louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03399890: The Influence of Neuromuscular Reversal on Neurological Physical Exam Time in Lumbar Neurosurgical Cases.
Official title: The Influence of Neuromuscular Reversal With Neostigmine or Sugammadex on Neurological Physical Exam Time in Lumbar Neurosurgical Cases.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Complication
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All lumbar surgeries performed during the study period were enrolled in the study.

Brief summary: Neurological physical exam is a very important outcome that should be evaluated as soon as possible after every lumbar procedures. The aim of this study was to evaluate the neurological physical examination time after lumbar procedures.

Detailed description: Neurological physical exam is a very important outcome that should be evaluated as soon as possible after every lumbar procedures. By that early postoperative neurological complications can be revealed and early interventions planned. The aim of this study was to evaluate the neurological physical examination time after lumbar procedures. Two routinely used different reversal agents (neostigmine or sugammadex) were compared according reversal times and muscle strength on PACU admission.

Eligibility criteria: Inclusion Criteria:

* Lumber surgery
* ASA I-II
* Elective surgery

Exclusion Criteria:

* Emergency cases
* Age lower than 18
* Age higher than 65
* Patient with existing neurological deficit
* Patient with existing renal insufficiency

Primary outcomes:
measure: Neurological physical examination time
timeFrame: postoperative first 30 minutes
Secondary outcomes:
measure: Muscle strength at PACU transfer
timeFrame: postoperative first 60 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine
Study officials:
affiliation: Ankara University Faculty of Medicine
name: Basak Ceyda MECO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03395990: Analgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty
Official title: Evaluation of the Comparative Analgesic Value of Adductor Canal Block Versus Femoral Block Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: femoral nerve block
adductor canal block
analgesia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 16
Sex: ALL
Minimum age (years): 56
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, blinded observational study
Primary purpose: TREATMENT

Brief summary: An observational study of the effect of femoral nerve block in addition to an adductor canal block for pain following total knee arthroplasty.

Detailed description: Subjects undergoing total knee arthroplasty will receive a preoperative adductor canal block with continuous catheter. Following a standardized general anesthetic for the procedure, subjects will be asked to rate their pain using the NRS-11 pain scale in the recovery room. Once the pain is reported at a 5/10 or above, a femoral nerve block will be performed using either 2% chloroprocaine or saline placebo (randomized). Pain scores are then evaluated over the next 30 minutes by a blinded investigator to determine if the femoral block adds any additional analgesic benefit over an adductor canal block.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective total knee arthroplasty
* ASA Physical Status I-III
* BMI 18-40 kg/m2

Exclusion Criteria:

* Inability to cooperate with protocol
* Inability to understand or speak English
* Allergy to any local anesthetic
* Chronic opioid consumption/abuse (30 or more morphine mg equivalents/day)
* Contraindication to adductor canal or femoral nerve block

Primary outcomes:
measure: Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
timeFrame: Baseline, up to 30 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Jeff Gadsden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05680090: Artificial Intelligent System for Eye Emergency Triage and Primary Diagnosis
Official title: Prospective Validation of an Artificial Intelligent System for Eye Emergency Triage and Primary Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergencies
Eye Diseases
Keywords: Artificial intelligence
Ophthalmic emergency triage
Primary diagnosis
Multimodal data
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Through the online popular science, news reports, and other channels, we will promote and inform patients about the relevant knowledge of ophthalmic emergencies, so that they can judge by themselves and freely decide whether to participate in this study or not.

Brief summary: Ophthalmic emergencies are acute vision-threatening disorders, for which a delay in prompt emergency response could result in catastrophic vision loss. Triage is an effective process for ensuring that timely emergency care is provided despite limited resource by prioritizing patients to appropriate orders for visits. Historically, registered nurses classify emergency patients based on personal experiences with high variation. Additionally, primary healthcare providers have been conventionally at the forefront of providing first aid care. However, most of ocular emergencies are wrongly diagnosed or referred due to non-eye specialists' limited knowledge and training in the ophthalmology.

Here, the investigators established and validated an artificial intelligence system, EE-Explorer, to triage eye emergencies and assist in primary diagnosis using metadata and ocular images. This system has been integrated into a website to be prospectively validated in the real world.


Eligibility criteria: Inclusion Criteria:

1. Suffering acute ophthalmic symptoms within one month
2. Visiting the ocular emergency department for the first time
3. Must be able to complete the triage form for ophthalmic emergency
4. Must be able to cooperate either by submitting smartphone photographs or receiving slit-lamp examination

Exclusion Criteria:

The image quality does not meet the clinical requirements.

Primary outcomes:
measure: The accuracy of the triage model
timeFrame: 2023.1
Secondary outcomes:
measure: The accuracy of the primary diagnostic model
timeFrame: 2023.1
Other outcomes:
measure: Acceptance of the patients
timeFrame: 2023.1
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
state: Guangdong
Study officials:
References:
Clinical trial NCT04481490: A Study to Objectively Measure Physical Activity and Sedentary Behavior During Cardiac Rehabilitation
Official title: Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation: Are Patients Achieving Recommendations/Guidelines
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiac Disease
Myocardial Infarction
Cardiac Valve Disease
Coronary Artery Disease
Keywords: cardiac rehabilitation
physical activity
accelerometry
home-based
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with qualifying indication for cardiac rehabilitation (e.g. acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, stable angina, heart failure).

Brief summary: The purpose of this study is to assess exercise patterns during home-based or center-based cardiac rehabilitation participation.

Detailed description: Participants enrolled in either home-based or center-based cardiac rehabilitation will be instructed to wear an accelerometer device for 7-days at baseline, 4-weeks, 8-weeks, and 12-weeks, to objectively measure their physical activity level during the cardiac rehabilitation program. A questionnaire will also be completed by the participant at baseline and 12-weeks to subjectively measure their physical activity level, based on self-report activities over the previous 7-days.

Enrollment in home-based versus center-based cardiac rehabilitation will be based on the availability of cardiac rehabilitation facilities and/or patient preference. There is no random allocation or assignment to groups by the study team.

Eligibility criteria: Inclusion Criteria:

* Adult 18 years and older.
* Able to provide consent.
* Has a qualifying indication for cardiac rehabilitation and able to participate in cardiac rehabilitation.

Exclusion Criteria:

* Unwilling or unable to participate in cardiac rehabilitation.

Primary outcomes:
measure: Change in minutes spent in moderate-vigorous physical activity, measured by accelerometry
timeFrame: Baseline, 4-weeks, 8-weeks, and 12-weeks
Secondary outcomes:
measure: Change in minutes spent in moderate-vigorous physical activity, measured by questionnaire
timeFrame: Baseline, 12-weeks
measure: Change in minutes spent in inactive (sedentary) behavior, measured by accelerometry.
timeFrame: Baseline, 4-weeks, 8-weeks, and 12-weeks
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Amanda Bonikowske, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01819090: Optimizing Communication During Ventilation
Official title: Optimizing Communication During Nasal Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Disorder
Respiratory Failure
Keywords: Neuromuscular disorder
Mechanical ventilation
Speech
Respiratory failure
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mechanical ventilation is one of the only treatment that has improved survival of patients with neuromuscular respiratory failure. As disease progresses, some patients may require longer ventilation period. Non invasive mechanical ventilation is the preferred method of ventilation but it may interfere with speech and communication of patients who require ventilation throughout the day. The investigators are evaluating the effect on speech and communication of a ventilation device which allows patients to momentarily and voluntarily withhold ventilation if they want to speak. This should allow the patients to have a more fluid speech.


Eligibility criteria: Inclusion Criteria:

* Patient with restrictive respiratory failure secondary to a neuromuscular disorder, without any bulbar involvement.
* Age greater than or equal to 18.
* Hospitalization in Home Ventilation Unit of the intensive care department of R. Poincaré Hospital.
* Non invasive mechanical ventilation for a duration equal or above 14h per day.
* Patient in a steady state at the time of the study
* written informed consent

Exclusion Criteria:

* patient's refusal to participate to the study
* Inability to read the selected text
* Inability to use the ventilator switch
* Inability to cooperate
* Hemodynamic instability
* Acute respiratory failure
* No affiliation to social security

Primary outcomes:
measure: Impact of patient's ventilation control on speech efficiency
timeFrame: 1 hour 30 min
Secondary outcomes:
measure: Patient ventilator synchronisation during speech
timeFrame: 1hour 30 min
measure: User friendliness of the ventilator during speech
timeFrame: 1hour 30 min
measure: Respiratory comfort during speech
timeFrame: 1hour 30 min
measure: Speech comfort during ventilation
timeFrame: 1hour 30 min
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
affiliation: Hôpital RAYMOND POINCARE
name: Helene PRIGENT, MDPHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02050490: Effect of a Symptom Diary on Symptom Care and Symptom Burden in Patients Treated With Chemotherapy: a Before-and-after-study
Official title: Effect of the Implementation of a Symptom Diary on the Symptom Care Received and the Symptom Burden Experienced by Adult Cancer Patients Treated With Chemotherapy: A Before-and-after-study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nausea
Vomiting
Pain
Anorexia
Etcetera
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Algemeen Ziekenhuis Maria Middelares
name: Flemish League Against Cancer
name: Onze Lieve Vrouw Hospital
First posted: 2014-01-30
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult (\>18) patients with (any type of) cancer treated with chemotherapy

Brief summary: This study investigates whether the implementation of a symptom diary for reporting and communicating chemotherapy-related symptoms improves symptom care and decreases symptom burden in adult patients treated with chemotherapy.

The hypothesis is studied using a before-and-after design. First, symptom care and symptom burden will be observed in a sample of patients not being offered a symptom diary. Next, the symptom diary will be implemented at the participating hospital and symptom care and symptom burden will now be observed in a new sample of chemotherapy patients.


Eligibility criteria: Inclusion Criteria:

* Adult (\>18) patients with (any type of) cancer treated with chemotherapy
* Understanding Dutch
* Being able to sign Informed consent

Exclusion Criteria:

* More than 3 lines of chemotherapy treatment in the past

Primary outcomes:
measure: symptom distress
timeFrame: T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1)
Secondary outcomes:
measure: symptom severity
timeFrame: T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1)
Other outcomes:
measure: symptom care
timeFrame: T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1)
Locations:
city: Ghent
country: Belgium
facility: General Hospital Maria Middelares
Study officials:
References:
Clinical trial NCT01458990: Proton Pump Inhibitors and Dysbiosis in Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Healthy
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
First posted: 2011-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: PPI withdrawal (decompensated patients only) and PPI initiation (compensated and decompensated patients)
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to find out whether the use of medications that suppress acid in your stomach can change the composition of your bowel bacteria.


Eligibility criteria: Inclusion Criteria for PPI initiation study:

* Cirrhosis not on current PPI or acid suppressive therapy
* No systemic antibiotics or probiotics

Exclusion Criteria for PPI initiation study:

* On systemic antibiotics
* On PPI or acid suppression therapy already
* unable to give informed consent
* Allergy to proton pump inhibitors

Inclusion Criteria for PPI withdrawal study:

* Cirrhosis on current PPI for an FDA-unapproved indication
* No systemic antibiotics or probiotics

Exclusion Criteria for PPI withdrawal study:

* On systemic absorbable antibiotics
* On PPI or acid suppression therapy for an FDA-approved indication
* unable to give informed consent
* unwilling to withdraw PPI

Primary outcomes:
measure: Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
References:
citation: Bajaj JS, Cox IJ, Betrapally NS, Heuman DM, Schubert ML, Ratneswaran M, Hylemon PB, White MB, Daita K, Noble NA, Sikaroodi M, Williams R, Crossey MM, Taylor-Robinson SD, Gillevet PM. Systems biology analysis of omeprazole therapy in cirrhosis demonstrates significant shifts in gut microbiota composition and function. Am J Physiol Gastrointest Liver Physiol. 2014 Nov 15;307(10):G951-7. doi: 10.1152/ajpgi.00268.2014. Epub 2014 Sep 25.
citation: Bajaj JS, Thacker LR, Fagan A, White MB, Gavis EA, Hylemon PB, Brown R, Acharya C, Heuman DM, Fuchs M, Dalmet S, Sikaroodi M, Gillevet PM. Gut microbial RNA and DNA analysis predicts hospitalizations in cirrhosis. JCI Insight. 2018 Mar 8;3(5):e98019. doi: 10.1172/jci.insight.98019.
citation: Bajaj JS, Liu EJ, Kheradman R, Fagan A, Heuman DM, White M, Gavis EA, Hylemon P, Sikaroodi M, Gillevet PM. Fungal dysbiosis in cirrhosis. Gut. 2018 Jun;67(6):1146-1154. doi: 10.1136/gutjnl-2016-313170. Epub 2017 Jun 3.
Clinical trial NCT06174090: The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
Official title: The Effect of Patient Education With Video Prior to Coronary Artery Bypass Graft Surgery on Pain, Anxiety and Knowledge Levels of Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group will watch a 12-minute video-education about pre-post surgical process and care in bypass surgery, for once the day before surgery. Video-education was created by the researcher based on the literature. Expert opinion was provided related to content. The control group will receive standard verbal education lasting 12-minute about the issue.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this research to examine the effectiveness of video-education on pain, anxiety, and knowledge levels on adult patients undergoing coronary artery bypass graft surgery.

Detailed description: A video based patient education will be used in this randomized controlled study. Patient education via video aims to reduce the patient's anxiety levels, control their pain, and improve their health outcomes by increasing knowledge levels. In addition, since this training is visual-based, it is aimed to provide effective learning by reducing the inequality due to sociodemographic and individual differences between participants. The video-education includes information about pre and post-surgical process and care.

Eligibility criteria: Inclusion Criteria:

* Being at least 18 years old
* Being hospitalized in Cardiovascular Surgery Clinic and Cardiovascular surgery intensive care unit
* Undergoing coronary artery bypass graft surgery for the first time, by sternotomy method
* Patients who agree to participate in the research and read and sign the "Informed Volunteer Consent Form for Scientific Research"

Exclusion Criteria:

* Patients with visual or hearing impariment
* Patients with psychiatric illness,
* Patients with known cognitive impairment (dementia, Alzheimer's).

Primary outcomes:
measure: Pain Level
timeFrame: from 24th of surgery to 72nd hour
measure: Anxiety level
timeFrame: from baseline prior to education to 72nd hour of surgery
measure: Preoperative anxiety
timeFrame: from baseline prior to education to 72nd hour of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Faculty of Health Sciences
state: Etimesgut
Study officials:
References:
Clinical trial NCT03692390: Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
Official title: A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Procedural Sedation
Keywords: Virtual Reality
Heart Rate
Blood Pressure
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Children often need procedural sedation in the emergency department during painful procedures (such as reducing fractures).

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain. VR may also reduce anxiety during sedation induction by reducing providing an alternative stimulus.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while undergoing procedural sedation. Investigators will measure heart rate, blood pressure, satisfaction (child, parent, provider), amount of sedatives used and compare between the two groups.


Eligibility criteria: INCLUSION CRITERIA

1. Children age 6 to 16 years
2. The managing physician determines need for procedural sedation
3. Parents will sign a consent form and children will sign an assent form

EXCLUSION CRITERIA

1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, inability to communicate)
2. Triage category 1 (resuscitation)
3. Facial features or injury prohibiting wearing the VR goggles

Primary outcomes:
measure: Change in Heart Rate as measured by heart rate monitor
timeFrame: During the procedure at 1 minute intervals
measure: Change in Blood Pressure as measured by blood pressure monitor
timeFrame: During the procedure at 1 minute intervals
Secondary outcomes:
measure: Emergence Phenomenon as measured by yes/no questions regarding participant experience.
timeFrame: Immediately after the procedure and by phone the next day
measure: Satisfaction among Children by global rating scale
timeFrame: Immediately after the procedure
measure: Satisfaction among Guardians by global rating scale
timeFrame: Immediately after the procedure
measure: Satisfaction among Emergency Staff by global rating scale
timeFrame: Immediately after the procedure
measure: Type and dose of medication
timeFrame: Intraoperative
measure: Time difference of the procedure
timeFrame: Intraoperative
measure: Length of stay in the Emergency Department
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ran Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References: