louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05378126: Evaluation of the Prognostic Impact of a Neuro-vascular Examination Associated with Cerebral MRI in the Acute Phase of Infectious Endocarditis
Official title: Prospective Pilot Study Evaluating the Prognostic Impact of a Neuro-vascular Examination Associated with Cerebral MRI in the Acute Phase of Infectious Endocarditis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endocarditis
Stroke
Keywords: Neurological assessment
Medical care
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Infectious endocarditis (IE) is a serious condition with an annual incidence of 3 to 10 per 100,000 people. Brain infarctions complicate approximately 20-40% of endocarditis.

Brain MRI can detect the presence of recent ischemic lesions and asymptomatic microbleeds. Preoperative brain imaging is part of the recommended assessment in the management of IEs, but the type of imaging and sequences are not codified and the impact of cerebral and vascular imaging findings on the therapeutic decision remains uncertain.

The level of evidence of the recommendations remains low, especially for complicated IEs of stroke. There is very little neurological clinical data on patients with IEs. Similarly, neurologists do not systematically participate in multidisciplinary meetings during the management of an IE. It therefore seems interesting to carry out a neurological cohort of this population and to evaluate what would be the contribution of vascular neurologists in the management of infectious endocarditis.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Certain infectious endocarditis according to Dukes Criteria
* Signed informed consent

Exclusion Criteria:

* Hospital admission due to neurovascular emergency
* MRI contraindications
* Pregnant or women of childbearing age who were not using contraception (oral diagnosis),
* Patient without health coverage,
* Patient under legal protection.

Primary outcomes:
measure: Medical care modification
timeFrame: at 3 months
measure: Medical care modification
timeFrame: at 3 months
Secondary outcomes:
measure: The description of the preoperative neurological impairment
timeFrame: During initial hospitalization
measure: The description of the preoperative neurological impairment
timeFrame: During initial hospitalization
measure: The description of the perioperative hemorrhagic risk
timeFrame: 24 to 96 hours post-surgery
measure: Prognosis assessment
timeFrame: at 3 months
measure: Evaluation of functional prognosis
timeFrame: at 3 months
measure: Evaluation of depressive anxiety disorders
timeFrame: at 3 months
measure: Evaluation of the cognitive prognosis
timeFrame: at 3 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Stroke Unit, Pierre Wertheimer hospital, GHE Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT00802126: Intravitreal Bevacizumab and Low Fluence Photodynamic Therapy
Official title: Efficacy of Combining Intravitreal Bevacizumab With Photodynamic Therapy Using Reduced Light Fluence Rate in Choroidal Neovascularization Secondary to Pathologic Myopia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myopia
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2008-12-04
Enrollment: 16
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to report the treatment effect and safety of combined intravitreal bevacizumab (IVB) and photodynamic therapy (PDT) with verteporfin using a reduced (RF) light fluence rate, in choroidal neovascularization (CNV) secondary to pathologic myopia.

Detailed description: In this retrospective interventional case series, 16 patients with myopic CNV were included. All patients were treated with 1.25 mg of intravitreal bevacizumab followed by RF-PDT (25 J/cm²), 2 days later. All patients were previously treated with IVB monotherapy and active leaking of CNV occurred 90 to 120 days after the treatment.

Best-corrected visual acuity (BCVA-ETDRS), foveal thickness (FT) on optical coherence tomography (OCT), and fluorescein and indocyanine green angiographic (FA; ICG) findings were recorded. Follow-up evaluations were carried out for 12 months.

Eligibility criteria: Inclusion Criteria:

* Myopic CNV, CNV leakage

Exclusion Criteria:

* CNV not associated with high myopia
* No activity of CNV

Primary outcomes:
measure: BCVA improved
timeFrame: 6 months
Secondary outcomes:
measure: no CNV leakage
timeFrame: 6 months
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Ophthalmology Department SUN
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Michele Rinaldi, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06741826: Confocal Laser Endomicroscopy Guided Cryobiopsy in the Diagnosis of Interstitial Lung Disease
Official title: The Diagnostic Performance and Safety of Confocal Laser Endomicroscopy Guided Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Solitary Pulmonary Nodule
Multiple Pulmonary Nodule
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A prospective multicenter randomized controlled trial was conducted to evaluate the diagnostic efficacy and safety of NCLE-NB-Rebus-guided peripheral pulmonary nodule biopsy, and to compare the diagnostic efficacy and safety of biopsy forceps biopsy and needle aspiration biopsy in peripheral pulmonary nodule biopsy guided by nCLE-NB-rEBUS.

Detailed description: A prospective, multicenter, randomized controlled trial was conducted to evaluate the diagnostic efficacy and safety of nCLE-NB-rEBUS guided peripheral pulmonary nodule biopsy. Patients with peripheral pulmonary nodules suspected of lung cancer and pulmonary tuberculosis were enrolled to sign informed consent. Subjects were randomized to the nCLE-NB-rEBUS Group (Group A) or the NB-rEBUS Group (Group B) subgroup (1:1 ratio) according to the random number table, and subjects randomly assigned to Group A or Group B were again randomized to the biopsy forceps subgroup or biopsy needle subgroup by the random number table. The diagnostic efficacy and safety of the NCLE-NB-REbus group and the NB-rEBUS group were compared to evaluate whether nCLE could improve the diagnostic rate of NB-REbus-guided peripheral pulmonary nodule biopsy. The diagnostic efficacy and safety of using biopsy forceps and biopsy needle in peripheral pulmonary nodule biopsy guided by nCLE-NB-rEBUS were compared to determine the reasonable biopsy method.

Eligibility criteria: Inclusion Criteria:

* Patients with peripheral pulmonary nodules suspected of lung cancer by CT examination
* Patients who intend to undergo a bronchoscopic lung biopsy to determine benign or malignant pulmonary nodules;
* Age ≥18 years
* Sign informed consent.

Exclusion Criteria:

* There is an uncorrectable coagulation disorder or anticoagulation therapy that cannot be stopped before surgery;
* Tumors can be seen in the bronchus
* Hemodynamic instability;
* Refractory hypoxemia;
* Patients with pregnant and lactating patients
* Any illness or condition that interferes with the completion of the initial or subsequent assessment.

Primary outcomes:
measure: Diagnostic rate of biopsy to obtain pathological diagnosis.
timeFrame: 6 months
Secondary outcomes:
measure: Occurrence of operation-related complications
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06688526: Auditory Stimulation Effect on Brain Oscillations and Sleep Dependent Learning
Official title: Auditory Stimulation Effect on Brain Oscillations and Sleep Dependent Learning
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Control
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators are testing the impact of quiet sounds played during sleep on brain oscillations and memory.

Detailed description: Participants will undergo two visits with a memory task and nap. During one of the visits, quiet sounds will be played timed with sleep oscillations. During the other visit, no sounds will be played. Brain oscillations and memory will be measured at each visit.

Eligibility criteria: Inclusion Criteria: Adult -

Exclusion Criteria: History of neurological disease, psychiatric disease, sleep apnea or sleep disorder.

-

Primary outcomes:
measure: Sleep spindle rate
timeFrame: 90 minutes
Secondary outcomes:
measure: Memory consolidation
timeFrame: 90 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03123757: Assessing the Determinants of 6-minute Walk Test and Its Correlation With Quality of Life
Official title: Assessing the Determinants of 6-minute Walk Test and Its Correlation With Quality of Life: A Survey of Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Lead sponsor: Precision Health Economics
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2017-04-21
Enrollment: 207
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects enrolled in our trial performed the 6-minute walk test and completed an EQ-5D quality of life questionnaire.
Primary purpose: OTHER

Brief summary: This study evaluates the determinants of mobility, measured by the 6-minute walk test, and its correlation with quality of life in near elderly patients.

Detailed description: To evaluate the determinants of mobility an its correlation with quality of life, we conducted a study that evaluated patients ability to perform the 6-minute walk test and their corresponding quality of life measured by the EQ-5D. Cognition was evaluated used the Callahan six-item screener, and additional measures of physical performance were assessed using the Short Physical Performance Battery. Participants disclosed self reported physical function and physical activity. Additionally, other participant characteristics including vital signs, medication history and healthcare utilization were determined as well as social, economic and health related information was collected.

Eligibility criteria: Inclusion Criteria:

* Willing to provide informed consent
* Willing to perform the 6-minute walk without the use of a walker, or the assistance of another person.
* Ability to speak and understand English

Exclusion Criteria:

* Medical condition that precludes safe participation in the 6 minute walk test

Primary outcomes:
measure: Patient-Reported Quality of Life
timeFrame: On the day of assessment
Secondary outcomes:
measure: Mobility
timeFrame: On the day of assessment
Other outcomes:
Locations:
Study officials:
affiliation: Precision Health Economics
name: Jason Shafrin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00548457: Endothelial Function in Patients With Ectatic Compared to Normal Coronary Arteries
Official title: Endothelial Function in Patients With Ectatic Compared to Normal Coronary Arteries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Ectasia
Keywords: the function of the endothelium of the arteries in patients suffering from ectatic coronary arteries
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-10-24
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were recruited after passing cardiac catherization and diagnosed as having ectatic arteries.

Brief summary: The aim of this study is to show the frequency of endothelial dysfunction in patients suffering from ectatic coronary arteries as compared to those who have normal coronary arteries. Should this frequency be significant we would recommend initiating conventional treatment in those patients with ectatic coronary arteries as is the practice in patients with endothelial dysfunction without ectatic arteries


Eligibility criteria: Inclusion Criteria:

* Ectatic coronary arteries defined by cardiac catheterization

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Heart Institute, Chaim Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Pierre Chouraqui, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04678557: A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus
Official title: An Open-Label Phase 1/2 Study to Evaluate the Safety, Engraftment, and Efficacy of VC-01™Combination Product in Subjects With Type 1 Diabetes Mellitus [T1DM]
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes
Lead sponsor: ViaCyte
Sponsor class: INDUSTRY
First posted: 2020-12-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: There are two Cohorts in this study design. Cohort 1 (Phase 1) enrolls up to 30 subjects total. After Cohort 1 enrollment is completed, Cohort 2 enrollment then occurs with up to an additional 40 subjects. A total of up to 70 subjects will be enrolled under this Phase 1/2 protocol.
Primary purpose: OTHER

Brief summary: VC01-103 will evaluate an experimental combination product, cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes.

Detailed description: This trial will test if VC-01 combination product can be implanted and maintained with safety, tolerability, and efficacy for up to Month 12/Week 52.

Eligibility criteria: Inclusion Criteria:

* Men and non-pregnant women
* Diagnosis of T1DM for a minimum of 3 years.
* Stable, optimized diabetic regimen
* Acceptable candidate for implant and explant procedures.
* Willing and able to comply with protocol requirements.
* Meet insulin dosing requirements per protocol

Exclusion Criteria:

• Advanced complications associated with diabetes

Primary outcomes:
measure: Cohort 1: The Percentage of Graft Cells Present at Post-implant Time Points Relative to Pre-clinical Models
timeFrame: Weeks 4, 8, 12 and 26
measure: Cohort 2: The Change in AUC (Area Under Curve) From Baseline to Week 26 in C-peptide During 4-hour MMTT
timeFrame: To Week 26
Secondary outcomes:
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
Study officials:
affiliation: ViaCyte, Inc.
name: Manasi Jaiman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01576757: Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies
Official title: Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Keywords: Stem cell therapy
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2012-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure undergoing evaluation for medical management at the University of Louisville or Jewish Hospital in Louisville, KY will be considered for participation based on the evaluation of enrollment criteria.

Brief summary: The purpose of this study is to determine whether the harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies is feasible.

Detailed description: Heart failure is a devastating condition affecting nearly 6 million patients in the United States alone. Ischemic cardiomyopathy, or pump failure secondary to previous heart attack, is considered by many to be the leading cause of heart failure. Stem cell therapy, or regeneration of the lost myocardium, is an intervention that has the potential for reversing the detrimental effects of this disease. Recently published evidence has shown preliminary results indicating the safety and feasibility of utilizing cardiac stem cells for the treatment of ischemic cardiomyopathy. The ability to use a commonly practiced method, such as endomyocardial biopsy, to isolate and expand stem cell cultures could, potentially, make this therapy widely available. The results of this study will be important for the design of future clinical trials.

Eligibility criteria: Inclusion Criteria:

1. Any heart failure patient scheduled for RHC without contraindication for biopsy.
2. Any patient undergoing biopsy for diagnostic purposes may also be included in the study.

Exclusion Criteria:

1. Severe comorbidities (AST, ALT, serum creatinine \> 3 times the upper limit of normal).
2. Pregnancy or women of childbearing potential.
3. Anticoagulation which cannot be stopped for 5-7 days.
4. Hepatitis B, C or HIV.
5. Inability to give informed consent.

Primary outcomes:
measure: Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Roberto Bolli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05305157: Telemedicine and Forensic Odontology
Official title: National Evaluation of the Expectations of Experts in Forensic Odontology on Telemedicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Caries
Keywords: Public Health
Forensic odontology
Telemedicine
Identification post mortem
dentist who is an forensic odontology expert
member of the AFIO or UIO
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Experts in forensic odontology members of the AFIO or UIO association

Brief summary: The aim of this study is to identify the expectations of experts in forensic odontology on telemedicine.

This study could improve, in multiple cases post mortem body identification.

Detailed description: Experts in forensic odontology will have to complete a questionnaire that will reveal their expectations and knowledge on telemedicine.

Eligibility criteria: Inclusion criteria:

- Experts in forensic odontology members of the AFIO or UIO association

Exclusion criteria:

- Dentist who not practicing forensic odontology

Primary outcomes:
measure: Evaluate the knowledge
timeFrame: 1 day
measure: Evaluate the expectations
timeFrame: 1 day
Secondary outcomes:
measure: Highlight the key points to work in legal teleodontology
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Camille INQUIMBERT, PhD
role: STUDY_DIRECTOR
affiliation: UH MONTPELLIER
name: Camille AMMOR, GRANDATI, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02174757: Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis
Official title: A Comparative Evaluation of the Effect of Probiotic Inersan and Doxycycline on Chronic Periodontitis - A Clinical and Microbiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: CD Pharma India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sree Mookambika Institute of Dental Sciences
First posted: 2014-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontitis is a multifactorial disease that can lead to the destruction of supporting tissues of the teeth resulting in pocket formation, recession or both. Since the primary etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm, efforts for disease prevention and treatment are mainly focused on pathogen reduction and strengthening of epithelial barrier, thus contributing to decreased susceptibility to infection. Due to emergence of antibiotic resistance and frequent recolonization of treated sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced to periodontal disease. The need was fulfilled by the introduction of Probiotics and Bacterial Replacement Therapy. The term probiotic is derived from the Greek, meaning "for life" are microorganisms proven to exert health promoting influences in humans and animals. Food and Agriculture Organization and WHO have stated that there is potential for probiotic foods to provide health benefits and that specific strains are safe for human use.


Eligibility criteria: Inclusion Criteria:

1. Subjects in both sexes
2. Age 25 - 60 yrs
3. Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in \> 30 % of the probing sites
4. Subjects in good general health

Exclusion Criteria:

1. Antibiotic therapy in the past 2 months
2. Allergic to doxycycline or probiotics
3. Subjects with diabetic mellitus, hypertension and psychiatric disorders
4. Subjects who are pregnant/ lactating
5. Smokers and/or alcoholics
6. Subjects who have undergone any periodontal therapy within last 6 months.

Primary outcomes:
measure: Improvement in periodontal clinical indices
timeFrame: 4 weeks
Secondary outcomes:
measure: Improvement in microbiological indices
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Kulasekharam
country: India
facility: Dept. of Periodontics and Implantology, Sree Mookambika Institute of Dental Sciences
state: Tamil Naidu
Study officials:
affiliation: Sree Mookambika Institute of Dental Sciences
name: Arya K.S., BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Sree Mookambika Institute of Dental Sciences
name: Elizabeth Koshi, MDS
role: STUDY_DIRECTOR
affiliation: Sree Mookambika Institute of Dental Sciences
name: Arun Sadasivan, MDS
role: PRINCIPAL_INVESTIGATOR
References: