louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02056860: Detecting Lung Infections Through Vibration
Official title: Feasibility and Optimization of High Frequency Oscillation (HFO) for Detection of Lung Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Infection
Keywords: cystic fibrosis
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy normal adults age 18 to 50 Individuals with cystic fibrosis

Brief summary: The purpose of this study is to test a lung air vibrator device for vibrating air inside the lung. This exploratory diagnostic trial will test a novel and non-invasive means of detecting lower airway infections using exhaled breath sample.

Detailed description: This study has two phases. Once the subject has consented phase 1 will start by the subject breathing air out of their lungs into the device. Next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air.

In phase 2, the subjects will breathe air out of their lungs into the device for 15 minutes. Next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air for 15 minutes.

Eligibility criteria: Inclusion Criteria:

* Age 18-50

Exclusion Criteria:

* History of major respiratory compromise (except cystic fibrosis if included within cystic fibrosis cohort)

Primary outcomes:
measure: Optimal Operating Conditions for HFO Device
timeFrame: 6 months
Secondary outcomes:
measure: Particle size and distribution from exhaled breath
timeFrame: One year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Erin P Silverman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004760: Study of Axial Mobility Exercises in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
Neurologic and psychiatric disorders
Rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 2000-02-25
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: ECT

Brief summary: OBJECTIVES:

I. Compare the benefit of exercise versus usual care (no exercise) on impairments and functional limitations in patients with Parkinson disease.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. Patients assigned to the Axial Mobility Exercise Program participate 3 times a week for 10 weeks. The program consists of individualized exercises specifically directed toward restoration of axial mobility in the context of functional tasks.

Patients assigned to the control group receive standard care (no exercise).

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Stage 2 or 3 Parkinson disease (Hoehn/Yahr scale) Able to ambulate independently Able to function independently in home Moderate rigidity No moderate or severe tremor --Prior/Concurrent Therapy-- Concurrent stable pharmacologic regimen required --Patient Characteristics-- Cardiovascular: No unstable angina Other: No psychiatric or medical contraindication to exercise, e.g., dementia, hip fracture; no other neurologic disorder, e.g., stroke, multiple sclerosis; resides within 30 miles of Duke University

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Margaret Schenkman
role: STUDY_CHAIR
References:
Clinical trial NCT04119960: Clinical Validation of InferRead Lung CT.AI
Official title: Clinical Validation of InferRead Lung CT.AI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Infervision
Sponsor class: INDUSTRY
First posted: 2019-10-09
Enrollment: 250
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lung cancer screening eligible patients

Brief summary: Lung cancer is the second most common cause of cancer-related death in men and women. Early pulmonary nodule screening is an effective means to prevent lung cancer, which is no less important than the diagnosis and treatment of lung cancer. Early lung cancer screening has been investigated and applied as a medical practice. InferRead Lung CT.AI by Infervision is a dedicated post processing application that generates CADe marks as an overlay on the original CT series intended to aid the radiologist in the detection of pulmonary nodules. This study was designed to evaluate radiologists' performance in detecting actionable nodules on chest CT when aided by InferRead.


Eligibility criteria: Inclusion Criteria:

* Lung cancer screening eligible patients

Exclusion Criteria:

-

Primary outcomes:
measure: Detection accuracy
timeFrame: 20 hours
Secondary outcomes:
measure: Reading time change
timeFrame: 20 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
References:
Clinical trial NCT04071860: Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study
Official title: Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnoea
Obstructive Sleep Apnoea
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Iceni Labs Ltd, Warwickshire, United Kingdom
First posted: 2019-08-28
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the sleep laboratory for inpatient polysomnography, irrespective of working or known diagnosis.

Brief summary: Sleep apnoea (SA) is a common condition in adults and children that causes disturbed sleep and daytime symptoms. It is characterised by disrupted breathing with disturbed sleep patterns. In adults this can lead to dangerous daytime sleepiness affecting for example driving performance. In children it may lead to hyperactivity in the day and poor school performance. There are a number of techniques for diagnosing the disorder but they can affect the quality of sleep which sometimes makes them inaccurate. Most are unsuitable for small children who cannot understand the value of the tests and tend to remove the monitoring wires and devices in the night. This study aims to validate a new non contact device "Safescan", based on low power radar technology, which can be put under a bed and record breathing patterns with no measuring device in contact with the sleeper. In this initial study the device will be validated in adults, against the gold standard of polysomnography (PSG) in the sleep laboratory at Royal Papworth Hospital.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Able to give informed consent

Exclusion Criteria:

* Patient with known sleep disordered breathing using a treatment device (e.g. continuous positive airway pressure) on the night of the study.
* Polysomnography study records less than 4 hours of respiratory data

Primary outcomes:
measure: Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography
timeFrame: overnight (8-10 hours)
Secondary outcomes:
measure: Agreement between the Safescan device respiratory rate (RR) as breaths per minute overnight and RR from PSG
timeFrame: overnight (8-10 hours)
measure: Agreement in recorded body position between Safescan device and PSG
timeFrame: overnight (8-10 hours)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
state: Cambridgeshire
Study officials:
affiliation: Royal Papworth Hospital
name: Ian Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05033860: The Influence of Education During Waiting Time of Vaccination on the Knowledge Towards COVID-19 Among Chinese Residents
Official title: The Influence of Education During Waiting Time of Vaccination on the Knowledge Towards COVID-19 Among Chinese Residents: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Knowledge, Attitudes, Practice
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 1. Intervention group: leaflets containing knowledge of COVID-19 and vaccination were distributed, and questionnaire surveys were conducted afterwards.
2. Control group: questionnaire surveys were conducted without leaflets distribution.
Primary purpose: PREVENTION

Brief summary: Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by a novel coronavirus, which has developed the global pandemic situation. The promotion of vaccination is an effective strategy to control the epidemic. A total of 19,5738,000 doses of COVID-19 vaccines have been reported in China until August 24th, 2021. During widespread vaccination, the education in COVID-19 prevention and vaccination for residents are also crucial. To figure out the influence of education during waiting time of vaccination, we have designed a randomized controlled trial and planned to distribute leaflets and questionnaires to the residents of Xidian (a town in Ninghai, Zhejiang). This study is of great significance for the prevention of COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18;
2. Residents who are vaccinated with COVID-19 vaccines at Xidian Passenger Station from August 18th to September 20th, 2021;
3. Able to understand the content of leaflets and questionnaires, and willing to participate in the study.

Exclusion Criteria:

1. Residents who are unable to get vaccinated with COVID-19 vaccines;
2. Unable to understand the content of leaflets and questionnaires, or unwilling to participate in the study;
3. Unreturned or incomplete questionnaires.

Primary outcomes:
measure: Scores of the questionnaire
timeFrame: 5-20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT03138460: Analysis of Orthopedic Patients Response to New Pain Modulating Substances and Drugs
Official title: Effect of New Pain Modulating Substances in Orthopedics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic pain sufferers mostly low back pain but also fibromyalgia and arthritis

Brief summary: Data of patient reported outcomes (PRO) are collected during treatment with various pain alleviation methods (drugs or substances)

Detailed description: The study aims at collecting BPI (brief pain inventory) and other PRO of patients in need of pain relief due to chronic orthopedic pain conditions

Eligibility criteria: Inclusion Criteria:

Chronic pain of orthopedic origin treated for at least one year unsuccessfully

Exclusion Criteria:

contra-indication for cannabis treatment

Primary outcomes:
measure: Brief pain inventory score (BPI)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Petaẖ Tiqwa
country: Israel
facility: Hasharon Hospital
Study officials:
affiliation: head orthopedic research unit
name: dror robinson, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00351260: BBC ONE - British Bifurcation Coronary Study
Official title: British Bifurcation Coronary Study - Old, New and Evolving Strategies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischaemic Heart Diseases
Stenosis
Angina
Keywords: Bifurcation
Coronary
Stenosis
Stent
drug elution
Lead sponsor: Royal Sussex County Hospital
Sponsor class: OTHER
First posted: 2006-07-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims to assess whether a SIMPLE or a COMPLEX strategy is best for the treatment of coronary bifurcation stenoses.

Detailed description: 500 patients will be randomised to either a SIMPLE strategy (provisional T stenting) or a COMPLEX strategy (crush or culotte stenting) with clinical follow-up at 9 months.

Eligibility criteria: Inclusion Criteria:\>18 years

* Coronary Bifurcation Lesion requiring treatment

Exclusion Criteria:

* Cardiogenic Shock
* Acute MI
* Additional type C lesion for Rx platelets \<50
* LVEF \<20%

Primary outcomes:
measure: Death
measure: Myocardial infarction
measure: Target vessel revascularisation
Secondary outcomes:
measure: Repeat angiography
measure: Stent thrombosis
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
Study officials:
affiliation: Royal Sussex County Hospital
name: David J.R, Hildick-Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Behan MW, Holm NR, de Belder AJ, Cockburn J, Erglis A, Curzen NP, Niemela M, Oldroyd KG, Kervinen K, Kumsars I, Gunnes P, Stables RH, Maeng M, Ravkilde J, Jensen JS, Christiansen EH, Cooter N, Steigen TK, Vikman S, Thuesen L, Lassen JF, Hildick-Smith D. Coronary bifurcation lesions treated with simple or complex stenting: 5-year survival from patient-level pooled analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Eur Heart J. 2016 Jun 21;37(24):1923-8. doi: 10.1093/eurheartj/ehw170. Epub 2016 May 8.
citation: Behan MW, Holm NR, Curzen NP, Erglis A, Stables RH, de Belder AJ, Niemela M, Cooter N, Chew DP, Steigen TK, Oldroyd KG, Jensen JS, Lassen JF, Thuesen L, Hildick-Smith D. Simple or complex stenting for bifurcation coronary lesions: a patient-level pooled-analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Circ Cardiovasc Interv. 2011 Feb 1;4(1):57-64. doi: 10.1161/CIRCINTERVENTIONS.110.958512. Epub 2011 Jan 4.
citation: Hildick-Smith D, de Belder AJ, Cooter N, Curzen NP, Clayton TC, Oldroyd KG, Bennett L, Holmberg S, Cotton JM, Glennon PE, Thomas MR, Maccarthy PA, Baumbach A, Mulvihill NT, Henderson RA, Redwood SR, Starkey IR, Stables RH. Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies. Circulation. 2010 Mar 16;121(10):1235-43. doi: 10.1161/CIRCULATIONAHA.109.888297. Epub 2010 Mar 1.
Clinical trial NCT01113060: Aspirin Effectiveness Study
Official title: Aspirin Effectiveness in Coronary Artery Disease Patients in Ireland
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Aspirin
Secondary Prevention
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
First posted: 2010-04-29
Enrollment: 500
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: Representative sample of coronary artery disease patients in Ireland receiving aspririn therapy for secondary prevention of cardiovascular events

Brief summary: Aspirin is an effective medicine for prevention of heart attacks in patients with coronary artery disease and works by preventing clots from forming. In previous studies aspirin has been found to be ineffective in between 2% and 65% of patients but none of these studies have looked specifically at coronary artery disease patients in Ireland. This study is being done to identify the percentage of patients in Ireland whose aspirin is not working effectively and help identify factors that could be used to target interventions to increase aspirin's effectiveness in Irish patients.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Patients with documented coronary artery disease
* Current treatment with any dose of aspirin daily for a minimum of 3 months
* Able to provide written informed consent based on competent mental status

Exclusion Criteria:

* Myocardial infarction, unstable angina or stroke during the preceding three months
* Platelet count \<125,000/mm
* Known haematological disorders
* Active malignancy on current chemotherapy or a recent diagnosis of cancer

Primary outcomes:
measure: Percentage of patients with non-response to aspirin
timeFrame: Following a minimum of 3 months of daily aspirin use
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin 9
country: Ireland
facility: Beaumont Hospital
state: Dublin
Study officials:
affiliation: Royal College of Surgeons, Ireland
name: Prof. Dermot Kenny, MB, BCh, BAO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05932160: Effect of Intravenous Dextrose on PONV in Patients Undergoing Gynecological Laparoscopy
Official title: Research Investigator
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: PONV
Lead sponsor: Weifang Medical University
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to explore the relationship between intravenous infusion of dextrose during emergence from anesthesia and the incidence of PONV in patients undergoing gynecology laparoscopy (GL).


Eligibility criteria: Inclusion Criteria:

1. ASA I or II;
2. Performing gynecologic laparoscopic procedures under general anesthesia;

Exclusion Criteria:

1. age \<18 or \>75
2. severe hypertension,diabetes mellitus, significant hepatic or renal disease
3. inability to follow protocol
4. refusal to participant

Primary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: Measured at 0.5 hours postoperatively.
measure: Postoperative nausea and vomiting
timeFrame: Measured at 2 hours postoperatively.
measure: Postoperative nausea and vomiting
timeFrame: Measured at 24 hours postoperatively.
Secondary outcomes:
measure: Consumption of postoperative analgesic
timeFrame: Approximately 24 hours after surgery.
measure: Postoperative pain response
timeFrame: Measured at 0.5 hours postoperatively.
measure: Postoperative pain response
timeFrame: Measured at 2 hours postoperatively.
measure: Postoperative pain response
timeFrame: Measured at 24 hours postoperatively.
measure: Recovery time of PACU
timeFrame: Approximately 24 hours after surgery.
measure: Consumption of postoperative rescue antiemetic
timeFrame: Approximately 24 hours after surgery.
Other outcomes:
Locations:
city: Weifang
country: China
facility: Jiang Liu
state: Shandong
Study officials:
affiliation: Weifang Medical University
name: Jiang Liu, B.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01321476: Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis
Official title: Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Disease
Lead sponsor: Piedmont Healthcare
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing a carotid, liver, and/or intestinal biopsy

Brief summary: This study will use excess tissue from endoscopic or surgical procedures to examine the elements of plaque that are found in the carotid walls of patients who have a type of heart and blood vessel disease called atherosclerosis. Tissue will be collected from patients undergoing carotid procedures as well as patients undergoing liver and/or intestinal biopsies. This lab study will examine the different types of proteins that play a role in developing heart plaque.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Scheduled for a clinically indicated, standard-of-care carotid endarterectomy (CEA) OR scheduled for a clinically indicated, standard-of- care surgical, laparoscopic or endoscopic intestinal biopsy or excision OR scheduled for a clinically indicated, standard-of-care surgical, laparoscopic or endoscopic liver biopsy or partial resection/excision
* Ability and willingness to consent and Authorization for use of PHI

Exclusion Criteria:

* Age ≤18 years
* Inability or unwillingness to consent and Authorization for use of PHI
* FOR CAROTID PATIENTS - history of carotid trauma, that is determined by the Principal Investigator to significantly have changed the carotid tissue structure
* FOR CAROTID PATIENTS - history of middle- or large-vessel vasculitis, that is determined by the Principal Investigator to significantly have changed the carotid tissue structure

Primary outcomes:
measure: Demonstrated Plaques
timeFrame: up to 30 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Piedmont Heart Institute/Piedmont Hospital
name: Joseph Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01330576: Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
Official title: Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Necrotizing Enterocolitis
Keywords: Hypothermia
cooling
necrotizing enterocolitis
NEC
neonates
preterm
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.


Eligibility criteria: Inclusion Criteria:

* weight at diagnosis \> 700 grams
* confirmed NEC (Bell's stage II or III)
* radiological evidence of pneumatosis coli
* systemic compromise as defined by increase in ventilation requirement and/or requiring inotopic support

Primary outcomes:
measure: Difference in sequential organ failure assessment (SOFA) score
timeFrame: 5 days
Secondary outcomes:
measure: Baseline time taken to establish full enteral feeds
timeFrame: 5 days
measure: Neurodevelopmental Assessment
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Trust
Study officials:
References:
citation: Hall NJ, Eaton S, Peters MJ, Hiorns MP, Alexander N, Azzopardi DV, Pierro A. Mild controlled hypothermia in preterm neonates with advanced necrotizing enterocolitis. Pediatrics. 2010 Feb;125(2):e300-8. doi: 10.1542/peds.2008-3211. Epub 2010 Jan 25.