louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01196923: Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Official title: Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: CardioFocus
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Symptomatic, Paroxysmal Atrial Fibrillation (AF)
* 18 to 70 Years of age
* Others

Exclusion Criteria:

* Generally good overall health as determined by multiple criteria
* Willing to participate in a study
* Others

Primary outcomes:
measure: Acute Isolation of Pulmonary Veins.
timeFrame: Acute PVI measured on the day of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
Study officials:
affiliation: CardioFocus
name: Burke Barrett
role: STUDY_DIRECTOR
References:
Clinical trial NCT04158323: What is the Gold Standard of Airway Management in the Anticipated Difficult Airway
Official title: Survey on the Current Significance of the Flexible Endoscopy as the Gold Standard for Airway Management in Patients With Anticipated Difficult Airway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Morbidity
Keywords: flexible endoscopy
awake intubation
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: anesthesists and intensive care physicians

Brief summary: A prospective Observationalstudie to analyze the current significance of the awake flexible endoscopy in German hospitals.

Detailed description: The aim of the study is to analyze the current significance of the awake flexible endoscopy in German hospitals, to identify strategies to securing the airway in patients with a anticipated difficult airway. The participants complete a pre-prepared questionnaire.

Eligibility criteria: Inclusion Criteria:

* experience in anesthesia or intensive care

Exclusion Criteria:

* no

Primary outcomes:
measure: What is the current practice for Airway Management in patients with a anticipated difficult airway?
timeFrame: through study completion, an average of 10 minutes
Secondary outcomes:
measure: What is the most preferred technique for awake flexible endoscopy?
timeFrame: through study completion, an average of 10 minutes
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Center Mainz
name: Marc Kriege, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05774223: Prefrontal iTBS on Working Memory
Official title: Exploring the Effects of Prefrontal iTBS on Working Memory in Healthy Participants: a Concurrent TMS/fNIRS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Theta-Burst stimulation (iTBS)
Functional near-infrared spectroscopy (fNIRS)
Concurrent TMS/fNIRS
Working memory
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Healthy volunteers will receive iTBS two times with active or sham stimulation separated by one week to investigate the effect duration of iTBS on working memory
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators previous pilot study showed that the brain remained activated after 3 minutes of intermittent theta burst stimulation (iTBS). Therefore, an open question remains that how long the effects will last and when the maximum effects will be achieved. In addition, many pioneering works showed the positive effects of repetitive transcranial magnetic stimulation (rTMS) on working memory. Intermittent theta burst stimulation (iTBS) is a patterned form of rTMS, it has shown a non-inferior efficacy in depression but with a much shorter time (approximately 3 mins) than traditional rTMS (approximately 40 mins).

As discussed above, this study aims to investigate the effects of prefrontal iTBS on working memory using concurrent iTBS/fNIRS and to explore the duration of the effects.


Eligibility criteria: Inclusion Criteria:

* right-handed participants
* normal or corrected-to-normal vision

Exclusion Criteria:

* a current or past diagnosis of any neurological or psychiatric disorder
* any severe medical conditions, seizure, and pregnancy
* contraindication to TMS (e.g., with mental implants)

Primary outcomes:
measure: N-back
timeFrame: before and post iTBS, up to 3 months
measure: N-back
timeFrame: before and post iTBS, up to 3 months
Secondary outcomes:
measure: Hemoglobin change
timeFrame: before and post iTBS, up to 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References:
Clinical trial NCT06599723: Racz Catheter Technique Versus Conventional Technique in Lumbar Epidural Steroid Injection for Management of Low Back Pain
Official title: Racz Catheter Technique Versus Conventional Technique in Lumbar Epidural Steroid Injection for Management of Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Racz Catheter
Conventional
Lumbar
Epidural
Steroid Injection
Low Back Pain
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare Racz catheter technique and conventional technique in lumbar epidural steroid injection for the management of low back pain.

Detailed description: Low back pain (LBP) is defined as a localized discomfort sensation below the costal margin and above the inferior gluteal folds, with or without leg pain. Conservative treatment for LBP is focused on delaying or preventing the need for surgery. Indeed, LBP can improve spontaneously or with non-surgical treatment. However, cases that fail to improve with conservative management may need to be considered for a surgical approach.

The epidural injection is a well-founded anesthetic and analgesic technique; moreover, nowadays, new technological devices can help anesthesiologists to learn and to administer it. One of these devices is Racz catheter epidural adhesiolysis. Racz catheter epidural adhesiolysis treatment addresses two issues, the injectate always reaches the area being targeted also the injections are likely to loosen fibrotic adhesions which may be the main cause of the pain in some cases.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* Patients suffering from persistent lumbar pain, grade 1 spondylolisthesis, facet osteoarthropathy, and small disc on radiological findings.

Exclusion Criteria:

* Uncooperative patients.
* Contraindications to perform the proper technique e.g., coagulopathy and skin infection.
* History of allergy to contrast medium.
* Rupture disc.
* Lumbar canal stenosis.
* Previously operated traditional spine surgeries.

Primary outcomes:
measure: Oswestry score
timeFrame: 6 month post-procedure
Secondary outcomes:
measure: Degree of pain
timeFrame: 6 month post-procedure
measure: Patient satisfaction
timeFrame: 6 month post-procedure
measure: Procedure technique time
timeFrame: Intraoperatively
measure: Incidence of complications
timeFrame: 6 month post-procedure
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT06763523: Arthroereisis With Corrective Osteotomy Versus Arthroereisis Alone in Management of Symptomatic Flexible Pes Planovalgus in Adolescents
Official title: Arthroereisis With Corrective Osteotomy Versus Arthroereisis Alone in Management of Symptomatic Flexible Pes Planovalgus in Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pes Plano Valgus
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Arthroereisis ,corrective osteotomies, flexible pes planovalgus, adolescents


Eligibility criteria: Inclusion Criteria:

* cases complaining of flexible pes planovalgus non responsive for conservative treatment and cases with generalized ligamentous laxity

Exclusion Criteria:

* neurological disorders and rigid peaplanovalgus

Primary outcomes:
measure: AOFAS score
timeFrame: 2 years from the start of the study
Secondary outcomes:
measure: VAS score
timeFrame: 2 years from the start of the study
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References:
Clinical trial NCT02356523: Incidence and Prognostic Value of Delirium in Patients With Acute Coronary Syndromes
Official title: Long-term Prognostic Value of Delirium in Elderly Patients With Acute Coronary Syndrome Admitted to Two Cardiac Intensive Care Units: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 700
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted in Cardiac Intensive Care Unit for any condition

Brief summary: The Purpose of this study is to evaluate the incidence of delirium in patients with acute coronary syndromes admitted to a Intensive Care Unit Patients.

Detailed description: The present study is a prospective, two-centre registry aimed at assessing the incidence, prevalence and prognostic significance of delirium in elderly patients with acute coronary syndromes

Eligibility criteria: Inclusion Criteria:

* Admission in Cardiac Intensive Care Unit
* Age ≥ 65 years

Exclusion Criteria:

* none

Primary outcomes:
measure: diagnosis of delirium by confusion assessment method
timeFrame: within 24 hours of admission
Secondary outcomes:
measure: adverse events incidence
timeFrame: 6 months
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Cardiovascular Department, Ospedale S.Donato
state: AR
Study officials:
affiliation: Cardiovascular Department San Donato Hospital Arezzo
name: Leonardo Bolognese, MD, FESC
role: STUDY_CHAIR
References:
citation: Inouye SK. Delirium in hospitalized older patients: recognition and risk factors. J Geriatr Psychiatry Neurol. 1998 Fall;11(3):118-25; discussion 157-8. doi: 10.1177/089198879801100302.
citation: Hsieh SJ, Ely EW, Gong MN. Can intensive care unit delirium be prevented and reduced? Lessons learned and future directions. Ann Am Thorac Soc. 2013 Dec;10(6):648-56. doi: 10.1513/AnnalsATS.201307-232FR.
citation: McPherson JA, Wagner CE, Boehm LM, Hall JD, Johnson DC, Miller LR, Burns KM, Thompson JL, Shintani AK, Ely EW, Pandharipande PP. Delirium in the cardiovascular ICU: exploring modifiable risk factors. Crit Care Med. 2013 Feb;41(2):405-13. doi: 10.1097/CCM.0b013e31826ab49b.
Clinical trial NCT02821923: Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers
Official title: Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes in the food industry and are also recommended to diabetic patients. Both substances are already in use in the food industry and are freely available. Since the 1970s, beneficial effects on oral health could be demonstrated as oral bacteria were influenced positively. A pilot study recently undertaken in the US (Flint N, 2014) has shown that diabetics profit from a daily intake of erythritol, as this natural sweetener enhances the elasticity of the blood vessels. In this trial, investigators aim to examine whether this effect can be found in a non-diabetic but obese cohort, and whether also xylitol improves vascular function.


Eligibility criteria: Inclusion Criteria:

* Obese volunteers (BMI \> 30kg/m2)
* Aged 18- max. 55 years
* Otherwise healthy.

Exclusion Criteria:

* Known cardiovascular disease
* Diabetes mellitus
* Smoking and drug abuse
* Arterial hypertension with antihypertensive treatment
* Dyslipidaemia with statin therapy
* Known chronic hepatic disease (NASH, hepatitis).
* Known renal disease: kidney failure
* Pregnancy
* Chronical diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract
* Substance abuse, alcohol abuse.
* Inability to follow procedures due to psychological disorders, dementia or insufficient knowledge of project language (German).

Primary outcomes:
measure: Central arterial stiffness measured by sonography
timeFrame: Change from baseline to 5 weeks after intake of polyol
Secondary outcomes:
measure: Glucose tolerance measured by oral glucose tolerance test
timeFrame: Change from baseline to 5 weeks after intake of polyol
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
Study officials:
affiliation: St. Claraspital Basel klinische Forschungsabteilung
name: Christoph Beglinger, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04407923: Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context : Impact on Therapeutical Managment
Official title: Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Juvenile Idiopathic Arthritis
COVID 19
Treatment
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 150
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Juvenile Idiopathic Arthritis patients with ongoing DMARD therapy.

Brief summary: The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Juvenile Idiopathic Arthritis is concerns by these fears (the patient and their parents). Patients are treated by several classes of immunomodulatory drugs, including non-steroidal anti-inflammatory drugs, corticosteroids and disease modifying anti-rheumatic drugs. The present study will characterize this issue by defining the proportion of patients whose usual treatment of Juvenile Idiopathic Arthritis has been modified in relation to the actual sanitary crisis, and also to return to school.


Eligibility criteria: Inclusion Criteria:

* Juvenile Idiopathic Arthritis satisfying Edmonton criteria
* Ongoing DMARD therapy or AINS for 3 months

Exclusion Criteria:

* Inhability to consent

Primary outcomes:
measure: Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Belfort
country: France
facility: CH de Belfort
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHRU de Brest
city: Le Kremlin-Bicêtre
country: France
facility: AP-HP Hôpital Kremlin-Bicêtre
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Vandœuvre les Nancy
country: France
facility: CHU de Nancy
Study officials:
References:
Clinical trial NCT01966523: A Pilot Study of an RCT to Improve Infection Management in Advanced Dementia
Official title: A Pilot Study of an RCT to Improve Infection Management in Advanced Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-10-21
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To conduct a pilot study of cluster randomized clinical trial of an practice intervention to improve the quality of care for suspected lower respiratory and and urinary tract infections among 60 nursing home residents with advanced dementia living in 4 facilities (2 matched intervention/control pairs) for 12 months. We hypothesize that 1. In the intervention compared to the control facilities there will be a trend towards a greater proportion of infections for which antimicrobials were initiated appropriately, and 2. in the intervention compared to the control facilities there will be a trend towards higher proxy satisfaction with decision-making, fewer hospital transfers, and lower antimicrobial exposure.


Eligibility criteria: Inclusion Criteria:

Resident eligibility criteria include: 1) Age \> 65, 2) Dementia, 3) Global Deterioration Scale score of 7,59 and 4) a proxy is available who can speak in English. Features of Global deterioration stage 7 include: profound memory deficits (cannot recognize family), total functional dependence, speech \< 5 words, incontinence, and inability to ambulate.

Eligibility criteria for providers in the intervention nursing homes include: Medical Doctor,a. nurse, nurse practitioner, physician assistant identified by a senior administrator as an individual who cares for residents with advanced dementia, and is 2. able to communicate in English because on-line course and algorithms are in English., and 3. over 21 years of age.

-

Exclusion Criteria:

Residents with cognitive impairment due to causes other than dementia (e.g., head trauma) and in short-term, sub-acute SNFs will be excluded. -

Primary outcomes:
measure: proportion of suspected infectious episodes for which antimicrobials were initiated appropriately
timeFrame: 12 months
Secondary outcomes:
measure: hospital transfers
timeFrame: 12 months
Other outcomes:
measure: antimicrobial use
timeFrame: 12 months
measure: Decision satisfaction
timeFrame: 12 months
Locations:
city: Boston
country: United States
facility: Hebrew SeniorLife
state: Massachusetts
Study officials:
References:
Clinical trial NCT01462123: Resect and Discard Strategy in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Assessment
Colonic Polyps
Endoscopic Surveillance
NBI
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2011-10-31
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive adult outpatients undergoing colonoscopy for routine clinical indications

Brief summary: Nowadays, post-polypectomy surveillance intervals are determined by combining endoscopic and pathologic data. Real-time imaging technologies, have shown promising results in discriminating adenomatous from non-adenomatous polyps.

The "resect and discard strategy" for small polyps (based on real-time assessment of the histology and on the endoscopic resection without pathological examination) has been shown to be cost-effective in simulation models. No data exist about the impact of this strategy in clinical practice.

The aim of present study was to assess whether the systematic use, in the everyday clinical practice, of the "resect and discard strategy" allows to correctly manage patients with small colonic polyps.


Eligibility criteria: Inclusion Criteria:

* consecutive adult outpatients undergoing colonoscopy for routine clinical indications

Exclusion Criteria:

* surveillance interval was not necessarily directed by endoscopic findings (history of colorectal cancer, inflammatory bowel disease, hereditary polyposis syndromes, hereditary non-polyposis colorectal cancer)
* colonoscopy was performed without NBI technology
* at least one lesion \> 10 mm or \< 10 mm but with morphologic features suspect for malignancy (depressed or ulcerated lesions) was detected
* bowel preparation was inadequate
* caecal intubation was not accomplished
* polyps could not be resected for concomitant anticoagulation treatment, 7) polyps were resected but not retrieved for pathology.

Primary outcomes:
measure: The primary outcome of the study was to assess the agreement between "endoscopy-" and "histology-determined" surveillance strategies after small adenoma resection.
Secondary outcomes:
measure: sensitivity of the endoscopic assessment (WL coupled with NBI) of small (<10 mm) adenomas
measure: operative characteristics for the diagnosis of diminutive (< 5 mm) adenomas
measure: the feasibility of non histologic evaluation, represented by the proportion of polyps in which a in-vivo diagnosis of adenoma can be made with high confidence
measure: specificity of the endoscopic assessment
measure: accuracy of the endoscopic assessment
Other outcomes:
Locations:
city: Como
country: Italy
facility: Valduce Hospital - Gastroenterology Department
state: CO
Study officials:
References:
citation: Paggi S, Rondonotti E, Amato A, Terruzzi V, Imperiali G, Mandelli G, Terreni N, Lenoci N, Spinzi G, Radaelli F. Resect and discard strategy in clinical practice: a prospective cohort study. Endoscopy. 2012 Oct;44(10):899-904. doi: 10.1055/s-0032-1309891. Epub 2012 Aug 2.