louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04635371: Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive Monitor
Official title: Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive PPG-based Monitor in the Cardiac ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cardiac Event
Acute Cardiac Failure
Acute Cardiac Pulmonary Edema
Keywords: Acute Catdiac Events; Remote Patient Monitoring
Lead sponsor: Biobeat Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 men and women admitted to the cardiac ICU with acute caridac event.

Brief summary: A prospective observational study in patients admitted with an acute cardiac disease, in which the PPG-based device will be attached to them on admission, for frequent monitoring of their vitals during hospitalization and interventional procedures. in parallel to currently-used and approved devices. Data will be crossed with gathered clinical and laboratory data, to study the device's ability to detect acute hemodynamic and respiratory changes during hospitalization, and gathering workflow information from the nursing staff.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 years and above admitted to the Cardiac ICU due to an acute cardiac event.

Exclusion Criteria:

* Pregnant women, subjects under the age of 18 years.

Primary outcomes:
measure: Detection of cardio-respiratory changes
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Workflow assessment.
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Holon
country: Israel
facility: The Edith Wolfson Medical Center
Study officials:
affiliation: The Edith Wolfson Medical Center
name: Ronen Rubinshtein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05154071: Impact of the Implementation of a Referral Veno-venous Extracorporeal Membrane Oxygenation Centre on Mortality
Official title: Impact of the Implementation of a Referral Veno-venous Extracorporeal Membrane Oxygenation Centre on Mortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extracorporeal Membrane Oxygenation
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 172
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: Patients supported by veno-venous ECMO

Brief summary: Current evidence suggest that regrouping patient supported by veno-venous ECMO in high-volume centre could improve outcome. A dedicated ECMO unit was implemented in Dijon.

The objective of the present study was to evaluate the implementation of this unit. The hypothesis was that patient taken care within this structured care system would have lower mortality.

This research comprises a retrospective observational study conducted in Dijon university hospital


Eligibility criteria: Inclusion Criteria:

* patient in an adult Dijon ICUs supported by veno-venous ECMO
* patient hospitalized between January the 1st 2011 and June the 30th 2021

Exclusion Criteria:

* Refusal to participate,
* patient admitted to pediatric ICU

Primary outcomes:
measure: Mortality rate
timeFrame: 90 days
Secondary outcomes:
measure: Rate of ECMO adverse events
timeFrame: through study completion, an average of 3 years
measure: Hospital length of stay
timeFrame: through study completion, an average of 3 years
measure: ICU length of stay
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT00227071: Aquatic Verses Land Exercise to Decrease Fall Risk
Official title: The Effect of Water Verses Land Exercise to Decrease Fall Risk in Older Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: accidental falls
osteoporosis
risk factors
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation
First posted: 2005-09-27
Enrollment: 73
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the effect of aquatic,land and no exercise on fall risk factors in women diagnosed with osteoporosis

Detailed description: Background and Purpose: Fall prevention through exercise is an ongoing goal of researchers and clinicians. This study compared the effects of aquatic exercise (AE), land exercise (LE) and no exercise (NE) on fall risk factors. Subjects: Seventy-three women, 60 or older, with osteoporosis (OP). Method: Randomized clinical trial comparing balance, posture, strength, mobility, function, falls, and quality of life. Results: Significant differences (p\<0.05) were found for participants' ratings of global change (AE and LE \> NE), tandem balance (AE \> LE) and function (LE \> AE). Joint pain and falls occurred more often during LE. Discussion and Conclusion: Participants experienced significant global improvement with both AE and LE. Less joint pain, reduced falls and improved balance were found in AE, however LE was more effective in improving functional ability at home. Clinicians should consider the individual's specific impairments and risk factors when recommending exercise programs on land or in water.

Eligibility criteria: Inclusion Criteria:

* age 60 or older
* diagnosed with osteoporosis
* female

Exclusion Criteria:

* has not been involved in regular exercise in past 2 months
* does not have any medical or neurological condition that would significantly limit activities of daily living, such that involvement in an exercise program would jeopardize safety

Primary outcomes:
measure: muscle strength
measure: balance
measure: mobility
measure: function
measure: quality of life
Secondary outcomes:
measure: bone status
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: School of Physical Therapy
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Cathy M Arnold
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06008171: Patient Decision Aid for the Treatment of Actinic Keratosis
Official title: Patient Decision Aid for the Treatment of Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Actinic Keratoses
Patient Decision Aid
Keywords: actinic keratosis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Catharina Ziekenhuis Eindhoven
First posted: 2023-08-23
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with an indication for treatment of field therapy for actinic keratosis will be consulted with patient decision aid or without patient decision aid (conventional)
Primary purpose: OTHER

Brief summary: This study evaluates whether a Patient Decision Aid for the field-directed treatment of actinic keratosis has an effect on shared decision making and patient satisfaction.

Detailed description: Actinic keratosis is the most common epithelial precancerous lesion among the Caucasian race. With an increase in prevalence worldwide due to an aging population and rise of ultraviolet exposure actinic keratosis are among the most frequently encountered skin lesions in clinical practice.

There are many therapeutic modalities for the treatment of actinic keratosis, depending on multiple factors such as distribution, characteristics, patient preference, side effects, availability and costs. Treatment options can be divided into: lesion directed therapy en field directed therapy.

A Patient Decision Aid for field-directed therapies for actinic keratosis may attribute to better shared-decision making and patient satisfaction which on their part may benefits treatment compliance and health outcomes and may lead to fewer disputes between patients and doctors.

Eligibility criteria: Inclusion Criteria:

* diagnosis actinic keratosis in MaastrichtUMC+ or CatharinaHospital, Eindhoven
* age \>18 years

Exclusion Criteria:

* no knowledge of Dutch language

Primary outcomes:
measure: Difference in patient satisfaction
timeFrame: First questionnaire at moment of consultation, between November 2022 and January 2024 (expected). Second questionnaire after finishing the treatment (1 week after consultation up to 6 months after consultation).
measure: Difference in shared decision making
timeFrame: First questionnaire at moment of consultation, between November 2022 and January 2024 (expected). Second questionnaire after finishing the treatment (1 week after consultation up to 6 months after consultation).
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Ellen Oyen
Study officials:
affiliation: Maastricht UMC+
name: Klara Mosterd, prof.dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00402571: Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics
Official title: Assessment of Hepatic Function in Alcoholic Patients Administered Therapeutic Dosing of Acetaminophen- a Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcohol Related Disorders
Keywords: acetaminophen
alcohol
liver injury
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
First posted: 2006-11-22
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The study objective was to determine whether liver injury develops in alcoholic patients who ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3 consecutive days and remain in the facility an additional 2 days for monitoring. The primary measures were aminotransferase measures taken at baseline and Days 2-5. We hypothesized that there would be no difference in aminotransferase measures between the acetaminophen and placebo study groups.


Eligibility criteria: Inclusion Criteria

Any patient, regardless of gender or ethnicity, who was:

1. 18 years or older
2. admitted to one of the two controlled access alcohol detoxification centers with a positive BAL at the time of admittance
3. signed a written informed consent form.

Patients were excluded from the study at baseline if any of the following were present:

1. serum acetaminophen level greater than 20 mcg/ml
2. serum AST or ALT levels greater than 200 IU/L
3. INR greater than 1.5
4. if female, positive for beta-subunit of chorionic gonadotropin
5. clinically intoxicated, psychiatrically impaired or unable to give informed consent
6. known hypersensitivity to acetaminophen
7. history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment
8. currently enrolled in another trial or had been enrolled in another trial in the preceding three months.

Primary outcomes:
measure: mean change in serum aminotransferase levels between study groups
Secondary outcomes:
measure: proportion of subjects tht developed an abnormal aminotransferase level
measure: proportion of subjects that developed hepatotoxicity (ALT>1000 IU/L)
measure: proportion of subjects that developed drug induced liver injury
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver CARES
state: Colorado
city: Seattle
country: United States
facility: Recovery Centers of King County
state: Washington
Study officials:
affiliation: Denver Health/Rocky Mountain Poison & Drug Center
name: Richard C Dart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04034771: The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol
Official title: The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol in Mechanically Ventilated Traumatic Brain Injury Patient: RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: TBI (Traumatic Brain Injury)
Keywords: melatonin
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study assess the effect of administration of exogenous melatonin as adjuvant to propofol on the level of sedation and consequently the rate of propofol infusion.

Detailed description: 38 patients with traumatic brain injuries requiring mechanical ventilation and sedation were randomly allocated to two groups (melatonin group)19 patients and (control group)19 patients. In both groups a bolus of propofol 1mglkg was given by titration till the patient reached a sedation level value of (60-70) on the bispectral index (BIS), Then propofol infusion started at a rate of 1mglkglhr as a maintenance and rate adjusted according to our targeted sedation level, melatonin 10 mg tablet was crushed and mixed with 20 ml of water and administrated through a nasogastric tube followed by another 20 ml to flush out the residue for (melatonin group). While (control Group) received a placebo tablets by the same wayBIS value and propofol infusion rate was recorded over 12 hours.

Eligibility criteria: Inclusion Criteria:

* Age group from 18 to 65
* Both sexes
* Patients on a mechanical ventilation and need sedation
* Patients who are vitally stable

Exclusion Criteria:

* Gastro intestinal tract impractabililty
* Pregnant female
* Vitally unstable patients who cannot tolerate propofol infusion

Primary outcomes:
measure: level of sedation
timeFrame: 6 hours
Secondary outcomes:
measure: • Arterial blood pressure
timeFrame: 6 hours
measure: Heart rate
timeFrame: Measuring the heart rate as beats per minutes just before and after propofol infusion and every hour for the next 6 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alini Univeristy Hospital
state: Giza
Study officials:
affiliation: Cairo University
name: Mahmoud s Soliman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samarkandi A, Naguib M, Riad W, Thalaj A, Alotibi W, Aldammas F, Albassam A. Melatonin vs. midazolam premedication in children: a double-blind, placebo-controlled study. Eur J Anaesthesiol. 2005 Mar;22(3):189-96. doi: 10.1017/s0265021505000335.
citation: Yousaf F, Seet E, Venkatraghavan L, Abrishami A, Chung F. Efficacy and safety of melatonin as an anxiolytic and analgesic in the perioperative period: a qualitative systematic review of randomized trials. Anesthesiology. 2010 Oct;113(4):968-76. doi: 10.1097/ALN.0b013e3181e7d626.
Clinical trial NCT03209271: Hemodynamic Effects of Cold Versus Warm Fluid Bolus
Official title: Hemodynamic Effects of Cold Versus Warm Fluid Bolus Infusion in Healthy Volunteers: a Randomized Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temperature Change, Body
Hypovolemia
Keywords: Fluid therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover study of 2 different temperatures of crystalloid fluid bolus.
Primary purpose: BASIC_SCIENCE

Brief summary: Fluid boluses are often administered with the aim of improving tissue perfusion in critically ill patients. It is unclear whether the temperature of the fluid has an impact on the hemodynamic response. The aim of this study is to describe the hemodynamic effects of a fluid bolus with two different temperatures.

Detailed description: A randomized, controlled, cross-over study in 21 healthy volunteers. The participants will receive a fluid bolus of 500 ml Ringer's Acetate at either 22°C or 38°C over 15 minutes in a randomized order. Non-invasive measures will be made of cardiac index, mean arterial pressure, systolic blood pressure, diastolic blood pressure, heart and pulse rate, saturation and temperature. Hemodynamic measure will be made using the Clearsight® system. Measurements will be made during 120 minutes. The second session will take place at least one day later, and the participant will then receive the other fluid temperature.

Eligibility criteria: Inclusion Criteria:

- Volunteers 18 years or older Previously healthy

Exclusion Criteria:

* American Society of Anesthesiologists classification 2 or above.
* Known pregnancy

Primary outcomes:
measure: Cardiac index 15 minutes
timeFrame: 15 minutes
Secondary outcomes:
measure: Cardiac index 120 minutes
timeFrame: 120 minutes
measure: Blood pressure 120 minutes
timeFrame: 120 minutes
measure: Heart rate 120 minutes
timeFrame: 120 minutes
measure: Temperature 120 minutes
timeFrame: 120 minutes
Other outcomes:
measure: Time to return to baseline for CI
timeFrame: 0-120 minutes
measure: Time to return to baseline for blood pressure
timeFrame: 0-120 minutes
measure: Time to return to baseline for heart rate
timeFrame: 0-120 minutes
measure: Time to return to baseline for temperature
timeFrame: 0-120 minutes
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet Södersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Maria Cronhjort, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wall O, Ehrenberg L, Joelsson-Alm E, Martensson J, Bellomo R, Svensen C, Cronhjort M. Haemodynamic effects of cold versus warm fluid bolus in healthy volunteers: a randomised crossover trial. Crit Care Resusc. 2018 Dec;20(4):277-284.
Clinical trial NCT01603771: Neural Activation and Connectivity in Response to Exercise and Cognitive Training
Official title: Neural Activation and Connectivity in Response to Exercise and Cognitive Training
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neural Connectivity
Keywords: Adult
Exercise
Cognition
MRI
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include 24 adults, male and female, aged 55-75 years who meet eligibility criteria for and are enrolled in the parent study, Combining Exercise and Cognitive Training to Improve Everyday Function (EXACT), Unique Protocol ID 201102416. Participants will be sedentary (not exercising regularly) but otherwise generally healthy.

Brief summary: The goal of this pilot study is to evaluate whether healthy, sedentary older adults have increased activation of specific brain areas, in response to exercise and cognitive training, in comparison to a control group, and whether improvements in psychometric test performance are related to increased activation of brain networks. Participants, between age 55-75 years will be recruited from an ongoing study of exercise and cognitive training, to undergo Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fcMRI).


Eligibility criteria: Inclusion Criteria:

* meet the inclusion criteria for the parent study, Combining Exercise and Cognitive Training to Improve Everyday Function (EXACT) study (Unique Protocol ID 201102416).

Exclusion Criteria:

* currently taking chronic psychotropic medication, beta blockers, or calcium channel blockers
* contraindication to MRI scanning
* inability to complete MRI scans in closed scanner

Primary outcomes:
measure: Functional connectivity of large-scale brain networks as seen through Blood Oxygen Level Dependent (BOLD) functional magnetic resonance imaging (fMRI)
timeFrame: Change in connectivity measurements between baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ellen F. Binder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06577571: Testing Educational Videos on Conservative Kidney Management
Official title: A Study of CKM-EMPOWER: Empowering Medical Professionals on CKM With Educational Resources
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Disease, Chronic
Keywords: Education
Conservative Kidney Management
Provider training
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to test the efficacy of a series of just-in-time educational videos on topics related to CKM (CKM-EMPOWER) in improving nephrology providers ability to provide CKM.

Detailed description: Conservative kidney management (CKM) is an important therapeutic alternative for patients who do not wish to pursue dialysis for their advanced chronic kidney disease (CKD). Despite a growing body of evidence and clinical services to support patients who do not wish to pursue dialysis, nephrologists receive very limited training in CKM. This is a randomized trial of nephrology fellows that utilizes surveys to assess their change in knowledge, confidence and practice of providing CKM with receipt of CKM-EMPOWER. The investigators hypothesize that the CKM-EMPOWER will improve nephrology fellows' knowledge and confidence with delivering key elements of CKM. Investigators will recruit 126 nephrology fellows from US fellowship programs and randomize participants in a 1:1 fashion to either receipt of the CKM-EMPOWER or non-receipt. Participants will complete web-based surveys to assess knowledge and confidence with providing CKM between groups.

Eligibility criteria: Inclusion Criteria:

* nephrology fellow enrolled in US nephrology fellowship training program

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in CKM knowledge
timeFrame: 2 weeks
Secondary outcomes:
measure: Confidence with CKM
timeFrame: 2 weeks
measure: Challenges to CKM
timeFrame: 2 weeks
measure: CKM practice change
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: