louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00386191: Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment
Official title: Evaluation of the Safety and Efficacy of Clopidogrel sulfate50mg and Clopidogrel Sulfate 75mg for the Treatment of Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebral Infarction
Keywords: Platelet Aggregation Inhibitors
Ischemic cerebrovascular disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 1110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral infarction with respect to incidence of bleeding adverse events.


Eligibility criteria: Inclusion Criteria:

* Patients with an episode of cerebral infarction (excluding cardiogenic cerebral thromboembolism) occurring at least 8 days prior to randomization and for whom the clinical course up to randomization is well-documented
* Patients with a cerebral infarct confirmed by Computed Tomography or Magnetic Resonance Image
* Body weight : \> 50 kg

Exclusion Criteria:

* Patients with cardiogenic cerebral thromboembolism or disease that could precipitate cardiogenic cerebral thromboembolism, such as atrial fibrillation or valvular hear disease (including valve replacement)
* Patients with Transient Ischemic Attack occuring after the last episode of cerebral infarction
* Patients with serious impairment that would hinder detection of new ischemic event
* Patients with bleeding diathesis, coagulopathy, or hemorrhagic disease
* Patients with history of intracranial hemorrhage
* Patients with diabetic retinopathy
* Hypertensive patients with a persistent increase of blood pressure.

Primary outcomes:
measure: Incidence of bleeding adverse events
timeFrame: study period
Secondary outcomes:
measure: Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events.
timeFrame: study period
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02511691: PET/MRI Imaging of Glutamate Release in the Brain
Official title: PET/MRI Imaging of Glutamate Release in the Brain of Healthy Controls
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Based on PET (18-PSS232) and MRI, glutamate release after N-acetylcystein challenge will be monitored in human brains.

Detailed description: Diagnostic trial with quantification of glutamate release in PET/MR.

Eligibility criteria: Inclusion Criteria:

* healthy volunteer

Exclusion Criteria:

* smoker
* drug addiction
* significant neurological or psychiatric conditions

Primary outcomes:
measure: Difference of Binding Potentials of 18F-PSS232 in different brain regions between Baseline PET and PET after medical challenge
timeFrame: Baseline PET and PET after medical challenge will be scanned within 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hopsital Zurich
Study officials:
affiliation: University of Zurich
name: Alfred Buck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04680494: Effect of Acute Physical Exercise on Memory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Physical Exercise
Keywords: fMRI
BDNF
endocannabinoid
physical exercise
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2020-12-23
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a within-subject study, all participants perform all conditions in cross-over randomized order.
Primary purpose: OTHER

Brief summary: An increasing amount of studies show the beneficial effect of regular exercise on cognitive and brain functions and especially in the memory domain. Yet little is known of what happens within an acute bout of exercise and whether it would also yield cognitive effects. The literature clearly shows that molecules such as brain derived neurotrophic factor (BDNF) and endocannabinoids (mainly anandamide, AEA) are heavily involved in neural plasticity mechanisms and increase when we exercise hinting at possible mechanisms underlying memory improvement after exercise.

This protocol assesses the effects of acute exercise on associative and motor sequence memory, their underlying neural activations (measured using fMRI) and blood biomarkers (BDNF and AEA). A related aim is to assess the effect of exercise intensity, therefore three exercising conditions (rest, moderate intensity and high intensity) were included. Finally, a 3-month delayed retest visit is also realized to assess effects of acute exercise on long-term memory consolidation.


Eligibility criteria: Inclusion Criteria:

* Male
* Right-handed,
* Exercising regularly (at least twice per week).
* VO2max comprised between 40ml/kg/min and 65ml/kg/min.

Exclusion Criteria:

- Psychiatric and neurological history

Primary outcomes:
measure: cognitive measures - performance
timeFrame: Till the end of the study for each participant, i.e.3 months (long time retest)
measure: cognitive measures - reaction times
timeFrame: Till the end of the study for each participant, i.e.3 months (long time retest)
measure: BDNF levels
timeFrame: up to 1 hour
measure: endocannabinoid levels
timeFrame: up to 1 hour
measure: brain activations
timeFrame: up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Marin Bosch B, Bringard A, Logrieco MG, Lauer E, Imobersteg N, Thomas A, Ferretti G, Schwartz S, Igloi K. Effect of acute physical exercise on motor sequence memory. Sci Rep. 2020 Sep 18;10(1):15322. doi: 10.1038/s41598-020-72108-1.
Clinical trial NCT03667794: Evaluation of Novel Lung Function Parameters in Patients With Pulmonary Hypertension (PH)
Official title: Evaluation of Novel Lung Function Parameters in Patients With Pulmonary Hypertension (PH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PH group: known or first diagnosis of PH

Healthy controls: normal lung function testing including whole-body plethysmography and transfer factor, no previously diagnosed pulmonary disease as well as no respiratory symptoms.

Non-healthy controls: stable pulmonary comorbidities including COPD, sarcoidosis, asthma, or fibrosis as well as non-pulmonary comorbidities.

Brief summary: Little is known about affection of small airways in patients with pulmonary hypertension as well as the ideal diagnostic approach. The investigators therefore aimed to evaluate novel or not widely used lung function tests for the evaluation of airway function in patients with PH.


Eligibility criteria: Inclusion Criteria:

* known or first diagnosis of PH

Exclusion Criteria:

* inability to perform lung function testing
* unable or unwilling to participate

Primary outcomes:
measure: LCI
timeFrame: 30 minutes
measure: D5-20
timeFrame: 30 minutes
Secondary outcomes:
measure: Discrimination small airway resistance
timeFrame: 30 minutes
measure: Discrimination ventilation heterogeneity
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsmedizin Mannheim
name: Frederik Trinkmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05942794: Identification of Oral Lesions Through an Autofluorescence System
Official title: Use of a Tissue Autofluorescence Detection System for Identification of Oral Mucosal Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Leukoplakia
Autofluorescence
Secondary Prevention
Keratosis
Oral Lichen Planus
Oral Cancer
Oral Disease
Keywords: Oral Leukoplakia
Lichen Planus
Squamous cell carcinoma
Keratosis
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The screening will start after a first oral examination, in order to rule out noticeable mucosal lesions.
Primary purpose: SCREENING

Brief summary: The aim of the study will be to evaluate the efficacy of a tissue autofluorescence detection system as an aid to clinical screening in identifying lesions of the oral mucosa. The screening process will be performed by 3 clinicians with a different level of experience. Sensitivity and specificity tests will be conducted.

Detailed description: Tissue autofluorescence analysis will be performed using GOOCLES® glasses, a device capable of detecting variations in fluorescence when the examined area is illuminated with a common photopolymerising lamp. Three clinical professionals will be identified:

* Dental hygienist (1);
* General dentist (2);
* Dentist expert in Medicine and Oral Pathology (3).

All patients will be included in the study after receiving an initial dental visit, in order to rule out patients with noticeable oral lesions.

Dental hygienist (1) will collect the patient's data by filling the "anamnestic record". Furthermore, (1) will perform the first clinical examination (with and without GOOCLES®), reporting his observations on his own "operator module".

The same screening (with and without GOOCLES®) will be conducted blindly by the general dentist (2) who, if he deems it necessary, will refer the patient to the oral pathologist (3), who will confirm or not (with and without GOOCLES®) the presence of an oral region such as to be further investigated (follow up or biopsy) and will report the observations on its own "operator module".

Inter-operator and intra-operator comparisons will be performed and the data thus obtained will be processed for statistical processing.

Eligibility criteria: Inclusion Criteria:

* Male and female;
* Age ≥ 18 years;
* Non-smokers and smokers

Exclusion Criteria:

* Cancer patients;
* Patients presenting a histological diagnosis of oral mucosal dysplasia/carcinoma.

Primary outcomes:
measure: Clinical change of oral mucosa
timeFrame: baseline and after 21 days
measure: Fluorescence change of oral mucosa
timeFrame: baseline and after 21 day
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: University of Naples Federico II
Study officials:
References:
Clinical trial NCT03284294: Influence of Vitamin D Supplementation on Serum BDNF Level and Cognitive Function in Schizophrenia
Official title: The Influence of Vitamin D Supplementation on Serum Brain Derived Neurotrophic Factor Level and Cognitive Function in Schizophrenia Treated With Atypical Antipsychotic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the influence of vitamin D supplementation on Serum Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with atypical antipsychotic. Methods: The investigator will use randomized controlled trial design. 40 chronic schizophrenia patients with vitamin D insufficiency or deficiency treated with atypical antipsychotic, will be randomly assign (1:1 ratio) to receive either daily oral cholecalciferol 2000 IU or placebo for 8 weeks. Assessment of BDNF serum and cognitive function will be performed at baseline and after 8 weeks period.


Eligibility criteria: Inclusion Criteria:

* Chronic schizophrenia
* Serum 25(OH)D level below 30 ng/ml
* Deficit in cognitive functions

Exclusion Criteria:

* Hypercalcemia
* Hepatic or renal failure
* Obese
* Metabolic syndrome

Primary outcomes:
measure: Cognitive Function
timeFrame: At the end of week 8
Secondary outcomes:
measure: BDNF serum level
timeFrame: At the end of week 8
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04294394: Rhomboid Block,erectör Spiane Block, Thoracotomy
Official title: Rhomboid Block Versus Erector Spinae Block in Thoracotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: rhomboid block
erectör spinae block
Lead sponsor: Kocaeli Derince Education and Research Hospital
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 to 75 years old patients will including in this study. Patients Asa Scores shold be ASA1,2,3

Brief summary: Effective analgesia is very important in terms of preventing respiratory, thromboembolic complications and providing early mobilization after open thoracotomy.

Although thoracic epidural analgesia is gold standart method for this aim, it causes common side effects such as hypotension, dural puncture,motor block In recent years, with the effective use of ultrasonography, different regional anesthesia methods have been developed to prevent such complications

Detailed description: A total of 75 patients will be included in the study in three groups: group ESPB, group RIB and control group (group K). Under general anesthesia, patients who will undergo both ESPB and RIB will be applied block with a 22 G and 100 mm block needle, accompanied by ultrasonography, and 20 ml 0.25% bupivacaine. Apart from the standard peroperative analgesia protocol applied to all three groups, no additional procedure will be performed in group control. Postoperative analgesic consumption amount, first analgesic requirement time and visual analog scale (VAS) values of the patients will be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients between 18-75 years old
* ASA1,2,3 group patients
* Patients undergoing thoracotomy under general anesthesia

Exclusion Criteria:

* The patient's refusal to participate in the study
* Allergy to local anesthetics

Primary outcomes:
measure: rhomboid block versus erector spinae block in thorachotomy
timeFrame: the study will comlete in three month
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Derince Eğitim Ve Araştırma Hastanesi
state: Derince
city: İ̇stanbul
country: Turkey
facility: Tahsin Şimşek
Study officials:
References:
Clinical trial NCT00048594: Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)
Official title: A Double-Blind, Placebo-Controlled, Multicenter Study of the Long-Term Efficacy of MK0869 in the Maintenance of Antidepressant Effect in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-11-05
Enrollment: 800
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: A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.

Detailed description: The duration of treatment is 20 months.

Eligibility criteria: Patients with Major Depressive Disorder

Primary outcomes:
measure: Total HAMD-17 score </= 10 after 10 weeks of treatment, time to relapse of depression over 6-10 months
timeFrame: after 10 weeks of treatment and over 6-10 months
Secondary outcomes:
measure: CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; an HAMA total score change from week 10 at Month 6.
timeFrame: Week 10 at Month 6
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03454594: Watch Laser Acupuncture With Nasal Radiation for Prevention of Coronary Artery Disease
Official title: Laser Hemotherapy Trial for Coronary Artery Disease Prevention in High Risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Coronary Artery Disease
Keywords: hypertension
high blood viscosity
hypercholesterolemia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of low level laser blood radiation applied to all participants for prevention of coronary artery disease in patients with high risk (hypertension,high blood viscosity, hypercholesterolemia as well as related immune issues)

Detailed description: The areas of low - intensity laser use have expanded in several conditions by different mechanisms and ways. Hypertension as one of coronary artery disease risk factors and early indicator of future cardiovascular events with high blood viscosity and elevated blood cholesterol levels with immune-pathological basis became necessary issue to be handled. Low Level Laser irradiation effects on blood is very essential way in revealing the mechanisms of the action of laser radiation on biological tissues by means of changes in metabolism, leading to molecular, cellular and systemic changes.

Eligibility criteria: Inclusion Criteria:

* stage I hypertensive patients
* patients from 30 to 34.9 kg/m2 body mass index
* medically stable patients
* all participants have sufficient cognition enough to understand the requirements of the study

Exclusion Criteria:

* history of malignant disease
* smoking
* history of progressive fatal disease
* history of drug or alcohol abuse
* blood donation within at least 30 days
* pregnant, trying to be pregnant or breast feeding
* cognitive impairment that will make it difficult to partake in the study

Primary outcomes:
measure: changes of blood pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: changes in blood viscosity
timeFrame: 8 weeks
measure: change in IL-17 level
timeFrame: 45 days
measure: change in functional capacity
timeFrame: 70 days
measure: change in CD 8 (cluster of differentiation 8) level
timeFrame: 45 days
measure: change in TC (total cholesterol) level
timeFrame: 60 days
measure: change in LDL (low density lipoprotien) level
timeFrame: 60 days
measure: change in TG (triglyceride) level
timeFrame: 60 days
measure: change in HDL (high density lipoprotien) level
timeFrame: 60 days
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo
state: Dokki
Study officials:
affiliation: Cairo University
name: Cairo Giza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02261194: Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy
Official title: Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Age-related Macular Degeneration
Keywords: depression
age-related macular degeneration
self-care
self-help
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
name: Fondation Antoine Turmel
First posted: 2014-10-10
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the short-term effect of a self-care intervention on depression in patients with age-related macular degeneration or diabetic retinopathy.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of wet or dry AMD or diabetic retinopathy
* age 50 years and older
* at least mild depressive symptoms (a score of 5 or more on the PHQ-9)
* no legal blindness (visual acuity better than 20/200 in better eye).

Exclusion Criteria:

* the current use of cognitive behavioural therapy
* suicidal intent
* ocular surgery during the study period (intravitreal anti-VEGF injections will be allowed, e.g. Lucentis)
* cognitive impairment
* inability to speak and understand French or English
* profound hearing impairment.

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in severity of anxiety symptoms
timeFrame: Baseline and 8 weeks
measure: Change in self-efficacy
timeFrame: Baseline and 8 weeks
measure: Change in life space
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital and University of Montreal
name: Ellen E. Freeman, PhD
role: PRINCIPAL_INVESTIGATOR
References: