louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02875964: Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings.
Official title: Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Presurgical evaluation of epileptic patients require a precise mapping of cerebral regions implied in epileptic discharges and in normal function.

The current practice in most cases is to implant intracerebral electrodes in order to localize these regions in a reliable manner. However, non-invasive methods have been developed in order to record brain activity with no risk for the patient.

Still, it is necessary to validate and improve the signal processing methods and the underlying models these methods in order to optimize their use in clinical practice. To do so, it is necessary to record simultaneously electroencephalogram (EEG) and magnetoencephalogram (MEG) and stereo encephalogram SEEG (intracerebral). Such simultaneous recordings will permit to confront the exact same activity recorded non-invasively at the surface of the head, and represented on the brain thanks to the model and directly within the brain.

The objective is to define the conditions under which one can represent faithfully the activity measured intracerebrally from the surface measurements.

It will be record simultaneously MEG, scalp EEG and intracerebral EEG on a series of 60 patients. It will be record resting state signals, as well as stimulation protocols. The interictal epileptic discharges will be marked on the different modalities, and evoked potentials/fields computed in response to protocols. Sensitivity of recordings to activity visible on depth recordings will be evaluated as a function of localization of brain generators. Advanced signal processing methods will be used such as source localization and independent component analysis, in order to increase sensitivity of measures.


Eligibility criteria: Inclusion Criteria:

- Patients for whom implanting intracerebral electrodes is underway

Exclusion Criteria:

* Patients minors
* Pregnant or lactating women

Primary outcomes:
measure: The number of epileptic discharges
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References:
Clinical trial NCT00561964: Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria
Official title: Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2007-11-21
Enrollment: 241
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with type Ⅱdiabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Fasting plasma glucose of untreated type II diabetes mellitus patients greater than or equal to 7.0 mmol/L, or the time between diagnosis of type II diabetes mellitus and treatment \> 3 months
* The patients of normal BP, or hypertensive patients receiving antihypertensive medication, Seated systolic blood pressure (SeSBP) is between 120-180mmHg and the Seated diastolic blood pressure (SeDBP) is between 80-110mmHg;
* Evidence of albuminuria defined as an AER of 20 and 500 ug/minute on a single timed overnight collection. Before randomization the patient must quality with two AERs of 3 days intervals in the absence of confounding factors such as urinary tract infection, acute febrile illness and cardiac failure. The two AERs measurement should be in the above defined range and the variability between the two AERs measurement must be \<35%. Value of basal AER is calculated as the mean of the 2 measurements. The UAER measured using immunity nephelometer method (DCA2000);
* Serum creatinine \< 150umol/L(1.7mg/dl) and serum potassium in the normal lab range (3.5-5.5 mol/L);
* 18 Kg/m2less than or equal to BMI less than or equal to 35Kg/m2

Exclusion Criteria:

* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Urine albumin excretion rate (UAER)
timeFrame: during the study conduct
Secondary outcomes:
measure: SeSBP, SeDBP, Total cholesterol, Triglycerides, HDL cholesterol, LDL cholesterol , glycated hemoglobin
timeFrame: during the study conduct
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Martin Thoenes
role: STUDY_DIRECTOR
References:
Clinical trial NCT00196664: Efficacy of Paroxetine in the Prevention of Depressive Syndrome in Patients With Chronic Hepatitis C Treated by PEG-Interferon Alfa Plus Ribavirin
Official title: Assessment of the Efficacy of Paroxetine in the Prevention of Depressive Syndrome in Patients With Chronic Hepatitis C Treated by PEG-Interferon Alfa Plus Ribavirin. Multicentric, Double-Blinded, Randomized Study. ANRS HC18 Paropeg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
Paroxetine
Depression
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
First posted: 2005-09-20
Enrollment: 144
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: Depression is a common side effect of interferon in the treatment of chronic hepatitis C. The aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant agent, in the prevention of depression induced by PEG-interferon given for the treatment of chronic hepatitis C.

Detailed description: The aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant agent, in the prevention of depression induced by PEG-interferon given for the treatment of chronic hepatitis C. This is a comparative study including two groups of patients randomly allocated : one with paroxetine and the other with the placebo. The rate of depression will be compared between the 2 groups

Eligibility criteria: Inclusion Criteria:

- Chronic hepatitis C which should be treated by PEG-interferon alfa and ribavirin with no contra-indication to anti-viral treatment

Exclusion Criteria:

* Allergy to paroxetine
* Current antidepressant treatment
* Depression diagnosed by the MINI International Neuropsychiatric Interview (MINI, DSM IV)
* History of bipolar syndrome
* History of psychotic syndrome
* Treatment by triptan, carbamazepine, millepertuis, methadone, oral anticoagulation
* Renal insufficiency
* HIV infection
* Breath feeding
* Contra-indication to PEG-interferon and or ribavirin

Primary outcomes:
measure: Incidence of depression based on MINI International Neuropsychiatric Interview (MINI, DSM IV)from D0 to W74
Secondary outcomes:
measure: Evolution of depression score (MADRS and BDI scales) to W74,Quality of life (HQL questionnaire), Fatigue, Compliance to PEG-interferon and ribavirin, Virological response at W74 ,Safety
Other outcomes:
Locations:
city: Vandoeuvre
country: France
facility: Service d'Hépato-gastroentérologie CHU de Nancy
Study officials:
affiliation: Service d'Hépato-gastroenterologie, CHU de Nancy, Vandoeuvre France
name: Jean Pierre Bronowicki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: C.I.C Nancy France
name: Faiez Zannad, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02956564: Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
Official title: Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fetal Hydrops
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Based on multi-center clinical research resources, a large-scale prospective cohort study will be conduted to make a more accurate diagnosis and intervention plan of Non-immune fetal hydrops (NIFH), and then establish NIFH accurate treatment strategy which is suitable for China's national conditions.

Detailed description: 1. Etiological study of Non-immune fetal hydrops(NIFH):

   1. Etiological study of NIFH in mid-pregnancy period;
   2. Etiological study of NIFH and hygroma colli in first trimester;
   3. Value assessment of technology for exome sequencing in diagnosis of NIFH;
2. The accuracy of NIFH intrauterine intervention and its effect assessment:

   1. Perinatal outcomes of NIFH ;
   2. The effect of intrauterine treatments.

Eligibility criteria: Inclusion Criteria:

* Cases corresponding to diagnosis standards
* Willing to accept the regular follow-up

Exclusion Criteria:

* Immune hydrops fetalis
* Multiple pregnancy, except for twin-to-twin transfusion syndrome IV

Primary outcomes:
measure: Neonatal mortality
timeFrame: 1 year
Secondary outcomes:
measure: Success rate for the operation
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00925964: Systolic Pressure Index in Assessing the Risk of Cardiovascular Events
Official title: Interest of Measuring the Systolic Pressure Index in Assessing the Risk of Cardiovascular Events Peri-operatively in the Surgery, Settled Out of Cardiovascular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardio-vascular Events
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 504
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from thoracic surgery, cardiovascular surgery and transplantation,urologic surgery, gastrointestinal surgery and orthopedic surgery services and coming to a preoperative anesthesia consultation are concerned with the study.

Brief summary: To investigate whether the presence of a Systolic pressure index (\<0.9 or\> 1.4) is a marker of risk of cardiovascular events after peri-operative high-risk surgery outside the cardiac and vascular surgery.


Eligibility criteria: Inclusion Criteria:

* age\> 40 years
* surgery set :
* Visceral surgery: gastrectomy or colectomy, abdomino-perineal amputation, pancreatic surgery, liver surgery, esophageal surgery
* In urological surgery: nephrectomy, total prostatectomy, cystectomy
* In thoracic surgery: pneumonectomy, lobectomy
* In orthopedic surgery: total hip replacement and total knee prosthesis

Exclusion Criteria:

* pathology making it impossible to measure Systolic Pressure Index
* life expectancy less than 6 months
* emergency surgery

Primary outcomes:
measure: It is a composite involving the following events: death, cardiovascular death, acute coronary syndrome, left cardiac decompensation, stroke, transient ischemic attack
timeFrame: day1, day 2, day 3, 1 month, 1 year
Secondary outcomes:
measure: - for the short term increase in the length of hospitalization - for the long term: death, cardiovascular death, hospitalization for acute coronary syndrome, cardiac decompensation left, TIA, stroke, acute ischemia and ischemia critical member.
timeFrame: day1, day 2, day 3, 1 month, 1 year
Other outcomes:
Locations:
city: Limoges
country: France
facility: Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)
Study officials:
affiliation: University Hospital, Limoges
name: Philippe LACROIX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02896764: Interest of the Cone-beam Computed Tomography in the Imagery of the Middle Ear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ear Diseases
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-12
Enrollment: 61
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: Cone beam computed tomography (CBCT), is a recent medical imaging technique where the X-rays are divergent, forming a cone.

As a result, this technique is less irradiating that the scanner. The purpose of this exploratory study is to compare the performance of the scanner and the cone beam in the detection of anatomical structures of the ear.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Indication of a CT scan of the ear
* Written and signed informed consent by the patient to participate in the study

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Patient under a legal protection procedure
* Lack of affiliation to a social security system

Primary outcomes:
measure: Sensitivity of the cone-beam CT vs CT scan
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A de Rothschild
Study officials:
References:
Clinical trial NCT02414464: Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel
Official title: In-Office Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel: a Randomized, Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Discoloration
Keywords: tooth bleaching
adolescent
clinical trial
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 53
Sex: ALL
Minimum age (years): 11
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to evaluate colorimetric changes and tooth sensitivity in young patients submitted to tooth bleaching with 20% and 35% hydrogen peroxide.

Detailed description: A randomized, controlled, clinical trial was conducted with 53 patients aged 11 to 24 years who were allocated to groups based on the use of the following commercial products: Whiteness HP - FGM® (35% hydrogen peroxide); Whiteness HP Blue Calcium - FGM® (35% hydrogen peroxide); and Whiteness HP Blue Calcium - FGM® (20% hydrogen peroxide).

After the bleaching procedure, the visual analog scale was used to measure tooth sensitivity and the classic Vita® scale was used to determine changes in tooth color.

Statistical analysis involved the Friedman, Kruskal-Wallis and Student-Newman-Keuls tests, with p-value ≤ 0.05 or ≤ 0.0001 considered indicative of statistical significance.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 11 to 24 years with a diagnosis of tooth discoloration and a signed statement of informed consent.

Exclusion Criteria:

* Individuals with dentofacial anomalies, those without the permanent dentition complete to the second molars, those in orthodontic or orthopedic treatment of the jaws, those who took medications that could alter tooth color and those who had previously been submitted to tooth bleaching

Primary outcomes:
measure: Discoloration
timeFrame: Change of teeth color after 48 hours, after 6 months, after 12 months, after 18 months
Secondary outcomes:
measure: Dental sensitivity
timeFrame: Sensivity alteration up to 48 hours after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: University of Nove de Julho
name: Sandra K Bussadori, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04439864: Perspectives Patient Education Randomized Study
Official title: Perspectives Post Percutaneous Coronary Intervention Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Cook County Health
name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
name: National Institute of Nursing Research (NINR)
First posted: 2020-06-19
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized clinical trial evaluating the educational program called My Interventional Drug Eluting Stent Educational App (MyIDEA) that is a pilot at two sites.


Eligibility criteria: Inclusion Criteria:

1. received a drug eluting stent during a Percutaneous Coronary Intervention (PCI) during a hospitalization for the PCI procedure,
2. were greater than 50 years old (funding agency requirement),
3. spoke and understood English.

Exclusion Criteria:

1. inability to give informed consent
2. allergy to aspirin

Primary outcomes:
measure: Feasibility of study design engaging elderly patients in novel tablet based education.
timeFrame: 3 months
Secondary outcomes:
measure: Medication adherence
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois at Chicago
name: Andrew D Boyd, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah V, Dileep A, Dickens C, Groo V, Welland B, Field J, Baumann M, Flores JD, Shroff A, Zhao Z, Yao Y, Wilkie DJ, Boyd AD. Patient-Centered Tablet Application for Improving Medication Adherence after a Drug-Eluting Stent. Front Public Health. 2016 Dec 12;4:272. doi: 10.3389/fpubh.2016.00272. eCollection 2016.
citation: Boyd AD, Moores K, Shah V, Sadhu E, Shroff A, Groo V, Dickens C, Field J, Baumann M, Welland B, Gutowski G, Flores JD Jr, Zhao Z, Bahroos N, Hynes DM, Wilkie DJ. My Interventional Drug-Eluting Stent Educational App (MyIDEA): Patient-Centered Design Methodology. JMIR Mhealth Uhealth. 2015 Jul 2;3(3):e74. doi: 10.2196/mhealth.4021.
citation: Boyd AD, Ndukwe CI, Dileep A, Everin OF, Yao Y, Welland B, Field J, Baumann M, Flores JD Jr, Shroff A, Groo V, Dickens C, Doukky R, Francis R, Peacock G, Wilkie DJ. Elderly Medication Adherence Intervention Using the My Interventional Drug-Eluting Stent Educational App: Multisite Randomized Feasibility Trial. JMIR Mhealth Uhealth. 2020 Jun 24;8(6):e15900. doi: 10.2196/15900.
Clinical trial NCT03632564: Modulation of Brain Blood Flow Using Dichoptic Visual and Auditory Stimulation
Official title: Modulation of Brain Blood Flow Using Dichoptic Visual and Auditory Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Arterial Diseases
Lead sponsor: Visior Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Modulation of brain blood flow using dichoptic Visual and Auditory stimulation using REVIVIEW system will be evaluated.

Detailed description: The participant will undergo baseline MRI to measure blood flow in the brain for comparison later on. After baseline MRI, the participant will observe stimulation using the REVIVIEW system for 20 minutes. The content the participants will see is a nature documentary, after which the participant will undergo additional MRI imaging to assess the change in blood flow in the brain.

Eligibility criteria: Inclusion Criteria:

- healthy subjects

Exclusion Criteria:

* History of brain diseases
* Glasses
* Diagnosed with Diabetes
* Diagnosed with Degenerative brain diseases
* Inability to undergo MRI

Primary outcomes:
measure: Change in blood flow in the brain in respond to the stimulation
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT04069364: Systematic Assessment of Self-help Tools for the Management of Chronic Tinnitus
Official title: Systematische Untersuchung Zum Einfluss Von Selbsthilfe Auf Die Subjektive Belastung Bei Chronischem Tinnitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus, Subjective
Lead sponsor: University Hospital Regensburg
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: With this study we want to investigate the impact of self-help tools on the subjective tinnitus distress in chronic tinnitus patients.

Furthermore, we want to investigate the influence of personal characteristics on the individual tinnitus improvement.

Detailed description: A smart-phone app running on iOS devices will be used to give self-help tips to the chronic tinnitus patients.

Eligibility criteria: Inclusion Criteria:

* chronic tinnitus, duration at least 6 monhts

Exclusion Criteria:

* acute psychosis, depression, substance abuse
* psychopharmaca
* epilepsy or other disease of the central nervous system
* other tinnitus treatments in the last 3 months
* drug, medication or alcohol abuse in the last 12 weeks

Primary outcomes:
measure: Change of Tinnitus Handicap Inventory
timeFrame: Before, after 4 months, and after 6 months
measure: Change of Tinnitus Numeric Rating Scale
timeFrame: Before, after 4 months, and after 6 months
measure: Change Clinical Global Impression
timeFrame: Before, after 4 months, and after 6 months
Secondary outcomes:
measure: Change of WHO Quality of Life
timeFrame: Before, after 4 months, and after 6 months
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg
Study officials:
References: