louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03700268: Programming Cochlear Implant With Artificial Intelligence
Official title: Programming Cochlear Implant With Artificial Intelligence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deafness; Perception
Keywords: Deafness
cochlear implant
Artificial Intelligence
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This thesis project proposes to investigate the "state of the art" of the programming of the cochlear implant. In the center of audiophonologie Brussels, the classic 'manual programming' has been in use over 20 years and also the new way 'Artificial Intelligence programming'. The investigators want to compare, objectify, and control this new mode of programming.

The study is planned over 4 years, in order to test, randomized, 15 subjects with manual programming and 15 other subjects with Artificial Intelligence programming. To test the performance of Cochlear Implant patients, audiological, language auditory perception and questionnaire tests will be presented.

This research aims to determine the contribution and results of Artificial Intelligence programming.


Eligibility criteria: Inclusion Criteria:

* unilateral cochlear implant
* post-lingual hearing loss
* a good command of French.

Exclusion Criteria:

* non deaf
* bilateral cochlear implant
* deaf without cochlear implant

Primary outcomes:
measure: Evaluate Fox software efficiency
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
References:
citation: Wathour J, Govaerts PJ, Deggouj N. Variability of fitting parameters across cochlear implant centres. Eur Arch Otorhinolaryngol. 2021 Dec;278(12):4671-4679. doi: 10.1007/s00405-020-06572-w. Epub 2021 Jan 3.
citation: Wathour J, Govaerts PJ, Deggouj N. From manual to artificial intelligence fitting: Two cochlear implant case studies. Cochlear Implants Int. 2020 Sep;21(5):299-305. doi: 10.1080/14670100.2019.1667574. Epub 2019 Sep 17.
Clinical trial NCT03753568: Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
Official title: Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anticoagulant Drugs
Diabetes Mellitus, Type 2
Keywords: medicine reminder
diabetes mellitus, type 2
direct oral anticoagulants
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects are monitored first before the intervention and then during the intervention.
Primary purpose: TREATMENT

Brief summary: In this study, the effect of an electronic device attached to a push through pill package and a smart phone application on chronic disease medication adherence is studied.

Detailed description: In this study study two different groups of medicine users are recruited. Both groups have 50 patients each. In the first study the participants are using oral medication for diabetes and in the second study the participants use new direct oral anticoagulants.

Participants use medicine reminder system consisting of an electronic device and an smart phone application. In the beginning of the study the reminder system is collecting data on how the patients are taking their medication for the first two months. Smart phone application is not providing any reminders and participants can't access the app to see the details.

After two months the application will be unlocked so that it starts reminding the users to take their medication at the right time. in this phase the patients can view their medication data from the application. The reminder phase of the study lasts for two months. After these two plus two months, the results are analyzed and published.

The study continues after these four months for the next four months and after that, the long term results are analyzed.'

The primary outcome is the possible change in the adherence between control and active period.

Eligibility criteria: Inclusion Criteria:

* use of direct oral anticoagulants or oral diabetic drugs
* age of 18 or more
* subjects have been using a smart phone

Exclusion Criteria:

* patients who don't use their medication without help

Primary outcomes:
measure: Adherence to the medication
timeFrame: 8 months
Secondary outcomes:
measure: Variation of daily pill taking times
timeFrame: 8 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
References:
Clinical trial NCT00916968: Comparison of Function and Fit of Standard and Gender-Specific CR High-Flex Total Knee Prostheses
Official title: Comparison of Function and Fit of Standard Posterior Cruciate-Retaining High-Flexion and Gender-Specific Posterior Cruciate-Retaining High-Flexion Total Knee Prostheses A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Gender specific
cruciate retaining
total knee arthroplasty
Bilateral Osteoarthritis of the knee joint
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 146
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.

Detailed description: The design features of the gender-specific knee prostheses have been claimed to improve fit and function of total knee arthroplasty in women. The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.

Eligibility criteria: Inclusion Criteria:

* End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.

Exclusion Criteria:

* Inflammatory arthritis
* Osteoarthritis effecting hip joint
* Traumatic arthritis
* Neurologic disorders affecting motor function of lower extremity
* foot and ankle disorders limiting ambulation of the patient

Primary outcomes:
measure: Knee Society Knee Score
timeFrame: 2 years
Secondary outcomes:
measure: Implant or bone overhang
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Yoowang Choi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01295268: Study of Emu Oil vs. Placebo for Vulvar Pain in Women.
Official title: The Efficacy of Emu Oil vs. Placebo in Minimizing Vulvar Pain Levels in Women--A Randomized, Double Blinded, Placebo-Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vulvodynia
Vestibulodynia
Keywords: Vulvar pain
Vulvodynia
Vestibulodynia
Vulvar vestibulitis
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine if vulvar (external female genitalia) pain is decreased with emu oil over a similar placebo oil (no active ingredient) by using measurement devices, examinations, and questionnaires. Topical emu oil has not been scientifically studied for this condition yet, but related reports show no significant side effects or potential benefits.

A total of 30 women will participate in the study at William Beaumont Hospital, Royal Oak.

Detailed description: * Women of all ages with vulvar pain may participate in this trial.
* Women will be randomized into 2 groups--a treatment group or placebo group for the 1 month study.
* At the end of the study, those in the placebo group may choose to participate in a 1 month follow-up evaluation using emu oil.

Eligibility criteria: Inclusion Criteria:

* Women with vulvar pain upon q-tip exam of \> 3/10 at 2 or more sites tested.
* Age 18 or older.
* Capable of giving informed consent.
* Capable and willing to follow all study procedures.

Exclusion Criteria:

* Pregnant women or those intending to become pregnant during the study period.
* Vaginitis (may be treated, then tested later).
* Vulvar disease (other than vulvodynia)-lichen planus, lichen sclerosis, neoplasia, tissue damage due to radiation.
* The subject is deemed unsuitable for enrollment by the investigators based on their history or physical examination.
* Neuropathy.
* Currently in pelvic floor physical therapy.

Primary outcomes:
measure: The change in the Global Response Assessment (GRA) for vulvar pain.
timeFrame: After 1 month of intervention
Secondary outcomes:
measure: The change in vulvar pain levels
timeFrame: After 1 month of intervention
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Women's Urology Center
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Donna J Carrico, WHNP, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00264368: Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
Official title: Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Renal Failure
Cytomegalovirus Infections
Multi Organ Failure
Keywords: Renal replacement therapy
CMV disease
Lead sponsor: University of Oslo School of Pharmacy
Sponsor class: OTHER
First posted: 2005-12-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In order to optimize anti-cytomegalovirus (CMV) treatment with ganciclovir (GCV), in patients with multi organ failure treated with continuous renal replacement therapy (RRT), more information about ganciclovir pharmacokinetics in this setting is needed.

The primary objective is to describe the pharmacokinetics of ganciclovir in critically ill patients with acute renal failure treated with continuous renal replacement therapy, with a special emphasis on the extra-renal clearance and distribution volume.

Secondary objectives are to investigate if any co-factors, such as serum creatinine, weight, general hydration status, rest function of the native kidneys, etc. can help to describe the pharmacokinetics of GCV in these patients on continuous RRT as well as the relative influence of filtrations and dialysis on GCV elimination during different modalities of the treatment.


Eligibility criteria: Inclusion Criteria:

* Patients in need of continuous RRT and GCV treatment
* 18 years of age or older.

Exclusion Criteria:

* Concomitant treatment with acyclovir or valacyclovir.
* Patient does not give informed consent.

Primary outcomes:
measure: comparing the total clearance with the RRT derived clearance of GCV
measure: comparing the volume of distribution with historic controls of non Intensive Care Unit (ICU) patients
Secondary outcomes:
measure: comparing GCV plasma concentration and population model derived estimates of these concentrations when including different relevant clinical co-factors such as: weight, S-creatinine, CL-creatinine, hydration, albumin, rest function of native kidneys etc.
measure: determine RRT derived GCV clearance during the different filtration/dialysis settings of the RRT machine
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet, Section of Nephrology
Study officials:
affiliation: University of Oslo School of Pharmacy
name: Anders Åsberg, Ph.D.
role: STUDY_DIRECTOR
affiliation: Rikshospitalet, Medical Department
name: Anders Hartmann, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rikshospitalet, Department of Anaesthesiology
name: Jan F Bugge, MD, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01141868: Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors
Official title: Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Insomnia
Breast Cancer
Keywords: insomnia
breast cancer survivor
Internet intervention
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study examines the efficacy of an Internet-delivered intervention to reduce symptoms of insomnia in breast cancer survivors. Breast cancer patients with insomnia (N=30) will be assigned to either gain access to the 6-week treatment program immediately (experimental group) or following study participation (control group).


Eligibility criteria: Inclusion criteria:

* Female
* Diagnosed with breast cancer
* Age 18 and older
* Completed primary treatment at least one month prior to enrollment
* Diagnosis of insomnia

Exclusion criteria:

* Experiencing a sleep disorder other than insomnia (e.g., sleep apnea)
* Experiencing a major depressive episode or other serious psychiatric disturbance
* Modification of psychotropic medications within the previous month
* Undergoing current psychotherapy treatment

Primary outcomes:
measure: sleep efficiency
timeFrame: 6 weeks
Secondary outcomes:
measure: total sleep time
timeFrame: 6 wks
Other outcomes:
Locations:
Study officials:
affiliation: Penn State
name: Jane Schubart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03204968: The Effect of Vagus Nerve Stimulation on the Inflammatory Response After Lung Lobectomy
Official title: The Effect of Vagus Nerve Stimulation on the Inflammatory Response After Lung Lobectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Response
Keywords: vagus nerve
Lung lobectomy
Lead sponsor: Otto Wagner Hospital
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Systemic inflammation is a potentially debilitating complication of thoracic surgeries that can result in significant physical and economic morbidity for afflicted patients. There is compelling evidence for the role of central nervous system in the regulation of systemic inflammatory responses through humoral mechanisms. Activation of afferent vagus nerve fibers by cytokines triggers anti-inflammatory responses. Direct electrical stimulation of the peripheral vagus nerve in vivo during lethal endotoxemia in rats inhibited Tumor necrosis factor (TNF) synthesis in liver preventing the development of shock. The vagal regulatory role of systemic inflammation after lung lobectomy is unknown.


Eligibility criteria: Inclusion Criteria:

* Lung Lobectomy or pneumonectomy
* Adult
* Open surgery

Exclusion Criteria:

* Current infection

Primary outcomes:
measure: The postsurgical inflammatory response: the effect of vagus stimulation on proinflammatory interleukin concentrations
timeFrame: 3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day
Secondary outcomes:
measure: The effect of vagus stimulation on changes in Serum C reactive protein (CRP) concentrations
timeFrame: 3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Thoracic Surgery, Otto-Wagner Hospital
Study officials:
affiliation: Otto Wagner Hospital
name: Michael Mueller, MD, PhD
role: STUDY_DIRECTOR
affiliation: Otto Wagner Hospital
name: Mohamed Salama, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salama M, Akan A, Mueller MR. Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve Attenuates the Acute Inflammatory Response After Lung Lobectomy. World J Surg. 2020 Sep;44(9):3167-3174. doi: 10.1007/s00268-020-05543-w.
Clinical trial NCT02861768: Improving the Diagnostic of Tuberculosis
Official title: Improving the Diagnostic of Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 991
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.

Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis pharyngeal.

Secondary

1. Measure the time to diagnosis of pulmonary TB by comparing the sample versus noninvasive pharyngeal samples taken routinely.
2. Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the sample versus noninvasive pharyngeal samples taken routinely.
3. Beijing genotype prevalence among patients with pulmonary tuberculosis.


Eligibility criteria: Inclusion Criteria:

* Patient taken for microbiological examinations "kit mycobacterium"
* Patient Major (\> 18 years).
* Patient who freely signed the informed written consent.
* Patient affiliated to a system of social security. Exclusion criteria
* Patient minor (\<18 years).
* Patient pregnant or nursing.
* Major Patient under guardianship.
* Private Patient liberty or under court order.
* Patient refusing to sign the informed consent form.

Primary outcomes:
measure: Percentage of patients with microbiological diagnosis of M. tuberculosis infection
timeFrame: 3 years
Secondary outcomes:
measure: pulmonary tuberculosis diagnostic time.
timeFrame: 3years
measure: Prevalence of diagnosed patients Beijing
timeFrame: 3 years
measure: Direct cost of microbiological diagnosis of extra Beijing genotype
timeFrame: 3 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT06760468: Development and Evaluation of Functional Probiotic Powder in Human Trials
Official title: Functional Probiotic Powder Human Trials
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Exercise Fatigue
Lead sponsor: Chengdu Sport University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose: To optimize the preparation process of probiotic powder and assess its impact on healthy athletes, providing a scientific basis for functional foods.

Procedures:

Probiotic Powder Preparation: Using vacuum freeze-drying to improve bacterial survival rates.

Human Trials: Recruiting healthy athletes aged 20-30, divided into placebo and probiotic powder groups for an 8-week trial.

Testing and Analysis: Conducting running exhaustion tests and blood biochemical analysis to evaluate the effects of probiotic powder.

Importance: Understanding the effects of probiotics on athletes helps develop better health products.


Eligibility criteria: Inclusion Criteria:

* Age Range: Individuals aged 20 to 30 years old.
* Health Status: Healthy, without chronic illnesses or disabilities.
* Athletic Background: Well-trained athletes with a history of regular physical activity.
* Lifestyle: No history of smoking or excessive alcohol consumption.
* Compliance and Consent: Capable of understanding and adhering to study protocols and willing to provide informed consent.

Exclusion Criteria:

* Chronic Illnesses: Individuals with unmanaged chronic diseases
* Substance Use: Current smokers or individuals with a history of substance abuse.
* Allergies and Supplements: History of food allergies or long-term use of nutritional supplements and medications.
* Probiotic and Antibiotic Use: Use of probiotics, fermented products, or antibiotics during the study period.
* Other Conditions: Pregnant or breastfeeding women, individuals with severe mental health conditions, or those participating in other clinical studies.

Primary outcomes:
measure: Lactic acid
timeFrame: 8 weeks
measure: Creatine kinase
timeFrame: 8 weeks
measure: Blood urea nitrogen
timeFrame: 8 weeks
measure: Liver glycogen
timeFrame: 8 weeks
measure: Muscle glycogen
timeFrame: 8 weeks
measure: Total superoxide dismutase
timeFrame: 8 weeks
measure: Glutathione
timeFrame: 8 weeks
measure: Malondialdehyde
timeFrame: 8 weeks
Secondary outcomes:
measure: Maximum Oxygen Uptake
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References: