louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02588794: Cytokine Adsorption in Sepsis and Acute Kidney Injury
Official title: Cytokine Adsorption in Sepsis and Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency or Renal Failure &or End-stage Renal Disease
Keywords: sepsis, acute kidney injury , CytoSorb
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to reduce the incidence of RIFLE stadium L and E after acute kidney injury in patients with severe sepsis/septic shock

Detailed description: Patient with proved severe sepsis/septic shock, treated in accordance to actual sepsis guidelines, who develope akute kidney injury (RIFLE I) or kidney failure (RIFLE F), were randomized in two groups.

One group is treated with CVVHD/ local citrat anticoagulation (standart clinical practice).

The other group ist treated with an additional cytokine adsorber ( 300ml CytoSorb device, 3804606CE01)

CytoSorb therapy is performed for 24h, then the adsorber is changed into a new device.

Cytosorb therapy is stopped, when Interleukin 6 leves drop below 1000 pg/ml in patient serum.

Eligibility criteria: Inclusion Criteria:

* severe sepsis or septic shock according to ESICM guidelines not older than 24 h

Exclusion Criteria:

* preexisting renal disease KDIGO stadium 4 and 5

Primary outcomes:
measure: RIFLE stadium L or E after acute kidney injury related to sepsis
timeFrame: 3 months
Secondary outcomes:
measure: mortality
timeFrame: 3 months
measure: length of renal replacement therapy
timeFrame: 3 months
measure: SOFA score
timeFrame: 3 months
measure: cumulative dose of vasopressor support
timeFrame: 4 weeks
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinik für Anästhesiologie
state: Bayern
Study officials:
affiliation: Department of Anaesthsiology
name: Kochs Eberhard, Chairman
role: STUDY_CHAIR
References:
Clinical trial NCT01617694: Comparison Between Remifentanil Target-controlled Infusion and Dexmedetomidine Bolus Administration for Smooth Emergence From General Sevoflurane Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Neoplasm
Keywords: dexmedetomidine
remifentanil
target-controlled infusion
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 65
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The investigators will compare the effects of two drugs on prevention of cough during emergence from general sevoflurane anaesthesia.


Eligibility criteria: Inclusion Criteria:

* female patient,
* aged 20-60 yr,
* ASA physical status 1-2,
* patients undergoing elective thyroidectomy under general anesthesia

Exclusion Criteria:

* sighs of difficult airway,
* history of respiratory disease or chronic cough,
* cardiovascular disease,
* pregnant or breast-feeding woman.

Primary outcomes:
measure: coughing response
timeFrame: from discontinuation of anesthetic agent (sevoflurane) to 5 min after extubation.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
citation: Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth. 2009 Jun;102(6):775-8. doi: 10.1093/bja/aep090. Epub 2009 May 2.
citation: Guler G, Akin A, Tosun Z, Eskitascoglu E, Mizrak A, Boyaci A. Single-dose dexmedetomidine attenuates airway and circulatory reflexes during extubation. Acta Anaesthesiol Scand. 2005 Sep;49(8):1088-91. doi: 10.1111/j.1399-6576.2005.00780.x.
citation: Turan G, Ozgultekin A, Turan C, Dincer E, Yuksel G. Advantageous effects of dexmedetomidine on haemodynamic and recovery responses during extubation for intracranial surgery. Eur J Anaesthesiol. 2008 Oct;25(10):816-20. doi: 10.1017/S0265021508004201. Epub 2008 Apr 10.
citation: Nho JS, Lee SY, Kang JM, Kim MC, Choi YK, Shin OY, Kim DS, Kwon MI. Effects of maintaining a remifentanil infusion on the recovery profiles during emergence from anaesthesia and tracheal extubation. Br J Anaesth. 2009 Dec;103(6):817-21. doi: 10.1093/bja/aep307. Epub 2009 Oct 28.
Clinical trial NCT00663494: Matrix Metalloproteinase (MMP) in Heart Failure
Official title: MMP is Produced in Failing Hearts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Stable Heart Failure
Keywords: heart failure
MMP
coronary sinus
Lead sponsor: Tottori University Hospital
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic heart failure

Brief summary: The purpose of this study is to evaluate the production of MMP in failing hearts.

Detailed description: Myocardial fibrosis is observed in failing hearts and parallel to the progression of chronic heart failure (CHF) and myocardial remodeling. Matrix metalloproteinases (MMPs) are considered markers of fibrosis. Recently, circulating MMPs can be measured and are elevated in patients with CHF. However, MMPs it is still unclear whether MMPs are produced in failing hearts. Thus, the purpose of this study is to evaluate the production of MMP in failing hearts.

Eligibility criteria: Inclusion Criteria:

* chronic stable heart failure

Primary outcomes:
measure: MMPs level of coronary sinus
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05729594: Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers
Official title: Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2023-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is being performed to compare the systemic pharmacokinetic profiles of T4032 and Lumigan 0.01% given that T4032 has a different formulation (in terms of excipients) from the reference product.


Eligibility criteria: Inclusion Criteria:

* Informed consent signed and dated
* Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study
* Participants with no ocular symptoms

Exclusion Criteria:

* History of ocular trauma, infection, or inflammation within the last 3 months
* Presence of an ocular pathology such as blepharitis, conjunctivitis, uveitis, or any other ocular infection or inflammation
* IOP \<10 mmHg or \>21 mmHg

Primary outcomes:
measure: Plasma concentrations of bimatoprost and bimatoprost free acid at each timepoint (in ng/mL)
timeFrame: at 2 timepoint : Baseline and week 2
measure: Ocular and systemic adverse events
timeFrame: up to week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Biotrial
state: New Jersey
Study officials:
References:
Clinical trial NCT05849194: Role of Early Point of Care Ultrasound in Management of Sepsis in Emergency Department
Official title: Role of Early Point of Care Ultrasound in Management of Sepsis in Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: Point of care ultrasound
Sepsis
Emergency department
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Aim of the study is to determine the diagnostic accuracy of point-of-care ultrasound and to determine its role in sepsis management .

Detailed description: Two groups of patients will be studied one group will undergo POCUS examination and the other will not undergo POCUS examination then comparison between them will be done regarding accuracy of diagnosis and time taken to reach diagnosis.

Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the Emergency Department (ED) of Alexandria Main University Hospital (AMUH) with sepsis.
* Patients presented with septic shock.

Exclusion Criteria:

* Age less than 18
* Trauma patients.
* Pregnant females.
* Patients with terminal malignancy.
* Patients taking immunosuppressive drugs or chemotherapy.

Primary outcomes:
measure: Diagnostic accuracy of POCUS approach compared with the definitive diagnosis.
timeFrame: 8 months
Secondary outcomes:
measure: Time taken to reach diagnosis in both groups
timeFrame: 8 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria main university hospital
Study officials:
References:
Clinical trial NCT06549894: Evaluation of Biomechanical Forced During the Practice of Endoscopic Submucosal Dissection
Official title: Evaluation of Biomechanical Forced During the Practice of Endoscopic Submucosal Dissection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endoscopic Submucosal Dissection
Physiology
Musculoskeletal Disorders
Keywords: Endoscopic submucosal dissection
biomechanic
physiology
Musculoskeletal Disorders
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
name: University Hospital, Lille
name: Rennes University Hospital
First posted: 2024-08-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The prevalence of musculoskeletal disorders (MSDs) among endoscopists is estimated between 29 and 89%. The most common disorders are carpal tunnel syndrome, De Quervain tenosynovitis, lateral epicondylitis and neck pain. Factors associated with MSD among gastroenterologists practicing endoscopy are: the high number of procedures (more than 20/week), the procedure time (more than 16 hours/week) and the number of years of practice.With the evolution of digestive endoscopy superficial cancer can endoscopically be removed by endoscopic submucosal dissection (ESD) avoiding surgical resections. The number of procedures is increasing, with longer examination times in case of ESD (about 2 hours). This volume of hours and procedures may in the near future further increase the risk of MSDs in the population of gastroenterologists. Some good practice recommendations have been proposed to improve practitioner comfort, similar to what is recommended for digestive surgeons. It is recommended to use a height-adjustable examination table, position the screen at eye level, and use a seat during the procedure. There is little data on the biomechanical forced experienced by an endoscopist when performing endoscopy and colonoscopy, and none when performing ESD.

The aim of this study is to evaluate the biomechanical forced experienced by the gastroenterologist during an ESD the practice of submucosal dissection.


Eligibility criteria: Inclusion Criteria:

* Adult subject (age ≥ 18 years)
* hepato-gastroenterologist
* hepato-gastroenterologist performing endoscopic submucosal dissection
* Person who has given consent for participation in the study

Exclusion Criteria:

* non hepato-gastroenterologist
* Person who has not given consent for participation in the study

Primary outcomes:
measure: variation of muscle angular during submucosal dissection
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
state: Picardie
Study officials:
References:
Clinical trial NCT02547194: Graft Patency as a Predictor of Health-related Quality of Life.
Official title: Graft Patency as a Predictor of Health-related Quality of Life in Coronary Artery Bypass Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Atherosclerosis
Keywords: coronary artery bypass grafting
saphenous vein
no-touch technique
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
First posted: 2015-09-11
Enrollment: 254
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients included in the study have been operated on at the department of Cardiothoracic and Vascular Surgery, Orebro University Hospital, Orebro, Sweden.

Brief summary: The health-related quality of life questionnaire "EQ-5D" has been collected in connection with several interventional and observational studies where the no-touch vein harvesting technique in CABG has been used. The results of the questionnaires will be compiled and reported in this study.


Eligibility criteria: Inclusion Criteria:

1. Operated at our department for a coronary artery bypass surgery with either the no-touch harvesting technique of conventional harvesting technique.
2. Completed the EQ-5D questionnaire.
3. Signed and dated consent.

Exclusion Criteria:

1. Substantial missing data from the EQ-5D questionnaire.
2. Unable to comprehend the different inquiries in the questionnaire.

Primary outcomes:
measure: The health-related quality of life.
timeFrame: 5-15 years postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital
Study officials:
affiliation: Örebro University, Sweden
name: Ninos Samano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samano N, Bodin L, Karlsson J, Geijer H, Arbeus M, Souza D. Graft patency is associated with higher health-related quality of life after coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2017 Mar 1;24(3):388-394. doi: 10.1093/icvts/ivw372.
Clinical trial NCT02034994: Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
Official title: Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: school-based intervention
after school physical activity
sugar sweetened beverages
sedentary behavior
schoolchildren
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Rio de Janeiro
First posted: 2014-01-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective is to evaluate the effects of a multicomponent, school-based intervention combining change in nutritional behaviors with after school physical activity activities in reducing the excessive weight gain in schoolchildren.

Detailed description: Specific objectives are:

- evaluate the effect of the program on: change in nutritional behaviors, such as reducing sugar sweetened beverages and cookies intake reduction of time spent in sedentary activities gains in school performance and cognition outcomes the amount of daily physical activity on the percentage of body fat, changes in biochemical markers and blood pressure.

Eligibility criteria: Inclusion Criteria:

Both prevention programs:

* 6th and 7th grades students
* consent form signed by parents / tutors

Secondary prevention program:

- overweight and obese children

Exclusion Criteria:

* pregnant girls

Primary outcomes:
measure: Body Mass Index
timeFrame: One Year
Secondary outcomes:
measure: Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean
timeFrame: One year
Other outcomes:
measure: Sedentary activities
timeFrame: One year
measure: Sugar sweetened beverages intake
timeFrame: one year
measure: cookies intake
timeFrame: one year
measure: fruits intake
timeFrame: one year
measure: physical activity
timeFrame: one year
Locations:
city: Niterói
country: Brazil
facility: Public Schools
state: Rio De Janeiro
Study officials:
References:
Clinical trial NCT05473494: THE EFFECT OF ONLINE TRAINING ON FOOT CARE
Official title: THE EFFECT OF ONLINE TRAININGS ON DIABETIC FOOT CARE ON FOOT CARE BEHAVIOR AND SELF-EFFECTIVENESS ATTITUDES OF INDIVIDUALS WITH TYPE II DIABETES
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2diabetes
Diabetic Foot
Keywords: Type2diabetes
DiabeticFootCare
OnlineEducational
DistanceEducation
Self-Effectıveness
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to determine the effect of online trainings on diabetic foot care on foot care behavior and self-efficacy attitudes of individuals with type II diabetes.

Purpose in accordance with the patient's Diagnostic Information Form, diabetic foot care self-efficacy Scale(DABOO), foot care Behavior Scale(ABDO) and diabetic foot risk screening forms are available in the data collection tools; education and Research Hospital Internal Medicine outpatient clinic with Deeply Izmit Seka state hospital, inpatient or outpatient treatment for persons with Type II diabetes who agree to volunteer to participate in research 90 shall apply. After that, the groups will be divided into two groups by randomization, and one of the groups will be given training sessions consisting of min 20 max 40 minutes for diabetic foot care in 5 sessions for nine weeks. After the training, the scales will be applied to the groups again. The data obtained before and after the training will be compared statistically in a computer environment


Eligibility criteria: Inclusion Criteria:

* Patients who were applied the Dietetic Foot Risk Screening form during the physician's examination and who were in the low and medium risk groups after the physician's examination.
* To be able to read and write.
* Being between the ages of 18-65.
* Being on oral antidiabetic (OAD) and/or insulin therapy.
* No restriction of access to the Internet.
* To be able to use the Zoom program or WhatsApp video conversation with or without support.
* Having computer and/or telephone skills.
* Volunteering to participate in the study (Informed consent form will be signed by the participants during the application)
* Not having sensory loss such as speech and hearing that prevents communication and no psychiatric problems.

Exclusion Criteria:

outside the inclusion criteria.

Primary outcomes:
measure: Diabetic Foot Care Self-Efficacy Scale
timeFrame: nine weeks
Secondary outcomes:
measure: Foot Care Behavıor Scale
timeFrame: nine weeks
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Ev
state: Izmit
Study officials:
References:
Clinical trial NCT01875094: Self-Management in Stroke Survivors
Official title: Promoting Self-Management in Stroke Survivors Using Health IT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Hypertension
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Berman Center for Outcomes and Clinical Research
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2013-06-11
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a feasibility study of using health-IT to promote self-management of risk factors in stroke survivors.


Eligibility criteria: Inclusion Criteria:

* Acute Stroke Survivors and their caregivers
* English speaking
* History of hypertension

Exclusion Criteria:

-Cannot use the health-IT system

Primary outcomes:
measure: Rate of blood pressure control into guideline recommended ranges
timeFrame: 3 months
Secondary outcomes:
measure: Medication Compliance
timeFrame: 3 months
measure: Use of online tool
timeFrame: 3 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University_of_Minnesota
state: Minnesota
Study officials:
References:
citation: Lakshminarayan K, Westberg S, Northuis C, Fuller CC, Ikramuddin F, Ezzeddine M, Scherber J, Speedie S. A mHealth-based care model for improving hypertension control in stroke survivors: Pilot RCT. Contemp Clin Trials. 2018 Jul;70:24-34. doi: 10.1016/j.cct.2018.05.005. Epub 2018 May 12.
Clinical trial NCT01906294: IMS® DIAREG Diabetes Registry - Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus
Official title: Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Lead sponsor: IMS HEALTH GmbH & Co. OHG
Sponsor class: INDUSTRY
First posted: 2013-07-24
Enrollment: 2104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Type 2 Diabetes Mellitus

Brief summary: This observation plan outlines the approach to build a diabetes registry to collect data on daily routine of treatment of Type 2 Diabetes Mellitus.

Detailed description: The choice to establish such a (general and specific) disease patient registry was based on several scientific and practical considerations as described in the AHRQ user's guide: registries for evaluating patient outcomes (www.ahrq.gov, 2007). From a public health point of view, such a register should monitor naturalistic (i.e., unbiased) use of diabetes treatment in the community and should primarily guide and assist medical professionals to make optimal choices in combating diabetes. The primary focus of this registry is therefore to monitor the medical and lifestyle treatment of diabetes in order to enable comparison of different treatment options and to provide data for future discussions of optimal treatment.

Eligibility criteria: Inclusion Criteria:

* Provision of signed written informed consent
* Age of 18 years or older
* Diagnosis of Type 2 Diabetes Mellitus (T2DM)

Exclusion Criteria:

Only patients who don't fulfill the inclusion criteria will be excluded. There will be no further possibility for the treating physician to exclude individual patients.

Primary outcomes:
measure: routine treatment data (composite of e.g. diagnostics, kind and dosage of pharmacological diabetes treatment)
timeFrame: From date of registration every 3 months until end of study (up to 120 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Praxis Dr. med. Birgit Böttger
Study officials:
affiliation: Verbund der Katholischen Kliniken Düsseldorf (VKKD) Westdeutschen Diabetes- und Gesundheitszentrum (WDGZ)
name: Stephan Martin, Prof. Dr.
role: STUDY_CHAIR
References: