken dutasteride for one year, or finasteride for the past 3 months.
* Have a screening PSA \< 2.0ng/mL.

Exclusion criteria:

* Have had or have breast or prostate cancer, sleep apnea, psychiatric illness, or any other clinically significant current condition.
* Have a trigliceride level =500mg/dL.
* Have abnormal thyroid or hormone levels.
* Would donate more than 500 ML of blood over a 2 month period.
* Physician does not think it is a good idea for you to participate in the trial.
* Are unwilling to abstain from alcohol during the study.
* Have a positive urine drug screen test.
* Plan to change your smoking habits during the course of the trial.
* Have Hepatitis C, Hepatitis B, or HIV.
* Have a lab or ECG abnormality.
* Have high or low blood pressure.
* Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.

Primary outcomes:
measure: lab tests for relative bioavailability of testosterone and dutasteride,
timeFrame: days 1, 2, 3, 19, 20, 21 & 26-31
Secondary outcomes:
measure: safety lab tests of various testosterone/dutasteride formulations,
timeFrame: days 1, 2, 3, 19, 20, 21 & 26-31.
measure: lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,
timeFrame: days 1, 2, 3, 19, 20, 21 & 26-31.
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: