louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04320407: Osia CPT Code Study
Official title: A Post-market Interventional Cohort Study Evaluating the Clinical Efficacy of the Osia 2 System in the US Market.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conductive Hearing Loss
Mixed Hearing Loss
Keywords: conductive hearing loss
mixed hearing loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2020-03-25
Enrollment: 20
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: To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent.
* Proficient in English.
* Hearing loss etiology of Conductive or Mixed Conductive loss.
* Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the treatment ear.
* Aged 18 years and older.

Exclusion Criteria:

* Unwilling to wear the treatment device or comply with the surgical and rehabilitation requirements of the study.
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
* Medical, audiological or psychological conditions, as judged by the investigator that might contraindicate participation in the clinical investigation.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or contractors engaged by Cochlear for the purposes of this investigation.
* Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
* Prior experience with a surgical bone conduction treatment option
* Insufficient bone quality to support the BI300 implant as determined by the surgeon

Primary outcomes:
measure: Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery
timeFrame: Preoperative, 3 months post-surgery
Secondary outcomes:
measure: Number of Device or Procedure Related Adverse Events
timeFrame: 6 months post-surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Ear Center
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chesterfield
country: United States
facility: Center for Hearing and Balance
state: Missouri
Study officials:
affiliation: Arizona Hearing Center
name: Mark Syms, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00803907: Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma
Official title: Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Carcinoma, Basal Cell
Keywords: immunomodulator
Carcinoma, Basal Cell
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the periorbital region.

Detailed description: This is a prospective study including patients presenting in aggregate primary lesions affected by nodular BCC of the eyelid (all subjects were submitted to incisional biopsy at 2 mm punch) at the commencement of this study. All were submitted to a local treatment with Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average). All subjects were submitted to a new incisional biopsy at 2 mm punch, after 12 weeks of treatment, and all of them were monitored monthly up to now.If positive biopsy (residue tumor) cases will managed with surgery.

Eligibility criteria: Inclusion Criteria:

* Patients whose injuries were confirmed by anatomical and pathological study (periocular superficial basal cell carcinoma).
* Patients with clinical counter indication for reconstructive surgery (high surgical risk).
* Patients who have refused a restorative surgery. (aesthetic reasons)
* Patients who have signed the free and informed consent.

Exclusion Criteria:

* Patients who have a hypersensitivity reaction to the formula components.
* Children under 12 years of age.
* Pregnant and breastfeeding women.
* Patients whose injury was not confirmed by anatomical and pathological study.
* Individuals with previous autoimmune or inflammatory disease.
* Patients who have refused to sign the free and informed term of consent.

Primary outcomes:
measure: post-treatment biopsy
timeFrame: post-treatment biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: E M macedo
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Macedo EM, Carneiro RC, de Lima PP, Silva BG, Matayoshi S. Imiquimod cream efficacy in the treatment of periocular nodular basal cell carcinoma: a non-randomized trial. BMC Ophthalmol. 2015 Apr 3;15:35. doi: 10.1186/s12886-015-0024-0.
Clinical trial NCT02740907: Premolar Autotransplantation in Juvenile Dentition: Quantitative Assessment of Vertical Bone and Soft Tissue Growth
Official title: Premolar Autotransplantation in Juvenile Dentition: Quantitative Assessment of Vertical Bone and Soft Tissue Growth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Dental Injury
Tooth Aplasia
Lead sponsor: MKG-Praxisklinik
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (mean age 13.6, f:10, m:10) suffering from tooth loss in the anterior maxilla (13-23). Thirteen patients suffered from traumatic dental injury (TDI) with subsequent tooth loss (n=16 transplants). In 7 patients, aplasia of teeth in region 13 to 23 was present (n=10 transplants).

Brief summary: Objective:

Premolar autotransplantation represents an effective therapeutic option for the treatment of juvenile dentition in traumatic dental injury with tooth loss. Numerous studies report on the osteoinductive potency of the method, however, to date no quantitative data has been provided. The objective of this prospective clinical study was to quantitatively assess the bone and soft tissue levels after autogenous premolar transplantation by clinical and radiographic parameters.

Materials/Methods:

In the study 26 premolars were transplanted in 20 patients after traumatic dental injury (n=10) or tooth aplasia (n=16) in the upper front. Standard clinical parameters were evaluated. Based on a standardized photo documentation, the relative soft tissue level was measured in comparison to the healthy adjacent teeth. Radiographic findings involved the evaluation of root resorption, pulp canal obliterations and the relative bone height. Patient satisfaction was determined using a standardized questionnaire.


Eligibility criteria: Inclusion Criteria:

* premolar transplantation after tooth loss in the anterior maxilla (13-23) by aplasia or trauma

Primary outcomes:
measure: Transplant survival
timeFrame: 2006-2014
measure: Soft tissue development
timeFrame: 2006-2014
measure: Bone development
timeFrame: 2006-2014
measure: Sensibility
timeFrame: 2006-2014
measure: Root resorptions
timeFrame: 2006-2014
measure: Pulp obliteration
timeFrame: 2006-2014
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: MKG Praxisklinik
state: Sauerbruchstraße 48
Study officials:
References:
Clinical trial NCT06059807: Root Resorption After Maxillary Expansion
Official title: A Cone-Beam Computed Tomography Evaluation of Root Resorption After Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances (Expanders)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maxillary Expansion
Keywords: expanders
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study will to evaluate the root resorption after RME by hyrax and hybrid hyrax appliances by using of cone beam computed tomography .


Eligibility criteria: Inclusion Criteria:

1. skeletal maxillary transvers deficiency
2. unilateral or bilateral posterior crossbite
3. negative buccal corridor
4. patient with good oral hygiene
5. patient with no previous orthodontic treatment
6. no systemic disease

Exclusion Criteria:

1. craniofacial congenital anomalies
2. a history of periodontal disease
3. incomplete treatment records

Primary outcomes:
measure: Change in root resorption after maxillary expansion
timeFrame: 12 weeks following end of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Miranda F, Cunha Bastos JCD, Magno Dos Santos A, Janson G, Pereira Lauris JR, Garib D. Dentoskeletal comparison of miniscrew-anchored maxillary protraction with hybrid and conventional hyrax expanders: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2021 Dec;160(6):774-783. doi: 10.1016/j.ajodo.2021.02.017. Epub 2021 Sep 9.
Clinical trial NCT03861507: Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound
Official title: Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study involves patients who are scheduled for standard care brachytherapy of focal tumours within the prostate, which is normally performed under standard 2-dimensional (2D) ultrasound guidance. The purpose of this study is the acquire power Doppler ultrasound while using a simple oscillator in physical contact with the end of a brachytherapy needle. The vibrations along the needle should be visible in the power Doppler ultrasound, helping to visualize the needle position within the anatomy.


Eligibility criteria: Inclusion Criteria:

* Male, aged 18 years or older
* Willing to provide written consent
* Pathologically confirmed prostate cancer on previous biopsy
* Suitable for and consenting to high-dose-rate brachytherapy for treatment as standard of care.

Exclusion Criteria:

* • Previous radiotherapy to the prostate

Primary outcomes:
measure: Needle Trajectory
timeFrame: 1 month following data collection
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT01173107: A Pilot Study for PK/PD Parameter of Colchicine in Chronic Kidney Disease Patient.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-07-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A pilot study for PK/PD parameter of colchicine in Chronic kidney disease patient.


Eligibility criteria: Inclusion Criteria:

* from 18yrs to 80yrs , man and women
* the patient who are taking colchicine
* On screening, the patient shows that MDRD GFR \>= 10 ml/min and \<= 50 ml/min
* the patient sign on the concent form

Exclusion Criteria:

* the patient have experience to take medication that have an effect on renal function
* At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP \<= 100 mmHg or \>=160 mmHg and DBP \<=60 mmHg \>=100 mmHg, or Heart rate \< 40 beats/min or \> 90 beats/min
* pregnancy or anticipate pregnancy with 6 month
* hypersensitivity to colchicine
* acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL
* serum albumin \< 3.5 mg/dL or \> 5mg/dL
* urinary retension, prostatic hyperplasia
* the patient show gout attack on taking colchicine
* the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.
* the patient who should take Atazanavir, Amprenavir, Apreptant, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil, cyclosporine, ranolazine
* the patient who had taken part in the other study within 3months
* the patient who had gotten blood transfusion
* pregnant, breast feeding

Primary outcomes:
measure: serum colchicine level
timeFrame: 0,1,6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05586607: Causes and Management of Aseptic Meningitis : A Retrospective Cohort Study in Strasbourg University Hospital
Official title: Causes and Management of Aseptic Meningitis : A Retrospective Cohort Study in Strasbourg University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aseptic Meningitis
Keywords: Aseptic Meningitis
Infectious
Inflammatory
Neoplastic
Drug-induced
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years old) with aseptic meningitis (CSF pleocytosis, negative bacteriology) from January 2015 to October 2020, at HUS

Brief summary: The diagnostic and therapeutic management of patients with aseptic meningitis is a challenge for the practitioner. There are many etiologies of this condition (infectious, inflammatory, neoplastic, drug-induced), which it is necessary to know how to evoke and look for specifically.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Subject with aseptic meningitis (CSF pleocytosis, negative bacteriology) from January 2015 to October 2020, at HUS
* Subject having not expressed, after being informed, their opposition to the reuse of their data for the purposes of this research.

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Subject under guardianship or curatorship
* Subject under safeguard of justice
* Positive VZV, HSV, or Enterovirus PCR in CSF
* CSF analysis performed as part of the assessment of a known pathology
* Traumatic or surgical etiology

Primary outcomes:
measure: Retrospective study of the etiologies of aseptic meningitis infection in Alsace
timeFrame: Files analysed retrospectively from January 01, 2015 to October 31, 2020 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Médecine interne et d'Immunologie Clinique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02800707: Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
Official title: Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Glucose Tolerance
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women.

Detailed description: This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women aged 35-55 years.

Eligibility criteria: Inclusion Criteria: Generally health adult men and women aged 35-55 years old -

Exclusion Criteria:Adults will not be eligible who have chronic disease (cancer, CHD, diabetes, chronic kidney disease); pregnant or breast feeding; menopausal; has a history of bariatric surgery; taking prednisone/steroids, taking medication for PCOS, or take medications that influence blood glucose.

-

Primary outcomes:
measure: 2-hour glucose
timeFrame: 14 days
Secondary outcomes:
measure: Gut microbiome
timeFrame: 14 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: ECRC
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Lyn M Steffen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03478007: Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients
Official title: Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Exercise Compliance
Health Coaching
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Innovative Design Labs
name: National Institute on Aging (NIA)
First posted: 2018-03-27
Enrollment: 119
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 purpose of the study is to develop, design and implement an easy-to-use, cloud-enabled software for patients with low back pain and evaluate the effect of the system on compliance and quality of life. The investigators hypothesize that a device which measures compliance to physical therapy regimens in patients with low back pain will increase patient participation.

Detailed description: Innovative Design Labs (IDL) proposes to develop and deploy a low-cost measurement system which tracks exercise compliance and enables remote health coaching for patients with low back pain. The system will consist of a series of small motion sensors built into a custom designed harness which connect wirelessly to the user's tablet or smartphone. A software application will guide the patient through the exercise routine while the sensor system monitors their motion, classifies exercise completion, and tracks their progress through the protocol. The results of the routine will be securely uploaded to caregivers where they can monitor progress, modify the patient's exercise prescription, and offer encouragement and coaching to continue the therapy. This research program aims to enable the long term treatment-tracking of patients with chronic low back pain.

Eligibility criteria: Inclusion

* 18 years or older
* Diagnosis of chronic low back pain (\> 3 months duration)
* Have a current prescription for at-home exercises for chronic low back pain

Exclusion

* Patients with a high likelihood of being lost to follow-up or contact
* Patients with an inability to provide good data or follow commands
* Patients with an inability to do mild exercise
* Patients with a history of spine surgery that included instrumentation or hardware
* Patients who are taking opioid medication chronically without reasonable reduction in pain

Primary outcomes:
measure: Change in Back Disability Related Quality of Life
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in Overall Pain
timeFrame: Baseline and 8 weeks
measure: Degree of Compliance
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kenton R Kaufman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07008807: The Facial Muscular Activity: A Paradigm for Understanding Facial Asymmetry
Official title: The Facial Muscular Activity: A Paradigm for Understanding Facial Asymmetry, A Prospective Correlation Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Facial Asymmetry
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Presenting with noticeable facial asymmetry.

Brief summary: Facial asymmetry, the degree to which the two sides of the face differ in size, shape, or the arrangement of features, is a near-universal human characteristic. The intricate network of facial muscles plays a crucial role in both the static structure and the dynamic expressions of the face. The continuous pull and action of facial muscles can influence the development and positioning of underlying soft tissues and even, over extended periods, potentially impact skeletal structures.


Eligibility criteria: Inclusion Criteria:

* Presenting with noticeable facial asymmetry
* Age \> 16 years
* General good health
* Absence of specific neurological conditions affecting facial muscles.
* Absence of congenital facial disorders that might cause facial asymmetry, like hemifacial microsomia and cleft lip and palate syndromes.

Exclusion Criteria:

* History of facial trauma or surgery
* Diagnosed Neuromuscular Disorders
* Active facial infections.

Primary outcomes:
measure: Facial Electromyography (EMG)
timeFrame: Day 1
measure: Facial Asymmetry Measurement
timeFrame: Day 1
Secondary outcomes:
measure: Demographic and Clinical Data
timeFrame: Day 1
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: orthodontic outpatient clinic, and students at Faculty of Dentistry, Alsalam University, Egypt
Study officials:
References:
citation: 4. Kowner, R. (1996). Facial asymmetry and attractiveness judgment in Western and Japanese cultures. Journal of Social Behavior and Personality, 11(2), 301-314.
citation: Ferrario VF, Dellavia C, Tartaglia GM, Turci M, Sforza C. Soft tissue facial morphology in obese adolescents: a three-dimensional noninvasive assessment. Angle Orthod. 2004 Feb;74(1):37-42. doi: 10.1043/0003-3219(2004)0742.0.CO;2.