louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06147661: Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue
Official title: Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Implants
Keywords: Breast Prosthesis
Breast Implants
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 119
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult woman (age ≥ 18 years) having benefited from primary aesthetic breast augmentation at Strasbourg University Hospital between June 27, 2017 and June 27, 2022

Brief summary: The use of autograft of adipose tissue for aesthetic breast augmentation is increasing year after year. According to the latest meta-analysis of 2016, autograft of adipose tissue in augmentation mastoplasty seems to be a promising method with a satisfactory resorption volume and patient and surgeon satisfaction. However, this technique allows for small to moderate breast augmentation and is therefore not suitable for patients wanting a significant increase.

Breast prostheses allow a significant increase. Numerous studies have shown an improvement in patient satisfaction and quality of life assessed using the BREAST-Q questionnaire.

On the other hand, very few studies have objectively evaluated the satisfaction of patients who have benefited from an autograft of adipose tissue as part of aesthetic breast augmentation. No study has yet compared the satisfaction of patients who have benefited from breast implants or lipofilling.

The aim of this study is to compare the satisfaction of patients who have benefited from breast augmentation by prosthesis or by lipofilling using a remote satisfaction interview.


Eligibility criteria: Inclusion Criteria:

* Adult woman (age ≥ 18 years)
* having benefited from primary aesthetic breast augmentation at Strasbourg University Hospital between June 27, 2017 and June 27, 2022
* not opposing the reuse of its data for scientific research purposes.

Exclusion Criteria:

* Woman who expressed her opposition to the reuse of her data for scientific research purposes
* Woman with a breast malformation: tuberous breasts or breast asymmetry of more than one cup
* Woman with comprehension difficulties
* Woman under guardianship or curatorship

Primary outcomes:
measure: Patient woman satisfaction
timeFrame: 1 to 4 years after breast implants
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Plastique, Reconstructrice et Esthétique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01857661: The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
Official title: The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Hearing Loss
Keywords: tinnitus
hearing loss
hearing devices
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-05-20
Enrollment: 49
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: The University of Sao Paulo Department of Otorhinolaryngology developed prototypes for a digital new hearing aid with an integrated sound generator. These prototypes assist both hearing rehabilitation (about 10% of the population) and tinnitus sufferers (about 17% of the population).

Currently, the Brazilian Public Heath Care does not have any such hearing aids. So, the development of devices for the hearing rehabilitation as well as the treatment of tinnitus represents an advance in the implementation of Public Policies in Brazil.

The aim of this study is to compare the efficacy of the hearing aid with an integrated sound generator and amplification alone for tinnitus control in patients with tinnitus associated hearing loss.

Detailed description: This study, in the form of a blind randomized clinical trial, was approved by CAPPesq under protocol number: 0163/10.

49 adults with tinnitus and sensorineural hearing loss were randomly assigned into 2 groups. Both groups received counseling about tinnitus. One group received hearing aids with only amplification and the other group received hearing aids with an integrated sound generator. After the fitting process, both groups were told to use the hearing devices 8 hours per day. The outcome measures as the tinnitus handicap inventory and psychoacoustics measurements were conducted by a blind audiologist that didn't know each group each patient belonged to.

Eligibility criteria: Inclusion Criteria:

* mild to moderate sensorineural hearing loss
* tinnitus (THI \> 20)
* first user

Exclusion Criteria:

* profound hearing loss
* conductive hearing loss
* THI \< 20

Primary outcomes:
measure: THI
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: dos Santos GM, Bento RF, de Medeiros IR, Oiticcica J, da Silva EC, Penteado S. The influence of sound generator associated with conventional amplification for tinnitus control: randomized blind clinical trial. Trends Hear. 2014 Jul 23;18:2331216514542657. doi: 10.1177/2331216514542657.
Clinical trial NCT00978861: Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tooth Whitening
Lead sponsor: JDC Tech
Sponsor class: INDUSTRY
First posted: 2009-09-17
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of REMEWHITE on tooth whitening.

Detailed description: This study intended to establish the efficacy of REMEWHITE after using the product under controlled conditions at the hospital.

The efficacy of the product was assessed at the end of the study; clinical examination by the dentist.

Eligibility criteria: Inclusion Criteria:

* ability to understand and provide informed consent
* general good health male and female adults, were 20 years or older
* no pregnant woman
* had six caines-free maxillary anterior teeth without restorations on the labial surfaces

Exclusion Criteria:

* had severe internal discoloration (tetracycline stains, fluorosis, pulpless teeth)
* evidence of fracture or major cracks on tooth
* were pregnant or nursing
* had tooth sensitivity
* smokers
* had teeth shade A1, A2

Primary outcomes:
measure: colorimeter
timeFrame: 12 weeks after treatment
Secondary outcomes:
measure: colorimeter
timeFrame: 24 weeks after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The cathiloc university of korea seoul st. mary's hospital
Study officials:
affiliation: The cathiloc university of korea seoul st. mary's hospital
name: Je-Uk Park, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05846061: Epidemiology of Helicobacter Pylori Infection in Children From Slovenia
Official title: Epidemiology of Helicobacter Pylori Infection in Children From Slovenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Transmission
Keywords: children
infection
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 430
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children from school of different age groups- community sample

Brief summary: The epidemiology of H. pylori infection among children in Slovenia has not been investigated. Therefore, we are conducting a study to examine the epidemiology of H. pylori and associated risk factors among children in Slovenia.

Detailed description: The population selection was from the three different geographic location in Slovenia. The selection of the studied places was based on their social and economic characteristics and medical provision. We included children from three age groups at the same time we collected information from the parents which may be important for H. pylori transmission.

Eligibility criteria: Inclusion Criteria:

* age 6, 14 and 17 years living in three different regions in Slovenia

Exclusion Criteria:

* none

Primary outcomes:
measure: The number of infected children in different age population
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Children's Hospital in Ljubljana
Study officials:
References:
citation: Polivanova TV, Malaty H, Vshivkov VA. Epidemiology Helicobacter pylori infection in children in the Tyva Republic (Russia). Helicobacter. 2022 Jun;27(3):e12882. doi: 10.1111/hel.12882. Epub 2022 Mar 13.
Clinical trial NCT03043261: Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation
Official title: Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: CHF
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: EMERGE is a PI-initiated feasibility study that aims to evaluate the accessibility, usability, effectiveness and relevance of an integrated psycho-behavioral intervention on heart failure patients in order to increase support, outreach and general well-being of these patients following hospitalization due to heart failure exacerbation.


Eligibility criteria: Inclusion Criteria:

* Adult male and female patients, age ≥ 18 hospitalized at Duke inpatient service because of heart failure
* NYHA Class ≥ II

Exclusion Criteria:

* Significant cognitive impairment, indicated as a mini-mental state exam (MMSE) total score of 23 or lower
* Lack of convenient internet access outside of hospital
* Alcohol or other drug dependence/abuse within past 90 days as evaluated by review of medical record and patient interview (SCID)
* Severe physical disability (visual, sensory or motor) that may interfere with study participation (assessment, online interactive learning)
* History or presence of psychoses, bipolar disorder, and/or severe personality disorders as evaluated by review of medical record and patient interview (SCID)
* Life-threatening co-morbidity with the likelihood of 50% mortality in one year
* Active suicidal ideations
* Female patients of childbearing potential
* Treatment with electroconvulsive therapy or transcranial magnetic stimulation within past 90 days
* Uncorrected hypothyroidism or hyperthyroidism

Primary outcomes:
measure: Subject retention
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Pamela Bonner
state: North Carolina
Study officials:
affiliation: Duke University
name: Wei Jiang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04692961: Change in the Lower Leg Muscle Stiffness Following Peroneal Artery-based Flap
Official title: Change in the Lower Leg Muscle Stiffness Following Peroneal Artery-based Flap: An Elastography Ultrasonographic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Donor Site Complication
Muscle; Ischemic
Keywords: Elastography; Donor site morbidity
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In the field of reconstructive microsurgery, donor site morbidity after free flap harvest is one of the key factors to consider when choosing among different options of free flap. Peroneal artery-based free flap, such as fibula flap or peroneal flap, is one of the popular options of free flap. There are a plenty of literature using a variety of modalities to evaluate the donor site morbidity after free fibula harvest, such as gait analysis. Elastography has been used to evaluate the stiffness change of soft tissue, such as skeletal muscle, or liver. The purpose of this study is to use elastography to evaluate the stiffness of lower leg muscle after peroneal artery-based free flap harvest.

Detailed description: A total of twenty-three patients will be recruited at National Taiwan University Hospital Yunlin Branch. All of them will receive fibula flap or peroneal flap harvest operations. At the time points of pre-operation, 1-month post-operation, 3-month post-operation, and 6-month post-operation, the muscles of both legs of each patient will be evaluated by elastography, and the function of both legs will be evaluated by American Orthopedic Foot and Ankle Score (AOFAS). Paired t-test will be used to compare the results of each evaluations.

Eligibility criteria: Inclusion Criteria:

* No previous major operations over both legs
* Able to walk freely during daily life
* Going to receive peroneal artery-based free flap harvested from one leg

Exclusion Criteria:

* Previous major operations over either leg
* Unable to walk freely during daily life

Primary outcomes:
measure: Lower Leg Muscle stiffness
timeFrame: 6 months
Secondary outcomes:
measure: American Orthopedic Foot and Ankle (AOFAS) scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital Yunlin Branch
state: Yunlin County
Study officials:
affiliation: National Taiwan University Hospital Yunlin Branch
name: Ying-Sheng Lin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04863261: Cabenuva Injection Tracking in CHORUS
Official title: Facilitating the Management of CAB+RPV LA Patient Visits Through Daily Alerts and Morning Huddles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: Epividian
Sponsor class: INDUSTRY
Collaborators: name: AIDS Healthcare Foundation
name: ViiV Healthcare
First posted: 2021-04-28
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial. The clinics will be randomized to either start using the Cabenuva Scheduling Alerts in the Retention \& Huddle modules of the CHORUS App (Intervention Arm) or to standard of care (Control Arm).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. The purpose of this study is to assess if receiving alerts can help providers manage the scheduling of monthly cabotegravir + rilpivirine long-acting injections for the treatment of HIV.

Detailed description: A novel long-acting HIV antiretroviral therapy has recently been approved by the FDA: cabotegravir and rilpivirine delivered through intramuscular injection. These injections should be administered monthly, on the same day of the month as the initiation injections, up to 7 days before or after the date of the scheduled monthly injection visit.

This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. Providers in the intervention group will receive alerts to remind them when patients are due for their injections, or if they missed their treatment window. Providers in the control group will not receive alerts and will manage injections as per their clinic's standard process. Surveys will be administered to understand the utility of the alerts for the management of these injections.

Eligibility criteria: Inclusion Criteria (patients):

* As per label, routine clinical care

Inclusion Criteria (clinics):

* AIDS Healthcare Foundation (AHF) Clinic
* HIV primary care clinic
* Minimum of 100 people living with HIV in care with a viral load \<50 copies/mL at the time of randomization (satellites will be included in the count of their parent clinic).

Primary outcomes:
measure: Adherence to treatment-window
timeFrame: 9 months
measure: Acceptability and usefulness of the intervention
timeFrame: Month 1
measure: Acceptability and usefulness of the intervention
timeFrame: Month 9
Secondary outcomes:
measure: Number of CAB+RPV LA patients managed through the app
timeFrame: 9 months
measure: Number of clinics that use the App for the management of CAB+RPV LA patients
timeFrame: 9 month
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
Study officials:
affiliation: AHF
name: Michael Wohlfeiler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04473261: Efficacy of Iodine Complex Against COVID-19 Patients
Official title: Efficacy of Iodine Complex in Mild to Moderate COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Covid19
SARS-CoV-2
Corona Virus Infection
Keywords: SARS-Cov-2
COVID-19
Coronavirus
Iodine Complex
Lead sponsor: Sheikh Zayed Federal Postgraduate Medical Institute
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, multi-armed, close-label, interventional study designed
Primary purpose: TREATMENT

Brief summary: The objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.

Detailed description: The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation ratio and superiority framework.

Eligibility criteria: Inclusion Criteria:

* Positive PCR with mild to moderate disease

Exclusion Criteria:

* Allergic to iodine
* Any co-morbidity other than hypertension and dietetics

Primary outcomes:
measure: qRT-PCR
timeFrame: 14 days
measure: HRCT chest
timeFrame: 14 days
Secondary outcomes:
measure: Severity of Symptoms
timeFrame: 14 days
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaikh Zayed Hospital
Study officials:
affiliation: University of Veterinary & Animal Sciences, Pakistan
name: Muhammad Ashraf, PhD
role: STUDY_CHAIR
affiliation: Harvard University, Massachusetts General Hospital, Boston, USA
name: Shoaib Ashraf, PhD
role: STUDY_DIRECTOR
affiliation: Mayo Hospital, Pakistan
name: Moneeb Ashraf, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaikh Zayed Medical Complex, Pakistan
name: Sohaib Ashraf, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashraf S, Ashraf S, Ashraf M, Imran MA, Kalsoom L, Siddiqui UN, Farooq I, Ghufran M, Khokhar RA, Akram MK, Shahid I, Sohaib Ur Rehman M, Akmal R, Tahir A, Zahid A, Ashraf S, Rafique S, Matti N, Nadeem MF, Humayun A, Malik A, Saboor QA, Ahmad A, Ashraf M, Izhar M. A quadruple blinded placebo controlled randomised trial to evaluate the effectiveness of an Iodine complex for patients with mild to moderate COVID-19 in Pakistan (I-COVID-PK): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Feb 10;22(1):127. doi: 10.1186/s13063-021-05081-3.
Clinical trial NCT00133861: Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles
Official title: Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles. Assessment of Efficiency of Botulinum Toxin on Spasticity in Agonist and Antagonist Muscles Using Clinical Assessment and Gait Analysis in Cerebral Palsy Children: Rectus Femoris and Semitendinosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cerebral Palsy
Keywords: cerebral palsy children
Botulinum toxin
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-08-24
Enrollment: 23
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to confirm the functional improvement obtained through treatment of spasticity on 2 agonist and antagonist muscles. The hypothesis is that treatment of both muscles gives a better and longer functional improvement than treatment of only one muscle. The target muscles are the rectus femoris and semitendinosus and the treatment is botulinum toxin. Clinical assessment (passive range of motion of the lower limbs, spasticity level, functional scales and subjective feeling) and gait analysis data (kinematics and kinetics data) are collected. Evaluations take place before treatment, 2 months and 6 months after treatment.


Eligibility criteria: Inclusion Criteria:

* Patients between 7 to 17 years old
* Cerebral palsy children with walking ability (even with crutch or knee-walker) allowing gait analysis.
* Patients with functional status allowing the use of botulinum toxin on target muscles.

Exclusion Criteria:

* Patients under 7 years old
* Patients up to 17 years old
* Patients in whom botulinum toxin is contra-indicated
* Patients who received botulinum toxin within a 6 month period before the beginning of the study

Primary outcomes:
measure: Clinical evaluation of the passive range of motion of the lower limbs
Secondary outcomes:
measure: Evaluation of the spasticity using Tardieu Scale, Ashworth Scale and Ely test
measure: Evaluation of functional outcome using Gross Motor Function Measure and Gillette Functional Assessment, subjective evaluation, physiological cost index
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot - Pavillon T bis
Study officials:
affiliation: Hospices Civils de Lyon
name: Bruno DOHIN, MD
role: PRINCIPAL_INVESTIGATOR
References: