louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00725998: Longitudinal Study Of The Evoked Compound Action Potential Measured In Children Cochlear Implant Users
Official title: Longitudinal Study Of The Evoked Compound Action Potential Measured In Children Cochlear Implant Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Nerve Disease
Keywords: Cochlear Implantation.
Cochlear nerve.
Child.
study
ECAP
During
First year
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-07-31
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The ECAP characteristics have been analyzed in 13 children implanted younger than three years old.

Brief summary: Introduction: In Cochlear Implant (CI) users, the recording of the electrically evoked compound action potential (ECAP) of the auditory nerve represents an option to assess changes in auditory nerve responses and the interaction between the electrode and the neural tissue over time.

Aim: To study ECAP in children during the first year of CI use.

Material and methods: The ECAP characteristics have been analyzed in 13 children implanted younger than three years old. SERIES STUDY.

Descriptors:

Cochlear Implantation,cochlear nerve,child.


Eligibility criteria: This study selected only children implanted younger than three years old and followed them during their first year of CI use.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Universidade de São Paulo
state: SP
Study officials:
References:
Clinical trial NCT03710798: Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema
Official title: Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipedema
Obesity, Morbid
Keywords: Diet, ketogenic
Pain
Quality of Life
Body Composition
Body Fat Distribution
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: University of Oslo
First posted: 2018-10-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective observational study with a diet intervention
Primary purpose: TREATMENT

Brief summary: Lipedema is a chronic disease with unproportional, symmetrical fat accumulation in the lower extremities. Patients experience pain in affected areas, and reduced quality of life. Today's treatment is physiotherapy and surgery (liposuction). Recent research shows that ketogenic-diet with low carbohydrate, high fat (LCHF) conant can lead to reduced pain, increased quality of life and change in body composition. Goals: Investigate the effect of LCHF diet on pain, quality of life and body composition.


Eligibility criteria: Inclusion Criteria:

* weight stable over the last three months (+ 2-3 kg)
* not currently dieting to loose weight.
* willing to meet for weekly follow-ups during the intervention and the reintroduction of a regular diet.
* sign an informed consent before entering the study.

Exclusion Criteria:

* pregnant or breast feeding
* history of infectious diseases
* medication known to affect obesity
* enrolment in any other obesity treatment
* have had a bariatric surgery
* history of psychological disorders
* mentally disabled
* not mastering a Scandinavian language
* having a malign disease or any disease that leads to dietary advice that is not consistent with intervention advices in the study

Primary outcomes:
measure: Lymphedema Quality of Life questionnaire
timeFrame: 6 weeks
measure: Pain indicated on a visual analog scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Obesity Clinic, St Olavs Hospital
Study officials:
affiliation: Norwegian University for Science and Technology
name: Bodil Landstad, prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02310698: Comparison of Whole Breast Screening Ultrasound and Contrast Enhanced Mammography for Supplemental Breast Cancer Screening
Official title: Comparison of Whole Breast Screening Ultrasound and Contrast Enhanced Mammography for Supplemental Breast Cancer Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Screening
Keywords: Ultrasound
Enhanced Mammography
14-240
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 487
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC clinic

Brief summary: Breast tumors are often detected on mammography but may be harder to see in women with dense breasts. This is why screening breast ultrasound is sometimes used as another test in women with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen on regular mammography.

Contrast Enhanced Digital Mammography (CEDM) is a FDA approved form of mammography. It is essentially a routine digital mammogram performed after iodine dye (the same that is used with CT scans) is injected into a vein in the arm. Like screening ultrasound, CEDM has been shown to detect breast cancers that are not seen on a regular mammogram. The purpose of this study is to compare whether CEDM or screening breast ultrasound is better at detecting cancer. Both will be done in this study and compared to one another.


Eligibility criteria: Inclusion Criteria:

* Women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other
* Women scheduled for screening CEDM alone
* Women scheduled for WBUS and screening CEDM on the same day or within 30 days of one another

Exclusion Criteria:

* Age \< 30 years old
* Male patients
* Patients with any clinical breast symptoms (palpable mass, nipple discharge, etc)
* Patients with known diagnosis of breast cancer
* Patients with any breast surgery or biopsy within 90 days prior to the study
* Patients who have had a lumpectomy for breast cancer within 18 months prior to the study
* Patients who are thought to have a breast MRI within 1 year prior to the study
* Patients with contraindication to the intravenous use of iodinated contrast agent (i.e. allergy to iodinated contrast or severely impaired renal function with a creatinine level ≥1.3)

Primary outcomes:
measure: The number of cancers and false positive findings identified on a CEDM and WBUS as a measure of sensitivity and specificity.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Janice Sung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02964598: SleepHelsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE
Official title: Sleep Helsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type
Keywords: Adolescent
Population-based
Social jetlag
Intervention
Bright light
Motivation
Circadian regulation
Behavioral change
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Academy of Finland
First posted: 2016-11-16
Enrollment: 270
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adolescence associates with alterations in sleep-wake organization, such as later circadian phase preference. Simultaneously external pressures, such as evening-driven social activities increase. These may lead to delayed sleep phase, which may cause serious problems for waking up at socially accepted times, and absenteeism from the school may follow. This project aims at tracking risk factors for later circadian regulation problems, characterizing interconnections of biological, psychological and behavioural mechanisms that maintain or induce poor sleep regulation in adolescence, and building a cost-effective, theoretically-based sleep intervention for adolescents with delayed sleep phase. This randomized control trial capitalizes on a new population-based cohort of 16-17-year olds.


Eligibility criteria: Inclusion Criteria:

* Late bedtime several times per week

Exclusion Criteria:

* Chronic disease that affects sleep. Ongoing therapeutic treatment relationship if considered overlapping by the participant

Primary outcomes:
measure: Circadian sleep rhythm
timeFrame: 8 weeks
measure: Circadian body temperature rhythm
timeFrame: 8 weeks
Secondary outcomes:
measure: Mood
timeFrame: 8 weeks
measure: Insomnia symptoms
timeFrame: 8 weeks
measure: Sleep problems
timeFrame: 8 weeks
measure: Depression
timeFrame: 8 weeks
measure: Anxiety
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
Study officials:
affiliation: University of Helsinki
name: Anu-Katriina Pesonen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04654598: BPA Levels Relationship With IVF/ICSI Outcomes in Low Ovarian Reserve
Official title: Could the Consumption of Water From Plastic Bottles Affect the Embryo Grade and Clinical Pregnancy Rate Obtained With IVF/ICSI in Low Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility Low Over Reserve
IVF
Infertility, Female
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 74
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The relationship between BPA elevation in urine, blood, and follicle fluid and embryo quality, IVF/ICSI outcomes.


Eligibility criteria: Inclusion Criteria:

* patients who underwent IVF due to low ovarian reserve
* patients provided urine, blood, and follicle fluid (FF) samples on the oocyte retrieval day
* patients who did not smoke or use alcohol
* patients did not work in the plastic industry

Exclusion Criteria:

* patients who underwent IVF due to unexplained infertility or tubal factor or male factor indications
* patients diagnosed with endometriosis
* patients with freeze-all cycles
* patients having previous ovarian surgery
* women with metabolic disease (such as hypertension or diabetes mellitus)
* patients with a known genetic problem (male or female)

Primary outcomes:
measure: Exposure to BPA
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sanlıurfa
country: Turkey
facility: Nefise Nazlı YENIGUL
Study officials:
References:
Clinical trial NCT02309398: CCC Project - Atrial Fibrillation
Official title: Improving Care for Cardiovascular Disease in China: A Collaborative Project of AHA and CSC (CCC Project) - Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Chinese Society of Cardiology
First posted: 2014-12-05
Enrollment: 67028
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients of atrial fibrillation

Brief summary: The purpose of this study is to develop and implement quality improvement programs for the treatment of atrial fibrillation (AF) in China based on the successful experience of the AHA-Get with the Guidelines program. This program will use data collection, analysis, feedback, and process improvement to extend the use of evidence-based guidelines throughout the healthcare system and improve patient care of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with discharge diagnosis as atrial fibrillation in 150 tertiary and 100 secondary hospitals.

Exclusion Criteria:

None

Primary outcomes:
measure: The overall composite of six performance measures for AF care
timeFrame: Duration of hospital stay, an expected average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing An Zhen Hospital
Study officials:
affiliation: Beijing Institute of Heart, Lung and Blood Vessel Diseases
name: Dong Zhao, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hao Y, Liu J, Smith SC, Huo Y, Fonarow GC, Ge J, Liu J, Taubert KA, Morgan L, Guo Y, Zhou M, Zhao D, Ma C; CCC-AF Investigators. Rationale and design of the improving Care for Cardiovascular Disease in China (CCC) project: a national registry to improve management of atrial fibrillation. BMJ Open. 2018 Jul 5;8(7):e020968. doi: 10.1136/bmjopen-2017-020968.
Clinical trial NCT01580098: Medium-term Health Coaching and Life-long Monitoring in Diabetes Mellitus
Official title: Regions of Europe Working Together for Health (Renewing Health)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Landeskrankenanstalten-Betriebsgesellschaft
Sponsor class: INDUSTRY
Collaborators: name: European Commission
First posted: 2012-04-18
Enrollment: 193
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with type 2 diabetes mellitus. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.


Eligibility criteria: Inclusion Criteria:

* T2DM diagnosed \> 3 months prior to the enrollment
* HbA1c \>= 6,5 %
* Capability of filling questionnaires by their own language
* Being able to use the devices provided
* Being cognitively able to participate

Exclusion Criteria:

Primary outcomes:
measure: Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
timeFrame: 12 months
measure: HbA1c
timeFrame: 12 months
Secondary outcomes:
measure: Blood Pressure
timeFrame: 12 months
measure: Blood Lipids
timeFrame: 12 months
measure: Body Weight
timeFrame: 12 months
measure: Medication Changes
timeFrame: 12 months
measure: Presence of Diabetic Complications
timeFrame: 12 months
measure: Number of Hospitalisations
timeFrame: 12 months
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt
state: Carinthia
city: Kötschach
country: Austria
facility: LKH Laas
state: Carinthia
city: Villach
country: Austria
facility: LKH Villach
state: Carinthia
Study officials:
References:
Clinical trial NCT06665698: Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment
Official title: Prospective Study to the Evaluate the Long-term Use of Synthetic I-STOP® Device for Treatment of Stress Urinary Incontinence in Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stress Urinary Incontinence (SUI)
Keywords: I-STOP
MUS
Sling
Lead sponsor: DILO Medical
Sponsor class: INDUSTRY
First posted: 2024-10-30
Enrollment: 500
Sex: FEMALE
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: The study population is made up of patients with SUI who should benefit from the implantation of an I-STOP® implant in one of the centers associated with the project.

Brief summary: Evaluate quality of life and rate of reoperation after implantation of the I-STOP sling for stress urinary incontinence

Detailed description: This is a prospective, multicenter, non-comparative, interventional post-marketing clinical follow-up study (PMCF) on a population of patients with SUI requiring surgical treatment with implantation of an I-STOP sling to document safety, the performance and effectiveness in the short, medium, and long term of these I-STOP® implants used in their intended purpose.

Eligibility criteria: Inclusion Criteria:

* Adult woman aged over 18 ;
* Patient with SUI, having escaped "conservative" medical treatment, with indication for surgical treatment with implantation of an I-STOP® strip via trans-obturator or retropubic route as indicated in the instructions for use of the SUI implant ;
* Patient affiliated to a social security scheme;
* Patient capable of completing a self-questionnaire;
* Patient able to understand the protocol and follow the visit schedule;
* Patient having signed informed consent.

Exclusion Criteria:

* Minor patient, pregnant or breastfeeding ;
* Adult patient subject to a measure of legal protection, guardianship, curatorship or deprived of liberty by judicial or administrative decision ;
* Patient presenting a contraindication to the use of the implant indicated in the instructions for use of the implant ;
* Patient with a medical contraindication to surgery and/or anaesthesia.

Primary outcomes:
measure: Rate of reintervention
timeFrame: One year after surgery and after each year during 10 years
Secondary outcomes:
measure: Quality of Life
timeFrame: One year after surgery and after each year during 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06338098: Effect of an 8-week Heartfulness Meditation Program on Burnout and Stress at Veterinary Specialty Hospital
Official title: Investigating the Effect of an 8-week Heartfulness Meditation Program on Employee Burnout and Stress at Veterinary Specialty Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Burnout, Professional
Keywords: Heartfulness
Lead sponsor: Heartfulness Institute
Sponsor class: OTHER
Collaborators: name: Angell Animal Medical Center
First posted: 2024-03-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This quantitative study assesses the effects of meditation and relaxation practices on the reduction of burnout and stress in veterinary care workers. Assessments at baseline will include the Perceived Stress Scale (PSS) and Maslach Burnout Toolkit, and the same questionnaires were collected in Week 8 and Week 16. The Google form questionnaire will ask the participant for their email address. The form will also include a question eliciting interest in participation in the 8-weeks Heartfulness Meditation program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, and tools to cope with burnout.

Detailed description: The purpose of this research is to investigate the effects of meditation and relaxation practices on the reduction of burnout and stress in veterinary care workers.

Eligibility criteria: Inclusion Criteria:

* Above the age of 18 years
* An employee of MSPCA-Angell Hospital

Exclusion Criteria:

* Experience suicidal ideation
* Diagnosed with manic-depressive disorders
* Diagnosed with post-traumatic stress disorder (PTSD)
* Diagnosed with psychotic disorders, or any other psychiatric conditions requiring treatment

All eligible members are encouraged to check with their healthcare provider before participation.

Primary outcomes:
measure: Assess the current level of Anxiety
timeFrame: Week 0
measure: Changes level of Stress
timeFrame: Week 8 and Week 16
measure: Assess the current level of Burnout
timeFrame: Week 0
measure: Changes level of Burnout
timeFrame: Week 8 and Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Angell Animal Medical Center,
state: Massachusetts
Study officials:
References:
Clinical trial NCT04718298: Laparoscopic Hernia Defect Obliteration With ProFlor-E
Official title: Laparoscopic Fixation Free Obliteration of Inguinal Hernia Defect With the 3D Dynamic Responsive Implant ProFlor-E - Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Inguinal hernia
Laparoscopic inguinal hernia repair
Inguinal hernia defect obliteration
Fixation free hernia repair
Regenerative scaffolds
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: feasibility study
Primary purpose: TREATMENT

Brief summary: This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect

Detailed description: The 3D dynamic-responsive prosthesis for inguinal hernia repair ProFlor-E® recently introduced to the market has been laparoscopically employed for the repair of one recurrent inguinal hernia previously managed with anterior open approach. The scope of this feasibility study is to demonstrate that the positive effects of the 3D implant already proven in open inguinal hernia repair are also effective or even superior for the laparoscopic of recurrent/bilateral inguinal hernias compared to conventional treatment concept.

Eligibility criteria: Inclusion Criteria:

* patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias

Exclusion Criteria:

* ASA \>4 patients

Primary outcomes:
measure: Feasibility of inguinal hernia defect obliteration with ProFlor
timeFrame: intraoperative
Secondary outcomes:
measure: Postoperative pain
timeFrame: from early stage until 18 months postop
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: University of Palermo
state: Please Select
Study officials:
affiliation: University of Cagliari - University of Palermo
name: Giuseppe Amato, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amato G, Lo Monte AI, Cassata G, Damiano G, Romano G, Bussani R. A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artif Organs. 2011 Aug;35(8):E181-90. doi: 10.1111/j.1525-1594.2011.01272.x. Epub 2011 Jul 13.
citation: Amato G, Romano G, Agrusa A, Marasa S, Cocorullo G, Gulotta G, Goetze T, Puleio R. Biologic response of inguinal hernia prosthetics: a comparative study of conventional static meshes versus 3D dynamic implants. Artif Organs. 2015 Jan;39(1):E10-23. doi: 10.1111/aor.12416.
citation: Amato G, Romano G, Goetze T, Cicero L, Gulotta E, Calò PG, Agrusa A Fixation free inguinal hernia repair with the 3D dynamic responsive prosthesis ProFlor: Features, procedural steps and long-term results. International Journal of Surgery Open 2019; 21:34-4