louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04720040: The Efficacy and Safety of tDCS in Patients With Mild to Moderate Major Depressive Disorder
Official title: Using YMS-201B in Patients With Mild to Moderate Major Depressive Disorder To Evaluate Efficacy and Safety for the Effect of Improving Depressive Symptoms Open, Single-group, Multicenter Confirmatory Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Ybrain Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Catholic University of Korea
name: Inje University
name: Korea University
name: Seoul National University Bundang Hospital
name: Hallym University Medical Center
name: Soonchunhyang University Hospital
First posted: 2021-01-22
Enrollment: 65
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluated the effectiveness and safety of improving depressive symptoms by applying tDCS for 6 weeks to patients with mild to moderate depression.

Detailed description: Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5\~7 times a week and they were evaluated every 2weeks through questionnaires.

Eligibility criteria: Inclusion Criteria:

* Has a diagnosis of a major depressive disorder as confirmed by the DSM-V and MINI (without psychotic features)
* Patients with a K-BDI-II score of 14 or more and 28 or less
* In the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, Patients with sufficient drug treatment periods of at least 5 times the drug half-life.

Exclusion Criteria:

* Patients diagnosed with Axis I disorders other than major depressive disorder
* Patients diagnosed with other depressive disorders besides major depressive disorder
* Patients who have attempted suicide within 6 months of screening
* Patients who are considered to have problems with EEG and DC stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems
* Patients judged to have other reasons for prohibition of use of tDCS medical devices
* Patients currently taking antidepressants

Primary outcomes:
measure: Korean-Beck Depression Inventory-II
timeFrame: At 6 weeks after treatment.
Secondary outcomes:
measure: Korean-Beck Anxiety Depression Inventory
timeFrame: Weeks 0, 2, 4, and 6
measure: Hamilton Rating Scale for Depression
timeFrame: Weeks 0, 2, 4, and 6
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: YBrain Inc.
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00768040: Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema
Official title: A Randomized, Double-masked, Placebo-controlled, add-on Study to Assess the Efficacy of Oral Aliskiren 300 mg Once Daily for Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Keywords: Diabetes
Macular edema
Aliskiren
Diabetic retinopathy
Diabetes mellitus type 1
Diabetes mellitus type 2
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema


Eligibility criteria: Inclusion criteria:

* Type 1 or type 2 diabetes
* Diabetic macular edema

Exclusion criteria:

* Recent intra-ocular surgery in the study eye (e.g., cataract surgery in the last 6 months)
* Recent laser photocoagulation in the study eye
* Recent treatment with Avastin, Lucentis, or intravitreal corticosteroids in the study eye

Other protocol-defined inclusion/exclusion criteria applied

Primary outcomes:
measure: Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment
timeFrame: Baseline to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Retina-Vitreous Associates
state: California
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Atlanta
country: United States
facility: Georgia Retina
state: Georgia
city: Baltimore
country: United States
facility: Elman Retina Group
state: Maryland
city: Boston
country: United States
facility: Joslin Clinic
state: Massachusetts
city: Grand Rapids
country: United States
facility: Vitreo-Retinal Associates
state: Michigan
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose and Throat Associate
state: North Carolina
city: Beachwood
country: United States
facility: Retina-Associates of Cleveland, Inc
state: Ohio
city: Houston
country: United States
facility: Retinal Consultants of Houston
state: Texas
city: Arhus
country: Denmark
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00378040: Systematic Assessment of Vascular Risk
Official title: Toronto Vascular Disease Risk Factor Assessment Program: Systematic Assessment of Vascular Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Vascular Disease
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2006-09-19
Enrollment: 800
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those with confirmend PAD

Brief summary: It is hypothesized that patients with vascular disease are undertreated for modifiable risk factors, leading to increased morbidity and mortality in this population.

The objective of this study is to develop a comprehensive database that will demonstrate the current adequacy of risk factor management in this high risk population, and that will provide needed guidance for future treatment options.


Eligibility criteria: Inclusion Criteria:

All patients who attend the Vascular Surgery Clinic at Toronto General Hospital, St. Michael's Hospital, and St. Joseph's Health Centre who have PAD, cerebrovascular disease (CBVD), or aneurysms will be eligible for this study. Patients who are currently enrolled in other clinical studies are eligible for this study; however proper adherence to the other study will take precedence over of the current proposal.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital, University Health Network
name: Thomas Lindsay, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00932867: Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment
Official title: Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Arterial Hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-07-03
Enrollment: 3114
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: * Any patient with a diagnosis of arterial hypertension, who do not tolerated ACE inhibitor treatment treated by the drug PRITOR
* Exclusion criteria for the patients treated by the drug PRITOR must be read in conjunction with the local product information

Brief summary: Surveillance of efficacy and safety of drug PRITOR in patieNts with arterial hypertension, who do not tolerate ACE inhibitoR treatment


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Arterial hypertension (SBP \< 160 mmHg and DBP \< 100 mmHg)
* Patients, who do not tolerate ACE inhibitors (must be documented in the official ambulant documentation)

Inclusion criteria for the control arm (treated by ACEi):

* Patients over 18 years of age
* Arterial hypertension (SBP \< 160 mmHg and DBP \< 100 mmHg)
* Patients, who tolerate ACEi treatment

Exclusion Criteria:

* Cholestasis, severe hepatic insufficiency
* Allergy to telmisartan
* Gravidity or lactation

Exclusion criteria for the arm of patient treated by ACEi:

* Cholestasis, severe hepatic insufficiency
* Allergy to ACEi
* Gravidity or lactation

Primary outcomes:
measure: To evaluate efficacy and safety of telmisartan in patients with arterial hypertension, who do not tolerate ACEI treatment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Romania
city: Many Location
country: Slovakia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04288167: Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
Official title: Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Lead sponsor: Medicortex Finland Oy
Sponsor class: INDUSTRY
Collaborators: name: Satasairaala
First posted: 2020-02-28
Enrollment: 58
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study will enroll children and adolescents (0 - 17 years) suspected of having concussion or mild traumatic brain injury (TBI). Samples of urine and saliva will be collected from the patients as well as from corresponding age- and gender-adjusted healthy controls.

Detailed description: The collected samples will be alienated to the Sponsor who will perform biochemical studies to identify and measure from the samples relative level of the brain injury-specific biomarkers.

Eligibility criteria: Inclusion Criteria:

* The subject is suspected of having an isolated mild TBI (Glasgow Coma Score 13 - 15)
* No more that 6 hours elapsed from the incident of injury at the first sampling
* The patient is conscious
* Informed consent received from the legal guardian, and the subject him-/herself when literate and capable of understanding study measures

Exclusion Criteria:

* More than 6 hours elapsed from the injury, or unknown time of trauma
* Multi-trauma patient
* History of head injury, seizures or stroke within three preceding months
* Chronic neurodegenerative, metabolic or autoimmune disease
* Known existing neurological condition

Primary outcomes:
measure: Biomarker levels
timeFrame: 12 months
measure: Biomarker profiles
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pori
country: Finland
facility: Satakunta Central Hospital
Study officials:
affiliation: Satasairaala
name: Sari Malmi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02475967: Study Assessing the Effectiveness of a Cardiac Web-based eLearning Platform
Official title: eEduHeart I: a Multi-center Randomized, Controlled Trial Investigating the Effectiveness of a Cardiac Web-based eLearning Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: E-Learning
coronary artery disease
telerehabilitation
e-health
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2015-06-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the trial cardiac patients will be provided with unrestricted access to the web-based eLearing platform for a one-month period.

Detailed description: Patients participating in the trial will be provided with a cardiac web-based eLearning platform for one month during study period. The medical content of the packages will be gathered from a multidisciplinary input of both medics (e.g. cardiologists) and paramedics (e.g. psychologists).

E-Learning packages type I: videos with information from caregivers. In these videos, medics and paramedics are interviewed to highlight the etiology, pathophysiology and treatment of coronary artery disease; the associated comorbidities and the ways to prevent recurrence.

E-Learning packages type II: videos in which patients are interviewed. Patients can help each other to adhere to their treatment plan, by sharing stories from their own experience about their illness and the rehabilitation afterwards. Short clips of maximum 2 minutes will be provided to study participants.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from coronary artery disease for which they are treated conservatively, with a percutaneous coronary intervention or with coronary artery bypass grafting

Exclusion Criteria:

* Patients with dementia or cognitive impairment not being able to sufficiently understand the E-Learning packages content
* (Foreign) patients unable to speak Dutch, thereby not being able to understand the content of the E-Learning packages
* Patients with advanced visual and/or auditory impairments, hindering them to adequately understand the E-earning packages
* Patients participating in another trial during the Pilot study period
* Patients refusing to provide signed consent

Primary outcomes:
measure: Health-related quality of life
timeFrame: 3 months
Secondary outcomes:
measure: Adherence to the E-learning packages
timeFrame: 3 months
measure: Effectiveness of E-learning packages
timeFrame: 3 months
measure: User experience of eLearning platform
timeFrame: 3 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: ZOL
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Hasselt University
name: Ines Frederix, drs.
role: STUDY_CHAIR
References:
Clinical trial NCT00163267: Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel
Official title: Follow-up Management of Peripheral Arterial Intervention With Clopidogrel MIRROR-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Peripheral Vascular Diseases
Keywords: peripheral arterial intervention
atherosclerosis
platelets
Age above 18
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Mirror Study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascular disease.

Detailed description: Clopidogrel is approved for secondary prevention of atherosclerosis in patients with peripheral vascular disease. Currently there are no data about the amount of platelet activation during peripheral arterial intervention, the effect of clopidogrel on platelet adhesion and its clinical impact.

Patients with chronic peripheral arterial disease receive placebo or clopidogrel before the intervention and for 6 months in follow-up. Platelet activation, the effect on macro-and microcirculation will be assessed as well as clinical endpoints.

Eligibility criteria: Inclusion Criteria:

* Peripheral arterial disease which requires intervention

Exclusion Criteria:

* Patient already on coumadin or clopidogrel
* Acute onset of PVD symptoms
* Patient requiring an operation
* Contraindication to aspirin and clopidogrel

Primary outcomes:
measure: Platelet activation during and after the intervention
timeFrame: 6-12 hours
Secondary outcomes:
measure: ABI
timeFrame: before patients leaves the hospital and at 6 months
measure: clinical improvement
timeFrame: up to 6 months
measure: Safety
timeFrame: up to 6 months
measure: rate of occlusions
timeFrame: wihtin 6 months
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital of Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Gunnar Tepe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strobl FF, Brechtel K, Schmehl J, Zeller T, Reiser MF, Claussen CD, Tepe G. Twelve-month results of a randomized trial comparing mono with dual antiplatelet therapy in endovascularly treated patients with peripheral artery disease. J Endovasc Ther. 2013 Oct;20(5):699-706. doi: 10.1583/13-4275MR.1.
Clinical trial NCT03645967: Efficacy of a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol for Catheter Care at Reducing CAUTI Rates
Official title: Efficacy of Meatal and Perineal Care With a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol in Reducing Catheter-Associated Urinary Tract Infections in Acute-Care Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter-Associated Urinary Tract Infection
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2018-08-24
Enrollment: 9891
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention in the standard of care for indwelling urinary catheter care and maintenance.
Primary purpose: PREVENTION

Brief summary: Superiority study evaluating the efficacy of a prepackaged cleansing cloth and standardizing cleansing protocol vs. previous standard-of-care for catheter care and maintenance.

Detailed description: A superiority study evaluating the efficacy of a complete cleansing system composed of 5 prepackaged, moistened cloths with a standardized cleaning method compared to the previous standard-of-care for catheter care and maintenance. The primary objective is to investigate if the implementation of prepackaged cleansing cloths with a standardized cleaning protocol for all indwelling urinary catheter (IUC) care and maintenance provides a reduction in CAUTIs. The ReadyCleanse complete cleansing system will replace the previous standard-of-care. The ReadyCleanse intervention will be compared to the previous standard-of-care retrospectively.

Eligibility criteria: Inclusion Criteria:

* any adult patient who requires an IUC to be placed during admission to one of the four study hospitals

Exclusion Criteria:

* patients \<18 years of age
* patients whose entire hospital stay occurs in: pediatric unit, psychiatric unit, labor \& delivery or postpartum units, and emergency room

Primary outcomes:
measure: Infections Per 1,000 (CAUTI) Days
timeFrame: 16 months
Secondary outcomes:
measure: Number of "Health Care Providers Responding to Health Care Provider Feedback Survey
timeFrame: Begins 3 months after start date. Time to take survey is approximately 10 minutes.
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem - Evanston
state: Illinois
city: Glenview
country: United States
facility: NorthShore University HealthSystem - Glenbrook
state: Illinois
city: Highland Park
country: United States
facility: NorthShore University HealthSystem - Highland Park
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem - Skokie
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Kamal S Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05913167: Comparison of Erector Spina Plan Block and Trnsversus Abdominis Plan Block in Laparoscopic Nephrectomy: Prospective Randomized Clinical Trial
Official title: Comparison of Erector Spina and Transversus Abdominus Plan Blocks
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Nephrectomy
Keywords: laparoscopy
nephrectomy
erector spina plan block
transversus abdominis plan block
morphine consumption
analgesia
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: erector spina and transversus abdominis plane blocks
Primary purpose: DIAGNOSTIC

Brief summary: Nephrectomy pain was higher. erector spina plan block and transversus abdominis plan block had shown to be effective in abdominal surgeries. This study aimed to compare these two bloc analgesic efficacy in laparoscopic nephrectomy patients. The primary aim is postoperative morphine consumption.

Detailed description: Patients ASA 18-65 who will undergo laparoscopic nephrectomy are included in this prospective randomized clinical trial. Patients will be divided into two groups; erector spina and transversus abdominis plane block. Anesthesia will. induced with propofol, fentanyl, and rocuronium will be administered for muscle relaxation. Bispectral index monitoring will be used for monitorisation of the depth of anesthesia. Remifentanil was used during the whole procedure. the amount of consumption will be recorded. Patient-controlled device will be used with morphine. The postoperative morphine consumption will also be recorded.

Eligibility criteria: Inclusion Criteria:

* 18-65 age
* patients undergoing laparoscopic nephrectomy
* ASA 1-3

Exclusion Criteria:

* \<18- \>65 \< age
* patients undergoing open nephrectomy
* ASA 4-5

Primary outcomes:
measure: Postoperative morphine consumption
timeFrame: 24 hour postoperatively
Secondary outcomes:
measure: Peroperative remifentanil consumptions
timeFrame: peroperatively
measure: postoperative analgesia numeric rating scales
timeFrame: postoperative 24 hours
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
References: