louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06124703: Different Dosing Regimens of STOP-AST
Official title: Comparing Two Dosing Regimens of the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hearing Loss
Tinnitus
Sensorineural Hearing Loss
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about the different dose regimens of the efficacy of oral steroids in the acute tinnitus population. Participants will receive different appropriate dosages of prednisone tablets and oral Ginkgo Biloba tablets.

Detailed description: The purpose of this clinical study was to investigate the efficacy and to compare two different oral doses of short-term systemic steroid therapy for acute tinnitus.

Eligibility criteria: Inclusion Criteria:

1. 18-60 years old;
2. primary complaint of subjective tinnitus ≤ 1 months of duration;
3. a decline in auditory function by audiological assessments on the day of the test, of which the outcome must either satisfy one of the following conditions:

   1. a reduced distortion product otoacoustic emissions (DPOAE) amplitude in individuals with normal Pure tone audiometry (PTA) results;
   2. more than a PTA threshold \> 20 dB with frequencies between 125 and 8000 Hz, but not exhibited idiopathic sudden sensorineural hearing loss;
4. a state of good general condition;
5. with good adherence to participation and signed informed consent.

Exclusion Criteria:

1. active middle ear pathology;
2. patients who had received treatment for their current condition prior to the study;
3. both the PTA and DPOAE with normal outcomes;
4. hearing implants;
5. history of known corticosteroids contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnant patients, and women on estrogen-containing oral contraceptive steroids).

Primary outcomes:
measure: tinnitus handicap inventory (THI)
timeFrame: one week from baseline
measure: tinnitus handicap inventory (THI)
timeFrame: two weeks from baseline
measure: tinnitus handicap inventory (THI)
timeFrame: one month from baseline
Secondary outcomes:
measure: visual analog scale (VAS)
timeFrame: one week from baseline
measure: visual analog scale (VAS)
timeFrame: two weeks from baseline
measure: visual analog scale (VAS)
timeFrame: one month from baseline
measure: the Athens Insomnia Scale-8 (AIS-8)
timeFrame: one week from baseline
measure: the Athens Insomnia Scale-8 (AIS-8)
timeFrame: two weeks from baseline
measure: the Athens Insomnia Scale-8 (AIS-8)
timeFrame: one month from baseline
Other outcomes:
Locations:
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Shan Sun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03253003: Quality Control of CE-Certified Phonak Hearing Aids - 2017_27
Official title: Quality Control of CE-Certified Phonak Hearing Aids - 2017_27
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Bilateral Sensorineural, Progressive
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2017-08-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.
Primary purpose: OTHER

Brief summary: A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure a stable overall performance of the new hearing systems, a good sound quality during phone calls as well as maximum benefit for the participant with the devices.

Detailed description: Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility criteria: Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature
* Smartphone user

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders

Primary outcomes:
measure: Stable performance in daily life
timeFrame: Three weeks
measure: Phone call - Sound Quality
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
affiliation: Sonova AG
name: Simone Ebbing, B. Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01496703: Reasons for Mycophenolate Mofetil Dose Reduction and Impact on Graft Outcome in Renal Transplant Recipients
Official title: Reasons for Dose Reduction of Mycophenolate Mofetil During the First Post-transplant Year in Renal Transplant Recipients and Its Impact on Graft Outcome: a Single-center Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Rejection of Renal Transplant
Renal Graft Loss
Keywords: reasons for MMF dose reduction
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 749
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who received a single renal transplant at the University Hospitals of Leuven between April 1996 (when MMF was introduced in the Leuven renal transplant program) and February 2007 and were treated with MMF (Cellcept®, Roche) as part of their initial maintenance immunosuppressive regimen were included in this retrospective analysis. If a patient underwent more than one kidney transplantation in the abovementioned 11-year period, only the last was considered. No other exclusion criteria were applied.

Brief summary: Mycophenolate mofetil (MMF) decreases the risk of acute rejection and is associated with improved graft survival in renal transplant recipients. However, MMF-related side effects often necessitate dose reduction which may expose transplant recipients to a higher risk of acute rejection and graft loss. This study's aim was to examine the reasons for MMF dose reduction during the first year after kidney transplantation and its impact on acute rejection, overall and death-censored graft loss. Methods: Retrospective electronic file based analysis of all patients who underwent a single kidney transplantation in our center between 1996 and 2007 and were treated with MMF as part of their initial maintenance immunosuppressive protocol (n=749).


Eligibility criteria: Inclusion Criteria:

* All patients who received a single renal transplant at the University Hospitals of Leuven between April 1996 (when MMF was introduced in the Leuven renal transplant program) and February 2007 and were treated with MMF (Cellcept®, Roche) as part of their initial maintenance immunosuppressive regimen were included in this retrospective analysis.

Exclusion Criteria:

* If a patient underwent more than one kidney transplantation in the abovementioned 11-year period, only the last was considered.

Primary outcomes:
measure: reasons for dose reduction of MMF
timeFrame: 400 days post-transplantation
Secondary outcomes:
measure: occurence of acute rejection
timeFrame: 400 days post-transplantation
measure: graft survival
timeFrame: 400 days post-transplantation
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Bert Bammens, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02236403: Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1%
Official title: Diagnosis of Demodex Blapharitis and Treatment With Ivermectin Gel 0.1%/ Metronidazole 1%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Blepharitis
Keywords: Blepharitis , Demodex, Ivermectin, Metronidazole
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Blepharitis is a endemic inflammatory disease caused mainly by Demodex folliculorum and Demodex Brevis, This mites are often associated with anaerobic bacteria that produces a skin inflammation, so a intervention that reduces the number of mites and bacteria would be desirable. Ivermectin a macrolid compound have demonstrated activity against scabies and lice in humans and in animals and a single application have show a good response in lice eradication.

In this study , investigators will determinate the security and effectiveness of this compound in the eradication of mites


Eligibility criteria: Inclusion Criteria:

* • Patients with symptomatic Demodex blepharitis for duration of at least 3 months.

  * Age range: 18 yeras and older.
  * Both genders and all ethnic groups comparable with the local community.
  * Able to understand and willing to sign a written informed consent
  * Able and willing to cooperate with the investigational plan.
  * Able and willing to complete all mandatory follow-up visits.

Exclusion Criteria:

* • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.

  * Children under 18.
  * Pregnant women or expecting to be pregnant during the study.
  * Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
  * Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
  * Concomitant use of systemic antibiotics or steroids.
  * Contact lens wear
  * Active ocular infection or allergy
  * Unable to close eyes or uncontrolled blinking Previous allergic reaction to metronidazole and / or ivermectin

Primary outcomes:
measure: Erradication of Demodex mites
timeFrame: 2 months
Secondary outcomes:
measure: Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score
timeFrame: 2 months
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Hospital de Engativa
Study officials:
References:
Clinical trial NCT03312803: Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children
Official title: Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A prospective study comparing the use of mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.

Detailed description: A prospective study comparing the use of mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children so that the patient can continue on his/her normal life early with less deformities

Eligibility criteria: Inclusion Criteria:

* This study will include children (3-12) years old with (10-30) % body surface area burns, admitted to Assuit university hospital burn unit.
* The raw areas in both upper and lower limbs will be the site of the study.

Exclusion Criteria:

* Patients younger than 3 years old.
* Patients with burns more than 30% of total body surface area.
* Patients with medical or mental diseases.

Primary outcomes:
measure: The major outcome is to specify if the regular single piece autogenous skin graft is better than the new technique that uses small pieces mini autogenous skin grafts for treatment of post burn wounds in children. or vice versa?
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Faculty of medicine
Study officials:
affiliation: Doctor Mostafa El Sonbaty
name: Mohamed St Salah El Din, Resident
role: STUDY_CHAIR
References:
Clinical trial NCT06809803: Extended-release Sodium Oxybate in Children
Official title: Safety, Convenience, and Tolerability of a Nightly Single Oral Dose of Extended-release Sodium Oxybate in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Narcolepsy Type 1 (NT 1)
Keywords: Narcolepsy
Children
Sodium oxybate
treatment
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Avadel
First posted: 2025-02-05
Enrollment: 36
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The main objectives of this study are to determine the treatment preferences of children with narcolepsy type 1 between Extended-release sodium oxybate and Non-extended-release oxybates (Sodium oxybate or a medication with the combination of Calcium, magnesium, potassium, and sodium oxybates). The study will also assess the safety, convenience, and tolerability of Extended-release sodium oxybate. Additionally, the researchers aim to assess how well Extended-release sodium oxybate works in treating narcolepsy type 1.


Eligibility criteria: Inclusion Criteria:

1. Participants must be under the care of a doctor at the Stanford Sleep Clinic.
2. Participants must have a documented diagnosis of narcolepsy type 1 shown by sleepiness and either: a spinal fluid marker for narcolepsy (hypocretin-1) at a specific level, or a history of sudden loss of muscle control (cataplexy), or a particular genetic marker for narcolepsy, or a sleep study showing a specific sleep pattern for narcolepsy.
3. Parent(s), or guardian(s) have signed a consent form and the child must agree to participate.
4. Participants are on a stable dose of medications

Exclusion Criteria:

Participants who have any of the following conditions will not be included in the study

1. Uncontrolled mental health problems
2. Uncontrolled sleep problems that lead to sleepiness.
3. Currently having thought about ending one's life or sadness or loss of interest
4. Currently having a problem with illegal drug use
5. Currently pregnant

Primary outcomes:
measure: Participant preference for selecting the extended vs non-extended release oxybates
timeFrame: Baseline, up to 8-12 weeks through study completion
Secondary outcomes:
measure: Change in Epworth Sleepiness Scales for Children and Adolescents (ESS-CHAD) score
timeFrame: Baseline, up to 8-12 weeks through study completion
measure: Number of cataplexy attacks
timeFrame: Baseline, up to 8-12 weeks through study completion
measure: Change in Patient Global Impression of Change (PGIc) scale score
timeFrame: Baseline, up to 8-12 weeks through study completion
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Oliver Sum-Ping, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06278103: Correlation Between Expression of Hormonal Receptors, Clinical Data, and Methylation Profile in Meningiomas (MethylRH-M)
Official title: Correlation Between Expression of Hormonal Receptors, Clinical Data, and Methylation Profile in Meningiomas
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Meningioma
Keywords: Meningioma
Hormonal receptors
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent surgery for a meningioma at the University Hospital of Nancy between 2000 and 2022.

Brief summary: This research aims to explore the relationship between hormonal receptor expression and the clinical and histopathological characteristics of meningiomas. The underlying hypothesis is that hormonal receptor expression, as well as the methylation profile of their gene promoters, are associated with specific aspects of meningiomas and patients' clinical outcomes. The main objective is to study the correlation between the immunohistochemical expression of hormonal receptors and clinicopathological data. The secondary objectif is to study the correlation between the methylation profile of hormonal receptor gene promoters and their immunohistochemical expression.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent surgery for a meningioma at the University Hospital of Nancy between 2000 and 2022.

Exclusion Criteria:

* Patients who did not express their consent to participate in the study.
* Patients with grade 2 or 3 meningiomas whose samples are no longer available or in insufficient quantity to perform an immunohistochemical study.
* Patients with grade 1 meningiomas not selected by randomization.
* Patients withdrawing their consent.

Primary outcomes:
measure: immunohistochemical expression of different hormonal receptors
timeFrame: up to 24 years after surgery
Secondary outcomes:
measure: methylation profile of the promoters of hormonal receptor genes
timeFrame: up to 24 years after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01703403: Physical Therapy Management in Degenerative Lumbar Diseases and Osteoporosis
Official title: Physical Therapy Management in Degenerative Lumbar Diseases and Osteoporosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Keywords: physical therapy
treated at NTUH and received rehabilitation at the PTC in recent ten years.
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with the diagnosis including lumbar spondylosis, low back pain, osteoporosis, compression fracture, back pain treated at National Taiwan University Hospital and received rehabilitation at the Physical Therapy Center in recent ten years.

Brief summary: Low back pain is a common health issue in elderly population. According to the statistics, more than 80% of Taiwanese suffer low back pain in the life. The cause of low back pain includes lumbar spondylosis, osteoporosis, compression fracture, muscle strain, spondylolisthesis...etc. In addition to drugs and surgery, physical therapy is an alternative choice for conservative treatment. Therefore, in this study, the investigators propose to analyze the physical examination, diagnostic methods, X ray, physical therapy records, physical therapy methods and clinical outcomes in patients with the diagnosis including lumbar spondylosis, low back pain, osteoporosis, compression fracture, back pain treated at National Taiwan University Hospital and received rehabilitation at the Physical Therapy Center in recent ten years.


Eligibility criteria: Experimental group:

Inclusion Criteria:

* patients with the diagnosis including lumbar spondylosis, low back pain, osteoporosis, compression fracture, back pain treated at National Taiwan University Hospital
* received rehabilitation at the Physical Therapy Center in recent ten years.

Control group:

Inclusion Criteria:

* patients with the diagnosis including lumbar spondylosis, low back pain, osteoporosis, compression fracture, back pain treated at National Taiwan University Hospital
* not received rehabilitation at the Physical Therapy Center in recent ten years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Study officials:
affiliation: School of physical therapy, National Taiwan University
name: Wei-Li Hsu, PT,PhD
role: PRINCIPAL_INVESTIGATOR
References: