louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00739843: Cognitive and Functional Status and Dialysis Outcomes in Older Hemodialysis Patients
Official title: Cognitive and Functional Status and Dialysis Outcomes in Older Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dementia
Cognition
End-stage Renal Disease
Keywords: Dementia,
Cognitive Disorders,
Hemodialysis
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2008-08-22
Enrollment: 55
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All prevalent and incident hemodialysis patients over the age of 60, receiving hemodialysis treatments at the University of Chicago outpatient dialysis program at the time of the study will be invited to participate.

Brief summary: The purpose of this study is to estimate how quickly cognitive status and functional status in older patients on hemodialysis declines.

Detailed description: Dialysis outcome measures, which predict morbidity and mortality of younger patients on renal replacement therapy, such as dialysis clearance, do not correlate with survival of the elderly patients on hemodialysis. Survival of older patients on hemodialysis is significantly worse when compared to that of the younger patients. Conditions commonly affecting older adults, such as functional decline, cognitive impairment, depression and declining quality of life have not been well studied in hemodialysis population. There may be an important relationship between these measurements and outcomes in older dialysis patients. Institution of appropriate age-specific interventions could result in improved health status and mortality of older patients on hemodialysis. Our broad objective is to better understand global functioning of the elderly dialysis patients and its possible impact on dialysis outcomes in attempt to improve health care of the older patients receiving hemodialysis.

Eligibility criteria: Inclusion Criteria:

* Prevalent and incident hemodialysis patients over the age of 60, receiving hemodialysis treatments at the University of Chicago outpatient dialysis program.

Exclusion Criteria:

* Patients 59 and younger, and patients with the following medical conditions: malignancies currently requiring chemotherapy or radiation therapy, severe heart failure (NYHA class IV), known HIV infection, or currently active hepatic encephalopathy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Chronic Hemodialysis Centers
state: Illinois
Study officials:
affiliation: University of Chicago
name: Nicole Stankus, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03356743: Spectrum Analysis in Ex-vivo Human Lungs
Official title: Spectrum Analysis of Endobronchial Ultrasound Radiofrequency of Lung Tumors in Ex-vivo Human Lungs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: lobectomy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will analyze spectral features of the radiofrequency of lung tumors in ex-vivo human lungs. The resected specimens will be evaluated using the spectrum analysis to determine the localization rate of the targets. Ultrasound measurement and images will be used for correlation of TS mode image findings with pathology by using HE and IHC slides of lung tumor and lymph node.


Eligibility criteria: Inclusion Criteria:

* Any patients scheduled for lobectomy of anatomical segmental resection for malignant lung tumors.
* 18 years of age or older

Exclusion Criteria:

* Any patients with inability to give informed consent.

Primary outcomes:
measure: To analyze the relationship of three spectral features of the radiofrequency of lung tumors in ex-vivo human lungs.
timeFrame: Within an hour after resection.
Secondary outcomes:
measure: To find the correlation of TS mode image findings with pathology by using lung tumor and lymph node samples.
timeFrame: Within an hour after resection
measure: To clarify the feasibility of using the conventional EBUS scope to visualize solitary pulmonary nodules in an ex-vivo human lung.
timeFrame: Within an hour after resection
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT04483843: Cosmic Weather and Cardiogenic Pulmonary Edema
Official title: Impact of Cosmic Weather on Pre-hospital Incidence of Cardiogenic Pulmonary Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Edema Cardiac Cause
Lead sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic
Sponsor class: OTHER
Collaborators: name: Masaryk Hospital Usti nad Labem
name: Institute of Experimental Physics, Slovak Academy of Sciences
First posted: 2020-07-23
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from the registry of the Emergency Medical Service of the Central Bohemian Region, Czech Republic who were treated prehospitally for cardiogenic pulmonary edema between 1.10.2008 and 30.6.2014.

Brief summary: Retrospective clinical study to evaluate whether there is any correlation between the pre-hospital incidence of cardiogenic pulmonary oedema (CPE) in the selected region and the space weather parameters.

Detailed description: Emergency Medical Service of the Central Bohemian Region is the exclusive provider of primary pre-hospital emergency care in the Central Bohemian Region, Czech Republic. The region includes both the rural and urban population, in total of 1 315 299 inhabitants on a total area of 11 015 km2. A computer search of patients with dyspnoea between 1.10.2008 and 30.6.2014 will be conducted and all cases of cardiogenic pulmonary oedema will be selected.

Physical parameters of space weather and geomagnetic field disturbances will be obtained from the database of Institute of Experimental Physics, Slovak Academy of Sciences, Slovak Republic. The datasets will be analysed whether there is any correlation between the pre-hospital incidence of CPE in the selected region and the parameters of space weather and geomagnetic field disturbances.

Eligibility criteria: Inclusion Criteria:

* All patients treated by Emergency Medical Service of the Central Bohemian Region for cardiogenic pulmonary edema between 1.10.2008 and 30.6.2014.

Exclusion Criteria:

* Dyspnea from other cause than cardiogenic pulmonary edema.

Primary outcomes:
measure: Significant correlation between incidence of CPE and activity of the space weather
timeFrame: 4 years
measure: Significant correlation between incidence of CPE and the degree of the geomagnetic field disturbance
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beroun
country: Czechia
facility: Emergency Medical Service of the Central Bohemian Region
state: Central Bohemian Region
Study officials:
affiliation: Emergency Medical Service of the Central Bohemian Region, Czech Republic
name: Roman Skulec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03546543: The Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms
Official title: The Effects of Prone Versus Supine Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant
Bronchopulmonary Dysplasia
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 23
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. Different interventions have been shown to influence the incidence of hypoxemic episodes in premature infants. A few studies point towards potential clinical benefits of better oxygenation and less hypoxic events by positioning very low birth weight infants prone, though a recent meta-analysis didn't find a clear benefit of prone position.

The aim of this study is to evaluate the changes in oxygenation among preterm infants receiving respiratory support when positioned prone versus supine, as documented by SpO2 histograms.


Eligibility criteria: Inclusion Criteria:

Premature infants with a weight \< 1500 g who are receiving respiratory support

Exclusion Criteria:

Congenital anomalies, acute lung pathology for example x-ray confirmed pneumonia, air leak, active culture proven sepsis or on inotropic support for low blood pressure.

Primary outcomes:
measure: Oxygenation instability
timeFrame: 3 hours in each position
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References:
Clinical trial NCT06675643: Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)
Official title: Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Skin Neoplasm
Melanoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 30
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: Adults with the diagnosis of skin cancer/melanoma undergoing dual ICI therapy with ipilimumab/nivolumab (IPI/Nivo) as part of regular clinical practice.

Brief summary: This study is being done to better understand patient experiences with using a mobile application, known as Vigilant, to monitor symptoms as outpatients and to gather preliminary data on the potential clinical benefit to remote monitoring of adverse events.

Detailed description: PRIMARY OBJECTIVES:

I. Optimize the patient (Aim 1) experience of the VIGILANT app workflow. II. Gather preliminary data on the number of patients who develop Grade 3 + 4 immune-related adverse event (irAE) or require ER visit within 100 days of registration and treatment with IPI/NIVO.

OUTLINE: This is an observational study.

Patients undergo standard of care treatment with ipilimumab/nivolumab and answer questions and enter symptoms in the mobile Vigilant application. Patients wearing a compatible watch have their vital signs recorded at the same time symptoms are being entered. Based on the severity of symptoms, patients may be recommended to reach out to their healthcare team or to go to the emergency room. Additionally, patients complete a survey and may have their medical charts reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Any skin cancer/melanoma patient starting dual \[ipilimumab/nivolumab (IPI/NIVO)\] immune checkpoint inhibitor (ICI) therapy

Exclusion Criteria:

* Does not meet inclusion criteria

Primary outcomes:
measure: Incidence of grade 3-4 IR-adverse events
timeFrame: Up to 100 days following treatment with IPI/NIVO
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Svetomir N. Markovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05963243: Automated Dating Scan Probe Pressure Data Collection Plan
Official title: A Volunteer Study to Collect Imaging Data for the Development of Identifying Probe Pressure as Part of ScanNav Assist Automated Dating Scan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound
Lead sponsor: IntelligentUltrasound Limited
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers from the South Wales region.

Brief summary: The goal of this observational study is to collect data in the form of ultrasound recordings from healthy volunteers, to aid the development of an Artificial Intelligence model that can identify ultrasound probe pressure.


Eligibility criteria: Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.

Primary outcomes:
measure: Ultrasound scan recordings
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Hodge House
Study officials:
affiliation: Intelligent Ultrasound
name: Steve Margetts, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01756443: Sciatic Nerve Block for Ankle/Foot Surgeries. A Comparison Between a Premixed Solution of Lidocaine Plus Bupivacaine and Consecutive Infiltration of Lidocaine and Bupivacaine
Official title: Sciatic Nerve Block for Ankle/Foot Surgeries. A Comparison Between a Premixed Solution of Lidocaine Plus Bupivacaine and Consecutive Infiltration of Lidocaine and Bupivacaine. A Double Blinded Randomised Controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open Reduction Internal Fixation(ORIF) of Lateral Malleolus
Keywords: sciatic nerve block
ORIF lateral malleolus
sequential injection
premixed injection
local anaesthetics
Lead sponsor: Cork University Hospital
Sponsor class: OTHER
First posted: 2012-12-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Regional anaesthesia has become the cornerstone of multimodal analgesia. With the advent of ultrasound guided nerve blocks regional anaesthesia has achieved both greater efficacy and a better safety profile as the injection of local anaesthetic is performed under direct vision. This has allowed a reduction of the amount of local anaesthetic injected as compared to peripheral nerve stimulation technique . Blockade of sciatic nerve combined with saphenous nerve provides anaesthesia and analgesia for ankle/foot surgeries. Various combinations of local anaesthetics have been used to provide optimal blockade . A mixture of lidocaine with a long acting local anaesthetic is commonly used. This provides a rapid onset of blockade, but of a consistently shorter duration compared to a long acting local anaesthetic alone. We hypothesize that sequential perineural injection of lidocaine and bupivacaine provides similar onset but a longer duration of sensory block compared to the same dose and volume of local anaesthetic mixed in advance.


Eligibility criteria: Inclusion Criteria:

* Patients with ASA 1 - 3 status
* scheduled to undergo semi-elective ankle/foot surgery under regional anaesthesia +/- sedation/opioid free general anaesthesia will be recruited

Exclusion Criteria:

* Patients having surgery on the medial aspect of the ankle/ foot
* allergy to local anaesthetics
* coagulopathy
* malignancy or infection in the popliteal area
* significant peripheral neuropathy
* neurologic disorder of the lower extremity
* any other contraindication to sciatic nerve block
* pregnancy
* history of alcohol or drug dependency/abuse (defined as \>40 IU/week)
* a history of significant cognitive or psychiatric disorder that may affect patient assessment

Primary outcomes:
measure: Postoperative analgesia/duration of block
timeFrame: 24 hours
Secondary outcomes:
measure: onset of block
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
Study officials:
affiliation: Cork University Hospital, Cork, Ireland
name: Gabriella Iohom, MB, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01528943: Effect of Prostacyclin on Haemostasis in Abdominal Surgery
Official title: The Effect of Prostacyclin on Haemostasis as Evaluated by Thrombelastography and Endothelial Markers in Patients Undergoing Major Abdominal Surgery. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Surgery
Keywords: prostacycline, endothel integrity and abdominal surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effect of continuous perioperative infusion of prostacyclin on haemostasis and endothelial functionality in patients undergoing major abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Men and women above 18 years old
* Undergoing Whipple surgery or liver resection
* Able and willing to give informed consent

Exclusion Criteria:

1. Allergy towards the study medication
2. In treatment with platelet ADP receptor inhibitors or heparin (not including thrombosis prophylaxis), Factor Xa inhibitors, trombininhibitors, Vitamin K antagonists
3. Autoimmune disease
4. Intracranial bleeding within the last 6 months
5. Acute coronary syndrome or myocardial infarction within the last 6 months
6. Congestive heart disease
7. Pregnant or breastfeeding
8. Participating in another clinical study within the last 30 days
9. Liver cirrhosis
10. Need for renal replacement therapy

Primary outcomes:
measure: Change in endothelial biomarkers
timeFrame: Baseline to 6 hours postoperatively
Secondary outcomes:
measure: Functional haemostasis evaluated by thrombelastography
timeFrame: Baseline to 6 hours postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Zealand
Study officials:
affiliation: Professor
name: Pär Johansson I Johansson, MD DMSc MPA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01766843: Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus
Official title: Bioequivalence Study Comparing Two Salmeterol/Fluticasone Propionate Dry Powder Inhalers, SF Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2013-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females aged 18-60 years
* Normal weight, at least 50 kg

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
* Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
* Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
* Known hypersensitivity to the active substance(s) or the excipient of the drug.
* Pregnant or lactating females.

Primary outcomes:
measure: Pharmacokinetic parameter Cmax of plasma salmeterol concentration
timeFrame: Within 34 h
measure: Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration
timeFrame: Within 34 h
measure: Pharmacokinetic parameter AUCt of plasma salmeterol concentration
timeFrame: within 34 h
measure: Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration
timeFrame: within 34 h
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Orion Pharma Clinical Pharmacology Unit
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Leena Mattila, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRW Consulting
name: Maria Sokka
role: STUDY_DIRECTOR
References:
Clinical trial NCT05006443: Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques
Official title: Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tricuspid Regurgitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in the heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).

Detailed description: 40 patients with moderate or more TR on echocardiography will undergo CMR/MRE with contrast to assess TR severity, and the associated extra-valvular cardiac and liver abnormalities as shown in the flow diagram below. Patients will continue their clinical management by their primary physicians as per the standards of care. 1-year follow up will be conducted via phone to inquire about patient's vital status (dead/alive), symptoms and hospitalizations.

Eligibility criteria: Inclusion Criteria:

* Moderate or more tricuspid regurgitation

Exclusion Criteria:

1. Prior tricuspid valve prosthesis
2. Pacemaker/defibrillator that would impede MRI imaging
3. Planned tricuspid valve surgery
4. Primary liver pathology

Primary outcomes:
measure: Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between severity of Tricuspid regurgitation by cardiac magnetic resonance imaging vs. elastography
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mohamad Alkhouli, MD
role: PRINCIPAL_INVESTIGATOR
References: