louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03812445: Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke
Official title: The Effect of Probiotics on Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Microbiome
Keywords: Probiotics
Gut microbiota
ischemic stroke
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of ischemic stroke patients.

Detailed description: This study aims to detect the impact of probiotics administration during the process of ischemic stroke treatment and recovery phase. The day of admission and 3months after stroke data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the stroke patients.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with acute ischemic stroke on the basis of World Health Organization diagnostic criteria1.

the time from paroxysm to admission ≤2weeks.

Exclusion Criteria:

* Imaging diagnoses hemorrhagic stroke Severe depression Severe disturbance of hearing vision and reading Illiteracy Have recognitive disorder before stroke (recorded in medical records) Treated with antibiotics probiotics or prebiotics in1month before admission

Primary outcomes:
measure: change from admission on gut microbiome at 3months by genome sequencing
timeFrame: 3months
Secondary outcomes:
measure: change from admission on cognitive function at 3months by Montreal Cognitive Assessment.
timeFrame: 3months
measure: change from admission on emotion at 3months by Hamilton Depression Scale.
timeFrame: 3months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Huanlong Qin
role: STUDY_CHAIR
References:
Clinical trial NCT05706545: Micro- and Macro-Circulation in Cardiac Surgery Patients
Official title: Micro- and Macro-Circulation in Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Cardiac Surgery
Coronary Artery Bypass Graft
Surgical Aortic Valve Replacement
Keywords: autonomic nervous system
heart rate variability
cardiac surgery
major morbidities
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 100
Sex: ALL
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: 100 consecutive patients scheduled for major cardiac surgery

Brief summary: The hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major morbidities (stroke, acute kidney injury, prolonged intubation, mediastinitis, surgical reopening, death).

The state of sublingual microcirculation, of peripheral microcirculation and cardiovascular control will be assessed in 100 patients undergoing cardiac surgery during general anesthesia before the intervention and at the end of the intervention at the arrival in post-surgery ICU by means of signal processing techniques.

The extracted markers will be used to assess a statistical prediction model of major morbidities.


Eligibility criteria: Inclusion Criteria:

* age \>18 yrs
* indication for a cardiac surgery intervention
* spontaneous sinus rhythm
* informed consent

Exclusion Criteria:

* know autonomic nervous systems pathologies or dysfunctions
* pregnancy

Primary outcomes:
measure: Prediction of major morbidities by means of the variability of cardiovascular and hemodynamics markers
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milan
Study officials:
References:
Clinical trial NCT06961045: Computer - Guided Inferior Alveolar Nerve Lateralization With Simultaneous Prosthetic Driven Implant Placement Will be Performed on 10 Surgical Sides (Mandibular Quadrants) to Evaluate the Postoperative Neurosensory Disturbances Following Guided Inferior Alveolar Nerve Lateralization
Official title: Computer - Guided Inferior Alveolar Nerve Lateralization With Simultaneous Prosthetic Driven Implant Placement
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Neurosensory Function of Inferior Alveolar Nerve
Keywords: Inferior Alveolar Nerve Lateraliztion
Computer Assisted
Clinical neurosensory Testing
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to primarily evaluate the postoperative neurosensory disturbances following guided inferior alveolar nerve lateralization with simultaneous implant placement in 10 surgical sides (mandibular quadrants distal to the mental foramen) either in males or females with age range from 30 to 75 years. The main questions it aims to answer are:

1. Will the postoperative neurosensory disturbances after the surgical intervention fade out and if not, will it be annoying to the patient?
2. Can we consider inferior alveolar nerve lateralization efficient substitute to short implants?
3. will the inserted implants going to be properly ossteointegrated at the site of osteotomy for lateralization?


Eligibility criteria: Inclusion Criteria:

* Atrophic mandibular ridges distal to the mental foramen with residual alveolar bone height ≤ 8 mm above the IAN.
* The width of the alveolar ridge ≥ 6 mm, 3mm down from the alveolar crest.

Exclusion Criteria:

* All patients suffering from any systemic disease that may contraindicate implant surgery or affect bone healing and osseointegration of implant.
* Previous history of bone augmentation or implant placement in the site planned for nerve lateralization.

Primary outcomes:
measure: clinical neurosensory testing of the inferior alveolar nerve function
timeFrame: Postoperatively 1 week, 1 month, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Dentistry, Tanta University, Egypt
state: Al Gharbiyah
Study officials:
References:
Clinical trial NCT00561145: Impaired Regulation of Energy Balance in Elderly People (Balance Study)
Official title: Impaired Regulation of Energy Balance in Elderly People and the Underlying Physiological Mechanisms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia of Ageing
Keywords: Anorexia of ageing
Anorexia of aging
Energy balance
Elderly
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Dutch Dairy Organization (NZO)
First posted: 2007-11-20
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Over the past century life expectancy has risen rapidly. As a result, the proportion of elderly people continues to grow. Elderly people probably have an impaired regulation of energy balance (energy intake versus energy expenditure) whereby the underlying physiological mechanisms are not fully understood.

The first objective of this study is to provide further evidence for an age-related failure to regulate energy balance in elderly. If the hypothesis of impaired regulation of energy balance in elderly is confirmed then the second objective becomes to elucidate the underlying physiological mechanisms of the age-related failure to regulate energy intake in elderly.


Eligibility criteria: Inclusion Criteria:

* men
* healthy
* 20-40 and 65-85 years of age
* normal weight
* free-living in Wageningen and surrounding

Exclusion Criteria:

* anemia
* diabetes
* restrained eating
* dementia
* weight changes of \> 2 kg during the last 2 months

Primary outcomes:
measure: Energy Intake Compensation
timeFrame: Average intake of energy during ad lib phase (9 days)
Secondary outcomes:
measure: Appetite/Satiety Hormones and Questionnaires
timeFrame: Before and after the energy restriction period.
measure: Gastrointestinal Function
timeFrame: Before and after the energy restriction period
measure: Resting Energy Expenditure, Body Composition and Body Weight
timeFrame: Before and after the energy restriction period
measure: Expression of Genes Involved in Energy Metabolism
timeFrame: Before and after the energy restriction period.
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University, Division of Human Nutrition
state: Gelderland
Study officials:
affiliation: Wageningen University
name: Lisette de Groot, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winkels RM, Jolink-Stoppelenburg A, de Graaf K, Siebelink E, Mars M, de Groot L. Energy intake compensation after 3 weeks of restricted energy intake in young and elderly men. J Am Med Dir Assoc. 2011 May;12(4):277-86. doi: 10.1016/j.jamda.2010.08.011. Epub 2010 Oct 20.
citation: Van Bussel IP, Jolink-Stoppelenburg A, De Groot CP, Muller MR, Afman LA. Differences in genome-wide gene expression response in peripheral blood mononuclear cells between young and old men upon caloric restriction. Genes Nutr. 2016 May 6;11:13. doi: 10.1186/s12263-016-0528-0. eCollection 2016.
Clinical trial NCT03925545: VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)
Official title: VisiOn Restoration With the FluidVisION AIOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: PowerVision
Sponsor class: INDUSTRY
First posted: 2019-04-24
Enrollment: 85
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of this study is to obtain an initial assessment of the safety and performance of an investigational AIOL in patients undergoing cataract extraction and IOL implantation.

Detailed description: This study was originally designed as a single arm, unilateral study (one eye, one product only) to obtain an initial assessment of the safety and performance of an investigational IOL in subjects undergoing cataract extraction and IOL implantation. The study design was later modified to a contralateral study (both eyes, different product in each eye) to compare the safety and performance of the investigational IOL to a commercially available monofocal IOL.

Eligibility criteria: Key Inclusion Criteria:

* Corrected distance visual acuity (CDVA) worse than 20/40, or presence of visually significant lens opacity;
* Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter (D);
* Calculated IOL power within range.

Key Exclusion Criteria:

* Current medication that may affect accommodation;
* Systemic disease or concomitant medication that may increase operative risk or confound results;
* Ocular conditions that may predispose the subject for future complications;
* Monocular subjects or subjects with significant permanent visual function loss in fellow eye;
* Previous intraocular or corneal surgery in either eye that may confound the results or increase the risk to the subject, including implantation of a multifocal IOL or other presbyopic corrective surgery in the fellow eye;
* Grade 4 cataract of any type.

Primary outcomes:
measure: Accommodative Amplitude (AA)
timeFrame: Month 6 postoperative
measure: Distance Corrected Visual Acuity
timeFrame: Month 6 postoperative
measure: International Organization for Standardization (ISO)-defined Cumulative and Persistent Adverse Events for Posterior Chamber IOL
timeFrame: Up to Month 6 postoperative
Secondary outcomes:
measure: Accommodative Amplitude
timeFrame: Month 3 postoperative
measure: Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity
timeFrame: Up to Month 6 postoperative
measure: Uncorrected Visual Acuity
timeFrame: Up to Month 6 postoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05429645: Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation
Official title: Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation: CRT3D Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Anomaly
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2022-06-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the feasibility of cardiac resynchronization under electroanatomic guidance in the event of primary implantation failure due to catheterization failure or instability in the coronary sinus ostium

Detailed description: As part of this study, to avoid surgery, the doctor will use a 3-dimensional (3D) guidance technique to position the heart probes in an optimal position during a new endovascular intervention.

Eligibility criteria: Inclusion Criteria:

* Patient with indication for implantation of a classic multisite pacemaker;
* New York Heart Association II/IV patient despite optimal medical treatment;
* Patient with left ventricular ejection fraction ≤35%;
* Patient with a widened QRS \> 120ms;
* Patient with at least one lateral coronary sinus vein visualized on angiography during the 1st procedure (if performed);
* Patient with failure of resynchronization via the endovenous route due to difficulty in accessing the coronary sinus or instability in the coronary sinus;
* Patient having been informed and having signed an informed consent form;
* Patient able to understand the information related to the study (absence of linguistic, psychological, cognitive problem, etc.), and to complete questionnaires.

Exclusion Criteria:

* Patient with resynchronization failure due to occlusion of the superior vena cava;
* Patient with no usable lateral coronary sinus vein;
* Patient with a life expectancy \< 3 months;
* Patient wearing a vena cava filter;
* Patient with active sepsis;
* Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.

Primary outcomes:
measure: Setting up with success of the Left Ventricular lead
timeFrame: during the time of the setting up of the pace maker
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Privé Le Bois
Study officials:
References:
Clinical trial NCT05232045: Automated System for Monitoring Urine Output in Intensive Care Patients
Official title: Automated System for Monitoring Urine Output in Intensive Care Patients: What Are the Advantages? Before-after Intervention Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Kidney Injury in the ICU
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-100, who were admitted to the General Intensive Care Unit in Meir Medical Center from January 2021 to January 2024

Brief summary: Acute kidney injury is common among ICU-admitted patients, and is associated with increased morbidity and mortality. Early recognition is essential to prevent complications. In this study we aim to examine whether strict monitoring of urine output may reduce the incidence of acute kidney injury, allow for less positive fluid balance and reduce the clinical symptoms of fluid overload in ICU patients. Currently we monitor urine output using a Urinometer, with manual recording. From June 2022 we will begin routine use of an automated urine monitoring system in the ICU and test its effect on the parameters listed above. We will conduct a before-after retrospective intervention. The group of patients in whom the automated system will be used, from June 2022 to January 2024, will be the study group. The patients admitted to the ICU in the period between January 2021 and June 2022 will be the control group. We will include patients aged 18-100, who were admitted to the General Intensive Care Unit in Meir Medical Center from January 2021 to January 2024, and had admission time longer than 48 hours. Patients without a urinary catheter will not be included. The study will be conducted in the format of observational data collection from hospital files and computerized systems (Metavision system and Chameleon system). We estimate that we will include about 900 patients in the study group and about 900 in the control group. All demographic and inpatient data will be statistically examined by a qualified statistician depending on the type of data.


Eligibility criteria: Inclusion Criteria: Patients aged 18-100, who were admitted to the General Intensive Care Unit in Meir Medical Center from January 2021 to January 2024, and had admission times longer than 48 hours.

-

Exclusion Criteria: Patients without a urinary catheter, Patients with admission times less than 48 hours.

-

Primary outcomes:
measure: Prevalence of acute kidney injury
timeFrame: June 2023-January 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT06933745: Ultrasound Assessment of Atherosclerotic Plaque Burden and Cardiovascular Risk: A 10-Year Prospective Study
Official title: Ultrasound of Carotid and Femoral Plaque Burden and Non-alcoholic Fatty Liver Disease as Predictors of Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Fatty Liver
Atherosclerosis of Femoral Artery
Carotid Artery Plaque
Stroke
Ischemic Cardiovascular Disease
Atheroscleroses
Keywords: Ultrasound
Carotid arteries
Femoral arteries
Cardiovascular Disseases
Plaque burden
Subclinical atherosclerosis
NORRISK2
Ischemic stroke
Ischemic heart disease
Atherosclerotic cardiovascular disease
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2025-04-18
Enrollment: 21029
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises consecutive persons 45-74 years self-reffered for a health check in one of 10 ultrasound clinics in Norway.

Brief summary: The P-SONAR study is a large, observational, prospective cohort study. The overall aim of the study is to investigate whether plaque burden estimation by 2D ultrasound of the carotid and femoral arteries may enhance cardiovascular risk prediction beyond NORRISK-2

Detailed description: Design: The P-SONAR Study is a prospective cohort study of all men and women aged 45-74 years attending a health check at one of 10 ultrasound clinics in Norway.

Time schedule: Study inclusion and baseline examinations took place in the period April 2022- March 20025.

Current status: Ultrasound follow-up examinations take place from January 2025 - December 2029.

Eligibility criteria: Inclusion Criteria: Persons attending a health check during the study period.

-

Exclusion Criteria:

* If they do not consent to participate

Primary outcomes:
measure: Carotid and femoral plaque burden cardiovascular (CV) predictive ability beyond NORRISK-2
timeFrame: From enrollment to an average of 10 years
measure: May plaque burden predict incident cardiovascular disease.
timeFrame: From enrollment to an average of 10 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Austad Diagnostikk
state: East
Study officials:
affiliation: University of Oslo
name: Jonn-Terje Geitung, MD, PhD, MHA
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Serena N.H. Tonstad, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02180945: ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae
Official title: ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae. A French, Observational, Prospective, Multicentric, Single Arm and Open Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arteriovenous Fistula
Keywords: dAVF
Arteriovenous fistula
ONYX
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2014-07-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presenting at the participating centers for whom an intracranial dAVF (not previosly treated) needs to be treated (unrelated to the planned treatment) and who agree to the collection and transmission of related data.

Brief summary: The objective of this study is to evaluate the safety and performance post last embolization with Onyx


Eligibility criteria: Inclusion Criteria:

* The patient has an intracranial dAVF which could be treated by ONYX embolization, whether or not associated to other embolization products.
* The patient is at least 18 years of age.

Exclusion Criteria:

* The patient needs to be treated for the dAVF with another treatment option (for example by surgery) than embolization within a period of less than 6 months (to be counted as from the first treatment)
* The patient participates to another clinical study during the treatment period for his/her dAVF, evaluating another medical devices, procedure or medication.
* The patient refuses to give consent to the collection and processing of data required for centralized monitoring.
* A condition which could jeopardize follow-up of the patient.

Primary outcomes:
measure: Neurological clinical evolution
timeFrame: 1Month post procedure
measure: Healing rate
timeFrame: 3-6 months post procedure
Secondary outcomes:
measure: Adverse event
timeFrame: 3-6 months after procedure
measure: Quality of life EQ-5D
timeFrame: pre-procedure and at 3-6 months
measure: Describe functional independence
timeFrame: 1 and 12 months after procedure
measure: Technical performance of the product
timeFrame: 12 months after procedure
Other outcomes:
Locations:
city: Paris
country: France
facility: Covidien
Study officials:
affiliation: University Hospital, Toulouse
name: Christophe Cognard, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Dijon
name: Frédéric Ricolfi, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: Patrick Courthéoux, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Beaujon
name: Laurent Spelle, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: