louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02953574: Daily Sleep Enhancement for Hospitalized People With Dementia Following a Nursing Protocol
Official title: Daily Sleep Enhancement for Hospitalized People With Dementia Following a 7 Step Nursing Protocol: a Quasi-experimental Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Dementia
Keywords: geriatric nursing
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-11-03
Enrollment: 40
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the daily performance of a 7 step bedtime nursing protocol for hospitalized people living with dementia is feasible and if it has an effect on bedtime and daytime variables.


Eligibility criteria: Inclusion Criteria:

* diagnosis of dementia of any severity and type
* Allocation to geriatric rehabilitation treatment

Exclusion Criteria:

* sleep related respiratory or moving related disorders or Parasomnia
* delirium
* end of life care

Primary outcomes:
measure: Bedtime in minutes
timeFrame: Daily for up to 14 days from date of giving informed consent to hospital discharge
Secondary outcomes:
measure: Sleeps through the night consistently, 5 point ordinal scale from "severe compromised" to "not compromised"
timeFrame: Every second day for up to 14 days from date of giving informed consent to hospital discharge
measure: Inappropriate napping, 5 point ordinal scale ranging from "sever" to "none"
timeFrame: Every second day for up to 14 days from date of giving informed consent to hospital discharge
measure: Cognitive performance (Mini-mental-status-test score)
timeFrame: Once in first three days after giving informed consent and another time 7 or 14 days later
measure: Physical performance measured with the Handgrip strength test
timeFrame: Once in first three days after giving informed consent and another time 7 or 14 days later
measure: Use of drugs promoting sleep (sedative neuroleptics, hypnotics, sedative antidepressant in the time between 18:00-24:00) (nominal variable: yes or no)
timeFrame: day 1,2 and day 6,7 or 13,14
measure: Medical chart review for discharge domicile after hospitalisation (nursing home, home, other institution, other)
timeFrame: day 7 or 14
Other outcomes:
measure: Application frequency of the nursing (ritual) protocol
timeFrame: Every day for up to 14 days from date of giving informed consent to hospital discharge
Locations:
Study officials:
affiliation: Center of Sleep Medicine
name: Hanna Burkhalter, Dr. sc. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01387074: Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity
Official title: A Prospective, Non-interventional, Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Spasticity
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-07-04
Enrollment: 108
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: Adult patients with upper limb spasticity following stroke who are eligible to receive botulinum toxin Type A treatment

Brief summary: This is a prospective, non-interventional, observational study to collect data on the use of botulinum toxin Type A in a routine setting in patients with upper limb adult spasticity.


Eligibility criteria: Inclusion Criteria:

* Adult patients with upper limb spasticity following a stroke
* Eligible to receive botulinum toxin Type A
* No previous botulinum toxin Type A therapy

Exclusion Criteria:

* None

Primary outcomes:
measure: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline
timeFrame: Baseline
measure: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24
timeFrame: Week 24
measure: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline
timeFrame: Baseline
measure: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24
timeFrame: Week 24
measure: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline
timeFrame: Baseline
measure: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24
timeFrame: Week 24
measure: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline
timeFrame: Baseline
measure: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Itzehoe
country: Germany
state: Schleswig-Holstein
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04952974: B-cell Chronic Lymphoid Malignancies Markers
Official title: Study of Cell Markers of Marginal Zone Lymphoma and Other B-cell Chronic Lymphoid Malignancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Lymphocytic Leukemia
Marginal Zone Lymphoma
Lymphoplasmacytic Lymphoma/Waldenström Macroglobulinemia
Mantle Cell Lymphoma
Hairy Cell Leukemia
Follicular Lymphoma
Keywords: Chronic B-cell malignancies
Flow cytometry
Biomarkers
Statistical algorithms
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years-old with of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies

Brief summary: Lymphoid chronic B-cell malignancies are frequent pathologies that affect adults, with a very variable prognosis and treatment (some of them can remain untreated). The diagnosis of these malignancies relies on the study of the morphology of tumoral cells and the expression by these cells of several markers, mainly via a technical approach called flow cytometry. Because the markers currently used remain imperfect, additional ones are needed for an accurate diagnosis that affect both prognosis and treatment.

In addition, because numerous markers are used at the diagnosis, there is a need of tools that synthetize the multi-dimensional structure of the data obtained.

The primary purpose of this study is to detect new markers that can be of help for the diagnosis of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies.

The secondary purpose of this study is to obtain a statistical algorithm that allow a good prediction of the different sub-types of chronic B-cell malignancies mainly using the results of flow cytometry.


Eligibility criteria: Inclusion Criteria:

* patients over 18 years-old with of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies
* patients that gave their informed consent for the conservation of blood or bone marrow cells (primary objective 1)
* patients that gave their informed consent for the retrospective use of their clinical and biological data

Exclusion Criteria:

* patients under guardianship or curatorship
* patients who did not gave their consent for the use of their cells and/or data

Primary outcomes:
measure: Retrospective study of laboratory data from patients with B lymphoid hemopathy, mainly lymphoma in the marginal zone
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hematology Laboratory - Strasbourg University Hospitals
Study officials:
affiliation: Hematology Laboratory - Strasbourg University Hospitals
name: Laurent MAUVIEUX, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06750874: Perioperative ACT for Preventing CPSP: a Single-arm Non-randomized Pilot Trial
Official title: Feasibility and Acceptability of a Single-session Perioperative Acceptance and Commitment Therapy (ACT) Workshop for Preventing Chronic Postsurgical Pain: a Single-arm, Non-randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Spinal Stenosis
Spondylosis
Spondylolisthesis
Back Injury
Keywords: acceptance and commitment therapy
chronic postsurgical pain
ACT
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2024-12-27
Enrollment: 45
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized, non-controlled pilot trial
Primary purpose: PREVENTION

Brief summary: The present study aims to adapt and modify a brief perioperative Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will assess the acceptability, feasibility, and preliminary efficacy of the intervention via a non-randomized, non-controlled pilot trial.


Eligibility criteria: Inclusion Criteria:

* scheduled to undergo fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy
* age 22 and older
* able to communicate fluently in English

Exclusion Criteria:

* inability to complete study procedures due to delirium, dementia, psychosis, or other cognitive impairment
* have a history of severe neurologic movement disorder
* are pregnant or intent to become pregnant during study
* have undergone previous spinal surgery
* have spinal deformity, pseudarthrosis, trauma, infection, or tumor as primary indication for surgery
* have undergone Acceptance and Commitment Therapy in last 2 years

Primary outcomes:
measure: Treatment helpfulness (THQ)
timeFrame: Immediately following the ACT workshop
Secondary outcomes:
measure: Treatment Helpfulness (THQ)
timeFrame: 1 month post-op
measure: Treatment Credibility
timeFrame: immediately following ACT workshop
measure: Treatment Expectancy
timeFrame: immediately following ACT workshop
measure: Pain Interference
timeFrame: 1 month post-op
measure: Pain Interference
timeFrame: 3 months post-op
measure: Pain Interference
timeFrame: 6 months post-op
measure: Pain Severity
timeFrame: 1 month post-op
measure: Pain Severity
timeFrame: 3 months post-op
measure: Pain Severity
timeFrame: 6 months post-op
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03646474: Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC
Official title: Evaluation of the Efficacy & Safety of a Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytoreductive Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 46
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: PREVENTION

Brief summary: The Tranexamic Acid group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision. In the control group, patients will receive a placebo of 100 mL 0.9% normal saline. The primary endpoint is reduction in blood loss, while the secondary endpoint was the number of patients needing transfusion and occurrence of postoperative thrombotic complications (myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.


Eligibility criteria: Inclusion criteria

* ASA 1 and ASA 2 patients scheduled for colorectal cancer surgery.
* Age above 18 years \& less than 65 years.

Exclusion criteria:

* Thrombophilia or any bleeding disorder.
* Previous or active thromboembolic disease.
* Family history of thromboembolism.
* Known Allergy to TA.
* Liver dysfunction.
* Preexisting renal dysfunction (serum creatinine \>1.2 mg/dL).
* Coronary stent insertion within a year prior to operation.
* Cardiovascular problem (e.g., myocardial infarction, atrial fibrillation, angina, heart failure),
* Lifelong warfarin therapy for thromboembolism prophylaxis.

Primary outcomes:
measure: change in blood loss
timeFrame: 1st 24 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute, Cairo University
Study officials:
References:
Clinical trial NCT03010774: Identifying At-Risk Patients and Predicting Deterioration of In-Patients Using Continuous Heart Rate, Respiratory Rate, and Movement Monitoring
Official title: Identifying At-Risk Patients and Predicting Deterioration of In-Patients Using Continuous Heart Rate, Respiratory Rate, and Movement Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: EarlySense Ltd.
First posted: 2017-01-05
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Currently, all patients in the hospital are woken up throughout the night to check for vital signs, no matter how sick they are. The investigators are doing this study to determine whether skipping routine vital sign checks at night improves participant sleep quality and satisfaction without increasing the risk of adverse events.

Detailed description: The purpose of this study is:

1. To determine the correlation between subjective and objective sleep quality measures.
2. To compare the objective and subjective measures of sleep quality and satisfaction between the intervention group and the control group.
3. To compare the adverse event rates in the intervention group and the control group, defined as ICU transfer or cardiac arrest occurring within 24 hours of risk stratification.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Hospitalized on study unit

Exclusion Criteria:

* Inability to provide consent
* Non-English speaking
* Order for physical wound checks
* Order for cardiac telemetry monitoring

Primary outcomes:
measure: Sleep Quality
timeFrame: 5 days
measure: Sleep Quality
timeFrame: 5 days
measure: Sleep Quality
timeFrame: 5 days
Secondary outcomes:
measure: Adverse Event Rate
timeFrame: within 24 hours of risk stratification
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Dana P Edelson, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06735365: Comparative Effectiveness of Oxiris Hemofilters Versus Conventional Hemofilters in Septic Patients
Official title: Comparative Effectiveness of Oxiris Filters Versus Conventional Hemofilters in Septic Patients: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis - to Reduce Mortality in the Intensive Care Unit
Hemodiafiltration
Cytokine
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2024-12-16
Enrollment: 426
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: study population includes patients who have admission on our clinic for more than 5 days and diagnosed with sepsis who has CRRT indication

Brief summary: We divided patients in 2 groups. First group was the patients who received Oxiris filters during CRRT. Second group was the patiens who have received CRRT filters other than Oxiris.

We compared the lab parameters (Urea, Creatinin, Lactate, ABG parameters and SOFA escore with together.


Eligibility criteria: Inclusion Criteria:

sepsis diagnosis CRRT indication

Exclusion Criteria:

patients under age of 18

Primary outcomes:
measure: SOFA Score
timeFrame: 6 month
Secondary outcomes:
measure: Survival comparison
timeFrame: 6 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Research and Training Hospital
Study officials:
References:
Clinical trial NCT03420365: The Effect of a Single Bout of Balance and Coordination Exercise on Cognitive Function in Elderly People
Official title: The Effect of a Single Bout of Aerobic Exercise Versus a Single Bout of Balance and Coordination Exercise on Cognitive Function in Elderly People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Cognitive Decline
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: The Academic College at Wingate, Israel
First posted: 2018-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Individuals of advanced age are at higher risk of cognitive deterioration.A single bout of aerobic exercise was found to improve cognitive functions. The aim of this study is to explore the effect of a single bout of balance and coordination exercise versus aerobic exercise on cognitive functions among elderly people.


Eligibility criteria: Inclusion Criteria:

* Able to undergo physical activity for 60 minutes
* Participates in a physical activity center at least twice a week

Exclusion Criteria:

* Scores beneath 24 on MMSE
* Unable to sign a consent form

Primary outcomes:
measure: Cognitive function - Attention
timeFrame: Each cognitive test will be performed immediately following the intervention
measure: Cognitive function - Executive functions
timeFrame: Each cognitive test will be performed immediately following the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: The Academic College at Wingate
Study officials:
References:
Clinical trial NCT01049165: Single Ascending Dose (BMS-813160) Study
Official title: Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-813160 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Accelerated Intimal Hyperplasia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-01-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to evaluate the safety and tolerability of single oral doses of BMS-813160 in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Men and women (not of child bearing potential) ages 18 to 45
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Women of Child Bearing Potential
* Organ dysfunction or any clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Primary outcomes:
measure: Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events
timeFrame: Dosing through Day 5
Secondary outcomes:
measure: Pharmacokinetics of BMS-813160
timeFrame: 9 times after dosing
measure: Pharmacodynamics (Plasma MCP-1)
timeFrame: 9 times post dose
measure: Pharmacodynamics (Circulating monocytes)
timeFrame: 5 times post dose
measure: Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood)
timeFrame: 5 times post-dose
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06405165: Jigsaw Learning Model and Urinary Catheter Care
Official title: The Effect of Flipped-Jigsaw Learning Models on Learning Knowledge and Skills for Urinary Catheter Care in Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Effect of the Flipped-Jigsaw Learning Model on Learning
Keywords: flipped training
Jigsaw learning model
nursing students
urinary catheter care
Lead sponsor: Bilecik Seyh Edebali Universitesi
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 37
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The effect of the flipped education-Jigsaw learning model on the knowledge level of urinary catheter care in nursing students.
Primary purpose: OTHER

Brief summary: This study was planned to evaluate the effect of the reversed Jigsaw learning model on urinary catheter care in nursing students. It is anticipated that the relevant method will increase the knowledge level of students.

Detailed description: In this research, it is aimed to use the flipped learning model and the Jigsaw learning model together. The group in which the intervention will be carried out will continue their education outside the classroom with videos and lecture notes, and will carry out group work during class time as required by the Jigsaw strategy. In a study in which these two teaching methods were applied to nursing students within the scope of an ethics course, an increase in the students; ethical sensitivity and familiarity with ethical dilemmas was noted. Therefore, in this study focusing on urinary catheter care, the academic success of the students will make a difference in patient safety. It is anticipated that this study is original in its field and will guide instructors within the scope of teaching techniques.

Eligibility criteria: Inclusion Criteria:

* Getting information about urinary catheter care for the first time
* Volunteering to participate in the study

Exclusion Criteria:

* Having received previous training on urinary catheter care
* Not volunteering to participate in the study
* Not participating in the posttest and follow-up test

Primary outcomes:
measure: The effect of the flipped education-Jigsaw learning model on the knowledge level of urinary catheter care in nursing students.
timeFrame: 5 weeks for each participant
Secondary outcomes:
Other outcomes:
Locations:
city: Bilecik
country: Turkey
facility: Bilecik Şeyh Edebali University
Study officials:
References: