louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00987818: Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU
Official title: Reduction of Antibiotic Use in the ICU: Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sepsis
Intensive Care
Keywords: Biomarkers
Antibiotic therapy
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Stichting Vrienden van het Alysis Leerhuis
First posted: 2009-10-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The adequacy of early empiric antimicrobial therapy is an important factor in determining the outcome in patients with severe sepsis. The duration of adequate antibiotic therapy in these patients however is less clear. Duration of antibiotic therapy in patients with sepsis in the ICU based on inflammatory markers has not been extensively studied.

Procalcitonin (PCT) is an acute phase protein that has prognostic value in critically ill patients and can be used to monitor disease activity in sepsis and systemic inflammation. This study will examine the effect of PCT guided antibiotic therapy compared with conventional antibiotic therapy on treatment duration in patients with sepsis admitted to the ICU.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICU
* Age \> 18 years
* Antibiotic therapy for sepsis with a suspected or proven focus of infection

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Infection or presumed infection requiring prolonged antibiotic therapy (osteomyelitis, meningitis, endocarditis, septic arthritis, mediastinitis, tuberculosis, Pneumocystis jiroveci pneumonia, Toxoplasmosis, Legionellosis, Listeriosis)
* Indication for prolonged systemic prophylactic antibiotic therapy
* Severe viral or parasitic infections (hemorrhagic fever, malaria)
* Antibiotic therapy started 48 hours before enrollment
* Severe immunocompromised patients (AIDS with a CD4 count \< 200cells/mm3, severe neutropenia(\<500 neutrophils/mm3), patients undergoing immunosuppressive therapy after solid organ transplantation)
* Patients foregoing life sustaining treatment

Primary outcomes:
measure: duration of antibiotic therapy
timeFrame: 28 days
Secondary outcomes:
measure: 28 day mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Alysis Zorggroep, Rijnstate Hospital
state: Gelderland
Study officials:
References:
Clinical trial NCT02216318: Energy-efficient and Health Promoting Light for Elderly People
Official title: A Study of Two Different Light Conditions for Healthy Subjects Above 65 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: sleep
circadian
melatonine
pupil response
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Elforsk
name: Albertslund Kommune
name: Gate 21
name: DTU Fotonik
name: VISO systems
name: AF Lightning
name: Philips Healthcare
name: Statens Byggeforskningsinstitut
First posted: 2014-08-13
Enrollment: 29
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: to investigate the effect of two lightning conditions on sleep hypothesizing that sleep length is influenced by the color of light during daytime

Detailed description: Lightning conditions seems to be important for the length and quality of sleep, as light have an influence on the production of the sleep hormone (melatonin) and the the circadian rhythm. Entrainment of the circadian rhythm to the surroundings is accomplished by light-sensitive retinal ganglion cells and these cells are sensitive to blue light.

Based on previous research, blue light early in the day and abscence of blue light during evening is important for the entrainment.

In this study, lightning conditions in the home of healthy subjects are set to either blue enriched or red enriched from 8 a.m to 1. p.m. The lightning condition is based on a randomization protocol in a cross-over study for 3 weeks in each condition, separated by a one week pause.

Eligibility criteria: Inclusion Criteria:

* age 65 to 85 years

Exclusion Criteria:

* Conditions which will interfere by the primary endpoint as evaluated by the medical doctor

Primary outcomes:
measure: Sleep length
timeFrame: 1 week
Secondary outcomes:
measure: actigraphy
timeFrame: 1 week
Other outcomes:
measure: pupillometry
timeFrame: the last day of each light period
measure: melatonin
timeFrame: the last day of each light period
measure: Questionnaire
timeFrame: 3 weeks
Locations:
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Line Kessel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05830318: Usability and Acceptability Study of the P-STEP Mobile Application
Official title: Usability and Acceptability Study of the P-STEP Mobile Application
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Interstitial Lung Disease
Coronary Heart Disease
Heart Failure
Type 2 Diabetes
Keywords: Exercise
Pollution
Air Quality
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be identified and recruited on a voluntary basis exclusively from the EXCEED cohort study. A longitudinal cohort study based in Leicester, UK.

Brief summary: Assess the usability and acceptance of the P-STEP app, through allowing participants with specific chronic conditions to pilot the app for 12-weeks.

Detailed description: Participants are asked to use mobile app for 12 weeks \& complete baseline, 6 week and 12 week assessments.

Eligibility criteria: Inclusion Criteria:

* Adult ≥ 18 years
* Live within the boundaries of the test site (Leicester, UK).
* Diagnosed with one (or more) of the following conditions: asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), coronary heart disease (CHD), heart failure (HF), type 2 diabetes
* Android smartphone which has access to the internet
* Can walk outside for a minimum of 5 minutes without feeling uneasy/unsteady
* Available to pilot the app for 12 weeks from August-December 2023
* Able to give informed consent to participate in the evaluation

Exclusion Criteria:

* English language restriction
* Advised not to do exercise by a health care professional, in the last 12 months.
* Access to an iOS smartphone only
* Diagnosed with dementia, learning disability, mental health disorders (other than depression or anxiety), epilepsy
* Receiving palliative care
* Pregnant
* Chest pain at rest
* Unsteady when standing or walking
* Current cancer patient
* Part of the P-STEP User Engagement group

Primary outcomes:
measure: System Usability Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Usability of P-STEP app
timeFrame: 12 weeks
measure: User Engagement Scale Short Form
timeFrame: 12 weeks
measure: SF-12 Health Questionnaire
timeFrame: 12 weeks
measure: Recent Physical Activity Questionnaire
timeFrame: 12 weeks
measure: Feasibility outcome - Interest
timeFrame: 2 months
measure: Feasibility outcome - Enrolment
timeFrame: 2 months
measure: Feasibility outcome - App administration
timeFrame: 3 months
measure: Feasibility outcome - App acceptability
timeFrame: 3 months
measure: Feasibility outcome - Acceptability of the outcome measures
timeFrame: 3 months
measure: All cause mortality
timeFrame: 3 months
measure: Cardiovascular events
timeFrame: 3 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University of Leicester
Study officials:
References:
Clinical trial NCT05402618: Minimally Invasive Versus Open Surgery for PHC
Official title: Minimally Invasive Versus Open Surgery for Perihilar Cholangiocarcinoma(PHC)：A Multicenter Real-world Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perihilar Cholangiocarcinoma
Keywords: laparoscopic
minimally invasive
open resection
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 783
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective review of a real-world institutional databases from 10 hospitals in China identified PHC patients who underwent curative LS or OP surgery (including R0 and R1) form January 2012 and January 2019.Patients with pathologically confirmed PHC and without any evidence of distant metastasis by preoperative examinations were included.

Brief summary: Brief Summary: This is a multicentric, retrospective, real-world study to investigate the surgical outcomes of minimally invasive surgery compared with open surgery for Perihilar Cholangiocarcinoma (PHC), with the perioperative characteristics and long-term overall survival being compared. We aimed to find out whether the minimally invasive surgery is safe or feasible for PHC. And we also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach.


Eligibility criteria: Inclusion Criteria:

Histologically confirmed PHC.

Exclusion Criteria:

1. Peritoneal seeding or metastasis to the liver, para-aortic lymph nodes, or distant sites;
2. Non-adenocarcinoma histology;
3. Incomplete clinical data.

Primary outcomes:
measure: Postoperative length of stay
timeFrame: up to 90 days
measure: Overall survival
timeFrame: through study completion, an average of 5 year
Secondary outcomes:
measure: Operation time
timeFrame: intraoperative
measure: postoperative complications
timeFrame: up to 90 days
measure: Reoperation within 90 days
timeFrame: up to 90 days
measure: Mortality
timeFrame: up to 90 days
measure: Readmission within 90 days
timeFrame: up to 90 days
measure: Operative details
timeFrame: intraoperative
measure: R0 resection
timeFrame: intraoperative
measure: Intraoperative blood loss
timeFrame: intraoperative
measure: Vessel reconstruction
timeFrame: intraoperative
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT04772118: Improving Cancer Outcomes Through Personalized Care Planning and Symptom Management.
Official title: Improving Cancer Outcomes Through Personalized Care Planning and Symptom Managment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Breast Cancer
Gynecologic Cancer
Lead sponsor: Carevive Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This Study is a case control Study conducted with 100 patients with a solid tumor cancer diagnosis (lung, breast, or gynecologic cancer). Records of 50 patients who received treatment plans as standard of care will be abstracted for control data. 50 patients undergoing cancer treatment will receive a treatment plan and report symptoms using Carevive PROmPT™.


Eligibility criteria: Inclusion Criteria:

* All participants must be 18 years of age or older.
* Subject participants must have a diagnosis of a breast, lung, or gynecologic cancer.
* Patients must have completed their navigation visit and received a Treatment Care Plan.
* Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
* Subjects must be starting or receiving treatment.
* All participants must be able to understand English.

Exclusion Criteria:

* Any patient who cannot understand written or spoken English.
* Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
* Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

Primary outcomes:
measure: Outcomes for Primary Aim 1 - 50 intervention participants with a diagnosis for lung, breast or ovarian cancer measuring the prevalence and severity of 18 different symptoms reported from home over 3 months.
timeFrame: 10 months
Secondary outcomes:
measure: Outcomes for Secondary Aim 2 - 50 intervention patients will complete the Patient Satisfaction Survey at the 3month timepoint to measure satisfaction with treatment decision and care experience.
timeFrame: 10 months
measure: Outcomes for Secondary Aim 3 - Feasibility will be measured by completion of the patient questionnaires and patient symptom reports by the 50 intervention patients. Usability will be measured through provider feedback.
timeFrame: 10 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mitchell Cancer Institute
state: Alabama
Study officials:
References:
Clinical trial NCT03044418: Anesthesia With Endotracheal Laser Tube
Official title: Anesthesia of Endolaryngeal Surgery With a Special Endotracheal Laser Tube
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Anesthesia Morbidity
Keywords: laser
endotracheal tube
total intravenous anesthesia
side effect
endolaryngeal surgery
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 30
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: patient with endolaryngeal laser surgery and after 18 years

Brief summary: The study examines the special endotracheal laser tube during anesthesia of endolaryngeal laser surgery.

Detailed description: The special endotracheal tube is covered by a special aluminum tape.

Eligibility criteria: Inclusion Criteria:

* laser surgery

Exclusion Criteria:

* allergy of propofol

Primary outcomes:
measure: Number of Participants With Side Effects
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pecs
country: Hungary
facility: PTE Department of ENT
Study officials:
affiliation: PTE Department of the Anesthesiology and Intensive Therapy
name: Lajos Bogar, MedHabil
role: STUDY_CHAIR
affiliation: PTE Department of ENT
name: Laszlo Lujber, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02369718: Cochlear Implants : Influence of Microphone Aging and Dirtying
Official title: Consequences of Aging and Dirtying of Microphones on the Performances of Cochlear Implants. Influence of Signal Coding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hard of Hearing
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cochlear implant microphones are subject to aging and dirtying. The evolution may affect their efficiency. Several signal coding strategies are used in cochlear implants and their behaviour may be more or less affected by the aging process. In this work the investigators wish to assess this phenomenon.


Eligibility criteria: Inclusion Criteria:

* French speaking persons (French native speakers; studies made in French)
* Ear, Nose and Throat (ENT) tests and check up for normal hearing listeners were normal (Hearing loss below 20 dBs for all frequencies situated in the 250-8000 Hz range)
* Not mentally retarded

Exclusion Criteria:

* Persons with tinnitus or headache
* Anxious people (taking psychiatric drugs)
* Mental alteration or mental retard
* Deafened persons or taking an ENT treatment (normal hearing listeners)

Primary outcomes:
measure: Percentage of correct syllable recognition
timeFrame: At day 1
Secondary outcomes:
Other outcomes:
Locations:
city: LYON cedex 03
country: France
facility: Pavillon ORL (U) - Hôpital Edouard Herriot
Study officials:
References:
Clinical trial NCT00424918: "Generation Fit and Exerlearning With In the Groove"
Official title: Generation-Fit, a Pilot Study of Youth in Maine Middle Schools Using an "Exerlearning" Dance Video Game to Promote Physical Activity During School
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Dance
Peers
middle school-based
feasibility
Lead sponsor: MaineHealth
Sponsor class: OTHER
First posted: 2007-01-22
Enrollment: 85
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: In middle schools participating in a statewide program called "Take Time", we are randomizing youth to a 10-12 week intervention using the dance mat games on the Playstation2 (like Dance Dance Revolution). This program is testing feasibility of using the dance mats as a way to increase activity during the school day. We are using "Groove Masters" as a peer-mentored mechanism to keep track of the activity of youth in the intervention compared to the control group. Our main objective is increase in activity time.

Detailed description: We met with administrators and teachers and obtained consent and assent for this study. After assessing baseline measures (end-of-grade test scores, absenteeism, Pediatric Quality of Life, physical fitness, GEMS Activity Rating Scale, Dennison's measure of sedentary screen time, Physical Activity Enjoyment Scale, BMI%ile, (with a small subset assayed for fasting lipids and glucose, with a smaller subset wearing ActiGraphs for objective measures of activity) we randomized to the intervention or control group.

In our intervention, youth play a dance game at school called "In the Groove", with the goal of 40 additional minutes each week of physical activity during the school hours.

We will obtain change scores and compare the groups to find an effect size for future studies, this this proves acceptable and feasible in Maine schools.

Eligibility criteria: Inclusion Criteria:

* Take Time middle school in Maine with consent/assent

Exclusion Criteria:

* Any condition that prevents a child from doing physical activity on the dance mat like photic seizures, broken leg, blindness.

Primary outcomes:
measure: Minutes of activity added in school day.
Secondary outcomes:
measure: Quality of Life change scores
measure: Relation to test scores, absenteeism
measure: Fitness change scores
measure: Change in biological endpoints
measure: Others
Other outcomes:
Locations:
city: Portland
country: United States
facility: Portland
state: Maine
Study officials:
affiliation: Research Attending
name: Ann E Maloney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lanningham-Foster L, Jensen TB, Foster RC, Redmond AB, Walker BA, Heinz D, Levine JA. Energy expenditure of sedentary screen time compared with active screen time for children. Pediatrics. 2006 Dec;118(6):e1831-5. doi: 10.1542/peds.2006-1087.
Clinical trial NCT02885818: Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis
Official title: Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with RA fulfilling ACR/EULAR criteria, in whom abatacept is started as part of their usual clinical care

Brief summary: Abatacept disrupts T-cell coactivation signals in rheumatoid arthritis (RA). Its potential effects on B cells are not well described. This study will assess the effects of abatacept therapy on the phenotype and function of peripheral blood B cells in patients with RA.


Eligibility criteria: Inclusion Criteria:

* RA as defined by ACR/EULAR criteria
* Clinical indication to start abatacept therapy

Exclusion Criteria:

* Treatment by rituximab in the previous year

Primary outcomes:
measure: Peripheral blood B-cell phenotype changes
timeFrame: 3 months
Secondary outcomes:
measure: In vitro B-cell function and regulatory properties
timeFrame: 3 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Jacques-Olivier Pers
role: STUDY_DIRECTOR
References:
Clinical trial NCT02846818: Cerebral Energy State in Cardiac Surgery
Official title: Continuous Monitoring of Cerebral Energy State During Cardiac Surgery - A Novel Approach Utilizing Intravenous Microdialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative; Dysfunction Following Cardiac Surgery
Keywords: Microdialysis
Cardiac surgery
Lactate to pyruvate ratio
Cardiopulmonary bypass
Neurological complications
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Impaired cerebral function remains an important complication of cardiopulmonary bypass (CPB) during cardiac surgery. The aim of the present study is to investigate whether the lactate to pyruvate (LP) ratio obtained by microdialysis (MD) of the cerebral venous outflow reflects a derangement of global cerebral energy state during cardiopulmonary bypass.

Detailed description: Patients undergoing primary, elective coronary artery bypass grafting were blindly randomized to usual range MAP (40 to 60 mmHg; n = 5) or intervention group MAP (60 to 80 mmHg; n = 5) during CPB. MD catheters were positioned in a retrograde direction in the internal jugular vein and a reference catheter was inserted into the brachial artery. The relations between LP ratio, MAP, data obtained from bi-frontal NIRS and neurological outcome measures were assessed.

Eligibility criteria: Inclusion criteria:

* Elective CABG on CPB

Exclusion criteria:

* Acute patients or reoperations
* Patients with epidural catheter
* Previous stroke
* Stenotic carotids
* Ejection fraction (EF) \< 50 %
* Estimated per operative risk \> 5%

Primary outcomes:
measure: Extracerebral microdialysis parameters
timeFrame: MD parameters were measured intraoperatively and for two hours postoperatively
Secondary outcomes:
measure: Mini mental state examination (MMSE)
timeFrame: Neurological complications with in 2 days after surgery
measure: Near-infrared spectroscopy (NIRS)
timeFrame: one day
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Fyn
Study officials:
affiliation: Odense University Hospital
name: Palle Toft, Professor
role: STUDY_DIRECTOR
References:
citation: Ahonen J, Salmenpera M. Brain injury after adult cardiac surgery. Acta Anaesthesiol Scand. 2004 Jan;48(1):4-19. doi: 10.1111/j.1399-6576.2004.00275.x.
citation: McDonagh DL, Berger M, Mathew JP, Graffagnino C, Milano CA, Newman MF. Neurological complications of cardiac surgery. Lancet Neurol. 2014 May;13(5):490-502. doi: 10.1016/S1474-4422(14)70004-3. Epub 2014 Apr 2.