louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04007887: Effect of an Adult EDUcation Program on CArdiovascular ouTcomEs in Post-myocardial-infarction Patients
Official title: Effect of an Adult Education Program on Cardiovascular Outcomes in Post-myocardial-infarction Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A non-MD-led adult education program consisting in 10 one-hour sessions designed to provide information and motivation will be offered to patients who have recently been hospitalized for acute myocardial infarction (STEMI and NSTEMI), regarding the management of their treatment and strategies to aggressively optimize control of cardiovascular risk factors..

The intervention arm will be compared to a control group of patients treated with usual care.


Eligibility criteria: Inclusion Criteria:

* History of acute ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), Type Ι, according to the 3rd Universal Definition of MI, within the preceding 6 weeks
* Absence of substantial cognitive dysfunction (Mini Mental State examination score ≥24)

Exclusion Criteria:

- Age \>80 years or \<18 years

Primary outcomes:
measure: Time to death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons
timeFrame: 24 months
Secondary outcomes:
measure: MACCE
timeFrame: 24 months
Other outcomes:
measure: Change in LDL-chol
timeFrame: 12 months
measure: Change in body-mass index
timeFrame: 12 months
measure: Change in arterial pressure
timeFrame: 12 months
Locations:
city: Athens
country: Greece
facility: Athens University Hospital Attikon
Study officials:
References:
citation: Giannopoulos G, Karageorgiou S, Vrachatis D, Anagnostopoulos I, Kousta MS, Lakka E, Giotaki S, Raisakis K, Sianos G, Toutouzas K, Cleman M, Deftereos S. A stand-alone structured educational programme after myocardial infarction: a randomised study. Heart. 2021 Jun 11;107(13):1047-1053. doi: 10.1136/heartjnl-2020-318414.
Clinical trial NCT04019587: Turkish Version of Fear of Falling Avoidance Behavior Questionnaire
Official title: Cross-Cultural Adaptation and Psychometric Properties of the Fear of Falling Avoidance Behaviour in Turkish Community-dwelling Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fall
Fear
Older People
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community dwelling older adults

Brief summary: This study is planned to translate the Fear of Falling Avoidance Behaviour Questionnaire (FFABQ) into Turkish and to assess the psychometric properties (validity, reliability, responsiveness, floor and ceiling effect) of this Turkish version.

Detailed description: The permission for the Turkish version was received by Landers. The translation will be made according to Beaton et al. guidelines. The internal reliability of the FFABQ Türkish version will be assessed using Cronbach's alpha, and item analyses will be conducted by examining the effect on Cronbach's alpha of excluding each of the six FOG-Q items individually. The test-retest reliability will be assessed using intraclass correlation coefficient (ICC).

Convergent validity will be evaluated by means of Spearman rank correlation coefficient (rs). In this section will be determined the correlation between the Activities-specific Balance Confidence Scale and visual analog scale for fear of falling.

Eligibility criteria: Inclusion Criteria:

* having good cognitive functions (Standardized Mini Mental Test score of 24 and above)
* To be able to live independently in the community,
* to voluntarily participate

Exclusion Criteria:

* The use of drugs that may affect balance
* Polypharmacy status
* Having serious musculoskeletal or neurological disorders,
* Lower or upper limb amputation that may affect balance.

Primary outcomes:
measure: Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
timeFrame: 7 minutes
Secondary outcomes:
measure: Activities-specific Balance Confidence (ABC)
timeFrame: 10 minutes
measure: Visual Analog Scale (VAS) for Fear of Balance
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Sevim ACARÖZ CANDAN
state: Altinordu
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Sevim A CANDAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03192787: A Registry Study of Sanwujiaowan Capsule Used in Clinical Real World
Official title: A Registry Study of Sanwujiaowan Capsule Used in Clinical Real World
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatism
Osteoarthritis
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Xiangya Hospital of Central South University
First posted: 2017-06-20
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aim population for observation is who using Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Brief summary: The purpose of this study is get to know what and how Sanwujiaowan capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.

Detailed description: In order to improving monitoring drug-induced liver injury or adverse drug reactions of Chinese medicine containing Radix Polygoni Multiflori in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or adverse drug reactions is one of the main aims for this study. Safety surveillance on Chinese medicine containing Radix Polygoni Multiflori is an important problem that needs to be sorted out through large sample observational study. According to the relevant regulations of the CFDA, 3000 cases need to be registered at least. The aim population is who using Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Eligibility criteria: Inclusion Criteria:

Patients using Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Exclusion Criteria:

NONE

Primary outcomes:
measure: Is there any abnormality in liver function test index（ALT、AST、TBil、GGT） after using sanwujiaowan capsule around four weeks later?
timeFrame: After using sanwujiaowan capsule around four weeks later
Secondary outcomes:
measure: Is there any abnormality in renal function test index（Bun、Cr） after using sanwujiaowan capsule around four weeks later?
timeFrame: After using sanwujiaowan capsule around four weeks later.
measure: Is there any abnormality in ECG after using sanwujiaowan capsule around four weeks later?
timeFrame: After using sanwujiaowan capsule around four weeks later.
measure: Is there any abnormality in basic life sign（body temperature, blood pressure and pulse）during using sanwujiaowan capsule around four weeks？
timeFrame: During using sanwujiaowan capsule around four weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yanming Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00393887: Inguinal Hernia Study Using Biodesign IHM
Official title: Inguinal Hernia Study: A Double Blinded Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Inguinal hernia
polypropylene
Biodesign IHM
lichtenstein
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Cook Biotech Incorporated
name: MED Institute, Incorporated
First posted: 2006-10-29
Enrollment: 100
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: Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.


Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Diagnosis of Unilateral inguinal hernia repair
* Able to provide written consent

Exclusion Criteria:

* Incarcerated hernia
* Allergic or religious beliefs that disallow porcine material
* Previous hernia repair on the designated hernia site
* Class IV or V anesthesia requirements
* Bowel obstruction
* Peritonitis
* Life expectancy \< 3 years

Primary outcomes:
measure: Number of Patients With Inguinal Hernia Recurrence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland
name: Tracy Timmons, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02719587: Dietary Supplementation With Low-Dose Omega-3 Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis
Official title: Dietary Supplementation With Low-Dose Omega-3 Fatty Acids Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Periodontitis
Keywords: saliva
omega-3
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators primary objective in this clinical intervention study, therefore, was to explore the impact of omega-3 PUFAs in conjunction with scaling and root planing on salivary markers (in patients with chronic periodontitis.

Detailed description: Thirty systemically healthy subjects with chronic periodontitis were enrolled and randomly allocated into two groups. The control group (n=15) was treated with scaling and root planing (SRP)+placebo whereas the test group (n=15) was treated with SRP and dietary supplementation of low-dose omega-3 PUFAs (6.25 mg EPA and 19.19 mg DHA). Clinical parameters were taken at baseline, 1, 3 and 6 months following therapy. Saliva samples were obtained at the same time intervals and analyzed for tumor necrosis factor-α (TNF-α) and superoxide dismutase (SOD).

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with chronic periodontitis
* had at least nine posterior teeth (not including third molars and teeth with bridges and crowns)
* with 5-7 mm pocket depth
* three teeth with 6 mm or more of probing attachment loss enrolled in the study

Exclusion Criteria:

* patients were excluded on the basis of periodontal surgery within the last year;
* SRP as part of initial periodontal therapy within the past 6 months;
* history of diabetes, any diseases or disorders that compromise wound healing, any history of acute or chronic inflammatory disease,
* any oral mucosal inflammatory condition (e.g., aphthous, lichen planus, leukoplakia, and oral cancer) and use of aspirin
* other non-steroidal anti-inflammatory drugs or antibiotics within the last 6 months.

Primary outcomes:
measure: change in levels of salivary TNF alpha
timeFrame: From baseline to 1, 3, 6 months
Secondary outcomes:
measure: change in levels of salivary SOD
timeFrame: From baseline to 1, 3, 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Keskiner I, Saygun I, Bal V, Serdar M, Kantarci A. Dietary supplementation with low-dose omega-3 fatty acids reduces salivary tumor necrosis factor-alpha levels in patients with chronic periodontitis: a randomized controlled clinical study. J Periodontal Res. 2017 Aug;52(4):695-703. doi: 10.1111/jre.12434. Epub 2017 Feb 8.
Clinical trial NCT00513487: Effects of Multiple Nasal Exposures to House Dust Mite Allergen on Nasal and Body Inflammation and Airway Sensitivity
Official title: Assessment of the Effects of Multiple Nasal Antigen Challenges With Dust Mite Allergen on Local and Systemic Allergic Inflammation and Bronchoreactivity in Subjects With Allergic Rhinitis Sensitive to House Dust Mite - a Feasibility and Site Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis
dust mites
IgE
IL-13
nasal
inflammation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will evaluate whether multiple nasal antigen challenges with dust mite allergen produces increases in nasal symptoms and local allergic inflammatory cells in the nose and the blood.


Eligibility criteria: Inclusion Criteria:

* Healthy non-smoking subjects with a history of allergic rhinitis consistent with dust mite allergy showing
* A positive skin prick test to dust mite at or within the 12 months before study start
* Demonstrate symptomatic worsening after graded nasal allergen challenge

Exclusion Criteria:

* Subjects found to be very sensitive to house dust mites (if the skin prick test produces a wheal of mean with a diameter greater than 11 mm).
* Presence of any respiratory disease other than a history of mild stable asthma not requiring regular treatment.
* Any known contraindications for methacholine challenge testing

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Total nasal symptom score recorded at baseline, and at pre-challenge,15 mins, 30 mins,and at 1,2,3,4,8 hours
timeFrame: throughout the study
Secondary outcomes:
measure: Peak nasal inspiratory flow at time points of total nasal symptom score. Mechanistic markers during challenge days. Exhaled nitric oxide,forced expiratory vol in 1 second & airway resistance at baseline, first & last day
timeFrame: throughout the study
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Novartis Investigative site
Study officials:
affiliation: Investigative site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03339687: Addiction Risk: The Influence of Mindset Induction on the Effect of a Brief Intervention to Reduce Alcohol Use
Official title: Research Group RISKDYNAMICS, Sub-Project 8, Work Package 1, Study 2: Addiction Risk: The Influence of Mindset Induction on the Effect of a Brief Intervention to Reduce Alcohol Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: University of Konstanz
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 66
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: Brief Interventions (BI) based on Motivational Interviewing are effective to reduce alcohol use. In this study the investigators test the hypothesis that that an open Mindset increases the positive effects of BI.

Patients who are newly admitted to the psychotherapy outpatient clinic are routinely screened for risky alcohol use. All patients with risky alcohol use are eligible to the study and all receive the WHO's ASSIST-linked BI.

Participants receive a brief Mindset induction prior to receiving BI. They are are randomly assigned to either the induction of an open or a closed Mindset according to Gollwitzer.

The investigators measure the change in alcohol-related risk perception, treatment motivation and real alcohol drinking.


Eligibility criteria: Inclusion Criteria:

* admitted to treatment at psychotherapy outpatient clinic

Exclusion Criteria:

* alcohol use disorder
* substance use disorder

Primary outcomes:
measure: Individual Risk Perception
timeFrame: The questionnaire assesses the variable related to the week before, i.e. time frame 1 week.
Secondary outcomes:
measure: Amount of alcohol drinking
timeFrame: The interviewers assess the number of standard units of alcohol consumed during month before assessment, i.e. time-frame 1 month
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz, Psychotherapy Outpatient Clinic
Study officials:
affiliation: University of Konstanz
name: Michael Odenwald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00813787: Investigation Into the Differentiation of Tumour and Healthy Brain Tissue Using Multi-exponential T2 Components
Official title: Investigation Into the Differentiation of Tumour and Healthy Brain Tissue Using a Specialized MRI Technique Called Multiexponential T2 Component Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Keywords: Magnetic Resonance Imaging
Glioma
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A. Any glioma patient who recieves treatment at our clinic (Cross Cancer Institute) who agrees to take part in the study.

B. Any normal volunteer who agrees to take part in the study.

Brief summary: The purpose of this study is to see if a specialized imaging technique using MRI called multi-exponential T2 component analysis can reliably differentiate between normal brain and brain tumour.

Detailed description: Existing methods of contouring tumours for radiation therapy involve manual interpretations of qualitative diagnostic images. These methods, being qualitative, do not offer a consistent and reproducible platform for contouring, making it difficult to evaluate the effects of contouring choices on treatment outcome. T2 component analysis in MRI has the potential to offer a quantitive basis for identifying tumor tissue- this potential is investigated in this pilot study.

Eligibility criteria: Inclusion Criteria:

* Eighteen years of age or older
* Clinical subjects must have not yet begun radiation therapy
* Must have signed our study-specific consent form

Exclusion Criteria:

-

Primary outcomes:
measure: T2 characteristics of glioma tissue versus normal
timeFrame: Before radiotherapy treatment begins
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Keith Wachowicz, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02573987: MEOPA Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.
Official title: MEOPA (Equimolar Mix of Oxygen and Nitrogen Monoxide) Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: determine if efficiency of MEOPA anesthesia is at least equivalent to local anesthetics into the chorionic villus sampling in the first trimester of pregnancy

Detailed description: Compare anxiety discomfort and side effects

Eligibility criteria: Inclusion Criteria:

* pregnant
* 18 and over
* monofetal pregnancy
* chorionic villus sampling medical indication without contra indication
* informed consent signature

Exclusion Criteria:

* pregnant under 18
* multiple pregnancies
* pregnancy inferior 11 aw
* no informed consent signature

Primary outcomes:
measure: Analgesia efficiency
timeFrame: 5 min after procedure
Secondary outcomes:
measure: assessment of anxiety
timeFrame: 5 min after biopsy
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital St Joseph
Study officials:
affiliation: Hôpital st Joseph Marseille France
name: Raoul Desbriere, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00653887: Biofeedback and Cortical Excitability
Official title: Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Incontinence
Constipation
Keywords: Biofeedback
anal sphincter
cortical excitability
magnetic stimulation
incontinence
constipation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Coloplast A/S
First posted: 2008-04-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.

Detailed description: Introduction: Nervous control of pelvic floor is not much known. The dysfunction of this musculature, and particularly of the external anal sphincter, is a frequent cause of anal incontinence and/or dyschesia. Biofeedback training is often offered to patients suffering from incontinence or constipation. However, its mechanisms of action is still controversial.

Objective of the study: to compare excitability of the cortical area responsible for control volunteer of the external anal sphincter in healthy subjects before and after 4 biofeedback sessions.

Subjects and methodology: we offer to perform two groups of 12 healthy subjects (one active and one control group) without any neurological or digestive disease and having never performed biofeedback. In each group, cortical excitability will be evaluated by cortical magnetic stimulation (curve intensity/amplitude, silent period, inter-stimulus period, motor threshold) before and after 4 biofeedback sessions (one session by week) in active group or 4 placebo sessions (placebo group).

We hope to show a modification of cortical excitability in subjects performing biofeedback compared to others.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between 18 years old and 35 years old
* Right handed\*

Exclusion Criteria:

* Pregnancy
* Pace-maker or other metallic piece implanted in the body
* Neurological disease
* Epilepsy
* Digestive disease
* Traumatic delivery
* Anorectal surgery
* Biofeedback
* Psychiatric disease
* Treatment anti-epileptic, hypnotic, psychotropic
* Participation to a previous protocol within 1 month

Primary outcomes:
measure: external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction
timeFrame: final
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Physiology Unit - Rouen university Hospital
Study officials:
affiliation: CHU Rouen
name: Anne-Marie LEROI, PhD
role: PRINCIPAL_INVESTIGATOR
References: