louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01198964: Optimization of Human Cortical Stimulation
Official title: U.S.-German Collaboration: Optimization of Human Cortical Stimulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Brain Injury
Keywords: ECoG
Epilepsy
cortical
stimulation
Electrocorticography
electrodes
mapping
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 8
Sex: ALL
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: Age 18 and older male and female epileptic patients who are referred for surgical implantation of electrodes.

Brief summary: We will observe epileptic patients who already have electrodes implanted on the brain and are receiving high-level brain stimulation for clinical purposes while testing their motor and language function. We propose to do a limited, low-level brain stimulation to show that the signatures of local activity in the target area change as an effect of brain stimulation. The goal of this study is to understand the feasibility of a novel recurrent brain-computer interface that could eventually promote targeted functional recovery in subjects who have had a brain injury.

Detailed description: The subject will have already been scheduled for placement of the ECoG electrodes on the surface of the brain and who will, for all clinical purposes, subsequently receive stimulation for mapping of function of the ECoG sites. The decision to place the electrodes on the brain, the location of the electrodes and the length of time the electrodes are in are all part of clinical care.

There will be two types of testing, motor and language. Motor will involve inducing stimulation to the thumb cortex and the wrist cortex. There will be a conditioning of this over 4-12 hours. Language will involve showing pictures on a computer screen and the subject will be observed whether speech is disrupted with stimulation or not.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Male and Female
* Able to understand English for consenting and testing
* Referred for surgical implantation of electrodes

Exclusion Criteria:

* Under 18 years of age
* Pregnant women
* Prisoners
* Mentally disabled IQ \< 70
* Non English Speaking
* Not candidates for surgical implantation of electrodes

Primary outcomes:
measure: Link EMG activity produced during a motor task to stimulation of a part of the brain
timeFrame: 5 years
Secondary outcomes:
measure: Evaluate distribution of current from stimulation
timeFrame: 5 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Jeffrey G Ojemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04647864: The Coronary AccEss After Tavi Registry - A Multicenter Prospective Registry for the Coronary Access After TAVI
Official title: The Coronary AccEss After Tavi Registry - A Multicenter Prospective Registry for the Coronary Access After TAVI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Disease
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Fondazione GISE Onlus
First posted: 2020-12-01
Enrollment: 600
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: Patients with a symptomatic aortic valve disease (stenosis or combined stenosis and regurgitation), who are candidate to TAVI according to local Heart Team evaluation. Valve-in-valve procedure due to degeneration of a previously implanted surgical bio prosthesis are also included in this study population.

All consecutive patients who undergo coronary access immediately after TAVI will be enrolled in this study.

Brief summary: The CAvEAT study is a not for profit, international, multicenter study aimed to assess the feasibility of selective coronary angiography (CA) after Transcatheter Aortic Valve Implantation (TAVI), to investigate predictors of successful selective cannulation (anatomical, technical, etc.) and to investigate if there is a significant difference among different type of transcatheter valves in selective coronary cannulation.


Eligibility criteria: Inclusion Criteria:

* Symptomatic aortic valve disease (stenosis or combined stenosis and regurgitation) candidate to TAVI according to local Heart Team evaluation, including valve-in-valve procedure due to degeneration of a previously implanted surgical bioprosthesis, who undergo coronary access in the same session of TAVI, immediately after transcatheter valve deployment (the procedures have to be consecutive);
* Provision of signed informed consent;
* Age ≥18 Years.

Exclusion Criteria:

* Chronic Kidney Disease stage IV-V (without dialytic treatment; otherwise, patients in dialytic treatment could be included);
* Current participation in an interventional clinical study;
* Age \< 18 years.

Primary outcomes:
measure: Successful selective cannulation of both coronary arteries
timeFrame: Immediately after TAVI
Secondary outcomes:
measure: Successful selective cannulation of only left coronary artery
timeFrame: Immediately after TAVI
measure: Successful selective cannulation of only right coronary artery
timeFrame: Immediately after TAVI
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedale Università Padova
Study officials:
References:
Clinical trial NCT03845764: Can a Pulmonologist Reliably Assess the Tumor Burden on ROSE Slides Obtained From Pulmonary Nodules and Lymphadenopathy
Official title: Interobserver Agreement Between Pulmonologist, Pathologist and Molecular Pathologist in the Assessment of Tumor Burden on ROSE Slides Obtained With Endoscopic Procedures From Pulmonary Nodules and Intrathoracic Lymphadenopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Maggiore Bellaria Hospital, Bologna
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with indication to bronchoscopy or endosonography for suspected lung cancer based on imaging (CT and/or PET)

Brief summary: The study is aimed at verifying if a pulmonologist can reliably assess the tumor burden for the extractive molecular analysis in ROSE samples obtained with endoscopic sampling procedures from intrathoracic lymphadenopathy and pulmonary nodules.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Indication for endoscopic sampling of suspected malignant lymphadenopathy or pulmonary lesion
* Written informed consent

Exclusion Criteria:

* High risk conditions for the performance of bronchoscopy and/or EBUS-TBNA
* High risk condition for deep sedation (ASA 4)
* Pregnancy

Primary outcomes:
measure: Accuracy with which a pulmonologist can assess the tumor burden on ROSE slides
timeFrame: The time frame is the duration of each bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled
Secondary outcomes:
measure: Interobserver agreement between pulmonologist, pathologist and molecular pathologist in then assessment of the tumor burden on ROSE slides
timeFrame: The time frame is the duration of each bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled
measure: Accuracy with which a pulmonologist can identify malignancy on ROSE samples
timeFrame: The time frame is the duration of each bronchoscopy endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Maggiore Hospital
state: Emilia Romagna
city: Bologna
country: Italy
facility: Policlinico S. Orsola
Study officials:
affiliation: Policlinico S. Orsola, Bologna
name: Rocco Trisolini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001664: Sleep Disorders of Patients With Diseases of the Nervous System
Official title: Training Protocol for Various Sleep Disorders in Patients With Neurological Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypersomnia
Narcolepsy
Nervous System Disease
Sleep Disorder
Keywords: Narcolepsy
Polysomnography
Multiple Sleep Latency Test
Sleep Disorders
Hypersomnia
Periodic Leg Movements
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 83
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to assist training doctors about different diseases of the nervous system affecting sleep.

Patients selected to participate in this study will have any of a variety of sleep disorders. They will undergo several tests including an overnight recording of brain activity, eye movement, leg movement, breathing, heart rate, and other measures.

Results of these tests will be used to better understand diseases causing sleep disorders and may be used to develop better treatments for them.

Detailed description: The objective of this protocol is to provide training in a broad range of neurological sleep disorders to clinical associates who are eligible for sitting in the Board examination of the Added Qualification of Clinical Neurophysiology administered by the American Board of Psychiatry and Neurology. This protocol is to supplement small accrual of research patients who are referred from within the NIH.

Eligibility criteria: * IINCLUSION CRITERIA:

Patients 5 years of age and older, with the following referring diagnoses:

Narcolepsy

Hypersomnia

REM behavior disorder

Frontal nocturnal dystonia

Restless legs syndrome

Insomnia

Parasomnia

Nocturnal epileptic seizure

Nocturnal movement disorder

Sleep-related diagnostic dilemma

Sleep apnea associated with neurological disorders

Patients who are ambulatory and who are able to comply with the study procedures.

Patients who are able to understand and sign the informed consent. (Parent or guardian for minors).

EXCLUSION CRITERIA:

Patients who have been diagnosed with acute and progressive neurological disorders.

Patients who are unable to comply with the study procedures and require other than standard care.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
References:
Clinical trial NCT03665064: Long Term Outcome Study in Patients With Pituitary Disorders
Official title: Long Term Outcome Study in Patients With Pituitary Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pituitary Diseases
Pituitary Neoplasms
Keywords: Pituitary tumor
Acromegaly
Cushing
Prolactinoma
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: tertiary referral center

Brief summary: To determine the outcomes of patients with different pituitary disorders whether they are managed medically, surgically or expectantly.

Detailed description: A chart audit of around 1500 patients seen in two specific clinics, the Medical Pituitary Clinic and the combined Endocrine/Neurosurgical Pituitary Clinic at the University of Alberta Hospital, will be performed to determine the effectiveness of various treatment strategies on the long term outcome of specific pituitary disorders. The investigator's will collect retrospective demographic (age, sex, ethnicity), clinical (mode of presentation, hormonal parameters) and therapeutic outcome (surgical, medical, expectant and / or radiation treatment; co-morbidities and complications) of patients seen in these two clinics between January 2000 and December 2020.

Eligibility criteria: Inclusion Criteria:

* patients with confirmed pituitary disease

Exclusion Criteria:

* patients who do not have confirmed pituitary disease

Primary outcomes:
measure: Progression free survival after pituitary surgery
timeFrame: up to 17 years post surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01475864: Prospective Evaluation of the Covered Self-expandable Metal Stents (CSEMS) for Incomplete Biliary Stone Clearance
Official title: Prospective Evaluation of the Clinical Utility of Endoscopically-placed Self Expandable Stents
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Choledocholithiasis
Keywords: Choledocholithiasis
metal stents
biliary duct stent
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 0
Sex: ALL
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: Those patients who have a biliary stone that has not been removed by standard medical care.

Brief summary: The current standard of care for bile duct stone are endoscopic sphincterotomy and stone extraction. Placement of plastic stents is an option for incomplete biliary stone clearance. This study will use the CSEMS in patients with complex biliary stones who failed stone extraction as they have the advantage of large stent diameter. CSEMS may offer a temporizing measure that allows more successful subsequent stone clearance. However, their use in benign condition has been limited especially for biliary stone removal. The purpose of this study is to determine the feasibility, safety, easy removability, stent-stone formation rate, and migration rate of CSEMS for complex biliary stones.

Detailed description: same as brief summary

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Bilary stone unable to be extracted with balloon, basket, large balloon dilation of the ampulla or mechanical lithotripsy.
* Stone can be bridged by the metal stent
* Subject must be able to give informed consent.

Exclusion Criteria:

* Any contraindication to ERCP
* Patient refuses consent for the study.

Primary outcomes:
measure: complete biliary stone clearance
timeFrame: 12 months
Secondary outcomes:
measure: other techniques used for stone clearance
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Peter V Draganov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03260764: Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts
Official title: the Comparison of Multifocal Contact Lenses and Bifocal Spectacles for Congenital Cataracts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multifocal Contact Lenses
Keywords: Multifocal Contact Lenses
Bifocal Spectacles
Congenital Cataracts
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators provide participants who had congenital cataract the multifocal contact lenses and bifocal spectacles in the purpose of seeking out a better way to make a definite diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of multifocal contact lenses and bifocal spectacles.

Detailed description: Children diagnosed as cataract without treatment were enrolled to a prospective, randomized controlled study. Patients were assigned to four groups: participants in group A wearing multifocal contact lenses a week and then bifocal spectacles a week;in Group B, the participants wearing bifocal spectacles a week and then multifocal contact lenses;in Group C, the participants wearing multifocal contact lenses four a year;in Group D, the participants wearing bifocal spectacles four a year. Investigators compare the acuity, refraction, contrast sensitivity and the results of questionnaire between A and B , C and D groups.

Eligibility criteria: Inclusion Criteria:

* diagnosed as binocular cataract
* after the surgery of binocular intraocular lens implantation more than one month

Exclusion Criteria:

* diagnosed as xerophthalmus
* diagnosed as other eye diseases or systemic diseases

Primary outcomes:
measure: Demography (age, sex, laterality and medical history)
timeFrame: baseline
Secondary outcomes:
measure: The refraction status (presented as spherical equivalent, SE)
timeFrame: after wearing contact lenses one month, three months ,six months and a year
measure: acuity
timeFrame: after wearing contact lenses one month, three months ,six months and a year
measure: contrast sensitivity
timeFrame: after wearing contact lenses one month, three months ,six months and a year
measure: questionnaire result
timeFrame: after wearing contact lenses one month, three months ,six months and a year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00461864: Diagnosis of Occult Hip Fractures With Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Fractures
Occult Fractures
Keywords: fracture
occult
hip
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: occult hip fractures present to the emergency room with a history of trauma,a painful hip and normal X-ray. these patients usually undergo other imaging modalities such as CT scans, MRI, or bone scans.

In this study we check the sensitivity and specificity of a directed ultrasound examination of the hip joint in diagnosing or excluding a hip fracture. We also compare the results of ultrasound examination by the orthopedic surgeon in the emergency room versus the consultant radiologist.

The patients undergo bone scans or CT to make the diagnosis.


Eligibility criteria: Inclusion Criteria:

* patients over age of 50 with clinical suspicion of a hip fracture

Exclusion Criteria:

* previous fracture or surgical intervention in the hip
* pregnancy
* flexion contracture of hip

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Alon Burg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01348464: A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy
Official title: Transumbilical Single Port Laparoscopic Appendectomy Versus Conventional Laparoscopic Appendectomy in Adult Patients: A Prospective Randomized Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Keywords: appendectomy
appendicitis
laparoscopic surgery
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2011-05-05
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cohorts will be the residents of Incheon, Korea

Brief summary: The aim of this study is to compare patients who undergone single-port access laparoscopic appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA) in a prospective randomized trial

Detailed description: * primary objective

  1. complication rate
* secondary objectives

  1. satisfaction rate
  2. pain scale difference

Eligibility criteria: Inclusion Criteria:

* age 5\~85 years
* any patient diagnosed with acute appendicitis on appendix sonography or abdominopelvic CT
* Patient performance status(PS) with greater than 80 or more on Karnofsky PS
* Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion Criteria:

* Pregnant or lactating
* Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
* History of Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated cancer
* Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.

Primary outcomes:
measure: Complication rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 24 weeks
Secondary outcomes:
measure: patient satisfaction
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 24 weeks
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon Univ., Gil Medical Center
Study officials:
affiliation: Gachon Univ. Gil Medical Center
name: Won-Suk Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raakow R, Jacob DA. Initial experience in laparoscopic single-port appendectomy: a pilot study. Dig Surg. 2011;28(1):74-9. doi: 10.1159/000322921. Epub 2011 Feb 4.