louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03545152: Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment
Official title: Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
TTM
Physical Activity
Cognitive Rehabilitation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 192
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project is proposed to be a three-year project. The purposes of this project are to develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, QOL and depression) among community-dwelling elderly adults with MCI.

Detailed description: Aim. develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, QOL and depression) among community-dwelling elderly adults with MCI.

Background. Mild cognitive impairment (MCI) is a common clinical syndrome that identifies people at high risk of developing dementia, and the prevalence range from 7.7 to 51.7%. Although treatments for MCI are currently unavailable, preliminary evidence has identified potential neuro-protective effects of exercise program and cognitive rehabilitation, which may lead to improved outcomes. However, the design and delivery of an appropriate program for people with MCI is challenging for having physical, psychological, cognitive, and social barriers.

Design. A prospective randomized control trial. We developed a Physical activity stage-matched intervention (SMI) (1st year), cognitive rehabilitation (2nd year) and New lifestyle program

Eligibility criteria: Inclusion Criteria:

* had a subjective memory complaint
* MMSE score\<16, 21 or 24, based on their years of education (illiterate, 6 or \>9 years, respectively, Yeh et al., 2000), but needed \>13 or objective memory impairment: AQ\>5 or at least one item of IADL dependence
* able to carry out activities in daily life

Exclusion Criteria:

* using walking devices
* depression or dementia diagnosis

Primary outcomes:
measure: Mini-Mental State Examination
timeFrame: 8min
measure: The Alzheimer's Questionnaire
timeFrame: 2min
measure: Taiwan version of Prospectiv and Retrospective Memory Questionaire (PRMQ)
timeFrame: 5min
Secondary outcomes:
measure: Mobility
timeFrame: 10min
measure: Depressive symptoms
timeFrame: 3min
measure: Quality of life
timeFrame: 8min
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02161952: Pirfenidone, an Antifibrotic and Antiinflammatory Drug
Official title: Pirfenidone, an Antifibrotic and Antiinflammatory Drug for Treatment of Patients With Cirrhosis Due to Hepatitis C Virus. Phase II/III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibrosis
Hepatitis C Chronic
Keywords: Fibrosis, necroinflammation, hepatitis C chronic
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
Collaborators: name: Cell Therapy And Technology, S.a. De C.v.
First posted: 2014-06-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.


Eligibility criteria: Inclusion Criteria:

* Patients with established advanced liver disease caused by hepatitis C virus (HCV) chronic infection defined by a positive test for anti-HCV antibodies and detectable serum HCV RNA (Amplicor HCV 2.0 polymerase chain reaction (PCR) assay).
* Sign an informed consent form to allow the collection of liver biopsies before and after treatment.
* No antifibrotic, antiviral or immunosuppressive drugs for at least 6 months before starting pirfenidone therapy.
* No alcohol intake for at least 6 months before nor during Pirfenidone (PFD) treatment.

Exclusion Criteria:

* Patients with clinical contraindications to hepatic biopsy

Primary outcomes:
measure: Fibrosis staging
timeFrame: 24 months
Secondary outcomes:
measure: Grade of necroinflammation activity
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Head, Molecular Biology and Genomics Department
name: Juan Armendariz-Borunda, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flores-Contreras L, Sandoval-Rodriguez AS, Mena-Enriquez MG, Lucano-Landeros S, Arellano-Olivera I, Alvarez-Alvarez A, Sanchez-Parada MG, Armendariz-Borunda J. Treatment with pirfenidone for two years decreases fibrosis, cytokine levels and enhances CB2 gene expression in patients with chronic hepatitis C. BMC Gastroenterol. 2014 Jul 27;14:131. doi: 10.1186/1471-230X-14-131.
Clinical trial NCT04241952: Effects of Early Exercise in Patients With Moderate to Severe Stroke.
Official title: Effects of Early Exercise in Patients With Moderate to Severe Stroke - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Exercise
Bedcycling
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: Purpose: to investigate the efficacy of early exercise in patients with moderate to severe stroke regarding functional outcome and walking ability.

Methods: Patients with medium to severe stroke (NHISS \>7) were recruited 24 - 48 hours after stroke onset from two stroke units in Sweden. Both groups received usual care. The intervention group received even 20 minutes bed-cycling 5 days per week with a maximum of 15 sessions. Functional outcome was measured with modified Rankin Scale (mRS) and Barthel index and walking with the 6-minute walking test (6MWT). Measurements were performed pre- and post-intervention (3 weeks), and at 3-months follow-up.


Eligibility criteria: Inclusion criteria:

* Age over 18 years.
* Diagnose stroke with The National Institutes of Health Stroke Scale (NIHSS) 7-42 points.
* Ability to understand the Swedish language.
* Approval of medical responsible physician to participate in the study.

Exclusion criteria:

• Medical or neurological diseases that can affect the performance of the exercise and severe cognitive impairment.

Primary outcomes:
measure: Change in Modified Rankin Scale (mRS)
timeFrame: Baseline 24-48 hours after onset, postintervention 3 weeks after baseline and follow up 3-months after baseline.
Secondary outcomes:
measure: Change in Barthel ADL-Index
timeFrame: Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.
measure: Change in 6-Minutes Walking test (6MWT)
timeFrame: Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.
Other outcomes:
Locations:
Study officials:
affiliation: Linkopings University,Sweden
name: Paul Enthoven, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandberg K, Kleist M, Enthoven P, Wijkman M. Hemodynamic responses to In-Bed Cycle Exercise in the acute phase after moderate to severe stroke: A randomized controlled trial. J Clin Hypertens (Greenwich). 2021 May;23(5):1077-1084. doi: 10.1111/jch.14232. Epub 2021 Mar 11.
Clinical trial NCT02386852: Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity
Official title: Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Blood Pressure
Cognition
Keywords: Ginseng
Ginkgo Biloba
cardiovascular reactivity
cognition
Lead sponsor: Sunway University
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: There is some evidence to suggest that ginseng and Ginkgo biloba can improve cognitive performance, however, very little is known about the mechanisms associated with such improvement. Here, we tested whether cardiovascular reactivity to a task is associated with cognitive improvement.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers ranging in age between 18 and 30.

Exclusion Criteria:

* Ginseng group: exclude those that regularly consume caffeine or Panax Ginseng, or those that are diabetic, have hormone sensitive conditions, autoimmune diseases, bleeding conditions, heart conditions or take medications that are known to interact with Panax Ginseng. These include anticoagulants, Warfarin, Ibuprofen, MAOIs, medications that are changed by the liver, and stimulant drugs (e.g. pseudoephedrine, epinephrine).
* Ginkgo Biloba group: exclude those that regularly consume caffeine or Ginkgo Biloba, or those that are diabetic, have experienced seizures in the past, have bleeding disorders, or take medications that are known to interact with Ginkgo Biloba. These include Ibuprofen, anticoagulants, Warfarin, Buspirone, Fluoxetine, Trazodone

Primary outcomes:
measure: Cognitive performance as modulated by either ginseng or ginkgo biloba
timeFrame: Acute effects (3 days of testing)
Secondary outcomes:
measure: Cardiovascular reactivity as a result of ginseng or ginkgo biloba intake
timeFrame: Acute effects (3 days of testing)
Other outcomes:
Locations:
city: Bandar Sunway
country: Malaysia
facility: Department of Psychology, Sunway University
state: Selangor
Study officials:
affiliation: Sunway University
name: Luca Aquili, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ong Lai Teik D, Lee XS, Lim CJ, Low CM, Muslima M, Aquili L. Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity: A Randomised Trial. PLoS One. 2016 Mar 3;11(3):e0150447. doi: 10.1371/journal.pone.0150447. eCollection 2016.
Clinical trial NCT01034852: Efficacy Study for Surgery After Previous Failed Catheter Ablation
Official title: Surgery After Previous Failed Catheter Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation Ablation
Keywords: Atrial Fibrillation
Maze
Ablation
Lead sponsor: Cardiopulmonary Research Science and Technology Institute
Sponsor class: OTHER
Collaborators: name: AtriCure, Inc.
name: Virginia Commonwealth University
First posted: 2009-12-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have undergone surgical ablation after failing catheter based ablation at investigator sites

Brief summary: Specific Aims: The primary objective of this registry is to determine the percentage of patients who are free from atrial fibrillation (AF) at 6 and 12 months following a surgical ablation procedure when the patient has a history of failing one or more previous catheter based ablations for AF. The first 3 months following surgical ablation will be a blanking period; any arrhythmia occurring during this time will not be used to determine success.

Primary Objectives:

1. Determine the percent success of surgical ablation for AF at 6, and 12 months both on and off of antiarrhythmic drugs (AAD) following a failed catheter based ablation for AF
2. Record and evaluate all complications associated with the surgical procedure.

Secondary Objectives:

1. Evaluate usage of anticoagulants at 6, and 12 months.
2. Determine the percentage of Pulmonary Veins (PV) that were electrically isolated by intra-operative, pre-surgical mapping


Eligibility criteria: Inclusion Criteria:

* Diagnosis of atrial fibrillation
* Has undergone one or more catheter based ablation procedures for AF and the procedure failed
* Has undergone a minimal access surgical ablation procedure for the treatment of AF following failure of catheter based ablation for AF

Primary outcomes:
measure: Determine the efficacy of surgical ablation for AF at 6, & 12 months both on and off of antiarrhythmic drugs following a failed catheter based ablation for AF.
timeFrame: 1 year post operatively
measure: Record and evaluate all complications associated with the surgical procedure.
timeFrame: 1 year post operatively
Secondary outcomes:
measure: Evaluate usage of anticoagulants at 6 and 12 months.
timeFrame: 1 year post operatively
measure: Determine the % of Pulmonary Veins that were electrically isolated by intra-operative, pre-surgical mapping.
timeFrame: 1 year post operatively
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Endovascular Research
state: Oregon
city: Dallas
country: United States
facility: Cardiopulmonary Research Science and Technology Institute
state: Texas
Study officials:
affiliation: Cardiopulmonary Research Science and Technology Institute
name: James R Edgerton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04056052: A Randomized Comparison Trial Examining the Impact of a Family-based Cooking Workshop
Official title: Mind the Gap! A Randomized Comparison Trial Examining the Impact of a Family-based Cooking Workshop on Vegetable Consumption, Self-efficacy and Willingness to Try of Children and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Keywords: Children
Family-based intervention
Lead sponsor: University of Victoria
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 65
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Increasing fruit and vegetable intake is important to health but children's vegetable intake remains low. In younger age groups parents act as gatekeepers by providing access, availability, persuasion and modelling. This study aimed to enhance parent vegetable serving behaviour and child vegetable intake through an 8-week social cognitive theory-based family cooking program.


Eligibility criteria: Inclusion Criteria:

* a family unit consisting of at least one parent and one child
* parents aged between 25 and 55 years of age
* children aged between nine and 13 years of age.

Exclusion Criteria:

* ability to comprehend English
* Participation of both the parent and the child

Primary outcomes:
measure: Parent Food Serving Frequency
timeFrame: 7 days
measure: Child Food Frequency Questionnaire
timeFrame: 7 days
Secondary outcomes:
measure: Cooking confidence (Parent and Child)
timeFrame: 7 days
measure: Outcome Expectations (Parent and Child)
timeFrame: 7 days
measure: Exposure, Food Neophobia and Tast Preference (Parent and Child)
timeFrame: 7 days
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: University of Victoria
state: British Columbia
Study officials:
affiliation: University of Victoria
name: Patti-Jean Naylor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00785252: EZIO Compared to Central Venous Lines for Emergency Vascular Access
Official title: Randomized Study of the EZIO Compared to Central Venous Lines Used for Emergency Vascular Access
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Catheters, Indwelling
Central Venous Line
Intraosseous Needle
Keywords: Catheters, Indwelling
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: Vidacare Corporation
First posted: 2008-11-05
Enrollment: 0
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: Multicenter randomized study to compare powered intraosseous access to standard central line access for the administration of fluids and drugs for patients in the Emergency Dept.


Eligibility criteria: Inclusion Criteria:

Over 18 years old Requires central access after peripheral access attempts have failed or are not otherwise feasible

Exclusion Criteria:

Fracture in target bone Not able to sign informed consent Excessive tissue or absence of adequate anatomical landmarks Known or suspected coagulopathies Pregnancy Patients in custody Patients with suspected great vessel injury Not fluid in English

Primary outcomes:
measure: Time taken to place the device
timeFrame: ED visit
Secondary outcomes:
measure: Incidence of complications
timeFrame: ED visit
measure: Costs for each of the two methods
timeFrame: Ed visit
Other outcomes:
Locations:
city: Washington
country: United States
facility: Dept of Emergency Medicine, The George Washington University Medical Center
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Jeremty Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Emergency Medicine, GWU
name: Jeremy Brown
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05898152: Interest of a Specific Care Pathway for the Management of Catamenial Epilepsy
Official title: Interest of a Specific Care Pathway for the Management of Catamenial Epilepsy Catamenial Epilepsy: Status Report and Point of View of a Cohort of Patients Who for Drug-resistant Epilepsy at the TOULOUSE University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy Menstrual
Keywords: Catamenial epilepsy
Menstrual cycle
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with catamenial epilepsy

Brief summary: This is a study of patients with catamenial epilepsy. Catamenial epilepsies are defined as epileptic seizures during the menstrual cycle. Today, there are no recommendations and no care pathway for these patients. The aim of this study is to assess the number of patients reporting a link between the occurrence of their epileptic seizures and their menstrual cycle.


Eligibility criteria: Inclusion Criteria:

* Adults patients (\>18 years)
* No menopausal
* Patients who have consulted in a Neurology department for refractory epilepsy
* Non opposition patient
* Affiliation to a social security scheme

Exclusion Criteria:

* Patients who understand French enough

Primary outcomes:
measure: Number of reporting patients
timeFrame: 4 months
Secondary outcomes:
measure: Listening satisfaction
timeFrame: 4 months
measure: Satisfaction of taking charge
timeFrame: 4 months
measure: Rate of women with drug-resistant epilepsy
timeFrame: 4 months
measure: Reconciliation of catamenial epilepsy
timeFrame: 4 months
measure: Association between catamenial epilepsy and menstrual cycle
timeFrame: 4 months
measure: Existing associations
timeFrame: 4 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Anna GOSSET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01904552: Accuracy of ERCLMDs in Teeth With Apical Periodontitis
Official title: Influence of Apical Periodontitis on the Accuracy of Three Electronic Root Canal Length Measurement Devices: An In Vivo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Apical Periodontitis
Keywords: Apical periodontitis
Dentaport ZX
electronic apex locators
i-Root
Raypex 5
working length
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-07-22
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this in vivo study is to evaluate the influence of apical periodontitis (AP) on the accuracy of Dentaport ZX, Raypex 5, and i-Root electronic root canal length measurement devices.

Detailed description: Thirty-two single-rooted teeth scheduled for extraction, consisting of 16 teeth with AP and 16 teeth with normal periapex (NP), were selected. Access cavity was prepared and coronal portion of the canal was flared. Electronic working length (EWL) was determined by each ERCLMD according to each manufacturer's instructions. Each tooth was extracted and actual working length (AWL) was determined by inserting a size 15 K-file until the tip could be seen at a position tangential to the major foramen and then 0.5 mm was subtracted from the measurement. The distance from the AWL to the file tip was calculated and compared between the two groups by t-test. The accuracy of each ERCLMD within ±0.5 mm was compared between the groups by Fisher's test. Statistical significance was set at P \< .05.

Eligibility criteria: Inclusion Criteria:

* single-rooted teeth
* clinical pulp necrosis and periapical index scores of 3, 4 or 5
* pulp vitality and a periapical index score of 1

Exclusion Criteria:

* Teeth with metal restorations
* Teeth with prosthetic crowns
* Teeth with pulp calcification
* Teeth with previous endodontic treatment

Primary outcomes:
measure: Actual working length (AWL)
timeFrame: 6 months
Secondary outcomes:
measure: Electronic working length (EWL)
timeFrame: 6 months
Other outcomes:
measure: working length
timeFrame: 6 months
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Masoud Saatchi, DDS MS
role: PRINCIPAL_INVESTIGATOR
References: