louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06770751: Family Involvement in ICU
Official title: Family Involvement in the Intensive Care Unit: a Prospective Cohort Study Exploring Its Effects on Sedation Dosages, Delirium, Ventilator-Free Days, and Length of Stay.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intensive Care Patients
Relatives
Delirium in the Intensive Care Unit
Sedatives
Family
Keywords: Intensive care patients
relatives
Delirium in the intensive care unit
Sedatives
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 122
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 in a tertiary intensive care unit of a university hospital

Brief summary: The aim of this prospective cohort study was to investigate the effect of the time spent with relatives of patients treated in a tertiary intensive care unit on patient outcomes.

The main question it aimed to answer was:

Does spending more time with relatives of patients in intensive care result in lower sedative agent requirements? Does spending more time with relatives of patients in intensive care result in less delirium, fewer ventilator days, and shorter ICU stays?


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 and over.
* Patients with at least one family member actively involved in the care process in the ICU.

Exclusion Criteria:

* Patients with pre-existing cognitive impairment or dementia.
* Patients with severe traumatic brain injury.
* Patients with an expected mortality in the ICU of more than 80%.
* Absence of family members for patients admitted to the ICU.

Primary outcomes:
measure: Sedative dose
timeFrame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.
Secondary outcomes:
measure: Delirium
timeFrame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.
measure: Ventilatory days
timeFrame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.
measure: Stay in intensive care unit
timeFrame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Cerrahpaşa Medical Faculty
Study officials:
affiliation: İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty
name: Oktay Demirkiran, Professor
role: STUDY_DIRECTOR
affiliation: İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty
name: Oguzhan Kayhan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780351: Dosing Vancomycin in Patients on Sustained Low Efficiency Daily Hemodiafiltration (SLEDD-f)
Official title: Pharmacokinetics and Dosing of Vancomycin in Sustained Low Efficiency Daily Hemodiafiltration (SLEDD-f)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Renal Failure
Keywords: vancomycin, SLEDD-f
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-10-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in intensive care unit.

Brief summary: 1. Sustained low efficiency daily hemodiafiltration(SLEDD-f) is a kind of renal replacement therapy with high-flux dialyser membrane (helixone).
2. The pore size of helixone is larger than most antibiotics, and vancomycin is supposed to be removed during dialysis.
3. Our study wants to find the amount of vancomycin removed during SLEDD-f, and try to find the most appropriate dose regimen for this kind of patients.

Detailed description: Vancomycin is the most important antibiotic in the treatment of resistant G(+) bacteria infections. Close monitor of serum level is important to ensure its safety and effectiveness. So far there is not enough data to support the optimal dose regimen of vancomycin in patients on SLEDD-f. In this study, we draw blood levels between 2 doses of vancomycin to determine the pharmacokinetic parameters of vancomycin and fraction removed by SLEDD-f so as to determine the most appropriate dose regimen.

Eligibility criteria: Inclusion Criteria:

* Acute renal failure of any cause
* Use SLEDD-f as renal replacement therapy
* Priscribe vancomycin for a known or suspected infection

Exclusion Criteria:

* None

Primary outcomes:
measure: The amount of vancomycin removed during one course of SLEDD-f
timeFrame: 8 hr (during one course of SLEDD-f)
measure: The pharmacokinetics and dosing regimen of vancomycin in patients on SLEDD-f.
timeFrame: 26 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: School of pharmacy, Graduate institute of clinical pharmacy, Department of Pharmacy of National Taiwan University Hospital, College of Medicine, National Taiwan University
name: Fe-Lin L Wu, MSCP, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, National Taiwan University Hospital, College of Medicine, National Taiwan University
name: Wen-Je Ko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02865551: Urinary Retention After Vaginal Delivery With Epidural Anesthesia.
Official title: The Rate of Urinary Retention in Women After Vaginal Delivery With Epidural Anesthesia Who Underwent Prolonged Catheterization Compared With Intermittent Catheterization During Labor.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Retention
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators intend to compare the rate of urinary retention among female patients after vaginal delivery under epidural anesthesia, depending on bladder catheterization type, either by a foley catheter inserted adjacent to epidural anesthesia or intermittent catheterization applied every 4 hours during labor.

Detailed description: An explanation about the study will be delivered to each participant and each participant will sign a confirmed consent. Patients will be randomized between 2 groups of treatment: 1. intermittent catheterization applied every 4 hours during labor. 2. foley catheter inserted adjacent to epidural anesthesia.

In patients with a foley catheter, the catheter will be removed soon after delivery. Participants will be followed by a clinician post labor. An abdominal US will be performed either 4 hours after delivery or after the participant urinates to check the bladder volume.

Patient information including demographic information, information regarding the patient's pregnancy and delivery will be collected from the patient's electronic record.

Eligibility criteria: Inclusion Criteria:

* Female patients in labor designated for vaginal delivery with epidural anesthesia.

Exclusion Criteria:

* Patients with neurological problems including gestational diabetes.
* Patients either designated for elective cesarean delivery or emergent cesarean delivery.

Primary outcomes:
measure: Rate of urinary retention after vaginal delivery with epidural anesthesia
timeFrame: Up to 3 days
Secondary outcomes:
measure: Rate of urinary tract infections
timeFrame: Up to 3 days
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Lior Lowenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06346951: Survey on the Current Status of IFD Diagnosis and Treatment by Intensive Care Physicians in Sichuan Province (IFS)
Official title: Survey on the Current Status of IFD Diagnosis and Treatment by Intensive Care Physicians in Sichuan Province (IFS)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Invasive Fungal Infections
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intensive care physicians in medical institutions at all levels in Sichuan Province. Anticipated total of 20 centers will participate in the study, with a total of 300 physicians to be included in the survey.

Brief summary: The goal of this survey is to learn about the current status of the diagnosis and treatment of invasive fungal infections among intensive care physicians in Sichuan Province (IFS). Its primary focus lies on answering the following questions: ①awareness and proficiency in diagnosis and treatment; ②the use of antifungal medications; ③the application of microbiological identification and diagnostic methods. We aim to analyze the problems and deficiencies that existed among intensive care physicians in order to provide a basis for the development of targeted training and intervention measures.


Eligibility criteria: Inclusion Criteria:

* Intensive care physicians in medical institutions at all levels in Sichuan Province

Exclusion Criteria:

* Exclude non-Sichuan physicians.
* Excluding physicians who are not engaged in intensive care unit.

Primary outcomes:
measure: The survey on the hospital's diagnostic and treatment standards and infrastructure for invasive fungal infections
timeFrame: From enrollment to the end of survey at 16 weeks
measure: The survey on the awareness of an invasive fungal infection among intensive care physicians
timeFrame: From enrollment to the end of survey at 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03499951: Remote Wheelchair Skills Training Efficacy
Official title: Remote Wheelchair Skills Training Efficacy Coordinating Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Quality of life
Participation
Training
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2018-04-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to evaluate the effectiveness of remote training to teach clinicians how to train others in wheelchair skills.


Eligibility criteria: Inclusion Criteria:

• Age 18 to 75

Exclusion Criteria:

• Upper or lower extremity injury that would preclude the ability to use a wheelchair.

Primary outcomes:
measure: Change from baseline in wheelchair skills capacity of trainees at study completion as measured by the Wheelchair Skills Test Questionnaire
timeFrame: Baseline, and at study completion ( an average of 3 weeks)
measure: Change from baseline in wheelchair skills confidence of trainees at study completion as measured by the Wheelchair Skills Test Questionnaire
timeFrame: Baseline, and at study completion ( an average of 3 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: South Florida Spinal Cord Injury System
state: Florida
city: Chicago
country: United States
facility: Midwest Regional Spinal Cord Injury Care System
state: Illinois
city: West Orange
country: United States
facility: Northern New Jersey Spinal Cord System
state: New Jersey
city: Pittsburgh
country: United States
facility: University of Pittsburgh Model Center on Spinal Cord Injury
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Michael Boninger, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Worobey LA, Kirby RL, Cowan RE, Dyson-Hudson TA, Shea M, Heinemann AW, Pedersen JP, Boninger ML. Efficacy of a Remote Train-the-Trainer Model for Wheelchair Skills Training Administered by Clinicians: A Cohort Study With Pre- vs Posttraining Comparisons. Arch Phys Med Rehabil. 2022 Apr;103(4):798-806. doi: 10.1016/j.apmr.2021.03.042. Epub 2021 Jun 6.
Clinical trial NCT06870851: Predicting Platelet Count From Viscoelastic Testing
Official title: Machine Learning Based Prediction of Platelet Concentration From ROTEM Measurements
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Thrombocytopenia
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: surgical patients in the operating room and the intensive care of participating centers

Brief summary: Viscoelastic testing is a highly recommended cornerstone of modern coagulation medicine, reducing transfusion needs. A disadvantage of viscoelastic tests is the impossibility of making a definitive statement about the platelet count.

Therefore, the aim of this retrospective observational study is, on the one hand, to predict the platelet count based on standard ROTEM parameters with the help of several machine learning methods and, on the other hand, to detect a low platelet count ( \<100000 ml-1 and \< 50000 ml-1).


Eligibility criteria: Inclusion Criteria:

* ROTEM measurement and platelet count measurement within 3 hours.

Exclusion Criteria:

* under 18 Years
* more than 3 hours between ROTEM and platelet count measurement

Primary outcomes:
measure: Predicition of platelet conentration from ROTEM measurements using machine learning
timeFrame: Obtained ROTEM analyses are the baseline at all four centres and patients will be included if platelets were determined concomitantly within three hours on the same day.
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Universitätsklinik für Anästhesie und Intensivmedizin
Study officials:
References:
Clinical trial NCT06656351: Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
Official title: Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chronic Babesiosis
Keywords: Chronic Babesiosis
Lead sponsor: 60 Degrees Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2024-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue


Eligibility criteria: Inclusion Criteria:

* Male or female, aged ≥ 18 years
* Has received a diagnosis of chronic babesiosis
* Severe disabling fatigue
* Able and willing to give written informed consent
* Able and willing to perform all study assessments
* If female negative urine pregnancy test and
* If female agree to use an acceptable method of birth control

Exclusion Criteria:

* Glucose-6-phosphate-dehydrogenase (G6PD) deficiency
* Breastfeeding
* Unmanaged Psychotic disorder
* Known hypersensitivity reaction to tafenoquine or other 8-aminoquinolines
* Current or planned treatment with quinine
* Any concomitant significant illness unrelated to babesiosis
* Any excluded concomitant medication
* Taking or intending to take quinine
* The patient is unable to tolerate medication by the oral route
* The patient has previously taken tafenoquine

Primary outcomes:
measure: Change in General Fatigue
timeFrame: From enrollment until Day 90 of treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04913051: Interest of Day Hospital Care for Patients With Chronic Regional Pain Syndrome Referred to the Chronic Pain Unit for the First Time
Official title: Interest of Day Hospital Care for Patients With Chronic Regional Pain Syndrome Referred to the Chronic Pain Unit for the First Time
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Regional Pain Syndrome
Keywords: Chronic Regional Pain Syndrome
day hospital
Chronic Pain Unit
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 40
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 Chronic Regional Pain Syndrome referred to the Chronic Pain Facility for the first time

Brief summary: Chronic Regional Pain Syndrome (CRPS) is a chronic disabling disease. Patients present a variable picture associating pain localized to an articular or peri-articular region, motor and vasomotor disorders and trophic disorders.

Its pathophysiology, still poorly understood to this day, results from local inflammatory phenomena complicated by peripheral sensitization and central spinal and cerebral sensitization.

The diagnosis is made difficult by the fluctuating nature of the symptoms and the absence of specific complementary examination.

The treatment of CRPS is symptomatic and requires multidisciplinary care. CRPS is responsible for an alteration in the patient's quality of life. This pathology has a global impact because it affects not only the biomedical sphere but also the socio-family, professional and psychological spheres.

The investigators hypothesize that multidisciplinary intervention in the Day Hospital would improve the quality of life of patients with CRPS. The investigators also think that the passage in Day Hospital would make it possible to improve the pains, the functionality of the affected limb as well as the satisfaction of the patients.


Eligibility criteria: Inclusion Criteria:

* Patient volunteers over 18 years of age
* Diagnosis of CRPS according to the Budapest criteria
* Referred to pain assessment and treatment center

Exclusion Criteria:

* Patients unable to express their wishes or understand the protocol
* Diagnosis of CRPS not meeting Budapest criteria
* Patients previously seen at pain assessment and treatment center for the care of CRPS

Primary outcomes:
measure: Evaluate impact of day hospital care on quality of life
timeFrame: 3 months after day hospital
measure: Evaluate impact of day hospital care on quality of life
timeFrame: 6 months after day hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References:
Clinical trial NCT01556451: ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)
Official title: An Open-label, Single-arm, Multi-center, Phase IV Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Herpes Zoster
Shingles
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-03-16
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical hypothesis testing will be conducted in the study.


Eligibility criteria: Inclusion Criteria:

* No fever on day of vaccination
* Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
* Underlying chronic illness must be stable

Exclusion Criteria:

* History of hypersensitivity reaction to any vaccine component
* Prior history of herpes zoster
* Prior receipt of varicella or zoster vaccine
* Pregnant or breastfeeding
* Have recently received immunoglobulins or blood products other than autologous blood transfusion
* Received any inactivated other live virus vaccine within 4 weeks prior to vaccination, or is expected to received any other live virus vaccine during the duration of the study
* Received any inactivated vaccine within 7 days prior to vaccination, or is expected to receive any inactivated vaccine during the duration of the study
* Use of immunosuppressive therapy
* Known or suspected immune dysfunction
* Use of nontopical antiviral therapy with activity against herpes virus
* Known or suspected active untreated tuberculosis

Primary outcomes:
measure: Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody
timeFrame: Day 1 (Baseline) and Week 4 postvaccination
measure: Geometric Mean Titer (GMT) of VZV Antibody
timeFrame: Day 1 (Baseline) and 4 weeks postvaccination
measure: Percentage of Participants With Clinical Adverse Experiences
timeFrame: Up to 42 days postvaccination
measure: Percentage of Participants Discontinued Due to Clinical Adverse Experiences
timeFrame: Up to 42 days postvaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Choi WS, Choi JH, Choi JY, Eom JS, Kim SI, Pai H, Peck KR, Sohn JW, Cheong HJ. Immunogenicity and Safety of a Live Attenuated Zoster Vaccine (ZOSTAVAX) in Korean Adults. J Korean Med Sci. 2016 Jan;31(1):13-7. doi: 10.3346/jkms.2016.31.1.13. Epub 2015 Dec 24.
Clinical trial NCT03832751: Human Beta-defensin 1 in Vitiligo
Official title: Estimation of Tissue Level of Human Beta-defensin 1 (HBD-1) in Vitiligo Before and After Narrowband UVB Phototherapy: a Case-control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: There is a need to know the role of human beta defensin-1 in vitiligo pathogenesis and the probability of finding newer and effective therapy for vitiligo in the future.


Eligibility criteria: Inclusion Criteria:

* Patients with non-segmental vitiligo.
* Both genders.
* Age more than 18 years old.
* New cases or cases not receiving any treatment for at least 3 months prior to the study.

Exclusion Criteria:

* Universal or segmental vitiligo.
* Any contraindication to phototherapy treatment.
* History of autoimmune diseases or other systemic diseases.
* Any other skin disease.

Primary outcomes:
measure: Tissue levels of human beta-defensin 1 before and after NB-UVB phototherapy
timeFrame: 6 months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: