louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02100709: The Effect of NIV on QoL and Exercise Capacity in a COPD Exercise Rehabilitation Program
Official title: The Effect of BiLevel Pressure Support NonInvasive Ventilation on Quality of Life and Exercise Capacity in a COPD Exercise Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation on COPD patients. In particular the effect on:

* the amount of daily physical activity
* Quality of life
* The 6-minute walk distance
* Time to exacerbation

and compare it to the effect of 4 weeks of outpatients rehabilitation with Noninvasive Ventilation as an adjunct therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD III+IV
* Age \>18 years
* Former NIV treatment for at least 6 weeks with a positive end-expiratory pressure of at least 4 cmH2O and a pressure support of 8 cmH2O or higher

Exclusion Criteria:

* Pulmonary Exacerbation requiring antibiotic treatment or hospitalization during the last 6 weeks
* non-pulmonary Exercise impairment (amputation, severe heart disease, etc)
* any disease that precludes exercise training
* inability to understand the patient information
* substance abuse
* oxygen requirement of more than 6l O2/min during exercise

Primary outcomes:
measure: Daily Physical Activity
timeFrame: 3 Months
measure: Exercise Capacity
timeFrame: 6 Weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: 3 Months
measure: Dyspnoea
timeFrame: 6 Weeks
measure: Change in Physiological Parameters
timeFrame: 3 Months
Other outcomes:
measure: Time to pulmonary exacerbation
timeFrame: 12 Months
Locations:
city: Tuschen
country: Germany
facility: Ruhrlandklinik
state: Essen
Study officials:
affiliation: Dept. Respiratory & Sleep Medicine - Ruhrlandklinik
name: Helmut Teschler, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06349109: Physical Activity in Children With Wolff-Parkinson-White Syndrome
Official title: Physical Activity Level and Determinants in Children With Wolff-Parkinson-White Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wolff-Parkinson-White Syndrome
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 26
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 7-18 years who are followed up by the Department of Paediatrics, Division of Paediatric Cardiology, Faculty of Medicine of a university will be included in the study.

Brief summary: The aim of this study was to investigate the level of physical activity and its determinants in children with WPW.


Eligibility criteria: Inclusion Criteria:

* Being between 7-18 years old
* Ensuring clinical stability in patients
* No change in drug therapy, if any, that adversely affects clinical stability

Exclusion Criteria:

* Neurological and/or genetic musculoskeletal disorders
* Diagnosed orthopaedic and cognitive problems that prevent the tests from being performed
* History before 4 weeks of cardiac or other body system problems
* The patient and/or his/her family does not want to be included in the study

Primary outcomes:
measure: The Physical Activity Questionnaire for Older Children Score
timeFrame: 15-20 mins
Secondary outcomes:
measure: VO2peak
timeFrame: 30-45 minutes
measure: aPWV
timeFrame: 15-20 minutes
measure: GLS
timeFrame: 30-45 minutes
measure: LASr
timeFrame: 30-45 minutes
measure: LASct
timeFrame: 30-45 minutes
measure: LAScd
timeFrame: 30-45 minutes
measure: Physical activity barriers (Parent) scale score
timeFrame: 15-20 minutes
measure: Physical Activity Outcome Expectancies (Child) scale score
timeFrame: 15-20 minutes
measure: Physical Activity Home Environment (Child) scale score
timeFrame: 15-20 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT03504709: REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
Official title: Advanced MRI and EEG to Predict Recovery of Consciousness After Severe Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Consciousness Disorder
Coma
Brain Injuries, Traumatic
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 79
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: Adults admitted to the intensive care unit for acute severe traumatic brain injury

Brief summary: The aim of this study is to assess the utility of advanced magnetic resonance imaging (MRI) and electroencephalographic (EEG) technologies for predicting functional outcomes in patients with severe traumatic brain injury (TBI).


Eligibility criteria: Patients:

Inclusion Criteria:

* Traumatic Brain Injury
* Glasgow Coma Scale score of 3-8 within 24 hours, unconfounded by sedation, paralysis, hypoxia, hypotension, hypothermia, or concurrent medical illness
* Clinical evidence of disorder of consciousness defined as coma, VS, or MCS

Exclusion Criteria:

* History of prior severe brain injury or dementia
* Emergence from MCS at time of initial CRS-R assessment

Healthy Subjects:

Exclusion Criteria:

History of brain injury or neurological disease, psychiatric disease, or any history of diabetes, high blood pressure, heart disease, or kidney disease

Primary outcomes:
measure: Disability Rating Scale total score
timeFrame: 6 months post injury
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Edlow BL, Chatelle C, Spencer CA, Chu CJ, Bodien YG, O'Connor KL, Hirschberg RE, Hochberg LR, Giacino JT, Rosenthal ES, Wu O. Early detection of consciousness in patients with acute severe traumatic brain injury. Brain. 2017 Sep 1;140(9):2399-2414. doi: 10.1093/brain/awx176.
citation: Bodien YG, Giacino JT, Edlow BL. Functional MRI Motor Imagery Tasks to Detect Command Following in Traumatic Disorders of Consciousness. Front Neurol. 2017 Dec 18;8:688. doi: 10.3389/fneur.2017.00688. eCollection 2017.
citation: Bodien YG, Chatelle C, Edlow BL. Functional Networks in Disorders of Consciousness. Semin Neurol. 2017 Oct;37(5):485-502. doi: 10.1055/s-0037-1607310. Epub 2017 Dec 5.
citation: Threlkeld ZD, Bodien YG, Rosenthal ES, Giacino JT, Nieto-Castanon A, Wu O, Whitfield-Gabrieli S, Edlow BL. Functional networks reemerge during recovery of consciousness after acute severe traumatic brain injury. Cortex. 2018 Sep;106:299-308. doi: 10.1016/j.cortex.2018.05.004. Epub 2018 May 12.
Clinical trial NCT01847209: Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions
Official title: Percutaneous Image Guided Video Assisted Thoracic Surgery (VATS) Resection of Lung Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: lung nodule
lung cancer
lung mass
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions USA - CSG
First posted: 2013-05-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II protocol to determine the safety and feasibility of Intraoperative CT fluoroscopy guidance for lung resection for small nodules.

Detailed description: This is a phase II protocol to determine the safety and feasibility of image guided CT marking for resection of small lung nodules. This is relevant because many such nodules are hard to localize for minimally invasive lung resection. It is hoped that this technology using fluoro CT capability available now in most operating room will improve safety and reliability of thoracic surgery.

Eligibility criteria: Inclusion Criteria:

* peripheral lung nodules \< 3cm in size
* Surgical candidate

Exclusion Criteria:

* Non surgical candidate

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
timeFrame: 30 days
Secondary outcomes:
measure: Patients Underwent a Successful Resection
timeFrame: 30 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Raphael Bueno, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gill RR, Zheng Y, Barlow JS, Jayender J, Girard EE, Hartigan PM, Chirieac LR, Belle-King CJ, Murray K, Sears C, Wee JO, Jaklitsch MT, Colson YL, Bueno R. Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial. J Surg Oncol. 2015 Jul;112(1):18-25. doi: 10.1002/jso.23941. Epub 2015 May 28.
Clinical trial NCT00795509: Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).
Official title: Special Investigation For Long Term Use Of Detrusitol (Regulatory Post Marketing Commitment Plan).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder, Overactive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-21
Enrollment: 374
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A6121187 prescribes the Tolterodine tartrate (Detrusitol® Capsule).

Brief summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes the first Detrusitol® Capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

* Patients need to be administered Detrusitol® Capsule in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Detrusitol® Capsule.

Primary outcomes:
measure: Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs).
timeFrame: 52 weeks
measure: Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00896909: HER-2 Mutations in Tumor Samples From Patients With Advanced Non-Small Cell Lung Cancer Treated on Clinical Trial ECOG-2598
Official title: Evaluation of HER2 Mutations in Patient Tumors From E2598
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE

Brief summary: RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at HER-2 mutations in tumor samples from patients with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial ECOG-2598.

Detailed description: OBJECTIVES:

* Correlate clinical response to trastuzumab (Herceptin®) with the presence of mutation in the HER-2 kinase domain in tumor samples from patients with advanced non-small cell lung cancer treated on protocol ECOG-2598.
* Correlate mutations with time to progression and survival of these patients.

OUTLINE: This is a multicenter study.

Tissue specimens are analyzed by polymerase chain reaction to assess mutations in the HER-2 gene. Laboratory/biomarker analysis data is correlated with clinical data from protocol ECOG-2598.

PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of non-small cell lung cancer meeting ≥ 1 of the following criteria:

  * Recurrent disease
  * Stage IIIB with pleural or pericardial effusion
  * Stage IV disease
* Treated on protocol ECOG-2598

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Correlation of HER-2 mutation with response, time to progression, and survival
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: David P. Carbone, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01738009: Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B
Official title: Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Keywords: Sleep Apnea
Pathophysiology
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The cause of PEN is unknown. The investigators will test if lung volumes and low respiratory drive play a role in PEN.

Detailed description: The mechanisms that lead to airway closure in OSA are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea.

The investigators will test if lung volumes and low respiratory drive play a role in PEN. To this end, the investigators will visualize the pharynx of sleep apnea patients during sleep using a thin endoscope during sleep while simultaneously measuring lung volumes, genioglossus electromyogram, and pharyngeal pressure during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP).

Eligibility criteria: Inclusion Criteria:

* Normal subjects or patients with OSA

Exclusion Criteria:

* Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
* Any medication known to influence breathing, sleep/arousal or muscle physiology
* Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
* Claustrophobia
* Inability to sleep supine
* Allergy to lidocaine or oxymetazoline hydroclhoride
* For women: Pregnancy

Primary outcomes:
measure: Difference in peak inspiratory flow
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: David A Wellman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06119009: New-onset Heart Blocks After Noncardiac Surgery: a Retrospective Study of More Than 280,000 Patients
Official title: New-onset Heart Blocks After Noncardiac Surgery: a Retrospective Study of More Than 280,000 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Block
Risk Factor
Keywords: Postoperative new-onset heart blocks
Noncardiac surgery
Machine learning
Prediction model
Prognosis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 281497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data were gathered from electronic medical records (EMRs) for all patients undergoing noncardiac surgery at the First Medical Center of the Chinese People's Liberation Army General Hospital (PLAGH) from January 1, 2008 to August 1, 2019. Patients with a surgical duration of less than 30 minutes or age \<18 years were excluded. Input data elements were extracted from the patient anesthesia and medical records. The survival data one year after surgery were obtained from medical records and telephone follow-up records confirmed by the Chinese Center for Disease Control and Prevention (CCDC)

Brief summary: This study aimed to investigate new-onset heart blocks after noncardiac surgery, identify risk factors, and develop a prediction model.

Detailed description: Objective: This study aimed to investigate new-onset heart blocks after noncardiac surgery, identify risk factors, and develop a prediction model.

Methods: A retrospective cohort study included 281,497 patients aged 18 or older who underwent noncardiac surgery at a single center between Jan 2008 and Aug 2019. The main outcome was postoperative new-onset heart blocks within one year, including atrioventricular and bundle blocks. Prognostic impact was assessed using Kaplan-Meier survival curves and time-dependent Cox regression analysis. Perioperative data was used for machine learning models (logistic regression, support vector machine, random forest, decision tree). Model performance was measured using the area under the receiver operating characteristic curve (AUC).

Eligibility criteria: Inclusion Criteria:

* patients above 18 yrs undergoing noncardiac surgery at the First Medical Center of the Chinese People's Liberation Army General Hospital (PLAGH) from January 1, 2008 to August 1, 2019.

Exclusion Criteria:

* surgical duration of less than 30 minutes
* incomplete data

Primary outcomes:
measure: New-onset heart blocks
timeFrame: within one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04627909: Robot Therapy in Pediatric Emergency
Official title: Emotional Support of a Social Robot at the Pediatric Emergency Department: a Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child, Only
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 109
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children in pediatric emergency department

Brief summary: The investigators are evaluating if the use of humanoid robots is an optimal distraction strategy in order to produce positive emotional states and facilitate the diagnosis and to reduce treatment time in pediatric age in emergency situations.


Eligibility criteria: Inclusion Criteria:

* children between the ages of 3 and 10 with white, green and yellow triage code

Exclusion Criteria:

* Red triage code
* inadequate knowledge of the Italian language,
* yellow triage code in case of: headache for recent trauma with visual impairment; headache with neck rigidity or vomiting; indifference to the environment; dyspnea and increased respiratory work; intoxication by inhalation of toxic substances; significant trauma to the head with altered state of consciousness.

Primary outcomes:
measure: Salivary cortisol level
timeFrame: The surveys have been made when children arrived, after their assigned 15-minutes interaction, and twenty minutes before medical physical examination.
Secondary outcomes:
measure: Psychological tests
timeFrame: The surveys have been made after a 15-minute interaction with the robot or mother or medical staff.
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: University of L'Aquila
Study officials:
References:
citation: Rossi S, Santini SJ, Di Genova D, Maggi G, Verrotti A, Farello G, Romualdi R, Alisi A, Tozzi AE, Balsano C. Using the Social Robot NAO for Emotional Support to Children at a Pediatric Emergency Department: Randomized Clinical Trial. J Med Internet Res. 2022 Jan 13;24(1):e29656. doi: 10.2196/29656.
Clinical trial NCT02856009: Role of Nutrition in Patients Over 75 Years of Age With Stroke
Official title: Impact of Nutritional Status and Frailty on the Prognosis of Patients Over 75 Years Old Who Suffered a Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 177
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Stroke in elderly subjects has a more severe clinical presentation (in terms of frequency of aphasia, hemiplegia or consciousness disorders), and a worse functional and vital prognosis. Patients older than 75 years also show excess mortality. One of the hypotheses to explain this situation is the high level of frailty in this population. Many tools to measure the concept of frailty have been developed. One important dimension of these tools is the nutritional status. Indeed, protein-energy malnutrition in the elderly, though a frequent situation, is also a complex phenomenon.

The aim of this study is therefore to analyse the impact of protein-energy malnutrition, as a marker of frailty, on the early prognosis (at 28 days) in the aftermath of stroke in subjects older than 75 years hospitalized in Dijon CHU.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic stroke defined according to WHO criteria (including cerebral infarction and intracerebral haemorrhage) managed at the stroke ICU, Neurology 1, Neurology 2, Internal Medicine 2 or Geriatrics at Dijon CHU during the period from 1st November 2015 to 30th September 2016.
* Patients aged 75 years and older.
* Patients who have provided informed consent to take part in the study.

Exclusion Criteria:

* Patients with meningeal haemorrhage or TIA.
* Patients who refuse to take part in the study.
* Patients with hypo-albuminemia not related to malnutrition: chronic infectious or inflammatory syndrome, nephrotic syndrome, exudative enteropathy, hydration disorders.
* Subjects in custody.
* Patients (or person of trust) who cannot be contacted by telephone during the follow-up.

Primary outcomes:
measure: Mortality rate
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References: